The Association of the British Pharmaceutical Industry

The UK’s medicines regulatory agency said it is working to “overhaul” its framework for approving rare disease therapies. The Medicines and Healthcare products Regulatory Agency (MHRA) said on Sunday it is planning to publish a new guidance sometime next year to speed up clinical studies, approvals and manufacturing for rare disease therapies in the UK. In a draft framework, one suggestion is that new rare disease therapies should only need one single approval for the initiation of clinical trials and marketing authorization. These two steps are currently separate, which is more time-consuming and costly. The single-approval process could also take into account data collected from artificial intelligence models and computer-based studies. Another recommendation includes biopharma companies sharing more data with each other to speed up rare disease therapy development. The UK should also increase post-approval surveillance of rare disease therapies. The final draft will be published by next spring, with an external review in the first half of 2026. The UK has been making moves to improve its life science industry to appease pharma companies. Drugmakers have been canceling or delaying investments in the UK, calling out the country’s government to improve its commercial drug market. Last month, the UK government said it is considering paying up to 25% more for medicines through a new deal with the White House. The UK also revealed a new £50 million ($65.7 million) R&D fund to attract more investment to the country. The proposed rare disease framework is supported by the Rare Disease Consortium, which includes pharma companies like AstraZeneca’s Alexion, Biogen and Ipsen; the MHRA; the National Institute for Health and Care Excellence; and other industry bodies like the Association of the British Pharmaceutical Industry. In February, ABPI warned the UK needs to improve its rare disease therapy access, noting the high rebate taxes in the country were turning companies away from launching drugs in the UK.

The UK is giving pharma companies more time to decide whether to leave the country’s drug rebate scheme as tension continues over the government’s investment in the sector. The UK government and trade group the Association of British Pharmaceutical Industry extended the deadline by two weeks for companies to exit the UK’s Voluntary Scheme for Branded Medicines Pricing and Access (VPAG), according to a Tuesday release . VPAG is the percentage of sales a company pays back to the UK’s National Health Service. VPAG launched last year in collaboration with the government and industry and was designed to lower the cost the NHS pays for branded drugs. Drugmakers have been lobbying for the government to lower its VPAG rate, which is set at nearly 23%. But the rate remains the same after UK Health Secretary Wes Streeting failed to strike a drug-pricing deal with pharma companies in August. The new deadline to exit VPAG is Nov. 14, reducing the minimum notice period pharma companies must give from two months to six weeks. If a company leaves, it will be subject to the Statutory Scheme for branded drugs instead, which is currently set at 23.8% and will increase to 24.3% in 2026, according to a government release in June. The VPAG rate for 2026 is currently unknown and will be based on sales forecast and sales growth up to the third quarter of 2025, according to a Department of Health and Social Care fact sheet . While such extensions are not “unusual,” there is “some uncertainty around the future UK commercial environment right now, so providing more time to clarify the situation is helpful,” an ABPI spokesperson told Endpoints News. Pharma companies have been rethinking investments in the UK over concerns that the government isn’t doing enough to improve the life sciences space. Merck scrapped a $1.3 billion laboratory build in London, AstraZeneca halted a $271 million investment in its Cambridge research site, and Eli Lilly said it’s not yet ready to finalize plans to bring its Gateway Labs to the country. Meanwhile, President Donald Trump is putting pressure on drugmakers to lower prices in the US. Eli Lilly reduced the price of Mounjaro in the US earlier this year, but said in August that it would raise the price in the UK . Pfizer and AstraZeneca were the first companies to strike “most favored nation” deals with the White House, under which they will lower some drug prices in the US in exchange for tariff exemptions. The UK government is reportedly in discussions with the White House to pay up to 25% more for medicines in exchange for “low to zero” tariffs on UK pharmaceutical products, according to a Financial Times report earlier this month.

The UK is reportedly prepared to pay up to 25% more for drugs, as biopharma companies urge the government to spend more on medicines and President Donald Trump pressures drugmakers for lower prices in the US. The UK’s National Institute for Health and Care Excellence (NICE) — its cost-effectiveness watchdog — weighs whether to recommend a new drug to the NHS, taking into account what’s called a quality-adjusted life year (QALY). If a drug is below the QALY threshold, NICE will recommend the drug to the NHS. The UK has a new proposal that includes raising that threshold by as much as 25%, according to a Wednesday Politico report citing two unnamed industry sources. Currently, a QALY’s upper limit is set at £30,000 a year. The UK trade group Association of the British Pharmaceutical Industry (ABPI) said on Tuesday that the government should raise the threshold to between £40,000 and £50,000, noting it has been stagnant for over twenty years. ABPI declined Endpoints News’ request for comment on Wednesday. “We’ve secured a landmark economic partnership with the US that includes working together on pharmaceutical exports from the UK, whilst improving conditions for pharmaceutical companies here,” a spokesperson from the UK’s Department of Health and Social Care (DHSC) told Endpoints in an email. The DHSC is in “advanced discussions” with the Trump administration to “secure the best outcome for the UK,” the spokesperson added. Negotiations are ongoing among Downing Street, the Treasury, DHSC and the Department for Science, Innovation and Technology on where the extra funding will come from, considering the NHS is already financially stretched, according to a Financial Times report. The patient advocacy group Just Treatment described the 25% hike as “deeply troubling” for the NHS. “This is a coordinated shakedown of the UK taxpayer by big pharma and Donald Trump focused solely on increasing the industry’s already inflated profits. The government should not be giving in to this bullying,” the Wednesday statement said. Last month, Just Treatment and two other advocacy groups demanded that the UK’s Competition and Markets Authority (CMA) look into whether drugmakers, trade groups and the US administration are working together to add pressure to the UK government to raise drug prices. But on Wednesday, CMA said it will not investigate such claims. “In this case, we have not seen any direct evidence that the public announcements were made as a result of anti-competitive collusion between the pharmaceutical companies,” CMA wrote in a letter seen by Endpoints addressed to Just Treatment. Over the past few months, drugmakers like AstraZeneca and Merck have canceled or halted their investment plans in the UK, with some calling on the government to improve its commercial drug market. These announcements rolled in after UK Health Secretary Wes Streeting failed to ink a deal with drugmakers on medicine pricing. Drugmakers Eli Lilly and Bristol Myers Squibb have recently announced plans to raise drug prices in the UK. Lilly said that in order for it to lower its US prices, it has to increase them elsewhere. Trump has been demanding drugmakers to follow his administration’s “most favored nation” pricing scheme. Last week, Pfizer inked an MFN deal and got a three-year exemption from pharma tariffs.