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Regulatory framework for the mandatory reporting of adverse drug reactions and medical device incidents by provincial and territorial healthcare institutions.

https://policybase.cma.ca/en/permalink/policy11814
Date
2016-01-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-01-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s consultation document Questions related to Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare Institutions. Prescription medication has an important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient’s capacity to function productively in the community. In consideration of this important role, the CMA has developed a substantial body of policy on pharmaceutical issues which includes policy on Canada’s post-approval surveillance system for prescription medication. It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan. The CMA welcomes Health Canada’s consultation on the new legislative authority established by Vanessa’s Law to implement mandatory reporting of adverse drug reactions (ADR) and medical device incidents by provincial and territorial healthcare institutions. The CMA appreciates all opportunities to work with governments, health care professionals and the public in strengthening Canada’s post-approval surveillance system and ensuring that the prescription drugs Canadians receive are safe and effective. The CMA’s submission is organized in three main sections. In the first section, the CMA’s concerns with the current ADR reporting system are identified as critical context for this regulatory development process. The second section provides an overview of the CMA’s recommendations on necessary improvements to this system. Finally, the CMA’s responses to the questions outlined in Health Canada’s discussion document are presented in the third section. Part 1: Context of CMA’s Recommendevices with which they have a concern, and also for research purposes.
Documents
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A new mission for health care in Canada: Addressing the needs of an aging population. 2016 pre-budget submission to the Minister of Finance

https://policybase.cma.ca/en/permalink/policy11803
Date
2016-02-09
Topics
Population health/ health equity/ public health
Health systems, system funding and performance
  1 document  
Policy Type
Parliamentary submission
Date
2016-02-09
Topics
Population health/ health equity/ public health
Health systems, system funding and performance
Text
The Canadian Medical Association (CMA) is pleased to confirm its strong support for the federal government's health and social policy commitments, as identified in the ministerial mandate letters. In this brief, the CMA outlines seven recommendations for meaningful and essential federal action to ensure Canada is prepared to meet the health care needs of its aging population. The CMA's recommendations are designed to be implemented in the 2016-17 fiscal year in order to deliver immediate support to the provinces and territories and directly to Canadians. Immediate implementation of these recommendations is essential given the current and increasing shortages being experienced across the continuum of care in jurisdictions across Canada. In 2014, the CMA initiated a broad consultative initiative on the challenges in seniors care, as summarized in the report A Policy Framework to Guide a National Seniors Strategy for Canada. This report highlights the significant challenges currently being experienced in seniors care and emphasizes the need for increased federal engagement. Finally, if implemented, the CMA's recommendations will contribute to the federal government's strategic commitments in health, notably the commitment to the development of a new Health Accord. 1) Demographic Imperative for Increased Federal Engagement in Health Canada is a nation on the threshold of great change. This change will be driven primarily by the economic and social implications of the major demographic shift already underway. The added uncertainties of the global economy only emphasize the imperative for federal action and leadership. In 2015, for the first time in Canada's history, persons aged 65 years and older outnumbered those under the age of 15 years.1 Seniors are projected to represent over 20% of the population by 2024 and up to 25% of the population by 2036.2 It is increasingly being recognized that the projected surge in demand for services for seniors that will coincide with slower economic growth and lower government revenue will add pressure to the budgets of provincial and territorial governments.3 Today, while seniors account for about one-sixth of the population, they consume approximately half of public health spending.4 Based on current trends and approaches, seniors care is forecast to consume almost 62% of provincial/territorial health budgets by 2036.5 The latest National Health Expenditures report by the Canadian Institute of Health Information (CIHI) projects that health spending in 2015 was to exceed $219 billion, or 10.9% of Canada's gross domestic product (GDP).6 To better understand the significance of health spending in the national context, consider that total federal program spending is 13.4% of GDP.7 Finally, health budgets are now averaging 38% of provincial and territorial global budgets.8 Alarmingly, the latest fiscal sustainability report of the Parliamentary Budget Officer explains that the demands of Canada's aging population will result in "steadily deteriorating finances" for the provinces and territories, who "cannot meet the challenges of population aging under current policy."9 Taken together, the indicators summarized above establish a clear imperative and national interest for greater federal engagement, leadership and support for the provision of health care in Canada. 2) Responses to Pre-Budget Consultation Questions Question 1: How can we better support our middle class? A) Federal Action to Help Reduce the Cost of Prescription Medication The CMA strongly encourages the federal government to support measures aimed at reducing the cost of prescription medication in Canada. A key initiative underway is the pan-Canadian Pharmaceutical Alliance led by the provinces and territories. The CMA supports the federal government's recent announcement that it will partner with the provinces and territories as part of the pan-Canadian Pharmaceutical Alliance. In light of the fact that the majority of working age Canadians have coverage for prescription medication through private insurers10, the CMA recommends that the federal government support inviting the private health insurance industry to participate in the work of the pan-Canadian Pharmaceutical Alliance. Prescription medication has a critical role as part of a high-quality, patient-centred and cost-effective health care system. Canada stands out as the only country with universal health care without universal pharmaceutical coverage.11 It is an unfortunate reality that the affordability of prescription medication has emerged as a key barrier to access to care for many Canadians. According to the Angus Reid Institute, more than one in five Canadians (23%) report that they or someone in their household did not take medication as prescribed because of the cost during the past 12 months.12 Statistics Canada's Survey of Household Spending reveals that households headed by a senior spend $724 per year on prescription medications, the highest among all age groups and over 60% more than the average household.13 Another recent study found that 7% of Canadian seniors reported skipping medication or not filling a prescription because of the cost.14 The CMA has long called on the federal government to implement a system of catastrophic coverage for prescription medication to ensure Canadians do not experience undue financial harm and to reduce the cost barriers of treatment. As a positive step toward comprehensive, universal coverage for prescription medication, the CMA recommends that the federal government establish a new funding program for catastrophic coverage of prescription medication. The program would cover prescription medication costs above $1,500 or 3% of gross household income on an annual basis. Research commissioned by the CMA estimates this would cost $1.57 billion in 2016-17 (Table 1). Table 1: Projected cost of federal contribution to cover catastrophic prescription medication costs, by age cohort, 2016-2020 ($ million)15 Age Cohort 2016 2017 2018 2019 2020 Share of total cost Under 35 years 113.3 116.3 119.4 122.5 125.2 7% 35 to 44 years 177.2 183.5 190.5 197.8 204.3 11% 45 to 54 years 290.2 291.9 298.0 299.2 301.0 18% 55 to 64 years 383.7 400.6 417.6 433.1 444.6 25% 65 to 74 years 309.2 328.5 348.4 369.8 391.6 21% 75 years + 303.0 315.5 329.8 345.2 360.1 20% All ages 1,566.8 1,617.9 1,670.5 1,724.2 1,773.1 100% B) Deliver Immediate Federal Support to Canada's Unpaid Caregivers There are approximately 8.1 million Canadians serving as informal, unpaid caregivers with a critical role in Canada's health and social sector.16 The Conference Board of Canada reports that in 2007, informal caregivers contributed over 1.5 billion hours of home care - more than 10 times the number of paid hours in the same year.17 The economic contribution of informal caregivers was estimated to be about $25 billion in 2009.18 This same study estimated that informal caregivers incurred over $80 million in out-of-pocket expenses related to caregiving in 2009. Despite their tremendous value and important role, only a small fraction of caregivers caring for a parent receive any form of government support.19 Only 5% of caregivers providing care to parents reported receiving financial assistance, while 28% reported needing more assistance than they received.20 It is clear that Canadian caregivers require more support. As a first step, the CMA recommends that the federal government amend the Caregiver and Family Caregiver Tax Credits to make them refundable. This would provide an increased amount of financial support for family caregivers. It is estimated that this measure would cost $90.8 million in 2016-17.21 C) Implement a new Home Care Innovation Fund The CMA strongly supports the federal government's significant commitment to deliver more and better home care services, as released in the mandate letter for the Minister of Health. Accessible, integrated home care has an important role in Canada's health sector, including addressing alternate level of care (ALC) patients waiting in hospital for home care or long-term care. As highlighted by CIHI, the majority of the almost 1 million Canadians receiving home care are aged 65 or older.22 As population aging progresses, demand for home care can be expected to increase. Despite its importance, it is widely recognized that there are shortages across the home care sector.23 While there are innovations occurring in the sector, financing is a key barrier to scaling up and expanding services. To deliver the federal government's commitment to increasing the availability of home care, the CMA recommends the establishment of a new targeted home care innovation fund. As outlined in the Liberal Party of Canada's election platform, the CMA recommends that the fund deliver $3 billion over four years, including $400 million in the 2016-17 fiscal year. Question 2: What infrastructure needs can best help grow the economy...and meet your priorities locally? Deliver Federal Investment to the Long-term Care Sector as part of Social Infrastructure All jurisdictions across Canada are facing shortages in the continuing care sector. Despite the increased availability of home care, research commissioned for the CMA indicates that demand for continuing care facilities will surge as the demographic shift progresses.24 In 2012, it was reported that wait times for access to a long-term care facility in Canada ranged from 27 to over 230 days. More than 50% of ALC patients are in these hospital beds because of the lack of availability of long-term care beds25. Due to the significant difference in the cost of hospital care (approximately $846 per day) versus long-term care ($126 per day), the CMA estimates that the shortages in the long-term care sector represent an inefficiency cost to the health care system of $2.3 billion a year.26 Despite the recognized need for infrastructure investment in the continuing care sector, to date, this sector has been unduly excluded from federal investment in infrastructure, namely the Building Canada Plan. The CMA recommends that the federal government include capital investment in continuing care infrastructure, including retrofit and renovation, as part of its commitment to invest in social infrastructure. Based on previous estimates, the CMA recommends that $540 million be allocated for 2016-17 (Table 2), if implemented on a cost-share basis. Table 2: Estimated cost to address forecasted shortage in long-term care beds, 2016-20 ($ million)27 Forecasted shortage in long term care beds Estimated cost to address shortage Federal share to address shortage in long term care beds (based on 1/3 contribution) 2016 6,028 1,621.5 540.5 2017 6,604 1,776.5 592.2 2018 8,015 2,156.0 718.7 2019 8,656 2,328.5 776.2 2020 8,910 2,396.8 798.9 Total 38,213 10,279.3 3,426.4 In addition to improved delivery of health care resources, capital investment in the long-term care sector would provide an important contribution to economic growth. According to previous estimates by the Conference Board of Canada, the capital investment needed to meet the gaps from 2013 to 2047 would yield direct economic benefits on an annual basis that include $1.23 billion contribution to GDP and 14,141 high value jobs during the capital investment phase and $637 million contribution to GDP and 11,604 high value jobs during the facility operation phase (based on an average annual capital investment). Question 3: How can we create economic growth, protect the environment, and meet local priorities while ensuring that the most vulnerable don't get left behind? Deliver new Funding to Support the Provinces and Territories in Meeting Seniors Care Needs Canada's provincial and territorial leaders are struggling to meet health care needs in light of the demographic shift. This past July, the premiers issued a statement calling for the federal government to increase the Canada Health Transfer (CHT) to 25% of provincial and territorial health care costs to address the needs of an aging population. It is recognized that as an equal per-capita based transfer, the CHT does not currently account for population segments with increased health needs, specifically seniors. The CMA was pleased that this issue was recognized by the Prime Minister in his letter last spring to Quebec Premier Philippe Couillard. However, the CMA is concerned that an approach to modify the transfer formula would potentially delay the delivery of federal support to meet the needs of an aging population. As such, rather than the transfer formula, the CMA has developed an approach that delivers support to jurisdictions endeavoring to meet the needs of their aging populations while respecting the transfer arrangement already in place. The CMA commissioned the Conference Board of Canada to calculate the amount for the top-up to the CHT using a needs-based projection. The amount of the top-up for each jurisdiction is based on the projected increase in health care spending associated with an aging population. To support the innovation and transformation needed to address the health needs of the aging population, the CMA recommends that the federal government deliver additional funding on an annual basis beginning in 2016-17 to the provinces and territories by means of a demographic-based top-up to the Canada Health Transfer (Table 3). For the fiscal year 2016-17, this top-up would require $1.6 billion in federal investment. Table 3: Allocation of the federal demographic-based top-up, 2016-20 ($million)28 Jurisdiction 2016 2017 2018 2019 2020 All of Canada 1,602.1 1,663.6 1,724.2 1,765.8 1,879.0 Ontario 652.2 677.9 692.1 708.6 731.6 Quebec 405.8 413.7 418.8 429.0 459.5 British Columbia 251.6 258.7 270.3 270.1 291.3 Alberta 118.5 123.3 138.9 141.5 157.5 Nova Scotia 53.6 58.6 62.3 64.4 66.6 New Brunswick 45.9 50.7 52.2 54.1 57.2 Newfoundland and Labrador 29.7 30.5 33.6 36.6. 46.1 Manitoba 28.6 30.6 33.5 32.5 36.6 Saskatchewan 3.5 4.9 7.3 12.7 15.4 Prince Edward Island 9.1 9.7 10.6 10.9 11.5 Yukon 1.4 2.6 2.1 2.5 2.5 Question 4: Are the Government's new priorities and initiatives realistic; will they help grow the economy? Ensure Tax Equity for Canada's Medical Professionals is Maintained Among the federal government's commitments is the objective to decrease the small business tax rate from 11% to 9%. The CMA supports this commitment to support small businesses, such as medical practices, in recognition of the significant challenges facing this sector. However, it is not clear whether as part of this commitment the federal government intends to alter the Canadian-Controlled Private Corporation (CCPC) framework. The federal government's framing of this commitment, as released in the mandate letter for the Minister of Small Business and Tourism, has led to confusion and concern. Canada's physicians are highly skilled professionals, providing an important public service and making a significant contribution to our country's knowledge economy. Canadian physicians are directly or indirectly responsible for hundreds of thousands of jobs across the country, and invest millions of dollars in local communities, ensuring that Canadians are able to access the care they need, as close to their homes as possible. In light of the design of Canada's health care system, the majority of physicians are self-employed professionals and effectively small business owners. As self-employed small business owners, they typically do not have access to pensions or health benefits. In addition, as employers, they are responsible for these benefits for their employees. In addition to managing the many costs associated with running a medical practice, Canadian physicians must manage challenges not faced by many other small businesses. As highly-skilled professionals, physicians typically enter the workforce with significant debt levels and at a later stage in life. For some, entering practice after training requires significant investment in a clinic or a practice. Finally, it is important to recognize that physicians cannot pass on the increased costs introduced by governments, such as changes to the CCPC framework, onto patients, as other businesses would do with clients. For a significant proportion of Canada's physicians, the CCPC framework represents a measure of tax equity for individuals taking on significant personal financial burden and liability as part of our public health care system. As well, in many cases, practices would not make economic sense if the provisions of the CCPC regime were not in place. Given the importance of the CCPC framework to medical practice, changes to this framework have the potential to yield unintended consequences in health resources, including the possibility of reduced access to much needed care. The CMA recommends that the federal government maintain tax equity for medical professionals by affirming its commitment to the existing framework governing Canadian-Controlled Private Corporations. 3) Conclusion The CMA recognizes that the federal government must grapple with an uncertain economic forecast and is prioritizing measures that will support economic growth. The CMA strongly encourages the federal government to adopt the seven recommendations outlined in this submission as part of these efforts. In addition to making a meaningful contribution to meeting the future care needs of Canada's aging population, these recommendations will mitigate the impacts of economic pressures on individuals as well as jurisdictions. The CMA would welcome the opportunity to provide further information and its rationale for each recommendation. Summary of Recommendations 1. The CMA recommends that the federal government establish a new funding program for catastrophic coverage of prescription medication; this would be a positive step toward comprehensive, universal coverage for prescription medication. 2. The CMA recommends that the federal government support inviting the private health insurance industry to participate in the work of the pan-Canadian Pharmaceutical Alliance. 3. The CMA recommends that the federal government amend the Caregiver and Family Caregiver Tax Credits to make them refundable. 4. To deliver the federal government's commitment to increasing the availability of home care, the CMA recommends the establishment of a new targeted home care innovation fund. 5. The CMA recommends that the federal government include capital investment in continuing care infrastructure, including retrofit and renovation, as part of its commitment to invest in social infrastructure. 6. The CMA recommends that the federal government deliver additional funding on an annual basis beginning in 2016-17 to the provinces and territories by means of a demographic-based top-up to the Canada Health Transfer. 7. The CMA recommends that the federal government maintain tax equity for medical professionals by affirming its commitment to the existing framework governing Canadian-Controlled Private Corporations. References 1 Statistics Canada. Population projections: Canada, the provinces and territories, 2013 to 2063. The Daily, Wednesday, September 17, 2014. Available: http://www.statcan.gc.ca/daily-quotidien/140917/dq140917a-eng.htm 2 Statistics Canada. Canada year book 2012, seniors. Available: www.statcan.gc.ca/pub/11-402-x/2012000/chap/seniors-aines/seniors-aines-eng.htm 3 Conference Board of Canada. A difficult road ahead: Canada's economic and fiscal prospects. Available: http://canadaspremiers.ca/phocadownload/publications/conf_bd_difficultroadahead_aug_2014.pdf. 4 Canadian Institute for Health Information. National health expenditure trends, 1975 to 2014. Ottawa: The Institute; 2014. Available: www.cihi.ca/web/resource/en/nhex_2014_report_en.pdf 5 Calculation by the Canadian Medical Association, based on Statistics Canada's M1 population projection and the Canadian Institute for Health Information age-sex profile of provincial-territorial health spending. 6 CIHI. National Health Expenditure Trends,1975 to 2015. Available: https://secure.cihi.ca/free_products/nhex_trends_narrative_report_2015_en.pdf. 7 Finance Canada. Update of Economic and Fiscal Projections 2015. http://www.budget.gc.ca/efp-peb/2015/pub/efp-peb-15-en.pdf. 8 CIHI. National Health Expenditure Trends,1975 to 2015. Available: https://secure.cihi.ca/free_products/nhex_trends_narrative_report_2015_en.pdf. 9 Office of the Parliamentary Budget Officer. Fiscal sustainability report 2015. Ottawa: The Office; 2015. Available: www.pbo-dpb.gc.ca/files/files/FSR_2015_EN.pdf 10 IBM for the Pan-Canadian Pharmaceutical Alliance. Pan Canadian Drugs Negotiations Report. Available at: http://canadaspremiers.ca/phocadownload/pcpa/pan_canadian_drugs_negotiations_report_march22_2014.pdf . 11 Morgan SG, Martin D, Gagnon MA, Mintzes B, Daw JR, Lexchin J. Pharmacare 2020: The future of drug coverage in Canada. Vancouver: Pharmaceutical Policy Research Collaboration, University of British Columbia; 2015. Available: http://pharmacare2020.ca/assets/pdf/The_Future_of_Drug_Coverage_in_Canada.pdf 12 Angus Reid Institute. Prescription drug access and affordability an issue for nearly a quarter of Canadian households. Available: http://angusreid.org/wp-content/uploads/2015/07/2015.07.09-Pharma.pdf 13 Statistics Canada. Survey of household spending. Ottawa: Statistics Canada; 2013. 14 Canadian Institute for Health Information. How Canada compares: results From The Commonwealth Fund 2014 International Health Policy Survey of Older Adults. Available: www.cihi.ca/en/health-system-performance/performance-reporting/international/commonwealth-survey-2014 15 Conference Board of Canada. Research commissioned for the CMA, July 2015. 16 Statistics Canada. Family caregivers: What are the consequences? Available: www.statcan.gc.ca/pub/75-006-x/2013001/article/11858-eng.htm 17 Conference Board of Canada. Home and community care in Canada: an economic footprint. Ottawa: The Board; 2012. Available: http://www.conferenceboard.ca/cashc/research/2012/homecommunitycare.aspx 18 Hollander MJ, Liu G, Chappeel NL. Who cares and how much? The imputed economic contribution to the Canadian health care system of middle aged and older unpaid caregivers providing care to the elderly. Healthc Q. 2009;12(2):42-59. 19 Government of Canada. Report from the Employer Panel for Caregivers: when work and caregiving collide, how employers can support their employees who are caregivers. Available: www.esdc.gc.ca/eng/seniors/reports/cec.shtml 20 Ibid. 21 Conference Board of Canada. Research commissioned for the CMA, July 2015. 22 CIHI. Seniors and alternate level of care: building on our knowledge. Available: https://secure.cihi.ca/free_products/ALC_AIB_EN.pdf. 23 CMA. A policy framework to guide a national seniors strategy for Canada. Available: https://www.cma.ca/Assets/assets-library/document/en/about-us/gc2015/policy-framework-to-guide-seniors_en.pdf. 24 Conference Board of Canada. Research commissioned for the CMA, January 2013. 25 CIHI. Seniors and alternate level of care: building on our knowledge. Available: https://secure.cihi.ca/free_products/ALC_AIB_EN.pdf 26 CMA. CMA Submission: The need for health infrastructure in Canada. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/Health-Infrastructure_en.pdf. 27 Ibid. 28 Conference Board of Canada. Research commissioned for the CMA, July 2015.
