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WHC's Response To The Health Protection Branch Transition Project's Discussion Papers and Workbook



 

 


TABLE OF CONTENTS:
Acknowledgments Decision Making: A Needs-Based
Approach to Drugs and Devices
Who We Are Addressing Risk
Our Experience with the Health
Protection Branch
Compensation Fund
Our Process Harmonization of Standards
Selected Examples of our Activities,
Experiences and Learnings
Consumer Education, Informed
Consent and Informed Choice
The Sum of our Experience Indicates Direct to Consumer Advertising
The Context Regulating Herbs and Other
Non-Traditional Therapies
Health Protection is not a Business Altered Foods: The Consumer's
Right to Know
Health Determinants: A Missing
Analysis
Women's Health Means More than
Just Health Issues for Women
A New Role for the HPB … Lack of Gender Analysis
Consumer Empowerment, Citizen
Participation and the "Public"
Summary of Recommendations
Legislation Conclusions
Funding Cuts Appendix One
Funding to Support In-House Research Endnotes


Acknowledgments

Thank you to the attendees of our discussion groups, the National Working Group on Women and the Health Protection Branch, the Centres of Excellence particularly the National Network on Women and Environment and the Maritime Centres, HAD-Europe and the clients, board, staff and volunteers of the Women's Health Clinic for your thoughts, vision and critiques.

A special thank you to our writing team:
Laurie Potovsky-Beachell, Sari Tudiver and Madeline Boscoe.
Women's Health Clinic

November 12, 1998

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Who We Are:

Women's Health Clinic is a non profit community health centre for women established in 1981. Our roots are in the consumer health movement, particularly the Canadian Women's Health Movement. (See Appendix One for an overview of our philosophy, approach and services.)

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Our Experience with the Health Protection Branch

The Women's Health Clinic is committed to addressing policy issues as they impact women's health status and the interests of Canadian women. As a result, we have been actively involved with issues relevant to the Health Protection Branch's mandate. This has meant we have had regular communication with the Branch as well as with other stakeholders such as health professionals, researchers and the manufacturing sector for over 15 years.

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Our Process

This position paper was created through open community discussions funded through our community outreach and donations program. Contributors included individuals, students, researchers, board members: those who are nursing in hospitals, running health information centres, working with rural women, providing volunteer counseling regarding birth control and unplanned pregnancy, editing a women's magazine and newsletters, running support groups, working for a university students' association, among others.

As well, we are part of an informal national network of groups and individuals working on gender, women and the Health Protection Branch review.

Within the time constraints of this current phase of the review, we reviewed the various discussion papers and the workbook. The following comments and recommendations build on our experiences and learnings.

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Selected Examples of our Activities, Experiences and Learnings:

  • DES
    Since 1981, we have provided outreach information, education and screening activities for women and men exposed to DES. We saw some strong federal leadership in helping to address this enormous problem. However the lack of good records and access to them, lack of research and the lack of a sense of responsibility by the industry remains a troubling legacy.


  • Tampons
    We expressed concerns about the lack of testing and regulation of these products and provide community education on them.


  • New Reproductive and Genetic Technologies
    We were founding members of the Manitoba Network of New Reproductive and Genetic Technologies, active participants in the Royal Commission on New Reproductive and Genetic Technologies and sponsored a research project on women's experiences with these technologies in pregnancy. We were and remain concerned that our regulatory system seems unable to address long term bio-medical safety issues much less the profound ethical, legal and social issues that these technologies pose. There was and remains no program to support initiatives for community education and debate on these complex issues except those funded by private clinics, clinicians and industry.

    We worry that home pregnancy tests for genetic conditions could be as easily approved as there is currently no risk review process for the ethical questions this technology raises for families and society.


  • Depo-provera
    We are active participants in the Canadian Coalition on Depo-Provera. Since 1983, this coalition has expressed concerns about the lack of consent required for drugs used for un-approved uses, lack of population-based research prior to approval of drugs, the secret nature of the drug approval system and the lack of public access to information about drugs. The recent approval of Depo-provera, behind closed doors, shows that these concerns have gone unheeded.

    There are indications that Depo is frequently being given to Aboriginal women prior to their return home after birthing in city hospitals. A recent call to the manufacturer shows that though there were, and have been, concerns about the use of Depo in women with lack of access to good primary care, risk for STDs, youth, and lipid metabolism, there are no research programs being undertaken to follow this.


  • Consumer health information
    We provide a health information resource centre for our community. As a result we review and often produce educational materials for women on various health issues. We are very concerned with the overwhelming amount of "patient" information that is produced with an eye to product promotion and unabashed advertising. There is little material that provides information increasing knowledge necessary for informed consent, much less informed choice. Information on prevention, health promotion or maintenance practices or health determinants is often thin or missing.

    We often find ourselves having to produce information for our clients. For example, we have written our own materials on hormone therapies for peri-menopausal women due to the lack of balanced information that presents what is known and not known about the drugs. We recently have undertaken the responsibility of publishing "A Friend Indeed", an independent women-centered newsletter for mid-life women.


