HEAL Committee Meeting

37th PARLIAMENT, 2nd SESSION

Standing Committee on Health

EVIDENCE

CONTENTS

Thursday, November 21, 2002

À

1040

The Chair (Ms. Bonnie Brown (Oakville, Lib.))

Professor Bernard Dickens (Faculties of Law and Medicine; Chair in Biomedical Ethics, Joint Centre for Bioethics, University of Toronto)

À

1045

À

1050

The Chair

Ms. Joan Bercovitch (Senior Director, Canadian Bar Association)

Mr. Brent F. Windwick (Past Chair, National Health Law Section, Canadian Bar Association)

À

1055

The Chair

Mr. Étienne Ouimette (Acting Director, Compliance and Enforcement, National Coordination Centre, Health Products and Food Branch, Department of Health)

Á

1100

The Chair

Ms. Cathy Parker (Manager, Biologics and Genetic Therapies Directorate, Centre for Policy and Regulatory Affairs, Health Products and Food Branch, Department of Health)

Á

1105

The Chair

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance)

Mr. Étienne Ouimette

Á

1110

Mr. James Lunney

Mr. Étienne Ouimette

Mr. James Lunney

Mr. Étienne Ouimette

Mr. James Lunney

Mr. Étienne Ouimette

Mr. James Lunney

Ms. Cathy Parker

Mr. James Lunney

Á

1115

Ms. Cathy Parker

Mr. James Lunney

Prof. Bernard Dickens

Mr. James Lunney

Prof. Bernard Dickens

Mr. James Lunney

Mr. Brent Windwick

The Chair

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ)

Prof. Bernard Dickens

Á

1120

Mr. Brent Windwick

Mr. Réal Ménard

Mr. Brent Windwick

The Chair

Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.)

Á

1125

Mr. Brent Windwick

The Chair

Mr. Stan Dromisky

Mr. Étienne Ouimette

Á

1130

Mr. Stan Dromisky

Mr. Étienne Ouimette

The Chair

Ms. Hedy Fry (Vancouver Centre, Lib.)

Mr. Étienne Ouimette

Ms. Hedy Fry

Mr. Étienne Ouimette

The Chair

Ms. Hedy Fry

Ms. Cathy Parker

Á

1135

The Chair

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP)

Ms. Cathy Parker

Ms. Judy Wasylycia-Leis

The Chair

The Chair

Mr. Réal Ménard

The Chair

Ms. Yolande Thibeault (Saint-Lambert, Lib.)

Á

1150

The Chair

Ms. Hedy Fry

The Chair

Ms. Hedy Fry

The Chair

Ms. Judy Wasylycia-Leis

The Chair

Mr. Paul Szabo (Mississauga South, Lib.)

The Chair

Mr. Réal Ménard

The Chair

Mr. Réal Ménard

The Chair

Á

1155

Ms. Judy Wasylycia-Leis

The Chair

Ms. Judy Wasylycia-Leis

Mr. Stan Dromisky

Mr. Stan Dromisky

The Chair

Ms. Hedy Fry

The Chair

Ms. Hedy Fry

Mr. Réal Ménard

Ms. Hedy Fry

The Chair

Ms. Hedy Fry

The Chair

Mr. Réal Ménard

The Chair

Mr. Réal Ménard

Â

1200

The Chair

Ms. Yolande Thibeault

The Chair

Mr. Réal Ménard

The Chair

Mr. James Lunney

The Chair

Mr. James Lunney

The Chair

Mr. James Lunney

The Chair

The Chair

Ms. Hedy Fry

Mr. Rob Merrifield (Yellowhead, Canadian Alliance)

The Chair

Mr. Rob Merrifield

The Chair

Ms. Hedy Fry

The Chair

Ms. Hedy Fry

Mr. James Lunney

The Chair

Mr. James Lunney

The Chair

Mr. Réal Ménard

Â

1205

The Chair

Mr. George Radwanski (Privacy Commissioner of Canada)

Â

1210

Â

1215

The Chair

Mr. Rob Merrifield

Mr. George Radwanski

Mr. Rob Merrifield

Mr. George Radwanski

Mr. Rob Merrifield

Mr. George Radwanski

Mr. Rob Merrifield

Mr. George Radwanski

Mr. Rob Merrifield

Mr. George Radwanski

Mr. Rob Merrifield

Mr. George Radwanski

Mr. Rob Merrifield

Â

1220

Mr. George Radwanski

The Chair

Mr. James Lunney

Mr. George Radwanski

Mr. James Lunney

Mr. George Radwanski

Â

1225

Mr. James Lunney

The Chair

Mr. James Lunney

The Chair

Mr. Stan Dromisky

Mr. George Radwanski

Mr. Stan Dromisky

Mr. George Radwanski

Mr. Stan Dromisky

Mr. George Radwanski

Â

1230

Mr. Stan Dromisky

Mr. George Radwanski

Mr. Stan Dromisky

The Chair

Ms. Hedy Fry

Mr. George Radwanski

Ms. Hedy Fry

Mr. George Radwanski

Â

1235

The Chair

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CANADA

Standing Committee on Health

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NUMBER 004

l

2nd SESSION

l

37th PARLIAMENT

---

EVIDENCE

Thursday, November 21, 2002

[Recorded by Electronic Apparatus]

À  (1040)  

[English]

    The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. It's my pleasure to call this meeting of the Standing Committee on Health to order.

    For my colleagues who are members of the committee, we have a motion to deal with this morning. I'm going to suggest that we hear the first set of witnesses, that we try to finish prior to 11:30 a.m., and that we do the motion before we hear from the Privacy Commissioner.

    With your approval of that, we'll begin.

    I'd like to introduce to you Professor Dickens, the professor in health law and policy and the chair in biomedical ethics, at the faculties of law and medicine and the Joint Centre for Bioethics at the University of Toronto. Boy, what a moniker.

    Professor Dickens, the floor is yours.

    Professor Bernard Dickens (Faculties of Law and Medicine; Chair in Biomedical Ethics, Joint Centre for Bioethics, University of Toronto): Thank you, Madam Chairman.

    I appreciate the opportunity to reappear before the committee. The directions I have are to be brief and to focus on the regulatory aspects of the agency.

    I have three observations to make in the time available to me. The framework is the desirability, in my opinion, of the agency being fairly closely modelled on the Human Fertilisation and Embryology Authority that functions in the United Kingdom. This is a sound model. It enjoys public confidence. We have seen, for example, the U.K. public being responsive to the government's proposal permitting embryos to be created for purposes of research, perhaps leading into therapeutic cloning. Because of confidence, the agency is monitoring and authorizing what happens.

    This I think is a model that deserves attention, and I'm pleased that the legislation in general principle seems to be accommodating the sort of agency that exists in the United Kingdom.

    The requirements are that there should be adequate expertise in reproductive medicine. This has to be built into the functioning of the agency. Whether a composition of 13 members, including a chair and president, would be sufficient to accommodate the different interests is something that requires attention.

    In addition to the technical expertise, the biomedical expertise, there has to be representation of interested parties. The parties would have two predominant characteristics. First, they would be predominantly women, and a strong representation, a leadership of women, I think is important. In addition, there should be representation, which was not part of the Canadian royal commission, of infertile people.

    At the end of its work, the Canadian royal commission reporting in 1993 had an entirely female membership, which itself is perfectly acceptable. We have a long tradition of respecting reports of committees, all of whose members are of the same sex, but they were all mothers of not less than two children. This created some dissatisfaction on the part of infertile groups, who are now more organized than they have been.

    One also has to avoid advocates of predetermined positions--those fundamentally hostile to any of the reproductive technologies, those fundamentally embracing of all of them. That is, if one is going to have a committee that enjoys public confidence, it has to be confidence that the actual issues will be dealt with on their merits, not in accordance with a background commitment.

    So the initial question is how the agency functions. If in fact the quality of expertise that is necessary to ensure public confidence can't be built into the composition of 13 members, then those with expertise could come in as members of panels or as consultants.

    The difficulty here is that the act provides that the agency can develop bylaws to deal with the recruitment and payment of those who act on panels, both board members and non-board members, and this gets into the question of how the agency is financed, a matter that the bill does not address.

    If it is entirely funded by the ministry, then this raises further questions of independence. There is a provision, you will be aware of, in subclause 44(3) of the bill, that when inspectors conduct inspections of licensed premises, then the costs can be recovered from those who hold the licences. But we've seen in the United Kingdom dissatisfaction, both within the Human Fertilisation and Embryology Authority and outside, that the agency becomes dependent for its funding on granting licences to those from whom it can then recover its costs. This presents a conflict, and the funding principles on which the agency works could be a matter of some complexity and a matter of some potential conflict, even dissatisfaction and a loss of credibility.

    That is reinforced in a second point I would like to make, the writing under subclause 25(1). This permits the Minister of Health not simply to seek advice of the agency, which, of course, the agency has its own capacity to offer even when uninvited, but to issue directions. This, of course, risks serious political compromise of the independence of the agency and perhaps the willingness of people to serve in it.

    The bill says this in subclause 25(1):

The Minister may issue policy directions to the Agency concerning the exercise of any of its powers, and the Agency shall give effect to directions so issued.

    A limitation of that is in subclause 25(2):

Policy directions issued by the Minister may not affect a matter that is before the Agency at the time they are issued and that relates to a particular person.

