For the past two decades in Canada, patient groups funded by pharmaceutical companies have dominated public conversations about the effectiveness and safety of prescription drugs. These groups receive unrestricted educational grants enabling them to develop websites and materials, to meet with Health Canada and to participate and speak at conferences in order to lobby on behalf of interests that parallel those of pharma.
During this same time period, Health Canada has stripped funding from many non-profit organizations that maintain their independence from the pharmaceutical industry and which are also concerned with drug safety and effectiveness. This has led many groups that see their role as providing a countervailing voice to commercial interests to close their doors or to drastically reduce their activities.
To address this imbalance, a new voluntary group made up of patients and caregivers who are deeply concerned about drug safety and effectiveness has been formed. As one of its first tasks, the Independent Voices for Safe and Effective Drugs has submitted a brief to the Parliamentary Standing Committee on Health (HESA) on the development of a National Pharmacare Program.
Discussions of a National Pharmacare Program have typically centered around two goals: increasing access to drugs and controlling costs. While we not dispute the value of these goals, our brief focuses on additional benefits related to meaningful drug effectiveness, transparent and verifiable drug safety as well as the need for the funding of patient voices that are financially independent of commercial interests.
Brief to the Health Standing Committee of the House of Commons (HESA)*
Independent Voices for Safe and Effective Drugs (IVSED)
*NOTE: This text incorporates minor changes to the brief submitted to HESA including a change in our name, which was previously Independent Patient Voices Network of Canada; see the end of the document for names of steering members.
Discussions of a National Pharmacare Program typically center around two goals: increasing access to drugs and controlling costs. While we do not dispute the value of these outcomes, our brief focuses on four additional health benefits, which can be best realized by a well-structured, democratically accountable National Pharmacare Program. These are to:
- Improve drug safety and effectiveness and define parameters for access to drugs that prioritize the values of balance, fairness and justice
- Take into account collective opportunity gains
- Increase transparency
- Reduce conflict of interest in drug decision-making
We are presenting these issues as a patient group that includes medication safety advocates, researchers, health care providers, legal experts and academics who have personally been affected by issues of drug safety and effectiveness. We represent a unique perspective because we are patients and caregivers who will not accept pharmaceutical industry funding or support because we believe it would place us in a conflict of interest position.
Our recommendations can be found at the conclusion of our submission.
I. Drug Safety and Effectiveness; Define Parameters to Access
A National Pharmacare program has the potential of improving drug safety primarily through a rigorously developed and restricted national formulary that places patient health and safety at its centre. Canadians spend almost $30 billion a year on prescription drugs, the third most expensive component of the Canadian health care system. The vast majority of Canadians take prescription drugs on a regular basis: 1/3 of seniors take 5 or more drugs and suffer more adverse reactions as a result. There is evidence that many drugs are overprescribed. For example, the majority of visits to physicians for common health problems end with a prescription, even when many of these conditions can be more appropriately and safely managed by non-pharmacologic approaches.
Global and national research shows us that adverse drug effects are frequent and may result in significant morbidity and mortality even though only 5% of ADRs are identified and reported. Canada has a poorly resourced system for collecting ADRs even though they place a significant burden on all components of our health care system.
We believe a restricted national formulary that is based on a thorough evaluation of the potential benefits and harms of prescription drugs would both reduce the level of over-prescribing in Canada and expose Canadians to fewer adverse drug effects. As an example, British Columbia has one of the more restrictive drug formularies in Canada. After a comprehensive assessment of all the clinical trial results of the painkiller Vioxx, the BC Pharmacare Program decided to exclude the drug from its provincial formulary. This prevented an estimated ~500 people from suffering fatal heart attacks and strokes. The drug was later withdrawn from the market for safety reasons.
Evaluating drug safety prior to placing a drug on a national formulary involves setting a higher standard for evidence. We believe that drugs should be evaluated in clinical trials not only against placebos but against other measures such as the best or other standard treatments available, even if this is an older treatment or does not involve drugs.
The implementation of a mandatory clinical trial registry with all research results being made available to researchers and the public would allow for a more systematic review of the benefits and risks of drugs being considered. Currently, Health Canada has a voluntary registry, which includes a minority of drug companies and does not report trial results. Full disclosure of Health Canada’s decision-making in the drug approval process should also be available so that the public understands any safety risks or lack of benefits that have already been identified for specific drugs.
