Two new reports on Generic Drugs in Canada reaffirm Health Council’s findings

John G. Abbott, CEO, Health Council of Canada

Earlier this week, I read with great interest the latest reports on generics drugs released by the Patented Medicine Prices Review Board (PMPRB).

One report, Generic Drugs in Canada: Price Trends and International Price Comparisons, 2007 compares the price trends of generic drugs in Canada to 11 other countries. The report found that ”…generic drugs cost less in foreign markets than in Canada. These price differences are substantial. The implications of the international price comparisons are clear… foreign prices are, on average, only about two-thirds of corresponding Canadian prices… for the majority of drugs and nearly all therapeutic classes”.

This independent assessment reaffirms findings in The Health Council’s recent report on generic drugs Generic Drug Pricing and Access in Canada: What are the Implications? Our report found that that international prices for generic drugs in 10 other developed countries to be 15-77% lower than average Canadian prices. Obviously little has changed (at least up to now).

The second PMPRB report Generic Drugs in Canada: Market Structure – Trends and Impacts suggests that generic drug products are highly concentrated in terms of sales. In 2007 the top four leading suppliers accounted for 96.7% of sales of generic drugs. The report noted that this concentration is not the fundamental source of difference between the Canadian and foreign prices. It goes on to refer to a recent study of the Canadian Competition Bureau that concluded “…competition among Canadian companies occurs principally through rebates provided to retailers. In a market framework of this sort one would expect more vigorous competition among companies to produce larger off-invoice rebates rather than lower prices”.

These reports reveal valid insight into generic drug pricing in Canada; however, their findings are based on 2007 and earlier data. Thus, they do not reflect the potential impact of recent policy changes to generic drug re-imbursement policies in Canada where provinces like Quebec, Ontario, Alberta, and British Columbia have taken major steps to reduce the cost of generic drugs.

For our health policy leaders, industry professionals, and the Canadian public to continue to make informed choices about generic drugs reports of this nature must be researched and published regularly.

Finally, I am encouraged by the progress to date. With leadership, positive changes are possible to control health system costs while improving access and maintaining quality. I look forward to reading future discussion papers that report on how the newly implemented policies and planned joint purchasing initiatives are reflected in downward pressure on generic drug prices in Canada and improved access to these drugs for Canadians.

Key Words: Pharmaceuticals Management, Generic Drugs

Social Determinants of Health - National Collaborating Centre for Healthy Public Policy Responds

Michael Keeling, English Writer and Editor, National Collaborating Centre for Healthy Public Policy and François Benoit, Lead, National Collaborating Centre for Healthy Public Policy

“Why do we have to structure our society in such a way as to create ill health?”

In the May/June edition of the Canadian Journal of Public Health (25 years ago) Dr. Trevor Hancock’s Beyond Health Care: From Public Health Policy to Healthy Public Policy contrasted public health policy, which “accepts the givens of our present socio-cultural system and within those givens plans an illness care system” to healthy public policy, which questions those givens by asking: “Why do we have to structure our society in such a way as to create ill health?” (1)

Responses to this and similar questions have produced a convincing body of literature calling for collective action to influence the economic, social, cultural and environmental landscapes that determine health. This includes acting on the policies informing them.

The Health Council of Canada’s Stepping It Up: Moving the Focus from Health Care in Canada to a Healthier Canada draws on this literature to show that policies which nominally have nothing to do with health can have profound, inequitable effects on the health of populations and different sub-groups. Stepping It Up engagingly summarizes and contributes to the story of making the case for acting structurally.

Despite the convincing arguments for the why of acting on the social determinants of health, we continue to confront the how. Among other things, this paper contributes to the how by asking us to observe:

• That “health is everybody’s business” (pp. 7, 20, 33). This expands the circle of responsibility to learn about and act upon health outcomes.
• That we must leave our silos in order to act. Intersectoral action is the way to address “complex, long-term and intertwined” issues (pp. 20, 23).
• That structural prevention influences behaviours. Healthy living strategies have limitations, and to advance further we need to act on determinants. (pp. 17, 32).

This critical perspective contributes to shifting thinking from the simple dossier (linear, unisectoral, clear cause-effect) towards the complex dossier (nonlinear, multisectoral, less-predictable). These latter features are the domain of the study of wicked problems, wherein interventions demand a “seismic shift” in our understanding.

In our role as a centre for expertise in healthy public policy, we are seeing promising trends.  First, there are tools emerging for tackling these issues. Health impact assessment uses a social determinants of health framework with an equity focus embedded in the process. Other promising tools include policy analysis methods which incorporate equity and applicability, and integrated approaches to guide issue mapping on wicked problems.

Another trend is that we are seeing more and more public health practitioners, community organizations, not-for-profits and members of communities working collaboratively across sectors to make a difference, whether in Sudbury, Saskatoon, Vancouver, Montréal, Toronto or Natuashish.

This paper will be a stimulating tonic to foster all of these efforts, adding to the pan-Canadian movement to prevent or relieve the “hardening of the categories.”

Note 1. Trevor Hancock (1985) “Beyond Health Care: From Public Health Policy to Healthy Public Policy” Canadian Journal of Public Health (76, Supplement 1, 1985)

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Michael Keeling is the English Writer and Editor and François Benoit is the Lead at the National Collaborating Centre for Healthy Public Policy. The NCCHPP seeks to increase the expertise of public health actors across Canada in healthy public policy through the development, sharing and use of knowledge. The NCCHPP is one of six centres financed by the Public Health Agency of Canada. The six centres form a network across Canada, each hosted by a different institution and each focusing on a specific topic linked to public health.  More details are available from their website at www.ncchpp.ca.

Social Determinants of Health - Debra Lynkowski Responds

Ms. Debra Lynkowski, CEO, Canadian Public Health Association

The Canadian Public Health Association (CPHA) congratulates the Health Council of Canada on the launch of this important report that highlights the need for an intersectoral and multifaceted national effort to address the determinants of health as a means of achieving Health for All in Canada.