Documents
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Consultation on the prescription drug list: Naloxone

https://policybase.cma.ca/en/permalink/policy11847
Date
2016-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2016-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide comment on the proposal by Health Canada1 to revise the listing for naloxone on the Prescription Drug List (PDL) to allow the non-prescription use of naloxone, "when indicated for emergency use for opioid overdose outside hospital settings". The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The harms associated with opioids, which include prescription medicines such as oxycodone, hydromorphone and fentanyl, as well as illegal drugs such as heroin, is a significant public health and patient safety issue. Harms include addiction, diversion, overdose and death. According to 2013 estimates2, Canada has one of the highest per capita consumptions of prescription opioids in the world. In North America, about 5% of the adult population, and substantially higher rates for teens and young adults, reported non-medical opioid use in the previous year. This rate is higher than all other illegal drugs, with the exception of marijuana.3 Data on the harms caused by opioids are not collected systematically in Canada; however, practitioners have seen the significant impact of these drugs on their patients and to whole communities, including indigenous peoples. Opioid addiction rates from 43% to 85% have been reported in some indigenous communities.4 5 In Ontario, according to the Office of the Chief Coroner, opioid-related deaths nearly tripled from 2002 to 2010.6 Canada's physicians believe that Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs, whether illegal or prescription-based.7 One component of this strategy is the prevention of overdose deaths and complications with appropriate medication and prompt emergency response. For over four decades, naloxone (or Narcan(r)) has been used as a prescription drug for the complete or partial reversal of opioid overdoses. Naloxone counteracts the life-threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally. The World Health Organization placed naloxone on its list of essential medications in 1983. Physicians have been encouraged to identify patients who could benefit from the co-prescription of naloxone, along with opioids, when these are necessary. Increased risk for opioid overdose includes previous episodes of overdose, history of substance use disorder, higher opioid dosages, or concurrent benzodiazepine use.8 9 More recently, with the increase in opioid overdoses, different provinces have created programs to increase access to naloxone outside of health care settings, such as "take-home naloxone programs". The experience in Canada and in other countries has been shown to have various benefits, including reducing overdose deaths.10 11 In Canada, naloxone has been administered through intramuscular or subcutaneous injection in these community-based programs, but in other countries it has also been available in a nasal spray form or in a pre-filled auto-injector format. Those that receive the naloxone kit are trained in the recognition of signs and symptoms of opioid overdose, in the administration of naloxone and first aid and in the need to call for medical follow-up. In its 2015 policy on Harms associated with Opioids and other Psychoactive Prescription Drugs, the CMA supports the improvement of access to naloxone, particularly by individuals who are at a high risk of overdose as well as third parties who can assist a person experiencing an opiate-related overdose. The CMA also encourages the creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. This would include training for health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.12 Also in 2015, the CMA approved a resolution supporting "the development and implementation of a national strategy on the use of naloxone".13 A report issued by the United Nations Office on Drugs and Crime and the World Health Organization supports making naloxone available to first responders as well as to people dependent on opioids, their peers and family members who are likely to be present when an overdose occurs.14 Many other organizations, such as the Canadian Pharmacists Association, the American Medical Association and the American Public Health Association, are also supportive of enhanced access to naloxone in the community.15 16 17 The prescription status has been one of the barriers to increased access to naloxone. It is more likely that a family member, partner or friend would need to administer the naloxone in an overdose than the person who is prescribed the drug. Community-based programs have had to work with standing orders from prescribers. First responders, such as police officers and firefighters, should be able to carry and administer the drug, given they are often the first professionals to arrive at a scene where someone has overdosed. According to Health Canada, the provinces and territories have collectively asked that the prescription status be re-evaluated. Health Canada has undertaken a Benefit-Harm-Uncertainty assessment of naloxone, and come to the following conclusions: This assessment recommended that naloxone could safely be administered without the direct supervision of a physician if the person administering the drug has appropriate training. The main risks associated with the unsupervised use of the drug are: * the administrator may have difficulty filling the syringe and administering the drug under pressure in an emergency situation; * the administrator may not seek professional care for follow-up of the patient after injection; * chance of the patient relapsing since the effects of naloxone may only last for up to one hour depending on amount and type of opioid causing the overdose; * that the patient may become very agitated and aggressive after coming out of the opioid depression (Acute Opioid Withdrawal Syndrome). These risks can be mitigated with appropriate training of the potential administrator before naloxone is distributed. The benefit of quickly responding to an overdose far outweighed these risks. Evidence from provincial take-home programs indicates that naloxone can be administered (intramuscularly or subcutaneously) by a layperson and its effects monitored successfully without practitioner supervision. Although an opioid overdose might be mistakenly diagnosed by a layperson, the injection of naloxone in a person not overdosing on an opioid will cause no serious harm.18 Various jurisdictions have delisted or are studying special conditions for the status of naloxone as a prescription drug, including Italy and some U.S. States.19 The CMA appreciates the opportunity to provide feedback on this important matter to physicians, and congratulates Health Canada in taking the initiative to make naloxone more accessible in the community; thereby helping to address the concerning levels of opioid overdoses in Canada. CMA Recommendations: That Health Canada proceed with the revisions to the listing for naloxone on the Prescription Drug List, to allow the non-prescription use of naloxone when indicated for emergency use for opioid overdose outside hospital settings. As outlined in Health Canada's assessment, the potential risks can be mitigated by well-designed community-based programs. That Health Canada assess the option of licensing naloxone products that don't require training for intramuscular or subcutaneous injection, such as nasal sprays or automated handheld injectors (similar to epinephrine auto-injectors for use in serious allergic reactions), in order to further increase accessibility. References 1 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17). 2 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013. Available: https://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2012/NDR_2012_Annex_2_EFS.pdf (accessed 2016 March 17). 3 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81. 4 Chiefs of Ontario. Prescription drug abuse strategy: 'Take a stand.' Final report. Toronto: Chiefs of Ontario; 2010. Available: www.chiefs-of-ontario.org/sites/default/files/files/Final%20Draft%20Prescription%20Drug%20Abuse%20Strategy.pdf (accessed 2016 March 17). 5 Health Canada. Honouring our strengths: a renewed framework to address substance use issues among First Nations people in Canada. Ottawa: Health Canada; 2011. Available: http://nnadaprenewal.ca/wp-content/uploads/2012/01/Honouring-Our-Strengths-2011_Eng1.pdf (accessed 2016 March 17). 6 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013. 7 Canadian Medical Association. Policy Document PD15-06 - Harms associated with opioids and other psychoactive prescriptions drugs. Ottawa: The Author; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed 2016-March 17). 8 National Opioid Use Guideline Group. Canadian guideline for safe and effective use of opioids for chronic non-cancer pain. Hamilton, ON: McMaster University; 2010. Available: http://nationalpaincentre.mcmaster.ca/opioid/ (accessed 2016 March 17). 9 Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain-United States, 2016. MMWR Recomm Rep. 2016;65(RR-1):1-49. Available: http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1er.htm?s_cid=rr6501e1er_w (accessed 2016 March 17). 10 Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: Interrupted time series analysis. BMJ. 2013;346:f174. Available: http://www.bmj.com/content/bmj/346/bmj.f174.full.pdf (accessed 2016 March 17). 11 Banjo, O, Tzemis, D, Al-Outub, D, et al. A quantitative and qualitative evaluation of the British Columbia Take Home Naloxone program. CMAJ Open, August 21, 2014;2(3) E153-E161. Available: http://cmajopen.ca/content/2/3/E153.full (accessed 2016 March 17). 12 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/ (accessed 2016 March 17). 13 Canadian Medical Association. Policy Resolution GC15-18 - National strategy on the use of naloxone. Ottawa: The Author; 2015. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 March 17). 14 United Nations Office on Drugs and Crime / World Health Organization Opioid overdose: preventing and reducing opioid overdose mortality. Discussion Paper UNODC/WHO 2013. Available: http://www.unodc.org/docs/treatment/overdose.pdf (accessed 2016 March 17). 15 American Medical Association. AMA adopts new policies at annual meeting. Press Release. New York, NY: Reuters; June 19, 2012. Available: http://www.reuters.com/article/idUS182652+19-Jun-2012+GNW20120619 (accessed 2016 March 17). 16 Drug Policy Alliance. American Public Health Association Policy Statement on Preventing Overdose Through Education and Naloxone Distribution. New York, NY: Drug Policy Alliance; October 30, 2012. Available: http://www.drugpolicy.org/resource/american-public-health-association-policy-statement-preventing-overdose-through-education-a (accessed 2016 March 17). 17 Canadian Pharmacists Association. CPhA Welcomes Health Canada Move to Change Prescription Status of Naloxone. News Release. January 14, 2016. Available: https://www.pharmacists.ca/news-events/news/cpha-welcomes-health-canada-move-to-change-prescription-status-of-naloxone/ (accessed 2016 March 17). 18 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17). 19 United Nations Office on Drugs and Crime / World Health Organization Opioid overdose: preventing and reducing opioid overdose mortality. Discussion Paper UNODC/WHO 2013. Available: http://www.unodc.org/docs/treatment/overdose.pdf (accessed 2016 March 17).
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Small business perspectives of physician medical practices in Canada

https://policybase.cma.ca/en/permalink/policy11846
Date
2016-03-21
Topics
Physician practice/ compensation/ forms
Health human resources
  1 document  
Policy Type
Parliamentary submission
Date
2016-03-21
Topics
Physician practice/ compensation/ forms
Health human resources
Text
The Canadian Medical Association (CMA) is the national voice of Canada's doctors, representing more than 83,000 physicians across all regions in the country. With this brief, the CMA provides a portrait of medical practice as small businesses in Canada. A significant proportion of Canada's physicians are self-employed, small business owners, whose medical practices are incorporated as Canadian-Controlled Private Corporations (CCPCs). Reflecting the significance of the CCPC framework to medical practice in Canada, the CMA strongly supports the federal government's commitment to reduce the small business taxation rate from 11% to 9%. However, the CMA has been concerned with some statements regarding the incorporation of professionals. In response to the federal government's statement, the CMA has received a significant volume of correspondence from its membership; unprecedented in our almost 150 year history. Presented within this brief are the results of a survey undertaken by the CMA to explore physician incorporation. The survey was distributed to a sample of 25,000 physicians on Dec. 21, 2015 and closed on Jan. 8, 2016 with a response rate of 9%. Among the key findings of the CMA's survey on incorporation was that more than 8 out of 10 respondents indicated that they were incorporated and reported an average of 2 full-time employees in their professional corporation, including themselves. When part-time employees where included, this increased to an average of 3 employees. Survey respondents confirmed that physician gross (pre-tax) salary is not representative of net salary; where overhead expenses were reported to be 29%, on average, of gross (pre-tax) professional income. Of note, there have been several studies at the provincial level that specifically researched overhead expenses; these studies found average overage expenses to exceed 40% of gross salary. The results of the CMA's survey confirms that the CCPC framework provides a critical tax equity measure that recognizes the unique challenges they face as small business owners and critical to the operation of the practice model, particularly supporting community-based care. In some cases, the practice model is only economical within this framework. An important fact is that unlike other small business owners, physicians cannot pass on any increases in compliance or operating costs to patients, given the design of Canada's public health care system. When asked to consider the likelihood of various actions they may take should the federal government alter the CCPC framework, a large majority (75%) of the respondents indicated that they would be very or somewhat likely to take one or more of these actions: * more than half (54%) of practicing physicians said that they would be very or somewhat likely to reduce the number of hours worked; * 42% would be very or somewhat likely to reduce office staff; and, * about one quarter indicated that they would be very or somewhat likely to pursue other measures such as closing their practice and retiring (24%) or relocating their practice to another provincial/territorial jurisdiction (26%) or to the U.S. or another country (22%). This brief also highlights the policy imperative for extending incorporation to medical professionals. As captured in Ontario's 2000 budget document, it is "to level the playing field with other self-employed individuals who can choose whether to operate their businesses through a corporation".1 Finally, the CMA's core recommendation to the federal government is to maintain tax equity for medical professionals by affirming its commitment to the existing framework governing Canadian-Controlled Private Corporations. Introduction The Canadian Medical Association (CMA) is the national voice of Canada's doctors. The CMA is the voluntary professional organization representing more than 83,000 physicians across all regions in Canada and comprising 12 provincial and territorial medical associations and more than 60 national medical organizations. The CMA's mission is helping physicians care for patients. The purpose of this brief is to provide an overview of medical practice as small businesses in Canada. As is discussed herein, a significant proportion of Canada's physicians are self-employed, small business owners, whose medical practices are incorporated as Canadian-Controlled Private Corporations (CCPCs). As such, the CMA strongly supports the federal government's commitment to reduce the small business taxation rate from 11% to 9%, as outlined in the mandate letter for the Minister of Small Business and Tourism.2 1) Most Physicians are Small Business Owners Canada's physicians are highly skilled professionals, providing an important public service and making a significant contribution to the knowledge economy. In light of the design of Canada's health care system, the vast majority of physicians are self-employed professionals operating medical practices as small business owners. More than 8 out of 10 respondents to the CMA's survey indicated that they were incorporated; 81% indicated that they were incorporated individually while 4% indicated they were incorporated in a group. Nationally, it is estimated that approximately 60% of physicians are incorporated.3 Physician-owned and run medical practices ensure that Canadians are able to access the care they need, as close to their homes as possible. In doing so, Canadian physicians are directly and indirectly responsible for hundreds of thousands of jobs across the country, and invest millions of dollars in local communities. Respondents to the CMA's survey on incorporation reported an average of 2 full-time employees in their professional corporation, including themselves. When part-time employees where included, this increased to an average of 3 employees. In operating their medical practices, Canada's physicians rent, lease or own office space and further contribute to local economies through municipal taxes on these properties. Like other self-employed small business owners, physicians typically do not have access to pensions or health benefits. In addition, as employers, physicians are responsible for the provision of payroll taxes and benefits for their employees. 2) Increased Cost-Burden for Canada's Doctors Canada's physicians face unique, additional financial and personal burdens in owning and operating medical practices in comparison with other small businesses. First, amongst Canada's small business owners4, Canada's physicians are highly skilled and trained professionals. On average, physicians enter the workforce at a later age with significant debt from education. The average age that family physicians enter practice is over 30 years and over 33 years for specialists.5 The 2013 National Physician Survey explored the issue of debt levels. It found that the proportion of medical students expecting debt of $100,000 or more doubled from 15% in 2004 to 30% in 2012.6 Further, a third of medical residents expect debt to be over $100,000 and 19% expect debt to exceed $160,000 before entering practice.7 For Canada's doctors, the high level of education-related debt and the later age they are able to initiate professional earnings represents a significant challenge for personal financial planning, notably retirement planning. Second, it is not well known that physician gross (pre-tax) salary is not representative of net salary. In addition to the expenses of running a medical practice, such as salaries and rent, physicians have a range of professional fees that are required by regulation to be submitted. According to the respondents to the CMA's survey on incorporation, these overhead expenses were reported to be 29%, on average, of gross (pre-tax) professional income. Of note, there have been several studies at the provincial level that specifically researched overhead expenses; these studies found average overage expenses to exceed 40% of gross salary.8 Finally, unlike most small business owners, as providers within a public health care systems, Canada's physicians cannot pass on any cost increases associated with operating their medical practice. The majority of physician remuneration in Canada is through "fee-for-service" systems9 whereby fees for insured physician services10 are set by the province following negotiations with the provincial medical association. Any increases in the cost of operating a medical practice, including changes in taxation, would be borne by the physician directly, as would the potential additional resource burden incurred in responding to a change to the CCPC regulatory framework. It is not surprising then that one study found that "high-income, self-employed physicians are much more sensitive to the marginal tax rate than would be suggested by previous labor-supply studies".11 The results of the CMA's survey on incorporation with respect to personal financial planning highlight the concerns associated with the unique burdens facing physicians in operating a medical practice. A strong majority (92%) of respondents rated the ability to save for retirement as very important for personal financial planning. A majority (61%) of respondents indicated the ability to pay off debt and half (50%) indicated the ability to manage practice overhead costs as very important for personal financial planning. 3) Role of Incorporation for Ensuring Tax Equity for Medical Professional As reviewed above, in light of the design of Canada's health care system, the majority of physicians are self-employed professionals and small business owners. Like other small business owners, physicians do not have access to pension and health benefits, despite investing in local communities and providing employment. Unlike other small business owners, physicians commence professional income later in life and carry high debt levels associated with education and training. In light of these significant considerations, the CCPC framework represents a measure of tax equity for Canada's physicians. In Canada, the 12 jurisdictions have extended the ability to incorporate to medical professionals. As stated in Ontario's 2000 budget document, the underlying policy purpose of extending incorporation to medical professionals is "to level the playing field with other self-employed individuals who can choose whether to operate their businesses through a corporation".12 For self-employed professionals, incorporation offers many well recognized benefits. As highlighted by most taxation guidance, the application to the small business deduction and the ability to retain income in the corporation are significant benefits of incorporation for small businesses.13 For self-employed medical professionals without access to an employer pension or benefits, the ability to retain income in the corporation contributes to retirement and pension planning capabilities. Finally, the CCPC framework allows for income splitting with family members in almost all jurisdictions. The CMA's survey on incorporation explored the benefits of the CCPC framework. The top rated benefit of incorporation was the ability for professional income to be taxed at the small business taxation rate, with 85% rating it as very important. In comparison, 60% of respondents indicated that income splitting with a family member was very important. 4) Changes to the CCPC Framework and Potential Unintended Consequences As noted above, the federal government has committed to reducing the small business taxation rate from 11% to 9%. In recognition of the significant financial pressures managed by physicians owning and operating medical practices, the CMA strongly supports this commitment. However, along with this commitment, the federal government has made concerning statements regarding professionals and the CCPC framework. While the federal government has not indicated a specific measure or timeline, the statements on their own have yielded significant uncertainty and concern. In response to the federal government's statement, the CMA has received a significant volume of correspondence from its membership; unprecedented in our almost 150 year history. The CMA cannot emphasize enough the need for caution in considering changes to the CCPC framework. The CCPC framework and the ability of incorporated physicians to maintain access to the small business rate is fundamental to the business model for these medical practices. Changes to the framework could have real and far-reaching impacts. Beyond the immediate impact to a physician, employees of a medical practice, and the region the medical practice serves, depending on the scope of changes to the CCPC framework, impacts could be at the health-sector level, particularly in terms of shifting the delivery of care away from institutionalized care toward community-based care. The physicians surveyed by the CMA were asked to consider the likelihood of various actions they may take should the federal government alter the CCPC framework. A large majority (75%) of the respondents indicated that they would be very or somewhat likely to take one or more of these actions: * more than half (54%) of practicing physicians said that they would be very or somewhat likely to reduce the number of hours worked; * 42% would be very or somewhat likely to reduce office staff; and, * about one quarter indicated that they would be very or somewhat likely to pursue other measures such as closing their practice and retiring (24%) or relocating their practice to another provincial/territorial jurisdiction (26%) or to the U.S. or another country (22%). The responses to the CMA's survey on incorporation align with the limited research available on this issue. In a study that explored the interprovincial migration of physicians confirmed that "the differences in real income have a positive and significant effect on a physician's decision to migrate from one province to another".14 Another study that explored the impacts of taxation on physicians, noted that "it has been demonstrated in the literature that physicians in higher-tax states work less on average".15 These studies emphasize the potential for unintended consequences should changes to the CCPC framework impact physician medical practice. Conclusion As outlined in this brief, the majority of Canada's doctors are self-employed, highly skilled professionals providing a critical health care contribution in communities across the country. For these physicians, the CCPC framework provides a critical tax equity measure that recognizes the unique challenges they face as small business owners. For the vast majority of incorporated physicians, the benefits of the CCPC framework are critical to the operation of the practice model, particularly supporting community-based care. In some cases, the practice model is only economical within this framework. In light of the intrinsic role of the CCPC framework to medical practice, and therefore the provision of medical care in Canada, the CMA encourages significant caution in considering any potential changes to this framework. The CMA's core recommendation to the federal government is to maintain tax equity for medical professionals by affirming its commitment to the existing framework governing Canadian-Controlled Private Corporations. References 1 Ontario Budget 2000 https://www.poltext.org/sites/poltext.org/files/discours/ON/ON_2000_B_37_01.pdf 2 Mandate Letter for the Minister of Small Business and Tourism http://www.pm.gc.ca/eng/minister-small-business-and-tourism-mandate-letter 3 CMA. 2014. Environmental Scan. 4 Industry Canada. Key Small Business Statistics 2013 https://www.ic.gc.ca/eic/site/061.nsf/eng/02814.html 5 Canadian Post M.D. Registry. 6 National Physician Survey http://nationalphysiciansurvey.ca/wp-content/uploads/2013/03/C3PR-Bulletin-StudentResidentDebt-201303-EN.pdf 7 National Physician Survey http://nationalphysiciansurvey.ca/wp-content/uploads/2013/03/C3PR-Bulletin-StudentResidentDebt-201303-EN.pdf 8 Alberta Medical Association. Setting the record straight on physician compensation. https://www.albertadoctors.org/Media%20PLs%202013/Feb1_2013_PL_Backgrounder.pdf and Ontario Medical Association. Payments to physicians and practice overhead expenses: separating facts from fiction in Ontario. https://www.oma.org/resources/documents/paymentsphysicians_pp18-19.pdf. and R.K. House & Associates Ltd. Executive Summary for the British Columbia Medical Association: 2005 Overhead Cost Study. 9 CIHI. Physicians in Canada, 2014: Summary Report. https://secure.cihi.ca/free_products/Summary-PhysiciansInCanadaReport2014_EN-web.pdf 10 Health Canada. Canada Health Act Annual Report 2014-15. http://www.hc-sc.gc.ca/hcs-sss/pubs/cha-lcs/2015-cha-lcs-ar-ra/index-eng.php 11 Mark H. Showalter and Norman K. Thurston. Taxes and labor supply of high-income physicians. Journal of Public Economics 66 (1997) 73-97. 12 Ontario Budget 2000 https://www.poltext.org/sites/poltext.org/files/discours/ON/ON_2000_B_37_01.pdf 13 Manulife. The Professional's Option - Professional Incorporation. https://repsourcepublic.manulife.com/wps/wcm/connect/02b56600433c4887b94dff319e0f5575/ins_tepg_taxtopicproopt.pdf?MOD=AJPERES&CACHEID=02b56600433c4887b94dff319e0f5575 14 Michael Benarroch and Hugh Grant. The interprovincial migration of Canadian physicians: does income matter? Applied Economics, 2004, 36, 2335-2345. 15 Norman K. Thurston and Anne M. Libby. Taxes and Physicians Use of Ancillary Health Labor. The Journal of Human Resources, XXXV 2.