    So the minister can't pre-empt the agency on any particular matter, but it can pre-empt the general functioning of the committee. This prejudices the arm's length design of an agency in that it could function, in fact, simply as a subdivision of the minister's own department, Health Canada. So the capacity to issue directions, though not binding in a specific case but binding on general matters of policy, risks politicizing the agency, frustrating and replacing the functions of the agency, and compromising its independence.

    The final point I would like to make is with regard to the general mandate of the agency under paragraphs 22(a) and 22(b). I'm quoting now from clause 22:

The objectives of the Agency are

(a) to protect and promote the health and safety, and the human dignity and human rights, of Canadians

    This is an important mandate, but of course the sense of human dignity is somewhat non-specific. It's been observed that human dignity exists in the eye of the beholder. We see it in different ways. It has very strong subjective elements.

    Human rights are more objectively determined, because we have the role of the judiciary. I think it's fair to anticipate that once legislation, in whatever form, is enacted, it will be subject to charter scrutiny and charter challenge.

    The second paragraph of clause 22 reads this way:

(b) to foster the application of ethical principles

Now, this is likely to be particularly difficult, because ethical principles evolve. I haven't time to be anecdotal, but when I was first involved with research involving humans, the ethical principle was that women of reproductive age not be included in starters. We've done a 180° turn on that--that is, if a product is not known to be harmful to fetuses, then it must be tested on pregnant women. What used to be a rule of mandatory exclusion has now become a rule of mandatory inclusion. Ethical principles evolve.

    In the United Kingdom, for example, the Human Fertilisation and Embryology Authority is just initiating public consultation on the question of whether sex selection can in fact be permissible when one doesn't have an acknowledged tradition of some preference, and the royal commission in Canada showed there is no such tradition in Canada. Then preventing a woman, preventing a family, from balancing the composition of children by disclosure of the sex of a second, third, or fourth fetus may well be unethical.

    There's an evolving ethical literature that when there is no tradition of objectionable son preference, then permitting family balancing could well be appropriate. The scenario is of the family whose child-bearing is complete. They have two or three children all of the same sex and then have an unplanned pregnancy. There may be a disposition to terminate that pregnancy, which of course we know is lawful in Canada. There are some who find it understandably objectionable, but there is a right to terminate a pregnancy.

À  (1045)  

    The woman, the couple, the family, may decide that they would be willing to continue the unplanned pregnancy if the child would be of the sex they don't have. That is, having two, three, four boys, they really don't want another child, and planned not to have one, but there is the unexpected pregnancy. If they knew it was a girl, then they would continue rather than terminate the pregnancy. There is a growing ethical sense that this is something that ought to be tolerated.

    Well, the agency won't be able to move on that, of course, because diagnosing the sex of a child to see whether the pregnancy can be continued or not attracts up to ten-years of imprisonment and $500,000 fines under the act. This seems to be dysfunctional within the terms of the act, but it also compromises the capacity of the agency to discharge its duty, under paragraph 22(b), to foster the application of ethical principles.

    In that sense, although the agency has this mandate, it's fairly clear that under the legislation, including the power of the minister to give directions, its ability will be severely constricted. One risks an agency--publicly maintained, publicly visible, with a level of public accountability--that is locked into responses to given situations that the wider community would consider unethical.

    These are matters that, with respect, I think warrant serious attention.

    Thank you.

À  (1050)  

    The Chair: Thank you, Professor Dickens. Very helpful.

    From the Canadian Bar Association we have Mr. Windwick and Ms. Bercovitch. I don't know who is going to speak.

    Okay, Ms. Bercovitch, please take the floor.

    Ms. Joan Bercovitch (Senior Director, Canadian Bar Association): Thank you.

[Translation]

    On behalf of the Canadian Bar, I thank you for giving us this opportunity to appear before you today. The improvement of the law and of the administration of justice are among the objectives and purposes of the Canadian Bar Association. Our presentation today is related to those objectives.

[English]

    Our brief will be presented by Brent Windwick, who is past-chair of the CBA's national health law section. He is also executive director of the Health Law Institute at the University of Alberta and practices health law in Edmonton.

    Mr. Brent F. Windwick (Past Chair, National Health Law Section, Canadian Bar Association): Bonjour, and thank you very much for giving the Canadian Bar Association the opportunity to appear before you once again.

    As Professor Dickens has indicated, I also have a direction to make my remarks brief. Obviously the committee has heard a lot of testimony and I think is probably more interested in engaging in discussions than in listening to more presentations, so I will be very brief.

    To try to give a little bit of context to the CBA's position on the bill, I simply want to remind the committee that we made a written submission on the legislative proposals, which I presented just about a year ago today. And subsequent to the bill being brought forward in the spring, a letter was sent to Madam Chair that outlined some additional comments.

    Those additional comments dealt primarily with three issues, one of which had been raised in the initial submission, which was the scope of explicit statutory prohibitions. The other two comments raised in the letter sent in June dealt with permitting surrogates access to professional services, and also some issues related to lawyer-client confidentiality and inspections.

    None of those subjects, with the possible exception of the first, are exactly pertinent to the discussions that are supposed to take place this morning. So with your leave, what I'll do is leave those comments alone--unless you have questions about them--and instead return to some general observations about the regulatory body, which were reflected in our original submission tabled last November.

    In so doing, I certainly would echo Professor Dickens' comments. We also had a chance to have breakfast together this morning and discuss this, so I knew somewhat in advance what he was going to say about this. The CBA's position on the regulatory authority I think is one that's quite widely held, that it needs to be underpinned by certain basic principles and needs to be able to carry out its function in an independent manner.

    The HFEA, which Professor Dickens has referred to, is really an excellent example I think of the type of regulatory authority that now has a track record behind it. It has a lot of elements that have been incorporated in the regulatory body that is contemplated under this legislation.

    What should it regulate? It should regulate procedures and professionals. It should regulate the handling of information and it should regulate research.

    How should it regulate? By licensing, by developing guidelines. I think there is a very important interpretive element that the regulatory authority needs to provide. Obviously there is much that is going to be developed by way of regulations that the agency will then attempt to implement, so there should be more clarity on things like the definition of “donor” and other items by the time the agency is in the implementation mode. Nevertheless, the regulatory agency will have a very valuable role to play in providing interpretation.

    Education is going to be an extremely important component, and that's something we stressed in our brief last November. I was on the HFEA website last week looking at some of the things they have done, and one can see the great scope not only for education but for public engagement that the agency can fulfil as a core function.

    On the collection and analysis of information, one issue that is on the horizon--it's not something that was part of our brief--is the relationship between the collection of health-recording information by the agency and medical research involving that information.

    I think HFEA's experience has been that the requirement to keep confidential identifiable information has to some extent limited the ability for that information to be used for research. But in some of the materials I was reading in preparation for this session, it was pointed out that information technology is increasingly making it possible to use non-identifying information from this research. I think this regulatory agency has a challenge and a mandate to try to create an engagement with the research community to permit evaluative studies and clinical research to be done with the information that is gathered in the context of these activities.

À  (1055)  

    What principles should guide these activities? I go back to the CBA's brief on this point. It should be representative, obviously. I won't say anything more than what Professor Dickens has said about that. I think the idea of having access to consultants or others to assist the 13 members of the agency and their activities is an excellent idea.

    Transparency, accessibility, responsiveness: I think Professor Dickens' point echoes something that the CBA has said before, which is that the framework of the legislation itself, not just the ability of the minister to give directions and to have an oversight role, has the potential to place constraints upon the ability of the agency to be responsive. And by the framework of the legislation I mean the scope of explicit statutory prohibitions.

    CBA has made submissions in the past, and I know you've heard from many others, about the expressed statutory prohibitions versus the regulatory offences model. I won't go into that any further, but that is all part of this discussion. Public accountability obviously is another very important thing.

    The legislation itself, in our submission, does generally meet those requirements in terms of how it structures the agency and the powers that the agency has been given.

    The CBA submission had suggested very broad representation on the committee, but it also had made a cautionary statement about the importance of keeping it at arm's length from government. Implicit in that caution was the type of concern that Professor Dickens had raised about the extent of ministerial oversight.

    As I've spoken not nearly as quickly as I had intended to, I'll close my presentation at this point. Thank you.

    The Chair: Thank you, Mr. Windwick.

    We'll move now to Mr. Ouimette from the Department of Health.

    Mr. Étienne Ouimette (Acting Director, Compliance and Enforcement, National Coordination Centre, Health Products and Food Branch, Department of Health): Good morning. It's again a pleasure to come in front of the Standing Committee on Health.

    Basically I was asked to talk about the specific issue of importation of donor semen and the regulatory requirements that reside in the semen regulations. I've prepared brief opening remarks, and I'll welcome any questions at the appropriate time.

    As per the semen regulations, Canadian processors and importers of donor semen are responsible to ensure that donor semen has been processed in accordance with the semen regulations. It is prohibited to import donor semen for distribution unless the requirements for the importation of donor semen, as outlined in the semen regulations, are met.

    A Canadian importer of donor semen is considered to be the legal agent in Canada and therefore has a responsibility to ensure that the imported semen satisfies Canadian regulatory requirements prior to being used or further distributed.