At the opening plenary session of CPHA’s 2008 Conference, Sir Michael Marmot reminded us that all government ministers are health ministers. We have been speaking about “determinants of health” for over three decades. CPHA, along with many other professional associations, non-governmental organizations and health groups, has advocated for investment in the “up-stream” population health issues. There is now mounting strong evidence, including the recent Manitoba study referred to in the Health Council’s report, as well as data from other countries, demonstrating the “business case” for investment in a determinants of health approach that addresses health equity.

As the Senate Subcommittee on Social Affairs, Science and Technology noted in its landmark 2009 report, Canada is far from where it should be in terms of the health status of our population. This is especially true for our country’s Indigenous peoples, for many population sub-groups in rural and remote areas, as well as those who fall into the lower socio-economic strata in our urban centres. Leadership by the federal government is essential to propel a national agenda for a pan-Canadian population health strategy. This report’s first two recommendations articulate what would be the foundational blocks of this national effort: that the Prime Minister take the lead in announcing, developing and implementing a population health policy at the federal level through the establishment and chairing of a Cabinet Committee on Population Health, and that the Prime Minister convene a meeting with First Ministers to establish an intergovernmental mechanism for collaboration on a pan-Canadian population health strategy.

This year marked a historic moment in the United States, when its Congress enacted the Affordable Care Act. Included in this landmark legislation are explicit, comprehensive prevention provisions with funding allocations that promote health and wellness. The Act addresses the fragmentation of policy and action and the lack of coordination across local, municipal, state and federal agencies through two initiatives. The first of these is the establishment of the National Prevention, Health Promotion and Public Health Council. Chaired by the U.S. Surgeon General, it is tasked with coordinating and implementing the national prevention agenda. The second initiative is the Prevention and Public Health Fund, designed to invest in prevention and public health programs to improve health outcomes and reduce health care costs. While we often criticize the US for failing to facilitate access to basic health care services for millions of its citizens, we might want to examine the provisions of the new health reform legislation and consider some of its progressive aspects, particularly those pertaining to public health.

Over the past few decades CPHA has called consistently for a population/public health approach here in Canada. Our Association fully endorses all of the recommendations of the Senate Subcommittee report. It wrote a letter to the Prime Minister urging him to take a lead role in putting into place a process that would result in the formulation of a pan-Canadian population health strategy.

Given the importance of income, employment and job security, housing, education, food security, and early childhood development, CPHA urged the Government of Canada, through the 2009 Budget, to create a special fund dedicated to supporting initiatives that take action on the social determinants of health. CPHA suggested an initial investment of $60,000,000, equivalent to approximately 10% of PHAC’s annual budget. This fund, to be administered through the Agency, would be dispersed in support of national, provincial/territorial and local level initiatives.

CPHA has called upon the federal government on several occasions to consider putting into place a new funding mechanism for public health, given that it is not included in the Canada Health Act, nor are public health services explicitly covered through the Canada Health Transfer (CHT). Given the lack of funds earmarked for public health through the CHT, CPHA recommended in its 2010 Budget brief to the Department of Finance the creation of a National Public Health Infrastructure Fund, valued at $1.0 billion over three years. The intent of this Fund would be to assist public health units across the country to implement the programs required to meet their client populations’ present needs. This Fund would also support national, provincial/territorial, and local-level disease prevention and health promotion initiatives, including those related to the social determinants of health.  As noted by Informetrica Limited, a $1 billion investment in health-related services could boost GDP by a factor of 1.8 and create almost 18,000 jobs.

Canada cannot mask the fact that a very serious situation exists in our country in terms of disparities in health across population groups. Public health is a public good. The federal government has an obligation and responsibility for national leadership that results in a high level of health equity for all Canadians. Investing in public health is critical, whether through core support to the Public Health Agency of Canada, through transfer payments to the provinces and territories which include funding earmarked in support of public health functions and/or programs, or through mechanisms that increase the amount of money available to Canadians to provide for their basic needs and which protects and enhances their health and well-being. The goal of Health for All is achievable. As the WHO Commission highlighted, “[a]chieving health equity within a generation is achievable, it is the right thing to do, and now is the right time to do it.“ Collectively, we can make a difference, and the time to do this is now.

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Ms. Debra Lynkowski is the CEO of the Canadian Public Health Association.

Social Determinants of Health - Dennis Raphael Responds

Dennis Raphael, Professor of Health Policy and Management, York University

The Time to Act is Now

Despite Canada’s history of developing health promotion and population health concepts and research findings, this report notes that Canada falls well behind other wealthy industrialized nations in having these ideas implemented in the form of public policy that strengthens the determinants of health. Canada’s incidence of poverty, the degree of social and health inequalities between the rich and poor, and its investments in social programs that support the health of the general population and especially the health of the most vulnerable fall well behind other wealthy nations. The report places these findings within a context that identifies how the determinants of health – or more simply living conditions – are the primary determinants of Canadians’ health. If we are to improve the health of Canadians, then we must improve their living conditions.  And as the Canadian Public Health Association has noted, the most effective means of improving the determinants of health is through advocacy for health promoting public policy.[i] Carrying out such activities through public policy action has not been a priority for most Canadian governments which instead have been focused on economic recovery, reducing deficits and debts, and maintaining the health care system.

