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Patient safety focus of Brexit talks over medicine access

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Patient safety will remain at the heart of medicines regulation once the UK leaves the European Union, ministers have pledged amid concerns that Brexit could lead to reduced information sharing about infectious diseases and delayed authorisation of drugs.

In a joint letter to the Financial Times, health secretary Jeremy Hunt and business secretary Greg Clark sought to reassure healthcare professionals and pharmaceutical firms about the future of regulation.

”Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines”

Letter from Jeremy Hunt and Greg Clark

They said they were keen to continue working closely with the EU on medicines and regardless of the outcome of Brexit negotiations, they would ensure a regulatory system that worked in the best interests of patients and supported the UK life sciences industry.

“The UK is fully committed to continuing the close working relationship with our European partners,” said the letter, published earlier this week on Tuesday.

“Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework,” it added.

Fears have been raised by some parts of the healthcare sector that the UK’s departure from the EU could mean losing access to a wider market for new drugs and also delays in medicines approval if the UK were no longer a member of the European Medicines Agency, which regulates drugs across Europe.

In addition, there could be public health implications due to the EMA’s work on areas such as infectious diseases and anti-microbial resistance.

”[The UK will be able to continue] to play a leading role promoting public health”

Letter from Jeremy Hunt and Greg Clark

In the letter this week, ministers said work to develop a new regulatory system would be governed by three key principles.

These were ensuring patients were not “disadvantaged”, that innovators could get their products into the UK market “as quickly and simply as possible,” and that the UK continued “to play a leading role promoting public health”.

They said they were keen to support Europe-wide initiatives to develop new medicines and ensure these could reach patients quickly through ongoing work with the EMA and international partners.

But they stressed that even if they did not achieve their “desired relationship with the EU” they would “set up a regulatory system that protects the best interests of patients and support the UK life science industry to go from strength to strength”.

”This letter is a welcome recognition that the future of medicines regulation is a key priority for the government”

Mike Thompson

“We will seek to process licences as quickly as possible, certainly no more slowly than at present. Our fee pricing will be competitive with current levels,” they added.

The letter was welcomed by the Association of the British Pharmaceutical Industry (ABPI), which said it was among health sector bodies pushing to ensure patients and public health were central to the Brexit negotiations.

“This letter is a welcome recognition that the future of medicines regulation is a key priority for the Government as we negotiate a new relationship with the EU,” said ABPI chief executive Mike Thompson.

“It also signals a readiness to take a pragmatic approach to Brexit negotiations that puts people’s health first. This is a great first step and we look forward to seeing more detail in the coming weeks and months.

“If patients in Europe are to continue to get safe and effective medicines in a timely fashion, the focus must be on agreeing regulatory partnership between the UK and the EU,” he added.

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