    To demonstrate compliance, the following evidence is required: that the semen specimen has been processed in accordance with sections 9 to 11, which basically detail donor exclusion criteria and donor testing; that the semen has been quarantined for a period of 180 days after the collection date; that the donor has been reassessed against all exclusion criteria and retested for the required infectious agents or markers on new specimens obtained from the donor after a quarantine period; and that the specimen and accompanying documents have been reviewed and compliance verified.

    Semen is not to be distributed if it is required to be quarantined or destroyed. An establishment is to be able to provide evidence that a specimen was assessed for compliance prior to distribution. To that effect, the importer is to request records of and other evidence as per the regulatory requirements from the foreign processor to verify that the processor has complied with all of the applicable Canadian regulatory requirements.

    During an inspection, the importer is to provide any record or other evidence from its foreign processor that may be required by the inspector. Again, an importer is to demonstrate compliance by providing evidence that they have assessed the donor's semen against the requirements of the semen regulations. The assessment is to include the test conducted and the results obtained in respect of the donor and specimens.

    As well, the outer shipping container in which the semen is transported is to clearly display the name and business address of the processor, a declaration signed by the processor or an authorization of the processor certifying that the semen was processed in accordance with the semen regulations and the reference sections of the directive, and that the semen was quarantined for a minimum period of 180 days.

    It should be noted that any additional information from the foreign supplier is to be available upon request at the Canadian importer's site. All information provided is to be specific to a particular donor and a collection date. It is to be clear that the supporting documents link directly to a particular semen donation.

    And lastly, donor semen may also be imported under the provisions of the donor semen special access program. The importer is to retain on file a copy of the special access authorization. If a donor semen specimen has been or will be imported under the provisions of that program and under the Food and Drugs Act, donor semen that is intended only for exportation is exempt from the regulatory requirements of the semen regulations.

Á  (1100)  

    The Chair: Thank you very much, Mr. Ouimette.

    Our fourth speaker this morning will be Ms. Parker of the Health Products and Food Branch.

    Ms. Parker.

    Ms. Cathy Parker (Manager, Biologics and Genetic Therapies Directorate, Centre for Policy and Regulatory Affairs, Health Products and Food Branch, Department of Health): I'd like to thank you for the opportunity to be here this morning.

    As Mr. Ouimette has said, human semen intended for assisted conception falls within the definition of a drug, and is regulated under the food and drug regulations. Other reproductive tissues are not currently regulated under the food and drug regulations, so I'd like to give you some updates on the development of proposed new regulations for the safety of cells, tissues, and organs.

    In 1995 the national consensus conference on the safety of tissues and organs specifically recommended that safety standards be developed for cells, tissues, and organs. On April 22, 1999, the Standing Committee on Health delivered a report entitled Organ and Tissue Donation and Transplantation: A Canadian Approach. The report recommended that national safety standards for cells, tissues, and organs intended for transplantation be made mandatory by incorporation by reference into regulations under the Food and Drugs Act.

    In response to that report, a draft Canadian general standard on the safety of cells, tissues, and organs intended for transplantation and assisted human reproduction was developed by an expert working group appointed by Health Canada. In addition to the general standard, tissue-specific standards, including those for reproductive tissues, have been developed. Reproductive tissues include any cells or tissues from the reproductive system intended for use in assisted human reproduction.

    The standards set out minimum safety requirements for acceptable performance. These requirements are in respect to donor selection; cell tissue or organ collection; processing, packaging, testing, labelling, storage and recall of cells, tissues and organs; and record-keeping, adverse event reporting, and look-back trace-back mechanisms.

    It is expected that the implementation and use of required safety standards will help establish and maintain safe practices, and motivate concerned parties to remain vigilant. Health Canada has signed an agreement with the Canadian Standards Association whereby, in consultation with stakeholders, they will formalize the safety standards and ensure they meet guidelines laid out by the Standards Council of Canada. The standards are expected to be published as national standards in early 2003.

    A Canadian regulatory framework for cells, tissues, and organs is under development. The new standards will be the basis of the proposed regulations under the Food and Drugs Act. These proposed regulations will stipulate requirements to be met with respect to the safety and quality of cells, tissues, and organs intended for transplantation and assisted reproduction. Other key elements of a regulatory framework will include requirements for surveillance, adverse event reporting, and compliance and enforcement strategy.

    Legal issues surrounding the development of the new regulatory framework are being examined, including the format of the new regulations, how existing regulations will be moved into the new framework, and the interface between this proposal and the assisted human reproduction legislation.

    Thank you.

Á  (1105)  

    The Chair: Thank you, Ms. Parker.

    We'll proceed now to the second part of our meeting, the question and answer period. This morning it will be led by Mr. James Lunney.

    Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): Thank you, Madam Chair.

    Perhaps we'll start with the issues raised by importation of sperm.

    In the regulations you went through, Mr. Ouimette, you said specimens from foreign processors should be available to the inspector, with certification from the importer that all of the requirements in Canada have been met.

    Do you envisage that Canada will send inspectors to the various countries of origin of sperm? Has that been taking place?

    Mr. Étienne Ouimette: That has not taken place yet. We keep that option in our back pocket for issues of non-compliance, or if we have evidence or third-party information to suggest the information provided to the Canadian importer is erroneous. We are basically ending the first year of our inspection program. The onus, the responsibility, is on the Canadian importer.

    You referred to the signed declaration. It is from the country of origin. It is provided with the semen when it leaves the foreign semen processor, and is to be kept at the Canadian importer sites.

Á  (1110)  

    Mr. James Lunney: It's all based on integrity, isn't it? It's based on the integrity of the people filling out the forms at the processing site, wherever that might be in the world. Is there not some considerable risk that violations can take place?

    Mr. Étienne Ouimette: The Food and Drugs Act and regulations, and especially the semen regulations, provide authority in this case only to Canadian entities. There are several means of getting the information for Health Canada to assess the safety of the semen being imported. There's the aspect of the information at the Canadian importer site, but also there is a general clause in the semen regulations that allows the minister to ask, at any time, for any additional information to assess the safety of the semen.

    I know it doesn't exactly answer your question, but basically if we are confident that these requirements are met, we will proceed with the inspection and we will accept the semen to be distributed.

    We have this opportunity to go outside of our border to perform inspections, but clearly we do not have the authority to do so. It will only be with the collaboration of the foreign semen processor. Clearly, if we are not happy with the evidence provided, and if the foreign processor objects to an inspection, we can close our border, and we have done so in the past.

    Mr. James Lunney: I'm really wondering what safeguards there are in that. As far as foreign inspections go, my gosh, on the fisheries committee we have relied on volunteer observers for NAFO for fishing. It's based on people on board a ship out at sea reporting on the catch. There has been tremendous recorded evidence and documented evidence of abuse. I don't know how we think we can control something outside our borders on a voluntary basis, and I wonder how naive we can be in setting up a regulatory agency that would include this.

    Are you aware of sperm being imported from prisoners in the United States?

    Mr. Étienne Ouimette: Oh, yes. I would say the vast majority of the semen being used in Canada, over the last three years, is from the States.

    Mr. James Lunney: For the general public, would this be the source that we could think of as being the first choice for reliable safety, for wanting to help people with reproductive technologies in Canada?

    Mr. Étienne Ouimette: We're getting a bit more on the patient's point of view, and basically, there are decisions with regard to the source of the semen where Health Canada, with the authority of its act and regulations, does not have the mandate to go after. I think it has to be made clear that the basis and the intent of our regulations is safety of the product, per se.

    Mr. James Lunney: Yes, okay. Perhaps I can take this another way.

    To Ms. Parker now, talking about regulations for the safety of cells, tissues, and organs also being imported, are you familiar with the tainted blood scandal that we've just gone through--

    Ms. Cathy Parker: Yes, I'm very much familiar with it.

    Mr. James Lunney: --and the charges that are coming forth because of HIV and hepatitis C in blood products? I wonder if you would consider there's some risk to Health Canada, to Canadians and to the government, in wanting to certify the safety of tissues being imported from here, there, and who knows where.

    For example, we were quite a number of years looking for the cause of AIDS, for the virus itself, searching for that causative agent. We were quite a number of years looking for the virus that causes hepatitis C. What other viruses are there? We're looking for sources of all kinds of other diseases, which we might want to name here, whether it's multiple sclerosis, systemic lupus, or a whole bunch of autoimmune diseases that may have pathogens behind them.

    What kind of risks, in your opinion, might we be exposing ourselves to if we're going to certify safety on tissues when we don't know what we're looking for yet?

Á  (1115)  

    Ms. Cathy Parker: I'd start off by saying that the objective behind our regulatory framework for soft tissues and organs is that we want to balance safety and efficacy with the availability of tissues.

    In terms of the approach we are taking to regulate through the use of standards, the reason we are going to a standards-based approach is that those standards are maintained by a committee of experts. With the standards approach, there is flexibility to update the standard to address a new emerging issue such as a new disease agent that would have to be suddenly tested for or accounted for in the regulations, rather than going through the process of changing regulations.

    I'm not sure if I've answered your question clearly.

    Mr. James Lunney: No, I appreciate it's not an easy question to answer, but I certainly recognize a big risk there.

    I'd like to go back to the regulatory agency, where we started our discussions.

    Professor Dickens, I note that you excluded some people as being qualified. You mentioned predominantly women, and you mentioned the coalition of infertile people. You said we should avoid certain advocates. Could you repeat for me what you said there, just briefly, please?

