Summary of Discussion: Science Advisory Board Meeting : September 26-27, 2007

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Table of Contents

• Participants
• Preliminary Matters
  • The Chair
  • Ken Bednarek, Minister's Office
  • Health Canada's Acting Chief Scientist
  • Statements from Members
• Applying Science in Support of Mandates
  • Progressive Licensing (Health Products and Food Branch - HPFB)
  • Framework for Research (First Nations Inuit Health Branch - FNIHB)
  • Research Framework (Healthy Environment and Consumer Safety Branch - HECSB)
• Science, Technology, Innovation
  • Federal Science and Technology (S&T) Strategy
  • Public Health Agency of Canada (PHAC) S&T Strategy and Mapping Science
  • Health Products and Food Branch (HPFB) Science Strategy
  • Health Canada S&T Strategy
• SAB Operational Issues
  • SAB Executive Committee
  • Agenda Planning
  • Future Meetings
  • SAB Secretariat
  • Matters for Information
  • SAB Requests

Participants

Science Advisory Board Members

Arnold Naimark, Howard Palley, Louise Lemieux-Charles, Renaldo Battista, Renée Lyons, Arminée Kazanjian, Jacques Simard, Rémi Quirion, Stephen Bornstein, Mamoru Watanabe

Ex-Officio Members

Wendy Sexsmith, Frank Plummer

Secretariat

Laird Roe, Catherine Rotor, Suzi Vivolo

Invited Guests

• Ken Bednarek, Minister's Office
• David K. Lee, Director, Office of Patented Medicines and Liaison, HPFB
• Maurica Maher, Senior Scientific Advisor, Office of Patented Medicines and Liaison, HPFB
• Frank Plummer, Chief Scientific Officer, PHAC
• Monique Stewart, Director, Health Information, Analysis and Research Division, FNIHB
• Dawn Walker, Executive Director, Strategic Policy and Planning, FNIHB
• David Blakey, Director, Environmental Health Science and Research, HECSB
• David Clapin, Branch Science Advisor, HPFB
• Ellen Birnbaum, Manager, Horizontal Science Strategies, Office of the Chief Scientist (OCS)

Regrets

Mark Goldberg, Lorne Babiuk, Kathryn O'Hara, Chris Loomis, Andreas Laupacis

Alternates

Monique Stewart, Peter Chan, Mark Razienne, David Clapin, Mostafa Askari

Regrets

Morris Rosenberg, Suzanne Vinet, Ian Potter, Susan Fletcher, Frank Fedyk, Carolina Giliberti, Karen Dodds, Meena Ballantyne, David Butler-Jones, Kin Choi, Alfred Tsang, Alan Bernstein, Bernard Dickens

Other Guests

Lisa Wardell, Martin Lawrence, Shane Quinn, Annie Bérubé, Ken McAllister

1. Preliminary Matters

1.1 The Chair

• welcomed members and guests;
• reviewed the meeting agenda and its focus on two topics: applying science in support of mandates and strategies on science, technology and innovation;
• noted that the Minister had appointed Andreas Laupacis as Vice-Chair of the SAB; and two persons as new members of the SAB;
• advised members that Stanley Vollant had tendered his resignation from the Board for personal reasons and that the SAB's appreciation of his contribution to its work would be conveyed to Stanley Vollant; and
• asked members, whose terms expire in 2008, to consider their interest in reappointment (for a second term) recognizing that renewals are at the Minister's discretion.

1.2 Ken Bednarek of The Minister's Office

• advised that the Minister's priorities include: review and renewal of the regulatory aspects of Health Canada's responsibilities in the light of the government's streamlining regulation initiative; global health; and, implications of the Federal S&T Strategy for the health portfolio. He noted that the health system is an important economic entity and that health innovation can be an important economic engine. Health Canada will need to focus on how to perform its regulatory functions while avoiding being "a bottleneck in the system". The Minister also places a priority on appropriate information flow (i.e. knowledge translation and transfer).

