HEAL Committee Meeting

STANDING COMMITTEE ON HEALTH

COMITÉ PERMANENT DE LA SANTÉ

EVIDENCE

[Recorded by Electronic Apparatus]

Tuesday, October 16, 2001

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[English]

The Chair (Ms. Bonnie Brown (Oakville, Lib.)): Good morning, ladies and gentlemen. I'd like to call the meeting to order.

We have a couple of items of committee business to go through. I'd like to go through them now, because you'll recall that I have to take the budget to the liaison committee. That meeting is at one o'clock, so I have to be out of here by 12:50 p.m. to get over there and get the money for our travel.

Anyway, I'll get to the announcements.

You'll recall that we have the director general of the World Health Organization coming tomorrow at 3:30 p.m. Her name is Gro Harlem Brundtland—quite a famous individual—and she has 45 minutes for us. She'll probably make a short presentation, and then we'll be allowed to ask questions on any topic.

In the meantime, I received a letter from our colleague Judy Wasylycia-Leis, who would like some kind of a briefing on what the health department is doing about the bioterrorism issue, and she'd like to see the minister, too. When I found out Mrs. Brundtland is only coming for 45 minutes, I decided to ask the health officials to come for the second 45 minutes tomorrow, so that we can have a briefing on that as quickly as possible. They will be ready to answer your questions. If we need more, if you're not satisfied with that 45 minutes of information, then at the end of tomorrow's meeting, we will plan when we might do something else about that topic. But I suggest we wait until we see what the health officials tell us before we make that decision.

Ms. Judy Wasylycia-Leis (Winnipeg North Centre, NDP): Thank you, Madam Chair. I appreciate that acknowledgement of my letter.

Just in terms of process, I'm wondering where copies of my letter are. We sent it to your office on Friday and have been in touch with the clerk's office. Our assumption was that it would be translated and then brought forward to the committee. I did request that, and I'm just wondering when that might take place.

The Chair: The clerk and I read the letter yesterday, and it did not actually say it was a notice of motion. I forget the exact wording, but if you have it in front of you, maybe you could read it.

The letter was demonstrating what you wanted to see happen, and it seemed to me that if it didn't happen, you would bring a notice of motion to make it happen. I'm trying to accommodate your wishes without that, in which case it doesn't need to be translated and distributed, unless you're dissatisfied with what happens subsequent to tomorrow.

Ms. Judy Wasylycia-Leis: Madam Chair, I'm not arguing with you at all. I just simply had understood that since we had sent the letter to you, copied it to all committee members, and then asked the clerk's office how this would be distributed, our assumption was that it would either have been done and circulated, or that it would have been brought forward to this committee. I'd be happy to read the letter at this point, just so there's a sense of what I was asking.

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The Chair: All right, go ahead.

Ms. Judy Wasylycia-Leis: I wrote to you on Friday, October 12, asking the committee to:

give urgent and priority attention to a discussion of the health-related aspects of anti-terrorism plans and, specifically, Canada's readiness to face the threat of bioterrorism.

It is particularly critical for our Committee to receive a briefing from the Health Minister about the state of affairs in this area and his proposals for addressing previously-identified deficiencies in our systems for responding to bioterrorism. As you know, a Health Canada report of March 2000 clearly documents major problems in the areas of health care protocols, emergency preparedness and vaccine availability. Those concerns have taken on a new sense of urgency and gravity given the tragic events of September 11, 2001.

I believe the Standing Committee on Health has a useful role to play in this regard and ought to be involved in deliberations responding to the threat of bioterrorism. I realize we have a full agenda pertaining to reproductive technologies. However, I believe the gravity of the situation today requires us to set aside time now to discuss health-related aspects of an anti-terrorism strategy. For all of us struggling to absorb the reality of September 11^th, and to ensure Parliament responds with effective measures that are adequate to protect the health of Canadians, it is vital that we base our decisions on the best information available.

I hope you will give this recommendation your serious consideration and allow for discussion of it as the first item of business at our next meeting on October 16, 2001. In terms of focusing this discussion, I am prepared to make a specific recommendation and to move the following motion:

That the Standing Committee on Health agree to set aside the ordinary business of the day to discuss strategies to address the threat of bioterrorism and that the Minister of Health be asked to appear before the Health Committee on an urgent basis to provide a briefing on plans and preparations in response to the threat of bioterrorism.

That's the letter.

The Chair: Okay, but it didn't say it is the notice of motion. It said you were prepared to make the following motion.

The only words I disagreed with in that letter were “set aside the ordinary business of the day”. As chair, I am quite willing to accommodate your wish for discussion and information on this topic, as we all agree it's urgent. On the other hand, we are under a time deadline, and my feeling would be that we should do this as best we can, when we can. I've tried to accommodate your wishes as quickly as possible by having people come tomorrow. This meeting was scheduled. We have witnesses. We have guests. I didn't really want to go into a discussion about this until we get a first briefing from the health officials who are coming tomorrow.

Do we really have to talk about this more, seeing as we have a plan?

Mr. Ménard.

[Translation]

Mr. Réal Ménard (Hochelaga—Maisonneuve, BQ): I would like a clarification. While it is true that we have a plan, the members are masters of this committee, and I think we should try to work this out together. You have invited officials to appear tomorrow, but we wanted the minister to appear. Do you foresee the minister coming before us anytime soon? He doesn't need to stay for ever; we would only need two hours to question him.

This is something that is of concern to all Canadians. Call us together at some other time if we can't do it in... [Editor's Note: Inaudible], but will you at least undertake to communicate with the minister to invite him to appear within the next few days, so that we can ask him about what is being done in the fight against bioterrorism? That is our colleague's question. Officials are all well and good, but the minister is responsible, and you did not mention him in your answer.

So, will the minister be coming or not?

[English]

The Chair: No, but in my earlier description of the plan to have the officials tomorrow, I said that after hearing what they have to say, we can then decide if we want to invite the minister.

Does that sound agreeable, Ms. Wasylycia-Leis?

Ms. Judy Wasylycia-Leis: Yes. Not knowing what will happen tomorrow with the briefing and what will transpire in the meantime, I will then give notice of motion based on what I've just read for....what does it take? It's 48 hours or whatever, so we could deal with the motion first thing at our Thursday meeting.

The Chair: What if, on Wednesday afternoon, we've already decided we want to hear from the minister? Why do we need a motion?

Ms. Judy Wasylycia-Leis: I'd still like to move this as a notice of motion.

The Chair: Okay.

Ms. Sgro.

Ms. Judy Sgro (York West, Lib.): Madam Chair, I think you have accommodated the issue that has been raised by getting health officials in here tomorrow. Where it goes after that can be decided tomorrow. Certainly, the committee shares the same interest in obtaining the information Ms. Wasylycia-Leis wants as well. I think you've accommodated her request. Let's recognize that and move on.

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The Chair: Thank you.

Moving on to other announcements—

Mr. Réal Ménard: But not regarding the minister.

The Chair: —we are hoping to get our budget passed today on our travel plans, so I would ask you to contact the clerk as to whether or not you wish to be in the group that travels east or west. I have already heard from Mrs. Beaumier, Mr. Dromisky, Ms. Wasylycia-Leis, Mr. Merrifield, and Madame Thibeault. For the rest of you, would you come up at the end of the meeting and just tell the clerk which way you'd like to go, east or west?

