Response to Health Canada's Workbook on Reproductive and Genetic Technologies

Thursday, 09 March 2000
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Introduction

The Catholic Organization for Life and Family (COLF) was jointly founded by the Canadian Conference of Catholic Bishops and the Knights of Columbus to promote respect for human life and dignity and the essential role of the family. Its Board of Directors includes a multi-disciplinary group of bishops and lay men and women.

On March 3, 2000, COLF Board members met with a number of resource people, including scientists, lawyers, educators, ethicists and theologians, to review the questions posed in the Workbook drafted by Health Canada and submitted widely for consideration. The unanimous consensus of the group was that the projected legislation represents a much needed and important initiative of the Government of Canada. As The Final Report of the Royal Commission on New Reproductive Technologies pointed out, the stakes in this area of scientific development are so high and the speed of changes so rapid that a well crafted set of prohibitions and regulations is indispensable. We welcome the opportunity to participate in this process and thank Health Canada for having provided this consultation. In preparing our own response, we will follow the pattern Health Canada proposes by responding to the questions you have listed for consideration.

A Review of the Introduction to the Workbook

While we are not specifically invited to reflect upon this section of the Workbook, the issues addressed within this section represent foundational concerns for the broad topic of reproductive and genetic research and therapy. More to the point, however, the discussions begun there point toward deeply held values of the Canadian culture.

We are not really dealing only with the concrete matters arising from new technologies or therapies; something much more basic is at play here. We are in the midst of a profound questioning of the values and vision which have shaped and which continue to shape our evaluations of new developments. This cannot be emphasized too highly. One must, therefore, pay specific attention to the ethical framework which will structure subsequent decisions. The alternative might well be a simple recourse to functional or situational concerns which provide no way of reflecting or achieving a basic consensus in Canada. Such a limited approach would leave any resulting regulatory organization with little or no framework for dealing with this dynamic area. More than ever, arriving at a consensus in our pluralist culture is a priority. The symbolic structure of values is too important a cultural and social reality to be easily overlooked.

We would propose, therefore, a series of foundational ethical values to shape the dialogue. These represent long-standing principles within the Judeo-Christian community; they are also at the heart of the Canadian political heritage. We list them in order of importance, since the way in which one crafts such a set of values also indicates an understanding of precedence.

We were concerned that in the Workbook precedence is sometimes given to safeguarding the "benefits to individuals and society of reproductive technologies" and to "protecting and promoting human health and safety," and only subsequently to "human dignity and rights." (p. 2; cf. also the way in which human rights and dignity are subsumed under "protecting health and safety" on p. 7.) Given the centrality which human dignity and rights occupies within the Canadian Constitution and within our political and cultural consensus, this strikes us as being of particular concern.1
The following hierarchy of values represents for us a helpful basis for the evaluation of new technologies and therapies. They are foundational to any consideration of either reproductive or genetic technologies and the therapies resulting from them.

  • Respect for the human person, including the dignity, rights and social connectedness intrinsic to the person.
  • Respect for human life from conception.
  • Promotion of human health and safety.
  • Protecting the interests and well-being of children.
  • Particular concern for the burdens borne by women in the area of human reproduction.
  • The non-commercialization, indeed non-objectification, of the human being and of all dimensions of human reproduction, including human gametes and genes.
  • Free and informed consent as a foundational condition of the use of any technology or therapy.
  • Acceptance of human limits with the need to balance access with responsible stewardship of natural goods.
  • At the same time, we note essential ethical principles with respect to the way in which any research or therapy is conducted. These are universally recognized as basic operational principles. They must, therefore, be at the heart of any regime of prohibition and regulation coming from the proposed legislation.
  • Medicine must be evidence-based.
  • All research and therapy as well as any regulatory body must be accountable to the public.
  • The freedom of conscience of providers and institutions in accordance with their vision of the "good life" must be respected.

Taken all together, these values present, we feel, a consistent and useful context within which to adjudicate the various technologies.

