Report of the Royal Commission on the Future of Health Care in Canada: Response from the Women and Health Protection (WHP) Working Group

Women and Health Protection
c/o DES Action Canada, 5890 Monkland Ave, Suite 203, Montréal, Québec, H4A 1G2

January 2003

The Women and Health Protection (WHP) Working Group is a network of individuals and organizations formed in 1998 to influence Health Canada's process of legislative renewal. We are a national working group that includes researchers, health providers, educators, and consumers interested in policy-directed research and public education on health protection issues. We focus particularly on the implications of health protection policies for women's health.

WHP applauds the writers of the Romanow Commission report for their clear commitment to maintaining and strengthening the principles of a public approach to health care in Canada. We are especially heartened to see the move towards a coherent national drug policy that incorporates ongoing strategies to promote better quality prescribing and use of medicines as well as improving the drug approval process and ongoing post-market evaluation.

Because the mandate of our organization is to examine federal legislation relating to the regulation of prescription drugs, and to monitor policies for their specific implications for women's health, we will limit our discussion largely to these two areas. We will address six themes found primarily in the "Prescription Drugs" and the "Information, Evidence and Ideas" chapters of the report.

Ensuring higher quality health care
WHP is heartened and encouraged by the many measures recommended in the report of the Royal Commission to ensure a higher quality of health care in Canada. The proposed National Drug Agency has the potential to improve on the current system for drug evaluation, approval and monitoring. If this agency is committed to evidence-based goals and practices as suggested, we further applaud the Commission. If this agency can succeed in bringing drug approvals in to line with public health need, we will have moved ahead significantly.

One concern we have about the proposed National Drug Agency that is not addressed in the report, however, is that of accountability. While the current system of drug evaluation, approval and monitoring is clearly flawed and too heavily influenced by pharmaceutical interests, it has at least the possibility of possessing a level of public accountability. Because the Therapeutic Products Directorate is part of Health Canada and the Minister of Health is ultimately responsible for all decisions of Health Canada, the public has some assurance that that individual can be held accountable (as demonstrated, for example, in the proceedings of the Krever Commission). A major concern with an independent agency, therefore, is that that level of accountability may be further weakened. The public requires assurance that such an agency would not be influenced by pharmaceutical industry interests (e.g most members of the Committee on Safety of Medicines (CSM) - the most important expert scientific advisory committee regarding human medicines in the U.K. - have ties to the industry), as well as the assurance that members of the public would have true input into decision-making.

A further caveat we offer with respect to the National Drug Agency is in relation to collaborating "with other similar agencies in industrialized countries to streamline the evaluation process and share information on the evaluation of new and existing drugs" (p.203). At present, Canada has observer status with the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). As we have noted in our publication, Who Benefits: International Harmonisation of the Regulation of New Pharmaceutical Drugs, the agenda of the ICH is largely driven by the brand name pharmaceutical industry and there is evidence that safety and testing standards have been lowered rather than raised through this process. We would therefore caution that any such collaboration must be built on a foundation of the fundamental public health principles which are eloquently put forth elsewhere in the Commission's report.

Although there are problems associated with the process, we endorse the notion of a national formulary of prescription drugs to make access to necessary, safe and effective medications equitable across the country. Care must be taken to ensure that the poorer provinces receive some form of equalization payment so that they can afford to cover the same basket of drugs as wealthier provinces.

We have the opportunity to create an agency in Canada that is truly innovative and could serve as a model to other countries. If it were also to include the monitoring of both new and existing drugs, and the assessing and monitoring of medical devices and diagnostic technologies, as well as of drugs, the Canadian agency would be truly ground-breaking. The need for safety and effectiveness in medical devices is as great as that for prescription drugs.

Increased access to needed medicines
WHP applauds the inclusion of a Catastrophic Drug Transfer to reduce disparities in coverage of prescription drug costs. We caution, however, that such a transfer may not be equitable in its impact on the population, specifically on women. We suggest, therefore, that the development of this initiative undergo a gendered analysis, something not currently found in the report. Because women are less likely to have supplementary health insurance coverage to pay for prescription drugs, they have traditionally born more of the financial burden than men in this area. Women are also greater users of prescription drugs. A snapshot of who is poor in Canada (Statistics Canada, 1999) reveals that more women than men consistently fall below the Low Income Cut-off nationwide. All these factors suggest that the pre-set threshold of $1500 will mean that many low-income women will forego purchasing medications they need in their struggles to cover their other necessary expenses. This could in turn lead to worsening health problems and the increased use of services which are more costly to our health care system (e.g. emergency department visits). We ask that the pre-set threshold figure be re-examined in this light.

