Expert Advisory Group On Marketing Of Opioids - Terms Of Reference

1. Context

There is a growing body of evidence that suggests that the marketing practices of opioid manufacturers may be a contributing factor in the over-prescribing of opioids, and in the current opioid crisis in Canada. While there is value in the pharmaceutical industry conveying educational and scientific information about a health product, careful examination is needed to determine the extent to which the pharmaceutical industry’s marketing of opioids negatively influences prescribing practices and, ultimately, patient health.

A wide range of pharmaceutical industry marketing practices exist. This includes a range of direct and indirect activities and incentives that aim to convey information and promote product use. This can include, for example, manufacturer-sponsored presentations at conferences, continuing education programs, advertisements in medical journals, and personal visits from sales representatives. It can also include use of promotional brochures, fees for research, consulting or speaking, reimbursement for travel and hospitality expenses to attend industry-sponsored events, and gifts of meals, equipment, and medical journals and texts.

Health Canada is initiating an Expert Advisory Group on Marketing of Opioids to provide the Department with input and advice regarding the evidence on the extent, impact and value of the pharmaceutical industry’s marketing and advertising of opioids.

2. Mandate

The mandate of the Expert Advisory Group is to provide timely information and advice to Health Canada on the evidence regarding the pervasiveness, value and influence of pharmaceutical industry marketing of opioids. This may include provision of information, assessment of evidence, review of strategic materials, deliberation of regulatory issues and considerations, and provision of broad expert strategic advice.

While the Expert Advisory Group provides Health Canada with input and advice, it is not mandated to make recommendations. Further, Health Canada retains decision-making authority and responsibilities.

3. Scope

In undertaking its work, the Expert Advisory Group will be guided by, but not restricted to, the following questions:

• What types of industry marketing practices, including advertising, of opioid therapies are the most prevalent in Canada, and for what different opioid therapies?
• To what extent do such industry marketing practices influence prescribing behaviour?
• Given the available evidence, are there or could there be negative health impacts as a result of changes in professionals’ prescribing behaviour due to industry marketing of opioid therapies?
• What is the effectiveness of existing systems for oversight and monitoring of industry marketing and advertising to health professionals, including measures to disclose and/or prohibit industry payments? 

4. Reporting Structure

The Expert Advisory Group will report to the Director General of the Policy, Planning and International Affairs Directorate (PPIAD), Health Products and Food Branch (HPFB), who will also act as the Executive Secretary to the Expert Advisory Group.

PPIAD will provide Secretariat support to the Expert Advisory Group.

5. Membership

Members of the Expert Advisory Group will include, but not be limited to, health professionals, researchers/academia, and regulatory experts. Emphasis will be placed on individuals with expertise in areas such as pharmaceutical marketing and promotion, opioids, and prescribing behaviour.

The Expert Advisory Group will include four members, ensuring the appropriate representation of expertise and experience, as well as ability to provide focused advice.

To preserve the independence of the Expert Advisory Group, Health Canada employees will not be eligible to serve as members of the Expert Advisory Group.

Members will be appointed for a one-year term by the Director General, PPIAD, HPFB, or until the dissolution of the Expert Advisory Group when its mandate is complete, as determined by the Director General, PPIAD, HPFB. Further, the Director General, PPIAD, HPFB, has the authority to dissolve the Expert Advisory Group at any time.

6. Roles and Responsibilities

Members of the Expert Advisory Group have a responsibility to Health Canada to offer their independent and objective advice. Member responsibilities are to:

• Review relevant documents provided by or requested from the Executive Secretary/Secretariat
• Apply their expertise and experience to provide informed input to the Expert Advisory Group's deliberations
• Actively participate in meetings and discussions
• Notify the Executive Secretary of any changes in the status of their affiliations and interests as it relates to the mandate of the Expert Advisory Group
• Make a verbal statement of affiliations and interests at the beginning of meetings, when asked by the Executive Secretary

The Executive Secretary is the Director General of PPIAD, representing Health Canada. The Executive Secretary provides leadership in the management of the Expert Advisory Group, including chairing Expert Advisory Group meetings, and setting meetings and meeting agendas in consultation with members and the Secretariat. The Executive Secretary works closely with the Secretariat to receive the input and advice provided by the Expert Advisory Group.

