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CMA's Presentation to the House of Commons Standing Committee on Health : H1N1 Preparedness and Response

https://policybase.cma.ca/en/permalink/policy9699
Date
2009-10-05
Topics
Population health/ health equity/ public health
  1 document  
Policy Type
Parliamentary submission
Date
2009-10-05
Topics
Population health/ health equity/ public health
Text
Good afternoon Madame Chair. The Canadian Medical Association is pleased to address the committee as part of its ongoing study of H1N1 planning and response. In the broad context of pandemic planning, the CMA has focused on developing information and education tools on cma.ca to ensure Canada's doctors are equipped to provide the best possible care to patients. We have also engaged in discussions with the Assembly of First Nations to address workforce shortages in First Nations and Inuit communities during a pandemic. Despite the work of governments and others, there remains much to do. To provide optimal patient care, individual physicians - primary care providers and specialists alike - require: * Regular updates on the status of H1N1 in their community; * Timely and easy access to diagnostic and treatment recommendations with clear messages tailored to their service level; * Rapid responses to questions; and * Adequate supplies of key resources such as masks, medications, diagnostic kits and vaccines. The CMA commends federal, provincial and territorial governments for creating the Canadian Pandemic Influenza Plan for the Health Care Sector. The CMA was pleased to provide feedback on elements of the plan and we are participating on the anti-viral and clinical care task groups. There are three issues that still must be addressed: First, the communications gap between public health officials and front-line providers; Second, the lack of adequate resources on the front lines; and finally, variability that exists across the country. The Communications Gap Physicians must be involved in the planning stages and must receive consistent, timely and practical plain-language information. They should not have to seek information out from various websites or other sources, or through the media. This communications gap also includes a gap between information and action. For example, we are told to keep at least a six-foot distance between an infected patient and other patients and staff. This will not be possible in a doctor's waiting room, nor will disinfecting examining and waiting rooms in-between each patient. Adequate resources Patient volumes may increase dramatically and there are serious concerns about how to manage supplies if an office is overwhelmed. There is also considerable concern over whether we can keep enough health care professionals healthy to care for patients, and whether we have enough respirators and specialty equipment to treat patients. Intensive-care units of hospitals can also expect to be severely strained as a second-wave pandemic hits. This speaks to a general lack of surge capacity within the system. Also, pandemic planning for ICUs and other hospital units must include protocols to determine which patients can benefit most when there are not enough respirators and personnel to provide the required care for all who need it. Beyond the need for more supplies, however, there is also the concern that there are only so many hours in a day. Doctors will always strive to provide care for those who need it, but if treating H1N1 cases takes all of our time, who will be available to care for patients with other conditions? Variability across the country CMA has consulted with provincial and territorial medical associations and their level of involvement in government planning as well as the general state of preparedness varies greatly. There is also marked inconsistency province-to-province around immunization schedules. We need a clear statement of recommendation to clear up this variability. In summary, there remains a great deal of uncertainty among physicians about: the vaccine, the supply of antivirals, the role of assessment centres and mass immunization clinics, delegated acts, and physicians' medico-legal obligations and protections. The bottom line is that there is still more work to do at all levels before front-line clinicians feel well prepared with information, tools and strategies they need. The CMA was pleased to meet with Dr. Butler-Jones to discuss our concerns last week and will continue to work closely with Public Health Agency of Canada to identify gaps and to prepare user-friendly information for clinicians. Thank you and I welcome any questions.
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Answering the Wake-up Call: CMA’s Public Health Action Plan : CMA submission to the National Advisory Committee on SARS and Public Health

https://policybase.cma.ca/en/permalink/policy1960
Last Reviewed
2010-02-27
Date
2003-06-25
Topics
Health systems, system funding and performance
Health care and patient safety
Population health/ health equity/ public health
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2010-02-27
Date
2003-06-25
Topics
Health systems, system funding and performance
Health care and patient safety
Population health/ health equity/ public health
Text
The public health system in Canada lies at the heart of our community values. It is the quintessential “public good” and is central to the continued good health of our population. When the public health system is working well, few are even aware that it is at work! Only when something goes terribly wrong — like the Walkerton tragedy or when we are faced with a new threat like SARS — is the integral, ongoing role of public health really recognized. The Canadian Medical Association (CMA) has been warning that our public health system is stretched to capacity in dealing with everyday demands, let alone responding to the latest crises. Canada’s physicians have repeatedly called for governments to enhance public health capacity and strengthen the public health infrastructure throughout Canada. Our public health system is the first — and often the only — line of defence against emerging and ongoing infectious and noninfectious threats to the health of Canadians. But we are only as strong as the weakest link in the emergency response chain of survival. As most health threats know no boundaries, our public health armaments must be in a constant state of “battle readiness.” In today’s climate of SARS, West Nile Virus, mad cow disease and monkey pox, even the thought that the public health system may be stretched beyond capacity strikes fear into the hearts of Canadians. Physicians have always been an integral part of the public health system serving as medical officers of health, community health specialists and other related roles. Indeed public health cannot successfully fulfill its mandate without the cooperation and commitment of front-line clinicians. In this submission, we reflect on the lessons to be learned from our recent experience with SARS and reflect on the longer-term needs of the public health system as a whole. The objectives of the pan-Canadian Public Health Action Plan proposed by the CMA are, first to realize a clearer alignment of authority and accountability in times of extraordinary health emergencies; and, second, to enhance the system’s capacity to respond to public health threats across the country (see recommendations, below, and Appendix 1). To achieve these twin objectives, three broad strategies are presented for immediate attention. They are legislative reform; capacity enhancement; and research, surveillance and communications. Legislative reform (see recommendations 1–3) The country’s response to SARS has brought into stark relief the urgent need for national leadership and coordination of public health activity across the country, especially during a health crisis. The apparent reluctance to act quickly to institute screening at airports, the delay in unifying the practice community for a concerted response and the appalling communications confusion worked against optimum handling of the outbreak — despite the best efforts of health care professionals. This is a wake-up call that highlights the need for comprehensive legislative reform to clarify the roles of governments with respect to the management of public health threats. A renewed and enhanced national commitment to public health should be anchored in new federal legislation to be negotiated with the provinces and territories. Specifically, the CMA recommends an Emergency Health Measures Act, to deal with emergent situations in tandem with the creation of a Canadian public health agency headed by a Chief Public Health Officer of Canada. Capacity enhancement (see recommendations 4–7) The SARS crisis has demonstrated the diminished capacity within the public health system. The Greater Toronto Area (GTA), with one of Canada’s most sophisticated public and acute health systems, has not been able to manage the SARS crisis adequately and carry on other health programs. The acute care system virtually ground to a halt in dealing with SARS. There was little or no surge capacity in Canada’s largest city. We should be grateful that SARS did not first strike a smaller centre in a far less-advantaged region of Canada. A critical element of the public health system is its workforce and the health professionals within the acute care system, such as hospital-based infectious disease specialists and emergency physicians who are the front-line interface. Let there be no doubt that the ongoing efforts of the GTA front-line providers are nothing short of heroic. However, the lack of coordinated contingency planning of hospital and community-based disease control efforts was striking. The overall shortage of critical care professionals and the inability of governments to quickly deploy the required professionals to areas of need contributed to the enormous strain on the public and health care system. Considering the importance of the public health system and its clearly limited capacity to protect and promote the health of Canadians, it is incomprehensible that we do not know how much is actually spent on the system. It is imperative that public health expenditures and capacity, in terms of both physical and human resources, be tracked and reported publicly. The CMA recommends a $1-billion, 5-year capacity-enhancement program to be coordinated with and through the new Canadian public health agency. Research, surveillance and communications (see recommendations 8–10) Canada’s ability to respond to public health threats and acute events, such as SARS, and to maintain its effective public health planning and program development depends on sound research, surveillance and rapid, real-time communications. A concerted pan-Canadian effort is required to take full advantage of our capacity for interdisciplinary research on public health, including infectious disease prevention and control measures. New-millennium challenges require moving beyond old-millennium responses. Enhanced surveillance is an overdue and integral part of public health, performing an essential function in early detection and response to threats of infectious diseases. Mandatory national reporting of identified diseases by all provinces and territories is critical for national and international surveillance. During times of crisis, rapid communication to the public, public health staff and front-line clinicians is of critical importance, but in many jurisdictions impossible. We tested our systems during the SARS outbreak and they came up short. The CMA recommends a one-time federal investment to enhance technical capacity to allow for real-time communication. Conclusion The CMA believes that its proposed three-pronged strategy, as set out in the attached recommendations, will go a long way toward addressing shortfalls of the Canadian public health system. Action now will help to ensure that Canadians can once again be confident that they are protected from any future threat of new infectious diseases. Action now will help Canada regain its position as a leader in public health. We wish the advisory committee well in its deliberations and offer the CMA’s assistance at any time in clarifying the strategies set out in our submission. Recommendations to the National Advisory Committee on SARS and Public Health Legislative reform ($20 million / 5 years*) 1. The enactment of a Canada Emergency Health Measures Act that would consolidate and enhance existing legislation, allowing for a more rapid national response, in cooperation with the provinces and territories, based on a graduated, systematic approach, to health emergencies that pose an acute and imminent threat to human health and safety across Canada. 2. The creation of a Canadian Office for Disease Surveillance and Control (CODSC) as the lead Canadian agency in public health, operating at arm’s length from government. 3. The appointment of a Chief Public Health Officer of Canada to act as the lead scientific voice for public health in Canada; to head the Canadian Office for Disease Surveillance and Control; and to work with provinces and territories to develop and implement a pan-Canadian public health action plan. Capacity enhancement ( $1.2 billion / 5 years*) 4. The creation of a Canadian Centre of Excellence for Public Health, under the auspices of the CODSC, to invest in multidisciplinary training programs in public health, establish and disseminate best practices among public health professionals. 5. The establishment of a Canadian Public Health Emergency Response Service, under the auspices of the CODSC, to provide for the rapid deployment of human resources (e.g., emergency pan-Canadian locum programs) during health emergencies. 6. Tracking and public reporting of public health expenditures and capacity (both physical and human resources) by the Canadian Institute for Health Information and Statistics Canada, on behalf of the proposed Canadian Office for Disease Surveillance and Control. 7. Federal government funding in the amount of $1 Billion over 5 years to build adequate and consistent surge capacity across Canada and improve coordination among federal, provincial/territorial and municipal authorities to fulfill essential public health functions. Research, surveillance and communications ($310 million / 5 years*) 8. An immediate, sequestered grant of $200 million over 5 years to the Canadian Institutes of Health Research to initiate an enhanced conjoint program of research with the Institute of Population and Public Health and the Institute of Infection and Immunity that will expand capacity for interdisciplinary research on public health, including infectious disease prevention and control measures. 9. The mandatory reporting by provinces and territories of identified infectious diseases to the newly established Chief Public Health Officer of Canada to enable appropriate communications, analyses and intervention. 10. The one-time infusion of $100 million, with an additional $2 million a year, for a “REAL” (rapid, effective, accessible and linked) Health Communication and Coordination Initiative to improve technical capacity to communicate with front line public health providers in real time during health emergencies. *See Appendix 2: Estimated cost of implementing recommendations. PURPOSE The CMA prepared this submission in response to an invitation from Dr. Naylor to provide input to the National Advisory Committee on SARS and Public Health. We applaud this initiative and welcome the opportunity to present the views of Canada’s medical community to the committee. The CMA’s basic message is that our health protection laws are woefully outdated and the public health system is stretched beyond capacity. This submission draws on our long history of engagement in public health in Canada and our experience both post-September 11, 2001 and with SARS. It builds on the knowledge and experience of our members, national specialist affiliated societies and provincial and territorial divisions. (We acknowledge, in particular, the outstanding efforts of the Ontario Medical Association and the Canadian Association of Emergency Physicians in battling SARS.) In this submission, we examine the lessons to be learned from our experience with the SARS outbreak and reflect on both the immediate and longer-term needs of the public health system as a whole. The objectives of the public health action plan proposed by the CMA are, first, to realize a clearer alignment of authority and accountability in times of extraordinary health emergencies and, second, to enhance the system’s capacity to respond to public health threats across the country, including those posed by preventable chronic disease. INTRODUCTION The public health system in Canada lies at the heart of our community values. It is the quintessential “public good” and is central to the continued good health of the population. When the public health system is working well, few are even aware that it is at work! Only when something goes terribly wrong — like the contamination of the blood supply in the 1980s, the Walkerton tragedy or SARS — is the integral, ongoing role of public health recognized. Our public health system is the first — and often the only — line of defence against emerging and ongoing infectious and noninfectious threats to the health of Canadians. But we are only as strong as the weakest link in the emergency response chain of survival. As most health threats know no boundaries, our public health system must be in a constant state of “battle readiness.” We can ill afford any weakness in our public health preparedness. In today’s climate of SARS, West Nile Virus, mad cow disease and monkey pox, the mere thought that the public health system may be stretched beyond capacity strikes fear into the hearts of Canadians. Physicians have always been an integral part of the public health system serving as medical officers of health, specialists in infectious disease and community medicine (who will not remember the stalwart efforts of Dr. Donald Low on SARS?) and in other related roles. Indeed, public health cannot successfully fulfill its mandate without the cooperation and commitment of front-line clinicians. The CMA has been warning for some time that our system is stretched to capacity in dealing with everyday demands, let alone responding to crises. Canada’s physicians have repeatedly called for governments to enhance public health capacity and strengthen the public health infrastructure throughout Canada. For example, the CMA’s submission to the House of Commons Standing Committee on Finance’s prebudget consultations on October 22, 2001 called for substantial investments in public health and emergency response as a first step to improve the public health system infrastructure and its surge capacity. This submission not only reiterates our previous recommendations, but also outlines specific actions that the CMA believes must be taken to ensure a strong public health system in Canada. The Enduring Impact of Severe Acute Respiratory Syndrome SARS (Severe Acute Respiratory Syndrome): in February 2003, these four letters sent massive shock waves around the world, causing widespread fear and confusion among health care officials and citizens of many countries. The “fear factor” extended across Canada as people realized the full threat of SARS. Since SARS was first identified in a patient in Toronto in March 2003, 438 probable or suspected cases have been reported to Health Canada and 38 people have died (as of June 23, 2003). However, these numbers do not reflect the full impact of the outbreak. The number of indirect deaths due to system shutdown will never be known. Local public health authorities across the country went on high alert. Those in the Greater Toronto Area (GTA) as well as their provincial counterparts diverted almost all of their resources to respond to the crisis. Acute care services were adversely affected as stringent infection-control and screening measures were put into place to control the spread of SARS. In the GTA, the health system — acute and public — was brought to its knees. Over half of the reported SARS cases involved front-line providers as the outbreak largely affected health care settings. Approximately 20 physicians in Ontario contracted SARS and close to 1000 were quarantined. Thousands of nurses and other health care workers also faced quarantine, some more than once. Institutions closed their doors, limiting access to emergency departments, clinics and physicians’ offices. Intensive care units were full and surgeries were cancelled. Front-line health care professionals involved in critical care were stretched to their physical and mental limits. Others found themselves underutilized due to the impact of the infection-control measures on their practice settings. Feast and famine co-existed. Although the outbreak was mainly confined to health care settings, the entire GTA felt the effects. Upwards of 20,000 people entered voluntary quarantine. Businesses were affected. The tourism industry is still reeling. The disruption that SARS caused continues to reverberate through health care systems and economies. In response to urgent requests from both the Ontario Medical Association and Health Canada, the CMA mobilized its membership and assisted in the country’s response to SARS. Everything that could be done was done to facilitate bringing in qualified personnel to relieve those on the front line and make appropriate information available in real time. The CMA has learned its own lessons, both positive and negative. A full chronology of CMA activity is attached as Appendix 3. It has become abundantly clear that Canada’s public health system was ill prepared to deal with the SARS outbreak. If not for the heroic efforts of public health officials, health care providers and research scientists, Canada’s experience would have been much worse. Public health in Canada Public health is the science and art of protecting and promoting health, preventing disease and injury, and prolonging life. It complements the health care system, which focuses primarily on treatment and rehabilitation, sharing the same goal of maximizing the health of Canadians. However, the public health system is distinct from other parts of the health system in two key respects: its primary emphasis is on preventing disease and disability and its focus is on the health needs of populations rather than those of specific individuals. Public health is the systematic response to infectious diseases. It also ensures access to clean drinking water, good sanitation and the control of pests and other disease vectors. Further, it is immunization clinics and programs promoting healthy lifestyles. But it is also there to protect Canadians when they face a public health crisis like SARS. If the public health system is fully prepared to carry out essential services, then communities across the country will be better protected from acute health events. The reality in Canada today is that a strong, consistently and equitably resourced and integrated public health system does not exist. Public health systems across Canada are fragmented — a patchwork of programs, services and resources across the county. In reality, it is a group of multiple systems with varying roles, strengths and linkages. Each province has its own public health legislation. Most legislation focuses on the control of communicable diseases. Public health services are funded through a variable mix of provincial and municipal funding formulae, with inconsistent overall strategies and results, and with virtually no meaningful role for input from health professionals via organizations such as the CMA, or the federal level, in terms of strategic direction or resources. Federal legislation is limited to the blunt instrument of the Quarantine Act and a variety of health protection-related acts. (e.g., Food and Drugs Act, Hazardous Products Act, Controlled Drugs and Substances Act, Radiation Emitting Devices Act) Some of the laws, such as the Quarantine Act, date back to the late 19th century. Taken as a whole, the legislation does not clearly identify the public health mandate, roles and responsibilities of the different levels of government. In many cases, the assignment of authorities and accountabilities is anachronistic. Moreover, there is little information available on the functioning and financing of Canada’s public health system. There is no “one-stop shopping” for authoritative information on public health issues. In 2001, a working group of the Federal, Provincial and Territorial Advisory Committee on Population Health assessed the capacity of the public health system through a series of key informant interviews and literature reviews. The consistent finding was that public health had experienced a loss of resources and there was concern for the resiliency of the system infrastructure to respond consistently and proactively to the demands placed on it. Significant disparities were observed between “have” and “have-not” provinces and regions in their capacity to address public health issues. The report’s findings are consistent with previous assessments by the Krever Commission and the Auditor General of Canada. In 1999, the Auditor General said that Health Canada was unprepared to fulfill its responsibilities in public health; communication between multiple agencies was poor; and weaknesses in the key surveillance system impeded the effective monitoring of injuries and communicable and non-communicable diseases. In 1997, Justice Horace Krever reported that the “public health departments in many parts of Canada do not have sufficient resources to carry out their duties.” The Challenges Ahead The 21st century brings with it an awesome array of new public health risks and ancient foes. Not all of them can be identified at the present time. New diseases (e.g., SARS, West Nile Virus) will likely continue to emerge. Dr. Alan Bernstein, President of the Canadian Institutes of Health Research, recently noted that SARS is here to stay. Old threats, such as contamination of a community water supply (e.g., Walkerton), can strike quickly if vigilance is relaxed or delegated to third parties. This century will likely bring greater focus on threats from the physical environment. Our social environment is also a source of illness as shown by the recent epidemic trends in obesity and type 2 diabetes mellitus. A substantial minority of Canadians continue to smoke. In short, there is no lack of public health threats to Canadians. Although for each of these issues, there is a clear role for clinical care, it is the public health system that will identify and monitor health threats and provide interventions to prevent disease and injury and improve health. The system will also be at the front lines in any response to a biological, chemical or nuclear event. The public health system must have the infrastructure to respond to a range of threats to health, including emergencies. The experience with SARS has reaffirmed that we do not have the system flexibility to respond to these events after they have occurred. It is vital that we take steps now “to embrace not just the essential elements of disease protection and surveillance but also new strategies and tactics capable of addressing global challenges.”<1> CMA’S PROPOSED PUBLIC HEALTH ACTION PLAN No one policy instrument can possibly address the multiple factors involved in meeting the public health challenge head on. Similarly, no one level of government or constituency (e.g., community medicine) can or should shoulder all of the responsibilities. Although we need to restore public confidence quickly, we must also do what it takes to get it right. Accordingly, the CMA is proffering a three-pronged approach to meet the challenge: * A legislative reform strategy * A capacity enhancement strategy * A research, surveillance and communication strategy. These three broad strategies make up the CMA’s proposed 10-point Public Health Action Plan. Taken together, the CMA believes the Plan, if adopted, will serve us very well in the future. Legislative Reform Our experience with SARS — and the seeming lack of coordination between international, federal, provincial and local system levels — should be a massive wake-up call. It highlights the need for legislative reform to clarify the roles of governments with respect to the management of public health issues and threats. Four years ago, national consultations on renewing federal health protection legislation<2> resulted in a recommendation that * “The federal government must be given, either through legislation or through memoranda of understanding among provincial and territorial governments, the authority it needs to effectively address any outbreak of a communicable disease, where the health risk extends beyond provincial borders. * “Federal health protection legislation should be amended to give Health Canada authority to act quickly and decisively in the event of a national health emergency... if it poses a serious threat to public health; affects particularly vulnerable segments of the population; exceeds the capacity of local authorities to deal with the risk; and involves pathogens that could be rapidly transmitted across national and international borders.” Such legislative reform is consistent with the federal government’s well-recognized responsibility to act to protect public health and safety. It fits well with Health Minister McLellan’s recently announced plans to act now to review and update health protection legislation. The SARS outbreak has provided further experience to support these, and in our view, even stronger recommendations. There is ample historical evidence to support the federal government’s role in the management of communicable disease, a role that dates back to the time of confederation. The quarantine power was the initial manifestation of this authority in 1867 under Section 91 of the British North America Act and it gave the federal government the responsibility for ensuring the containment of infectious diseases. The outbreak of the Spanish Flu epidemic in 1918 further highlighted the need for coordinated national efforts and (at the urging of the CMA and others) resulted in the creation of the federal Department of Health in 1919. It would be reasonable to assume that legislators at the time had an expansive view of the need for centralized authority to deal with pan-Canadian health threats. One hundred and thirty-five years after confederation, we have a highly mobile global community. This mobility and the attendant devastating speed with which diseases can spread demand a national response. Currently, there is tremendous variation in public health system capacity among the various provinces and territories and, more particularly, among municipalities and local authorities. Inconsistencies in provincial approaches to public health matters have resulted in significant disparities between and within the provinces.<3> Health Canada’s mandate as set out in its enabling legislation states that “[t]he powers, duties and functions of the Minister extend to and include all matters over which Parliament has jurisdiction relating to the promotion and preservation of the health of the people of Canada.” The CMA believes that it is time for the federal government to take responsibility for public health matters that touch the lives of all Canadians. The legal staffs at CMA, in consultation with external experts, have conducted a detailed review of existing legislation. We have concluded, as Health Minister McLellan recently announced, that there is a long overdue need to consolidate and rationalize current related laws. We also believe there is now public support and a demonstrable need to enhance the powers afforded the federal government. We recognize that the government has put forward Bill C-17, the Public Safety Act and a review of health protection legislation is underway. We believe that amending and updating existing legislation is necessary but not sufficient to address today’s public health challenges. The CMA is calling for the enhancement of the federal government’s “command and control” powers in times of national health emergencies. Specifically we are recommending a three-pronged legislative approach. 1. The CMA recommends The enactment of a Canada Emergency Health Measures Act that would consolidate and enhance existing legislation, allowing for a more rapid national response, in cooperation with the provinces and territories, based on a graduated, systematic approach, to health emergencies that pose an acute and imminent threat to human health and safety across Canada. The existing Emergencies Act gives the federal government the authority to become involved in public welfare emergencies when regions of the country are faced with “an emergency that is caused by a real or imminent... disease in human beings... that results or may result in a danger to life or property... so serious as to be a national emergency.” However, to use this power, the federal government must declare a “national emergency,” which itself has political and economic ramifications, particularly from an international perspective, and mitigates against its use. The CMA believes that this all-or-nothing approach is not in the public’s best interest. The concept of emergency in the context of public health requires a different response from governments in the future. Although we recognize that provincial and municipal governments currently have preplanned sets of responses to health threats, the CMA is proposing new legislation to allow for a rapid federal response to public health emergencies. The proposed Emergency Health Measures Act clarifies the roles and authority of governments and ensures a consistent and appropriate response with sufficient human and financial resources to protect Canadians faced with a public health emergency. Of utmost importance, all Canadians, regardless of their location, can be assured that the response to a health emergency will be delivered systematically by experts who can sustain the effort as needed. The proposed legislation would be founded on a graduated approach that would give the federal government the powers necessary to deal with a crisis, in an appropriately measured way, as it escalates. As the emergency grows, the government could implement stronger measures as required to meet the challenge — in principle, akin to the Unites States’ homeland security levels, which increase as the level of threat increases (see Appendix 4 for a description of the Canadian Emergency Health Alert System). The CMA strongly believes that the federal government must have jurisdiction to act when the ability of the provinces to respond to public health emergencies is so disparate. The inability of one province to stop the spread of virulent disease would have serious implications for the health of residents in the rest of the country. The federal government and the provinces must work together to ensure the safety of all our citizens. 2. The CMA recommends The creation of a Canadian Office for Disease Surveillance and Control (CODSC) as the lead Canadian agency in public health, operating at arm’s length from government. Although some provinces have established centres of public health expertise, considering the breadth of public health issues, the relative population sizes and differences in wealth, it will never be feasible to have comprehensive centres of public health expertise for each province and territory. Even if one achieved this, there would increasingly be issues of economies of scale and unnecessary duplication among centres. This issue is not unique to Canada.1 The CMA is proposing the development of a Canadian Office for Disease Surveillance and Control (CODSC) operating at arm’s length from any level of government. CODSC would have overall responsibility for protecting the health of Canadians. The Office would provide credible information to enhance health decisions and promote health by developing and applying disease prevention and control, environmental health and health promotion and education activities. CODSC would enable a consistent and coordinated approach to public health emergencies as well as play a key role in the prevention and control of chronic diseases and injuries. It would provide national health surveillance, apolitical scientific expertise, system development including standards and guideline development, development and dissemination of an evidence base for public health interventions, skills training and transfer of expertise (i.e., through secondment of staff) and resources, including funding for core programs, to other levels of the system (e.g., provincial and local). 