The evidence that living conditions are the primary determinants of health is extensive and compelling, not least when it comes to the health of children.[ii] Adverse living conditions not only shape the health of children but threaten the foundations of health such that the eventual onset of type II diabetes and cardiovascular disease during adulthood is firmly related to such childhood adversity. And preventing these health problems benefits not only the ones affected but also the entire society in terms of increasing productivity and reducing health care and social services costs. Improving the situation of families with children involves instituting the kinds of public policies that have been implemented in other wealthy nations as described in Appendix 2 of this report.  Canada is richer than most of these nations and has no excuse for not doing so. But we must not limit our efforts to strengthening the determinants of health of children. The largest groups of low income Canadians – with their attendant adverse determinants of health – are unattached non-elderly males and females. Public policy must be directed to improving the determinants of health for all Canadians, right across the economic spectrum.

Public policies that strengthen the determinants of health are of two kinds.  The first kind is investing in the population through provision of benefits, supports, and services.  Sometimes this involves spending on programs that benefit virtually all Canadians such as early child education and care, employment training, and provision of community-based health care and social services.  Other times this spending involves provision of adequate benefits to those who are unable to work because of illness, disability, or unemployment due to the loss of jobs in a changing economy. Recent scholarship indicates that Canada is among the lowest-spending nations in providing the determinants of health.[iii] This is surprising as evidence from the Organisation for Economic Cooperation and Development as well as the Conference Board of Canada demonstrates that such spending is not inconsistent with economic productivity and innovations but is very consistent with improved health and quality of life.[iv]

The second kind of public policy that strengthens the determinants of health is that which provides rights and privileges to Canadians that are taken for granted in many wealthy developed nations.  This involves the institution of collective employment bargaining, sometimes through the facilitation of workplace unionization, other times through employer provision of employment security and benefits. Wealthy developed nations that have strengthened the determinants of health have done so by reaching out to their citizens to ensure that meeting citizen needs – which are also determinants of health -- such as income, housing, and employment, does not fall by the wayside against the needs of those who manage the economy.  Such balance is possible and can be seen not only in the Scandinavian nations but also in the Continental nations of Europe. Put simply, democratic processes that involve Canadians from all across the economic spectrum are good for developing health promoting public policy.

Part of the reason that Canadian governments have not instituted such far reaching public policy activities is the lack of awareness on the part of Canadians about the determinants of health.  Without such awareness such public policy activities may not be positively received by voters, which is an important consideration. There are numerous reasons for this lack of awareness but much of it stems from the lack of media reporting on the determinants of health. Hopefully, this report and others that have been produced will educate governments, institutions, and the general public as to what needs to be done to improve their and their families’ and neighbours’ health.[v] The Health Council of Canada is to be commended for undertaking this task of kick-starting Canadian public policy that will improve the health of Canadians.
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* Read Dr. Raphael's article, The health of Canada's children. Part I: Canadian children's health in comparative perspective 
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Dennis Raphael, PhD, is a Professor of Health Policy and Management at York University in Toronto. Dr. Raphael is editor of "Social Determinants of Health: Canadian Perspectives", co-editor of "Staying Alive: Critical Perspectives on Health, Illness, and Health Care" and author of "Poverty and Policy in Canada: Implications for Health and Quality of Life", all published by Canadian Scholars' Press. "Health Promotion and Quality of Life in Canada: Essential Readings", an edited collection was released in January 2010 and "About Canada: Health and Illness" was released in September of 2010 by Fernwood Publishers. 

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[i] Canadian Public Health Association. (1996). Action Statement for Health Promotion in Canada. Ottawa: CPHA

[ii] Raphael, D.  (2010). The Health of Canada’s Children. Parts I-IV. Paediatrics and Child Health, 15, January-April 2010. Available at http://tinyurl.com/292pcyw

[iii] Raphael, D. (2010).  The Political Economy of Health Promotion. Presentation at the Meeting of the International Union of Health Promotion and Education. Available at http://tinyurl.com/2dk3o3z

[iv] Organisation for Economic Cooperation and Development. (2004). OECD Employment Outlook 2004. Paris: OECD; Conference Board of Canada. (2010). How Canada Performs: A Report Card on Canada. Ottawa: Conference Board of Canada.

[v] Mikonnen, J. and Raphael, D. (2010). Social Determinants of Health: The Canadian Facts. Toronto: York University School of Health Policy and Management. Available at http://thecanadianfacts.org

Social Determinants of Health - Pamela Fralick Responds

Pamela Fralick, President and CEO, Canadian Healthcare Association

Health Council of Canada’s Stepping it Up:Moving the Focus from Health Care in Canada to a Healthier Canada

On the bottom shelf of a bookcase at home I have, among other relics, three dusty and tattered original documents – prized possessions, actually. They are the seminal 1974 A New Perspective on the Health of Canadians, the internationally acclaimed 1986 Ottawa Charter, and the groundbreaking F/P/T Agreement on Determinants of Health, signed in Victoria, BC in 1994. And now, we have the Health Council of Canada’s report, Stepping it Up.  Will this be the one that nudges us precipitously towards the tipping point where action will actually take place?

As a matter of course, I review a great number of papers on a wide variety of “hot” health system topics.  Most are informative and well presented. This report, however, actually got me excited – something to say for a serious tome!

This paper brings together all of the past and present proclamations on determinants of health in a non-emotional, professional way, yet manages to light a fire.  For instance, highlighting Senator Wilbert Keon’s statement:  “increased expenditures on health care are likely impacting negatively on the general health of our population by virtue of diminished investments by other areas like education...” frankly causes me to wince, as I reflect on how true this statement is, and how little we collectively have done.

And compelling statements such as “...our analysis confirms what the literature has already told us: research and analysis about health promotion and the determinants of health are not being translated into public policy and program  action in Canada to the degree that was expected,” add to the ‘wince factor’.  More than a fire, this should create a blaze!

The report is filled with provocative sidebar snippets, quotes from all of the major reports, and evidence/data that can only allow us to conclude ‘there must be something to this’. Even the challenging cost-benefit question is taken on, allowing the reader to understand progress made and questions remaining.

How is it then, when we know so much, that efforts to change our approach have been so relatively futile?

