The Canadian Medical Association endorses the white paper Advancing safety as a component of quality improvement in Canada as outlined in Appendix A to BD 12-132.
The Canadian Medical Association endorses the white paper Advancing safety as a component of quality improvement in Canada as outlined in Appendix A to BD 12-132.
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The Canadian Medical Association endorses the white paper Advancing safety as a component of quality improvement in Canada as outlined in Appendix A to BD 12-132.
The Canadian Medical Association insists that physicians be protected from intimidation when engaging in health and health care system related advocacy.
The Canadian Medical Association insists that physicians be protected from intimidation when engaging in health and health care system related advocacy.
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The Canadian Medical Association insists that physicians be protected from intimidation when engaging in health and health care system related advocacy.
The Canadian Medical Association, recognizing the vital role of ambulance services in providing mobile life support for the acutely ill and injured, recommends that
i) ambulance services be considered, where practicable, a direct extension of a hospital emergency department and integrated with the emergency services,
ii) ambulance services incorporate standards of personnel education, vehicular design and life support equipment commensurate with those of the overall emergency care system.
The Canadian Medical Association, recognizing the vital role of ambulance services in providing mobile life support for the acutely ill and injured, recommends that
i) ambulance services be considered, where practicable, a direct extension of a hospital emergency department and integrated with the emergency services,
ii) ambulance services incorporate standards of personnel education, vehicular design and life support equipment commensurate with those of the overall emergency care system.
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The Canadian Medical Association, recognizing the vital role of ambulance services in providing mobile life support for the acutely ill and injured, recommends that
i) ambulance services be considered, where practicable, a direct extension of a hospital emergency department and integrated with the emergency services,
ii) ambulance services incorporate standards of personnel education, vehicular design and life support equipment commensurate with those of the overall emergency care system.
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
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The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
Be it resolved that the Canadian Medical Association recommend that breast-feeding mothers consult their physician two weeks post partum especially if they are breast-feeding for the first time;
and be it further resolved that the CMA support:
a) the provision of a physical environment in maternity units favourable to the initiation and continuation of successful breast-feeding; and
b) the adoption of measures to facilitate the continuation of breast-feeding for women working outside the home.
Be it resolved that the Canadian Medical Association recommend that breast-feeding mothers consult their physician two weeks post partum especially if they are breast-feeding for the first time;
and be it further resolved that the CMA support:
a) the provision of a physical environment in maternity units favourable to the initiation and continuation of successful breast-feeding; and
b) the adoption of measures to facilitate the continuation of breast-feeding for women working outside the home.
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Be it resolved that the Canadian Medical Association recommend that breast-feeding mothers consult their physician two weeks post partum especially if they are breast-feeding for the first time;
and be it further resolved that the CMA support:
a) the provision of a physical environment in maternity units favourable to the initiation and continuation of successful breast-feeding; and
b) the adoption of measures to facilitate the continuation of breast-feeding for women working outside the home.
The Canadian Medical Association (CMA) endorses the document entitled Call to Action: The Need for a National Pain Strategy for Canada as outlined in Appendix A to BD 13-10.
The Canadian Medical Association (CMA) endorses the document entitled Call to Action: The Need for a National Pain Strategy for Canada as outlined in Appendix A to BD 13-10.
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The Canadian Medical Association (CMA) endorses the document entitled Call to Action: The Need for a National Pain Strategy for Canada as outlined in Appendix A to BD 13-10.
The Canadian Medical Association supports a national strategy to assist communities in the development and implementation of comprehensive health plans to address short- or long-term adverse effects associated with a sudden change in the economic climate.
The Canadian Medical Association supports a national strategy to assist communities in the development and implementation of comprehensive health plans to address short- or long-term adverse effects associated with a sudden change in the economic climate.
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The Canadian Medical Association supports a national strategy to assist communities in the development and implementation of comprehensive health plans to address short- or long-term adverse effects associated with a sudden change in the economic climate.
Thank you for this opportunity to appear before this committee on behalf of the CMA and its 76,000 members. Canadians believe that transforming our health care system to meet the needs of 21st century Canada must be among the highest priorities for all levels of government, including the federal government.
I would like to begin by commenting on the health transfer framework announced by the Minister of Finance in December. This announcement provided some predictability for the years ahead.
However, with the federal government reducing its involvement in several areas affecting health or health care, added costs will end up in the laps of the provinces and territories.
So while this budget may enhance the federal government's fiscal prospects, it will do so to the detriment of the provinces and territories.
But there's more to this debate than funding. We believe that Canadians would be better served if federal health care transfers came with specific guidelines ensuring that the system provides care of comparable access and quality to Canadians across the country, regardless of their circumstances.
We are encouraged that the Minister of Health has indicated she wants to collaborate with the provinces and territories on developing accountability measures to ensure value for money and better patient care. We look forward to the
minister's plan for accountability.
This budget is notable for other missed opportunities. For many years, groups across the political spectrum have called for a pharmaceutical strategy to reduce national disparities. In fact, such a strategy was committed to by governments under the 2004 Health Accord.
Minister Kenney referred to this issue indirectly when he said the recent cancellation of supplemental health benefits for refugee claimants is justified because refugees should not have access to drug coverage that Canadians do not have.
Rather than cutting off those desperately vulnerable people, Canada's physicians urge the federal government to work with the provinces and territories to develop a plan that ensures all Canadians have a basic level of drug coverage.
Indeed, we now appear to be in a race to the bottom in the way we treat vulnerable groups - by, for example, deferring Old Age Security for two years; and changing service delivery to veterans, mental health programs for our military and the Employment Insurance program.
Significant policy changes have been announced since the budget, with little opportunity for debate and little evidence provided. We note, as well, the lack of open consultation with Canadians on matters of great import to their lives. Successful policy requires buy-in, which is best achieved when those interested are able to participate in the policy-making process.
This brings me to a wider concern shared by our members - that policy-makers are not paying adequate attention to the social determinants of health, factors such as income and housing that have a major impact on health outcomes. We remind the government that every action that has a negative effect on health will lead to more costs to society down the road.
The federal government is the key to change that benefits all Canadians. While there are costs and jurisdictions to consider, the CMA believes the best way to address this is to make the impact on health a key consideration in every policy decision that's made. The federal government has used this approach in the past, in considering rural Canadians, for example.
We therefore call for a new requirement for a health impact assessment to be carried out prior to any decision made by cabinet. This would require that, based on evidence, all cabinet decisions take into account possible impacts on health and health care, and whether they contribute to our country's overall health objectives. A similar model is in use in New Zealand and some European countries.
For instance, what health impact will cuts in funding to the tobacco strategy have?
Such an assessment would in particular have a dramatic impact with regard to poverty. Poverty hinders both human potential and our country's economic growth - and needlessly so as there are many ways to address it effectively.
The National Council on Welfare - which will disappear as a result of this budget - reported last fall that the amount it would have taken in 2007 for every Canadian to have an income over the poverty line was $12.6 billion, whereas the consequences of poverty that year added up to almost double that figure.
Close to 10 per cent of Canadians were living in poverty in 2009, many of them children, as UNICEF underlined yesterday. This is a huge challenge for our country.
In closing, as this budget cycle ends and as you begin to prepare for the next, please bear in mind that as prosperous as our country is, if we do nothing for the most vulnerable in our society - children, the elderly, the mentally ill, Aboriginal peoples - we will have failed.
Thank you.
Good afternoon. My name is Dr. Maura Ricketts and I am the Director of Public Health for the Canadian Medical Association. The CMA appreciates the opportunity to appear before this Committee today as part of your study of clinical trials and drug approvals.
