Executive Summary
The Irish Pharmaceutical Healthcare Association (“IPHA”) has published an updated Code of Practice for the Pharmaceutical Industry, Edition 8.6 (the “Revised Code”) which will become effective on 1 June 2025.
Who is IPHA?
IPHA is a membership organisation of pharmaceutical and healthcare companies with activities in Ireland. IPHA leads the self-regulation of its member companies in Ireland. IPHA is a member of a number of international associations including the European Federation of Pharmaceutical Industries and Associations (“EFPIA”).
Though membership of IPHA is voluntary and the Revised Code only strictly applies to IPHA member companies, all businesses active in the pharmaceutical sector should be aware of the updates brought by the Revised Code, in particular due to its approval by the Minister for Health in accordance with Regulation 26 of the Medicinal Products (Control of Advertising) Regulations 2007.
The Revised Code
The Revised Code replaces the previous edition from March 2021. Key changes include the following:
- It is more closely aligned with the EFPIA Code in particular due to new definitions for “Events” and “Sponsorship”.
- The prohibition on gifts in relation to the promotion of prescription medicines has also been expanded to the offering of cash, cash equivalents or personal services and promotional aids.
- The Revised Code also adds a new provision for additional vetting via an “e4ethics platform” in certain circumstances, where an IPHA member participates, collaborates, or sponsors a European third-party organised event.
- Removal of the requirement to provide textual and audio-visual with printed promotional material.
- Option to use the combination of a name and / or international non-proprietary name of the medicine and / or trademark for advertisement material, removing the previous requirement of having to choose only one.
- Option to use QR codes linking directly to supplemental information on promotional materials, in addition to the printed version of required information.
Updated Provisions on Reimbursement
The Revised Code consolidates provisions on reimbursement in promotional material allowing for more flexibility. For example:
- Inclusion of reference to a ‘reimbursement statement’ and removing of an expiry date.
- Relaxing of stylistic requirements of the reference material to no longer require specific print size, typeface, or the inclusion of the relevant code number and / or price.
Sanctions and Complaints
The Revised Code states that “Sanctions must be proportionate to the nature of the infringement, have a deterrent effect and take account of repeated offences of a similar nature or patterns of different offences”. Pursuant to this, the IPHA may request that companies cease practices which led to a breach of the Code and provide proof of measures taken to avoid a similar breach in the future, within a prescribed time limit.
The IPHA may order a company to correct inaccurate information with a corrective notice, and the 10-day waiting period after a Decision has been issued before action against the company has been removed.
Further details are available on the IPHA website here.
For further information on the above, please contact Kate McKenna, a member of the Competition and Regulation group or your usual Matheson contact.