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New Belgian Article 10 Guidelines: A Fresh Start for Honest Collaboration Between Industry and Healthcare Professionals

How do the guidelines affect our current practices?

The core principle hasn’t changed – but the expectations have. At its heart, the rule is simple and strong: No premiums, financial benefits, or gifts linked to prescribing, supplying, dispensing, or administering medicines or medical devices — unless they fall squarely into one of the legal exceptions. The Guidelines repeatedly remind us: you must be able to prove that every interaction genuinely fits an exception. No grey areas.

Only three allowed exceptions.

The FAMHP clearly defines just three categories:

1     Gifts of negligible value that are relevant to professional practice

2     Scientific meetings (now much stricter — and much clearer)

3     Legitimate scientific services provided by healthcare professionals

Everything else? Still prohibited. The biggest section of the Guidelines is dedicated to scientific events. To be compliant, a meeting must meet all five cumulative criteria:

•            Exclusively scientific content
•            Hospitality strictly limited to the scientific purpose
•            Appropriate venue and reasonable duration
•            Funding limited to official participation costs
•            Sponsorship only for eligible healthcare professionals

The distinction is now crystal clear: Scientific meetings ≠ Promotional events. Product launches, commercial roadshows, business dinners, open days, and promotional workshops are explicitly not allowed under this exception. Transparency is no longer optional — it’s essential.

What are the expectations of participants in the pharmaceutical industry?

One of the strongest messages in the Guidelines is the demand for real transparency. Companies and organisers must keep:

•            Written agreements
•            Detailed budgets
•            Traceable payments
•            Original invoices
•            Solid supporting documentation

Retention period? Ten years. This is what inspectors will expect to see.

What should companies do now? This is the moment to act. Review and strengthen:

•            Sponsorship and congress approval processes
•            Advisory board and consultancy agreements
•            Event budgets and financial flows
•            Documentation systems
•            Internal SOPs and compliance training

The Guidelines will very likely become the benchmark document during future FAMHP inspections.

Final thoughts — why this matters 

This isn’t just another regulatory update. It’s a real step toward cleaner, more transparent, and more scientifically independent relationships between industry and healthcare professionals. It raises the bar on integrity while providing much-needed clarity. For compliance teams, Medical Affairs, and Responsible Persons for Information and Publicity (RIPs), now is the perfect time to revisit your processes — before the next inspection. The goal remains what it always was: protecting patients through ethical, science-based collaboration. These Guidelines simply make it easier for everyone to get it right.