3. The CMA recommends The appointment of a Chief Public Health Officer of Canada to act as the lead scientific voice for public health in Canada; to head the Canadian Office for Disease Surveillance and Control; and to work with provinces and territories to develop and implement a pan-Canadian public health action plan. Many national or federal–provincial–territorial committees play an important role in recommending public health strategies or actions. The National Advisory Committee on Immunization and the Federal, Provincial and Territorial Advisory Committee on Population Health are two excellent examples. But there is currently no single credible public health authority in whom is vested, through legislation or federal–provincial–territorial agreement, the overall responsibility for pan-Canadian public health issues. Therefore, the CMA is recommending the appointment of a Chief Public Health Officer of Canada. Potential roles for this officer may include: * Serve as the head of the Canadian Office for Disease Surveillance and Control * Serve as the national spokesperson for public health with the independence to comment on critical public health issues * Report annually on the health of the population * Develop, implement and report independently to parliament on public health system performance measures * Lead processes to identify and address gaps in the nation’s public health system. Capacity enhancement The public health system infrastructure is the foundation that supports the planning, delivery and evaluation of public health activities. In March 2001, the Federal, Provincial and Territorial Advisory Committee on Public Health<3> reported, In the view of respondents the system ‘is lacking in depth.’ This means that a sustained crisis would seriously compromise other programming. While the research does not indicate that the public health system in Canada is strained beyond capacity, there does appear to be agreement that there is a capacity to manage just one crisis at a time. However, just 2 years later, the GTA, an area with one of Canada’s most sophisticated public and acute care health systems, was not able to manage the SARS crisis and carry on any other programs. The Ontario government recognized this state of affairs when, on 12 June, Ontario’s Health Minister Tony Clement said, “I was concerned that if we had one additional large-scale crisis, that the system would crash.” Important public health issues ranging from immunization to suicide prevention went virtually unaddressed, as the public health capacity in Toronto was overwhelmed. In the absence of a mechanism to share resources within the system and a general lack of overall system surge capacity, the city of Toronto and the province competed with each other to recruit trained staff from other health departments. The SARS outbreak has shown there is no surge capacity in Canada’s largest city. The acute care system in Toronto virtually ground to a halt in dealing with SARS. We must ask ourselves what would have happened if SARS had struck first in a smaller centre in a far less-advantaged region of Canada. Clearly Canada is not fully prepared. We should not have needed a crisis to tell us this. The CMA sees several components to rebuilding the capacity of the public health system. Public health human resources For the essential functions of the public health system to be realized, public health agencies need a workforce with appropriate and constantly updated skills. Canada’s public health workforce is extremely thin. There appear to be too few graduate-level public health professionals (i.e., those holding a master’s degree and physicians who are certified specialists in community medicine); those who do exist are not distributed equitably across jurisdictions. The scarcity of hospital-based infection control practitioners and emergency physicians within the acute care system and the lack of integration of hospital and community-based disease control efforts have been particularly striking during the SARS outbreak. The knowledge and skills required for effective public health practice are not static. They continually evolve as new evidence is identified. However, continuing education programming for public health practitioners is woefully underdeveloped in Canada. Health Canada has made some limited progress in this area, but the issue needs to be addressed much more substantively. 4. The CMA recommends The creation of a Canadian Centre of Excellence for Public Health, under the auspices of the CODSC, to invest in multidisciplinary training programs in public health, establish and disseminate best practices among public health professionals. Canada has world-class expertise in public health. However, it does not have the depth of other countries, partly because we do not have a national multidisciplinary school of public health of the calibre of Harvard in Boston, Johns Hopkins in Baltimore and the School of Hygiene and Tropical Medicine in London. A national school of public health, which might be based on a virtual network of centres nationwide, could * Develop a plan to assess and address the substantial educational needs of new and existing public health staff * Address the coordination of the various academic training programs to meet the needs of the field * Ensure self-sufficiency of our public health workforce. 5. The CMA recommends The establishment of a Canadian Public Health Emergency Response Service, under the auspices of the CODSC, to provide for the rapid deployment of human resources (e.g., emergency pan-Canadian locum programs) during health emergencies. The SARS outbreak clearly demonstrated the need for a pre-planned approach to supporting and augmenting the public health and acute care workforce during a crisis. When health professionals in the GTA were overwhelmed, we were ill prepared to move health professionals in from other jurisdictions to help. Health professional associations like the CMA took the first steps in investigating and overcoming obstacles regarding licensure and insurance. We were taken aback when we found that the Ontario government had unilaterally awarded an exclusive contract to a for-profit company to arrange for emergency relief. The further delay caused by concerns about privacy, confidentiality and harmonizing fees hampered relief efforts. The deployment of health professionals during health emergencies is too important to be left in the hands of for-profit organizations as it was during the SARS experience. An established Canadian Public Health Emergency Response Service, operating on a non-profit basis, would * Maintain a “reserve” of public health professionals who are fully trained and could be deployed to areas of need during times of crisis * Co-ordinate the logistics of issues such as portable licensing, malpractice and disability insurance * Identify funding for staff training and a more equitable distribution of numbers and skills among jurisdictions. Investment in public health Considering the importance of the public health system and its capacity to protect and promote the health of Canadians, it is amazing that we have no reliable or comprehensive information about how much money is actually spent on the system or what public health human resources are available across Canada. This is partially due to the lack of uniform definitions, service delivery mechanisms and accounting practices. Even in the absence of reliable data on public health expenditures, there is ample evidence that the public health system continues to operate under serious resource constraints across Canada. 6. The CMA recommends Tracking and public reporting of public health expenditures and capacity (both physical and human resources) by the Canadian Institute for Health Information and Statistics Canada, on behalf of the Canadian Office for Disease Surveillance and Control. In its latest report on health system expenditures, the CIHI states that 6% of total expenditures in 2000 were spent on “public health and administration.”<4> The inclusion of administrative costs in this figure means that public health funding is substantially less than 6% of health system expenditures.2 Federal Government Estimates report that Health Canada allocated $433 million in 2003–2004 for health promotion and prevention activities with spending scheduled to decrease to $308 million by 2005–2006 or by almost 30%. This decrease in spending exemplifies a decade that has seen tremendous fluctuations in spending on public health activities. The situation is alarming when looked at from a current-dollar basis; there was an 8.8% decrease in funding of public health activities between 1994–1995 and 1997–1998. In fact, federal spending on public health on a constant dollar basis did not regain its 1994–1995 level until 2000–2001. Although the late 1990s saw some reinvestment in public health initiatives, the most recent 2003–2004 estimates suggest that, once again, federal investment in public health will decrease dramatically over the next few years. Indeed, public health continues to represent only a small fraction of total federal direct spending on health (9.7% in 2002–2003). At the provincial level, although we cannot distance public health from administration, we know that it fell victim to the brutal climate of fiscal retrenchment of the 1990s, when in real terms provincial–territorial per capita health spending declined for 5 consecutive years after 1991–1992. During this period, public health was further destabilized by regionalization. According to the Survey of Public Health Capacity in Canada most provincial and territorial officials reported reductions in programming as a result of the transfer of funding and responsibility to regional structures. Although Ontario did not regionalize, in 1997 public health funding was downloaded to municipalities, which left public health departments scrambling to find funds to meet existing programs as well as new services that were mandated by the provincial Health Protection and Promotion Act. Whether talking about federal or provincial–territorial jurisdictions, we can no longer afford to have funding for health and safety subject to the vagaries of financial cycles. However, what perhaps is most alarming is the potentially large economic impact of underinvestment in this area. Although the net cost of the SARS outbreak in Ontario is not yet known, recent estimates suggest that it could be as high as $2.1 billion.3 Given this, the proverbial ounce of prevention that is worth a pound of cure comes to mind suggesting that a relatively modest increase in funding for public health could potentially result in substantial savings in the longer term. 7. The CMA recommends Federal government funding in the amount of $1 billion over 5 years to build adequate and consistent surge capacity across Canada and improve coordination among federal, provincial/territorial and municipal authorities to fulfill essential public health functions. The best way to ensure that the public health system is capable of addressing the range of public health threats, including emergencies, is to significantly increase investment in its capacity. This investment must assist all levels of the system to fulfill essential public health functions, with particular attention to local and regional agencies. The strategic national leadership that we are calling for includes the development of new mechanisms for federal cost sharing of basic public health services and the guarantee of a basic core set of local programs serving everyone in Canada, regardless of where they live. The system also needs to receive targeted funds so that it can do its work smarter and more effectively. Priority areas for this targeted funding should include development of an integrated information system and staff training. Research, surveillance and communications Canada’s ability to respond to emerging public health threats and acute events, such as the SARS outbreak, and to maintain its effective public health planning and program development depends on sound research, surveillance and rapid, real-time communications. 8. The CMA recommends An immediate sequestered grant of $200 million over 5 years to the Canadian Institutes of Health Research to initiate an enhanced conjoint program of research with the Institute of Population and Public Health and the Institute of Infection and Immunity that will expand capacity for interdisciplinary research on public health, including infectious disease prevention and control measures. Similar to the efforts in clinical care to support the use of evidence-based practices, interventions in public health must be based on research, evidence and best practices. A national effort should be undertaken to develop and make widely available, on an ongoing basis, a comprehensive and up-to-date review of the evidence base for public health programs. This information would support effective practice, enhance public health research capacity and support other infrastructure elements (e.g., minimum programs and services, performance measurement, system funding). It could also reduce unnecessary duplication of efforts by different public health agencies. We applaud the tremendous work of the unique trans-Canada partnership of 4 CIHR-funded research teams who, in just 11 weeks, discovered the complete DNA sequence of the coronavirus associated with SARS. This is a perfect example of what can be accomplished when our talented research teams work together. The recent announcement by the CIHR of an integrated national strategy for research on SARS reflects the intent of this recommendation for other public health challenges. 9. The CMA recommends The mandatory reporting by provinces and territories of identified infectious diseases to the newly established Chief Public Health Officer of Canada to enable appropriate communications, analyses and interventions. Public health surveillance is defined as the ongoing, systematic collection, analysis and interpretation of health data necessary for designing implementing and evaluating public health programs. It is an integral part of the public health system and performs an essential function in early detection and response to threats to human health. Current surveillance systems for communicable and noncommunicable diseases are inadequate to allow public health professionals to detect and react to major health issues. For effective public health management, surveillance must be a continuous process covering a range of integrated data sources to provide useful and timely information. 10. The CMA recommends The one-time infusion of $100 million, with an additional $2 million a year, for a “REAL” (rapid, effective, accessible and linked) Health Communication and Coordination Initiative to improve technical capacity to communicate with front line public health providers in real time during health emergencies. In today’s world, international travel, business and migration can move infectious diseases around the world at jet speed. But during the SARS experience, governments and public health authorities were unable to communicate in real time with health professionals on the front lines. Gaps in the basic communication infrastructure prevent public health agencies from talking with each other in real time, and also hinder exchanges between public health staff, private clinicians and other sources of information about emerging new diseases. In response to requests from both the Ontario Medical Association and Health Canada, the CMA mobilized its communication networks to provide physicians with critical information about public health management of SARS. In less than 48 hours, via email and fax, we reached over 45,000 physicians with authoritative information. Through the good offices of the Canadian Council of Health Services Accreditation, this information was also made available to over 1500 accredited health facilities across Canada. Although necessity caused the limits of the system to be tested, SARS highlighted the fact that we do not have information systems in place to facilitate real-time communication with health professionals. Information is the key to effective response during times of emergency. Information in real time is also essential for effective day-to-day health care to provide, for example, information on adverse drug reactions. CONCLUSION SARS brought out the best in Canada and Canadians’ commitment to one another. It also turned a bright, sometimes uncomfortable spotlight on the ability of this country’s health care system to respond to a crisis, be it an emerging disease, a terrorist attack, a natural disaster or a large-scale accident. We must learn from the SARS experience and quickly move to rebuild the infrastructure of a strong public health system. The CMA believes that this 10-point Public Health Action Plan will go a long way toward addressing shortfalls in the Canadian public health system. Action now will help to ensure that Canadians can be confident once again that their governments are doing all they can to protect them from the threat of new infectious diseases. We wish the advisory committee well in its deliberations and offer the CMA’s assistance at any time in clarifying the strategies set out in our submission. APPENDIX 1: THE CMA’S PUBLIC HEALTH ACTION PLAN [TABLE CONTENT DOES NOT DISPLAY PROPERLY. SEE PDF FOR PROPER DISPLAY] [TABLE END] APPENDIX 2: ESTIMATED COST OF IMPLEMENTING THE RECOMMENDATIONS [TABLE CONTENT DOES NOT DISPLAY PROPERLY. SEE PDF FOR PROPER DISPLAY] Recommendation Estimated cost over 5 years Legislative and institutional reform 1. Canada Emergency Health Measures Act N/A 2. Canadian Office for Disease Surveillance and Control (CODSC) ? $20 million 3. Chief Public Health Officer of Canada Capacity enhancement 4. Canadian Centre of Excellence for Public Health $100 million 5. Canadian Public Health Emergency Response Service $35 million 6. Canadian Institute for Health Information and Statistics Canada $35 milliona 7. Surge capacity $1 billionb Research, surveillance and communications 8. Canadian Institutes of Health Research $200 millionc 9. Mandatory reporting Included under 2 and 3 above 10. Enhanced reporting $110 million TOTAL $1.5 billion a. Work is currently underway to break-out public health from the current category of “public health and administration.” b. This is an incremental investment in addition to funding currently available under Health Canada’s Health Promotion and Prevention Strategic Outcome area. c. Funding must be sequestered specifically for new initiatives related to public health. Additional money could also be acquired through funding from the Canadian Foundation for Innovation, which received an additional $500 million in 2002–2003 (announced in the 2003 federal budget) to enhance the Foundation’s support of public health infrastructure. [TABLE END] APPENDIX 3: CHRONOLOGY OF THE CMA’S RESPONSE TO SARS 2002 November 16 * First known case of atypical pneumonia (SARS) occurs in Guangdong province, China 2003 February 11 * World Health Organization (WHO) receives reports from the Chinese Ministry of Health about SARS; 305 persons affected and 5 deaths February 13 * Canadian index case arrives in Hong Kong for a family visit February 18-21 * Canadian index case is a guest at the Metropole hotel in Kowloon February 21 * A medical doctor from Guangdong checks into Metropole hotel in Kowloon. The physician, who became ill a week before staying at the hotel, is considered to be the original source of the infection * This leads subsequently to outbreaks in Vietnam, Hong Kong, Singapore and Canada after guests leave the hotel and return home February 23 * Canadian index case returns home to Toronto March 5 * Canadian index patient dies in Toronto, 9 days after the onset of her illness March 12 * WHO issues global alert about SARS March 13 * National and international media reports begin appearing about SARS * The Canadian index patient’s son, Canada’s second SARS victim, dies 15 days after the onset of his illness March 14 * First reports from Toronto about deaths from SARS March 16 * Health Canada receives notice of SARS patients in Ontario and British Columbia; begins regular updates on SARS on its website * Health Canada initiates its pan-Canadian communication infrastructure, based on its pandemic influenza contingency plans March 17 * CMA calls Health Canada to offer assistance and request “real time information.” CMA immediately placed on list of participants in daily pan-Canadian teleconferences. * CMA adds a SARS page to its website home page (cma.ca) with CMA Shortcuts to expert information and daily updates March 19 * CMA alerts all its divisions and affiliates to the Health Canada and CMA SARS web pages * eCMAJ includes SARS updates on its website March 20 * CMA divisions add a link to SARS information for health professionals to their websites * Health Canada requests CMA’s assistance to inform physicians of the public health management guidelines for SARS March 28 * CMA sends an email to 33,000 members (copied to divisions and affiliated societies) to alert them to Health Canada’s SARS public health management documents and SARS web page April 1 * CMA CEO initiates cross-directorate task force and deploys dedicated staff resources. Some other CMA programs deferred/delayed. Task force begins daily staff SARS Working Group meetings * CMA communicates with the Ontario Medical Association on a daily basis April 2 * CMA holds teleconference with divisional communication directors re: SARS April 3 * CMA contacts the British Medical Association to establish whether we can secure a supply of masks from European sources * CMA organizes a teleconference among national health care organizations to discuss SARS developments April 7 * CMA posts electronic grand rounds on SARS for clinicians on cma.ca; * CMA sends email and fax communication to physicians to raise awareness of SARS e-grand rounds on cma.ca * Working with the Mental Health Support Network of Canada, CMA prepares and posts on cma.ca, fact sheets for health professionals and the public on coping with the stress caused by SARS April 9 * CMA hosts second teleconference among national health care organizations to discuss SARS developments April 17 * Electronic grand rounds on SARS updated and promoted through cma.ca April 23 * CMA sends email to membership requesting volunteers for the CMA Volunteer Emergency SARS Relief Network April 24 * CMA consults with the American Medical Association regarding the possibility of US physicians volunteering for the relief network April 25 * CMA CEO sends letter to deputy minister of health about the urgent need to create a national ministerial SARS task force April 30-May 1 * CMA participates in Health Canada-sponsored international SARS conference in Toronto May 6 * Health Canada announces the National Advisory Group on SARS and Public Health, headed by Dr. David Naylor May 12 * Opinion editorial by Dr. Dana Hanson, CMA president, on SARS and public health surge capacity published in The Ottawa Citizen; May 28 * CMA organizes a meeting of national health care organizations to discuss lessons learned from SARS June 3 * CMA receives an invitation to submit a brief to the National Advisory Group on SARS and Public Health June 6 * CMA sends e-mail to targeted segment of its membership (community medicine, public health, infectious disease and medical microbiology) requesting volunteers for the CMA Volunteer Emergency SARS Relief Network June 25 * CMA president outlines the CMA’s Public Health Action Plan during a speech at the Canadian Club in Toronto * CMA submission to the National Advisory Committee on SARS and public health APPENDIX 4: CMA’S PROPOSED HEALTH EMERGENCY ALERT SYSTEM [TABLE CONTENT DOES NOT DISPLAY PROPERLY. SEE PDF FOR PROPER DISPLAY] Health alert may be declared in: Level 1 Level 2 Level 3 Level 4 Level 5 * Any area under federal jurisdiction * Any community or province/territory with a risk of transmission to other provinces/territories or countries * Any community or province/territory with insufficient resources to manage the public health emergency within the capacity of the local public health authorities Definition of the area of concern Voluntary quarantine for individuals or property Increasing surveillance Chief public health officer takes the lead in coordinating the response Regulation or prohibition of travel Facilitating communication Reviewing and updating health emergency procedures Determination of local capacity to lead and respond Coordinating necessary response efforts with national disaster relief agencies, armed forces or law enforcement agencies at the federal–provinical–territorial level Medium to significant limitations of civil rights and freedoms Mandatory surveillance Assessing future resource requirements Deployment of a national response team Medium to significant limitations of civil rights and freedoms Evacuation of persons and the removal of personal property Providing the public with necessary information. Discretionary deployment of the national response team or on request of local authorities Quarantine of individuals and/or property with enforcement by law Implementing interventions, as appropriate, and emergency response actions Regulation of the distribution and availability of essential goods, services and resources Assessing further refinement of actions Restricting access to the area of concern Requisition, use or disposition of property Required consent of governor in council No No Yes Yes Yes Lead response team Municipal or provincial Provincial or national Provincial or national National or international International [TABLE END] REFERENCES 1. Garrett, L. Betrayal of trust: the collapse of global public health. New York: Hyperion; 2000. 2. Health Canada. National consultations, summary report: renewal of the federal health protection legislation. Ottawa: Health Canada; 1999. 3. Federal, Provincial and Territorial Advisory Committee on Population Health. Survey of public health capacity in Canada: highlights. Ottawa: The Committee; 2001. 4. Canadian Institutes for Health Information. National health expenditure trends: 1975–2002. Ottawa: CIHI; 2002. 5. Lévesque M. The economic impact of SARS. TD Economics Topic Paper. TD Bank Financial Group; 6 May 2003. Available: http://www.td.com/economics/topic/ml0503_sars.html (viewed: 20 June 2003). 1 Many countries (e.g., United States, United Kingdom, Norway and the Netherlands) have developed critical masses of public health expertise at the national level. The Centers for Disease Control and Prevention in the United States, which has a critical mass, great depth of scientific expertise and the tools and fiscal resources to fund public health programs at both state and local levels through demonstration projects, is a sterling example of the effectiveness of such a central agency. 2 A review by the Canadian Institute for Health Information recognizes the problem with current expenditure tracking systems and has recommended separating public health from government administrative costs and prepayment administration in future health system cost estimates. 3 On 6 May, the TD Bank released a paper<5> suggesting that the cost of SARS to the Canadian economy may be between $1.5 and $2.1 billion.
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Notes for an address by Dr. Eugene Bereza, Chair, Committee on Ethics, Canadian Medical Association : Bill C-13 - An act respecting assisted human reproduction : Presentation to the House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy1963
Last Reviewed
2010-02-27
Date
2002-11-20
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2010-02-27
Date
2002-11-20
Topics
Ethics and medical professionalism
Text
BILL C-13 - AN ACT RESPECTING ASSISTED HUMAN REPRODUCTION Presentation to the House of Commons Standing Committee on Health Ottawa, Ontario November 20, 2002 BILL C-13 - AN ACT RESPECTING ASSISTED HUMAN REPRODUCTION Madame Chair and Members of the Committee: My name is Dr. Eugene Bereza. I am a physician and clinical ethicist at the Royal Victoria Hospital in Montreal and Chair of the Canadian Medical Association Committee on Ethics. I am here today representing our members, more than 54,000 physicians from across Canada. I also wish to speak as a advocate for our patients, especially those affected by infertility and those who are or will suffer from diseases for which medical science is searching for cures. I am accompanied today by Dr. John Williams, our Director of Ethics. You will recall that we appeared before this Committee on October 23, 2001 in company with representatives from eight other national health provider and scientific organizations to present our views on draft legislation on assisted human reproduction. Although we were pleased that your December 2001 report recommended the establishment of an assisted reproduction regulatory body outside the Department of Health, we were disappointed that you did not find favour with other recommendations we put forward. The government responded to your report with Bill C-56, now Bill C-13. It is this bill that we are here to address today. Although there are many details in the bill on which we would like either clarification or changes, we intend to focus our remarks on the issue that we consider of greatest importance for our patient’s wellfare and the practice of medicine. That issue is the use of the criminal power to deal with medical and scientific activities. The Standing Committee Report and Bill C-13 In your December 2001 report, you acknowledged our position on this issue: “Some witnesses recommended the elimination of the prohibited activities category altogether. Citing the benefits of regulatory flexibility, they felt that all activities should come under the controlled activity category, including the more reprehensible activities like reproductive cloning for which licences, arguably, would never be allowed under the regulations” (page 9). However, you rejected this view on the grounds that “a licence-related prohibition of this sort would not carry the same weight or degree of social censure as the statutory prohibition…. An outright statutory ban signals more clearly that certain activities are either unsafe or socially unacceptable. The use of the statutory ban also signals that these activities are of such concern to Canadians that their status as a prohibited activity may not be altered except with the approval of Parliament” (page 9). Bill C-13 reflects your views on this matter. We recognize your good faith in proposing and defending this position but we are convinced that its potential for harm outweighs its potential benefits. And so we are pleased to have this opportunity to reiterate the reason why the CMA believes that Bill C-13 will adversely affect the patient-physician relationship and the advance of medical science. Need to Change Bill C-13 As you know, our position on this matter is supported by legal scholars such as Patrick Healy, McGill University Faculty of Law, Tim Caulfield, Director of the University of Alberta Health Law Institute, and Bartha Knoppers, Université de Montréal Centre de Recherche en Droit Publique. In essence, our position is that the criminal law is a blunt instrument and very difficult to change and is therefore appropriate for activities whose status is unlikely to change over time, such as murder and theft, rather than medical and scientific activities that are constantly developing. The latter are better left to a representative regulatory body to determine if and when changes in health and safety considerations and public attitudes and values might justify allowing certain formerly prohibited activities to take place under specific conditions. Bill C-13 begins with the statement: “This enactment prohibits assisted reproduction procedures that are considered to be ethically unacceptable.” This echoes the conclusions in your report. However, as the transcripts of your hearings demonstrate, many Canadians, especially those who are infertile, do not consider some or all of these procedures to be ethically unacceptable. As a matter of public policy, should Canadians who hold this view be denied access to medical treatment for infertility because others consider such treatments to be ethically unacceptable? Should patients who suffer from conditions for which research that is forbidden in Bill C-13 might lead to a cure be denied that opportunity? We question whether criminal prohibitions are appropriate for dealing with activities on which there is considerable ethical disagreement among Canadians. In Canada legislators have been justifiably reluctant to use the criminal law to deal with medical and scientific issues such as abortion, withdrawal of life-sustaining treatment and the conduct of medical research. Why is an exception being made for assisted reproduction? What sort of precedent will this set for other controversial bioethical issues? We are also concerned about the bill’s penalties for infractions: jail terms up to 10 years and fines up to $500,000. These are disproportionate to the penalties for crimes that injure persons or property and, as such, will create a climate of undue fear and excessive caution for physicians and scientists working in this area, such that they will avoid any activity that is potentially covered by the bill, even to the detriment of patient care. Given the rapid advance of science and medical practice and the difficulty of anticipating new developments, it will be difficult to adjust the law to deal with new applications of prohibited activities that may be ethically acceptable. An Alternate Solution The CMA has stated repeatedly that we are not opposed to the prohibition of certain assisted human reproduction activities. Instead of instituting criminal prohibitions within the legislation, we remain convinced that an independent body on an ongoing basis should determine the activities that are permissible or prohibited on the basis of up-to-date scientific research, public input and ethical review. This can be accomplished very easily in Bill C-13 by moving the procedures listed under “Prohibited Activities” (sections 5-9) to “Controlled Activities” and adding the words “except in accordance with the regulations and a licence” to each of the provisions in sections 5-9. Consistent with this recommendation we consider that the regulatory agency should be established as soon as possible and be given as much authority as possible over the matters that Bill C-13, section 65, reserves to regulations of Governor in Council. We hope that the agency will build upon the experience and expertise of existing organizations and structures in the field of assisted reproduction that deal with practice standards, education, certification and accreditation. Conclusion To summarize, we strongly support government efforts to regulate assisted human reproduction and related activities, including the prohibition of certain practices either temporarily or permanently. However, like others who have appeared before this Committee, we do not believe that criminalizing the medical and scientific activities named in the bill is an appropriate way to achieve those objectives. We consider that the objectives could be as well achieved by far less drastic means than criminalization and, moreover, that criminalization would create major obstacles to legitimate medical and scientific progress in the treatment of infertility. We recommend that the proposed agency be empowered to regulate these practices and that the criminal power be invoked when controlled activities are performed without authority of a licence from the agency or in defiance of the licensing conditions established by the agency. Thank you, Madame Chair and members of the Committee. We will be pleased to respond to your questions.
