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Donate a definition.

Statutes employ definitions to give content to the law. Bill C-13, the Assisted Human Reproduction Act, (1) is no exception. Definitions, by definition, give meaning to terms, explain their scope, clarify, or fix with precision. (2) Definitions are especially critical for research with novel genetic technologies such as embryonic stem cell research. Bill C-13 prohibits the conduct of research with an in vitro embryo without the consent of the embryo "donor." (3) But the meaning of this term is deferred to the regulations. (4) While this move is straightforward from a legislative drafting perspective, it is not clear that this is an appropriate policy choice. The wisdom of this choice is analysed below.

I. Who Are the Embryo Donors?

Section 8(3) of Bill C-13 declares that,

No person shall make use of an in vitro embryo for any purpose unless the donor has given written consent, in accordance with the regulations, to its use for that purpose.

Breach of this would-be statutory prohibition incurs a maximum fine of $500,000 and/or a maximum often years in prison. (5) Section 3 of the bill defines "donor" as follows:

"donor" means

(a) in relation to human reproductive material, the individual from whose body it was obtained, whether for consideration or not; and

(b) in relation to an in vitro embryo, a donor as defined in the regulations

Only part (b) of this definition is relevant to s. 8(3).6 The identity of the embryo donor is unknown within the four comers of this bill. Therefore, a huge gap in the prohibition against the use of an in vitro embryo for research without the "written consent" of the donor remains. (7) The Governor-in-Council could clarify this definitional omission by enacting regulations. However, s/he is not obligated to do so. Arguably, because Bill C-13 is apt to be characterized as a public interest statute of considerable import, any failure to provide a definition of this term would not necessarily render s. 8(3) a nullity. Rather, some meaning could be implied when and if the matter came before the courts. Essentially, the precise meaning of the term embryo donor would be open for debate.

II. Who Could Be the Embryo Donors?

No one is, without question, an embryo donor under Bill C13, as it is currently written. But the answer to this question of identity is not indeterminate. True, there are several possibilities to take into account. An embryo donor may be an individual who either alone or with another individual, has requested IVF services, in the course of which the gametes of that individual (or both individuals) are used for the creation of embryos. That is, the embryo donors are the individuals who have utilised IVF services and who have provided their own gametes during the course of those services. Alternatively, an individual or individuals who make use of IVF services may not be able to use their own gametes for embryo production. Gametes donated by other individuals for reproductive purposes will be necessary. In that case then, the embryo donor(s) and the gamete donor(s) are not one and the same individual(s). Thus, the embryo donors can be the individuals participating in the IVF services, the individuals who provid ed their gametes for the use in IVF services, or both. Conceivably, the clinic itself, or other third parties who are charged with storing, transferring, importing or exporting embryos, (8) could also be deemed embryo donors. This is perhaps most likely where a couple, which had enlisted IVF services in the past, has abandoned excess embryos remaining from treatment.

III. Why Not Choose a Definition?

In light of all these possibilities, the federal government may hold the view that it is better to leave the definition open-ended by making the definition a regulatory matter. This policy decision may be premised upon at least two rationales.

The first rationale concerns added flexibility and efficiency: regulations can generally be enacted in very short periods imposing significantly less strain on scarce legislative resources, and with next to no public debate. Also, given the dynamic nature of this area of embryo research, being amenable to change may be desirable. The second rationale is much more political: the government may wish to avoid taking a stance on this issue. Other parts of Bill C-13 are extremely controversial, so why not try to minimise debate wherever possible? For example, the government could feel forced to choose between whether the consent of one individual (e.g. a woman) alone or both individuals is sufficient. Whether same-sex couples may be characterized as embryo donors is also a live issue. The drafters would have to provide for the situation where the embryo donors and the gamete donors are not the same individuals. The legislation might also specify whether other persons, such as companies who are licensed to transpor t embryos, are donors as well. Finally, if the embryos are imported from another country, is the consent of the persons from whom they are obtained, whether private company, IVF clinic, or individual gamete and embryo providers, required?

At this stage in the legislative drafting process, it is necessary to examine whether these rationales provide sufficient justification for the conscious decision to not identify who is or are the embryo donors for the purpose of a criminal prohibition.

Consider the flexibility-efficiency rationale. Bill C-13 contains special provisions for a regulation-enacting procedure that is totally atypical. (9) The Governor-in-Council must bring regulations before both Houses of Parliament, facilitating public disclosure and possibly stimulating detate. (10) Thus, the discrepancy in time and cost between modifying a piece of legislation and passing a set of regulations is greatly narrowed. In fact, the period for which a regulation need be before the House of Commons is potentially greater (60 days) than the fastest time during which legislation can be passed (24 days). (11) In terms of scientific considerations, assuming therapeutic cloning remains banned, (12) any move to alter the definition so that only the consent of the donor of the ovum would be necessary, for example, would just not make sense. Therefore, this is not a strong basis for favouring the current no-content definition of an embryo donor.

