The Revised Code will become effective on 1 June 2025 and IPHA members are required to be compliant with its provisions from that date.

The IPHA is a key organisation in the Irish and broader European pharmaceutical landscape representing the innovator industry whose members develop, manufacture, and bring to market prescription medicines, self-care medicines and vaccines. While the IPHA is at the core of the international healthcare and pharmaceutical industry and is a member of several international associations including the European Federation of Pharmaceutical Industries and Associations (“EFPIA”), its membership is voluntary for the Irish research-based pharmaceutical industry.

The Code will nonetheless be of importance to non-IPHA members and given its endorsement and approval by the Minister for Health in accordance with Regulation 26 of the Medicinal Products (Control of Advertising) Regulations 2007, such non-IPHA members should also strongly consider complying with its provisions. The IPHA’s other code of practice, the Self-Care Advertising Code, has not been updated.

The revised IPHA Code of Practice for the Pharmaceutical Industry (Edition 8.6) effective 1 June 2025 – Key Changes

The Revised Code replaces the previous Edition 8.5 which had been in place since 1 March 2021 (the “Previous Code”). You can read more about the Previous Code and the original updates to the IPHA Codes, which took place in 2021. Some of the key changes include the following:

The EFPIA Requirements and Updated Definitions

While the provisions of the Previous Code provided for the reflection of the standards of the EFPIA Code, several clauses have since been updated to bring the Revised Code into compliance with EFPIA requirements. Definitions have now been inserted for, amongst other terms, ‘Events’ and ‘Patient Organisations’, as per EFPIA requirements. Indeed, the provision on Gifts has been updated to explicitly provide for the well-accepted, but not previously enumerated, prohibition on the provision of promotional aids to persons qualified to prescribe or supply, Healthcare Organisations or Patient Organisations.

Further alignment with EFPIA requirements can be seen in the provision on Hospitality, Sponsorship and Meetings, which now clarifies that for events held in EFPIA countries, the monetary threshold for a meal is that of the country in which the event is taking place.

Prescribing Information and QR Codes

The Previous Code outlined in relation to prescribing information, the minimum information compatible with the Summaries of Product Characteristics (“SmPC”), that must be an integral part of an advertisement where the purpose of promotional material is to provide persons qualified to prescribe or supply, with sufficient information upon which to reach a decision for prescribing or for use. The Revised Code now provides that for persons who are qualified to prescribe or supply a medicine in Ireland, a QR Code that links directly to this required information may be added to printed promotional advertisements, but it must be supplementary to, and not as a substitute for, the foregoing required information.

It further provides in relation to ‘full advertisements in the form of banner stands, or other stands, only…’, that a prominent statement may be included if the required information is at an adjacent company table and/or a QR code that links directly to the required information. It should be noted that this aspect of the Revised Code is similar to that contained in the code of practice of the corresponding UK pharmaceutical body, the Association of the British Pharmaceutical Industry (“ABPI Code”), although the APBI Code does not refer specifically to ‘banner stands or other stands’ advertisements, and instead provides detailed guidance for the provision of prescribing information by way of QR codes.

Updates to Provisions on Promotion

With respect to reminder advertisements and in line with the Health Products Regulatory Authority’s position in relation to same, the Revised Code now provides that all of the following may be included in such advertisements concurrently and not merely in lieu of one another: the name of the medicine, and/or the international non-proprietary name, where such exists, and/or the trademark.

Furthermore, certain provisions have been streamlined in their revision. The requirement to provide accompanying printed material for all audio-visual material provided to persons qualified to prescribe or supply, is now removed. The provisions surrounding company responsibilities in relation to their employees and promotion, have also been revised. While the Previous Code provided that companies must ensure that employees who are concerned in any way with the ‘drafting or approval of promotional material’, including those of third parties and contracted on behalf of the company, are fully conversant and compliant with the Code’s requirements, the Revised Code has broadened this language to cover employees who are involved in ‘any activities covered by the Code’, and to ensure that they are both trained in and compliant with the requirements of the current version.