The CMA represents more than 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with all Canadians, for the highest standards of health and health care.
Because prescription drugs are an essential component of health care, the CMA has developed a considerable body of policy on pharmaceutical issues. This work can be distilled into one fundamental principle: The CMA believes that our country requires a National Pharmaceutical Strategy to ensure every individual has timely access to safe, effective and affordable prescription drugs. Despite the commitment in the 2004 Health Accord to the creation of such a strategy, Canadians continue to wait for government leadership on this issue. Drugs replace more costly and invasive medical interventions. They are an essential tool in the physician's tool box.
To ensure safety and effectiveness, the CMA also believes in the need for a strong, unbiased, evidence-based system for research and approval. This is at the heart of our commitment to patient-centred care.
In evaluating whether to prescribe a new drug to a patient, a physician will weigh several factors: Does this product offer any benefits over what I am prescribing now? Will it be more effective? Will this new drug be safer? Will it solve any tricky clinical problems, such as drug interactions, or reduce side effects that prevent a medication from being used properly? The physician may also ask: What is the evidence that this new drug is an improvement? Can I trust the evidence? Where can I get access to accurate, reliable information and data on this drug?
Pre-approval drug research must provide answers to these fundamental questions.
Clinical Trials
I will now focus on two particular issues of concern to practising physicians with regard to clinical trials:
* First, what is being compared to what? Clinical trials may be sufficient for Health Canada's regulatory purposes, but may provide only part of the information a physician needs. For example, is a new cholesterol drug effective on all patients, or only on some of them? Would other patients derive equal benefit from an already existing drug, or from a lifestyle change such as diet or exercise? The CMA recommends that researchers compare a new product to other drugs on the market - and to other interventions, as well.
* Second, is timely, reliable and objective information available on all clinical trial results, not just the positive ones? Canadians need to be informed when a drug has performed disappointingly in trials if they are to make informed decisions about their health care. The CMA, therefore, recommends the results of all clinical trials, not just those with positive results, be made available to health professionals and the public.
I would like to add that the current documentation is not very user-friendly. We recommend that Health Canada prepare summaries of the most essential data, not only for physicians, but for all Canadians to be able to access this information.
The Drug Approval Process
Turning now to the drug approval process, the CMA believes the following principles should apply:
* The primary criteria for approval should be whether the drug improves health outcomes and offers an improvement over products currently on the market.
* The review process should be as timely as is consistent with ensuring optimal health outcomes and the safety of the drug supply.
* The review process should be impartial and founded on the best available scientific evidence.
* The review process should be open and transparent.
* Finally, approval of a drug is not an endpoint, but rather one step in that drug's life cycle. It is not uncommon to identify serious safety hazards after a drug has been approved, because that's when it first goes into wide use. It is important that the approval process be complemented by a rigorous and vigilant post-market surveillance process. We look forward to presenting our recommendations on this subject to your Committee at a future session.
Before closing, I would like to briefly address two other matters:
First, the issue of drugs for rare disorders. We are aware that the current clinical trial and approval processes, which place a high value on studies with large population samples, may be unable to adequately capture the value of drugs that are prescribed to only a handful of people. Some patient groups active in the area of rare disorders, such as the Canadian MPS Society and Alpha-1 Canada, have shared their concerns about this with us. These groups, along with the Canadian Organization for Rare Disorders, have been advocating for years for a fair process for evaluating drugs for rare diseases. Because Canada doesn't have a rare disorders strategy, Canadian patients have access to fewer therapies than patients in other developed countries. The issue of how to approve drugs for rare disorders merits closer consideration. The CMA recommends that the federal government develop a policy on drugs for rare disorders that encourages their development, call for ongoing evaluation of their effectiveness, and ensures fairness so that all patients who might benefit have reasonable access to them.
The second matter is that Health Canada's review process provides little guidance on another question which physicians are increasingly asking: Can my patient afford this drug? It is not sufficient that the Common Drug Review conducts reviews of the cost effectiveness of drugs and that provincial/territorial formularies undertake similar studies, as the fact remains that cost is one of the factors physicians need to consider when deciding whether to prescribe a new drug. This is especially true in the case of new biologics, which are very expensive. Canadian doctors believe that the difficulty of making effective prescribing decisions without information about cost needs to be overcome. This only underscores the necessity of a National Pharmaceutical Strategy.
Thank you. We would be happy to answer your questions.
Question 1: Economic recovery and growth (What federal measures are required for sustained economic recovery and growth?)
The health sector has an important role in sustaining Canada's economic recovery and enhancing economic growth beginning with supporting a healthy and productive workforce and providing over one million high value jobs, representing about 10 per cent of the labour force.
Despite the importance of the sector, there is general agreement that Canada's health care system is no longer a strong performer when compared to similar nations. While the OECD's 2011 Health Data ranks Canada 7th highest of 34 member states in per capita health care spending, the performance of Canada's health care system continues to rank below most of our comparator countries.
Health spending accounts for an increasing proportion of provincial and territorial budgets, and many warn of increasing future demands on the overall system. In his Economic and Fiscal Outlook Report of May 17, 2012, the Parliamentary Budget Officer stated that "the provincial-territorial long-term fiscal situation has deteriorated." Taken together, these issues highlight significant potential for the health sector, through efficiency improved gained by health care transformation, to support long-term economic recovery and growth in Canada.
While the provinces and territories have initiated positive steps to collaborate on sharing best practices, there are key responsibilities under federal leadership that would contribute to these efforts by addressing the overall performance of the health care system in Canada. The CMA recommends that:
- The federal government recognize the relationship of the social determinants of health on the demands of the health care system and that it implement a requirement for all cabinet decision-making to include a Health Impact Assessment (see Question 5 for more detail).
- Further to the comments by the Health Minister following the new fiscal arrangement announcement, the federal government should prioritize federal-provincial-territorial engagement focused on accountability and undertake a consultative process with the aim of identifying pan-Canadian metrics and measurement that will link health expenditures and comparable health outcomes.
Question 2: Job creation (What federal actions should be taken to promote job creation in a context of enhanced internal and international trade?)
A high performing health care system across the country will help support labour mobility and job creation. An effective, comprehensive public health care system provides an important international competitive advantage. The contribution of Canada's health care system to the international competitiveness of our economy has been repeatedly demonstrated in KPMG's Competitive Alternatives report.
However, there are several signs that indicate health care services and coverage are not keeping up with Canadians' needs and vary depending on where one lives in Canada. For instance, long wait times for medical care can be found in smaller provinces, while drug coverage and services for seniors are particularly poor in Atlantic Canada. Wide variation in access to pharmaceutical treatments remains the most glaring example of inequity in our health care system-all Canadians should have a basic level of drug coverage. These variations are growing and will hinder job creation in some regions, serving as barriers to labour mobility for Canadians wishing to seek work elsewhere in the country. We believe that Canadians would be better served if federal health care transfers came with specific guidelines ensuring that the system provides care of comparable access and quality to Canadians across the country, regardless of their circumstances.
Recognizing the contribution of the health care system to Canada's international competitive advantage, improvements in Canada's health care system would further support job creation. The federal government should focus its efforts towards supporting the transformation of our health care system to better meet the objectives of better care, better health and better value. The CMA recommends that:
- The federal government, in consultation with provincial, territorial and other stakeholders, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drugs.
- The federal government, together with the provinces and territories, develop and implement a pan-Canadian strategy for continuing care which would integrate home care and facility- based long-term, respite and palliative care services fully within health care systems.