  • Tobacco
    We have worked on issues related to the regulation of tobacco as a result of our concerns about its impact on the health of women. Effective labeling and control of nicotine content have been very slow to evolve. This reluctance, together with the on-going debates related to regulation of advertising that promotes either smoking or thinness, increases our concerns that the industry appears more important than our health.

  • Dalkon Shield IUD
    We coordinated an educational and outreach program on the Dalkon Shield IUD that included intervening into the US Class Action and Chapter 11 bankruptcy hearing to argue for equal status for international claimants and a notification and recall program in Canada. Despite many requests for a timely public recall, the HPB only sent letters to physicians.


  • Over-use and misuse of tranquilizers
    We coordinated education programs for community groups and professionals regarding the over-use and misuse of tranquillizers in women. This includes the "It's Just Your Nerves" program, funded by Health Canada, and coordinating the local tour of the Popular Education play, "Side Effects", on women and pharmaceutical use.


  • Breast implants
    We coordinated a large support group and community education program, did outreach to family doctors, mammography technicians and plastic surgeons and provided counseling and assessment to individuals with or considering breast implants. During this program, we worked with provinces to urge them to cover the costs of removing ruptured or leaking breast implants and any necessary plastic surgery.

    We had hoped for much stronger leadership from the HPB than we have observed. The concept of an inadequately reviewed device being used did not appear to give officials cause for concern. It appears to us that the concerns of consumers regarding device breakdown, scar tissue, pain and disfigurement were dismissed far too easily. The department did not appear to see consumers as their "client".

    Department activities were uneven and often occurred without transparency. Indeed the only official meeting with consumer groups was instigated by the Women's Health Bureau in the Policy Branch, not the HPB. Although we have been participating on an advisory committee to develop an information package for women who are considering or who presently have breast implants, after a silence of over 18 months we have just received a copy of an information package, in a completed form, from Health Canada. It is not clear who has authored it. We have significant concerns about this document. For example it uses the term "wear out" when describing the temporary nature of the devices when, in fact, the silicone shells break down as a direct result of their in vitro instability. We wonder who reviewed this material and what their interests are. In its present form, we do not think this material is useful.

    It was shocking that there was no timely and sensitive system in place to address the costs of the failure of these devices. Women were abandoned by the manufacturers, the federal government, and all too frequently the provincial government and their physicians. We are grateful to the staff that showed leadership and initiative in addressing this; however, as taxpayers we remain enraged that Canadians paid for these removals while the profits from their sales remain in the control of the industry.

  • RU-486 and the Morning After Pill
    For many years, we, with other groups, have urged the Health Protection Branch to approve RU-486 and a "Morning After Pill". The argument that no company has asked to sell it does not make us confident that the department is taking a pro-active approach to women's health issues.


  • Bill C-91
    We participated in a national coalition to oppose Bill C-91 on the extension of patent protection which we still see as a flawed decision that should be repealed.


  • Other issues
    Broader issues such as Bovine Growth Hormone, the impact of violence on women's lives, labeling of genetically altered or radiated foods, environmental issues and water quality, to name a few, have also been a source of concern and action for us.

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The Sum of our Experience Indicates:

  • Our confidence in the Health Protection Branch is decreasing. This lack of confidence is shared by many individuals and groups.
  • We believe funding cuts have deprived the Branch of its ability to set and enforce standards independent of industry influence.
  • We see an absence of sensitivity to issues of gender, culture, class or power and an increasing lack of ability to see or respond to the Canadian public/consumer (as opposed to industry or professionals) as either the real "client" or "partner" in meeting the HPB mandate.
  • There appears to be no real understanding of the health determinants approach in the processes within the Branch despite the emphasis in Health Canada generally. Such understandings would lead to fruitful new criteria for "safety", new methods for post marketing evaluation of drugs and devices and social and ethical evaluation of new initiatives.
  • The environment of secrecy, in the drug and device approval process, is not in the interests of the citizens of Canada.
  • The HPB is drifting into the role of protecting industry and its economic growth and abandoning the role of protecting the health of Canadians.

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The Context

The public review of the HPB's plans in restructuring and reorientation is welcome, though long overdue. We have approached this discussion with a very clear understanding of the problems we feel need to fixed. We do not get a clear sense from the department regarding what problems they hope the transition process will address.

We recommend that the HPB clearly articulate the problems they expect the Transition process to address.

This review is occurring at a time when our new understandings of the health determinants are being integrated into the health system and the health service system and when there is growing pressure on our publicly insured health system. The work of the National Forum on Health and the integration of these new understandings into all aspects of government policy gives us a sense of optimism. However, the pressures on the health service system and on the economy along with the impact of globalization has brought about a revival of the debate as to the proper role of the "for profit" manufacturing and research sectors in health service. As Robert Evans notes in his article, Going for the Gold: the Redistributive Agenda behind Market-Based Health Care Reform

"Conflict over the respective roles of the state and the market in health care has a long history. Current interest in market approaches represents the resurgence of ideas and arguments that have been promoted with varying intensity throughout this century. (In practice, advocates have never wanted a truly competitive market, but rather one managed by and for particular private interests.) Yet international experience over the last forty years has demonstrated that greater reliance on the market is associated with inferior system performance - inequity, inefficiency, high cost and public dissatisfaction."