    Prof. Bernard Dickens: Yes. The point I was making, and again it comes from the U.K. experience, is that the members of the board of directors would be expected to address the merits of individual issues.

    Mr. James Lunney: Excuse me, but I just wanted to know about the people you said we should avoid.

    Prof. Bernard Dickens: People with preconceptions of what is the right thing to do. They would not pay attention to evidence but would apply particular preconceptions.

    Mr. James Lunney: Thank you, Professor Dickens.

    To the CBA, I notice that you said a good deal of thought would be needed to be given to the structure and composition of the body. You suggested that it should be composed of individuals from a wide variety of relevant disciplines, including law, medicine, science, and ethics, and it should include members of Parliament and members of the public.

    I wonder if you would agree with Professor Dickens, whom, I presume, would say that someone from a faith-based community would be ineligible to sit on that.

    I presume that's where you're going, Professor Dickens.

    Would you agree with Professor Dickens' exclusions ?

    Mr. Brent Windwick: Speaking for the CBA, I don't think the type of inclusive definition that we're talking about would exclude members of faith-based communities. I think the important thing is to ensure that there is a wide spectrum of views on the issues. Those views don't necessarily have to agree--they don't necessarily even have to be close to one another--but they need to represent a balanced set of views, reflective of the population. I think that's the main principle we're trying to get at.

    The Chair: Thank you very much, Dr. Lunney.

    I'm going to caution my committee members that we're fairly short of time. I have three more speakers, and if each of them takes five minutes, we will be out of time.

    Mr. Ménard, five minutes.

[Translation]

    Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): I will be brief. I have two simple questions.

    Mr. Dickens, you seem concerned about the financial independence of the agency. This committee, from the beginning of its work, eliminated the scenario of a cost recovery policy, like the ones that govern other agencies. Do you belive that we were mistaken and that we should have considered that possibility?

    My second and last question is addressed to the people from the Canadian Bar Association. If we exclude the criminal law scenario, to ensure that certain practices are prohibited in public or private laboratories, what other possibility can we consider, since you say in your brief that criminal law is not adapted to this type of situation?

[English]

    Prof. Bernard Dickens: Perhaps I could respond first. An element of cost recovery is appropriate, but there shouldn't be an overwhelming dependency on cost recovery. That is to say, if the capacity of the agency to function depends on recovering its costs from those who hold licences, then it has a strong disposition to grant licences, perhaps in a somewhat indiscriminate way. And if one wants to ensure that only suitable individuals and only suitable facilities would be empowered to undertake reproductive technologies, then there can't be an excessive dependence on those who receive licences. As I've said, it does compromise the independent functioning of the agency in that it does depend on those it licenses.

    There's an additional factor, of course. If the licence-bearers are subject to cost recovery not simply for the particular services they receive, but also for the overarching functioning of the agency, then the costs will be higher and what is already a form of luxury medicine will become even more restrictive. In that sense, the role of public regulation, which is an important role, has to be supported by a sizable proportion of public expenditure.

Á  (1120)  

    Mr. Brent Windwick: Mr. Ménard, I must apologize; I understood your question was about the Canadian Bar Association's view on statutory prohibitions and its relationship to both public and private labs, but the translation ended up being a bit confused. I wonder if I could impose upon you to repeat the question.

[Translation]

    Mr. Réal Ménard: Insofar as the criminalization of certain practices is concerned, you state that criminal law is not appropriate because this is an area where things are evolving too quickly. You are not the first witness to say this. Be that as it may, the question remains unanswered. To the extent that Canada and all of the provinces want to see certain practices prohibited—here, of course, I am referring to cloning for therapeutic or humane purposes—if criminal law is not used to prevent this, we cannot really resort to fines, either. So, what do we do?

    Yesterday, I put the question to the witnesses and referred to the example of the Italian gynecologist who once gave a press conference in Canada, but no one seems to have an answer to that question.

[English]

    Mr. Brent Windwick: Merci. I understand your question.

    The answer we have is not that certain practices should not be prohibited, nor that there should not be penal sanctions for certain practices. Rather, this relates back to both the vehicle by which the prohibitions are laid down and the vehicle by which the sanctions are to be imposed.

    Our concern, and I know you've heard this view from many others, so I won't belabour it, is the scope of explicit criminal sanctions in the legislation. Our concern is with the problems associated with not giving the agency, with the appropriate accountability and transparency, the ability to adapt those prohibitions and sanctions to the changes in technology and the changes, frankly, in social views about those practices.

    We have no disagreement at all that certain practices should be prohibited. In two year's time there may be practices that should be prohibited that would not be considered to be so now, and vice versa. But what we say is that the way to do that is through a primarily regulatory model, saving express criminal prohibitions in the statute, only for those activities where there is a clear social consensus and a clearly important message that needs to be sent that these activities are unacceptable, such as reproductive cloning.

    Does that address your question?

    The Chair: Thank you, Mr. Ménard.

    We'll move to Mr. Dromisky.

    Mr. Stan Dromisky (Thunder Bay—Atikokan, Lib.): Thank you very much, Madam Chairperson.

    First of all, I have to agree that the lawyers are on the right path regarding the surrogacy. The concerns you raised today, and the recommendations you made, are the kinds of concerns that I've raised many times in the past. Thank you very much for the information.

    However, I'm going to play the devil's advocate regarding the issue that Mr. Lunney has brought forth regarding solicitor-client confidentiality. I think this is a double-edged issue. I often think about immigration cases that, you know, money is involved here. We do have lawyers who will misguide deliberately their clients, because it is a very lucrative situation when they can put them along the wrong path, which can lead to a greater margin of profit for the lawyer. What kind of protection would you advocate for the clients regarding that type of service?

    To Mr. Ouimette, again, we're talking about big bucks. We have a wholesale in Toronto that distributes semen all over this country. That's a big moneymaker for a certain company, there's no doubt about it.

    The whole issue is complicated, because we have to deal with any kind of case, or any kind of infraction, or misdemeanour. All of a sudden state rules and regulations and laws come into effect. U.S. federal laws, state laws, regulation laws, come into effect, versus the Canadian legal system and whatever structure we come up with. How are they going to blend with each other to be sure that the clients are protected?

    It's a nightmare, there's no doubt about it. Money is to be made here. Always keep in mind, there is big profit.

    Would you think that a 100% Canadian model would be far more manageable, more credible, and reliable as far as the citizens of Canada who require this kind of service are concerned, and that we should not depend upon a foreign supply system?

Á  (1125)  

    Mr. Brent Windwick: To address your question about professional services for surrogates, I would say that what you're really dealing with is the engagement of government regulation of the activities to make the rules to try to ensure that practices are safe and that commodification is avoided. It's really to ensure the essence of professionalism, which is not necessarily restricted to the legal profession but also includes the medical profession and counsellors, or those who would provide these services.

    To make this effective, there obviously needs to be rules set by the government, or by the agency, on what is appropriate and what is not, and standards. I'm not sure the Human Fertilisation and Embryology Authority in the U.K. specifically addresses this issue, but it does have codes of practice that are applicable to all of those involved in the activities we're talking about.

    Beyond that, I think what you're really talking about is the faith that the public and governments put in self-regulating professions to ensure that their members behave in an appropriate fashion. I think the sanction for a lawyer or a physician who would inappropriately counsel, is the professional disciplinary sanction. I guess if one were to dispute whether that were sufficient, then one would be disputing the sufficiency of professional self-regulation in general, which would probably take quite a long time to work through if we were to do it today.

    The Chair: Thank you.

    Dr. Dromisky, is there someone else you want a comment from?

    Mr. Stan Dromisky: Yes, from Mr. Ouimette on a 100% Canadian model.

    Mr. Étienne Ouimette: I'll answer that question more in terms of the scope of the semen regulations, which look basically at the safety of the product and do not apply to any contractual agreement, including money transactions at any point of distribution of semen. Our scope in terms of authority, and the requirements applying to a semen establishment—for example, in Toronto—resides only with respect to safety. That is the scope of the semen regulations as of today.

    Reflecting on my answer to the previous question, which also links to your question, I was asked if I was aware of semen coming from prisons. I did not hear the word “prison”; I thought the question was on whether I was aware of semen coming from the U.S. I'm sorry about that.

    Basically, today we know for a fact that the vast majority of semen being distributed in Canada is not from Canadians. We know that for a fact. However, the requirements looked only at the safety of the product, not at whether it was Canadian or non-Canadian semen.

Á  (1130)  

    Mr. Stan Dromisky: Don't you think we would have better control of it if the whole model was 100% Canadian, instead of depending upon another source at arm's length, of which we have practically no control?

    Mr. Étienne Ouimette: I would say that certainly it poses challenges in regulating a product that originates from foreign establishments. We have put a number of safeguards in the regulations, and we have a number of safeguards in our activities, but certainly challenges reside.

    The Chair: Thank you.

    Dr. Fry.

    Ms. Hedy Fry (Vancouver Centre, Lib.): Thank you very much, Madam Chair.

    Réal already asked my question, the one about criminal sanctions. I think you answered it very well, so I won't repeat it.

    My question actually is for Mr. Ouimette. I think you're the one on the hot seat today. I agree with you completely that we should only consider safety. That should be the basic consideration. But under the Food and Drugs Act, when you bring in oranges or grapes from another country, you do random testing when they're in the supermarket. Do you now do, or you going to propose to do, random testing on imported semen in order to verify efficacy, or are you just going to take the word of the importer and the exporter? That's the first question.

