Life Sciences Bit: Dutch Inspectorate for Health and Youth Care investigates inducement ban in medical devices sector
The Dutch Inspectorate for Health and Youth Care (IGJ) will start an investigation regarding the inducement ban in the medical devices sector.
On 1 January 2018, the inducement ban on suppliers of medical devices came into effect. As of then, the offering of money, services or goods in order to promote the sale of medical devices is prohibited. The upcoming investigation of the Inspectorate will focus on inducements in the sub-segments cardiology, orthopaedics and dental implants.
The inducement ban in the medical devices sector is reciprocal. It applies both to parties with a commercial interest in the application of the medical device, such as manufacturers and suppliers, and to anyone who uses the medical devices professionally or who has an influence on the selection of medical devices, such as doctors, buyers for healthcare institutions and health insurers. There are four exceptions to the prohibition: the reimbursement of participation fees for relevant congresses, meetings, or refresher courses, the agreement of service provision relationships, the offering of gifts of small value, usable in the professional practice, and the offering of industry-related discounts and bonuses that concern the purchase of the medical devices.
Since 2012, there have been rules in place regulating inducement payments in the medical devices sector, which are laid down in the Dutch Code of Conduct for Medical Devices (GMH). After the introduction of the inducement ban, working agreements were drawn up concerning the interaction between the Code and the Inspectorate regarding the scope of their competences.
In its forthcoming study, the Inspectorate will focus on service agreements between suppliers and healthcare professionals in the cardiology, orthopaedics and dental implant sub-segments. In addition, meetings of relevant suppliers that have been organised or are yet to take place will be examined. If the rules are violated, the Inspectorate can impose an administrative fine. The IGJ aims to present its results in early 2019.
Do you have any questions concerning the prohibition of the inducement ban? Please do not hesitate to contact your regular Loyens & Loeff advisor or Marc Wiggers.
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Marc WiggersPartner Attorney at law
Marc Wiggers, attorney at law, is a member of the Competition & Regulatory practice group. He specializes in EU- and (Dutch and European) competition, healthcare and tech.T: +31 20 578 56 14 M: +31 6 51 10 27 75 E: email@example.com