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Reducing barriers to physician mobility and for a more uniformed healthcare system in Canada

https://policybase.cma.ca/en/permalink/policy11850
Date
2016-05-12
Topics
Health human resources
  1 document  
Policy Type
Parliamentary submission
Date
2016-05-12
Topics
Health human resources
Text
On behalf of 83,000 physician members, the Canadian Medical Association (CMA) welcomes this opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study on internal barriers to trade. For the purposes of this brief, an internal barrier to trade is any regulation or policy that restricts mobility or otherwise creates a perverse incentive for mobility. Basic Facts on the Canadian Physician Workforce The physician workforce in Canada has always been a mobile one. As of January 2016, just over one in four (26%) licensed physicians who graduated from one of Canada’s 17 medical schools was practising in a different province from the one where they obtained their medical degree.1 It might be added that only 8 of Canada’s 13 provinces and territories have medical schools. Another important dimension of mobility is the fact that Canada continues to rely to a significant degree on the medical services provided by International Medical Graduates (IMGs). Presently, IMGs represent 24% of practising physicians in Canada, and this figure has remained steady over the past two decades (and previously) despite significant increases in medical enrolment.1 A key reason for this dependence is that Canada trains fewer physicians relative to population than other developed countries. According to the Organization for Economic Cooperation and Development (OECD), in 2013, Canada ranked 28th out of 34 member countries in terms of medical graduates per 100,000 population; at 7.5 graduates per 100,000, Canada was one-third below the OECD average of 11.1.2 Another key consideration of the physician workforce in Canada is that beyond the tuition that medical students pay at the undergraduate level, it is virtually exclusively publicly funded. By way of illustration, in 2012, 99% of physician professional incomes came from the public purse in Canada, compared to an average of 72% for the 22 OECD countries for which data were available.3 1 Canadian Medical Association Physician Masterfile, January 2016. 2 Organization for Economic Cooperation and Development. OECD Health Statistics, 2015. http://stats.oecd.org/Index.aspx?DataSetCode=HEALTH_REAC. Accessed 05/05/16. 3 Organization for Economic Cooperation and Development. OECD. Stat. Accessed 05/05/16. 4 Internal Trade Secretariat. Agreement on Internal Trade. http://www.ait-aci.ca/agreement-on-internal-trade/. Accessed 05/05/16. 5 Federation of Medical Licensing Authorities of Canada, Association of Canadian Medical Colleges, Medical Council of Canada. Licensure, postgraduate training and the Qualifying Examination. Can Med Assoc J 1992;146(3):345. 6 Federation of Medical Regulatory Authorities of Canada. Model standards for medical registration in Canada. Ottawa, 2016. 7 Federal/Provincial/Territorial Advisory Committee on Health Delivery and Human Resources. Report of the Canadian Task Force on Licensure of International Medical Graduates. Ottawa, 2004. 8 Medical Council of Canada. Practice-ready assessment. http://mcc.ca/about/collaborations-and-special-projects/practice-ready-assessment/. Accessed 05/08/16. 9 Canadian Heritage. The Canadian Charter of Rights and Freedoms. http://publications.gc.ca/collections/Collection/CH37-4-3-2002E.pdf. Accessed 05/08/16. 10 Canada. Canada Health Act R.S.C., 1985, c. C-6. http://laws-lois.justice.gc.ca/PDF/C-6.pdf. Accessed 05/08/16. 11 Canadian Institute for Health Informaiton. Prescribed drug spending in Canada, 2013: a focus on public drug programs. https://secure.cihi.ca/free_products/Prescribed%20Drug%20Spending%20in%20Canada_2014_EN.pdf. Accessed 05/08/16. National Standards for Eligibility for Licensure The medical profession was well out in front of the 1994 Agreement on Internal Trade (AIT) and its objective in Chapter Seven of eliminating or reducing measures maintained by the provinces and territories that restrict or impair labour mobility in Canada.4 In 1992, the Federation of Medical Licensing Authorities of Canada, the Association of Canadian Medical Colleges and the Medical Council of Canada adopted a standard for portable eligibility of licensure in all provinces except Quebec.5 When the AIT was revisited in the late 2000s, the Federation of Medical Regulatory Authorities of Canada (FMRAC) worked on the development of an agreement on national standards that was endorsed in all jurisdictions in 2009. This has continued to evolve, and presently, the Model Standards for Medical Registration in Canada set out the: . Canadian standard for full licensure; . route from a provisional license to a full license (which would apply to most IMGs that do not come through the post-MD system in Canada); and . requirements for provisional licensure.6 The result of this effort is that the number of different medical licences in Canada has been reduced from more than 140 to fewer than 5. Since the early 2000s the federal government has played a strong leadership role in assisting the professions to come into compliance with the labour mobility provisions of the AIT. In the case of the medical profession, the key issue has been the mobility of IMGs. In 2002, the federally funded Advisory Committee on Health Delivery and Human Resources established the Task Force on Licensure of International Medical Graduates, which brought together representatives from national and provincial/territorial health ministries, medical regulatory and certifying bodies and medical schools with a mandate to aid in the integration of IMGs into the Canadian medical workforce. The recommendations in the 2004 final report of the Task Force essentially set out a workplan that has resulted in considerable progress on several initiatives.7 Federal funding through programs such as Employment and Social Development Canada’s (ESDC) Foreign Credential Recognition Program and Health Canada’s Internationally Educated Health Care Professional Program, in addition to significant investments by the medical bodies themselves, has contributed to several successful initiatives on the part of the Medical Council of Canada (MCC) and FMRAC and its provincial/territorial members. These have included: . $3.5 million from Health Canada to MCC to develop programs to facilitate the integration of IMGs into the physician workforce such as the National Assessment Collaboration examination, a standardized examination that assesses the readiness of an IMG for entrance into the Canadian post-MD training system; . $8.4 million from Human Resources and Skills Development Canada/ESDC to MCC to streamline and standardize the processes of application for medical licensure and to develop physiciansapply.ca, a single electronic web-based application process for registration with each of the 13 medical regulatory authorities; and . $6.7 million from ESDC to MCC to develop a more flexible MCC Qualifying Examination Part I that can be administered internationally, which will enable IMGs thinking of immigrating to Canada to assess whether they have one of the requirements for full licensure. The work to date has contributed significantly to the integration of IMGs but much remains to be done. Many IMGs enter practice in Canada without entering the post-MD system through a process of provisional licensure. One process that jurisdictions have developed over the past decade to facilitate this route to practice is called Practice Ready Assessment (PRA). PRA is an assessment process to determine if an IMG is able to provide safe medical care to the Canadian public under provisional licensure. This consists of a period of practice under supervised direct observation of a licensed physician in a clinical setting with patients. This has the advantage of expediting the process of assessment to approximately 12 weeks versus 2+ years in a residency program. To the present, PRA programs have been developing in a non-standardized way across jurisdictions. With support from Health Canada, an initiative is underway at the MCC with collaboration from FMRAC, the regulatory bodies, the certifying colleges and provincial IMG assessment programs to develop a pan-Canadian PRA program.8 The goal of this program is to address pan-Canadian specialty areas of need, including family medicine, psychiatry and internal medicine. The elements of this program will include: . IMG candidate orientation to the Canadian health care context; . identification of core competency for each specialty; . clinical assessor training; . standardized assessment tools; and . guidelines. This initiative is presently in the implementation phase, and the plan includes development of additional work-based assessment tools.i i For further information contact MCC – www.mcc.ca or FMRAC – www.fmrac.ca Recommendation one: The Canadian Medical Association recommends that the federal government continue to support the Medical Council of Canada and the Federation of Medical Regulatory Authorities of Canada in the implementation of a pan-Canadian Practice Ready Assessment Program for International Medical Graduates and the development of work-based assessment tools. Mobility and Medicare The right of Canadian citizens and permanent residents to move freely and pursue a livelihood in any jurisdiction is set out in the 1982 Canadian Charter of Rights and Freedoms.9 This is supported in the objectives of the AIT that refer to an “open domestic market” and “free movement of persons”. 4 This is certainly the spirit in which Canada’s Medicare program was established, beginning in the 1950s, and which has now come to be regarded as a much-cherished basic right by Canadians. The preamble of the 1984 Canada Health Act (CHA) includes the objective “to facilitate reasonable access to health services without financial or other barriers”, and portability of health insurance from one jurisdiction to another is one of five criteria for eligibility for federal funding (subject to a three month waiting period in which benefits are paid for by the originating jurisdiction).10 However, the letter of the CHA defines insured health services as “hospital services, physician services and surgical-dental services provided to insured services”10 and that is how it continues to be interpreted by the provinces and territories. An issue that has been identified in many recent reports is the uneven access to prescription drugs. The Canadian Institute for Health Information (CIHI) has estimated that in 2014, the federal and provincial governments accounted for 42% of prescription drug spending, with the majority accounted for by private insurance (36%) or out-of-pocket (22%) spending.11 There is wide variation in public per capita spending on prescription drugs across the provinces. In 2015, CIHI has estimated that expenditure ranged from $219 in British Columbia and $256 in Prince Edward Island (PEI) to $369 in Saskatchewan and $441 in Quebec.12 Even more striking variation is evident when looking at household out-of-pocket spending on prescription drugs by income quintile. Statistics Canada’s 2014 Survey of Household Spending shows that the poorest one-fifth (lowest income quintile) of PEI households spent more than twice as much ($645) on prescription drugs than the poorest one-fifth in Ontario ($300).13 Aside from overall differences in public spending, there are also differences in which drugs are covered, particularly in the case of cancer drugs. For example, the Cancer Advocacy Coalition of Canada reported in 2014 that in Ontario and Atlantic Canada, cancer drugs that must be taken in a hospital setting and are on the provincial formulary are fully funded by the provincial government; if the drug is taken outside of hospital (oral or injectable), however, the patient and family may have to pay significant costs out-of-pocket.14 More generally, the Canadian Cancer Society has reported that persons moving from one province to another may find that a drug covered in their former province may not be covered in the new one. 15 12 Canadian Institute for Health Information. National Health Expenditure Database 1975 to 2015. Table A.3.1.1. https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/08/14. 13 Statistics Canada. CANSIM Table 2013-0026 Survey of household spending (SHS), household spending, by age of reference person. Accessed 03/27/16. 14 Cancer Advocacy Coalition of Canada. 2014-15 Report Card on Cancer in Canada. http://www.canceradvocacy.ca/reportcard/2014/Report%20Card%20on%20Cancer%20in%20Canada%202014-2015.pdf. Accessed 05/08/16. 15 Canadian Cancer society. Cancer drug access for Canadians. http://www.colorectal-cancer.ca/IMG/pdf/cancer_drug_access_report_en.pdf. Accessed 05/08/16. 16 Ipsos Reid. Supplementary health benefits research. Final report, 2012. 17 Conference Board of Canada. Federal policy action to support the health care needs of Canada’s aging population. https://www.cma.ca/Assets/assets-library/document/en/advocacy/conference-board-rep-sept-2015-embargo-en.pdf. Accessed 05/08/16. 18 Hall E. Canada’s national-provincial health program for the 1980’s ‘A commitment for renewal’. 1980. 19 Canada. Statutes of Canada 2012 Chapter 19. http://laws-lois.justice.gc.ca/PDF/2012_19.pdf. 20 Canadian Medical Association. Submission to the Minister of Finance: Small Business Perspectives of Medical Practice in Canada. https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-medical-practice-as-small-business-march-17-2016.pdf Another consequence of the “patchwork quilt” of prescription drug coverage in Canada is the potential for “job lock” among those with employer sponsored benefits. Research carried out by Ipsos Reid for the CMA in 2012 among Canadian adults found that 51% of respondents had employer-sponsored supplementary benefits, with almost all of them reporting prescription drug coverage. Among those with employer benefits, just over four in 10 (42%) indicated that their employer benefits program would be a factor in whether or not they would switch jobs.16 Uneven access to and coverage of prescription drugs across Canada raises two concerns with respect to population mobility. On one hand, there could be a temptation to move to another jurisdiction with better access and coverage, and on the other, there could be a reluctance to move to another jurisdiction for fear of lesser access and coverage. Uncertainty about health care coverage should not be a factor in Canadians’ decisions about where they choose to live and work. One concrete step that the federal government could take to mitigate these concerns would be to introduce a program of drug coverage that would cap high out-of-pocket drug costs for individual Canadians. In 2015, the Conference Board of Canada conducted research for the CMA to estimate the cost of a drug program that would cover prescription drug costs that are greater than either $1,500 per year or 3% of household income (so-called catastrophic costs). They estimated that this would cost the federal government $1.6 billion in 2016.17 Recommendation two: As a positive step toward comprehensive, universal coverage for prescription medication, the Canadian Medical Association recommends that the federal government establish a new program for catastrophic coverage of prescription medication. The Canada Health Act and Physician Mobility In his 1979 review of the Medicare program that led to the CHA, Justice Emmett Hall clearly recognized the power imbalance of the shift to an exclusive public payer for physician services, stating “I reject totally the idea that physicians must accept what any given Province may decide unilaterally to pay. I reject too, as I did in the report of the Royal Commission, the concept of extra-billing.” Justice Hall’s recommended solution to this imbalance was provision for that “when negotiations fail and an impasse occurs, the issues in dispute must be sent to binding arbitration, to an arbitration board consisting of three persons, with an independent chairperson to be named by the chief justice of the relevant Province and one nominee from the profession and one from the Government”.18 Provision for reasonable compensation was built into the CHA in sections 12 (1) and (2). In most jurisdictions, bargaining disputes between the government and the medical association over the amounts that physicians should be paid are subject to a binding dispute resolution mechanism that includes some form of arbitration, as Justice Hall envisioned. However, in Ontario, the physicians have been without a contract since March 31, 2014, and Nova Scotia has given Royal Assent to, but not yet proclaimed the Public Services Sustainability (2015) Act, which suspends the right of the medical association (Doctors Nova Scotia) to arbitration. As noted in the basic facts enumerated above, Canadian physicians are highly mobile, but they should not be motivated to move on the basis of unfair treatment by the government, as is currently the case in Ontario. There is recent precedent for amending the CHA. In 2012, the Jobs, Growth and Long-term Prosperity Act amended the CHA to remove members of the Royal Canadian Mounted Police from the list of exclusions of insured persons.19 Recommendation three: The Canadian Medical Association recommends that Section 12(2) of the Canada Health Act be amended to require: (a) Provincial and territorial governments to enter into an agreement with the provincial/territorial organization(s) that represent(s) practising medical practitioners in the province; and (b) The settlement of disputes relating to compensation through, at the option of the provincial/territorial organization(s) referred to in paragraph (a), conciliation or binding arbitration that is equally representative of the provincial/territorial organization(s) and the province/territory and that has an independent chairperson, to satisfy the “reasonable compensation” criterion in s. 12(1)(c) of the Act for full federal funding. Incorporation Eligibility and Access to the Small Business Deduction A significant proportion of Canada’s physicians are self-employed, small business owners, whose medical practices are incorporated as Canadian-Controlled Private Corporations (CCPCs). The ability to incorporate and access to the small business taxation rate play an important role in the allocation of resources in Canada’s health care system. As explained in the CMA’s recent submission to the Minister of Finance20, incorporation eligibility for medical professionals has been advanced by provincial governments to support the achievement of health policy objectives and, in part, to level the playing field with other self-employed individuals. The CMA strongly welcomed the federal government’s recognition in the budget of the contribution of health care practitioners as small businesses. However, the CMA has significant concerns with the proposed amendments (clause 54 of the Notice of Ways and Means Motion to Amend the Income Tax Act and Other Tax Legislation) to alter eligibility to the small business deduction. It is not clear whether these measures will impact group medical structures. The results of a recent survey by the CMA of its membership confirms that the CCPC framework provides a critical tax equity measure that recognizes the unique challenges they face as small business owners and is critical to the operation of the practice model, particularly supporting community-based care. In some cases, the practice model is only economical within this framework. An important fact is that unlike other small business owners, physicians cannot pass on any increases in compliance or operating costs to patients, given the design of Canada’s public health care system. Of significance to the committee’s study on internal trade, approximately 26% of survey respondents indicated that they would be very or somewhat likely to relocate to another provincial/territorial jurisdiction (26%) or to the U.S. or another country (22%) if they were no longer able to incorporate under the CCPC framework. Recommendation four: Given the potential for negative unintended consequences, such as rendering group medical structures economically unviable or introducing perverse incentives for mobility, particularly out of country, the Canadian Medical Association strongly encourages the federal government to provide clarification regarding the 2016 budget measures with regard to the Canadian-Controlled Private Corporation framework.
