On 31 August 2017, the Dutch Ministry of Health published Policy Rules providing guidance on the ban on inducements, which was introduced by the amendment of the Dutch Medical Devices Act of 17 May 2017. The amendment establishes a prohibition on inducements, whether in cash or in kind, offered by medical device suppliers to professionals with the aim of promoting the sale of medical devices, subject to a fine of up to EUR 900,000.
The Policy Rules provide guidance on the scope of the ban, and clarify that the prohibition applies to any person professionally involved with the use of medical devices (e.g. healthcare institutions and health insurance providers). They also provide guidance on the four categories of inducements that are exempted from the prohibition:
- Compensation offered for attending meetings or events, provided the compensation is limited to cover the costs for attendance: reimbursement of costs for a scientific congress is limited to either (i) EUR 500 per congress with a maximum of EUR 1500 a year or (ii) 50% of the participation costs is paid for by the attendee. For other non-scientific meetings reimbursement should be limited to EUR 75 per meeting with a maximum of EUR 375 per year.
- Remuneration for services granted by professionals, provided that the compensation is reasonable in terms of market value and the service is relevant to the medical device supplier: the maximum hourly rates as included in the Dutch self-regulatory Code of Conduct Medical Devices are considered in line with fair market value (e.g. EUR 100 for a general practitioner).
- Gifts of limited value provided they are relevant to the practice of the professional: a gift is of limited value if it costs less than EUR 50 per gift and the annual amount does not exceed EUR 150 per recipient.
- Discounts or bonuses related to the purchase of medical devices: these should be determined in writing and are only allowed to the extent they are set of between the parties that are directly involved in the related business transaction.
The amendment enters into force on 1 January 2018 and will complement the principles set in the self-regulatory Code of Conduct on Medical Devices that have, so far, provided the only framework for interactions between professionals and medical devices companies.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, September 2017 Issue (Thomson Reuters).