As part of this initiative we would like to see a more accessible web-based tool that would provide drug safety and effectiveness information on drugs selected on the formulary to the Canadian public. As a start this would include updated and current Drug Monograph information including more comprehensive data for patients, now contained in some patient leaflets and all Health Canada summary safety reviews.
At the current time research on drug safety outcomes is collected in a fragmented way through individual administrative databases managed in each of the provinces. A National Pharmacare program should require the development of a national, rigorously privacy-protective, database on drug use, health outcomes, and costs. The privacy provisions of the database might be modelled on the protections afforded census data, the legislation for which to be drafted in consultation with the Office of the Privacy Commissioner of Canada. The resulting tool would be vital in determining the impact of the National Pharmacare Plan on reducing overprescribing and improving health outcomes.
About 10-20% of prescriptions in Canada are off-label – that is, they are being used for purposes or for patients for which they have not been approved; 80% of these drugs lack evidence of effectiveness. There is also evidence that off-label drugs are associated with more adverse effects. For example, it is estimated that 20-30% of seniors in care homes are prescribed anti-psychotics off-label leading to over sedation, falls, confusion and aggressive behaviors. The effective monitoring and reduction of unsafe and ineffective off-label prescribing practices should be incorporated into the purpose and structure of a National Pharmacare Program.
A National Pharmacare Program also offers the opportunity to address the question of drug effectiveness in a more rigorous manner. Less than 1/10 of drugs approved each year in Canada are new molecular entities that provide a therapeutic advantage over existing drugs. A national drug formulary should be restricted to drugs that offer a therapeutic advantage to Canadians. Outcomes should be based on patient-relevant endpoints such as survivability and decreased morbidity rather than intermediate surrogate markers that may not reflect meaningful health outcomes.
A National Pharmacare program provides a unique opportunity to address drug safety and effectiveness problems that have exposed patients to harm without proven benefits and have increased the cost burden on our healthcare system. We hope that the Parliament of Canada will support our recommendations when the development of such a program is undertaken.
II. Opportunity Costs
Since 1964, when the Royal Commission on Health Services, headed by Emmett Hall, recommended that prescription drugs be part of medicare, the creation of a national and universal Pharmacare program has been part of Canada’s national dialogue. Thirty years after the Hall Report, the National Forum on Health said a national drug plan must be adopted in Canada, one supported by systems and policies “to manage utilization, ensure appropriate prescribing, and control costs”, through a process of competitive bulk purchasing and reference based pricing. The call for a national strategy was also a position echoed by Senator Michael Kirby and former Saskatchewan premier Roy Romanow in 2002.
Then in 2004, Canada’s first ministers called on Ottawa to establish a national drug plan, describing it as “the first major innovation to health care in a generation.” Among the nine goals linked to a national Pharmacare program was increased sustainability for Canada’s health care system; more open, transparent and evidence-based drug-related decision-making; equitable drug coverage; and “[u]ltimately, improved health outcomes for Canadians”. A national Pharmacare program, the premiers said, would aim to negotiate with drug and vaccine makers to obtain best prices, to improve prescribing patterns among physicians, speed up access to generic drugs, and improve post-approval monitoring for safety and effectiveness. 
While support for national Pharmacare has grown, progress towards implementation has been limited. Many of the objectives identified by Federal/Provincial/Territorial first ministers in 2004 remain unmet. A review of the 2004 Health Accord by a committee of the Senate noted that collaboration among federal, provincial and territorial governments had “slowed substantially after 2006”, including work to establish a national catastrophic drug program, with wide disparities in coverage across the country. Other elements of a national pharmaceutical strategy that have fallen short of the 2004 objectives include a national standard of Pharmacare coverage across the country; a strategy to reduce the cost of prescription medicines carried by both public and private payers; access to innovative, breakthrough drugs; improvements in post-market surveillance; and research on treatments for rare diseases.
