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Proceedings - Science Advisory Board (SAB)

May 4-5, 2011 Meeting

Table of Contents

Executive Summary

The Science Advisory Board met on May 4 and 5, 2011 in Ottawa, Ontario. Renaldo Battista chaired the meeting with 13 of the Science Advisory Board members present.

Presentations

Update on Health Products and Food Branch's Paediatric Initiative: David Clapin, Health Products and Food Branch, Health Canada - the Science Advisory Board endorsed Health Canada's sponsorship of "Mind the Gap", a study proposal submitted to the Council of Canadian Academies. The Board wants to have an update on the Department's involvement with the United States National Children Cohort Study for the next meeting. The Public Health Agency of Canada will bring Fetal Alcohol Syndrome Disorder issue and the work being done, to the Science Advisory Board in the future.

Health Canada's Strategic Science Needs: Pierre Charest, Strategic Policy Branch, Health Canada; Public Health Agency of Canada's Science and Research Strategic Plan: Frank Plummer, Public Health Agency of Canada
The Board felt that the work done was in line with stated mandates, however, they found that the science around the sustainability of the Health Care system was absent. It was suggested that a Health Canada "top priority" be used in a case study to ascertain what types of internal and external expertise/resources are needed. Given the current fiscal situation, it is important that Health Canada, the Public Health Agency of Canada and the Canadian Institutes of Health Research improve the way they work together to access new science for decision-making. The Board would be well placed and pleased to assist in finding linkages to communication mechanisms/channels.

Performance Measurement for the Science Advisory Board: Laird Roe, Strategic Policy Branch, Health Canada - The Board members will review the deck and send feedback on areas to be measured and indicators to the Science Advisory Board Secretariat. The Science Advisory Board Secretariat will look at how other Boards' performance is measured, i.e., Canadian Agency for Drugs and Technologies in Health. There will be follow up on this topic before the next meeting in November.

Science & Technology Foresight: Leah Soroka, Strategic Policy Branch, Health Canada - The Department needs to look at how other jurisdictions, such as Finland and the United States (i.e., Phil Sharp at the Massachusetts Institute for Technology) approach the issue of Foresight. It was acknowledged that Foresight activities are needed to merge systems dynamics and broaden perspectives to better integrate technology with other trends and drivers (i.e., population health). The Science Advisory Board would like to see a business plan for the Foresight Initiative presented at the next meeting.

Antimicrobial Resistance: Rainer Engelhardt, Public Health Agency of Canada - Health Canada and the Public Health Agency of Canada need to look at the cohesiveness of the Acts and Regulations that deal with the myriad of different products that contribute to Antimicrobial Resistance. A more robust public awareness campaign would warn consumers of the risks, and give them precautions they can take to avoid contributing to this global health problem. The Science Advisory Board will provide comments on the Action Plan that is due out in mid summer.

Activities of the Drug Safety Effectiveness Network: Robert Peterson, the Canadian Institutes for Health Research - This was presented as an information item. There was a very informative discussion and the Board will follow up once the performance evaluation of the Drug Safety Effectiveness Network is completed.

Health Technology Management: Patrick Morin, Strategic Policy Branch, Health Canada - although the Board was engaged in the topic, they felt that they needed more basic information and context before they could provide truly valuable advice. They would like to have this topic brought back to the Board with the participation of Brian O'Rourke, Chief Executive Officer of the Canadian Agency for Drugs and Technology in Health.

Action items/Next steps

The Science Advisory Board was very engaged in discussing the issues surrounding the Department's Regulatory Renewal process as it touches many of the topics presented at the meeting. It was suggested that the Board's expertise could be used to assist in this work. The Science Advisory Board Secretariat will draft a memo to the Deputy Minister to that effect. On the subject of membership, the Deputy Minister's request to have an official from the United States Food and Drug Administration to fill one of the three vacant positions will be actioned with the help of the Science Advisory Board.

