[Recorded by Electronic Apparatus]
Wednesday, May 17, 1995
.1530 
[Translation]
The Chairman: I would like to welcome everyone
[English]
to the Sub-Committee on HIV/AIDS of the Standing Committee on Health.
This afternoon as witnesses we have, from the health programs and services branch, the assistant deputy minister, Mrs. Kay Stanley, and Dr. Mary Ellen Jeans, director general, research program, policy and planning. From the health protection branch, we have Dr. Ron St. John; Mr. Dann Michols, executive director, national pharmaceutical strategy and drugs directorate; and Dr. Claire Franklin, director of the bureau of human prescription drugs. Also with us, from the Medical Research Council of Canada, we have Dr. Michel Denis.
At the request of Mrs. Stanley, we are going to start with Dr. St. John.
Ms Kay Stanley (Assistant Deputy Minister, Health Programs and Services Branch, Department of Health): Before Dr. St. John speaks, Mr. Chairman, I would like to say a few words to set the context for our presentation this afternoon, bearing in mind that as it is for the full committee, brevity is the order of the day, so I will be brief.
[Translation]
Once again I am pleased to be here today to provide the sub-committee with further details on a national AIDS strategy and to answer questions from the members.
Today, as requested by the sub-committee, the presentations will focus primarily on issues related to research, an important component of the strategy.
[English]
You've already been introduced to the members of the team from the three responsibility centres within Health Canada and our colleague from the Medical Research Council.
Members of the committee will recognize that research must continue to be an important component of our efforts on HIV/AIDS. Nearly half of the strategy funding goes toward research and epidemiological monitoring, including extramural research funded through the national health research and development program and the Medical Research Council.
[Translation]
Health Canada is committed to facilitating and coordinating research activities. A national planning forum for HIVAIDS research is in the process of being finalized.
.1535
Its first meeting is anticipated next month. The forum is in keeping with a public commitment to develop a national framework for HIV/AIDS research planning, made in the National AIDS Strategy.
The forum will bring together national partners, researchers, representatives from community-based organizations and other stakeholders to identify research planning issues, examine current planning processes and recommend issues to be addressed.
[English]
Before we start with Dr. St. John, I would like to touch on a few issues that were raised at the subcommittee last week. A comprehensive update on HIV/AIDS epidemiology was presented to this subcommittee by departmental officials last December, and I believe Dr. St. John was present for that. Since members asked for further clarification about the changing face of the epidemic last week, I wanted to make a couple of points in that regard.
In the first 15 years of the epidemic, there have been about 11,000 cases reported. The total number of cases, adjusted for delay and corrected for under-reporting, is estimated at 16,000 AIDS cases. The best data currently estimates that 27,000 Canadians are living with HIV, and it is expected that 15,000 of them will develop AIDS by the year 2000.
[Translation]
This disease is spreading at different rates among various population groups. There has been an increase of AIDS cases in specific populations, such as women, intravenous drug users and prisoners. Even though the total number of reported AIDS cases among the aboriginal populations is low, the actual number is probably higher and is a concern.
In addition, there is a concern that there may still be an increasing number of new infections among men who have sex with men, particularly young gay men.
[English]
Turning to the question relating to the effective implementation of the national AIDS strategy, I'd like to indicate to you that a mid-term review will be conducted by the end of 1995, as well as a final evaluation. Last week, I suggested that the recommendations of this committee would be helpful in the preparation and the assessment that is part of the review. These results will certainly help us as we look to the future.
Members also raised questions regarding administrative costs in the national AIDS strategy, and I just want to summarize. I had given a quick figure before the committee last week, but of the annual Treasury Board allocation of $40.7 million over the five-year period from 1993-1998, 65% or $26.5 million is allocated to the various grants and contribution programs administered under the strategy.
Salaries and benefits comprise approximately 10% or $4 million of the total allocation. We noted there are 64 positions allocated under the strategy and approximately 5 are in management, 41 are professional staff, and the remaining 15 are administrative and support positions.
With those introductory comments, Mr. Chairman, I'd be most happy to turn the floor over to Dr. St. John from the health protection branch.
The Chairman: Dr. St. John, please.
Dr. Ron St. John (Senior Adviser to the Director General, Office of Special Health Initiatives, Health Protection Branch, Department of Health): Thank you, Mr. Chairman, and thank you for your indulgence in allowing me to go a little bit out of turn and also for your forbearance when, with your permission, I will leave to return to the Ebola crisis in Zaire.
You've already, I believe, appreciated that LCDC, the Laboratory Centre for Disease Control, has two major components under the national AIDS strategy. One is the division of HIV epidemiology for monitoring the directions and trends in this epidemic, and the other is the bureau of HIV/AIDS laboratories and research of which I am a director.
I will mention just highlights and then be happy to respond to your questions.
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The bureau of HIV/AIDS laboratories and research is the national HIV reference laboratory for Canada and has four major components: diagnostic reference services, molecular immunology, flow cytometry, and viral pathogenesis.
The diagnostic reference services have three major activities, many in support of our provincial HIV laboratories. Our quality assurance program for HIV serology and for HIV cultures is a leading program in Canada for guaranteeing the quality of our laboratory testing throughout the nation.
We also assist the provinces by receiving specimens that pose difficult diagnostic problems for the provinces because we have additional expertise and advanced technology for resolving those diagnostic issues.
Finally, in collaboration with our medical devices bureau in the environmental health directorate, we do pre-market evaluation of all HIV kits before they receive notice of compliance for sale in Canada.
In our molecular immunology section, we have our expertise for viral genetics and we use that expertise in two principal ways: to establish surveillance for the HIV strains that are circulating in Canada, and to provide support for the investigation of the genetics of the strains isolated in particular clusters or outbreaks so that we can relate the strain from one patient to another patient, like the DNA PCR technology in a famous trial that is under way at the present time.
Our flow cytometry is really a tool. This is a special diagnostic technique using advanced technology for sorting different kinds of cells, and this tool runs a quality assurance program in support of the clinical trials network and 46 of the hospitals in Canada that use this methodology to sort different kinds of cells - in particular, for HIV, the cell that has the CD-4 marker, which is used as a marker for disease progression.
Finally, in our viral pathogenesis area, we are actively exploring the vaccine model, using the Simian Immunodeficiency Virus or SIV and certain genetic deletions in that virus as an animal model for possible development of a future vaccine against HIV.
I'd be pleased to answer any additional questions, Mr. Chairman.
The Chairman: Thank you, Dr. St. John.
Do you have any questions, Mr. Ménard?
[Translation]
Mr. Ménard (Hochelaga - Maisonneuve): Don't you feel, Mr. Chairman...
The Chairman: Mr. St. John has to leave because he has other commitments this afternoon.
Mr. Ménard: In fact, I was the one who asked for this meeting. Indeed, I expect a lot from this meeting, since it will determine the future course of our work.
Here is what I am interested in. If I understood correctly, you work for the Health Protection Branch. Is your branch responsible for the certification of drugs?
Dr. St. John: No.
Dr. Ménard: You don't have anything to do with certification? I've been in touch with BioChem Pharma. Its representatives have high hopes for 3TC, which, if taken with other medication, provides real health benefits which cannot be obtained by any other means. However, I was dismayed to find out - and I hope our committee will have flexibility to change this - that the Americans might approve 3TC before Canada does, despite the fact that the drug was developped in a Quebec laboratory, and that a company from English Canada, more precisely from Mississauga, will market it.
Is your branch at all responsible for dealing with this kind of situation, and how do you think we can make the drug available sooner to infected people?
.1545
[English]
Dr. St. John: It's not an area for the bureau of HIV/AIDS laboratories and research. Our area is laboratory technology, not therapeutics.
[Translation]
Mr. Ménard: When we met with the Canadian Association of HIV Researchers represented by Dr. Catherine Hankins who is well known in the research community and among persons with AIDS, and we met other witnesses as well, they all seemed to be telling us that there were two deficiencies in the identification of research in Canada. First of all, despite the fact that Canada has the third largest number of infected persons per capita among industrialized countries, it is ranked second to last in terms of the funding available.
Of course, you are going to tell me that this is a political issue and not just an administrative one, but there seems to be some difficulty in identifying research priorities. Four such priorities had been identified by a number of stakeholders. I can list them quickly: natural history, that is the immunology and pathogenesis of the HIV infection, the role of K cells or cytotoxic lymphocytes that you discussed earlier, gene therapy and genetic markers.
Can you give us your assessment not of the funds available, but of the way that research orientations are established? What kind of research is being done in the laboratories that are under your responsibility for each of the four headings I've just listed?