In large part because of the failure to move forward on a national public drug plan, Canadians pay some of the highest prices in the world for generic drugs, and the second highest prices for patented brand name medicines. Almost one in four have no drug coverage at all, while an additional 10-20% are inadequately covered by public or private insurance plans. The lack of access to affordable prescription drugs contributes to poor health outcomes and increased costs in the long run. The fact is that coverage matters. Access to medicines after myocardial infarction can add, on average, a year to someone’s life. A study by Irfan Dhalla and colleagues found that the number of deaths from cardiovascular disease fell by 50% between 1980 and 2000 – and a central reason was “the increased availability and usage of medications for secondary prevention after myocardial infarction”. The authors concluded that “[f]ull public coverage is cost-effective compared to the status quo”.
Canada remains one of the few developed nations without a national pharmaceutical program. Only 42% of our $28.8 billion total prescription drug bill is publicly funded, with the balance shared between private insurers (36%) and consumers (22%). There are wide variations in coverage across the country by employer-sponsored extended health benefits (EHB). In 2014, for example, the number of employees with EHB ranged from a high of 73% in Ontario and Newfoundland/Labrador to a low of 30% in PEI and New Brunswick. But there are also significant differences in public coverage from province to province, ranging from 51% in Saskatchewan to below 35% in B.C. and New Brunswick.
The over-reliance on private insurance or individual finances imposes significant hardship on Canadians, more than 8% of whom are unable to fill a doctor’s prescription because of cost. One in four Canadians report they have no private insurance coverage at all, and another 10%-20% are inadequately protected. The result is one of the most inequitable systems within the OECD in regard to access to medicines.
We can do better using a single, public system that manages costs and enhances safety and effectiveness through universal public insurance; a national formulary of essential drugs; independent evidence-based drug evaluation; and bulk purchasing. Conservative estimates put the savings from universal Pharmacare at $1.45 billion using evidence-based therapeutic options, with an additional $1.49 billion in savings from the elimination of administrative costs related to private insurers. Adopting an approach similar to New Zealand could net annual savings of up to $10.7 billion in – an amount equal to 43% of Canada’s prescription drug bill. The largest cost reductions would come from a realignment of industrial policies that support high drug prices in exchange for pharmaceutical investments in research and development in Canada. This arrangement has netted $1.31 billion in R&D investment (59% of which is subsidized with tax dollars), but a drug expenditure $1.5 billion above the average OECD prices on brand name drugs. Most of the savings that accrue from a national Pharmacare program would come from evidence-based drug reviews and price negotiations for bulk purchasing. 
The absence of robust leadership at the federal level is a key reason for Canada’s failure to move more quickly towards a national Pharmacare program. However, provincial governments have implemented a number of important and innovative changes. These include the Institut national d’excellence en santé et en services sociaux (INESSS) in Quebec, the Canadian Agency for Drugs and Technologies in Health (CADTH) and, within CADTH, the Common Drug Review. With a 90% rate of compliance with CDR recommendations, provinces have established a “pan-Canadian” formulary and have taken important steps towards negotiating bulk purchasing prices with manufacturers on specific drugs. Over a two-year period, 2013-2014, the provinces negotiated discounts on 10 commonly used generic drugs with savings amounting to $150 million a year among participating public drug plans. An additional $80 million in annual savings was achieved through the pan-Canadian Pricing Alliance. These examples underscore the value of price negotiations with the pharmaceutical industry, a strategy adopted by countries around the world with universal public drug coverage.
But the lack of a federal commitment to a national Pharmacare program is a serious restraint on progress towards eliminating disparities among Canadians and establishing a fair, equitable and affordable system of drug coverage.
These disparities are seen not only in the number of residents covered by public and/or private drug plans, but in regard to overall public expenditures for pharmaceutical products. For example, per capita drug expenditures in British Columbia were 28% below the national average in 2008, while Nova Scotia had the lowest rate of increase in prescribing costs between 1998 and 2007. The reasons for these differences are not entirely clear, but the number of drugs covered did not appear to be one of them. Ontario, for example, had the lowest number of formulary listings among provinces, but above average drug costs. 
