After almost 50 years as part of a European market, the UK medicines, medical devices and life sciences industries were among the foremost in the world. This was highlighted recently as they rapidly identified treatments and a vaccine for Covid-19. They have been a bright spot on the often bleak national picture of productivity.
The NHS benefited from easy access to a large market, which was first in the queue for the latest innovations. By 2018, the ease of supply lines meant that 75% of NHS medicines, and most clinical consumables, came from or via the European Economic Area.
Brexit has now changed the fundamentals of this world. The Trade and Cooperation Agreement secures continued mutual recognition of factory inspections for medicines, and access to European science funding. But everywhere else – clinical trials approval, medicines authorisation, medical devices assessment, testing of batches, and every aspect of customs – the UK and EU are now separate markets, and companies will pay a price in paperwork and costs each time their operations cross between the two.
As companies plan, the UK is the odd one out among its European peers, offering additional friction and complexity. That puts it at a disadvantage for investment at every stage in the supply chain. It incentivises firms to charge more, or to introduce new products later in the UK – or in marginal cases, perhaps not at all.
On the defensive
Insofar as the UK has begun to respond, it has focused on reducing the risk of shortage or delays for the NHS and for patients. The UK will unilaterally accept EU regulation in most of these areas for a time – accepting European regulators’ assessments of conformity until June 2023, for example. It has also joined a medicines access consortium with Switzerland, Australia and small non-EU countries – pooling resources and accepting applications jointly to reduce delays in new drugs.
Pharmaceutical and devices companies have long complained not primarily of the speed of approval in the UK, but the speed at which the NHS actually adopts new products and the rigorousness of the cost effectiveness standards applied by the National Institute for Health and Care Excellence (NICE). Because there will still be costly barriers to imports into the UK, especially around customs and tax, there will be an incentive to attract new products by looking harder at these.
At its best, this could mean addressing well-known and quite real problems with the uptake of innovation. The new Innovative Licensing and Access Pathway, which allows companies to work with regulators and cost effectiveness bodies throughout the process, may be an example of this.
At its worst, however, the higher costs for bringing products to the UK may further incentivise lobbyists and politicians to push for looser cost effectiveness policies, paying over the odds to compete and swallowing NHS funds that could have saved more lives elsewhere – as we saw with the spiralling costs of the Cancer Drugs Fund a decade ago. The upcoming review of NICE’s methodology will be an important moment.
Touting for business
These measures smooth the flow in only one direction, making it easier for firms to sell products here while doing little to incentivise designing, testing and manufacturing in this country. Officials we spoke to for our Brexit tracker programme, funded by the Health Foundation, told us they believed the UK needed to change regulation, the role of the NHS and industrial policy to compete.
EU regulation in this sector is far from perfect: some aspects are inefficient, while others do not go far enough in protecting patients. The messy, decentralised, overburdened system of devices regulation has seen a series of scandals. The streamlined system set out by the 2014 Clinical Trials Regulation has progressed agonisingly slowly.
Options floated by our interviewees included more help throughout the development and manufacturing stages and using data to try to reduce the need for bigger and more costly clinical trials.
But plans appear to be at an early stage. It is unclear, for example, if there is an intention to try to align with the EU regulation for trials or diverge, perhaps for particular sub-sectors.
And such changes must be fully thought through. Anything perceived to reduce the rigour of trials and regulation relative to other countries could undermine public trust. “Picking winners” among firms and sectors to support is a difficult game. Anything that crosses into simply subsidising firms in this country may not only waste taxpayers’ money, but run afoul of the agreement with the EU, leading to further barriers to trade.
Without the luxury of a large market, having a medicines and devices sector that excels for patients and the economy in the UK means a struggle against economic gravity. There are options, but they are not easy or without drawbacks. Without serious and strategic action, we might look back on the scientific successes of 2020 as the end of an era.
Dayan M (2021) “The end of an era? Brexit’s impact on the UK’s scientific successes”, Nuffield Trust comment.