Clinical trials in the United Kingdom after Brexit
As the final part in our series on Brexit and its consequences for pharmaceutical companies (see our articles “Brexit with or without a deal: Consequences for pharmaceutical companies”, “The impact of Brexit on medicinal product marketing authorisations” and “Consequences of Brexit for the distribution of medicinal products in Europe”), this article provides you with an overview of the consequences of Brexit for conducting clinical trials in the United Kingdom.
Legal framework for clinical trials in Europe
The requirements for conducting clinical trials are harmonised across Europe on the basis of Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 (“Clinical Trials Directive”). Accordingly, a favourable opinion of a competent ethics committee is required in addition to the approval of the competent national authority in the respective case (in Germany either the BfArM (Federal Institute for Drugs and Medical Devices) or the PEI (Paul-Ehrlich-Institute) depending on the medicinal product). In addition, the sponsor of any clinical trial (or if the sponsor is located outside the EU, its legal representative) must be established in the EU.
The approval procedure will, however, change considerably in the future based on Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“Clinical Trials Regulation”).
The Clinical Trials Regulation is already in force. It first applies, however, six months after the Commission has published a notice stating that the EU portal and the EU database have achieved full functionality and meet the functional specifications (“Launch”), cf. Article 99 sentence 2 in conjunction with Article 82(3) of the Clinical Trials Regulation.
Launch of the EU portal was originally planned for 2018; however, has been moved to October 2021 according to the officially published timeline. Whether this date can be complied with is likewise questionable. In view of current political developments, however, it can be assumed that the United Kingdom is no longer an EU Member State on the date of Launch.
When the Clinical Trials Regulation becomes applicable, the approval procedure will no longer be purely national, but centralised via the so-called EU portal and thus comparable to the procedure for obtaining a central marketing authorisation for medicinal products. In particular, this will make it possible to obtain the approvals of Member States concerned simultaneously for clinical trials that are to be carried out in the respective Member States. In addition, information on the approval, conduct and results of clinical trials carried out in the EU will be made publicly available through the EU portal and thus made transparent, in particular for professionals. Finally, the EU portal has the advantage that the reports with regard to the clinical trials made by the Member States concerned can be taken into account in the marketing authorisation application for the respective medicinal product.
Legal framework after a hard Brexit
When the United Kingdom’s withdrawal from the EU takes effect, British companies can no longer act as sponsors for clinical trials conducted in the territory of the remaining Member States (“EU 27”).
On the other hand, clinical trials conducted within the United Kingdom will require the designation of a British sponsor. Therefore, in the future it may be necessary to appoint two different sponsors for the same clinical trial. However, the United Kingdom has already announced that it may recognise sponsors from certain EU 27 countries as sponsors for clinical trials within the United Kingdom. Further developments have to be awaited here.
It is, however, already foreseeable that the United Kingdom will not participate in the future EU portal and it will therefore in the United Kingdom not be possible to access the information published in the EU database. This will in particular affect British research institutes and potential sponsors of clinical trials, who rely on a rapid exchange of information. This is particularly the case because clinical trials serve the development of new medicinal products and are associated with considerable investment costs.
Finally, Brexit and the United Kingdom’s associated withdrawal from the EU mean that standards laid down by European law for conducting clinical trials, in particular the Clinical Trials Directive and the Clinical Trials Regulation, as well as the Guideline for Good Clinical Practice, will no longer directly apply in the United Kingdom. If a European authorisation (MRP/DCP or central authorisation) of the medicinal product is desired following the clinical trial, the applicability of the relevant European regulations should be expressly provided for in the contract for the clinical trial with the British Investigator and this should therefore be taken into account when drafting new contracts and, if possible, integrated into existing contracts.
This applies irrespective of the fact that the European Union (Withdrawal) Act, which came into force on 26 June 2018, means that the EU regulations initially continue to apply in the United Kingdom after Brexit. Since after Brexit this is then only national (British) law, future deviations from EU law are possible and probable.
Despite the ongoing negotiations between the United Kingdom and the EU 27 and the associated uncertainty regarding the withdrawal date and the conclusion of a Brexit agreement, companies must continue to prepare for a Brexit on 29 March 2019.
In particular, pharmaceutical companies based in the territory of the EU 27 should carefully examine whether the clinical trial should be conducted in the United Kingdom taking into consideration a possible European marketing approval. We also recommend that the applicability of the relevant European regulations be expressly integrated into contracts for clinical trials with British testing organisations.
Additional information on the impact of Brexit on clinical trials in the United Kingdom is contained in the “Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal” of the British Medicines & Healthcare Products Regulatory Agency.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
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Any questions? Please contact: Susann Jahn; Evelyn Schulz
Practice Groups: Healthcare; Regulierung & Governmental Affairs