BC’s below-average per capita drug expenditures are due, in part, to the establishment of Reference-based Pricing (RP) in 1995. This system supported “moderate to large savings in drug expenditures”, according to a 2002 report in the Canadian Medical Association Journal. “There is more evidence supporting the economic and clinical value of BC’s RP policy than exists for any other drug-benefit policy”, the report’s authors noted. Reference-based Pricing shifted prescribing from more expensive drugs to more cost-effective but therapeutically equivalent alternatives within the same drug class. A 2008 Pharmaceutical Task Force in BC suggested that the savings from RP were “moderate”, but that is likely due to the fact that only five drug classes are currently included in the program. British Columbia is the only province to have implemented Reference-based Pricing, but it provides an example of a safe and effective strategy to control drug costs, one that could be applied to a significantly expanded scope of drugs.
A universal Pharmacare program, bolstered by a National Pharmaceutical Strategy, would bring Canada in line with most high-income countries around the world. It’s long overdue and well within our capacity to accomplish. To echo a 2014 report of the Senate Standing Committee, we urge the federal government to “work with the provinces and territories to develop a national Pharmacare program based on the principles of universal and equitable access for all Canadians; improved safety and appropriate use; cost controls to ensure value for money and sustainability; including a national catastrophic drug-coverage program and a national formulary”.
Creating a publicly funded drug program that aims merely to increase access to medications is not only a paltry goal, but an ambiguous one, as well. We support many academic and expert bodies in concluding that a properly formulated Pharmacare program would contribute significantly and demonstrably to improving the health of Canadians. Such a program would require increasing access to some medications, while decreasing access to others. The only means to achieve these ends are to ensure transparency and accountability through an evidence-based process of determination as to whether a drug or medical device should be funded. The data and the process by which the data are assessed must be publically available for the informational needs of patients and health care providers, the scrutiny of researchers and academics, and citizen accountability.
It is imperative that the Committee understand that a crisis of confidence exists with respect to pharmaceutical regulation decision-making. Patients, researchers and health care providers alike are increasingly voicing their concerns with respect to the lack of accountability and dangerous secrecy that surround the processes that govern Canadians’ access and use of pharmaceuticals.
To take a particularly striking example, recall the Toronto Star report on Dr. Nav Persaud’s three-and-a-half yearlong runaround with Health Canada seeking information about Diclectin, a drug taken for morning sickness. His dogged pursuit of information needed to ensure the safety of his pregnant patients, ultimately resulted in 359 pages of documents, fully 212 of them entirely redacted, including the sections on “Adverse Events”. As Dr. Persaud stated, “This shows that it is practically impossible for a doctor to get information from Health Canada – even for a drug that is commonly prescribed to pregnant women.” 
Simply put, the model upon which Health Canada is currently operating is flawed, detrimental to the safety of patients and hindering improvements to treatment efficacy. How, for example, is the Canadian public served when Health Canada negotiates secretly with pharmaceutical companies in selecting the information that will be disclosed to prescribing doctors?
Of course, non-disclosure by Health Canada is not the only issue of concern. Increasingly, a crisis in the legitimacy of the regulatory process is at stake. Specifically, the information that Health Canada assesses, and the myriad ways that this information can, and is regularly manipulated and distorted, is problematic and disturbing. Indeed, “there has been rapid accumulation of evidence on the reliability of literature on pharmaceuticals, biologics and medical devices. This is slowly leading to a rethink of the value of considering literature as ‘evidence’.”
We agree with the views of Tom Jefferson that, “publicly-funded reimbursement decisions of any important intervention used by the health services (such as pharmaceuticals…) should be based only on independently produced and analysed robust evidence.” The regulatory process requires extra vigilance and ever-increasing transparency. We need a National Pharmaceutical program that is free of drug industry influence to provide such evidence.
IV. Independent Patients’ Voices Are Needed to Inform Policy
In Canada today, and in many high-income countries, Patient Advocacy Organizations (PAOs) that seek to affect pharmaceutical policy often receive funding from the pharmaceutical industry. We agree with policy analysts who believe these alliances are a problem; we are therefore committed to financial independence from the industry. PAOs can provide important real life insights for regulators, legislators, the media, and the public, but these perspectives must authentically reflect the full range of patients’ experiences.