Potential agenda items for November meeting:

  • Follow-up on items from May 2011 meeting:
    • A business plan for the Science and Technology Foresight Initiative
    • Case study on one Health Canada top priority science need, outlining scenarios in accessing in-house and external science expertise
    • Performance Measurement Indicators for the Science Advisory Board
    • A comprehensive briefing on paediatric issues from Health Canada and the Public Health Agency of Canada, i.e., Fetal Alcohol Syndrome Disorder
    • Comments on the performance evaluation of the Drug Safety Effectiveness Network
  • Barriers to clinical research with humans in Canada
    • Research Ethics Board Standards
    • Scientific Integrity
  • Health Care sustainability research at Health Canada
  • Nanotechnology
  • The regulation and monitoring of Natural Health Products / Non-traditional therapies
  • New technologies - personalized medicine; exposure to pesticides: Pest Management Regulatory Agency's Integrated Toxicology Testing report - Summer of 2010
  • Scientific literacy in Canada
  • Re-use of single use medical devices

Attendance

Science Advisory Board (SAB) Members

  • Present
    • Renaldo Battista
    • Lorne Tyrrell
    • Annalee Yassi
    • Susan Kennedy
    • Marie-Élise Parent
    • Yola Moride
    • Lori Sheremeta
    • Jacques Simard
    • Chris Loomis
    • John O'Neil
    • Renee Lyons
    • Stephen Bornstein
    • Claire Franklin
  • Regrets
    • Jack Gauldie
    • Ahmed El-Sohemy

Ex-officio Members

  • Present
    • Glenda Yeates, Deputy Minister
    • Abby Hoffman, SPB
    • Pierre Charest, HC
    • Frank Plummer, PHAC
    • Rainer Engelhardt, PHAC
    • Ken Scott, PHAC
    • Robert Peterson, CIHR
    • Janet Storch, Research Ethics Board
  • Alternates
    • David Clapin, HPFB
    • Marie-Anne Bradford, CFOB
    • Peter Chan, PMRA
    • Jean Tremblay, RAPB
  • Invited Participants/Presenters
    • Leah Soroka, SPB
    • Nelson Millar, SPB
    • Jean Pruneau, SPB
    • Patrick Morin, SPB
  • SAB Secretariat - HC
    • Laird Roe
    • Jean Sharp
    • Niyi Lawuyi
  • Observers
    • Ken Mcallister, FNIHB
    • Lori Engler-Todd, SPB
    • Annie Bronsard, SPB
    • Louise Bouchard, SPB
    • Manisha Mehrotra, HPFB
  • Regrets
    • Health Canada
      • Anne Marie Robinson, Associate DM
      • Anne Lamar, PACCB
      • Kin Choi, CSB
      • Germain Tremblay, CFOB
      • Paul Glover, HPFB
      • Hilary Geller, HECSB
      • Michel Doré, RAPB
      • Jamie Tibbetts, CFOB
      • Richard Aucoin, PMRA
      • Michel Roy, FNIHB
    • PHAC
      • David Butler-Jones, CPHO
      • Kathryn Howard, PHAC
      • Jane Billings, PHAC
    • CIHR
      • Alain Beaudet, CIHR

Key to Acronyms

HC
Health Canada
RAPB
Regions and Programs Branch
CFOB
Chief Financial Officer Branch
HPFB
Health Products and Food Branch
PACCB
Public Affairs, Consultation and Communications Branch
PMRA
Pest Management Regulatory Agency
HECSB
Healthy Environments and Consumer Safety Branch
FNIHB
First Nations and Inuit Health Branch
SPB
Strategic Policy Branch
CSB
Corporate Services Branch
PHAC
Public Health Agency of Canada
IDPCB
Infectious Disease Prevention and Control Branch
EMCA
Emergency Management and Corporate Affairs
CIHR
Canadian Institutes of Health Research

Proceedings

Day 1, Wednesday, May 4, 2011

1. Preliminary Matters

Opening / welcoming remarks were provided by Renaldo Battista along with introductions of Board Members, ex officios, invited guests and the Science Advisory Board Secretariat. Two new members, Marie-Élise Parent and Yola Moride, were welcomed to the Board.

2. Remarks from Abby Hoffman, Acting Assistant Deputy Minister, Strategic Policy Branch, Health Canada

Abby Hoffman provided the Science Advisory Board with an update on some of the notable changes in the Strategic Policy Branch that have occurred since the Science Advisory Board meeting in November 2010. The departure of Karen Dodds to a new position at Environment Canada raised concerns around the lack of a "Science Champion" for the Department (Pierre Charest, Director General, Science Policy Directorate, is acting as Science Champion to the Department).

The Science Advisory Board was a key proponent in the creation of the Office of the Chief Scientist (now the Science Policy Directorate) and feels that it is very important that the Assistant Deputy Minister of Strategic Policy Branch have a strong science background. Abby noted that Strategic Policy Branch brings together the fields of social science and health science to guide policy-making. The role of the Science Advisory Board is to view issues in terms of the policy implications as well as the science focus and help find a link between the two.