The Health Council calls into play the “wicked question” concept. True enough. But fortunately, the Health Council doesn’t use that ‘excuse’ to let us off the hook; there is the hint of a path to action. For instance, the report identifies the existing bodies it feels are well positioned to lead action. The Health Council also proposes a whole-of-government approach as necessary for change, or success, and cites the September 2010 declaration of the country’s Health Ministers as reason for optimism.

But this declaration is heavy on prevention and promotion, lighter on determinants of health and too new to prove successful in terms of concrete action.

In the end, although tantalizingly close to ‘next steps’ recommendations, the report frustrates in its lack of pointed direction for the future.  Given the challenges and failures of past decades, perhaps that was too much to expect. Perhaps the most important message to take away is that we all must find our role as change agents, and put that in motion. Now.

For our part, CHA recently approved a new six-point plan for its advocacy efforts in the coming years. Several of the plan’s points will incorporate a determinants of health approach, particularly within the illness prevention/health promotion focus area. We, too, can do more to move our work from health/healthcare-specific to health-determining. And must.

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Ms. Pamela C. Fralick is the President & CEO of the Canadian Healthcare Association. She also acts as co-chair of the Health Action Lobby, a coalition of 37 national health associations and organizations, co-Chair of the Canadian Coalition for Public Health in the 21st Century, and Chair of the Quality Worklife-Quality Healthcare Collaborative.

Social Determinants of Health - Irving Rootman Responds

Irving Rootman, Visiting Professor, Department of Gerontology, Simon Fraser University

As a member of the Expert Panel for this report, I am delighted to see it come to fruition. In my view, it is a milestone document that has the potential to inspire a significant shift in the way politicians, bureaucrats and the general public view health in Canada. After reading this document no one can argue that health is simply a matter of individual responsibility or the responsibility of the health care system. It is rather the responsibility of everyone and every organization and institution in Canada if we want to have the healthiest population possible.

The report is not saying anything that has not been said before as the many quotations from previous documents suggest. However, it brings together evidence and experience from Canada and other countries in a logical and convincing manner and in a way which clearly provides a recipe for action by governments and others. In particular, it concludes with a checklist for whole-of-government or intersectoral work which includes specific suggestions regarding the values and commitment, information and data and infrastructure that government needs to move forward to address the key factors that determine the health of Canadians.

It also makes some other suggestions for moving forward based on the evidence and experience that was gathered. One that I think is particularly critical is the need for more public engagement on the determinants of health. This is not an easy matter to address as the general public and the media have been surprisingly resistant to linking health to the broader conditions of life, perhaps because many feel that there is not much that they can do about it--and to a large extent this is true. However, governments, organizations and communities can do a lot to address these conditions as is illustrated in the report. But they may not act to do so without public understanding and support. So the public does have an important role in terms of reminding politicians and the media that this is something that they understand and are concerned about and want action on.

In conclusion, I think that this is an outstanding report that we all need to pay attention to and I thank the Health Council of Canada for putting it on the public agenda.

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Irving Rootman is a visiting professor in the Department of Gerontology at Simon Fraser University where he teaches a course in health promotion to graduate students. He has worked in the field of health promotion for more than 30 years as a researcher, manager, teacher, consultant and volunteer at the international, national, provincial and local levels.

Social Determinants of Health - Dr. Blake Poland responds

Dr. Blake Poland, Professor, Dalla Lana School of Public Health

Stepping It Up – Let’s Begin Now!

There is much to commend the Health Council of Canada’s new Stepping It Up report on whole-of-government approaches to addressing fundamental determinants of health in the context of growing inequities in health between rich and poor. Few topics are more important. Or timely. Of particular note, the report goes beyond the available literature to distill the wisdom and insights of numerous highly placed key players with decades of collective on-the-ground experience. As such, it represents a significant contribution to the debate about how to best protect and promote the health of Canadians. On these grounds alone Stepping It Up should be required reading in every school of public health and public policy training program across the country.

Still, as Health Council CEO, John Abbott notes in his foreward to the report, understanding the determinants of health is not new; we’ve long known that health is powerfully shaped by economic, institutional, social and cultural factors well beyond the purview of the Ministry of Health. Twenty-five years of policy reports from all levels of government have called for a shift in emphasis from treatment to prevention, and a broadening of prevention from lifestyle education to the full spectrum of determinants of health. And yet inter-ministerial collaboration to address these determinants remains a challenge. Stepping It Up is a welcome and timely appraisal of the potential of whole-of-government approaches to address this, with a much needed Canadian focus.

But make no mistake: the structural barriers and disincentives to whole-of-government approaches are considerable. The Health Council of Canada is to be commended for addressing many of the barriers to translating knowledge into action. Most significantly, key respondents canvassed for the report offer insightful and cogent advice on how to move forward with a whole-of-government approach, based on years of experience and collective wisdom, much of which is not available in the published or ‘grey’ literature.  As a result, the report contains a wealth of ideas about how to work with or around many of the most common barriers.

Reflecting on the report leaves me pondering three questions.

First, how can the system be redesigned to create incentive structures that encourage and reward intersectoral collaboration rather than making whole-of-government work a nice-to-do-when-you-can add-on with uncertain funding, variable leadership, and questionable sustainability? The report offers some intriguing possibilities, but wisely cautions against grasping for one-size-fits-all solutions. The structural dynamics of contemporary political systems place a number of limitations on what can be achieved with even the most ingenious work-around solutions.


Second, while there is much that governments can do (and to varying extents are doing) to show leadership on this issue, for whole-of-government approaches to become widespread common practice, the voting public needs to also demand it. What is the likelihood of that? That turns out to be a harder question to answer.

