Strategies for Public Consultation and Citizen Access at the Therapeutic Product Programme, Health Protection Branch


Barbara Mains
August 2000


Executive Summary

The Canadian tradition of secrecy around the approval of drugs and devices, coupled with inadequate post-marketing surveillance, has harmed Canadian women and their families. Proposed changes to the legislative framework must ensure greater transparency and accountability to the approval process as well as enforcement of more stringent conflict of interest guidelines. Citizens must be guaranteed access to all information about drugs, drug promotion, drug safety and effectiveness from the point of application through post marketing and recall.

Necessary measures include:

The inequities of the current context for public consultation, in which salaried industry and government spokespeople lobby against unpaid citizen advocates, must be redressed. Adequate compensation must be secured for citizen advocates. Lastly, if a system of training is necessary for citizen advocates to participate on advisory committees or in drug reviews, advocates should determine the nature of training.



In 1998-99, Health Canada hosted a nation-wide series of public consultations to address proposed changes to federal health protection legislation. Members of the WORKING GROUP ON WOMEN AND HEALTH PROTECTION participated in these consultations and subsequently developed recommendations to safeguard the health and wellbeing of Canadian women, men and children. These recommendations were detailed in the Working Group's position papers and posted on the Working Group website (

The Working Group urgently recommends that Health Canada return to first principles. The Department must affirm that their primary objective is to protect the health and wellbeing of Canadians.

Primary objective: to protect the health of Canadians That the stated objective of the new legislation shall be the protection of the health and safety of Canadian women, men, and children.
Primary values include accountability and transparency That a code of ethics shall be written directly into the new legislation and that it shall include the following as primary values of Health Canada and the Health Protection Branch: accountability,transparency, protection of health and safety, and demonstration of need
Minister accountable and liable for the Department That the principle of "shared responsibility" shall be so defined that it is clear that neither consultations nor public debate shall render the Minister any less accountable or liable for decisions, actions, or inactions of the Department
Public safety paramount That the values of "freedom of choice" and "risk-benefit decisions" shall be so defined that they cannot overrule the establishment and maintenance of high standards for public safety.[1]


Public consultation and citizen engagement

Distinct roles for the Canadian public and the private sector That the private sector shall not participate in consultations with the Canadian public; that distinct roles shall be formulated for the Canadian public and the private sector.
Private sector excluded from safety and efficacy reviews That guidelines shall be implemented to exclude the private sector from any and all evaluations of the efficacy or safety of products under review.
That an independent watchdog shall monitor the implementation of these guidelines.
Independent watchdog That the new legislation shall ensure funding for an independent citizen safety agency, accountable only to Parliament, and empowered to police the effectiveness of health and safety regulations.[2]
Conflicts of interest identified and documented That all participants in the review of drugs, devices or other products shall be required to declare their interests before any reviews are launched; that these declarations shall form part of the public record.
Open meetings That the new legislation shall ensure open meetings of advisory committees and expert panels, with a right of public input at the start of meetings.
That the new legislation shall ensure the independence, integrity and expertise of advisory committees, along with the transparency of their proceedings.
Public interests represented in safety and efficacy reviews That provisions shall be made to create participatory decision-making structures that include citizens who represent the public interest.
That, in order to put citizens on a level playing field with industry, budgets and resources shall be allocated for citizen participation.[3]
Women's interests represented in safety and efficacy reviews That provisions shall be made to include representation of women's interests in decision-making structures.[4]
That women's health organizations shall receive advance notice when products for use solely or mainly for women are scheduled for review.
Full and timely public access to all information That the new legislation shall ensure full and timely access[5] by the public to all information used in evaluating products; that this shall include all of the content of evaluations, reviews, deliberations and proceedings of expert advisory committees and other decision-making systems.
No charge or minimal charge for information That there shall be no charge or minimal charges involved in obtaining this information.
Readily accessible formats That this information shall be made available in a manner than ensures easy access [e.g., web-sites rather than microfiche].
Training determined by advocates That if training is necessary for citizen advocates or for women's advocates, advocates should determine the nature of training.
Petitions to remove drugs or tighten warnings That the new legislation shall allow for citizen petitions asking for drugs to be removed from the market or safety warnings to be tightened.


Independent information for consumers

Several recommendations from the Working Group address the need for a national commitment to supply Canadians with independent, unbiased information about drugs and devices.