You have on your desk a copy of a letter I received from four ministers on the issue of genetically modified organisms. I don't want to talk about that letter today, because there's a vote in the House tonight on a private member's bill, as you all know. But I think you can see that, either way, if the bill passes second reading, it will come to us anyway. We have sixty sitting days to begin looking at it. That would allow us to finish our work on the topics we're doing now, and we could start that in February. If the bill does not pass, we have this letter that is referring the subject to us anyway, so there's no escaping it.

The last issue is the fact that Dr. Françoise Baylis, the ethicist who was here at the committee, will be speaking at the Breakfast on the Hill seminar on Thursday, from 8 a.m. to 9:30, at the Parliamentary Restaurant on the sixth floor of Centre Block.

For those of you who are new members of the committee, I would say I think those of us who were present for her analysis of this issue were pretty impressed with Dr. Baylis. I certainly was. So since she is the guest speaker, it seems to me you could catch up on some of the ethical issues that have implications on our topic of assisted human reproduction by going to that breakfast.

Mr. James Lunney (Nanaimo—Alberni, Canadian Alliance): Is that tomorrow?

The Chair: That's Thursday, October 18, at 8 a.m., in the Parliamentary Restaurant. For anybody who could go, it would probably be a good idea. If you can't, that's too bad, but I did want to alert you to it.

Okay, now let's get to the business of the day.

I apologize to our witnesses, who were here on time, but every once in a while we have to have a little cleanup of business, particularly after a week on break.

We have three organizations with us this morning, the first one being the Canadian Council on Health Services Accreditation. Mr. Lanteigne and Ms. Greco are here representing that group.

I'm wondering if you would like to begin your presentation. We'll hear all three presentations, and then we'll have questions.

[Translation]

Mr. Lanteigne, you have the floor.

Mr. Gilles Lanteigne (Assistant Executive Director, Canadian Council on Health Services Accreditation): Thank you.

The French version of my presentation will be ready on Monday. We will be happy to forward it to the clerk as soon as it is available.

[English]

The Canadian Council on Health Services Accreditation is an independent, non-profit, non-governmental organization whose mission is to promote excellence in the provision of quality health care and the efficient use of resources in health organizations throughout Canada. CCHSA has been in existence for close to fifty years. It recognizes that the ultimate beneficiary of its work is the people of Canada.

Through the accreditation process, CCHSA evaluates the quality of health services provided by over 1,600 Canadian health services organizations. It has a specific accreditation program for community health, home care, acute care, long-term continuing care, mental health, rehabilitation, cancer treatment centres, and regional health organizations, and it is currently establishing programs for first nation health services, Canadian Forces health services, Canadian correctional health services, and assisted reproductive technology. CCHSA liaises with a variety of international groups, and has assisted a number of countries in establishing mandatory and voluntary accreditation programs.

Generally, participation in accreditation is voluntary. The organization's performance is assessed against a national set of standards set by CCHSA in collaboration with the health service community and other stakeholders. The standards of excellence are designed to address structure, process, and outcome, with a focus on continuous quality improvement. The value of the accreditation is in the internal self-assessment that an organization undergoes in preparation for the survey visit, and in the consultative state of a peer review process that is part of an on-site survey team visit.

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A team of surveyors carries out the visit. The team is selected from a pool of approximately 300 skilled surveyors from a variety of health service professions across Canada. The on-site visit recognizes areas of excellence, as well as areas for improvement. An organizational level of compliance with the standard is ascertained through evaluation of all the information obtained through self-assessment, the survey visit, and patient and other stakeholder interviews.

If the level of risk associated with non-compliance of any standard is considered high, the organization is either not accredited or is given the opportunity to make improvements. If, after follow-up, required improvements are not forthcoming, accreditation status is not granted.

CCHSA is interested in the topic. With the increasing demand for new reproductive technologies and concern about their use in recent years, the federal government appointed the Royal Commission on New Reproductive Technologies in 1989. Among other recommendations, the commission reported that a regulatory and licensing body must be established for certification licensing in the field. In response to this recommendation, and prior to the Canadian government passing related legislation, the Canadian Fertility and Andrology Society and the Society of Obstetricians and Gynaecologists of Canada established a Committee on Accreditation of New Reproductive Technologies in order to develop guidelines for accreditation.

As assisted reproductive technology services are provided in teaching hospitals and community clinics, including private physicians' offices across Canada, the committee approached CCHSA in 1994 for assistance. A partnership between CCHSA and the Committee on Accreditation of New Reproductive Technologies was formed. Draft clinical and laboratory standards for in vitro fertilization and donated eggs and sperm to treat infertility were also pilot tested in five university-based hospitals across Canada and in one private clinic in 1996-97. The pilot project successfully advanced greater knowledge in the activity of private clinics.

Following this review, Health Canada provided funding for several initiatives, including the review and update of clinical and laboratory standards for accreditation purposes, a review of the relationship of accreditation with a regulatory framework, and the pilot study to collect and analyse outcome measurements data. Reports of these initiatives were submitted to Health Canada in 1999.

In 1998, a new voluntary body, the IVF Director Group, emerged, representing all private and university-based clinics. In collaboration with CCHSA, approaches to accreditation, performance indicators, and requirements for data handling have been established. The approach to the use of performance indicators was implemented as a pilot during 1999-2000.

In June 2000, a first report from seventeen of the twenty clinics for the year 1999 was made public. Most clinics in Canada have embraced the concept that the provision of credible clinical outcome data will be an essential part of gaining third-party acceptance and public recognition through accreditation. Since that time, national standards and an accreditation program have been developed. More recently, a significant number of clinics have expressed an interest in joining the accreditation program, and the next step will be to establish a formal program.

Turning to the interface between accreditation and legislation, historically CCHSA has reviewed during the survey process the results of any other voluntary or mandatory accreditation or inspections to which the organization has been subjected, in order to ensure that basic health and safety requirements are met. The findings and recommendations of these reviews will be considered during CCHSA's accreditation and deliberation. Failure to meet licensing requirements in any area will be considered a significant risk factor. The degree to which a failure to meet a licensing standard would influence the accreditation of work for the organization as a whole would depend upon the assessment of the individual risk in the context of the total risk of the organization.

In the case of reproductive technologies for which regulation and accreditation models are being developed concurrently, there is an opportunity to integrate the two to the benefit of all stakeholders. Pilot testing of CCHSA standards has shown them to be feasible, and the field is anxious to participate in such a program.

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To the Royal Commission on New Reproductive Technologies and in subsequent consultations, the public has expressed a strong desire for regulation in the field. The challenge is to meet the need for public protection and quality control, and to foster a climate of quality improvement while avoiding duplication and consequent resource burdening on the regulatory authority, the service provider, and the accrediting agency. A partnership between accreditation, regulation, and service providers may well be a significant step toward a shared climate of quality improvement.

CCHSA has reviewed the draft legislation on assisted human reproduction and is pleased to provide feedback to the standing committee before the bill is introduced to Parliament. Listed below are the perceived strengths of the proposed legislation, suggestions for improvement, and recommendations. As requested, the feedback provides focus primarily on what would need to be in place to ensure a fit between licensing, inspection and enforcement, and accreditation.

Over the years, CCHSA has worked with a number of stakeholders to ensure several elements are integrated into the standards and accreditation program. These include: at a minimum, maintaining health and safety for Canadians; responding to the needs of clients or patients and protecting clients' rights; ensuring that health service providers are appropriately qualified; ensuring that basic structures are in place to support health service activities; promoting a philosophy of continuous improvement; ensuring that standards and accreditation respond and adapt to trends and changes in the health field environment; and finally, obtaining clients' and patients' input about the quality of the health service provided.

