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May seeks negotiations on medicines authorisation process to prevent post Brexit delays

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By lealegraien@cogora.com
5 March 2018

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Prime Minister Theresa May is seeking talks with the European Union's (EU) medicines watchdog to prevent delays to accessing new treatments after Brexit.

Prime Minister Theresa May is seeking talks with the European Union's (EU) medicines watchdog to prevent delays to accessing new treatments after Brexit.

Mrs May said in an announcement on Friday (2 March) that she would ‘explore with the EU the terms on which the UK could remain part of EU agencies' including the EMA to ensure that the nation's medicines approval process does not slow down after Brexit.

She added: ‘Associate membership of these agencies is the only way to meet our objective of ensuring that these products only need to undergo one series of approvals, in one country.

‘For example, membership of the EMA would mean investment in new innovative medicines continuing in the UK and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations.

‘To achieve this, we will need a comprehensive system of mutual recognition.’

No-deal scenario

Data from the European Federation of Pharmaceutical Industries and Associations (EFPIA) shows that the UK receives 37 million patient packs from the EU and European Economic Area (EEA) every month.

In January, healthcare pressure group Brexit Health Alliance warned that certain medicines might be delayed in reaching patients or become unavailable if no Brexit deal was reached.

According to the Alliance, Switzerland – which is not a member of the EMA – gains access to new medicines on average five months later than the EU.

‘Vital’ deal

Commenting on Mrs May's speech, co-chair of the Brexit Health Alliance Niall Dickson said that ‘a far-reaching science and innovation pact with the EU is vital for the UK and the rest of Europe’.

He continued: ‘It is great to see the Prime Minister championing this, as well as a commitment to cover our share of costs to take part in EU programmes.

‘It was also good to hear the desire to remain part of the EMA, to abide by its rules, and make appropriate financial commitments.

‘That is the best way to make sure patients have quick access to the drugs and treatments they need.

‘For the Alliance, the key in all this is to put patients first – both the UK Government and European Commission must make public health and patient safety a priority in the negotiations.

‘Nothing less will do.’

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