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Protecting the national blood supply from the West Nile Virus : CMA Submission to House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy1964
Last Reviewed
2010-02-27
Date
2003-02-19
Topics
Population health/ health equity/ public health
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2010-02-27
Date
2003-02-19
Topics
Population health/ health equity/ public health
Health care and patient safety
Text
INTRODUCTION On behalf of its more than 54,000 members, the Canadian Medical Association (CMA) is pleased to provide the House of Commons Standing Committee on Health with recommendations in regard to protecting the national blood supply from the West Nile Virus (WNV). As physicians, we understand both the perceived and actual risks associated with blood-borne diseases and the impact on individuals, families and communities. BACKGROUND WNV has emerged in North America, presenting a threat to public, animal and equine health. The most serious human manifestation of WNV infection is fatal encephalitis (inflammation of the brain). WNV is spread by the bite of an infected mosquito and can infect people, many types of birds, horses and some other animals. Most people who become infected with WNV will have either no symptoms or only mild ones. However, on rare occasions, WNV infection can result in severe and sometimes fatal illnesses. Certain people, including seniors, the young and those with weak immune systems, are at greater risk for serious health effects. In 2002, West Nile Virus was documented in five provinces (Manitoba, Nova Scotia, Ontario, Quebec and Saskatchewan). Further to this, the United States Centre for Disease Control and Prevention reported the first documented cases of person-to-person West Nile Virus transmission through organ transplantation, blood and blood product transfusion and possibly breastfeeding. It is imperative that the risk associated with the transmission of West Nile Virus through blood transfusions be minimized. We understand that the Canadian Blood Services (CBS) is working towards a validated laboratory test which may be available by the next mosquito season and that in the absence of this test there are a number of contingency plans. It appears that the CBS and Hema Quebec are maintaining vigilance and maximizing efforts towards controlling contamination through blood. This is commendable. We believe that these efforts are one component of what is required to maintain the health and safety of Canadians from the spread of known and emerging diseases. A second component is to ensure that communication about WNV to the public is accurate, timely and consistent. Effective risk communication is imperative not only to promote a safe blood supply, but also to manage risk perception associated with a positive test for WNV. A comprehensive approach is required to protect the public from emerging health problems such as the WNV. A strong public health infrastructure is necessary to ensure that governments are able to protect and promote health and to prevent illness. This involves prevention, early detection, containment, communication and information dissemination. STRENGTHENING PUBLIC HEALTH Through its public health infrastructure, society protects and promotes health and works to prevent illness, injury and disability. In today’s world these public health functions require an increasingly specialized and well-trained workforce; sophisticated surveillance, monitoring and information systems; and adequate and continuously available laboratory support. Its ultimate effectiveness, however, depends upon the ability of the system to communicate crucial information and health advice to the right professionals in real time, when they need it. The devastating impact of the failure to effectively communicate essential information is evident in examples as diverse, yet dramatic, as the tragedy of Walkerton and the untimely death of Vanessa Young. In both cases the information health professionals needed to make optimum decisions was not accessible in a reliable and timely manner. Reports indicate that across this country public health workers are stretched to the limit to perform routine work. The public health infrastructure is put to the test further whenever there is a disaster, large or small, in Canada and, not withstanding best efforts, it does not always pass. The public health system is also challenged by the potential for a disconnect in communications between differing jurisdictions that may be found when, for example, First Nations communities under federal jurisdiction overlap areas of provincial/territorial jurisdiction. In the aftermath of 9/11 and the anthrax scare in the United States, Canadians must be assured of a rapid, knowledgeable, expert response to emergency public health challenges. Commissioner Roy Romanow suggests in the recent report of the Royal Commission on the Future of Health Care that “a portion of the proposed new Primary Health Care Transfer should be targeted to expanding efforts by provinces and territories to prevent illnesses and injuries, promote good health, and integrate those activities with primary health care.” The Fifth Report of the Senate Committee on Science, Technology and Social Affairs, chaired by Senator Kirby, notes that “The major problem with public health programs is that funding is low, and usually unstable or inconsistent. As a result, the public health infrastructure in Canada is under considerable stress and has deteriorated substantially in recent years.” The Senate Committee recommended that the federal government, “ensure strong leadership and provide additional funding of $200 million to sustain, better coordinate and integrate the public health infrastructure in Canada as well as relevant health promotion efforts.” During the First Ministers’ meeting in September 2000, the First Ministers committed to strengthening their investments and commitments to public health, including the development of strategies and policies that recognize the determinants of health, enhance disease prevention and improve public health. They made several commitments towards achieving the goal, including: * Promoting those public services, programs and policies that extend beyond care and treatment and which make a critical contribution to the health and wellness of Canadians; * Addressing key priorities for health care renewal and supporting innovations to meet the current and emerging needs of Canadians; * Reporting regularly to Canadians on health status, health outcomes, and the performance of publicly funded health services, and the actions taken to improve these services. In 1999, the Auditor General found Health Canada unprepared to fulfill its responsibilities in public health; communication between multiple agencies was poor and weaknesses in the key surveillance system impeded the effective monitoring of communicable and noncommunicable diseases and injuries. In 1997, Justice Horace Krever reported that the “public health departments in many parts of Canada do not have sufficient resources to carry out their duties.” RECOMMENDATIONS The capacity of the public health care sector to deliver disease prevention and health promotion programs in Canada is currently inadequate, and its ability to respond varies from coast to coast. This is due to a lack of trained professionals and a lack of operational funds. Enhanced commitments are needed from governments at all levels to ensure that adequate human resources and infrastructure are in place to respond to public health issues when they arise. This includes the expansion of the public health training programs to enhance the resources in this field. The ability of the public health system to respond to these issues has a direct impact on the wellbeing of the people of Canada in a manner as important as the ability of the acute care system to respond to medical emergencies. Therefore the CMA recommends that: The federal government invest in human resources and infrastructure needed to develop an adequate and effective public health system capable of responding to emerging public health issues. The public health system is complex and multifactorial. It is therefore imperative that different departments and sectors coordinate and communicate effectively to coordinate efforts and avoid duplication. The development of an adequate surveillance system and consideration of mandatory reporting of WNV infections in humans is one component of this requirement. In addition to collecting these data, a more extensive communication and dissemination plan should be developed to enhance the impact of skilled professionals, programs and policies. Responsible messaging should be developed in a timely manner, for the public and for individuals who are detected to have (or previously had) a WNV infection. Such messaging must carefully balance public awareness of risk against threats to the CBS/Hema Quebec donor pool and the creation of anxiety in people who need to use blood or blood products. It is essential that the federal government take a leadership role to ensure that the communication tools and information technology necessary to enable a more rapid and informed response to situations such as identification of emerging diseases in the blood supply, natural disasters, disease outbreaks, newly discovered adverse drug reactions, and man-made disasters or bio-terrorism are accessible in real time in all regions of the country. In its pre budget submission, the CMA called on the government to strengthen the public health system to ensure that governments are able to protect and promote health and to prevent illness. This involves the detection of emerging health problems, like West Nile Virus transmission, as well as containment, communication and information dissemination. Therefore the CMA recommends that: The federal government provide a one-time infusion of $30 million for the creation of a R.R.E.A.L (Rapid, Reliable, Effective, Accessible and Linked) Health Communication and Coordination Initiative which would strengthen Canada’s public health infrastructure and enhance coordination and communication amongst all levels of government, public health officials, health educators, community service providers, physicians and organizations such as the Canadian Blood Service/Hema Quebec, Canadian Public Health Association and the Canadian Medical Association.
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Canada Pension Plan Disability Program : CMA Presentation to the Sub-Committee on the Status of Persons with Disabilities

https://policybase.cma.ca/en/permalink/policy1965
Last Reviewed
2010-02-27
Date
2003-03-18
Topics
Population health/ health equity/ public health
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2010-02-27
Date
2003-03-18
Topics
Population health/ health equity/ public health
Text
The Canadian Medical Association appreciates the opportunity to once again participate in the deliberations of the Sub-Committee on the Status of Persons with Disabilities. I am accompanied today by Mr. William Tholl, Secretary General and Chief Executive Officer of the Canadian Medical Association. Before I begin my remarks, I want to congratulate this Committee, and particularly the Chair of the Committee, for your efforts in regard to another federal program, the Disability Tax Credit. Your 2002 report on this program, Getting it Right for Canadians, no doubt led to some of the important measures in regard to disabilities undertaken by the government in the recent federal budget. The appointment of the Technical Advisory Committee on eligibility criteria and the $105 million allocated over the next two years to improve assistance for persons with disabilities is, in our view, significant progress. The CMA appreciates this opportunity to discuss issues relating to the Canada Pension Plan (CPP) specifically as the program relates to the disability benefit. I will focus my remarks today in three areas: * Physician experience with federal health programs and forms * The need for common criteria * Recommendations for action While the subject matter before the Subcommittee today is the CPP disability program, we believe a broader focus on the issue of “disability” and federal health programs in general is needed. Issues related to the CPP disability program are issues common to other federal disability assistance programs. THE PHYSICIAN EXPERIENCE I don’t think I need to tell this Committee about the alarming shortages of physicians and other health care providers in Canada. Canada’s physicians have been stretched to the limit and beyond. Therefore, it’s more important than ever that physician’s time be managed in such a way as to maximize our interaction with patients. Unfortunately however, this is not the case. Increasingly physicians are spending more and more of their time filling out forms. Forms for federal health programs such as the CPP or for-private insurance claims, pension benefits, tax credit eligibility, pharmaceutical plans and workers compensation claims to name just a few. To figure out all the various forms and determine eligibility you almost need to be a physician, a lawyer and a tax expert. The result of the proliferation in the number of forms and their increasing complexity has resulted in less time for what physicians are trained to do; treating illness and providing care to patients. If you were to ask the average physician his or her greatest frustration with the health system, the response would be too much time spent administrating the system and not enough time in providing care to patients. In regard to the CPP specifically, we have had in the past a good working relationship with the officials who manage this program. We have worked together well in the past in regard to improving the forms and bring great integrity to the program which has resulted in a reduction of appeals under the program. The CMA believes that in terms of a federal health program, the CPP set the template both in terms of administrative processes and cooperation that should be adopted across all federal programs in this area. That said, there is still considerable room for improvement. I urge the Committee to take into consideration the cumulative impact these various health programs, such as the CPP, have on our health provider workforce. We must look at ways in which to relieve the heavy administrative burden so that physicians can concentrate their efforts on what they do best, patient care. COMMON CRITERIA As with our presentation on the Disability Tax Credit program, the CMA recommends that a standard of fairness and equity be applied across all federal disability benefit programs. Currently, there is virtually a different definition and a different assessment process for each and every program. A common frustration of physicians is that while a patient qualifies as “disabled” under one disability program, that same patient does not under another. When you look at some of the common criteria used to determine the level of a disability, the problem is readily apparent. The CPP criteria define “severe” as preventing an applicant from working regularly at any job and “prolonged” as long term or that which may result in death. However, the DTC program notes that “severe” is to be interpreted to mean markedly restricting any of the basic activities of daily living and that a disability must be “prolonged” over a period of at least 12 months. While daily living includes working regularly at any job it encompasses so much more. Under the CPP criteria the physician is responsible for determining how to define long term; six months or twelve months. Other programs, such as the Veterans benefits that have entirely different criteria, are added to this mixture. This is confusing for physicians, patients and others involved in the application process. If the terms, criteria and the information about the programs are not as clear as possible then we have no doubt that faulty interpretation on the part of physicians when completing the forms can occur. This could then inadvertently disadvantage those who, in fact, qualify for benefits. There needs to be some consistency in definitions across the various government programs. This does not mean that eligibility criteria must be identical. However, there must be a way for a more standardized approach. Inconsistency in the application and administration of the program is likely without a more standardized definition of the program. The reality is that certain individuals with conditions or disabilities may qualify for the CPP disability benefit in one region of the country, while in other regions, an individual with the same condition will be deemed ineligible. There are a number of conditions that society would today view as a “disability,” yet may not fit under the current program. Severe and prolonged is a rigid standard, especially as it is applied to some medical conditions. The reality is that such a standard cannot be applied fairly in all situations. There needs to be greater flexibility and more realistic criteria that takes into account the special nature of some medical conditions that may not meet yesterday’s standards. RECOMMENDATIONS Canada’s physicians offer four specific actions for the Committee to consider: 1. That an emphasis be placed on reducing the administrative burden placed on health care providers under all federal health programs. The CPP program, both in terms of the consultative and administration process, should serve as the template for change. Unlike other federal health programs, the cost of having the eligibility form completed by a physician is subsumed under the program itself. The CMA believes this should be the case for all federal health programs. 2. The establishment of a joint governmental and stakeholder advisory group, similar to the recently announced DTC Advisory Committee, to monitor and appraise the performance of the CPP disability program to ensure it meets its stated purpose and objectives. Representation on this advisory group would include senior program officials; health care providers; various disability organizations; and patient advocacy groups. 3. That there be some consistency in definitions across the various government programs. This would not circumvent the purposes or mandates of the programs. 4. That a comprehensive information package be developed for health care providers and the public that provides a description of each program, its eligibility criteria, the full range of benefits available, copies of sample forms, physical assessment and form completion payment information, etc. CONCLUSION To conclude, the CMA believes that the CPP is a deserving benefit to those Canadians living with a disability. We again congratulate the Committee for the progress it has achieved on behalf of people with disabilities in regard to the recent initiatives announced in the federal budget. The CMA looks forward to working with all concerned to improve the CPP program and all other federal disability health programs. Thank You.
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Elder Abuse and Disability Hearing: CMA's Presentation to the Parliamentary Committee on Palliative and Compassionate Care

https://policybase.cma.ca/en/permalink/policy10060
Date
2010-10-25
Topics
Population health/ health equity/ public health
  1 document  
Policy Type
Parliamentary submission
Date
2010-10-25
Topics
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) wishes to commend the multi-party group of Members of Parliament who have come together to form the Parliamentary Committee on Palliative and Compassionate Care. The challenge we face today in caring for our aging population is only going to get greater. Statistics Canada has projected a rapid increase in the proportion of seniors in the population. The first wave of the baby boom generation turns 65 next year. By 2031, seniors will account for roughly one-quarter of the population, nearly double the 13.9% observed in 2009.1 Canadians are clearly concerned about their ability to cope with future health care expenses, either their own or those of their parents. Respondents to the CMA's 2010 Annual National Report Card on Health Care survey anticipate a range of implications associated with our aging population: * 29% reported that they will likely alter their retirement plans (e.g., work longer) to help pay for their own future costs or those of their parents; * Almost one in five (19%) anticipates moving their parents into their own home and supporting them financially; and * One in six (16%) anticipates paying for their parents to live in a nursing home.2 The CMA believes that the federal government could play a key role in allaying Canadians' concerns about the future by leading negotiations with the provinces and territories and taking direct action on extending access along the continuum of care. These actions should focus on three priority areas: * Increasing access by all Canadians to affordable prescription drugs; * Supporting informal caregivers; and * Increasing access to palliative care at the end of life. If nothing is done to extend Medicare to cover more of the continuum of care, it will erode over time as a national program. When the Canada Health Act (CHA) was passed in 1984, physician and hospital services represented 57% of total health spending; this had declined to 42% as of 2009.3 While there is significant public spending beyond CHA-covered services (more than 25% of total spending) for programs such as seniors' drug coverage and home care, these programs are not subject to the CHA principles and coverage across the provinces and territories varies significantly. Access to Prescription Drugs The federal government missed an excellent opportunity to modernize Medicare in July 2004 when Premiers called on it to upload responsibility for drug programs. The Premiers stated that "a national pharmaceutical program should immediately be established. The federal government should assume full financial responsibility for a comprehensive drug plan for all Canadians, and be accountable for the outcomes."4 The federal government did not give this offer even fleeting consideration. Instead, the September 2004 10-Year Plan to Strengthen Health Care contained a watered-down version of the First Ministers' 2003 commitment to ensure that all Canadians would have reasonable access to catastrophic drug coverage by the end of 2005/06. The 2004 Accord reduced this commitment to the development of costing options for pharmaceutical coverage, as part of a nine-point National Pharmaceuticals Strategy (NPS).5 Costing options were included in the 2006 progress report of the NPS but they included estimates of the cost of catastrophic coverage wildly exceeding those of Romanow and Kirby, ranging from $6.6 billion to $10.3 billion.6 Nothing further has been heard about the NPS since stakeholder consultations were held in fall 2007. As recently as September 2008, the provinces and territories (PTs) were still interested in federal participation in pharmaceuticals. In the communiqué from their annual meeting, the PT health Ministers called for a three-point funding formula to support a national standard of pharmacare coverage, including: * PT flexibility and autonomy in program design; * Prescription drug costs not to exceed 5% of net income; and * Federal and PT governments to cost share 50/50, estimated at $2.52 billion each in 2006.7 Again there was no reaction from the federal government. Since then the PT governments have appeared to be giving up hope of federal participation in access to pharmaceuticals. At their June 2009 meeting, the western Premiers announced they would develop a joint western purchasing plan for pharmaceuticals,8 and more recently at the August 2010 meeting of the Council of the Federation, Premiers agreed to establish a pan-Canadian purchasing alliance for common drugs, medical supplies and equipment.9 Health Ministers reaffirmed this commitment at their September 2010 meeting.10 One can speculate that had the federal government taken up the Premiers' offer in 2004, many aspects of the NPS would be in place by now. Meanwhile, access to prescription drugs presents a hardship for many Canadians. In the CMA's 2009 National Report Card survey, nearly one in six (14%) reported they had either delayed or stopped buying some prescription drugs. This ranged from more than one in five (22%) with annual incomes of less than $30,000 to just over one in 20 (7%) of those with incomes greater than $90,000.11 The wide geographic disparity in out-of-pocket drug expenditures is shown in the table below, which is compiled from Statistics Canada's 2009 Survey of Household Spending. Table 1 shows the percentage of households spending more than 3% and 5% of after-tax income on prescription drugs, by province, in the year prior to the survey. [Note - see PDF for correct display of table information] % of Households Spending Greater than 3% and 5% of After-tax Income on Prescription Drugs, Canada and Provinces, 2008 Geography >3% >5% Canada 7.6 3.0 Newfoundland and Labrador 11.6 5.4E Prince Edward Island 13.3 5.8E Nova Scotia 8.9 3.8 New Brunswick 9.1 4.1E Quebec 11.6 3.3 Ontario 4.7 2.2E Manitoba 12.0 5.2 Saskatchewan 11.5 5.9 Alberta 4.6E 2.2E British Columbia 7.5 3.6 E - Use with caution - high coefficient of variation Source: Statistics Canada, CANSIM Table 109-5012 Under both thresholds there is a more than two-fold variation across provinces in the incidence of catastrophic drug expenditures. At the 5% threshold the range is from 2.2% of households in Ontario and Alberta to 5.8% in PEI and 5.9% in Saskatchewan. With the growing availability of more expensive drugs, this variation is only likely to be exacerbated in the years ahead. Recommendation 1 The federal government should negotiate a cost-shared program of comprehensive prescription drug coverage with the provincial/territorial governments. This program should be administered through provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies. Such a program should include the following elements: * A mandate for all Canadians to have either private or public coverage for prescription drugs; * Uniform income-based ceiling (between public and private plans across provinces/territories) on out-of-pocket expenditures on drug plan premiums and/or prescription drugs (e.g., 5% of after-tax income); * Federal/provincial/territorial cost-sharing of prescription drug expenditures above a household income ceiling, subject to capping the total federal and/or provincial/territorial contributions either by adjusting the federal/provincial/territorial sharing of reimbursement or by scaling the household income ceiling or both; * Group insurance plans and administrators of employee benefit plans to pool risk above a threshold linked to group size; and * A continued strong role for private supplementary insurance plans and public drug plans on a level playing field (i.e., premiums and co-payments to cover plan costs). In negotiating this plan, consideration should be given to the following: * Establishing a program for access to expensive drugs for rare diseases where those drugs have been demonstrated to be effective; * Assessing the options for risk pooling to cover the inclusion of expensive drugs in public and private drug plan formularies; * Provision of adequate financial compensation to the provincial and territorial governments that have developed, implemented and funded their own public prescription drug insurance plans; and * Provision of comprehensive coverage of prescription drugs and immunization for all children in Canada. Supporting Informal Caregivers As the population ages, the incidence of diseases associated with dementia is projected to increase dramatically. A 2010 study commissioned by the Alzheimer Society of Canada has reported that the 2008 level of an estimated 103,728 new dementia cases is expected to more than double to 257,811 per year by 2038. Over this period, the demand for informal caregiving will skyrocket. In 2008, the Alzheimer Society reports, the opportunity cost of unpaid care giving was estimated at almost $5 billion. By 2038 this cost is expected to increase by 11-fold, to reach $56 billion, as the overall prevalence of dementia will have risen to 1.1 million people, representing 2.8% of the Canadian population.12 The burden of informal care giving extends beyond the costs related to dementia. Statistics Canada's 2007 General Social Survey has documented the extent to which Canadians are providing unpaid assistance to family, friends or other persons with a long-term health condition or physical limitation. Nationwide, 1.4 million adults aged 45 or over living in the community were receiving care in 2007. Of this number almost one in two (46.9%) were receiving both paid and unpaid care, almost three in 10 (27.4%) were receiving unpaid care only, and just under one in five (18.8%) were receiving paid care only. This underscores the importance of the informal sector. In terms of who was providing this care, an estimated four million Canadians were providing care, of whom one million were aged 65 or over, while almost two million (1.8) were in the prime working age range of 45 to 54. The provision of unpaid care represents a significant time commitment. The caregivers who reported helping with at least one activity spent an average 11.6 hours in a typical week doing so. Those providing care reported significant personal consequences. One in three reported spending less time on social activities (33.7%) or incurring extra expenses (32.7%), almost one in five cancelled holiday plans (18.7%) or spent less time with their spouse (18.7%), and more than one in 10 (13.7%) reported that their health had suffered. The 2.5 million informal caregivers who were in the paid labour force were likely to report that caregiving had had a significant impact on their jobs. Almost one in four (24.3%) reported missing full days of work and one in six (15.5%) reported reducing hours of work. Compared to the total population, informal caregivers were more likely to report stress in their lives. Almost three in 10 (27.9%) reported their level of stress on most days to be either quite a bit or extremely stressful compared to fewer than one in four (23.2%) of the total population.13 As the demand for informal care grows, it seems unlikely that the burden of informal caregiving will be sustainable without additional support. The federal government took the positive step in 2004/05 of introducing Employment Insurance (EI) Compassionate Care Benefits for people who are away from work temporarily to provide care or support to a family member who is gravely ill and at risk of dying within 26 weeks.14 So far, however, this program has had limited uptake. In 2007/08, 5,706 new claims were paid.15 This pales in comparison to the 235,217 deaths that year (although not all of these would be candidates for this type of care).16 Recommendation 2 The federal government should implement measures within its jurisdiction, such as the use of tax credits, to support informal caregivers. Increasing Access to Palliative Care at the End of Life The Senate of Canada, and Senator Sharon Carstairs in particular, have provided exemplary leadership over the last 15 years in highlighting both the progress and the persistent variability across Canada in access to quality end-of-life care. The Senator's 2005 report Still Not There noted that only an estimated 15% of Canadians have access to hospice palliative care and that for children the figure drops even further to just over 3%.17 The 2005 report repeated the 1995 call for a national strategy for palliative and end-of-life care. To date, palliative care in Canada has primarily centred on services for those dying with cancer. However, cancer accounts for less than one-third (30%) of deaths in Canada. Diseases at the end of life, such as dementia and multiple chronic conditions, are expected to become much more prevalent in the years ahead. The demand for quality end-of-life care is certain to increase as the baby boom generation ages. There will be an estimated 40% more deaths a year by 2020. While the proportion of Canadians dying in hospital has been decreasing over the past decade, many more Canadians would undoubtedly prefer to have the option of hospice palliative care at the end of their lives than current capacity will permit. In the 2004 Health Accord, First Ministers built on their 2003 Accord by agreeing to provide first dollar coverage for certain home care services by 2006, including end-of-life care for case management, nursing, palliative-specific pharmaceuticals and personal care at the end of life. Seven years later we have no comprehensive picture of the availability of end-of-life care across Canada. The Health Council of Canada's last detailed reporting on the implementation of the 2003 Accord was in 2006. At that time, the only province to report comprehensive end-of-life care was British Columbia.18 For most other jurisdictions, end-of-life care was discussed under "next steps." Since then, the Health Council has ceased comprehensive reporting on the Accord. In the 2007 National Physician Survey, doctors across Canada were asked to rate the accessibility of the range of services for their patients. Just one in three (32%) rated access to palliative care services as either excellent or very good.19 In 2006, the Canadian Hospice Palliative Care Association and the Canadian Home Care Association jointly issued a 35-point "gold standard" for palliative home care, covering the areas of case management, nursing care, pharmaceuticals and personal care, which they commended to governments.20 In its April 2009 report, the Special Senate Committee on Aging recommended a federally funded national partnership with provinces, territories and community organizations to promote integrated, quality end-of-life care for all Canadians, the application of gold standards in palliative home care to veterans, First Nations and Inuit, and federal inmates, and renewed research funding for palliative care.21 In 2010, the Quality End-of-Life Care Coalition of Canada (QELCC), of which the CMA is a member, released its Blueprint for Action 2010 to 2020. The four priorities are: * Ensure all Canadians have access to high-quality hospice palliative end-of-life care; * Provide more support for family caregivers; * Improve the quality and consistency of hospice palliative end-of-life care in Canada; and * Encourage Canadians to discuss and plan for end-of-life.22 This blueprint embodies the sound ideas that have emerged over the past decade. In June 2010, Senator Carstairs released her latest report Raising the Bar, which, while acknowledging some of the achievements that have been made in palliative care, repeats her previous calls for a national role and active engagement of the federal government.23 A wide range of stakeholders either have, or should have, a significant stake in the issue of palliative care. They include patients and the organizations that advocate on their behalf, caregivers (both formal and informal), the institutional and community health sectors, and the employer/business community. Recommendation 3 The CMA urges the federal government to collaborate with the provincial and territorial governments to convene a national conference in 2011 to assess the state of palliative care in Canada. Notes 1 Statistics Canada. Population projections for Canada, provinces and territories 2009 to 2036. Catalogue no. 91-520-X. Ottawa. Minister of Industry, 2010. 