Question 3: Demographic change (What federal measures should be implemented to help address the aging population and skills shortages?)
The CMA remains concerned about the status of Canada's retirement income system and the ability of Canada's seniors to adequately fund their long-term and supportive care needs. Steps need to be taken to ensure that Canada is prepared to handle the long-term care needs of its citizens, including the funding of necessary infrastructure and additional support for both health care providers and informal caregivers.
The availability of long-term care facilities has an important role in the efficiency of the overall health care system. For example, in its most recent report, the Wait Time Alliance noted that dementia is a key diagnosis related to the rise in alternate-levels-of-care (ALC) patient stays in hospitals. This is yet another issue facing all provinces and territories for which the federal government is well positioned to coordinate a pan-Canadian strategy. In addition, as part of the next long-term infrastructure program, the federal government should include a targeted health sector infrastructure fund for long-term care facilities as part of a pan-Canadian strategy to redirect care from the hospitals to homes, communities and long-term care facilities, where better care is provided at a lower cost.
The CMA recommends that:
- The federal government establish programs to encourage Canadians to save for their long- term care needs by pre-funding long-term care, including private insurance, tax-deferred and tax-prepaid savings approaches, and contribution-based social insurance, such as an RESP- type savings vehicle.
- That a targeted health infrastructure fund be established as part of the government's long- term plan for public infrastructure. The purpose of this fund would be to address infrastructure shortages in the health sector that prevent the optimization of health human resources and exacerbate wait times.
The CMA has supported the federal government's efforts to expand retirement savings options by establishing the Pooled Retirement Pension Plans. However, as highlighted by federal, provincial and territorial finance ministers, this is only one component of a larger pension reform framework to address the retirement income adequacy needs of Canadians. The CMA encourages the federal government to continue working with the provinces, territories and stakeholders to implement all elements of this framework.
Question 4: Productivity (What federal initiatives are needed to increase productivity in light of labour market challenges such as the aging of Canada's population?)
An effective and comprehensive health care system supports the productivity of the Canadian workforce. Failure of our health care system to respond to workers' health needs, on the other hand, leads to loss of productivity and high costs both in terms of lost income for Canadian families as well as foregone tax revenues for governments. Numerous studies have pointed out the enormous cost of waiting (in the billions of dollars per year) affecting both individuals and the economy.
Another related issue that has the potential to increasingly affect productivity is the burden of providing care to family members. Without adequate provision of long-term care resources and support for home care, Canada's labour force may experience a productivity drag through increased leaves and absenteeism to care for elderly relatives.
The 2011 federal budget took a first step at providing tax relief for informal caregivers through the Family Caregiver Tax Credit. However, this credit of a maximum of $300 per year by no means provides sufficient support for informal caregivers.
A 2004 Canadian study estimated that the annual cost of a caregiver's time at market rates for moderately to severely disabled home care clients ranged from $5,221 to $13,374 depending on the community in which they reside. An increase to the Family Caregiver Tax Credit is positive for the development of one aspect of the necessary support informal caregivers require but the CMA believes other enhancements will also be needed in the coming years.
In order to meet the needs of our country's aging population, the CMA recommends that:
- The federal government expand the relief programs for informal caregivers to provide guaranteed access to respite services for people dealing with emergency situations, as well as increase the Family Caregiver Tax Credit to better reflect the annual cost of family caregivers' time at market rates.
- That a targeted health infrastructure fund be established as part of the government's long-term plan for public infrastructure. The purpose of this fund would be to address infrastructure shortages in the health sector that prevent the optimization of health human resources and exacerbate wait times.
Question 5: Other challenges (Who is facing most challenges, what are they and what federal action is required?)
Despite significant investments in health and improvements in medical treatment and technologies, health outcomes in Canada have not been moving in the right direction. Chronic diseases such as diabetes and the corresponding risk factors, among them obesity, continue to rise. These negative outcomes can have a significant impact on the prosperity of the country as health is necessary for individuals to lead a prosperous and autonomous life. Research suggests that 50 per cent of population health is determined by our social and economic environment. While a strong health care system is vital, changes to medicare alone will not improve health outcomes or reduce the disparities that currently exist in disease burden and health risks.
What is needed is a process to address the social determinants of health that can be barriers or enablers to health, a process to ensure healthy public policy for all Canadians. A Health Impact Assessment (HIA) is a systematic process for making evidence-based judgments on the health impacts of a policy and to identify and recommend strategies to protect and promote health. HIA is used in several countries, including Australia, New Zealand, Norway, the Netherlands and the United States. HIA is also used in Canada, most extensively for policy appraisals in Quebec.
HIA is necessary for ensuring that all government departments are able to consider the health impacts of their work. Such a tool would have been very beneficial in assessing cuts to program spending to ensure the impact on health would not be counterproductive (i.e., lead to higher overall costs to society once the health impact is taken into account). The adoption of an evidence-based HIA is one way in which the federal government can play a leadership role in health care. The CMA recommends that:
- The federal government include a Health Impact Assessment as part of its policy development process to ensure that the health of Canadians is a key factor in every policy decision it makes.
- The federal government recognize the relationship of the social determinants of health on the demands of the health care system.
As previously indicated in the Retirement Income Improvement Coalition's (RIIC) letter to the Minister of Finance on August 10, 2011, the CMA supports the federal government's proposal to expand access to pensions, specifically by establishing a legislative and regulatory framework to permit pooled registered retirement plans (PRPPs).
The CMA is concerned that as currently proposed, the PRPP framework, including Bill C-25 and the proposed legislative amendments to the Income Tax Act, would limit the potential for PRPPs to contribute to expanding access to, and investment in, pensions for self-employed individuals.
With respect to the pension framework, a critical issue, two principles are central to the CMA's membership of over 76,000 physicians. These are, to encourage the federal government to: 1) ensure that self-employed Canadians can retire with an appropriate level of retirement income (e.g., a 70% of pre-retirement income target); and, 2) expand the retirement savings options that are available to self-employed Canadians. The CMA's comments herein on the proposed amendments to the Income Tax Act are in support of these two principles.
As elaborated below, the CMA encourages the federal government to:
1. Increase the retirement savings capacity of self-employed individuals by raising the combined limit for RRSPs;
2. Expand the PRPP framework to include defined benefit and targeted benefit pension plans; and,
3. Clarify the eligibility criteria of "PRPP administrators" to include professional associations.
1. Increase the combined contribution limit for PRPPs and RRSPs
As proposed, it is our understanding that the core benefit of the PRPP framework is in providing smaller businesses access to low-cost pension plans, thereby providing a vehicle to encourage employers to establish, and contribute to, pensions for their employees. While the CMA recognizes the value of, and supports, this objective, this proposal in effect maintains the status quo for self-employed individuals.
Under Clause 10 of the proposed amendments to the Income Tax Act, the contribution limit to PRPPs would be calculated as an additional component of the current registered retirement savings plan (RRSP) contribution limit. As outlined in the Explanatory Notes, "an employer's contributions to an individual's PRPP account [and...] an individual's PRPP contributions in a taxation year will immediately reduce the individual's ability to make deductible RRSP contributions in that same year."
While individuals with employer contributions stand to benefit from increased retirement savings via employer contributions, self-employed individuals are merely provided with access to an alternate retirement savings vehicle. As explained in the Summary Report on Retirement Income Adequacy Researchi, "[h]igher income groups tend to exhibit a greater tendency to substitute one form of saving for another since they tend to be bound by limits...[I]f newly introduced plans are included in limitations imposed on the degree to which contributions may be deductible for tax purposes, saving may not increase for individuals who are constrained (i.e. saving up to their limit), since they would more likely substitute one type of saving for another (e.g., RRSP for a private pension plan)."
