Supervision of inducements

Inducements are about offering money, services or goods with the apparent aim of promoting the sales of a medical device. This could for example be giving 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.

This ban applies to:

  • All parties that have a commercial interest in the use of a medical device (the providers). Examples are manufacturers and suppliers.
  • Anyone who has a professional influence on the choice of a medical device (the recipients). This includes doctors, nurses, purchasers from healthcare institutions and health insurers.

The rules apply in both directions: what a provider is not allowed to give must not be accepted by a recipient.

Exceptions

There are four exceptions to the ban on inducement:

  1. Remuneration of participation costs for e.g. (scientific) conferences, product-related meetings and refresher courses. This is allowed, but should be limited to what is strictly necessary to take part in the meeting or event. Important aspects are 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.
  2. Genuine consulting arrangements  laid down in a written service agreement.
  3. Gifts of limited monetary value that can be used for professional practice.
  4. Sector-related discounts and bonuses concerning the purchase of medical devices.

You can 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’).

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). These working arrangements state the division of tasks and the cases in which the Inspectorate and Stichting GMH can refer complaints to one another. The working arrangements will be published after they have been signed off.

Autumn 2018: start of supervision

In the autumn of 2018, we are starting an investigation into incentives at suppliers of medical devices. It concerns the following subsegments:

  • cardiology
  • orthopaedics
  • dental implants

This means that the Health and Youth Care Inspectorate will look at service provision agreements that suppliers have concluded with care professionals. We will ask suppliers for overviews of meetings they have organised or will be organising. We will then test the service provision agreements concluded with care professionals against the law. We expect the results by early 2019.

Enforcement by the Inspectorate

Article 11 paragraph 1 of the Medical Devices Act states that the Inspectorate is charged with supervision of the Medical Devices Act. Article 14 of the Medical Devices Act deals with enforcement. The Inspectorate can  impose an administrative fine if the regulations on inducements have been violated.

The priority of the Inspectorate during the first six months of 2018 is on working out its supervisory task in detail and on communication to the parties that have to comply with provisions set out in the new regulations.

Applicable rules

Article 10h of the Medical Devices Act (Dutch) and the Policy Rules (Dutch) on Inducements under the Medical Devices Act.