2 Canadian Medical Association. 10th Annual National Report Card on Health Care, August, 2010. http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Media_Release/2010/report_card/2010-National-Report-Card_en.pdf. Accessed 09/28/10. 3 Canadian Institute for Health Information. National health expenditure trends 1975 to 2009. Ottawa, 2009. 4 Canadian Intergovernmental Conference Secretariat. Premiers' action plan for better health care: resolving issues in the spirit of true federation. July 30, 2004. http://www.scics.gc.ca/cinfo04/850098004_e.html. Accessed 09/28/10. 5 Canadian Intergovernmental Conference Secretariat. A 10-year plan to strengthen health care. http://www.scics.gc.ca/cinfo04/800042005_e.pdf. Accessed 09/28/10. 6 Health Canada. National Pharmaceuticals Strategy Progress Report. June 2006. http://www.hc-sc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 09/28/10. 7 Canadian Intergovernmental Conference Secretariat. Annual Conference of Provincial-Territorial Ministers of Health. September 4, 2008. http://www.scics.gc.ca/cinfo08/860556005_e.html. Accessed 09/28/10. 8 Canadian Intergovernmental Conference Secretariat. Premiers taking action on pharmaceuticals. June 18, 2009. http://www.scics.gc.ca/cinfo09/850114004_e.html. Accessed 09/28/10. 9 Council of the Federation. Premiers protecting Canada's health care systems. http://www.councilofthefederation.ca/pdfs/PremiersProtectingCanadasHealthCareSystem.pdf. Accessed 09/28/10. 10 Canadian Intergovernmental Conference Secretariat. P/T health Ministers work together to advance common issues. September 13, 2010. http://www.scics.gc.ca/cinfo10/860578004_e.html. Accessed 09/28/10. 11 Canadian Medical Association. 9th Annual National Report Card on Health Care. http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Media_Release/2009/report_card/Report-Card_en.pdf. Accessed 09/28/10. 12Alzheimer Society of Canada. Rising tide: the impact of dementia on Canadian society. http://www.alzheimer.ca/docs/RisingTide/Rising%20Tide_Full%20Report_Eng_FINAL_Secured%20version.pdf. Accessed 09/28/10. 13 Statistics Canada. 2007 General Social Survey: Care tables. Catalogue no. 89-633-X. Ottawa, Minister of Industry, 2009. 14Human Resources and Skills Development Canada. Information for health care professionals: EI Compassionate Care. http://www.rhdcc-hrsdc.gc.ca/eng/publications_resources/health_care/ei_ccb.shtml. Accessed 09/28/10. 15 Human Resources and Skills Development Canada. Table 2.12 Compassionate care benefits. http://www.hrsdc.gc.ca/eng/employment/ei/reports/eimar_2009/annex/annex2_12.shtml. Accessed 09/28/10. 16 Statistics Canada. Deaths 2007. The Daily, Tuesday, February 23, 2010. 17 Carstairs S. Still not there. Quality end-of-life care: a status report. http://sen.parl.gc.ca/scarstairs/PalliativeCare/Still%20Not%20There%20June%202005.pdf. Accessed 09/24/09. 18 Health Council of Canada. Jursdictional tables on health care renewal. Companion document to Health care renewal in Canada Measuring up? Annual report to Canadians 2006. Toronto, ON, 2007 19 College of Family Physicians of Canada. Canadian Medical Association. Royal College of Physicians and Surgeons of Canada. National Physician Survey 2007. Q25a. Please rate the accessibility of the following for your patients. http://www.nationalphysiciansurvey.ca/nps/2007_Survey/Results/ENG/National/pdf/Q25/Q25aALL.only_NON.CORE.only.pdf. Accessed 09/28/10. 20 Canadian Hospice Palliative Care Association. Canadian Home Care Association. The pan-Canadian gold standard for palliative home care. http://www.chpca.net/resource_doc_library/pan-cdn_gold_standards/Gold_Standards_Palliative_Home_Care.pdf. Accessed 09/28/10. 21 Special Senate Committee on Aging. Final report: Canada's aging population: Seizing the opportunity. April 2009. http://www.parl.gc.ca/40/2/parlbus/commbus/senate/com-e/agei-e/rep-e/AgingFinalReport-e.pdf. Accessed 09/28/10. 22 Quality End -of-life Coalition of Canada. Blueprint for action 2010 to 2020. http://www.chpca.net/qelccc/information_and_resources/Blueprint_for_Action_2010_to_2020_April_2010.pdf. Accessed 09/28/10. 23Carstairs S. Raising the bar: a roadmap for the future of palliative care in Canada. June 2010. http://sen.parl.gc.ca/scarstairs/PalliativeCare/Raising%20the%20Bar%20June%202010%20(2).pdf. Accessed 09/29/10.
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Healthy Living: CMA's Presentation to the House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy10058
Date
2011-02-08
Topics
Population health/ health equity/ public health
  1 document  
Policy Type
Parliamentary submission
Date
2011-02-08
Topics
Population health/ health equity/ public health
Text
I would like to thank the Committee for inviting the Canadian Medical Association to appear on this very important topic. As a family physician in Saskatoon and the past president of the CMA, I can assure you that Canada's physicians have an acute interest in drawing attention to the health consequences of poor nutrition and lack of physical activity, and the challenge of obesity. We know that obesity is a contributor to a number of chronic diseases, such as diabetes, cardiovascular disease, hypertension and liver disease, as well as breast, colon and prostate cancer. We know that over-consumption of salt, sugars, and saturated and trans fats can be a factor in hypertension, cardiovascular disease and stroke, and kidney disease. And we know that Canadians have become dramatically less physically fit in recent decades. As a country, we need to espouse a culture of health and wellness, based on good nutrition and physical activity. Finding solutions will require a collaborative, system-wide approach involving all levels of government, the health, education, industry, finance and transportation ministries, and the private sector. We know that if provided with support when young, children can adopt healthy life styles. That is why the CMA continues to call on governments across the country to work with school boards to: * provide at least 30 minutes of active daily physical education for all primary and secondary grades, given by trained educators in the field; * provide access to attractive, affordable, healthy food choices and clearly post the nutrition content of the foods they sell; and * ban junk food sales in all primary, intermediate and secondary schools in Canada. The CMA has advocated policies and regulations for food safety, and promoted healthy eating and physical activity as key components of healthy living and the prevention of disease. The CMA policy statement Promoting Physical Activity and Healthy Weights calls for a Canada-wide strategy for healthy living that includes: * information and support for Canadians to help them make healthy choices; * support for health professionals in counselling patients on healthy weight and in treating existing obesity; * community infrastructure that makes healthy living choices easier; and * public policies that encourage healthy eating and physical activity. All Canadians need access to nutritious food at affordable prices. The price of milk, produce and other healthy foods varies greatly in different parts of Canada. In remote areas, they are even more expensive because of high transportation costs. In urban areas, nutritious food may be unaffordable for people on low incomes and unavailable as grocery stores move to the suburbs thus creating "food deserts". Among other strategies, governments should consider: implementing school meal programs; and taking into account the cost of nutritious food when setting social assistance rates. The proliferation of packaged, prepared foods and fast foods has contributed to excess amounts of salt, sugar, saturated and trans fat and calories in our diet. While we welcome the federal government's support for the reduction of trans fats and sodium levels in processed foods, reliance on the food industry to voluntarily reduce these ingredients has not been successful. We believe that regulation is needed to safeguard the health of Canadians. Healthy living begins with an awareness of the impact of food and exercise on health. While individuals must take responsibility for making healthy choices, the CMA believes that governments have an obligation to provide guidance on healthy eating and physical activity that can be easily incorporated into daily lives. We commend the federal and provincial/ territorial governments for their recent Framework for Action to Promote Healthy Weights. Physicians were also pleased to see the revised Canada's Food Guide in 2007, and the recent update to Canada's Physical Activity Guide. The CMA supports nutrition and caloric labeling on packaged foods to help Canadians make informed food choices. The federal nutrition labeling awareness initiative is useful to consumers but we think information can be simplified. For example, the UK is testing front of pack 'traffic light' coding for fats, salt, sugar and calories. The CMA has also called for a clear display of caloric counts, and sodium, trans-fats and protein levels on restaurant and cafeteria menus. The CMA believes encouragement of active transportation, that is walking and cycling, is a way to increase physical activity. Communities need to make it easier for Canadians to be physically active in their day-to-day life by providing sidewalks and pedestrian-friendly intersections; bike lanes, paths and parking spaces; and trails, parks and green spaces. One area that we believe warrants further study is the use of incentives to promote healthy behaviours. By transferring funds or other benefits to an individual, incentives provide immediate rewards for behaviours that can lead to long-term health gains. An example in Canada is the Children's Fitness Tax Credit, which is intended to help children be more active by off-setting some of the costs incurred by families for sports and leisure programs. Government disincentives largely involve the use of regulation and taxation in order to change individual behaviour. This helps to create an environment in which healthy choices are easier to make. It is impossible to overstate the importance of nutrition and physical activity to our health. Encouraging Canadians to make healthy choices requires a wide ranging, long-term and collaborative approach. The CMA believes this challenge should be met urgently. Canada's physicians are more than ready to work with governments to ensure that Canadians can improve and maintain their health.
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Nutrition Labelling: CMA's Presentation to the House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy10085
Date
2011-03-03
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Parliamentary submission
Date
2011-03-03
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
Thank you very much for inviting the Canadian Medical Association back to this committee as you continue your study on healthy living. A few weeks ago my colleague Dr. Doig was here to talk about the health consequences of poor nutrition and lack of physical activity and the policies CMA has advocated to promote healthy living. Today I would like to expand upon nutrition labelling and health claims on foods, and on the labelling of foods regulated as natural health products. Nutrition facts tables can be an important source of information, but many Canadians have difficulty interpreting them. A 2009 Health Canada review of research on nutrition labelling indicated that: * those with little nutrition knowledge have difficulty using the tables and are unable to relate the information they contain to their own dietary needs; and that * the concept of percentage of daily value is often misunderstood. There has been an increase in the use of health claims on the front of packaging expressed as slogans or logos such as "healthy choice," as well as in disease reduction and nutrient content claims. Studies have shown that foods carrying health-related claims are seen by consumers as healthier choices. But the myriad of different claims can be confusing and may, in fact, draw attention away from the less healthy characteristics of a food, or oversimplify complex nutritional messages. We believe a standard consistent "at a glance" approach to front-of-package food labelling could reduce confusion and help consumers make informed dietary choices. The "traffic light" front-of-pack labelling currently in voluntary use in the UK is an example. The front-of-pack labels on composite processed foods use green, amber and red to indicate low, medium or high levels of the nutrients most strongly associated with diet-related health risks: fat, saturated fat, sugars and salt. Also included is calorie count per serving and percentage daily amount information. Research in the UK has shown that consumers generally understand these labels. Shoppers are most likely to use them when buying a product for the first time; to compare different products; when shopping for children; when trying to control intake of certain ingredients such as fat or salt, for health reasons; or when trying to lose weight. Not surprisingly, research in the UK and Canada also shows that those most likely to read nutrition labels are those who are already interested in healthy eating. For this reason, labelling policy must be embedded in a broader nutrition policy that uses multiple instruments to foster education and interest in healthy eating, and helps ensure that Canadians have healthy food choices by, for example, regulating amounts of salt in processed food. In addition, physicians have become quite concerned about a recent tendency toward regulating 'fortified foods 'as Natural Health Products. The Food and Drugs Act effectively prevents products classified as foods from being marketed as having medicinal benefits unless there is compelling scientific evidence that the claims are true and the products are safe. The same strong legislation does not apply to Natural Health Products (NHPs), which are regulated under a different act. This is a concern because a trend is emerging whereby manufacturers of products normally sold as foods fortify their products with approved natural health products such as vitamins or minerals. Examples of these are energy drinks and vitamin-enhanced juice, power bars, gums and candy. The manufacturer can then request federal approval to market the product as a 'health product in food format.' If approved, food labelling requirements no longer apply and health claims that would not be allowed under the Food and Drugs Act can be made. Without proper nutrition labelling, it is difficult, if not impossible, for consumers to make informed food choices. This can be particularly troubling for those with special diets or health concerns. Further, those misled by dubious health claims might be consuming empty calories or high amounts of fat or sodium, with no corresponding benefit. The result is that the health of Canadians may be compromised. The CMA has called on Health Canada to require compelling evidence of health benefits before changing a product's regulatory status from food to natural health product, and nutrition labelling for all foods regulated as a natural health product. Faced with an array of products and health claims, and a barrage of advertising extolling their benefits, Canadians can find it challenging to make healthier food choices. To find our way through to the right choice, we need good nutritional information, and the ability to access and understand this information. Governments and health care providers share a responsibility to help Canadians make choices that will help them achieve and maintain good health. Canada's doctors are partners in healthy living and are ready to work with governments and others toward a healthy population. I welcome your questions.
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The Right Drugs, at the Right Times, for the Right Prices: Toward a Prescription Drug Policy for Canada : CMA Presentation to House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy1955
Last Reviewed
2011-03-05
Date
2003-11-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2011-03-05
Date
2003-11-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
Every year, three hundred million prescriptions – about 10 for every man, woman and child – are filled in Canada. Prescription drugs have benefited both the health of Canadians, and the health care system itself; they have meant dramatically improved quality of life for many Canadians, and have saved the country a great deal in hospitalization, social benefits and other expenses. However, it could be questioned whether all of Canada’s prescription drug use is appropriate; patients may be receiving too few medications, too many medications or suboptimal medications for their conditions. In addition, prescription drugs carry a price tag of their own. Since 1975, expenditures on prescription medication have risen faster than any other category in the health sector in Canada, and more is now spent on prescription drugs than on physician services. Governments, health care providers, drug manufacturers and the public must constantly strive to ensure that Canadians receive optimal and appropriate prescription drug therapy: the right drugs, at the right times, for the right prices. A considered, coherent, comprehensive, “made in Canada” approach to prescription drug policy should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. Prescription drug policy in Canada should address: Access: to * efficacious new drugs within an appropriate time; * coverage for medically necessary drugs for catastrophic care; * generic drugs at reasonable prices; * a patient/physician consultation as part of the prescribing process; * continued research and development capacity in Canada. Information for health care providers and the public that is balanced and accurate. Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada’s doctors are committed to working with others to ensure that Canadians receive the right drugs, at the right times, for the right prices. Summary of CMA Recommendations: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to all drugs that demonstrate a substantial improvement over products already on the market. 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for all Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship which exists between the patient and the physician. 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada. 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. PURPOSE The Canadian Medical Association (CMA) has prepared this submission for the House of Commons Standing Committee on Health’s review of prescription drugs in Canada. We applaud this review and welcome the opportunity to present the views of Canada’s medical community. Our vision is simple: that all Canadians should receive, if appropriate, the right drugs for their conditions, at the right times, for the right prices. Governments, health care providers, drug manufacturers and the public should all work together to develop a “made in Canada” prescription drug policy to realize this vision. This policy must be considered, coherent and comprehensive, and should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. In developing this policy we consider it particularly important to address the issues of: Access to quality health care In this context, the CMA’s vision of a National Access Strategy includes appropriate access to * efficacious new drugs within an appropriate time, * coverage for medically necessary drugs for catastrophic care, * generic drugs at reasonable prices, * a patient/physician consultation as part of the prescribing process, * continued research and development capacity in Canada. * Information for health care providers and the public that is balanced and accurate. * Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada’s doctors look forward to working with others to realize our vision. In this submission we will discuss the steps that the CMA recommends be taken. INTRODUCTION The value of prescription medications Prescription drugs play an important role in preventing and treating health conditions. Every year, three hundred million prescriptions – about 10 for every man, woman and child – are filled in Canada1. In recent years, powerful new medications have meant dramatically improved quality of life, or substantial change in modes and patterns of treatment, for many Canadians. Anti-retroviral treatment has saved thousands of people with HIV infection from rapid, fatal progression to AIDS. Thanks to selective serotonin reuptake inhibitors (SSRIs) millions of people with chronic depression who might otherwise have been incapacitated or institutionalized can lead normal, productive lives in the community. Drugs to treat peptic ulcer disease have changed its treatment profile from one based mainly on surgery to a largely medical one. Though the cumulative savings on hospital care, lost workforce productivity, social benefits and disability insurance payments due to prescription drug use have not been quantified, they have undoubtedly been significant. Areas of Concern In short, prescription drugs have benefited both the health of Canadians, and the health care system itself. However, they have also created concerns that must be addressed. Utilization: is it Appropriate? Experts have questioned whether all of Canada’s prescription drug use is appropriate: are patients receiving too many medications, too few medications, or suboptimal medications for their conditions? Over-utilization of prescription drugs has been a topic of some attention, but under-utilization also exists. For example, as many as 60% of people with high blood pressure may not be receiving treatment; many of these people do not even know they have the condition.2 In addition, patient compliance with prescription drug therapy is increasingly recognized as a problem, especially for long-term or chronic conditions. Compliance is a potential issue in all treatments but is of special concern in conditions where few clinical symptoms are present: for example in hypertension, where lack of treatment over the long term may result in kidney damage, vascular and opthalmological damage, stroke or heart disease. One study found that only 50% of patients comply with long-term drug therapy, and an even smaller percentage comply with lifestyle alterations.3 Partial compliance with antibiotic therapy for infectious diseases is well recognized as one cause of anti-microbial resistance to common infectious pathogens. Cost: is it too high? More is now spent on prescription medicine than on physician services. Since 1975, expenditures on prescription medication have risen faster than any other category;4 during the 1990’s they rose more than twice as quickly as overall spending on health care.5 In 2002 retail spending on drugs in Canada (prescribed and non-prescribed) was estimated to be at least 16% of total health care spending. Prescription medication accounts for 80% of this category, up from 70.3% in 1990. What drives drug expenditure in Canada? There is considerable debate on this subject, but some of the drivers are believed to be: * Increased utilization: as the population ages there is an increased prevalence of conditions such as hypertension, type 2 diabetes mellitus and osteoarthritis, which often require pharmacological treatment. * Newer (patented) drugs, which are more expensive than generics, dominate the prescription market. Between 1995 and 2000, five drug categories (including cholesterol lowering agents, high blood pressure drugs, acid-reducing agents and anti-depressants) contributed significantly to the overall rise in drug costs.5 These categories are dominated by newer, patented drugs, many of which are heavily promoted. * Prices of generic drugs, though lower than those of patented drugs, are higher in Canada than in some other countries. For example, generic drug prices are 26% lower in Germany and 68% lower in New Zealand.6 * Marketing practices such as mass media direct to consumer advertising (DTCA) in the United States, and its attendant “spillover” into the Canadian marketplace, may contribute to increased utilization. In Canada the Patent Medicine Prices Review Board (PMPRB) maintains price controls on brand-name drugs. Similar price-control mechanisms exist in European Union countries. However, no such controls exist for generic medications in Canada. All in all, prescription medications can be costly for Canadians, especially for those who lack any kind of insurance coverage. The Role of Physicians and the Canadian Medical Association Canada’s doctors are committed to ensuring that Canadians have access to the right drugs, at the right times, at the right prices, to help them achieve the right results – in other words, the best possible health outcomes. The goal of drug therapy is to improve patients’ health and quality of life by preventing, eliminating or controlling diseases or symptoms. Patients, physicians and pharmacists must work in collaboration to achieve this goal. The physician’s role in drug therapy goes well beyond the act of writing out a prescription; it encompasses: * Diagnosing diseases, assessing the need for drug therapy and designing the medication regime; * Working with patients to set treatment goals and monitor progress toward them; * Monitoring the patient’s response to drug therapy, revising the care plan when necessary to support compliance and achieve the best possible health outcomes; * Sharing with the patient specific information about the diseases and the drug therapy, including its effects and potential side effects (including, in some cases, the potential for prescription drug addiction).7 The CMA’s activity has been focused on promoting excellence in prescribing, and on disseminating drug information to physicians.8 In 1999, the CMA worked with Health Canada and the Canadian Pharmacists Association (CPhA) to convene an expert roundtable on the subject of “Best Practices in Prescribing”. This was but one effort of the profession to explore why some therapies appear to be under-prescribed, while others may be over-prescribed. CMA has developed principles on the issues of physician information and of providing information on prescription drugs to consumers; both these documents will be discussed later in this submission. CMA and CPhA have also developed a joint policy statement on approaches to enhancing the quality of drug therapy (attached as Appendix I). In addition CMA is co-funding, with the Canadian Institute of Health Research, an interdisciplinary research team focussed on Drug Policy Futures. The team’s identified areas of study include: financing and public expectations; improving quality; health care evaluation and technology assessment; and public advice-seeking in the era of e-health. The CMA publishes Drugs of Choice, a definitive Canadian guide to first- and second-line drug therapies for hundreds of clinical conditions. It is now in its third edition. In addition CMA maintains an extensive database of clinical practice guidelines, including prescribing guidelines, available to physicians and the public through the CMA Web site, and has developed an on line course for physicians on Safe Medication Practices. The cma.ca web site also provides access to a Canadian online drug database that can be downloaded and used with state-of-the-art PDA (personal device) technology at the point of clinical care. CMA’S PRIORITIES FOR ACTION A) Access to quality health care CMA’s history of advocating for access to needed health care services goes back many years. In 2004, a National Access Strategy will be one of the association’s highest-priority activities. With respect to prescription drugs there are several access-related problems: slow approval of new drugs, uneven insurance coverage, and the possible consequences of cross-border shopping on the availability of drugs in Canada. i) Drug Approvals: The Right Drug at the Right Time CMA recommends: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to drugs that demonstrate a substantial improvement over products already on the market. Stakeholders have repeatedly drawn attention to the slowness of Canada’s drug review process. Between 1996 and 1998 Canadian approval times (median 518 days) were significantly longer than Sweden (median 371 days), the UK (median 308 days) and the United States (median 369 days). These have not improved significantly even after Health Canada implemented a cost-recovery approach to funding the drug review process. Delays in the drug review process mean delays in access to new, potentially life-saving medications. For example, 15 other countries approved Singulair, a major breakthrough in asthma therapy, before it was approved in Canada, even though the drug was developed in Montreal! Approximately 10% of children between 5 and 14 years of age have asthma and could have benefited from this relatively safe drug. Intravenous tissue plasminogen activator (tPA), a medication for treatment of acute stroke, was approved for use in the United States in 1996 but was not approved in Canada until 1999. Canada’s long drug review times are mainly attributed to lack of resources at Health Canada. CMA recommends that Canada implement a timely and efficient drug review process to reduce these times to an appropriate level. The 2003 federal budget announcement of $190 million over five years to improve the timeliness of the regulatory process was encouraging. We hope that this will soon translate into a significant reduction in drug review times. Many drugs submitted for approval are not genuinely innovative; some are virtual copies of drugs already on the market. Others, however, could offer substantial improvement over what is currently available. They could be more clinically effective; or they could have fewer side effects; or their mechanism of delivery could increase compliance (for example, medication that can be taken only once a day instead of three or four times a day). CMA recommends that the pharmaceutical industry give priority to research and development on products and delivery mechanisms that offer substantial additional benefit to Canadian patients. It seems logical that drugs that offer benefits not yet available to Canadians should reach patients who need them more quickly. Recently, Health Canada implemented a priority review process for drugs to treat serious, life threatening or debilitating conditions, for which there is substantial evidence that the drug is a significant improvement over existing therapies. This is a promising step. CMA recommends that Health Canada apply a priority review process to all drugs deemed to offer substantial improvement over what is already on the market. This will also serve as an incentive to the pharmaceutical industry to emphasize drugs that offer substantial benefit in their research and development plans. ii) Coverage: Making the System Work CMA recommends: 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. Coverage for all Canadians. Prescription drugs are Canada’s most notable example of a public/ private partnership in health services delivery. Our country’s blend of public and private drug insurance coverage has worked reasonably well; but there is room for improvement. The Canada Health Act’s mandate covers “drugs, biologicals and related preparations when administered in the hospital”. Provincial and territorial drug programs vary with most covering only seniors and people on social assistance.9 Many Canadians get their drug coverage through private plans offered by their employers. But many people in Canada lack any kind of drug coverage. We do not know exactly how many. According to a report prepared for the Canadian Life and Health Insurance Association, 2% to 4% of Canadians have no coverage, but other reports place the number closer to 10%.10,11 At a minimum, 1 million to 3 million Canadians are in need of basic prescription drug coverage. Drug therapy may be more cost-efficient than some forms of hospital care. Is the current health care system promoting inefficiency by covering hospital services more completely than prescription drug therapy? In 1997 the National Forum on Health recommended that drugs become part of the publicly funded system. However, such a system would be prohibitively expensive; estimates range from $12.4 billion for a combined public and private model (with co-payments) to $13.8 billion for fully funded, public only model (no co-payments).12 The report of the Romanow Commission acknowledged this when it emphasized the need to “move in a gradual but deliberate and dedicated way to integrate prescription drugs more fully into the continuum of care”. For the short term, the report recommended a Catastrophic Drug Transfer to ensure that Canadians who face the greatest financial burden can continue to access the medications they need. The Trillium program in Ontario is an example of such a program. We need to know more about both the number of people who need drug coverage and the best means of providing them with it. As a first step, CMA recommends that the government, insurance providers and all partners in the public and private sectors conduct research to more accurately identify current gaps in prescription drug coverage, and develop policy options for bridging them. Given the ever larger role that prescription drug therapy is playing in health care in Canada, governments should consider expanding the current basket of “core services” to include prescription drugs. Under the Canada Health Act provinces and territories must ensure that medically necessary physician and hospital services are provided on a first-dollar basis. CMA has recommended that the scope of the basket of core services be updated regularly to reflect the realities of health care delivery and the needs of Canadians. Given the potential of prescription drugs to improve the system’s cost-effectiveness, we believe that Canadian governments must consider whether the concept of “core services” needs to be revised to reflect their importance, provided that this does not further compromise access to medically necessary hospital and physician services. Drug Pricing Policies: Toward a Policy for All Drugs in Canada. As mentioned previously, PMPRB controls the prices of brand-name patent medications in Canada. However, generic drug make up 40% of the drugs prescribed in this country. Canada has no mechanism to control the prices of generic drugs, as do some other countries (France, for example, has a decree stating that the price of a generic product must be at least 30% less than the price of the original patented brand.) 