1.3 Health Canada's Acting Chief Scientist

• outlined the state of evolution of Health Canada's S&T strategy which is being crafted not only to ensure that the Department remains at the leading edge of science but also as a response to the Federal S&T Strategy; and noted that consultations with external stakeholders and science based departments and agencies (SBDA) are part of the process;
• indicated that collaboration and integration remain overarching themes within the Health Canada Science and Technology Strategy, including initiatives designed to: strengthen science and research linkages within the Health Portfolio among Health Canada, PHAC and the Canadian Institutes of Health Research (CIHR) and externally; to define mechanisms to support an "enterprise approach" whereby Health Canada's ability to work together with other SBDAs will be enhanced; and, to ensure that Health Canada has both appropriate in house capacity in key areas and the mechanisms to access external S&T expertise as circumstances require;
• noted the establishment of an Independent Panel of Experts on the Transfer of Federal Non-Regulatory Laboratories by the federal government (A. Naimark and K. Keough are both members of this new panel);
• advised the SAB that Health Canada has expressed continued support for the Post-Doctoral Program for another five years; and that Health Canada is considering the establishment of a program (similar to the National Research Council's (NRC's) Research Associate Program) in which university graduate trainees are hired for a two-year term as junior scientists; and
• informed the members that the review of the SAB will commence on in the fall of 2007 with the reviewer's report expected in late December or early January 2008.

The SAB:

• inquired whether the Canadian Health Services Research Foundation (CHSRF) and other health partners would be involved in the new the approach where the three organizations (Health Canada, PHAC and CIHR) will work together on common research issues so as to provide coherent input to the Minister; in response, it was noted that the intent of both the Health Canada and Federal S&T Strategies is to facilitate and encourage working together;
• inquired about the process for the SAB review. The Chief Scientist advised that the consultant will provide Health Canada with information on perceived Health Canada and PHAC needs for external science advice, current sources for that advice, the functioning of the existing SAB, and the needs for an external science advisory body moving forward. The review will include best practices from the operation of science advisory bodies in other SBDAs. Plans include interviews with Health Canada SAB members and key departmental individuals in order to ascertain their view on what the Department requires (taking into consideration the evolution of Health Canada over the past ten years). The report will be provided to the Associate Deputy Minister and the Deputy Minister upon finalization; and
• noted that it would have been helpful to the process if the SAB had been given an opportunity to review the terms of reference of the consultant in advance so that the members could have identified topics for the review that would have enhanced its scope and value. The A/Chief Scientist noted that the Review Terms of Reference had been discussed with the Chair of the SAB.

1.4 Statements from Members

• Arnold Naimark, SAB Chair, informed the Board of the panel he is chairing - Independent Panel of Experts on the Federal Non-Regulatory Laboratories, and indicated that its two main tasks were: to develop a framework for evaluating potential transfers of non-regulatory labs and, on the basis of proposals for transfer submitted to the Panel, to identify 5 laboratories that could be early candidates for transfer (development includes a series of roundtables across the country, academia, government, and the public sector). He also noted that Alan Bernstein, President of the CIHR and an ex-officio member of the SAB would be demitting office shortly; and
• Renée Lyons updated the Board on the SAB/PHAC Task Force (September 14, 2007 meeting) where an additional focus was defined - Global Health Initiatives (GHI) - and the decision taken to place this issue at the top of the list. She conveyed the interest of the Task Force in adding a presentation on GHI to the March 2008 SAB meeting.

2. Applying Science in Support of Mandates

2.1 Progressive Licensing (Health Products and Food Branch - HPFB)

David K. Lee, Director, joined by Maurica Maher, Senior Scientific Advisor, Office of Patented Medicines and Liaison, HPFB, presented HPFB's Progressive Licensing Program - a new regulatory framework for pharmaceuticals and biologics in Canada. The objective of this project is to develop a modern drug regulatory framework that supports: access to new drugs; the continuous monitoring, assessment, and communication of drug information (benefits and risks) throughout the product life-cycle; and, optimal use of drugs to maximize benefits and minimize risks. The four key elements of this new framework include: a life-cycle approach to regulation; evidence-based decision making; planning and accountability.

Mr. Lee noted that current legislation and regulation are considerably outdated given that drugs are becoming more complex as new combination products and new technologies are developed. Work on the Progressive Licensing Project has included consultation with stakeholders on the framework and on notable challenges involved in data acquisition and evaluation over the life cycle of drugs which can extend over many years.