The Science Policy Directorate is currently undergoing a review to ensure that its work provides the best value for the Department. Over the past year, there have been several new Assistant Deputy Ministers (ADMs) appointed. Some of them are new to the Department, and some are from within Health Canada. It is essential that all ADMs are fully engaged with the Science Advisory Board and understand the importance and benefits of bringing their issues forward for advice.

3. Opening remarks from Glenda Yeates, Deputy Minister, Health Canada

The Deputy Minister firmly believes that Science Advisory Board's advice is having an impact on files such as human toxicology, the Chemicals Management Plan, and the Department's Science Priorities. Among her main concerns are: accessing the critical science that Health Canada needs to maintain its role as a regulator in this fiscal climate, dealing with emerging health issues; and keeping up with the growing volume of work while protecting Canadians from health risks.

She stated that although these are the challenges that we face, they can also be seen as opportunities to forge partnerships with other groups and organizations to provide Canadians with the best science-based health advice available.

The Deputy Minister also covered:

  • The Department's fiscal situation and challenges facing the federal government;
  • Health Canada's role in radiation monitoring in the wake of the earthquake and nuclear power plant situation in Japan; and
  • Strengthening the delivery of health services to First Nations and Inuit communities.
Discussion
  • The Science Advisory Board expressed concern over the low level of Canadians' science literacy, in particular regarding the recent Japanese radiation issue, and what challenges can arise when communicating potential risks to the public. The utility of Health Canada's Web site was discussed and the Science Advisory Board was informed that changes are being made to update and streamline the site.
  • The Science Advisory Board requested a heads-up when Health Canada is bringing in potentially controversial changes to policies and regulations. The Deputy Minister noted that there are issues on which the Board can be provided with advance warning and instances where that is just not possible;
  • The Science Advisory Board's role in the context of the end of the Health Accord in 2014 was discussed.
  • Health Canada's policy on cost recovery fees being charged to product sponsors was explained to the Science Advisory Board. These fees do not compromise the integrity of the regulatory process, rather they allow the Department to hire more reviewers and speed up the process.
  • The work being done to harmonize Health Canada's drug review process with other jurisdictions was discussed. The Deputy Minister agreed that the Department needs to maximize processes to achieve cost savings, but not compromise values to do so.

4. Opening remarks from Frank Plummer, Chief Scientific Officer - Public Health Agency of Canada

The Public Health Agency of Canada was created seven years ago as a result of challenges facing the federal government in its role to detect and address public health issues, in particular, chronic and infectious diseases. A review is currently being conducted to ascertain whether or not the Agency is focusing on the right activities. The Public Health Agency of Canada is developing a strategic plan with policy priorities focused on a tuberculosis strategy, the One Health initiative, antimicrobial resistance, and obesity. They are also working on the Multiple Sclerosis/Liberation Procedure file with the Canadian Institutes for Health Research and Health Canada.

The Public Health Agency of Canada is focusing on:

  • Collaborating with the United States Centers for Disease Control on cholera. This work is capitalizing on the Public Health Agency of Canada's expertise in bioinformatics that will advise Canadians on how to protect their health when travelling to affected countries;
  • Working with Health Canada, the Canadian Food Inspection Agency, and authorities in certain Canadian provinces to actively investigate an outbreak of E.coli in walnuts;
  • Security and counterterrorism activities related to chemical, biological, radiological and nuclear events, specific emergency management issues and general health preparedness and response information; and
  • Building and renovating laboratories in Winnipeg to expand capabilities in the shipping and receiving of packages and to develop advanced laboratory testing capabilities.

5. Update on the Paediatrics Initiative - David Clapin, Branch Science Advisor, Health Products and Food Branch, Health Canada

The Board was asked about the science needed to support the proper use of medications in children. Children are often treated with health products developed and tested only on adults. As a result, many of the products may not have sufficient information on the label to guide their proper use in this demographic. Key issues of food safety and nutrition relevant to the paediatric population were introduced. Comments were also sought on Health Canada's proposal called Mind the Gap (an assessment of the state of the science of children's medication) submitted to the Council of Canadian Academies.

Discussion

Health Canada's participation in the American National Longitudinal Survey of Youth-Child (NLSY) Cohort (1988 - 2006) was discussed. It was stated that Health Canada (Healthy Environments and Consumer Safety Branch) commented on some initial aspects of the study's design, namely on the maternal infant study on environmental factors, but since then has not been active on this file.