6 Most provinces have policies encouraging substitution of a brand drug by a comparable generic where appropriate. CMA believes it is time for Canadian governments to explore mechanisms for ensuring appropriate pricing of generic medications. Product Substitution: Making health the first priority. Even under their current system of limited coverage, federal and provincial governments have expressed concern about the cost of their drug programs, and implemented measures to reduce this cost. One of these is drug product substitution. Generic substitution, discussed in the previous section, is now commonplace; British Columbia has taken the concept further with its system of reference-based pricing. While CMA recognizes the motives behind drug product substitution, we believe that it should only be implemented if it does not jeopardize quality of care or patient confidentiality. Doctors would be happy to participate in discussion of initiatives around drug product substitution, to ensure that the health of the patient continues to be the highest priority to all stakeholders. iii) Access and Cross-Border Prescribing CMA recommends: 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship that exists between the patient and the physician. Prices of brand-name prescription drugs prices are higher in the US, where no price review body exists, than they are in Canada. As a result access to the need for prescription medication can pose considerable financial hardship, particularly for America’s elderly and poor. The rising cost of brand-name medications in the United States has led many Americans to look to Canada for less expensive alternatives. At least one US city, Springfield, Massachusetts, has begun a voluntary program to purchase prescription medication from Canada for its workers and retirees13 and the State of Illinois is examining the feasibility of following Springfield’s lead.14 US drug costs have also spurred a growth industry in Canada: Internet pharmacies. According to estimates in US media, approximately $650 million (US) worth of prescriptions are sold online every year.15 The prospect of accessing cheaper Canadian drugs is particularly appealing to elderly Americans who have turned to the Internet to purchase prescriptions they would be unable to afford at home. The burgeoning cross-border export of pharmaceuticals has had its consequences. Several brand-name multinational pharmaceutical manufactures have moved to stop or limit supplies to those Canadian pharmacies they believe are selling drugs over the Internet. They must now order directly from the manufacturer instead of from wholesalers.16 The brand-name companies have also held out the prospect of boycotting Canada in response to legislation passed by the US House of Representatives that would allow the importation of drugs by Americans.17 This legislation is now before the US Senate Health, Education, Labor and Pensions Committee. The US Food and Drug Administration has opposed importation on safety grounds. The CMA shares the increasingly prevalent concern that cross-border export will result in reduced access to prescription drugs in Canada, and damage the research and development capacity of brand-name prescription drug manufacturers in Canada. Therefore the CMA recommends that Canada monitor and, if necessary, regulate the export of brand-name drugs to ensure their continued availability in this country. Many Internet pharmacies offer the services of physicians who will sign prescriptions without seeing the patient in a consultation. This is not acceptable to the CMA, or to the regulatory Colleges of Physicians and Surgeons or the Canadian Medical Protective Association. It is clear that, in principle, to form an appropriate therapeutic relationship a physician must take a history, perform an appropriate physical examination, and order and interpret appropriate diagnostic tests on her patients. The role of the physician in drug therapy is a complex one; to be most effective it requires a strong ongoing professional relationship between patient and physician. This relationship is the foundation of medical practice; it is key to a prescribing decision and it must be maintained. Our position is discussed in greater detail in CMA’s Statement on Internet Prescribing (attached as Appendix II). B) Consumer Drug Information: From DTCA to DTCI CMA recommends: 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada. 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. In the past few years an increasing amount of information on prescription medication has become available to consumers. Much of this reaches Canadians in the form of direct to consumer advertising (DTCA) for specific brands, transmitted across the border from the United States, where it is a billion-dollar-a-year business. DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, advertisers have taken advantage of loopholes in the law to promote brand-name drugs in this country – for example, the controversial television campaign for Viagra. DTCA is also transmitted by print and TV across the border from the United States, and worldwide through the Internet. There is a strong lobby for a relaxation of the DTCA restrictions in Canada. DTCA boosts sales of advertised drugs. In 1999, 25 drugs accounted for 40% of that year’s increase in retail drug spending in the US; all these drugs were advertised to the public.18 Further, DTCA adversely affects the patient/physician relationship. Doctors report feeling pressure and ambivalence when patients ask them to prescribe a specific brand-name drug. 19,20 About 20% of respondents to the CMA’s 2003 physician survey felt patients’ request for advertised drugs had a negative impact on the patient/physician relationship.21 Advocates for DTCA maintain that it provides “consumers” with the information they need to become partners in their own health care. They maintain that DTCA does not undermine the patient/physician relationship, because it does not alter the fact that ultimate prescribing authority remains in the hands of the physician. However, the CMA believes that direct to consumer advertising of prescription drugs is inappropriate. DTCA * does not communicate risk adequately, or provide enough information to allow the consumer to make appropriate drug selections. Generally it does not provide information about other products or therapies that could be used to treat the same condition, * stimulates demand by exaggerating the risks of a disease and generating unnecessary fear, * contributes to a culture of “overmedicalization” by treating normal human conditions such as aging and baldness as diseases, and offering “a pill for every ill”. Brand-specific direct to consumer prescription drug advertising should not be permitted in Canada. CMA calls on the federal government to enforce the existing restrictions on DTCA found in the Food and Drug Act and its regulations to the full extent of the law. We believe that the public has a right to accurate, unbiased direct to consumer information (DTCI) on drugs and other therapies, to enable patients to make decisions regarding their own health care. This information may increase the appropriateness of prescription drug use. For example, it may encourage consumers to get treatment for conditions that are currently under-treated. However, there are more effective ways to provide this information than brand-name advertising. CMA has developed “Principles for Providing Information about Prescription Drugs to Consumers” as an alternative to DTCA; these are attached as Appendix III. We call on Canadian stakeholders, including governments, health professionals, consumer groups and industry, to work together to provide information for the public based on these principles. Further, the CMA calls on the federal government to develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. C) Safety: Ensuring Best Practices in Prescribing CMA recommends: 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. The health care system is complex, involving many inter-related and interdependent factors which could influence the frequency and intensity of medication incidents. Such “systems factors” might include * shortage of qualified health professionals (physicians, nurses and others), * inappropriate use of new technology, * unclear labeling or similar-looking drug preparations, * prescription drug misuse, including over-prescribing or under-prescribing of certain medications. Canada’s doctors are working to promote drug safety on a number of fronts. For example, CMA is working with governments at all levels to ensure that we do not “enrich the nation’s urine” through unnecessary prescribing. The Canadian Medical Association Journal regularly publishes research on prescribing practices. CMA also publishes Safe Medication Practices, a physician guide to patient safety; a companion online course is available on the cma.ca web site. We propose that the health care system work to create a culture that promotes optimal prescribing, by fostering outcomes research, creating supportive infrastructures, strengthening the capacity for post-marketing surveillance, and making the best possible use of technology. Our suggestions are discussed below. Closing the Care Gap. Given our present knowledge base, it is often difficult to ascertain whether current drug utilization patterns lead to improvements in health. For example, research on compliance with drug therapy, and the factors that improve it, is in its infancy and though we know that direct-to-consumer advertising affects drug sales we have yet to determine whether it affects health outcomes. A commitment to outcome-based research on drug utilization would help us find the answers to these and other questions. Research on prescribing patterns should respect the conditions outlined in CMA’s “Principles Concerning Physician Information” (attached as Appendix IV). The CMA calls on all stakeholders (governments, health professionals and the private sector) to join in supporting and encouraging outcome-based research to ascertain best practices in drug utilization and prescribing, and close care gaps when they are identified. Creating an infrastructure for safety. The CMA has no doubt of the overall quality of the prescription medications approved for use in Canada. However, the more drugs are used, the greater their potential for unintended harm. Studies in the United States have found that almost 2% of patients admitted to hospitals experienced a significant adverse drug event, and that the number of deaths due to medications increased over 200% over five years.22 Though studies are still in progress in Canada, we assume that rates of adverse medication events are similar in the two countries. The 2003 federal budget committed $10 million per year to establish a Patient Safety Institute to monitor and prevent medical incidents. This is an important step toward building a safer health care system, and Canada’s doctors are committed to moving this initiative forward. The CMA, with 11 other health care organizations, is a member of the Canadian Coalition on Medication Incident Reporting and Prevention. This initiative is led by Health Canada and has recently been funded through the Patient Safety Initiative. The federal government has also recently funded the Canadian Medication Incident Reporting and Prevention System to collect data on medication incidents and disseminate information designed to reduce their risk. The CMA believes that to be effective a patient safety initiative must * be voluntary, * be non-punitive; and * protect the privacy and confidentiality of physicians and patients. Further, efforts towards ensuring patient safety should address in a timely manner the “systems” issues referred to above, supporting and fostering a culture of safety. CMA is calling on governments to accelerate activities to establish the Patient Safety Institute using a “systems” approach. Strengthening Post-Marketing Surveillance. No matter how rigourous the drug approval and review process, it cannot identify all of a medication’s effects; many of these are only identified once the drug is in widespread use in the general population. A strong post-marketing surveillance system is needed to gather this knowledge and ensure patient safety. A post marketing surveillance system should include timely collection of data related to * adverse drug reactions, * medication incidents, * targeted drug effectiveness studies, * optimal utilization of medications. The goal of an enhanced post-marketing surveillance system is to monitor the ongoing safety and risk/benefit ratio of medications once they have been approved and are being used in the broad population. An ideal surveillance system would go beyond collecting and collating data, to analyze it and produce information that health care professionals and policy makers can use in decision-making at the population level. For example, data could be used to * communicate product related risks to health professionals and patients, * determine the incidence of adverse drug reactions and medication incidents in the Canadian population as a whole and various subgroups over time, as well as their health and economic impact. Currently post-marketing surveillance of drugs in Canada is inadequate, relying on reporting which is often erratic and inconsistent, and for which reporters are not compensated. Canada needs a coordinated post-marketing surveillance system to monitor the ongoing safety of marketed drugs. Surveillance should include medication incidents and adverse drug reactions, and should document and consider the effect of the “systems factors” contributing to these events. Making use of supportive technology. We mentioned that the current reporting system is erratic and inconsistent. An investment in supportive technology would reduce inconsistencies by increasing physicians’ capacity to report and even prevent medication incidents. Under the September 2000 federal/provincial Health Accord, the Government of Canada announced $500 million to expand the use of health information and communications technologies, including the adoption of electronic health records (EHRs). One of the advantages cited for a pan-Canadian EHR is that it could reduce the occurrence of adverse drug events – for example, handwritten prescription and interpretation errors. Progress has been slow, but CMA will follow with interest the pilot EHR program just announced in Alberta. While we expect improvement in prescribing practices and outcomes under such programs, we expect them to respect the principles of patient confidentiality and the right of prescribers to the privacy of their prescribing information. Technology can also make real-time communication within the health care system much easier. and CMA strongly recommends an investment in systems that can link physicians to one another and to the rest of the health care system. In its 2003 brief to the Finance Committee’s pre budget hearings, CMA recommended that the federal government immediately fund dedicated Internet connectivity for all physicians in Canada. CMA has also repeatedly called for sustained and substantial investment in a “REAL” (rapid, effective, accessible and linked) Health Communications and Coordination Initiative to improve technical capacity to communicate with front-line health providers in real time. Real-time information is essential for effective day-to-day health care and will form the cornerstone of an adverse drug reaction communication program for the 21st century. Conclusion It is vital to Canada’s physicians that our patients receive the right medications for their condition, at the right times, at the right prices. CMA calls on the federal government and all other stakeholders to work together to develop a comprehensive “made in Canada” prescription drug policy to realize this vision – one that promotes optimal prescribing, puts the health of patients first, respects the relationships of patient and physician and of patient and pharmacist, and honours the principle of patient confidentiality and the privacy of patient and prescriber information. The reports of the Romanow Commission on the Future of Health Care in Canada and the Senate Standing Committee on Science, Social Affairs and Technology review discussed issues surrounding prescription drug policy in Canada. We hope that the review by this parliamentary committee will lead to prompt and decisive action. APPENDIX I CMA POLICY APPROACHES TO ENHANCING THE QUALITY OF DRUG THERAPY A JOINT STATEMENT BY THE CMA ANDTHE CANADIAN PHARMACEUTICAL ASSOCIATION This joint statement was developed by the CMA and the Canadian Pharmaceutical Association, a national association of pharmacists, and includes the goal of drug therapy, strategies for collaboration to optimize drug therapy and physicians' and pharmacists' responsibilities in drug therapy. The statement recognizes the importance of patients, physicians and pharmacists working in close collaboration and partnership to achieve optimal outcomes from drug therapy. Goal of This Joint Statement The goal of this joint statement is to promote optimal drug therapy by enhancing communication and working relationships among patients, physicians and pharmacists. It is also meant to serve as an educational resource for pharmacists and physicians so that they will have a clearer understanding of each other's responsibilities in drug therapy. In the context of this statement, a "patient" may include a designated patient representative, such as a parent, spouse, other family member, patient advocate or health care provider. Physicians and pharmacists have a responsibility to work with their patients to achieve optimal outcomes by providing high-quality drug therapy. The important contribution of all members of the health care team and the need for cooperative working relationships are recognized; however, this statement focuses on the specific relationships among pharmacists, physicians and patients with respect to drug therapy. This statement is a general guide and is not intended to describe all aspects of physicians' or pharmacists' activities. It is not intended to be restrictive, nor should it inhibit positive developments in pharmacist-physician relationships or in their respective practices that contribute to optimal drug therapy. Furthermore, this statement should be used and interpreted in accordance with applicable legislation and other legal requirements. This statement will be reviewed and assessed regularly to ensure its continuing applicability to medical and pharmacy practices. Goal of Drug Therapy The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Optimal drug therapy is safe, effective, appropriate, affordable, cost-effective and tailored to meet the needs of patients, who participate, to the best of their ability, in making informed decisions about their therapy. Patients require access to necessary drug therapy and specific, unbiased drug information to meet their individual needs. Providing optimal drug therapy also requires a valid and accessible information base generated by basic, clinical, pharmaceutical and other scientific research. Working Together for Optimal Drug Therapy Physicians and pharmacists have complementary and supportive responsibilities in providing optimal drug therapy. To achieve this goal, and to ensure that patients receive consistent information, patients, pharmacists and physicians must work cooperatively and in partnership. This requires effective communication, respect, trust, and mutual recognition and understanding of each other's complementary responsibilities. The role of each profession in drug therapy depends on numerous factors, including the specific patient and his or her drug therapy, the prescription status of the drug concerned, the setting and the patient physician pharmacist relationship. However, it is recognized that, in general, each profession may focus on certain areas more than others. For example, when counselling patients on their drug therapy, a physician may focus on disease-specific counselling, goals of therapy, risks and benefits and rare side effects, whereas a pharmacist may focus on correct usage, treatment adherence, dosage, precautions, dietary restrictions and storage. Areas of overlap may include purpose, common side effects and their management and warnings regarding drug interactions and lifestyle concerns. Similarly, when monitoring drug therapy, a physician would focus on clinical progress toward treatment goals, whereas a pharmacist may focus on drug effects, interactions and treatment adherence; both would monitor adverse effects. Both professions should tailor drug therapy, including education, to meet the needs of individual patients. To provide continuity of care and to promote consistency in the information being provided, it is important that both pharmacists and physicians assess the patients' knowledge and identify and reinforce the educational component provided by the other. Strategies for Collaborating to Optimize Drug Therapy Patients, physicians and pharmacists need to work in close collaboration and partnership to achieve optimal drug therapy. Strategies to facilitate such teamwork include the following. Respecting and supporting patients' rights to make informed decisions regarding their drug therapy. Promoting knowledge, understanding and acceptance by physicians and pharmacists of their responsibilities in drug therapy and fostering widespread communication of these responsibilities so they are clearly understood by all. Supporting both professions' relationship with patients, and promoting a collaborative approach to drug therapy within the health care team. Care must be taken to maintain patients' trust and their relationship with other caregivers. Sharing relevant patient information for the enhancement of patient care, in accordance and compliance with all of the following: ethical standards to protect patient privacy, accepted medical and pharmacy practice, and the law. Patients should inform their physician and pharmacist of any information that may assist in providing optimal drug therapy. Increasing physicians' and pharmacists' awareness that it is important to make themselves readily available to each other to communicate about a patient for whom they are both providing care. Enhancing documentation (e.g., clearly written prescriptions and communication forms) and optimizing the use of technology (e.g., e-mail, voice mail and fax) in individual practices to enhance communication, improve efficiency and support consistency in information provided to patients. Developing effective communication and administrative procedures between health care institutions and community-based pharmacists and physicians to support continuity of care. Developing local communication channels and encouraging dialogue between the professions (e.g., through joint continuing education programs and local meetings) to promote a peer-review-based approach to local prescribing and drug-use issues. Teaching a collaborative approach to patient care as early as possible in the training of pharmacists and physicians. Developing effective communication channels and encouraging dialogue among patients, physicians and pharmacists at the regional, provincial, territorial and national levels to address issues such as drug-use policy, prescribing guidelines and continuing professional education. Collaborating in the development of technology to enhance communication in practices (e.g., shared patient databases relevant to drug therapy). Working jointly on committees and projects concerned with issues in drug therapy such as patient education, treatment adherence, formularies and practice guidelines, hospital-to-community care, cost-control strategies, sampling and other relevant policy issues concerning drug therapy. Fostering the development and utilization of a high-quality clinical and scientific information base to support evidence-based decision making. The Physician's Responsibilities Physicians and pharmacists recognize the following responsibilities in drug therapy as being within the scope of physicians' practice, on the basis of such factors as physicians' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of pharmacists (see The Pharmacist's Responsibilities). In addition, it is recognized that practice environments within medicine may differ and may affect the physician's role. Assessing health status, diagnosing diseases, assessing the need for drug therapy and providing curative, preventive, palliative and rehabilitative drug therapy in consultation with patients and in collaboration with caregivers, pharmacists and other health care professionals, when appropriate. Working with patients to set therapeutic goals and monitor progress toward such goals in consultation with caregivers, pharmacists and other health care providers, when appropriate. Monitoring and assessing response to drug therapy, progress toward therapeutic goals and patient adherence to the therapeutic plan; when necessary, revising the plan on the basis of outcomes of current therapy and progress toward goals of therapy, in consultation with patients and in collaboration with caregivers, pharmacists and other health care providers, when appropriate. Carrying out surveillance of and assessing patients for adverse reactions to drugs and other unanticipated problems related to drug therapy, revising therapy and, when appropriate, reporting adverse reactions and other complications to health authorities. Providing specific information to patients and caregivers about diagnosis, indications and treatment goals, and the action, benefits, risks and potential side effects of drug therapy. Providing and sharing general and specific information and advice about disease and drugs with patients, caregivers, health care providers and the public. Maintaining adequate records of drug therapy for each patient, including, when applicable, goals of therapy, therapy prescribed, progress toward goals, revisions of therapy, a list of drugs (both prescription and over-the-counter drugs) currently taken, adverse reactions to therapy, history of known drug allergies, smoking history, occupational exposure or risk, known patterns of alcohol or substance use that may influence response to drugs, history of treatment adherence and attitudes toward drugs. Records should also document patient counselling and advice given, when appropriate. Ensuring safe procurement, storage, handling, preparation, distribution, dispensing and record keeping of drugs (in keeping with federal and provincial regulations and the CMA policy summary "Physicians and the Pharmaceutical Industry (Update 1994)" (Can Med Assoc J 1994;150:256A-C.) when the patient cannot reasonably receive such services from a pharmacist. Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Care also should be provided in accordance with accepted scientific and ethical standards and procedures. The Pharmacist's Responsibilities Pharmacists and physicians recognize the following responsibilities as being within the scope of pharmacists' practice, on the basis of such factors as pharmacists' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of physicians (see The Physician's Responsibilities). In addition, it is recognized that, in selected practice environments, the pharmacists' role may differ considerably. Evaluating the patients' drug-therapy record ("drug profile") and reviewing prescription orders to ensure that a prescribed therapy is safe and to identify, solve or prevent actual or potential drug-related problems or concerns. Examples include possible contraindications, drug interactions or therapeutic duplication, allergic reactions and patient nonadherence to treatment. Significant concerns should be discussed with the prescriber. Ensuring safe procurement, storage, preparation, distribution and dispensing of pharmaceutical products (in keeping with federal, provincial and other applicable regulations). Discussing actual or potential drug-related problems or concerns and the purpose of drug therapy with patients, in consultation with caregivers, physicians and health care providers, when appropriate. Monitoring drug therapy to identify drug-related problems or concerns, such as lack of symptomatic response, lack of adherence to treatment plans and suspected adverse effects. Significant concerns should be discussed with the physician. Advising patients and caregivers on the selection and use of nonprescription drugs and the management of minor symptoms or ailments. Directing patients to consult their physician for diagnosis and treatment when required. Pharmacists may be the first contact for health advice. Through basic patient assessment (i.e., observation and interview) they should identify the need for referral to a physician or an emergency department. Notifying physicians of actual or suspected adverse reactions to drugs and, when appropriate, reporting such reactions to health authorities. Providing specific information to patients and caregivers about drug therapy, taking into account patients' existing knowledge about their drug therapy. This information may include the name of the drug, its purpose, potential interactions or side effects, precautions, correct usage, methods to promote adherence to the treatment plan and any other health information appropriate to the needs of the patient. Providing and sharing general and specific drug-related information and advice with patients, caregivers, physicians, health care providers and the public. Maintaining adequate records of drug therapy to facilitate the prevention, identification and management of drug-related problems or concerns. These records should contain, but are not limited to, each patient's current and past drug therapy (including both prescribed and selected over-the-counter drugs), drug-allergy history, appropriate demographic data and, if known, the purpose of therapy and progress toward treatment goals, adverse reactions to therapy, the patient's history of adherence to treatment, attitudes toward drugs, smoking history, occupational exposure or risk, and known patterns of alcohol or substance use that may influence his or her response to drugs. Records should also document patient counselling and advice given, when appropriate. Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Products and services should be provided in accordance with accepted scientific and ethical standards and procedures. APPENDIX II CMA POLICY Statement on Internet Prescribing The act of prescribing medication is a medical act carried out in the context of a patient-physician relationship. As such, it is subject to the clinical standards of practice, as well as the ethical guidelines of the medical profession and applicable law. Physicians should be aware of and comply with the legal requirements in their province or territory. If a physician wishes to sign a prescription for an individual who has not previously been his/her patient or a patient of his/her group practice or shared call group, basic principles of assessment and diagnosis must be applied. It is incumbent upon the physician to obtain an adequate history and perform an appropriate physical examination to reach a diagnosis which will ensure that the prescribed medications are appropriate. The physician should be expected to provide advice about any prescribed medication, and, where appropriate, would be expected to provide advice about appropriate monitoring requirements. The physician is advised to fully document the encounter. It is not acceptable for a physician to sign a prescription without properly assessing the patient. APPENDIX III CMA POLICY Principles for Providing Information about Prescription Drugs to Consumers Approved by the CMA Board of Directors, March 2003 Since the late 1990’s expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada23, it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public. Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information. The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the “biological revolution”, e.g. gene therapies. The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 24 Principle #1: The Goal is Good Health The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care. Principle #2: Ready Access Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator. Principle #3: Patient Involvement Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically. Principle #4: Evidence-Based Content Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available. Principle #5: Appropriate Information Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following: * indications for use of the drug * contraindications * side effects * relative cost. In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies). Principle #6: Objectivity of Information Sources Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information. Principle #7: Endorsement/ Accreditation Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board. Principle #8: Monitoring and Revision Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate. Principle #9: Physicians as Partners Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory. Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient’s condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public. Principle #10: Research and Evaluation Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes. APPENDIX IV CMA POLICY PRINCIPLES CONCERNING PHYSICIAN INFORMATION In an environment in which the capacity to capture, link and transmit information is growing and the need for fuller accountability is being created, the demand for physician information, and the number of people and organizations seeking to collect it, is increasing. Physician information, that is, information that includes personal health information about and information that relates or may relate to the professional activity of an identifiable physician or group of physicians, is valuable for a variety of purposes. The legitimacy and importance of these purposes varies a great deal, and therefore the rationale and rules related to the collection, use, access and disclosure of physician information also varies. The Canadian Medical Association (CMA) developed this policy to provide guiding principles to those who collect, use, have access to or disclose physician information. Such people are termed “custodians,” and they should be held publicly accountable. These principles complement and act in concert with the CMA Health Information Privacy Code,25 which holds patient health information sacrosanct. Physicians have legitimate interests in what information about them is collected, on what authority, by whom and for what purposes it is collected, and what safeguards and controls are in place. These interests include privacy and the right to exercise some control over the information; protection from the possibility that information will cause unwarranted harm, either at the individual or the group level; and assurance that interpretation of the information is accurate and unbiased. These legitimate interests extend to information about physicians that has been rendered in non-identifiable or aggregate format (e.g., to protect against the possibility of individual physicians being identified or of physician groups being unjustly stigmatized). Information in these formats, however, may be less sensitive than information from which an individual physician can be readily identified and, therefore, may warrant less protection. The purposes for the use of physician information may be more or less compelling. One compelling use is related to the fact that physicians, as members of a self-regulating profession, are professionally accountable to their patients, their profession and society. Physicians support this professional accountability purpose through the legislated mandate of their regulatory colleges. Physicians also recognize the importance of peer review in the context of professional development and maintenance of competence. The CMA supports the collection, use, access and disclosure of physician information subject to the conditions outlined below. 1. Purpose(s): The purpose(s) for the collection of physician information, and any other purpose(s) for which physician information may be subsequently used, accessed or disclosed, should be precisely specified at or before the collection. There should be a reasonable expectation that the information will achieve the stated purpose(s). The policy does not prevent the use of information for purposes that were not intended and not reasonably anticipated if principles 3 and 4 of this policy are met. 2. Consent: As a rule, information should be collected directly from the physician. Subject to principle 4, consent should be sought from the physician for the collection, use, access or disclosure of physician information. The physician should be informed about all intended and anticipated uses, accesses or disclosures of the information. 3. Conditions for collection, use, access and disclosure: The information should: * be limited to the minimum necessary to carry out the stated purpose(s), * be in the least intrusive format required for the stated purpose(s), and its collection, use, access and disclosure should not infringe on the physician’s duty of confidentiality with respect to that information. 4. Use of information without consent: There may be justification for the collection, use, access or disclosure of physician information without the physician’s consent if, in addition to the conditions in principle 3 being met, the custodian publicly demonstrates with respect to the purpose(s), generically construed, that: * the stated purpose(s) could not be met or would be seriously compromised if consent were required, * the stated purpose(s) is(are) of sufficient importance that the public interest outweighs to a substantial degree the physician’s right to privacy and right of consent in a free and democratic society, and * that the collection, use, access or disclosure of physician information with respect to the stated purpose(s) always ensures justice and fairness to the physician by being consistent with principle 6 of this policy. 5. Physician’s access to his or her own information: Physicians have a right to view and ensure, in a timely manner, the accuracy of the information collected about them. This principle does not apply if there is reason to believe that the disclosure to the physician will cause substantial adverse effect to others. The onus is on the custodian to justify a denial of access. 6. Information quality and interpretation: Custodians must take reasonable steps to ensure that the information they collect, use, gain access to or disclose is accurate, complete and correct. Custodians must use valid and reliable collection methods and, as appropriate, involve physicians to interpret the information; these physicians must have practice characteristics and credentials similar to those of the physician whose information is being interpreted. 7. Security: Physical and human safeguards must exist to ensure the integrity and reliability of physician information and to protect against unauthorized collection, use, access or disclosure of physician information. 8. Retention and destruction: Physician information should be retained only for the length of time necessary to fulfill the specified purpose(s), after which time it should be destroyed. 9. Inquiries and complaints: Custodians must have in place a process whereby inquiries and complaints can be received, processed and adjudicated in a fair and timely way. The complaint process, including how to initiate a complaint, must be made known to physicians. 10. Openness and transparency: Custodians must have transparent and explicit record-keeping or database management policies, practices and systems that are open to public scrutiny, including the purpose(s) for the collection, use, access and disclosure of physician information. The existence of any physician information record-keeping systems or database systems must be made known and available upon request to physicians. 11. Accountability: Custodians of physician information must ensure that they have proper authority and mandate to collect, use, gain access to or disclose physician information. Custodians must have policies and procedures in place that give effect to the principles in this document. Custodians must have a designated person who is responsible for monitoring practices and ensuring compliance with the policies and procedures. 1 Romanow R. Building on Values: the Future of Health Care in Canada. Report of the Commission on the Future of Health Care in Canada; November 2002. 2 Chobanian et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. JAMA 2003; 289. 3 Butler C, Rollnick S, Stott N. The practitioner, the patient and resistance to change. Recent Ideas on Compliance 1996;14(9):1357-62. 4 Canadian Institute for Health Information. Health spending to top $112 billion in 2002, reports CIHI. Media release. December 18, 2002. http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=media_18dec2002_e 5 Patent Medicine Prices Review Board. Pharmaceutical Trends, 1995/96 – 1999/00. Prepared for the Federal/Provincial/Territorial Working Group on Drug Prices; September 2001. 6 Patent Medicine Prices Review Board, A study of the Prices of the Top Selling Multiple Source Medicines in Canada. November 2002. 7 Approaches to Enhancing the Quality of Drug Therapy.” Joint policy of the Canadian Medical Association and Canadian Pharmacists Association. 8 It should be noted that the CMA does not have the authority to enforce directives on physicians with regard to prescribing. The provincial and Territorial Colleges of Physicians handle licensing and regulatory matters. 9 Manitoba, British Columbia and Saskatchewan provide some coverage to all residents after the co-payments and deductibles are paid. Quebec provides universal coverage to those not in a private plan. 10 Fraser Group/Tristat Resources. Drug Expense Coverage in the Canadian Population – Protection from Severe Drug Expenses. CLHIA. August 2002. 11 Palmer D’Angelo Consulting Inc. National Pharmacare Cost Impact Update Study. Executive Summary. September 4, 2002. 12 Ibid 13 Tynan T. Cash-strapped Springfield, Mass., begins buying Canadian prescription drugs. Edmonton Journal July 29, 2003. http://www.canada.com/edmonton/story.asp?id=21FB8445-1143-4C13-B282-76F380CB4FE1 14 CBSNews.com. Illinois looks to Canada for drugs. CBS News September 15, 2003. http://www.cbsnews.com/stories/2003/07/29/health/main565611.shtml 15Kedrosky P. Dangerous popularity of online pharmacies. National Post August 13, 2003. 16 Harris G. Pfizer moves to stem Canadian drug imports. New York Times August 7, 2003. http://www.nytimes.com/2003/08/07/business/07DRUG.html 17 Cusack B., Stinson S. US drug firms set to boycott Canada. National Post August 7, 2003. http://www.nationalpost.com/home/story.html?id=363CC2EA-1832-42F2-954C-0F52D1828E23 18 “Prescription Drugs and Mass Media Advertising.” National Institute for Health Care Management Research. Washington, DC, 2001. 19 Mintzes B, Barer ML, Kravitz RL at al. How does direct to consumer advertising affect prescribing? a survey in primary care environments with and without legal DTCA. CMAJ 169 (2003): 405 –412. 20 Food and Drug Administration. Direct to consumer advertising of prescription drugs: physician survey preliminary results. Accessed at www.fda.gov/cder/ddmac. 21Survey shows strong opposition to direct to consumer advertising. Accessed at http://www.cma.ca/cma/ 22 Canadian Coalition on Medication Incident Reporting and Prevention. A medication incident reporting and prevention system for Canada: business Plan. March 2002. 23 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, “information-seeking” advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media. 24 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general. 25 Canadian Medical Association. Health Information Privacy Code. CMAJ 1998;159(8):997-1016.
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Health Protection and a Canadian Public Health Strategy: A Comprehensive Approach To Public Health: Submission to Health Canada

https://policybase.cma.ca/en/permalink/policy1958
Last Reviewed
2011-03-05
Date
2004-04-12
Topics
Population health/ health equity/ public health
  2 documents  
Policy Type
Parliamentary submission
Last Reviewed
2011-03-05
Date
2004-04-12
Topics
Population health/ health equity/ public health
Text
This submission is the response of the Canadian Medical Association to Health Canada's request for feedback on its detailed "Health Protection Legislative Renewal" legislative proposal released in June 2003. Our submission calls for and is embedded in the broader context of a comprehensive approach to public health. The Canadian Medical Association is committed to working with others to realize the vision of a comprehensive, robust public health strategy as a vital component of Canada's health care system. This strategy should rest upon three pillars: * Emergency Response Empowering rapid and effective response to health emergencies, e.g. communicable disease outbreaks, water contamination, bio-terrorist attacks. * Health Protection: Ensuring that Canadians are protected from health risks in their daily environment; for example, risks associated with the use of health or consumer products, or with the potential spread of infectious disease. * Health Promotion and Disease Prevention Instituting programs to encourage healthy behaviour and advocating for public policy and fiscal policy that supports health. Though these three pillars have different foci and different legislative instruments, they must all be part of a strategy to enhance public health and public health service delivery in Canada. With specific reference to health protection, CMA believes that legislation should rest on the following principles: a) Commitment to the primacy of health and safety. b) Commitment to evidence-based decision making. c) A thorough risk-analysis procedure based on the relative risk of products or services. d) Support for informed patient decision-making. e) Accountability vested in the Government of Canada. f) A comprehensive, effective post-marketing surveillance system. g) Enforcement through effective, meaningful penalties for noncompliance. h) Flexibility to quickly and efficiently accommodate new technologies. i) Openness and transparency. j) Encouragement of collaboration and co-operation with other stakeholders, while respecting existing jurisdictions and legislative mechanisms. Recommendations A Canadian Public Health Strategy 1) That the federal government ensure that legislative and administrative measures related to public health complement one another in function and are connected through communications and co-ordination mechanisms. The Drug Review Process 2) That the federal government implement a timely and efficient drug review process to reduce review times to the fastest level consistent with ensuring improved health outcomes and the safety of the drug supply. 3) That the federal government consider co-operative agreements for drug review with comparable agencies in Europe, the United States and Australia, while retaining final authority as to whether a new product should be allowed on the Canadian market. 4) That the drug review and approval process be open and transparent, providing updates on review status and the opportunity for stakeholder input. 5) That Health Canada apply a priority review process to "breakthrough" drugs, i.e. those that demonstrate a substantial improvement over products already on the market. Patient Safety and Post-Marketing Surveillance 6) That Health Canada work in partnership with stakeholders including CMA and other national medical and health professional associations, to develop a rigourous post-marketing surveillance system to monitor the ongoing safety of marketed drugs. 7) That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 8) That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 9) That the federal government invest in measures such as electronic communications networks, to increase physicians' capacity to report medication incidents and to improve the timeliness of adverse event reporting. Drug Information and Advertising 10) That all stakeholders work to ensure that Canadians have ready access to a source of comprehensive, reliable information on health products and their uses, and that governments fund development and dissemination of validated information to physicians and to the public. 11) That the legislation define "promotion" and "advertising" so as to clearly distinguish them from unbiased health information, and from counselling by health professionals. 12) That the current safeguards against deception be strengthened in order to * Forbid fraudulent or misleading health claims in advertisements, on labels or in any other promotional or descriptive material pertaining to the product; * ensure pre-clearance and ongoing review of all health claims by an objective agency; * provide meaningful penalties for infraction. 13) That Health Canada maintain the current ban on advertising health products for treatment, prevention and cure of conditions or disease states to be identified in a regulatory schedule or administrative list; the inclusion of conditions in this list should be determined through a set of criteria that are written into the Act or regulations. 14) That the existing ban on direct to consumer advertising of prescription drugs be maintained and enforced to the full extent of the law, and that the loophole that currently permits advertising the name, price and quantity of a prescription drug be closed. 15) That all stakeholders, including medical associations and industry groups, work together toward effective regulation of drug promotion to health practitioners. Safeguarding the Privacy of Health Information 16) That the Health Protection Act respect the provisions of the Charter of Rights and Freedoms, the Federal Privacy Act and the Personal Information Protection and Electronic Documents Act (PIPEDA). 17) That the privacy provisions in the Health Protection Act meet the legislative test outlined in Section 3.6 of CMA's Health Information Privacy Code. Other Issues 18) That the Health Protection Act give Health Canada a clear mandate to develop guidance documents to address health and safety issues raised by new technologies. 19) That Natural Health Products be regulated on a strict framework that ensures their safety, quality and efficacy as well as the provision of complete and unbiased information to the public. 20) That the Act provide Health Canada with a clear mandate to collaborate with provincial/territorial and local governments across Canada in reviewing legislation governing all aspects of drinking water from source to consumption to ensure that comprehensive programs are in place and being properly implemented. 21) That Health Canada urgently review the Quarantine Act and modernize its provisions. 1. Introduction This submission is the response of the Canadian Medical Association (CMA) to Health Canada's request for feedback on its detailed "Health Protection Legislative Renewal" legislative proposal released in June 2003. Our submission calls for and is embedded in the broader context of a comprehensive approach to public health. It also includes recommendations dealing with selected specific issues raised in the proposal, particularly those that have a potential major impact on physicians and other health professionals, and on the practice of medicine. The Canadian Medical Association supports the government's efforts to update and revitalize health protection legislation. Physicians are committed to working with others to realize the vision of a comprehensive, robust public health strategy as a vital component of Canada's health care system, in order to realize Canada's potential as a healthy nation. Recent headlines illustrate the diversity of public health challenges facing Canadians: * The spread of avian flu across Asia, and the reappearance of SARS in China; * Reports linking the use of Selective Serotonin Reutake Inhibitor antidepressants to increased suicide and other behavioural disorders in children and adolescents, which led to a public warning against their use in this population; * The rapidly rising rates of obesity in Canada and other developed countries. To deal with these problems and others, a comprehensive public health strategy is required. This strategy should rest upon three pillars: emergency response, health protection and health promotion (Figure 1). Each of these pillars is discussed in greater detail in the following section. 2. Three Pillars of a Canadian Public Health Strategy a) Pillar #1: Emergency Response The 2003 SARS outbreak shone a merciless light on the difficulties that Canada's stretched public health system can encounter when it needs to respond to health emergencies. The 21st century has brought a disturbing array of new public health risks (such as avian flu) and old risks revisited (such as contamination of water supplies). A comprehensive public health strategy should be able address these risks by: * Empowering rapid and effective response to health emergencies, e.g. communicable disease outbreaks, water contamination, bio-terrorist attacks. * Supporting health surveillance, screening and research, to identify potential health risks. [FIGURE CONTENT DOES NOT DISPLAY PROPERLY. SEE PDF FOR PROPER DISPLAY] Figure 1. The Three Pillars of Public Health [FIGURE END] CMA Position: CMA's 2003 submission to the National Advisory Committee on SARS and Public Health (the Executive Summary is attached as Appendix I) recommended a number of measures to strengthen Canada's capacity to respond to health emergencies. These included: * The enactment of a Canada Emergency Health Measures Act to allow for a more rapid national response to emergencies that pose an acute and imminent threat to human health and safety in Canada. * The creation of an independent Canada Public Health Agency, headed by a Chief Public Health Officer of Canada who would work with provinces and territories to develop and implement a pan-Canadian public health action plan. * Enhancements to the current system of disease surveillance and response, so that it remains privacy sensitive and ensures a two-way flow of information between public health experts and front-line clinicians. In 2004 CMA reiterated these recommendations to the Honourable Carolyn Bennett, Minister of State for Public Health, in response to her request for consultation on a Canada Public Health Agency. b) Pillar #2: Health Protection The Health Protection function ensures that Canadians are protected from health risks in their daily environment; for example, risks associated with the use of health or consumer products, or with the potential spread of infectious disease. Specific health protection functions include: * Ensuring that Canadians have access to the right pharmaceutical drugs, which have been proven safe and efficacious, at the right times, for the right prices. Our policy in this area is further discussed in our 2003 submission to the House Standing Committee on Health's review of prescription drugs, an executive summary of which is attached (Appendix II). * Monitoring Canada's pharmaceutical drug supply to ensure its safety, effectiveness and continued availability. * Ensuring the safety of natural health products, medical devices, hazardous products and other consumer products. This should include the regulation of toxic substances, including tobacco. * Regulating health claims for consumer products. * Monitoring the advertising and promotion of health products to the public. * Administering quarantine procedures. * Developing regulatory frameworks to ensure the safety and effectiveness of new technologies such as gene therapy and genetically modified foods. CMA Position: The principles that CMA believes should guide review of health protection legislation are discussed in Section 3. c) Pillar #3: Health Promotion and Disease Prevention For more than 30 years the federal government has incorporated the promotion of health, as well as the treatment of disease, into its mandate. Activities undertaken in pursuit of this function include: * Programs to encourage healthy behaviours, e.g. physical activity strategies. * Advocating for or implementing public policy that supports health e.g. bans on tobacco advertising and sponsorship, and fiscal policies, such as high tobacco taxes. * Research strategies to increase our understanding of the determinants of health. CMA Position: The CMA has called on the federal government to commit to the goal of establishing Canada as the top country in the world with regard to the health status of its citizens. Canada remains one of the few countries in the industrialized world without a clear statement of national health goals, targets and strategies. All levels of government should enable the Health Council of Canada to monitor and report on defined health goals and priorities. In addition, the CMA has developed policies and statements urging action on specific health promotion issues including: obesity control; injury prevention; physical activity; tobacco control; mental health; and many others. Though these three pillars have different foci and different legislative instruments, they must all be part of a comprehensive legislative agenda and strategy to renew and enhance public health and public health service delivery in Canada. Addressing issues under one pillar without reference to the other pillars or to a comprehensive public health framework and strategy fails to address the overall public health needs of Canadians. Recommendation 1. That the federal government ensure that legislative and administrative measures related to public health complement one another in function and are connected through communications and co-ordination mechanisms. 3. A Policy Framework for Health Protection Legislation This submission is a response to a legislative proposal regarding health protection; consequently the rest of this document will focus on the second of the three pillars described above, the "health protection" pillar. This section discusses the overall policy framework that the CMA believes should govern health protection in Canada. The CMA holds that health protection legislation should rest on the following principles: i) Primacy of Health and Safety. Legislation should commit to protection of public health and safety as its primary objective. ii) Core Values. Legislation should recognize the core values of Canadians, such as privacy of health and personal information, freedom of choice, and protection of vulnerable citizens, and be sensitive to cultural, gender, socio-economic and other factors where relevant. Where there is a conflict between Principle (i) and other values, this conflict and the grounds on which to resolve it should be explicitly stated. iii) Evidence-based Decision Making. Legislation should reflect a commitment to scientific, evidence-based decision making. It should provide for the requisite mechanisms to ensure that reviews of risk are independent and unbiased. iv) The Risk Assessment Process. Legislation should reflect a thorough risk-analysis procedure including risk assessment and evaluation. The pre-approval scrutiny to which a product1 is subjected should be based on its relative risk: regulatory requirements should be greater for products with greater risk and lower for those with less risk. Risk assessment should take into account risk to the community as well as to individuals. While the risk assessment process should be science-based, it should also recognize that public perception might influence the management and communication of risk. In areas of risk uncertainty, application of the precautionary principle could be considered on a case-by-case basis. v) General Safety Requirement. The CMA supports the proposal to include in the legislation a General Safety Requirement that would make it illegal for anyone to manufacture, promote or market a product that may present an undue risk to health, under reasonably foreseeable conditions of use. However, this overall requirement should not be used as a substitute for enacting regulations to cover specific products if evidence indicates that such regulations are necessary to protect public health. Nor should it be used as a rationale for relaxing regulatory regimes currently in place. vi) Support for Informed Patient Decision-Making. Legislation should ensure that Canadians have access to reliable, evidence-based information to support them in making decisions regarding their own health, and should ensure that the information they receive is not misleading or deceptive. vii) Accountability. Legislation should ensure that there is clear accountability for decision-making, and that this is vested in the Government of Canada. viii) Surveillance. Legislation should ensure comprehensive, effective post-marketing surveillance of drugs and other health products. This should be co-coordinated with surveillance and research programs governed by related public health acts such as the proposed Canada Emergency Health Measures Act. ix) Enforcement. Legislation should provide and enforce effective, meaningful penalties for noncompliance. x) Flexibility. Legislation should allow for flexibility in product approval, consistent with Principle i, in order to quickly and efficiently accommodate emerging issues (such as new technologies) developed in Canada and internationally. xi) Openness and Transparency. Legislation should operate transparently, incorporating ongoing, two-way communication with stakeholders, including health professionals and the public. xii) Working with Others. Legislation should encourage collaboration and co-operation with other federal departments, with provinces and territories, and with non-governmental and international organizations. At the same time it should respect existing jurisdictions and existing legislative and administrative mechanisms. 4. Impact of Health Protection Legislation on Medical Practice Physicians, along with other health professionals, play an important role in maintaining high health standards and communicating appropriate health information to Canadians. Some of the proposals included in the legislative proposal could have a significant positive or negative impact on medical practice. These include: a) The Drug Review Process Stakeholders have repeatedly drawn attention to the slowness and secrecy of Canada's drug approval process. Between 1996 and 1998 Canadian approval times (median 518 days) were significantly longer than Sweden (median 371 days), the UK (median 308 days) and the United States (median 369 days). These have not improved significantly even after Health Canada implemented a cost-recovery approach to funding drug reviews. In addition, the review process may not distinguish genuinely new and innovative "breakthrough" drugs from imitations of products already on the market. The legislative proposal discusses possible means of modernizing the drug review process, including co-operative agreements with comparable drug review agencies in other jurisdictions, and establishment of a mechanism for public comments. The CMA approves both these suggestions. To ensure that Canadians have access to the right drugs for their conditions as quickly as is consistent with safety, the CMA recommends: Recommendations 2. That the federal government implement a timely and efficient drug review process to reduce review times to the fastest level consistent with ensuring improved health outcomes and the safety of the drug supply. 3. That the federal government consider co-operative agreements for drug review with comparable agencies in Europe, the United States and Australia, while retaining final authority as to whether a new product should be allowed on the Canadian market. 4. That the drug review and approval process be open and transparent, providing updates on review status and the opportunity for stakeholder input. 5. That Health Canada apply a priority review process to "breakthrough" drugs, i.e. those that demonstrate a substantial improvement over products already on the market. b) Patient Safety and Post-marketing surveillance Recent reports have drawn public attention to the need for a rigourous, well-resourced post-marketing surveillance system to monitor the ongoing safety of marketed drugs and other health products in Canada. CMA strongly recommends that Health Canada work in partnership with stakeholders to develop such a system. The system should be non-punitive, supporting a "culture of safety" rather than one of blame, and should respect the privacy of patients and physicians. In this context the CMA supports the establishment of the Patient Safety Institute. In developing its post-marketing surveillance capacity, Health Canada should ensure that sufficient resources are in place to enable the system to: * Facilitate the reporting of adverse reactions by health professionals and others. The CMA supports activities that encourage the voluntary reporting of adverse reactions by physicians and others. For example, to facilitate timely and comprehensive reporting, forms should be easily accessible and the reporting process should be computerized, simple and transparent. * Collect and analyze data and produce information that health care professionals and policy makers can use in decision-making at the population level. With appropriate privacy safeguards, this information could also be used for a number of research purposes, e.g. monitoring the importation and use of drugs not yet licensed in Canada; ascertaining best practices in prescribing. * Communicate this information back to the provider in real time. The importance of real-time two-way communication with front-line practitioners and institutions cannot be overstated. The CMA has repeatedly called for sustained and substantial investment in a Health Communications and Coordination Initiative to improve the technical capacity of front-line health providers to communicate in real time with one another and with the rest of the health care system. This is a critical endeavour and should be undertaken immediately, using funds established for health surveillance in the March 2004 Federal Budget, and implemented within the next 6 months. This network could form the cornerstone of an adverse drug reaction reporting system. Recommendations: 6. That Health Canada work in partnership with stakeholders including CMA and other national medical and other health professional associations, to develop a rigourous post-marketing surveillance system to monitor the ongoing safety of marketed drugs. 7. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 8. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 9. That the federal government invest in measures such as electronic communications networks, to increase physicians' capacity to report medication incidents and improve the timeliness of adverse event reporting. c) Drug Information and Advertising CMA believes that the public has a right to unbiased, accurate information on drugs and other therapeutic products. This information should be provided in accordance with CMA's "Principles for Providing Information about Prescription Drugs to Consumers" (Appendix III). Brand-specific product advertising is a less than optimal way of providing this information, and should be carefully monitored to discourage fraudulent or misleading claims. In particular, direct to consumer advertising of prescription drugs should not be permitted in Canada. Physicians and their associations are willing to work with Health Canada and other stakeholders in developing and disseminating accurate, unbiased information to the public and to health professionals about drugs and other health products. Recommendations: 10. That all stakeholders work to ensure that Canadians have ready access to a source of comprehensive, reliable information on health products and their uses, and that governments fund development and dissemination of validated information to physicians and to the public. 11. That the legislation define "promotion" and "advertising" so as to clearly distinguish them from unbiased health information, and from counselling by health professionals. 