In the latest news for pan-EU clinical trials involving the UK, the European Commission has urged all interested parties who are either conducting or planning to conduct clinical trials, as well as investigators and other persons involved in the preparation and conduct of clinical trials in the EU to take into account the legal repercussions that need to be considered when the UK becomes a third country. The main areas affected will be the supply of investigational medicinal products, the establishment requirements for the sponsor or the legal representative and the submission of clinical trial information.On 6 September 2018, the European Commission issued a notice to stakeholders setting out the consequences for clinical trials following UK’s withdrawal on 30 March 2019. From that point onwards, unless a ratified withdrawal agreement establishes another date, all EU primary and secondary law will cease to apply to the United Kingdom, which will then become a “third country” and treated as such. The European Commission states in the notice that as of the withdrawal date, the EU rules on clinical trials, and in particular Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, will no longer apply to the UK.  In light of this, companies involved in clinical trials must:

  1. Assess if stockpiling for investigational medicinal products will be required, as according to Article 13(1) of Directive 2001/20/EC, the import of investigational medicinal products into the EU is subject to the holding of an authorisation;
  2. Ensure that as of the withdrawal date, a sponsor established in the UK and conducting a clinical trial in the EU-27 has to ensure that a sponsor or a legal representative is established in the EU-27; and
  3. Assess what clinical information must be submitted in EudraCT and what to MHRA and account for additional costs for parallel filings.

While the MHRA in a recent statement had confirmed that the UK is working to ensure the best possible environment in which to support clinical trials and emphasised that the overall aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines, the new Clinical Trials Regulation (CTR) replaces Directive 2001/20/EC and is anticipated to become applicable in 2019 after the Brexit date. If the CTR does not come into force during the implementation period, then the Government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, in order that researchers conducting clinical trials can plan with greater certainty. The two key elements of the CTR that the UK would not be able to implement though on its own after this time are the use of a shared central IT portal and participation in the single assessment model, both of which would require a negotiated UK/EU agreement regarding UK involvement following the end of the implementation period. However, according to the same MHRA statement, no matter what the outcome of the negotiations is, the UK is committed to offering a competitive service for clinical trial assessment. If the UK is outside of the EU network following the end of the implementation period, it will still be possible for sponsors to run multistate trials involving the UK. Sponsors would have to apply to MHRA, as well as to the EU concerned states; but MHRA would take every effort to ensure this parallel submission is as streamlined and efficient as possible (for example by using the same application dossier).

For further information please contact Elina Angeloudi or Julia Gillert of our London office, or Els Janssens of our Abu Dhabi office.

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

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