Nowhere is this more apparent than in those issues within the mandate of the Health Protection Branch.

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Health Protection is not a Business

We are concerned that the HPB sees its mandate as protecting the interests of the industry and its economic growth. We worry that "health" is being seen as a business with the implication that it is an industrial sector and a source of jobs and profits. This commercial concept is at the root of many of the problems in the Health Protection Branch and is certainly perceived as a strong influence in its changing relationships with the pharmaceutical industry.

As an example, the HPB talks about the economic benefits of serving the client and bringing new drugs rapidly to market, while consumers and policy makers in hospitals and provincial governments are faced with a plethora of increasingly expensive products, inadequately tested relative to older and cheaper drugs. Nor is there available the type of cost/benefit data necessary for evidence-based decision making. Our system is being cluttered with devices with theoretical effectiveness but little or no actual effectiveness.

As well, we need to develop mechanisms to assess the fiscal consequences of new drugs and devices. For example, at the same time as costs of new drugs and total drug expenditures increase, huge cutbacks occur in such essential areas as nutrition support programs and home care.

We recommend that Health Canada, and the Health Protection Branch, should have as its goal the protection and improvement of the health of Canadians and give no consideration to the impact of its decisions on the industry.

We recommend that the Branch develop a relationship with provincial and national processes such as offices of technology assessment and the WHO Essential Drugs program.

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Health Determinants: A Missing Analysis

The concept of "health as a business" appears at first blush as a way of increasing economic opportunities for Canadians and a method for addressing health determinants. Indeed, employment and income are determinants of health status. However, many women know from direct experience how unemployment and cuts in social programs impact negatively on their health and that of their families. If expansion in the pharmaceutical industry causes the income gradient to simply grow steeper without benefit to the individuals (or provinces) that are having to pay the costs of the new drugs, if jobs in the health care and the social sector are cut as the result of drug policies favoring industry profits, then women are likely to be net losers rather than gaining opportunities for employment.

As well, although the discussion papers mention health determinants and issues such equity, diversity and gender, there is little to suggest these principles have been applied in any way to the new thinking within the Transition processes. New surveillance models are needed which will ensure that health impacts such as violence and unemployment are monitored and articulated.

We recommend that all future strategy documents regarding the HPB include an expanded analysis regarding health determinants. This would include, for example, integrating this analysis into surveillance systems, device and product regulatory activities and risk management processes.

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A New Role for the HPB: Advocating for the Health of Canadians

The Branch, in a proactive role, should become genuine advocates for healthy public policy, working to ensure that the impacts of other jurisdictional policies on health status are monitored and articulated. The HPB should provide leadership to ensure that health impact assessments are required and that they are publicly articulated. The new regulations should require health impact assessments on policies of other branches of government and their constituencies.

We recommend that the Health Protection Branch become proactive in advocating for healthy public policy and use a health determinants approach in carrying out its mandate.

We recommend that the new regulations require health impact assessments of the other departmental policies and policy change.

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Consumer Empowerment, Citizen Participation and the "Public"

The definition of public used in the document is troubling. There is a lack of analysis of the various types of "publics" and their interests. We do not see the pharmaceutical and manufacturing sector as the public. It is true that they are stakeholders and their issues and concerns need to be included in discussions; however, these interests are very different from the interests of Canadians as consumers and funders of the health service system.

As troubling is the assumption that researchers, health care institutions and universities are independent voices that can represent the interests of Canadians. As a result of the impact of changes in control of research dollars and examples such as the experiences at the Hospital for Sick Children, too often those who we might have expected to be our advocates are silent or silenced. New mechanisms need to be created and resourced.

We recommend that those who would profit either directly or indirectly from HPB decisions should not be defined as part of the "public".

The Minister of Health has noted that "health protection is everybody's business. All Canadians share responsibility for safeguarding and improving health, just as all Canadians share the benefits of having a healthy population and work force."

We agree. However, we are concerned that this may mean that the onus is essentially being placed on the individual. While Canadians can and should take measures to protect their health, there are large-scale forces operating at a systemic level that threaten their well-being and put them at risk, and which are virtually out of their control. Women are significantly affected by these forces more so than men, given their lesser degree of control on the governance of society and their inferior socio-economic status. The state has a responsibility to influence societal factors that threaten health protection and to be, in itself, a protective and positive force, especially on behalf of groups in society that are disadvantaged.

We strongly support the inferences in the discussion paper that mechanisms are needed to empower Canadians to make healthy choices and to be active participants in decision making. However this analysis should be made more apparent and put in context.

Canadians have been demanding more input into decisions that affect their health and into the governance of the health service system. As a result of regionalization, citizens are reviewing and approving health service budgets. Consumers are no longer content to just be patients; they have the legal right to give informed consent. They own the information in their medical records and have the right to access it. Consumers are demanding to be active participants in policy development.