In keeping with the above elements, and in addition to ensuring that the basic safety and structural requirements are in place, the legislation must provide the foundation to ensure the following: that health service providers are adequately credentialed; that the rights of Canadians, including the unborn child, are protected; that key stakeholders have access to required information; that the work of existing organizations is not duplicated; that the legislation, regulatory, and licensing requirements respond and adapt to rapid changes in technology; and that the regulatory system supports a system for continuous improvement.

Given these things, the perceived strengths of the legislation are as follows: References made in paragraph 17(b) and in clauses 23 and 33 provide a basis for collaboration with organizations in establishing standards or guidelines for controlling activities and enforcing the act. The act adequately protects the privacy and confidentiality of donors, women, and unborn children. The act provides the public and individuals born from RGT with access to information through the use of registries. First and foremost, the act adequately addresses basic health and safety for Canadians by outlining a lengthy list of licensed activities, and by issuing licenses to permit the use of premises and individuals undertaking these activities. The act integrates the principle of free and informed consent as a fundamental condition governing the use of assisted human reproduction. The general nature of the act maximizes flexibility by outlining the specifics of the use of assisted reproduction activities through regulation, guidelines, standards, and codes of practice.

Gaps in the draft legislation and/or suggestions for improvements include the following: Given the rapid changes that occur in assisted human reproduction activities, the legislation and/or regulatory framework should be flexible enough to adapt to emerging issues and new technologies, and to address ethical issues in a timely fashion. Reference to a five-year review in clause 42 could make it difficult to review and alter legislation in a timely fashion. The proposed legislation does not refer to regulations on the requirement of the regulatory system. As a result it is difficult to ascertain the role, responsibility, and accountabilities of existing organizations working within the areas of assisted reproduction. References in clause 23 to 29 are more punitive than positive. As a result, it is more difficult to promote the philosophy of continuous improvement.

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We have recommendations for changes. Although there are a number of strengths in the proposed legislation overall, the following recommendations are made for consideration by the Standing Committee on Health: that the committee reviews and and reconsiders the timeframe referred to in clause 42 to review and revise the legislation, so as to ensure that it supports a system that is flexible and adaptable to rapid changes in the environment; that the committee considers integrating into the proposed legislation references to regulations and the requirement of a regulatory system; that such a system not duplicate existing structures that are in place, but should support a share model that operates at arm's-length from government and should include representation from all stakeholders, including infectious disease specialists, geneticists, ethicists, clients, and patients; that the committee consider revising clauses 23 to 29 to create a more positive approach to inspection—for example, peer review and evaluation against national standards should play an integral part of a compliance system.

[Translation]

The Canadian Council on Health Services Accreditation would like to thank the committee for giving us the opportunity to provide our comments on the bill. Thank you.

[English]

The Chair: Thank you, Mr. Lanteigne.

We'll move onto Mr. Étienne Ouimette, from Health Canada.

Mr. Étienne Ouimette (Blood, Tissues and Organs Compliance Coordinator, Health Products and Food Branch Inspectorate, Department of Health): First of all, I would like to thank you for the invitation to appear in front of the committee.

I'm from the Health Products and Food Branch Inspectorate of Health Canada. The inspectorate is responsible for delivering national inspections and enforcement activities for products regulated under the mandate of the branch.

I just want to focus the scope of my presentation this morning. I've been asked to present on compliance and enforcement issues as they relate to the semen regulations. The federal government regulates the processing, distribution, and importation of donor semen for use in assisted conception under the authority of the Food and Drugs Act and regulations.

The Processing and Distribution of Semen for Assisted Conception Regulations, better known as the semen regulations, detail prohibitions, exceptions, and specific requirements pertaining to notification, donor screening, laboratory controls, labelling, and tracing of semen. As of December 1, 2000, the semen regulations also contain provisions for special access, under certain conditions, to donor semen not fully compliant with the requirements of the semen regulations.

It is important to note that part A of the food and drug regulations, in respect of labelling, importing, and packaging of drugs, and part C, in respect of requirements for establishment licensing, good manufacturing practices, and drug identification numbers, do not apply in respect to semen. Compliance is normally achieved through a cooperative approach between the regulated party and Health Canada.

The responsibility of Health Canada is to assess compliance and identify deficiencies. Where non-compliance is brought to the attention of an establishment by Health Canada or otherwise, it is the establishment's responsibility to take timely and appropriate action to comply with legislative and regulatory requirements. However, when this cooperative approach has ceased or when the regulated party is unable to correct the deficiencies, a number of compliance and enforcement options will be considered by Health Canada.

The stepped approach to compliance and enforcement is based on various aspects, including the following: the risk to health and safety; the compliance history of the establishment; whether the establishment acted with indifference or premeditation; the degree of cooperation offered by the establishment to Health Canada officials; the likelihood that the same problem will reoccur; and the chances of success of the enforcement action being contemplated.

It is the responsibility of the establishment to identify and implement actions to ensure compliance. The responsibility of Health Canada is to clarify what is required to achieve compliance. Except for specific legislative requirements, Health Canada will not dictate how compliance is to be achieved. One or more of the following options or tools can be used to achieve compliance if applicable: voluntary disposal, voluntary detention, recall, negotiated compliance, warning letters, stop sell, customs lookout or alert, import refusal, formal hearing, seizure and detention, prosecution, injunction, public warning, and media advisory.

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Inspections and investigations of establishments processing, distributing, and importing donor semen for use in assisted conception are conducted by blood, tissue, organ, and xenograft compliance specialists of the Health Products and Food Branch Inspectorate who are designated as inspectors by the Minister of Health. These activities are filtered by the expertise of the Biologics and Genetic Therapies Directorate.

The primary role of the inspectorate is to deliver a national compliance and enforcement program under the mandate of the Health Products and Food Branch, supporting the branch risk management approach to decision-making. Coordination and support of operational activities is done nationally to ensure fairness and consistency of approach, and to maintain functional links with involved program areas.

The inspectorate's commitment to quality in fulfilling the branch's mandate is demonstrated through the integration and promotion of quality management principles within its organization. Proficient training of staff ensures uniformity and a high standard of quality for all operations delivered nationally and internationally.

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

We'll move on to the Society for the Policing of Cyberspace, and we'll hear from Mr. Earl Moulton.

Chief Superintendent Earl Moulton (Royal Canadian Mounted Police; President, Society for the Policing of Cyberspace): Thank you, Madam Chair.

By way of introduction, I wear at least two hats today, and I offer my apologies to the committee, as I'm not as prepared as my more prepared colleagues. As the committee will understand, the world of policing has been somewhat tossed on its head since September 11, so my time for preparation was limited.

By way of background I'm a chief superintendent in the Royal Canadian Mounted Police, and I'm now serving in British Columbia. I have some 24 years experience. My current position is analogous to that of the commissioner of the Ontario Provincial Police in the delivery of policing services to the province of British Columbia.

The second hat is that of the president of the Society for Policing Cyberspace, which is a rather difficult moniker. This group ultimately is hoping to address some of the arising issues that are created as our society and others move to digital and very rapid communication around the world. This legislation you are studying here faces squarely some of the difficulties that undoubtedly will face drafters in other areas over time. Unfortunately, what I would offer today are probably illustrations of problems. Unfortunately, I offer fewer solutions than I can offer problems.