Right to know That the "right to know" shall be established as a fundamental operative principle, under legislative protection that restricts claims of confidentiality to what is inarguably essential to protect national security.[6]
Commitment to supply independent information to consumers That the new legislation shall emphasize Health Canada's commitment to supplying Canadians with independent, unbiased health education and information relating to drugs.
That such consumer education and information shall be developed independent of the pharmaceutical industry. The Canada Drug Guide pilot study demonstrated the feasibility of developing and implementing patient drug guides.
Independent information distinguished from advertising That such consumer education and information shall clearly distinguish advertising and promotional material from drug information from independent sources.
Information to be clear, reliable, comprehensible That such consumer information shall be clear, reliable, and adapted to the reading and comprehension level of the users.
Information to be evidence-based That such consumer information shall be evidence-based.
Package inserts to meet standards for product labeling That the new legislation shall require the standards for patient package inserts to function as a component of approved product labeling, and that these standards shall apply to both prescription and over the counter drugs.[7]



[1] For a discussion on the concept of "choice" as it relates to health protection, see SHERWIN, SUE (1999): A Response To Health Protection Branch Discussion Papers From the Maritime Centre Of Excellence For Women's Health [MCEWH].

[2] Established on the models of anti-trust and cartel agencies with wide powers of investigation, decision-making and fining of violators, the Agency shall act as an intermediary between consumers, workers, and their NGO's, and regulatory authorities and industry. The Agency shall act as "an Ombudsman with teeth."

[3] Citizens must be able to participate from the beginning of the review process, when standards are established. Financial support will be necessary for grassroots women's health groups to undertake policy development.

[4] This is especially crucial when evaluating products, drugs and devices that will largely be used by women. The product being considered for approval must be analyzed in terms of its effects on women's health, rights, and social position. Women must be involved in discussions of its impact on their lives, in evaluations to determine whether the product is necessary, and in identifying the areas of research to be encouraged.

[5] Timely access may be defined as 10-15 days after the request has been made.

[6] The right to know includes the regulation of drug promotion. Unlike the citizens of many other countries, Canadians don't have sufficiently detailed public information to know when promotional activities have been found in violation of regulatory standards.

[7] The National Health Service in the United Kingdom has developed Consumer Information Pamphlet that Health Canada may wish to consider as a model.




The Working Group on Women and Health Protection is a coalition of women's health and public interest organizations, academics and activists who came together in September 1998 to address the proposed federal overhaul of Canada's health protection statutes. This ad hoc coalition formed to address growing concerns about the proposed deregulation, self-enforcement of safety standards by industry rather than government, and the proposed lifting of a ban on direct-to-consumer advertising of prescription drugs. All of these measures hold profound implications for the health of women in Canada.

Women have a special interest in ensuring adequate safeguards because they have, within only a generation, suffered serious harm from some of the worst drug and device disasters (thalidomide, the Dalkon Shield, breast implants, DES). Ironically, the most dangerous of these was also the least effective for its approved indication. Diethylstilbestrol, ineffectively prescribed to pregnant women to prevent miscarriage, launched a nightmare whose end is not in sight. In the rodent model, damaging effects of the drug are now documented in the third generation after exposure. The ominous combination of weak science and inadequate surveillance became all the more memorable when the product actually failed in its therapeutic purpose.

Women are also unlikely to forget the salutary tale of Depo Provera.

Several years ago, women's groups across Canada banded together and successfully pressured Health & Welfare Canada to hold off approval of theinjectable contraceptive Depo Provera…. An advisory committee to the Health department had recommended approval of the drug, but the consumer umbrella group painstakingly highlighted the drug's inadequate testing…. The protest showed two things: first, it is possible to affect health policy in Canada; second, an extraordinary effort is required in order to have an impact.*

But there was a third lesson, which only became apparent in 1996, when Depo Provera was ultimately approved for use as birth control in Canada. This time 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. Had government and industry also learned from the earlier defeat? Public protest, this time round, came too late in the story to change the ending.

* Nicholas Regush. Safety Last: the Failure of the Consumer Health Protection System in Canada. Key Porter: Toronto, 1993: p.184


Q:  Who is "the public?"

A:  The people of Canada are "the public."

Health Canada Our mission is to help the people of Canada maintain and safeguard their health.

"Public consultation" is consultation with the people of Canada: private sector interests are necessarily excluded. Health Canada cannot fulfill its mission unless it puts first principles first and the health and wellbeing of Canadian citizens ahead of all other considerations. This means separating "interested parties" from "affected parties" and developing separate roles for each.