The Health Protection Branch needs to rethink its approach to be effective in collaborating with the public. Our wide community experience has demonstrated repeatedly that, given appropriately supportive opportunities, consumers willingly become contributors to the discussions and decision-making that leads to more balanced public policy.

The activities of health protection must be transparent, open and equal. This means that programs are needed to ensure that citizen groups have the resources to educate their members and develop position papers. New mechanisms to encourage education and debate need to be put in place. The Health Promotion Branch's community action program would be the ideal way for community based groups to have access to funding for these activities. Special attention must be taken to ensure equal participation by all citizens groups, particularly those who are the voices for the most at risk and who are often excluded. Equality principles are essential here.

The summer release of the discussion papers, the short notice and lack of clarity regarding attendance at the public consultations, the lack of outreach and community-based educational activities mitigated against awareness of the Transition initiative. We fear this lack of awareness will reduce feedback on the discussion papers. We feel strongly that this should not be construed as a lack of interest, but rather that it reflects the reduced capacity of consumer and citizen groups to respond, primarily due to reductions of governmental funding which impacts on the resources available to facilitate the work of volunteers.

We recommend that the HPB provide outreach and education activities as well as support to ensure equal participation in a more open and transparent process.

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Legislation

The current Food and Drug Act is being described as an outdated, badly performing piece of legislation. It is interesting to contemplate what could possibly be outdated about an Act that is all about keeping our water, food and drugs safe and pure. We are concerned that opening the Act would make it vulnerable to changes that would not be in the best interests of the public. The process of regulatory change is less cumbersome than the process of changing an Act of legislation and would ensure its integrity would be maintained.

We recommend that the Food and Drug Act be maintained and no changes be introduced that would eliminate or reduce the degree of criminal responsibility as it presently applies to the Minister, other Health Canada officials and to the industry.

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Funding Cuts

We are very concerned that Canada's public health protection system has been weakened to a dangerous level of ineffectiveness. Cutbacks in funding leave very little leeway for the development of new policies that would allow for more inclusive patterns of research such as we believe are necessary to improve health quality for women. Cutbacks in resources and resulting change to the research capabilities of the Health Protection Branch create a growing reliance upon or participation in economic "partnerships". Partnering with the private sector or universities -- whose own funding is often reliant on the same industries who intend to profit through products for which they seek approval -- leaves the frightening perception that HPB is moving from its traditional role of protecting public health interests to the task of developing a profitable health industry at the expense of public safety.

Most of us are familiar with the old expression, she who pays the piper calls the tune. Administrative assurances to the contrary, it is difficult to imagine how Health Protection Branch can work for the public good if the Branch's performance target is tied to the amount of fees it will collect. If greater numbers of approvals equal greater dollars, HPB is vulnerable not only to actual political and industry influence but also to the public's perception that these are its motivating factors. Fee for service licensing is unethical unless that fee is completely blinded from the approval process and is not an indicator of department effectiveness.

We recommend that fees for review of drugs or devices should be returned to general revenues and not be seen as a source of departmental revenues or an indicator of effective performance.

We are concerned that this policy also produces barriers to smaller companies who are unable to compete against the financial resources of large multinational, vertically integrated companies. For example, there is no corporation which wants to manufacture RU-486 in Canada, so it remains unavailable. Firms whose product lines are alternative therapies -- such as natural progesterone or herbs -- have little capacity to meet these licensing fees.

We recommend that new mechanisms be found to ensure that products that are needed by the Canadian public are able to be reviewed in a timely manner not dependant on the licensing fee.

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Funding to Support In-House Research

Testing for drug quality, toxicity, bioequivalence and clinical applications are no longer routine procedures done in-house. "Jobbed out" product review and the possibility that industry self-regulation may become accepted practice will do little to convince a skeptical public that we are the client for whom HPB is working. It is somewhat encouraging that budget restorations will bring funding close to the 1993-94 level in 1999-00. However, this funding is specific (AIDS and cancer research), it will do nothing to restore the in-house research that was the foundation of independent product review.

We recommend that the HPB be funded adequately to retain its independence and expertise.

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Decision Making: A Needs-Based Approach to Drugs and Devices

Transition discussion papers provide little sense of how the current problems in the system would be addressed. There is a need to examine the relationship between approvals and their funding from the funding insurance system. As new drugs or devices are not funded by the provincial governments, we see increasing privatization of this part of the health care system. Using criteria that includes "use effectiveness" and needs-based criteria would mitigate this situation. There are international models to review. The WHO's Essential Drugs program helps provide guidance to many countries. As well, Norway provides an interesting and significant example of a successful National Drug Policy[3]. It incorporates characteristics such as:

  • A 'need clause' (which implies a drug is assessed not only from a scientific and technical viewpoint but also in relation to medical need and thus the social perspective of health priorities);

  • A restrictive attitude to fixed combination drugs, and;

  • Limiting of approval and registration of a drug to a five-year period which has kept the number of pharmaceuticals at a reasonable level (just over 2000) and protected consumers from useless or unnecessary drugs.