In respect of the legislation as drafted, I would echo the concern Mr. Lanteigne has mentioned in terms of its ability to anticipate changes. Clearly, one of the issues you have before you in C-47 is the rapid advance of the technology and the inability to predict where it is going either in a year or in five years.

I would suggest that it may be possible, within the regime proposed in this legislation, to maintain the dichotomy between prohibited and controlled activities by re-examining the wording in clause 8 around controlled activities, where it's consigned or refined by the wording “for the purpose of”. I think you may reach your same objective by removing that wording, thus leaving the ability to control activities in a much wider range, and allowing for dealing with activities, within a much tighter timeframe, either on a regulatory basis or by licensing whatever may come.

I'm in no position to assess what may be coming. While I profess some knowledge of cyberspace issues and certainly of policing, I can claim no expertise in the technology around assisted human reproduction.

The other large or macro-issue that I would raise in respect of the legislation is that it...I was going to say “fails”, but that's not the right word. It has the same difficulty faced by others in anticipating what's going to happen in relation to offering and advertising, for example, if people are offering and advertising to Canadians from other places in the world, from places where we cannot touch them legislatively at the moment. By way of example, if an offshore Internet service provider puts an advertisement on the web for activities prohibited here, thus making them available for Canadians, what is our response then?

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Certainly, in the commentary around the legislation, where there's reference to the World Health Organization's proposals and other international agreements around this technology, I think it may be possible, perhaps on a partnership basis with other countries, to formulate very similar or exactly the same legislation so that it can be applied equally around the world.

Or perhaps it may be simpler to incorporate, within the body of the legislation, wording explicitly saying that if you are offering services to Canadians by whatever means, wherever those services may be done or actually accomplished, it still constitutes an offence here. If somebody chooses to do that in Antigua and then stays in Antigua, we can't touch them. But if some portion of their operation—perhaps their payment for the activity—occurs here, that at least makes them reachable.

That kind of issue is certainly consistent in my world, in policing. If there is a vacuum of legislation in whatever portion of this activity, the people interested in it will move to fill that vacuum. If there is a hole in the legislation saying they can move, for example, the payment for these services through Canada—which I would suggest is probably an allowable activity in the legislation as drafted—then they will do so, and you will not be able to reach the activity.

I should perhaps preface some of what I'm saying in that, in respect of Mr. Ouimette, he touches most of what happens in inspection, as does Mr. Lanteigne in accreditation. In the policing world, we deal with that small percentage, the 1%, who don't run afoul of your legislation because of inadvertence or because they can't reach a technical capacity. We deal with the people who set out to breach your legislation. I would suggest you have to draft it with that in mind, because there will be people who will do so.

Clearly, this all arises because there is a demand for these services. In prohibiting activities, if you emphasize that demand, the demand will go elsewhere. When there is high demand, there's money to be made. When there's money to be made, people will breach your legislation. I think it behooves the committee to take that into account, and to perhaps anticipate that people will set out to do prohibitive activities. They will do so in whatever jurisdiction allows them to do so, or they will carry it out amongst jurisdictions by using whatever holes exist in legislation. So I would suggest consistency internationally is very important. To that end, I'd perhaps move to some nuts-and-bolts issues that I think are important.

With the regime as anticipated, with inspectors, one of the things we've seen over the years is that once you start to try to deal with that 1%, you require a different expertise and you require a different level of powers in order to be effective in investigating and prosecuting breaches of the law. I would suggest the committee may want to consider naming members of the RCMP as inspectors under the act, perhaps by an ex officio means. That's not with any intention at all that we would be taking part in inspections or accreditations, because we're simply not capable of that. We don't have the right background, so we would defer to those who do. But once you enter the realm of investigating people who are taking measures to hide their activities, that's our world.

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It is useful to empower us in advance to do such things—and I would offer as an example the former Bankruptcy Act legislation, under which inspector's powers were granted to the RCMP, or the current Customs Act, under which we're deemed ex officio officers—as taking actions in, for example, rural areas where parts of this activity can occur. Or allow us to exercise powers much more similar to peace officer powers, for example, under warrants that are also contemplated here.

The other aspect is that you end up in a situation that we've just discovered under the Canada Elections Act, whereby the courts would not issue to a person not holding peace officer powers a warrant to take action under the Canada Elections Act. This would avoid those kinds of situations.

In empowering the inspectors under the act, clause 24 speaks directly and only to controlled activities. I would suggest that you may wish to re-examine whether controlled activity is necessarily all you wish to control. You may simply wish to control “activities”—which would include the prohibited—and then provide the powers to the inspectors to take action in respect of people whose activities are otherwise unregulated.

On the exercise of powers, generally speaking, there are some difficulties around trying to amalgamate very peace officer-like powers, like the exercise of a warrant for search. It's illustrated in the draft legislation in the somewhat fractured wording or attempt to deal with exercise of force in the execution of a warrant, and requiring a peace officer to be along, to anticipate the need for that force, and to have it in the warrant. In my world on the streets, those sorts of things cannot be anticipated with any degree of certainty. The need to use force to get into or to access whatever arises at the spur of the moment. To deal with it in the manner with which is dealt here would, I think, make it very unwieldy and very difficult to deal with.

The problem I would just mention in respect of subclause 24(1), that of only addressing controlled activities, is exacerbated by clause 25, which deals with the warrant issue for dwelling houses. Again, with that wording, it reads that if, for whatever reason, somebody was engaged in a prohibited activity within a house, this legislation would not touch that activity. There's a bit of a vacuum there.

I would just simply refer you to subclause 25(3), which is the wording requiring that an inspector be accompanied by a peace officer and that they anticipate that action. The wording of the warrant includes force, and that is simply inviting difficulties.

The other general suggestion I would have is that a number of the purposes the enforcement portion of the legislation is addressed to are already fulfilled within the body of the Criminal Code. I would simply suggest that it might be somewhat simpler to read in those legislative provisions, particularly in respect of what it is you do with stuff once you seize it. Within the Criminal Code, there are very clear guidelines as to what has to happen. The Criminal Code brings the stuff within the custody and control of a judge, who can then deal with it. That is generally what this legislation is doing, but it does it slightly differently. When you do those sorts of things, though, my experience is that you get unanticipated results from the courts. If you were to simply read in the provisions of the Criminal Code, mutatis mutandis, you would then have some certainty around the result once it comes before the courts.

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The other issue that I think may need addressing as well—and it may perhaps speak more to the 1% issue I addressed earlier—is that the provisions around forfeiture generally leave open the possibility whereby individuals who purposively go out to break your law may, for example, be employees of an otherwise entirely legitimate operation, while using the property, the intellectual property, the lab equipment, to undertake an illegal activity entirely outside the knowledge of their employer. As written, the legislation puts at risk all of that employer's assets, simply on the consent of the person acting illegally. By being the person in possession, they could, by consent, forfeit all the employer's assets. That might not be exactly the objective the committee was trying to reach.

The Chair: Thank you, Mr. Moulton. You've used up ten minutes now. I wonder if we could stop there, and perhaps you can get to the other points you wanted to make in answers to questions.

The committee will now move to the question-and-answer session, and I'll begin with Mr. Merrifield.

Mr. Rob Merrifield (Yellowhead, Canadian Alliance): Actually, it's a fascinating study, but I'm really intrigued, Mr. Moulton, by what you were saying with respect to enforcing the areas that are prohibited. You're suggesting that if prohibitions happen within a home, this legislation would not touch them. Is that what you're saying?