Therefore, the CMA encourages the federal government to consider increasing the retirement savings capacity of self-employed individuals by raising the combined limit for RRSPs and PRPPs.
2. Include defined benefit and targeted benefit pension plans
As noted under Clause 12, the registration criteria for PRPPs will be established by the PRPP Act, Bill C-25. Of concern, Bill C-25 limits PRPPs to defined contribution pension plans by specifically excluding from eligibility of registration: (a) a pension plan as defined by 2(1) of the Pension Benefits Standards Act; (b) an employees' or a deferred profit sharing plan; (c) an RRSP or a retirement compensation arrangement defined by 248(1) of the Income Tax Act; and, (d) any other prescribed plan or arrangement.
As highlighted by the Summary Report on Retirement Income Adequacy Research, "defined benefit pension funds and annuities enable investors to share longevity risks as well as pool risky investments to diversify risk." By pooling risk, defined benefit and targeted benefit pension plans provide more secure savings vehicles than defined contributions plans. The CMA encourages the federal government to expand the PRPP framework to include defined benefit and targeted benefit pension plans. While the CMA will advance this recommendation to the House of Commons Finance Committee during its consultation on Bill C-25, we include it as part of this submission as modifications to the proposed amendments to the Income Tax Act would be required.
3. Clarify the eligibility criteria of "PRPP administrators" to include professional associations
Further clarification is required on the type of organization that may qualify as a PRPP administrator. As noted under Clause 12, an administrator of a PRPP is authorized under the PRPP Act. As Bill C-25, the PRPP Act, is still in the legislative process, the CMA will elaborate on this issue during the formal Parliamentary consultation.
However, as it stands, further clarification is required on the eligibility criteria proposed by Bill C-25. While Bill C-25 can be interpreted to extend administrator eligibility to organizations that are able to fulfill the criteria established by the PRPP Act, Finance Canada's Framework for PRPPs states that eligibility of administrators would be limited to "regulated financial institutions that are capable of taking on a fiduciary role". Well-governed professional organizations that represent a particular membership should be able to sponsor and administer RPPs and PRPPs for their own members, including self-employed members.
Conclusion
While the CMA supports the proposed PRPP framework in principle, the proposed limitations to PRPPs should be addressed to ensure that they also provide value to self-employed Canadians, including physicians. The CMA appreciates the opportunity to comment on the proposed amendments to the Income Tax Act and to once again advance recommendations to Finance Canada on the PRPP framework.
i Prepared for the Research Working Group on Retirement Income Adequacy of Federal-Provincial-Territorial Ministers of Finance.
The Canadian Medical Association (CMA) appreciates the opportunity to provide additional comments and recommendations as part of Finance Canada's 2012 pre-budget consultations.
The health sector provides essential services and high value jobs supporting communities across Canada. Statistics Canada reports that employment in the health sector accounts for 10% of the Canadian labour force.i In considering possible additional economic stimulus measures that build on the success of Canada's Economic Action Plan, the CMA encourages the federal government to consider investments that target efficiency improvements in the health sector. Efficiency improvements in the health sector yield benefits to all orders of government and Canadians.
The following recommendations are advanced for Finance Canada's consideration:
* In order to improve the delivery of better care, better health, and better value, the CMA recommends that the federal government work with the provinces, territories and health sector stakeholders to develop a model for accountability and patient-centred care. The CMA encourages the federal government to adopt the Principles to Guide Health Care Transformation, developed by the CMA together with the Canadian Nurses Association and since endorsed by over 60 organizations, as the basis of a pan-Canadian model for accountability and patient-centred care.
* Recognizing the significance of nationally comparable metrics on health outcomes and the health care system together with the effectiveness of national public reporting in demonstrating accountability, the CMA recommends that the federal government undertake efforts towards identifying pan-Canadian metrics and measurement that will link health care expenditures to comparable health outcomes.
* As the federal government prepares to engage with the provinces and territories to further map out improvements to Canada's health system, the CMA strongly encourages consideration be given to the federal role in coordinating the development of pan-Canadian clinical practice guidelines (CPGs).
* While, as previously indicated, the CMA supports the federal government's proposal to expand access to pensions, specifically by developing pooled registered retirement plans (PRPPs), the limitations to PRPPs should be addressed to ensure that they provide value to self-employed Canadians, including physicians. Specifically, addressing the limitations would include: (1) expanding the PRPP framework to include defined benefit and targeted benefit pension plans; (2) increasing the retirement savings capacity of self-employed individuals by either raising the RRSP limit or providing a distinct limit for PRPPs; and, (3) ensuring the PRPP framework expands the eligibility of administrators beyond financial institutions.
Introduction
The Canadian Medical Association (CMA) appreciates the opportunity to provide additional recommendations to the Government of Canada as part of its 2012 Pre-Budget consultation. Building upon the CMA's recommendations to the House of Commons' Finance Committee, this submission focuses on three issues: (1) improving accountability and patient-centred care in the delivery of new federal health care funding; (2) coordinating the development of pan-Canadian clinical practice guidelines; and (3) addressing limitations in the federal framework for pension reform.
1. Accountability and patient-centred care
"Raising sufficient money for health is imperative, but just having the money will not ensure universal coverage. Nor will removing financial barriers to access through prepayment and pooling. The final requirement is to ensure resources are used efficiently." World Health Organization (2010)
As the federal government finalizes the Strategic and Operating Review and considers other measures to eliminate the deficit, including scaling down the Economic Action Plan, it must be recognized that improved health systems and the resultant improved productivity pay economic dividends for the country; and, further, that "health" by today's standards is not just the assessment and treatment of illness, but also the prevention of illness, and the creation and support of social factors that contribute to health should also be considered.
With the recent announcement by Minister Flaherty with respect to the Canada Health Transfer (CHT) and Canada Social Transfer (CST), the financial parameters for future health care funding have been established.
Consistent with previous public opinion research, recent polling by Ekos Research Associates shows that 76% of Canadians identify improving health care as the leading priority for the federal government, ahead of reducing the national debt and deficit.ii However, as we have learned with the 2004 Health Accord, funding alone is not sufficient to ensure Canadian taxpayers benefit from improvements in health care, health outcomes, and value for money.
Despite laying out laudable objectives, progress to improve our health care system has been slow following the 2003 and 2004 agreements. There is a general agreement that Canada's health care system is no longer a strong performer when compared to similar nations. The OECD's Health Data, 2011 ranks Canada eighth highest of 34 member states in per capita health care spending, the second highest in hospital spending per discharge, and the seventh lowest in the number of physicians per capita. While Canada outperforms the U.S. on most measures, we fall below the median performance of the OECD on common health quality and system measures. With the new health care funding commitment to 2024, it is now time to plan how to transform the health care system.
Principles-based approach is required
The CMA is advocating built-in accountability mechanisms to ensure Canada's health care system is focused on delivering improved patient outcomes. Developing a system that is accountable and patient-centred depends on continuously striving to achieve the Institute for Healthcare Improvement's (IHI) Triple Aim objectives of better care, better health and better value. Launched in 2007, the IHI Triple Aim initiative was designed to direct the improvement of the patients' experience of care (including quality, access, and reliability) while lowering the per capita cost of care.
It was with the Triple Aim objectives in mind that the CMA jointly developed Principles to Guide Health Care Transformation in Canada with the Canadian Nurses Association (CNA). It is our strong belief that discussions about the future of health care in Canada must be guided by these principles.
