So the UK left the EU. It was an unfathomable to many, but the voters made their voices heard, although it’s been reported that many voters stayed home thinking it couldn’t possibly happen. But now that it has, the CEO of the country’s BioIndustry Association (BIA), Steve Bates, is raising concerns regarding the key issues that will affect the life sciences industry, especially in regard to questions about the regulation of drugs, which is generally done by EU regulators—and then how this will impact venture capital investment.
The key questions Bates is concerned about include how the regulation of medicine, access to the single market and talent, and intellectual property will play out—and what the precise nature of the future relationship of the UK with Europe will look like within the new political climate. “This,” he says, “will require detailed and dispassionate thinking and the BIA will make its and its members’ expertise available to the government and its key agencies in the coming weeks and months as we work through these complex issues.”
And the impact of this split indeed creates a great deal of complexity for the life sciences sector. Sarah Hanson, Head of UK Lifesciences at international law firm CMS, discussed the split and European Economic Area (EEA) markets in this way: “First and foremost we must consider its effect on the significant body of EU legislation that governs the development and supply of medicines and medical devices,” she said in a statement. “Companies engaging in any way with the EEA markets will face increased regulatory burdens from having to deal with separate UK and EU regulation. The industry faces an arduous job ahead, keeping abreast of all relevant legislation to work out which parts of the UK and EU regulatory regimes will remain the same and which parts will diverge.”
Bates, of course said the vote to leave the EU is not the outcome that the BIA wanted. However, he added in a statement: “We 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. The fundamentals of UK bioscience remain strong,” he added. “In terms of potential new therapies in the pipeline, the UK is by far the strongest in Europe. But these key issues for our sector are now in flux.”
And despite the change in the political climate, and the unknowns involved in the split, he stressed, “The BIA remains committed to making the UK the third global cluster for life sciences and we will work closely with government and relevant agencies to see how this ambition can be delivered within the new political context we now find ourselves in as a country.”