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Questions and Answers on the HPFB Strategic Science Plan

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Overall

General questions on the Science Plan

Questions on the SSP Consultation

Overall

1. Why is Health Canada reviewing the science it uses for regulating health products and food?

Health Canada (HC) is a science-based organization and the Health Products and Food Branch (HPFB) recognizes the importance of a strong science foundation to support its role as a scientific and regulatory authority for health products and food. This Plan will enable HPFB to:

  • Recognize and act on science opportunities by articulating clear, strategic priorities in science;
  • Engage and build strong partnerships in science;
  • Provide clarity, depth and precision for overarching Branch Strategies; and
  • Communicate our science to a broad audience of lay people and experts alike.

In addition, HPFB has identified a need to create conditions in which truly multi-disciplinary approaches can be fostered in order to deal with complex issues such as nanotechnology, pharmacogenomics and biosystematics. By bringing together the science that different Directorates are undertaking and by viewing science from a horizontal perspective within HPFB, we can maximize opportunities for synergies, reduce duplication, maximize stakeholder engagement and generate new ideas.

2. Does Health Canada have a vision of what the new system will look like, how it will be different and the benefits it will provide for Canadians?

The Health Products and Food Branch (HPFB) Strategic Science Plan will guide our scientific efforts, including our mission, vision, objectives, key strategies, proposed sources of outputs and outcomes. Our approach is centered on defining multiple key science strategies, each with several associated science activity clusters. The clusters represent activities around issues ranging from public input and consumer outreach to emerging health technologies and environmental impacts. The key strategies are comprehensive enough to encapsulate all of our current science-based activities, and yet flexible enough to incorporate new science as it appears on the horizon.

3. What impact will the Science Plan have and how will it affect Canadians and their access to safe and effective medicine, health products and food?

While the Science Plan does not directly affect Canadians, the Plan is designed to support Health Products and Food Branch's mandate which is to improve and protect the health of Canadians. Improvement to our internal processes will result in better service to Canadians.

4. How does this fit into the federal government's science and technology (S&T) plans? How does this fit into Health Canada's S&T plans?

There is new and exciting science happening in the world at every moment. This work shows how science fits into Health Products and Food Branch's other framework strategies, such as the HPFB Strategic Plan 2007-2012, HPFB's Blueprint for Renewal II and the Product Life-Cycle Framework. The Science Plan adds clarity, depth and precision to these strategies and better integrates a strong science foundation into our identity as a Branch.

The Health Canada Science and Technology Strategy and the HPFB Strategic Science Plan have several common facets and objectives. While the Department's S&T Strategy is designed to better integrate science into the Health Canada (HC) decision-making process, the Science Plan speaks directly to the science being undertaken within the specific mandate and product responsibility areas of HPFB; for example, foods, drugs and medical devices.

In addition, the HC S&T strategy focuses more on strengthening the contribution of science to delivering on key Health Canada portfolio priorities, and reinforcing the broad internal links between HC science and HC policy. The HPFB Strategic Science Plan has been designed more as an operational system to (a) assess incoming requests to HPFB for collaborations or partnerships in external research initiatives, and (b) help to prioritize HPFB science activity clusters to better meet upcoming health risks and benefits from food and therapeutic products and their resulting regulatory challenges under the jurisdiction of the Food and Drugs Act.

General questions on the Science Plan

5. As this is the first comprehensive strategic science plan, would this mean that your decisions up to now have been based only on policy? Does this mean you have never done this science before?

No, the Branch has a rich history of strategic evaluation and forward thinking with respect to our science-dependent decision making. Our scientific efforts have always been to better protect and promote the health and safety of all Canadians. Our scientists have been constantly engaged in the cutting-edge science that pertains to optimal health. The Strategic Science Plan represents an up-to-date examination of key science trends, particularly those areas which are revealing new profound links between health and disease, and food and health product technologies. From the very beginning, Health Products and Food Branch (HPFB) has had internal strategies in place to guide our research directions. Upon review of these strategies within HPFB's Blueprint for Renewal I and II, one issue highlighted by stakeholders was that HPFB science could be missing opportunities for collaboration. We anticipate that the Plan can provide a mechanism by which HPFB can promote research and science strategies into the broader context of national and international collaboration.

6. How does this fit into the Health Products and Food Branch (HPFB) Roadmap, the Blueprint for Renewal and the Branch's Strategic Plan?

