Summary of Discussion
Science Advisory Board Meeting
November 14-15, 2000Help on accessing alternative formats, such as PDF, MP3 and WAV files, can be obtained in the alternate format help section 
Table of Contents
Day 1
Day 2
Day 1
In Attendance: Roberta Bondar, Yves Morin, Doug Elliott, Lynn McIntyre, Allan Ronald, Russ Graham, Karen Grant, Rodney Ouelette, Stuart Macleod, Michel Bergeron, Leslie Millin, Gabriel Plaa, Neena Chappell.
Ex Officio Members: David Dodge, Marie Fortier, Diane Gorman, Robert McMurtry
Secretariat: Kata Kitaljevich, Valerie Marshall
Opening Remarks
Roberta Bondar, Chair
The Chair welcomed members to the November meeting of the Science Advisory Board (SAB). She noted the change in how members received meeting materials from the Secretariat and asked for comments to be directed to the Secretariat. She requested in the future, board members start early on Day 1 of the meeting, allowing for time to cover all items on the agenda. She noted there had been requests from Health Canada employees to sit in on meetings as observers. She suggested one way of dealing with this was to allow observers to sit in on presentations, answer questions and then leave while the board had the opportunity to openly debate the issues. She asked the board members to think of other options to deal with this question. The Chair also informed the board that she had been requested to remain as Chair for one more meeting. She had agreed to do so and requested any members who were finishing their term consider staying on through the next meeting in February.
Health Canada: A Report
Dr. David Dodge
The Deputy Minister was welcomed to the board by the Chair. He emphasized how important the Board's work is for the department and how helpful it was to have some overall guidance from the Board. He thanked members for their time and effort. He updated members on the hiring of the Chief Scientist, saying by the end of the month there should be news on this front, adding he had been very impressed by the quality of the candidates.
With respect to CIHR, the Deputy noted the next CIHR Board meeting was the first week of December and said by that time most, if not all, of the scientific directors would be named. He stressed how important CIHR is to the department and how important it was to involve Health Canada scientists in the wider world of research. He said he would appreciate it if the Board would re-emphasis the importance the members attach to building links between Health Canada and CIHR.
One of the immediate issues for Health Canada is that of ethics and ethics boards. The structure already in place will have to change to keep pace and the Deputy has asked that a research ethics board be developed for Health Canada.
The Deputy spoke about the recent court decision with regard to some Health Canada scientists, noting the department has moved on the issues raised in the decision. The court found that the scientists had endeavoured on several occasions to have their concerns addressed internally without success. Where issues involve human health and safety, legitimate scientific voices need to debate and raise concerns within the department. There are two issues involved, he noted, the issue of process and the issue of culture. In the process area, the Deputy Minister believes the department has moved to address problems and work is ongoing in terms of improving the culture.
The Deputy also reported that two Deputy Ministers' Committees have been set up. One is looking at life science as an engine for economic and social development over the next 20 years. There is also an acknowledgement of the need to renew the government's scientific community. There are five government departments who have heavy science components. Canada will be facing big competitive pressures in order to renew science. Deputy Ministers will be looking at ways to work together on this problem, for example, in the water area, Environment, Fisheries, National Research and Health Canada could co-ordinate efforts so more can be done.
In conclusion, the Deputy thanked the Chair for agreeing to stay on and encouraged other members of the Board to remain into the new year to make sure there was continuity.
Discussion included the following comments:
- The importance of ethics accreditation was stressed, noting the United States has acted quickly on this issue and their accreditation standards would affect funding of Canadian researchers.
- The Deputy responded that the discussion was very useful given the importance of the issue. Health Canada is going to have to deal with this, noting the department would have to proceed under what authority it has under the Foods and Drug Act, adding if it is done right, then it becomes the "gold standard" for ethics boards across the board. The Deputy expects this to move forward within the next six months.
Recommendations:
- The Board applauds the initiative of Health Canada in beginning the process to set up a research ethics board for its own research.
- The Board urges and supports Health Canada in assuming a leadership position in the support of the accreditation and monitoring of research ethics boards across Canada.