As public advocates, PAOs have a responsibility to speak not only of potential benefits of new drugs, but their toxic side-effects, the distorted messages communicated to prescribers and the public, the opportunity costs of spiraling drug prices, and the threat these prices pose to an equitable, fair healthcare system. These goals can be at odds with the industry’s primary obligation to maximize shareholders’ profits, achieved in part by creating pressure to have new drugs added rapidly to drug insurance formularies, and pricing products according to what the market will bear.
A national Pharmacare program is one example of a program in which patients’ interests diverge from those of the pharmaceutical industry. Such a program integrated into medicare would improve patient safety and health, contain drug expenditures and reduce inequalities based on sex, age and disability in accessing essential drugs. In one brief to this committee a PAO argues that “a national Pharmacare program must allow patients the ability to choose medications that work for them.”  But we believe that is the wrong frame and that evidence of safety and effectiveness, not “choice”, should guide both decisions to include pharmaceutical products in a national formulary as well as patient access to needed drugs. New drugs are approved on the basis of preliminary research evidence, only, and consequently, patients cannot foresee the long-term risks and benefits of these medications any better than researchers, physicians and policy makers.
Research shows that while industry-funded PAOs consistently demand that new drugs be put on drug formularies, such funding is “an almost universal conflict of interest for patient groups.” We do not question the sincerity of these patient advocates but we recognize what one of us has called, “…the extreme vulnerability of the patient and the patient’s advocates, and relatives, especially in light of the pressure and incentives that drug companies can and do exert.” We strongly submit, as well, that the groups funded by the pharmaceutical industry do not represent the views, experiences, or interests of all patients. Many members of our group have taken issue with the way POAs advocate for drugs for a variety of diseases. We regretfully have concluded that, having become dependent on funds from drug companies for their advocacy, these groups are hampered from speaking freely about the true harms and effectiveness of costly new drug treatments that are experienced by their own members as well as the broader public.
PAOs that accept funding from the pharmaceutical industry argue that they have few other options. They are correct. In the past three decades governments have not only cut community-based advocacy funding, but have severely restricted the ability of organizations with charitable tax status to act as advocates, while encouraging civil society groups to partner with the private sector. PAOs like ours, that refuse to accept pharmaceutical industry funding, are rarely able to hire staff, rent an office, attend national or international meetings, or maintain a web presence. This is why one rarely hears critical perspectives from patients on overprescribing, opportunity costs, transparency and safety, in the media, at conferences, and at hearings like this one. Patient advocacy groups need public not private funding to effectively represent their communities, work that provides a valuable public service and therefore should be publicly, not privately funded. Canada needs a democratically accountable public program for funding these groups.
At the moment, the amount of money the pharmaceutical industry invests in PAOs is largely hidden from scrutiny, because POAs are not obliged to report industry funding and many do not. Since 2007, the U.S. Department of Justice has signed “corporate integrity agreements” with more than 30 pharmaceutical companies that had been fined for bribery and fraud and these agreements required companies to disclose the grants they gave to patient advocacy organizations. This has provided a rare window into the grants the industry gives to PAOs and the amounts are staggering. Eli Lilly, for example, gave $3,211,114 to US health services providers and PAOs in the first two quarters of 2007, with 87% of the money going to organizations in its three main therapeutic areas. Such practices must end, and some governments have recognized this. In September, 2015, the Parliamentary Assembly of the Council of Europe (PACE) called on member countries to fund patient advocacy groups. Germany already had a system in place since 2004 in which health insurers annually pay a small percentage per individual insured to a fund that supports PAOs that remain independent of the pharmaceutical industry.
A universal Pharmacare program, bolstered by a National Pharmaceutical Strategy, would bring Canada in line with most high-income countries around the world. We are long overdue for such a program and well within our capacity to accomplishing it. To echo a 2014 report of the Senate Standing Committee, we urge the federal government to “work with the provinces and territories to develop a national Pharmacare program based on the principles of universal and equitable access for all Canadians; improved safety and appropriate use; cost controls to ensure value for money and sustainability; including a national catastrophic drug-coverage program and a national formulary”..