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National pharmacare in Canada: Getting there from here

https://policybase.cma.ca/en/permalink/policy11959
Date
2016-06-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2016-06-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of 83,000 physician members, the Canadian Medical Association (CMA) welcomes this opportunity to provide input to the House of Commons Standing Committee on Health study on the Development of a National Pharmacare Program. Recognizing that the term “pharmacare” is used in different contexts, for the purposes of this brief, pharmacare is defined as a program whereby Canadians have comparable access to medically necessary prescription medications, irrespective of their ability to pay, wherever they live in Canada. The Canadian Medical Association (CMA) is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients. On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. Key Facts According to the Canadian Institute for Health Information (CIHI), in 2014, of the estimated $28.8 billion spent in Canada on prescription medications (representing 13.4% of total health spending), governmentsi accounted for 42.0%, and private insurers and out-of-pocket (OOP) payment accounted for 35.8% and 22.2% respectively.1 The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. i Includes federal. Social security fund and provincial/territorial spending 1 Canadian Institute for Health Information. Prescribed drug spending in Canada, 2013: a focus on public drug programs. https://secure.cihi.ca/free_products/Prescribed%20Drug%20Spending%20in%20Canada_2014_EN.pdf. Accessed 05/15/16. 2 Royal Commission on Health Services. Report Volume One. Ottawa: Queen’s Printer, 1964. 3 Canadian Institute for Health Information. National Health Expenditure Database 1975 to 2015. Table D 3.1.1-D3.13.1 https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/08/16. 4 Statistics Canada. CANSIM Table 203-0022 Survey of household spending (SHS), household spending, Canada, regions and provinces, by household income quintile. Accessed 05/18/16. 5 Cancer Advocacy Coalition of Canada. 2014-15 Report Card on Cancer in Canada. http://www.canceradvocacy.ca/reportcard/2014/Report%20Card%20on%20Cancer%20in%20Canada%202014-2015.pdf. Accessed 05/08/16. 6 Canadian Cancer Society. Cancer drug access for Canadians. http://www.colorectal-cancer.ca/IMG/pdf/cancer_drug_access_report_en.pdf. Accessed 05/08/16. 7Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15. 8 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23. 9 Law M, Cheng L, Dhalla I, Heard D, Morgan S. The effect of cost on adherence to prescription medications in Canada. CMAJ 2012. 184)3):297-302. 10 Tamblyn R, Eguale T, Huang A, Winslade N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care. Ann Inter Med 2014;160:441-50. Pharmacare is clearly part of the unfinished business of Medicare. Numerous authors have pointed out that Canada is the only developed country that does not include prescription medications as part of its universal health program. Table 1 below shows how Canada compares with the 22 member countries of the Organization for Economic Cooperation and Development (OECD) on the proportion of public spending for major categories of health expenditure in 2012. Table 1. Public spending as % of total spending: Major health spending categories, Canada and 22 OECD country average, 2012 % Public Spending Prescription Drugs Hospitals Doctors’ Offices Canada 42 91 99 OECD Average 70 88 72 Source: OECD.Stat, Doctors’ offices figure for Sweden is 2009 In the case of prescription medications, Canada was more than one-third (40%) below the OECD average. The Patchwork Quilt of Public-Private Coverage In 1964 the Hall Commission recommended 50/50 cost-sharing between the federal and provincial governments toward the establishment of a prescription drug program, with a $1.00 charge for each prescription. At the time, prescription medications represented 6.5% of spending on personal health services.2 This recommendation was not implemented. It might be further added that the Hall report contained 25 forward-looking recommendations on pharmaceuticals that remain current to this day, including bulk purchasing, generic substitution and a national formulary.2 As a result of the lack of inclusion of prescription medications in Medicare, there is wide variation today in public per capita spending on prescription drugs across the provinces. It may be seen in Table 2 that, for 2014, CIHI has estimated that public per capita expenditure ranged from $219 in British Columbia and $255 in Prince Edward Island (PE) to $369 in Saskatchewan and $437 in Quebec.3 CIHI does not provide estimates of private per capita prescription drug spending (private insurance plus OOP) below the national level. Table 2: Spending on prescription drugs: Selected indicators by province and territory, 2014 Province/ Territory Public spendinga ($ million) Public per capita spendinga ($ ) Private insuranceb ($ million) Average household out-of-pocketc $ NL 156.7 297 177 454 PE 37.3 255 32 516 NS 302.2 321 337 429 NB 210.8 280 284 477 QC 3,588.7 437 2,369 466 ON 4,730.4 346 4,626 324 MB 411.3 321 249 516 SK 415.4 369 192 514 AB 1,383.7 336 1,065 409 BC 1,015.8 219 894 456 YT 14.0 383 - - NT 17.5 400 - - NU 13.6 372 - - Territories 45.1 385 23 - Canada 12,297.4 334d 10,247 408 a CIHI, National Health Expenditure Database 1975-2015, includes all public funding sources b Canadian Life and Health Insurance Association c Statistics Canada, Survey of Household Spending, 2014 d Provincial/territorial average Table 2 also shows the significant role of private insurance in every region of Canada. Data provided by the Canadian Life and Health Insurance Association, shown in Column 3 of Table 2, show that private health insurance companies paid out $10.2 billion for prescription drug claims in 2014, representing 83% of the $12.3 billion paid for by governments. In three provinces — Newfoundland and Labrador, Nova Scotia and New Brunswick — the amount paid by private insurance exceeds that paid by governments. Table 2 also shows that there is wide variation in average household OOP spending on prescription drugs, according to Statistics Canada’s Survey of Household Spending (SHS). In 2014 this ranged from a low of $324 in Ontario to a high of $516 in PE and Manitoba.4 Even more striking variation is evident when looking at household out-of-pocket spending on prescription drugs by income quintile (detailed data not shown). According to the 2014 SHS the poorest one-fifth (lowest income quintile) of PE households spent more than twice as much ($645) OOP on prescription drugs than the poorest one-fifth in Ontario ($300).4 Aside from overall differences in public spending there are also differences in which medications are covered, particularly in the case of cancer drugs. The Cancer Advocacy Coalition of Canada reported in 2014 that four provinces have fully funded access to cancer medications taken at home. In Ontario and Atlantic Canada however, cancer drugs that must be taken in a hospital setting and are on the provincial formulary are fully funded by the provincial government; if the drug is taken outside of hospital (oral or injectable), the patient and family may have to pay significant costs out-of-pocket.5 More generally the Canadian Cancer Society has reported that persons moving from one province to another may find that a medication covered in their former province may not be covered in the new one. 6 Other sources confirm that prescription medication spending is an issue for many Canadians. On the Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.7 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.8 At least two Canadian studies have documented the impact that out-of-pocket costs, lack of insurance and low income have on non-adherenceii to prescription regimens. Law et al. examined cost-related non-adherence in the 2007 Canadian Community Health Survey and found that those without drug insurance were more than four times as likely to report non-adherence than those with insurance. The predicted rate of non-adherence among those with high household incomes and drug insurance was almost 10 times as high as that among those with low incomes and no insurance (35.6% vs. 3.6%).9 Based on a large-scale study of the incidence of primary non-adherence (defined as not filing a new prescription within nine months) in a group of some 70,000 Quebec patients, Tamblyn et al. reported that there was a 63% reduction in the odds of non-adherence among those with free medication over those with the maximum level of co-payment. They also reported that the odds of non-adherence increased with the cost of the medication prescribed.10 ii Non-adherence can be defined as doing something to make a medication last longer or failing to fill or renew a prescription. Previous Pharmacare Proposals In a recent monograph Katherine Boothe has contrasted the development of national prescription medication programs in Australia and the United Kingdom with the failure to do so in Canada.11 11 Boothe K. Ideas and the pace of change: national pharmaceutical insurance in Canada, Australia and the United Kingdom. Toronto: University of Toronto Press, 2015. 12 National Forum on Health. Directions for a pharmaceutical policy in Canada. http://www.hc-sc.gc.ca/hcs-sss/pubs/renewal-renouv/1997-nfoh-fnss-v2/index-eng.php. Accessed 05/18/16. 13 National Forum on Health. Canada health action: building on the legacy. Ottawa: Minister of Public Works and Government Services, 1997. 14 Bank of Canada. Inflation calculator. http://www.bankofcanada.ca/rates/related/inflation-calculator/?page_moved=1. Accessed 05/18/16. 15 Statistics Canada. Table 051-0001 Estimates of population, by age group and sex for July 1, Canada, provinces and territories. Accessed 05/15/16. 16 Canadian Institute for Health Information. National health expenditure database 1975 to 2015. Table C.3.1. Public health expenditure by use of funds, Canada, 1975 to 2015. https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/25/16. 17 Berry C. Voluntary medical insurance and prepayment. Ottawa: Queen’s Printer, 1965. 18 Receiver General for Canada. Volume I Public Accounts of Canada for the fiscal year ended March 31, 1969. Ottawa: Queen’s Printer for Canada, 1969. 19 Receiver General for Canada. Volume I Public Accounts of Canada for the fiscal year ended March 31, 1972. Ottawa: Information Canada, 1972. 20 Privy Council Office. Speech from the Throne to open the first session thirty-sixth Parliament of Canada. http://www.pco-bcp.gc.ca/index.asp?lang=eng&page=information&sub=publications&doc=aarchives/sft-ddt/1997-eng.htm. Accessed 05/18/16. 21 Standing Senate Committee on Social Affairs, Science and Technology. The health of Canadians – the federal role. Volume six: recommendations for reform. Ottawa, 2002. 22 Commission on the Future of Health Care in Canada. Building on values: the future of health care in Canada. Ottawa, 2002. 23 Canadian Intergovernmental Conference Secretariat. 2003 First Ministers’ accord on health care renewal. http://www.scics.gc.ca/CMFiles/800039004_e1GTC-352011-6102.pdf. Accessed 05/18/16. 24 Council of the Federation. Premiers’ action plan for better health care: resolving issues in the spirit of true federalism. Communiqué July 30, 2004. http://canadaspremiers.ca/phocadownload/newsroom-2004/healtheng.pdf. Accessed 05/18/16. 25 Canadian Intergovernmental Conference Centre. A 10-year plan to strengthen health care. http://www.scics.gc.ca/CMFiles/800042005_e1JXB-342011-6611.pdf. Accessed 05/18/16. 26 National Pharmaceuticals Strategy. National Pharmaceuticals Strategy progress report. http://www.hc-sc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 05/18/16. 27 Canadian Intergovernmental Conference Secretariat. Backgrounder: national pharmaceutical strategy decision points. http://www.scics.gc.ca/english/conferences.asp?a=viewdocument&id=112. Accessed 05/18/16. 28 Canada’s Premiers. The pan-Canadian Pharmaceutical Alliance: April 2016 Update. http://www.pmprovincesterritoires.ca/en/initiatives/358-pan-canadian-pharmaceutical-alliance. Accessed 05/18/16. 29 Canadian Medical Association. General Council Resolution GC15-C16, August 26, 2015. 30 Gagnon M. The economic case for universal pharmacare. 2010. https://s3.amazonaws.com/policyalternatives.ca/sites/default/files/uploads/publications/National%20Office/2010/09/Universal_Pharmacare.pdf. Accessed 05/18/16. 31 Gagnon M. A roadmap to a rational pharmacare policy in Canada. Ottawa: Canadian Federation of Nurses Unions, 2014. 32 Morgan S, Law M, Daw J, Abraham L, Martin D. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ. 2015 Apr 21;187(7):491-7. doi: 10.1503/cmaj.141564. 33 Morgan S, Martin D, Gagnon M, Mintzes B, Daw, J, Lexchin, J. Pharmacare 2020. The future of drug coverage in Canada. http://pharmacare2020.ca/assets/pdf/The_Future_of_Drug_Coverage_in_Canada.pdf. Accessed 05/18/16. 34 Canadian Medical Association. Policy resolution GC15-C19, August 26, 2015. 35 Conference Board of Canada. Federal policy action to support the health care needs of Canada’s aging population. https://www.cma.ca/Assets/assets-library/document/en/advocacy/conference-board-rep-sept-2015-embargo-en.pdf. Accessed 05/18/16. 36 Government of the United Kingdom. Written statement to Parliament NHS charges from April 2016. https://www.gov.uk/government/speeches/nhs-charges-from-april-2016. Accessed 05/18/16. 37 Appleby J. Prescription charges: are they worth it? BMJ 2014;348:g3944 doi: 10.1136/bmj.g3944. Among the several Canadian attempts that she describes, the most activity occurred in the decade following the National Forum on Health (NFH), which was struck in 1994 and reported in 1997. A NFH working group paper on pharmaceutical policy recommended first dollar coverage for prescription medications, but acknowledged that it could not occur overnight: “over time we propose to shift private funding on prescribed pharmaceuticals (estimated at $3.6 billion in 1994) to public funding”.12 The NFH included this recommendation in its final report, noting that “the absorption of currently operating plans by a public system may involve transfer of funding sources as well as administrative apparatus”.13 It is instructive to place the 1994 prescription drug expenditure cited by the NFH in today’s context. According to the Bank of Canada’s inflation calculator, the $6.5 billion in 1994 would have cost $9.5 billion in 2014.14 CIHI estimates that actual spending in 2014 was $28.7 billion1 – 203% above the level of 1994 spending, compared to population growth of 23% over the same time period.15 Annual prescription drug spending increases averaged 7.3% over the period, although they have averaged just over 1% since 2009. 16 A significant shift from private to public funding is not without precedent. A study prepared for the Hall Commission estimated that 9.6 million Canadians, representing 53% of the total population, had some form of not-for-profit or commercial insurance coverage for medical and/or surgical services in 1961.17 With the passage of the Medical Care Act in 1966 these plans were all displaced as the provinces joined Medicare. The funding shift did not occur overnight, although it did move quickly. In the first year, 1968/69, Ottawa paid out $33 million to the provinces pursuant to the Medical Care Act, which grew quickly to $181 million in 1969/70, and reaching $576.5 million in 1971/72.18,19 Since the 1997 NFH report the closest that the federal government has come to acting on pharmacare was a commitment in the 1997 Speech from the Throne to “develop a national plan, timetable and a fiscal framework for providing Canadians with better access to medically necessary drugs”, but nothing further was ever made public.20 Pharmacare was subsequently examined in two national studies, both of which recommended federal involvement in reimbursing “catastrophic” prescription drug expenditures above a threshold of household income. The Senate study on the State of the Health Care System in Canada, chaired by Michael Kirby, was authorized in March 2001 and the Commission on the Future of Health Care in Canada, headed by Roy Romanow, was approved in April 2001. Both issued their final reports in 2002. The Kirby plan was designed so as to avoid the necessity of eliminating existing private plans or the provincial/territorial public plans, not unlike the approach taken by Quebec in 1997. In the Kirby plan, in the case of public plans, personal prescription medication expenses for any family would be capped at 3% of total family income. The federal government would then pay 90% of prescription drug expenses in excess of $5,000. In the case of private plans, sponsors would have to agree to limit out-of-pocket costs to $1,500 per year, or 3% of family incomes, whichever was less. The federal government would then agree to pay 90% of drug costs in excess of $5,000 per year. Both public and private plans would be responsible for the difference between out-of-pocket costs and $5,000, and private plans would be encouraged to pool their risk. Kirby estimated that this plan would cost approximately $500 million per year.21 The Romanow Commission recommended a $1 billion Catastrophic Drug Transfer through which the federal government would reimburse 50% of the costs of provincial and territorial drug insurance plans above a threshold of $1,500 per person per year.22 The advantage of these proposals is that they are fully scalable. The federal government could adjust either the out-of-pocket household income threshold, the ceiling above which it would assume costs, or the percentage of costs that it would pay above the ceiling. Following the Kirby and Romanow reports there was a back and forth exchange between the federal and provincial-territorial (PT) governments on a plan for catastrophic coverage. In their February 2003 Accord, First Ministers agreed to ensure that Canadians would have reasonable access to catastrophic drug coverage by March 2006.23 At their annual summer meeting in 2004 the Premiers later called on the federal government to “assume full financial responsibility for a comprehensive drug program for all Canadians”, with compensation to Quebec for its drug program.24 In the September 2004 Health Accord, First Ministers directed health ministers to develop a nine-point National Pharmaceuticals Strategy (NPS), including costing options for catastrophic coverage.25 A federal-provincial-territorial Ministerial Task Force on the NPS was struck and a progress report was issued in June 2006. The estimates of catastrophic spending were markedly higher than those of the Kirby and Romanow reports. Using a variable percentage of income threshold it estimated that, based on public plan costs, only catastrophic spending represented 42% of total prescription drug spending. If private plan costs were also considered, catastrophic spending would represent 55% of total prescription drug spending. This report proposed four options for catastrophic coverage with estimates for new public funding ranging from $1.4 to $4.7 billion.26 Although no account of the methods was provided it is evident that a significant proportion of existing plan costs were included in the estimates of catastrophic expenditure. At their September 2008 meeting, the PT health ministers called for a national standard for drug coverage not to exceed 5% of net income and for the federal government to share 50/50 in the estimated $5.03 billion cost.27 The uncertainty about the projected cost of a pharmacare plan resulting from widely varying estimates has doubtless contributed to a reluctance of governments to engage on advancing this issue. Recent Developments At the PT level, there has been a concerted effort on price negotiations during the past few years through the pan-Canadian Pharmaceutical Alliance (pCPA) that was established in 2010. As of March 31, 2015, the pCPA reported that price reductions in generic and brand-name prescription medications result in annual savings of an estimated $490 million.28 The federal drug plans are now participating in the pCPA and the CMA has recommended that the pCPA should also invite the participation of private health insurance companies.29 The prospect of savings through lower prices has been foundational to two recent studies that have made the case that a single public payer pharmacare program with little or no co-payment is affordable. The first was by Marc-André Gagnon in 2010. The proposal was developed on the basis of a review of cross-provincial and international practices in pharmaceutical policy. The review formed the basis of a set of 11 assumptions that were used to develop four scenarios that resulted in estimates of prescription drug cost savings over the 2008 baseline expenditure of $25.1 billion that ranged to $2.7 billion to $10.7 billion.30 In a 2014 update Gagnon estimated that a first dollar coverage program would save 10% to 41% of prescription drug costs, representing savings of as much as $11.4 billion annually on a 2012-13 base of $27.7 billion.31 Steve Morgan and colleagues (2015) have estimated that a universal public plan with small co-payments could reduce prescription drug spending by $7.3 billion.32 Subsequently, in Pharmacare 2020 Morgan et al. set out five recommendations calling for the implementation of a single payer system with a publicly accountable management agency by 2020.33 Taking a First Step Forward At its 2015 annual meeting, the CMA adopted a policy resolution that supports the development of an equitable and comprehensive national pharmacare program.34 Reflecting on the experience of the past 40 years since the enactment of the Established Programs Financing Act in 1977 that eliminated 50:50 cost-sharing, it seems highly unlikely that the federal government would take on a new open-ended program in the health and social arena, cost-shared or not. However, notwithstanding the progress of the pCPA, we are unlikely to address the significant access gaps in prescription medication coverage without the involvement of the federal government. These are fiscally challenging times for both levels of government, with budget deficits expected for several years to come. As noted previously, the Kirby and Romanow proposals for a federal funding role in pharmacare are scalable. In 2015 the CMA commissioned the Conference Board of Canada to model the cost of covering prescription medication expenditure beyond a household spending threshold of $1,500 or 3% of gross household income, based on Statistics Canada’s 2013 Survey of Household Spending. The projected costs over the 2016 to 2020 are shown in Table 3 below. The cost to the federal government of covering the entire amount above the ($1,500 – 3%) threshold would be $1.6 billion in 2016.35 Recommendation 1: The Canadian Medical Association recommends that the House of Commons Standing Committee on Health request the Parliamentary Budget Officer to conduct a detailed examination of the financial burden of prescription medication coverage across Canada and to develop costing options for a federal contribution to a national pharmacare program. Recommendation 2: As a positive step toward comprehensive, universal coverage for prescription medications, the Canadian Medical Association recommends that the federal government establish a cost-shared program of coverage for prescription medications. First dollar coverage? The issue of co-payment arises in most discussions of pharmacare. Hall recommended a $1.00 prescription charge in 1964. In England, which does include prescription medications in the National Health Service (NHS), the current prescription charge is £8.40, although the government has previously noted that 90% of prescription items are provided free of charge.36 Appleby has noted however that the NHS’s in Wales, Northern Ireland and Scotland have eliminated prescription charges.37One observational study of dispensing rates in Wales found that the overall impact of removing prescription charges was minimal.38 Table 4 shows the total volume of prescriptions dispensed in Scotland over the period 2009-2015, which straddles the removal of prescription charges on April 1, 2011. It indicates that percentage increases in the annual dispensing volume diminished after 2012 and the increase observed in 2015 was just 1.4%. It should be added, however, that patient charges accounted for less than 4% of Scotland’s dispensing expenditures in 2010.39 It will be interesting to see the results of further studies in these jurisdictions. 38 Cohen D, Alam M, Dunstan F, Myles S, Hughes D, Routledge P. Abolition of prescription copayments in Wales: an observational study on dispensing rates. Value in Health 2010;13(5):675-80. 39 ISD Scotland. Prescribing and medicines. Data tables. http://www.isdscotland.scot.nhs.uk/Health-Topics/Prescribing-and-Medicines/Publications/data-tables.asp?Co=Y. Accessed 05/15/16. 40 Canadian Medical Association. A prescription for optimal prescribing. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf. Accessed 05/18/16. 41 Canadian Medical Association. Vision for e-prescribing; a joint statement by the Canadian Medical Associaiton and the Canadian Pharmacists Association. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD13-02.pdf. Accessed 05/18/16. 42 Department of Finance Canada. Growing the middle class. http://www.budget.gc.ca/2016/docs/plan/budget2016-en.pdf. Accessed 05/18/16. Table 4 Prescription Dispensing in Scotland, 2009 – 2015 Year Number of Prescriptions % increase from previous year (million) 2009 88.4 3.8 2010 91.0 3.0 2011 93.8 3.1 2012 96.6 3.0 2013 98.4 1.9 2014 100.6 2.2 2015 102.0 1.4 Source: annual tabulations - Remuneration and reimbursement details for all prescribing made in Scotland.39 Other Elements of a National Pharmaceuticals Strategy It was noted previously that the Hall Report contained 25 recommendations on pharmaceuticals, and the 2004 Health Accord called for a 9-point National Pharmaceuticals Strategy. Two of the NPS points that the CMA would emphasize are the need to influence prescribing behaviour and the need to advance electronic prescribing (e-prescribing). The CMA refers to the first of these points as “optimal prescribing” and defines it as the prescription of a medication that is: the most clinically appropriate for the patient’s condition; safe and effective; part of a comprehensive treatment plan; and the most cost-effective available to best meet the patient’s needs. Toward this end the CMA has identified principles and recommendations to promote optimal prescribing, including the need for current information on cost and cost-effectiveness.40 The CMA believes that e-prescribing has the potential to improve patient safety, to support clinical decision-making and medication management, and to increase awareness of cost and cost-effectiveness considerations. In 2012 the CMA and the Canadian Pharmacists Association adopted a joint vision statement calling for e-prescribing to be the means by which prescriptions are generated for Canadians by 2015.41 Clearly that date has come and gone and we are not there yet. The current state primarily consists of demonstration projects and “workarounds”. The CMA was pleased to see an amount of $50 million allocated to Canada Health Infoway in the 2016 federal budget to support the advancement of e-prescribing and telehomecare.42 Finally the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures governments might take to implement a pharmacare program these must not exacerbate drug shortages. Recommendation 3: The Canadian Medical Association recommends that the Federal/Provincial/Territorial health Ministers direct their officials to convene a working group on a comprehensive National Pharmaceuticals Strategy that will consult widely with stakeholders representing patients, prescribers, and the health insurance and pharmaceutical industries to report with recommendations by spring 2017. Conclusion In conclusion, few would argue that prescription medications are less vital to the health and health care of Canadians than hospital and medical services. We would not have had the Medicare program that Canadians cherish today without the leadership and financial contribution of the federal government, and similarly without it now we will not have any form of a national pharmacare program.