The second rationale--circumventing more controversy--is also problematic. To begin, failing to define this term in the legislation conflicts with some basic attributes of laws; namely, certainty and transparency. How effective will a prohibition be without naming the wronged party? (13) Moreover, in Canada the principle of informed consent is deeply entrenched in the common law. (14) In the context of research ethics, informed consent is perhaps the most basic and fundamental requirement. (15) To be sure, this provision is distinguishable insofar as the donors, whoever they might be, are not consenting to take part in a research project themselves. Nonetheless, the informed consent principle has been highlighted in this scheme as well. On the recommendation of the Standing Committee, the drafters elevated the status of this principle by moving it from the preamble to a formal declaration within the bill itself, in addition to the prohibition formulated in s. 8(3). (16) Provided that the conduct of research with an embryo without the consent of the donor is a definitive "public evil" (17) deserving of criminal prohibition, it is appropriate to make this adherence to the principle of informed consent more than superficial by clearly identifying the embryo donor(s).

There are additional reasons for the federal government to give content to the definition of an embryo donor within the confines of the legislation. For instance, while it is fair to assume that someone's consent would be obtained even without further specification, it does not follow that the "who" would be consistent across research endeavours. The potential disconnect between gamete and embryo donors, has escaped the mind's eye of policy-makers in other countries. (18)

This uncertainty could also give rise to litigation. In an analogous situation, whether an embryo created by therapeutic cloning met the definition of an "embryo" as stated in the Human Fertilisation and Embryology Act of the United Kingdom, was disputed all the way to a UK Court of Appeal. (19) Because such an entity is not created by fertilisation, the Pro-Life Alliance argued that the cloned embryos were not subject to the regulatory scheme of the Act at all. The Court of Appeal did not find this reasoning persuasive. The spirit of the Act extended beyond its narrow wording, and exempting cloned embryos from its purview would clearly be contrary to its stated objects. (20) Fair enough--Canadian courts could employ similar manoeuvring to establish donor identity. But why not avoid lengthy and costly litigation a priori by defining the term in the relevant section of the proposed legislation?

IV. What Are the Options?

Drafting a clear and concise definition of donor in relation to an in vitro embryo and s. 8 is by no means facile. The following are a few suggestions that may help the federal government to clarify its position.

If the government believes that an embryo donor for the purposes of s. 8(3) can be either one individual or two individuals together and only the consent of the individual or individuals who sought to have an embryo created for reproduction is needed, the following definition could be employed:

"donor" means the individual (female or male) or the individuals (whether opposite- or same-sex) who has or have had an embryo created in pursuit of a reproductive goal

Alternatively, the drafters of Bill C-J3 may want to recognize the intentions of those individuals who originally consented to the use of their gametes for reproduction, by requiring their consent to research as well:

"donor" means the individual (female or male) or the individuals (whether opposite- or same-sex) who has or have had an embryo created in pursuit of a reproductive goal where the gametes used to create the embryo are the gametes of those same individuals; where the gametes are those of different individuals then those individuals are also to be considered donors for the purposes of s. 8(3)

Of course the federal government may choose not to specify whether the donor individual can be of either sex, and/or whether individual couples must be opposite- or same-sex. If other third parties (e.g. IVE clinics) are thought to be potential donors, then this should be expressly stated. However, naming such third parties as embryo donors for the purposes of the prohibition ins. 8(3) seems inconsistent with the principle of informed consent. The interests of such third parties clearly contrast with the interests of the gamete providers and/or the individual(s) undergoing IVE, vis-a-vis donor embryos. The latter interests should be the ones that Bill C-13 aims to protect.

V. So...Donate a Definition

Bill C-13 leaves the definition of an embryo donor devoid of meaning. Opinions differ as to the appropriateness of a number of the other prohibitions contained in this bill. (21) Yet the importance of informed consent in this context is indisputable. The right thing to do is this: take the basic first step and identify the embryo donor(s). Flexibility, efficiency, and politics do not provide ample justification for any other (in)action. Moreover, this policy choice runs contrary to the objects of the bill as a whole. Section 2 of the bill declares in part:

...the benefits of assisted human reproductive technologies and related research for individuals and for society in general can be most effectively secured by taking appropriate measures for the protection and promotion of human health, safety, dignity and rights in the use of these technologies and in related research;

the principle of free and informed consent must be promoted and applied as a fundamental condition of the use of human reproductive technologies;

The federal government is surely cognizant of the possibility that the definitions used in Bill C-13 do not have to be of the all-or-none variety. In other words, should they give content to the term embryo donor, they could add the qualifying phrase "subject to the regulations." But the failure to do anything, to leave a key term undefined, may frustrate the purpose of the bill in its entirety.

(1.) 2d Sess., 37th Pal., 2002 [Bill C-I 3] (1st reading 9 October 2002).

(2.) See The Canadian Oxford Dictionary, s. v. "define."

(3.) Bill C-13 supra note 1, s. 8(3).

(4.) 4. Ibid., s. 3.

(5.) Ibid., ss. 60-61.