- That the development of a National Pharmacare Program be based on:
- A restricted formulary that considers all clinical trial data and demands a higher standard of evidence for formulary inclusion; and
- The inclusion of drugs that provide a clear therapeutic advantage over existing drugs and that are based on meaningful patient outcomes
- That a National Pharmacare Program incorporate:
- A national drug prescribing/use database to track prescription drug use including overprescribing and off-label use and the assessment of health outcomes including harms from ADES;
- Resources to expand the collection, analysis and reporting of adverse drug effects from Canadian healthcare providers and the public;
- The development of a publicly accessible database for consumers on comprehensive and current data on use, safety and effectiveness of all drugs on the formulary;
- Complete transparency and accountability in the manner information is acquired and assessed, integrated into our social and health care policies to instill public trust in the process; and
- A mechanism to provide independent funding for patient advocacy organizations.
Members of the Independent Voices for Safe and Effective Drugs
Sharon Batt, Halifax
Janet Currie, Vancouver
Colleen Fuller, Vancouver
Linda Furlini, Montreal
Harriet Rosenberg, Toronto
Johanna Trimble, Vancouver
Micheal Vonn, Vancouver
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 Gagnon, op.cit.
 Gagnon, Marc-Andre (2010). Ibid.
 Based on 2008 expenditures of $25.1 billion, an estimated saving of 43% would apply to the $24,995,800 spent in 2009.
 Gagnon, op.cit.
 Letter from John Wright, Deputy Minister of Health, Saskatchewan to Rob Merrifield, Chair, House of Commons Standing Committee on Health, June 6, 2007. This strong-worded letter is available at: http://www.cadth.ca/media/cdr/cdr-pdf/cdr_letter_Merrifield_Wright_e.pdf.
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 “Health Canada hands over documents but muzzles doctor,” David Bruser and Jesse McLean, Toronto Star (Toronto), October 14, 2015.
 Jefferson, T. Facing the Unreliability of Clinical Trials Literature. Drug and Therapeutics Bulletin of Navarre, Spain 2015 23:1-11.
 See, for example, Hughes, David and Bryn William-Jones, 2013. Coalition Priorité Cancer and the Pharmaceutical Industry in Quebec: Conflicts of Interest in the Reimbursement of Expensive Cancer Drugs? Healthcare Policy 9(1): 52-64; Baggott, Rob and Rudolf Forster. “Health Consumer and Patients’ Organizations in Europe: Towards a Comparative Analysis.” Health Expectations 11 (2008):85-94; and Löfgren, Hans and Agnes Vitry. “Health Consumer Groups and the Pharmaceutical Industry: Is Transparency the Answer?” In Democratizing Health: Consumer Groups in the Policy Process, edited by Hans Löfgren, Evelyne de Leeuw and Michael Leahy, 239-254. Northampton, MA: Edward Elgar Publishing Ltd., 2011.
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 Brief from the Mood Disorders Society of Canada to HESA, Rec. 3, p. 2.
 Arie S., Mahoney C. 2014. Should patient groups be more transparent about their funding? BMJ 349:g5892:14.
 Furlini, Linda. 2010. The Alzheimer Society. In Anne Rochon Ford and Diane Saibil, The Push to Prescribe: Women & Canadian Drug Policy. Toronto: Women’s Press, 73-74.
 See “Thousands of diabetics report adverse effects from GE [genetically engineered] Insulin”, retrieved September 7, 2016 from: http://tinyurl.com/ho5fq9b; Linda Furlini, 2007. “Why I am no longer a member of the Alzheimer Society” BMJ 335, 400. Retrieved September 7, 2015 from http://tinyurl.com/hp5hau3; and Sharon Batt. 2000. The New Genetic Therapies: The Case of Herceptin for Breast Cancer, In The Gender of Genetic Futures: the Canadian Biotechnology Strategy, Women and Health, F. Miller, L. Weir, R. Mykitluk. NNEWH Working Paper Series, Toronto: York University. Retrieved September 7, 2016 from: http://tinyurl.com/hsb9v56.
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 Geissler, Jens. “Health Policy in Germany: Consumer Groups in a Corporatist Polity.” In Democratizing Health: Consumer Groups and the Policy Process, edited by Hans Löfgren, Evelyn de Leeuw and Michael Leahy, 127-142. Cheltenham, U.K. and Northampton, MA: Edward Elgar, 2011.