    The second question has to do with Ms. Parker and it has to do somewhat with the blood issue. My understanding is that it's not just that the blood was unsafe, but that there was at the time international standards in which it was accepted that there were certain tests--newer tests, more accurate tests--used by other countries for testing for HIV that took a very long time to be implemented in Canada.

    My question is that within the standards you are setting, I am hoping there would be something that would discuss the issue of using all of the international standards with regard to testing as soon as they are available and in a very timely manner, rather than having a repetition of Canada not making decisions to use what is already internationally accepted medical practice and testing modules.

    So those are the two questions.

    Mr. Étienne Ouimette: Thank you for the question.

    There have been subjective discussions with regard to lab testing, but again, there are challenges, because most of the testing is performed on serum samples and only a few on the semen itself. What we see coming through the border is only the semen itself.

    With regard to testing more specifically, there are regulations in Canada that regulate medical devices, screening test kits that are to be used for the testing. Basically there are provisions in the semen regulations to that effect. The testing is being done. We have access to the kit being used. We have access to validation data of these kits, if at all needed. We also have access to test results.

    At this point, we consider this is sufficient in terms of assessing compliance in regard to the safety of a semen sample. However, there are possibilities that could be looked at in terms of doing some testing, and that has been discussed, yes.

    Ms. Hedy Fry: If we could do it for grapes, we could do it for semen. I'm just suggesting that you think about that as something that is a real possibility, because testing the kits for testing and accepting the results of testing alone I don't think is sufficient given the nature of the material that can carry with it obviously blood-borne and body-fluid borne diseases. I think that random testing in the same way as you do under the Food and Drugs Act for other items might be something you should consider.

    Mr. Étienne Ouimette: Thank you for the recommendation.

    The Chair: Thank you, Dr. Fry.

    I have a very short question from Ms. Wasylycia-Leis to conclude--

    Ms. Hedy Fry: Ms. Parker hasn't answered my question.

    The Chair: Oh, I'm sorry.

    Ms. Parker.

    Ms. Cathy Parker: Thank you for your question. With respect to the standards for soft tissues and organs and what is available as international standards, the standards have been developed by Canadian scientists, by a committee of experts, and I do mean experts. The standards have been developed taking into consideration all existing international standards in that area. When the standards are published, you will see an extensive reference list to other standards. Because the standards are being published as part of the Canadian Standards Association process, they're actually independent of Health Canada. We participate in the committee that will maintain them, but we are not driving or directing the standards.

    As to the process for maintaining the standards, we are funding that process, but the process allows for a trigger to identify a new safety issue that triggers a series of steps to have that standard updated. Any safety trigger could result in that, but monitoring what is happening internationally is key.

    Then once that standard is updated to reflect a new requirement, the standard sets minimum safety. So you cannot go below what is in the minimum safety. By referencing the standards in our regulations, we hope to get to the point where the standard can be updated quickly, and the update is reflected immediately within the regulations.

Á  (1135)  

    The Chair: Ms. Wasylycia-Leis, very quickly, please.

    Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): On the issue of regulations and standards, I have a question for Cathy Parker, although this might be separate from Health Canada. The standards are to be incorporated into the Food and Drugs Act. I'm wondering if the committee could get a copy of the proposed standards, and I'd like to know when the actual draft standards will be placed in the Canada Gazette for public comment. That's one quick question.

    The other has to do with surveillance. You can have all the great standards in the world, but if we don't have the resources for surveillance in the field, it's pretty hard to regulate. It's pretty hard to know even what's happening.

    My question is, what is being done to address the serious concerns unearthed by the TV program the fifth estate in this summer's documentary about brain tissue patches coming from human corpses containing CJD and entering our health system? What is being done about getting a handle on the number of tissue banks, semen donor banks, you name it, to control the fact that people are making charitable donations to tissue banks or other banks in Canada and not knowing that sometimes those banks then send and sell that tissue, semen, or eggs to private clinics in another country to be used for cosmetic purposes, such as facial surgery and the enlargement of penises? What is being done to get a handle on and regulate this whole area?

    I think that would guide us in our approach to reproductive technologies.

    Ms. Cathy Parker: Thank you for the question. With regard to the standards themselves, the standards development process includes a public review period, and that was conducted between December and January of this year. So the public review has been done.

    The standards for soft tissues and organs, as I said, are expected to be published early next year. We are at the very final stages. They are in the process of translation and printing right now. So the standards will be published by the Canadian Standards Association early next year, hopefully by the end of February.

    With regard to surveillance, I can only speak in general terms of what we are doing with our regulatory framework project. As I said, we are building a set of regulations around the standards. The standards themselves have requirements for adverse reporting, disease testing, and surveillance, but in order for it to be mandatory, it must be referenced in regulations. That is part of what we are working on with our regulatory framework, including a whole subproject on surveillance issues. With surveillance, there's not only disease surveillance to look at, but other types of adverse outcomes from tissue transplantation. That is a very active part of our framework. We're doing that in conjunction with the Population and Public Health Branch of Health Canada.

    I don' t know if that answers your question in enough detail.

    Ms. Judy Wasylycia-Leis: I don't think the chairperson will let me ask for any more time, so we'll have to pursue this later.

    Thank you.

    The Chair: Thank you, Ms. Wasylycia-Leis.

    On behalf of the committee, I'd like to thank the witnesses for coming, and some of them for coming again, and propose that we may need to call you to ask for clarification or require your expertise in some form again. Thank you very much.

    We'll now close this section of the meeting.

Á  (1140)  

---

Á  (1145)  

    The Chair: Thank you for your patience, ladies and gentlemen.

    As I said at the beginning of the meeting, we would have the motion between the two sets of witnesses. The motion is before you, moved by Mr. Ménard.

    Mr. Ménard, would you like to speak to your motion briefly. It's fairly self-explanatory.

[Translation]

    Mr. Réal Ménard: It will be very clear. I think it is not possible for a committee that is as large as ours to settle all of the issues in meetings of the full committee. There are administrative matters, details, that must be settled by a subcommittee. I am not against the idea of making amendments, but it seemed to me that all parties had to be represented at the subcommittee, and that the parliamentary secretary also had to be there because he has information on the government agenda.

    So, I move, for the purpose of making us more efficient, that we strike a subcommittee, a steering committee. Many other committees have such a subcommittee. Certain persons have made representations to me to the effect that we should perhaps change things. I am willing to consider that idea. The purpose is for us to be effective and not to have to settle every issue in full committee meetings.

[English]

    The Chair: Madame Thibeault.

[Translation]

    Ms. Yolande Thibeault (Saint-Lambert, Lib.): Madam Chair, I am entirely in agreement with the idea of striking a steering committee. However, concerning its makeup, I would like to move the following amendment. With your permission, I am going to read the proposal I would like to see accepted this morning.

It is moved that the Standing Committee on Health proceed with the striking of a steering committee made up of the Chair, the two Vice-Chairs, the Parliamentary Secretary of the Minister of Health and one representative of the Canadian Alliance.

    That is my suggestion to you this morning.

Á  (1150)  

[English]

    The Chair: Madame Thibeault, the motion is actually moved by Mr. Ménard, so what you are proposing is an amendment. The amendment proposes the addition of the parliamentary secretary and a period after the Canadian Alliance.

    Any discussion of that motion?

    Ms. Hedy Fry: I agree with the idea of a steering committee. I think Mr. Ménard's idea is a good one. I actually think we should amend it to have the composition that most standing committees have, which is

[Translation]

    the chair, the two vice-chairs and

[English]

the parliamentary secretary, and nobody else.

    The Chair: So that would be a different amendment. Are you going to support Madame Thibeault's amendment?

    Ms. Hedy Fry: No.

    The Chair: Okay.

    Ms. Wasylycia-Leis has a vested interest in this.

    Ms. Judy Wasylycia-Leis: I'll speak against the amendment and I'll suggest to the committee that I think the standard practice of committees is to strike a steering committee that does represent all political parties. I find it offensive that the recommendation is to exclude two, possibly three, political parties, depending on who holds the vice-chair positions. So I would think out of parliamentary democracy and human decency we would have a steering committee that includes at least one representative of each political party around this table.

    The Chair: Mr. Szabo.

    Mr. Paul Szabo (Mississauga South, Lib.): I wonder if the clerk has a copy of the standard resolution that committees have used with regard to forming steering committees, because I believe it does sustain what Ms. Wasylycia-Leis has just said, that it be collaborative.

    The Chair: Mr. Ménard.

[Translation]

    Mr. Réal Ménard: I cannot imagine a steering committee where there would be no representative from the official opposition. Whatever one's position, I think the opposition has to...

[English]

    The Chair: That's why it shouldn't say “the Canadian Alliance”; it should say “the official opposition”.

[Translation]

    Mr. Réal Ménard: I also believe that there should be an additional person. Judy works assiduously on the committee and is interested in health issues. We want the steering committee to wok well. The PC may not be represented because it never sends anyone to the committee, but the NDP is always present at the committee and works seriously. I think that the purpose of the steering committee is to clear the underbrush so that the committee as a whole can ratify everything.