Development of an equitable National Drug Policy in Norway has occurred without any major conflict between the health authorities, the professional organizations and the drug industry. The reason for this may be that the Norwegian drug policy has developed in stages throughout this century and has been part of a health policy and an overall social policy where the emphasis on equity has been one of the main pillars. We note that part of the profit from drug sales is used to inform patients, doctors and pharmacists about drugs and their rational use, including when not to take them as solutions to everyday problems.

Equally important is the need for open, transparent review processes that address social and ethical considerations. This requires public access to the research done by licence applicants, adequate public notification of applications and engagement mechanisms.

We recommend that models and principles in programs such the World Health Organization's Essential Drug Program and Norway's National Drug policy be implemented in Canada.

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Addressing Risk

Assessment of and managing risk is more than a documentation of the results of successful double blind clinical trials. The Health Protection Branch needs to grapple with social and ethical implications of a wide array of new drugs and devices from biotechnical/genetically-altered material to the increasing popularity of herbal and non-traditional therapies.

Risk assessment must incorporate a long-term vision, such as the aboriginal philosophy of looking ahead to seven generations. It must be supported by an overarching ethical structure that considers environmental impacts as well as ethical, social and cultural determinants of health as they affect both individuals and groups:

    "Health protection policy must identify a delicate balance between the individual and collective risk and choice. Illness and injury affect individuals (and thereby, their families, workplaces and communities) in an immediate, direct way, so a fundamental aim of all health policies must be to promote and protect the health of individuals. Nonetheless, risks are also borne by social groups and by society as a whole. Health policies can have a profound effect on social groups that extends beyond their impact on individuals considered in isolation …"

Risks managed only in industry terms may mean that health protection standards move from proof of safety to proof of harm. Industry's interpretation of risk management puts too much emphasis on economic risk and corporate self-interest and could result in grotesque calculations that put dollar assessments on human lives. For example, Health Canada blood regulators, working with their "client" - the manufacturer of blood products - could decide that the benefits of distributing contaminated blood products (i.e. $100's of millions in revenue for the company) outweigh the costs (i.e. liability for loss of life and injury which is often difficult to prove).

In developing HPB's risk assessment framework, the Branch is examining the degree of certainty the legislation should require prior to Health Canada's intervention when facing an emerging issue. An important lesson must be learned from the contamination of the blood supply. As stated by Justice Horace Krever in his final report:

    "The slowness in taking appropriate measures to prevent the contamination of the blood supply was in large measure the result of the rejection, or at least the non-acceptance, of an important tenet in the philosophy of public health: action to reduce risk should not await scientific certainty."

We recommend that a new definition of safety must incorporate good research with sensitivity to gender, cultural and ethical issues and must also require assessments of the long-term effects of drugs and devices.

We recommend that HPB adopt an active, not passive, approach to assessing risk that takes a broad definition of risk including social, ethical and long term risks.

We are very aware that there is a need for new therapies to be made available to Canadians in a timely manner; however, criteria should be complex enough to allow immediate access to therapies for those dealing with life threatening illness and yet provide stringency on products which will be used for well individuals. New models of pro-active post marketing research programs -- engaging consumers and involving their input -- would restore confidence, be early indicators of unexpected outcomes, and corroborate needs-based evidence.

We recommend that post marketing evaluation programs be removed from responsibility of the industry and new mechanisms for involving the Canadian public be undertaken.

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Compensation Fund

Women's experiences with the Dalkon Shield, DES and silicone breast implants, and the Canadian public's experience of the tainted blood disaster, establishes the need for a compensation fund. Such a fund would ensure that Canadians are compensated for harm caused by the use of drugs or devices that are defective -- whether through unforeseen or other circumstances. Access to this fund should not preclude bringing suit or, for that matter, criminal charges against the responsible parties should neglect of duty be the key cause of harm.

We recommend that a compensation fund be created to support compensation for unintended problems with drugs, products and devices.

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Harmonization of Standards

It would appear at first glance to be a sensible plan to use the evidence of other countries, particularly if they are known to have like-standards of scientific rigor. It would, for instance, be one way in which standards for herbal and non-traditional therapies might be set up without the expense of testing in Canada. However, a cautionary tale must be included here.

One of the legacies of the Reagan and Bush administrations in the US was a gutting of the budget and independence of the FDA. Women saw some of the consequences of this in the turn-around approval of Norplant and Depo-Provera. Trade agreements with other nations can affect Canada's autonomy when it comes to maintaining control in the market place. Our government's inability to cancel the use of MMT -- a gasoline additive seen to be without merit as well as environmentally destructive -- can be applied directly to rBST should it be approved for use in Canada. Political barriers will prevent its removal, even if Canadian evidence later proves it unacceptable to our national standards.

Just as troubling is the fact that no government is immune from political pressure internally. The HPB will need mechanisms to assess this. Given the resistance to external reviewers, we remain skeptical that this can be undertaken which means that harmonization will not be workable.

