HPRA Compliance Programme on Advisory Boards

Commencing January 2021

The HPRA wishes to notify Market Authorisation Holder (MAH) companies and their affiliates in Ireland that we have established a compliance programme in relation to Advisory Board meetings. This follows on from a pilot project carried out in 2016 and 2017 to evaluate the compliance status of those meetings with the provisions of the Medicinal Products (Control of Advertising) Regulations 2007.

To facilitate this, we request that MAHs or their affiliates in Ireland notify the HPRA (via email to advertisingcompliance@hpra.ie) prior to holding any advisory board which meets the criteria for notification included in the table below:

We would appreciate six weeks advance notice, if possible, for each Advisory Board meeting, so that we can determine whether we should attend and observe the meeting. We acknowledge that, at this time, Advisory Board meetings may be running virtually and so our attendance may not be in person for all meetings selected for review.

*Note: Local Irish Affiliate involvement in Advisory Boards includes any of the following:

Information to provide to the HPRA 

The information that the HPRA needs to receive on each planned Advisory Board meeting is as follows:

• The name and address of the Advisory Board 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.

To simplify the notification process, this required information may be submitted to the HPRA using our Notification of advisory board meeting form or any similar advisory board pre-notification form.

It would be useful for the organisers of Advisory Board meetings to let the attendees know the following information in advance of holding any such meetings: 

• The HPRA may attend Advisory Board meetings, in full or in part, for the purpose of checking compliance with relevant medicines legislation.

• The HPRA’s attendance at any Advisory Board meeting is not intended to regulate or apply oversight to the attendees (advisors) at the meeting; it is intended to evaluate the company’s running and management of the meeting.

• The HPRA will not actively participate in the meeting – if it does attend an Advisory Board meeting, it will be only as an observer;

• This is one aspect of the HPRA’s surveillance monitoring of the pharmaceutical industry, and the HPRA’s attendance at any Advisory Board meeting in no way implies that a non-compliance issue exists with that particular company.