A Fresh Start: Final Report of the ONHP Transition Team

Executive Summary

On March 26, 1999, the Minister of Health, the Honourable Allan Rock, announced the Government's acceptance of all 53 recommendations made by the Standing Committee on Health in its 1998 report on natural health products.¹ In accordance with the Standing Committee's report, the Minister acted to initiate the creation of a new Office of Natural Health Products (ONHP) under the direction of the Assistant Deputy Minister, Health Protection Branch. In addition, the Minister announced the creation of an ONHP Transition Team to ensure an appropriate process to build public confidence in a new approach to the regulation of natural health products (NHPs).

The mandate of the ONHP Transition Team was to structure an administrative and regulatory framework and identify broad policy directions to assist Health Canada in implementing the 53 recommendations made by the Standing Committee on Health in its landmark report.

Since its inception, the Team has made substantive progress in conceptualizing and delineating an operational framework for the newly created office. During the process, the Team moved forward on a number of fronts. The task has been both provocative and rewarding. Throughout the process, the Team has been guided by the 53 recommendations as presented by the Parliamentary Standing Committee on Health and accepted by the Government.

The following recommendations are the embodiment of almost ten months of creative effort of the ONHP Transition Team, submitted for the Minister's consideration. They lay the foundation for a fresh start in the regulation of natural health products in Canada. Hopefully, they also will act as a catalyst in helping to move Canada toward a more pro-active, holistic health care paradigm.

Creating the Vision

1. Mission Statement: The mission of the Office of Natural Health Products is to ensure that all Canadians have ready access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

2. Vision Statement: The new Office of Natural Health Products shall be:

1. acknowledged as the national authority for the regulation of natural health products used in Canada;

2. recognized worldwide as a leader in natural health product regulation;

3. a leading national and international partner in the management of natural health products; and,

4. the vehicle for Health Canada to create and maintain an innovative regulatory environment, based on a wellness model that will set a global standard in natural health product regulation.

Organizational Structure

3. Organizational Structure: The organizational structure of the ONHP, including the Executive Director, Director of Policy and Regulatory Affairs, Director of Research and Development, Director of Outreach and Communications, and Director of Product Regulation, as outlined in Sections 2.1 to 2.5 of the report, be accepted as proposed.

4. Field Inspectors: The ONHP should ensure that field inspectors carrying out the duties of the Office are trained and knowledgeable about NHPs and that inspection duties are performed consistently and on a regular basis to ensure uniform enforcement of regulations across the country.

5. Expert Advisory Committee: The mandate and structure of the Expert Advisory Committee (EAC), as outlined in Section 2.6 of the report, be accepted as proposed.

6. Transition Advisory Team: A sub-group of four to five ONHP Transition Team members, with a quorum being three members, should be retained on an interim basis to serve as a Transition Advisory Team (TAT). The TAT should be assembled at the call of, and report to, the Executive Director. The TAT should provide ongoing advice and counsel to help ensure that the vision and intent of the Standing Committee and ONHP Transition Team recommendations continue to be reflected in the new Office and operational framework. While travel and accommodation expenses should be paid, members should not receive any remuneration for their counsel.

7. Ongoing Consumer Representation: Upon the winding down of the TAT, the Executive Director should ensure that a consumer representative, having strong knowledge in and experience with NHPs, be appointed to the EAC.

8. Management of NHPs within HPB: The Assistant Deputy Minister, Health Protection Branch (HPB), should:

1. play a strong role in coordinating the policy and regulatory activities of the Branch's various regulatory units with respect to NHPs;

2. ensure that such policy and regulatory activities do not result in duplication and/or inconsistent regulation; and,

3. immediately begin to coordinate regulatory activities based on the leadership provided by the ONHP.