The CMA-CNA principles are summarized as follows:
* Patient-centred: Patients must be at the centre of health care, with seamless access to the continuum of care based on their needs.
* Quality: Canadians deserve quality services that are appropriate for patient needs, respect individual choice and are delivered in a manner that is timely, safe, effective and according to the most currently available scientific knowledge.
* Health promotion and illness prevention: The health system must support Canadians in the prevention of illness and the enhancement of their well-being, with attention paid to broader social determinants of health.
* Equitable: The health care system has a duty to Canadians to provide and advocate for equitable access to quality care and commonly adopted policies to address the social determinants of health.
* Sustainable: Sustainable health care requires universal access to quality health services that are adequately resourced and delivered across the board in a timely and cost-effective manner.
* Accountable: The public, patients, families, providers and funders all have a responsibility for ensuring the system is effective and accountable.
In order to ensure that future federal funding delivers on the Triple Aim objectives of better care, better health and better value, a model for accountability and patient-centred care is required. Such a model would expand upon the CMA-CNA Principles through the development of a set of measurable indicators related to each principle that can be used for setting national standards, monitoring progress and demonstrating accountability to Canadians.
The CMA therefore urges the federal government to facilitate discussions with the provinces and territories to identify how resources will be used to improve patient care and health outcomes across the country. To this end, the CMA has urged the Minister of Health to move quickly to engage the provincial and territorial health ministers on transforming the health care system.
The CMA recommends that the federal government work with provinces and territories, in consultation with national health sector stakeholders, to develop a model for accountability and patient-centred care. The CMA encourages the federal government to adopt the CMA-CNA Principles to Guide Health Care Transformation as the basis of a pan-Canadian model for accountability and patient-centred care.
Improving public reporting: The cornerstone of accountability
The federal government has a significant stake in national public reporting on the health of Canadians and on the performance of the health care system. As required by the Canada Health Act, the Minister of Health must publicly report administration, operation and adherence to the Act each year. Further, as the largest contributor to the single-payer system, the federal government has a unique role in demonstrating value for money and reporting on strategies to improve the quality, effectiveness and sustainability of the health care system. To facilitate public reporting, in addition to Statistics Canada, the federal government is supported by the Health Council of Canada and the Canadian Institute for Health Information, both established as government-funded non-profits, however, with distinct mandates.
Despite pan-Canadian efforts such as provincial health quality councils and federal and non-governmental reporting, there remains significant room for improvement in the area of monitoring and reporting, both on health outcomes and system performance. As noted in the Commonwealth Fund's report on international health care systems, "reporting on health system performance [in Canada] varies widely across the provinces and territories...there is so far little connection between financial rewards and public reporting of performance." Not surprising, this issue was also identified by the Health Council of Canada in its Progress Report 2011. It highlights the challenges in reporting progress and explains the difficulties inherent to the current patchwork, "[w]here provinces and territories had set and publicized targets, it was easier for us to track progress. Where we could not find targets, assessing progress was more difficult."
The CMA has long supported improved pan-Canadian public reporting on health and health care. Most recently, the CMA hosted a symposium with health reporting stakeholders to discuss the current status of national reporting and the need for the development of a pan-Canadian reporting framework. As recognized by the symposium's participants, there is a great deal of excellent data collection work occurring across the country. However, these efforts are largely uncoordinated and do not tell the full story of the health of Canadians or adequately assess the performance of the health care system. Indeed, despite an abundance of metrics and measurement, in many cases, data is not necessarily usable by the public or decision-makers and, unfortunately, is not necessarily comparable between jurisdictions.
The CMA recommends that the federal government recognize the significance of nationally comparable metrics on health and the health care system and national public reporting in demonstrating accountability (i.e. better health, better care, and better value). In achieving these objectives, the CMA recommends that the federal government mandate an appropriate national organization, such as the Health Council of Canada, to undertake a consultative process with the aim of identifying pan-Canadian metrics and measurement that will link health expenditures and comparable health outcomes.
2. Coordinate the development of pan-Canadian Clinical Practice Guidelines
As the federal government prepares to engage with the provinces and territories to further map out improvements to Canada's health system, the CMA strongly encourages consideration be given to the federal role in coordinating the development of pan-Canadian clinical practice guidelines (CPGs). Such a role would build upon the commitment made by the provinces and territories under the auspices of the Council of the Federation to collaborate on the development of three to five CPGs over the coming year.
CPGs are systematically developed, evidence- or consensus-based statements to assist health care providers in making decisions about the most appropriate health care to be provided in specific clinical circumstances. There is compelling evidence in the literature, supported by the experience of other countries, that well-designed and disseminated CPGs can enhance the clinical behaviour of providers and provide a positive impact on patient outcomes.
The principle argument in support of CPGs is their ability to enhance quality of care and patient outcomes. In addition, CPGs have been found to:
* Provide publicly accessible descriptions of appropriate care by which to gauge health care performance;
* Help to reduce inappropriate variations in care across diverse geographical and clinical settings;
* Offer the potential of empowering patients as to appropriate care expectations; and,
* Contribute to public policy goals, such as cost containment, through encouraging more appropriate provider use of resources.
However, in the absence of a pan-Canadian approach, CPGs across Canada are of uneven quality and even excellent guidelines may not be effectively disseminated or implemented. In contrast to Canada, peer-nations such as the United Kingdom, the United States and Australia have committed at a national level to support the development and dissemination of CPGs.
In November 2011, the CMA, together with leading national medical and health sector stakeholders, convened a Canadian Clinical Practice Guidelines Summit, attended by representatives of the federal and most provincial and territorial governments, to explore key components of a pan-Canadian strategy on CPGs. Emerging from this summit was a clear consensus that it was the federal role to provide the infrastructure support necessary to facilitate the development and dissemination of high-quality CPGs, customizable to the needs of all jurisdictions in Canada.
Guideline development and implementation is a complex, lengthy and resource-intensive process. In the absence of federal coordination in Canada, guidelines are produced by disparate, disease-specific groups, often funded by the pharmaceutical industry. This creates an obvious potential for conflict of interest where the guideline development process is far from transparent. Many guidelines are published without disclosure on conflict of interest or methodology applied. Concern over the quality of guidelines presents one the most persistent barriers to adoption by physicians of the recommended practice. The resulting underutilization of CPGs in Canada is widely documented. Clearly, the development and dissemination of pan-Canadian CGPs present a unique and significant opportunity for improvement in Canada's health care system.
The CMA recommends that as part of further discussions with the provinces and territories, the federal government commit to working with the provinces, territories and health sector stakeholders towards the development of a pan-Canadian clinical practice guideline initiative. In particular, the CMA recommends that the federal government commit support for the infrastructure necessary for the development, maintenance, and active dissemination of relevant, high-quality clinical practice guidelines.
3. Address the limitations proposed under the pension reform framework
As previously indicated in the August 2011 submission to Finance Canada by the Retirement Income Improvement Coalition (RIIC), the CMA supports the federal government's proposal to expand access to pensions, specifically by developing pooled registered retirement plans (PRPPs).
While we are currently assessing the package of proposed Income Tax Act amendments and will provide more detailed comments as part of the legislative process, the CMA is concerned that the framework, as proposed, limits the potential for PRPPs to expand physician access to, and investment in, pensions.