The Secretariat liaises between Expert Advisory Group members and the Executive Secretary, and acts as a resource for members. It works closely with the Executive Secretary to provide strategic advice regarding the management of the Expert Advisory Group. In addition, the responsibilities of the Secretariat are to:

• Coordinate the process to confirm membership, such as the affiliations and interests declarations and security clearances
• Coordinate the preparation of meeting agendas, prepare information packages, and draft the record of proceedings for membership and the Executive Secretary’s  approval
• Maintain information about the Expert Advisory Group, its mandate, or work that may be posted on Health Canada’s website
• Coordinate requests for travel reimbursement
• Carry out additional duties, as appropriate, in support of the Expert Advisory Group

7. Member Resignation

If an Expert Advisory Group member chooses to resign, the member will provide written notice to the Executive Secretary at least 14 days in advance of the member’s resignation date.

8. Member Termination

A member’s failure to act according to the Terms of Reference may give cause for termination. The Executive Secretary will advise the member in writing, stating the reasons for the termination and the effective date.

9. Travel and Expenses

Members will be reimbursed for expenses incurred during their work on the Expert Advisory Group, such as travel and accommodation, according to the Treasury Board Travel Directive and Hospitality Policy.

10. Indemnification and Legal Assistance

All members serve on the Expert Advisory Group on a volunteer basis. In keeping with the Treasury Board Policy on Legal Assistance and Indemnification and Volunteer Policy, members are eligible for the same protection against personal civil liability as federal employees when faced with comparable risks while acting within the mandate of the Expert Advisory Group.

11. Disclosure of Affiliations and Interests

Expert Advisory Group members are expected to act in an unbiased, professional, respectful and fair way at all times. They may not use their position on the Expert Advisory Group for any private or collateral purpose. To be considered for appointment, potential Expert Advisory Group members are required to complete and return to the Secretariat an Affiliations and Interests Declaration Form, a summary of which will be published online. In addition, the Executive Secretary will ask members to verbally state their relevant affiliations and interests at the beginning of Expert Advisory Group meetings.

12. Confidentiality

To support their ability to provide well-informed advice, Expert Advisory Group members may receive confidential information. Therefore, all Expert Advisory Group members will be required to sign a Confidentiality Agreement that will prohibit the disclosure of confidential information received through participation in the Expert Advisory Group. The Executive Secretary will ensure that members receive clear instructions on applicable confidentiality restrictions.

While information on the Expert Advisory Group will be posted and publicly available on request, members’ advice, deliberations and confidential materials will not be publicly disclosed in order to protect the integrity of the policy development process.

13. Media and Communications

All media requests related to the Expert Advisory Group’s activities will be directed to Media Relations, Health Canada. A member may discuss the Expert Advisory Group’s work with media, at conferences or other external events only with prior permission from the Executive Secretary. The Executive Secretary may appoint a member to be the media spokesperson, if required.

14. Security Clearance

All members are required to attain an appropriate security clearance. This may require the member to submit fingerprints to the RCMP. The Secretariat will provide required forms to candidates and will coordinate the process for securing security clearance.

15. Transparency

Health Canada is committed to ensuring transparency by:

• Ensuring that the meeting schedule is arranged in advance and is predictable, where possible
• Publicly posting Expert Advisory Group materials, with confidential and personal information removed. These materials may include:
  • Terms of Reference
  • Membership
  • Summary of expertise, experience, affiliations and interests

16. Meeting Agendas

The agenda and materials for Expert Advisory Group meetings will be determined by the Executive Secretary, in consultation with members and the Secretariat.

17. Meeting Notices and Invitations

Meetings are held at the call of the Executive Secretary. Meeting attendance is by invitation only. The meeting notice is sent to members by the Secretariat. Members will receive the agenda and materials in advance of the meeting.

18. Frequency, Type and Location of Meetings

Meetings will be held on a regular basis, as necessary as determined by the Executive Secretary in consultation with members. More frequent meetings are required at the outset of the Expert Advisory Group to provide advice and inform the development of key products and materials in a timely fashion. Meetings may be held in the National Capital Region, and/or by teleconference.