Last week, the Deputy Minister told us that the five partners meet with her once every three weeks on average. That's very interesting and laudable, but despite the fact that there's that kind of collaboration, this proximity between the partners and the Deputy Minister's office, it seems that there is no agreement on research priorities and that the priorities that are set are not those considered most appropriate by the five partners.
[English]
Ms Stanley: Dr. St. John will respond to those elements of the member's question that refer to his area of expertise. Drs. Jeans and Denis will speak on priority setting when I talk about the AIDS coordinators' meeting every three weeks. Partners...I always think of the NGOs in the community...the coordinators within the department. They will address that aspect of the question.
Dr. St. John: Our research is predominantly directed at laboratory technology development and vaccine. On the laboratory technology areas, we attempt to monitor the latest testing technology, bring that technology into our laboratory even before it is distributed widely, and explore the different limitations, advantages, and disadvantages of that technology as a guide to our provincial partners in the HIV laboratories in the provinces on what kinds of tests, what kinds of technologies, they should be prepared to incorporate into the testing of people for HIV.
In the vaccine area, again our major effort has been to explore the animal model using the simmuno-deficiency virus as a model, we hope, to contribute to the development of a human vaccine.
In our case our animal research is not really standard animal research. It is using a specific model that has shown some promise as a model for understanding the pathogenesis of HIV in humans. I refer to the monkey model using SIV as the agent.
.1550
We do this research in collaboration with a consortium in the U.K., Switzerland and I think Denmark, and with partners in the United States. So we are collaborating on this particular model. For example, we're developing certain clones of the SIV virus and making them available to the consortium of researchers who are working on this model to try to understand it for getting clues to how we could develop a human vaccine.
[Translation]
Mr. Ménard: With regard to the cases, I believe it's Dr. Jeans. For each of the headings that are identified as future research priorities by the partners, namely natural history, the role of cytotoxic lymphocytes, gene therapy and gene markers, is any research being done by federal laboratories?
[English]
Ms Stanley: We're back to labs.
The Chairman: Yes. If any of these questions can be answered later on we'll do that. For now we're just going to focus on Dr. St. John. You could take note of the questions and at the end of your presentation you could respond to these questions.
[Translation]
Mr. Ménard: But we won't forget, Mr. Chairman.
[English]
The Chairman: No, I just asked Dr. Jeans to take note of these questions.
Dr. St. John.
Dr. St. John: Thank you. In our laboratory we are exploring genetic markers in the virus and also cell markers, looking for the surrogate markers for progression of disease.
[Translation]
Mr. Ménard: Are you confident? Do you think that we can be confident that based on Canadian expertise in both basic and applied research, and despite the lack of funding, we can contribute to discovering something sufficiently curative that we can relieve infected persons? Do you think this is a reasonable expectation? This 3TC that we're told about... If you only knew the number of calls that I personally receive at my constituency office, which is very close to the gay village! Are you, as a researcher, as a physician, confident that we can use 3TC in Canada or Quebec to relieve the infected persons and seek to market the product commercially?
[English]
Dr. St. John: Again, it's not my area to comment on 3TC, but I can say that our laboratory has already contributed in the research area. Our laboratory developed a technology for using filter papers as a technique for the transport of blood specimens and then testing them in the laboratories.
Our laboratory has contributed; in fact, the director of our flow cytometry laboratory is a nationally and internationally renowned expert in flow cytometry and has developed new techniques for sorting out cells so that you can tell which cells carry certain markers on their surface, and they can be counted to see how the patient is progressing with the disease.
[Translation]
Mr. Ménard: I would like to ask you a last question regarding what's being done in the Canadian HIV Trials Network. How does their work compare with the kind of research you do? What distinguishes you from the Trials Network in which we invested nearly $3 million as the Deputy Minister reminded us? What distinguishes the type of research done by the Canadian HIV Trials Network in the 10 provinces from the type of research you do in a federal laboratory?
[English]
Dr. St. John: Perhaps I should explain that one of our roles is to support the clinical trials network by making sure the CD-4 counts that are done as an integral part of the clinical trial are accurate. So we monitor the laboratories that are doing those counts.
For example, the way we do that is we send them specimens in which we know the answer but they don't. It's like a test or a quiz. They run those specimens and send us back the results and we judge them on whether or not they get the answer correct. If they haven't got the answer right, then we provide technical assistance for improving their performance.
This is vital for a clinical trial of any new therapeutic agent because the end point for judging the efficacy of that clinical agent is surrogate markers other than death or recovery. The surrogate markers include the CD-4 count and how it is either recovering or continuing to progress downward. If you don't have an accurate count, you can't really assess the effectiveness of that drug. We guarantee the accuracy of that count.
.1555
The Chairman: Thank you, Dr. St. John. Just before you leave us, I would like you to elaborate for maybe thirty seconds on the fact that your bureau embodies Canada's experts in HIV molecular genetics and provides an HIV DNA tracking service. Please elaborate on this HIV DNA tracking service.
Dr. St. John: Dr. Michael Montpetit is our expert in viral genetics. He is recognized both here and in the United States and elsewhere for his work on developing or simplifying some of the technology for studying the genetic sequences of the virus. When you take that virus and pick apart its genetic information, you can compare one virus with another virus. So we actively collect viruses from around the country and we digest them, if you will, genetically. We then compare them with the known families of viruses from around the world to see whether or not any new viruses have been introduced into Canada.
This is a very important surveillance system, because if a new strain were to be introduced into Canada from somewhere else, there's always the question whether our tests are capable of detecting that particular strain. We're very interested in whether that strain is genetically different from the strains our current testing technology can detect.
So we do that aspect of molecular genetics. The second aspect is from time to time we have been asked by provincial authorities for legal purposes to analyse the relationship between isolates in persons involved in legal situations - cases of assault, outbreaks of disease - to try to relate whether this is one strain from one person or multiple strains from multiple people. Our genetic techniques can do that.
The Chairman: Thank you very much, Dr. St. John, for your visit.
Dr. St. John: Thank you so much, and forgive me for leaving.
Ms Stanley: We wish you good luck.
Mr. Chairman, I'd like to turn to Dr. Mary Ellen Jeans now. In her capacity as director general of the research policy and planning directorate she will be talking about some of the points Mr. Ménard has already raised. Then Dr. Denis will speak from the Medical Research Council's perspective, so we keep that research component as an entity before the subcommittee.
[Translation]
Mr. Ménard: Ms Stanley, could you repeat the title once again?
The Chairman: Research, policy and planning directorate. You have it here.
[English]
Ms Stanley: In the health programs and services branch.
[Translation]
Dr. Mary Ellen Jeans (Director General, Research, Policy and Planning Directorate, Health Programs and Services Branch, Department of Health): Mr. Chairman, ladies and gentlemen, I'm very pleased to be here today to talk to you about research activities of the National Health Research and Development Program. Research is an important component of the National AIDS Strategy and I am pleased to have this opportunity to inform you about the activities being supported by our program.
[English]
The national health research and development program has been supporting investigator-initiated research since AIDS was first identified in the early 1980s, before the national AIDS strategy. Since the announcement of the strategy, the NHRDP and the Medical Research Council of Canada have provided funding for research projects, career and training awards, and research-based conferences. We currently have two competitions per year, on March 15 and September 15, and we manage four peer-review committees that assess the scientific merit of the proposals submitted to the program.
At the end of the last fiscal year the program had funded 851 projects, for a total of $49,267,704. We have funded 105 training and career awards.
The demand on the program has increased well beyond our capacity. For example, in our last competition in March we received a total of 110 research applications, more than double the number submitted under phase one of the strategy, which represents the largest intake since we began funding AIDS research.
.1600
Until recently, the NHRDP, together with MRC, has been able to fund all the proposals that were recommended by the peer review committees. Approximately 30% of the total number of applications submitted for review are actually recommended for funding. I would point out that this is somewhat higher than the approval rate in most of our regular research programs.
We are currently supporting three national health scientists, nine national health scholars, and ten post-doctoral fellows.
The research activities supported under the NHRDP and MRC AIDS program directly relate to the goals identified in phase two of the national AIDS strategy. Our job is basically to generate evidence that will lead to stopping the spread of HIV; to provide adequate and quality care, treatment, and support for people living with HIV/AIDS and for their care-givers, families, and friends; and to generate knowledge to identify effective vaccines, drugs, and therapies.
For phase two of the strategy the NHRDP has an annual allocation of $5.3 million in dedicated AIDS resource, which is augmented by an additional $2 million from the Medical Research Council in support of biomedical and clinical research. The two programs together support research ranging from epidemiological studies to clinical and biomedical research, drug and drug therapy research, care and treatment, prevention education, and social and policy issues.