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Health Canada’s Consultation on “Plain and Standardized Packaging”

https://policybase.cma.ca/en/permalink/policy13817
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation, May 2016. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” Over the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The current Health Canada proposal will help realize that goal and the CMA supports the measures outlined in the consultation paper. There are two elements that the CMA recommend be addressed in this consultation. The CMA recommends that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. In a similar vein, the CMA recommends a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.” While the CMA supports these measures, they must be part of the overall goal of further reducing and eliminating smoking. These measures will be an essential element of a sustained, well-funded and comprehensive program to reduce tobacco use, combining policy interventions with educational and social-marketing interventions including mass media campaigns. These programs should reflect current best practices, and be evaluated regularly for effectiveness and impact. To that end, the CMA calls on the federal government to renew the Tobacco Strategy before it expires in March 2017. At the same time, the CMA also recommends that the government allocate adequate funding to ensure implementation of the strategy. Finally, the consultation paper closes with some potential challenges to the implementation of these proposals. With respect to the problem of counterfeit cigarettes, all levels of government should take the strongest possible measures to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. The problem of retailers having difficulty implementing the regulations, resulting in service delays to their customers, is not really an issue related to these proposals. It is very doubtful that the retailers will experience such problems for very long and will find ways of resolving such difficulties. As for the problem of the manufacturers continuing to innovate in order to circumvent these measures, there should be sufficient enforcement tools within the regulations that will enable Health Canada to deal with such infractions. The Canadian Medical Association remains committed to working with governments and stakeholders to address this issue. We reiterate our long-standing support for plain and standardized packaging for tobacco products. In summary, the CMA recommends that: 1) only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed; 2) a single allowable length of cigarette and that a minimum diameter or width be established; 3) the federal government renew the Tobacco Strategy before it expires in March 2017 and that that the government allocate adequate funding to ensure implementation of the strategy. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism
Vice-président, Professionnalisme médicale Canadian Medical Association
Association médicale canadienne
Documents
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Legalization, regulation and restriction of access to marijuana

https://policybase.cma.ca/en/permalink/policy11954
Date
2016-08-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  2 documents  
Policy Type
Response to consultation
Date
2016-08-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to make this submission in response to the consultation led by the federal Task Force on Marijuana Legalization and Regulation, which has the objective of providing advice to the government on the design of a new framework for marijuana for non-medical, or recreational, purposes. On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. The Government of Canada has made a commitment to legalize, strictly regulate and restrict access to marijuana in response to the high rates of marijuana use among Canadians, particularly youtha 1 2, despite its current illegal status. The existing approach to drugs has resulted in high rates of criminal records for non-violent drug offences each yearb 3, affecting disadvantaged groups disproportionately. Organized crime is supported by these high levels of use. This situation has resulted in considerable harm to society. a Marijuana is the most commonly used illegal substance in Canada. 43% of Canadians claim to have used marijuana at some point in their life, despite almost a century of prohibition. Canadian youth has the highest rate of marijuana use among 29 developed countries. Almost a quarter of the population aged 15 to 24 years reported past-year use. b According to a Stats Canada report, there were 73 thousand marijuana-related criminal offences (67% of all police-reported drug offences) in 2013. 1 Rotermann M, Langlois, K. Prevalence and correlates of marijuana use in Canada, 2012. Health Reports. 2015 Apr;26(4):10-5. Statistics Canada Catalogue no. 82-003-X. Available: http://www.statcan.gc.ca/pub/82-003-x/2015004/article/14158-eng.pdf (accessed August 12, 2016). 2 UNICEF Office of Research. Child Well-being in Rich Countries: A Comparative overview. Innocenti Report Card 11. Florence: UNICEF Office of Research; 2013. Available: https://www.unicef-irc.org/publications/pdf/rc11_eng.pdf (accessed August 12, 2016). 3 Cotter A, Greenland J, Karam M. Drug-Related Offences in Canada, 2013. Juristat. 2015 Jun 25;1-38. Catalogue no. 85-002-X. Available: http://www.statcan.gc.ca/pub/85-002-x/2015001/article/14201-eng.pdf (accessed 2016 Aug 11). 4 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed July 25, 2016). 5 Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana. CMA Submission to the House of Commons Standing Committee on Health. Ottawa: Canadian Medical Association; 2014. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2016 Aug 12). Public opinion in Canada and internationally has risen steadily in support of the removal of criminal sanctions for simple marijuana possession, as well as for the legalization and regulation of marijuana. The federal Task Force has developed a discussion paper, Toward the Legalization, Regulation and Restriction of Access to Marijuana4, which includes the following objectives for the new regime for legal access to marijuana:
Protect young Canadians by keeping marijuana out of the hands of children and youth;
Keep profits out of the hands of criminals, particularly organized crime;
Reduce the burdens on police and the justice system associated with simple possession of marijuana offences;
Prevent Canadians from entering the criminal justice system and receiving criminal records for simple marijuana possession offences;
Protect public health and safety by strengthening, where appropriate, laws and enforcement measures that deter and punish more serious marijuana offences, particularly selling and distributing to children and youth, selling outside of the regulatory framework, and operating a motor vehicle while under the influence of marijuana;
Ensure Canadians are well-informed through sustained and appropriate public health campaigns, and, for youth in particular, ensure that risks are understood;
Establish and enforce a system of strict production, distribution and sales, taking a public health approach, with regulation of quality and safety (e.g., child-proof packaging, warning labels), restriction of access, and application of taxes, with programmatic support for addiction treatment, mental health support and education programs;
Continue to provide access to quality-controlled marijuana for medical purposes consistent with federal policy and Court decisions; and
Conduct ongoing data collection, including gathering baseline data, to monitor the impact of the new framework. Context The CMA has longstanding concerns about the health risks associated with consuming marijuana, particularly in its smoked form.5 6 Children and youth are especially at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. 6 Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: Canadian Medical Association; 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2016 Aug 16). 7 Volkow ND, Baler RD, Compton WM, Weiss SR. Adverse health effects of marijuana use. N Engl J Med. 2014 Jun 5;370(23):2219–2227. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4827335/pdf/nihms762992.pdf (accessed 2016 Aug 15). 8 Wilkinson ST, Yarnell S, Radhakrishnan R, Ball SA, D'Souza DC. Marijuana Legalization: Impact on Physicians and Public Health. Annu Rev Med. 2016 Jan 14;67:453-466. doi: http://dx.doi.org/10.1146/annurev-med-050214-013454. (accessed 2016 Aug 12). 9 World Health Organization (WHO). Management of substance abuse: Cannabis. Geneva: World Health Organization; 2016. Available: http://www.who.int/substance_abuse/facts/cannabis/en/ (accessed 2016 Aug 16). 10 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. The Lancet, 2009 Oct 23;374(9698):1383-91. doi: http://dx.doi.org/10.1016/S0140-6736(09)61037-0. (accessed 2016 Aug 12). 11 Statistics Canada. Canadian Community Health Survey – Mental Health, 2012. The Daily. Ottawa: Statistics Canada; 2013 Sep 18. Component of Statistics Canada catalogue no. 11-001-X. p. 1-2. Available: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2016 Aug 12). 12 Shenfeld A. Growing Their Own Revenue: The Fiscal Impacts of Cannabis Legalization. Economic Insights. Toronto: CIBC World Markets Inc.; 2016 Jan 28. p. 7-8. Available: http://research.cibcwm.com/economic_public/download/eijan16.pdf (accessed 2016 Aug 11). 13 Canadian Centre on Substance Abuse (CCSA). Cannabis Regulation: Lessons Learned In Colorado and Washington State. Ottawa: Canadian Centre on Substance Abuse, 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2016 Aug 15). 14 Canadian Centre on Substance Abuse (CCSA). Marijuana for Non-Therapeutic Purposes: Policy Considerations. Ottawa: Canadian Centre on Substance Abuse, 2014. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Non-Therapeutic-Marijuana-Policy-Brief-2014-en.pdf (accessed 2016 Aug 15). 15 Retail Marijuana Public Health Advisory Committee. Monitoring Health Concerns Related to Marijuana in Colorado: 2014. Denver (CO): Colorado Department of Public Health and Environment; 2015. Available: http://www2.cde.state.co.us/artemis/hemonos/he1282m332015internet/he1282m332015internet01.pdf (accessed 2016 Aug 16). 16 Blue Ribbon Commission on Marijuana Policy. Pathways Report: Policy Options for Regulating Marijuana in California. Denver (CO): Blue Ribbon Commission on Marijuana Policy; 2015. Available: https://www.safeandsmartpolicy.org/wp-content/uploads/2015/07/BRCPathwaysReport.pdf (accessed 2016 Aug 15). 17 Walsh J, Ramsey G. Uruguay’s Drug Policy: Major Innovations, Major Challenges. Washington (DC): Brookings Institution, Washington Office on Latin America; 2015. Available: https://www.brookings.edu/wp-content/uploads/2016/07/Walsh-Uruguay-final.pdf (accessed 2016 Aug 15). 18 Centre for Addiction and Mental Health (CAMH). Cannabis Policy Framework. Toronto: Centre for Addiction and Mental Health; 2014. Available: http://www.camh.ca/en/hospital/about_camh/influencing_public_policy/documents/camhcannabispolicyframework.pdf (accessed 2016 Aug 10). Our understanding of the health effects of marijuana continues to evolve. c 7 8 9 Marijuana use is linked to several adverse health outcomes, including addiction, cardiovascular and pulmonary effects (e.g., chronic bronchitis), mental illness, and other problems, including cognitive impairment and reduced educational attainment. There seems to be an increased risk of chronic psychosis disorders, including schizophrenia, in persons with a predisposition to such disorders. The use of high potency products, higher frequency of use and early initiation are predictors of worse health outcomes. c Unlike pharmaceuticals, marijuana is a complex combination of more than 100 different chemicals. The main psychoactive component is delta-9-tetrahydrocannabinol (THC), but other components, such as cannabidiol (CBD), also act on the central nervous system and may modify the effects of THC. The concentration of these compounds can vary substantially, making it difficult to characterize the specific positive or negative health effects of marijuana, especially in uncontrolled and epidemiological studies. As well, the average content of THC in marijuana has increased substantially in the last 30 years. For these and other reasons, research and attribution of harm and benefit are challenging. d Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine. e Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs. f Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs. The lifetime risk of dependence to marijuana is estimated at about 9%d, increasing to almost 17% in those who initiate use in adolescence.10 In 2012, about 1.3% of people aged 15 and over met the criteria for marijuana abusee or dependencef – double that of any other drugs – due to the high prevalence of marijuana use. 11 Another area of great concern is that of impairment and the operation of vehicles, as well as the performing of work in an unsafe manner. There is an increased risk of motor vehicle collisions up to 6 hours after use, depending on method of use, dose and tolerance. As well, experience in the U.S. and even in Canada has shown that there can be an increased risk of unintentional overdoses in children due to marijuana edibles. The CMA’s overarching recommendation to the federal government is that the government must take a broad public health policy approach to address the legalization and regulation of marijuana for non-medical use. A public health approach would place an increased focus on: preventing drug abuse and dependence; the availability of assessment, counselling and treatment services for those who wish to stop using; and harm reduction to increase the safety for those who are using. This approach seeks to ensure that the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation. Monitoring, surveillance and research of marijuana use are essential to better understand the short and long term harms as well as to develop policy options to address prevention, treatment, harm reduction and enforcement. There are huge economic pressures at play that need to be considered in a new regime and it is essential that public health objectives be central to the process of legalization and regulation. A recent report12 estimates that it could create a $10 billion a year industry in Canada, including production and distribution. As well, legalizing marijuana will bring in considerable tax revenue, and governments could collect as much as 50% or more of that if the rate of taxation is high, as in the ‘sin’ tax on the sale of alcohol and tobacco. As well, legalization could also lead to substantial savings in enforcement and incarceration. Given these pressures by private corporations, governments and other lobby groups, it is essential that the federal and provincial/territorial governments be held accountable to public health objectives of decreasing harms of marijuana use, particularly in children and youth. The CMA’s submission does not address the question of whether marijuana should be legal; the current federal government has already made it clear that this is their intent. Instead, this submission focuses on specific recommendations from physicians as they apply to the regulatory framework, with the objective of protecting individual and public health. It is based on input from CMA’s members, discussions with key stakeholders and experts from specialty societies, a review of reports on the experience in jurisdictions that have legalized marijuana for non-medical use, such as Colorado, Washington and Uruguay13 14 15 16 17, as well as expert literature18 19. 19 George T, Vaccarino F. (eds.). Substance abuse in Canada: The effects of cannabis use during adolescence. Ottawa: Canadian Centre on Substance Abuse; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Effects-of-Cannabis-Use-during-Adolescence-Report-2015-en.pdf (accessed 2016 Aug 16). 20 Centers for Disease Control and Prevention (CDC). Behavioral Risk Factor Surveillance System (BRFSS) Survey. Atlanta (GA): Centers for Disease Control and Prevention; 2016. Available: http://www.cdc.gov/brfss/ (accessed 2016 Aug 10). 21 Rocky Mountain High Intensity Drug Trafficking Area (RMHIDTA). Legalization of Marijuana in Colorado. The Impact. 2014 Aug;2:1-166. Available: http://www.rmhidta.org/html/august%202014%20legalization%20of%20mj%20in%20colorado%20the%20impact.pdf (accessed 2016 Aug 15). 22 Monte AA, Zane RD, Heard KJ. The implications of marijuana legalization in Colorado. JAMA. 2015;313(3):241-42. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/pdf/nihms679104.pdf (accessed 2016 Aug 15). 23 Retail Marijuana Public Health Advisory Committee. Monitoring Health Concerns Related to Marijuana in Colorado: 2014. Denver (CO): Colorado Department of Public Health and Environment; 2015. Available: http://www2.cde.state.co.us/artemis/hemonos/he1282m332015internet/he1282m332015internet01.pdf (accessed 2016 Aug 16). 24 Cunningham JA, Blomqvist J, Koski-Jannes A, Raitasalo K. Societal Images of Cannabis use: Comparing Three Countries. Harm Reduct J. 2012 Jun 18;9:21. Available: http://www.biomedcentral.com/content/pdf/1477-7517-9 -21.pdf (accessed 2016 Aug 15). 25 Porath-Waller A, Brown J, Frigon A, Clark H. What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse; 2013. Available: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf (accessed 2016 Aug 12). 26 Health Canada. Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Health Canada; 2006. Available: http://publications.gc.ca/site/eng/349980/publication.html (accessed 2016 Aug 15). 27 Fischer B, Jeffries V, Hall W, Room R, Goldner E, Rehm J. Lower Risk Cannabis Use Guidelines for Canada (LRCUG): A Narrative Review of Evidence and Recommendations. Can J Public Health. 2011 Sep-Oct;102(5):324-27. Available: http://journal.cpha.ca/index.php/cjph/article/view/2758 (accessed 2016 Aug 16). 28 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Ottawa: Health Canada; 2013. Available: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php (accessed 2016 Aug 12). 29 Young MM, Student Drug Use Surveys Working Group (SDUS). Cross-Canada report on student alcohol and drug use: Technical report. Ottawa: Canadian Centre on Substance Abuse; 2011. Available: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf (accessed 2016 Aug 16). 30 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Available: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf (accessed 2016 Aug 16). The Task Force’s discussion paper presents the potential elements of a new system, which were grouped into five themes: 1) minimizing harms of use; 2) establishing a safe and responsible production system; 3) designing an appropriate distribution system; 4) enforcing public safety and protection; and 5) accessing marijuana for medical purposes. Each theme includes questions on specific concerns for which the Task Force is seeking input. Presented below are the CMA’s recommendations to the federal government for each section of the discussion paper. A summary of all recommendations is listed at the end of the brief. RECOMMENDATION: The CMA recommends that the federal government take a broad public health policy approach in legalizing marijuana for non-medical purposes, and that it be held accountable to these public health objectives. 1. MINIMIZING HARMS OF USE 1.1. Do you believe that these measures are appropriate to achieve the overarching objectives to minimize harms, and in particular to protect children and youth? Are there other actions which the government should consider enacting alongside these measures? Legalization and strict regulation of marijuana for recreational use seeks to reduce health and social harms, particularly in higher risk groups; however, with the increased access, there could be an inverse effect, with the potential that harms could be intensified. There is also the considerable risk that the degree of “normalization” of use that already exists could increase. Colorado has seen an increase in marijuana-related traffic deaths and an increase in the use of health care due to intoxication, burns and cyclic vomiting syndrome, as well as overdoses in children due to marijuana in edibles.20 21 22 Many of the regulatory interventions used in reducing tobacco normalization and rates, as well as controlling the harms of alcohol at a population level, are proposed in the Task Force’s discussion paper as part of a framework for marijuana legalization and regulation. These include: 1) Minimum age for legal purchase with the objective of protecting children and youth, particularly since the risks of marijuana use are higher in ages where the brain is still in development. 2) Advertising and marketing restrictions to minimize the profile and attractiveness of products, seeking to prevent or at least reduce the “normalization” of use in society, particularly among children and youth. 3) Taxation and pricing to discourage use and provide the government with revenues to offset related costs (such as substance abuse services, law enforcement and regulatory oversight). 4) Restrictions on marijuana products, particularly with regards to the THC component, given higher concentration products have added risks and unknown long term impacts, with most impact on children and youth. Restrictions would include maximum THC limits and prohibition of high-potency products. 5) Restrictions on types of marijuana products, particularly edibles, to prevent accidental or unintentional ingestion, particularly by children. Limits would be placed on dosing and potency. 6) Limitations on quantities for personal possession, with the objective of helping to reduce demand and to minimize opportunities for resale of legally purchased marijuana on the illicit market (particularly to children and youth). 7) Limitation on where marijuana can be sold in order to minimize harms. Despite the merit of each of the proposed measures, collectively these may not adequately protect children and youth. A pathway to better implementation would require: . Taking the time to adequately prepare for the implementation, including developing the capacity to meet demand, administer the system, enforce regulations and deal with adverse effects. A phased-in approach or pilots in certain jurisdictions should be considered before going nationwide. . Learning from the lessons gained in jurisdictions that have made changes in drug policy, including the U.S. states of Colorado and Washington, Uruguay, the Netherlands and Portugal. . Learning from successes and failures in the regulation of tobacco and alcohol, with respect to the objectives of reducing or eliminating use for all Canadians (tobacco) and promoting responsible use among adults, while prohibiting use in youth (alcohol). . Developing the capacity to carry out a rigorous national-level evaluation of the impact of legalization of marijuana on the health and safety of Canadians. Data collection and analysis cannot be conducted if national surveillance systems do not exist. Important data to be monitored include marijuana-related emergency room visits and hospitalizations, rates of drug-impaired driving, recreational injuries, unintentional poisonings, product contamination, overconsumption and food-borne illness from edible products.23 . Support for a research agenda to better understand harms of marijuana, particularly among vulnerable groups such as children and youth, pregnant women, people with mental illness and chronic diseases. Research should also support policy interventions, including those to address second hand smoke, harm reduction measures, treatments and effective education strategies. The CMA is supportive of the regulatory interventions proposed by the government to reduce the harms, regarding: Marketing and advertising: The CMA recommends that the marketing and advertising of marijuana be prohibited, as is currently the case for tobacco and cigarettes. Measures such as plain packaging, prohibition of appealing flavours and shapes, adequate content and potency labelling, as well as health warnings, should be incorporated to discourage experimentation. A package insert should outline health risks and supporting references, the need for securing the product in the home, preventing access by youth and children, and recommendations not to drive or work with hazardous chemicals or equipment. The insert should include information detailing the health and social consequences, including legal penalties for providing marijuana to those under a designated minimum age for purchasing. Taxation and pricing: Taxation and pricing levers should be used to discourage use, with revenues clearly earmarked for covering the health and social costs of legalization. In Colorado, for example, revenue is used in substance abuse programs, regulation of marijuana and for public school construction. However, as with tobacco, final pricing must be such as to discourage the illegal production and trafficking of marijuana. Most of future tax revenues should be redistributed to the provinces and territories. This is because they will feel the impact of legalization directly as they have jurisdiction over health care, education, social and other services, as well as responsibility for enforcement. Restrictions on the potency of marijuana products: Experience in jurisdictions where marijuana has been legalized has shown that restrictions on the potency of products (i.e., THC limits) are necessary, given the higher risks of harm associated with higher potencies. Prohibition of high potency products is important. However, there is a risk that the prohibition could lead to an illicit market of more potent marijuana preparations. Restrictions on types of marijuana products: It is essential that restrictions be placed on the dosing of products, particularly of edibles, given the incidence of accidental overdoses of children. Content in a package should not be sufficient to cause an overdose. Because of these incidents, child proof packaging should also be required. Limitations on quantities for personal possession: Placing maximum limits on quantities that can be purchased would help to reduce the opportunities for illegal distribution and sale, especially to those below the established minimum age limit. The proposed measures related to minimum age for legal purchase and limitation on where marijuana can be sold are discussed in Sections 1.2 and 3, respectively, below. In addition to the regulatory interventions proposed in the “Minimizing Harms of Use” section of the discussion paper, others are equally fundamental, including: A clear process for identifying, testing and charging individuals who are driving under the influence of marijuana should be in place prior to legalization (see further discussion under Section 4). Public education: The use of public education tools to inform youth and families of the risks and harms of marijuana use is necessary. Awareness of Canadians of the harms of marijuana is generally low.24 25 26 Youth tend to emphasize the drug’s ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There are also many dangerous myths, such as that marijuana can counter the harmful effects of smoking tobacco by preventing cancer or that marijuana makes people better drivers. There is also a perception amongst some that marijuana is not an addictive substance because it is “natural”. However, traditional public campaigns and educational programs for youth have been shown to be minimally effective. There is a need for more effective programs, including those that incorporate skills-based training that teaches youth how to handle situations that involve drugs and/or alcohol. Harm reduction measures, such as those outlined in the Lower Risk Cannabis Use Guidelines for Canadag 27 should be discussed, particularly with teens, in an effort to minimize harm, even if they choose to continue to use. g These include delaying use until early adulthood; avoiding frequent use; preferring smokeless delivery systems; using less potent products; not driving after use; and abstaining from use when at higher risk of cannabis-related problems (people with a personal or family history of psychosis, cardiovascular problems and pregnant women). It is important that these education programs be designed by governments and health professionals, and not marijuana producers or distributers. However, costs of such programs could come from the profits of such industries. Expanded access and immediate availability of substance use, mental health and social stabilization services is another very important measure to minimize harm. These services are currently difficult to access in the community and have long wait times; in many parts of Canada they are simply unavailable. A plan to expand training programs in addiction medicine and access to treatment should be in place prior to legalization. Enforcement of regulations: Licensed producers and retail outlets should be held accountable in their compliance with policies, guidance and good practices to prevent contaminants that may cause additional health issues if consumed, particularly by minors (See also Section 3). 