The HPFB Strategic Plan 2007-2012 identifies Strategy 4 - Establish Strategic Partnerships to fulfil our Mandate. To accomplish this, the HPFB Blueprint for Renewal II has, as one of its commitments, the direction to “implement a Science Plan to measure and evaluate our contribution to the advancement of government science as we capitalize on science opportunities. The Strategic Science Plan is designed to fulfill that commitment.

At the same time, however, the Strategic Science Plan is designed to support all components of the Branch Strategy, and all objectives of the Blueprint for Renewal II.

7. How will this help fulfill the Branch's policy and regulatory commitments?

The Plan will help to fulfill Health Products and Food Branch's policy and regulatory commitments by establishing clear and consistent guidelines as to which research areas are of strategic importance to HPFB. This will help us plan for regulatory and policy oversight in these areas. The Plan also provides a foresight function so that the Directorates within the Branch will now have the ability to plan for and allocate internal resources which will help target the scientific activity clusters that are relevant. The plan speaks to all functional responsibilities of the Branch Science enterprise, such as product evaluation, inspection, and regulatory policy development.

8. Changes in science occur at a very fast rate. How will Health Products and Food Branch (HPFB) keep up?

The Plan is “evergreen” and is designed to be malleable and change with the times and with other input as it is implemented over the next five years.

9. Will you be looking at new investments? Will more money be invested into science research in Health Products and Food Branch (HPFB)?

Implementation of this plan does not depend on new investment. The implementation of the Strategic Science Plan will help the HPFB innovation base, leading to a better overall balance between cooperation and competition for resources. Encouraging more focus and coordination between different scientific areas of expertise and sources will help to optimise scientific investment, build capacity and increase efficiencies.

The Plan will also address resource needs and sources. It will help us examine potential avenues to leverage investment in HPFB science and enhance coordination between funding sources (for example, Genome Canada, etc).

The Plan is also intended to help prioritize resources for scientific activity clusters. As the implementation of the Plan continues, we will look for initiatives and opportunities through external partnerships and collaborations.

10. How will the Plan be implemented?

Implementing the Science Plan will involve looking at an inventory of all priorities in science and research, which can be identified from the following sources:

  • A review of the strategies of component organizations of the Branch;
  • Staff-level surveys and workshops;
  • Comprehensive review and operational planning;
  • The logic of Directorate operations (for example, enforcement/compliance, surveillance, policy development, testing, risk communications, etc.) where an identified strategic science priority might need to be pursued; and
  • Environmental scans, such as the annual Health Canada environmental scan, prepared each year by the Health Policy Branch.

The inventory of science activities includes current and projected items. Investments will be prioritized based on strategic and operational risk.

11. What are the key areas Health Canada is focusing on in the Science Plan?

This Science Plan outlines Health Products and Food Branch's strategic science agenda over a five year period, including the time it has taken to develop the plan to this stage. It will help us to recognize and act on science opportunities, serve as a basis for scientific engagement and partnership, and communicate HPFB science priorities to a wider audience. It identifies seven key science strategies along with science activities that address a range of issues from engaging with and communicating science to the public to combating disease and promoting sustainable development. These initiatives provide a clear strategic approach for HPFB to carry forward its standard of science excellence and will support its mission to help Canadians maintain and improve their health.

12. What criteria have been used to select these scientific activity clusters? Why were these areas selected?

The scientific activity clusters were selected via an extensive internal consultation process amongst Health Products and Food Branch's internal Directorates driven by the needs of the Branch. It is expected that the selection will be further refined by our eConsultation with stakeholders and the public.

The selection criteria are quite broad, but for the most part, the identified science activity clusters within the matrix must have three general attributes:

(1) the scientific activity cluster falls within our main Objectives and Key Strategies as outlined in the Plan, and;

(2) the scientific activity includes one or more aspects of the following: research, development, evaluation, policy making, or information dissemination, and;

(3) the activities are often performed in collaboration with partnering organizations.

13. Are any of these scientific activity clusters more critical than others?

The scientific activities listed within the clusters are purposely not prioritized in the initial Plan, as they are designed only as an inventory of scientific endeavours which are of strategic importance to Health Products and Food Branch (HPFB). They are interdependent and are all equally critical; prioritization will follow Health Canada's guidance on priority setting for science as the plan moves forward for implementation.

It is important to note that the concept of prioritization within the science activity clusters is highly topical and rapidly shifting as new issues and health threats emerge. A priority set at any particular moment in time may not be the same priority in the longer term as the knowledge gaps are filled on the topic. However, the Plan allows for the rapid engagement of HPFB science in those areas identified within the matrix, and this can be considered a tool to limit or expand HPFB's purview in any of the specialized areas within the Plan.

