Life sciences have been steadily losing ground in the UK with a significant drop in global R&D investments and a decreasing number of patients enrolled in clinical trials. The British government has announced a GBP 650 million “Life Sci for Growth” package along with some pro-innovation regulation and a review of the country’s clinical trials framework to stimulate growth in the sector, but after many such plans and amid industry pushback over a voluntary rebate scheme, there remains a certain scepticism about the new initiative’s potential impact.
Lagging Behind
The UK has made a number of attempts to stimulate a life sciences sector that despite the country’s leading universities, strong research base and long-standing National Health Service (NHS) has been losing competitiveness for some time.
According to a 2022 report from the Institute for Public Policy Research, the UK’s share of global R&D investments, including those in health and life sciences, shrunk from 4.2 percent in 2014 to 3.4 percent in 2019, before the COVID-19 pandemic. Ranking 11th in the Organisation for Economic Co-operation and Development (OECD) for total R&D investment as a percentage of GDP, the UK is lagging behind not only global leaders like the US, but also mid-sized European powerhouses like Austria and Switzerland.
The government recognises the huge opportunity waiting to be grasped if the UK can unlock the economic potential of its life science industry
Richard Torbett, chief executive of Association of the British Pharmaceutical Industry
“While we’ve got great strengths and enormous potential to grow life sciences in this country, we are falling behind our global competitors,” said Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry (ABPI) in response to the latest Life Science Competitiveness Indicators published by the government.
In addition, the latest data on UK clinical trial enrolments is also concerning, with the number of patients entered into commercial studies decreasing by 44 percent since 2017 and causing the UK’s position in the global trials ranking to fall from fourth place in 2017 to 10th in 2021.
Government Initiatives
The UK government’s efforts to incentivise life sciences in recent years can be traced back to 2017 when it brought forth a vision to become a “global hub for clinical research and medical innovation.” Again, the 2021 life sciences vision claimed it would “cement the UK’s position as a science superpower,” yet critics have claimed that these ideas and visions have always lacked the financing and momentum to make them a reality, or as GSK CEO Emma Walmsley put it, they suffer from an “execution gap.”
Larger geopolitical uncertainties, both at home (Brexit) and abroad (the war in Ukraine), have not helped to advance life sciences in the UK. “Brexit was a big change for the UK in terms of our place in the world and our place in Europe and it was never going to be an easy process in the first two or three years,” said the UK’s Minister of State for Science, Research and Innovation, George Freeman, at a recent BIO2023 forum. “Those years went then straight into the pandemic, and then straight into a war in Europe.”
The fragilities of the UK healthcare system were also laid bare by the COVID-19 pandemic and as the NHS continues to recover, it has struggled to prioritise clinical trials. According to National Health Service (NHS) CEO Amanda Pritchard, in late 2022 British healthcare was in a worse place than in the early days of the COVID-19 pandemic.
Life Sci for Growth
The UK government’s latest initiative, the Life Sci for Growth package, is set to put money where its mouth is and embraces ten different funding-backed packages including GBP 121 million to improve commercial clinical trials, up to GBP 48 million to prepare for future health emergencies, GBP 154 million to increase the capacity of the UK’s biological data, and up to GBP 250 million to incentivise pension schemes to invest in sciences and tech firms.
“Our Life Sciences sector employs over 280,000 people, makes GBP 94 billion for the UK each year and produced the world’s first COVID vaccine. These are businesses that are growing our economy while having much wider benefits for our health – and this multi-million-pound investment will help them go even further,” said Chancellor Jeremy Hunt upon launching the new scheme.
Regulatory Reform
Beyond its broader intentions of creating incentives and growing the broader UK economy, the package comes with a Pro-innovation Regulation of Technologies Review that looks to address specific regulatory opportunities with plans for action within the next 12-18 months. Namely, through the review the government wants to make it easier for innovation to get to NHS patients “by cutting the regulatory burden of approving clinical trials.”
“The regulatory piece [of the review] is particularly important,” said Freeman who claimed that the UK is looking to align its regulatory framework with EMA and other agencies while maintaining what he called the “regulatory freedom” that came out of its exit from the EU. “We want to use our regulatory freedom in the UK to be a bit more agile, to move quickly. It is not a criticism of the EU, but when you have 27 countries agreeing on this stuff, it takes time,” he added.
Our aim is to try and make the UK a testbed for some of the novel therapeutics with novel regulatory frameworks
George Freeman, Minister of State for Science, Research and Innovation
Within its independence from Europe and through renewed regulatory structures, the UK is looking to become a testing ground for innovative areas such as cell and gene therapies while maintaining its connection to the European Medicines Agency (EMA). “Our aim is to try and make the UK a testbed for some of the novel therapeutics with novel regulatory frameworks and to work very closely with the EMA. We want to become an annexe, a testbed, a good European partner, taking a bit more risk, and helping this industry to find that regulatory pathway,” Freeman claimed.
Freemen recognised the importance of clinical trials. “If we really want to make sure that our healthcare systems are open to innovative new products, and all our citizens can access the benefits of innovation, and innovative medicines, then clinical trials are key,” he said. Because of the import of commercial trials, the government aims, as Freeman put it, to “really accelerate entry into trials and give everyone around the UK the chance to get in.”
Industry Concerns
Representatives of the British pharma and biotech sector welcomed the government’s Life Sci for Growth initiative. Richard Torbett of the ABPI stated that: “Today’s announcements show that the government recognises the huge opportunity waiting to be grasped if the UK can unlock the economic potential of its life science industry.” Steve Bates, CEO of the Bioindustry Association also supported the plan: “Today’s package of support for the UK life sciences sector will help address fundamental challenges large and small companies in our industry face as they look to invest and grow in the UK.”
Torbett did however express misgivings about the plan, specifically prompting UK legislators to rethink the voluntary scheme for branded medicines, pricing, and access (VPAS). “Improving research is only one part of the equation. To get innovative medicines to patients and fully capture the growth opportunity, we must also fix the commercial environment, and for that, we also look forward to agreeing with Government to a new and improved voluntary scheme as soon as possible.”
Pharma companies providing branded drugs to the UK’s NHS are subject to the Statutory Scheme unless they chose to join the VPAS. Under the VPAS companies were set to limit total NHS drug costs to a two percent yearly increase, and to pay back revenues above that. For the first three years, they paid back 5 to 10 percent, but the clawback rate then rose to 15 percent in 2022 and soared to 26.5 percent in 2023. AbbVie and Eli Lilly withdrew from the voluntary scheme while Bristol Myers Squibb claimed that as a result of a system it called “punitive,” it would limit its UK footprint.