9. Interim Management Strategy: In the interim and until such time as the regulatory framework is fully implemented, Health Protection Branch (HPB) immediately implement an Interim Management Policy for the current regulation of NHPs. This policy should include the following:

1. the ONHP Executive Director should be the level of interim management contact and decision making;

2. all matters of regulatory action on NHPs (or those products deemed NHPs under the ONHP's working definition) proposed by any HPB Directorate or other branch of Health Canada should be undertaken through the ONHP; and,

3. all regulatory decisions and actions should be conducted in an open manner and reported with full explanatory communications to all stakeholders and the Canadian public in a timely fashion.

Regulatory Framework

10. Working Definition of a Natural Health Product: The ONHP and Health Canada should work toward appropriate legislative or regulatory change to ensure that the legal interpretation of natural health products (NHPs) clearly differentiates these products from foods and pharmaceuticals.

11. Site Licensing: The specified criteria deemed essential for an effective ONHP site licensing program, as outlined in Section 3.2.1 of the report, be adopted as proposed.

12. Importation for Personal Use: The ONHP, in conjunction with Health Canada's Legislative Renewal Initiative, develop a regulatory provision which clarifies the reasonable grounds respecting the importation of NHPs for personal use.

13. Product Licensing - Guiding Principles: The Guiding Principles for developing a product licensing system, as outlined in Section 3.2.2(a) of this report, be adopted as proposed.

14. Product Licensing - Establishing Safety, Quality and Claim: The ONHP should adopt a process for product licensing which relies on two basic methods for establishing the safety, quality and claim of products:

1. the use of available evidence, including non-attestable monographs, on a product-byproduct review and assessment process; and,

2. the use of ONHP-approved attestable monographs against which lower risk product applications can be audited.

15. Product Licensing - Monographs: Monographs should be subject to a process of regular review, update, revision and assessment of risk.

16. Lower Risk Products with Attestable Monographs: The ONHP should adopt an approach to optimizing the use of ONHP-approved attestable monographs which has, as its initial approach, a pre-market audit process with a 45 calendar day limit on government response to the application.

17. Lower Risk Products - Post-Market Notification Trial Project: Within three years of the coming into force of the new regulations, the ONHP should move to further optimize the monograph system. Specifically, a trial project utilizing a post-marketing notification to product registration should be implemented and evaluated for a limited number of ONHP-approved attestable monographs. If successful, the ONHP could further expand the use of such a post-market system.

18. Lower Risk Products without Attestable Monographs: For lower risk products without ONHP-approved attestable monographs, the provision of acceptable evidence, consistent with the margin of safety of the product, should be required for assessment of the product by ONHP.

19. Higher Risk Products: For higher risk products, performance standards for the review and assessment of submissions should be set in consultation with stakeholders.

20. Cancellation of Product License: The conditions under which the Executive Director may cancel licenses need to be set out in regulations. Product recall, product seizure and other compliance activities should be available to the Director and subject to a timely appeal process by the marketer.

21. Public Registry: A public registry of all ONHP registered products, that is easily accessible by the public and stakeholders, should be established; the registry should include the product name, active ingredients, registration number and company name for each product.

22. Electronic Submissions: An electronic submission system should be established for all product reviews, and in the case of products for which there is an ONHP-approved attestable monograph, an electronic submission and review system for abbreviated assessments (or audits) should be developed.

23. Good Manufacturing Processes: The ONHP begin consultation with manufacturers, packagers and importers to develop the specific regulatory requirements and guidelines for good manufacturing practices (GMPs) of natural health products, which will assist inspection and compliance to GMP regulations.

24. Standards of Evidence:

1. The evidence to support the safety and claim of a product must not be limited to double blind clinical trials, but may also include other types of evidence, such as generally accepted and traditional references, published monographs, expert opinion reports, other types of clinical trials and other clinical or scientific evidence;

2. the ONHP, with the assistance of the EAC, should establish a list of acceptable references, develop the criteria for ONHP-approved monographs and develop criteria for linking levels of evidence to health claim validity; and,

3. claim approval by the ONHP, on the basis of scientific evidence, should be allowed to be applied to other products, with supportive scientific evidence of at least an equal level of claim assessment.