Approval of September 2000 Meeting Report
Roberta Bondar, Chair
Board members with specific concerns on the wording of one section asked that area be corrected. The Report will be deemed approved when these changes are made.
Follow-Up Report on Therapeutic Products' Cost Recovery Evaluation and the Board's Drug Review Process Report
Doug Elliott, Leslie Millin
As part of its Drug Review Process Committee Report of February 2000, the SAB recommended the Minister "revisit cost recovery". The question posed of board members Doug Elliott and Leslie Millin was: Is the current "Phase IV" process of cost recovery review that is being undertaken by TPP meeting the concerns of the SAB?
In presenting his report, Doug Elliott said the answer was clearly no, the process was not meeting the concerns expressed earlier by the SAB. He suggested the current review process is incomplete in scope. It has not properly examined the negative impact of cost recovery on consumer confidence and how that might be ameliorated. The review fails to ask the fundamental question of the appropriateness of cost recovery in the regulatory setting. No one seems to be challenging Treasury Board's edicts about cost-recovery. In Doug Elliott's opinion, in a regulatory environment the government should be funding the lion's share of the costs to maintain public confidence.
Doug Elliott stated the concept underlying the Report, namely that it is for Treasury Board and not Health Canada to decide this impact question, was not a satisfactory response in the view of the presenters. Either Health Canada must examine this fundamental question itself or insist that Treasury Board do so. Merely investigating whether Health Canada is complying with Treasury Board's existing guidelines is avoiding the key question which is of concern to the Canadian public. Treasury Board is likely to be of the view that the impact on public confidence is a Health Canada issue.
The question is not just whether cost recovery is a wise policy in a regulatory environment, but whether there are ways of effectively maintaining public confidence by adjustments to any such cost recovery policy or otherwise. Leslie Millin concurred with Doug Elliott's remarks.
Discussion included the following comments:
- Measuring public confidence is difficult, but the general view is that the public is concerned about cost-recovery process. Industry is also concerned.
- It is important to look at private versus public benefit.
- There has not been a great deal of parliamentary debate on cost-recovery. What has happened is that cost recovery provides funds to departments but is not subject to parliamentary scrutiny because the funds are not taxes.
- Assistant Deputy Minister Diane Gorman invited Andy Butterfield, who was at the meeting as an observer to comment on the results of the October 2000 meeting on this issue. Mr. Butterfield noted that the action plan would be on the TPP website within two months. He added TPP was looking at doing more than what was included in the KPMG report.
Deputy Minister Dodge thanked the Board for their comments. He agreed the issue of the consumer view needed to be examined.
Recommendation:
- The Board recommends that Health Canada commission a study of the impact of cost-recovery activities on the confidence the Canadian public places on the quality, integrity and comprehensiveness of the scientific activities of the Therapeutic Products Programme.
- The Board recommends that, pending the outcome of such a study, Health Canada ensure that program resources derived from Parliamentary appropriations should at least match those derived from cost recovery for TPP programs.
- The Board recommends that the appropriateness of cost recovery in a regulatory environment be addressed in a broader context, by Health Canada, Treasury Board or both.
The Canadian Institutes of Health Research
Dr. Alan Bernstein
Dr. Bernstein told the Science Advisory Board he was extremely impressed with the quality of the names that came forward for positions of directors and scientific boards. In his presentation, he outlined the four pillars of research in CIHR: Biomedical, Clinical, Health Services and Health Systems; Health of Populations. Dr. Bernstein believed the most transformative impact of institutes is that it is the first time we will have an organization developing a set of strategic initiatives for the country to follow. Canada needs this discussion to ask far-ranging questions such as what should we be doing as a country about aboriginal health, congestive heart failure and vaccines?
Dr. Bernstein stressed the CIHR was not simply a funding agency, but a research agency. He suggested as a country, we have failed our research scientists. We know our English literature stars, but we should also know who is doing research. We know who Margaret Atwood is, but we don't know the recently deceased Michael Smith, a Nobel Laureate.