    I have no objection to the parliamentary secretary being a member, but I think that we have to ensure that the political parties who want to work on the committee will be represented. In any case, the idea is not to put the government in a minority situation, because the decisions of the steering committee must be ratified by the committee as a whole. Nobody thinks that we are going to put the government in a minority situation, since the important decisions must be ratified by the full committee. We cannot work without at least one representative from each party being present. So, why exclude the NDP, which does work? Where the Canadian Alliance is concerned, it is inevitable.

    We could accept Ms. Thibeault's amendment by adding the words «a representative of the NDP».

[English]

    The Chair: The situation I'm trying to avoid is this. I was on a committee once that followed that rule. It gave the opposition the majority on the steering committee. So we'd meet for the steering committee, the opposition would win every battle, so to speak, and it would come back to the full committee, where the government has the majority, and there would be the same debate all over again. So you'd spend an hour in the steering committee, an hour in the plenary committee, and at that point the government would overturn the recommendation of the steering committee.

    What I'm try to get to is a way to smooth things out so that the recommendations of the steering committee have a chance of succeeding at the plenary committee.

    Ms. Wasylycia-Leis.

Á  (1155)  

    Ms. Judy Wasylycia-Leis: I think the objective of this motion is for us to operate on a consensus basis and to pool the ideas of members who have a strong interest in health policy issues. It seems to me--

    The Chair: Everybody knows that. Do you have a suggestion?

    Ms. Judy Wasylycia-Leis: Well, yes. The suggestion is that for a proper steering committee we should have one person from each party. We'd get together and have discussions, and operate on consensus, and we'd bring some guidance to this committee as opposed to feeling it's all about votes, and battles, and drawing lines.

    The Chair: Which, in the end, it is.

    Ms. Judy Wasylycia-Leis: It seems to me that's the point of this, to bring together the five parties, to have those discussions, and bring it back to this committee.

    The Chair: Dr. Dromisky.

    Mr. Stan Dromisky: I have to agree with all the sentiments of expression that are coming forth this morning. There's no doubt that from an idealistic viewpoint we have to work as a perfect model, everybody is in agreement, consensus has been made and so forth, but then we have to look at the reality of the situation. There are other factors that we're not taking into consideration. That is, regarding health, what are the objectives and aims of the political party that's in power? Do you think for one moment that if the NDP or the Bloc or the Alliance or the Conservatives were in power they would allow the opposition to control the agenda? It doesn't happen that way, and this is the reality of the situation.

    Mr. Réal Ménard: No, don't say that. I'm hurt.

    Mr. Stan Dromisky: That's true. You're too young to know that the history of this country is based on that basic principle.

    So what I'm trying to say is that we have to face the real situation. Really, in the long run, the control regarding the agenda should be in the hands of the government that's in power, which is totally responsible for whatever policy the government comes forth with--the funding of that policy, the implementation of that policy, and everything else. It's not the opposition that is responsible for all those factors. It's the responsibility of the government.

    An hon. member: Stan, are you advocating that there be no opposition members on the steering committee?

    Mr. Stan Dromisky: No, I never said that.

    The Chair: Dr. Fry has the floor.

    Ms. Hedy Fry: I would like to speak against the amendment for the simple reason that you gave, Madam Chair.

    A steering committee is not here to be a nice, warm consensus body, it's here to create an efficiency. So a lot of the process about where we're going to go, what we're going to do, gets dealt with when we come to this committee, you've presented your things and everyone can accept it. If you have an imbalance on that committee, you do exactly what the chair says: you come back here and rehash everything. And you've thereby killed the whole concept of efficiency.

    I support the motion because it's an efficiency issue, and the committee should spend its time debating issues of health and not issues of process, etc., which I think are efficient things to do by steering committee.

    So my position is this: the steering committee should be made up in the manner of my earlier suggestion as opposed to Madame Thibeault's. That's all.

    The Chair: Please clarify for me, Dr. Fry; are you voting for or against Madame Thibeault's amendment?

    Ms. Hedy Fry: Against.

    Mr. Réal Ménard: But she is in favour of my motion, I think.

    Ms. Hedy Fry: No, against your motion as well.

    The Chair: Perhaps Dr. Fry could suggest to us if she's going to make another amendment and what that would be. What would it be?

    Ms. Hedy Fry: That the Standing Committee on Health proceed with the striking of a steering committee made up of the chair, the two vice-chairs, and the parliamentary secretary.

    The Chair: Very small, then, without the official opposition.

    That's going to be the choice of amendments unless somebody comes up with another one.

    I'm going to call the question on Madam--

[Translation]

    Mr. Réal Ménard: Just a minute. I want to say one thing to the government.

    Up till now, our committee has worked well. If the government is taking advantage of its majority to strike a steering committee which has not been agreed to by all of the parties, we are going to stir up trouble. We can block the work of the committee.

    Mr. Dromisky can serve up the speech on the lines of authority. That can be said. Yes, that is reality. There must be a steering committee that represents all of the parties, everyone. If you want to maintain the position about the lines of authority, we can block the work of the committee. The opposition parties can easily do that.

[English]

    The Chair: You've made your point, Mr. Ménard. Let's call the question.

[Translation]

    Mr. Réal Ménard: Madam Chair, I am saying that the government members must have in mind the idea that a steering committee must be functional and represent all of those who have been elected to Parliament. The government party is not the only one to have elected members, and Mr. Dromisky should not forget that.

  (1200)  

[English]

    The Chair: We have an amendment before us.

    Madame Thibeault.

[Translation]

    Ms. Yolande Thibeault: May I ask a question? Earlier, someone asked the clerk what was being done in other committees in this respect. Is it normal that there be a chair, two vice-chairs and the parliamentary secretary, or does each committee have different ideas in this regard? Do you have an answer to that question?

    A voice:No, not here.

[English]

    The Chair: He doesn't know, and each committee has the right to decide its own.

    My memory is that some of them have taken a member of each of the opposing parties, so that's four. And all they've done is taken five from the government side, to ensure that...so then you have nine people meeting for an hour. They come back, and then the full committee gets into it.

    You know, nine people is a lot for a steering committee.

[Translation]

    Mr. Réal Ménard: We do not need a government majority to come to an agreement.

[English]

    The Chair: I'm going to call the question on Madame Thibeault's amendment. Just to repeat it for you, it amends the motion before you, on page 2, by adding parliamentary secretary to the list and putting a period after the Canadian Alliance.

    Mr. James Lunney: So we're just adding the parliamentary secretary?

    The Chair: No, we're also deleting the New Democrats and the Progressive Conservatives. Really, the only purpose is to make sure there's a majority on the government side.

    Mr. James Lunney: On a point of order, Madam Chair, are there rules on quorum?

    The Chair: That wouldn't be relevant here.

    Mr. James Lunney: It would be in the sense that a steering committee should include the opposition, for a quorum.

    The Chair: I'm sure there are rules about that, but we don't have to talk about that here. There'll be something in the standing orders, which the clerk will look up. There will be quorum rules.

    (Amendment negatived)

    The Chair: Do we have another amendment?

    Madam Fry.

    Ms. Hedy Fry: Notwithstanding what I said earlier--and Mr. Ménard knows of our experience on another committee--I have what I hope will be a compromise, that the Standing Committee on Health proceed with the striking of a steering committee made up of the chair, the two vice-chairs, the parliamentary secretary, and one representative of an opposition party, to be decided by amongst themselves.

    Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Get real. And is this the amendment that was on, that we were just supposed to be voting on?

    The Chair: Excuse me, Mr. Merrifield. You're late. The first one was from Madame Thibeault. We have a motion on the floor from Mr. Ménard. There was one amendment from Madame Thibeault, and now we have a second amendment from Dr. Fry.

    Mr. Rob Merrifield: Okay. I had understood that she'd meant it as a motion.

    The Chair: She may say she's moving a motion; I'm ruling that it is an amendment.

    Ms. Hedy Fry: No, no, I'm not moving a motion. I just read the whole thing to put the amendment in place, that's all.

    The Chair: She just read the whole thing that was based on Mr. Ménard's, and how she would change it.

    Just for clarification again, Dr. Fry, who do you want on the steering committee? Don't read the whole motion.

    Ms. Hedy Fry: The chair, the two vice-chairs, the parliamentary secretary, and a member of the opposition parties, to be decided by amongst themselves.

    Mr. James Lunney: Objection.

    The Chair: Let's just call it. Either you like it or you don't. You know what it means.

    Mr. James Lunney: You need to have an official opposition.

    (Amendment negatived)

    The Chair: Is there another amendment?

[Translation]

    Mr. Réal Ménard: Madam Chair, I would like to ask the government to take my proposal into consideration, which I am going to withdraw today, but which will be voted on at the next meeting. I would like us all, on each side, to reflect on the best possible way of organizing our work. So, I will withdraw my main motion for the purposes of this discussion.

  (1205)  

[English]

    The Chair: So you're moving that we table this motion for the time being and come back with a different proposal.

    (Motion allowed to stand)

    The Chair: This business item is set aside for the time being. Maybe the vice-chairs will get together to try to figure out something that is acceptable to all.

    Thank you very much for your efforts. Thank you very much to those who came to assist us.

    I'll now call Mr. George Radwanski, Privacy Commissioner of Canada, to come forward.

    Mr. George Radwanski (Privacy Commissioner of Canada): Good afternoon. I very much appreciate the invitation to meet with you today to discuss this very important legislation. I must say that, particularly in the current climate, I always find it very gratifying whenever Parliament recognizes and underscores the importance of privacy considerations in the decisions our society must make.