We recommend that if and where review processes are shared, the HPB must retain the ability to overturn decisions and the capacity to audit the processes in other jurisdictions to ensure no inappropriate influences were experienced. Harmonizing the review process with other countries should never result in lowering standards used in the Health Protection Branch.

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Consumer Education, Informed Consent and Informed Choice

Over the past 100 years there has been a growing understanding of the spectrum of differences between unregulated and irresponsible advertising of health products, responsible advertising, accurate transparent information about a product and its use and educational information about a health concern. It is not clear in actual terms how much impact this critical thinking has had.

Plain language leaflets, packaging and shelf signage are as important in the determination of effectiveness as is scientific research when it comes to protecting the public. Although patient inserts are now present, they are generally difficult to read and to comprehend. Materials designed to accompany drugs and devices -- whether over-the-counter or by prescription -- do not carry complete information regarding side-effects or are presented in a manner that encourages informed consent. This means that it is difficult for consumers to make informed choices and provide informed consent. We have often produced our own materials or worked with provincial governments and other consumer groups to ensure that there is useful information available.

New understandings of use effectiveness, the role of prevention and health promotion activities must be communicated in accessible forms. Clearly spelling out use effectiveness in, for example, mammography, bone densitometry, or oral contraceptives for adolescents, would enlighten consumers and practitioners and would greatly enhance informed choice. There are few resources available for consumer groups or professionals to prepare and provide unbiased education about a health problem or issue and possible methods and or products to address them. It is time for a consumer health education process to be initiated, separate from promotional materials and the purview of the industry.

We recommend that responsibility for the preparation of information materials be removed from industry and an independent mechanism for their development be initiated.

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Direct to Consumer Advertising

Pharmaceutical industry marketing practices have a long history of poor compliance with ethical guidelines and standards in industrialized countries, such as Canada, as well as in developing countries. The industry is becoming a source of funds for consumer groups, medical education and research. Large corporate budgets determine market share of products.

Direct to consumer ads reflect a further, serious erosion of balanced, independent sources of information for consumers and health care providers. Advertising is not education. It is a sales tool and is meant to stimulate a desire for the product it features. Commercial messages "leak" in through foreign media sources and can be found on the Internet. Review is needed and regulations imposed. This must be done quickly as our society already suffers from an overuse and misuse of medication.

We recommend that the existing prohibitions about direct to consumer marketing be maintained and strengthened.

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Regulating Herbs and Other Non-Traditional Therapies

Herbal and other non-traditional therapies are an increasing interest among women but using these products is problematic. Complementary medicines are looked upon with scepticism or hostility by allopathic providers. Naturopaths, herbalists and other non-traditional practitioners are unregulated. Smaller manufacturers often lack the resources to do research to have their products licensed. There are few quality controls in place. Products are sometimes withheld from sale in Canada. The market is generally one of "buyer beware" and it is left to the user to ferret out information on potency, quality, dosage and side-effects.

We are very concerned about the risks to health in the current situation. For example, St John's Wort is a popular herbal compound available through health food specialty shops as well as chain drug stores. The specialty shops are generally knowledgeable about the product and usually will provide information and side-effects warnings. However, the product may also be purchased off a drug store shelf with no accompanying information.

We recommend that new mechanisms be found that will assure standards for good quality control and accurate information on product use through labeling. Those with expertise in the use of herbs should be providing leadership in this process.

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Altered Foods: The Consumer's Right to Know

Food that has been genetically altered may turn out to be a great boon, as is the current hope of the industry. Or it may become the root of health problems that have yet to be imagined. Until enough long-term evidence has been collected to be conclusive, a caution light should be flashing. The overall manipulation of plant and livestock biologies: to enhance production, to increase pest resistance, to provide a source of disease prevention or cure that is organic in nature are, at a glance, well-intended. Strong overarching principles of ethics must be in place to balance the quest for market control and profit. Under the present circumstances, there is little public confidence that such a balance is in place.

Ultimately, it should be the consumer's right to choose or refuse products that have been genetically altered. Access to balanced information is an effective tool for consumers and reinforces their ability to make responsible and rational decisions. The responsibility of the Health Protection Branch is to make information available and widely distributed.

We recommend that genetically altered food be identified by labeling.

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Women's Health Means More than Just Health Issues for Women

Our interest in the Health Protection Branch is not only as major consumers of health products, drugs, devices and services. For many women, the health of their families and communities is also their business. Women are often the health guardians and advocates in society. Our sense of responsibility and concern gives us the legitimate right to speak out on all issues affecting health for everyone in our community, young and old, male and female. This includes everything from drugs to food and the environment; from non-enforcement of legislation to cutbacks which impact socio-economic determinants of health. As an example, in the context of the Health Protection Branch, health as women's business makes the Bovine Growth Hormone as legitimate an issue for women as Depo-provera or Tamoxifen.

The women's health movement has developed an analysis that examines health problems from a holistic perspective. We recognize the impact of violence and poverty on health status and the impact of inequalities between men and women and among men and women as significant health determinants. If health is to be protected and enhanced, these impacts must be addressed. We see this as a new role for the Health Protection Branch; monitoring and communicating these risks to health.

