New Reproductive Technology Bill Awaits Delivery

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By Penni Mitchell

Spring is in the air and the federal government is soon expected to deliver new legislation on new reproductive and genetic technologies or NRGTs. The bill is expected to be comprehensive and will likely start where the government's last attempt to regulate the technologies, Bill C-47, left off. For starters, expect a ban on the buying and selling of the products of human reproduction: including eggs, sperm, zygotes, and so-called "surrogacy arrangements." Bill C-47, an initial attempt to prohibit what are considered by many to be the most repugnant tests, procedures and experiments, died on the order paper when the federal election was called last spring.

The new-and hopefully improved- bill is expected to give rise to a new era in bio-ethical medicine and human research. It is anticipated to include prohibitions on germ-line genetic alteration; the development of artificial wombs and the retrieval of sperm or eggs from cadavers or eggs from fetuses. The legislation is expected to limit human embryo research and prohibit gametes from being used without the informed consent of the donors.

Right now, Canada has a voluntary moratorium on some NRGTs, but no laws governing or prohibiting their use. When Bill C-47 was first introduced in 1996, some private fertility clinics balked at the proposed prohibitions and vowed to ignore them. Meanwhile, women's advocacy groups who first conceived of the need for government legislation on NRGTs more than 10 years ago, were disappointed the bill didn't include an overall education and management structure that would establish the conditions under which new tests and procedures could be introduced. The Royal Commission on New Reproductive Technologies published its mammoth, two volume report Proceed With Care in 1992. Headed by geneticist Patricia Baird, the Commission recommended a comprehensive, ethics-based approach to regulation, licensing and prohibitions. The federal government responded with a selective approach that introduced a voluntary moratorium on certain procedures in 1995. Since then, an advisory committee on New Reproductive and Genetic Technologies has been monitoring moratorium compliance and advising the federal government. The advisory committee is chaired by Dr. Sheilah Martin, Dean of the Faculty of Law, University of Calgary.

In 1997, Scottish researchers claimed to have cloned a sheep using an adult sheep's udder cell, and public awareness of the potential dangers of unregulated NRGTs has since increased. Responding to widespread opposition to research that would lead to human cloning, 19 European partners signed a treaty banning human cloning in January. Health Minister Allan Rock's new bill, like C-47, will likely include the same prohibition.

Even more important, however, will be the bill's handling of the crucial issue of licensing and regulation enforcement. It is expected to govern private clinics and outline a regulatory structure to enforce regulations on experiments and practices involving gametes, zygotes and embryos. Private clinics are not currently licensed and some offer zygote freezing, in vitro fertilization, 'sex selection' for abortions, and sperm and egg storage.

Some women's health advocates are cautiously optimistic that the government will adopt a framework that emphasizes caution. There is also a concern, however, that the government's trend toward deregulation and privatization could make it a hard sell in cabinet for an approach firm on restrictions, licensing and inspections. Lobbying by the powerful pharmaceutical lobby is also a factor that could change the bill's chemistry.

No one knows for sure what will be in the bill, but the latest Health Canada discussion paper, Setting Boundaries, Enhancing Health contains many clues, according to Health Canada officials. The paper says that new legislation must protect the dignity and security of women and children and ensure "the appropriate treatment of human reproductive materials." But who will get to decide what is 'appropriate'?

Abby Lippman, a Montreal health researcher and co-editor of Misconceptions: The Social Construction of Choice and the New Reproductive and Genetic Technologies, notes that NRGTs are a hydra-headed problem: it is impossible to deliver certain procedures without unleashing others. For example, with in vitro fertilization (IVF) comes freezing zygotes, since it's both costly and painful to remove eggs from women, and the low success rate for IVF means many attempts are usually made. Freezing zygotes raises ethical problems that lead to legal and moral issues. Should zygotes be disposed of at some point? What right do children born from sperm 'donors' have to genetic information? Who "owns" unimplanted zygotes? Should zygotes be subjected to genetic testing or manipulation?

Pre-natal diagnosis is another complex set of 'what ifs' given new emphasis by the NRGTs. Although 'genetic counselling' may sound like state-of-the-art health care, disability rights groups suggest that more and more counselling on fetal testing puts pressure on women to detect and abort fetuses that may have certain deformities or illnesses.

Contemplating the most effective way to spend limited health resources is unavoidable. For example, would spending more to prevent the known causes of disabilities be a wiser investment than more tests to detect certain conditions in fetuses? These questions are compounded by a rush toward high tech, expensive treatments that attempt to bypass infertility. More cost effective public health policies aimed at preventing sexually transmitted diseases-a huge cause of infertility-now appear less attractive.

While a wide range of women's advocates will be looking for strong regulation and prohibitions, expect most private fertility clinics to argue for few regulatory measures or prohibitions. Infertility groups will be looking for an approach that will stress informed consent and choice.

Taking all of these concerns into consideration, it will be essential for the government bill to have a strong preamble to set the tone for establishing a framework for all NRGTs. With many of the 'grey areas' left to the licensing and regulation body, the overriding question becomes, 'who gets to decide'? Consumers, medical and bio-ethicists, children's and disability rights advocates and women's health advocates will want to make sure that those with a strong base in ethics and public health, not commercial interests (pharmaceutical companies, private fertility clinic doctors) will be in control.

Whether the bill is viable will depend partly on the process of debate, so get involved. Once the bill is tabled, you can call for a copy at (819) 956-4800. You can make a presentation to the Standing Committee on Health when it holds public hearings.

Some things to look for when the new NRGT bill is tabled:

A list of prohibitions (from the 1995 Interim Moratorium):

  1. sex selection for non-medical purposes;
  2. buying and selling of eggs, sperm and embryos, including their exchange for goods, services or other benefits;
  3. germ-line genetic alteration;
  4. ectogenesis (maintaining an embryo in an artificial womb);
  5. creation of animal-human hybrids;
  6. retrieval of sperm or eggs from cadavers or fetuses;
  7. commercial "surrogacy" arrangements.

Look for these additional prohibitions:

  1. transfer of embryos between human and other species;
  2. use of human sperm, eggs or embryos without informed consent of the donor(s);
  3. research on human embryos later than 14 days after conception;
  4. creation of embryos for research purposes only,
  5. offer to provide or offer to pay for prohibited services.

From Setting Boundaries, Enhancing Health, Health Canada June 1996.

Additional Resources:

Have your own briefing on the issue while you wait:

  • New Reproductive and Genetic Technologies: Setting boundaries, Enhancing Health, June 1996. (Minister of Supply and Services)

  • Proceed with Care, the final report of the Royal Commission on New Reproductive Technologies, 1992. (Minister of Supply and Services)

  • Misconceptions. The Social Construction of Choice and the New Reproductive and Genetic Technologies, Editors Gwynne Basen, Margrit Eichler, Abby Lippman, Voyageur Publishing [English and French] 1991.

  • On the Eighth Day, A documentary on new reproductive and genetic technologies, produced by Studio D., the National Film Board. $39.95 Contact: NFB PO Box 6100 Station A, Montreal H3G 3H5 1-800-267-7710.

  • Research on Human Embryos in Canada, Final Report of the Discussion Group on Embryo Research, 1995 Health Canada.