LONDON – The CEOs of Astrazeneca plc and Glaxosmithkline plc (GSK) are to head an industry-government task force formed to set out priorities for life sciences in the negotiations for the U.K. leaving the EU.
Pascal Soriot, of Astrazeneca, and Andrew Witty, of GSK, are part of a 15-strong group, which also will include representatives of the Bioindustry Association (BIA) and the Association of the British Pharmaceutical Industry. The group will draw up a list of what the industry wants in terms of access to the EMA regulatory system, the ability to recruit from mainland Europe, access to the European single market, the intellectual property regime and eligibility to apply for EU research grants.
The intention is to provide a blueprint to inform discussions once the new prime minister, Theresa May, who is due to take up office Wednesday, gives formal notice to the EU of the U.K. intention to withdraw. That will trigger a two-year period of negotiations on the terms of the U.K. exit.
"We hope the life sciences task force will provide the new prime minister with a playbook on what life sciences needs," said Steve Bates, CEO of the BIA.
The formation of the task force to deal with plans for Brexit can be seen as a sign that the sector, which was strongly in favor of remaining in the EU, is starting to come to terms with the vote to leave.
In a webinar, Bates told member companies that the initial shock at the result will last a while, the withdrawal negotiations will be prolonged, and future arrangements will take some time to bed in.
The situation the industry faces is "similar to a grief process," said Bates. People are angry and in denial. "We need to get to a state of acceptance as soon as possible," he said.
The biotech industry is used to dealing with setbacks and it is important to remember that the underlying fundamentals of funding, the clinical pipeline and management teams are strong. However, Bates said, there are challenges ahead, with three key issues of the regulatory environment, access to human capital and the intellectual property system that underpin the sector, likely to be fundamentally affected by Brexit.
Bates stressed that other fundamentals, including the U.K.'s R&D infrastructure, the market incentives in the National Health Service and support for technology transfer from U.K. universities will be unchanged.
The difficulty for the task force is that it remains far from clear what the U.K.'s overall negotiating position will be. Theresa May, newly crowned as leader of the ruling Conservative Party and therefore de facto prime minister, was on the remain side in the referendum campaign.
However, in speeches on Monday in Birmingham in support of her leadership bid, and in London after her only rival for the Conservative Party leadership dropped out of the race, May said, "Brexit is Brexit and we're going to make a success of it."
The various scenarios for the U.K.'s future relationship with the EU include some type of reformed membership, along the lines of that held by Norway and Switzerland, which pay into the EU in order to participate in schemes such as the Horizon 2020 R&D program, a distinct U.K.-EU bilateral agreement, or a complete severing of ties.
The government continues to stress that for now nothing has changed and the U.K. remains a full member of the EU until withdrawal negotiations are complete. However, there has already been significant economic and political fallout, with a flight from sterling and the imminent installation of a new prime minister.
DEFENDING THE LIFE SCIENCES SECTOR
Maintaining the integrity of European medicines regulation has emerged as a key issue both in the U.K. and in the EU as a whole. The U.K. regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has a leading role at a European level, reviewing a third of marketing authorization applications filed with the EMA.
In addition, the U.K.'s National Institute for Biological Standards and Control is a global leader in the development of standardized assays and a source of new regulatory science.
After sticking to a "no comment" stance in the lead up to referendum, the London-based EMA finally made a statement last week, acknowledging the vote and saying its procedures and work streams are not affected by the outcome.
"The European regulation network as a whole is a very strong and flexible system that is able to adapt to changes without jeopardizing the quality and effectiveness of its work," the EMA said.
As an EU agency, the EMA must be located in a member state and there have been approaches from other countries to be the future host. The EMA said it "welcomes the interest" but the decision on a new location for the agency and its 890 employees (many of whom are British) will not be taken by the EMA, but at an EU level.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) gave an anodyne response immediately after the vote, but has since voiced concern that Brexit could have a negative impact on regulatory capacity, processes and time frames, calling for "regulatory integration" of MHRA into the EMA's ecosystem.
The inevitable uncertainty generated by the Brexit vote makes long-term investment decisions and business planning problematic, EFPIA said. As policy makers consider how Britain leaves the EU, "every effort should be made to reduce uncertainty" for patients and companies.
With so much up in the air, Bates was reading the runes of May's speech in Birmingham, in which she outlined principles for a new industrial strategy, and cited the life sciences sector to demonstrate the need for reform.
"It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry, and Astrazeneca is one of the jewels in its crown," May said. "Yet two years ago the government almost allowed Astrazeneca to be sold to Pfizer, the U.S. company with a track record of asset stripping and whose self-confessed attraction to the deal was to avoid tax."
May said a proper industrial strategy would not automatically stop the sale of U.K. companies to foreign ones, but she said, "It should be capable of stepping in to defend a sector that is as important as pharmaceuticals is to Britain."
Bates said, "I'm sure we'll see a lot more flesh put on the bones of this sentence in the coming months, but I think it bodes well that the incoming Conservative leader understands from day one the importance of our sector to the future of the U.K. economy.
"It also hints that 'proper industrial strategy' will be part of her government – so I hope this will include a reinvigorated strategy for the life sciences," he added.