Is research in Canada limited to "surplus" embryos?

• Author: Johnston, Josephine

Introduction

From the moment Canada's Assisted Human Reproduction Act (then known as Bill C-56) was introduced to Parliament in May 2002, much public debate focused on those few provisions that would affect embryonic stem cell research. Specifically, debate centered around the Bill's prohibitions against creating a cloned embryo and against creating an embryo for "any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures." (1) By these two prohibitions, the Bill effectively prohibited the creation, by cloning or other means, of embryos specifically for use in many kinds of research, including stem cell research. Contravention of these prohibitions became a criminal offence when the Bill became law on March 29, 2004, with guilty persons liable for fines of up to $500,000, ten years imprisonment, or both. (2)

It has been assumed that the prohibitions in the Assisted Human Reproduction Act [the Act] limit embryo research to what are sometimes called "unused," "spare," or "surplus" embryos. That is, that the Act limits research to embryos originally created in the course of fertility treatment that were not in fact used by the woman or couple undergoing fertility treatment and that are now in frozen storage pending destruction or donation to another woman or couple. (3) While it is clear that such surplus embryos exist in Canada (although the numbers are much lower than is often suggested, simply because many frozen embryos are not yet surplus (4)), it is not clear that the Act limits research to these surplus embryos. As this commentary will show, a strict reading of the Act permits the creation of embryos for certain kinds of research as well as the conduct of research on embryos that are not-yet-surplus, including on fresh embryos that might otherwise be frozen for later use in a pregnancy attempt.

The Assisted Human Reproduction Act

The Act primarily serves to regulate the provision of assisted reproductive services. However, because it became law at a time of great scientific interest in, and significant debate over, embryonic stem cell research, much of the parliamentary and public debate accompanying the passage of the Act focused on two of its prohibitions. These prohibitions are contained in paragraphs (a) and (b) of section 5(1) of the Act and they outlaw the creation of a cloned embryo and the creation of an embryo for "any purpose other than creating a human being or improving or providing instruction in assisted reproduction procedures." (5) The prohibitions were seen by some critics as hindering the progress of scientific research (particularly stem cell research), as inappropriately using criminal sanctions to regulate scientific research, (6) and as instituting cumbersome prohibitions instead of flexible regulation. (7) These same provisions were criticized by other groups and individuals for not containing a blanket ban on the use of embryos in research, and for thus implicitly condoning the intentional destruction of human life for the sake of scientific research. (8)

In defending both the prohibition contained in section 5(1)(b) and the absence of a complete prohibition on the research use of embryos, Canada's Health Minister, Anne McLellan, argued in the House that "[i]t would be up to the couple to choose whether their unused embryos would be discarded or donated either for research or to other infertile Canadians." (9) In discussion with the media, McLellan asked reporters: "Do you know what happens to surplus embryos? Do you know what happens? They go in the garbage." (10) In both these comments, McLellan assumed that the Act would limit research to surplus embryos as defined above: that is, to embryos originally created in the course of fertility treatment that were not in fact used by the woman or couple undergoing fertility treatment and that were in frozen storage pending destruction (McLellan did not mention the possibility of donation to another woman or couple). Yet, the Act contains no provision to that effect.

What the Act does do in section 5(1)(b) is stipulate the only three legitimate reasons for creating human embryos: to create a human being, to improve assisted reproduction procedures, or to provide instruction in assisted reproduction procedures. Strictly interpreted, the first reason requires that anyone creating an embryo do so with the intention that the embryo be transferred to a woman in the hopes of eventual live birth of a child. (11) The second and third reasons act as exceptions to the first, permitting the creation of embryos that are not intended to eventually lead to a live birth, provided those embryos are intended for use to improve assisted reproduction procedures or to provide instruction in assisted reproduction procedures. "Improve" and "provide instruction in" are not defined in the Act, but "assisted reproduction procedure" is defined to include the alteration, manipulation, treatment, or use of an in vitro human embryo for the purpose of creating a human being. (12) These exceptions to the prohibition against creating embryos for non-reproductive purposes could capture, for example, the creation of embryos for use in research aimed at improving methods of injecting sperm into eggs or the creation of embryos for use in testing equipment or instructing trainees in methods of freezing and thawing embryos. Therefore, under the Act, embryos can be created for defined non-reproductive purposes including particular kinds of research. Nevertheless, much research that uses human embryos, including most (although not all) (13) embryonic stem cell research, will not fall under the terms of section 5(1)(b) of the Act because it does not aim to improve assisted reproduction. (14)

By limiting the purposes for which embryos may be created, the Act limits the embryos that may be used in research to those that were originally created for assisted reproduction or for assisted reproduction improvement or instruction. Thus, researchers, including embryonic stem cell researchers, must seek embryos either from women and couples who are undergoing, or who have undergone, assisted reproduction or from fertility clinics that created the embryos for improvement or instruction purposes (under the Act, clinics need to obtain consent from donors before creating embryos for these purposes). (15) There is no data available on how many embryos are created in Canada for use in improving or providing instruction in assisted human reproduction [AHR] procedures. In fact, anecdotal evidence indicates that clinics do not typically create embryos for this purpose, (16) and survey data shows that clinics use embryos donated by women and couples (including because such embryos were not considered suitable for transfer) to improve procedures or provide instruction. (17) I will therefore proceed on the assumption that most embryos donated to research will originally have been created for the reproductive use of women and couples, rather than for improving or providing instruction in assisted human reproduction procedures even while I note the possibility of these embryos for subsequent use in other kinds of research.

Importantly, the Act does not say anything about when women and couples may donate their embryos to research. There is no requirement in the Act that women and couples complete their assisted reproduction before they donate embryos to research or that these embryos be otherwise destined for destruction or donation to another woman or couple. By comparison, the CIHR Updated Guidelines for Human Pluripotent Stem Cell Research [CIHR Guidelines] require that embryos used in embryonic stem cell research be "no longer required for [reproductive] purposes." (18) Similarly, Australia's Research Involving Human Embryos Act 2002 limits research to "excess ART embryos," which are defined as embryos created for use in the assisted reproductive technology treatment of a woman and that are now excess to the needs of the woman or couple for whom they were created. (19)

It is not clear why the drafters of the Canadian legislation did not include language such as that found in the CIHR Guidelines or the Australian legislation as no explicit discussion of this consequence is found in the various official explanations accompanying the bill. (20) The Legislative Summary accompanying Bill C-6 (the last of the three bills that would become the Act) used the term "excess" in referring to the embryos that would be available for research under the Act, noting that "[t]here was also considerable debate on whether research on so-called "excess" in vitro embryos should be allowed. Clause 5(1)(b) prohibits the "creation" of in vitro embryos for any purpose other than creating a human being or improving or providing instruction in AHR procedures, but it does not prohibit their subsequent "use," whether for research or other purposes. Such uses would come under the controlled activity category in clause 10(2) and would thus require a licence and compliance with the regulations." (21) However, this discussion, like that of the Minister cited above, also appears to assume that embryos used in research under the Act would be "excess" or surplus embryos, although the Act contains no provision to that effect. Indeed, on a strict interpretation of the Act, women or couples can create embryos specifically for use in certain kinds of research, and they can also donate fresh or frozen embryos originally created for reproductive purposes to research before they have completed assisted reproduction, including embryos that are not-yet-surplus.

Compatibility with CIHR Guidelines

In its Updated Guidelines for Human Pluripotent Stem Cell Research, CIHR limits human pluripotent stem cell research (otherwise and hereafter known as embryonic stem cell research) to embryos that "whether fresh or frozen, were originally created for reproductive purposes and...