U.K. biopharma sector delivers wish list for Brexit negotiations

LONDON – After a summer of concerted effort to scope out and reach a unified view, the life sciences sector had its first meeting with the government's new Department for Exiting the EU, to put forward the industry's wish list and requirements once negotiations on U.K. withdrawal from the EU get underway.

The process to draw up the list has been "fantastic" and the industry now has a playbook for Brexit, said Steve Bates, chief executive of the Bioindustry Association (BIA).

The BIA worked with the Association of the British Pharmaceutical Industry (ABPI) to draw up a report summarizing the key issues and providing background to inform the government on the policies that are important to the sector. (See BioWorld Today, July 25, 2016.)

Four areas have been prioritized, two of which are specific to life sciences and two that apply to other sectors. The generic requirements are for the ability to recruit staff across the EU and for open markets in goods, services and capital to be maintained.

In terms of sector specific requirements, BIA and ABPI are asking for public funding to continue to support collaborative research networks across Europe and that the U.K. remains an integrated part of the EMA's medicines regulation system.

The report was presented by the U.K. EU life sciences steering group, a 15-strong task force co-chaired by Pascal Soriot and Andrew Witty, CEOs of Astrazeneca plc and Glaxosmithkline, respectively.

The task force was set up after the referendum vote on June 23 came down in favor of the U.K. leaving the EU by 51.9 percent to 48.1 percent. (See BioWorld Today, July 13, 2016.)

The industry "has done the thinking" and "got ourselves together," Bates told BioWorld Today.

The same is not true for the government, which as yet has no overall strategy for Brexit, let alone having inquired into the requirements of individual industrial sectors.

A further obstacle in getting the industry's voice heard is the reorganization of government by Theresa May after she became prime minister on July 13. That means the case must be made to new ministers and civil servants, based in different departments, and who are unfamiliar with the complexities of life sciences.

In addition to the Department for Exiting the EU, the task force was presenting the wish list to minister and officials from the prime minister's office, the Department of Health and the Office of Life Sciences.

"The U.K. government works on the principle of collective responsibility to get a single view. We've got new departments and new players, but I'm confident we'll get there," Bates said.

On the issues of free trade and access to talent that are of general concern, Bates said sectors should work together to present the case.

Meanwhile, maintaining harmony with the rest of the EU on drug regulation is "a detailed area that needs detailed discussion," he said.

JAPAN'S GOVERNMENT PUBLISHES MEMO

The presence of the EMA's headquarters in London has been an important factor in attracting pharmaceutical investment into the U.K. While there is little doubt the agency will be relocated, there is a desire to see the U.K. Medicines and Healthcare products Agency (MHRA) remain part of the EMA regulatory system.

That extends beyond the U.K. and Europe, with the Japanese government requesting that the U.K. continues to follow EMA rules in a memo published earlier this month calling for an end to the uncertainty over Brexit.

The memo notes that Japanese businesses have received overtures from U.K. inward investment agencies to come to the U.K. as the gateway to the EU single market and sets out requirements of Japanese companies from sectors including banking, automotive and pharmaceuticals if they are to remain invested in the U.K.

Nearly half of Japanese direct investment in the EU in 2015 flowed to the U.K.

Through their government, Japanese companies are calling for maintenance of the status quo in terms of trade, investment, services and access to skills, and for harmonized regulation and standards post-Brexit.

"The government of Japan trusts that the U.K. . . . will maintain the current business environment or alleviate the impacts of any radical changes, so as to remain an attractive destination for doing business," the memo said.

On matters of specific interest to Japanese pharma companies, the memo asks for unified protection of intellectual property rights, U.K. access to EU research funds and for the EMA to remain in London.

While that last requirement almost certainly is not going to be met, it makes clear that the U.K.'s standing in medicines regulation is an important part of the Anglo-Japanese relationship, Bates said. "Anything that highlights some of the issues we think are important is helpful."

As yet, no other government, nor the EU as a whole, has gone public on Brexit wish lists. But with the return to the fray after the long summer break, Bates said that "it will be interesting to see the thinking emerging from Brussels and other capitals on what they want."

Official negotiations will not begin until the U.K gives formal notice of an intention to withdraw, which May has said will not happen until 2017. And at odds with the Japanese government's request for transparency – so that there are no unpleasant surprises – May also has said she will not give a running commentary as the negotiating position evolves.

The BIA and ABPI hoped that taking the initiative in drawing up a plan over the summer would put the sector in a strong position. But it seems that while the report has been accepted as a source of information, it has not been taken on board as a blueprint for negotiations.

"There is a desire to engage on the details, particularly on the part of new officials," said Bates.

In addition, David Davis, the minister heading the Department for Exiting the EU, has said he wants to engage with the expertise of the life sciences sector.

"The industry is at the table for discussions going forward," Bates said. However, these are uncharted waters and the form of the negotiations is not known.

Source