I could go into more detail in breaking these areas down, but I would say that a lot of the research funded by these programs is in direct support of the other program areas in the AIDS strategy. In other words, there's evidence that supports the work of LCDC, which we just heard about. There's evidence that supports the drug approval process, the care and treatment programs, and the education and prevention programs.
Because the question apparently came up at your last meeting and Ms Stanley referred to it a few minutes ago, I thought I would tell you that, with respect to HIV/AIDS and women, we're providing support for two research programs that I think are important and that I will share with you.
The first is the Canadian women's HIV study, led by Dr. Catherine Hankins, who was referred to earlier, at the Centre for AIDS Studies in Montreal. This is a multi-site national study of the relationships between human papilloma virus infection, human immunodeficiency virus infection and immunodeficiency, and cervical disease.
A second study is called Histoire naturelle de l'infection au VIH des femmes enceintes et des enfants: étude prospective d'une cohorte mères-enfants. This is led by Normand Lapointe at the Hôpital Ste-Justine in Montreal. It's tracking the characteristics of mothers transmitting HIV, diagnosis of perinatal infection, and the natural history of pediatric infection, with emphasis on the hypothesized bimodal distribution of disease progression.
It's evident that the research, training, and career development supported under the extramural research initiative have significantly contributed to assisting the department to achieve the goals stated in the national AIDS strategy. There's no question that there is much to be done in understanding and looking for a cure for this devastating and unpredictable disease.
If I may, I would like to respond to a couple of the questions posed earlier.
The Chairman: If you don't mind, we're going to answer the questions at the end of all the presentations.
[Translation]
Dr. Denis, please.
Dr. Michel Denis (Scientific Officer, Medical Research Council of Canada): Good afternoon, Mr. Chairman.
[English]
I am here to tell you about the efforts of the MRC to fund biomedical research in the field of HIV disease. I will try my best to answer your questions after my presentation.
.1605
The goal of the MRC is to fund the best medical research possible, whether basic or applied, in the different areas of the biomedical sciences, including AIDS. The MRC has been involved in funding research into HIV infection since the beginning of the AIDS pandemic.
Since 1983, MRC has invested over $16 million in research activities on HIV and HIV-related diseases. Recently, as pointed out by Dr. Jeans, the MRC has entered a collaborative initiative with Health Canada via its national health research and development program. As part of the federal government AIDS strategy, the MRC and NHRDP have integrated their approaches to the review and funding of clinical and biomedical research, and personal support, in the areas of AIDS research. There is now a single process for the evaluation of AIDS-related grant applications. A panel established jointly by MRC and NHRDP reviews the applications and makes recommendations for support.
The agencies cost-share the successful applications, and the NHRDP is the administrative home of the program. This, in effect, streamlines the process for Canadian researchers interested in seeking funds for research in the AIDS area. It also consolidates the efforts of Canadian agencies involved in the funding of AIDS research, and it ensures that minimal funds are spent on administrative items and a maximum amount of money is given to our researchers.
At the present time, MRC is committed to providing at least $2 million per year in funds for AIDS research until the year 2000. As NHRDP and MRC are coordinating their efforts through the joint panel, this means that MRC's commitment will be progressively transferred to the joint initiative.
At the present time, MRC is committed to funding research projects in the fundamental and clinical aspects of HIV research. A list of projects that were funded entirely by MRC - some of which are still ongoing - is presented in appendix III of the hand-out. Other documents in the hand-out illustrate the salient aspects of MRC funding of AIDS research and its relationship to funding by other agencies.
Since the beginning of the AIDS pandemic, MRC has been involved in the funding of numerous projects concerning possible treatments and/or prevention of AIDS. For example, several groups, notably that of Dr. Kang in London, Ontario, have been involved in the development of candidate vaccines that could protect exposed populations.
The group of Sekaly, Jolicoeur and colleagues at the Clinical Research Institute of Montreal has developed novel theoretical frameworks for the immuno-pathology of HIV infection. Validation of these models could shed considerable light on the progression of AIDS and suggest novel forms of therapy.
Funding of research conducted by the group of Dr. Cohen and his associates at the University of Montreal has permitted the identification, cloning and characterization of novel HIV proteins that could be intimately related to the progress of the disease and to the susceptibility of victims to infectious agents.
The MRC has also funded very original work by Dr. Francis Plummer and his associates at the University of Manitoba, who are working with African prostitutes. Their work has provided the startling evidence that some individuals exposed to the HIV virus may develop a form of resistance to the virus. This has very important implications in terms of vaccine design and also with regard to possible immunotherapeutic procedures. The work has attracted worldwide attention.
.1610
All of these research projects, and many other projects supported by MRC and the joint initiative with NHRDP, may have important consequences for everyone, but particularly for members of groups at high risk for HIV infection, including the more disadvantaged individuals in our society. The development of a good vaccine would be a particularly cost-effective public health measure that would protect members of high-risk groups.
Other areas of research supported by MRC also have great potential of developing new avenues for treatment or prophylaxis of AIDS. Many Canadian researchers, supported by MRC, have made progress that has put the AIDS research community in Canada at the forefront of the research effort on AIDS in the world. MRC-funded research may therefore result in advances against AIDS that will be accessible to all through Canada's medicare system.
Thank you for your attention, Mr. Chairman.
The Chairman: Merci, Mr. Denis.
Mr. Michols.
Mr. Dann M. Michols (Executive Director, National Pharmaceutical Strategy and Drugs Directorate, Health Protection Branch, Department of Health): Thank you very much for the opportunity to appear before you today.
I am, as you noted, the executive director of the drugs directorate. With me is Dr. Claire Franklin, who is the director of the bureau of human prescription drugs. Judging from a couple of the questions asked earlier, you may have some questions for us.
I believe that notes containing our contents were passed to you, so perhaps I will just do a survey of those to give you some context for our operation. Under the Food and Drugs Act and its regulations, we are the operation within Health Canada that is responsible for assessing and managing the risks and benefits associated with the availability and use of all types of drugs in Canada. We also administer the Narcotic Control Act, so we have responsibilities for narcotic and controlled substances as well.
Basically, we undertake this work by assessing and approving clinical trials undertaken in Canada by assessing the safety, efficacy and quality of all drugs before they are allowed on the Canadian market and then by undertaking various activities to continually assess those drugs thereafter. Our work is done by roughly 450 scientists, physicians, pharmacists, etc., in Ottawa, and inspectors and laboratory personnel across the country.
As I mentioned, there are perhaps four or five broad areas that might be of interest to the committee in our work concerning AIDS drugs. The bureau of human prescription drugs is that arm of the drugs directorate that probably has the most activity in terms of assessing new AIDS drugs. Dr. Franklin will speak to the responsibilities of her bureau in a little more detail.
We have had for some years, and have just revamped, an expert advisory committee that we set up on HIV therapies, which is composed of a number of physicians, immunologists and representatives from the community. It serves as a sounding board and as a forum for us as we undertake our work.
We also have a bureau of drug research within the drugs directorate. This organization is primarily oriented towards undertaking research to support the regulatory process, and in the HIV/AIDS area we have done considerable work in the area of drug-drug interactions.
We also undertake some studies in the area of genetic metabolism of various drugs, and one in the notes you have indicates a study that we have undertaken with the Inuit population to determine if they metabolize drugs differently from other cultures within Canada.
We also have the responsibility, under the act, of managing the emergency drug release program, which is a mechanism whereby we can authorize the release of drugs that have not yet been approved in Canada or, for some reason, perhaps have been approved but are not marketed for one reason or another.
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This program has shown in the past to be of considerable interest to the AIDS community, and we have just undertaken a full review of that program and have a proposal for revamping it under the label of a special access program. That document is about to go out for consultation across the country.
In the notes we have given you, there's more detail on the primary objectives of the special access program to address some of the concerns that various communities, as well as physicians and industry, have had with the management of that program. So we have addressed that.
As part of our operation, we are going through a two-year re-engineering process on all of the processes within the drugs directorate, trying to ensure transparency in all of our operations, trying to set up working relationships with the full range of stakeholders that we relate to, and attempting to streamline our process and clarify our policies and procedures - all of this to ensure ultimately the timely access of safe and effective drugs to Canadians.
The Chairman: Thank you, Mr. Michols. Dr. Franklin, please.
Dr. Claire Franklin (Director, Bureau of Human Prescription Drugs, Department of Health): Thank you, Mr. Chairman. The bureau of human prescription drugs is responsible for regulating all prescription drugs to ensure that only safe and effective drugs are approved for marketing.
