Dutch Code of Conduct for Medical Devices: Extended Disclosure Requirement as of 2017
The Dutch Code of Conduct for Medical Devices (Gedragscode Medische Hulpmiddelen, the Code) entered into force on 1 January 2014. The Code is a self-regulatory initiative and sets forth a framework for the promotion of medical devices in the broadest sense. Among other things, it regulates the interactions between suppliers and/or manufacturers of medical devices and healthcare professionals (HCPs). In 2015, by way of a pilot project, the Code was supplemented with an external disclosure requirement with respect to the financial relations between certain HCPs on the one hand, and suppliers of particular medical devices on the other. Following this pilot’s positive evaluation, the scope of the disclosure requirement has been significantly extended as of 1 January 2017.
General disclosure requirement as of 1 January 2017
As of 1 January 2017, the scope of the disclosure requirement under the Code is extended to cover financial relations between all medical device suppliers and all HCPs included in the Dutch BIG register (such as doctors, dentists, pharmacists and nurses), with the exception of general practitioners. 2 Against this background, the disclosure requirement applies to (i) most agreements for the provision of services (such as participating in an advisory board), and (ii) sponsorship agreements (except for sponsoring relating to certain events) . It should be noted that the transparency obligations applies not just to financial relations entered into with individual HCPs, but also to financial relations with, for example, health care centers and partnerships. Finally, service agreements relating to clinical trials or research covered by the Dutch Act on Medical Research on Human Subjects (Wet Medisch-wetenschappelijk onderzoek met mensen) are explicitly excluded from the extended disclosure requirement under the Code.
Obligation to report
In principle, the medical device supplier is responsible for disclosure of a financial relation covered by the reporting obligation. However, there are two key exceptions to this rule: (i) when it comes to the financial relation between a Dutch HCP and a foreign medical device supplier, the former is responsible for disclosure and (ii) HCPs and medical device suppliers may, in writing, agree who shall be responsible for disclosure of a particular financial relation.
The disclosure requirement exclusively applies to covered financial relations if the total amount of payments by the supplier to the HCP exceeds EUR 500 per calendar year.
Dutch transparency register
Covered financial relations are reported to - and made publically available through - the Dutch Transparency Register (Transaparantieregister Zorg). In relation to any particular HCP (or collective of HCPs), the register provides information on the amount of payments made to that HCP, the payer and the type of agreement the payments were made under. For the avoidance of doubt, this data is already accessible with respect to the financial relations covered by the 2015 pilot project.
All agreements between medical device suppliers and HCPs (in accordance with the above) with an invoice date as of 1 January 2017, should include provisions covering the extended disclosure requirement under the Code. This means that the template agreements regarding sponsoring and services between medical device suppliers and HCPs should be amended accordingly. Baker McKenzie’s multi-jurisdictional healthcare group is happy to assist.
1 The 2015 pilot project covers cardiologists and orthopedics (and partnerships and centers in this respect) on the one hand, and medical device suppliers of ICDs, pacemakers, stents and hip- and knee prosthetic devices.
2 The Code does not provide for an ‘opt-out’ for HCPs.