Based on preliminary analysis, it is our understanding that the core benefit of the PRPP framework is in providing small businesses access to low-cost pension plans, thereby providing a vehicle to encourage employers to establish, and contribute to, pensions for their employees. Given that a significant proportion of physicians are self-employed, they would not benefit from employer contributions to a PRPP. Further, as proposed, the contribution limit to PRPPs would be calculated as an element of the current RRSP and pension contribution limit. Finally, further clarification is required on the type of organization that may qualify as a PRPP administrator. Well-governed organizations that represent a particular membership should be able to sponsor and administer RPPs and PRPPs for their own members, including self-employed members.
While the CMA supports the proposed PRPP framework in principle, the limitations to PRPPs should be addressed to ensure that they provide value to self-employed Canadians, including physicians.
The CMA recommends that Finance Canada consider amendments to the proposed Income Tax Act amendments to address limitations to PRPPs, specifically: (1) expanding the PRPP framework to include defined benefit and targeted benefit pension plans; (2) increasing the retirement savings capacity of self-employed individuals by either raising the RRSP limit or providing a distinct limit for PRPPs; and, (3) ensuring the PRPP framework expands the eligibility of administrators beyond financial institutions.
Conclusion
The comments and recommendations provided herein represent the CMA's priority recommendations for targeted federal funding towards the achievement of efficiency improvements in Canada's health sector.
It is the CMA's position that these measures will contribute to a healthy, more productive and innovative economy by contributing to better care, better health and better value in the health care system.
Once again, the CMA appreciates the opportunity to provide these additional comments and recommendations.
i 2006 Census data
ii http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Media_Release/2011/Dec-Poll_en.pdf
CMA's Submission to the House of Commons Standing Committee on Finance: Amending Bill C-25 to expand the PRPP framework to provide value to self-employed Canadians
The Canadian Medical Association (CMA) supports the Government of Canada's efforts to improve Canada's retirement income system, specifically by establishing a legislative framework to permit pooled registered pension plans (PRPPs) as proposed in Bill C-25, the PRPP Act.
The CMA has long supported the Government of Canada's efforts to expand access to pensions, including by permitting PRPPs. However, the CMA is concerned that as currently proposed, Bill C-25 limits the potential for PRPPs to expand the access to, and investment in, pensions of self-employed individuals.
The CMA has participated in, and made recommendations to, Finance Canada over the course of the department's multi-year consultative process, including responding to the 2010 consultative paper Ensuring the Ongoing Strength of Canada's Retirement Income System. The CMA has also made recommendations to Finance Canada as a member of the Retirement Income Improvement Coalition (RIIC), which consists of 11 national professional associations representing over 1 million self-employed professionals. The following discussion and recommendations align with those previously made by the CMA and the RIIC.
The pension framework is a critical issue to CMA's membership of over 76,000 physicians. In addressing the pension framework, including permitting PRPPs, two principles are central to the CMA's membership: to ensure that self-employed Canadians can retire with an appropriate level of retirement income (e.g., a target of 70% of pre-retirement income); and, to expand the retirement savings options that are available to self-employed Canadians.
The CMA's comments herein, and recommendations to the Finance Committee to amend Bill C-25, are in support of these two principles. As elaborated below, the CMA encourages the Finance Committee to:
1. Amend Bill C-25 to raise the combined limit for RRSPs and PRPPs in order to increase the retirement savings capacity of self-employed individuals.
2. Amend Section 12(1) of Bill C-25 to expand the PRPP framework so it includes defined benefit and targeted benefit pension plans, which provide more secure savings vehicles than defined contributions plans.
3. Ensure the eligibility clauses of Bill C-25 (Sections 14-26) would allow well-governed professional organizations that represent a particular membership to be able to sponsor and administer RPPs and PRPPs for their own members, including self-employed members.
1. Increase the combined contribution limit
It is our understanding that the core benefit of the proposed PRPP framework is in providing smaller businesses access to low-cost pension plans, thereby providing a vehicle to encourage employers to establish, and contribute to, pensions for their employees. However, as explained by the Explanatory Notes accompanying the proposed Income Tax Act amendments, "an employer's contributions to an individual's PRPP account [and...] an individual's PRPP contributions in a taxation year will immediately reduce the individual's ability to make deductible RRSP contributions in that same year." While the CMA recognizes the value of, and supports, this objective, this proposal in effect maintains the status quo for self-employed individuals.
Like the Canadian population at large, physicians represent an aging demographic - 38% of Canada's physicians are 55 or older - for whom retirement planning is an important concern. In addition, the vast majority of CMA members are self-employed physicians and, as such, they are unable to participate in workplace registered pension plans (RPPs). At present, physicians are more reliant on registered retirement savings plans (RRSPs) relative to other retirement savings vehicles.
While individuals with employer contributions stand to benefit from increased retirement savings via employer contributions, self-employed individuals are merely provided with access to an alternate retirement savings vehicle. As explained in the Summary Report on Retirement Income Adequacy Researchi, "[h]igher income groups tend to exhibit a greater tendency to substitute one form of saving for another since they tend to be bound by limits...[I]f newly introduced plans are included in limitations imposed on the degree to which contributions may be deductible for tax purposes, saving may not increase for individuals who are constrained (i.e. saving up to their limit), since they would more likely substitute one type of saving for another (e.g., RRSP for a private pension plan)."
Therefore, the CMA encourages the Finance Committee to consider amending Bill C-25 to increase the retirement savings capacity of self-employed individuals by raising the combined limit for RRSPs and PRPPs.
2. Include Defined Benefit and Targeted Benefit Pension Plans
As currently proposed, Section 12(1) of Bill C-25 limits PRPPs to defined contribution pension plans by specifically excluding from eligibility of registration: (a) a pension plan as defined by 2(1) of the Pension Benefits Standards Act; (b) an employees' or a deferred profit-sharing plan; (c) an RRSP or a retirement compensation arrangement defined by 248(1) of the Income Tax Act; and, (d) any other prescribed plan or arrangement.
As highlighted in the Summary Report on Retirement Income Adequacy Research, "defined benefit pension funds and annuities enable investors to share longevity risks as well as pool risky investments to diversify risk." By pooling risk, defined benefit and targeted benefit pension plans provide more secure savings vehicles than defined contribution plans. The CMA encourages the Finance Committee to amend Bill C-25 to expand the PRPP framework to include defined benefit and targeted benefit pension plans.
3. Clarify the eligibility criteria of "PRPP administrators" to include professional associations
Further clarification is required on the type of organization that may qualify as a PRPP administrator under Bill C-25. While Sections 14-26 of Bill C-25 can be interpreted to extend administrator eligibility to organizations that are able to fulfill the criteria it establishes, Finance Canada's Framework for Pooled Registered Retirement Plans states that eligibility of administrators would be limited to "regulated financial institutions that are capable of taking on a fiduciary role."
The CMA encourages the Finance Committee to ensure that the eligibility clauses of Bill C-25 would allow well-governed professional organizations that represent a particular membership to be able to sponsor and administer RPPs and PRPPs for their own members, including self-employed members.
Conclusion
While the CMA supports the proposed PRPP framework in principle, the limitations currently proposed by Bill C-25 should be addressed to ensure that PRPPs also provide value to self-employed Canadians, including physicians. The CMA appreciates the opportunity to comment to the Finance Committee as part of its study of Bill C-25.
Summary of Recommendations
Recommendation 1
Amend Bill C-25 to raise the combined limit for RRSPs and PRPPs in order to increase the retirement savings capacity of self-employed individuals.
Recommendation 2
Amend Section 12(1) of Bill C-25 to expand the PRPP framework so it includes defined benefit and targeted benefit pension plans, which provide more secure savings vehicles than defined contributions plans.
