A Fresh Start: Final Report of the ONHP Transition Team

2.0 Organizational Structure

Throughout its deliberations the Transition Team recognized the need to design an innovative regulatory system for natural health products in Canada, which encourages the full participation of clients, stakeholders and the public. Critical to this task is the assurance that the organizational structure promotes open and transparent decision making and serves as an incubator for new ideas and novel approaches to product regulation and public awareness of NHPs.

Staffed with individuals with expertise in the field of NHPs, the ONHP is envisioned to be a lean, efficient and flexible organization, which can adjust to varying demands quickly and effectively. Open, creative, accountable and entrepreneurial, the proposed structure of the Office and its administrative positions is non-hierarchical; decision making and delegation of authority are more horizontal than vertical in nature. Such a structure encourages synergy and teamwork rather than confinement to rigidly defined roles of authority (see operational model, page 9).

Natural Health Products:
A New Vision

3. The Government give consideration to the advisability of creating a new regulatory authority for NHPs that reports directly to the Assistant Deputy Minister of the Health Protection Branch.

4. The structure for this new regulatory authority be established within the next six months and be permanently staffed by individuals with expertise and experience in the field of NHPs.

5. The selection of personnel be agreeable to both government and NHP stakeholders.

The Executive Director acts as the central coordinator, while individual directors, or Team Leaders, oversee the areas of product regulation, research and program development, policy and regulatory affairs, and outreach and communications. Division of labour into these management teams or Points of Delivery (PODs) encourages innovation, teamwork, synergy, flexibility and cost efficiency. It is proposed that central staffing requirements be minimal, with a small core of staff fulfilling daily office tasks and responsibilities for each POD. It is also proposed that much of the work be out-sourced, thus negating the natural tendency of inefficient and self-perpetuating bureaucratic growth. Such out-sourcing must, necessarily, be accomplished in a manner which maintains the integrity of the ONHP, its mandate and its mission.

Organizational Model of the ONHP

2.1 Executive Director

The Executive Director leads the ONHP and reports to the Assistant Deputy Minister, HPB, Health Canada. The Executive Director will solicit counsel, as desired, from the Expert Advisory Committee (EAC) and from the Transition Advisory Team (TAT) on matters where guidance is sought. The Executive Director orchestrates the strategic direction of the ONHP, providing vision, purpose and principle-centered leadership. Specifically, the Executive Director:

1. develops integrated and coordinated approaches in managing policy and program files on behalf of the Assistant Deputy Minister;
   
   
2. consults on an ongoing basis with the EAC;
   
   
3. directs the implementation of a policy and regulatory framework for evaluating the evidence supporting claims, safety and quality of NHPs;
   
   
4. provides communications activities and coordinates policy activities across Canada;
   
   
5. liaises with central agencies on key policy directions;
   
   
6. represents Health Canada with major clients and partners;
   
   
7. promotes across Health Canada the current government and ministerial priorities;
   
   
8. advises senior management on evolving policy, political and societal developments, and their impact on corporate priorities and planning;
   
   
9. provides ongoing pulse-taking and analysis;
   
   
10. develops and tracks progress in the implementation of the ONHP business plan; and,
    
    
11. provides leadership in utilizing the ONHP as an instrument of change and a catalyst in propelling Canada toward a more holistic and wellness-centered, healthcare paradigm.

After considerable deliberation regarding the specifics of this key position, the posting was advertised nationally and a final candidate hired. Phil Waddington, ND, has now assumed his post with the Office.

2.2 Director, Policy and Regulatory Affairs

The Director of Policy and Regulatory Affairs is accountable for conceptualizing and designing the required regulatory and policy framework for the ONHP, defining relevant policy issues and developing methodologies for policy analysis and program design.

Natural Health Products:
A New Vision

51. Health Canada work with Foreign Affairs and International Trade to ensure that existing International Agreements that currently protect biological diversity are not violated and that additional strategies are developed if needed to prevent depletion of these valuable health resources.

