Life Sciences & Medical Devices: Are you ready for Brexit?
Key regulatory issues
- Market authorization of pharmaceuticals and medical devices;
- Shifting regulatory framework for clinical research;
- Access to health insurance and health care;
- Automatic recognition of British professional qualifications in the Netherlands;
Pharmaceuticals and medical devices
For a long time the EU has been working towards single markets for pharmaceuticals and medical devices. Market authorizations and certifications are now valid in other EU member states. However, as the UK will become a third country, UK authorizations/certifications may no longer be valid in the EU requiring UK held Market authorizations to be transferred to holders established in the EU.
A substantial number of Notified bodies that certify medical devices are based in the UK. As new devices being placed on the EU market should be authorized by an EU Notified body, such companies need to move (or expand) their place of business to an EU member state.
Although this outcome is of course dependent on the Brexit negotiations, in a worst-case scenario it will no longer be possible to place products that depend on a UK authorization/certification on the EU market and vice versa.
The Dutch government is prepared for a no-deal Brexit scenario and is actively informing the relevant industries. Specific legislation will enable manufactures – after approval of the Dutch government – to place medical devices on the Dutch market based on a UK certification. Similar exemptions can be provided by the health care inspectorate (IGJ) for pharmaceuticals in the event of shortages. In addition, the IGJ is coordinating with Dutch customs to address logistical issues that may result in shortages of pharmaceuticals, medical devices or in-vitro-diagnostics.
Even with the Dutch government doing its utmost to prevent health care issues, the Dutch National institute for public health and environmental protection (RIVM) warned that preparing an overview of all critical issues is not possible due to the variety of products on the market. Manufacturers and health care providers such as hospitals are urged to make their own assessment of key issues (and hopefully have prepared this by now).
Clinical research
A no deal Brexit will most likely also have a large impact on clinical research. The UK has always been a hub for clinical trials and research. Following Brexit, the EU clinical trial regime will no longer include the UK. This could result in additional administrative burdens, particularly in case of multicentre clinical trials in the EU and the UK. Practical problems could include the impossibility to exchange patient data under the GDPR, requiring additional patient consent outside the applied research protocols. Issues may also arise with the import of (experimental) pharmaceuticals required to conduct such clinical research.
Medical professionals
Medical professionals active in the Netherlands with a UK license prior to Brexit can continue their practice. However, a no deal Brexit will prevent medical professional to start practicing in the Netherlands based on a UK license. Application for recognition of their license and taking a medical exam will be required. Consequently, Dutch health care providers will have to amend their current procedures when hiring new personnel.
Please also see the articles on the impact of Brexit in other practice areas. For a more detailed analysis of the impact of Brexit on your business, please do not hesitate to contact any of our experts.
