NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
Transferring non-anonymised data to a third party or an affiliate is permitted, provided that the require- ments of the GDPR are met. In the context of clinical trials, this is typically complied with by obtaining con- sent from the data subject (Article 6 (1)(a) GDPR). For the purposes of processing sensitive data, an explicit consent from the data subject is required (Article 9 (2) (a) GDPR). Additional requirements apply where data is transferred outside the EU/EEA. If the research data is fully anonymised and can no longer be traced back to a natural person, such data falls outside the scope of the GDPR and is no longer considered personal or sensitive data. In that case, the GDPR restrictions on processing and transfer do not apply. 2.6 Personal or Sensitive Data Since 25 May 2018, the GDPR has been directly appli- cable in the Netherlands. Where the GDPR allows room for national choices in its implementation, these have been elaborated upon in the GDPR Implementa- tion Act (UAVG). The GDPR provides that the process- ing of personal data relating to health or mental condi- tion is permitted only if there is a lawful basis. Such a basis may be laid down in law; otherwise, consent is required to process health data. The GDPR privacy statement and the use of data are also assessed as part of the application for a medicinal product study. The Database Act ( Databankenwet ), based on the Database Directive 96/9/EC, and the Copyright Act apply to the database itself.
fied as a pharmaceutical based on either its “presen- tation” or its “function”. Medical Devices With regard to medical devices, the MDR provides that any (amongst others) instrument, apparatus, implant or other article (i) intended by the manufac- turer to be used for human beings for specific medical purposes (Article 2 (1) MDR) and (ii) which does not achieve its principal intended action by pharmaceuti- cal, immunological or metabolic means, but may be assisted in its function by such means. In other words, of importance are the intended purpose provided by the manufacturer and the mechanism of action of the device. Whether a product classifies as one of the two is determined on a case-by-case basis. For instance, if a device does not have a medical purpose (assigned by its manufacturer), it would not be considered a medical device. Similarly, if a device is intended by its manufacturer to be used for specific medical pur- poses, but achieves such purposes because of its pharmaceutical, immunological or metabolic means, it would, in principle, be considered a pharmaceutical under the Directive 2001/83/EC (and the Medicines Act). In that respect, it should be noted that a product that has been classified as a medical device in another member state does not necessarily mean it will be classified as such in another member state. 3.2 Marketing Authorisation for Biologic Medicinal Products Dutch law does not provide for specific authorisation procedures in relation to biological medicinal prod- ucts. However, where an application concerns a bio- logical medicinal product for which the applicant can demonstrate that it is generic vis-à-vis the reference medicinal product, a fast-track procedure becomes available. Furthermore, it should be noted that (i) medicinal products developed by means of biotech- nological processes, as listed in Annex 1 (1) of Regula- tion (EC) 726/2004, and (ii) certain ATMPs, as listed in Annex 1 (a) of Regulation (EC) 726/2004, are subject to a centralised procedure.
3. Marketing Authorisations 3.1 Product Classification Pharmaceuticals
The criteria of medicinal products are laid down in Directive 2001/83/EC and the Medicines Act. A medicinal product is (i) any substance or combination thereof presented for treating or preventing disease in human beings or (ii) any substance or combination thereof which may be administered to human beings with a view to making a medical diagnosis or to restor- ing, correcting or modifying physiological functions in human beings. In other words, a product can be quali-
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