Evaluation of the Proposed List of Prohibitions

(Response to question 1.1, p. 6 of the Workbook)

We commend Health Canada for its attention to the much needed differentiation between prohibited and regulated fields of research and therapeutic activity. Clearly, as the Royal Commission pointed out, providing such clear parameters for scientific and medical activity is essential. We have framed our own reflections in dialogue with the recommendations of the Royal Commission and the Council of Europe and UNESCO documents, all within the traditional ethical framework within which we operate. We will address each prohibition in turn, noting both the benefits and concerns arising from each. We adopt as our own the listing of prohibited topics provided by the Workbook.

cloning for the purpose of creating another human being

  1. With respect to "cloning", we endorse fully the prohibition of human cloning as being inconsistent with the dignity to be afforded the human person and human reproduction. Nevertheless, we are concerned with the wording of the proposed prohibition. While clearly the intention of the authors in modifying the prohibition with "for the purpose of creating another human being" was to strengthen and clarify the prohibition, the clause has exactly the opposite effect. Current reproductive and genetic technologies are revealing the ways in which cloning can also aim not simply at "creating another human being" but at using clones (notably through twinning) for diagnostic or therapeutic purposes which aim at using or destroying the clone. The wording, ironically, opens up areas of development which should be prohibited. We would urge, therefore, a total prohibition of all cloning involving human cells or gametes and resulting in a human embryo(2) whatever the resulting objective of the procedure.

fusion of a human cell with the cell of another species or fusion of a human embryo with the embryo of another species, for the purpose of creating a viable organism 

  1. We have the same concern with respect to the "fusion of a human cell with the cell of another species or fusion of a human embryo with the embryo of another species." Again, the way in which the prohibited purpose of the procedure actually narrows what is concretely rejected is problematic. The final document must emphasize respect for the human person and prohibit any such fusion which results in a human embryo regardless of the purpose of such an action.

germ-line alteration (modifying a human genome such that the modification can be passed on to descendants) 

  1. With regard to "germ-line alteration," while we appreciate full well the promise which such a therapy may hold for the future, the absolute prohibition must stand both because of potential hazards to the human genetic heritage resulting from such therapy and of the treatment of the human embryo implied in such alterations.

use of the cells of entities that do not have the capacity to consent to their use (embryos, foetuses, anyone under 18 years of age, or a corpse), to create an embryo, foetus or person. The legislation could also prohibit anyone from using gametes from a corpse for research purposes, unless the person had consented to this specific use prior to death. The legislation could also prohibit anyone from using a cell of a person taken prior to create an embryo, foetus or human being after the death of the person. 

  1.  We welcome the affirmation of the need for specific consent of the person(3) to the use of any cells in reproductive or genetic research, though here too we are concerned that the objective of the action ("to create an embryo, foetus or person") actually authorizes a significant range of potential options which could be seriously problematic, as noted above in dealing with cloning and fusion.
    1. We are also concerned about the modalities of such a limit. At the moment, people often give a global permission for the use of tissues after death, notably to facilitate transplantation; specific distinction has to be made regarding human gametes and human genetic material such as cell nuclei. These must be clearly distinguished from other "tissue" in global permissions; at the same time, specific permission for reproductive and genetic research or therapy must be obtained.
    2. We would also note that this prohibition raises the critical issue of the use of frozen embryos in research. The legislation must prohibit research upon frozen embryos since a permission for the use of human cells in research or therapy could be extended to include such embryos. As distinct human beings, these embryos must be protected; no sense of "ownership" of an embryo should be permitted, only a sense of "guardianship" or responsibility.

sex-diagnosis or sex-selection, unless for purposes related to the health of the embryo or foetus  

  1. Concerning "sex-diagnosis or sex-selection" we endorse the prohibition of such activity. This represents a critical social and ethical concern. We would raise three remaining areas of concern.
    1. First, the modification of the prohibition for "health" raises potentially the issue of eugenics, a morally problematic concern; the legislation must attend to this issue.
    2. Second, specific attention must be paid to the cultural issues which can result in pressures for sex-diagnosis or sex-selection.
    3. Third, the modifying clause may actually open the way to significant pressure for eugenic or discriminatory activity. This must be carefully addressed.

maintenance of an embryo outside the human body after the 14th day following fertilization. Time spent in a frozen state would be excluded from calculation of this time frame.

