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Can a post-Brexit UK stay aligned with Europe on clinical research?

There's still no guarantee the UK can keep in step with EU

The UK’s position as a leader in clinical trials in Europe is being put under a cloud by Brexit, but the country’s national regulator the MHRA has this week set out what to expect – at least during the proposed transition phase.

At the heart of those considerations is the forthcoming Clinical Trials Regulation (CTR) – new legislation that has been welcomed by the pharma industry, academia and medical charities alike as streamlining and simplifying clinical trial registration and assessments – which is due to come into effect in 2020.

If that schedule is followed, the CTR will arrive in the midst of the UK’s two-year, post-Brexit implementation period and – according to the MHRA – would therefore apply to the UK under the divorce terms. And even if the legislation is delayed, the regulator says 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.”

It’s apparent that’s the only sensible course of action, as the CTR is widely seen as a major step forward for clinical research. Nevertheless, the elements outside the UK’s control, namely the use of a shared central IT portal and participation in the single assessment model, would require a deal to be agreed and in place after the implementation period.

Sheuli Porkess

The ABPI's Dr Sheuli Porkess

The MHRA notice has been welcomed by Dr Sheuli Porkess, deputy chief scientific officer the Association of the British Pharmaceutical Industry (ABPI), who notes in a blog post that in 2017 there were 823 applications to run commercial medicine trials in the UK. She adds: “it is in the interests of patients and medicines development for us to find a way to continue to work together” with the EU.

The MHRA document came shortly before medical charity Cancer Research UK published its take on how Brexit will affect clinical trials, including the importance of the UK staying aligned with the CTR but also other issues such as impacts on trade, access to new medicines, data, funding and the workforce.

“The UK government should continue to seek full regulatory alignment with the [CTR],” says CRUK’s report. “This should include a bespoke agreement for access to the EU portal and database and to ensure the UK can take part in the centralised assessment process.”

Meanwhile, where full alignment with the provisions of the CTR is not possible, the government “should seek a proportionate approach to regulation that balances alignment with the opportunities to innovate,” it continues.

In her blog, Porkess suggest that trade barriers should not impact on clinical trials, not least because it is estimated that 70% of all investigational medicinal products (IMPs) in ongoing EU trials are released by a qualified person (QP) based in the UK.

“It is important to make sure that patients who are participating in trials – both in the UK and the EU – at the time of Brexit are able to continue to get their trial medicines,” she writes.

The ABPI also concurs with other points raised by CRUK, including the need for the UK government to focus on long-term funding initiatives or clinical trials, and developing mechanisms to enable continued collaboration between scientists and doctors in the UK and EU.

“When patients take part in clinical trials, they are helping the patients of the future,” says Porkess. “This important report sets out just why we must take great care to safeguard the future of clinical research for patients not just in the UK, but across the whole of the EU.”

Article by
Phil Taylor

9th August 2018

From: Regulatory



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