Medical devices

The Dutch self-regulatory Code of Conduct for Medical Devices (Gedragscode GMH, GMH) will be amended as of 1 January 2017. This amendment entails that financial relations between all medical device suppliers and all medical specialists regarding services and sponsoring must be disclosed. Disclosure of the 2017 relations will take place in 2018. This means that services and sponsoring agreements should - as of 1 January 2017 - contain a disclosure clause to ensure compliance with this general disclosure obligation.

Background

As of 1 January 2015 sunshine requirements have been introduced in the GMH as a pilot project for certain physicians (cardiologists and orthopedics) and suppliers of certain implantable medical devices (e.g. ICDs, pacemakers, stents and/or hip and knee prostheses. Please see our previous newsletter on this topic here. Further to this pilot project it has now been decided to have the disclosure obligation apply to the entire medical devices field as set out below.

Disclosure requirements as of 1 January 2017

The obligation to disclose financial relations regarding services and sponsoring applies to all medical device suppliers and all medical specialists (medisch specialist) included in the Dutch BIG register as physician. General practitioners (huisartsen) are excluded from the disclosure obligation. The disclosure obligation also applies to payments made to hospitals and to partnerships, that consist of medical specialists.

The obligation to disclose payments applies if the total amount exceeds EUR 500 per calendar year. The first disclosure of 2017 payments shall take place in 2018 in the publicly accessible Dutch Transparency Register and shall contain: inter alia, the following data: amount paid, type of agreement (sponsoring or services), data regarding supplier and HCP, i.e. name, address details.

Physicians do not have an opportunity to "opt-out": they are also bound by the GMH.

Services agreements regarding clinical trials or research that is covered by the Dutch Medical Research Human Subjects Act is excluded from the disclosure obligation.

Disclosure of the financial relation to the Dutch Transparency Register will take place by the medical device supplier, unless (a) it concerns a foreign medical device supplier in which case the Dutch HCP is responsible for disclosure or (b) parties have agreed otherwise in writing.

The obligation applies to all financial relations as set out above invoiced as of 1 January 2017.

What does this mean?

All agreements between medical device suppliers and medical specialists regarding the provision of services or sponsoring with an invoice date as of 1 January 2017 should contain provisions on the disclosure of the financial relation.

Netherlands-based medical device suppliers must report the required data regarding the financial relations of 2017 to the Dutch Transparency Register, unless contractually agreed otherwise.