Mr. Earl Moulton: The draft proposal is such that, under the wordings of subclause 24(1) and clause 25, it addresses the ability to obtain a warrant only for controlled activities. Under the provisions of this act, it could therefore not be touched.

Mr. Rob Merrifield: Okay, that's something we certainly should be looking at.

The other thing I'm intrigued by is how you would enforce the prohibitions or the legislation. Would you be going into clinics, opening the fridges, and counting the Petri dishes? Questions arise in my mind. What do you do if you find a clone or something that is prohibited? What do you do with that product? What are the rights of it? I guess all of that has to be thought about when you decide what is a best mechanism or vehicle to actually do the enforcement. You're suggesting the RCMP should be part of the inspectorate and the inspections. Can you elaborate on what you think is the most appropriate way?

Mr. Earl Moulton: Perhaps I've been unclear. I think we need to be part of a much more global solution that would include, as Mr. Ouimette says, the stepped kind of enforcement. Those people with the knowledge go in to look at the Petri dishes—I certainly don't claim any of my people today have that knowledge, and if we do, then it's by accident—and somebody points out to us at some point just what it is that's of concern or of need.

Indeed, the subsequent handling of those kinds of items is not unknown to us in terms of our handling of DNA and other substances. But to echo Mr. Ouimette's comments, I think there definitely needs to be kind of a stepped approach, and we would only become involved on an as-needed basis, either once an inspection turned up a problem or as a result of a complaint.

Mr. Rob Merrifield: Okay.

Just to shift things a little bit, with regard to semen in Canada now, is there semen being used in vitro that is not, let's say, recorded? Is there a tracking system in place right now so that you know where all semen is used in Canada?

Mr. Étienne Ouimette: In terms of the semen regulations, there is a requirement for the tracing of semen. That means the processor—the establishment that collects and tests the semen—the distributors, and importers need to keep records to demonstrate the tracing of semen, from where it has been processed to where it has been used. This requirement allows the inspector to have evidence to go through to ensure compliance or to verify compliance with this requirement. This is the way in which the inspector will see where the semen is coming from, if it has been tested according to the requirements, etc., if the distribution requirements have been met, and all other requirements as well.

Mr. Rob Merrifield: Is there not a voluntary moratorium on the charging for semen in Canada right now?

Mr. Étienne Ouimette: The semen regulations do not have any requirements in terms of paid donors, etc. It doesn't take into account any contract issue.

• 1155

Mr. Rob Merrifield: My other question, then, is on semen from out of country. Are they being used in Canada now, and do they meet the same or similar criteria, or are they stricter? How do we know that...?

Mr. Étienne Ouimette: In the way in which the semen regulations have been drafted, the responsibility for imported semen lies with the Canadian importer. This is the establishment or the physician that imports semen. He needs to ensure, to provide evidence to demonstrate the semen being imported complies with all of the requirements under the Canadian regulations.

The inspector will do an inspection, or maybe an investigation, depending on the trigger. During the inspection, the inspector may ask for a number of samples being imported in order to get all of the information from the foreign semen banks. The importers will have to communicate with the foreign semen banks to get all of the information in order to demonstrate compliance of the semen with the Canadian regulations. So the standard is the same.

Mr. Rob Merrifield: It's all a little foggy from a layman's perspective, let's say.

The whole idea of accreditation strikes me as interesting, as well. You're a non-profit organization as accreditors. When you accredit what you're talking about, that being the safety and health of the facilities and the procedures, do you deal with outcomes?

Mr. Gilles Lanteigne: The accreditation process that we have is very much focused on outcomes at this stage. We went through three programs in the past ten years. In the first one, we made sure policies and procedures were in place. The second one actually focused on processes. The one that is in implementation now focuses on outcomes. We have standards that are related to environment, human resources, leadership, and different care keys. They're global standards and they're very specific to every sector of an organization.

The Chair: Can we go on?

Mr. Rob Merrifield: I was going on.

The Chair: I know, you really were.

Mr. Ménard.

[Translation]

Mr. Réal Ménard: Madam Chair, I would like to take the opportunity while Mr. Ouimette is here to ask him to clarify something that puzzles me. When someone goes to a fertility clinic, what is the role of your organization and what type of screening is used?

If you could explain the sequence of events and tell us how the donors are screened, I think you would be doing us a great service, as it is something that has been unclear to us since we started to examine this bill. My colleague broached the same subject.

So let us begin at the beginning and see how things unfold.

Mr. Étienne Ouimette: To properly understand the context, you must understand that only the safety of the sperm is regulated by Health Canada. According to the legislation on sperm donations, a six-month quarantine is required for analysis of infectious agents at the outset and after the six-month quarantine period. So only the safety is a factor.

Mr. Réal Ménard: You mean that they ensure that there are no germs or infectious agents in the sperm.

Mr. Étienne Ouimette: That's right. All of the requirements surround the safety of the sperm. The act is in three parts. The responsibility of assuring that the sperm is safe is based on three types of activity: the facilities where it is processed, the importers, and the distributors. That is the order of the level of risk, because it is obvious that the facilities that collect and analyze the sperm will be classified as having the highest risk.

Mr. Réal Ménard: Just a minute. Can you give me an example of a facility that processes the sperm?

Mr. Étienne Ouimette: A name? PROCREA, in Montreal.

Mr. Réal Ménard: These are private clinics.

Mr. Étienne Ouimette: Yes, these are private clinics.

Mr. Réal Ménard: Those who import—

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Mr. Étienne Ouimette: It can be a clinic like ReproMed in Toronto. That clinic imports sperm. Moreover, any physician who wants to use donated sperm for the purposes of assisted reproduction for one of his patients becomes an importer.

Mr. Réal Ménard: Therefore, when they import, it doesn't mean that the sperm comes from the United States; it comes from outside the office.

Mr. Étienne Ouimette: No, it comes from outside the country.

Mr. Réal Ménard: Okay. So it might be a doctor from Toronto ordering sperm from the United States.

Mr. Étienne Ouimette: That's correct.

Mr. Réal Ménard: Those who distribute—

Mr. Étienne Ouimette: They are the ones who use the sperm from a Canadian processor, either a Canadian importer or from all of those who use the sperm. A facility that processes the sperm will also eventually distribute it. The importer will also be a distributor, and the physician who uses it will distribute it. All of those people are distributors.

Mr. Réal Ménard: Why is there a triple classification when a dual one applies?

Mr. Étienne Ouimette: One of the challenges is to clarify the requirements of the legislation.

Mr. Réal Ménard: Okay. Therefore—

Mr. Étienne Ouimette: Thanks to inspections and investigations we can pick up on small technical details within, firstly, the regulations but also within the policies at Health Canada as well as what is done in practice. A number of things must be considered.

Mr. Réal Ménard: With respect to the act, we were told that the committee has as one of its mandates to make recommendations on the conditions for storing the sperm, which will be in the guidelines as well as in the regulations. Therefore, at this point in time, your organization is not concerned with the way in which the sperm is stored.

Mr. Étienne Ouimette: Precisely. It isn't the quality that concerns us at this time, but rather the safety.

Mr. Réal Ménard: It's the safety.

Mr. Étienne Ouimette: To come back to your first question, when the donor arrives at the clinic, there is a series of regulatory requirements that the facility must follow by asking him certain questions so as to exclude infectious organisms; the donor and the sperm must first be tested before it is distributed so as to detect the presence of a variety of infectious organisms.

