Expert Advisory Group on Marketing of Opioids - Summary of Expertise, Affiliations and Interests

Purpose

The following table summarizes the information about the experience, affiliations and interests relevant to the Expert Advisory Group on Marketing of Opioids mandate, as declared by Expert Advisory Group members. The Health Products and Food Branch considered these declarations as part of the selection process and has made this summary available as part of its commitment to openness and transparency.

Assessment of affiliations and interests prior to each meeting

Prior to Expert Advisory Group meetings, Health Canada assesses members' affiliations and interests, including direct financial interests, as they may apply to agenda items for discussion. Depending on the nature of the member's affiliations and interests, Health Canada may limit the participation of a member in the meeting or ask him/her to make a verbal statement of affiliations and interests at the beginning of the meeting. Members' affiliations and interests are reviewed and updated as required, based on changes in the status of their affiliations and interests.

In accordance with the Health Products and Food Branch Review of Regulated Products: Policy on Public Input and Health Canada’s Policy on External Advisory Bodies, a person with a direct financial interest in the outcome of a review of a regulated product may be a member of an advisory body whose broader mandate encompasses matters of policy, management, or program development. However, such a member would not be asked to participate in any discussion, or formulation of advice to Health Canada relating to that review.

1. Direct financial interests

1. Current employment, investments in companies, partnerships, equity, royalties, joint ventures, trusts, real property, stocks, shares, or bonds with the regulated industry.

2. Indirect financial interests

1. Within the past five years, payment from a party that has an interest in the mandate of the Expert Advisory Group, including past employment, contracts, or consulting; or financial support including research support, personal education grants, contributions, fellowships, sponsorships, and honoraria.
2. Within the past five years, materials, discounted products, gifts, or other benefits, or attendance at meetings where all or part of the travel and accommodation costs were provided by a party that has an interest in the mandate of the Expert Advisory Group.
3. Within the last three years, grants or other funding from a party that has an interest in the mandate of the Expert Advisory Group to any of the organizations where the member is currently employed or participates in internal decision making.

3. Intellectual interest

1. Within the last five years, any formal advice or opinion to industry; a Canadian federal, provincial, or municipal government; a foreign government; or a non-government organization on a matter of relevance to the mandate of the Expert Advisory Group.
2. Any public statement or publicly stated point of view.
3. Current professional or volunteer affiliations such as membership of professional societies, lobbying, public interest, or advocacy groups.

4. Other

1. Any other affiliations and interests or potential circumstances that might give a well-informed member of the public reasonable grounds for concern regarding the integrity and objectivity of the member’s participation.

Summary of Expertise, Experience, and Affiliations and Interests

Name and indicated sector/perspective and expertise/experience		Summary of responses
Irfan Dhalla	General Internist, Hospital, University, Health Policy.	1a. No		2a. No	2b. No	2c. No	3a. Yes	3b. Yes	3c. Yes		4a. No
		Provided testimony at a United States Food and Drug Administration hearing in 2013 about opioid prescribing and opioid-related harms. Witness at House of Commons Standing Committee on Health in 2016 related to the development of a national pharmacare plan. Author of several research papers and commentaries about opioid prescribing and opioid-related harm. Vice-President of Evidence Development and Standards at Health Quality Ontario, a provincial agency that has made evidence-based recommendations about opioid prescribing. Volunteer Member of the Board of Directors of Physicians for Responsible Opioid Prescribing.
Andreas Laupacis	Hospital, Health Services Researcher, University, NGO, Palliative Care Physician, Evidence Based Medicine, Appropriate Use of Pharmaceuticals, Health Policy.	1a. No		2a. No	2b. No	2c. No	3a. No	3b. Yes	3c. Yes		4a. No
		Advisor for Open Pharma. In the past 5 years has served on Data Safety Monitoring Boards for clinical trials in patients with multiple sclerosis sponsored by Novartis. Currently a Data Safety Monitoring Board member for a clinical trial of a drug for patients with intracranial hemorrhage. Data Safety Monitoring Boards review results of on-going clinical trials, focused on patient safety. Members are paid by industry, but recommendations are made independent of industry involvement.
Trudo Lemmens	University, Health Law and Policy, Public Health, Ethics (Bioethics, Research, Knowledge Production), Pharmaceutical Governance, International Health (PAHO).	1a. No	2a. Yes		2b. No	2c. No	3a. No	3b. Yes		3c. Yes	4a. No
		Presented on the regulation of research ethics committees at a conference organized by the La Asociación de Médicos Especializados en la Industria Farmacéutica (AMEIFAC) (a Mexican Rx&D organization) in conjunction with the National Autonomous University of Mexico. Travel expenses were paid and the speaker fee was donated directly to a non-governmental organization. Publicly advocates for federal action on the opioid crisis and has published widely on the need to strengthen regulatory oversight and transparency in the context of pharmaceutical and medical device production and promotion.
Barbara Mintzes	University, Epidemiology, Population and Public Health, Pharmaceutical Policy, Pharmacoepidemiology, Effects of Direct-to-Consumer Advertising of Medicines, Quality of Information provided by Sales Representatives to Family Doctor, Regulatory Safety Advisories on Medicines, NGO.	1a. No	2a. Yes		2b. No	2c. No	3a. Yes	3b. Yes		3c. Yes	4a. No
		Expert witness for plaintiffs on company marketing practices in two class action suits related to harmful effects of medicines. Advisor for Open Pharma. Interview with media on funding of patient organizations by opioid manufacturers. Co-author of publications addressing regulation of pharmaceutical promotion in Canada and empirical studies of the quality of promotional information in Canada. Publicly advocates for the regulation of pharmaceutical promotion in Canada. Member of the European Network of Health Action International, Association Mieux Prescrire, and the Evidence, Policy and Influence Collaborative at the University of Sydney. Affiliated with the Therapeutics Initiative, a research group based at the University of British Columbia.