We recommend that the HPB staff include those with expertise in ethics, social sciences, gender and equity issues.

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Lack of Gender Analysis

That the Health Protection Branch has not adequately addressed gender has been a longstanding issue. Gender refers to the array of social, behavioural and attitudinal differences between women and men (see Appendix Two). These are socially constructed and can be changed, indeed do change, as society evolves; it is sex and its related biological determinants that we can't change, although their impacts can be mitigated.

We recommend that the legislative renewal process be submitted to a gender-based analysis (which is a federal and departmental requirement) and that health and women's organizations, among others, be invited to participate in developing the process

Only belatedly has drug research been required to include women in clinical trials. Typically only minimal consideration has been given to distinct differences between the sexes in spite of obvious physical factors such as body weight, ratio of lean to fat tissue, concentrations of steroids in men's bodies, a difference in hormones as well as the artificial use of hormones by women as they proceed through various stages of their lives: birth control, fertility treatments, menopausal symptoms. It appears no consideration is given to cultural differences and the possibly different risk factors therein. Male bias also influences studies on occupational health and safety, often ignoring distinct risks faced by women who enter traditionally male job categories.

In order to develop health policies that will provide equitable results, it is essential that research into threats to health be conducted in ways that will reveal whether or not there are gender-related risks attached. This requires not only that studies include women in sufficient numbers to obtain statistically significant results but also that the data be collected and analyzed in ways that will reveal this information. Qualitative and quantitative studies are needed. Moreover, such analysis may also have to consider whether specific groups of women (e.g., elderly women, pregnant women and various cultural and ethnic groups) are at particular risk whenever there is reason to suspect relevance of such differences.

Women are not only under-represented in research, they are under-represented in decision-making. When products for women are under review, the absence of public hearings or other participatory mechanisms, prevents women's access to the Health Protection Branch. Equitable health policies and affordable avenues of communication are needed.

We recommend that the HPB have explicit processes to address gender and to ensure that principles of equity and diversity are in place.

We recommend that special meetings with women's groups and with equality groups be undertaken as part of the transition process and prior to the finalization of the white paper.

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Summary of Recommendations

  1.  
    1. Health Canada, and the Health Protection Branch, should have as its goal the protection and improvement of the health of Canadians and give no consideration to the impact of its decisions on the industry. This means that those who would profit either directly or indirectly from HPB decisions should not be defined as part of the "public". It also means that HPB must adopt an active, not passive, approach to assessing risk, taking a broad definition of risk including social, ethical and long term risks.

    2. Models and principles of programs such as the World Health Organization's Essential Drug Program and Norway's National Drug policy should be implemented in Canada.

    3. New definitions of safety must incorporate good research with sensitivity to gender, cultural and ethical issues and must also require assessments of the long term effects of drugs and devices. This means that explicit processes are needed to address gender and to ensure that principles of equity and diversity are in place. HPB will require staff with the expertise to recognize and deal with this new approach.

  2.  
    1. The Food and Drug Act must be maintained and no changes should be introduced that would eliminate or reduce the degree of criminal responsibility as it presently applies to the Minister, other Health Canada officials and to the industry.

    2. The legislative renewal process must be submitted to a gender-based analysis (which is a federal and departmental requirement) and health and women's organizations, among others, should be invited to participate in developing the process.

  3.  
    1. New regulations must require health impact assessments of other departmental policies and policy change.

    2. Post marketing evaluation programs should be removed from responsibility of the industry and new mechanisms for involving the Canadian public must be undertaken.

    3. New mechanisms must be found that will assure standards for good quality control and accurate information on product use through labeling. Improvements in the educational value of all labeling and product information are needed; however, this would also apply specifically to herbal and non-traditional products. Those with expertise in the use of herbs should be providing leadership in this process.

    4. Genetically altered food should be identified by labeling.

  4.  
    1. The Health Protection Branch must clearly articulate the problems they expect this Transition to address. All future strategy documents should include an expanded analysis regarding health determinants. This would include, for example, integrating this analysis into surveillance systems, device and product regulatory activities and risk management processes. Special meetings with women's and equality groups should be undertaken as part of the transition process and prior to finalization of the white paper.

    2. HPB must become proactive in advocating for healthy public policy and use a health determinants approach in carrying out its mandate. This means developing relationships with provincial and national processes such as offices of technology assessment and the WHO Essential Drugs program and providing outreach and education activities as well as support to ensure equal participation in a more open and transparent process.

    3. New mechanisms are needed to ensure that products that are needed by the Canadian public are able to be reviewed in a timely manner, not dependent on licensing.

    4. Fees for review of drugs or devices should be returned to general revenues and not be seen as a source of departmental revenues or an indicator of effective performance. HPB must be funded adequately to retain its independence and expertise.

    5. A fund must be created, through a new industry tax, that would support compensation for unintended problems with drugs, products and devices. This tax could also support independent mechanisms (ie, without the participation of those who would profit either directly or indirectly from the activities) for:
      • long-term monitoring of drugs, devices, altered foods, etc.;
      • development of consumer information including inserts ;
      • removing barriers to licensing products that are presently considered alternative therapies or goods for which there has been no industry interest in production.