The Director provides strategic and tactical advice to senior management regarding program, policy and legislative issues and liaises extensively on ONHP priorities, including legal and product definitions, standards, compliance and enforcement. The Director provides direction and support for related policy and program development within and outside Health Canada, works with the EAC and stakeholders to develop and implement an ONHP regulatory, product licensing and administrative framework, and contributes to the strategic direction of the ONHP as a member of the management team.

2.3 Director, Research and Program Development

The Director of Research and Program Development is accountable for developing and implementing the ONHP's strategic research agenda, identifying relevant research needs, overseeing the development of a research framework and strategy for the ONHP, evaluating the effectiveness of the research framework and directing adjustments to approaches and methodologies. The Director liaises with and negotiates research partnerships with other federal, provincial, territorial and private agencies in order to attract additional research funds from external sources, integrates and distributes relevant NHP research findings to stakeholders and contributes to the strategic direction of the ONHP as a member of the management team.

Natural Health Products:
A New Vision

45. The federal government research bodies, including Health Canada, begin immediately to encourage research on NHPs. This could include studies focussing on the interactions of herbal products with conventional medications as well as studies that explore different uses by various groups in Canada.

2.4 Director, Outreach and Communications

The Director of Outreach and Communications oversees the dayto- day information and communications needs of the ONHP and its interactions with other government agencies, stakeholders and the general public. The Director works with other ONHP Directors to fulfill demand for information from all stakeholders, both domestic and foreign, including: other governmental and nongovernmental agencies, practitioners, educators, researchers, suppliers of NHPs and the general public.

Natural Health Products:
A New Vision

42. Health Canada immediately utilise existing formats and forums for more open and transparent communication on NHPs with the broader public and practitioners.

43. Communication efforts include details about decisions and actions regarding NHP products (removal from market, change of status, etc.).

44. Relevant consumer, industry and practitioner groups be consulted on a regular basis about the nature of the required information.

The Director is accountable for conceptualizing and implementing a communications strategy to allow Canadians to make informed choices on NHPs. The Director manages the development of a strategic communications plan for the ONHP, develops a consultative process on proposed regulatory changes, and evaluates and identifies public needs with regard to NHPs. As well, the Director contributes to the strategic direction of the ONHP as a member of the management team.

2.5 Director, Product Regulation

The Director of Product Regulation is accountable for implementing criteria, standards and review processes for facility and product licensing and the evaluation of product safety, quality and claims. The Director oversees the development of product monographs and databases for NHPs, regulates product labelling and marketing, and implements inspection, investigation, enforcement and post- market surveillance. The Director recommends to the Executive Director the issuance of product/facility licenses, manages GMP inspection and NHP compliance procedures, and contributes to the strategic direction of the ONHP as a member of the management team.

Natural Health Products:
A New Vision

48. The new regulatory framework for NHPs be enforced in a regular and consistent manner and done in conjunction with education.

7. All relevant inspection personnel be provided with training specific to NHPs.

18. Inspection activities be performed consistently and on a regular basis by inspectors knowledgeable about the products.

The Transition Team recommends that:

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.

The Transition Team further recommends that:

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.

2.6 Expert Advisory Committee

The Expert Advisory Committee (EAC) has been populated with individuals having strong knowledge and experience with NHPs in order to provide expert advice and opinion to the ONHP. Issues of interest related to the safety, quality and effectiveness of natural health products and matters regarding the development and implementation of regulations for NHPs may be referred to the EAC. The collective expertise from the EAC will assist the management team in making decisions; however, final responsibility and authority remains within the ONHP. The EAC reports directly to the Executive Director, ONHP.

2.6.1 Mandate

The mandate of the EAC is to provide the ONHP with timely, expert advice with respect to questions on the safety, use and regulation of NHPs. Questions referred to the EAC from the ONHP may be from a broad range of issues, but will focus on areas where detailed or difficult evaluation is required. Such issues referred for advice and recommendation may include (but will not be limited to) the following, as required:

1. providing advice to implement the new regulatory environment;
   
   
2. developing procedures to create new Canadian monographs based on nationally and internationally collected information;
   
   
3. establishing specific requirements for product labelling;
   
   
4. evaluating data sources used to establish safety, quality and health claims;
   
   
5. evaluating data submissions to establish safety, quality and health claims;
   
   
6. providing advice on specific issues related to reported adverse reactions, incidents and effects;
   
   
7. evaluating critical situations concerning the safety of a product or ingredient; and,
   
   
8. advising on research needed to support regulatory decisions.
   