The following questions were posed for the Board's consideration.

• Given current and anticipated developments in science and technology, which scientific competencies will be needed by the Branch in the future to assess the benefits and risk of new products? How would the Board prioritize these competencies? Does the Board have any suggestions for how the Branch should proceed with ensuring that we have the competencies we will need?
• Participation of academic institutions and health care professionals in post-market activities has been identified by stakeholders as key opportunities for learning about how drugs behave in wide populations. Does the Board have any suggestions as to how a Progressive Licensing Framework can effectively engage with institutions and health care professionals?
• Biologics (biologically derived drugs) are becoming more widely used and subsequent-entry biologics (biogenerics) are now being developed. Does the Board think that such products should have unique regulatory requirements given their unique methods of manufacturing complexity?

In response the Board observed:

• Special attention should be given to upgrading skills involved in developing and maintaining longitudinal databases that can address the complexities of data gathering and follow up in a widely dispersed system, ensuring expertise in the development and use of biologics, hybrids of drugs and devices, and drugs derived from genetic modification of plants and other organisms. Another area of priority is the development of expertise in the nuances of conducting and validating small clinical trials in the era of "personalized" medicine. The Branch should develop stronger and more flexible linkages with universities in order to improve its ability to recruit young scientists with the new skill sets and to organize retraining opportunities for its existing personnel.
• Some universities are already focused on issues with some bearing on key aspects of progressive licensing and on real world effects of pharmaceuticals. This is an area that is ripe for more inter-sectoral (government, universities, private sector) scientific integration and cooperation.
• The introduction of biologics and other complex molecules does impose a requirement for "special" regulatory processes. They may be special either because they are unique or because they require intensification of aspects of certain aspects of the regulatory processes now in place. Biogenerics pose a special challenge because the methods of production of biologics are complex and time consuming with significant issues related to replicability and reliability.

The SAB noted that in the development of the framework and its promulgation, attention should be paid to:

• clarity of the difference between progressive licensing and provisional licensing;
• a nuanced definition of risk that recognizes differing perceptions of risk and the implications of progressive licensing for information conveyed in labelling;
• including the social aspects of harms and benefits;
• cost/benefit analysis; and
• international practices /partners.

2.2 Framework for Research (First Nations Inuit Health Branch - FNIHB)

Monique Stewart, Director, Information, Analysis and Research Division, FNIHB was joined by Dawn Walker, Executive Director, Strategic Policy and Planning, FNIHB. Ms. Stewart noted that:

• FNIHB's Framework for Research was developed according to previous advice from the SAB;
• the Framework provides guidance on promising best practices in the collaboration between FNIHB, researchers and research funders. It clarifies research-related roles for the Branch in an effort to encourage and sustain research practice that promotes excellence in the conduct of research and reduces variations in practice;
• the Framework also outlines current research activities within the Branch; identifies research priorities; highlights potential collaborative activities both within the Department and with external non-governmental/research organizations; and suggests opportunities for the Branch to pursue linkages in partnerships on issues relating to Indigenous health research;
• the mandate of the Branch is focussed on First Nations on reserve and Inuit in northern communities, but research will have implications for the broader Aboriginal population in Canada and, in some cases, indigenous populations in other post-colonial countries; and
• the Framework also provides a foundation for the development of a research agenda for Aboriginal health. The development of this research agenda will be based on FNIHB's current roles, responsibilities and programs.

Expectations of the SAB include advice regarding the:

• implementation of the Framework including next steps in the development of a research agenda for Aboriginal health; and
• identification of specific linkages with exiting science and technology initiatives such as the Federal S&T Strategy and Health Canada's S&T Strategy, as well as international linkages.

In the ensuing discussion, the SAB:

• noted that the Framework could be strengthened if the rationale were moved to the beginning of the document;
• encouraged the addition, under building capacity, of non-Aboriginal researchers;
• cautioned that knowledge translation is an important factor; and
• noted that research capacity is a central issue and thought should be given to mechanisms that create a program targeted to building capacity.