    6. Where review processes are shared, the HPB must retain the ability to overturn decisions and the capacity to audit the processes in other jurisdictions to ensure no inappropriate influences were experienced. Harmonizing the review process with other countries should never result in lowering standards used in the Health Protection Branch.

    7. Existing prohibitions on direct to consumer marketing must be maintained and strengthened.

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Conclusions

The Health Protection Branch Transition process presents an opportunity to restore its credibility. We urge the serious consideration of the issues and recommendations made in this document. The Women's Health Clinic would welcome an opportunity to work with the Health Protection Branch during this Transition process to ensure it is equitable, ethical and improves the health status of Canadians.

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Appendix One

The Women's Health Clinic (WHC)-- Who We Are

The Women's Health Clinic (WHC) serves as a community resource to a broad range of individual women - from teens to elders, as well as to service providers and agencies in Manitoba. It provides primary health care that emphasizes health promotion, education and client empowerment. In addition, the Clinic monitors emerging issues of importance to women's health, brings together coalitions and networks for debate and discussion, encourages and sponsors research and develops policy options and innovative service approaches within a population health framework.

The Clinic strives to integrate practice with research and policy development, so that work in each area informs and enriches the quality of the other. In 1997, the WHC was recognized by the Commonwealth Secretariat and received the Commonwealth Award for Excellence in Women's Health Practice for its unique model of care. We are an active member of the Centres of Excellence for Women's Health, a program of Health Canada.

Women's Health Clinic had its origins in the 1970s and has played a significant role in the Canadian women's health movement since that time. It developed from the vision of Manitoba women who identified the need for quality reproductive health care and contributed their time, effort and money to ensure that such services would be provided. The model of a clinic run by and for women evolved to include a broad range of programs and services that met women's health needs in a holistic way.

Women's Health Clinic Philosophy

The Women's Health Clinic Model of Care is based on the following philosophy and principles:

All women deserve fundamental respect and have the right to make informed decisions about their health care. In particular, it is recognized that:

  • All women bring valuable and diverse experiences as care providers of family and friends, as workers, and as consumers of health services. Their ideas and insights should be encouraged and valued in developing health services appropriate to their needs.

  • An equity and human rights framework is necessary to ensure that women from diverse communities, including Aboriginal women, immigrant and visible minority women, women with disabilities, and lesbians, have opportunities to bring their unique experiences and insights to an understanding of health and illness. Often marginalised in the planning of health service delivery, their involvement and participation is essential for the development of quality, culturally appropriate services.

  • Empowerment is a contributing factor in health status, that health status improves when a person has a greater sense of control over her life situation.

  • Believing that a person's health must be understood holistically, with an appreciation for the interrelationship of physical, social, emotional and spiritual aspects, the design and delivery of all Women's Health Clinic programs and services reflect the understanding that:

  • Gender is a key determinant of health, for example, women within all socio-economic and cultural backgrounds are at a higher risk than men of experiencing poverty, abuse and violence, all of which serve to seriously undermine health status.

  • Women's health status is determined by a variety of social and structural determinants, including social status, income and employment, education, and social supports.

  • Gender sensitive health care services help women reclaim and re-define normal life transitions which have been overly medicalized or pathologized (e.g. childbirth, menopause).

Recognizing that health promotion, primary prevention and healthy public policy are essential strategies for influencing the determinants of women's health, Women's Health Clinic emphasizes community and group-based approaches as a means to effect positive change in women's health status.

Programs and Staffing

Women's Health Clinic staff are an interdisciplinary team of health care providers who work collaboratively. Women's Health Clinic has a current staff complement of 18.5 EFTs, which include: physicians, nurse practitioners, health educators, a dietitian, counselors, outreach volunteer co-ordinators, client service workers, a medical assistant and administration personnel.

WHC operates the following programs:

  • Health Education
  • Counseling and Social Support
  • Primary Health Care
  • Resource Centres and Publications
  • Professional Education and Research
  • Public Policy

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Endnotes

[1]Robert G. Evans, Journal of Health Policy and Law, Vol 22, No 2, April 1997
[2] Health Canada, Shared Responsibilities, Shared Vision: Renewing the Federal Health Protection Legislation, An Invitation to a Discussion... from the Minister of Health, Catalog number: H39-435/1998.
[3]Norway's National Drug Policy: Its Evolution and Lessons for the Future., Marit Andrew, Bjorn Joldal and Goran Tomson. Development Dialogue 1995:1. Journal of the Dag Fammerskjold Foundation pp.25-53.
[4]Maritime Centre of Excellence in Women's Health (MCEWH), October 1998, A Response to Health Protection Branch Discussion Papers, pp.
[5]Canadian Health Coalition, September 1998, Transition=abdication, pp 6.
[6]The Honourable Mr Justice Horace Krever, Commission of Inquiry on the Blood System in Canada, Final Report, Volume 3, 1997, pp 989.

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