I'd also like to indicate that although the review of prescription drugs is not part of the national AIDS strategy program, per se, the availability of safe and effective drugs for treatment of AIDS is of utmost importance to both the program as well as to patients as a whole in the community.
Within my bureau there are numerous divisions, and we are structured along functional lines. We have an AIDS and viral diseases division. It's involved in the review of investigational new drugs, referred to as INDs; new drug submissions, which are the very large submissions that come in, in support of a drug that is to be marketed; supplemental new drug submissions, which are new indications that may arise. It's involved in all of these for treatment of HIV infection.
The division is also responsible for evaluation of drug submissions related to other viral diseases. So they have several components. These could be herpes diseases, viral hepatitis, chronic fatigue syndrome, and so on.
The role of the division is to take necessary action to ensure that the drugs used in clinical trials and intended to be sold on the market are safe and effective. There are five full-time members and one part-time reviewer within the division.
The division also provides clinical information needed by members in the emergency drug release program, and in this particular area that's a very close relationship because of the urgency to have early access to a number of these products.
As Mr. Michols indicated, we have been going through a restructuring within the directorate, and we've set up within my bureau a centralized unit to handle IND drugs to try to make certain we do get these out very quickly. During this transition period, the AIDS division is still very actively involved with that particular newly structured unit.
The high profile of AIDS-related drugs and the urgency to find effective treatments have created pressures on the division that I'm sure many of you are aware of. We're trying to streamline and expedite the review process.
It's with pride that I can tell you that the AIDS division was the first division to undertake a joint evaluation of a drug with the U.S. FDA, and this was really quite a benchmark for both agencies. The drug we were involved with was ddI. There have been several others; ddC, Mepron, and Neutrexin are examples of either joint or integrated reviews that we've done with the FDA.
My bureau is also involved in collaborative international activities with other countries, such as Australia, the United Kingdom, and Sweden. In addition, we have observer status on a significant international committee, called the International Conference on Harmonization of Technical Requirements for Pharmaceuticals.
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The intent with all of these activities is that we're really up to date with what's going on with new initiatives and new situations around the world.
We also participate in the PER scheme, in which approximately 12 other countries are involved.
The performance standard for the evaluation of a new drug submission is 360 calendar days. This timeframe is reduced to 180 days when a new drug submission meets the criteria established for priority review. That's a really significant point, and it's something that really was initiated because of AIDS drugs. The idea was to try to do the reviews faster.
We established priority review criteria for AIDS drugs initially. We have expanded those criteria to include other important drugs for serious diseases. But, again, the AIDS area certainly has shown us that we have to look for new ways in which to get drugs on the market in a timely fashion.
With respect to timely availability of drugs for AIDS patients, I wish to point out that since 1991 the following significant drugs - ddI, ddC, Mepron, Nutrexin - were granted notices of compliance with an average time of 210 calendar days. In comparison, the time to NOC, or notice of compliance, which is really the statement that a product can be marketed, across the bureau for priority submissions was, for other than AIDS drugs, 369 days.
Again, I point out that we give the utmost priority to AIDS drugs, and I think the statistics are showing that we are successful in achieving these very quick times to marketing capacity or capability.
We compare very favourably with other countries. The only timeframes I have that I can cite at this point are for the U.K. Their timeframe for what would be equivalent to a notice of compliance - in other words, a capability to market the drug - is in the range of over 900 days. So I think it's important that you are aware of the fact that our performance is certainly as good as, if not better than, that of many other countries.
In 1994 the AIDS division recommended approval of Foscavir, which is a drug for treatment of CMV retinitis. The clinical indications of Clarithromycin have been amended to include the treatment of Mycobacterium avium. Another one that has been very important is Retrovir. The indications have been modified to allow use of AZT for the prevention of HIV maternal-fetal transmission.
Again, from the time the submission was in until the product was available for this use was approximately nine months.
Numerous clinical trials have been cleared by the division, including the use of combination or combinations of drugs. Protocols, including new chemical entities, have also been cleared. These include promising HIV protease inhibitors.
For the AIDS division, 1995 will be another busy year. Practically everything is a priority in that division, so they really do work with a tremendous amount of pressure. We've received requests for priority reviews for several drugs, including 3TC, and we anticipate that there will be at least two more requests for priority reviews before the end of this calendar year.
As you can see, we've implemented numerous changes over the years to expedite the review of AIDS drugs, and we'll endeavour to maintain our excellent record with respect to rapid market entry of safe and effective drugs.
Thank you, Mr. Chairman.
The Chairman: Thank you very much, Dr. Franklin.
We still have Ms Gowanlock, who is the executive director of the National AIDS Secretariat.
Ms Gweneth Gowanlock (Executive Director, National AIDS Secretariat): I'm here to help answer questions if necessary, Mr. Chairman.
The Chairman: That's fine. I just wanted to introduce you.
Mr. Ménard has already asked his question. For the answers, we're going to hear from the panellists.
[Translation]
Mr. Ménard: We should make sure to have time for -
[English]
Dr. Jeans: I was going to address the question you asked about priorities and priority-setting. It's important to understand that in the beginning the priority was to establish the capacity in Canada to conduct research in the field of AIDS in Canada. ]It was a new epidemic. We didn't have existing laboratories, research teams, and extensive programs of research to build on. So the first priority was in fact to have a strategy, to put in place resources to stimulate the development of that capacity. That was the priority.
.1625
The priority was not fixed to the finite sub-topics or the substantive topics of the disease. Certainly it was a priority to have research in basic biomedical fields to try to understand the physiology and the spread of this disease, the immunology, and so on.
In the beginning, in the first phase of this strategy, the bulk of the research funding was indeed in the basic or the biomedical area, trying to begin to understand, trying to develop laboratories, teams, and programs of research.
As we moved to the second stage, I think we began to expand our horizons in the research field and we began to fund more research in the applied area. We asked what are the best ways to educate people about preventing HIV infection? What are the best ways to care for people who have contracted the virus? So right now, in phase two, the distribution of research across the broad spectrum is about 60% to 65% in the basic field and about 35% to 40% in the more preventive, applied aspects of research.
I'm not surprised that the scientists are now saying we need priorities. Ten years ago the priority was let's do something, let's get going, let's build our programs. To some extent, throughout these several years of the initiative, the investigators themselves have told us what the priorities are.
In the extramural program we have to give some credence to the scholars in the field who tell us what is important. We have to count on the objectivity and the intelligence of peer review committees to determine whether to recommend something for funding because they think it's important. That in a sense is how the priorities have evolved.
Today the researchers are saying we haven't had a plan, and to some extent they're right. They haven't sat down together and looked into the future. They've sat down in their individual programs and research labs and asked themselves where they are going vis-à-vis the particular area they study, but they haven't necessarily sat down together and asked where they are going for the future. That's what they want to do. That's what the national forum will address, together with all of the stakeholders. What can the plans be for the future? What will the priorities be for the future?
So I feel it had to take that history. It had to evolve to where we had the capacity in this country, and I think today we certainly have much more capacity than we did in phase one.
[Translation]
Dr. Denis: I think that Dr. Jeans' comments were quite appropriate. Initially it was important to put in place a system allowing researchers to develop in the area of AIDS research. There was no question of setting priorities or putting in place a very complex networking in which the various researchers could interact. The idea was just to lay the groundwork for the eventual establishment in Canada of a research network whose output would be competitive internationally and that would be able to interact with research conducted worldwide.
.1630
I think that, as Dr. Jeans mentioned, this first phase was very successful.
In 1983, when the funding effort was first initiated both at the NHRDP and MRC level, there were labs that started from nothing and within a few years became competitive laboratories recognized around the world as leaders, in spite of resources which some say are not as plentiful as they should be. We must therefore recognize that we have come a very long way from the basic level of just laying groundwork. What we are seeing today, in my sense, are very significant and positive results.
[English]
The Chairman: Merci. Ms Bridgman, do you have some questions?
Ms Bridgman (Surrey North): Thank you, Mr. Chairman.
Thank you very much for providing this opportunity. I have three questions. Possibly the first two can be grouped.
I understand you made reference in your presentation to the National Planning Forum for HIV/AIDS Research and I'm assuming - I'm sorry, I wasn't actually here when you did this - that it's a structure relating to research and the coordination, etc.
I'm pleased to see that there is a coordinating process here even if it is only addressing the research component of our Canadian approach to the AIDS problem. Does Canada actually have a master plan and a strategy?
