The HPRA’s compliance programme on advisory boards

In general, any meeting at which external experts (healthcare professionals or others) are being paid to provide their advice to a company should be considered an advisory board.

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

Companies must notify us when planning to hold certain advisory board meetings. We evaluate the compliance of any advisory board meetings we attend with the requirements of the Medicinal Products (Control of Advertising) Regulations 2007.

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

You must notify us six weeks in advance, where possible, for each advisory board meeting that meets the criteria outlined in the tables below. This will allow us time to determine whether we should attend and observe the meeting. For advisory board meetings which are being held virtually, we may not attend in person.

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 Advisory boards held in Ireland table and Advisory boards held outside Ireland table.

Advisory boards held in Ireland

Advisory boards held outside Ireland**

*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.

**If the local Irish affiliate's only involvement in advisory boards being held outside of Ireland, to which Irish advisors are invited to participate, is to make payments to the Irish advisors then these do not need to be notified to the HPRA. This means that if the only role of the local Irish affiliate in an advisory board taking place outside of Ireland (e.g. a globally organised advisory board which includes Irish advisors selected and invited by the Global organisation) is to pay the Irish advisors and include this in the annual transfer of value (ToV) report, then these advisory boards do not need to be notified to the HPRA.

How to notify the HPRA

You can notify us of a planned advisory board meeting by completing and emailing our notification of advisory board meeting form.

Companies can use a similar advisory board notification form if it provides all of the information that is 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.
• 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.
• 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 particular company.

We have provided advice to the organisers of advisory board meetings on the running of these meetings. Visit our Advice from the HPRA in relation to advisory boards page for more information.