14. Does this mean that if a particular science area is not stated in the science clusters that there will be no investment or desire for that science in Health Products and Food Branch (HPFB)?

The clusters that have been articulated are a starting point for discussion around how much science should be conducted by us versus how much science should be conducted through partnerships or through external initiatives. Hence, the science cluster of activities is designed to be fluid, and other science activity clusters can be added, however the new activity must satisfy our main objectives and key strategies contained in the Plan (See question 12).

15. How does the Strategic Plan affect the daily work of Health Products and Food Branch (HPFB)?

The Plan will allow HPFB to have a keener focus on meeting our science needs, and will be a means to present HPFB science to the world. The recommendations of this strategic plan will help the organization operate more efficiently. Using these objectives and strategies, action plans will be developed to identify concrete actions that will be taken by HPFB to achieve our overarching scientific goals and strategies.

16. How will the Health Products and Food Branch (HPFB) Strategic Science Plan be implemented at a citizen and stakeholder level?

HPFB will work closely with employees, stakeholders and citizens to collectively carry out the strategic actions of the plan. The strategic plan is a living document, in a constant state of evaluation, built by the loop of ongoing feedback between individuals, stakeholders, and HPFB. HPFB views strategic planning as an ongoing process. We will continue to analyze outcomes, policies and practices and gather feedback from the public and our partners.

The HPFB's vision is to play a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory authority for health products and food in Canada and internationally. The goals and strategies of this plan help to fulfill that vision.

17. How long will the Science Plan take to conduct and implement?

Health Products and Food Branch (HPFB) will begin an intensive process of internal and external consultation to refine version 1.0 of the Plan and if warranted, will publish a version 1.1 after the end of the consultation. Other changes and inputs will be incorporated on a cyclical basis as necessary. The outcomes of this strategy will be evaluated at the end of a five-year period by:

  • Assessing the nature and value of new partnerships;
  • Monitoring uptake of science opportunities;
  • Qualitative assessment of selected science activities; and
  • Annual tracking of indices of science capacity.

18. In the meantime, is the current system sufficiently safe to evaluate and monitor safety, quality and effectiveness of Canadian health products and food?

Health Products and Food Branch recognizes the importance of a strong science foundation to support its role as a scientific and regulatory authority for health products and food. The Science Plan will serve to strengthen and add science capacity to the existing system as a whole. The current system remains one of the world's safest and most comprehensive regulatory systems in the world for health products and food.

Questions on the SSP Consultation

19. How is the consultation process being conducted?

The consultation on the Health Products and Food Branch (HPFB) Strategic Science Plan is being done in two parts. The current e-consultation is the first part and the Branch anticipates that it will run until the end of September 2009. At that point, the feedback will be compiled and analyzed. A consultation report will be produced and posted on-line.

Depending on the feedback from the on-line consultation, the Branch will assess the need for further consultations. When consultations are completed, the feedback and analysis will be used to finalize the Strategic Science Plan and implement its objectives.

20. How will the input be used?

The opinions and concerns of Canadians and other interested parties are of the utmost importance to Health Products and Food Branch (HPFB). To help maximize your input into the HPFB Science Plan, we have constructed a series of guiding questions which will help us better integrate your comments and concerns. Following an analysis of the received comments, HPFB will revise the Science Plan and publish a final version. HPFB will then begin the implementation of the strategies.

21. Where is the information concerning the consultation?

The Web site for the Strategic Science Plan is http://www.hc-sc.gc.ca/sr-sr/consult/_2009/strat-scien/intro-eng.php. The site contains all the science plan documents and links to other important material such as the Health Canada Science & Technology Strategy and the Branch's Blueprint for Renewal documents. This Web site will act as the hub for the Strategic Science Plan, and the final consultation report will be posted there once the consultation is complete.

Please direct any concerns regarding the Science Plan or the Web site to hpfb_dgpsa_scienceplan@hc-sc.gc.ca.

22. Who are you consulting on this process?

We will consult a wide range of Health Products and Food Branch (HPFB) stakeholders on the Strategic Science Plan, including scientists, academics, health professionals, industry, patients and consumers. These stakeholders will represent HPFB's activities: veterinary drugs, medical devices, food, natural health products, biologics, genetic therapies, pharmaceuticals, and over-the-counter (OTC) drugs. HPFB is committed to listening to interested Canadians.

Additionally, HPFB will consult with other Health Canada staff, other government departments and our provincial/territorial partners.

Date Modified: 2009-10-09

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