  1. The limitation of the maintenance of embryos outside the human body is very important; the dignity of the embryo must be preserved. The whole issue, however, raises the important concern for the good of the child. Scientific research, notably in the psychological field, emphasizes the importance of the maternal environment to developing human life. Legislation must address this issue and note this critical issue placing the good of the child at the forefront of all considerations.
    1. We recommend the prohibition of the freezing of human embryos as this objectifies the human life involved, and leads to the problem of what to do with unclaimed "spare embryos".
    2. To deal with the consequent problem of the need to require the woman to undergo treatment for retrieving more ova should I.V.F. therapy be unsuccessful, we urge that research funds and efforts be devoted to developing means of freezing ova for possible future use.

trans-species implantation (human gamete, embryo or foetus in an animal, or vice versa)  

  1. Concerning trans-species implantation, we are pleased that Health Canada has included this area in the list of prohibited procedures, notably since recent scientific advances make this increasingly probable. We would note, moreover, that the development of an "artificial uterus" also now does not lie beyond the realm of possibility. While such a reality could provide important resources in the therapeutic care afforded to embryos, any emerging legislation or regulation must provide a clear affirmation of the concern mentioned earlier for attention to the unique and necessary maternal environment provided for a developing foetus or embryo. This would be an essential element of any legislative regime.

advertising and commercialization of any of the above practices  

  1. We applaud the bold statement of prohibition of "advertising and commercialization of any of the above practices." Clearly, given the pressure for development and implementation arising from market forces, such an absolute barrier is necessary. We affirm also that the broader issue of the commercialization of the entire realm of reproductive and genetic research must be taken into account. Even the linking of this proposed legislation to the control of Food and Drugs notes the way in which we are dealing with an industry wherein the controlling forces are more often economic than either ethical or those of "good medicine." While market forces certainly have their legitimate role, as ultimate criteria for action they create serious problems, often disadvantaging the most vulnerable, in this case especially foetuses, embryos, children and women.

commercialization of surrogacy. The payment, offer of payment and advertising the payment of consideration to a woman to act as a surrogate mother could be prohibited. Similarly, the payment, offer of payment and advertising the payment of consideration to another person to arrange for the services of a surrogate mother could be prohibited. Surrogacy itself would not be prohibited.  

  1. The question of surrogacy as presented in the Workbook does address many of the most significant ethical and legal issues. We note, however, the way in which a prohibition can actually permit the practice while depriving people of recourse in difficult situations. The Civil Code of Québec, for example, declares null and void any contract entailing surrogacy. The impact, however, is both to permit surrogacy (as long as there is no problem in the relationship, it never becomes "public") and to deprive people of legal recourse (the contract being null and void, courts cannot adjudicate the situation). The eventual law must address this in a way which prevents any commercialization of this area, not merely depriving it of a legal form. The commercialization of the relationship between a woman and child and between a woman and her body is seriously problematic and contradicts our most basic assumptions regarding such realities. We note as well that because of such concerns, the Catholic community has rejected surrogacy categorically, even when it is used for "noble" purposes, as within a family, one of whose members is unable to bear a child to term. We would prefer an outright ban on the procedure as inconsistent with the dignity of the child and the woman. We shall return to this consideration below.

the inducement of a woman in a dependant relationship with the contracting party to become a surrogate mother, and the provision of medical services to assist a women to become a surrogate mother in such circumstances  

  1. Certainly any "inducement of a woman in[to] a dependant relationship" must be prohibited for the reasons previously given. Similarly, the use of the medical community to support such relationships violates the nature of care of the patient, in this case both the woman and the child. We note two serious concerns which arise from our perspective.
    1. First, any surrogate relationship is by nature "dependant." The woman in question always depends upon those who construct the implied contract. One must act to prevent such a clear violation of the dignity of the woman.
    2. Second, the structure of the proposed prohibition which requires the providers of medical care to ascertain whether such a "dependant relationship" exists raises key concerns. How is the physician or technician to recognize that such a case exists?

the sale, purchase, barter or exchange, or advertisement for transactions of human gametes, embryos and foetuses, including any parts thereof. Reimbursement for reasonable expenses associated with collection, storage or distribution of humangametes, embryos and foetuses would be allowed. The prohibition could extend to the purchase and sale of human genes for the purpose of creating a human being (purchase of human gene lines for scientific research purposes would not be prohibited, for example).  