25. Administrative Lists: The ONHP develop an administrative list of NHP categories based on the proposed working definition. The list should include broad categories of products, such as those set out in the working definition, and there should be flexibility in the inclusion of products in the list and a means to amend such a list. Monographs for products which fall into these categories and which meet the criteria developed for monographs used in audit applications should be adopted by reference to other standards.

26. Determination of Risk: The specified factors deemed essential for an effective determination of risk, as outlined in Section 3.2.5(e) of this report, be adopted as proposed.

27. Post-Market Monitoring: The specified criteria deemed essential for an effective postmarket monitoring program, as outlined in Section 3.2.5(f) of the report, be adopted as proposed.

28. Product Labelling: The specified criteria deemed essential for an effective labelling program, as outlined in Section 3.2.6 of the report, be adopted as proposed.

29. Product Labelling - Standing Committee Recommendations: The ONHP develop the policy framework to address the spirit and intent of recommendations 23 and 24 of the Standing Committee's report.

30. Penalties for Non-Compliance: The specified criteria deemed essential for an effective, yet reasonable, program of compliance, as outlined in Section 3.2.7 of the report, be adopted as proposed.

31. Cost Recovery: Fees imposed by the ONHP should adhere to cost recovery and charging policy guidelines, adopted April 1997, by the federal Treasury Board. In establishing such fees the ONHP should undertake meaningful consultations with clients to ensure that those who must pay for the service have a voice in the design and delivery of such service. The aim of consultations should be to avoid the imposition of unfair or unreasonable cost burdens on clients, while ensuring necessary rigour in the licensing and regulatory process. Any fees imposed should be directly related to, and reflect fairly, the cost of service and should be subject to proper impact assessments.

32. Appeals Mechanism: The Appeals Mechanism, including the structure of the Appeals Committee, proposals for cost recovery, use of expert advisors, time frame for review, formulation of a guidance document and proposals for consistency of application, as outlined in Section 3.3 of the report, be adopted as proposed.

Modifications to Current Regulations

33. Vitamins, Minerals and Amino Acids: Divisions 4 and 5, Part D of the Food and Drug Regulations should be repealed and replaced by the NHP regulatory framework.

34. Schedule F: Changes to Schedule F should continue to follow the current administrative processes to ensure adequate consultation where required; however, the need for gazetting in addition to this process should be removed. Schedules should become administrative lists and scheduled products should have their conditions of sale attached to their product licenses

35. Division 8: Division 8 should be amended to reflect a relative-risk product licensing system, as well as the cultural, philosophical and historical context of product usage.

36. Section 3 and Schedule A: Section 30(1) of the Food and Drugs Act should be invoked to remove all diseases listed in Schedule A; Sections 3(1) and 3(2) should be revoked through the Legislative Renewal Initiative.

37. Sampling: Current sampling restrictions should be removed from the Food and Drugs Act through the HPB Legislative Renewal Initiative. More appropriate guidelines and regulations should be drafted to reflect the relative risk of the product.

Research

38. National Repository: The ONHP should establish itself as a national repository for current NHP research that will assist in the development of future research proposals.

39. Peer Review: The ONHP should act as a disseminator of peer-reviewed published research and other reliable information to researchers, consumers and all other interested parties.

40. Catalyst for Wellness-centered Research: The ONHP should foster research on natural health products in the areas of safety, effectiveness, quality and health economics by acting as a catalyst in the stimulation of wellness-centered research, utilizing NHPs.

41. Research-based Market Incentives: The ONHP should develop market incentives to encourage continued research into new claims for established products.

Communications

42. Support and Promotion of the ONHP: The Minister of Health should offer visible public support and promotion of the ONHP through media activities focussing on the work of the Office as well as NHP policy and/or regulatory changes; the Minister should incorporate Health Canada's commitment to NHPs as part of all public representations on wellness.

43. Stakeholder Consultation: The ONHP should move quickly to utilize the communication tools outlined in its Strategic Communications Framework and develop a process for stakeholder consultation on proposed regulatory changes in concert with the new Office of Consumer Affairs and Public Involvement.