Recommendation 3
Ensure the eligibility clauses of Bill C-25 (Sections 14-26) would allow well-governed professional organizations that represent a particular membership to be able to sponsor and administer RPPs and PRPPs for their own members, including self-employed members.
i Prepared for the Research Working Group on Retirement Income Adequacy of Federal-Provincial-Territorial Ministers of Finance.
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Health Committee for consideration as part of its study on drug supply in Canada. The severe impact of the disruption in production at one pharmaceutical company's manufacturing facility has demonstrated the significant shortcomings in how drug shortages are managed in Canada. This submission focuses on what is needed to ensure Canada's health care system delivers patient-centred care.
In order to deliver the best possible care to patients, physicians require timely, comprehensive and accurate information about current and anticipated drug supply shocks and constraints. With this objective in mind, we have provided input to the government and to the pharmaceutical industries. Further, Canada requires an uninterrupted supply of medically necessary medication for patients.
Impacts on Patients and the Health Care System
Canada's doctors are deeply concerned about the persistent shortages of drugs that they and their patients are encountering. Prescription drugs can prevent serious disease, reduce hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Pharmaceuticals benefit the health care system by reducing costs in other areas such as hospital stays and disability payments. Disruptions in the supply of pharmaceuticals can impact patient care, patient health and the efficiency of the overall health care system.
At the CMA, patient organizations are telling us about the anxiety, pain and harm that drug shortages are inflicting on patients. Below are excerpts of these experiences:
* According to the Brain Injury Association of Canada: "Any drug medication shortage endangers Canadian patients. In the brain injury community, anti-depressants are prescribed to some, as is pain medication, so if there is a shortage some members in the community will be endangered even if the medication is altered."
* The interim-president of the Canadian Arthritis Patient Alliance, Louise Bergeron, wrote CMA to say: "Actually, I have had this happen to me on three occasions and it is quite scary when you know you will not have access to certain drugs for an extended period of time, since you know your health will be on the line."
* Sharon Baxter, Executive Director, of the Canadian Hospice Palliative Care Association, says: "All are encouraging the government to find a solution very quickly as pain medication at the end of life is essential and urgent. I don't think we are at the stage where people are dying without access, but getting to that end is totally unacceptable in a country like Canada."
Among the impacts of drug shortages are:
* delays in access to needed medication;
* delays or disruptions to clinical treatment;
* delayed or cancelled surgeries;
* loss of therapeutic effectiveness when an appropriate alternate therapy is not available;
* increased risk of side effects when alternate therapies are used; and
* increased non-compliance when patients, particularly those on long-term therapy, find it harder to comply with a new medication regime.
Any one of these situations can impact patient health, particularly in patients with complex problems. In many instances, this in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments.
In a survey of physicians conducted by the CMA in 2011, two-thirds of respondents said that the shortage of generic drugs had had negative consequences for their patients or practice.
Of these physicians, 22 per cent indicated that the consequences were that their patient suffered clinical deterioration because an alternate drug was substituted. Similarly, in a survey of pharmacists by the Canadian Pharmacists Association in 2011, 69 per cent of respondents indicated that they believed that patients' health outcomes had been adversely affected by drug shortages.
Notably, of the physicians who indicated the shortage of generics resulted in consequences to their patients or practice, 28 per cent reported that their patient did not fill the substitution prescription due to the cost of the medication. Numerous respondents raised concerns about the financial impact of substitute medications on patients.
Survey responses also shed light on the increased demand on the health care system created by the lack of information on drug shortages provided to physicians. When physicians are not made aware of a drug shortage, and prescribe that medication, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Better informing physicians about drug shortages can reduce demand on the health care system by eliminating the inefficiencies associated with drug shortages.
Scope of Drug Shortages
In an attempt to outline the scope of the problem, the Canadian Agency for Drugs and Technologies in Health (CADTH) stated that:
"It is difficult to quantify and determine the extent of drug shortages in Canada because manufacturers are not required to report disruptions in drug supply to Health Canada and because there is no single accountable Canadian organization that provides system-wide drug distribution oversight."i
Surveys by the CMA and the Canadian Pharmacists Association (CPA) shed light on the lack of drug shortages management in Canada. Taken together, the results of these surveys paint an alarming picture of drug shortages management in Canada and underscore the need to improve our system.
In terms of notification, the majority of physicians and pharmacists indicated they never (51 per cent and 29 per cent) or infrequently (32 per cent and 33 per cent) receive advance notice of shortages. Ironically, given the high proportion of pharmacists reporting they never or infrequently receive notice, 65 per cent of physicians indicated that they receive notification from pharmacists. Meanwhile, 30 per cent of physicians also indicated that they were notified of drug shortages by their patients.
Alarmingly, 81 per cent of the pharmacists surveyed indicated they had trouble locating medications to fill a prescription during their last shift prior to completing the survey and 93 per cent had difficulty over the week prior.
This is not a new problem, but since we surveyed CMA members in the fall of 2011, the situation has worsened. Currently about 250 medications are listed on Canadian drug shortage websites. Before the dire impact of the loss of production at Sandoz, Canadian hospitals were already dealing with shortages in the supply of sterile injectables - critical in specialties like surgery, oncology and anesthesia.
What Canada's Doctors Require to Provide Care
Physicians have expressed their frustration at the time it takes to find an appropriate drug for substitution - time taken from the physician, the pharmacy and the patient. Time better spent with patients is being used by physicians to work with pharmacists to identify alternative drugs and therapies.
Of greatest concern are those drugs that are single sourced. When single source medications are in short supply, there are no clear substitutes. The impact of this is being felt now in hospitals across the country as they grapple with the loss of numerous Sandoz products and are forced to ration the remaining stock.
The majority of physicians surveyed by the CMA indicated that greater knowledge of drug supply issues would allow them to deliver better patient care.
To this end, the CMA strongly supports the development of a comprehensive system for monitoring and responding to domestic shortages of medically necessary drugs. Canada needs a sustainable, adequately resourced system to: identify shortages, rapidly and proactively inform health care professionals, and respond quickly to allocate supply as needed to resolve shortages.
The CMA has provided input to both industry and government on the key information needs of doctors. These are:
* Information about the product in short supply;
* Expected duration of the shortage;
* Therapeutic alternatives;
* Regions affected;
* Notification of the end of the shortage.
While the recent establishment of the online inventories by the pharmaceutical industry associations marks an improvement in Canada's management of drug shortages, significant issues remain to be addressed. These include the need for: complete and more consistent information; automatic notifications to alert physicians, pharmacists and other health care providers; a mechanism to prevent potential disruptions; and a mechanism to seek new or interim sources of supply during a shortage.
The CMA recognizes that other countries are also grappling with drug shortages. Canada must also work with its partners abroad to find an international solution to this phenomenon.
Conclusion
Drug shortages management in Canada has significant shortcomings that impact patients, doctors and the health care system. With the current shortage of injectable drugs teetering on the verge of a crisis, quick action and cooperation are required to address the supply shock.
The CMA calls on Members of Parliament to exercise leadership to ensure that Canada's health care providers have access to the information necessary for them to care for their patients, and that Canadians have access to medically necessary drugs.
i Canadian Agency for Drugs and Technologies in Health. (2011) "Environmental Scan: Drug Supply Disruptions." Ottawa: CADTH, accessed online at: http://www.cadth.ca/media/pdf/Drug_Supply_Disruptions_es-18_e.pdf, 1.
