HEAL Committee Report

The Health Committee has been assisted by many witnesses during our examination of this wide-ranging topic, witnesses who have shared both their expert opinions and personal experiences. These are complex issues and emotional ones for many and we greatly appreciate the contribution these witnesses have made to our deliberations.

The Committee has made a number of very significant recommendations in its report toward regulating reproductive technologies. The prohibition of human cloning, strict controls on embryonic stem cell research, an end to donor anonymity, a ban on commercial surrogacy and the need for a quasi-independent regulatory body, for example, are proposals supported by New Democrats. There are other areas, however, such as women’s health protection, infertility prevention and the impact on persons with disabilities where we feel the Committee has failed to strike the right balance.

Urgent Action Needed

Clearly, there is a need for urgent government action. Canada stands almost alone among industrialized nations without a legal framework to deal with these new scientific developments.

The Baird Royal Commission laid the foundation for legislation in its 1993 report. It made 293 recommendations in that report based on four years of consultations with an estimated 15,000 Canadians through interviews, surveys and focus groups. The Liberal government waited until 1996 to introduce legislation. However, that legislation, Bill C-47, died on the Order Paper with the 1997 election and was never re-introduced. We are now entering 2002 with only a draft document, not even a bill.

In the interim, scientific discovery and industrial development in this area have proceeded apace outside of any regulatory framework. Socially positive and negative impacts cohabit a legal limbo and Canadians are left without necessary health protections. A virtual zoo full of cloned species, patented higher life forms, manipulable human stem cells, internet surrogacy and embryonic screening are all now part of our daily lives. Unobstructed by regulation and with public health insurance helping to pay some of the costs, biotechnology corporations have turned Canada into a giant laboratory to research and develop their products and services with Canadians as the guinea pigs.

Recommendation: We urge the Health Minister to table an actual bill immediately upon the resumption of House of Commons business in January and to draft regulations as quickly as possible with a view to passing the legislative package into law before the end of the Spring sitting. During the interim, we urge the government to enforce its voluntary moratorium on such practices as germ-line alteration, human embryo cloning and the buying and selling of eggs, sperm and embryos and to use existing laws, in areas such as drug safety, to protect women’s health.

End Commercialization

The benefits of appropriately regulated technology should be available to all Canadians through our public health system. However, the lack of active government intervention over the past decades has left control of this field firmly in the grip of multinational biotechnology corporations.

All Canadians should benefit equally from improvements to infertility treatment. This is far from the case now where public coverage of infertility conditions is practically non-existent and private insurance often excludes fertility drugs or imposes severe limits on reimbursement. National leadership is required to validate infertility as a medical condition and to ensure that all women have access to safe, science-based and effective treatment.

Recommendation: We call on the federal government to initiate measures—in conjunction with provincial and territorial governments where appropriate—to bring reproductive technology within the public/non-profit sector. We urge the federal government to encourage and support efforts like that of the Manitoba government to reclaim for-profit services for public health care, particularly in relation to reproductive technology.

Knowledge of the genetic building blocks of life forms part of our common human legacy and the public good. It should not be forfeited to the private preserve of giant life science and drug corporations. However, that has been the effect of the government’s over-zealous support for patent protection and its placing of intellectual property rights over the public interest. The Canadian Patent Office is already beset with patent claims on various genetically manipulated human cells.

Recommendation: We call on the government to change the Patent Act to prohibit the patenting of human genetic material and to preempt applications currently before the Canadian Patent Office for patents on genetically engineered human stem cells. We also urge the federal government to play a leading role internationally, in line with the UNESCO 1997 Declaration on the Human Genome and Human Rights, to keep international trade agreements from overriding the health interests of Canadians. This is an important pro-active step toward shaping international trade law to prevent Canada from being obligated to grant patents on human genes in the future.

Women’s Health: A Priority

The rights and health of women must be the first consideration in regulating reproductive technologies. Our approach to reproductive technology must be grounded solidly in the concept of women’s reproductive freedom. This requires the federal government to ensure that reproductive technologies are proven to be safe before being permitted, that the risks and benefits of any treatment for women are fully disclosed, that the evaluation of reproductive health services include women’s experiences and that the funds needed to achieve these objectives are made available.

Currently, women are often not informed about the links between some fertility drugs and cancers or about the real success/failure rates of fertility clinics. Canada’s drug approval process is failing women if unsafe drugs are allowed to remain on the market.