Canadian citizens have a role to play in health protection, as in other decision-making that will influence their lives (see Appendix A. Rationale for Citizen Participation). What are the goals of their participation? From the perspective of Canadian women and women's health organizations, these might be:

  1. To participate in the decision-making process
  2. To gain access to information about the decisions under consideration and about the basis for decision-making
  3. To ensure the accountability of decision-makers.*

From the point of view of government departments and agencies that undertake public consultation, the goals might be:

  1. To improve decision-making by expanding access and perspectives beyond the normal elite2
  2. To develop regulations and policies that are more socially responsive and responsible, as well as more widely supported
  3. To build public confidence by ensuring that citizens have the capacity, by monitoring and challenging government regulatory decisions, to judge how well government is doing its job.

In other words: consultation - genuine, transparent and timely consultation - serves the interests of government as much as the citizens who elect it. Consultation, so defined, "enhances democracy by fostering civic engagement."**

*Richard E. Sclove. "Better approaches to science policy." Science Vol. 279, No. 5355. 27 February 1998, p. 1283

**David H. Guston. "Evaluating the Impact of the First U.S. Citizens' Panel on Telecommunications and the Future of Democracy." Presentation at 1998Annual Meeting of the American Political Science Association, Boston, MA. 3-6 September 1998


Secrecy around the review of drugs and devices does not serve the public interest. Whose interests are served remains all too clear: why does the Health Protection Branch persist with special privileges for industry? On this front Canada compares poorly with the United States, where companies cannot prohibit the release of information on health and safety data and where the FDA releases the comments of its reviewers on the data that the companies have submitted.

Why isn't safety data available in Canada?

Participatory frameworks: structuring consultation
Representation of women's interests in decision-making structures is obviously critical. When the products being considered for approval will mainly be used by women, women must be involved in their assessment. The analysis must examine the effects of the product on women's health, rights, and social position. Women must be involved in the discussion of that product's impact upon their lives, of whether the product is necessary, and of which areas of research should be encouraged.

Effective consultation with women will only be possible:

What Canadian women do not want
Change is needed at the Health Protection Branch. The agency needs to operate with greater transparency and openness, real sanctions, and the use of scientific, rather than political standards of risk assessment and management.

The interests of Canadian women are not well served when:

  1. Drug and device assessments are conducted behind closed doors
  2. Pre-scripted 'consultations' are conducted in the presence of the private sector
  3. Citizens are afforded token involvement on review panels, without adequate preparation, training, structural and financial supports.




Rationale for Citizen Participation


Who should sit at the table when science policy is being decided?

From Science 279 27 February 1998




Training of Citizen Advocates

Consider the advocate model used by the U.S. Dept of Defense in peer review panels for breast cancer research. Some of these features may be worth borrowing, especially in regard to the selection, training, and integration of advocates. Note that advocates on the Dept of Defense panels are paid the same honorarium as the scientist reviewers.

"This significant research program [$135 million in 1998] was created and is maintained largely through the efforts of breast cancer advocates, and advocates are full-voting members of both the peer-review and integration panels," wrote a Canadian observer in her 1997 report to the Canadian Breast Cancer Network.* Breast cancer advocates first participated as full panel members, able to vote, in 1995.

In this model, constituent organizations are invited to nominate two advocates each, who are asked to provide a description of their activities and a curriculum vitae. Dept of Defense staff score the applicants on education, knowledge and interest in breast cancer science, and ability to communicate in the peer-review environment. Top candidates are selected, with attention paid to national representation, race and ethnicity, rural and urban populations. (As it turns out, many of those selected are graduates of Project LEAD, an intensive training program in breast cancer advocacy. Training emphasizes the basics and terminology of science, but includes assertiveness training and the recognition that the lived experience of advocates is also valuable.) Advocates who happen to be scientists already are not excluded from participation on peer review panels, but they are placed on panels unrelated to their field of expertise.

To ensure continuity, 51% of advocates from the previous year will return for the next round of reviews. Returning advocates are rotated through the panels to gain wider experience. Other salient features:

*Diane Carr. Report on U.S. Department of Defense, Breast Cancer Review Panels [September 8-10, 1997]. For Canadian Breast Cancer Network.

The FDA process is much friendlier to consumers than the one in Canada. Most drugs in the US go to Advisory Committee before a final decision is made about them. These committees meet in public and before they begin their deliberations there is time set aside for anybody who wants to make a presentation. Starting this year, documentation provided to committee members will also be made available to members of the public who want to make presentations to the committee.

U.S. also allows for citizen petitions asking for drugs to be removed from the market or safety warnings to be tightened.


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