1.2. What are your views on the minimum age for purchasing and possessing marijuana? Should the minimum age be consistent across Canada, or is it acceptable that there be variation amongst provinces and territories? In order to achieve the first objective of legalization, i.e., to protect young Canadians by keeping marijuana out of the hands of children and youth, a minimum age for its purchase and possession must be adopted. This has been an important measure in tobacco and alcohol regulations. Existing evidence on marijuana points to the importance of protecting the brain during its development. Since that development is only finalized by about 25 years of age, this would be an ideal minimum age based on currently accepted scientific evidence, although knowledge on brain development is still evolving. However, marijuana use among youth (ages 15 to 24) is still double that of the general population, at 20%, even though there has been a slight decrease in use in recent years.28 A 2011 report on student alcohol and drug use in Canada showed that of those youth who had used marijuana in the past 3 months, 25% had used it daily. The average age of initiation was 16.1 years. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.29 A minimum age lower than 25 years should be considered in order to deter youth from seeking marijuana from organized crime groups, where they are exposed to other more dangerous drugs, sometimes even laced into marijuana. In jurisdictions where marijuana has been legalized, the minimum age has been set at the same minimum age for purchase of alcohol, i.e., 21 years. In Canada, the age limits for acquiring alcohol and tobacco are either 18 or 19 years of age, depending on the province or territory. In a survey carried out with a sample of the CMA membership, 25.4% recommended age 21, 20.3% age 25, 19.7% age 18, and 14.2% age 19. The CMA recommends that the minimum age should be set at 21, and that quantities and the potency of marijuana be more restricted to those under age 25 to discourage use and sharing with underage friends. The CMA recommends that the minimum age be established at the national level, and federally regulated, to avoid differences at the provincial/territorial level. This would reduce problems with enforcement in areas near provincial/territorial borders. SECTION 1 RECOMMENDATIONS: The CMA recommends that the federal government incorporate the following measures to support improved implementation of the legalization of marijuana: a) Ensure sufficient time to adequately prepare for the implementation of the legalized regime, including a phased-in approach and piloting legalization in smaller regions prior to national roll-out; b) Assess international experience with legalization and incorporate lessons-learned from other jurisdictions into Canada’s approach; c) Assess the domestic experience in the regulation of tobacco and alcohol against meeting the national objectives for each substance and incorporate lessons-learned from those experiences; and, d) Develop capacity for national surveillance to ensure rigorous national-level monitoring and evaluation. e) Support for a research agenda. The CMA recommends that the federal government prohibit the marketing and advertising of marijuana and that packaging requirements include plain packaging, potency labelling and health warnings. The CMA further recommends that the federal government prohibit flavouring and shapes. The CMA recommends that the federal government employ taxation and pricing levers to discourage consumption and that the revenues of this taxation be allocated to the provinces and territories and clearly allocated for health and social services. The CMA recommends that the federal government establish potency restrictions to reduce the harms associated with higher potencies. The CMA recommends that the federal government establish dosing restrictions on marijuana products, notably edibles. The CMA recommends that the federal government establish maximum limits on quantities of marijuana that can be purchased. The CMA recommends that the federal government employ effective public education tools, including skills-based training, to inform youth and families of the risks and harms of marijuana usage. The CMA recommends that the federal government expand access and availability of substance use, mental health and social stabilization services simultaneously to the legalization of marijuana. As part of this initiative, the CMA recommends that the federal government implement a plan to expand training programs in addiction medicine. The CMA recommends that the federal government set the minimum age of purchase and consumption at 21 and that quantities and potency be restricted for those under the age of 25. The CMA recommends that the federal government establish the minimum age at the national level to ensure consistency across all jurisdictions. 2. ESTABLISHING A SAFE AND RESPONSIBLE PRODUCTION SYSTEM 2.1. What are your views on the most appropriate production model? Which production model would best meet consumer demand while ensuring that public health and safety objectives are achievable? What level and type of regulation is needed for producers? There will be no perfect production model, with each one having its risks and benefits. The CMA would support a tightly regulated competitive model. A set number of licenses should be granted to producers, who are part of a competitive system, and there should be a reasonable cost associated to offset regulatory expenses. Producers would have to comply with policies and guidelines set by Health Canada, and be subject to inspections. It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls. 2.2. To what extent, if any, should home cultivation be allowed in a legalized system? What, if any, government oversight should be put in place? The CMA does not recommend home cultivation in a legalized system for non-medical purposes, as it presents many challenges to municipal, enforcement and public health authorities, particularly given the potentially high number of homes that could seek to cultivate marijuana. There are many health and safety hazards in cultivation, such as high humidity and temperatures, risk of fire, as well as the use of hazardous chemicals, including pesticides used for the control of fungi, bacteria and insects. There is little quality control regarding contamination and potency of the product. As well, home cultivation has an enhanced risk of abuse, if individuals use the production for sale rather than exclusively for personal use. Access to marijuana by children and youth is also a serious concern with home cultivation. In the present marijuana for medical purposes system, where some users have been allowed to continue to grow for personal use, there is great difficulty in monitoring and inspecting these properties. However, this has been allowed given the Allard v Canada court decision, to not hinder access for medical purposes. Washington has not permitted home cultivation, but Colorado has allowed the growth of a small number of plants for personal use (up to 6 plants, with a maximum 3 mature ones, in an enclosed, locked space). 2.3. Should a system of licensing or other fees be introduced? Should limited home cultivation for non-medical purposes be an option, a system of registration and licensing would have to be set up to allow for tracking and inspections of home production. It would also allow penalties for non-registered producers as well as larger scale operations. This would be a system that would require intense government regulation, oversight and tremendous resources to be effective. 2.4. The MMPR set out rigorous requirements over the production, packaging, storage and distribution of marijuana. Are these types of requirements appropriate for the new system? Are there features that you would add or remove? The requirements for production, packaging, storage and distribution of marijuana set out by the MMPR are appropriate for the new system. However, a rigorous review of the MMPR should be conducted to determine if there are weaknesses that need to be corrected before expanding to a non-medical market. Ongoing evaluation will be warranted as well. Distribution would have to expand beyond the mail service. 2.5. What role, if any, should existing licensed producers under the MMPR have in the new system (either in the interim or the long-term)? The CMA’s policy position does not extend to whether the existing licensed producers should be suppliers to the recreational market. The experience in Colorado, however, showed that having the industry set up for medical purposes first allowed a smoother transition, in contrast with Washington, which did not have an industry. SECTION 2 RECOMMENDATIONS: The CMA supports a tightly regulated competitive model wherein production and distribution is heavily regulated and includes strict oversight. The CMA recommends that the federal government prohibit home cultivation in the legalized system for non-medical use. The CMA recommends that the federal government evaluate the requirements established by the MMPR system for production, packaging, storage and distribution to introduce improvements for implementation in the new legalized system for non-medical use. 3. DESIGNING AN APPROPRIATE DISTRIBUTION SYSTEM 3.1. Which distribution model makes the most sense and why? There is the need to continue mail availability for patients accessing marijuana for medical purposes to ensure nationwide access, however, a distribution system based exclusively on mail service would probably not meet the objectives of a recreational system. When a sample of our membership was asked about distribution models, first preference was given to existing non-health care structures, such as liquor stores. In some provinces, they would have the additional benefit of having a tightly regulated government monopoly by control board entities with a social responsibility mandate. Restrictions could be placed to limit the acquisition of both alcohol and marijuana. As stated earlier, marketing should be prohibited. Staff in these stores receives training and hours can be limited. A close second preference was given to legal storefronts, similar to the independent dispensaries. Several municipalities have been in varied degrees of discussion on the regulation of the presently illegal dispensaries, and those regulations could be looked at as models in a legalized environment. When asked about health care settings, such as pharmacies, respondents to the survey did not support this model. Almost 60% disagreed or strongly disagreed. A reason for this lack of support could be that placing marijuana in pharmacies could lend it credibility as a pharmaceutical medication, whereas placing it in liquor stores would send the message that it needs strict and formal controls. As per previous discussion, the creation of private industries for production and distribution would have to be very tightly controlled to avoid commercialization. As we have learned from the alcohol and tobacco industries, private companies have an interest in recruiting customers and encouraging high levels of ongoing consumption. It is important that the regulatory framework be protected from these commercial and fiscal interests. Regardless of the actual point of sale, storefront densities should be federally set and restrictive. There is good evidence from the regulation of alcohol that the less restrictive retail outlet density is, the more harms associated with alcohol use occur. Restrictions would also be placed on distances from schools, parks, playgrounds, colleges and universities, as well as on hours of sale. Regulations would lay out standards, including for the control of product sources, proof of minimum age required for purchase and restrictions on quantities sold. 3.2. To what extent is variation across provinces and territories in terms of distribution models acceptable? In the CMA’s survey of our members, there was not a consensus among respondents as to whether provincial and territorial governments should decide on their own distribution mechanisms. Many comments stated that a federal standard is warranted due to the need for initial close oversight and the ability to make effective changes more quickly. The CMA position is that there is an important role for the federal government to play in ensuring consistency across the country and avoiding provincial/territorial variation. 3.3. Are there other models worthy of consideration? The CMA recommends a phased in approach to the roll out of the system of distribution. Several pilot locations could be considered before going nationwide. Given the novelty and impact of this new legislation, particular caution is absolutely necessary from a regulatory and public health perspective. SECTION 3 RECOMMENDATIONS: The CMA recommends that the distribution model should occur outside health care structures, for example, in liquor stores, and that storefront densities should be federally set and restrictive. The CMA recommends that the distribution model should be established at the federal level and be consistent across jurisdictions. The CMA recommends a phased implementation approach prior to national availability. 4. ENFORCING PUBLIC SAFETY AND PROTECTION 4.1. How should governments approach designing laws that will reduce, eliminate and punish those who operate outside the boundaries of the new legal system for marijuana? The severity of punishment for simple possession and personal use of marijuana should be eliminated with the removal of criminal sanctions. The CMA recommends that resources currently devoted to combating simple marijuana possession through the criminal law be diverted to public health and education strategies, particularly for youth. Having a criminal record limits employment prospects, and the impact on health status is profound, disproportionately among marginalized populations. Laws should include such things as the facilitation of access by individuals to services to address substance use, mental health and social stabilization. Laws should be drafted in a clear fashion to minimize ambiguity and provide as much guidance and direction to users, health care providers, enforcement authorities, producers, distributors and others. 4.2. What specific tools, training and guidelines will be most effective in supporting enforcement measures to protect public health and safety, particularly for impaired driving? The use of marijuana is associated with an increased risk of impairment, and is incompatible with the operation of vehicles and work in safety sensitive positions due to risk of injury to oneself, coworkers or the general public. Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Report on Student Alcohol and Drug Use30 states that 14–21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug. Often, marijuana is associated with alcohol use, having an additive effect. A clear and reliable process for identifying, testing and imposing consequences on individuals who use marijuana and drive absolutely needs to be in place nationally prior to legalization. This will be complicated by the fact that a roadside test for marijuana use is not in widespread use; blood and urine testing also pose challenges. Another issue is the fact that recent use does not necessarily equate to impairment and no scientific standard for impairment exists in the literature. All individuals charged with impaired driving should have a specialist assessment to determine whether a substance use disorder is present. Individuals with substance use disorders should have immediate access to addiction treatment, mental health services and social stabilization. There is also a need for the development of guidelines for employers for the assessment and management of risk. 4.3. Should consumption of marijuana be allowed in any publicly-accessible spaces outside the home? Under what conditions and circumstances? No public smoking should be permitted, due to the risk of second hand smoke. Second hand marijuana smoke contains many of the same toxins, including carcinogens, found in directly inhaled marijuana smoke, in similar amounts, if not more. There is special concern for harmful health effects, especially among children. The CMA does not recommend the exposure of children to second hand smoke in public areas or in the home. The success in the reduction of tobacco use rates is significantly related to banning of smoking in public places. In the CMA’s survey of a sample of its members, 51.7% disagreed with consumption in designated public places, such as the Dutch model of coffee shops. SECTION 4 RECOMMENDATIONS: The CMA recommends that the federal government reallocate resources currently dedicated to the enforcement of marijuana infractions, to public health, education and treatment programs. The CMA recommends that the federal government ensure that a clear and reliable process for identifying, testing and imposing consequences on individuals who operate a motor vehicle under the influence of marijuana be in place nationally prior to the legalization of marijuana. The CMA recommends that the federal government prohibit smoking of marijuana for non-medical purposes in public places. 5. ACCESSING MARIJUANA FOR MEDICAL PURPOSES 5.1. What factors should the government consider in determining if appropriate access to medically authorized persons is provided once a system for legal access to marijuana is in place? The CMA recognizes that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with marijuana used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency (levels of THC, CBD), interactions with medications and adverse effects. Health Canada does not approve of marijuana as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical. The present system poses a serious challenge for physicians in providing the best care to patients. The CMA has long called for more research to better understand potential therapeutic indications, as well as its risks. It is important that there be support for research of marijuana in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol®), nabilone (Cesamet®) and THC/CBD (Sativex®). The present marijuana for medical purposes regime operates as an exception to a criminal prohibition for production, possession and trafficking of marijuana. It was developed in reaction to court challenges regarding the right to legal access of individuals to marijuana for medical purposes. With the new legal system for marijuana for non-medical use, the requirement to maintain a separate regulatory framework would not be necessary, given court-mandated access will be provided. As well, the experience of legalization for non-medical use in Colorado and Washington has shown that two separate regimes with distinct regulations can be very difficult to enforce given the dual standards (including different minimum ages, purchase quantities and taxation). Provisions would have to exist within the new system to attend to legitimate medical needs of individuals who are under the minimum age for purchase of marijuana, or for those with a requirement for a more potent product than that which is legally available. Consideration might also be given to affordable access for those with low incomes. As stated previously, the option of distribution through mail would have to continue, to facilitate access in remote areas. As well, patients or their families would be able to access marijuana through the distributors of marijuana for non-medical purposes, such as storefronts or liquor store-like entities, which would have employees trained to support patients and their needs. The use of marijuana products for medical indications, through this system, should preferably be done under research protocols. This framework would contribute to the provision of more robust scientific data. SECTION 5 RECOMMENDATION: The CMA recommends that there be only one regime for marijuana, following legalization of non-medical marijuana, with provisions for the medical needs of those who would not be able to acquire marijuana in a legal manner, e.g., those below the minimum age or those with a requirement for a more potent product than legally available. 6. Summary of Recommendations The CMA appreciates the opportunity to provide feedback on this important matter to physicians and the public. Legalization of marijuana for non-medical purposes is a fundamental shift in the approach to drugs. The CMA’s position is that it is essential that the government consult with experts, key stakeholders and the general public not only at this phase in preparation for legislation on this matter, but throughout the process of the development of regulations and implementation. Recommendations: 1) The CMA recommends that the federal government take a broad public health policy approach in legalizing marijuana for non-medical purposes, and that it be held accountable to these public health objectives. Section 1 2) The CMA recommends that the federal government incorporate the following measures to support improved implementation of the legalization of marijuana: a) Ensure sufficient time to adequately prepare for the implementation of the legalized regime, including a phased-in approach and piloting legalization in smaller regions prior to national roll-out; b) Assess international experience with legalization and incorporate lessons-learned from other jurisdictions into Canada’s approach; c) Assess the domestic experience in the regulation of tobacco and alcohol against meeting the national objectives for each substance and incorporate lessons-learned from those experiences; and, d) Develop capacity for national surveillance to ensure rigorous national-level monitoring and evaluation. e) Support for a research agenda. 3) The CMA recommends that the federal government prohibit the marketing and advertising of marijuana and that packaging requirements include plain packaging, potency labelling and health warnings. The CMA further recommends that the federal government prohibit flavouring and shapes. 4) The CMA recommends that the federal government employ taxation and pricing levers to discourage consumption and that the revenues of this taxation be allocated to the provinces and territories and clearly allocated for health and social services. 5) The CMA recommends that the federal government establish potency restrictions to reduce the harms associated with higher potencies. 6) The CMA recommends that the federal government establish dosing restrictions on marijuana products, notably edibles. 7) The CMA recommends that the federal government establish maximum limits on quantities of marijuana that can be purchased. 8) The CMA recommends that the federal government employ effective public education tools, including skills-based training, to inform youth and families of the risks and harms of marijuana usage. 9) The CMA recommends that the federal government expand access and availability of substance use, mental health and social stabilization services simultaneously to the legalization of marijuana. 10) As part of this initiative, the CMA recommends that the federal government implement a plan to expand training programs in addiction medicine. 11) The CMA recommends that the federal government set the minimum age of purchase and consumption at 21 and that quantities and potency be restricted for those under the age of 25. 12) The CMA recommends that the federal government establish the minimum age at the national level to ensure consistency across all jurisdictions. Section 2 13) The CMA supports a tightly regulated competitive model wherein production and distribution is heavily regulated and includes strict oversight. 14) The CMA recommends that the federal government prohibit home cultivation in the legalized system for non-medical use. 15) The CMA recommends that the federal government evaluate the requirements established by the MMPR system for production, packaging, storage and distribution to introduce improvements for implementation in the new legalized system for non-medical use. Section 3 16) The CMA recommends that the distribution model should occur outside health care structures, for example, in liquor stores, and that storefront densities should be federally set and restrictive. 17) The CMA recommends that the distribution model should be established at the federal level and be consistent across jurisdictions. 18) The CMA recommends a phased implementation approach prior to national availability. Section 4 19) The CMA recommends that the federal government reallocate resources to the enforcement of marijuana infractions to public health, education and treatment programs. 20) The CMA recommends that the federal government ensure that a clear and reliable process for identifying, testing and imposing consequences on individuals who operate a motor vehicle under the influence of marijuana be in place nationally prior to the legalization of marijuana. 21) The CMA recommends that the federal government prohibit smoking of marijuana for non-medical purposes in public places. Section 5 22) The CMA recommends that there be only one regime for marijuana, following legalization of non-medical marijuana, with provisions for the medical needs of those who would not be able to acquire marijuana in a legal manner, e.g., those below the minimum age or those with a requirement for a more potent product than legally available. CMA Statement - Legalization of Marijuana Ottawa, September 9, 2016 - The CMA's submission to the Task Force on Marijuana Legalization and Regulation is framed by the fundamental position that the legalization of marijuana is a societal prerogative; the CMA is not weighing in on this decision as it has already been made. Keeping with our mandate as the national voice for the highest standards of health and health care, the CMA is squarely focused on minimizing the negative impact on individuals and public health. The CMA has longstanding concerns about the health risks associated with consuming marijuana, particularly in smoked form. Children and youth are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. As such, the CMA's submission is framed by the overarching recommendation that the government must take a broad public health policy approach in developing the legalization framework. Focusing on the legalization issue alone is inadequate to deal with the complexity of the situation. The CMA recommendations build on Canada's experience regulating alcohol and tobacco. The legalization framework must include:
Marketing and packaging restrictions
Restrictions on the types of products and their potency
Prohibiting home cultivation
Expanding access to support services such as mental health and substance use services
Expanding access to training programs in addiction medicine, and
Making extensive educational resources on the risks of harm to the user and others available We must recognize that the legalization of marijuana is a complex matter. Overall the CMA has submitted to the Task Force 22 evidence-based recommendations for a broad public health approach. For interviews: mediainquiries@cma.ca 613-806-1865
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Avoiding negative consequences to health care delivery from federal taxation policy

https://policybase.cma.ca/en/permalink/policy11957
Date
2016-08-31
Topics
Health human resources
Physician practice/ compensation/ forms
  1 document  
Policy Type
Response to consultation
Date
2016-08-31
Topics
Health human resources
Physician practice/ compensation/ forms
Text