    I want to tell you very frankly, though, that I'm not sure I have a huge contribution to make with regard to this particular bill. I say that because this is very complex legislation that raises a great many issues of every kind--legal, medical, ethical, and of course the privacy kind.

    With regard to privacy, on the whole, I think, Health Canada has struck the right balance. I don't have what I would categorize as any grave concerns about most of this legislation from a privacy perspective. However, I do have a few general comments to offer.

    I am very concerned that key provisions regarding privacy rights are left to be determined by regulation. I'd like to commend Health Canada for its efforts to understand and address the privacy considerations, and I would like to thank the department for keeping me and my office informed about this initiative as work went forward. These efforts have proved very helpful in sorting out a very complex subject.

    My interest in this bill as Privacy Commissioner is limited to the provisions dealing with the protection of the personal information that is collected as part of the assisted human reproductive process and the oversight regime that will govern it.

    A person's medical information really is the most intimate and private information that one can envisage. Under this bill, clinics, physicians, and other licensed facilities providing these services would be required to collect--and I quote--“highly sensitive health reporting information” and provide it to the proposed assisted human reproduction agency, which will fall under the responsibility of the Minister of Health.

    If people donating reproductive material or people making use of these reproductive techniques cannot feel confident that this health reporting information is adequately protected, they almost certainly won't be likely to participate.

    The legislation provides some important protections for this information. It imposes certain responsibilities on the proposed assisted human reproduction agency. The bill has specific provisions dealing with disclosures. Written consent is required, except for specified disclosures. It provides for access and correction rights and has provisions dealing with the destruction of personal information, and it requires licensees to inform individuals in writing of these requirements.

    On the whole I think these are good provisions. Furthermore, the proposed assisted human reproduction agency would be subject to the Privacy Act and thus to oversight by me and by my office.

    I will also have oversight, under the Personal Information Protection and Electronic Documents Act, of the collection, use, and disclosure of personal information by licensed facilities engaged in commercial activities, except in those provinces that have passed substantially similar private sector legislation of their own.

    So I'm generally satisfied with the oversight regime that will exist. But--there's always a but--there are two areas on which I'd like to briefly comment.

    The first area relates to the right of offspring to information about the donors versus the right of the donor to have information withheld unless he or she consents. These are both important privacy rights. We, as a general principle, have the right to obtain access to personal information about ourselves, which could certainly be taken to include information about our biological parentage.

    On the other hand, the essence of privacy is a right of consent--the right not to have personal information about ourselves disclosed to others without our express consent. That of course brings us to the question of whether the identity of the donor should be disclosed to the offspring without the donor's consent.

  (1210)  

    Philosophically, my view would be closer to the view of this committee--namely, that the rights of offspring should take precedence over the rights of the donor. No one is compelled to become a donor, under whatever rules are made clear right at the outset, but on the other hand, people have no control over the circumstances under which they are brought into this world. They may have powerful psychological or practical reasons to want to find out information about their parents.

    So philosophically, I'm closer to the view of this committee, but after consultations with Health Canada, as we went through this process, I have accepted their concern, as a practical matter, that this approach could very much discourage people from becoming donors, and open up a whole host of legal issues and concerns. Part of the problem, as they explained, is that one can't do the obvious thing, for instance, and exempt donors from certain types of legal liability, financial support or what have you, because that would fall under the provincial jurisdiction.

    So I was presented with some of those arguments. Health Canada also made the very persuasive point that their approach was consistent with the existing rules governing adoption, under which the identities of birth parents can be disclosed only with the consent of the birth parents.

    I'm of the view, then, that on this very complex issue, to which there really is no right or wrong answer, the decision of Health Canada strikes a reasonable balance by ensuring that an offspring will have access to pertinent information in a way that does not disclose the identity of the donor. The bill doesn't preclude the offspring from ever being able to know the identity of the donor; it simply makes it dependent on the donor's consent.

    Still on the issue of consent, paragraph 15(2)(d) provides for disclosure without consent, when required by any federal or provincial law respecting health and safety. Given the sensitivity of the information involved, this clause, as worded, is too general and too permissive. The legislation should limit the circumstances to specific enumerated matters, where this highly sensitive information could be disclosed without consent.

    The second issue involves regulation-making authority, and here I do have a very serious concern. Subclause 65(1) gives the governor in council the authority to make regulations on a number of matters. Most of these deal with specific issues that do not concern privacy, but paragraph 65(1)(n) requires the governor in council to make regulations, “respecting the collection, use and disclosure of health reporting information”.

    This provision is so broad that regulations could be issued after the fact that would reduce or substantially change the level of protection afforded health reporting information. Regulations are appropriate for matters such as specifying the qualifications of inspectors. They are not appropriate, in my view, for altering the fundamental rights of individuals.

    I also have a particular concern about clause 16, which would permit the destruction of health reporting information, “in the circumstances and to the extent provided by the regulations”. Frankly, I can't see any circumstances under which this information should be destroyed without the consent of the offspring who is entitled to have access to it. This certainly should not be left to regulation. As I have commented, with respect to other legislation, such matters should be specifically addressed in the legislation and not in the regulations.

    Those are really all the overview points I want to make. I'll be happy to address any questions or comments you want to discuss.

  (1215)  

    The Chair: Thank you very much.

    We'll begin with Mr. Merrifield.

    Mr. Rob Merrifield: Thank you for coming in and sharing your insight on the legislation.

    I'd like you to go back to a period before Health Canada got hold of you. I'm actually concerned about what would happen if there were no consent, one way or the other, between the donor's right and the offspring's right. The concept we've been under as a committee is that when the right of the donor conflicts with the right of the child, the right of the child prevails. Is that the way it would be now?

    Mr. George Radwanski: If there were no legislation at all?

    Mr. Rob Merrifield: Yes, right now.

    Mr. George Radwanski: In the absence of any legislation, I don't know any mechanism by which the individual, in most circumstances, would be able to access information about the donor, nor would it necessarily even be recorded.

    Mr. Rob Merrifield: So would that come out to a court decision?

    Mr. George Radwanski: Well, first of all, it presupposes that in the absence of legislation there would be information about the donor to be obtained, which there might not be in the absence of any legislation. If it's done privately, for example, how would you find that out?

    Mr. Rob Merrifield: If there was information there, and the donor said, “I don't want my information to go”, and the offspring said, “Listen, I need to know my genetic history, the social history of my donor,” whose will, in your estimation, would win?

    Mr. George Radwanski: I understand the question. I think, in all honesty, we would be in uncharted territory, simply because this is a new field, which is why we're seeing this legislation. I would guess the closest analogy that would be followed would be what exists in adoption matters, and that is, the identity of the parents is not disclosed without their consent. I'd be hard-pressed to predict how it would play out.

    I did want to come back to one thing you said, though. I know you're saying it partly in jest, but I wouldn't want to be characterized as having taken a position based on Health Canada or anyone else getting “hold” of me. Of course, as Privacy Commissioner, I'm entirely independent.

    What one tries to do in these matters is both offer a device, obviously, and help to strike good balances. So, faced with the practical concerns that in a certain type of regime it might be virtually impossible because of legal implications and so on to find donors, certainly ones who would participate in the regulated process, I am not able to say that the point of view they take is unreasonable from a practical perspective.

    That's really as far as I can go on that point.

    Mr. Rob Merrifield: Thank you. What you're saying is that really we have no clearer guidelines on who would win, but if it would fall back on the right of the adoption history, let's say, it would probably be the right of the donor rather than the right of the offspring. If we could clarify it, now is the golden opportunity to clarify it. I'm wondering if you feel we have enough teeth in the legislative part of this, in the vacuum of no regulations on it, to be able to guarantee that right.

    Mr. George Radwanski: My point isn't that there shouldn't be more detail or that things should not be more spelled out; my point is that, where rights are concerned, spelling out of detail should occur in the legislation proper, not in the regulations.

    My difficulty with regulations is that they can be readily changed often, without this kind of process; even if they are put before Parliament, they're not subject to parliamentary vote or to the same level of scrutiny. If you believe there's a need for further detail, I'd prefer that the balance of rights be in the legislation proper.

    Mr. Rob Merrifield: And do you feel there should be more in legislation than what you see in Bill C-13 before you? That's where we rely on your expertise.

    Mr. George Radwanski: With regard to that balance of rights, I think for the most part it's relatively clear. To me, the legislation says the health information, the information about current lists, the genetic information and so forth will be held and will be made available to the offspring but in a form that does not disclose the actual identity--the name of the donor--without the donor's consent.

    The trouble is, you have a provision that says regulations can be made pertaining to the collection, use, and disclosure of information under this bill. And it's not so much that the bill isn't clear, on the face of it; it's that the regulations could impact on what is now that clarity by saying, well, actually what this means is x, y, z, which could bring us to a very different place than we think we are at.

    Mr. Rob Merrifield: Could you give a recommendation to the committee on how you change the wording to not allow that to happen in regulations?

  (1220)  

    Mr. George Radwanski: Well, my point has been that there should not be a general phrase regarding regulations of this type--about collection, use, and disclosure--and that only specific matters should be left to regulation. And they should be really administrative matters. For instance, if you want to define the qualifications necessary for inspectors or that kind of technical thing, you can do it in regulations. Rights should not be defined in regulation; that's the general point I make. So I would lose that very sweeping provision and only identify things that are appropriately done by regulation.