I understand we're going to look more proactive than reactive in research. But do we have in place a master plan based on some objectives, etc., so that if someone were to ask what we as Canadians are doing about AIDS we would actually be able to come up with this outline of the plan of what everybody's trying to do? Or do we know what everybody's trying to do? Are there organizations that can find a cause in relation to AIDS in their community and make a grant application and we're not aware of it?
If that is the case, is Health Canada looking at - I don't even know if you're the appropriate department - trying to coordinate our efforts?
Those are my first two questions.
For the third question, I'm going to take a bit of liberty here, as we have you at the table and we're addressing AIDS. I'm thinking of today's world in relation to AIDS, and maybe in relation to other types of viruses as well.
A number of years ago we were plagued with the communicable diseases of smallpox and those types of things, and we developed a game plan. When that condition arose we had a game plan that was very common knowledge for the average Canadian. We went into quarantine. We had to stay at home for two weeks and put a sign on the door, and goodness knows what all.
I believe I asked once before why AIDS doesn't fall under communicable diseases and there wasn't an appropriate answer given at the time. It didn't meet the parameters that smallpox and some of those other diseases do. But it's not just AIDS out there. There are other viruses out there that are transferred by body fluids or something.
Is Health Canada going to come up with a game plan like we had for communicable diseases to address these kinds of viruses we're facing today, or are we going to wait and sort of react like we are doing with this Ebola virus?
.1635
Ms Stanley: Thank you, Ms Bridgman.
I'll just start with respect to the national planning forum because I think one of the things that became quite evident through phase one of the national AIDS strategy was the need for this broad and big picture with respect to the planning for our research efforts.
So in phase two there is a specific commitment to facilitate the development of a research planning process, again involving partners and stakeholders.
As Dr. Jeans has outlined, through the first phase it was reactive; now it has moved into a more proactive mode.
We had a discussion paper that we circulated in November 1994 with respect to the shape of a national planning forum. The meeting I referred to in my remarks is the outcome of some discussion that has already taken place.
Dr. Jeans, perhaps you would like to comment.
Dr. Jeans: You ask if there's a larger agenda. Do we know all of the research that's going on? The short answer is no, but there are procedures and processes that help to accumulate that data.
Research occurs through federal funding, supported by MRC, NHRDP, the Social Sciences and Humanities Research Council and the Natural Sciences and Engineering Research Council. Research is also funded in some of the provinces through special initiatives, provincial research funding programs. Research is funded by a whole variety of non-governmental organizations such as the National Cancer Institute of Canada, the Heart and Stroke Foundation and so on.
It is funded by pharmaceutical companies and other kinds of health-related industry. It's funded or supported by universities in a variety of ways.
A complete roll-up of everything that is being done in any given area is very difficult. However, in the past couple of years this very question has been at the top of a lot of people's minds. What is Canada's big plan for science and technology?
In the past year there was a government-wide, Canada-wide science and technology review asking many of these questions. Where are our resources? Where should they be? How do we distribute limited resources across the broad spectrum of research, whether its in health or in anything - economics, and all kinds of things.
As well, within Health Canada there were program reviews looking specifically at research, science and technology, looking at where we spend our money, how we can coordinate better, how we can spend more wisely, and how we can ship priorities to meet things that we can see coming in the future.
Also there's a National Advisory Board on Science and Technology that is shortly, I believe, going to present a report to the Prime Minister that will address some of these issues, giving advice about Canada's research agenda.
The deputy ministers of health are very interested in discussing what the distribution of resources should be in the health field. Not so much disease by disease, but who should be playing what role? How do we fund students? How do we protect researchers so that they can do the best science and the best research? How do we support a number of different programs?
So there are number of processes in place, to try to answer the question you asked.
In terms of your other question, I suspect....
Ms Stanley: I don't want to steal the minister's thunder, but she may be referring to some of this when she appears before the full committee tomorrow, or with respect to whether we have a game plan for dealing with communicable diseases of the type that Dr. St. John - who had to leave our table early today - spoke of in terms of Ebola.
Ms Bridgman: I can substitute a question.
We'll leave that question until tomorrow then and we'll see what happens when we do have an opportunity to get the answer.
What I would like to ask is whether the national planning forum is another networking organization.
Ms Stanley: No.
Ms Bridgman: It's more than that?
Ms Stanley: It's doing....
Ms Bridgman: It has a mandate and it has.... Thank you.
.1640
[Translation]
Dr. Denis: As for Canadian research having a special role to play in AIDS research, I want to say that our panel of experts must, in reviewing research proposals under the joint NHRDP/MRC initiative, identify those projects that show great promise. So, there's a form of natural selection in terms of the scientific assessment of the various research projects.
Perhaps the profile of Canadian AIDS research will emerge naturally, that is to say through a process by which panel experts will identify who are the best Canadian researchers to carry out research on AIDS. The approach at MRC and NHRDP has always been to say that the best research projects are the ones that have the best chances of resulting in discoveries that will impact positively on the patients.
[English]
Mrs. Ur (Lambton - Middlesex): I have just a couple of questions. We have had many groups appear before us with presentations on the various aspects of the areas they are working on with the HIV/AIDS program.
I would like to know what criteria you use for funding these groups. Have dollars been given to some groups that perhaps do not meet your criteria, and have dollars been withdrawn from those groups? I like to think positive, but I also have to be realistic.
Ms Stanley: It's a subject, of course, that would fall under the AIDS community action program, which was part of the presentation last week. But just to reassure you, it's based more on the legitimacy of the proposal as opposed to some sort of test of whether the group is viable or not.
The exercise has a peer review process similar to that of applied research, which indicates what the proposal is and the people planning to execute the activity. It goes through that process. The minister approves the contribution to them. They do not get the money up front. They have to submit almost a business plan and they are funded as their project evolves.
We have terms and conditions in those contribution agreements that if they do not do what they say they're going to do, or deviate from the proposal that was originally approved, we inform them that either the money has to come back to us or there will be no further money going to them.
Mrs. Ur: Has that happened?
Ms Stanley; Yes, that has happened.
Mrs. Ur: The number of HIV/AIDS cases is escalating and obviously there's a problem. What do you see is the major change that has to be made? In which direction should we be moving? What should we be doing differently? What is there now doesn't appear to be addressing the problem.
Ms Stanley: I will ask Gweneth, as the executive director of the AIDS secretariat, to respond to this.
It is a dilemma in terms of whether we have the proper balance in the strategy. Should we be spending more on research and on the pharmacology side? Should we be doing more on community action?
Phase two of the strategy is based on very broad consultations, not only with members who are activists in the community, but wide consultation involving provinces and officials from the provinces and territories. They have tried to bring that balance between the science or the research side, and the behavioural change side, which is really what community action attempts to do.
.1645
The proof of whether we have it right or not will be, of course, in the evaluation and assessment of our programs. Maybe Gweneth would like to comment on that.
Ms Gowanlock: Various witnesses who have come before the committee have talked about all of the aspects they are trying to address, whether it's laboratory, prevention education, community action and so on. Indeed, it is a question of the mix and the balance.
One of the things we do know so far in conducting and carrying out the strategy is there's no indication that any one of those areas should be dropped to concentrate all other activity on, for example, only research or only community action education prevention.
At the moment, since we don't have a cure or a vaccine, prevention is one of the only ways we can go in terms of stopping the spread. Part of the problem in terms of the escalating figures you spoke about is the delay in developing the disease. People who were infected 10 or 15 years ago may only be developing AIDS now.
If you look at increases now, you can't necessarily say we should be putting all of our money into prevention, because maybe what we did 15 years ago was the problem and not what we are doing now. The evaluation Ms Stanley talked about will try to help us in the format process of any future action, such as readjusting areas we're funding and prioritizing. Things like the national planning forum on research will help focus some of those aspects too.
We don't have really good answers that will guide us now to all of a sudden make a giant shift. Right now we're trying to create a balance in all the areas you heard about in the strategy. It's imperfect; a work in progress.
Mrs. Ur: Is there someone here who can answer a question about laboratories and research? The other doctor has left.
Ms Stanley: I always listen in awe when he speaks. Dr. Jeans might be able to help. Pose your question.
Mrs. Ur: With regard to HIV testing, what are the main technical problems that laboratories incur when testing and results aren't accurate or correct? What are the major difficulties incurred in laboratories?
Dr. Jeans: In all tests, whether it's for HIV or not, there are always false positives and false negatives. I think we could ask our colleagues in the laboratories to give you the specific technical problems around HIV testing, unless any other members of the panel know the answer to that. I suspect it's fairly specific to that testing.