  1. As to prohibition of the commercialization of "transactions" in human gametes, embryos and foetuses, we applaud the stance suggested by the Workbook. This has to be a key element of any eventual legislation to defend the dignity of the persons involved. We would raise a number of questions to help the clarification and implementation of this prohibition.
    1. The first sentence of the proposal assumes a state of equality in those engaged in such transactions. All too often, pressures of various kinds can severely limit the freedom of people. For example, those who are often desperate to have I.V.F. technology available to them in effect "give" eggs to another to receive funds for the procedure; it is unclear whether the prohibition as stated would deal with this issue.
    2. Second, the issue of "reimbursement" in the second sentence raises serious issues. As with many current pharmaceutical trials, the line between "reimbursement for reasonable expenses"and profit is a very fine one. Sperm banks currently operate as a source of income, akin to blood clinics in the United States; the same can be said for the trade in ova. This affirms the need within the regulatory regime for a closer scrutiny of present patterns of reimbursement. This raises two key concerns.
      1. One must respect such fundamental human realities as gametes as being more than just "goods for commerce."
      2. If one is going to allow IVF or A.I., the question of access is critical. The commercialization of transactions in gametes effectively disenfranchises most people from ever making use of these technologies, a clear injustice. This is especially the case with respect to ova.
    3. One must note that provincial legislation, as in Québec's Civil Code, already demands that any such transactions must be free.
    4. This proposed prohibition provides one case in which a clear dividing line has to be made between gametes and embryos and foetuses. Under no circumstances can embryos or foetuses be treated as if they were objects of transaction. All such practices must be precluded absolutely, notably given the current practice of experimentation on "surplus embryos," something we reject.
  1. We are grateful for the prohibition of the "purchase and sale of human genes for the purpose of creating a human being." Yet, we do have a number of concerns which would need to be addressed in any legislation.
    1. The wording of the prohibited objective ("for the purpose of creating...") may actually open up issues which we do not wish to consider. Since the gene is a basic building block of human life, other manipulations of the gene may equally need to be considered, notably in terms of manipulation of the germ line.
    2. We also note that the question of the "ownership" of the gene must be taken into account. While this proposed legislation may not be the place for dealing with such a complex issue, there is a need to clarify the regulatory limits to such ownership given the broader question of genes as part of our common patrimony.
    3. In no way would we support the abolition of commercialization of all transactions in genes since this has become an established and useful aspect of research into human genetics.

use of human gametes, embryos and foetuses for research of assisted reproduction procedures without the consent of the donor.

  1. The final prohibition certainly raises important questions. We are grateful that the proposed legislation may well deal with them. At the same time, we note a number of significant issues for clarification.
    1. The conflation of "human gametes, embryos and foetuses" is not helpful since it places together radically different realities. This is more than semantics. Clear differentiation is necessary for a number of reasons.
      1. The use of human gametes for assisted reproduction requires the consent of the donor given the importance of this human reality. The donor of the gametes becomes involved in the creation of new human life and assumes a responsibility, thereby requiring some form of consent.
      2. As to research on human gametes, we do not understand why consent would be required since no new life arises from their use and hence no new responsibilities for the donor. Given the value of research on gametes in treating human infertility, notably in difficult cases, we would hesitate to require consent.
      3. As to experimentation on human embryos or foetuses, we cannot understand how consent makes such an action acceptable. One does not own an embryo or foetus in the way one does a gamete. Consent itself is not sufficient for permitting such experimentation save in cases of a therapeutic nature, seeking the good of the embryo or foetus.
      4. We would seek the prohibition of experimentation on human embryos and foetuses, even realizing the possible benefits which might accrue from such research. The respect for human life demands this clear dividing line.
      5. On a broader level, a key question is overlooked throughout the document, the creation of human embryos for research or experimentation.
      6. While we challenge any experimentation upon embryos, we recognize that IVF frequently results in "surplus embryos." These must be accorded the respect due them as human. An important border is crossed when one creates human life for use as an object of experimentation or research; we use the word "object" deliberately in this case. This shows a lack of respect to the human life involved and must be prohibited. We would request that any legislation deriving from this process prohibit "creation of embryos for research purposes."(4) This would open the door to an assault upon the human person per se.

