As of 1 January 2018 a ban on inducement regarding medical devices will enter into force in the Netherlands. Violation could lead to fines up to EUR 900.000. Please see our previous newsletter on this here. The ban applies to 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 (HCPs), healthcare institutions, health insurance companies or other persons professionally involved in the application/use of medical devices. The following forms of interaction will however still be allowed (legal exceptions):
- 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 HPC and a written services agreement must be in place.
- Gifts of limited value that are of relevance for the HCPs practice.
- Discounts and bonuses related to the purchase of medical devices.
The Ministry of Health (MoH) has now published policy rules providing further guidance to this ban on inducement.
Scope of the ban
The scope of the ban is quite broad. First of all the ban not only applies to medical device suppliers, but also to recipients of inducement, e.g. a health institution or HCP. The ban and the legal exceptions to the ban furthermore apply to a broad number of people and entities as these do not only apply to HCPs, but also to all persons professionally involved in the application/use of medical devices. This means that the ban and the legal exceptions thereto may also apply to e.g. hospital procurement officers. Besides to the manufacturers, the ban also applies to retailers and composers of medical devices.
Sponsoring or the provision of various grants is not considered as a form of inducement if certain criteria have been met. Sponsoring should for example not be contingent on any sale. Prior written approval of the board of the sponsoree should be obtained. Consideration other than the mentioning of the sponsor's name is not allowed, etc. If the sponsoring has a commercial element it is likely to be considered as a form of prohibited inducement for which no legal exception applies.
Reimbursement of participation costs for congresses and meetings are further defined in the policy rules. Such reimbursement is subject to maximum financial thresholds per person, per event and per year. Reimbursement of costs for a scientific congress is limited to either (a) EUR 500 per congress with a maximum of EUR 1500 a year or (b) 50% of the participation costs is paid for by the person attending the congress. For other non-scientific meetings costs to be reimbursed should be limited to EUR 75 per meeting with a maximum of EUR 375 per year.
Fees for services
Providing fees for services is allowed if certain criteria have been met. The hourly rate should be in line with fair market value. The policy rules refer to the maximum hourly rates as included in the Dutch self-regulatory Code of Conduct Medical Devices (GMH):
|Medical specialist||EUR 140|
|General practitioner||EUR 100|
Gifts and discounts/bonuses
The policy rules provide that a gift is of limited value if it costs less than EUR 50 per gift and the annual amount shall not exceed EUR 150 per recipient. Discounts and bonuses are allowed to the extent these are set of between the parties directly involved in the related business transaction. Discounts and bonuses should furthermore be in writing and a discount in kind is only allowed if it concerns sector related products