Given the extent to which the Canadian media frames health as an issue of health care, it is perhaps not surprising that public demand for whole-of-government approaches has been muted. A recent study from Simon Fraser University of over 4700 ‘health’ news stories in 13 major Canadian daily newspapers showed that only 6% of stories linked health to socio-economic factors, whereas 65% dealt primarily or exclusively with issues of health care delivery, management, or regulation. And yet, other research - not just survey research of the kind cited in the report, but qualitative studies that give a more detailed, nuanced and holistic understanding of how people think about health - suggests that the public also intuitively knows that prevention matters, that poverty kills, and that health care, while vital and universally valued, is more about restoring health compromised by other factors than it is about prevention and ensuring the vitality of the population. Moreover, this research suggests that how people explain inequalities in health has a lot to do with their social class and position in the social hierarchy. Not surprisingly, perhaps, those who are relatively privileged tend to claim that good health is the result of personal choice or lifestyle. By contrast, marginalized groups who have experienced institutional racism, classism, poverty, and discrimination are only too well aware of how structural factors and institutional practices powerfully shape well-being. Who decides, and whose voices typically count, in decision-making about government priorities and spending?

When it comes to appraising public appetite for renewed attention to fundamental determinants of health, recent political trends are not encouraging. Governments elected on law-and-order, deficit reduction, tax cuts, and border protection platforms are not obvious allies for whole-of-government action on basic determinants of health such as poverty alleviation. This makes the report’s figures on potential savings on health care spending associated with reducing social inequity (aka “the business case”) all the more compelling in ways that should cut across the ideological spectrum, unite disparate actors, and survive sometimes volatile swings in political leadership.

On a related note, the third question I’m left with arises from the observation that what seems to be lacking here is not knowledge but political will. Convincing politicians of the merits of this work, realigning incentives, creating new organizational structures, and mobilizing public opinion and public pressure seem essential, but potentially insufficient. Beyond these might there be some powerful cultural barriers to doing what we already know would be most effective? Malcolm Gladwell’s 2006 analysis of “million dollar Murray,” about one homeless man with mental health issues bounced in and out of emergency rooms and time-limited programs, illustrates how our societal aversion to the provision of supportive housing, for example, means that in the end we pay much more (fiscally, socially, and in terms of human suffering) than we would with a more proactive and comprehensive approach. Making a strong business case may be important, but it’s not sufficient in the face of such powerful cultural barriers (which, it should be noted, are regularly fueled by neoliberal discourse of ‘welfare cheats’, ‘deserving vs. undeserving poor’, etc.). 

The report concludes with a call for “seismic shifts in how government works, and in how politicians and government officials think about health”.  If ever there was a time for out-of-the-box thinking, it is now. Shifting the debate from collaborative service provision to the creation of a Guaranteed Annual Income, to take one example, will not be easy, though at least one municipality in Canada has already passed such legislation.  In a recessionary economy (one that may be long-lasting), lifting up the poor will increasingly mean stepping up redistributive efforts (rather than relying on growth to lift up the poor, though the record on that one is disappointing). Recent history suggests that this will be a challenge.

One thing is clear: health is political!  Whether governments “step it up” with renewed efforts at intersectoral action on fundamental determinants of health depends not just on inspired leadership but on whether Canadians “step up” and demand it. On that score, we have our work cut out for us, even as we acknowledge the incredible work being done by countless citizens groups and NGOs on this front. Ultimately, it is the coming together of state and non-state actors (a mix of ‘top-down’ and ‘bottom-up’ advocated by Glen Laverack and others) that will make this happen. Let us begin!

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Dr. Blake Poland is a professor in the Dalla Lana School of Public Health and past Director of the MHSc Program in Health Promotion at the University of Toronto, as well as former Health Promotion Critic for the Green Party of Canada.

New Angus Reid poll in line with 2010 Commonwealth Fund Survey results

Heather Dawson, Director of Analysis and Reporting, Health Council of Canada

Angus Reid recently published a poll after surveying Canadians about their experiences with the health care system, comparing the satisfaction of patients among provinces. Findings align with those of our recent Health Council of Canada bulletin, How do Canadians Rate the Health Care System? which compared Canadians’ perceptions of the health care system with 10 other  OECD countries.

Overall, the Angus Reid study found that Canadians generally feel satisfied with the care they receive once exposed to the health system. In fact, about 90% of Canadians reported that they were satisfied with theirlast visit to a family doctor or a specialist, or to have a diagnostic test.

The results from our bulletin, which looked at survey results from the 2010 Commonwealth Fund International Health Policy Survey, also line up with the Angus Reid study when it comes to dissatisfaction in emergency rooms. According to the Angus Reid study, at least 40% of Canadians said their last experience in an emergency room was not satisfactory. The Commonwealth Fund Survey revealed that almost half of Canadians have had at least one visit to the emergency department in the last two years, making this an extremely important issue affecting large portions of our population. Data from the Commonwealth survey showed that almost half of emergency room users could have been treated elsewhere by their regular care physician had the physician been available, which may be a source of the overcrowding of emergency rooms.

These types of surveys are particularly important to ensuring the Canadian public has a voice in decisions made about their health care system. As governments address health reforms and make new investments in the system, it is important they have the input from the public. The Commonwealth Fund Survey indicates that over half of Canadians believe fundamental changes are required to make the health care system work better, and surveys like these reinforce the message as to where Canadians believe the changes need to happen.

Drug Safety and Effectiveness in Canada – Charles Hain, Canadian Patient Coalition

The Health Council of Canada – Keeping An Eye on Prescriptions - report is to be commended for bringing forward the idea of a protocol for drug safety messages and their dissemination to stakeholders.

Earlier in 2010, a group of about 30 patient health organizations came together to host the first ever Canadian Patient Summit.  Over the course of two days at the end of March, more than 100 Canadians living with chronic health conditions discussed the future sustainability of healthcare policy in Canada from their vantage point.

