“Every extra moment of uncertainty means decisions that were straightforward two years ago, are being deferred,” Lisa Anson, president of the Association of the British Pharmaceutical Industry (ABPI), said April on 26 at an ABPI conference. That’s when U.K. voters approved a referendum to leave the E.U., popularly termed Brexit.
“Right now many companies are actively working on duplicate systems and contingencies because of the lack of certainty about medicines regulation in less than twelve months’ time,” said Anson, who is also the outgoing president of AstraZenecaUK.
Pharmaceutical companies will not know the details of the U.K.’s eventual relationship with the E.U.—such as whether they will be able to recruit E.U. workers or the level of import tariffs—until at least October, less than six months before the U.K. is slated to officially leave the E.U. in April 2019. The industry accounts for 64 billion pounds ($89.1 billion) in the U.K. economy annually.
Need to Implement Strategy
Anson, who this week was appointed the new chief executive officer of Redx Pharma, said that the U.K. already has a “blueprint to secure an environment that ensures that U.K. life sciences can thrive and flourish” once it has left the E.U.
She was referring to the Life Sciences Industrial Strategy the government launched last August, with the goal of helping the U.K. retain its competitive edge post-Brexit by boosting investment in clinical trials for drug approvals and deploying patient data from the U.K.’s public health organization—the National Health Service (NHS).
“I believe that as we leave the E.U., we are going to need to deliver a level of partnership with the NHS like never before,” she said. But she warned that to achieve this, the government needs to “implement the Life Sciences Industrial Strategy in full. And fast.”
ABPI members supply more than 80 percent of all branded medicines used by the NHS.
“Wholly Inadequate” Efforts
A group of bipartisan lawmakers share Anson’s view about the urgency required to push forward the Life Sciences Industrial Strategy.
In a report published on April 23, the House of Lords Science and Technology Committee said the ruling Conservative government’s efforts to date have been “wholly inadequate” and that the NHS’ commitment to the strategy so far has been “incoherent, uncoordinated, and ineffective.”
To make up for its failure to provide “clear authority and accountability,” the committee advised the government to take steps like creating a single body to oversee its Life Sciences Industrial Strategy and exploring how to offer financial incentives to NHS entities to adopt innovations.
In an April 26 statement, Steve Bates, the CEO of the BioIndustry Association, which speaks for innovative life sciences in the U.K., agreed that the committee was “right to highlight implementation, accountability and buy-in from all parties to ensure an effective industrial strategy for UK life sciences.”
Government Defends Record
Both government departments most directly linked to the life sciences strategy defended their records since the launch of the initiative.
“The government does not recognise the Committee’s assessment,” a spokesman for the Department of Health and Social Care (DHSC) told Bloomberg BNA in an April 26 email.
He stressed that the government published a Life Sciences Sector Deal earlier this year, committing nearly 500 million pounds ($696 million) of government investment into the U.K. life sciences industry, backed by investment from 25 global pharmaceutical companies including MSD, Johnson & Johnson, GlaxoSmithKline, and AstraZeneca.
In an April 26 email, John Bell, a University of Oxford genetics professor who was behind most of the strategy’s proposals, said he was “surprised by the House of Lords comments given the enthusiasm of the sector for this strategy and the progress made.”
He cited how the government recently launched the world’s largest genomics program and “is creating digital pathology centres with industry and digital innovation hubs to work with industry.”
The Life Sciences Implementation Board (LSIB), which Bell cochairs, plans to report on progress on May 16 during the first meeting of another new body, the Life Sciences Council (LSC), a spokeswoman for the Department for Business, Energy and Industrial Strategy (BEIS) told Bloomberg Law.
The LSC’s joint chairmans are the secretaries of state for BEIS and DHSC and Pascal Soriot, the chief executive of Anglo-Swedish pharmaceutical company AstraZeneca.
Need for Single Body
But the committee disagrees that the LSIB and LSC are necessary, arguing in its Who’s Driving the Bus report that they make implementing the strategy “too complex and duplicative.”
Instead, the government should create a single body called the Life Sciences Governing Body, which should be solely responsible for the strategy, the report said. The body should be cochaired by the BEIS and DHSC secretaries of state and with executive leadership from Bell as Life Sciences Champion.
The body should include a dozen members including senior figures from the NHS, industry, academia, and the charities sector and meet regularly as well as set clear milestones, timelines, and criteria for success, the report said.
In an April 26 response, the Royal Society of Chemistry said that the governing body should also include small and medium enterprises “given their crucial role in the life sciences ecosystem.”
The government should also create a new statutory body—the Office for Industrial Strategy—with authority over the implementation of the strategy and to report annually on progress made by each government department.
Brexit Uncertainty
The committee also highlighted the uncertainty for life sciences businesses from Brexit, particularly the “potential barrier to the U.K.’s access to talent from the EU and to the access that UK citizens have to professional development opportunities in other member states.”
As Menelas Pangalos, Ph.D., AstraZeneca’s executive vice president of Innovative Medicines and Early Development, put it in the report: “We are starting to see people turn us down now in the UK because they do not know what the outcome will be for future employment.”
Pharmaceutical companies are also concerned about any deviation from regulatory standards post-Brexit and how that could affect funding. “The government must take account of the interconnected impacts on funding and collaboration, mobility, and regulation,“ Mindy Dulai, Ph.D., Royal Society of Chemistry senior policy adviser, said in an April 26 statement.
Read more in Anson’s ABPI speech and the Science and Technology Committee’s Life Sciences Industrial Strategy report.
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.