UK biotech repeats Brexit concerns

The government has been using statutory instruments (secondary legislation) to create a legal framework quickly to facilitate medicines regulation to function if there is a no-deal Brexit. SIs covering four key areas – a serious shortages protocol, medicines regulation, clinical trials and medical devices – have been laid before Parliament.
The ABPI and the BIA continue to impress that a no-deal Brexit must be avoided. They continue to stress UK life sciences sector’s world leading expertise in academic research, industry R&D, and its burgeoning biotech sector, pointing out that last year UK biotech raised more funds than anywhere else in Europe. It seems very likely that the protracted Brexit process will make the UK less attractive to international investment, and the sector is focused on ensuring its medicines can reach UK patients after Brexit.
Steve Bates, the BIA’s chief executive, said it is now clear that a no-deal Brexit would mean total duplication of regulation in the UK outside the EU, with new red tape and expense for pharma, biotech and medical devices companies, which would render the UK a market of secondary importance. He said: “I still think that we will see before the end of March an extension or a delay to Brexit, and I think that will either be because there is a mooted deal or talks to get to a deal. There is a great deal of detail now in the public domain from the government which shows that they are suggesting expensive duplicative red tape and an impact for NHS patients. We really are in a world upside down position. I still think that we will see before the end of March an extension or a delay to Brexit, and I think that will either be because there is a mooted deal or talks to get to a deal.”