12. That the current safeguards against deception in advertising be strengthened in order to * Forbid fraudulent or misleading health claims in advertisements, on labels or in any other promotional or descriptive material pertaining to the product; * Ensure pre-clearance and ongoing review of all health claims by an objective agency; * Provide meaningful penalties for infraction. 13. That Health Canada maintain the current ban on advertising health products for treatment, prevention and cure of conditions or disease states to be identified in a regulatory schedule or administrative list; the inclusion of conditions in this list should be determined through a set of criteria that are written into the Act or regulations. 14. That the existing ban on direct to consumer advertising of prescription drugs be maintained and enforced to the full extent of the law, and that the loophole that currently permits advertising the name, price and quantity of a prescription drug be closed. 15. That all stakeholders, including medical associations and industry groups, work together toward effective regulation of drug promotion to health practitioners. d) Safeguarding the privacy of health information Patients must be able to feel assured that anything they tell their physicians will remain confidential, imparted to others only to the extent necessary to ensure optimal care. Accordingly, the privacy and confidentiality of patient-specific and physician-specific information should be safeguarded to the fullest extent possible. New technologies, e.g. electronic health records, have made the transfer of information simpler and more efficient. They have also made it more vulnerable to infringements on a patient's right to privacy. Several important pieces of legislation to safeguard privacy have already been enacted. In addition, the CMA has developed a Privacy Code (Appendix IV) that discusses confidentiality issues specific to health information. Section 3.6 of this Code contains a legislative test to which all proposed legislation, including the Health Protection Act, should be submitted. Recommendations 16. That the Health Protection Act respect the provisions of the Charter of Rights and Freedoms, the Federal Privacy Act and the Personal Information Protection and Electronic Documents Act (PIPEDA). 17. That the privacy provisions in the Health Protection Act meet the legislative test outlined in Section 3.6 of CMA's Health Information Privacy Code. e) Other Issues The legislative proposal discusses giving Health Canada the power to develop guidelines or regulatory frameworks for specific circumstances, e.g. for new products and technologies such as genetically modified foods; or for situations in which the health of the public may otherwise be at risk, such as contamination of drinking water. In addition, the proposal discusses the possibility of modernizing existing laws that have become outdated. The CMA supports the direction of these proposals. The Quarantine Act, for example, is a piece of legislation the CMA believe merits urgent updating; new legislation should incorporate quarantine provisions for possible vectors leaving as well as entering Canada, and for inter-provincial as well as international traffic. With regard to specific issues not addressed elsewhere in this submission, the CMA recommends: Recommendations 18. That the Health Protection Act give Health Canada a clear mandate to develop guidance documents to address health and safety issues raised by new technologies. 19. That Natural Health Products be regulated on a strict framework that ensures their safety, quality and efficacy as well as the provision of complete and unbiased information to the public. 20. That the Act provide Health Canada with a clear mandate to collaborate with provincial/ territorial and local governments across Canada in reviewing legislation governing all aspects of drinking water from source to consumption to ensure that comprehensive programs are in place and being properly implemented. 21. That Health Canada urgently review the Quarantine Act and modernize its provisions. 5. Conclusion Health protection is one of three pillars of an effective public health system, along with rapid and effective emergency response, and programs and policies to maintain health and prevent disease. The CMA is pleased to have been able to advise governments on all of these pillars, in order to establish the health of Canadians on a strong foundation. We look forward to continued consultation with Health Canada on the proposed Health Protection Act, both on its overall framework and on specific issues of concern to the medical profession. We trust that the result will be strong legislation, founded on fair and enduring principles, to safeguard the health and security of Canadians. APPENDIX I Answering the Wake-up Call: CMA's Public Health Action Plan CMA Submission to Naylor Advisory Committee on SARS and Public Health (Executive Summary) The public health system in Canada lies at the heart of our community values. It is the quintessential "public good" and is central to the continued good health of our population. When the public health system is working well, few are even aware that it is at work! Only when something goes terribly wrong - like the Walkerton tragedy or when we are faced with a new threat like SARS - is the integral, ongoing role of public health really recognized. The Canadian Medical Association (CMA) has been warning that our public health system is stretched to capacity in dealing with everyday demands, let alone responding to the latest crises. Canada's physicians have repeatedly called for governments to enhance public health capacity and strengthen the public health infrastructure throughout Canada. Our public health system is the first - and often the only - line of defence against emerging and ongoing infectious and noninfectious threats to the health of Canadians. But we are only as strong as the weakest link in the emergency response chain of survival. As most health threats know no boundaries, our public health armaments must be in a constant state of "battle readiness." In today's climate of SARS, West Nile Virus, mad cow disease and monkey pox, even the thought that the public health system may be stretched beyond capacity strikes fear into the hearts of Canadians. Physicians have always been an integral part of the public health system serving as medical officers of health, community health specialists and other related roles. Indeed public health cannot successfully fulfill its mandate without the cooperation and commitment of front-line clinicians. In this submission, we reflect on the lessons to be learned from our recent experience with SARS and reflect on the longer-term needs of the public health system as a whole. The objectives of the pan-Canadian Public Health Action Plan proposed by the CMA are, first to realize a clearer alignment of authority and accountability in times of extraordinary health emergencies; and, second, to enhance the system's capacity to respond to public health threats across the country (see recommendations, below). To achieve these twin objectives, three broad strategies are presented for immediate attention. They are legislative reform; capacity enhancement; and research, surveillance and communications. Legislative reform (see recommendations 1-3) The country's response to SARS has brought into stark relief the urgent need for national leadership and coordination of public health activity across the country, especially during a health crisis. The apparent reluctance to act quickly to institute screening at airports, the delay in unifying the practice community for a concerted response and the appalling communications confusion worked against optimum handling of the outbreak - despite the best efforts of health care professionals. This is a wake-up call that highlights the need for comprehensive legislative reform to clarify the roles of governments with respect to the management of public health threats. A renewed and enhanced national commitment to public health should be anchored in new federal legislation to be negotiated with the provinces and territories. Specifically, the CMA recommends an Emergency Health Measures Act, to deal with emergent situations in tandem with the creation of a Canadian public health agency headed by a Chief Public Health Officer of Canada. Capacity enhancement (see recommendations 4-7) The SARS crisis has demonstrated the diminished capacity within the public health system. The Greater Toronto Area (GTA), with one of Canada's most sophisticated public and acute health systems, has not been able to manage the SARS crisis adequately and carry on other health programs. The acute care system virtually ground to a halt in dealing with SARS. There was little or no surge capacity in Canada's largest city. We should be grateful that SARS did not first strike a smaller centre in a far less-advantaged region of Canada. A critical element of the public health system is its workforce and the health professionals within the acute care system, such as hospital-based infectious disease specialists and emergency physicians who are the front-line interface. Let there be no doubt that the ongoing efforts of the GTA front-line providers are nothing short of heroic. However, the lack of coordinated contingency planning of hospital and community-based disease control efforts was striking. The overall shortage of critical care professionals and the inability of governments to quickly deploy the required professionals to areas of need contributed to the enormous strain on the public and health care system. Considering the importance of the public health system and its clearly limited capacity to protect and promote the health of Canadians, it is incomprehensible that we do not know how much is actually spent on the system. It is imperative that public health expenditures and capacity, in terms of both physical and human resources, be tracked and reported publicly. The CMA recommends a $1-billion, 5-year capacity-enhancement program to be coordinated with and through the new Canadian public health agency. Research, surveillance and communications (see recommendations 8-10) Canada's ability to respond to public health threats and acute events, such as SARS, and to maintain its effective public health planning and program development depends on sound research, surveillance and rapid, real-time communications. A concerted pan-Canadian effort is required to take full advantage of our capacity for interdisciplinary research on public health, including infectious disease prevention and control measures. New-millennium challenges require moving beyond old-millennium responses. Enhanced surveillance is an overdue and integral part of public health, performing an essential function in early detection and response to threats of infectious diseases. Mandatory national reporting of identified diseases by all provinces and territories is critical for national and international surveillance. During times of crisis, rapid communication to the public, public health staff and front-line clinicians is of critical importance, but in many jurisdictions impossible. We tested our systems during the SARS outbreak and they came up short. The CMA recommends a one-time federal investment to enhance technical capacity to allow for real-time communication. Conclusion The CMA believes that its proposed three-pronged strategy, as set out in the attached recommendations, will go a long way toward addressing shortfalls of the Canadian public health system. Action now will help to ensure that Canadians can once again be confident that they are protected from any future threat of new infectious diseases. Action now will help Canada regain its position as a leader in public health. We wish the advisory committee well in its deliberations and offer the CMA's assistance at any time in clarifying the strategies set out in our submission. Recommendations to the National Advisory Committee on SARS and Public Health Legislative reform ($20 million / 5 years*) 1. The enactment of a Canada Emergency Health Measures Act that would consolidate and enhance existing legislation, allowing for a more rapid national response, in cooperation with the provinces and territories, based on a graduated, systematic approach, to health emergencies that pose an acute and imminent threat to human health and safety across Canada. 2. The creation of a Canadian Office for Disease Surveillance and Control (CODSC) as the lead Canadian agency in public health, operating at arm's length from government. 3. The appointment of a Chief Public Health Officer of Canada to act as the lead scientific voice for public health in Canada; to head the Canadian Office for Disease Surveillance and Control; and to work with provinces and territories to develop and implement a pan-Canadian public health action plan. Capacity enhancement ( $1.2 billion / 5 years*) 4. The creation of a Canadian Centre of Excellence for Public Health, under the auspices of the CODSC, to invest in multidisciplinary training programs in public health, establish and disseminate best practices among public health professionals. 5. The establishment of a Canadian Public Health Emergency Response Service, under the auspices of the CODSC, to provide for the rapid deployment of human resources (e.g., emergency pan-Canadian locum programs) during health emergencies. 6. Tracking and public reporting of public health expenditures and capacity (both physical and human resources) by the Canadian Institute for Health Information and Statistics Canada, on behalf of the proposed Canadian Office for Disease Surveillance and Control. 7. Federal government funding in the amount of $1 Billion over 5 years to build adequate and consistent surge capacity across Canada and improve coordination among federal, provincial/territorial and municipal authorities to fulfill essential public health functions. Research, surveillance and communications ($310 million / 5 years*) 8. An immediate, sequestered grant of $200 million over 5 years to the Canadian Institutes of Health Research to initiate an enhanced conjoint program of research with the Institute of Population and Public Health and the Institute of Infection and Immunity that will expand capacity for interdisciplinary research on public health, including infectious disease prevention and control measures. 9. The mandatory reporting by provinces and territories of identified infectious diseases to the newly established Chief Public Health Officer of Canada to enable appropriate communications, analyses and intervention. 10. The one-time infusion of $100 million, with an additional $2 million a year, for a "REAL" (rapid, effective, accessible and linked) Health Communication and Coordination Initiative to improve technical capacity to communicate with front line public health providers in real time during health emergencies. APPENDIX II The Right Drugs, at the Right Times, for the Right Prices: Toward a Prescription Drug Policy for Canada CMA Submission to House of Commons Standing Committee on Health Every year, three hundred million prescriptions - about 10 for every man, woman and child - are filled in Canada. Prescription drugs have benefited both the health of Canadians, and the health care system itself; they have meant dramatically improved quality of life for many Canadians, and have saved the country a great deal in hospitalization, social benefits and other expenses. However, it could be questioned whether all of Canada's prescription drug use is appropriate; patients may be receiving too few medications, too many medications or suboptimal medications for their conditions. In addition, prescription drugs carry a price tag of their own. Since 1975, expenditures on prescription medication have risen faster than any other category in the health sector in Canada, and more is now spent on prescription drugs than on physician services. Governments, health care providers, drug manufacturers and the public must constantly strive to ensure that Canadians receive optimal and appropriate prescription drug therapy: the right drugs, at the right times, for the right prices. A considered, coherent, comprehensive, "made in Canada" approach to prescription drug policy should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. Prescription drug policy in Canada should address: Access: to * efficacious new drugs within an appropriate time; * coverage for medically necessary drugs for catastrophic care; * generic drugs at reasonable prices; * a patient/physician consultation as part of the prescribing process; * continued research and development capacity in Canada. Information for health care providers and the public that is balanced and accurate. Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada's doctors are committed to working with others to ensure that Canadians receive the right drugs, at the right times, for the right prices. Summary of CMA Recommendations: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to all drugs that demonstrate a substantial improvement over products already on the market. 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for all Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship which exists between the patient and the physician. 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada, 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. APPENDIX III CMA POLICY Principles for Providing Information about Prescription Drugs to Consumers Approved by the CMA Board of Directors, March 2003 Since the late 1990's expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada 2 , it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public. Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information. The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the "biological revolution", e.g. gene therapies. The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 3 Principle #1: The Goal is Good Health The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care. Principle #2: Ready Access Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator. Principle #3: Patient Involvement Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically. Principle #4: Evidence-Based Content Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available. Principle #5: Appropriate Information Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following: * indications for use of the drug * contraindications * side effects * relative cost. In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies). Principle #6: Objectivity of Information Sources Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information. Principle #7: Endorsement/ Accreditation Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board. Principle #8: Monitoring and Revision Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate. Principle #9: Physicians as Partners Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory. Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient's condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public. Principle #10: Research and Evaluation Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes. APPENDIX VI CMA POLICY HEALTH INFORMATION PRIVACY CODE This Code articulates principles for protecting the privacy of patients, the confidentiality and security of their health information and the trust and integrity of the therapeutic relationship. Its provisions are more exacting than those currently in place in the Canadian health care system. Although a patchwork of laws across Canada permit or require health information collection, use, disclosure and access without patient consent, or even knowledge, this Code would require that all of these laws and any proposed laws be reviewed for consistency with its provisions. Moreover, existing practices and initiatives concerning health information collection, use, disclosure and access, including health information systems or networks, may be contrary to patient expectations and the physician's duty of confidentiality. These practices and initiatives must also be reviewed for consistency with this Code. Many laws, practices and initiatives may not withstand the kind of scrutiny deemed necessary and reasonable for the protection of privacy and the trust and integrity of the therapeutic relationship. CMA issues this Code in recognition that its implementation raises numerous issues and challenges, and that the changes it envisions will require time and the expenditure of resources. CMA appreciates that, given the complexity of the health care system, agreement and cooperation among a wide range of users and collectors of health information will be essential to the successful implementation of this Code. In view of these challenges, CMA issues this Code to the Canadian health care community at this time as an ideal to strive for, to guide and coordinate the efforts that need to be made to protect the privacy of patients, the confidentiality and security of their health information and the trust and integrity of the therapeutic relationship. Moreover, this Code is issued in the understanding that those to whom it applies will not be able to achieve full compliance with its provisions until such time as numerous implementation issues have been clarified and resolved through cooperation and the coordinated efforts of many different stakeholders. Consequently, companion implementation documents are being developed that provide for a gradual implementation of the Code's provisions over a five-year span and outline work that needs to be done to achieve the ideal it envisions. Section A: Scope This Health Information Privacy Code ("Code") has been produced by physicians to protect the privacy of their patients, the confidentiality and security of their health information and the trust and integrity of the therapeutic relationship. This Code is based on the Canadian Standards Association's Model Code for the Protection of Personal Information ("CSA Code") as a sectoral code of the CSA Code. This Code provides instruction and guidance respecting health information collection, use, disclosure and access. 1. This Code describes the minimum requirements to protect the privacy of patients and the security and confidentiality of their health information. 2. This Code has been developed by physicians in their capacity as clinicians and in recognition of their principal obligation to patients. 3. This Code recognizes the potential benefits of the use of health information for secondary purposes, including teaching, research and system planning, and contains provisions to permit such use under clearly defined terms and conditions. 4. This Code has been developed as a sectoral code of the Canadian Standards Association's Model Code for the Protection of Personal Information and consequently adopts the minimum standards contained in the CSA Code and augments them to meet the special circumstances of health information. 5. The development of this Code has been inspired by the report of the House of Commons Standing Committee on Human Rights and the Status of Persons with Disabilities, entitled Privacy: Where Do We Draw The Line? 6. The Code applies to all health information and to all individuals, groups or organizations that collect, use, disclose or access such information. Its objective is to instruct in the development and implementation of policies, practices, health information systems or networks and legislation. 7. The principles that make up this Code are interrelated. Health information custodians adopting this Code shall adhere to these principles as a whole. 8. Health information custodians must subscribe to the principles contained in this Code and agree to uphold them, but may tailor this Code by modifying or adding principles provided the changes afford no less protection to the privacy of patients and the confidentiality and security of their health information. 9. Statements containing "shall" or "must" indicate requirements that must be met by any health information custodian who wishes to adopt this Code and be recognized for having done so. The use of "should" indicates a recommendation or aspiration. Section B: Definitions The following definitions apply in this Code: "Access" means the ability to acquire or possess health information in any information format. "Accountability" means having clearly defined and understood responsibilities in connection with health information, agreeing to accept those responsibilities and being subject to appropriate sanctions for failing to fulfil accepted responsibilities. "Authorized" means that which occurs with patient consent or within the provisions of this Code and applies to purposes, collection, use and disclosure of, or access to, health information. "Authorized user" is someone permitted to collect, use, disclose or access health information under the provisions of this Code, who is properly instructed on his or her limits and responsibilities, and who can be held accountable for his or her compliance. "Collection" means the act of accessing, receiving, compiling, gathering, acquiring or obtaining health information from any source, including third parties, and by any means. It includes information collected from the patient, as well as secondary collection of this information in whole or in part by another provider or user. "Confide" and "confided" mean the revelation of information by a patient within the therapeutic context. "Confidentiality" and "confidential" mean that health information that is confided by a patient is to be kept secret and not disclosed or made accessible to others unless authorized by patient consent. A breach of confidentiality occurs whenever a health professional discloses or makes health information available to others without or inconsistent with the patient's consent. "Consent" means a patient's informed and voluntary agreement to confide or permit access to or the collection, use or disclosure of his or her health information for specific purposes. Express consent is given explicitly, either orally or in writing. Express consent is unequivocal and does not require any inference on the part of the provider seeking consent. Implied consent arises where agreement may reasonably be inferred from the action or inaction of the individual and there is good reason to believe that the patient has knowledge relevant to this agreement and would give express consent were it sought. "Disclosure" means the provision of health information to a third party for any reason, or making health information available for a third party to collect. It includes any transfer or migration of health information from one provider or user to another. "Duty of confidentiality" means the duty of physicians and other health professionals in a fiduciary relationship with patients to ensure that health information is kept secret and not disclosed or made accessible to others unless authorized by patient consent. "Emergency situations" mean those instances when health care must be provided to preserve life or prevent severe harm to a patient who is unable, owing to the circumstances, to be cognizant of the context and whose surrogate is not immediately available to make decisions on the patient's behalf. "Fiduciary duty" means the obligation to act with the utmost good faith for the benefit of another. "Health information" means any information about a patient that is confided or collected in the therapeutic context, including information created or generated from this information and information that is not directly or indirectly linked to the provision of health care. It includes all information formats. "Health information custodian" means any organization or institution that has custody, care or control of health information, and includes hospitals, regional boards, governments, corporations and solo or group medical practices. "Information format" means any form containing or recording health information, including: (a) a form that identifies or could identify a specific patient, either directly or indirectly; (b) a form that removes the link between the patient and information about him or her and which could, either directly or indirectly, be manipulated to reconnect the link between the patient and information about him or her ("deidentified-relinkable"); (c) a form that removes the link between the patient and information about him or her with the intent of preventing any reconnection of the link between the patient and information about him or her in accordance with recognized standards ("anonymous"); or (d) the composite form produced when health information is linked to any information about the patient from any other source, whether or not it is also health information. "Integrity of health information" means the preservation of its content throughout storage, use, transfer and retrieval so that there is confidence that the information has not been tampered with or modified other than as authorized. "Health professional" is any person having a fiduciary duty to patients who is registered and entitled by provincial or territorial law to practise or provide health care in that province or territory. "Knowledge" means the patient's awareness of what can or must happen with the health information he or she confides or permits to be collected. "Linkage" is the joining together of health information with information from any other source or database, in whatever form. When health information is linked to any other information, the composite is also health information. "Nonconsensual" collection, use, disclosure or access, whether justified or not, occurs without a patient's consent and contravenes the patient's right of privacy. "Patient" means the person about whom health information is collected and, for the purposes of this Code, may also mean a surrogate or guardian acting on behalf of this person. "Physician" means a person who is registered and entitled under the laws of a province or territory to practise medicine in that province or territory. "Primary" means that which occurs for the therapeutic benefit of a particular patient. Secondary means not directly related to the therapeutic benefit of the particular patient from whom the information has originated. "Purpose" means an end or aim for which health information is collected, used, disclosed or accessed. A description of purpose can be general enough to incorporate a range of like information uses provided that the generic description is sufficiently narrow and limited so as to communicate to the ordinary person a clear understanding of the potential information uses that could reasonably be expected to be relevant to their consent. The primary therapeutic purpose is the delivery of health care to a particular patient with respect to a particular and immediate health need or problem. It encompasses consultation with and referral to other providers on a need-to-know basis. A primary longitudinal purpose concerns developing composite health information about a particular patient, such as a detailed medical history, beyond direct application to any particular and immediate health need or problem, in order to enhance ongoing care to that person. Secondary legislated purposes have been subjected to the legislative test specified in this Code and have subsequently been written in law. Secondary nonlegislated purposes are any other purposes, such as education or research not governed by legislation, that meet the provisions of this Code and the secondary nonlegislative test provided by this Code. "Provider" means a health professional or institution that delivers health care services or products in the therapeutic context. "Right of privacy" includes a patient's right to determine with whom he or she will share information and to know of and exercise control over use, disclosure and access concerning any information collected about him or her; it entails the right of consent. Nonconsensual collection, use, disclosure or access violates the right of privacy, even if it is justified. "Security" means reasonable precautions, including physical and technical protocols, to protect health information from unauthorized collection, use, disclosure and access, and to ensure that the integrity of the information is properly safeguarded. A breach of security occurs whenever health information is collected, used, disclosed or accessed other than as authorized, or its integrity compromised. "Sensitivity" of health information refers to the patient's interest in keeping the information secret. It varies according to the nature of the information, its form, and the potential negative repercussions of its collection, use or disclosure on the patient's interests. "Therapeutic context" means a setting in which information is confided by or collected from, about or on behalf of a patient who: (a) is in a therapeutic relationship with or under the care of a physician or health professional; (b) is resident in or seeking health care within a facility or institution whose principal purpose is the provision of health care, including physicians' offices, hospitals and other health care facilities; (c) confides information within a fiduciary relationship to a health care professional and with the belief that the health care professional will maintain its confidentiality, subject to very limited exceptions; or (d) confides information in the belief that it is necessary for the safe, timely and effective delivery of health care. "Transparency and openness" are the characteristics of policies, procedures and practices that seek to ensure that patients know what can or must happen with the health information they confide or permit to be collected, used, accessed or disclosed. "Use of health information" means any processing of health information including storage, retention, retrieval, manipulation, connection or linkage to other sources of information in any format. Section C: Principles Principle 1: The Right of Privacy The right of privacy is fundamental in a free and democratic society. It includes a patient's right to determine with whom he or she will share information and to know of and exercise control over use, disclosure and access concerning any information collected about him or her. The right of privacy and consent are essential to the trust and integrity of the patient-physician relationship. Nonconsensual collection, use, access or disclosure violates the patient's right of privacy. The right of privacy is important and worthy of protection, not just for the good of individuals in society but also for the good of society as a whole. 