International Cooperation in Health Regulation - RFP 020 Request for Proposals for Primary Research

FUNDING AND GENERAL INFORMATION

• Deadline for applications: November 25, 2004 (must be courier stamped November 24, 2004 for next day delivery).
• Up to $1,000,000 has been set aside in this competition for the support of up to six research projects. Maximum funds per project: $300,000. Contribution funding will not exceed 24 months.
• Applicants should consult the Eligible Activities section of the HPRP Guide to research project funding. Applications for pilot, demonstration, implementation or evaluation projects will not be accepted.

Proposals must:

• add to the body of knowledge regarding the role of international regulatory cooperation (IRC) in health regulation; and
• produce findings that can be applied to the multiple products and services regulated by Health Canada¹.

SCOPE OF COMPETITION

Objective

Health Canada seeks information to support its policy decisions regarding engagement in IRC activities. As Health Canada has a long history of working in the global regulatory community, the issue is not whether to cooperate, but how to ensure the best outcomes in the delivery of ongoing regulatory programs and in the development of new regulatory frameworks.

Background

For the purposes of this competition, IRC is defined as cooperation (either bilaterally or multilaterally) between governments, agencies, or organizations, on regulatory activities, where this may include:

• the development of legislation, regulation or standards, and
• any related activities, e.g., the development of harmonized regulatory processes², etc.

Regulatory cooperation therefore covers a range of activities including, but not limited to: information sharing; laboratory collaborations; joint review; parallel review; development of memoranda of understanding; preparation of mutual recognition agreements; and harmonization of data requirements or scientific assessment processes.

IRC is becoming more common as regulatory authorities around the world must deal with issues that transcend a single population or jurisdiction. Other driving forces for a move toward increased IRC include globalization, the attendant increased movement of products and services, and in the health context, the need to address rapid advances in technology. The desire for efficiency and transparency in regulatory approaches is also an important driver for increased IRC. And yet, regulators must continue to adhere to the Government of Canada Regulatory Policy³, which states that the government's regulatory activity must both serve the public interest, and ensure that resources are focussed where they do the most good.

In 2002, the Government of Canada launched the Smart Regulation initiative, with a view to developing a regulatory strategy that meets the challenges of a 21^st Century policy environment. The External Advisory Committee on Smart Regulation (EACSR)⁴ was established in 2003 and given the mandate of proposing a regulatory strategy that promotes and enhances Canada's social and economic interests in parallel. While the EACSR has yet to release its final report, its preliminary research supports the value of international agreements, and encourages regulators to take full advantage of opportunities for cooperation with other governments. Health Canada considers the EACSR focus as an opportunity to expand our knowledge on specific questions pertaining to IRC.

There is evidence in the literature to suggest that engagement in IRC requires consideration of a number of factors, and these factors may vary depending on the nature of the IRC engagement^5,6 and/or the nature of the product sector to which IRC is being applied⁷. Health Canada seeks research that moves beyond the existing literature, to provide evidence applicable to a range of IRC activities, and to the range of products and services it regulates.

RESEARCH QUESTIONS

1. How does the analysis of the health, economic, legal, and social policy advantages and disadvantages of harmonization of standards or processes with other jurisdictions help in determining when to harmonize? The application of innovative methodologies to real situations is encouraged.

2. How can public confidence in Canada's regulatory decisions be maintained or even strengthened if decisions are based, in whole or in part, on foreign information and/or analysis? How can the public's values and views on IRC issues be determined and given appropriate consideration prior to and during engagement with other governments, agencies or organizations?

3. What are the enablers and challenges relating to the successful implementation of international cooperative arrangements⁸ (binding and non-binding)?

4. What criteria or considerations could be applied in monitoring IRC, evaluating the impact of IRC activities on Health Canada's regulatory programs, and in carrying out effective performance measurement of IRC activities?

5. How might IRC be used to address international public health or humanitarian assistance goals?

POLICY CONTACT

Applicants must get in touch with the policy contact at least once during the development of their application. The policy contact is responsible for ongoing interaction with researchers on the policy issues and context. Inquiries should be directed to: Jocelyn Kula, Manager, Departmental Regulatory Affairs Secretariat, Health Policy Branch, tel.: (613) 952-3125, Email: jocelyn_kula@hc-sc.gc.ca.

ADMINISTRATIVE CONTACT

Inquiries regarding registration, eligibility/ineligibility, administrative questions about time frames and budgets, application formatting and content, the review process, and terms and conditions of the HPRP should be directed to: Sherrill MacDonald, tel.: (613) 954-0830; email: sherrill_macdonald@hc-sc.gc.ca

HOW TO APPLY

Applicants are required to register in order to obtain an application form. Applications must be received by November 25, 2004 (must be courier stamped November 24, 2004 for next day delivery).

Applicants should consult the HPRP Guide to research project funding before registering, which can be found at: http://www.hc-sc.gc.ca/iacb-dgiac/arad-draa/english/rmdd/guide/eguide.html

Bibliography

External Advisory Committee on Smart Regulation. (2003). The Regulatory Process: Enabling Smart Regulation A Dialogue with Stakeholders. Retrieved July 13, 2004, from http://www.smartregulation.gc.ca/en/03/01/bk-03.asp

Health Canada. (2000). Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks. Retrieved July 13, 2004, from http://www.hc-sc.gc.ca/hpfb-dgpsa/hcrisk_e.pdf

Privy Council Office, Government of Canada. (2003). Regulatory Cooperation Between Governments. Retrieved July 13, 2004, from http://www.pco-bcp.gc.ca/raoics-srdc/docs/publications/regulatory_coop_gov_e.pdf

References

1. For a list of products subject to regulation by Health Canada, please see: Health Canada. (2003). Health Canada, 2003-2004 Estimates, Part III - Reports on Plans and Priorities. Retrieved July 13, 2004 from http://www.tbs-sct.gc.ca/est-pre/20032004/pdf/health-e.pdf

2.Where regulatory harmonization refers to the establishment, recognition and application, by at least two governments, agencies or organizations having identified a mutual benefit in working together, of common regulatory processes or standards applied in determining compliance with regulation.

3. Government of Canada Privy Council Office. (1999). Government of Canada Regulatory Policy Retrieved July 13, from http://www.pco-bcp.gc
.ca/raoics-srdc/default.asp?Language=E&Page=Publications&Sub=
GovernmentofCanadaRegula

4. External Advisory Committee on Smart Regulation. (2004). International Regulatory Cooperation. Retrieved June 28, 2004, from http://www.smartregulation.gc.ca/en/05/01/i1-01.asp

5.Raustiala, Kal. (2000). Compliance and Effectiveness in International Regulatory Cooperation. Case Western Journal of International Law. Volume 32: 387-440.

6. Abraham, John and Tim Reed. (2001). Trading Risks for Markets: The International Harmonisation of Pharmaceuticals Regulation. Health, Risk & Society, Vol 3, No. 1, 2001, 113-128.

7. Indech, Barbara. (2000). The International Harmonization of Human Tissue Regulation: Regulatory Control Over Human Tissue Use and Tissue Banking in Select Counties and the Current State of International Harmonization Efforts. Food and Drug Law Journal, 55 (3), 343-72.

8.Where international cooperative arrangements are the written documents that define the terms under which governments have elected to work together; they are either binding (governed by international law), e.g., treaties or international agreements, or non-binding, e.g., memoranda of understanding