In our Belgian Pharma Law Summer Blog Series, we examine recent developments in Belgian pharmaceutical law. Whether you are looking for an informative summer read or a concise overview of the latest legal developments to catch up on after the holidays, our series has you covered. Part 2 focuses on the new guidance on the interpretation and application of Article 10 of the Belgian Medicines Act of 25 March 1964 (the “Guidance”), which was unveiled by the Federal Agency for Medicines and Health Products (“FAMHP”) in May 2026. Given its breadth and detail, the Guidance is set to become the new anchor point for checking off internal policies on pharmaceutical promotion to healthcare professionals (“HCPs”). We highlight for you what is relevant, new, or stands out.

Consolidated guidance, without changing the law

In May 2026, the FAMHP issued the Guidance (Dutch version; French version), citing uncertainty in practice regarding the application of Article 10 of the Medicines Act. The FAMHP presented the Guidance at a dedicated information session (slides and Q&A), emphasising there that it is without prejudice to Article 10, whose wording and ratio legis always prevail over an interpretative document.

While the FAMHP’s earlier Article 10 guidance – in the form of several circulars – has not been formally repealed, the new Guidance should be considered a consolidation, supplemented by some novelties. The Guidance also has a direct impact on the Mdeon FAQ, which has already been updated accordingly. The most significant change concerns the organisation and sponsorship of scientific events (V2 visa applications): the three categories introduced in Mdeon’s June 2024 newsletter – exclusively scientific meetings, mixed events, and exclusively promotional events – are no longer maintained.

The general rule: no premiums and benefits

The prohibition under Article 10 of the Medicines Act is notoriously broad as it prohibits “in the context of the supply, prescribing, dispensing or administration of medicinal products, to promise, offer or grant, directly or indirectly, premiums or benefits in cash or in kind to wholesalers, brokers, persons authorised to prescribe, dispense or administer medicinal products, or to institutions where such medicinal products are prescribed, dispensed or administered”. Yet this prohibition does not catch everything, and the Guidance helpfully makes this explicit on two specific points – though these are not intended to be exhaustive: first, whether Article 10 applies where a company operates in a mixed activities/portfolio context; and second, the carve-out for payments for booth space.

Cases of mixed activities/portfolios

First, it is worth reiterating that Article 10, despite forming part of the Medicines Act, is not limited in scope to medicinal products. Its reach has been expressly extended to medical devices, meaning that companies active in both sectors are fully covered by the provision. It is less straightforward for companies whose activities straddle medicinal products for human use and veterinary use. The Guidance expressly states that it applies only to medicinal products for human use, as premiums and benefits in the context of veterinary medicinal products are governed by different rules. That said, the FAMHP clarified at the information session that companies with activities in both human and veterinary medicinal products are not “fully excluded” from the scope of Article 10.

The Guidance makes a related and broader point: wherever there is any connection with the supply, prescribing, dispensing, administration or use of medicinal products or medical devices, Article 10 applies – irrespective of the company’s other activities. For example, a company distributing both medicinal products and food supplements falls within the scope of Article 10 to the extent of its medicinal products activities, even if most of its overall activities lie outside the scope of the Medicines Act.

Payments for booth space

Whether Article 10 of the Medicines Act is engaged often turns on whether something can be characterised as a “premium” or “benefit” within the meaning of that provision. The Guidance confirms that these terms are interpreted broadly, encompassing any form of financial, material or non-material advantage conferred directly or indirectly on an HCP or healthcare organisation.

One commercial transaction that the Guidance does not treat as a premium or benefit within the meaning of Article 10 – alongside commercial rebates – is the payment for booth space in the context of an exhibition or other event. The FAMHP sets out the following points in this regard:

• The FAMHP treats payments for booth space as a purely commercial transaction, a fee in exchange for a concrete service or facility (e.g. a booth location, technical support, logistics, or visibility), which must be market-conform and agreed upon in writing.
• The booth fee must not be used to confer a advantage on HCPs. It cannot cover: registration fees, travel or accommodation costs, any form of hospitality (whether at the company’s stand or elsewhere during the event), or funding of non-scientific lectures, presentations, or other programme elements that could constitute a benefit to HCPs.
• If the booth fee is used – in whole or in part – to finance direct or indirect advantages for HCPs, the transaction loses its commercial character and constitutes a prohibited benefit.

The (soon to be redundant) exception of “gifts of very low value”

One of the statutory exceptions to the prohibition of Article 10 of the Medicines Act are the so-called gift of very low value, referring to small gifts that do not have the potential to influence the therapeutic freedom or independence of HCPs and are relevant to the practice of the healthcare profession.

