The Health Products Regulatory Authority (HPRA) has announced a new compliance programme addressed to the Advisory Board meetings of Marketing Authorisation Holders (MAHs) and their affiliates in Ireland, which came into operation on 1 January 2021. Under the programme, the HPRA has requested 6 weeks advance notice of Advisory Board meetings taking place both within and outside of Ireland. The advance notice request applies to Advisory Board meetings that are organised by an Irish affiliate of the MAHs and/or have health professionals or other persons from Ireland attending as advisors. The HPRA has requested this notice with a view to possibly attending and observing such meetings.
In addition, the recently updated Irish Pharmaceutical Healthcare Association’s (IPHA) Code of Practice for the Pharmaceutical Industry (Code of Practice), which came into effect on 1 March 2021, now contains an Annex VI dealing specifically with the organisation and conduct of Advisory Boards.
Advisory Boards are not defined or prescribed by legislation. However, the new Annex VI of the IPHA Code of Practice clarifies that an Advisory Board:
“…is a group of external experts assembled by companies to obtain professional guidance, advice, insights or other information to further legitimate scientific or business needs, on a specific topic for which the expertise and knowledge are not available within the company. Advisors are selected on the basis that they have the necessary ability and qualifications to advise on specific scientific, commercial, and healthcare issues. Advisors may be registered healthcare professionals (HCP), scientists, payers, patients and representatives of Patient Organisations.”
Compliance with the advertising regulations
The purpose of the HPRA’s new compliance programme is to ensure that MAHs and their Irish-based affiliates comply with the requirements of the Medicinal Products (Control of Advertising) Regulations 2007 (the Regulations) during their Advisory Board meetings. These Regulations forbid any canvassing or inducement designed to promote the prescription, supply, sale or consumption of medicinal products to persons qualified to prescribe or supply medicines. They also impose restrictions on hospitality, gifts, benefits-in-kind and pecuniary advantages provided to qualified persons.
The new compliance programme follows on from the HPRA’s general Guidance on Advisory Boards that was issued in November 2020. This Guidance recognises that it is acceptable for companies to arrange Advisory Board meetings in furtherance of legitimate purposes like the development of medicinal products. It also recognises the standard industry practice of paying healthcare professionals and others for advice on subjects relevant to their products and activities.
However, it goes on to set out a series of rules aimed at providing greater transparency of the purpose of such meetings. It also aims to provide greater clarity around acceptable levels of hospitality, expenses and fees provided to participants.
This general Guidance also signals that, while the HPRA recognises the role of self-regulation of the conduct of Advisory Board meetings, it intends to “monitor these meetings on an occasional basis” to check for compliance.
In addition to the HPRA’s Guidance and compliance programme, the new Annex VI of the IPHA Code of Practice deals specifically with the organisation and conduct of Advisory Boards. For example, it warns that Advisory Board meetings should be strictly non-promotional and must not be conducted to induce prescribing or other improper purposes.
The HPRA has requested 6 weeks advance notice for each Advisory Board meeting, where possible. Advance notices should be sent to email@example.com and set out the details of the proposed meeting. Full details of the specifics required are available here.
The HPRA has also clarified that they only require advance notice where there are Irish based advisers at the meeting, or where there is “local Irish affiliate involvement” in planning or organising the meeting. Such affiliate involvement can include selecting advisors, issuing invitations, involvement in travel arrangements, hosting the meeting, paying the advisors, and even attendance of the meeting itself. The trigger for advance notice to the HPRA is quite wide.
Considered alongside the new Annex VI of the IPHA Code of Practice, the HPRA’s recent Guidance on Advisory Boards and this new compliance programme signifies that the organisation and conduct of Advisory Board meetings is now an area of focus for the HPRA’s monitoring and surveillance activities. Affected stakeholders should consider the details of the relevant regulations and guidance and ensure their procedures and practices are compliant.
The content of this article is provided for information purposes only and does not constitute legal or other advice.