When a patient approaches her doctor seeking donated sperm, we must understand that the act only covers sperm that has been donated. It does not cover the sperm provided by the woman's husband or partner. The act covers donated sperm. That is an important point.

Mr. Réal Ménard: We must be clear on that.

Mr. Étienne Ouimette: It's very important.

Either the patient already knows who she would like to provide the sperm, for example, from a given sperm bank, in which case she would ask the doctor to contact the operator of the sperm bank in order to have the procedure performed, or the patient simply goes to a facility that collects sperm and discusses a profile with them.

That is not covered by the act. The profile is not covered. There is nothing in the act about the contract nor is there any provision covering the patient-doctor relationship. It was decided that this did not represent a medical procedure. I'm not sure if that is the answer you were looking for.

Mr. Réal Ménard: Yes. Okay.

It does not happen often, Madam Chair, but I have run out of questions. Please keep my name on the list for the next round.

[English]

The Chair: Thank you, Mr. Ménard.

Ms. Sgro.

Ms. Judy Sgro: Thank you, Madam Chair.

Mr. Lanteigne, in listening to your presentation, do you know how many laboratories or facilities are currently operating in Canada in the area of human reproduction?

Ms. Paula Greco (Manager, Research and Development, Canadian Council on Health Services Accreditation): There are eighteen clinics in total, but I'm not sure in terms of labs. I don't know the exact numbers.

Ms. Judy Sgro: There are approximately eighteen of them. How many of them, if any, have expressed an interest in becoming involved in your organization?

Ms. Paula Greco: About fourteen.

Ms. Judy Sgro: About fourteen of them.

In terms of the surveyors you referred to, rather than inspectors, what's the similarity in the training programs?

Mr. Gilles Lanteigne: All the surveyors hold senior positions in the health sector. Maybe as a related example, if we were going to an acute care centre to do an accreditation, we would have a senior administrator who is a doctor, a senior administrator in nursing, and a senior administrator in management. We try to get all the components related to the specific field into which we're going. In other words, there would be peer people occupying senior management and clinical positions within that sector.

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Ms. Judy Sgro: How do the regulations that we're talking about or that Health Canada is talking about introducing compare with the voluntary accreditation?

Ms. Paula Greco: If a set of regulations exists, we'll often refer to them in our standards, and we'll look at any reports or recommendations coming forward from the other bodies to make sure the compliance is there. We take that into consideration when we decide whether or not an organization gets accredited.

Ms. Judy Sgro: Thank you, Madam Chair.

The Chair: Mr. Lunney.

Mr. James Lunney: Thank you, Madam Chair.

Mr. Moulton, I want to come back to the questions you raised here about clauses 24 and 25. You raised some very interesting questions about a dwelling house and what types of activities might take place there. In looking over clause 25, I see that if it is in a dwelling place, we cannot enter without consent, except under the authority of a warrant. I was wondering about something. In your experience, what types of offences, or how many of the proposed offences under the draft bill, might conceivably happen within a dwelling house?

C/Supt Earl Moulton: I would think probably very few. My concern is that there's nothing...if you look at what a dwelling house is in my legal world, as long as there's somebody staying there, that could affect the building. You're therefore going to have a lot of claims for what is a dwelling house. If you have a cot in the corner, you're going to have a claim for a dwelling house. It's certainly our experience that any hole that's left or any uncertainty that's left in a piece of legislation will be made good use of once it reaches the courts.

Mr. James Lunney: Well, we certainly have some very large houses. If you have somebody residing there on a full-time basis, you can potentially conceive of somebody having a complete laboratory in a basement or a lower level of a building, so I think you've raised a very interesting question here.

Do you have any suggestions as to how we might get around that? By the time you get a warrant, convince a judge, and then go back, they could clean out a lot of portable things. Things could conceivably disappear.

C/Supt Earl Moulton: My suggestion would again be to refer to the suggestion around invoking the existing Criminal Code regime. If you're at that stage of an enforcement proceeding, you simply engage what we engage for every other kind of investigation. Indeed, some consideration might be given to the idea that any actions taken in enforcement might be buttressed by having a warrant that would separate the inspection and the enforcement functions.

In Canada, I think we have a fairly well established set of precedents that allow an inspection-type regime to examine and ensure safety, health, and those kinds of issues. As soon as you move into an enforcement-type action, the courts are very concerned—and rightly so—with protecting the right to be free from arbitrary search and seizure. You then get the need for a court authorization to search and seize. Indeed, as the legislation is now designed, it would allow an inspector to access and seize medical and financial information that, to my knowledge, is ordinarily and always dealt with by way of warrant at this point.

So, again, that may come back to my comment around the need to provide, within the body of the legislation, for enforcement for that 1% in addition to the others.

Mr. James Lunney: I think that's something we should take note of. Perhaps we need to tune that one up.

Can I come back to another issue that you raised, that being the issue of offshore Internet advertising for a service that's prohibited in our jurisdiction? If I understood you correctly, payment would be provided within Canada for services. Somebody would be paying in Canada for services provided in other jurisdiction. Is there a way we can close that door?

C/Supt Earl Moulton: I believe so, and there would be perhaps two ways of doing that. One would be by providing some blanket statement covering any actions taken to assist or enable the prohibited activities, wherever those prohibited activities take place. That would be useful.

• 1210

The other aspect is that there's a corollary to that kind of thing. At least, my reading of the proposed legislation is that if I was to offer something in Canada, if I was to advertise in the paper or create a website in Canada, but my offer was to do the services elsewhere, that probably is not caught by the legislation either as it is currently written. So, again, those cross-jurisdictional issues need to be addressed. I believe some consideration of that may be found within the legislation introduced yesterday in respect of anti-terrorism and the ability to read actions taken outside of Canada into Canadian jurisdiction.

Mr. James Lunney: If I can just make a comment, I think Mr. Moulton has raised some very good points that we should be looking at adding to our draft legislation.

Thank you.

The Chair: Thank you, Mr. Lunney.

Dr. Castonguay.

[Translation]

Mr. Jeannot Castonguay (Madawaska—Restigouche, Lib.): Thank you, Madam Chair.

My question is for Mr. Ouimette. I had a look at the document that was circulated, and at the part dealing with compliance:

When a case of non-compliance by a facility is brought to the attention of Health Canada or is otherwise detected, it is up to the facility to take rapid and appropriate steps to comply with the requirements—

Then, a progressive approach is mentioned. Practically speaking, if an institution becomes non-compliant, must it simply cease its operations until it has complied or is it allowed to continue to operate in the hope that it will come around?

Mr. Étienne Ouimette: We do not usually evaluate each lot of sperm that is imported or every lot that is collected in Canada. It would be extremely difficult to do. We cannot be in every clinic every day, week after week.

We have an annual inspection program under which facilities that treat, import and distribute are routinely inspected. A number of factors are also used to initiate investigations. Complaints are often received from other doctors, other companies, and patients, etc. The inspection policy is to follow up on all of these complaints.

Clearly, we must be transparent and fair. We must also be able to determine if there is a health risk. That is our first point. When we investigate a facility following a complaint, the first thing to determine is if there is a danger to health, and if yes, we must determine if it is imminent. If the danger is not imminent, it will be extremely difficult to use the strict enforcement measures in the act.

