Revised Code by Irish Pharmaceutical Healthcare Association to take effect on 1 June 2025
The Irish Pharmaceutical Healthcare Association (IPHA) has recently unveiled its updated Code of Practice for the Pharmaceutical Industry, known as Edition 8.6, which will come into effect on 1 June 2025. This revised code is a crucial document in the pharmaceutical landscape of Ireland and, more broadly, Europe. The IPHA plays a central role in the global healthcare and pharmaceutical industry, representing innovator companies that develop, produce, and introduce prescription medicines, self-care medications, and vaccines. Although membership in the IPHA is voluntary for the Irish research-based pharmaceutical sector, the new Code is significant for non-members as well, as it has been endorsed and approved by the Minister for Health in line with Regulation 26 of the Medicinal Products (Control of Advertising) Regulations 2007.
One of the notable highlights of the Revised Code is its alignment with EFPIA requirements and definitions. Sections of the Previous Code have been updated to ensure compliance with EFPIA standards. New definitions have been introduced for terms like ‘Events’ and ‘Patient Organisations’, in accordance with EFPIA guidelines. Additionally, the rules regarding Gifts have been refined to explicitly prohibit the distribution of promotional aids to individuals qualified to prescribe or supply, Healthcare Organisations, or Patient Organisations. The provisions related to Hospitality, Sponsorship, and Meetings have also been amended to reflect EFPIA regulations, specifying that the monetary threshold for meals at events held in EFPIA countries should adhere to the respective country’s standards.
Another interesting feature of the Revised Code concerns prescribing information and QR Codes. While the Previous Code mandated the inclusion of specific information compatible with Summaries of Product Characteristics (SmPC) in promotional material for prescribers and suppliers, the Revised Code now allows for QR Codes linking directly to this essential data in printed ads. However, the use of the QR Code should be supplementary to, not a replacement for, the prescribed information. In cases where such information is available at adjacent company tables or via QR Codes, a clear statement must accompany the advertisement.
The Revised Code also brings changes to provisions related to promotion practices. Reminder advertisements now permit the simultaneous display of the medicine name, international non-proprietary name, and trademark, aligning with the Health Products Regulatory Authority’s stance on the matter. The requirements for providing written material alongside audio-visual content to prescribers and suppliers have been eliminated, streamlining the process. The responsibility of companies to ensure that employees involved in Code-related activities are fully compliant has been expanded to cover a broader range of employees and third parties, including advertising agencies, consultants, and market research firms. Moreover, the guidelines for online promotions now emphasize maintaining a balance between safety and efficacy in digital campaigns, highlighting the importance of upholding standards in the digital sphere.
In conclusion, the Revised Code from the Irish Pharmaceutical Healthcare Association marks a significant update in the pharmaceutical industry’s ethical practices. With its alignment with international standards and a focus on transparency and compliance, the Code sets a benchmark for pharmaceutical companies, both members, and non-members, to follow in their promotional activities.