New rules on multi-country medical trials

Replacing the current law which makes it difficult to use patients from European countries in UK studies, it is hoped that multi-country studies will now place a reduced bureaucratic burden on NHS organisations.

Elisabetta Zanon, Director of the NHS European Office, said: “Research is a key component of a high-quality healthcare system and more than 99 per cent of NHS trusts recruited patients for clinical studies in the last year. They directly contribute both to better patient care and early adoption of innovation. The existing EU rules have placed a huge bureaucratic burden on NHS organisations involved in clinical trials for a decade now. We have lobbied hard to secure important changes to the EU regulatory framework and reduce the administrative burden.

“The new EU law on clinical trials will bring more proportionate and streamlined procedures for the approval and the conduct of clinical trials, while fully safeguarding the safety of patients participating in these studies. As an example of the positive changes it will be possible to submit a single application for multi-country studies, using an EU portal which will act as the single entry point for all information related to the clinical trial. This new EU law is good news for the NHS and our patients.”

Rob Webster, Chief Executive of the NHS Confederation and speaking at an event at the Conservative Conference, A healthy relationship? What does the EU do for healthcare?" said: “The EU affects the NHS more than people realise – as a commissioner and a provider of healthcare, but also as an employer and a business. Other health systems are more fragmented, meaning they don’t have the ability to speak as one at the European level – we are fortunate that we can still do this and should be looking to maximise the influence we have.”

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