Supervision of inducements
Inducements are about offering money, services or goods for the apparent objective of promoting the sales of a medical device. Inducements may relate to gifts or remunerating dinners, business or other trips and payment of registration, travel and accommodation for conferences. Inducements in the medical devices sector have been prohibited by law as of 1 January 2018. The Health and Youth Care Inspectorate is responsible for supervising compliance in this regard.
This ban applies to:
- All parties that have a commercial interest in the use of a medical device (the providers), such as manufacturers and suppliers.
- Anyone who has a professional influence on the selection of a medical device (the recipients). This includes doctors, nurses, purchasers from healthcare institutions and health insurers.
The rules apply in both directions: a recipient may not accept that which a provider is prohibited from giving.
There are four exceptions to the ban:
- Remuneration of participation costs for e.g. conferences, product-related meetings and refresher courses. This is permitted but should be limited to what is strictly necessary to take part in the meeting or event. Important aspects include the balance between the scientific and non-scientific parts of the programme (main objective of the meeting) and whether it is held at a suitable location.
- Appropriate consulting arrangements laid down in a written service agreement.
- Gifts of limited monetary value that can be used for professional practice.
- Sector-related discounts and bonuses concerning the purchase of medical devices.
Please find more information in the FAQs about the ban on inducements. The complete regulations (in Dutch), including the conditions for the grounds for exceptions, can be found in the text of the act and the policy rules (‘Beleidsregels’). In addition the Code of Conduct for Medical Devices (GMH) and the Foundation for the Code for Pharmaceutical Advertising (Stichting Code Geneesmiddelenreclame, CGR) have developed the decision-making tool How do I remain independent (in Dutch). This website is intended for healthcare professionals entering into financial commitments with companies, such as providers of medicinal products and of medical devices.
The ban on inducements likewise applies to the pharmaceutical sector.
Code of Conduct for Medical Devices
Self-regulation rules about inducements have been set out in the Code of Conduct for Medical Devices (Dutch: GMH) since 2012. Working arrangements have been drawn up between the Inspectorate and the Foundation GMH (Dutch: Stichting GMH), which set out the division of duties and responsibilities and the cases in which the Inspectorate and GMH can refer complaints to one another.
Supervision of inducements in the medical devices sector 2019 and follow-up study 2021
A supplier and users of medical devices will lay down working arrangements in a service provision agreement (DVO). This may, for example, relate to fees provided for giving lectures.
Based on a review conducted among 15 suppliers of medical devices into 50 service agreements concluded with healthcare professionals, the Health and Youth Care Inspectorate concluded the following as early as 2019, namely that the presence of service provision agreements was a positive development. However, it equally concluded that a greater degree of transparency on compensation was required. More information about the investigation in 2019:
In 2019, the Inspectorate reviewed the DVOs of 8 suppliers, which related to some 350 documents in total.
One positive aspect is that there was a sufficient degree of transparency in the service provision agreements on the hourly rate charged and the expense allowances.
Please find more information about the Inspectorate’s experiences and an outline of the review in the fact sheet:
The Inspectorate launched a follow-up review in 2021. The focus was on the financial relationships between suppliers and users of medical devices. We specifically examined the financial records of the outgoing cash flows (payments) from suppliers to users of medical devices. In addition, we focused on the underlying documents and the reasons for the amounts paid.
Inspection reports on inducements
Please find the relevant reports under Publications (in Dutch). Then make the following selection in the search settings: ‘Medical devices, inducements’.
Enforcement by the Inspectorate
Section 10 of the Medical Devices Act states that the Health and Youth Care Inspectorate is charged with the supervision of the Medical Devices Act. Section 14 of the Medical Devices Act subsequently governs enforcement. The Inspectorate can impose an administrative fine if the regulations on inducements have been violated.
Section 6 of the Medical Devices Act (Dutch) and the Policy Rules (Dutch) on Inducements under the Medical Devices Act.