While the Summit was not specifically convened to address pharmaceutical issues in Canada, drugs, medical devices and supplies were identified as costly out-of-pocket expenses for patients and a barrier to compliance to prescribed therapies.  For patients with chronic conditions, prescription medications and clinically prescribed therapies are often what helps them to live well, and outside of our hospital system or care facilities.

One critical observation made during the Summit was that in Canada, the patient is left out of any discussion leading to healthcare policy and implementation.  This includes, of course, the absence of an informed patient voice (their concerns, needs, and abilities) with respect to pharmaceutical development, approvals, surveillance and safety to name only a few of the issues.

No one disputes the need for greater after-market surveillance and reporting, nor could anyone desire anything less than rapid and broad disclosure of warnings after adverse drug reactions.  What is often lacking in this area is the process to include patients in discussions earlier in the development and deployment of surveillance protocols.

While MedEffect Canada is laudable, it continues to languish underutilized and perhaps misunderstood.  The sense among patient groups is that the public does not know of the existence of MedEffect rather than their lack of understanding or support for it.  Compliance in reporting adverse reactions would be higher if patients were involved in designing the forms, the process for reporting and for identifying what is important to report.  We have a tendency to blame patients when they don’t act upon the advice of experts.  Perhaps experts need to think more about whether what we are asking is overwhelming or difficult for patients to act upon.  Perhaps we need to ask patients what would work more effectively.

 A final thought has to do with jurisdiction.  In Canada’s federal system, it is not always clear which level of government has or should have the responsibility for various aspects of health care.  A national pharmaceutical program would be welcome by the majority of the public.  Likewise, the Canadian Patient Coalition, which arose from the Summit, advocates for a single electronic patient record which would allow experts to collect and analyse information on adverse reactions through a real-world surveillance of pharmaceutical therapeutic use, for example.

But the greatest positive contribution to sustainable healthcare policy in Canada is to increase patient and public engagement in these critical discussions.

For more information about the Canadian Patient Coalition: http://www.canadianpatientcoalition.ca/

Charles Hain

Public Affairs, Canadian Association of Wound Care & Coordinator,
Canadian Patient Coalition

How Do Canadians Rate the Health Care System?

Christine Pierroz, Director, Communications, Health Council of Canada

Today the Health Council of Canada presents you with a revealing bulletin, How Do Canadians Rate the Health Care System?, based on survey results from the 2010 Commonwealth Fund International Health Policy Survey. http://bit.ly/bvq5pl

Canadians feel strongly about their health care system, but they recognize the need for improvement. The bulletin shows that of all the countries surveyed, Canadians have the greatest difficulty when it comes to access to care in the evenings, weekends, and on holidays – anywhere other than the emergency room. Other areas where Canada did not fare well, compared to international counterparts, were around timely access to medical appointments and coordination of care. In contrast, Canadians are very satisfied with the quality of medical care that they receive and are confident that they could have access to the most effective treatment should they become seriously ill.

This bulletin follows yesterday’s release in New York of the Commonwealth Fund’s own analysis of this 11-country survey. The focus there was on the US, a survey participant whose performance yielded statements such as “US adults most likely to forego care due to cost, have trouble paying medical bills; US stands our for highest out-of-pocket costs and most complex health insurance.”

In Canada, we stand to learn from survey results in some of the highest performing countries around questions of interest to us – countries such as the Netherlands, the United Kingdom, and Switzerland. Perhaps you have had some experiences with these systems you would like to share. We look forward to your insights.

Drug Safety and Effectiveness in Canada - David U Responds

David U, President and CEO, Institute for Safe Medication Practices Canada

On behalf of the Institute for Safe Medication Practices Canada (ISMP Canada), I would like to thank and congratulate the Health Council of Canada for preparing and disseminating their findings on the important topic of drug safety in Canada. It is encouraging to learn that a number of new initiatives are being put in place to enhance post-marketing surveillance and monitoring such as the “progressive licensing” approach, working with industry to encourage Phase 4 studies on marketed drugs, supporting Canadian research centres to focus on selected drugs for studying their real world effectiveness and safety, as well as creating the Drug Safety and Effectiveness Network. The discussion paper facilitates learning from information available nationally as well as internationally and will help enhance Canada’s ability to ensure the drugs being marketed and used in Canada are safe and will not trigger undesirable and potentially harmful side effects.

I would also like to take this opportunity to emphasize that we must ensure drugs are being used appropriately to prevent harm. Medication incidents (medication errors) leading to harm and death can be prevented. For example, there have been a number of fatal incidents involving the fentanyl transdermal system (fentanyl patches) and important information about this has been published by Health Canada. One such publication is the July 2008 issue of the Canadian Adverse Reaction Newsletter which highlights 52 cases with fatal outcome involving fentanyl patches; examples include incidents (errors) which involve healthcare professionals and consumers. ISMP Canada has also received incident reports related to fentanyl patches, and has issued several alerts and safety bulletins to healthcare practitioners as well as sharing learnings with manufacturer(s) for the purpose of enhancing labelling and packaging.

As part of Canadian Medication Incident Reporting and Prevention System (CMIRPS), the incident reports received by ISMP Canada contribute to knowledge in medication safety. For example, contributing to some harmful medication incidents is the confusion that has occurred from look-alike/sound-alike drug names and from look-alike labelling and packaging of pharmaceutical products. In October 2008, Health Canada initiated the development of a conceptual framework for the assessment of health product names for look-alike/sound-alike name attributes. An Expert Advisory Panel was created to support this development process, with representation from Health Canada, the Food and Drug Administration in the United States, ISMP Canada along with experts in the area of psycholinguistics and human factors. The proposed conceptual framework will inform the basis for the revision of the current Health Canada Guidance for Industry - Drug Name Review: Look-alike Sound-alike (LA/SA) Health Product Names. The guidance document will strive to bring greater scientific validity, transparency, objectivity and predictability to the evaluation of health product names for look-alike/sound-alike attributes. It is proposed that the framework and guidance will apply to the following product types for human use: prescription and non-prescription drugs, biologics, and natural health products. Over the past year, efforts have been focused on putting a number of health product names through each step of the proposed name review process to establish "proof of concept". It is anticipated that data gathering and analysis will be complete by 2011 followed by stakeholder consultation. Development of a similar framework is planned for labelling and packaging of pharmaceutical drugs for human use.

