Cameron promotes new partnership between research, industry, and the NHSBMJ 2011; 343 doi: http://dx.doi.org/10.1136/bmj.d7956 (Published 06 December 2011) Cite this as: BMJ 2011;343:d7956
The prime minister has launched a plan to speed up access to new drugs for NHS patients and to simplify access to NHS data for life science companies.
The package, which includes an £180m (€210m; $280m) fund to assist the adoption of new ideas, aims to create a better environment for biomedical investment. Rising research costs, combined with a smaller pipeline of new products and higher marketing hurdles, are making Britain less attractive as a research base and risk stifling its most important high tech industry. The decision by Pfizer earlier this year to close its laboratory in Sandwich, Kent, in spite of its many successes, brought the issue to a head (BMJ 2011;342:d771, doi:10.1136/bmj.d771).
In a speech on 5 December David Cameron claimed that the plan would benefit the industry, the NHS, and patients. The United Kingdom already had many strengths in life sciences, together with an industry that provided 165 000 jobs and a £50bn annual turnover, but the world was changing. “To keep pace we’ve got to change radically—the way we innovate, the way we collaborate, the way we open up the NHS,” he said, urging the NHS to become “the fastest adaptor of new ideas in the world, acting as a huge magnet to pull new innovations through.”
Among the changes he proposed would be an early access scheme so that patients in the advanced stage of a disease with no other treatments available would be able to be treated with new drugs much earlier in their development. “As long as the drug qualifies for the scheme, it should be up to patients and doctors to decide whether they want to use it,” Mr Cameron said.
Ana Nicholls, a healthcare analyst at the Economist Intelligence Unit, said that the scheme would extend existing “compassionate use” policies that already make access to unlicensed drugs possible for some patients defined by their doctors as special cases. But she warned that the risks and costs would have to be carefully monitored, given that the drugs had passed neither marketing nor cost effectiveness hurdles.
Richard Barker, a former director general of the Association of the British Pharmaceutical Industry, said that patients were waiting too long because of the lengthy and extremely costly process for gaining full regulatory approval. “Health systems ultimately have to pay for these costs in the price of new products. It makes sense for the UK, with its research strengths, respected regulators, and major life science investments, to take a lead,” he said.
The Medicines and Healthcare Products Regulatory Agency has devised an early access scheme for drugs, in consultation with the Association of the British Pharmaceutical Industry and other bodies. The scheme would be open to drugs that have completed phase III or, in exceptional cases, phase II trials. Companies can choose to apply for drugs to be included and can set their own prices. Approval will last for one year, renewable if necessary. The National Institute for Health and Clinical Excellence will not be involved, as there will be no central mandate for funding such drugs. It will be up to primary care trusts to find the money.
Although the outlines of the scheme were completed some time ago, ministers decided in May not to proceed with it. But Mr Cameron’s speech indicates that it has been revived.
The package presented by Mr Cameron also seeks to more successfully harness the mass of patient data generated by the NHS. The need to seek patients’ consent for use of data has hampered researchers in the university and private sectors, so the plan would assume such consent for anonymised data, in the absence of a formal objection by individual patients.
Labour’s shadow health secretary, Andy Burnham, said that he was not opposed to the idea of private companies getting access to some NHS data, but he added that Mr Cameron had to tread carefully. “What he calls red tape others might see as essential safeguards,” Mr Burnham said. “Some areas need proper regulation, and patient records is certainly one of them.”
Liz Fitzsimons of the law firm Eversheds said that she hoped a code of practice on anonymisation being developed by the UK information commissioner would help satisfy doubters that patients’ confidentiality was being sufficiently safeguarded while allowing valuable data to be unlocked.
Mark Walport, director of the Wellcome Trust, said he was delighted that the government had listened to research charities and recognised the importance of allowing researchers to get hold of patient information, with appropriate safeguards. He said, “A patient once said to me, ‘Giving my anonymous data is the most painless thing I can do to help others get better.’ These proposals will allow many more willing patients to do exactly that, delivering a step change in patient care and real improvements in the health of the population.”
BMA leaders warned ministers that they should ensure that patient confidentiality was protected in the new arrangements. Vivienne Nathanson, head of science and ethics at the BMA, said, “It is encouraging that the government has recognised the importance of the life science industry to both the NHS and the wider UK economy.
“Whilst the BMA does believe that the use of anonymised health data could benefit patients, we are concerned that elements of the government’s proposals could, if implemented, undermine patient confidentiality.
“We are especially worried by recommendations that would grant researchers, possibly from large commercial companies rather than the patient’s healthcare team, access to patient records. This could mean that details of an individual’s health status and treatment will be revealed if researchers are able to search through records and identify patients in order to contact them.”
Mr Cameron’s plans, widely trailed by Number 10 in advance of his speech, include a £180m “biomedical catalyst fund” to bring innovations by universities and small and medium sized enterprises to market.
Three reports were issued to coincide with the speech: a government report, Investing in UK Health and Life Sciences (www.number10.gov.uk/wp-content/uploads/2011/12/8971-BIS-Life-Sciences-Prospectus-BMK_Spreads.pdf), a report by the Department of Business Innovation and Skills entitled Strategy for UK Life Sciences (www.bis.gov.uk/assets/biscore/innovation/docs/s/11-1429-strategy-for-uk-life-sciences.pdf), and an NHS report on how to accelerate the adoption and diffusion of new ideas (www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_131299 ).
Cite this as: BMJ 2011;343:d7956