New year brings healthcare professional interaction rule update in Belgium
Published on 4th Jan 2023
The new rules offer more flexibility to life sciences businesses interacting with health professionals and organisations
New compliance or "anti-gift" principles entered into force in Belgium on 1 January 2023. In Belgium, local compliance rules apply to any interaction between, on the one hand, a pharmaceutical or medical device business (regardless of the location of its registered seat); and on the other hand, a healthcare professional (HCP), a healthcare organisation (HCO), a distributor or a broker registered in Belgium.
They arise out of the Belgian legislation and are interpreted in a detailed and legally binding code of deontology enacted by Mdeon, the non-profit organisation entitled by decree to deliver prior authorisations, or "visas", before certain interactions can take place between the specified businesses and local HCPs or HCOs. It further facilitates the reporting of those interactions on the Belgian transparency platform.
The last update to the code took place in September 2018, when a decision was made to ban the sponsoring of HCP and HCO fellowships lasting more than three weeks. Since then a number of minor modifications were introduced through the Mdeon FAQ.
In late December 2022, it was announced that the Mdeon Code and some compliance principles would be amended again, with the approval of the Belgian healthcare regulator the Federal Agency for Medicines and Health Products.
The broad concept of "scientific event" is clarified to explicitly include face-to-face ("physical"), virtual and hybrid events of a scientific nature. The criterion for a virtual scientific event is the ability for HCPs to participate from anywhere, by connecting via a PC, laptop or any other mobile device. A hybrid scientific event is where HCPs can freely choose to participate virtually or in face-to-face settings.
Consequences for visa applicants
Mdeon visas remain mandatory for a scientific event that takes place over several consecutive calendar days: if the attendance of HCPs is being sponsored by a pharmaceutical or medical device company (including distributors and other economic operators), either directly or through an HCO (V1 visa); or if the organisation of the event is being sponsored by any of these companies through a V2 visa, which needs to be filed by the organiser.
The code clarifies that a virtual event is only subject to a visa if it takes place over several consecutive calendar days and if registration fees are being paid. By contrast, fully digital scientific modules that are available online at any time (for example, e- learning sessions) are not subject to a visa.
Fees for visa applications have been decreased and aligned with the amounts that were requested before the Covid-19 pandemic, namely €165 for a V1 visa application (or €100 if the company is a member of a local industry association) and €240 for a V2 visa application, all excluding VAT.
New gifts of negligible value
The list of permitted gifts of negligible value has been extended to include the digital scientific modules and more specifically the "registration fee to be able to consult such modules virtually". This means that the transfer of value must comply with the applicable legal principles and the maximum thresholds set by Mdeon (in euros and excluding VAT). So long as they meet those conditions, they do not have to be reported on www.betransparent.be under the Belgium "Sunshine Act" of 18 December 2016 and implementing decrees.
Payment of hospitality costs
A key principle remains that costs (including hospitality costs) relating to the organisation of or an HCP's participation in an event should only be paid if the event is a scientific one (that is "of an exclusively scientific nature"). Conversely, Mdeon does not grant visas if an event is "purely or mostly of a promotional nature".
However, the code now clarifies that virtual scientific events – unlike like face-to-face events – do not have to include at least six hours of scientific activities per day. The updated code further confirms previous industry guidance enacted during the Covid-19 pandemic: an HCP participating virtually in a scientific event should not be offered any hospitality (such as travel arrangements, accommodation, food and drinks) and payments should be strictly limited to registration fees.
New legal thresholds and maximum amounts
Acceptable amounts for hospitality costs paid to HCPs in the context of scientific events either directly or through an HCO have been revised as follows:
|Before 1 January 2023||After 1 January 2023|
All amounts include all taxes (such as VAT) and costs (such as drinks, coffee breaks room rental and, for overnight stays, breakfast).
Again, payment of these amounts is only allowed if the event is scientific, which means that the purpose of the event is to inform HCPs about topics that have a direct link to the exercise of their profession and are necessary to ensure a qualitative exercise of that profession in the interest of patients. Mdeon guidelines and criteria around what is or is not a scientific event remain unchanged.
Osborne Clarke comment
The new compliance rules should offer more flexibility to life sciences businesses interacting with HCPs registered in Belgium, directly or through HCOs. They imply an update of compliance policies, processes, contracts and templates that govern those interactions. The requirements apply to businesses that manufacture, import, deliver, distribute and rent out medical devices or medicinal products (including marketing authorisation holders), whether or not they have a corporate establishment in Belgium.