2.3 Research Framework (Healthy Environment and Consumer Safety Branch - HECSB)

David Blakey, Director, Environmental Health Science and Research, HECSB, described the approach being implemented in the Safe Environments Programme for planning research to ensure alignment with Programme priorities. The approach is based on the concept of a science continuum embracing exposure to noxious elements, hazard identification, mechanistic studies and population studies. The outcomes of the science activities of the foregoing elements form inform the processes of hazard assessment, risk assessment, risk management and communication and policy and programme development for disease prevention.

Expectations of the Board:

• It was noted that the Board expressed an interest in how decisions are made regarding the direction of research and the approval of projects; hence it is invited to comment on the research framework as presented and offer advice on its implementation internally as well as with Health Canada's partners in the research community.

During the following discussion, the Board:

• encouraged the inclusion of social factors in the Framework;
• encouraged continuing interaction with Environment Canada;
• noted that a CIHR institute on environmental health could be useful, recognizing that the creation of a new institute is dependant on the quantity of grants related to environmental health;
• learned that the greatest challenge facing the Branch in bringing this concept to fruition is a capacity issue (human resources);
• encouraged integration/linkages, including academia;
• complimented the Branch on the clarity of the Framework with regard to the direction (i.e. orientation) of research but noted that the presentation of the Framework did not include a discussion of the factors (criteria), other than alignment with the continuum, that drive the determination of research priorities within the key elements of the continuum and among them. For example, to what extent are priorities influenced by the current pattern of expertise within the Branch? and
• noted that some of the scientific activities described in the presentation were of a type (i.e. research and experimental development) that might fit the definition of "non-regulatory science" and might therefore be amenable to integration with similar or complementary work being done in universities. David Blakey responded by indicating the Branch is exploring linkages with university scientists. However, he noted that some topics of R&D were critical to fulfilling the Branch's regulatory mission.

3. Science, Technology, Innovation

3.1 Federal Science and Technology (S&T) Strategy

Laird Roe, A/Director, Policy, Planning and Partnerships Division, OCS, elaborated on the Chief Scientist's earlier remarks on the recently released Federal S&T Strategy (the Strategy). The Prime Minister encouraged Ministers to deliver on the policy commitments of the Strategy, link science related announcements to the Strategy, and engage stakeholders and advisory groups.

Within the health portfolio, the OCS is coordinating the input related to the policy commitments in the Strategy of relevance to Health Canada per se and to interdepartmental issues involving Health Canada. Mr. Roe noted that developments in response to the Strategy could span a two-year horizon, and that other Strategy-related work is also being done independently by the PHAC and CIHR (in collaboration with the other granting councils).

As to stakeholder engagement, the Minister will be hosting a round table with a selected group of research leaders, scheduled for October 9, 2007, to gauge the reaction of the research community to the Strategy and to seek input on its implications for the health portfolio.

In addition to the Minister's round table, the Department will be hosting several multi-stakeholder meetings (including the community, and federal partners and agencies) to gauge reactions to both the Federal S&T Strategy and Health Canada's S&T Strategy and its needs. An electronic consultation in October is also planned to allow stakeholders to look at the Strategy and portions of the Health Canada S&T Strategy and provide input electronically.

In the ensuing discussion, the Board:

• requested further details on the consultations with the Minister to which Mr. Roe noted:
  • the Minister is interested in hearing directly from research leaders;
  • approximately 10-12 individuals will be in attendance; and
  • the Minister wishes to learn of the policy priorities of stakeholders for the health research sector going forward and their views about the portfolio's role in this regard.
• encouraged Health Canada to include stakeholders in the health services industry and to examine how the Health Canada S&T Strategy intersects with the interests of that sector;
• cautioned Health Canada about the need to design an appropriate Knowledge Translation (KT) pipeline;
• noted that Canada's innovation system needs to rethink its approach to Knowledge Translation and Transfer; the systems currently in place in academia and government do not reward KT activities;
• indicated that it is important to align the commercialization of advances in S&T with social determinants of health and the fundamental dynamics of the health service industry in which significant economic and health benefits do not depend on commercialization;
• noted that "commercialization" should be interpreted broadly in the health field - often the application of new knowledge (whether or not it generates direct commercial returns) is the desired outcome; and
• expressed its desire to play a continuing role in this process.