Mr. Culbert (Carleton - Charlotte): Good afternoon. Ms Stanley, I feel I've seen you so much in the last two or three weeks I should be able to call you Kay by now.
Ms Stanley: You certainly may.
Mr. Culbert: Thank you. We'll probably see you some more by the looks of the estimates and so on, although we won't see you next week.
I was very interested in Dr. Denis' comments about incidents in Africa, and how certain women have been found to develop an immunity to HIV/AIDS. I'm wondering about the whys, hows, whens and wheres. What's being done to follow up and find out why? When we find out why, maybe the light switch will come on, so to speak. If it can be done naturally through our body systems, then perhaps we can reproduce that artificially in some form. Maybe that's the light switch we will need.
The other point was along the same line. For the new drug process in Canada, regardless of whether the research is being discovered in Canada or some other country in the world and that process comes forward again, can you just briefly tell me the steps that are taken? In other words, if the proposal, the invention or disclosure, comes here in Canada in comparison with being found somewhere else in the world, what steps are taken?
.1650
Dr. Denis: I can certainly address the fact that a number of HIV-exposed sex workers in Africa have been found to develop a form of resistance to the disease. One of the pioneer researchers in this area is Dr. Francis Plummer at the University of Manitoba. He has been working on this area through MRC and NHRDP for a number of years now, and we are still supporting Dr. Plummer. This year he's presenting a renewal application for his group grant to continue his studies of this phenomenon. It's a highly interesting phenomenon, obviously, and it has very important ramifications for developing therapeutic procedures for HIV.
A number of groups are interested in this area. There's not only Dr. Plummer. A number of very good groups at the Aaron Diamond institute in the U.S. are also looking at it. A number of American citizens have very clearly been exposed to HIV. One can retrieve some cells called T lymphocytes from the blood of these patients, cells responsive to the virus, but these individuals do not become sero-positive, which is the hallmark of infection with HIV.
So this is a highly interesting phenomenon. It's being studied intensively by Dr. Plummer. I do not know of any recent breakthrough in identifying why these T lymphocytes are responsive to HIV and why they should protect the individual who is potentially infected with the virus, but this is an area of intense study. MRC is involved in funding the work of Dr. Plummer, and it's a very hot area in HIV research, not only in Kenya - Dr. Plummer is pursuing his studies in Kenya - but in many parts in the world. But there is no clear answer at present.
Mr. Culbert: I would think with this type of flag as a breakthrough we would be putting pressure and encouraging a lot of effort, both here in Canada and with whatever we can do on the international scene, to encourage research in that area and compare notes. I admit, from a lay perspective it would seem it suggests a breakthrough is very possible if we can find out why that is happening.
Again, are we putting the emphasis on that area as far as research goes here in Canada and with whatever we can do internationally? I know we probably don't carry a great deal of weight. Money seems to carry the weight when it comes to research grants and how far we go.
Dr. Denis: Emphasis is placed on this type of research from the standpoint of scientific novelty. It's a very novel type of approach and it's a very new finding. It's very exciting. So yes, the scientific review panels place this type of research at the very top of their priority list. It's not a perceived place on our priority list at MRC and NHRDP, but our scientific review panels will certainly flag this as being breakthrough-type research.
.1655
Ms Stanley: I think Mr. Culbert makes a very good point. Members of the committee may have seen articles a few weeks ago about infants in the state of California who had shown the signs immediately upon birth, but then when they were revisited at age three or four, some of the signs were no longer evident. Because much of the research in this area is done by international consortia, there is a good sharing of information when studies of this nature are done. I know MRC and NHRDP are plugged into those networks.
But you did ask a question about drugs and I will ask Dann to respond to that.
Mr. Michols: Your question, if I understand it, is generally what the drug approval process in Canada is.
Mr. Culbert: Yes, for most of those that are researched and discovered in Canada and those that may be discovered offshore somewhere.
Mr. Michols: Basically there is no difference between the two types. Our mandate is to assess the safety, efficacy, and quality of drugs used or marketed in Canada. So they may be developed in Canada or they may be developed elsewhere. Our mandate is specifically the safety, efficacy - which is to say does the drug do what it claims to do - and then the quality in terms of consistency of manufacture or impurities or what not. We have no powers to deal with the price of the drug; there's no economic evaluation involved in our process at all.
When we talk about drugs used or marketed in Canada, that brings into our realm the assessment of drugs that would be used in clinical trials in Canada as well as those that a manufacturer wishes to market and therefore needs approval for. So we get involved in both of those processes.
We deal in reaction to a submission from the manufacturer, so we set out a range of guidelines that indicate to the manufacturer what sort of data we would require to support various claims. Then that submission comes in and we determine from the nature of the submission which part of the drugs directorate it should be analysed within. If it's biologic, it goes to the bureau of biologics. If it's a prescription drug, a synthetic new chemical entity, more likely it goes to Dr. Franklin's bureau. If it's a generic or non-prescription drug, it goes elsewhere.
So the sort of process it goes through depends on the type of drug, but basically the whole process is to determine the risks that particular drug represents and the benefits it offers. We are involved in a situation of trade-offs.
If the benefits are greater than the risks, it's a drug that should probably be approved, and then the job becomes detailing the risks for the benefit of physicians and/or consumers to indicate to them that generally it will do what it says it will do under these conditions and so on. That information is captured in a product monograph that is contributed by the manufacturer. We spent a lot of time working on it to make sure it represents the facts of the drug.
We issue a notice of compliance. That is the mechanism within Canada of allowing a drug on the market. It basically says this drug is in compliance with the Food and Drugs Act and regulations.
If the data is insufficient or if we find a problem, we can return to the manufacturer and say here are a number of deficiencies, react to them and give us the information we need if you have it. If they don't have it, we then would issue a notice of non-compliance, which basically says this drug may not be marketed until you do provide a range of data that would satisfy our needs.
Following that, if the drug is approved, we also have mechanisms for monitoring, collecting, and analysing adverse drug reactions after the drug is on the market, such that we could hopefully react quickly if a problem does arise for some reason once the drug gets out of the clinical testing forum into use within the general population, where it's being taken with other drugs, by seniors as well as children, and the wide range of reality that is represented in the country.
[Translation]
The Chairman: Thank you. We're now going over to the questions. Thank you for being so patient, Mr. Ménard, it is your turn now.
Mr. Ménard: Mr. Chairman, you know that patience is one of my virtues.
.1700
I will speak of what is most important to me and start with two preliminary remarks. I got in touch with your services. I believe I spoke with Mrs. Patricia Russell, and I would very much appreciate if we came to you to have a briefing, sit together and understand in depth how you give approval for a drug.
I'm now going to ask some questions, because from our understanding will depend the way we will pursue our work. This is very important. I'm going to ask you questions about the 3TC, but I would first officially suggest that we meet at your place and that will be given a very thorough briefing.
Secondly, I would like us to be invited to the National Forum on Research Planning, in order to examine with the partners how all this is done and what format it will take. At this point I would like to make a small comment.
We have all one thing in common, one concern, namely the HIV. The decision-makers can hardly be reproached with having been caught off guard when the disease started spreading, in the 1980s, because there had been no precursor signs and no one, at the time, could foresee what was to come. I have however been told that there was a difference between the attitude of the Canadian and of the Australian decision-makers: very early Australia set up mechanisms which allowed it to monitor, as soon as the disease started spreading, a cohort of patients. Australia therefore has much more data than Canada on the evolution of a disease that was practically unknown in the 1980s.
I don't expect you to answer on that point, but it seemed useful to point that out, which was explained to me by none other than Dr. Beaulieu, the Chairman of the Canadian Network of Clinical Tests, when I met him.
Canada indeed has a network of clinical tests which receives a dismally low subsidy, namely $3 million. It had requested $10 million at the start, and then $5 million, but it received only $3 million. One of the characteristics of Canada, I have been told, is that the federal government doesn't fund any of the research of the network of clinical tests, only the infrastructure, so that the Network finds itself in a very peculiar situation where, to all intents and purposes, the drug manufacturers dictate the main lines of research. You can hardly hold it against them if the research is then done with an eye on the marketing potential of a product; this is only too foreseeable.
Will the committee listen to the recommendations of AIDS Action Now! which urges, in a country that cares about people, the drug manufacturers, whether by regulation or by law, be obliged to show compassion? In other words, when the federal government authorizes clinical tests the drug manufacturer which will participate will have to allow access to them. I've been told that in that case the tests are not with simple drugs, but with research drugs.