Position Statements

44. Wellness - ONHP as a Catalyst for Change: The mandate of the new ONHP should be expanded to allow it to function as an effective catalyst for change toward a more holistic and pro-active, wellness-centered model of healthcare delivery in Canada. As an agent for such change, the ONHP should:

1. increase public awareness of the benefits of prevention, wellness and self-care;

2. promote lifestyle change and the benefits of prevention, wellness and self-care, particularly among our youth and emerging adult sectors;

3. promote a wellness model of healthcare delivery that accommodates and celebrates the cultural and ethnic diversity of Canada;

4. encourage research that further defines the benefits of prevention, wellness and selfcare with respect to health optimization and risk reduction; and,

5. act as an International Ambassador for a wellness-centered model of health management.

45. Wellness - Minister's Role: The Minister of Health should become the 'Champion of the Cause' for wellness and work toward establishing Canada as a global leader in the evolution toward a more holistic, pro-active and wellness-centered, healthcare paradigm.

46. Wellness - Financial Incentives: The Minister of Health should work with stakeholders and other government authorities to develop a comprehensive program of incentives which will promote greater use of prevention, wellness and self-care by Canadians.

47. Codex Alimentarius: A position paper should be prepared outlining Canada's new position on NHPs for dissemination to all government officials with responsibility for international trade and relations, including Canada's Codex delegation. This briefing document should delineate the following:

1. the background leading up to the Minister's announcement of the new Office of Natural Health Products and its regulatory regime;

2. the definition and scope of NHPs within the new regime;

3. the new regulatory class of NHPs as separate from foods and drugs;

4. an organizational overview of the new Office of Natural Health Products and identification of relevant contact points;

5. a summary of key initiatives to be undertaken;

6. a strategic approach to facilitate the dissemination of Canada's new position on NHPs to relevant foreign officials; and,

7. a strategic approach to facilitate the dissemination of Canada's position on the regulation of NHPs at the next meeting of Codex, to be convened in Bonn, Germany in June, 2000.

48. Genetically Modified Organisms - Labelling: Consumers should be allowed to make an informed choice through mandatory GMO labelling of genetically modified NHPs and excipients. In the interim, the ONHP should create a framework and develop standards to allow the labelling of non-GMO natural health products, including both active ingredients and excipients, and should liaise with other government departments and agencies to effect the necessary changes to make this possible.

49. Cultural Considerations - Guidelines for Use: The ONHP should be cognizant of traditional and culturally-based practices and, where circumstances require, give full consideration to, and tailor specific guidelines for, the use of culturally-based NHPs.

50. Cultural Considerations - Standards of Evidence: The ONHP should recognize and accommodate the traditional cultural references, terminologies and concepts of ethnic minorities as part of the standards of evidence for purposes of licensing, and ensure proper and thorough consultation by engaging respective cultures and foreign governments as a necessary part of the ONHP's consultation process.

51. Role of the Practitioner: a pan-Canadian conference of federal, provincial, territorial and First Nation health representatives, and leaders and educators of the various traditional associations and teaching institutions, and practitioners should be convened to initiate and facilitate communication and education of all stakeholders. The objectives of this process should include:

1. education and sensitization of federal, provincial and territorial governments on natural healthcare (NHC) practitioners' practices and conventions;
   
   
2. education and sensitization of NHC practitioners to government regulatory and safety issues;
   
   
3. education of governments on current impediments to traditional practices;
   
   
4. implementation of joint efforts to support and better regulate the practice of traditional medicines in Canada within the context of insuring public safety; and,
   
   
5. publication of conference proceedings and position papers to facilitate the development of appropriate regulatory frameworks at the provincial and territorial levels.

It is with a sense of pride and accomplishment that the Transition Team for the Office of Natural Health Products presents the foregoing recommendations to the Minister of Health, unanimously endorsed by all members of the Team.

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¹ Natural Health Products: A New Vision. Report of the Standing Committee on Health, November 1998.