    Mr. Rob Merrifield: Thank you.

    The Chair: Thank you, Mr. Merrifield.

    Dr. Lunney.

    Mr. James Lunney: I wanted to come back to something, and perhaps I'll need some help from our researchers or other committee members here. I'm aware that when we had this discussion about anonymity of the donors we had witnesses here with models from other countries--it was either Australia or Sweden, although I think it was Sweden--where they had gone to a completely open system with no anonymity in the donation.

    The myth that's put forward, that it would shut down the whole industry, that nobody would donate, just didn't materialize. In fact, things did progress, and in a much more responsible and regulated manner.

    So going back to your wish list, with Health Canada saying nobody would come, if there are other working models where an open system works, should we not consider those models, Mr. Radwanski?

    Mr. George Radwanski: I have not studied the experience of other countries, in all fairness, so I don't know, for example, whether in Sweden, where there is, you say, full disclosure, there are also other legal provisions on the other hand that preclude the offspring, for instance, from demanding child support from the donor or anything like that. I don't know what the total package of the legislative framework is. That would be the complexity.

    Mr. James Lunney: I think it's a given that you have to provide for the donor that protection from legal responsibility or prosecution for support.

    Mr. George Radwanski: But the difficulty in the context of this legislation, as I understand it and as it was explained to us by Health Canada, is that it's not possible constitutionally to create that in this legislation, because those would be matters of liability and civil rights and property--whatever you want to call it--that fall under the jurisdiction of provincial governments.

    This legislation could create a regime that provides half the equation without any assurance that the other half would in fact be provided. That was the difficulty that was explained to me in the Canadian context.

    All that said, let me be very clear that this is not an issue on which the privacy dimension is black and white. Philosophically, as I say, I'm closer to the view of this committee. I wouldn't be up in arms from a privacy perspective in either scenario as long as the rules of the game are clear from the outset. I mean, no one is forced to donate biological materials against their will, and if the rules are clear that they will be subject to full disclosure or partial disclosure or whatever else, well, then, those are the rules.

    I was persuaded that it might not be a practical way to go, given those other considerations. That keeps me from saying that from a privacy perspective this is the better way to go, period. But if the practical implications were of no concern to Parliament or to this committee, I certainly would not regard either legal framework as being incompatible with privacy rights, as long as it is clear and as long as there's no possibility of having one set of rules and then having a more permissive regime introduced later by regulation--or even, quite frankly, I'd be worried about having it introduced by amendment. We'd be getting into the kind of issue that in a completely different field we're having with historical census data, for instance: that once the government gives its word to people and they base privacy-relevant choices on it, that word should never be changed subsequently. That's of concern.

    But I wouldn't want this committee to come away with a perception that I'm saying on this issue it has to be this way or that way; either is a reasonable position.

  (1225)  

    Mr. James Lunney: Thank you very much.

    Is it possible for the researchers to shed some light on that? Do you remember, was there protection from prosecution?

    The Chair: The problem isn't the protection, as I understand it, the problem is that Sweden is probably a unitary state, where their federal legislature has complete control over all this, whereas we are a federation and certain responsibilities have been assigned to the provinces. This is one of them. That's why Mr. Radwanski has been convinced there's no point in us putting it into our bill.

    I'm wondering if there might not be another way to skin the same cat, just to use an expression, or if there's some kind of an equivalency thing. At any rate, we can pursue it.

    Mr. James Lunney: Thank you.

    The Chair: Dr. Dromisky.

    Mr. Stan Dromisky: Thank you.

    Following that line of thinking, the Canadian Bar Association, in their brief, brings up that concern regarding the scope of information reporting to the minister that can be required without consent. Somehow, I find that disturbing. Shouldn't all the information we're playing around with be only offered with consent?

    Mr. George Radwanski: That is, in a sense, built into the whole process. If those are the rules of the game, then there is consent at the point at which an individual agrees to be a donor or a participant in the process.

    Mr. Stan Dromisky: That's what I mean. How can we take that information, or any information, from a donor, or pertaining to a donor, and offer it to the ministry without consent of the donor?

    Mr. George Radwanski: To me, though, their consent is engaged at the point where the donor chooses to become a donor under this law.

    Mr. Stan Dromisky: I can understand that, but what are the limits of that? There must be some kind of agreement with the donor. There would be pertinent information, simple things such as you're a white, Caucasian, 21 years old, and you're donating your sperm, but there must be some other bits of information about which it's understood that this information would be given automatically, without your consent. But if he signs that paper there are some basics that have to be given and there are some other bits of information that cannot be given without the donor's consent. And this whole statement that says the ministry can receive information about a donor without the donor's consent bothers me.

    Mr. George Radwanski: I hear what you're saying, but my interpretation, as I say, is that it's without explicit consent at a given point, because in effect there is consent, when you become a donor, under this law, to the ministry accessing all pertinent information without your further consent. Really, I read that--

  (1230)  

    Mr. Stan Dromisky: Without “further” consent. Okay.

    Mr. George Radwanski: That's how I read the intent of that. The consent is really obtained at the point of participating.

    Again, it's a different matter if the Ministry of Health, or anybody, wants to set out tomorrow to collect a considerable amount of personal information about you, who have done nothing to engage in a process that entitles the ministry to do so. But if you engage in a process that is covered by law--in this case, being a donor--and the rules of that process are that all pertinent health information about you, etc., is to be made available to this agency, then you're going into it with your eyes open. You're consenting to participate in that process. And to me, that would be a problem only if the original requirement were unreasonable.

    If, for instance, there was a condition that all your financial history had to be recorded, then I might say, well, that seems to be using one process to achieve something for an unrelated process. It's in a form that's in a sense extorting consent; it's not reasonable or what have you. But in the scheme of this legislation, it doesn't strike me as unreasonable. So, frankly, because the whole thing is voluntary to begin with, I'm not struck by the problem.

    Mr. Stan Dromisky: What I'm driving at, Madam Chairperson, is we'll have to take a look at clause 18 in the bill and make sure the kind of information and the guidance that has just been given Mr. Radwanski is taken into consideration when we re-examine that clause and its parts.

    The Chair: Thank you, Dr. Dromisky.

    Dr. Fry.

    Ms. Hedy Fry: Thank you very much, Mr. Radwanski.

    I'm not going to deal with the donor issue, but I think your concern about informed consent is a very real one, as is the ability for any arm of the state or anyone to have access to information and records that are either from your lawyer or from your physician.

    Let's imagine you saw a woman who is going to engage in artificial insemination or in vitro fertilization. You will be taking all of her history that may or may not have anything to do with the actual process you're going to go through. There may be psychiatric history and all kinds of other history involved.

    As a physician, I have a very real concern that any state person, because they're in charge of looking at the regulations, can demand to know what you did when you were 16--whether you had a motor vehicle accident or whether you had your appendix removed--that has nothing to do with anything. In the same way, there is a tendency to want to do that now in state-run insurance, under motor vehicle insurance, for instance, where they demand to know everything about the patient and not just what relates to the accident and is pertinent to the accident.

    I think your point about pertinent and relevant information to the reproductive technology is what we should be looking at, and not have this open, carte blanche, to everything that went on in your life long before that has no relevance to the health of the individual and to the ability to be part of the process.

    I'm not speaking of the donor here. I'm just speaking of the patient or the couple having the process done. That is a real concern to me, and it is what the Canadian Bar Association raised. I think that is something we should really be concerned about in terms of personal privacy.

    Mr. George Radwanski: I certainly take your point. I would add, as I said earlier, that only relevant information should be collected. That makes sense. As well, I think it has to be ironclad clear that if information is collected by this agency for purposes of this program, largely from the point of view of ensuring that the offspring would eventually be able to access it, obviously, and also for regulating the program--preventing various abuses and so forth--then it is absolutely, crucially fundamental that it not be able to migrate into the hands of either Health Canada or other agents of the state in a nominal form for any other purposes whatsoever.

    Again, that is why I'm so concerned about leaving things to regulation.

    Ms. Hedy Fry: So you're stressing non-nominal access in some instances.

    Mr. George Radwanski: Well, certainly there may be a desirability for research access, statistical access, whatever. If it's not nominal, as the bill says, and in such a form that even without being nominal it can't readily be traced back, that's a whole different set of issues. One certainly doesn't want to stand in the way of research and follow-ups and what have you, but I am extremely concerned that there be no possible back doors whereby this information can find its way from the agency into more centralized government databases, into the hands of not only Health Canada but also, more broadly, insurers, state authorities, or police.

    That's why it's so important to circumscribe the scope for regulation pertaining to collection, use, and disclosure, because before you know it, you can find that this sensitive information is migrating. And that would be terrible.

  (1235)  

    The Chair: Thank you very much, Dr. Fry.

    Thank you, Mr. Radwanski, for assisting us with this rather thorny subject. You may have opened more questions in our minds than we have come up with today, so we may want to call you again to clarify some things. We thank you for the effort you put into this and for coming out today.

    Thank you to my colleagues on the committee for their participation. I remind you that the next meeting is Tuesday morning at 9 o'clock in La Promenade, room 701. The purpose will be a videoconference with the infertile community, all those people who asked to come here. We decided to do it by videoconference because of the expense.

    This meeting is adjourned. Thank you.