HPRA establish Compliance Programme on Advisory Boards
The Health Products Regulatory Authority (the “HPRA”) has established a new compliance programme in relation to Advisory Board meetings. This programme is effective from 1 January 2021 and applies to Market Authorisation Holders (“MAH”).
The Irish Pharmaceutical Healthcare Association (“IPHA”) has also included a new Annex (Annex VI) on the conduct of Advisory Board meetings in its updated Code of Practice for the Pharmaceutical Industry. These developments make it clear that this area is coming under increasing scrutiny from a compliance perspective.
1. Notification Requirement for an Advisory Board Meeting
The HPRA have stated that from 1 January 2021, MAHs or their affiliates in Ireland must notify the HPRA (via email to email@example.com) in advance of holding any Advisory Board meeting in Ireland or outside Ireland if the meeting is organised (in part or in full) by MAHs or their affiliates in Ireland, and/or which include healthcare professionals or other persons from Ireland as advisors. Ideally, this notification would be made six weeks in advance of the meeting. A member of the HPRA may decide to attend an Advisory Board meeting as an observer for the purposes of reviewing compliance with relevant medicines legislation. When making the notification, the following information regarding the planned Advisory Board meeting is required:
- The name and address of the meeting sponsor, and the details of a contact person at that company/organisation;
- The name / title of the meeting, as well as information on its date(s), duration and location (if a physical meeting is being held);
- The agenda of the meeting (even if only available in draft at that time);
- Concise information on the objectives of the meeting, including the nature of the advice that is being sought from the attendees;
- Information on the clinical / therapeutic area of concern for the meeting, as well as information on any medicinal product(s) that will be the subject of the meeting;
- Information on the types and number of healthcare professionals or other persons who may be invited to attend the meeting;
- Information on the payments (expenses and fees) that will be made to the attending advisors;
- An outline of the hospitality arrangements (and their cost) that will be put in place for the meeting – this applies to Advisory Board meetings held in person;
- A copy of any procedure (SOP) in place at the sponsoring company in relation to holding Advisory Board meetings.
2. Guidance from the HPRA in relation to Advisory Boards
The HPRA has issued the following guidance in relation to an Advisory Board meeting:
- Advisory Boards should only be held to enable companies to answer legitimate questions to which they do not already know the answer. The meeting should have a clear and documented purpose.
- The agenda should allow adequate time for discussion.
- The meeting should not be promotional in content or design.
- The sponsor of the meeting should ensure that attendees are not misled about the benefits or risks associated with a medicinal product.
- Invitations to the Advisory Board meeting should state the purpose of the meeting, the expected advisory role of the attendees and the expected amount of work be undertaken.
- Content of such meetings should relate solely to the matter at hand.
- The choice and number of participants should stand up to independent scrutiny.
- Multiple Advisory Board meetings on the same topic should be avoided unless there is a clear need for them.
- The arrangements for such meetings should comply with the inducements and hospitality provisions of Regulation 21 of the Medicinal Products (Control of Advertising) Regulation, 2007.
- The hospitality, fees and expenses should be limited and the venue appropriate to the purpose of the meeting.
- Where medical consultants are used to help organise or run a meeting, there should be a written contract or agreement in place with them which should strictly relate to the meeting and not to the supply, recommendation or sale of any medicinal product.
For more information please contact Colin Kavanagh or Bridget McGrath in the Life Sciences Regulatory and Compliance Group.