NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Pharmaceuticals The principal national legislation governing phar- maceuticals in the Netherlands is the Medicines Act ( Geneesmiddelenwet ). The Medicines Act regulates matters such as marketing authorisations, the clas- sification of medicinal products, supply and prescrip- tion, labelling and package leaflets, advertising, and enforcement. In addition, the Medicines Act Regula- tions ( Regeling Geneesmiddelenwet ) and the Medi- cines Act Decree (Besluit Geneesmiddelenwet) are also relevant. Directive 2001/83/EC has been implemented into the Medicines Act, together with other relevant EU leg- islation. Furthermore, the Individual Healthcare Pro- fessions Act ( Wet op de beroepen in de individuele gezondheidszorg , Wet BIG) regulates certain aspects of the prescribing of medicinal products. Other relevant legislation includes (i) Regulation (EC) No 726/2004, (ii) the Pharmaceutical Pricing Act ( Wet geneesmiddelen- prijzen ), and (iii) the Healthcare (Market Regulation) Act ( Wet marktordening gezondheidszorg , Wmg) and the Healthcare Insurance Act ( Zorgverzekeringswet , Zvw), which contain rules related to enforcement and reimbursement of (amongst others) medicinal prod- ucts and medical devices. Medical Devices Medical devices are governed by EU law, more spe- cifically the Regulation (EU) 2017/745 (Medical Device Regulation, MDR) (for in vitro diagnostics: Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation, IVDR)). These regulations do not require transposition into Dutch law, as they have direct effect. National legislation on medical devices is laid down in the Medical Devices Act ( Wet medische hulpmiddel- en ). The Medical Devices Act also regulates national competences and enforcement. In addition, the Medi- cal Devices Decree ( Besluit medische hulpmiddelen ) and the Medical Devices Regulation ( Regeling medis- che hulpmiddelen ) are relevant. Other relevant legisla- tion includes, inter alia, the Wmg and Zvw.
Regulatory bodies governing medicinal products and medical devices There are various regulatory bodies responsible for overseeing the application and enforcement of the aforementioned legislation. • The Minister of Health, Welfare and Sport (MoH) is responsible for the overarching pharmaceutical policy (eg, pricing of authorised medicinal prod- ucts). • The Medicines Evaluation Board (MEB, • College ter Beoordeling van Geneesmiddelen ) is responsible for assessing medicinal products, monitoring adverse reactions and risks and pro- moting the proper use of medicinal products. • Farmatec (an implementing organisation of the Ministry of Health, Welfare and Sport) is responsi- ble for, amongst others, granting medicinal prod- ucts authorisation, registration of certain medical devices, issuing certificates for the purposes of export of medicinal products, and setting maxi- mum prices for medicinal products. • The Dutch Health Care and Youth Inspectorate (IGJ) is tasked with the oversight and enforcement of inter alia the Medical Devices Act and the Medi- cines Act • The Dutch Healthcare Authority ( Nederlandse Zor- gautoriteit , NZa) is tasked with market regulation as well as the supervision of compliance with, inter alia, the Wmg and Zvw. • The Dutch Competition Authority ( Autoriteit Consu- ment & Markt , ACM) is responsible for the over- sight of compliance of competition laws, including the markets of medicinal products and medical devices. • The National Healthcare Institute ( Zorginstituut Nederland , ZIN) has an advisory role in relation to the reimbursement of care. • There are various notified bodies responsible for assessing whether medical devices (of a certain class) satisfy the necessary legal requirements allowing them to be marketed throughout the Euro- pean Union. These are DEKRA, BSI and Kiwa Dare and Scarlet. Legal nature and autonomy The MoH, ZIN, ACM, IGJ and NZa are governmental bodies. The ACM, IGJ, MEB, ZIN and NZA are con-
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