Tell us now how you proceed, in your department, when you have to approve a drug. Are there four steps, like the four steps of the clinical tests, of which the first one is done on about 100 patients in order to check on the toxicity of the drug or research drug? What exactly are those steps and what are the changes that should be made to make it compulsory, when clinical tests are done on the Network, that those research drugs be accessible? Is it necessary to amend an act and, in that case, which one? This is my first questions.
[English]
Ms Stanley: I'll start and then I'll ask Dann, because your second question does fall into a couple of areas of the strategy.
First of all, with respect to an invitation to sit down in the offices or labs or to participate in the forum on HIV/AIDS research, perhaps, Mr. Chairman, we could follow the usual procedure of you making that request to the minister. Then we would respond accordingly.
The Chairman: That's fine.
[Translation]
Mr. Ménard: But she's going to refuse; I may be a nice guy, but she doesn't like me.
The Chairman: I'll make the request, sir.
Mr. Ménard: Make the request to her.
Ms Stanley: This is not true, sir.
Mr. Ménard: Indeed? I feel now much better.
.1705
[English]
Ms Stanley: There are some labs in Health Canada that I have never been in because there are many restrictions as to whether you can even go in them. So it's not just members of Parliament who sometimes have difficulty with access, but I am sure -
[Translation]
Mr. Ménard: You also follow a minister?
[English]
Ms Stanley: You will have to have all the right shots and everything if you are going to be in among the rhesus monkeys and so forth that are part of those trials, but that's another issue.
On the subject of the cohort, the Australian situation did demonstrate a different kind of foresight. Again, it is difficult in hindsight to be able to respond and say that we should have done that. I think the good news of that is that our linkages with our colleagues in Australia are very strong and we do benefit by the research that's going on in Australia.
In terms of clinical trials - and this is not the first time you have raised this issue and I expect you will not be totally satisfied with my reply - the integrity of Health Canada's role as a regulator has prevented us from funding clinical trials to the extent that you would prefer. What we have done through the AIDS care and treatment area is give the infrastructure support for national and regional offices in order to keep those networks working, but not funding the direct cost of the clinical trials.
Your observation is that therefore the agenda is being driven by the pharmaceutical industry. I am not in a position to question that.
I do, though, have to say that it is a policy decision -
[Translation]
Mr. Ménard: That's what the Network said, during the presentation of its brief...
[English]
Ms Stanley: One of the things this committee will be doing, I am sure, is making recommendations with respect to how government and government policy address these concerns, but for now the policy is that because of our regulatory responsibilities, we have not funded direct cost.
Dann, do you want to comment at all?
Mr. Michols: Yes.
[Translation]
Mr. Ménard: It's the approval.
[English]
The Chairman: Would you please talk a little bit more slowly.
[Translation]
Mr. Ménard: It's quick?
[English]
Mr. Michols: Exactly. I'll ask Dr. Franklin to speak to your specific question on the phases of clinical trials. I'd like to speak more generally on your concern about the clinical trial milieu, if you like, and compassionate access.
We do not have the mandate through the Food and Drugs Act to force ``the pharmaceutical industry'' to deal with clinical trials in a particular way or to make the drug available for free, at lower cost, or whatever. Our mandate is simply to ensure that the product that is being used is safe, efficacious, and of high quality.
We do have, through the act, the mechanism to enable the manufacturer to release a product that hasn't been approved, through, as I mentioned, the emergency drug release program. We are doing all we can to streamline the access, but it is still voluntary. We cannot force a company to release the drug, and one of the main concerns is the price that would be charged.
[Translation]
Mr. Ménard: Before you give the floor to you colleague, so that we properly understand approval, I'll tell you about something we experienced. Glaxo, as you know, is getting ready to release 3TC. Glaxo is an international consortium whose major decisions are made in Scotland. Glaxo was, up until quite recently, a very good corporate citizen. It had made available to approximately 1,000 people, in North America, samples of 3TC. I went to meet with this company many times and the most important thing to me, is that 3TC is the future. I understand we have to be careful. It was explained to me that 3TC in and of itself doesn't mean anything; it must be administered in conjunction with another drug.
.1710
According to this company, your department dragged its feet in the processing of these files and the numbers you put in your documents, with all due respect, are challenged by the Pharmaceutical Manufacturers' Association of Canada, which is normally quite accommodating with the government; they've also been challenged by the Generic Drug Manufacturers' Association of Canada.
The speed you claim to work at hasn't been applied in the Glaxo's case. There's no mention of it on the part of the Pharmaceutical Manufacturers' Association of Canada.
I'm not questioning individual people's will, because I know it's a matter of the apparatus, systemic pressures, but once we've understood the approval process, what should we expect for 3TC?
We were told that if, in June, the company doesn't have its compliance notices, it will not be able to continue until it has changed its production technology. It will no longer be able to make a 1,000 samples of the drug available to HIV positive people in North America. These samples were available, obviously, because of the emergency drug release program.
That is why it seems to be important for the committee, without questioning the good intentions of anyone, to better understand the process and amend the act where necessary.
[English]
Mr. Michols: I appreciate the opportunity to explain the process.
We did write to the chair of the committee after the president of the Pharmaceutical Manufacturers Association of Canada, or ACIM en français, appeared to contest a number of the performance times they were using. They are using dated information from two or three years ago, not the current information, and we spent a lot of time streamlining it. I suspect that's a debate we will have with PMAC for some time.
We have the figures to prove what the process is currently doing in terms of processing submissions.
That said, the processing and approval of a submission is a partnership. It depends very much on the quality and amount of information that the manufacturer puts together to present its case, and then it depends very much on the efficiency and the rigour with which we review it. Not in every case is the slowness of the system due to inefficiencies in our process. If they aren't giving the information that we need in order to make the determination that the drug is safe and efficacious, then we continue to work with them.
That's a general comment on the system. We'll be delighted to respond to your request for a visit, and we'll be delighted to spend all the time you would like to explain the process and our performance standards.
I'll ask Dr. Franklin perhaps to....
Mr. Ménard: With a briefing.
Mr. Michols: We would be delighted. Anybody who is interested in us, we are interested in them.
The Chairman: Dr. Franklin.
Dr. Franklin: I have to express a certain amount of concern on the comments you're making with regard to 3TC. We have not yet received an application from the company, so that with -
[Translation]
Mr. Ménard: I have the file. This is serious, what's being said here. You say that neither the parent company nor Glaxo, in Laval, filed a request for follow-up to the approval with your section. Is that what you're saying?
[English]
Dr. Franklin: They have not filed their submission for approval of 3TC. They have filed a request for a priority review, which is not filing the submission.
The process for priority review is that the company makes a request and asks that they be given an expedited review, because not all products qualify for that. We have agreed to do that. The company has been informed. They had to agree that we could give you that information today, because under normal circumstances we're not at liberty to discuss filing of applications or the status of an application, and the company has not yet filed an application for 3TC.
[Translation]
Mr. Ménard: All this is being said in very technocratic jargon, with all due respect. I'm the MP for the riding next to the gay village in Montreal, I'm a member of the gay community and I live with an HIV positive person. What worries me beyond all these technocracies, is the situation where, because of government non-intervention, access to 3TC has been restricted.
We can keep on talking. Perhaps I didn't use the right terms and I'm sorry. That's why I want a briefing session. What can you tell us, as section manager, concerning the imminent availability of 3TC for HIV positive people? That's the point of my question. That's what I would like to understand.
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You make a subtle distinction between a priority request and a request for approval. Could you explain the difference and tell us what the steps are. That's what we want to understand.
I could have asked my question differently by saying: Why did Glaxo have to reduce the availability of 3TC for HIV positive people? That, concretely, is what concerns me. We went from 1,000 samples a week to 300. I thought that this availability was due to the emergency drug release program. Explain it to us in detail so that we understand once and for all.
[English]
The Chairman: I understand your question very well, Mr. Ménard.
I think Dr. Franklin's comments need to be heard again just to be sure that everyone understands the difference between a request for a priority and what happens after the acceptance of that request, which is the request for approval.
If you want to repeat that for Mr. Ménard very slowly, then we could be sure all the members will understand that little difference in procedures.
Dr. Franklin: I am pleased to try to explain what is a complicated process, and I was not trying to suggest that your information was intentionally incorrect.
There are several points at which a drug is available.
The drug can be available through the emergency drug release program, which means the drug is not eligible to be marketed in the country at that point in time. We have implemented that program to provide early access not just for AIDS patients but for patients with all kinds of diseases.
For a company or a patient, through the physician, to make a request for a drug at that stage has nothing to do with whether there's a submission in or whether the company has made an application to have the drug approved. The emergency drug release program operates outside of that. It's a completely separate process, and it's just a way of having access -
[Translation]
Mr. Ménard: The doctor calls. That's it?