Learning from medication incidents occurs from reports received by both consumers and healthcare professionals as it provides useful information in detecting problems in the medication use system. In the spring of 2010, ISMP Canada launched a consumer medication incident reporting and learning web site: SafeMedicationUse.ca. Consumer reporting in Canada has resulted in important contributions to medication safety —10 newsletters and alerts have been published to provide incident learning and prevention strategies for all Canadians.

Another key project towards drug safety is the collaborative Canadian Pharmaceutical Bar Coding Project which aims to implement standardized bar codes on all aspects of pharmaceutical labelling. Headed jointly by the Institute for Safe Medication Practices Canada (ISMP Canada) and the Canadian Patient Safety Institute (CPSI), the initiative is guided by a national Implementation Committee and being developed with assistance from a 34-member Technical Task Force (TTF), representing six identified healthcare sectors. Adoption of the GS1 global standard for automated identification (e.g., bar coding) of pharmaceutical products in Canada has been endorsed. The multiphase project has developed draft technical requirements for Canadian pharmaceuticals in the following areas: bar code components and symbologies, product database elements, medications to be included in the categories to be bar coded, and packaging levels and bar code placement.
The report prepared by the Health Council of Canada will no doubt help to further raise the profile of drug safety. It provides the opportunity for the collective challenge in Canada for all of us to move collaboratively towards the common goal of drug safety.

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David U is the President and CEO at the Institute for Safe Medication Practices Canada (www.ismp-canada.org)

Drug Safety and Effectiveness in Canada - Hugh McLeod Responds

Hugh B. MacLeod , CEO, Canadian Patient Coalition

From the patient’s perspective, medication can be a tricky proposition. On one hand, we put our faith in pharmaceuticals in order to cure disease and improve our quality of life. On the other, we know the disastrous effect they can have if prescribed or taken incorrectly.

In a recent discussion paper commissioned by the Health Council of Canada, designed in part to inform Canadians and stakeholders about drug safety and effectiveness issues in Canada and abroad, it is suggested that Health Canada adopt a protocol for developing drug safety messages and disseminating them to the various stakeholders following harmful incidents.

As it happens, the Canadian Patient Safety Institute (CPSI) is involved in the creation of a series of initiatives to equip healthcare providers with the information and supports necessary to minimize, and hopefully eliminate, the occurrence and severity of harmful medication incidents in Canadian healthcare organizations. This work could not have been accomplished without the support and dedication of Health Canada, the Canadian Institute for Healthcare Information (CIHI), the Institute for Safe Medication Practices Canada (ISMP Canada) and stakeholders from throughout the healthcare sector.

For example, earlier this year, CPSI launched a project resulting in national consensus with respect to the use of GS1 global bar coding standards for labeling medication packaging in Canada. This system is far and away the safest way to track pharmaceutical products from manufacture to administration.

Another initiative is the Canadian Medication Incident Reporting and Prevention System (CMIRPS). The aim of the CMIRPS Program is to strengthen Canada’s capacity to reduce and prevent harmful medication incidents and to manage and share information about voluntarily reported medication incidents. For instance, in the aftermath of a death in hospital due to the inadvertent injection of the drug epinephrine, which is intended for topical use, ISMP Canada issued a nationwide alert giving healthcare providers the information they need to ensure the error is never repeated.

While this type of information sharing on a national scale is commendable, we need to start thinking about patient safety on a global scale – after all, why make our own mistakes causing undue harm to patients when we can learn from those who have already gone down that path?

In the words of Dr. Dale E. Turner, “the error of the past is the wisdom and success of the future.”

We encourage you to become a patient safety champion in your organization by kick-starting the discussion around medication safety and how you can leverage the wealth of information that exists to minimize, and hopefully eliminate, the occurrence and severity of harmful medication events.

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Hugh B. MacLeod is CEO of the Canadian Patient Safety Institute (CPSI) 

To learn more about CMIRPS and bar coding visit www.patientsafetyinstitute.ca and to learn more about our medication reconciliation intervention visit www.saferhealthcarenow.ca.

Drug Safety and Effectiveness in Canada - Susan Eng Responds

Susan Eng, Vice-President, Advocacy, CARP

Are our drugs safe? Most Canadians assume so, given the clinical trials and multiple layers of government regulation – and perhaps more persuasively, complaints from pharmaceutical companies that such regulation unduly impedes market entry of their drugs. But it may not be so, according to the just released Health Council of Canada report, “Keeping an Eye on Prescription Drug, Keeping Canadians Safe.”

Once drugs get on the Canadian market, according to the report, there is no systematic scrutiny of the real world experience with the drugs. Clinical trials are limited in size and scope and do not usually include people with multiple medical conditions. The report concludes that as a result, more and more people are being exposed to unsafe drugs and cites the example of the high profile withdrawal of Vioxx and Baycol for safety reasons.

Consumer safety now depends on voluntary reporting of adverse drug reactions but this captures only 1% – 10% of such reactions. What is needed is a system to protect the public through early detection of safety concerns – called pharmacovigilance – a systematic monitoring of drug safety once the product is released onto the market.

Pharmacovigilance is still new and evolving worldwide, and the report canvasses and compares some international examples. None are comprehensive but Canada is barely on the grid.

A big part of the problem is that Health Canada – which has the primary responsibility for consumer safety – has limited authority to order the kind of steps necessary to monitor or uncover safety problems or to take action to prevent further use of drugs with safety problems. The report argues it has also failed to fully and effectively utilize the authority it does have. Presumably, the technical review and modernization process now being undertaken by Health Canada will help address these gaps.

