As Britain’s plans to leave the European Union—Brexit—stagger toward the March 29 deadline, the UK biopharma industry is taking stock of the likely impact.
As Britain’s plans to leave the European Union—Brexit—stagger toward the March 29 deadline, the UK biopharma industry is taking stock of the likely impact.
One big move was simply that the European Medicines Agency (EMA), the equivalent to the U.S. Food and Drug Administration (FDA), moved its headquarters from London to Amsterdam. During the transition, the EMA was scaling back some of its operations, particularly as it dealt with an expected loss of about 30 percent of its staff.
Major UK drug makers, as well as European drugmakers, such as AstraZeneca, GlaxoSmithKline, Sanofi, Novartis and Roche, all made plans to stockpile extra drugs in preparation for the likelihood of supply chain disruption. More than 2,600 drugs, according to Reuters, have some stage of manufacture in Britain, and 45 million patient packs are supplied from the UK to other European countries, with another 37 million going from Europe to the UK.
In fact, that import number appears to be quite low. Novartis recently indicated that its contingency plans were continuing and the company was making “all preparations possible to ensure continuity of supply to UK patients of the over 120 million packs of medicines we import to the UK from Europe each year.”
As of Feb. 7, there’s no deal, although UK Prime Minister Theresa May vowed she would deliver Brexit “on time,” although the European Commission President Jean-Claude Juncker has ruled out the types of changes May wanted.
As the deadline looms and no deal is on the horizon, the issue is heating up. European Council President Donald Tusk recently said there was a “special place in hell” for those who campaigned for Brexit without a plan to actually make it happen. May responding, saying his language “was not helpful” and had “caused widespread dismay in the United Kingdom.”
A recent editorial in The Washington Post by Ian Dunt, editor of Politics.co.uk and the author of “Brexit: What the Hell Happens Now?” wrote, “Brexit was a political project based on the idea that identity politics could answer technocratic questions. If the technocratic question keeps proving problematic, you just need to have more faith in your identity. It was like trying to unlock a door with a slice of bread.”
Meanwhile, as the entire process grinds along, seemingly accomplishing nothing, many in the UK biopharma industry are expecting long-term damage to the industry. The Association of the British Pharmaceutical Industry (ABPI) recently warned that the UK was in “in danger of losing its world-leading research and development status, backed by the country’s two biggest pharma investors, AstraZeneca and GlaxoSmithKline.”
An analyst with GlobalData wrote that in the past decade the UK has seen a 16 percent increase in students studying STEM topics. However, the number of EU students studying STEM topics in the UK rose more than 52 percent over the same period, with the number of non-EU students raising more than 63 percent.
The analyst, Gavin Davidson, wrote, “With Brexit creating lots of uncertainty in the UK’s future, there is no denying that it could act as a deterrent for overseas higher education students coming to the UK to study and then work. Restrictions currently being debated in the Commons in the form of a post-Brexit immigration bill would see immigrants earning less than Á30,000 facing restrictions—something which would hit many undergraduates and graduates starting out in the R&D sector.”
He also points out that the pharmaceutical industry is a major investor in the UK’s economy. That R&D investment has fallen by 22 percent between 2011 and 2016. The ABPI, he said, “has unveiled concrete countermeasures to prevent this and support the sector, but without appreciation of how immigration restrictions could affect Pharma and healthcare, the UK could see a dramatic shortfall in skilled workers post-Brexit.”
In fact, the ABPI in a statement said that “these highly-skilled scientific roles—vital to the UK’s successful pharmaceutical and biotech sectors—could move to other parts of the world if the situation is not addressed as a matter of urgency.”
They further identified four major areas, as identified by over 30 companies, that are most likely to be affected by Brexit: genomics, immunology, bioinformatics and chemoinformatics, and clinical pharmacology.
ABPI is working with various organizations, including the British Science Association, to encourage more students into STEM careers, but it also recommended to the Home Office that “Clinical Pharmacology be added to the shortage occupation list, and that the Home Officer view the shortage occupation list more frequently to be able to react quickly to the fast-moving science landscape.”
A more recent concern that came up by the ABPI was the House of Lords debate over the Patents (Amendment (EU Exit) Regulations 2018 Statutory Instrument. Supplementary Patent Certificates are extensions for drug patents. The ABPI has expressed concerned that the changes might damage the UK’s reputation as a leading life sciences hub and global leader on intellectual property (IPO) protection.
Mike Thompson, chief executive officer of ABPI, stated, “Britain is internationally renowned for its strong IP framework and this has made it an attractive home for investment from all industrial sectors, including pharmaceuticals. We’re concerned that these measures are a step backwards and seriously undermine the strong life sciences sector that we’ve worked so hard to build over the past 70 years.”
Apparently, the proposed changes to the SPC regulation would decrease the patent exclusivity on drugs in the UK.
Even if negotiations come together in the next six weeks or so, the ripple effects of Brexit on the biopharma industry specifically and the UK economy in general is likely to last for years.
In a recent discussion titled “Brexit Impact on Biotech” published by Kineticos Life Sciences Consulting between several industry experts, Derek Hennecke, former president of Capsugel Tampa and former chief executive officer and president of Xcelience before it merged with Capsugel, said, “The money part is definitely important, it’s going to be bad for all of Europe, but specific to the UK, the UK has had a very strong pharma history and I think they’re still going to hold leadership in terms of GMP and regulatory guidance. But the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) is talking about infrastructure, and knowledge, and leadership, which are all facets. As Mark (Osterman, senior vice president of Kineticos’ Biopharmaceutical Practice) said, money is important, but so are people and knowledge and skills.”