The Canadian Medical Association (CMA) provides this submission in response to Finance Canada’s consultation on Legislative Proposals Relating to Income Tax, Sales Tax and Excise Duties (Draft Tax Legislative Proposals). The CMA is the national voice of Canadian physicians. On behalf of its more than 83,000 members and the Canadian public, the CMA’s mission is helping physicians care for patients. In fulfillment of this mission, the CMA’s role is focused on national, pan-Canadian health advocacy and policy priorities. As detailed in this brief, the CMA is gravely concerned that by capturing group medical structures in the application of Clause 13 of the Draft Tax Legislative Proposals, the federal government will inadvertently negatively affect medical research, medical training and education as well as access to care. To ensure that the unintended consequences of this federal tax policy change do not occur, the CMA is strongly recommending that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction in Clause 13 of the Draft Tax Legislative Proposals. Relevance of the Canadian Controlled Private Corporation Framework to Medical Practice Canada’s physicians are highly skilled professionals, providing an important public service and making a significant contribution to our country’s knowledge economy. Due to the design of Canada’s health care system, a large majority of physicians – more than 90% – are self-employed professionals and effectively small business owners. As self-employed small business owners, physicians typically do not have access to pensions or health benefits, although they are responsible for these benefits for their employees. Access to the Canadian-Controlled Private Corporation (CCPC) framework and the Small Business Deduction (SBD) are integral to managing a medical practice in Canada. It is imperative to recognize that physicians cannot pass on any increased costs, such as changes to CCPC framework and access to the SBD, onto patients, as other businesses would do with clients. In light of the unique business perspectives of medical practice, the CMA strongly welcomed the federal recognition in the 2016 budget of the value that health care professionals deliver to communities across Canada as small business operators. Contrary to this recognition, the 2016 budget also introduced a proposal to alter eligibility to the small business deduction that will impact physicians incorporated in group medical structures. What’s at risk: Contribution of group medical structures to health care delivery The CMA estimates that approximately 10,000 to 15,000 physicians will be affected by this federal taxation proposal. If implemented, this federal taxation measure will negatively affect group medical structures in communities across Canada. By capturing group medical structures, this proposal also introduces an inequity amongst incorporated physicians, and incentivizes solo practice, which counters provincial and territorial health delivery priorities. Group medical structures are prevalent within academic health science centres and amongst certain specialties, notably oncology, anaesthesiology, radiology, and cardiology. Specialist care has become increasingly sub-specialized. For many specialties, it is now standard practice for this care to be provided by teams composed of numerous specialists, sub-specialists and allied health care providers. Team-based care is essential for educating and training medical students and residents in teaching hospitals, and for conducting medical research. Put simply, group medical structures have not been formed for taxation or commercial purposes. Rather, group medical structures were formed to deliver provincial and territorial health priorities, primarily in the academic health setting, such as teaching, medical research as well as optimizing the delivery of patient care. Over many years, and even decades, provincial and territorial governments have been supporting and encouraging the delivery of care through team-based models. To be clear, group medical structures were formed to meet health sector priorities; they were not formed for business purposes. It is equally important to recognize that group medical structures differ in purpose and function from similar corporate or partnership structures seen in other professions. Unlike most other professionals, physicians do not form these structures for the purpose of enhancing their ability to earn profit. It is critical for Finance Canada to acknowledge that altering eligibility to the small business deduction will have more significant taxation implication than simply the 4.5% difference in the small business versus general rate at the federal level. It would be disingenuous for Finance Canada to attempt to argue that removing full access to the small business deduction for incorporated physicians in group medical structures will be a minor taxation increase. As taxation policy experts, Finance Canada is aware that this change will impact provincial/territorial taxation, as demonstrated below in Table 1. Table 1: Taxation impacts by province/territory, if the federal taxation proposal is implemented In Nova Scotia, for example, approximately 60% of specialist physicians practice in group medical structures. If the federal government applies this taxation proposal to group medical structures, these physicians will face an immediate 17.5% increase in taxation. In doing so, the federal government will establish a strong incentive for these physicians to move away from team-based practice to solo practice. If this comes to pass, the federal government may be responsible for triggering a reorganization of medical practice in Nova Scotia. Excerpts from physician communiques The CMA has received as well as been copied on a significant volume of correspondence from across our membership conveying deep concern with the federal taxation proposal. To provide an illustration of the risks of this proposal to health care, below are excerpts from some of these communiques:
“Our Partnership was formed in the 1970s…The mission of the Partnership is to achieve excellence in patient care, education and research activities….there would be a serious adverse effect on retention and recruitment if members do not have access to the full small business deduction…The changes will likely result in pressure to dissolve the partnership and revert to the era of departments services by independent contractors with competing individual financial interests.” Submitted to the CMA April 15, 2016 from a member of the Anesthesia Associates of the Ottawa Hospital General Campus
“The University of Ottawa Heart Institute is an academic health care institution dedicated to patient care, research and medical education…To support what we call our “academic mission,” cardiologists at the institute have formed an academic partnership…If these [taxation] changes go forward they will crippled the ability of groups such as ours to continue to function and will have a dramatic negative impact on medical education, innovative health care research, and the provision of high-quality patient care to our sickest patients.” Submitted to the CMA April 19, 2016 from a member of the Associates in Cardiology
“We are a general partnership consisting of 93 partners all of whom are academic anesthesiologists with appointments to the Faculty of the University of Toronto and with clinical appointments at the University Health Network, Sinai Health System or Women’s College Hospital…In contrast to traditional business partnerships, we glean no business advantage whatsoever from being in a partnership…the proposed legislation in Budget 2016 seems unfair in that it will add another financial hardship to our partners – in our view, this is a regressive tax on research, teaching and innovation.” Submitted to the CMA April 14, 2016 from members of the UHN-MSH Anesthesia Associates Recommendation The CMA recommends that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction, as proposed in Clause 13 of the Draft Tax Legislative Proposals. Below is a proposed legislative amendment to ensure group medical structures are exempted from Clause 13 of the Draft Tax Legislative Proposals: Section 125 of the Act is amended by adding the following after proposed subsection 125(9): 125(10) Interpretation of designated member – [group medical partnership] – For purposes of this section, in determining whether a Canadian-controlled private corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician is a designated member of a particular partnership in a taxation year, the term "particular partnership" shall not include any partnership that is a group medical partnership. 125(11) Interpretation of specified corporate income – [group medical corporation] – For purposes of this section, in determining the specified corporate income for a taxation year of a corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician, the term "private corporation" shall not include a group medical corporation. Subsection 125(7) of the Act is amended by adding the following in alphabetical order: "group medical partnership" means a partnership that: (a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and (b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice; "group medical corporation" means a corporation that: (a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and (b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice. "medical practice" means any practice and authorized acts of a physician as defined in provincial or territorial legislation or regulations and any activities in relation to, or incidental to, such practice and authorized acts; "physician" means a health care practitioner duly licensed with a provincial or territorial medical regulatory authority and actively engaged in practice;
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Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada

https://policybase.cma.ca/en/permalink/policy13936
Date
2016-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Date
2016-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Health care and patient safety
Text
Thank you Mr. Chair. I am Dr. Jeff Blackmer, the Vice-President of Medical Professionalism for the Canadian Medical Association. On behalf of the CMA, let me first commend the committee for initiating an emergency study on this public health crisis in Canada. As the national organization representing over 83,000 Canadian physicians, the CMA has an instrumental role in collaborating with other health stakeholders, governments and patient organizations in addressing the opioid crisis in Canada. On behalf of Canada’s doctors, the CMA is deeply concerned with the escalating public health crisis related to problematic opioid and fentanyl use. Physicians are on the front lines in many respects. Doctors are responsible for supporting patients with the management of acute and chronic pain. Policy makers must recognize that prescription opioids are an essential tool in the alleviation of pain and suffering, particularly in palliative and cancer care. The CMA has long been concerned with the harms associated with opioid use. In fact, we appeared before this committee as part of its 2013 study on the government’s role in addressing prescription drug abuse. At that time, we made a number of recommendations on the government’s role – some of which I will reiterate today. Since then, the CMA has taken numerous actions to contribute to Canada’s response to the opioid crisis. These actions have included advancing the physician perspective in all active government consultations. In addition to the 2013 study by the health committee, we have also participated in the 2014 ministerial roundtable and recent regulatory consultations led by Health Canada — specifically, on tamper resistant technology for drugs and delisting of naloxone for the prevention of overdose deaths in the community. 3 Our other actions have included: · Undertaking physician polling to better understand physician experiences with prescribing opioids; · Developing and disseminating new policy on addressing the harms associated with opioids; · Supporting the development of continuing medical education resources and tools for physicians; · Supporting the national prescription drug drop off days; and, · Hosting a physician education session as part of our annual meeting in 2015. Further, I’m pleased to report that the CMA has recently joined the Executive Council of the First Do No Harm strategy, coordinated by the Canadian Centre on Substance Abuse. In addition, we have joined 7 leading stakeholders as part of a consortium formed this year to collaborate on addressing the issue from a medical standpoint. I will now turn to the CMA’s recommendations for the committee’s consideration. These are grouped in four major theme areas. 1) Harm Reduction The first of them is harm reduction. Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. Despite the fact that there is broad recognition that we are in a public health crisis, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach rather than a public health approach. In its current form, this strategy does not significantly address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. The CMA strongly recommends that the federal government review the National Anti-Drug Strategy to reinstate harm reduction as a core pillar. Supervised consumption sites are an important part of a harm reduction program that must be considered in an overall strategy to address harms from opioids. The availability of supervised consumption sites is still highly limited in Canada. The CMA maintains its concerns that the new criteria established by the Respect for Communities Act are overly burdensome and deter the establishment of new sites. 4 As such, the CMA continues to recommend that the act be repealed or at the least, significantly amended. 2) Expanding Pain Management and Addiction Treatment The second theme area I will raise is the need to expand treatment options and services. Treatment options and services for both addiction as well as pain management are woefully under-resourced in Canada. This includes substitution treatments such as buprenorphine-naloxone as well as services that help patients taper off opioids or counsel them with cognitive behavioural therapy. Availability and access of these critical resources varies by jurisdiction and region. The federal government should prioritize the expansion of these services. The CMA recommends that the federal government deliver additional funding on an emergency basis to significantly expand the availability and access to addiction treatment and pain management services. 3) Investing in Prescriber and Patient Education The third theme I will raise for the committee’s consideration is the need for greater investment in both prescriber as well as patient education resources. For prescribers, this includes continuing education modules as well as training curricula. We need to ensure the availability of unbiased and evidenced-based educational programs in opioid prescribing, pain management and in the management of addictions. Further, support for the development of educational tools and resources based on the new clinical guidelines to be released in early 2017 will have an important role. Finally, patient and public education on the harms associated with opioid usage is critical. As such, the CMA recommends that the federal government deliver new funding to support the availability and provision of education and training resources for prescribers, patients and the public. 4) Establishing a Real-time Prescription Monitoring Program Finally, to support optimal prescribing, it is critical that prescribers be provided with access to a real-time prescription monitoring program. 5 Such a program would allow physicians to review a patient’s prescription history from multiple health services prior to prescribing. Real-time prescription monitoring is currently only available in two jurisdictions in Canada. Before closing, I must emphasize that the negative impacts associated with prescription opioids represent a complex issue that will require a multi-faceted, multi-stakeholder response. A key challenge for public policy makers and prescribers is to mitigate the harms associated with prescription opioid use, without negatively affecting patient access to the appropriate treatment for their clinical conditions. To quote a past CMA president: “the unfortunate reality is that there is no silver bullet solution and no one group or government can address this issue alone”. The CMA is committed to being part of the solution. Thank you.
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Front-of-package labelling consultation

https://policybase.cma.ca/en/permalink/policy13800
Date
2016-10-31
Topics
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-10-31
Topics
Health care and patient safety
Text
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices. In this regard, CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans fat and calorie content of processed foods and prepared meals; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels.1 We commend Health Canada on recent work on updating the nutrition facts table and the current revision of the Canada Food Guide and are very pleased to provide a response to the consumer questionnaire on the Health Canada proposal for front-of-package (FOP) nutrition labelling. FOP nutrition labelling approach and possible symbols Do you support Health Canada's proposal to use a symbol to identify foods that are high in sodium, sugars and/or saturated fat? Please explain. In 2011, appearing before the House of Commons Standing Committee on Health, the CMA supported a standard "at a glance" approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices.2 There is a growing body of evidence linking the consumption of diets high in saturated fats, sugars or sodium to cardiovascular and chronic disease (hypertension, dyslipidemia, diabetes mellitus, obesity, cancer, and heart disease and stroke) - leading preventable risk factors and causes of death and disability within Canada and worldwide. Therefore, the CMA does support the proposal to use a symbol for "high in" FOP labelling of foods high in sugar, sodium or saturated fats. FOP labelling on packaged foods may help Canadians make healthier food choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling. Which symbol would help you recognize foods high in sodium, sugars and/or saturated fat? Please explain. Of the proposed symbols, we believe that those that resemble a stop sign would send a strong and recognizable signal of a food to avoid. The triangle yield sign shape is too similar to the shape often used to indicate a hazard such as poison. We would recommend holding focus groups with Canadians to better understand how the proposed symbols will be understood by consumers. Foods that do not have nutrition labelling Do you think these foods should be exempt from FOP symbols even if they're high in sodium, sugars and/or saturated fat? Please explain. The CMA can support the exemption of FOP labelling for products in very small packages but we would like to see a provision to include information on "high in" sugar, salt or saturated fats on foods such as sausages, bakery products, prepared dishes from the deli produced and prepackaged by grocery stores/retailers as they are categories of foods often high in these nutrients. A "high in" sticker could be added to the retailer's packaging to be consistent with other packaged foods. Nutrient levels for a "high in" FOP label Do you think the proposed nutrient levels make sense to identify foods that are high in sodium, sugars and/or saturated fat? Please explain. The CMA supports the proposed nutrient levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring that the "high in" threshold and the 15% "a lot" daily value (DV) message are consistent delivers a clear message of concern. While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we suggest that the threshold for "high in" sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education. Updating nutrient content claims and other nutrition-related statements Do you support not allowing a "no added sugars" claim on foods high in sugars? Please explain. Allowing a food that qualifies for a "high in" sugar FOP symbol to also display a "no added sugars" claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing "no added sugar" claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion. Labelling of foods that have sweeteners Do you support that these sweeteners be declared in the list of ingredients only, rather than in the list of ingredients and the front of the package? Please explain. We do not support the elimination of the labelling requirement for artificial sweeteners on the principle display panel. For products that have high intensity sweeteners added and which bear claims such as "unsweetened" or "no sugar added," a declaration of "artificially sweetened" should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn't need to be on the principal display. For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government's Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism 1 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca. 2 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca --------------- ------------------------------------------------------------ --------------- ------------------------------------------------------------
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Regulation of Self-Care Products in Canada

https://policybase.cma.ca/en/permalink/policy13802
Date
2016-10-31
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-10-31
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) appreciates the opportunity to respond to the Health Canada consultations on the regulation of self-care products in Canada. The CMA is encouraged that Health Canada is proposing a framework for the regulation of self-care products that is reliant on scientific proof to support health claims. The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The CMA’s comments on the regulation of self-care products, particularly natural health products and non-prescription drugs is based on the CMA Policy on Complementary and Alternative Medicine attached as Appendix 1. Our position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Canadians deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end.1 CMA supports a regulatory approach to self-care products such as natural health products that is based on risk assessment and the development of standards. 2 1 Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf F:\E-sig\JB_Signature.jpg 2 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 3Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf 4 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 5 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. 6 Canadian Medical Association. Brief BR2014-09 - Bill C-17 An Act to amend the Food and Drugs Act. Ottawa: The Association; 2014. Risk Based Approach As noted above CMA has recommended a regulatory approach that is based on risk assessment. We are troubled that the consultation document does not provide enough information on Health Canada’s risk assessment process. We are concerned that the proposal for a risk based approach could place many natural health and homeopathic products in a lower risk category based on whether or not the product makes a health claim which would require no Health Canada review or licensing of these products. As noted in the consultation document all health products have some level of risk and Health Canada’s role is to ensure that the benefits of a product outweigh any know risks. CMA does not believe that a determination of risk can be made based on historical use of a product or on the basis of a philosophical system not supported by science. The CMA has a long standing position that the same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. 3 CMA would recommend that the initial risk assessment of a self-care product should be evidence informed and based on the same standards of proof and efficacy as those for conventional medicines and pharmaceuticals. As such, we are concerned that homeopathic and natural health products are given as examples of lower risk products that would not require Health Canada review or licensing. Health Claims The consultation document redefines a health claim to only those that pertain to diagnosis, treatment, prevention, cure or mitigation of disease or serious health condition. These claims will need to be supported by scientific evidence and only these health claims will be allowed and reviewed by Health Canada. The CMA has recommended that safety and efficacy claims for natural health products, and claims for the therapeutic value of these products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications currently regulated by Health Canada. 4 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.5 Therefore the CMA supports the proposal that two products making similar claims would have to provide the same level of scientific evidence and are held to the same standard. CMA would not be in support of the proposal that products can still make claims “based on traditional systems of medicine or alternate modalities” with only “adequate supporting information” to be maintained by the company without review or licensing by Health Canada. CMA would also recommend that even those products that do not make health claims are held to the same standard as those established for pharmaceutical products. Since our position is that all self-care products from lower risk to higher risk should be reviewed for safety and quality, all products should undergo review by Health Canada. Information It is certainly problematic that, as noted in the consultation document, fewer than 2 in 5 Canadians surveyed rated themselves knowledgeable about the effectiveness of self-care products. Canadians have the right to reliable, accurate information on self-care products to help ensure that choices they make are informed. It is very important that Canadians understand the level of scrutiny a product has undergone by Health Canada. CMA can support the proposal for an authorization number on those products that have been reviewed and approved by Health Canada. Equally, a disclaimer on the product label that indicates that the product has not been reviewed or approved by Health Canada for effectiveness is very important. We must guard against an assumption by the public that if Health Canada did not need to review a product there is no risk associated with the product. The Information provided on self-care products should be user friendly and easy to access and include a list of ingredients, instructions for use, indications that the product has been proven to treat, contraindications, side effects and interactions with other medications. In an era when product claims can be spread vie social media and the internet and cannot be easily monitored it is important to ensure consistent oversight of product marketing. Health claims can only be promoted if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Additional Powers In its submission on Bill C -17 An Act to amend the Food and drugs Act – Protecting Canadians from Unsafe drugs the CMA recommended that the ministerial authorities and measures to address patient safety risks should extend to natural health products.6 We would therefore suggest that Health Canada explore the need for additional powers and tools to require a company to change labels, or order a recall of an unsafe product and institute new penalties to address patient safety issues. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's regulatory framework for self-care products to ensure that the health related products Canadians receive are safe and effective. Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism Canadian Medical Association CMA POLICY COMPLEMENTARY AND ALTERNATIVE MEDICINE (Update 2015) This statement discusses the Canadian Medical Association’s (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA’s position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should “consider first the well-being of the patient.”1 The ethical principle of non-maleficence obliges physicians to reduce their patient’s risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM. 1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. 2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies. CAM in Canada CAM has been defined as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.”i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health. analysis, the CMA divides CAM into four general categories: . Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based. . Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products. . Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise. . Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada. Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the “holistic” concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM. Toward Evidence-Informed Health Care Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious. The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA’s Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below: a) Research: Building an Evidence Base To date, much of the public’s information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public. b) An Appropriate Regulatory Framework Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments. i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada. The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products’ safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include: 5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies. 6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. Available: 9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. 12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. * manufacturing processes that ensure the purity, safety and quality of the product; * labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6 The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm’s length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8 The Canadian Medical Association advocates that foods fortified with “natural health” ingredients should be regulated as food products and not as natural health products The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada’s MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada. ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge. Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients. Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to: . Resist any influence or interference that could undermine their professional integrity;9 . Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10 . Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient. c) Information and Promotion Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include: . Instructions for use; . Indications that the product or therapy has been convincingly proven to treat; . Contraindications, side effects and interactions with other medications; . Should advise the consumer to inform their health care provider during any encounter that they are using this product.12 This information should be provided in such a way as to minimize the impact of vested commercial interests on its content. In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims. The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease. The Role of Health Professionals Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients. Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically. The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
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Federal tax proposal risks negative consequences for health care delivery

https://policybase.cma.ca/en/permalink/policy11960
Date
2016-11-18
Topics
Physician practice/ compensation/ forms
  1 document  
Policy Type
Parliamentary submission
Date
2016-11-18
Topics
Physician practice/ compensation/ forms
Text
