The world woke up today to discover the UK public had voted 52-48% in favour of leaving the European Union (EU), the single-market economy it has been a prominent member of since 1973.
While there has been an immediate response on the markets, not much is known as to the longer-term impact to industry, not least the UK’s biopharma sector which had been in favour of remaining in the EU to, among other reasons, retain its regulatory influence and ensure access to lower-cost biosimilars.
The UK’s recently formed British Biosimilars Association (BBA) – part of the British Generic Manufacturers Association (BGMA) – has previously aired its concerns that a Brexit would delay approvals and launches in the UK, and could also impact Britain’s R&D industry.
And in a statement sent to us today, Warwick Smith, director general of the BGMA and BBA, said patients, the National Health Service (NHS) and industry have all benefitted from a single European marketing authorisation for medicines and hopes not to lose this environment following the referendum result.
“The single European marketing authorisation reduces cost and complexity for manufacturers, facilitating the production and regulation of high quality medicines and their availability to patients,” he said.
“The UK generic and biosimilar medicines industry therefore urges the Government to do everything possible to maintain this European marketing authorisation system in the forthcoming negotiations with the European Union.”
Meanwhile biosimilar maker Sandoz told Biopharma-Reporter.com that its parent company Novartis expects in the short-term “no significant impact on [its] activities and businesses as the mechanisms and measures for the exit still must be defined.”
Sandoz spokesperson Duncan Cantor added the firm would “continue to work with the UK Government to ensure that the UK’s relationship with the EU delivers for patients, UK state healthcare provider the NHS and our industry.”
Unwanted but unfazed
In a statement issued by the UK’s BioIndustry Association (BIA) this morning, CEO Steve Bates said this was not the outcome the association wanted but industry will have to accept the views of the UK people.
“The life sciences sector is a resilient community, unfazed by new challenges and staffed by great management teams used to working in a global environment.”
However, while he said “the fundamentals of UK bioscience remain strong,” he admitted the sector has been left insecure by the vote.
“Questions about the regulation of medicine, access to the single market and talent, intellectual property and the precise nature of the future relationship of the UK with Europe are now upon us,” he said. “This will require detailed and dispassionate thinking,” and will be worked on over the coming weeks and months.