H.P.B. - "To Do No Harm"

WHY WOMEN ARE CONCERNED ABOUT THE DISMANTLING OF HEALTH PROTECTION LEGISLATION IN CANADA

This position paper was developed at a consultative meeting on: Proposed Changes to Canada's Health Protection Legislation - Women's Health and Responsible Regulation in Toronto, September 12-13, 1998. The meeting was organized by DES Action Canada with funding from the National Network on Environments and Women's Health. Representatives from the following organizations participated in the meeting and helped to contribute to this paper:

• the Alliance for Public Accountability,
• Breast Cancer Action Montreal,
• the Breast Cancer Prevention Coalition,
• the Canadian Health Coalition,
• the Canadian Women's Health Network,
• the Consumers Association of Canada,
• DES Action Canada,
• Health Action International,
• the Medical Reform Group of Ontario,
• the National Network on Environments and Women' Health,
• the Women's Network on Health and the Environment,
• the World Alliance on Breastfeeding Action,

Women's health and consumer groups have become increasingly worried about the gradual erosion of our public health protection system in Canada. The regulation of drugs and devices in particular - of which women are amongst the greatest users - and food safety - of which women are the greatest managers - is in a state of flux. This paper will help to outline some of the background to this transition and why many feel there is cause for concern.

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Background

In July 1998, Health Canada released a discussion paper called: Shared Responsibilities, Shared Vision: Renewing the Federal Health Protection Legislation. This paper calls for an overhaul of Canada's health protection statutes. It follows on a series of proposals for changes to the structure and functioning of Canada's Health Protection Branch dating back to 1992.

A series of public consultations are being held in major Canadian cities in September and October of 1998 to discuss proposed changes and solicit public input into what kinds of legislative changes are needed. The need for sensitivity to gender issues is raised throughout Health Canada's discussion paper, indicating that the consultation procedure will be carried out in a way which allows for representation of women's interests, but no detailed analysis of the implications of the proposed changes for women's health or rights has as yet been carried out.

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Current Regulatory Climate

The Federal health protection legislation is implemented by Health Canada's Health Protection Branch, which has already undergone major changes in structure and funding during the last few years. The government's plans to "modernize" national health protection legislation follow large-scale funding cuts to the regulatory agency, down from a budget $237 million in 1993-1994 to a projected $118 million in 1999- 2000. In-house drug research laboratories, which were responsible for investigating drug quality, toxicity, bioequivalence and clinical applications, have been quietly closed.

The Therapeutic Products Directorate, which is responsible for licensing new drugs and medical devices and for banning or restricting drugs and devices which prove to be unsafe, now relies on industry user fees to cover about 70% of its operating costs. Its costs were previously covered out of general tax revenues, in a similar manner to other public agencies. There are concerns that this change in funding leading the agency to view the industry as its main client, rather than the Canadian public. In a May 1997, Globe & Mail interview, Dr Landry, acting chief of the Veterinary Drugs Bureau, appeared to agree with this view: "I guess if you focus it that way, the client and the public, industry is our client…"

Other events in the news have contributed to our unease. Within the last month, it has been reported that the RCMP is investigating the Health Protection Branch's failure to protect women against unsafe breast implants. There has also been a public protest by six senior staff scientists who say their safety concerns about cattle growth hormones (BGH) were overridden.

In the longer term, the health protection branch has agreed in principle to go along with a pharmaceutical industry suggestion to tie the amount of fees collected each year to the branch's 'performance targets'. These targets are for faster drug approval. If this proposal goes through, it would lead to even greater conflicts of interest. Speedy, sloppy reviews of applications for marketing, which avoided too much discussion of public safety concerns would be rewarded with higher fees from the industry. Health protection branch staff would be likely to face more and more of the types of pressures described above.

It is within this context that Health Canada is talking about "modernizing" health protection legislation by making it more "flexible" and doing away with accountability under the criminal code.

Why should we be concerned about women's health with the overhaul of health protection legislation? There are three main reasons that women have a strong interest in what kind of health protection legislation is in place:

1. Women are the main users of health services, but are underrepresented in decision-making. There has also been a historical bias in drug research toward male patients. Many drugs currently sold in Canada were only tested on men before they were approved, although women also use them. There are no public hearings or participation when new drugs are approved in Canada, so organizations representing women in Canada - or women with a specific illness - have no way to present their views to the health protection branch when a product intended only for women is under review.
2. Given that women have been the majority of the people to suffer serious harm from some of the worst drug and device disasters, such as DES (diethylstilboestrol), thalidomide, breast implants and the Dalkon Shield, we have a particular interest in ensuring that there are proper safety safeguards to prevent similar tragedies in the future.
3. A consistent concern raised by the women's health movement since the 1970's has been the unnecessary medicalization of women's lives. On the one hand, individual drug treatment is an inappropriate solution to the distress women experience because of broader social problems related to discrimination, poverty and violence. On the other hand, it is inappropriate and demeaning to women to define normal aspects of women's lives such as menopause as a quasi disease state, in need of drug treatment. As pharmaceutical marketing has played a large part in this medicalization, we need to look at what types of regulatory policies could prevent future unnecessary medicalization.

