Currently, under the Clinical Trials Directive (“CTD”), the sponsor had to submit separate clinical trial applications for multinational study to the authorities and ethics committees of each of the EU member states involved. Multiple applications and authorisations are required when a trial is conducted in multiple members states (or, indeed, in multiple countries). The CTD has long been criticised for its complexity and bureaucracy and, it is thought, has led to a reduction in the number of clinical trials taking place in Europe between 2007 and 2011.
The Clinical Trial Regulation (“CTR”)’s aim is to harmonise the position across the UK by having one application form for all member states. There will also be a new portal and database which all member states can access, which will avoid duplication of work, and hopefully, save time and money. It is hoped this will speed up registration of trial results and the marketing and licensing of new drugs within the EU.
The CTR, therefore, looked like it was going to solve some of the major problems with the CTD and make the EU a very attractive place to hold trials. The problem was, due to a delay in getting the portal and database set up, the CTR was not set to come into force until after the UK had left the EU on 29 March 2019 and, therefore, would not be incorporated in to UK law.
There was concern that this would significantly reduce the amount of trials being held in the UK as trial sponsors would be enticed by the harmonised system the EU were offering. This would have impacted on patients in both the UK and EU, especially those suffering with rare diseases or cancers, as individual member states would not have had enough participants to take part in trials for such conditions. The UK would have lost funding from EU research schemes and the EU would have lost its ability to rely on UK based experts and the UK’s world class facilitates. It was also thought that deviating away from the CTR could have restricted the effectiveness of European and global health initiatives, such as pandemic responses.
Update
We welcome news that the UK will seek to align as closely as possible with the EU rules on clinical trials following Brexit.
It means the EU and UK should be able to continue to collaborate and work together effectively after Brexit, draw on each other’s expertise and continue to run world class multi-member state trials, which will benefit patients in the UK, the EU and internationally. This also ensures that patients will gain access to trial medicines without delay.
However, there is still much to consider. A study by Global Future has said that each of the proposed Brexit scenarios would leave Britain poorer and cost the taxpayer hundreds of millions of pounds each week. This means less funding is available for the NHS. While it is extremely encouraging that the UK and EU are going to continue to enjoy a close relationship with regards to clinical trials after Brexit more needs to be done to ensure Brexit does not come at “too high a price” and put patients at risk.
Issues surrounding freedom of movement for patients to travel across the EU may still cause problems and how attractive the UK’s migration system will be for researchers involved in clinical trials remains to be seen, but this is a positive step in ensuring that the beneficial collaboration between the UK and the EU in clinical trials continues.
