May employees of companies making, importing or distributing medical devices be present in the surgical area? Yes, but only under certain conditions.
The Belgian legislation sets forth that manufacturers, importers and distributors of medicines or medical devices may not promise or offer any benefits to their customers. Does this mean that employees of the companies may be present in the surgical area or not? The FAMHP clarifies the conditions for this in a circular letter (available in Dutch or French).
Prohibited without compensation
Employees of manufacturers, importers or distributors of medical devices who are present in a surgical area without the hospital paying for them? No. That’s not allowed. The law considers their presence as an advantage or bonus. And companies may not offer these. Hospitals may also not accept them.
Permitted if contract mentions compensation
Does the contract between the company and the hospital mention the presence of employees in the surgical area and does the hospital pay a surcharge for this? Then that’s allowed. The surcharge the hospital pays may be part of the total price or it can be a separate price.
In any case, factual elements must show that a price is indeed paid for this additional service. If this is not the case, this may mean a violation.