As noted above, we do see a number of omissions which need to be addressed and prohibited in any resulting legislation:

* embryonic stem cell research; unless the embryos result from spontaneous miscarriages

* creation of embryos for experimentation and research.

2. We use the definition of embryo found on p. 18 of the Workbook, noting that it represents a change from previous usages by Health Canada with respect to such legislation and that it is different from the definition given on page 20 of the Overview Paper, dated December, 1999. We would recommend that those involved in drafting the eventual legislation pay special attention to clarity of definition and in usage of words as this document can at times (in both the English and French versions) lead to problematic readings precisely because the use of words is not clear or is not kept to a standard form. In particular, including gametes, genes, embryos under the rubric "human genetic material" is not helpful, blurring critical distinctions.

3. We would advise those involved in preparing the eventual legislation to pay special attention to the problematic issues raised by too broad a sense of "autonomy," notably in the sense of ownership and therefore unlimited right of disposal of embryos by parents or those who have provided gametes. Autonomy must always be balanced by the common good of society and the good of the embryo as a foundational concern.

4. We would note the similar prohibition in article 18 of the Convention on Human Rights and BiomedicineConvention. 

Evaluation of the Proposed List of Regulated or Controlled Activities

(Response to question 1.2, p. 6 of the Workbook)

We welcome Health Canada's clear desire to clarify the regulatory regime in reproductive and genetic technologies. Our comments seek to assist the drafters of any legislation in implementing this desirable goal. We address some areas of lack of clarity in the listing of "controlled activities." This lack of clarity in some cases strikes at the heart of the distinction between prohibited and regulated activities which the document wisely adopts. We would recommend adopting the regulatory emphases addressed by the Final Report of the Royal Commission.(5) We will address each proposed "regulated activity" in the order provided by the text in the Workbook hoping to help with the process of clarification.

 

the manipulation of human genes, cells, embryos and foetuses to facilitate reproduction (this would apply to technologies such as assisted insemination by donor or by partner, embryo transfer, gamete interfallopian transfer (GIFT), intracytoplasmic sperm injection (ICSI), and in vitro fertilization (IVF).

 

  1. With respect to "manipulation ... to facilitate reproduction," we have serious concerns resulting from the conflation of two divergent realities. The current phrasing of the regulation allows what one would have prohibited in the previous section of the document.

a. There is a fundamental distinction within "human genes, cells, embryos and foetuses." We would note that these fall into two absolutely different realms.
I. Human genes, cells and gametes constitute the possible matter from which a human person could result. They may be used in the technologies listed.

 

ii. Even within this list, cells is best replaced by gametes. The only other conclusion we could have arrived at through the use of "cells" would be precisely the kind of cloning forbidden in the previous section.

 

iii. "Embryos and foetuses" as human beings are of a completely different nature and value from cells and gametes. We are at a loss to understand how these can be used in the reproductive therapies listed. They should be removed completely from this list. Embryonic stem cells must be included in this prohibition as they are potential human beings in themselves. The alternative could well be that unintentionally one allows that manipulation of human embryos and foetuses which must be precluded.

 

b. Official Roman Catholic teaching prohibits many of the practices listed in this section (with the exception of GIFT). If they are to be allowed within Canada, a strict regulatory regime preserving the human dignity and good of the resulting child and recognizing the limits of human agency has to be put in place.

 

I. We note the way in which people desiring a child and unable to conceive naturally constitute a particularly vulnerable population which can be easily manipulated for the sake of financial gain. This must be carefully scrutinized to prevent abuse of the system.

 

ii. The desire for a child does not constitute a right to a child. We are concerned lest the understandable desires of a couple lead to their resorting to or being enticed toward unproven or dangerous technologies.

 

iii. Questions of justice and common good need to be addressed. Within the limited range of resources for medical and scientific research within Canada, we must ask whether such a diversion of resources, while often quite remunerative, represents a just allocation of resources. The priority of vulnerable populations in need of medical care must be taken into account.

 

iv. Any regulations must foster the informed consent of those who might consider such therapies. There must be clear protocols for gathering and publicizing information concerning success rates for the various procedures in general and in particular clinics/hospitals. Unrealistic expectations are fostered given the lack of clear information. This constitutes a manipulation of a vulnerable population.