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Safety concerns

The regulation of drugs and devices is a key factor determining the type of health services available to women in Canada. Women's health and consumer groups have spoken up about the need for greater public participation and accountability and more stringent standards for product effectiveness and safety. In addition to the particular harms to women noted above, some groups of women, for example older women and women with chronic illnesses, are especially vulnerable to harmful drug reactions. A recent meta-analysis of studies of serious harmful drug reactions found that their importance has been vastly underrated. They are estimated to be between the fourth and sixth leading cause of death in North America. One disconcerting proposal Health Canada is considering would allow bodies other than the Health Protection Branch, such as pharmaceutical industry standards associations, to enforce regulations themselves.

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Lack of accountability

In 1995, when women in the United Kingdom, Norway and Germany were warned that they should switch brands of birth control pills if they were using a "third generation product", newer pills containing one of two forms of the hormone progesterone, desogestrel or gestodene, Canadian women heard nothing even though these third generation products are widely prescribed in Canada These pills have been found to be riskier than alternative brands. These pills had been found to be riskier than alternative brands. The Health Protection Branch set up an external expert advisory committee to discuss what to do, but no representatives of women's health or public interest groups were invited. The advisory committee decided there was no need to warn women or to change the labelling on these pills.

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Direct to Consumer Advertising

Another important issue for women is the extent to which direct-to-consumer advertising of prescription drugs should be allowed in Canada with the pharmaceutical industry lobbying strongly for loosening of current restrictions. Given the heavy emphasis on promotion of drugs for healthy women in US direct-to-consumer advertising - such as estrogen therapies for menopause or phosphate drugs to prevent osteoporosis, as well as classes of drugs where overprescribing to women has been identified as a problem, such as antidepressants - this is a concern not only for the Canadian public as a whole, but also very specifically for women. As the primary guardians of health care in the home, women are also the target audience for a wide range of drugs used by all family members.

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Lack of Sufficient Information to Make Informed Choices

The information rights of users of medicines are inadequately addressed by current legislation in Canada. Unlike Europe and Australia, Canada has no legally mandated patient leaflets accompanying prescription drugs. Such provisions could minimally ensure that users of medicines have access to information in lay language on approved uses, warnings, risks, interactions, contraindications etc. for each medicine they take. This is especially crucial for pregnant and breastfeeding women and women facing multiple medicine use because of chronic illness.

The Canadian public has inadequate information on the safety and effectiveness of new drugs, because Health Canada considers all studies of a drug's safety and effectiveness which are submitted as part of an application for a marketing license to be proprietary information belonging to the manufacturer. Typically most are unpublished studies. Canadian women considering using a new drug do not have the basic information they need to compare it to other treatments. In this respect, Canada compares poorly to the U.S.A., Sweden, and the European Medicines Evaluation Agency.

When Depo Provera was approved for use as birth control two years ago in Canada, no women's groups, disability groups or Aboriginal organizations were informed about the upcoming decision or consulted, although these groups had previously raised concerns about the long term health effects of human rights abuses with this product. Canada's drug regulation is much less democratic than the United States, which has public hearings, access to safety and effectiveness information in drug files, and a special FDA women's health office.

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Post-Marketing Issues

Another concern is ongoing evaluation of a drug after it is accepted for marketing. Currently, post-marketing information on drug risks is mainly collected through voluntary adverse reaction reports, yet estimates of the fraction of harmful drug reactions this picks up range from less than 1% to 10%. Furthermore, there is no requirement that the government and the pharmaceutical industry notify women if an approved drug is later determined to be dangerous. For example, the hormone drug DES, prescribed to hundreds of thousands of Canadian women during pregnancy between 1941-1971, was banned for use during pregnancy in 1971 after it was learned that daughters could develop vaginal cancer. To this date the pharmaceutical companies who manufactured DES have never issued a public warning that women and children exposed to the drug face health risks. Between 1971 and 1982, when the consumer group DES Action was formed, the federal government had only issued one press release to the public on DES.

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Harmonization of Drug Regulation Procedures

Another identified area for change is the extent to which Canada's drug regulatory procedures should be h