There are 13 CIHR institutes: Population and Public Health; Gender and Health; Nutrition, Metabolism and Diabetes; Musculoskeletal Health and Arthritis; Aboriginal Peoples' Health; Genetics; Cancer Research; Neurosciences, Mental Health and Addiction; Circulatory and Respiratory Health; Health Services and Policy Research; Infection and Immunity; Healthy Aging; Human Development, Child and Youth Health. The SAB was told there would be inter-institute relationships. The Institute Advisory Boards will provide a key link between institute and community with membership made up of researchers, voluntary sector organizations, patient groups, individual citizens and public/private sectors.
There are opportunities for links between CIHR and Health Canada, especially in the suggested CIHR Strategic Initiatives. Dr. Bernstein outlined the initiatives: National Initiative on Colorectal Canada Screening; Child Health/ Child Development; Infectious Diseases; Proteomics and Structural Biology; Aboriginal Health; Targeted Training and Capacity Building; National Databases; Determinants of Health.
There are ongoing discussions between CIHR and Health Canada on the parameters for the participation of Health Canada scientists in CIHR competitions.
Discussion included the following points:
- Health Canada is in a major recruitment mode because of the aging of its scientists. As CIHR is moving into capacity building, the needs of Health Canada could be considered.
- It is very important that Health Canada is involved in the CIHR process.
- There is a mentality that still exists that CIHR is just MRC with a different name.
- CIHR must ensure the Social Science community has a home as well.
- CIHR must make an effort to increase science capacity in research across the country.
- The research community is not mandated to respond to emergencies. Health Canada is. But money can be put on the table to encourage the research community to become involved.
- Communication is extremely important not only to involve the scientific community, but the Canadian public as well.
Recommendations:
- The Board recommends that Health Canada, through the Chief Scientist encourage the involvement of Health Canada scientists in research opportunities with the CIHR.
- The Board recommends that CIHR reach out to the scientific community and the Canadian public with the message that it is a research and granting agency (with greater emphasis on the research component).
- The Board recommends that Health Canada, in consultation with CIHR, set out concrete goals and objectives for a planned interrelationship and to make a progress report to the Board at its next meeting.
Emerging and Re-emerging Pathogens
Dr. Paul Gully
Recent years have been marked by the appearance of new infectious diseases and re-emergence of previously known diseases, which are threats to the health of Canadians. These threats present challenges to the Department as they require a rapid response by expert public health scientists to assess risk, to enable risk management, to ensure a national public health response and to provide support to provinces, territories and professionals.
The advent of West Nile virus in North America is the latest in this series of infectious disease threats. Others include Hantavirus Pulmonary Syndrome, Lyme Disease, E.coli 0157:H7, cyclosporiasis, changing trends in "old" diseases such as tuberculosis and related issues such as antimicrobial resistance and adverse attitudes to immunization. There are many factors or "drivers" behind this emergence.
Issues such as zoonotic diseases (those from animals), globalization, migration and increased travel, climate change, anti-microbial resistance, trend to resist vaccines all have, or could have a dramatic impact on the health care system and the health of Canadians.
The health care system, because of these threats, faces a need to change in terms of partnerships, a need for flexibility in programming and a strain on resources. As an example, the Walkerton outbreak used all of the investigative resources for the year. One case of multiple resistant TB could cost the health care system $500,000. The cost of West Nile to Health Canada this year was $500,000 and there has yet to be a confirmed case.
Discussion included the following points:
- There was a thorough debate on what should Health Canada's response be.What should the response be? What should our response be in international situations (ie Ebola)? How can Health Canada respond to everything?
- Funding is sometimes tied to specific issues: blood, food, Hepatitis C, with residual funds for dealing with new issues. Public health issues that rise to the federal level are either unique and need to be dealt with or are failures at the local level. Lack of public health capacity at the local level is the most essential thing for Canada.
Recommendations:
The Board does not feel that it has sufficient information at this time to make substantive recommendations. It would like additional information on the state of HC's preparedness, capacity and scientific expertise, particularly with respect to the potential impact of global warming and areas in which Health Canada can demonstrate leadership, to be presented at a future meeting.
Day 2
In Attendance: Roberta Bondar, Yves Morin, Lynn McIntyre, Allan Ronald, Russ Graham, Karen Grant, Rodney Ouellette, Gabriel Plaa, Neena Chappell, Stuart McLeod, Leslie Millin.
