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UK pharma leader warns on ‘untenable’ Brexit deal

Draft agreement is a major step back for UK

Mike Thompson

The UK pharma industry association’s leader was among a group of industry sector leaders who repeated grave warnings about a ‘no deal’ Brexit to MPs yesterday.

The ABPI’s chief executive Mike Thompson gave evidence to the Exiting the European Union Committee alongside representatives from supermarkets, small businesses, the road haulage industry, who were all asked to focus on the impact of a possible no deal from 29 April 2019.

There were warnings that the UK could face shortages of food on supermarket shelves, and huge tailbacks of lorries coming and going through the English channel ports – as Thompson repeated his concerns about medicines supplies.

While UK big pharma is now prepared for no deal, thanks to stockpiling, smaller companies, and those on the continent could face problems. Thompson pointed out that the European Medicines Agency chief Guido Rasi is now predicting that there will be medicines shortages on the continent, despite the best efforts of the regulator and the industry.

Thompson called on the EU27 to follow the UK’s lead in preparing for a no deal – the UK recently declaring that it wouldn’t require medicines coming from the EU to undergo further batch release testing.

“We are now looking for the EU to do the same thing,” he said – a move that would avoid the duplication of testing facilities on both sides of the channel – something that couldn’t be set up in time for next April in any case.

He said this would “ensure that the 2,600 medicines that have some part of their manufacturing done in the UK can also go to patients in Europe.”

Bombshell on withdrawal agreement

However Thompson also dropped a bombshell in regard to the draft Brexit ‘withdrawal’ agreement which was agreed in March between the two sides.

This sets out a framework for future relations, but Thompson revealed for the first time that the ABPI viewed this as a major step backwards for the life science sector.

This is in particular relation to a proposed ‘associate membership’ with the EMA, where the UK would be part of the regulatory network, and would pay into the system, but would not have a vote or be allowed to lead on regulatory work.

A similar situation would exist in the EU’s Horizon 2020 research framework – something which Thompson thought was ‘untenable’.

“At the moment, the withdrawal agreement says we can 'pay to play' but we cannot play a role in the design of what we are paying for. We think that’s not tenable in the long run.”

This means that the UK pharma industry thinks the one slender, draft agreement in place is not fit for purpose – but as this stands this is how the UK-EU relationship would proceed, presuming a deal could be struck.

Addressing Horizon 2020, he commented: “When you think that we are the world’s third largest biomedical research cluster - we have got the best R&D here of anywhere in Europe - why would we put money into something that has been designed by somebody else? I think that is not tenable, we need to get that back.”

Regarding the UK regulator the MHRA’s relations with the EMA, he added: “I think it’s untenable for us to be a participant but not to have a voice. I think if a minister is standing in Parliament to respond to a public health issue and has to say “this is a decision of the EMA but the UK has no voice", that is a very difficult position for the country to take.”

While Thompson was careful not to put forward any political solutions to the problems from the industry perspective, he did also reiterate the sector’s support for staying in the EMA network.

On the subject of the UK's post-Brexit migration controls, Thompson also expressed grave concerns "if we get this wrong" but said the government had the chance to make a more streamlined visa system for foreign nationals compared to the current cumbersome system.

On the political level, the next major turning point in the fraught negotiations comes on 18 October, by which time the EU27 wants to have reached a deal.  However despite positive noises from both sides, there remains no solution available to give the UK frictionless trade whilst also leaving the customs union and single market.

Watch the full evidence session at the Exiting the European Union Committee here

Article by
Andrew McConaghie

16th October 2018

From: Regulatory



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