The report argues for the establishment and funding of independent research and monitoring of the safety and effectiveness of drugs after they have been put onto the market plus a progressive licensing system to give Health Canada continuing authority to require compliance with drug safety measures including post–market [Phase IV] clinical trials. [1]

Hopeful signs include the recent creation and funding of the Drug Safety and Effectiveness Network which will research post market drug safety – but with no apparent responsibility for monitoring – and the proposed progressive licensing system which died on the order papers at the last prorogation.

CARP is a national, non-profit, non-partisan organization with 300,000-plus members across the country which advocates for changes that improve the quality of life for all Canadians as we age. Consumer safety is clearly a priority and our members would be appalled to think that the safety of the drugs they are taking [especially the newer ones] is not monitored on a systematic basis much less guaranteed and that there is no apparent process or responsibility to provide that guarantee.

Canadians are right to expect from the drug companies themselves a high level of integrity and good quality testing for safety and effectiveness before a drug comes onto the market. However, the limitations of the pre-market testing and the lack of systematic monitoring of post-market drug safety is a cause for concern.

The report’s recommendations are directed at redressing this concern and action should be taken on them as soon as possible.

--Susan Eng is Vice President of Advocacy for CARP, the national, non-partisan, non-profit organization committed to advocating for social change that will bring financial security, equitable access to health care and freedom from discrimination for all Canadians as we age.

Drug Safety and Effectiveness in Canada - Dr. Proton Rahman Responds

Dr. Proton Rahman, MD, FRCPC 

I wish to thank Health Canada for providing me with the opportunity to comment on this discussion paper. The paper which highlights why effective regulatory systems are needed is well informed providing a clear summary of the pharmacovigilance systems in place in a number of countries. This information is concisely summarized within table 3; although the inclusion of further information regarding the systems currently in place in Canada would add value to both the body of the text and the summary table. Analysis of this information will provide regulatory bodies with a springboard from which to develop a strategic vision for the implementation of effective pharmacovigilance systems throughout Canada.

The paper helpfully presents two planned developments for enhancing pharmacovigilance in Canada; the development of the Drug Safety Effectiveness Network (DSEN) and the introduction of Progressive Licensing. While the development of both of these initiatives should be applauded it should be noted that the DSEN is still in very early stages of development and a thorough review of the network’s effectiveness should be undertaken following an appropriate period of operation. The development of the DSEN should not lead to the exclusion of other post marketing research. As highlighted in the paper there is some concern regarding the impartiality of industry funded research, however this research should not be disregarded but instead the research environment be managed in such a way as to ensure impartiality in reporting.

The proposed introduction of Progressive Licensing, including conditional licensing (or release) would have a positive impact on “Keeping Canadians Safe” and potentially allow the earlier introduction of new drugs, however unless the introduction is backed with adequate legislation this impact will be severely reduced. The examples given of systems in place in other countries clearly highlight the need for supporting legislation to ensure the success of Progressive Licensing. Only through supporting legislation can it be ensured that pharmaceutical industries will abide by the terms of the license, such as the requirement for monitoring adverse events and the development and implementation of risk management plans. Progressive Licensing should not however be seen as the only answer, as there is benefit in other initiatives such as approvals through surrogate endpoints and mandatory post marketing surveillance of drugs known to have a higher risk of adverse events.

It should be noted that not all clinically relevant situations are assessed by randomized controlled trials. In such circumstances, information from disease registries can make an important contribution to the evidence base. In order for non-randomized prospective disease registries to adequately reflect clinically relevant outcomes it is important to register all relevant patients and capture accurate and comprehensive data through the collection of information on these patients in a defined area in a set time period. For this to occur it is vitally important for funding agencies to provide adequate and sustained resources for national disease registries. In the past, this has often not been a priority of funding agencies as such registries have been considered a “non hypothesis driven” initiative.

Regardless of how effective the pharmacovigilance and post-marketing surveillance systems are they are of limited use without the incorporation of effective methods of communication with prescribing Drs. The discussion paper highlights the need for developing more effective ways of communicating safety messages and this should be seen as one of the priorities of any resulting strategic plan.

The discussion paper also raises a number of issues regarding data collection, with many of the recommendations put forward reflecting the systems currently in place in Newfoundland and Labrador, where partner agencies have developed effective collaborative working arrangements to identify how disparate data sets may be shared and analyzed in a secure environment. Any initiatives to bring about collaboration and data sharing between provinces must give full consideration to the privacy and confidentiality issues that will arise, and as to how these relationships will be impacted by provincial privacy legislation.

On reading the paper it became clear that in order to prevent confusion in the future development of policy there is a need to ensure consistency in terminology when discussing pharmacovigilance and post marketing surveillance.

In order to ensure that any future strategies or policies reflect emerging technologies and future trends it is essential that consideration be given to the role of pharmacogenetics and personalized medicine in the enhancement of drug safety.

In summary this paper provides a good starting point for the development of a strategic vision for the introduction of nationally regulated pharmacovigilance, however if we are to truly “Keep Canadians Safe”, the vision must be developed in concert with all partners and address the broader issues of governance, privacy, data access and drug accessibility.

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Proton Rahman MD, FRCPC a rheumatologist and genetic epidemiologist in the Faculty of Medicine at Memorial University. He is an associate professor of medicine and consultant rheumatologist to Eastern Health at the St. Clare’s site.

Roy West1 PhD, Don MacDonald2 PhD, Catherine Street1 B.Pharm(Hons), Khokan Sikdar2 MSc, MAS, PhD (candidate), Proton Rahman1 MD1Population Therapeutic Research Group, Memorial University, St. John’s NL
2Newfoundland and Labrador Center for Health Information, St. John’s, NL