Author: Wim Neckebroek, Director, Regulatory Affairs

The Belgian Federal Agency for Medicines and Health Products (FAMHP) has introduced new guidance on the application of Article 10 of the Law of 25 March 1964. This is a crucial step toward clarifying one of the most complex and frequently debated areas of pharmaceutical compliance. 

The impetus for this guidance is clear. Despite longstanding rules, uncertainty has persisted in practice around how Article 10 should be interpreted and applied. For many companies, the challenge has not been understanding the principle itself but navigating its boundaries in real-world scenarios – particularly in areas such as event sponsorship, advisory engagement, and indirect value transfer. This new guidance seeks to address that gap.  

A Broad Interpretation of “Benefits” 

One of the most significant aspects of the guidance is how broadly it defines “premiums and advantages.” Rather than focusing solely on direct payments, it captures a wide range of value transfers: financial, material, and indirect. The guidance reinforces a broad interpretation of “benefits,” covering: 

• direct payments or reimbursements 

• non-market-conform discounts 

• free goods or services 

• indirect advantages that reduce operational costs 

In practical terms, this means that compliance cannot be assessed purely through financial transactions. Even activities that do not involve direct payment may fall within scope if they create an advantage that could influence professional judgment. 

This reinforces the need for companies to take a holistic view of their interactions with healthcare professionals and organisations, considering both the substance of what is provided and how it may be perceived. 

The Exceptions: Clearly Defined, Closely Controlled 

While Article 10 imposes a general prohibition, it also allows specific exceptions. The guidance reaffirms these but sets out their conditions in greater detail. The first relates to low-value items. These remain permissible, but within strict limits and only where they are professionally relevant. The intention is to ensure that even minor benefits do not undermine independence or create inappropriate influence. Quite surprising is that standard desk accessories like pens and Post-its remain acceptable within this guideline which is contradictory to the deontological code of Pharma.be that has a clear “ban” on these types of gifts. 

The second—and more complex—exception concerns scientific events. Funding for participation is allowed, but only when the event is genuinely scientific in nature. Content must be objective, evidence-based, and free from promotional bias. 

The guidance places particular emphasis on the concept of separation. Scientific programmes must be clearly distinguished from any social, promotional, or recreational elements, both in structure and in funding. Industry support may extend only to the scientific component, and hospitality must be limited to what is necessary for participation. 

This has practical implications. Many events historically combined scientific and non-scientific elements, but the expectations around how these are separated and managed are now more explicit. Companies will need to ensure not only that programmes meet these criteria, but that they can clearly demonstrate compliance. 

The third exception allows for compensation of healthcare professionals for legitimate scientific services. Advisory work, research participation, and speaking engagements can all fall within scope, provided that certain conditions are met. 

Crucially, the emphasis is on substance. There must be a genuine need for the service, clearly defined deliverables, and a fair relationship between the work performed and the compensation provided. Activities that are primarily commercial in nature, even if framed as scientific, do not qualify. 

Greater Scrutiny of Institutional Funding 

The guidance also addresses financial contributions to research, education, and other institutional activities. While such funding is not prohibited, it is not automatically permitted either. Financial support is not automatically exempt and must meet strict criteria: 

• full independence of recipients 

• no influence on prescribing or treatment decisions 

• transparent governance and documentation 

This reflects a wider regulatory focus on indirect value transfers and institutional funding models. This reflects a broader shift in regulatory focus. As controls on direct interactions with individual healthcare professionals have tightened, attention has increasingly turned to indirect forms of value transfer, including institutional funding models. 

The message is clear: these arrangements are subject to the same principles of transparency, independence, and accountability as any other interaction. 

What This Means for Pharma Companies 

For pharmaceutical and medical device companies, the implications are both practical and strategic. The real risk is no longer just non-compliance but misinterpreting increasingly specific rules. Companies should: 

• audit current practices against the guidance 

• reassess event sponsorship and advisory structures 

• ensure alignment with updated Mdeon requirements 

• prepare for increased scrutiny 

More broadly, the guidance reinforces the importance of integrating compliance into decision-making early. Rather than being treated as a final check, compliance considerations will increasingly need to shape how activities are designed from the outset. 

Looking Ahead 

The FAMHP has already announced an information session to present the guidance in more detail—highlighting both its importance and the level of engagement expected from industry. On top of that Healixia will be organising a dedicated webinar with Mdeon representatives tackling the most relevant take aways from this guideline. 

While the law itself has not changed, its interpretation has become more clearly defined. For many companies, this will require adjustments in how they approach interactions with healthcare professionals and organisations. The direction is clear: greater transparency, clearer boundaries, and higher expectations around accountability. 

At Kintiga, we work with pharmaceutical and medtech companies to translate regulatory change into clear, actionable strategy. In Belgium we currently have 6 experts with the RIP (Responsible for Information and Publicity) certification that can provide in depth insights on all (Art. 10) compliance matters. If you are assessing how the FAMHP guidance could impact your organisation, now is the time to act.