The new provision also extends the obligation to ensure conversance and compliance with the Revised Code to both third parties working for or on the company’s behalf, including ‘advertising companies, business consultants, market research companies etc’ and those working in partnership, ‘such as joint ventures and licensees’. Indeed, changes have been made to the provisions concerning online promotion, with the inclusion of the requirement to always maintain the balance of safety and efficacy in digital advertisements. Linking to the SmPc is also no longer a panacea for companies seeking to meet their regulatory requirements, with the Revised Code now providing that such linking does not preclude the need for information contained in the advertisement itself to be balanced in terms of safety and efficacy.

Clarity on References to Reimbursement

The requirements surrounding references to reimbursement in promotional material have been amended to provide IPHA members with greater clarity and flexibility. The Previous Code concerned references to the Primary Care Reimbursement Service (“PCRS”) only, whereas the Revised Clause is broadened to address a ‘reimbursement statement’ which is not particularised to a scheme.

While the restriction on the use of the phrase ‘freely prescribable’ or similar phrases that suggest a lack of restriction or restraint, is retained, there is no requirement governing the content of the reference and the scope of the permitted references is no longer confined to including only the relevant code number and/or price. There is also no longer a requirement to ensure that the print size and typeface of the references in promotional material are the same as those used for the marketing authorisation number.

This provision has been refined to provide that the size and emphasis of the reimbursement statement must be proportionate to the rest of the information in the communication. Furthermore, the temporal limit on the inclusion of references to reimbursement statements in promotional material, has been removed. The provision that a reimbursement statement may be carried for no longer than 12 months from the date of the addition or restoration of the product to the PCRS list, has been deleted from the Revised Code accordingly.  

Hospitality, Sponsorship and Meetings

Definitions for ‘Sponsorship’, ‘Events’ and ancillary related definitions – ‘Contribution to Costs’, ‘Donations and grants’, ‘Extravagant’, ‘Gifts’ and ‘Location’ – have now been inserted into the Revised Code. Updates include the increase of the threshold for meals and drinks from 80 euro to 90 euro, along with the addition of various clarifying provisions such as the inclusion in the provision concerning promotional, scientific or professional meetings, congresses, conferences, symposia and other similar events, of a requirement on each company that invites a healthcare professional to clearly disclose, in the invitation, the promotional nature of the event.

The provisions on the organisation or sponsorship of international events have also been updated to provide that where a company participates in, collaborates with or sponsors a European third-party organised event (“TPOE”) with an attendance of over 500 healthcare professionals from at least five different EFPIA countries, the event must be qualified under the EFPIA e4ethics platform. This platform reviews compliance of TPOEs with the provisions of EFPIA’s Code of Practice.

Sanctions

The provisions on sanctions contained in Annex I, Administration of the Code and Complaints Procedure, have been amended and new wording inserted. Notably, the section is now prefaced with language that addresses the objective of imposing sanctions, stating: ‘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.’

The effect of the revision is to increase the obligations on companies in breach of the Revised Code, with a new requirement on companies to provide proof to the Code Council of the necessary steps taken by the company within a defined period decided by the Chair, in order to avoid a similar breach occurring in the future. The sanction of a reprimand of the company in breach is now deleted.

The revised provisions also provide for the publication of a corrective notice with respect to inaccurate information not only in the medical and/or pharmaceutical press, per the Previous Code, but now, additionally or in lieu of the foregoing, the publication in the lay media, if relevant. It is also clarified that the cost of this publication must be borne by the company in breach. Companies should be aware of other discrete changes to this section, including that that there is no longer a requirement for the IPHA to wait a period of ten days after the issuing of a Code Council or Appeals Board decision prior to carrying out an action against a company.

For more information, please contact our Life Sciences Group.

Thanks to Eva Glynn for her assistance with this piece.