[English]
Dr. Franklin: Yes. The doctor phones. We have to be sure that a physician is involved in this because in fact we have no information, during the very early stages of a drug, as to whether it works or whether it's safe. We do not have that information in our hands at that point in time.
In some cases, we have some information. In some cases, we have quite a bit of information. But you have to understand that the emergency drug release is at a very early stage of development of the drug, and the company has not made an application to the government at that point in time.
So the decision to release a drug is taken with a great deal of concern on our part. But we believe that if the drug is available anywhere else in the world a physician should be able to have access for a patient, and the program we have puts a lot of effort into making drugs available under those circumstances.
The emergency drug release program was really intentionally developed for a physician who wants to have the product for a particular patient. So it's a one-time release for one patient.
If we have, as we have in situations for AIDS, maybe a thousand patients who would like to have access to the drug, it becomes a bureaucratic nightmare for all of the calls in to have release of all these drugs on a one-by-one release. This is the way in which the regulations are set up. Because, as I have explained, we have very limited information, we feel there has to be at least some semblance of order in this.
What we try to do for AIDS drugs, or for any drugs needed by a lot of patients, is to compress those requests by putting the drug into what we call a compassionate use protocol.
[Translation]
Mr. Ménard: Just so that I understand correctly, let's take a down-to-earth example. Somebody who is HIV positive and needs 3TC goes to the L'Actuel clinic with Gervais-Fréchette, and Gervais-Fréchette, on his Hippocratic oath, is prepared to say that yes, this drug should be given to that person to relieve them.
I thought I'd understood that for access to drugs, it was the manufacturer who said: ``I'll make 1,000 samples available to people with HIV.'' You only approve the process, your department does not say to the manufacturer: ``There will be 1,000, 800 or 600.'' What do you make of the bureaucratic nightmare at that point?
The Chairman: If there are 1,000 people requesting it at the same time, it's one by one. That's the nightmare.
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[English]
Dr. Franklin: Exactly. The emergency drug release program is set up on a one-by-one basis. It's not set up for pre-registration marketing of a drug by a company. The process is set up to respond to what are considered to be emergency situations. The physician has to call to get a release for each patient and then contact the pharmaceutical company. The pharmaceutical company then makes the material available for that patient.
Mr. Michols: Or not.
Dr. Franklin: Or not. That's exactly correct. The pharmaceutical company has the responsibility to determine whether it wishes to release it or not for that particular patient. That's what the process is.
What we've tried to do to make the process or the situation faster so we don't have this one-at-a-time and all this type of release for it is to put this into what we call a ``compassionate use'' protocol. That means the company is then allowed to release the product in a different way. It doesn't have to come to us on a one-by-one basis.
The main function of that was to expedite that and to gather some information. As you well know, we're in the very early stages with these drugs. By putting it into a compassionate use protocol...there are certain requirements...very limited. We're asking to get whatever information we can, because that's critical information to assist in the decision whether or not the product actually then gets, subsequently to that, marketing when the company comes in.
[Translation]
Mr. Ménard: The officials are getting restless, Mr. Chairman. I think we will have to go and vote.
The Chairman: No, the bell has not started ringing yet. If people are willing to stay, we have a bit of time left.
Mr. Ménard: That is comforting given the urgency of being briefed on the Food and Drugs Act, access to emergency drugs and the approval process. It is very important.
Once a company has made a discovery which it believes may have a curative value, you say it is possible to have the product on the market in 360 days. What are the necessary stages? We were told that there are four clinical trials and that most companies do three.
When we talk about approvals, if I've understood correctly, we mean drugs that are to be marketed which have received your stamp of approval. How is it that the PMAC challenges your diligence? What stages are involved? Please respond generally.
I know that during briefings we go into a lot of detail. If, as a committee, we truly want there to be mandatory compassionate access, the Food and Drug Act will have to be amended, if I've understood correctly.
[English]
Mr. Michols: That's correct. We do not have the power under the Food and Drugs Act, and now its regulations, to force a manufacturer into releasing the drug. We simply react to their submission to market the drug.
Dr. Franklin has explained the emergency drug release program, which was basically a way for us to give physicians access to a drug that was not approved. The company would have to come to us to have approval to use the drug in a clinical trial situation. Dr. Franklin can go into more detail, but that could be at any of the phases within the clinical trial process, depending on what the company wanted to do.
Once the company has the results and has analysed all the data from its clinical trials and various other areas of research, it then puts together a dossier - and those dossiers can be huge, depending on what it is the company is asking for - and submits that to us. We screen that dossier to determine whether or not all the information is there on a general basis. Once we have accepted that dossier, our performance standards, which we have recently put into effect, say we will make a decision on the adequacy of that dossier within 360 days. That is competitive with any other drug regulation agency around the world.
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If the information is adequate, if it's all there, then that decision in the 360 days could be a notice of compliance. In other words, within 360 days, the company could have approval to market. If that dossier is not adequate for any number of reasons, there is a second step where we give the company an opportunity to complete the dossier, and then we have another performance standard set to do that second review, if you like, whereby we would review those portions of the dossier that were inadequate the first time around.
Any submission, according to our performance targets, ought to receive a definitive yes or no within 720 days - it's actually less than that; it's 680, or whatever. That, too, is competitive around the world.
The problem that the pharmaceutical associations have and the reason they are using some of the numbers they are using, which was what I was concerned with at the previous appearance, is that in the past we have not had the mechanism whereby we could say, enough, take this file away and do it properly. So while the company was rebuilding its dossier, the time was ticking away. There are some dossiers we've had sitting on our shelves for years - mostly months - the prime reason for the delay being that the company does not have its act together. That's where we take it.
So when we get blamed for the 2,000 days, or whatever, and in fact it turns out that 1,000 of those belong to the company, that's when we become concerned with the response.
[Translation]
Mr. Ménard: I would like to ask one last question, if I may, Mr. Chairman. Give us the opportunity to really meet with you to get to the bottom of these issues. When we met with the people of the Network, I learned that you only financed infrastructure. I think that things could be different at the political level, but it's not up to you to comment on that.
It is absurd that the National Strategy does not set aside money to fund research, but only infrastructure. I thought your services authorized clinical trials. For a manufacturer to be able to run a trial in your facilities, your service has to authorize it. You examine the research protocol, the impacts and a certain number of criteria. Is my reading of this correct?
[English]
Ms Stanley: You heard Dr. St. John earlier talk about the assistance they give in the Laboratory Centre for Disease Control to the clinical trials process, but I want Dr. Denis to respond, because the Medical Research Council does fund the clinical trials process. So it's not as if we've turned over this area totally to the pharmaceuticals. Dr. Denis.
[Translation]
Mr. Ménard: You've redeemed yourself, Madam Deputy Minister.
Dr. Denis: First of all, I would like to join some of my colleagues in inviting you to take advantage of the transparency of certain departments. I am pleased to invite you to attend an MRC-NHRDP committee where we assess applications that are presented as part of the MRC-NHRDP program on AIDS research. An observer such as you would be welcome. We would be pleased to have someone like you to observe the scientific assessment process, the difficulties involved and the value of the process itself.
I would also like to comment on the clinical trials. First of all, the MRC is involved in two ways. Firstly, the MRC contributes modestly to the Network for clinical trials on medications or drugs relating to AIDS. Secondly, I'd like to clarify the objective of this program. At the MRC, we have a program called University-Industry. The Counsel offers industries the opportunity to join forces with academics who are involved in AIDS research in order to advance clinical trials on AIDS.
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So whether it be during phase I, II, III or IV, the various drugs can be tested in various ways and MRC provides financial assistance so that these clinical trials progress more quickly. This helps the clinical trials progress more quickly and adds another scientific evaluation to the one that the manufacturer did with a view to undertaking an evaluation of the drug.
Mr. Ménard: I accept the invitation.
[English]
The Chairman: It's going to be over soon. The bell is calling the members to vote in 15 minutes.
First of all, I'd like to thank you very much for your visit this afternoon. It was very interesting.
I notice also your invitation, Mr. Michols, to share some information with the committee. We are going to send you a letter, and a letter probably to the health minister regarding this national forum. If we cannot participate, maybe at least we can get someone from the staff here to participate as an observer.
I have a last request. Would it be possible, Ms Stanley, for your department to provide to the members of this committee a diagram about all we discussed this afternoon, where it starts, when the medication comes, where it goes, to which department, and 100 days, 160 days, or 300 days...to try to get a diagram. I think it will help all the members to understand a little bit more.
Once again, thank you very much.
The meeting is adjourned.