In the Netherlands, the Minister of Health submitted a legislative proposal to the House of Representatives. It aims to include a ban on improper inducements in the Medical Devices Act.
Inducements in the medical device sector
The current Dutch Medical Devices Act (Wet op de medische hulpmiddelen – "WMH") does not regulate inducement or other financial relations between medical device companies and healthcare professionals, such as gifts, hospitality, fee for service or rebates and discounts.
The legislative proposal introduces a ban on inducements that are aimed at stimulating the prescription or supply of medical devices by awarding, offering or promising benefits in cash or in kind to healthcare professionals, healthcare institutions or health insurance companies.
What would still be allowed?
- Compensation for (or not charging of) participation fees for meetings including travel costs and hospitality, provided that this remains limited to what is strictly necessary to participate in the meeting.
- Fees for service, provided that the fees are reasonable and proportionate. The service should be relevant for the medical device company or for the healthcare professional and a written services agreement must be in place.
- Gifts of limited value that are of relevance for the healthcare professional's practice.
- Discounts and bonuses related to the purchase of medical devices.
The proposed ban is reciprocal: medical device companies may not offer improper inducements and healthcare professionals, institutions and health insurance companies may not ask for or accept improper inducements.
The proposed ban and the exceptions are similar to the regulatory framework in the pharmaceutical sector, a key difference being that the proposal for medical devices not only applies to inducements towards healthcare professionals, but also explicitly applies to inducements towards health insurance companies.
Financial relations in the medical device sector, including those that qualify as inducement, are currently only governed by a self-regulatory industry code: the Code of Conduct for Medical Devices (Gedragscode Medische Hulpmiddelen – "GMH"). The GMH is, strictly speaking, only binding upon its member companies. Violation of the self-regulatory GMH cannot be enforced by the competent authorities. The legislative proposal would introduce a statutory prohibition and a legal basis for governmental enforcement, such as the possibility to impose financial penalties.
Violation of the prohibition on inducement could be punished by administrative fines. The Health Care Inspectorate (Inspectie voor de Gezondheidszorg – "IGZ") would have inspection powers and the Minister of Health could impose administrative fines of up to a maximum of EUR 900,000. The standard sum for administrative fines for violation of the ban on inducements will be included in a policy document issued by the Minister of Health.
Transparency of financial relations with healthcare professionals is regulated by the self-regulatory Code of Conduct for Medical Devices, GMH, as well as in the self-regulatory Code of Conduct for Pharmaceutical Advertising ("CGR"). The Minister of Health strongly supports the transparency provisions. The legislative proposal would provide for a solid legal basis for using the specific healthcare professional's personal registration number ("BIG-nummer") for transparency purposes in the medical device sector. Arranging for this in the statute itself is deemed important in particular for data privacy reasons. Although the legislative proposal does not provide that financial relations between medical device companies and healthcare professionals should be made transparent, it does confirm that the legislator strongly supports the self-regulatory framework for transparency/sunshine, with disclosure in the central publicly accessible transparency register (Transparantieregister Zorg).
The legislative proposal (nr. 34 330) was submitted to the House of Representatives (Tweede Kamer) on 29 October 2015. Amendments to the draft act can still be made and political debate on the draft is yet to start. If the draft is approved by the House of Representatives, the draft will be presented to the Senate (Eerste Kamer) for final approval.