Ex Officio: Diane Gorman
Secretariat: Kata Kitaljevich, Valerie Marshall
Council of Science and Technology Advisors Project: Phase II
Dr. Yves Morin
The CSTA is seeking perspectives from the members of the Health Canada Science Advisory Board on the operation and impact of Science Advisory Boards. A list of key questions has been developed by the CSTA to guide these consultations. In the course of the CSTA's work, it has become apparent to members that the SABs are mandated and operate very differently from one another. In order to maximize and capitalize on the contributions of SABs, the CSTA has launched a best practices examination of the mandates and operating parameters of SABs
Progress Report on the Recommendations of the Peer Review Committee on Endocrine Disruptors
Rod Raphael, Michael Wade
In April, 2000, the Medical Research Council of Canada, at the request of Health Canada, assembled an external panel of experts who carried out a peer review of the HPB scientific activities which addressed the human health consequences of exposure to endocrine disrupting substances. This review was conducted to evaluate, not only the quality of science conducted within the Health Protection Branch, but also the degree to which these activities are coordinated, how science is managed and how priorities within the issue are determined.
This presentation to SAB noted progress made on implementing the recommendations of the Review Panel and to provide advice on further development of a Departmental strategy on endocrine disruptors.
Discussion included the following points:
- The research group is very well represented in male reproductive science, but not female. The recruitment in this area is weak.
- There is some reticence in applying for money from CIHR because the people on the review structure are from the MRC.
- A vibrant program is what we want at Health Canada. We really need a "seize the day" mentality and it has to be built on science collaborations.
- SAB would prefer to see this group aggressively go after funding for research.
Recommendations:
- The Board is strongly supportive of the Endocrine Disrupting Substances Working Group and the work it is conducting. However, the Board feels that some issues requiring decisions are not being raised to the appropriate level for decision-making, and this concern must be addressed.
- The Board would like a strategic plan for the endocrine research program, complete with hiring and building capacity elements, to be presented to the Board in the new year.
Water Quality and Health Canada Responsibilities
Dr. Paul Sockettt, Dr. Mike Shannon, Rod Raphael
Water quality is a key determinant of population health; access to clean, safe water is essential to maintaining good health. In Canada, the responsibility for water quality is shared between the federal, provincial, territorial, municipal and local governments, industry, and non-governmental organizations. In general, the provincial and territorial governments are responsible for ensuring safe drinking water is provided on their lands. Similarly, the federal government is responsible for ensuring safe drinking water is provided within its territory, as well as on First Nations' lands.
The federal government has traditionally provided scientific and technical support, expertise, and advice to all jurisdictions within Canada (as well as internationally), on request. This support includes conducting health risk assessments of microbiological pathogens and chemical and radiological contaminants found in Canadian drinking water supplies. These assessments form the basis of the Guidelines for Canadian Drinking Water Quality. These guidelines are in turn used as the basis for enforceable provincial and territorial guidelines, objectives, and regulations. The department provides emergency advice in spill situations and will identify and respond to disease outbreaks upon request by a province or for major outbreaks of national scope.
Federal responsibilities reside with: Health Canada (including the Pest Management Regulatory Agency); Environment Canada; Indian and Northern Affairs; Agriculture and Agri-Foods (including Canadian Food Inspection Agency); Fisheries and Oceans; Natural Resources; Industry; Foreign Affairs and International Trade; and Public Works. There are more than 20 Federal Acts and regulations regarding water. Many of the federal responsibilities and activities related to water are shared with the provinces/territories. The many constitutional powers over water highlights the multi-jurisdictional complexity of responsibilities for drinking water.
In light of the recent events related to safety of drinking water, the federal government is reviewing its responsibilities and considering the development of a national water strategy, in collaboration with the provinces & territories, to protect Canadian waters and the health of Canadians.
Water quality and health is no longer a Third World issue. The challenges to be met in Canada put pressure on capacity of Health Canada to respond.
Discussion included the following points:
- We need one over-riding act on safe drinking water.
- Water conservation is also an issue which reflects on the whole issue of water supply.
- Comparison to guidelines in other countries may be beneficial, but Canada has more bodies of water than other countries.
- On guidelines, we compare closely. What may be different is on contaminant by contaminant closely.