The use of foreign regulatory evidence was discussed as a way to mitigate the lack of data. For all pharmaceuticals, there is a preponderance of "foreign" evidence in support of regulation. There is some late Phase 3 testing being done but this is in essence an early market entry before registration. Pharmaceutical and medical devices registration is harmonized and the process was started in 1990 through the International Conference on Harmonisation, at which Canada is an observer.

When asked about children's nutrition and junk food availability in schools, Dr. Plummer explained that this issue is complex and cross-jurisdictional. The Public Health Agency of Canada has launched a strategy on sodium reduction and healthy food choices that will affect this specific age group.

Health Canada has a program of active Adverse Drug Reactions surveillance that has inherent limitations with mixed results for the paediatric population. Health Canada is aware of these issues and is committed to further investigation.

It was stated that it would be helpful for the Science Advisory Board to get a clearer picture of what is going on in the Health Portfolio around child-centred issues and where it is tied together. This is especially important when dealing with food safety, nutrition and medication.

Summary Advice
  • The Science Advisory Board endorsed Health Canada's sponsorship of "Mind the Gap" Its aim is to address key science challenges that may be limiting drug manufacturer's ability to develop therapies designed for use in Canadian children which the regulator could evaluate for market approval.
  • For the November 2011 meeting, the Science Advisory Board requested a more comprehensive briefing from Health Canada and the Public Health Agency of Canada on paediatric issues and an update on the Department's involvement with the American National Longitudinal Survey of Youth-Child Cohort (1988 - 2006). The Public Health Agency of Canada will bring the issue of Fetal Alcohol Syndrome Disorder to the Science Advisory Board agenda in the future; and
  • The Board would like to complement the work being done by the Paediatric Expert Advisory Committee on Health Products and Food. The Science Advisory Board could provide advice on the larger issues, i.e., environmental factors.

Action items: The Science Advisory Board Secretariat will make the document "Mind the Gap" available to the Science Advisory Board.

6. Health Canada's Strategic Science Needs - Pierre Charest, Director General, Science Policy Directorate, Health Canada

Setting science priorities is a key component of the Health Canada Science Plan. The development phase of this initiative has now been completed. The final document Health Canada Strategic Science Needs 2011-2016: Guidance Document presents the broad range of science needs for the Department. From the 33 strategic science needs, seven top tier priorities emerged that must be addressed on a more urgent basis. They focus mainly on emerging technologies and the health of First Nations and Inuit peoples and vulnerable populations.

Health Canada sought advice on the implementation of its top-tier strategic science knowledge needs identified as part of the Science Plan's Setting Health Canada Science Priorities initiative.

Discussion

The Science Advisory Board found that the document appropriately identifies science priorities related to the regulatory mandate of the department focusing on natural / biomedical sciences. As pointed out at the last Science Advisory Board meeting, the area of science around the sustainability of the Health Care system is absent.

The discussion centred on the issue of defining what is science at Health Canada. Apart from the delivery of health services to First Nations and Inuit communities, Health Canada is not in the health services business. Leaving health care sustainability out of the document leaves a gap; however, this area has not been identified as a priority, as it is important for a very small policy audience in the Department.

The question of whether or not community-based research could be included was discussed, as well as the issue of the lack of support for discovery science activities. The discussion centred on how to access the necessary science, create synergies and divide responsibilities between Health Canada, the Public Health Agency of Canada, and the Canadian Institutes for Health Research.

The Board found that these exercises were in line with the philosophy illustrated by the Deputy Minister's remarks given at this meeting.

7. The Public Health Agency of Canada's Science and Research Strategic Plan - Frank Plummer, Chief Scientific Officer

The Public Health Agency of Canada Science and Research Strategic Plan is an internal document developed to bring cohesion and clarity to the Public Health Agency of Canada's future science and research directions over the next five years. Because science and research are at the heart of the Public Health Agency of Canada's activities, and touch the work of all Agency employees, internal consultations will be undertaken to aid in the development of the Plan. Their views on the organization's science and research strengths, challenges, and priorities are fundamental to the development of the Plan.

Following completion of the Science and Research Strategic Plan in the summer of 2011, an implementation plan will be developed. The Science Advisory Board will have the opportunity to discuss the components of this stage at a future meeting.