3.2 Public Health Agency of Canada (PHAC) S&T Strategy and Mapping Science

Frank Plummer, Chief Scientific Officer, PHAC, gave a status report on PHAC's S&T Strategy and its science mapping exercise. Frank Plummer confirmed that PHAC is working in partnership with others to address issues in the Strategy. As an example, he noted that the Winnipeg lab is collocated and several departments and agencies came together for the Canadian Human Immunodeficiency Virus (HIV) Vaccine initiative.

Frank Plummer noted that a key part of PHAC's S&T Strategy is the mapping of PHAC's science resources - who, where, what etc. The Agency has been drafting a document that will soon be ready to share with the Board. He indicated that the Agency requires structural changes, especially with its management of science. A science "client branch" is being considered as well as reorganization in other areas. It was noted that Winnipeg is becoming the science innovation pillar and Ottawa the policy pillar of PHAC.

In the discussion that followed, the SAB:

• inquired about the science components of the collaborating centres; Frank Plummer replied that there are six collaborating centres across the country where putting health knowledge into practise is important. The Collaborating Centres are a knowledge translation and generation mechanism; the centres are in various stages of development (ex. HIV - reorienting to focus on prevention);
• requested a verbal update on Pandemic Planning; Frank Plummer noted that PHAC is working on implementing the federal investment from Budget 2006. There is a lot of activity internationally and this is an issue that the Minister wants to get involved with personally.

3.3 Health Products and Food Branch (HPFB) Science Strategy

David Clapin, Branch Science Advisor, HPFB, gave the Board its first view of HPFB's Strategic Science Plan. He stated that the focus of the Plan includes the nature and scope of the science needs of the Branch. The Plan includes: the identification of the science performed presently; the changes in the key methods for the generation and analysis of evidence; and the evolution of science and technology as it affects the nature of the products that fall with the Branch's mandate.

He noted that given the variety and breadth of the Branch's science activities and interests, the challenge will be to bring the appropriate degree of focus to the Branch's critical needs. Science needs can be stated at many levels from the general to the specific. Fields include: health products; food and nutrition; research needs; and regulatory decision sciences.

David Clapin invited the Board members to provide advice on their thoughts with respect to the science needs of the Branch. The SAB:

• inquired as to where epidemiology falls; David Clapin responded that it falls under social trends;
• asked for clarification of "related scientific activities" (RSA); David Clapin responded that RSA refers to scientific activities that are not research based, including scientific data collection;
• Indicated that the analysis provided was impressive;
• encouraged the Branch to consider the whole range of issues surrounding a Plan, including: human resources; continuing professional education; recruitment (internal and external); and knowledge transfer; and
• recognized the interest of HPFB, to synthesize the information collected from the SAB and then to return to the Board with a further developed iteration of the Strategy.

3.4 Health Canada S&T Strategy

Laird Roe defined the goal of the Health Canada S&T Strategy as an improvement in the Department's ability to meet its mandate and indicated that one of its key features would be an assessment of needs for S&T and a set of principles to guide the development of strategies to fulfill those needs.

In June, OCS hosted a departmental retreat (45 departmental employees) and as noted earlier is planning a retreat with stakeholders in October 2007 and is also planning electronic consultations. Ongoing input from the SAB will also play an important role in this process. A steering committee and several working groups were established to work on drafting a strategy (November 2007 - January 2008). Throughout February and March of 2008, stakeholder consultations on the draft Strategy will take place, along with the finalization of the Strategy.

