WF_Brexit

Life Sciences– Top 5 Issues (23 Dec 2020)

  1. Legislation - The life sciences industry is highly regulated with much of the UK's laws governing this field originating from EU Directives and Regulations. Regulations, which, are directly applicable and would therefore not have gone through national implementation, will no longer automatically apply in the UK at the end of the transition period. The uncertainty of Brexit, coupled with the UK's apparent aim to distance itself and future legislation from European laws is likely to result in a significant regulatory challenge for life sciences companies. This is particularly problematic against the backdrop of the long-awaited European Clinical Trials Regulations and Medical Devices Regulations becoming fully applicable. 
  2. Supply Chains - The life sciences sector supply chains are greatly facilitated by the harmonised regulatory environment and lack of border controls in the European Union. Following Brexit, companies will need to analyse and prepare for the impact of reduced harmonisation caused by the re-introduction of UK border controls and requirements, such as import/export licenses, product classification and so on. Life sciences companies will need to take the necessary steps to ensure sufficient stock levels and continuity of supply both in the period leading up to and post 31 December 2020.
  3. Marketing Authorisations - Following Brexit, the UK will cease to form part of the centralised procedure under Directive 2001/83/EC and will carry out its own independent assessment of marketing authorisation applications for medicinal products (MA). Therefore, separate UK MAs will need to be applied for post-Brexit and pharmaceutical companies with existing UK MAs granted through the centralised procedure will have to transfer their MA to an EU member state/ EEA location. This dual requirement of having to apply for MAs in the UK and the EU will again add to the regulatory burden and increase costs for the life sciences sector.
  4. Quality Control - Pursuant to Directive 2001/83/EC, medicinal products imported into the EU must undergo quality control testing (i.e. batch testing) in an EU Member State/EEA. Post Brexit, products batch-tested in the UK will not be accepted for release to the EU market. Life sciences companies will have to relocate their entire quality control operations (personnel, equipment, materials, etc.) from the UK to an EU/EEA location. This will also necessitate the transfer of skills, know-how and training new personnel.
  5. Pharmacovigilance - Post-Brexit, the Qualified Person for Pharmacovigilance (QPPV) will no longer be able to be based in or operate from the UK and will instead have to be located in an EU Member State/EEA location. Similarly, the Pharmacovigilance System Master File (PSMF) will no longer be able to be stored in the UK. Companies must therefore prepare to relocate their QPPV to the EU and make provisions for storing their PSMF in the EU also. For companies this will mean the transfer of personnel and systems to ensure ongoing comprehensive, and prompt collection of data, adverse reaction reporting, risk management, and transparency in respect of the products they manufacture.

Contact:

Charleen O'Keeffe
Charleen O'Keeffe
Partner

Email Charleen
+353 1 489 6694