Article 10 is designed to prevent the inappropriate influence of healthcare professionals and to ensure that therapeutic decisions are made solely in the interest of patients. To achieve this objective, the law broadly prohibits the offering, promising, granting, requesting or accepting of financial or non-financial benefits when these are linked to the prescribing, dispensing, administration, supply or use of medicines and medical devices.
On 22 May 2026, the Belgian Federal Agency for Medicines and Health Products (FAMHP) published a long-awaited guidance document on the application of Article 10 of the Medicines Law of 25 March 1964.
On 27 May 2026, several of our colleagues attended the FAMHP information session on the new guidance. As Article 10 is closely linked to the compliance responsibilities overseen by the Responsible Person for Information and Publicity (RIP), the session provided valuable insights into the agency’s expectations. Here are our key takeaways.
What’s changing
According to the FAMHP, the guidance was developed in response to practical observations made during inspections, questions raised by stakeholders, previous agency communications and existing ethical codes. Its purpose is to provide a practical and interpretative framework for the consistent application of Article 10, while recognising that the guidance itself neither replaces nor modifies the law.
For many organisations, the challenge is not understanding the principle behind Article 10, but determining where the boundaries lie in day-to-day business activities. Questions frequently arise around sponsorships, scientific events, consultancy agreements, hospitality, educational grants and other forms of interaction with healthcare professionals. The new guidance aims to provide greater clarity in these areas.
What to do now
The guidance reinforces the need for companies to carefully assess all transfers of value and interactions involving healthcare professionals. Sponsorship arrangements, scientific advisory boards, consultancy agreements, educational grants, congress support and hospitality should not be viewed as routine business activities. Instead, they should be assessed against the requirements of Article 10 by the Responsible Person for Information and Publicity (RIP) to determine whether they fall within one of the permitted exceptions and whether they are appropriately documented, transparent and justifiable.
Companies should also use this guidance as an opportunity to review the compliance governance. This includes verifying that a suitably qualified RIP has been formally appointed, confirming that the RIP meets all applicable legal requirements, and ensuring that robust procedures are in place for the prior review and approval of promotional activities, sponsorships and interactions with healthcare professionals.
How MPCA can help
For more than 25 years, we have supported pharmaceutical companies across the Benelux with exactly these types of regulatory responsibilities. We can act as your outsourced RIP, review your interactions with healthcare professionals, assess your advertising and information review processes, and support you in establishing a compliant framework with clear procedures, appropriate documentation and effective oversight. Read more on our RIP service page, or see the FAMHP’s own guidance on the responsible person.
This article is for general information and reflects the situation at the time of writing. Always consult the FAMHP’s official publications for binding requirements.