On 18 April 2017, the House of Representatives adopted a legislative proposal to amend the Dutch Medical Devices Act in order to include legal provisions on favouritism (gunstbetoon) in the medical devices sector. To date, interactions between medical devices companies and healthcare professionals have only been governed by the self-regulatory Code of Conduct on Medical Devices. The legislative proposal establishes a legal framework for such interactions, thus providing a legal basis for the Health Care Inspectorate to enforce violations of the relevant rules by way of administrative fines.
The proposal complements the principles set forth by the Code of Conduct on Medical Devices and is very similar to the legal framework on favouritism that applies to the pharmaceutical sector under the Dutch Medicines Act.
The proposal defines favouritism as offering or granting money or goods or services with a monetary value to a healthcare professional, healthcare institution or health insurance body with the aim of promoting the sale of a medical device. The proposed legal framework prohibits favouritism, with the following limited exceptions:
- Financial contributions to the costs of participating in scientific or promotional meetings for healthcare professionals provided such contribution is limited to what is strictly necessary to participate.
- Remuneration for services provided that the remuneration is reasonable in terms of market value, the service is recorded in writing in an agreement and relevant for the medical devices company or professional activity of the healthcare professional.
- Gifts (money or goods or services with a monetary value) provided they are of limited value and are relevant to the business of the healthcare professional.
- Discounts and bonuses related to the purchase of medical devices.
The proposal also introduces a specific legal basis to allow public disclosure of health care professionals’ registration number (BIG-nummer) in the framework of the existing transparency register (www.transparantieregister.nl), the Dutch self-regulatory initiative to publicly disclose relationships between pharmaceutical/medical devices companies and health care professionals.
The proposal can either be accepted or rejected by the Senate in its current form (modifications not being allowed).
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2017 Issue (Thomson Reuters).