UK to fast-track drug trials to boost post-Brexit life sciences
Companies will need to apply separately to register new medicines when Britain leaves EMA
Britain was the first country in the world to approve the Pfizer/BioNTech Covid-19 vaccine © AFP via Getty Images
Sarah Neville in London YESTERDAY
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Drugmakers will be offered fast-tracked approvals for innovative medicines in the UK as ministers seek to build on the country’s world-leading approval of a Covid vaccine and attract life sciences companies to invest post-Brexit.
The UK’s medicines regulator will become independent of EU pharmaceutical rulemaking when Britain quits the European Medicines Agency at the end of the year, which means companies will need to apply separately to register drugs.
With ministers eager to try to refashion the UK as a post-Brexit hub for global life sciences, companies with drugs that promise to treat unmet medical needs will be offered help through the development process, including manufacturing, according to three people familiar with the situation.
Under the so-called Innovative Licensing and Access Pathway, companies are set to be offered the same rolling review of data that speeded approval of the Pfizer/BioNTech Covid-19 vaccine ahead of the rest of the world.
The move will also try to counter the threat that pharmaceutical companies will push Britain to the back of the queue for drugs given it accounts for just 3 per cent of global pharma sales.
Officials and some National Health Service staff fear that new medicines will be delayed in the UK if companies are discouraged by the extra bureaucracy from seeking approval from the UK regulator, the Medicines and Healthcare products Regulatory Agency.
One person familiar with the plans said that “life sciences can be one of the things at the centre of the UK’s post-Brexit policies”.
The UK is still locked in eleventh hour talks with the European Commission over a trade deal, with disagreements remaining over fisheries and the fair competition level playing field.
The person added: “[Ministers] want [the UK] to be seen as a place where people come to develop innovative medicines. That’s why they were over the moon about the Covid vaccine being the first [to be approved] in the world.”
However, one industry figure, who spoke on condition of anonymity, was sceptical that a company would tailor its trials and data generation to the demands of the British market.
“A company is not going to do data just for NICE [National Institute for Health and Care Excellence] when the UK is a fraction of global pharma sales; it’s not going to spend millions on studies just for the UK,” they added.
The executive argued that a far bigger overhaul was needed of the framework that NICE uses to calculate value-for-money. A review of the agency’s methodology is under way and any changes are expected to be announced in the spring.
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Britain has long been criticised by the pharma industry for the slow rate at which the NHS adopts new medicines.
An analysis commissioned by Pfizer in 2017 identified Britain as a laggard in the speed at which patients received new treatments, with a 75 per cent lower uptake of new drugs in their first year of release compared to France, Germany, Japan, Switzerland and the US.
Later that year, the UK’s life sciences industrial strategy set a goal that Britain “should be in the top quartile of comparator countries, both for the speed of adoption and the overall uptake of innovative, cost-effective products, to the benefit of all UK patients by the end of 2023”.
Under the new plan, the NICE and its Scottish equivalent, the Scottish Medicines Consortium — the bodies which determine whether a treatment offers value for money — would be “in the room” from early in the development process.
Companies would be given immediate feedback on what a drug trial would need to demonstrate, and what data it would need to generate, to have the best chance of receiving a positive assessment. Patients’ views and priorities will also be integrated into the development process.
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