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On 8 April 2024, the Dutch Minister of Medical Care (the Minister) sent a letter to the Dutch House of Representatives (Kamerbrief) outlining certain measures she intends to prepare to prevent unwanted influence of healthcare professionals by medical companies. This letter is part of an ongoing trajectory of the Dutch government, focusing on transparency in the medical industry and the prevention of unwanted influence of health care professionals. In this article, we outline the current measures taken and the proposed measures to prevent certain issues identified.
1. Current Dutch measures
The current legislative and self-regulatory framework in the Netherlands all have the same underlining principle. In general, financial flows between healthcare professionals and medical companies are useful and necessary. It benefits healthcare research, innovation and education, which is ultimately in the patient’s interest. At the same time, patients must be able to rely on healthcare professionals to make decisions regarding, for example, medical devices based on care-related grounds and not based on their own financial interest. Various measures have therefore been taken to prevent unwanted influence of healthcare professionals by medical device companies and pharmaceutical companies. The two most important measures currently in place are briefly described below.
I. Ban on financial inducement
The Netherlands has had a legislative prohibition on financial inducement (gunstbetoon) since 2018.[1] Inducement is the offering of money, services or goods with the apparent aim of promoting the sale of a medical device. There are some exceptions to this prohibition including, briefly, the situation where the remuneration is in reasonable proportion to the performance delivered by the healthcare professional.[2] The Dutch Healthcare and Youth Inspectorate (Inspectie Gezondheidszorg en Jeugd – IGJ) monitors compliance with the ban on financial inducement.
Further, which is not discussed in the letter of the Minister in the context of inducement, the self-regulatory Code of Conduct Medical Devices covered inducement since 2012.
II. Healthcare transparency register
One (self-regulatory) measure taken by the field parties themselves, and thus founded on self-regulation, is the Healthcare Transparency Register (Transparantieregister Zorg – TRZ). Since 2012, financial relations between healthcare providers and the medical industry have been recorded in the TRZ. The TRZ is a central and public register for registering financial relations between suppliers of medical devices and medicines on the one hand and healthcare professionals on the other. The Code applies to suppliers, healthcare professionals and hospitals that are member to the relevant (voluntary) code of conducts, which are the abovementioned Code of Conduct Medical Devices, Code of Conduct Pharmaceutical Advertising and the Code of Conduct Advertising Veterinary Products .
1.1 Issues identified under the current framework
According to the Minister, at the heart of the current problems, is a lack of transparency on the financial relations between healthcare professionals and hospitals on the one hand and medical companies on the other hand. The consequence of this isthat IGJ, is unable to adequately supervise whether financial relations are not registered. In addition, the TRZ does not work properly and, in practice, registrations of financial relations regularly turn out to be missing or not findable. It has also been found that the boards of Dutch healthcare institutions are often unaware of their healthcare professional’s financial relations with medical companies.
The solution put forward by the Minister lies in a fundamental change in legislative approach: where previously the emphasis was on self-regulation, the Minister wants to move towards regulation.[3] The Dutch House of Representatives endorses this shift from self-regulation to government regulation.[4]
2. Proposed measures
To solve the problems outlined above, which at their core mainly boil down to the lack of transparency about financial relations between healthcare professionals and medical companies and the limited ability to enforce them, the Minister proposes three ‘focus points’, which are (i) strengthening the current legislation, (ii) the improvement of the current transparency register and (iii) intensifying oversight. With regard to the first focus point, strengthening the current legislation regarding transparency and inducement, the following measures are proposed:
I. Establishing a statutory transparency register
As mentioned, the current transparency register is based on self-regulation. The Minister wants to establish a statutory transparency register that will apply broadly, where the starting point should be that all healthcare providers and medical companies are transparent about their financial relations. A threshold amount of EUR 500 will apply to the statutory transparency register (which is in line with the current threshold). The legal transparency register should also have better search functions than the current register according to the Minister.
II. An increased role for boards of healthcare providers in establishing financial relations between healthcare providers and medical companies
In addition, the Minister wants to come up with a legal proposal under which boards of Dutch healthcare providers, for example of hospitals, will be obliged to grant approval when entering into a financial relation between healthcare professionals and medical companies. By doing so, the Minister aims to increase internal transparency of healthcare institutions, leading to the board of such healthcare institution gaining a better understanding of the financial flows.
III. A better legal framework for sponsorship
Finally, the Minister wants to outline a clearer legal framework with respect to sponsorship. Currently, it is unclear under Dutch law what should be considered as sponsorship. The IGJ has indicated that the current legal framework is not sufficiently clear and therefore they are not able to apply their supervisory powers. There would also be a lack of transparency regarding sponsorship. The Minister is considering including sponsorship as an additional exception to the ban on financial inducement.
3. Concluding
With this letter, it is clear that the government feels that currently there is a lack of transparency on financial relations between healthcare professionals and medical companies and the limited ability to enforce it. At the same time, it is noted that legislation alone is not going to prevent all problems. In the last years, amongst others, all the self-regulatory code of conducts for the medical industry (as mentioned above) included new rules to increase transparency, both via the TRZ as well as internal transparency in the institutions, and it is clear that the industry has made efforts to improve. However, since the legislative proposal in 2020 concerning an obligatory transparency register, it has been clear that new additional legislation was on the horizon for the industry.
Following general developments in the medical sector, self-regulation is slowly replaced by an increasing legislative framework – which does often not fully align with the daily practice of the healthcare industry. If done wrong, it leads to a significant burden on the healthcare institutions and industry, thus hindering healthcare in general and more specifically innovation in this sector. If done right, it could increase trust in the healthcare sector as a whole and ensure a fair level playing field amongst the many different healthcare actors.
[1] Article 6 Dutch Act on Medical Devices (Wet medische hulpmiddelen).
[2] For further requirements, see the Policy Rules on favouritism under the Medical Devices Act (Beleidsregels gunstbetoon Wet op de medische hulpmiddelen.).
[3] Letter from the Minister, ‘Progress trajectory on transparency and prevention of undue influence of medical professionals by companies’, dated 8 April 2024.
[4] ‘ Beslisnota bij Kamerbrief over voortgang traject transparantie en voorkomen van ongewenste beïnvloeding van medische professionals’, 26 March 2024.
