Drug companies with "innovative" medicines would be able to bypass current safeguards and sell to the NHS at a high price under a fast-track procedure to be proposed next week by the Office for Life Sciences (OLS), run by science minister Lord Drayson.
The proposal, in a blueprint being prepared behind closed doors with input from the pharmaceutical industry, will effectively undermine the present system of approving medicines for the NHS.
It will allow companies with medicines they claim are valuable and original to bypass the National Institute for Health and Clinical Excellence (Nice), which currently must assess every new drug to ensure it offers value for money before it can be used in the health service.
The pharmaceutical industry has been fiercely critical of Nice since its inception in 1999 because it blocks sales of expensive drugs to the NHS that are of only limited benefit.
Its protests have been backed by an outcry from patient groups, often partly funded by the pharmaceutical industry, which want new drugs to treat their particular condition.
The proposal comes from OLS, run by Drayson, a former drug company boss.
His remit is the promotion of the life sciences as potential big earners for Britain. Lord Mandelson, whose business department oversees the OLS, believes pharmaceuticals are key to the revival of the economy.
The blueprint will recommend that medicines thought suitable for fast-tracking should be allowed into the NHS for a period of time without Nice scrutiny.
Pharmaceutical companies are reluctant to launch new drugs in the UK at low cost because 25% of the global market is influenced by the UK price.
Under the OLS proposal, Nice would appraise the drug after perhaps three years – but at that point the company may be willing to drop the price here. Critics will say the proposal threatens to undermine Nice by allowing into the NHS costly drugs that may offer no real health gain.
It comes at a time when other countries are actively considering setting up equivalents to Nice. First among them, and most important for the pharmaceutical industry, is the US. President Obama is known to be interested in some sort of cost-effectiveness scrutiny of medicines, which is bitterly opposed by the industry.
Joe Collier, emeritus professor of medicines policy at St George's, University of London and an adviser to the select committee on health's inquiry into the pharmaceutical industry, said there were already safeguards in Nice to propel medicines that are truly innovative and needed into the NHS rapidly, and a fast-track proposal was not needed.
"It should not need to embarrass the current arrangements. If it either is designed to, or it does, then the system has got to be rethought," he said.
"If it is an attempt to undermine the Nice process or throw the Nice process, then it is misguided and mischievous."
While the scheme is the brainchild of Drayson's office, the implications for the Department of Health have led to cross-departmental negotiations, which were still going on at a late stage this week.
Crucial to winning the support of health ministers and primary care trusts‚ which foot drugs bills locally‚ has been the Treasury, which agreed to fund a pot of money to pay for "innovative" drugs, so the NHS does not have to bear the cost.
Who decides which drugs are sufficiently innovative may be more difficult. It is likely that Nice itself will be invited to help select them. Those that are original and claim to offer better treatment or a longer life – but to small groups of patients – will be prime candidates. One of the arguments for this approach is the invention of "targeted" drugs such as Herceptin, which work on people with a certain genetic make-up but not others.
Scheme to let new drugs bypass NHS value watchdog | Society | The Guardian
so the UK regulatory system, NICE, although not ideal, serves as a decent body which attempts to ensure that the NHS isn’t going to be ripped off any more than it already is when paying for drugs with effectivness unproven outside of the pharmaceuticals own bs testing. other countries, most notably, the US, are now looking to reign in spending on drugs supplied by these companies in setting up similar bodies modelled on NICE. with the US being the largest market, the pharms are getting into a bit of a tizzy and so are now trying deploy new strategies to undermine and effectively rid of NICE in the UK.
the worrying thing here is that the Department for Health is actively negotiating on these proposals. if accepted, and acquire the backing of the Treasury, it means any kind of drug could be pushed through as innovative with a subsequent ridiculous mark-up. as NICE apparently has considerable influence on the global market prices, it would surely mean prices inflate everywhere else.
hopefully the government will throw the proposals out, while Obama pursues his own interests in creating something similar.