Based on the self-regulatory Code for medical devices (GMH Code) all financial relations between all medical device suppliers and all medical specialists regarding services and sponsoring in 2017 must be disclosed in the publicly accessible Dutch Transparency Register. Data on the financial relations will have to be submitted ultimately on 1 June 2018 and disclosure of the data is expected in July 2018. This is the first time after a period of pilot projects that financial relations regarding medical devices will be disclosed.
The obligation to disclose financial relations regarding services and sponsoring applies to all medical device suppliers (if they are indirect or direct member of the GMH) and all physicians 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 data to be disclosed shall contain: inter alia, the following data: amount paid, type of interaction, data regarding supplier and HCP, i.e. name, address details. The disclosure obligation applies to medical device companies that are (indirectly) a member of the self-regulatory GMH Foundation. Physicians do not have an opportunity to "opt-out": they are – through professional organizations - 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.
Disclosure of financial relations is part of a bigger trend in the Netherlands towards more transparency and more rules on relations between medical device companies and professionals involved in the use of medical devices, such as the recently introduced ban on inducement.