Work begins on plan to prioritize U.K. life sciences post-Brexit

LONDON – Work starts Monday on drawing up a life sciences transition program that the industry intends to present to government on Sept. 6 as a blueprint for negotiating the U.K.'s exit from the EU on favorable terms for the sector.

The intention is to spend the next six weeks scoping the risks that need to be addressed and identifying opportunities to make the U.K. domestic landscape as strong and attractive as possible in the post-Brexit future.

"It is vitally important that we are getting ready as a sector," said Steve Bates, CEO of the Bioindustry Association (BIA), outlining the plan. "We have to stay ahead of the curve and put our issues in an organized fashion to the key people."

Existing businesses are facing real challenges thrown up by Brexit, and it is essential to ensure there is no omission in the thinking of the government when it engages in exit negotiations. But is also is necessary to consider the potential to reshape the environment. "We should look at opportunities that are in the future, rather than only mitigating risks – to look positively to what a Brexit landscape might look like," Bates said.

The work is being led by the BIA and the Association of the British Pharmaceutical Industry (ABPI), which have formed a program team with representatives from their member companies, including Astrazeneca plc, Glaxosmithkline plc, Janssen UK, Merck, Sharp & Dohme Ltd., Novartis AG, Pfizer Inc. and UCB Pharma SA.

The focus will be on the six areas of drug regulation, mobility of labor, manufacturing and supply, publicly funded research and development, intellectual property, and fiscal and trade issues.

Each topic will be discussed in a daylong workshop, with the first, covering potential changes to the regulatory framework, taking place Monday and the final workshop scheduled for Aug. 1.

Apart from the overall complexity of disentangling U.K. life sciences from the EU – with a 40-year history of drug regulation at a European level for example – there is the fundamental problem that as yet there is no agreed U.K. negotiating position for its withdrawal from the EU.

To further complicate things, the new prime minister, Theresa May, has changed all the key personnel, with life sciences minister George Freeman getting moved elsewhere and his responsibilities being split among three other ministerial positions.

In addition, it will be necessary to engage with the new department for Brexit, led by ministers who Bates fears will not appreciate the subtleties of the life sciences sector. "We are facing a raft of new ministers. We have got to make sure it is easy for them to understand us," he said.

The lack of an agreed strategy for Brexit means there is a blank sheet of paper and the aim over the summer is to understand how it might be filled, said Virginia Acha of ABPI.

"The government needs ideas of what it can do to make the most of leaving the EU," Acha said. The transition program "will provide options for how the U.K. can negotiate with the EU and the relevant EU life sciences bodies to obtain the optimal outcome."

The work program has been agreed by an industry-government task force formed earlier this month at the instigation of Freeman. Pascal Soriot, CEO of Astrazeneca, and Andrew Witty, CEO of Glaxosmithkline, are co-chairs. (See BioWorld Today, July 13, 2016.)

As yet, no new minister has been named to take Freeman's place on the task force. However, Bates said, with 18 industrial sectors each lobbying and vying for attention, life sciences is not the government's only concern and the speedy formation of the task force has put life sciences on the front foot.

Some issues, such as mobility of labor, research and development and intellectual property, cut across different sectors; others, such as clinical trials, drug licensing and pharmacovigilance, do not.

"We are fortunate because we are fast out of the block and have the leadership of Andrew Witty and Pascal Soriot," said Bates. "The government and civil servants are keen and willing to engage." Having a blueprint to present at the beginning of September "will give us access to their thinking," he said.

Formal negotiations to leave the EU will not begin until the U.K. triggers Article 50 of the Lisbon Treaty, which covers the terms for a member state withdrawing from the union. Once that happens, there is a negotiating period of up to two years in which to reach agreement. Government lawyers have said Article 50 will not be invoked until 2017.

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