The HPRA’s compliance programme on advisory boards

In general, any meeting at which healthcare professionals and others are paid to provide their advice to a company should be considered an advisory board.

The HPRA operate a compliance programme in relation to advisory board meetings.

We require notification of planned advisory board meetings in Ireland and evaluate the compliance of these meetings with the Medicinal Products (Control of Advertising) Regulations 2007.

When do I need to notify a planned advisory board meeting to the HPRA?

We require six weeks advance notice, where possible, for each planned advisory board meeting. This will allow us time to determine whether we should attend and observe the meeting. Our attendance may not be in person for an advisory board meeting which is being held virtually.

We request that marketing authorisation holders, or their affiliates in Ireland, notify the HPRA before holding any advisory board which meets the criteria for notification included in the table below.

*Companies should note that Local Irish Affiliate involvement in advisory boards includes any of the following:

• Planning the advisory board
• Selecting the advisors
• Issuing the invitations to the advisors on its own letterhead/email, etc.
• Involvement in arrangements for the advisory board – e.g., making or assisting with hotel bookings, travel arrangements, room booking, hospitality, providing a medical writer, etc.
• Hosting the advisory board
• Running the advisory board
• Attending the advisory board
• Paying the advisors

How to notify the HPRA

You can notify us of a planned advisory board meeting by completing our notification form and emailing it to advertisingcompliance@hpra.ie.

Companies can use another similar advisory board pre-notification form once it provides all the information required in the HPRA form.

HPRA attendance at advisory board meetings

Organisers of advisory board meetings should inform the attendees of our role in these meetings.

• We may attend advisory board meetings, in full or in part, for the purpose of checking compliance with relevant medicines legislation.
• Our 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.
• Where we do attend a meeting, it will be only as observers and we will not actively participate.
• Our attendance is part of our role in surveillance monitoring of the pharmaceutical industry and in no way implies that a non-compliance issue exists with that company.

More information can be found in our guidance document in relation to advisory boards.