People almost never say that they do not want to bring the product into compliance or co-operate with us. That is very rare. They want to co-operate, but they will hide certain things. They will not submit some kinds of information, etc., and that is why the expertise of the inspector is so important. It is important to verify the evidence and restructure the case to see exactly where the weaknesses and shortcomings lie and to make observations in those areas. At that point, the facility must identify its action plan to remedy these shortcomings, and it is based on that that we assess the situation with the facility, on a very routine basis and in terms of health risks, in order to ensure that progress is made and all the necessary steps are taken to remedy the situation.

Mr. Jeannot Castonguay: When you conduct on-site investigations, do people know ahead of time that you are coming for an inspection and do they have time to prepare, or do you show up and conduct an inspection and inform them that they are not in compliance? My fear is that it is very easy for them to predict that an inspector will come in three months.

Mr. Étienne Ouimette: That is why we have an inspection program and investigations. Under the inspection program, inspections are scheduled roughly three weeks or a month before we go on site. The inspection program also includes unannounced inspections.

• 1215

So we can show up at a facility without prior warning and conduct an inspection or an investigation. If we have reason to believe that there may be a problem with respect to compliance with the act, we can go to the facility and conduct an investigation. But when we do show up, we must clearly stipulate the reason for our visit.

Mr. Jeannot Castonguay: I now want to turn to Mr. Lanteigne and Ms. Greco. When you talk about accrediting facilities, if I understand you correctly, as regards hospitals, they are not accredited or they are accredited for one, two or three years, which leads me to believe that they have probably not complied with certain criteria.

For clinics, shouldn't there simply be criteria that must absolutely be met? In the end, I think that the committee wants to ensure that the tissue that will be worked with will be treated with respect; we are talking about human tissue. We do not think there is too much leeway.

If we adopt an approach with accreditation for one, two or three years, that leads me to say that standards vary. Do you see that as an approach or should we be rather strict and say that standards are high and anything below that is out of the question? I would like to hear your views on that.

Mr. Gilles Lanteigne: First of all, the recognition system used by the Canadian Council on Health Services Accreditation has changed slightly over time. Now, instead of one, two or three years, what we recognize is accreditation or the lack of accreditation. If accredited facilities are granted a three-year status that requires them to produce follow-up reports on specific aspects, in keeping with recommendations stemming from risks linked to specific incidents that have been identified by way of a report, a site visit or a report and a site visit, then when we actually return to the facility that has been asked to produce a report depends on the risks assessed. It may be six months, one year, or 18 months.

It has changed somewhat, in that now, we take a much more specific look at the risk for each element. The higher the risk, the more closely we monitor the follow-up that must be undertaken with the facility.

Mr. Jeannot Castonguay: With this new approach that, if I understand correctly, is one that is much more co-operative and collaborative in nature, and not a punitive approach that would involve identifying those who are at fault, which is perhaps the way things were done in the past, have you seen greater co-operation on the part of institutions? I spoke earlier to institutions that said they were expecting a visit and that they were going to prepare for it by ensuring that everything was in place.

Mr. Gilles Lanteigne: For facilities participating in the program, yes. However, since it is a voluntary approach, there are facilities that do not participate in the program. It becomes quite difficult to see if they are motivated to get involved in ongoing improvement.

However, for other facilities, the approach is ongoing. What we are now seeing in health facilities in Canada is the emergence of a culture to enhance quality on an ongoing basis. In the end, in a cycle that repeats itself, people improve the system using information compiled based on objective and valid data. But we do not have that information for the facilities that do not participate in the program.

Mr. Jeannot Castonguay: Do you think that all fertility clinics should be required to be accredited or should it simply remain voluntary?

Mr. Gilles Lanteigne: Let's say it's a debate. It is a choice made by the people in charge. However, we note that when they want to implement an approach to enhance quality on an ongoing basis, most countries do so on a voluntary basis. Moreover, in some countries, like France, this approach was deemed essential and mandatory. It is a choice.

Mr. Jeannot Castonguay: Thank you.

[English]

The Chair: Thank you.

Anybody else? Ms. Wasylycia-Leis.

Ms. Judy Wasylycia-Leis: I just wanted to follow up on James Lunney's question on what I and others have called the egg trade. It's a major preoccupation with many across the country. How do you actually deal with this buying, selling, and trading in eggs, sperm, and other reproductive components, especially given the modern technology?

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We often hear about advertisements geared to young university students. They offer women with a high IQ, certain racial features, and certain other characteristics, $20,000 or $30,000 for eggs—and whether it's one or more, I'm not sure. I think the spirit of this bill aims at trying to end that kind of commercialization.

My question really goes back to James' question. Can we really do it through this bill or through regulations? What's happening now in this field in real terms? We hear about different reports. How extensive is this trade? After so much has happened, is it now hard to really put a curb on it and to try to prohibit this once and for all?

That's for anybody. It's a wide open question.

C/Supt Earl Moulton: I'll take a stab at it, probably as the person who least understands the technology.

I guess my response would be that, very clearly, the legislation here sets out exactly what is prohibited and known, and exactly what could now be controlled activity. By adjusting the wording of, I think it's clause 8, you can draw everything else under an umbrella of licensing, simply by saying you can't do anything else other than the prohibited, except under a licensing regime. That at least provides some leverage and doesn't provide a vacuum, as it were.

For example, my reading of the legislation would be that if you were to perhaps conduct research on eggs and sperm that is unrelated to an eventual reproduction aspect, that's totally uncaught here. What you would do, however, is create banks of both that could be dealt with illegitimately and could indeed be used for reproductive purposes. The risk you run in that is compounded, because that also escapes the requirements for health-related information and such, and then you have exacerbated the problem. So I think it's very important that the net that is cast is complete.

Mr. Étienne Ouimette: I have something to add.

It's also important to have clear relations with other regulatory agencies to exchange information on these activities. This is happening now for certain products under the mandate of the branch. We have those kinds of agreements with the FDA in the United States, to exchange information about establishments or activities that are banned or that we've found some problems with. For activities over which we do not have jurisdiction because they're outside of the country, when we know those products are coming in at some point, we can communicate with the FDA to see what their actions will be in this regard.

I also would like to add that the inspectorate is also a member of an international committee that looks at the trade of blood, blood products, and tissues, and it's important to have this scope and this understanding. I'm the Canadian member on such a committee that has representation from 28 countries, so we know exactly what's going on around in the world, what the activities are that are banned activities but are going on, and what the different paths between countries are. We can expect products coming into the country by participating in those committees.

Ms. Judy Wasylycia-Leis: Do we have lessons that we can learn from the way in which we now are able to regulate commercialization of buying and selling of human organs, or even blood and tissue? For example, I'm thinking of the recent—I forget where it was—news story about at least some allegations of a clinic at which someone was involved in the buying of organs for transplantation purposes. Within that regulatory system, are we able now to respond accordingly and appropriately?

Mr. Étienne Ouimette: We always have the choice to take all precautionary measures to prevent any harm to health. It's quite challenging for products where no specific regulations exist, but we can do it.

• 1225

We can always ask. That's not an issue. It's when the other party decides not to cooperate that it becomes an issue. But for those products currently not regulated under any authority, and for which specific regulations do not exist, it is very much a challenge to follow up on these issues.

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

Mr. Merrifield.

Mr. Rob Merrifield: You suggested there are eighteen clinics active in Canada, fourteen of which are accredited.

Ms. Paula Greco: Fourteen expressed interest in joining the program.

Mr. Rob Merrifield: Oh, I see.