2.6.2 Membership

The inaugural EAC has been proposed by a screening committee selected by the Assistant Deputy Minister (ADM), Health Protection Branch (HPB) in consultation with members of the Transition Team. The EAC will be chaired by a member external to the Public Service of Canada and chosen by the ADM, HPB. Subsequent members and Chairpersons will be chosen by the Executive Director, ONHP.

Members have been, and will be, identified through broad consultation with stakeholder groups, including: health professional and scientific societies, academia, industry associations, consumer associations and government agencies. The membership of the committee will endeavour to reflect an appropriate blend of gender, regional, ethnic and linguistic representation for Canada.

Natural Health Products:
A New Vision

9. An Expert Advisory Committee be established immediately to assist Health Canada in the general and specific tasks necessary to design a new NHP regulatory environment.

10. This Expert Advisory Committee review the re-establishment options for an NHP section with research and laboratory capacities and report its findings to Health Canada.

11. The selection of members for the Expert Advisory Committee be agreeable to both NHP stakeholders and Health Canada.

6. When necessary, working groups reflecting the various segments that make up the NHP category be set up to advise the new regulatory authority.

Members have been, and will be, selected for their knowledge and expertise in NHPs. Members have been, and will be, appointed as individuals on the basis of their expertise and will not represent their firms, organizations or associations directly. They will serve in the best interests of all Canadians, recognizing the roles and responsibilities of all stakeholders in optimizing access to, and the safe use of, NHPs.

The EAC may form sub-committees or seek out ad hoc members, where necessary, to ensure adequate expertise on matters referred to the committee. Sub-committee and ad hoc members will be selected by the EAC with the concurrence of the Executive Director.

Health Canada staff will provide secretariat support and may actively participate in discussions, as observers, at the call of the Chair.

2.6.3 Tenure

The EAC Chairperson and committee members will be appointed for a two or three year term at the discretion of the Executive Director, ONHP. There may be consideration for reappointment to office up to a maximum period of six years. Appointments shall be scheduled to ensure continuity and systematic rotation of membership within the EAC. Committee members who are absent from three consecutive meetings of the EAC may forfeit membership in the committee.

An individual may withdraw from service on the EAC at any time, upon written notification to the Executive Director. Membership may be terminated at any time, upon written notification from the Executive Director.

2.6.4 Management and Administration

The EAC will be managed and operated under the guidelines for Expert Committees established by Health Canada. These include security and conflict of interest issues as well as administrative guidance regarding compensation and management of the committee activities.

2.6.5 Compensation

Members of the EAC will be remunerated for time and compensated for travel expenses, according to Federal Government policy.

The Transition Team recommends that:

the mandate and structure of the Expert Advisory Committee, as outlined in Section 2.6 of the report, be accepted as proposed.

2.7 Transition Advisory Team

While not specified in the recommendations of the Standing Committee on Health, the ONHP Transition Team identified the need to ensure that the vision and spirit of the 53 recommendations continue to be reflected in the new operational framework. The Transition Team agreed on the need for an ongoing management advisory body, to consist of a subgroup of Transition Team members. Such a body will ensure a continuity of vision and carry forward the spirit and intent of the Standing Committee recommendations and the subsequent work of the Transition Team.

The Transition Team recommends that:

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.

The Transition Team further recommends that:

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.

2.8 Management of NHPs within HPB

The Transition Team recognizes that there may be activities within the Health Protection Branch (HPB) that will overlap and duplicate the activities of the ONHP. The Transition Team also recognizes the ONHP as the pre-eminent regulatory body for natural health products.

The Transition Team recommends that:

The Assistant Deputy Minister, 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.
   

Natural Health Products:
A New Vision

52. The interim enforcement policy regarding NHPs continue to be applied until the new framework is in place.

The Transition Team further recommends that:

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.