1.1 Canadians are entitled to expect and enjoy fundamental privacy rights and guarantees, which include: (a) physical, bodily and psychological integrity and privacy; (b) privacy of personal information; (c) freedom from surveillance; (d) privacy of personal communications; and (e) privacy of personal space. 1.2 The basic duties owed to others to ensure that their privacy rights are adequately respected include: (a) the duty to ensure consent; (b) the duty to take all the steps necessary to respect adequately others' privacy rights or, if their rights must be infringed, to interfere with privacy as little as possible; (c) the duty to be accountable; (d) the duty to be transparent; and (e) the duty to build privacy protection features into technological systems and designs. 1.3 The specific duties related to the protection of the patient's right of privacy in health information include: (a) the duty to hold health care information in trust; (b) the duty to limit information collection to what is necessary and justifiable for the benefit of the patient; (c) the duty to ensure that patients are informed by reasonable means about purposes for collection, use, disclosure or access at or before the time of collection, including the potential for such to occur nonconsensually; (d) the duty to ensure that the information is accurately recorded; (e) the duty to ensure consent by reasonable means, except in limited circumstances where the right of privacy and of consent are justifiably infringed by some compelling right, good or duty; (f) the duty to ensure that the right of privacy and the right to consent are infringed no more than is necessary by the compelling right, good or duty; (g) the duty to use and disclose health information only as consistent with the purposes identified at or before the time it was collected; (h) the duty to keep health information only for as long as necessary to fulfil identified purposes; (i) the duty not to disadvantage people because they elect to exercise their right of privacy; and (j) the duty of physicians and other health professionals to hold information in confidence. 1.4 Although the patient's interests and concerns about health information may vary depending on the sensitivity of the information, the right of privacy extends to all health information in whatever format. Principle 2: Special Nature of Health Information Governing principles and rules for health information must recognize the patient's right of privacy in health information, its highly sensitive nature, the circumstances of vulnerability and trust under which it is confided or collected, and the fiduciary duties of health professionals in relation to this information. The patient-physician relationship as defined by trust and a professional promise of confidentiality is a societal good worthy of protection. 2.1 Principles and rules governing health information must recognize: (a) its high level of sensitivity and protect the patient's right of privacy accordingly; (b) that the principal purpose for confiding and collecting this information is to benefit the patient; (c) that in the therapeutic context patients may be vulnerable and under duress, and must not be subjected to manipulation, coercion or exploitation; (d) that patients confide information to physicians and other health professionals under a very special trust, and that physicians and other health professionals have fiduciary duties to patients, including a duty to hold information in confidence. 2.2 Principles and rules governing health information must ensure that physicians and other health professionals can discharge their fiduciary duties and therefore shall take into account that: (a) patients may be in a situation of vulnerability owing to infirmity or incapacity, urgent need, lack of knowledge and power, or simply because they have needs and have to rely or depend upon providers to meet those needs; (b) patients confide information that is ordinarily considered by them to be private because they have certain needs that require the care of a provider and believe the information is required by the provider to help meet those needs; (c) were it not for those needs, and the expectation that the provider can help patients meet them, the occasion for the collection of the health information would not exist and the information would remain private; (d) were it not for the reputation of health professionals for trustworthiness and the expectation that information disclosed to them will be held in confidence, patients would be less willing to confide health information fully and truthfully in the therapeutic context; and (e) to the extent that provisions for health information inhibit patients from confiding health information fully and truthfully, their health care will be adversely affected. Principle 3: Constraints on Purposes and Limitation on Collection, Use, Disclosure and Access The principal purpose for the collection of health information is to benefit the patient who confides or permits information to be collected for a therapeutic purpose. Secondary purposes for the use of the information shall not be pursued if they inhibit patients from confiding information for the primary purpose, exploit patients' vulnerability, compromise the ability of physicians to discharge their fiduciary duties to patients or borrow on the trust patients invest in physicians for the primary therapeutic purpose. Collection, use, disclosure or access for secondary purposes shall be restricted to what is necessary for those purposes and shall not impede the confiding or collection of information for primary purposes. Nonconsensual access to and collection, use or disclosure of health information is a violation of a patient's right of privacy, compromises the physician's duty of confidentiality and is potentially disruptive of the trust and integrity of the therapeutic relationship. Therefore, it must only occur in very limited circumstances - namely emergency situations, in accordance with legislation that meets the requirements of this Code, or in response to a court decision or order. Even consensual collection, use, disclosure or access may erode the right of privacy and the trust and integrity of the therapeutic relationship. Therefore, it must only occur with due consideration of possible negative impacts and with measures designed to maximize privacy protection. 3.1 Provided that the principles contained in this Code are adhered to, and in particular that the principles related to patient consent are rigorously applied, health information may be collected, used, disclosed or accessed for the following purposes: (a) Primary purposes: (i) Primary therapeutic purpose is the initial reason for a patient seeking or receiving care in the therapeutic context, and pertains to the delivery of health care to a particular patient with respect to the presenting health need or problem. It encompasses consultation with and referral to other providers on a need-to-know basis. (ii) Primary longitudinal purpose concerns developing composite health information about a particular patient, such as a detailed medical history, beyond direct application to the presenting health need or problem, in order to enhance ongoing care to that person. (b) Secondary purposes: (i) Secondary legislated purpose refers to health information collection, use, disclosure or access required or permitted by legislation or regulation that meets the provisions of this Code and the legislative test provided by this Code. (ii) Secondary nonlegislated purpose is any other purpose, such as education or research not governed by legislation, that meets the provisions of this Code and the secondary nonlegislative test provided by this Code. 3.2 Health information collection, use, disclosure or access for the primary therapeutic and longitudinal purposes may be as extensive as necessary to fulfil these purposes and reflect the high level of trustworthiness and accountability of health professionals in the therapeutic context. 3.3 Health information collection, use, disclosure or access for any secondary purposes shall be as minimal as necessary in recognition of the need to protect the patient's right of privacy in the therapeutic context. 3.4 Health information collection, use, disclosure or access without patient consent shall only occur in the limited circumstances provided by this clause. Nonconsensual health information collection, use, disclosure or access, including the conversion of health information from one information format to another, is a violation of a patient's right of privacy, may compromise the physician's duty of confidentiality, and is potentially disruptive of the trust and integrity of the therapeutic relationship. Therefore, it must only occur under strict conditions and in these very limited circumstances: (a) when permitted or required by legislation or regulation that meets the requirements of this Code; or (b) when ordered or decided by a court of law. 3.5 Any existing or proposed secondary purpose for health information collection, use, disclosure or access, including health information systems or networks, shall be subjected to a patient privacy impact analysis that shall include an evaluation of: (a) the likely impact of the proposed measures on the right of privacy of patients; (b) the likely impact of the proposed measures on the relationship between patients and their physicians, and in particular on the duty of confidentiality and the trust within this relationship; (c) the likely impact of the proposed measures on the willingness of patients to disclose health information; (d) the likely impact of the proposed measures on the ability of patients to receive health care; and (e) compelling evidence to demonstrate broad public support for the proposed measures. 3.6 Any proposed or existing legislation or regulation made under legislative authority that permits or requires health information collection, use, disclosure or access shall be subjected to the following legislative test: (a) There must be demonstration that: (i) a patient privacy impact assessment has been conducted, the analysis has been made public and has been duly considered prior to the introduction of legislation; (ii) collection, use, disclosure and access will be limited to the greatest degree possible to ensure that - the collection of health information by persons external to the therapeutic context will neither trade on nor compromise the trust of the patient-physician relationship; - patients are not likely to be inhibited from confiding information for primary purposes; - the ability of physicians to discharge their fiduciary duties to patients will not be compromised; and - patient vulnerability will not be exploited; (iii) collection, use, disclosure and access will be restricted to what is necessary for the identified purpose(s) and will not impede the confiding or collection of information for primary purposes; (iv) provisions exist for ensuring that patients are provided with knowledge about the purpose(s) and that, subject to 3.6(b), patient consent is clearly voluntary; (v) the means used are proportionate and the collection will be limited to purposes consented to or made known to the patient; (vi) the patient's privacy will be intruded upon to the most limited degree possible in light of the purpose(s) consented to or made known to the patient; (vii) linkage of the health information will be limited; and (viii) unless clear and compelling reasons exist, - all reasonable steps will be taken to make health information anonymous; and - if it has been demonstrated that making health information anonymous would render it inadequate for legitimate uses, the information will be collected and stored in a deidentified-relinkable format. (b) When nonconsensual collection, use, disclosure or access is permitted or required by legislation or regulation that meets the requirements of this Code, the following conditions must also be met: (i) the right of privacy has to be violated because the purpose(s) could not be met adequately if patient consent is required; and (ii) the importance of the purpose(s) must be demonstrated to justify the infringement of the patient's right of privacy in a free and democratic society. (c) Any legislative provision or regulation that permits or requires health information collection, use, disclosure or access nonconsensually shall not, without compelling reasons, be applied retroactively to existing health information. 3.7 Any proposed or existing secondary nonlegislated purpose shall be subjected to the following nonlegislative test: (a) Before a health information custodian uses health information in its custody for secondary nonlegislated purposes, or before it releases or makes health information accessible to an external third party for secondary nonlegislated purposes, it must demonstrate or require the third party to demonstrate that: (i) a patient privacy impact assessment has been conducted, the analysis has been made public, the results have been duly considered and uses for that purpose will not be pursued if there is an adverse effect on privacy; (ii) collection of health information by persons beyond the therapeutic context will not exploit or compromise the trust of the patient-physician relationship; (iii) patients are not likely to be inhibited from confiding information for primary purposes; (iv) the ability of physicians to discharge their fiduciary duties to patients will not be compromised; (v) patient vulnerability will not be exploited; (vi) collection will be restricted to what is necessary for the identified purpose(s) and will not intrude upon primary purposes; (vii) patients will be fully informed of the purpose(s) and patient consent will be clearly voluntary; (viii) patient privacy will be intruded upon to the most limited degree possible in light of the purpose(s) consented to; (ix) linkage of health information will be restricted and consented to by the patient; (x) unless clear and compelling reasons exist, - all reasonable steps will be taken to make health information anonymous; - if it has been demonstrated that making health information anonymous will render it inadequate for legitimate uses, then the information will be collected and stored in a deidentified-relinkable format; (xi) any third party to whom health information is released has adopted this Code or has equivalent provisions in place; and (xii) the purpose(s) will not be applied retroactively to existing health information unless patient consent is given. 3.8 Health information shall not be collected by means that are unlawful, unfair or exploit the patient's vulnerability, nor shall any of the patient's beliefs or potentially false expectations about subsequent collection, use, disclosure or access be exploited. 3.9 Courts of law should respect the provisions of this Code when issuing orders or decisions. 3.10 Health information shall be retained only as long as it is necessary to fulfil authorized purposes. Once the authorized purposes are fulfilled it shall be securely destroyed, unless some issue or decision related to the patient and pertinent to the patient's health information is pending. Principle 4: Knowledge and Specification of Purpose, Collection, Use, Disclosure and Access In the therapeutic context, health information is confided by or collected from patients under the patient's presumption that it is necessary to meet his or her therapeutic needs. The potential that health information, in whole or in part, may be subsequently collected, used, disclosed or accessed for other purposes without their consent, and what those purposes might be, must be made known to the patient by reasonable means before it is confided or collected for primary purposes. It is not acceptable to withhold such knowledge from patients deliberately out of concern that knowledge could inhibit them from confiding important information fully and truthfully. 4.1 A health information custodian must have documentation that lists all purposes for which it uses or discloses the health information it collects, including to whom it permits access to what information, in what format and whether consent is required. 4.2 Within the therapeutic context health information is confided or provided by patients in the knowledge or with the belief that it is necessary to achieve therapeutic purposes. Patients must be explicitly informed about any other purposes. 4.3 Health information must not be used for purposes not identified to the patient at or before the time it is confided or collected, unless patient consent is subsequently sought and obtained. 4.4 Patients must either have or be provided by reasonable means with knowledge about what can or must happen with their health information. The degree of detail or specificity of this knowledge is what could be presumed germane to the decision of a reasonable person in the circumstances of the patient. 4.5. Unless a particular patient has given indication to the contrary, the conveyance of generic information is a reasonable means of providing knowledge. When the preferences of a particular patient for being informed are known or can be reasonably inferred given his or her circumstances, the provision of knowledge should as much as possible be tailored to these known preferences. 4.6 The goal of providing knowledge to patients is to ensure that before they confide information or permit information to be collected they actually understand what can or must subsequently happen with their information, particularly without their consent. Principle 5: Consent The patient's ability to decide with whom he or she will share information is crucial for the protection of the right of privacy and for the preservation of trust in the therapeutic context. Only the patient's consent to health information collection, use, disclosure and access for the primary therapeutic purpose can be inferred. Except for the very limited nonconsensual purposes addressed in this Code, any other collection, use, disclosure or access requires express consent. Nonconsensual collection, use, disclosure or access infringes the right of privacy and compromises the trust of the fiduciary relationship. To satisfy the requirement that consent be informed, the patient must have, or by reasonable means be provided with, knowledge about the potential for subsequent nonconsensual collection, use, disclosure or access before he or she confides any information. 5.1 Except for the very limited conditions set out in 3.4 concerning nonconsensual collection, use, disclosure or access, consent is required for health information collection, use, disclosure or access for any purpose. 5.2 For the purposes of this Code, consent for health information collection, use, disclosure or access in emergency situations is deemed to have been given to the extent necessary to allay the emergency as consistent with legal principles governing emergency medical care. The protection accorded this information shall be consistent with the provisions of this Code. 5.3 Consent to health information collection, use, disclosure and access for the primary therapeutic purpose may be inferred. Consent to subsequent collection, use, disclosure and access on a need-to-know basis by or to other physicians or health providers for this purpose, and for this purpose alone, may be inferred, as long as there is no evidence that the patient would not give express consent to share the information. 5.4 Interpretation of "need-to-know" shall be guided by consideration of what the reasonable person in similar circumstances would expect, or otherwise authorize by his or her consent. If expectations are unclear or ambiguous, care should be taken to ascertain those expectations and to make the flow of information among providers in the therapeutic context consistent with those expectations. 5.5 Consent to collection, use, disclosure and access for longitudinal primary purposes must be express unless the provider has good reason to infer consent. 5.6 For the purposes of this Code, disclosure of health information to the patient's relatives or significant others is recognized as assisting in primary purposes. Consent to this disclosure must be express unless the provider has good reason to imply patient consent. 5.7 Consent can only be inferred in the case of primary purposes, and for primary purposes alone; collection, use, disclosure or access thus authorized must be limited either to the known expectations of a particular patient or to what the reasonable person in similar circumstances would likely believe necessary to receive health care. 5.8 Implied consent does not deprive the patient of the right to refuse consent or the right to challenge the provider's finding of implied consent. 5.9 Patient consent for secondary nonlegislated purposes shall be express, voluntary and fully informed. 5.10 Where express consent is required, patients must be informed of their right to refuse consent. It is not acceptable to compromise care deliberately as a consequence of the patient's refusal to provide express consent or to exploit any fear the patient might have that this could occur. 5.11 Consent shall not be obtained by coercion, deception or manipulation. Failure to inform the patient by reasonable means of relevant information pertinent to consent invalidates this consent. 5.12 Although all health information is sensitive and should be treated as such, the more sensitive the health information is likely to be, given what is known about the circumstances or preferences of the patient, the more important it is to ensure that consent is voluntary and informed. Principle 6: Individual Access Patients have the right of access to their health information. In rare and limited circumstances, health information may be withheld from a patient if there is a significant likelihood of a substantial adverse effect on the physical, mental or emotional health of the patient or substantial harm to a third party. The onus lies on the provider to justify a denial of access. 6.1 The patient is entitled to know about, and subject to 6.5 to have access to, any information about himself or herself under the custody of the health information custodian. 6.2 Patients should be informed that they have the right to access their health information, to read it and to have copies of it. 6.3 Patients who wish to access their information should be given the opportunity to do so with explanation from a health professional who is knowledgeable about this information and capable of interpreting it for the patient. 6.4 Patients must be able to receive copies of their health information at a reasonable cost that does not exceed the cost of providing the information. 6.5 Providers may, in rare and limited circumstances, withhold health information from a patient if there is a significant likelihood of a substantial adverse effect on the physical, mental or emotional health of the patient or substantial harm to a third party. The onus is on the provider to justify a denial of access. 6.6 Patients are entitled to know who has gained access to their health information and for what purposes. Principle 7: Accurate Recording of Information Accurate recording is important to protect the patient's right of privacy and to meet the purposes for its collection, use, disclosure or access. 7.1 Health information shall be recorded as accurately as possible, and shall be as complete and current as necessary for authorized purposes. 7.2. The recording of statements of fact, clinical judgements and determinations or assessments should reflect as nearly as possible what has been confided by the patient and what has been ascertained, hypothesized or determined to be true using professional judgement. 7.3 Patients who have reviewed their information and believe it to be inaccurately recorded or false have the right to suggest amendments and to have their amendments appended to the health information. 7.4 Whenever possible, health information should be recorded in a form that allows for authorized secondary purposes consented to by the patient. Any standardization of recording requirements relevant to subsequent secondary purposes shall not impede recording of information for primary purposes. Principle 8: Security Security safeguards must be in place to ensure that only authorized collection, use, disclosure or access occurs. Such safeguards must also assure the integrity of the available information. 8.1 Health information, regardless of the information format, shall be protected by security safeguards to ensure compliance with the provisions of this Code. 8.2 The development of security safeguards with respect to levels of access for various users shall recognize the differences in the sensitivity of health information and permit access accordingly. 8.3 Security safeguards shall impede as little as possible health information collection, use, access and disclosure for primary purposes. 8.4 A health information custodian shall ensure that persons are able to collect, use, disclose or access health information in its control only as authorized. Persons thus authorized must have a clear understanding of the authority, parameters, purposes and responsibilities of their access, and of the consequences of failing to fulfil their responsibilities. 8.5 An authorized person's access to health information, including persons or groups external to the health information custodian, shall be limited to only the information needed for the authorized purpose(s), in the least intrusive format. 8.6 Security safeguards shall include both physical and human resource safeguards to prevent unauthorized health information collection, use, disclosure and access. Physical security measures include such safeguards as locked filing cabinets, restricted access to certain offices or areas, and the use of passwords, encryption and lock-boxes. Human resource security measures include security clearances, sanctions, training and contracts. 8.7. Health information custodians must protect health information in their custody so as to ensure its integrity and have assurance that the integrity of information received from other health information custodians has been similarly safeguarded. 8.8 Security safeguards should incorporate identification, authentication, information integrity/availability and non-repudiation, as appropriate. Principle 9: Accountability Accountability is owed first and foremost to the patient. Health information custodians must have in place policies and procedures that recognize this principal accountability and health professionals' duty of confidentiality to the patient. Anyone a health information custodian authorizes to have access to health information must be capable of being held accountable for his or her actions. In addition, health information custodians must designate a qualified person responsible and accountable for monitoring and ensuring internal compliance with this Code. 9.1 Health information custodians are responsible for the security of health information they collect, use, disclose or permit access to. 9.2 Health information custodians must ensure that persons, including administrative and technical support staff, receive authorization to access health information only as necessary to fulfil authorized purposes. 9.3 A health information custodian must ensure that anyone permitted to have access to health information has clearly defined and understood responsibilities in connection with health information, agrees to accept those responsibilities, and is subject to appropriate sanctions for failing to fulfil the accepted responsibilities. 9.4 Health information custodians must designate a qualified person responsible and accountable for monitoring and ensuring internal compliance with this Code. The designated accountable person shall have the autonomy, authority, and resources necessary to ensure the health information custodian's adherence to the Code. In the case of small private practices, practitioners may designate themselves. 9.5 Policies and procedures to ensure compliance with this Code must consider the special, direct accountability of health professionals to their patients. The high level of trust vested in health professionals is crucial to the initial confiding of health information for the therapeutic purpose. 9.6 Health information custodians must ensure that third parties privy to health information have adopted this Code or are bound by equivalent provisions. Provided that this has been determined before health information is disclosed or made accessible, health information custodians are not accountable for the actions of third parties or for what subsequently happens to the information. 9.7 Although it is the responsibility of the health information custodian to ensure that patients are appropriately informed, secondary users whose information requirements impose a burden upon the health information custodian are responsible for covering their share of any related costs or resource requirements (e.g., preparation of brochures). Health information custodians may reasonably require secondary users to cover their own costs as a condition of making health information available to them as authorized. Principle 10: Transparency and Openness Policies, procedures and practices relating to health information must be transparent so that patients can clearly understand the extent and circumstances of health information collection, use, disclosure and access. They must be explicit enough that patients are adequately informed and able to acquire knowledge germane to their confiding of information, and must be open to scrutiny and challenge. 10.1 Health information custodians must have transparent, explicit and open policies, procedures and practices, tailored to their practice setting, that seek to ensure that patients are provided with information about what can or must happen with their health information without their consent. 10.2 Policies, procedures and practices shall be as explicit as necessary to ensure that patients are aware of any considerations that could be relevant to deciding what information they elect to freely confide or consent to be collected, used, disclosed or accessed. Nothing must be left implicit that, if made explicit, could reasonably be expected to alter a patient's decision to freely confide information. Information about nonconsensual collection, use, disclosure and access must be made explicit. 10.3 Patients should be able to discuss the health information custodian's policies, procedures and practices concerning health information with a knowledgeable person and have specific questions about their own health information answered in a timely fashion. 10.4 A health information custodian's policies, procedures and practices shall ensure that patients can understand what might, can or must happen to their health information, that consent is sought as required by this Code and that nothing is left implicit or unknown to patients that if known or made explicit could reasonably be expected to alter a patient's decision to freely confide information. 10.5 Patients shall be able to challenge the health information custodian's compliance with the provisions of this Code by addressing their concerns to the designated accountable person. 10.6 Procedures shall be in place to receive and respond to complaints or inquiries about policies, procedures and practices relating to health information collection, use, disclosure and access. The complaint process must be easily accessible and simple to use. 10.7 Patients who make inquiries or lodge complaints shall be informed of the existence of relevant complaint mechanisms. 10.8 All complaints shall be investigated. If a complaint is found to be justified, appropriate remedial measures shall be taken such as amending policies, procedures or practices. Section D: Health Information Policies Health information custodians must have in place and implement policies, procedures and practices that give effect to the principles of this Code. 1.1 Health information policies, procedures and practices should be tailored to the specific health care setting of the custodian and shall address and provide for: (a) complying with and giving effect to the principles of this Code; (b) protecting the security of health information; (c) ensuring the accurate recording and integrity of health information; (d) documentation of all purposes for which the health information custodian uses or discloses the health information it collects, including to whom it permits access to what information, in what format and whether consent is required; (e) documentation of what health information may be linked to other pieces of information; (f) documentation of what health information is made available to third parties; (g) allowing access only to authorized users in the appropriate format and for the limited purposes for which they are authorized; (h) identification of the person who is accountable for the policies, procedures and practices and to whom complaints or inquiries can be made; (i) receiving and responding to complaints and inquiries; (j) ensuring that persons who collect, use, disclose or access health information can be held accountable and are under an enforceable duty to keep information secure; (k) ensuring that persons who work for or in the health institution know and receive sufficient training about this Code and related institutional policies, procedures and practices to ensure accountability; (l) the means of gaining access to one's own health information held by the health institution; (m) making available information that a particular patient specifically requests or reasonably can be presumed to wish to know; (n) ensuring that patients have, or by reasonable means are provided with, knowledge about their health information and that consent is sought and obtained as appropriate; and (o) specification of minimum and maximum retention periods and rules for the succession, transfer and destruction of health information. 1.2 The health information custodian's policies must be readily available to patients and should include information about practices and procedures. 1 Though this submission uses the word "product" in this context, it is understood that services, e.g. therapeutic procedures, may also be covered by the Health Protection Act. 2 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, "information-seeking" advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media. 3 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general.
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