Discussion

The general perception is that the strategic planning exercises at Health Canada and the Public Health Agency of Canada are at different stages. As Health Canada has done with its Strategic Science Needs exercise, the Public Health Agency of Canada should create a mechanism to decide what science activities need to be undertaken to fulfill their mandate.

For Health Canada, now that the priorities have been identified, the question is "how to determine what science is done internally and what should be accessed externally?". It was acknowledged that Health Canada performs certain science activities very well, such as regulatory duties, and rapid response to health issues such as radiation concerns from the Japanese earthquake and nuclear power plant damage; and the challenge will be to access the science knowledge that is not available in-house.

Summary Advice for Health Canada and the Public Health Agency of Canada
  • Given the current fiscal situation, it is important for Health Canada, the Public Health Agency of Canada and the Canadian Institutes of Health Research to work better together to access science knowledge to aid in decision-making. The Science Advisory Board can assist in finding linkages with regards to communication mechanisms and channels;
  • Health Canada needs to find functional links to research outside of the Department outside Ontario and Quebec where a bulk of the work is carried out. Health Canada needs to look to other provincial organizations and national networks for expertise;
  • The Science Advisory Board recommended that Health Canada start with one top priority science need and work up a case study using the two scenarios of in-house and external science expertise. This exercise will provide a pathway to guide the implementation of this initiative. Health Canada will present this item at the next Science Advisory Board meeting; and
  • Health Canada and the Public Health Agency of Canada need to develop and maintain international collaborations by allowing officials to travel, thereby fostering networking and knowledge transfer.

8. Performance Measurement Tools for the Science Advisory Board - Laird Roe, Director, Policy, Planning and Coordination Division, Science Policy Directorate, Health Canada

At the last meeting, in November 2010, there was a discussion on how to measure the importance of the Board's advice to Health Canada and the Public Health Agency of Canada and what indicators should be used. It is important to look at how the Department is using the Science Advisory Board and its advice and what issues are not being brought before the Science Advisory Board. This will give the Science Advisory Board a better idea of where their advice fits into the Department and the Public Health Agency of Canada's decision-making process, and in turn improve the efficacy, efficiency, and satisfaction of the Board.

Discussion

The Science Advisory Board was very engaged in finding appropriate ways to measure the impact of their advice to the Department and the Public Health Agency of Canada. The discussion included ways to improve the format of the meetings to allow a more fulsome contextual understanding of the topics being presented.

The question was asked "How does the Science Advisory Board see itself influencing government direction?" The Science Advisory Board would like to see how its advice affects health policy and health systems' sustainability, not just the management of science within Health Canada and the Public Health Agency of Canada. The Board would like to advise on high level science related to the health of Canadians.

For the next meeting it was agreed that a board member will be identified for each forward agenda item and will be responsible as lead discussant to provide a more in-depth view. The Science Advisory Board would like to have more input into what issues are brought before them.

Summary Advice
  • The Board members will review the presentation and send indicators and feedback on areas to be measured to the Science Advisory Board Secretariat by mid-July, 2011;
  • The Science Advisory Board Secretariat will look at how other Boards' performance is measured, i.e., Canadian Agency for Drugs and Technologies in Health; and
  • There will be a discussion at the next meeting on the nature and role of the Science Advisory Board's advice, not only on policy and management issues, but also on the science that Health Canada and the Public Health Agency of Canada uses in its decision-making.

9. Science & Technology Foresight - Leah Soroka, Director, Foresight and Science Promotion Division, Science Policy Directorate, Health Canada

Health Canada's Foresight Initiative was designed to anticipate trends, challenges and opportunities that inform present day decision-making to improve the health of Canadians. The presentation on this subject given to the Science Advisory Board at the last meeting focused on how new trajectories of Science & Technology could impact health outcomes. This presentation gave the results of this investigation. Also provided at the same time were the Science & Technology Foresight Insights Brochure and the Strategic Planning Reference Guide, which aim to aid in strategic long-term planning in the Department.

The Science Advisory Board was asked to provide their advice on how these findings could be best applied to the health sector.

Discussion

The Board was interested in knowing what forward looking trends are important for Health Canada and the discussion centred around the practicality of applying this Foresight concept, given how Health Canada functions; how to apply it to the health system; and how can these new trends in Science & Technology renew how Health Canada operates.

