Belgian regulator introduces new rules on hospitality and meals for healthcare professionals
Published on 17th Jul 2024
The changes came into effect on 1 July for all medical devices and pharmaceutical companies interacting with HCPs
New standards for the provision of hospitality, particularly meals, to healthcare professionals (HCPs) in Belgium are applicable since 1 July, following recent regulatory updates. The amendments were introduced by Mdeon, the ethical platform in charge of overseeing and providing guidance on certain aspects of the promotion and information around medicinal products and medical devices in Belgium. Compliance with the new rules is monitored by the federal agency for medicines and health products (FAMHP), the local healthcare regulator.
The changes aim to establish a clear distinction between HCPs participating as consultants and those attending as participants in scientific events. Mdeon also provides clarifications on the cost of overnight accommodations made available to HCPs.
Participants and consultants
Participants are now defined as HCPs attending a scientific event primarily to gain knowledge. They do not typically receive honoraria for their participation. Consultants, on the other hand, are HCPs who provide scientific services during the event, often for a fee. These services can include speaking engagements, conducting research or offering expertise; conversely, activities such as poster presentations or giving feedback after a conference would not qualify as consulting, according to Mdeon.
Detailed rules on meals
Meals provided to HCPs continue to be subject to strict regulations to ensure they are directly linked to scientific activities. Meals can only be offered immediately before, during or after an official scientific activity. As a general rule, they cannot be provided in transit, at airports or train stations, and hospitality must strictly adhere to the duration of the scientific event.
For instance, it is permissible to offer a meal at the end of a meeting abroad if it is impossible to return to Belgium on the same day and the dinner coincides with the end of the scientific programme. However, if the programme ends before 17:30, dinner cannot be offered to the HCP. Similarly, lunch before the start of a scientific event can be provided only if the programme begins before 14:30. If the programme starts after this time, lunch cannot be offered.
The maximum allowable costs for meals remain unchanged: €45 for lunch, €90 for dinner, and €23 for a coffee break. Additionally, a total maximum of €135 per day applies if the programme includes at least six hours of scientific activity. If the programme duration is less than six hours, the meal cost is capped at €23 per complete hour of scientific activity. These amounts cover all costs, including beverages, VAT and room rental. Notably, the offer of a dinner the night before a scientific event is only authorised if there is a scheduled scientific programme the previous evening.
The calculation of the scientific programme duration considers only the effective scientific content. Non-scientific periods such as lunch breaks, coffee breaks and participants' reception are excluded. The maximum amounts of €45 for lunch, €90 for dinner and €23 for a coffee break must always be adhered to, and unused amounts cannot be carried over to other days.
Exceptions for consultants
Mdeon now considers that consultants may receive meals that do not directly follow the scientific programme or meals the day before an event without a scheduled scientific programme, provided these are justified and documented in a contract.
The cost of the meal should, however, remain reasonable and within authorised amounts, unless justified otherwise. For example, a higher priced dinner attended by both Belgian consultants and foreign consultants can be justified. That is to ensure uniformity and facilitate scientific discussions among all consultants regardless of their country of practice and the regulatory limitations that apply to each one of them. Such justification must be included in the Mdeon visa application when a visa is required.
Consultants on a speaker tour that is providing training at different hospitals may receive meals not directly following the training sessions if stipulated in the agreement. For instance, providing lunch for evening training sessions can be included in the consulting agreement.
The contract detailing these provisions must be attached to the visa application, including the relevant clause setting out an exception to applicable rules. The exception regime for consultants apply only to meals directly related to their consulting services. If a consultant also participates as a participant, the hospitality provided must differentiate between these roles. The consultant's status must be clearly documented in the supporting materials.
Overnight stays
Mdeon introduces a clarification regarding the cost of overnight accommodations offered to HCPs in the context of scientific event. The maximum allowable cost per night remains at €250, inclusive of breakfast and taxes. Exceptions apply to countries where a decree of 2008 (in French and in Flemish) allows for a higher maximum lodging allocation.
In such cases, exceptions can be granted if specific conditions are met. Firstly, at least five separate hotel quotes must be submitted with the visa application, demonstrating that it is not feasible to stay within the €250 limit. Only the lowest quote should be accepted. Secondly, the hotels must be within a reasonable distance (a maximum 10 kilometres) from the event venue. Thirdly, the venue must meet the reasonableness criteria outlined in the Mdeon Code, meaning that they cannot be luxury hotels. Lastly, Mdeon stresses that their services will verify that there are no cheaper reasonable options available.
Osborne Clarke comment
The introduction of these new standards by Mdeon and FAMHP underscores the importance of transparency and clear documentation when providing hospitality to HCPs. By delineating the roles of participants and consultants and setting specific guidelines for meals, the new Mdeon guidance aims to maintain ethical standards and prevent undue influence.
Companies involved in organising or sponsoring scientific events must carefully review their consulting agreements and overall hospitality practices to ensure compliance. These changes will require meticulous planning and contractual clarity, particularly when justifying exceptions for meal provisions.
Non-compliance with Mdeon standards may have negative consequences for businesses, including reputational damage, warnings and/or sanctions from the FAMHP services. Sanctions provided by Belgian law include fines ranging from €4,000 to €240,000 (against corporations) or from €1,600 to €120,000 (against individuals).
For more detailed advice on these regulations or assistance with compliance strategies, please contact our team at Osborne Clarke.