Mr. Roe invited the SAB to respond to some of the questions being posed to the various stakeholder engagement processes:

• What emerging scientific and technical trends do you foresee will require different/new scientific work or outputs from Health Canada? 1-5 years; 5-10 years? The SAB identified:
  • stem cell therapy, genetic testing, gene therapy, biological sciences;
  • knowledge translation; and policy development;
  • scientific trends are not only national, they are global;
  • interdisciplinary work;
  • technological advancement;
  • pooling of resources with institutions etc.;
  • increasing complexity and time pressure of problems - Health Canada is encouraged to improve methods to get the advice it requires on an expedited basis;
  • resources in database development, data collection and data mining;
• What are the top science needs that Health Canada must fulfill to achieve its mandate? 1-5 years; 5-10 years? The SAB identified:
  • Knowledge translation pipeline;
  • Knowledge about how to protect populations and not just individuals;
  • Development of a science foresight capability and process;
  • More extensive linkages with scientists in universities and industry;
  • An expanded and intensified human resources renewal programs involving both new recruitment and retraining;
  • Renewal of physical plant and equipment;
  • Effective implementation of its S&T strategy Stimulate public partnerships with Health Canada;
  • Advisory body to Health Canada consisting of academic community; and
  • Facilitate partnering trust - replicate the CHSRF linkage and exchange idea in trying to broker the relationship between university and industry.

4. SAB Operational Issues

The SAB reviewed several matters pertaining to its internal operations.

4.1 SAB Executive Committee

The SAB Executive Committee was developed as a mechanism to provide assistance to the Chair between SAB meetings to assist the Chair with such issues as agenda development. As the Board tentatively agreed, in January 2007, to reduce its meeting schedule from four full-scale meetings to two, the Chair determined that, at the moment, an executive committee is no longer required. The Board will return to this issue at a later date if necessary or desirable.

4.2 Agenda Planning

The Agenda for the November 7, 2007 SAB meeting was distributed. The A/Chief Scientist provided a brief overview of the November Agenda detailing that a portion of the morning would focus on SAB operations and the remainder of the day would focus on highlighting Health Canada's and PHAC's efforts from a science perspective, including a lab visit to provide an idea of how science is used in the Department and the Agency. It was noted that a presentation on the Health Policy Branch was missing from the agenda. Amendments will be made to accommodate the addition to the agenda.

Additionally, the Board requested a short backgrounder on Health Canada's resources allocated to science, including the breakdown of science and human resources and a piece from PHAC on knowledge translation.

4.3 Future Meetings

The next meeting of the SAB was scheduled for November 7, 2007. This was to be a one-day meeting preceding Health Canada's annual two-day Science Forum. (The November SAB meeting was cancelled due to lack of quorum; the March meeting has been rescheduled and is now targeted for March 25-27 - half day orientation and two-day meeting)

4.4 SAB Secretariat

Laird Roe, A/Director, Policy, Planning and Partnerships Directorate, OCS, updated the Board on the work of the SAB Secretariat. It included:

• a brief analysis of the Board's evaluation forms from the March 2007 meeting, which revealed a strong interest in the Board receiving feedback on how its advice is used within the department; Mr. Roe noted the new processes in place to ensure that the SAB's advice is received by Health Canada and PHAC and that a formal response is made by the Minister;
• an update on the SAB's Extranet: usage is low; a training manual for the SAB was distributed at the last meeting (March 2007); continued diligence of the Secretariat was requested to ensure instructions are distributed each time material is electronically distributed to the SAB; and the Secretariat will arrange for usernames and passwords to be resent to SAB members so that they can access the Extranet; and
• a status report on the Agriculture and Agri-Food Canada (AAFC)/Health Canada SAB Task Force identifying that the Minister of Health has approved the project (including the financial aspect) but confirmation from AAFC that they have received the same approval has not yet been received.

4.5 Matters for Information

Updates for information were received on the following issues:

• Cancer Control;
• Pandemic Planning;
• Mental Health Commission;
• Children's Health; and
• Climate Change.

4.6 SAB Requests

The SAB asked that the Secretariat:

• distribute to the Board, an article from the Globe and Mail on John Evans' lecture as recipient of the Henry G. Friesen International Prize in Health Research;
• share Health Canada's recruitment and retention plan;
• (for the next meeting) request a report from Health Canada Branches describing the branch's scientific capacity and the pattern of academic qualifications of the scientific staff;
• the Board requested a copy of the terms of reference of the consultant, (as described in the statement of work) engaged to review the SAB;
• ensure that Branch presentations at future meetings include a thumbnail sketch of the scale of operations (budget, full-time equivalent's (FTE's) by employment category); and
• consult the Board on the results of the next phase of consultations with respect to Health Canada's S&T Strategy.