 

v. The development of these technologies requires clear attention to "evidence-based medicine." The publication of information on success rates and possible complications is required for appropriate scholarly reflection and research.

 

the use of human gametes, embryos or foetuses for research or medical purposes (any procedure for the prevention, diagnosis or treatment of a disease or any other medical condition)

 

2. With respect to "the use of human gametes, embryos and foetuses for research or medical purposes" we have the same kind of concerns listed above.

  1. Research or medical procedures on human gametes does not present serious issues, notably because of the potential benefits accruing to those seeking to cope with fertility problems.
  2. We reject the use of embryos or foetuses for research purposes. We note, however, that two different issues are involved.

I. As previously mentioned in citing article 18 of the Convention on Human Rights and Biomedicine issued by the Council of Europe in November, 1996, the creation of embryos and foetuses for the purpose of research or even medical diagnosis must be rejected. This objectifies the human person and regulates what has been listed for prohibition in the previous section.
ii. There is also the issue of "surplus embryos." Clear concern must be paid to their care.

 

iii. We would include within this embryonic stem cell research noting that this is tantamount to research on an embryo and request its prohibition.

  1. Following Roman Catholic teaching, we would reject research on foetuses or embryos when its clear goal is the research per se, with the human life reduced to an object for manipulation and request that it be included in the list of prohibited practices.
  2. Where the issue is therapeutic intervention for the sake of the foetus or embryo, such intervention could be permitted with a clear regime of regulation to guarantee that the only object is the good of the foetus or embryo, ensuring the preservation of the life and integrity of the developing foetus or embryo.

combining human genes with the genes of other species under certain conditions

 

3. As to the combination of human genes with the genes of other species, much depends upon what one means by "under certain conditions."

 

a. At the moment combining human genes with those of other species is a standard procedure in labs either to facilitate study or to help create transgenic creatures. We would note that the normal requirements for ethical research would have to be followed. In cases involving the combination occurring within a human person, all such research must always recognize the good of the human person and the human germ line as a foundational value and therefore must only be used in a therapeutic context.

 

b. We note that the regulated activity as currently structured could, in fact, allow germ-line therapy which has to this point been considered seriously problematic because of potential serious impacts on the human gene line.

 

All transactions (collection, storing, processing, destruction, importing or exporting) involving human gametes, embryos or foetuses

4. As to "transactions ... involving gametes, embryos and foetuses," many of our previous concerns emerge again concerning the mixing of radically different realities under one rubric. Such transactions are critically important, so important as to demand clarity.

a. We support a regimen of regulation with respect to gametes. Transactions involving gametes have degenerated into pure commercialization; Canadian regulation of such issues would be helpful.

b. The inclusion of embryos and foetuses in this area would allow what was prohibited earlier.

I. Destruction of embryos represents a significant problem from our perspective; the issue of how one copes with "surplus embryos" must be addressed. We would ask that they not be created in the first place.

ii. Allowing "importing or exporting" permits precisely the commercialization of trade in human life which the earlier list of prohibitions wisely excluded.

iii. Given current practices of cryopreservation of embryos, a regime of regulation would be highly desirable.

5. We strongly endorse Canada's desire to craft clear guidelines for prohibition and regulation. The State has a major interest in the way in which we engage in research and medical care. The lack of a regulatory regime has allowed seriously problematic practices to emerge. At the same time, we urge that there be a clear delineation between prohibited and regulated areas.

6. We regret that there is no attention to providing regulations for two key areas, namely pre-natal and pre-implantation diagnostic techniques. These are critically important, especially given their possible links to later discrimination against those involved. This is a serious lacuna.

Concerning questions of priority (question 2.3, p. 9), we would put great stress on developing a regulatory regime to ensure proper functioning of those facilities dealing with the gathering, storage and provision of sperm and ova. A regulatory regime must establish clear regulations, including protocols for reporting on technologies used and their success rates. This is a critical issue.

At the same time, we would urge that any regulatory regime recognize the right of conscientious objection for institutions and persons. For the Roman Catholic community this would be an important concern.

As long as embryos and foetuses are removed from the list of objects of research, we would not see the need to move as quickly to provide regulations for research on gametes.