(6.) It is worth noting that Health Canada, in the Proposals for legislation governing assisted human reproduction, (draft 2001), online: Health Canada <http://www.hc-sc.gc.ca/english/pdf/repoduction/legislation.pdf> (date accessed: 15 September 2002), refers only to an embryo, not an in vitro embryo. Strictly interpreted then, the prohibition equivalent to Bill C-13's s. 8(3) contained in the Proposals for Legislation may not have required the consent of the donor(s) of the in vitro embryo -- the only type of embryo that would be used in research. The drafters of Bill C-13 have since corrected this error. The donated object -- the in vitro embryo -- is now in both the prohibition and definition sections.

(7.) This shortcoming has already been brought to the attention of the Standing Committee: see F. Baylis, "Brickbats and Bouquets for the Draft Legislation on Assisted Human Reproduction" (2001) 10 Health L. Rev. 3 at 4.

(8.) All of which are licensable controlled activities: see Bill C-13, supra note 1, s. 10(3).

(9.) Ibid., ss. 66-67.

(10.) The exceptions outlined in s. 67 of Bill C-13 would not appear to apply to the circumstances surrounding obtaining consent for embryo research. Possibly the regulation could be made "immediately in order to protect the health or safety of any person" (s. 67(b)).

(11.) Bill C-13, supra note 1, s. 66(3) provides that a regulation may be made "on the expiry of 60 calendar days after the proposed regulation is laid before Parliament" or "at an earlier time when the committees of both Houses of Parliament have reported their findings with respect to the proposed regulation." In theory, legislation can be enacted in only 24 days: see F. Baylis & J. Downie "Ban Cloning Do You Copy?" The Globe & Mail (3 July 2002) A13.

(12.) In its present form, Bill C-13 effectively prohibits both reproductive and therapeutic cloning via s. 5(1)(a), which reads: "no person shall knowingly... create a human clone, or transplant a human clone into a human being." Once again, the operation of this prohibition is contingent upon the definition of the crucial term: "human clone" means an embryo that, as a result of the manipulation of human reproductive material or an in vitro embryo, contains the same nuclear deoxyribonucleic acid sequence as found in the cell of a living or deceased human being, foetus or other embryo": see Bill C-13, supra note l, s. 3.

(13.) Moreover, the prohibition may itself be subject to attack. Supposing an individual was charged with breaching this provision of Bill C-13, s/he could argue that because embryo donor is undefined the law was not knowable in advance, and therefore in violation of the principles of fundamental justice as entrenched in the Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (U.K.), 1982, c. 11: see for e.g., U.N.A. v. Alberta (Attorney General) (1992), 13 C.R. (4th) 1 (S.C.C.).

(14.) Reibl v. Hughes, [1980] 2 S.C.R. 880; Hopp v. Lepp, [1980] 2 S.C.R. 192.

(15.) See Halushka v. University of Saskatchewan et al. (1965), 55 W.W.R. 608 (Sask.C.A.).

(16.) For a full list of the Standing Committee on Health's recommendations, delivered in December 2001, see online: Parliament of Canada <http:\\www.parl.gc.ca/ InfoComDoc/37/1/HEAL/Studies/Reports/healrp01/09-rec-e.htm> (date accessed: 15 September 2002).

(17.) On repeated occasions, the Supreme Court of Canada has endorsed the view that criminal prohibitions are directed at remedying various forms of "public evil"; see for e.g., Reference re Validity of Section 5(a) of the Dairy Industry Act, [1949] S.C.R. 1; see also RJR-MacDonald Inc. v. Canada (A.G.), [1995] 3 S.C.R. 199. The federal government has stated that its jurisdiction to enact legislation in this realm is premised upon its jurisdiction over the criminal law under s. 91(27) of the Constitution Act, 1867 (U.K.), 30 & 31 Vict., c. 3, reprinted in R.S.C. 1985, App. II, No. 5; see T. Caulfield, "Clones, Controversy, and Criminal Law: A Comment on the Proposal for Legislation Governing Assisted Human Reproduction" (2001) 39 Alta. L. Rev. 335 at 344.

(18.) M. Herder, "The U.K. Model: Setting the Standard for Embryonic Stem Cell Research?" (2001) 10 Health L. Rev. 14.

(19.) R (on the application of Quintavalle on behalf of Pro-Life Alliance) v. Secretary of State for Health, [2002] E.W.C.A. Civ. 29.

(20.) Ibid., especially at paras. 37-38, 40-41.

(21.) See T. Caulfield, supra note 17; contrast F. Baylis & J. Downie, supra note 11.

Matthew Herder, Research Assistant, Department of Bioethics, Dalhousie University. Halifax, Nova Scotia.

The author would like to thank the members of the Novel Genetic Technologies Research Team for their great comments on drafts of this paper. in particular Francoise Baylis and Jason Robert. As well, the author would like to thank Professor William Lahey for his remarks on an early version of this paper. Thanks are also owed to the law firm of McCarthy Tetrault LLP, and the Stem Cell Network, a member of the Centres of Excellence, for supporting this research.
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Title Annotation:Canada; Assisted Human Reproduction Act
Author:Herder, Matthew
Publication:Health Law Review
Date:Dec 22, 2002
Words:2953
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