- Prevention is also an important element in the water quality issue in terms of effluent, chlorination and others.
- Guidelines on boiling water are set by the Medical Officers of Health and the definition of boiling is confusing to the public. The Disinfection Committee is looking at the whole science of prevention, but won't report back for about 18 months.
- Canada may need a Water Czar to provide an overview.
- There is a human resource issue in the sciences, but in this case, the epidemiologists are available.
- Safe water is the foundation of public health and long term strategies are important.
Recommendations:
Reliable access to safe water is the cornerstone of public health. Pressures upon the water supply are increasing in all parts of Canada, and will continue to increase. The Federal Government and Health Canada should be uniquely positioned to direct policy and support in this context.
SAB recommends that the Minister accept that efforts to safeguard the water supply should be a departmental priority and that Health Canada management should be directed to prepare a long-term, national strategy to address this priority. Such a strategy will of course require consideration of interdepartmental and intergovernmental elements.
In the immediate term, steps should be taken to strengthen the Health Canada capacity to monitor and react promptly to developments that impact upon this priority.
SAB has noted that Health Canada's present capacity, to provide timely advice to public authorities and the public is described a "critically low".
Office of Consumer and Public Involvement
Murielle Brazeau
In March 1999, the Science Advisory Board discussed establishment of OCAPI and the specific roles it would play and activities it would undertake. OCAPI's main objectives were "to provide a focal point within Health Canada for designing, coordinating and implementing initiatives to facilitate citizen engagement in the development of, and improve public awareness and understanding of the Government of Canada's policies, programs and decisions in health protection."
In May 1999, Health Canada announced OCAPI's establishment and the department began setting it up. Public involvement, outreach and communications are now well under way. Other initiatives - like regional issues, research and surveillance - are in development.
OCAPI functions have been strengthened by:
- Increasing responsibility and accountability, with the appointment of a director general solely responsible for the functions of OCAPI;
- Embarking on the public involvement process - providing expert advice to the Health Products and Food directorates on specific public involvement initiatives dealing with natural health products, xenotransplantation, prions, biosafety protocol and food irradiation, as well as work now under way with the directorates to plan other public involvement initiatives;
- Leading a major public involvement initiative on key branch-wide issues planned for winter 2001;
- Building relationships with individuals and groups representing them, through an ongoing program of outreach beginning with sectors not usually consulted (multicultural, interfaith, consumer groups, women's health etc.); and
- Increasing OCAPI's public involvement and communications capacity, as well as moving to fill key positions, to ensure that the organization can provide Canadians with "more information about health protection issues and more involvement in the development of policies and programs designed to protect their health and safety."
OCAPI's future activities include:
- External advisory committee
- Upcoming meetings with individuals and stakeholders
- Training of departmental speakers
- Ongoing website improvements
The major challenges for OCAPI are:
- Indentification and involvement of consumers
- Ensuring more equality between consumers and interest groups
- Increasing recognition of the value of public input
- Increase public confidence in branch-related issues
Discussion included the following comments:
- OCAPI could play a role in identifying someone from the public and training them to deal more effectively with science issues to participate in a body like the Science Advisory Board.
- A Speaker's Bureau is well intended, but does not respond to core objectives.
- There are different ways of consulting the public and research into how different communities approach the process could help OCAPI in learning how to do so effectively.
- A strategy based on the web is not the ideal way to reach all Canadians. There is a segment of the public who are not connected.
Recommendation:
SAB applauds the efforts of OCAPI in presenting a coherent plan to the Board, however, it is concerned that much of OCAPI's strategy is based on the Internet, a tool not always readily or uniformly available to small groups or individual concerned citizens. Consideration must also be given to additional methodologies appropriate reach such groups and citizens, including those with special needs.
Business Arising from Meeting
Dr. Roberta Bondar
The Chair asked Board members if the kind and amount of information received before the meeting was sufficient to their needs. Board members agreed the format suited them better than previous formats.
The next meeting in February will include an evaluation based on members comments which will be made before the next meeting and compiled by the Secretariat.
The Chair wished Board members the best of the holiday season.
The meeting adjourned at 3:30 p.m.
|