Some members felt that Health Canada's approach to Foresight is refreshing and are supportive. Others do not agree and feel that this direction is not adding value and does not take a deep enough look at how science and technology influences the real work being done at Health Canada. Foresight activities are needed to bring together systems dynamics and broaden perspectives, and better integrate technology with other trends and drivers (i.e., population health). The challenge is to apply these technologies within Canada's Health System.

Summary Advice
  • The Science Advisory Board advised Health Canada to look at how other jurisdictions, such as Finland, handle foresight; and investigate work being done by Phil Sharp at the Massachusetts Institute of Technology;
  • The Science Advisory Board would like to see a business plan for the Foresight Initiative presented at the next meeting.

Day 2, Thursday, May 5, 2011

10. Antimicrobial Resistance - Applying a One Health Perspective - Rainer Engelhardt, Assistant Deputy Minister, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada

For over a decade, the World Health Organization has been calling Antimicrobial Resistance one of the most serious global threats to the prevention and treatment of infectious disease. Developing a coordinated approach to address this issue has been a difficult task due to the complex pathway by which Antimicrobial Resistance emerges and spreads as a result of human, animal and environmental factors.

In November 2010, the Board was introduced to the Public Health Agency of Canada's One Health concept which provides an effective strategy to overcome the current challenges in coordinating action on Antimicrobial Resistance and promotes the concept of antimicrobials as a non-renewable resource. This integrated strategy builds support for the broad application of antimicrobial stewardship strategies.

The expertise of the Board was sought to validate the scientific rigour of these concepts, as well as to evaluate whether these ideas will resonate with a diverse range of audiences. The Public Health Agency of Canada also sought advice and recommendations regarding other potential strategies to address Antimicrobial Resistance, such as, engaging the pharmaceutical industry in its prevention.

Discussion

It was noted that antimicrobial resistance is a concern not just at the point of care but that it affects every aspect of our lives. From the legislative perspective, Health Canada is well placed to deal with this problem. One of the challenges in confronting this public health issue is that antimicrobials are regulated in several different Branches under more than one Act. The public may be exposed to antimicrobials through many different sources (e.g., prescriptions, hard surface disinfectants, clothing, and veterinary drugs) as well as through global travel.

The Board agreed that the low level of science literacy in Canada means that often public health crises get turned into "junk information" leading to misinformation and sometimes panic. There needs to be a mechanism that allows Health Canada and the Public Health Agency of Canada to inform journalists on the correct science that will convey the right messages to the public. Passive information via Web sites is not effective enough. The United States Centers for Disease Control has an internship program for journalists that "embeds" them within the agency where they learn first hand how to better report the facts. In Canada there is the Massey Fellows Program at the University of Toronto where journalists may study for a year to gain exposure to subjects of their choice.

It was noted that pharmaceutical companies are not developing new antibiotics because they become ineffective quicker and are not on the market long enough to make the profit necessary to cover the development costs.

The Public Health Agency of Canada is organizing the inter-departmental effort to identify assets, capacity, gaps, early risk assessments, and populations at risk and at the end of this year will be requesting funding for this coordinated approach.

Summary Advice
  • Health Canada and the Public Health Agency of Canada need to focus on the cumulative effect that antibiotic use has on the health of Canadians. Antimicrobial products are regulated through different regulatory acts and the Science Advisory Board recommended that Health Canada and the Public Health Agency of Canada look at their cohesiveness. It is critical that there be good interaction on this issue between the various Branches in Health Canada and the Public Health Agency of Canada;
  • Reducing the need for antimicrobials should be considered through the better education of physicians (i.e., not "treating" viruses with antibiotics); a reduction in the use of antimicrobials in consumer products, and different animal husbandry practices;
  • There needs to be a more robust public awareness campaign to warn Canadians of the risks in the overuse of antimicrobials and instruct them on what precautions they can take. The media needs to be better educated on the facts and enlisted to help in this issue;
  • Health Canada and the Public Health Agency of Canada should look to other jurisdictions for tools and methods to fight antimicrobial resistance (i.e., in the Netherlands there is a quarantine period for pet owning patients before they enter the hospital for scheduled surgery); and
  • The Science Advisory Board will comment on the Action Plan that is due out in mid summer 2011.

11. Briefing on the Activities of the Drug Safety Effectiveness Network - Robert Peterson, Executive Director of the DSEN, Canadian Institutes of Health Research

The Drug Safety and Effectiveness Network has been established to increase the availability of evidence on post-market safety and the effectiveness of drugs to regulators, provincial/territorial authorities, policy-makers, health care providers and patients; and to increase capacity within Canada to undertake high-quality research in this area.

