Regulatory framework in the Netherlands
The rules on financial relationships between physicians and medical device suppliers in the Netherlands are laid down in the Medical Devices Act (in Dutch: “Wet medische hulpmiddelen”), the Policy Regulation inducement Medical Devices Act (in Dutch: “Beleidsregels gunstbetoon Wet Medische Hulpmiddelen”) and the self-regulatory Code of Conduct Medical Devices (in Dutch: “Gedragscode Medische Hulpmiddelen”, GMH). Under these regulations the prospecting, offering, or granting of money or services valuable in money or goods by a supplier of medical devices to a natural person involved in the application of a medical device, a health care provider or a health care insurer, with the apparent aim of promoting the sale of a medical device, is prohibited. This prohibition is reciprocal: the acceptance as well as the offer of inducement is forbidden.
There are exceptions to this prohibition, for example for the payment of the provision of services or sponsorships, under certain conditions. Non-compliance with these conditions may result in administrative fines, and under exceptional conditions penalties under criminal law.
Findings of the authorities
In 2022 Dutch media reported that cardiologists in several hospitals received payments that may have been in violation of the Dutch regulations on inducement. Subsequently, the IGJ carried out inspections at four hospitals, more specifically at the respective cardiology departments. At all the hospitals that were visited, the IGJ concluded that the internal understanding and controls were insufficient. Moreover, according to the IGJ, there was a lack of knowledge of the regulations regarding inducement among the directors of the hospitals and the physicians.
Financial structures were often deemed to be untransparent. For example, budgets were missing, or it was unclear to what project certain payments related. Further, it appeared that financial relations were often not between the medical devices company and the hospital, but rather with personal legal entities held by physicians or certain research foundations. As a result, the boards of the hospitals were often not aware of the existence of the financial relations.
The hospitals that were under investigation are now required to address the above shortcomings and report to the IGJ their proposed actions for improvement. The IGJ has not (yet) imposed any administrative fines. However, the IGJ remarked in the published inspection reports, that in case of any non-compliance during future inspection visits, it may take enforcement measures.
Next steps
In the coming period, the IGJ will visit more hospitals to investigate potential inducement. In addition to cardiology, the IGJ will also look at the financial relationships of other medical specialties. The IGJ has also conducted investigations among medical device manufacturers. The results of these investigation are expected to be published soon.
Our teams routinely advise on financial relationships that medical device companies as well as pharmaceutical companies have with health care professionals and hospitals. Our teams also regularly assist with governmental investigations and with defense against any penalties imposed for alleged non-compliance. Please contact the authors or the Hogan Lovells attorneys with whom you regularly work for additional information.
Authored by Milan Tuijp, Samantha van Dijk, and Hein van den Bos.