Further to our concerns regarding the health needs of women, if a goal is to "…move in a gradual but deliberate and dedicated way to integrate prescription drugs more fully into the continuum of care" (p. 190), we would like to see an eventual pharmacare program cover more than "catastrophic" situations. In particular we feel it is critical to include methods of birth control in any proposed plans. Indeed it is discriminatory against women to not be including birth control devices since women assume not only the lion's share of responsibility relating to birth control, they also assume the most responsibility for unplanned births.

We are heartened to see that linking of medication management to primary health care is encouraged, and we support this move away from viewing drug therapy in isolation. If properly managed, this could significantly decrease high-end health care costs such as emergency department visits, surgery and hospital admissions. With respect to the proposal to put disease management protocols in place, we would argue that evidence-based management should be the prevailing strategy, particularly if the disease management model proposed is commercial in nature. Primary and secondary prevention measures tend to be a lower priority than the generation of prescriptions when pharmaceutical companies with vested interests are involved in disease management protocols. The profit motive may interfere with the goal of improving care for patients with chronic disease, by encouraging more costly medications or showing preference to medications over diet and exercise options.¹

Reduced drug costs
We applaud the recommendation to mandate the proposed National Drug Agency with negotiating and monitoring drug prices of both patented and generic drugs nationally. To have the National Drug Agency assume the price control functions of the PMPRB with the aim of improving drug prices for consumers also gives us reason to be hopeful. As greater users of both prescription and non-prescription drugs, women and representatives of equality-seeking women's health organizations should be adequately represented on the proposed agency.

The Commission's proposed review of pharmaceutical industry practices related to patent protection is timely and appropriate. We are also encouraged to see that the issue of "evergreening" of patents has been addressed in the report. We have seen questionable examples of patent protection extended to allow for a re-packaging of existing medications to appeal exclusively to a female market (a recent US example particularly relevant to women is "Serafem", a repackaging of fluoxetine [Prozac] for the use of severe PMS). Extension of patents can only mean higher drug costs for those most harshly affected - women, seniors and people with disabilities.

Improved access to information
We feel it is appropriate to charge the National Drug Agency with responsibility for communicating evidence-based information and guidance to both health professionals and the public, and further that this role should not be left to the pharmaceutical industry. We are equally encouraged by the stance taken by the Commission against direct-to-consumer advertising (DTCA) of prescription drugs. There is no rationale for introducing DTCA in Canada on public health grounds. It does not provide patients and the public with the type of impartial, balanced information needed for informed health care choices. In 2001, WHP held a cross-Canada public education campaign on the issue of DTCA; we enclose a copy of our brochure on this topic.

Preventing conflicts of interest

WHP was pleased to see the clear acknowledgement of conflict of interest in the current system of financing of the drug approval process through licensing fees from pharmaceutical companies. With respect to the work of the National Drug Agency, we applaud the suggestion that a "firewall' must be established between industry's financial contributions and the Agency's work" (p. 203). Marketplace needs are often in direct contradiction to public health needs. A comprehensive publicly-insured health care system must have at its foundation a clear analysis of conflict of interest and zero tolerance for it. We encourage those implementing the recommendations of the report to uphold the same level of caution about conflict of interest as is demonstrated throughout the report.

Access to information on which regulatory decisions are based
Currently in Canada, all unpublished laboratory and clinical studies of drug safety and efficacy on which drug approvals are based are considered to be commercially confidential documents. Given the limited published data available in many cases, this means that often patients and physicians have no access to key information needed when deciding whether to try a new drug. Additionally, drug approval decisions are carried out behind closed doors, with no public input into the process. Any reform of the current drug approval process needs to ensure full public access to safety and efficacy information, as well as enable public input into the decision-making process.

Currently only the manufacturer may make a submission to Health Canada considering a new product being considered for approval. Women's organizations, consumer and public health groups should also have an opportunity to make submissions and participate in public hearings on new drug submissions. Such a change would be in keeping with principles of accountability outlined in the report.

top

------------------------------------------------------------------

In summary, the Women and Health Protection working group congratulates Mr. Romanow and his Commission on the production of a series of recommendations which will help to move Canada further along the road towards a publicly funded health system that is universally accessible and offers equal and timely service to all. In their forthcoming deliberations, we encourage those who have been mandated to implement the Commission's recommendations to give adequate consideration to the needs of women -- who make up 80% of those providing paid health care services, provide the majority of unpaid health care services and are a majority of those receiving care, especially among the elderly.

top

------------------------------------------------------------------

Please address any correspondence in relation to this document to:

Women and Health Protection

annerf@web.ca

top

------------------------------------------------------------------

Notes

¹ For elaboration on these points, we refer you to Bodenheimer T., "Disease management-promises and pitfalls". New England Journal of Medicine 1999;340:1202-5

top