These in vitro clinics are part of that as well, and I'm interested in the idea that you set up an accreditation standard by profession. I understand there is a significant difference between some of the standards and some of the ethics in regard to how many eggs are actually to be fertilized within an in vitro procedure from clinic to clinic. What measures do you use and do you see as appropriate? Are there some abuses there? For example, do we perhaps see some embryos that are potentially not intended for anything other than research? Is that happening in Canada?

Ms. Paula Greco: I think you're right with your comments in relation to the fact that there is some discrepancy across the country in terms of the number of eggs to be fertilized. What we try to do when we're developing our standards is bring all the stakeholders around the table and come to a consensus on the best approach in terms of referencing those in the standards. Right now, in terms of what we're seeing and whether or not embryos are being used or cultivated specifically for research, we haven't seen any of that in the clinics.

Mr. Rob Merrifield: They probably wouldn't say so now anyway. Nonetheless, I guess my question gets back to what I said earlier. It probably wasn't that clear, because my time was short and I talked at length.

Some hon. members: Oh, oh!

Mr. Rob Merrifield: On this question.

An hon. member: Does that go on the record?

Mr. Rob Merrifield: With regard to what I asked about outcomes, when an embryo is produced, it's obviously for the outcome of producing a child. That's the intent. There are certain clinics that use two eggs, while there are others that can potentially go up into the teens. There has to be a standard there somewhere that is appropriate. Under accreditation, you obviously must have wrestled with this.

The Chair: Can I just ask a question for clarification here?

When you first began, I thought you had visited and had developed standards, and that you had accredited some of these. In the latter part of the meeting, I've been getting the feeling that all we have are fourteen clinics that have expressed an interest in accreditation. Literally, there are no accredited clinics in Canada, is that right?

Ms. Paula Greco: Yes, that's right.

The Chair: Also, you do not yet have a standard or set of standards by which you would measure the first clinic that invited you in to accredit them.

Ms. Paula Greco: No. We do have an established set of standards and an accreditation program that we have developed. The next step for us now—and it has just recently been presented to the IVF group in B.C.—is to establish a formal program. What we have circulated to all of the clinics are letters of intent, just to get a feel for how many are interested. That's how we came to the number of about fourteen that are—

The Chair: Have those clinics sat around the table, as you have suggested, and agreed upon what the standards will be?

Ms. Paula Greco: That's right.

The Chair: You've been through that process?

Ms. Paula Greco: That's right.

Mr. Gilles Lanteigne: We've tested them already.

Ms. Paula Greco: We have tested them. I think it has been almost ten years in the making since we actually started with this.

The Chair: So one could say you have a lot more experience accrediting hospitals and that very complex set of activities than you do accrediting IVF clinics.

Ms. Paula Greco: I would say so.

Mr. Gilles Lanteigne: Well, there are a limited number of clinics. From there, we have much less, limited experience. I think we have tested it in five clinics.

The Chair: You've done what?

Mr. Gilles Lanteigne: We've tested the standards in five clinics that were elaborated.

The Chair: So you have visited five clinics?

Ms. Paula Greco: Yes, we have.

Mr. Gilles Lanteigne: And we then made modifications to the standards based on the feedback we received for this process.

Mr. Rob Merrifield: Can we come back to my original question?

The Chair: Yes, I'm sorry. Go ahead, Rob.

At first I thought they had all this experience, but it isn't true. They are just developing this.

Mr. Rob Merrifield: It's good that they're movable.

My question is, what are the standards you have come up with?

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Mr. Gilles Lanteigne: I have two elements that I think will help you on this. The first one is that we would request of the organization that they have systems and indicators in place by which they measure their outcomes. Related to your questions, specific indicators would be something that I think would need to be developed.

The second element related to that—and I think we also cover that in the leadership section—is that we make sure that, internally, there are systems and processes by which there are ethical debates and ethical issues—such as these—brought up by competent people. The organization then compares itself with what is going on in the world, in the industry, and in the sector. If they don't come up to those standards, they must take the appropriate measures to comply.

So there's the ethical issue, and there's also the information that is used to compare. Every clinic will have...there is no set of defined indicators that is used. It depends on the nature of the business the organization is in, on the pending issues related to that organization, and on the pending issues related to the field.

Mr. Rob Merrifield: So there are no defined numbers. That's what you're saying.

Mr. Gilles Lanteigne: There are no defined numbers. It depends, because they can be changed as time goes.

Mr. Paula Greco: It's evolving.

Mr. Rob Merrifield: Yes, it is.

The Chair: So says Mr. Merrifield.

Mr. Rob Merrifield: The other thing you mentioned during your presentation—and you ran over it very quickly—was something about the ethics, about the rights of the unborn child in the accreditation process. It was vague. Maybe I heard it incorrectly, I don't know, but I thought that's what you had said.

Ms. Paula Greco: In the standards themselves that we have now related to ART, there is a reference to the unborn child and making sure that particular individual has access to all the information they might need down the road in relation to medical history. There are certain requirements in the standards that require the clinic to evaluate the potential parents in order to determine whether there are any risks down the road in terms of bringing that child into that particular environment. There is some reference around the whole counselling piece, and making sure the potential parents have some awareness of the situation—what the risks are, what the surrounding environment is with respect to that unborn child. So we make several references in the standards with respect to that child.

The Chair: Mr. Lunney.

Mr. James Lunney: I'd just come back to the advertising and the question there. I wasn't sure about the response I heard to Judy Wasylycia-Leis' question about advertising for ova and so on, and targeting university women. Is it possible to add a section here prohibiting such advertising or the promotion of services that are prohibited?

For instance, believe it or not, in my own riding just recently, I found an advertisement for hydroponic equipment used to grow medicinal marijuana now that it's perceived the health minister has permitted people to grow their own medicine. They're just blatantly advertising this in one of our local papers. If this kind of thing is certainly conceivable, is it possible to close the door? Could this be added here?

C/Supt Earl Moulton: I would say yes, and there are certainly examples of it in our legislation and in American legislation. Perhaps extrapolating on the growing operations, the precursor legislation in respect of synthetic drugs and the prohibition around gathering, and again going back to any dealing, manipulating, or storing—those kinds of words—of human reproductive products, I think your needs are met simply by removing those words from the existing proposal within the body of this particular legislation and going with “for the purposes of”. Dealing with them in any way, shape or form then becomes at least a licensed or a licensable activity, as opposed to something that falls in the void.

Mr. James Lunney: Did I hear the word “advertising” in that list?

C/Supt Earl Moulton: It would be. Again, that would fall within prohibited activity as well—“to assist or enable”, or those kinds of words.

Mr. James Lunney: Even if it wasn't in our jurisdiction, we're into that—

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C/Supt Earl Moulton: Then I would suggest you would want to also read in an explicit section saying that, wherever this occurs, if some portion of the activity occurs within Canada, it constitutes an offence.

Mr. James Lunney: Thank you.

The Chair: Anybody else? No?

Seeing no other hands, it's my pleasure to thank you for coming, for the preparation you have done, and for the frank answering of our questions.

I would also say our researchers are charged with the responsibility of writing the report, which we will approve or tear apart, whatever it happens to be. Anyway, they may have more questions. Could I ask you to welcome their calls and to give them as much information as you can? That would assist us indirectly, but essentially, for our task.

And thank you to all my colleagues. We're back tomorrow at 3:30 p.m. for Mrs. Brundtland.

This meeting is now adjourned.