Questions and Answers Pertaining to the HPFB Policy on the Voluntary Statement of Information for Public Involvement (VSI-PI)

Q1. What are the benefits of having a Policy on Voluntary Statement of Information for public involvement participants and the Health Products and Food Branch?

• The Health Products and Food Branch believes that it can foster public trust in its activities and decisions by implementing practices that increase transparency.
• Participants will benefit from receiving a Participant Voluntary Information Summary in advance of, or at the beginning of, each public involvement activity that lists the information provided by each participant. The policy also requires that this summary be appended to any public reports or documents resulting from the public involvement activity and posted on the Branch website.

Q2. Why is the drug industry included in the definition of "public stakeholder"?

• Drug companies are corporate citizens, with attendant obligations (eg., paying taxes). As regulatees, these companies have a vested and very significant interest in the regulatory consultative process.

Q3. Why is the policy being proposed as a voluntary process and not mandatory?

• The purpose of the policy is to support increased transparency of the Branch's public involvement activities.
• The Branch's commitment to being a transparent regulatory authority includes developing mechanisms that provide stakeholders with improved opportunities to know about and be engaged in the work of the Branch. Health Canada has no legal authority to compel a participant to provide any information, personal or otherwise, for the purposes of public involvement activities. Therefore, a decision was taken that the provision of information will be voluntary and that participation will not be based on providing any or all of the information on the Participant Voluntary Information Form.
• The Health Products and Food Branch's collection, use and disclosure of information is subject to the requirements of the federal Privacy Act and Access to Information Act. Therefore, if the Branch collects information from participants for the purposes of increasing the transparency of public involvement activities, the participant or individual to whom the information pertains must consent to the Branch's use and disclosure of that information. That consent must be informed and voluntary.

Q4. Has there been any research done on practices and models used in other jurisdictions (e.g. Australia, Korea, EU countries) on dealing with public involvement and declaration of conflict of interest?

• Some research has been done on practices in other jurisdictions that covers other regulatory bodies, publication practices, and conference speakers.
• Examples that were considered best practices include guidelines from the Conseil de l'éducation médicale continue du Québec, the British Medical Journal and the United States Food and Drug Administration.
• The models examined all adopt a voluntary approach to the declaration of competing and or conflicts of interest.
  

Q5. Shouldn't information of a financial nature be quantified? In other words, participants should be asked to indicate (in dollars) the amount of financial support received for an initiative that is being discussed at the public involvement activity?

• Yes, this will be added to the Participant Voluntary Information Form.
• Stakeholders have clearly identified the need and desire to know more about who is "at the table" at any given public involvement activity. This desire goes beyond funding issues and includes such things as an organization's mandate, size and governance structure.

Q6. Why is the title of the policy HPFB Policy on Voluntary Statement of Information for Public Involvement, and the process not reflective of the issue of conflict of interest/competing interests?

• As part of the work OCAPI is doing to address the issue of "stakeholder representation", stakeholders indicated that the issue in question went beyond whether a participant had a conflict of interest/competing interest on an issue being discussed at a public involvement activity. It was discussed as an issue of transparency. Participants wanted a process in place that would allow them to know who is "at the table" at any given public involvement activity.

Q7. Why is the definition of "conflict of interest" in the policy taken from the Treasury Board of Canada Secretariat's policy on Conflict of Interest and Post-Employment Code for the Public Service?

• The OCAPI Project Team wanted to use a Canadian standard for the definition.
• Based on external feedback, we have modified the definition used by the International Committee of Medical Journal Editors for the Policy.
• The revised definition in the Policy is as follows:
  Conflict of Interest exists when an individual or the individual's organization has financial or personal relationships that inappropriately (bias) influence his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from those with negligible potential to those with great potential to influence judgment, and not all relationships represent true conflict of interest. The potential for conflict can exist whether or not an individual believes that the relationship affects his or her judgement. Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine credibility. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion.

Q8. Will the Participant Voluntary Information Summary also be made available publicly?

• Yes, a copy of the Summary will also be appended to any publicly available reports resulting from the activity and will be posted on the Branch website.

Q9. How is this Policy different from the Lobbyist Registration Act?

• The policies are similar in that both are intended to support increased transparency in government processes. However, the Policy on Voluntary Statement of Information is not legislated as is the Lobbyist Registration Act.