The IPHA issued an update to their Code of Practice for the Pharmaceutical Industry in March 2025, replacing version 8.5, which has been in place since 1 March 2021. The updated version 8.6 will come into effect on 1 June 2025. The updates bring the Code in line with the HPRA’s Guide to Advertising Compliance, as well as incorporating the latest requirements of the EFPIA Code. The following is a summary of the main changes introduced with this update:
Scope & Definitions (Clause 1): New definitions introduced for terms like Events, Location, Reasonable, Extravagant, etc., in line with EFPIA requirements.
Textual and Audiovisual Promotional Materials (Clause 7):
- For printed promotional materials and full advertisements, new guidance has been added on the use of QR codes linking to the minimum required information to prescribe or supply a medicine
- For reminder advertisements, use of brand name, and/or INN, and/or trademark now permitted, as per HPRA guidance
- Audio-visual materials no longer need accompanying printed material.
References to the Primary Care Reimbursement Service (Clause 9):
- Permitted references to reimbursement schemes in promotional materials have been amended to provide greater flexibility and clarity
- Explicitly prohibits use of phrases like “freely prescribable”
- Restricts use of official documents (e.g., prescription forms) for promotional purposes
Employees (Direct & Contracted) (Clause 12):
- Member companies must ensure compliance with the code of both direct and contracted employees and third-party partners (e.g., consultants, licensees).
Gifts (Clause 14):
- Provision of promotional aids to prescribers, suppliers, Healthcare Organisations and Patient Organisations is now explicitly prohibited, in line with EFPIA requirements.
Grants & Healthcare Supports (Clause 15):
- Companies must notify senior management of Healthcare Organisations that Transfers of Value (ToV) to the organisation appear on the IPHA ToV website
- It is no longer necessary to receive written confirmation of the authorised account for ToV payments from the organisation.
Hospitality, Sponsorship & Meetings (Clause 16):
- Meal threshold raised from €80 to €90 in line with EFPIA requirements
- ‘Host country principle’ applies for non-EFPIA countries
- Promotional nature of meetings must be stated in invitations to HCPs
- European third party events with over 500 HCPs from 5+ EFPIA countries must be qualified under EFPIA e4ethics platform
- No longer distinguishes between “small” and “large” HCP-led meetings.
Code Administration and Complaints (Annex I):
- Sanctions must be proportionate to the infringement by the member company; the cost of corrective actions must be borne by the company in breach; fee has been imposed to cover the costs of the administration of the Code Council or Appeals Board
- Written justification now required to withdraw a complaint
- Up to four non-IPHA members may now sit on the Code Panel
- Only Chief Representatives of IPHA member companies may propose changes to the Code.
Patient Organisations (Annex III) :
- Clarifies that support to Patient Organisations must be healthcare, research or education-related and fully documented
- States that the organisation in receipt of support will not undertake promotion of the companies’ Prescription-Only Medicines.
Digital Communication (Annex IV) :
- Banner Ads now contain a reference to “Prescribing Information” instead of “Abbreviated Prescribing Information”
- New clause (Clause 2.3 (v)) added to address HPRA’s previously raised concerns about balance in digital advertisements in terms of efficacy and safety.
Transfers of Value (Annex V)
- Under General Obligation, the wording “subject to internal corporate compliance…” is removed to improve clarity
- Encourages Legitimate Interests as legal basis for HCP disclosure of ToVs.
Advisory Boards (Annex VI)
- Sponsors must address any misleading statements about their medicines made by advisors during Advisory Board meetings
- One additional internal attendee (admin/note taker only) is permitted at meetings
- HPRA guidance on Advisory Boards now explicitly referenced.
If your company needs support in assessing the impact of these changes on your current processes or if you need an experienced regulatory professional to review your promotional material, contact Gemma at Acorn Regulatory at enquiries@acornregulatory.com, and we will be happy to support your needs.