Discussion

This presentation was very well received. It was noted that the emerging collaboration between Health Canada and the Canadian Institutes of Health Research is an innovative model for building health capacity in a regulatory environment. The Canadian Institutes of Health Research is in the position to have more equitable relationships with drug sponsors as it is not in the role as a regulator.

The discussion brought to light many different viewpoints to be considered. Drug regulators are working on Progressive Licensing initiatives; patients and payers are looking at keeping costs down; industry is concerned with structured entry. It was noted that it is a huge challenge to manage these divergent perspectives.

There was a discussion on the availability of funding, and the issues surrounding drug safety in vulnerable populations i.e., paediatric populations, women of reproductive age, First Nations and Inuit communities, and the elderly. The Science Advisory Board noted that this model supports innovation and research with real world approaches and that the current system is not reactive enough. The only information currently available is public health records, meta-analysis and prospective studies. When the performance evaluation on the Drug Safety Effectiveness Network is complete, the Science Advisory Board Secretariat will make it available to the members and they will provide comments.

12. Updates

Pierre Charest provided a brief update on the Multiple Sclerosis file, Personalized Medicine and Blood Safety Issues

Multiple Sclerosis - The Canadian Institutes of Health Research, in collaboration with Health Canada and the Public Health Agency of Canada, has developed a Health Portfolio Action Plan to identify areas for federal action to address issues and questions raised by Canadian Multiple sclerosis patients in light of Dr. Zamboni's Liberation Treatment. This Action Plan focuses on the four following areas: Evidence-based Research on Multiple Sclerosis; Canadian Multiple Sclerosis Monitoring System; Stakeholder Outreach; and Communications.

The Scientific Expert Working Group held its first meeting on November 23, 2010 and confirmed that there is a lack of scientific evidence to recommend conducting therapeutic clinical trials on Liberation Treatment at this point. The next meeting will take place on June 28, 2011 to discuss preliminary results of seven existing studies and any other related research projects.

The Government of Canada announced, on March 23, 2011, the establishment of a Canadian Multiple Sclerosis Monitoring System.

Blood Safety Issues - Health Canada

A possible linkage of infection with Xenotrophic Murine Leukemia Virus Related Virus and Chronic Fatigue Syndrome was identified in 2009.

Published data from several laboratories shows that mouse DNA contamination may have contributed to some of the positive results observed in the studies. Two international working groups studying this issue have published preliminary data in March 2011. To date no cases of transfusion transmission of Murine Leukemia Virus Related Virus have been reported internationally. Blood Centres in Canada have expanded efforts to prevent those with Murine Leukemia Virus Related Virus from donating blood by providing information to prospective donors about the Virus before being accepted as a blood donor. Donors with Murine Leukemia Virus Related Virus are permanently deferred.

Health Canada and the Public Health Agency of Canada are contributing to international study groups and will continue to monitor the science regarding Xenotrophic Murine Leukemia Virus Related Virus and possible ties to disease states such as Chronic Fatigue Syndrome.

Personalized Medicine - Health Canada

Key advice received from the Science Advisory Board during the November 2010 meeting was incorporated into the scoping paper, i.e., increasing the focus on prevention as a key part of personalized medicine; clarifying the definition of "sub-populations"; strengthening the public health aspects; introducing Nutrigenomics; recognition of non-genetic components affecting health; and highlighting Canadian examples and including the Canadian context where possible.

With respect to the advice given on the appropriateness of the term "Personalized Medicine" to describe this file in a Canadian context, the Personalized Medicine Working Group Secretariat undertook a terminology analysis based on public literature as well as discussions at various national and international meetings and conferences. While recognizing "personalized medicine" might not be the most accurate term, the Working Group expressed strong opinions to maintain this title as it has been used by stakeholders in Canada, is recognizable, and is harmonized with current international terminology (e.g., at the International Conference on Harmonization).

13. Health Technology Management - Patrick Morin, Director, Sustainable Innovation and Pricing Policies Division, Strategic Policy Branch, Health Canada

Technology is a defining feature of the modern health care system, with new diagnostics, devices, and procedures being introduced at an unprecedented rate. This ongoing technological evolution presents both challenges and opportunities for health systems and health care providers. New innovations offer the prospect for earlier diagnosis, improved treatment options and ultimately, better patient outcomes. While these opportunities provide value to the health care system, the designing of appropriate policy instruments to support health care decision makers in the management of the technological life-cycle (i.e., adoption, value assessments and retirement decisions) is a significant challenge.