The CMA is the national voice of Canadian physicians. On behalf of its more than 83,000 members and the Canadian public, the CMA’s mission is helping physicians care for patients. In fulfillment of this mission, the CMA’s role is focused on national, pan-Canadian health advocacy and policy priorities. As detailed in this brief, the CMA is gravely concerned that by capturing group medical structures in the application of Section 44 of Bill C-29, the federal government will inadvertently negatively affect medical research, medical training and education as well as access to care. To ensure that the unintended consequences of this federal tax policy change do not occur, the CMA is strongly recommending that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction in Section 44 of Bill C-29. Relevance of the Canadian Controlled Private Corporation Framework to Medical Practice Canada’s physicians are highly skilled professionals, providing an important public service and making a significant contribution to our country’s knowledge economy. Due to the design of Canada’s health care system, a large majority of physicians – more than 90% – are self-employed professionals and effectively small business owners. As self-employed small business owners, physicians typically do not have access to pensions or health benefits, although they are responsible for these benefits for their employees. Access to the Canadian-Controlled Private Corporation (CCPC) framework and the Small Business Deduction (SBD) are integral to managing a medical practice in Canada. It is imperative to recognize that physicians cannot pass on any increased costs, such as changes to CCPC framework and access to the SBD, onto patients, as other businesses would do with clients. In light of the unique business perspectives of medical practice, the CMA strongly welcomed the Finance Committee’s recommendation to maintain the existing small business framework and the subsequent federal recognition in the 2016 budget of the value that health care professionals deliver to communities across Canada as small business operators. Contrary to this recognition, the 2016 budget also introduced a proposal to alter eligibility to the small business deduction that will impact physicians incorporated in group medical structures. What’s at risk: Contribution of group medical structures to health care delivery The CMA estimates that approximately 10,000 to 15,000 physicians will be affected by this federal taxation proposal. If implemented, this federal taxation measure will negatively affect group medical structures in communities across Canada. By capturing group medical structures, this proposal also introduces an inequity amongst incorporated physicians, and incentivizes solo practice, which counters provincial and territorial health delivery priorities. Group medical structures are prevalent within academic health science centres and amongst certain specialties, notably oncology, anaesthesiology, radiology, and cardiology. Specialist care has become increasingly sub-specialized. For many specialties, it is now standard practice for this care to be provided by teams composed of numerous specialists, sub-specialists and allied health care providers. Team-based care is essential for educating and training medical students and residents in teaching hospitals, and for conducting medical research. Put simply, group medical structures have not been formed for taxation or commercial purposes. Rather, group medical structures were formed to deliver provincial and territorial health priorities, primarily in the academic health setting, such as teaching, medical research as well as optimizing the delivery of patient care. Over many years, and even decades, provincial and territorial governments have been supporting and encouraging the delivery of care through team-based models. To be clear, group medical structures were formed to meet health sector priorities; they were not formed for business purposes. It is equally important to recognize that group medical structures differ in purpose and function from similar corporate or partnership structures seen in other professions. Unlike most other professionals, physicians do not form these structures for the purpose of enhancing their ability to earn profit. It is critical that the federal government acknowledge that altering eligibility to the small business deduction will have more significant taxation implication than simply the 4.5% difference in the small business versus general rate at the federal level. It would be disingenuous to argue that removing full access to the small business deduction for incorporated physicians in group medical structures will be a minor taxation increase. As demonstrated below in Table 1, the effect of this federal taxation change will vary by province. Table 1: Taxation impacts by province, if the federal taxation proposal is implemented In Nova Scotia, for example, approximately 60% of specialist physicians practice in group medical structures. If the federal government applies this taxation proposal to group medical structures, these physicians will face an immediate 17.5% increase in taxation. In doing so, the federal government will establish a strong incentive for these physicians to move away from team-based practice to solo practice. If this comes to pass, the federal government may be responsible for triggering a reorganization of medical practice in Nova Scotia. Finance Canada Grossly Underestimating the Net Impact The CMA is aware that Finance Canada has developed theoretical scenarios that demonstrate a minimal impact to incorporated physicians within group medical structures. Working closely with our subsidiary, MD Financial Management, the CMA submitted real financial scenarios from real financial information provided to the CMA from incorporated physicians in group medical structures. These real examples demonstrate that there will be a significant impact to incorporated physicians in group medical structures, if this federal tax proposal will apply to them. The theoretical scenarios developed by Finance Canada conclude the net financial impact to an incorporated physician in a group medical structure would be in the magnitude of hundreds of dollars. In stark contrast to the theoretical scenarios developed by Finance Canada, the CMA submitted financial scenarios of two incorporated physicians in group medical structures. The financial calculations undertaken by the CMA is based on the real financial information of these two physicians. The examples revealed yearly net reduction of funds of $32,510 and $18,065 for each of these physicians respectively. Projecting forward, for the first physician, this would represent a negative impact of $402,330 based on a 20-year timeframe and 4.8% rate of return1. Extending the same assumptions to all incorporated members of that physician’s group medical structure, the long-term impact for the group would be $39.4 million.2 1 Source: MD Financial Management 2 Please note that these projections have not been adjusted for the inherent tax liability on the growth. 3 Source: MD Financial Management 4 Please note that these projections have not been adjusted for the inherent tax liability on the growth. For the second physician, projecting forward, this would represent a negative impact of $223,565, based on a 20-year timeframe and 4.8% rate of return3. Extending the same assumptions to all incorporated members of that physician’s group medical structure, the long-term impact for the group would be $13.4 million.4 Unprecedented Level of Concern Expressed by Physicians Following the publication of the 2016 federal budget, the CMA received a significant volume of correspondence from its membership expressing deep concern with the proposal to alter access to the small business deduction for group medical structures. The level of correspondence from our membership is quite simply unprecedented in our almost 150 year history. As part of the CMA’s due diligence as the national professional organization representing physicians, we informed our membership of Finance Canada’s consultation process on the draft legislative measures. In response, the CMA was copied on submissions by over 1,300 physicians to Finance Canada’s pre-legislative consultation. In follow up, the CMA surveyed these physicians to better understand the impacts of the budget proposal. Here’s what we heard: . Most respondents (61%) indicated that their group structure would dissolve; . Most respondents (54%) said they would stop practicing in their group structure and that other partners would leave (76%); . A large majority (78%) indicated that the tax proposal would lead to reduced investments in medical research by their group; . Almost 70% indicated that the tax proposal would limit their ability to provide medical training spots; and, . Another 70% indicated that the tax proposal will mean reduced specialty care by their group. The full summary of the survey is provided as an appendix to this brief. To further illustrate the risks of this proposal to health care, below are excerpts from some of the communiques received by the CMA from its membership: . “Our Partnership was formed in the 1970s…The mission of the Partnership is to achieve excellence in patient care, education and research activities….there would be a serious adverse effect on retention and recruitment if members do not have access to the full small business deduction…The changes will likely result in pressure to dissolve the partnership and revert to the era of departments services by independent contractors with competing individual financial interests.” Submitted to the CMA April 15, 2016 from a member of the Anesthesia Associates of the Ottawa Hospital General Campus . “The University of Ottawa Heart Institute is an academic health care institution dedicated to patient care, research and medical education…To support what we call our “academic mission,” cardiologists at the institute have formed an academic partnership…If these [taxation] changes go forward they will crippled the ability of groups such as ours to continue to function and will have a dramatic negative impact on medical education, innovative health care research, and the provision of high-quality patient care to our sickest patients.” Submitted to the CMA April 19, 2016 from a member of the Associates in Cardiology . “We are a general partnership consisting of 93 partners all of whom are academic anesthesiologists with appointments to the Faculty of the University of Toronto and with clinical appointments at the University Health Network, Sinai Health System or Women’s College Hospital…In contrast to traditional business partnerships, we glean no business advantage whatsoever from being in a partnership…the proposed legislation in Budget 2016 seems unfair in that it will add another financial hardship to our partners – in our view, this is a regressive tax on research, teaching and innovation.” Submitted to the CMA April 14, 2016 from members of the UHN-MSH Anesthesia Associates Recommendation The CMA recommends that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction, as proposed in Section 44 of Bill C-29, Budget Implementation Act, 2016, No. 2. Below is a proposed legislative amendment to ensure group medical structures are exempted from Section 44 of Bill C-29, Budget Implementation Act, 2016, No. 2: Section 125 of the Act is amended by adding the following after proposed subsection 125(9): 125(10) Interpretation of designated member – [group medical partnership] – For purposes of this section, in determining whether a Canadian-controlled private corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician is a designated member of a particular partnership in a taxation year, the term "particular partnership" shall not include any partnership that is a group medical partnership. 125(11) Interpretation of specified corporate income – [group medical corporation] – For purposes of this section, in determining the specified corporate income for a taxation year of a corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician, the term "private corporation" shall not include a group medical corporation. Subsection 125(7) of the Act is amended by adding the following in alphabetical order: "group medical partnership" means a partnership that: (a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and (b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice; "group medical corporation" means a corporation that: (a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and (b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice. "medical practice" means any practice and authorized acts of a physician as defined in provincial or territorial legislation or regulations and any activities in relation to, or incidental to, such practice and authorized acts; "physician" means a health care practitioner duly licensed with a provincial or territorial medical regulatory authority and actively engaged in practice; Incorporation Survey, October 2016 *Totals may exceed 100% as respondents were allowed to select more than one response 65% 13% 6% 5% 2% 2% 2% 2% 2% 1% ON AB BC NS MB NL QC SK NB YT % Distribution by Province of Practice 65% 28% 22% 15% 9% 8% 8% 6% 6% 3% 3% 3% 3% Academic health sciences centre Private office / clinic University Community hospital Emergency department (in community hospital or AHSC) Community clinic/Community health centre Non-AHSC teaching hospital Research unit Free-standing lab/diagnostic clinic Free-standing walk-in clinic Nursing home/ Long term care facility / Seniors' residence Administrative office / Corporate office Other % Distribution by Work Setting 20 12 9 8 8 7 7 6 5 5 4 Ottawa Hospital (Ottawa) University Health Network (Toronto) Sunnybrook Health Sciences Centre (Toronto) Foothills Medical Centre (Calgary) St. Joseph's Health Centre (Hamilton) Mount Sinai Hospital (Toronto) London Health Sciences Centre (London) South Calgary Health Campus (Calgary) St. Micheal's Hospital (Toronto) Children's Hospital of Eastern Ontario (Ottawa) Royal Alexandra Hospital (Edmonton) Most frequently mentioned hospitals where respondents work in group medical structures Synopsis 61 54 76 78 67 68 30 36 19 16 23 24 9 10 5 6 10 8 Group medical structure will dissolve Stop practice in your group medical structure Partnering members leave the group medical structure Reduced investments in medical research Reduced medical training spots Reduced provision of specialized care Physicians perceptions about the likelihood of the following outcomes Likely or very likely Unsure Unlikely or very unlikely The federal government is advancing a tax proposal that will alter access to the small business deduction. If implemented, this proposal will affect incorporated physicians practicing in partnership group medical structures. The Canadian Medical Association (CMA) is actively advocating for the federal government to exempt group medical structures from the application of this tax proposal. 94% 2% 4% Importance of Exempting Group Medical Structures from the Tax Proposal Important or very important Unsure Unimportant or very unimportant To support the effectiveness of its advocacy efforts, the CMA conducted an online survey seeking input from members who had voiced their concerns about this issue directly with the Department of Finance and who had copied the CMA on their submissions. Sample: physician type, province, and work setting The survey was sent to 1089 CMA members, of which 174 responded (15.9% response rate). All sample respondents were incorporated and practiced in a group medical structure; 26% were family physicians (N=45) and 74% were specialists (N=129). Most respondents indicated practicing primarily in Ontario (65%) and Alberta (13%). With respect to practice settings, the majority reported working in an academic health sciences centre (65%), followed by a private office/clinic (28%), university (22%), community hospital (15%), emergency department (9%), community clinic/community health centre (8%), non-AHSC teaching hospital (8%), research unit (6%), and free-standing lab/diagnostic clinic (6%). In total, respondents worked in 79 hospitals spread around 36 cities. Likelihood of outcomes resulting from the federal tax proposal When asked about the possible consequences of the proposed changes, the largest share of respondents (78%) felt a reduction in investments in medical research was likely or very likely. Almost as many (76%) also felt that partnering members would likely leave the group medical structure. . Most respondents (61%) indicated that their group medical structure would be likely or very likely to dissolve if the federal tax proposal to change access to the small business deduction was implemented. Less than one-third (30%) felt unsure while only a few (9%) reported it as unlikely or very unlikely. . More than half of respondents (54%) indicated that they would be likely or very likely to stop practicing in their group medical structure if the tax proposal was implemented. More than one-third (36%) were unsure while only a few (10%) reported it as unlikely or very unlikely. . More than three-quarters of respondents (76%) indicated that other partnering members would be likely or very likely to leave their group medical structure if the tax proposal was implemented. About 20% remained unsure while only 5% reported it as unlikely or very unlikely. . Almost 8 in 10 respondents (78%) indicated that implementing the tax proposal would be likely or very likely to reduce investments in medical research for their group medical structure. 16% remained unsure while 6% reported it as unlikely or very unlikely. . Approximately two-thirds of respondents (67%) indicated that implementing the tax proposal would be likely or very likely to reduce the ability of the group medical structure to provide medical training spots. About a quarter (23%) remained unsure and 1 in 10 reported it as unlikely or very unlikely. . Almost 7 in 10 respondents (68%) indicated that implementing the tax proposal would be likely or very likely to reduce provision of specialized care by their group medical structure. Almost a quarter (24%) remained unsure while 8% reported it as unlikely or very unlikely. Importance of exempting group medical structures from the tax proposal More than 9 in 10 respondents (94%) felt that it is important or very important for the federal government to exempt group medical structures from the tax proposal to avoid negatively affecting health care delivery in their province. The remaining respondents were unsure (2%) or considered it unimportant or very unimportant (4%). Other Impacts – Write-in Question Before submitting the survey, respondents were given the chance to provide additional comments about other potential impacts that the proposed changes might produce. Most responses touched upon a few and inter-related themes, including: 1. Impact on education and research will be detrimental and will eventually affect patient care: o “Without the group medical structure, we cannot adequately support teaching education and research activities. Physicians in academic health sciences centres will be forced to use their time to see patients, in order to bill fee-for-service to make a living. Very little time will be left over to spend doing the research that is critical to advancing medical science, to supporting our university, and our nation’s prominent place in the world of medicine” o “Support is given to the academic health sciences centres by the provincial government in order to facilitate research and education. The federal government's changes will penalize physicians who already dedicate much of their time to providing the stepping stones to advance medicine forward. These physicians generally make less income than physicians working in private practice. They are willing to take this monetary hit because they love what they do. However we all need to support our families and put food on the table. With the government's changes, this may not be possible in the current system, and these group medical structures will need to be dissolved and the physicians working will have much less time to dedicate to research and education.” o “Less education, research activity to focus on fee-for-service procedures to compensate for higher taxes.” o Our ability to provide teaching for medical education and research, which are currently not remunerated, would be curtailed. There would be no incentive but rather a significant disincentive to provide these activities because we would be financially penalized compared to physicians in the same specialty that are not in group medical structures.” o “As the main teaching practice structure, we will lose full time faculty who provide the backbone to the program. They currently earn much below the average for Family Physicians in the province and our ability to support education and research will be compromised.” 2. Discourages practice in academic centres: o “Working in an academic center as a general pediatrician means that we already make substantially less money than our community colleagues. There is very little incentive to remain in academic practice if we not only earn less, but are then not entitled to the same tax savings. I would leave academic practice and I suspect many of my colleagues would as well. I think we could see the end of the current group medical structure, as it would no longer support a financially viable model for academic practice.” o “Creates a further divide between working in an academic centre and in the community. It will continue to be more advantageous to work in a smaller community - more money, less cost of living, less administrative and academic hassles, less research funding. Why bother working at an academic centre with such disadvantages.” o “This policy seems to target academic physicians in groups disproportionately. These physicians currently support research and education by reallocating our own funds generated from clinical care. It is puzzling as to why the Federal Government is waging this war on the academic physician workforce.” 3. Physician retention and recruitment will be challenging: o “I will retire sooner than otherwise.” o “At the present time it is very difficult to recruit family doctors who are interested in teaching, research and administration of academic family medicine. This tax change will make it increasingly more difficult to recruit such individuals.” o “I'm concerned that the proposed changes erase any benefits from a corporation structure and leave me with a loss. Work is so stressful and demanding that if I find myself in a disadvantaged situation financially as well, this would be another factor encouraging me either to retire or move outside of Canada. If I'm going to be faced with losses and more stress, why not instead focus on my quality of life instead?” o “It would severely restrict our ability to recruit research and specialty physicians. We would not be able to compete with community centres and would see a dramatic decline in our ability to provide for teaching and research activities now funded through the group structure.” o “I am a dual citizen and would seriously entertain moving to the USA.” o “It will basically force me to go to a free standing walk in clinic.” o “It would be less likely to recruit the best quality of medical staff to academic practice as there will be a significant financial disincentive, especially compared to what that same individual could earn on their own in a community practice. This is on top of the fact that academic practitioners tend to earn less to start with.” 4. Discourages team-based collaborative care: o “The bill sets up an unfair system where it is more attractive to be a solo MD rather than to collaborate and be part of a team.” o “This creates an every person for themselves philosophy.” o “The provision of our group services is required to ensure best patient care. It is wrong to penalize this model of comprehensive care.” 5. Practice will close and services will be limited in certain areas: o “Any reduction in research, administration, academic activity, and members would affect patient care at our facility and therefore be a threat to patient safety. e.g., if multiple physicians leave, then we won't have enough physicians to cover the emergency department appropriately, wait times will increase, and serious patient safety concerns will arise.” o “Reduces productivity of the doctors concerned and hence quality of service provided. Access will also be affected!” o This would be unattractive for some, and they may leave (or others may not join.) If partners leave, the overhead will go up and we would likely close. Because our overhead is already borderline unacceptable. Shared between fewer docs would make it economically impossible. And this could easily happen if docs leave. o “Reduced physician coverage if members opt out of group medical structure, which would have an impact on greater access and the quality of care.” o “Our ability to have a large interdisciplinary team to assist in serving our patients could not continue to exist. Our ability to continue to provide 24/7 on-call and after hours clinics would decrease due to a change in the structure leading to less practitioners.”
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Supporting the enactment of Bill C-14, Medical Assistance in Dying

https://policybase.cma.ca/en/permalink/policy13693
Last Reviewed
2019-03-03
Date
2016-05-02
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2019-03-03
Date
2016-05-02
Topics
Ethics and medical professionalism
Text
In this submission to the House of Commons Standing Committee on Justice and Human Rights, the CMA’s feedback is focused on three of the legislative objectives of Bill C-14, given their relevance to the CMA’s Principles-based Recommendations for a Canadian Approach to Assisted Dying. On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. i) Robust Safeguards First, the CMA supports the legislative objective of ensuring a system of robust safeguards to the provision of medical assistance in dying. The safeguards proposed by Bill C-14 include: patient eligibility criteria, process requirements to request medical assistance in dying, as well as monitoring and reporting requirements. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. ii) Consistent, Pan-Canadian Framework Second, the CMA supports the legislative objective that a consistent framework for medical assistance in dying in Canada is desirable. In addition to robust safeguards, key measures proposed by Bill C-14 support the promulgation of a consistent framework across jurisdictions include legislating definitions for “medical assistance in dying” and “grievous and irremediable condition.” The CMA’s Principles-based Recommendations reflect on the subjective nature of what constitutes “enduring and intolerable suffering” and a “grievous and irremediable condition” as well as the physician’s role in making an eligibility determination. iii) End-of-Life Care Coordination System Thirdly, the CMA supports the objective to develop additional measures to support the provision of a full range of options for end-of-life care and to respect the personal convictions of health care providers. The fulfilment of these commitments with federal non-legislative measures will be integral to supporting the achievement of access to care, respecting the personal convictions of health care providers, and developing a consistent, pan-Canadian framework. The CMA encourages the federal government to rapidly advance its commitment to engage the provinces and territories in developing a pan-Canadian end-of-life care coordinating system. It will be essential for this system to be in place for June 6, 2016. At least one jurisdiction has made a system available to support connecting patients with willing providers. Until a pan-Canadian system is available, there will be a disparity of support for patients and practitioners across jurisdictions. iv) Respect Personal Convictions Finally, it is the CMA’s position that Bill C-14, to the extent constitutionally possible, must respect the personal convictions of health care providers. In the Carter decision, the Supreme Court of Canada emphasized that any regulatory or legislative response must seek to reconcile the Charter rights of patients wanting to access assisted dying and physicians who choose not to participate in medical assistance in dying on grounds of conscientious objection. The CMA’s Principles-based Recommendations achieves an appropriate balance between physicians’ freedom of conscience and the assurance of effective and timely patient access to a medical service. From the CMA’s significant consultation with our membership, it is clear that physicians who are comfortable providing referrals strongly believe it is necessary to ensure the system protects the conscience rights of physicians who are not. While the federal government has achieved this balance with Bill C-14, there is the potential for other regulatory bodies to implement approaches that may result in a patchwork system. The CMA’s position is that the federal government effectively mitigate this outcome by rapidly advancing the establishment of the pan-Canadian end-of-life care coordinating system. CMA Supports Cautious Approach for “Carter Plus” The CMA must emphasize the need for caution and careful study in consideration of “Carter Plus”, which includes: eligibility of mature minors, eligibility with respect to sole mental health conditions, and advance care directives. The CMA supports the federal government’s approach not to legislate these issues, rather to study them in greater detail. Word count: 750
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