Recommendation: We urge the government to review, on a precautionary rather than risk assessment basis, the safety of fertility drugs currently being marketed in Canada and to promptly remove any drugs of questionable safety. We further recommend that the proposed regulatory body for reproductive technologies establish formal mechanisms to ensure direct input from the Women’s Bureau at Health Canada. It is also incumbent on the government to ensure funding for the participation of the women’s health community in reproductive technology decisions and we recommend that this funding be a mandated budget item.

We support a precautionary approach to women’s health in which the onus is on providers and researchers to prove a procedure’s safety before it is approved for use.

Recommendation: We call for the precautionary principle to be explicitly set out in the legislation as a prerequisite for the approval of all standards and procedures.

A priority on women’s health requires a focus on the causes of infertility. Neglecting the causes of infertility means that women are being subjected to intrusive and risky procedures to treat problems that might very well have been preventable. Sexually transmitted diseases, environmental toxins, workplace hazards and delayed child bearing for economic reasons are well-known contributors to infertility, yet the Committee Report relegates these to "additional concerns".

Recommendation: Prevention must be seen as a central aspect of any policy on reproductive technologies and a key part of the work of any newly established regulatory authority.

Genetics: Who Charts the Future?

Reproductive technology has given us new tools to predict and manipulate our genetic futures. There are negative as well as positive implications. Advocates for persons with disabilities have raised concerns that genetic testing for the purpose of eliminating disabilities is a form of eugenic cleansing that will effectively lead to the bio-medical elimination of diversity. There are further concerns that these questions are being decided by private corporations beyond public control.

Genetic-based discrimination is also an issue. Without regulation, we already see: pre-natal testing taking place without a full knowledge of what is or is not treatable; routine screening of newborns without parental consent; no prohibition of "home" genetic tests; employer demands for genetic testing; and life insurance companies demanding genetic test results as part of customer screening. Since 1993, 30 gene therapy experiments have been approved without any policy framework or national genetics strategy. Without regulation, there are serious safety concerns for persons engaged as subjects in genetic experimentation.

Like organ transplantation, genetics transcends federal-provincial jurisdictional boundaries. It requires a national vision and federal leadership—especially given the extent of commercial activity in the area.

Recommendation: We call on the federal government to move quickly to develop a national strategy on genetics based on respect for human dignity and diversity. We must enshrine specific legal rights, including the right to genetic privacy and informed consent and the right to freedom from all forms of genetics-based discrimination. And we must ensure that persons with disabilities and their organizations are involved in all discussions in this area.

New reproductive and genetic technology must not be used to further marginalize people with disabilities. Policies and legislation must reflect the fundamental principle that every person is unique and by way of their gifts and assets contributes to their own well-being and to the well-being of society as a whole.

Safety is Paramount

Above all, the area of reproductive and genetic technologies needs a strong regulator. The Committee recommendations for a regulatory framework are a step in this direction. The proposal for a quasi-independent regulatory body is an acknowledgement of the frequently voiced call for independence, transparency, accessibility, accountability and diversity. However, the central requirement for active, not passive regulation in this area remains a key concern, whether the regulatory authority is housed within government or an external agency. A precautionary approach takes more than the establishment of a new structure. It requires a commitment from government to support active oversight and a halt in its pursuit of the passive risk-management model. If we have learned anything from the tainted blood tragedy, it is that when safety is not foremost, Canadians pay with their health and their lives. The recommendations of Justice Krever for this country’s blood system are equally applicable to reproductive and genetic technologies. Accordingly, it is imperative that a national safety system include the capacity, the resources and the mandate to actively identify the risks that threaten the safety of those involved, conduct frequent inspections of fertility clinics, strictly enforce all regulatory requirements, communicate promptly and constantly review the scientific and medical literature.

As Justice Krever stated, a regulatory authority must not assume a passive or responsive role, or rely on a philosophy of voluntary compliance to protect the health of Canadians. The regulations governing this area must be strictly enforced and the actions taken by those involved to comply with the regulatory directives must be closely monitored.

When taken as a whole, the government’s performance to date casts serious doubt on its intention to arm a regulatory agency with the mandate needed, backed by the tools and resources needed. The strength of political will is the determining test for any regulatory effort. It signals those charged with enforcement and it signals those engaged in regulated activity. The strongest possible commitment to the ongoing regulation of reproductive technology must be evident in the mandate of the regulatory body and the urgency with which the government acts to bring in legislation.