The Science Advisory Board was asked for its advice on:

  • the priorities for evidence development; and
  • approaches to better align evidence producers and decision-makers toward the rational use of technologies in Canada's health care system.
Discussion

A fulsome discussion was held on the exact nature of Health Canada's work in Health Technology Management. It centred on what products are covered by this initiative (e.g., drugs, medical devices); the level of funding for various organizations such as the Canadian Institutes for Health Research and Canadian Agency for Drugs and Technologies in Health; federal, provincial and territorial jurisdiction issues; and value for money invested.

Summary Advice
  • The Board felt that they need more basic information and context before they can provide comprehensive advice on this subject. There was a suggestion put forth that this item be brought back to the Science Advisory Board with the participation of Brian O'Rourke, Chief Executive Officer of the Canadian Agency for Drugs and Technologies in Health;
  • The Science Advisory Board would like to help foster relationships that will lead to a more systematic approach to health care. They deemed that the work being done so far is very useful, it might be time to think about an "HTM 2.O".

14. Closing Remarks - Abby Hoffman

Ms. Hoffman praised the Science Advisory Board for their useful advice and intellectual and energetic questions that help Health Canada and the Public Health Agency of Canada frame issues in a forward thinking way.

15. Members' Comments and Adjournment

  • There was a suggestion that there be an in-depth orientation for Board members on topics such as:
    • the Terms of Reference
    • travel procedures
    • mandates of Health Canada in relation to the Canadian Institutes for Health Research; in relation to the Public Health Agency of Canada - which organization (federal/ provincial/territorial) has the responsibility/jurisdiction for each file (such as junk food in schools)
    • health care delivery
    • regulatory mechanisms
  • The topics being presented at the meetings are from a broader spectrum of Health Canada and the Public Health Agency of Canada and the Science Advisory Board sees that as an improvement over previous years' experience. Presentations generally are more tailored to get the advice they want from the Science Advisory Board. There was a question put forth on whether the Board is to provide advice on a purely scientific basis or is there room for a science policy angle. Is the Science Advisory Board a "science" or "scientific" board? That will need to be discussed at the next meeting;
  • The Science Advisory Board sees one of its roles to be the promotion of collaborating and creating linkages. For example, the presentation on the Drug Safety Effectiveness Network - one suggestion would be for the Board to commission a survey on leading models for collaborations among the members of the Health Portfolio, perhaps using chronic disease as a case study;
  • It was agreed that a lead discussant will be chosen for each of the topics to be presented at the next meeting. The logistics will be worked out over the next months.
Potential agenda items for November 2011 meeting:
  • Follow-up on items from May 2011 meeting:
    • A business plan for the Science and Technology Foresight Initiative
    • Case study on one Health Canada Top Priority Science Need, outlining scenarios of accessing in-house and external science expertise
    • Performance Measurement Indicators for the Science Advisory Board
    • Comprehensive briefing on paediatric issues from Health Canada and the Public Health Agency of Canada, i.e., Fetal Alcohol Syndrome Disorder
    • Comments on performance evaluation of the Drug Safety Effectiveness Network
  • Barriers to clinical research with humans in Canada
    • Research Ethics Board Standards
    • Scientific Integrity
  • Health Care sustainability research at Health Canada
  • Nanotechnology
  • The regulation and monitoring of Natural Health Products / non-traditional therapies
  • New technologies - personalized medicine; exposure to pesticides: Pest Management Regulatory Agency's Integrated Toxicology Testing report - Summer of 2010
  • Scientific literacy in Canada
  • Re-use of single use medical devices
For future meetings:

Members would like to see what Health Canada and the Public Health Agency of Canada are doing in the following areas:

  • regulatory mechanisms that Health Canada may use to influence change, such as business models, Intellectual Property, Bill C-51, progressive licensing;
  • how the department is going to pay for general health data given that the long form census is no longer compulsory; and
  • Health Technology Management topic brought back with the participation of Brian O'Rourke, Chief Executive Officer of the Canadian Agency for Drugs and Technologies in Health.
  • The Public Health Agency of Canada's role in the chronic disease strategy
  • Post market geriatric drug surveillance
  • Issues related to aging and the elderly

Next meeting: November 8-9, 2011 (coincides with the Health Canada Science Forum to be held November 7-8, 2011)

Date Modified: 2012-06-19

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