After Brexit: new directions for clinical trials
A new regime for clinical trials in Europe is coming into force in 2018. However, there are uncertainties about what clinical trials legislation will apply in the UK once it leaves the EU. This article is a brief summary of the changes that will come into force for businesses based in Europe and for global businesses running clinical trials in Europe, and the potential impact of Brexit.
Currently, clinical trials on medicinal products for human use conducted in EU member states are governed by the EU’s clinical trials directive (Directive 2001/20/EC), together with national legislation to implement the directive. As a result, its interpretation and application is not uniform across member states. The directive has faced criticism for its bureaucracy and complexity, with multiple applications and authorisations required where a trial is conducted in multiple member states.
When it comes into force as expected in 2019, the EU clinical trials regulation (No. 536/2014) is set to overhaul the regulatory regime for clinical trials in Europe. The regulation aims to harmonise the application and authorisation processes throughout the EU and to provide greater transparency on clinical trials and their results. It is hoped this will be achieved through a new, publicly accessible clinical trials database to be set up and administered by the European Medicines Agency (EMA), in collaboration with the member states and the European Commission.
Sponsors will be required to register a trial before it starts, and any data in support of a trial application must come from a trial that is also registered in an accessible database or for which results have been reported in an independent, peer-reviewed publication in order for that data to be admissible (article 25[6]). A summary, together with a lay summary, of results of a clinical trial must also be generally submitted to the database within a year of a trial ending (article 37[4]).
The EU database will be publicly accessible unless the data or information contained within it is subject to an exemption, which can include where confidentiality is justified on the grounds of protecting personal data and commercial information (article 81[4]). However, the regulation provides that unless there is an overriding public interest in disclosure, data contained in the application dossier shall not be publicly accessible before the decision on the clinical trial has been made (article 81[5]).
If a clinical trial is intended to be used in an application to obtain a marketing authorisation for a new drug, then under the regulation, a detailed clinical study report must be made available through the database within 30 days after the marketing authorisation has been granted, the procedure for granting the marketing authorisation has been completed, or the applicant for the marketing authorisation has withdrawn the application (article 37[4]).
It is envisaged, and hoped, that these new processes will encourage new clinical trials to be conducted within the EU. In particular it is thought the new regulation will particularly benefit trials being conducted between multiple member states, by providing a single, harmonised process.
Brexit
The new regulation is broadly welcomed within the industry. However, the UK’s vote in June 2016 to leave the EU has raised uncertainty over what effect Brexit will have on this new system in the UK.