This exception, however, will soon become redundant once the European pharmaceutical reform enters into application. Indeed, the compromise text of the ‘Directive on the Union code relating to medicinal products for human use’ states that “where medicinal products are being promoted to healthcare professionals, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to such persons”, without prejudice to the exception for hospitality at scientific events.

For some companies this exception had effectively become redundant because the deontological rules of their industry association already prohibited such practices (e.g. pharma.be’s code of deontology).

When training on the proper use of medicinal products or medical devices qualifies as a “scientific event”

A further statutory exemption under Article 10 of the Medicines Act covers the invitation to and the funding of participation in a scientific event, including hospitality. A key qualifying criterion is whether a gathering can be characterised as a “scientific event” within the meaning of that provision. The Guidance clarifies that scientific events may take various forms, but the event must be exclusively scientific in nature – although a strictly separate and non-sponsored segment of a promotional or social nature alongside the scientific programme is tolerated.

To assist in distinguishing between scientific events eligible for sponsorship and those that fall outside that category, the Guidance sets out examples of both. Notably, it devotes considerable attention to trainings on the proper use of medicinal products or medical devices, which can only qualify as a scientific event where the following requirements are met:

• they are provided exclusively following the purchase of the product and are objectively necessary and indispensable for the correct, safe and effective use of the product;
• they do not form part of the HCP’s regular professional training;
• they are exclusively technical and functional in nature and strictly limited to objective information on the functioning and correct use of the product; they may not contain any commercial or promotional content;
• in the case of medical devices: where the device is not available in Belgium and training or a demonstration at another location is demonstrably unavoidable – including because specific infrastructure is required – it may, for example, take place on the company’s premises, provided that all less intrusive or less costly alternatives for organising the training or demonstration (such as remote demonstration, a temporary test setup or the availability of the device at another institution) have been objectively assessed and ruled out in advance with reasons given;
• any form of support or sponsorship is strictly limited to the costs that are necessary for participation in the training or demonstration, and is provided in accordance with the general principles of Article 10;
• all conditions and modalities of the training or demonstration are set out clearly, transparently and in writing in advance, and form an integral part of the purchase agreement or a document connected thereto.

Financial transparency, traceability and accountability

The Guidance heavily underscores that the financing of scientific events is only permitted where the funds are demonstrably and exclusively used for the scientific component. The sponsoring company, the organiser and any healthcare organisations share joint responsibility for ensuring correct, transparent and verifiable use of the funds. Adherence to the following principles is recommended to that end:

• A scientific event sponsored by pharmaceutical or medical device companies must retain an exclusively scientific character at all times. Where an event also includes other components, the scientific part must be clearly distinguishable from any non-scientific components. This also means that financial flows must be clearly and unambiguously distinguishable, so that an inspection can immediately establish which funds have been specifically allocated to the scientific component.
• It is strongly recommended that all parties involved retain detailed and verifiable supporting documents from which it can be established which funds were received, their origin and the specific expenditure for which they were used. The supporting documents must demonstrate unambiguously that the funds were used exclusively for the scientific component. The financial accountability must include at minimum the headings described in Appendix A to the Guidance.
• Unused funds must always be returned to the sponsors or used in accordance with the statutory provisions. The retention of any remaining funds by beneficiaries is not permitted.
• There must always be a written sponsorship agreement between the relevant parties, which should include at least: (i) the purpose of the sponsoring, (ii) an estimate of the costs covered, (iii) a clause on compliance with Article 10 of the Medicines Act, (iv) an obligation to provide supporting documents after the event, (v) a provision setting out what happens to any unused funds, and (vi) where applicable, an obligation to provide the Mdeon visa decision to the sponsoring company and/or participants.
• The parties must keep all relevant documents available for inspection for ten years.

Conclusion

The Guidance does not alter the text of Article 10 of the Medicines Act but provides a consolidated and detailed framework for its interpretation and application. As such, it serves as a valuable reference point for companies, healthcare organisations and other stakeholders seeking to align their internal policies and practices with the requirements of Article 10. The FAMHP has acknowledged, however, that certain requirements set out in the Guidance had not previously been expressed in explicit terms, and that the working methods described therein are not exhaustive – the FAMHP has indicated its willingness, as has already been observed in practice, to validate alternative practical approaches on a case-by-case basis, provided they guarantee an equivalent level of compliance with the principles of Article 10. As market actors become more familiar with the Guidance and its implications in day-to-day practice, it can be expected that the FAMHP will continue to update and refine it accordingly.

Looking for Part 1 of our Belgian Pharma Law Summer Blog Series? You can find it here.

ALTIUS’s Life Sciences team closely monitors regulatory developments in the pharma sector. For more information on this topic, please contact Christophe Ronse ([email protected]), Kirian Claeyé ([email protected]) and Bart Junior Bollen ([email protected]).