CMA's Submission to the Senate Committee on Social Affairs, Science and Technology - Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals
The Canadian Medical Association is pleased to take part in the second phase of the study of prescription pharmaceuticals by the Senate Standing Committee on Social Affairs, Science and Technology. During the first phase, we presented the CMA's policy position regarding clinical trials and the process for approving new drugs for use. In this phase we will discuss our position and recommendations on post-approval surveillance of prescription drugs.
The Canadian Medical Association represents 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care.
Prescription drugs are a very important part of high quality and cost-effective health care. They 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. Therefore, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription drugs.
The essence of our position is contained in our first recommendation:
Recommendation 1:
The CMA recommends that federal and provincial/territorial governments collaborate to develop and implement a national pharmaceutical strategy to ensure that every Canadian has timely access to an adequate supply of safe and effective prescription drugs.
This recommendation has two elements: "safe and effective" and "adequate supply," both of which we will discuss in this submission.
2) Ensuring Safety and Effectiveness
As we have previously told this Committee, the CMA supports a robust regulatory framework and system for researching and approving new pharmaceutical products. But however strong Canada's pre-approval system is, it will not identify all potential problems with a new drug. Pre-approval clinical trials tend to focus on small numbers of patients, and exclude vulnerable groups such as children and the elderly. They also tend to be of short duration, whereas in the real world, patients may take these drugs for years. As a consequence, problems with a drug are often identified only after widespread, long-term use in the general population. For this reason, it is essential that Canada have in place a robust regulatory framework that includes a timely system to monitor the performance of prescription drugs after they come on the market.
The Government of Canada has taken several recent steps to enhance its drug surveillance system. In 2009, it established the Drug Safety and Effectiveness Research Network. In 2008, it introduced Bill C-51, An Act to Amend the Food and Drugs Act, to improve drug safety and effectiveness monitoring by Health Canada. Unfortunately, the bill died with the 2008 election call and has not been re-introduced. That is why we are pleased that the Senate has chosen to re-open this issue.
What would a comprehensive post-approval surveillance regulatory framework and system look like? In order to effectively monitor the safety and effectiveness of the country's drug supply, the CMA believes it should include:
a) Comprehensive processes for gathering drug safety and effectiveness data
In gathering data about adverse drug reactions (ADRs) in Canada, Health Canada has traditionally relied on spontaneous reports from manufacturers and health professionals. The government could enhance its capacity to gather information by:
* making it easier for physicians and other health professionals to report ADRs voluntarily. This can be accomplished by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of ADR reports over the past 10 years. The reporting process could be made even more efficient by incorporating it directly into the Electronic Medical Record (EMR) as this is developed.
* augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report ADRs in detail, and who, because of these contractual obligations, would be committed to assiduous reporting.
b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety.
Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received.
Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally.
Post-market monitoring should do more than identify safety risks. It should also provide information about a drug's efficacy and effectiveness. Does it achieve the health outcome for which it is being marketed? Does it perform better than other drugs or therapies for the same condition?
c) Communication of useful information to health care providers and the public.
When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available.
Recommendation 2:
The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to:
* Make it easier for health professionals to submit voluntary ADR reports;
* Analyze the data that has been gathered in a rigorous and timely manner; and
* Communicate essential information to health care providers and the public in a timely and user-friendly manner.
d) Increased regulatory authority for Health Canada
Drug safety is a serious issue; recent research has revealed that nearly a quarter of new drugs approved in Canada will eventually receive a serious safety warning1. Given the potential risks to patient safety we believe Health Canada should have the legal authority to take strong action when a safety problem is identified.
The CMA recommends that Health Canada should be given the authority to:
* require post-market studies of newly approved drugs if clinical trials identify possible safety risks;
* require manufacturers to disclose information if Health Canada thinks it germane to making a decision in the interest of patient safety; and
* take action if post-market research uncovers new safety concerns. This could mean ordering changes to product labels, or pulling a product off the market.
Granting Health Canada this regulatory authority is only the first step. Health Canada should not hesitate to use this authority if the situation warrants.
3) Ensuring an Adequate Drug Supply
In the past few years Canada's doctors have become deeply concerned about the persistent shortages of drugs that they and their patients are encountering. In a survey of physicians conducted by the CMA in September 2012, two-thirds of respondents said that the shortage of drugs was a significant issue in terms of its impact on patient care and outcomes. Of these physicians, 70 per cent indicated that their patient received a less effective medication, and 20 per cent had patients who had suffered clinical deterioration because an alternate drug was substituted. This in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments. Twenty-three per cent reported that their patient suffered financially due to the cost of the substituted medication, since many of the drugs in short supply are older, low-cost generics.
The lack of information about shortages compounds the stress of dealing with them. When physicians prescribe a medication, unaware that it is in short supply, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Physicians have expressed their frustration at the time it takes to find an appropriate substitute drug - time which could better be spent in patient care.
As a consequence, the CMA strongly supports the development of a comprehensive system for monitoring domestic shortages of medically necessary drugs. To be of greatest benefit to doctors, such a system should include:
* Information about the product in short supply;
* Expected duration of the shortage;
* Therapeutic alternatives;
* Regions affected;
* Notification of the end of the shortage.
Although pharmaceutical industry associations and drug manufacturers are now supporting a drug shortage reporting website (http://www.drugshortages.ca/drugshortages.asp), there is room for improvement. The reporting website does not yet capture all of the drug product shortages. It must become more user friendly for health practitioners and the public, with search and sort functions to easily find product listings. In addition, a mechanism to obtain information on possible therapeutic substitutions would be of value to practitioners.
Recommendation 3:
The CMA recommends that Health Canada work with provincial and territorial governments, industry groups and health professionals to enhance the current system for reporting drug shortages and ensure its sustainability.
Finally, while a reporting system to provide information to health professionals and Canadians on drug shortages is valuable, it is essential that Canada address the root causes of drug shortages. A review of the supply processes, both domestic and international, is strongly recommended.
While the CMA acknowledges that provinces are responsible for purchasing drugs, we believe that solutions will be stronger if all provinces, and the federal government, work together on them. And since drug shortages are an international concern, it is the responsibility of the Government of Canada to work with other countries in seeking solutions.
Recommendation 4:
The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada.
4) Other Important Elements of a National Pharmaceutical Strategy
As Recommendation 1 states, the CMA believes that Canada's federal and provincial/territorial governments should implement a national pharmaceutical strategy, one of whose objectives would be to ensure an adequate supply of prescription drugs. The strategy should address other important objectives, as well, notably:
* ensuring comprehensive prescription drug coverage for all Canadians. According to a recent CMA survey, one in 10 Canadians has gone without a prescription drug because they couldn't afford it. Governments should work with private insurers and other stakeholders to develop a system to provide equitable, comprehensive prescription drug coverage to all Canadians.
* encouraging optimal prescribing by health professionals. To accomplish this, the CMA has recommended a strategy that includes education, user-friendly guidelines and practice tools, and the provision of impartial information to health professionals and the public.
5) Conclusion
Once again, we commend the Senate Social Affairs Committee for bringing this issue to your table. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective and in adequate supply.
1 Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012;():1-2. doi:10.1001/archinternmed.2012.4444.
The Canadian Medical Association will support any provincial/territorial medical association in a court challenge to a refusal by their provincial/territorial government to participate in a fair bargaining process.
The Canadian Medical Association will support any provincial/territorial medical association in a court challenge to a refusal by their provincial/territorial government to participate in a fair bargaining process.
Text
The Canadian Medical Association will support any provincial/territorial medical association in a court challenge to a refusal by their provincial/territorial government to participate in a fair bargaining process.
