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LONDON (Reuters) - British drugmakers on Wednesday accused Theresa May's Conservative government of breaking a manifesto commitment to improve access to new medicines, following approval of new cost rules that take effect on April 1.
The angry response from both Big Pharma and biotech firms comes despite a concession by government in the latest version of the scheme, which increases the cost threshold for certain drugs for rare diseases from the previously planned level.
Some charities, including the Alzheimer's Society, also expressed concern that the measures could mean delays for people with serious conditions in getting new treatments.
The row comes at a sensitive time for the government, which is about to trigger proceedings to leave the European Union but wants to encourage investment by strategic industries, including the high-tech pharmaceuticals sector.
Drug companies are already concerned that Brexit could make Britain a less attractive market, especially if the country ends up outside the current EU-wide system for drug licensing.
The National Institute for Health and Care Excellence (NICE), which determines the cost-effectiveness of new drugs, and NHS England say their new procedures will fast-track the availability of drugs that offer exceptional value.
But drug industry executives believe few, if any, new medicines will actually benefit from this provision and the overall impact of the changes will be outweighed by newly introduced budget curbs.
"Today’s proposals from NICE/NHS England break the Conservative Party's 2015 manifesto promise to speed up the introduction of cost-effective medicines into the NHS," said Mike Thompson, CEO of the Association of the British Pharmaceutical Industry.
The new system means that new drugs costing the National Health Service (NHS) more than 20 million pounds ($24 million) a year will no longer be automatically funded, even if they are cost-effective. Instead, companies will have to enter negotiations to justify their use and work out funding.
Alzheimer's Society CEO Jeremy Hughes said any new drug to help all 850,000 people with dementia in Britain would have to cost just 23.50 pounds a year to fit the threshold.
Similar limitations will apply to drugs for very rare diseases that cost more than 300,000 pounds for each year of high quality life delivered.
Previously, the proposed a cap for rare diseases had been 100,000 pounds but NICE CEO Andrew Dillon said the authorities had revised the plan after listening to feedback.
Even at the higher level, drugmakers argue the introduction of cost caps for medicines treating a handful of patients would be damaging and could threaten the flow of new medicines.
Significantly, the new rules apply only to England, leaving a different system in place for Scotland.
"They will build a Hadrian's Wall for English patients who will no longer be able to access innovative new treatments that will continue to be available in Scotland," said Steve Bates, CEO of the BioIndustry Association.
Reporting by Ben Hirschler; Editing by Ruth Pitchford