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Brexit rebels win vote on European Medicines Agency alignment

EMA membership will be a key negotiating aim; Sir John Bell sees independent MHRA post-Brexit

Another day, another Brexit drama in Westminster: yesterday saw the government narrowly defeat moves to keep it tied into the customs union, scraping through with a majority of only six votes.

However rebels within its own Conservative party did land one blow of great significance to the pharma and biotech sectors: they won a vote which means that the government must make the UK remaining a member of the European Medicines Agency (EMA) a key negotiating objective with the EU27.

The NC17 amendment to the Trade Bill was tabled by Conservative MP Phillip Lee (pictured), who resigned last month as justice minister ahead of an earlier decisive vote on the EU withdrawal bill.

Philip Lee

He told the Commons yesterday evening:  “This [amendment] is vital because that is how we get our people and our NHS the medicines they need, it is also important for our pharmaceutical sector.

“The European medicines regulatory network partnership makes the process of accessing life saving new medicines and moving medicines quick and easy. If we leave that partnership the NHS would get ground breaking new drugs like those for cancer, dementia and diabetes long after other parts of the world.”

In a joint statement on behalf of the pharmaceutical industry in the UK, Mike Thompson, chief executive of the ABPI, and Steve Bates, chief executive of the BIA, said:

“Parliament has sent a clear message that patients and public health should be a top priority for the government in these negotiations. Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. “

The amendment is a victory for those MPs in Parliament who are seeking a ‘soft Brexit’ however the balance of power between these former Remainers and Brexiteers in Westminster remains finely balanced.

This split means many believe there is no House of Commons majority for either a Hard Brexit or the new Soft Brexit outlined in last week’s government white paper.

The government’s current position is that it wants an “association agreement” to govern relations with the EU after Brexit, covering free trade and regulatory alignment – a model currently used by countries such as Ukraine, Moldova and Georgia.

Yesterday also saw the launch of a new analysis of a post-Brexit environment: Just what the doctor ordered? Is the Life Sciences Industrial Strategy the right prescription for Britain’s life science sector.

The report was commissioned by life sciences data and technology firm IQVIA and authored by policy advisory group Public Policy Projects. Speaking at the IQVIA event in London, PPP’s managing director Ben Howlett said the remained huge uncertainty about where the Brexit process was heading, including on issues relating to pharma and future EMA relations.

Commenting on the association agreement plans, he quipped: “I can say though, without having to look at the data, that the UK looks incredibly different to the Ukraine in terms of life sciences.”

Could the MHRA go it alone?

IQVIA’s market development director for UK and Ireland, Angela McFarlane said Brexit had “redefined the word uncertainty” and that her company’s report sought to create an evidence-based plan for all possible scenarios. She identified the Life Sciences Industrial Strategy as a good opportunity for the pharma industry, although there remains scepticism and low awareness of the plan within the sector itself.

IQVIA’s forecast for the UK market aren’t encouraging, either: it says the UK is expected to show a decline in terms of forecasted volume, with Germany likely to emerge as the leader in growth and size by 2021.

Sir John Bell, life sciences leader and author of the UK life sciences industrial strategy report said the UK's current proposal for the UK to be an EMA member, but not to have a say in its rule-making, was unsatisfactory. Speaking at the IQVIA event, he suggested that post-Brexit the UK's MHRA regulator should become a specialist regulator in cutting edge areas such as advanced medicines, in order to attract the sector to the UK.

Article by
Andrew McConaghie

18th July 2018

From: Regulatory



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