5. Proceed with Care: Final Report of the Royal Commission on New Reproductive Technologies (Ottawa, 1993), 116-117. 

Commentary on the Privacy Regulations

(Response to question 1.4, p. 6 of the Workbook)

We endorse the concern of the Workbook to guarantee confidentiality in so sensitive an area. While there are limits to privacy, some of which we will note, we affirm the general direction given in that text. Our concerns are essentially threefold in this regard.

1. The general preference for a restriction of communication of information to "health information" has a wisdom which should be respected. Yet, increasingly the need of children to know something of the social context from which they come is important. Health should be read broadly, even as one guards the identity of the donor. This would include some modality for ensuring that privacy regulations do not result in siblings entering into marital relationships due to ignorance.

2. The importance of privacy regulations is highlighted by current concerns over discrimination (notably with respect to the provision of insurance and other goods requiring insurance coverage) resulting from the availability of genetic information. The regulatory regime should ban the use of such genetic data for the adjudication of insurance suitability of persons whose genetic constitution is known.

3. Privacy regulations must never be used as a shield to prevent the dissemination of data required for the informed consent of those contemplating use of reproductive or genetic technologies. Privacy is a defence of those potentially vulnerable. 

Reflections on Options for a Regulatory Body

Response to question 2.1, p. 9 of the Workbook.)
Certain basic concerns govern our response to this set of questions. Good regulations are necessary. They must attend to issues touching upon proper consent (including gathering of and making available result rates). Attention must be focussed on the use of unverified techniques which make clients unintentional research subjects. This needs to be addressed quickly.
We note a fundamental ambiguity involved concerning the options for a regulatory body. On the one hand, the proposed body would be a bureaucracy to ensure the implementation of the law and its regulatory standards, including licensing and monitoring. On the other hand, a regulatory body in this field needs authority to deal with new developments in a level-headed way. This latter concern would call for a "think-tank" which could rapidly assess new developments from a scientific, ethical, clinical and social perspective.
Reproductive and genetic technologies are evolving so quickly that there is a need for a group of scientists (including social scientists, ethicists, clinical specialists) and interested citizens (including those using these services) who could evaluate the impact of new technologies and discoveries and move quickly with new regulation or prohibition as required. Both dimensions need to be addressed. With this in mind, we propose the following recommendations.

1. The regulatory oversight body (the bureaucracy) should be part of Health Canada's regular structure, reporting to the Minister of Health.

2. The "think-tank," with a proper mandate to enact and implement decisions and with sufficient authority not to be overridden by the bureaucracy, should be an independent body. It would gather data from affected parties and assess new developments, periodically reviewing as well the suitability of existing regulations. It would develop its own standards by which decisions would be made and thus would require an arm's-length relationship to the government. The regulatory body created by the United Kingdom in 1991 might serve as a model. We would urge that this "think-tank" pay particular attention to the six areas for regulation specified by the Royal Commission's Final Report, including the call for "monitoring of future technologies and practices" and "ensuring that future development is in the public interest,"(6) concerns currently missing from the Workbook.

3. Membership on a "think-tank" should include some named by public nominations, with safeguards against a hijacking of the committee by particular interest groups or stakeholders. It must have truly broad-based representation given the impact of developments in this area upon Canadian society. This should include representatives from faith-based constituencies.

4. Public education concerning the emerging reproductive and genetic technologies and their impact on society would be part of the mandate of such a commission.

5. The "think tank," responsible for reviewing developments, must be given the mandate to make its report public, not simply reporting to the Minister; the reporting system for the Auditor General could be used as a model. This is due to the significant public concern in this area. Annual reporting could be a useful way of stimulating involvement in this process by a broad sector of the Canadian public.

6. Given the way in which much of the development in this field is driven by market forces, we would oppose recovery of cost through licensing fees since this could well pose a significant conflict of interest.

 

6. Proceed with Care, 121, 124-125. 

Conclusion

The Catholic Organization for Life and Family appreciates the work done on this initiative of Health Canada. We have long anticipated the clarity which such legislation could bring to an area of such potential benefits and challenges. We note with pleasure the way in which the Workbook takes seriously the need to safeguard the dignity, health and well-being of the people of Canada. We look forward to participating in a continued dialogue with Health Canada on this matter, especially as the legislation is brought forward. We are ready to respond to your further questions or concerns.