Following the release of an important report, the UK government is planning to set up a single body to oversee all health research in universities and hospitals—and to facilitate partnerships between government agencies and industry.
The new body, called the Office for Strategic Coordination of Health Research (OSCHR), was established in December to bring together the budgets of the existing Medical Research Council and the government's Department of Health. It will have a ring-fenced budget of nearly $2 billion a year, which means the funds are protected and cannot be siphoned off elsewhere. In charge will be Sir John Bell, professor of medicine at Oxford University and president of the Academy of Medical Sciences.The goal of the streamlined approach is to establish the United Kingdom as a leader in drug development. Finance minister Gordon Brown described OSCHR as a "new drive to identify for Britain the most useful and fruitful areas for potential medical breakthroughs."
A key part of Cooksey's report is a recommendation about how OSCHR should work to create a new "drug development partnership." This should be done in conjunction with the National Institute for Clinical Excellence (NICE), which makes decisions on clinical and cost effectiveness, the Medical and Healthcare Products Regulatory Agency, the Association of British Pharmaceutical Industry (ABPI), and individual pharma companies.
The report cites the increasing complexity of the regulatory scene, and the fact that NICE's assessments are carried out too late and with insufficient input from industry. Cooksey says a more streamlined approach is essential, which may involve NICE giving "conditional approval" to new medicines.
The report says OSCHR also should alert pharma and biotech companies to the United Kingdom's health priorities, and should brand those projects that it thinks will meet unmet medical needs. These projects would be granted faster approval times for clinical trials within the National Health Service (NHS) and speedier progression through the NICE process.
"The recommendation for a new drug-development pathway could have a dramatic impact by reducing the cost of drug development, which can only be good news for UK patients," said Aisling Burnand, chief of the Bioindustries Association. "What is needed now is action. It is important that the recommendations are implemented swiftly and that sufficient funding is provided to enable this."
The report's suggestions, in essence, mirror FDA's Critical Path initiative. Drug companies would be required to work alongside researchers from the NHS, with requests for safety and cost-effectiveness data being met in the clinical trials. In exchange, pharma companies would be granted "conditional licensing," which would give some patients access to the experimental drugs as early as the end of Phase II trials.
Another proposal in the report is that health technology assessments (HTAs) should consider more factors than simply how much money can be saved. "We need to take into account the total impact on the economy of drugs," reads the report, which notes that HTAs should be more widely used and should have a more rapid uptake. If this recommendation were implemented, it inevitably would have funding implications for NHS, which already struggles to implement NICE recommendations fully, particularly for expensive cancer treatments.
Industry has welcomed the report with open arms. "The ABPI is committed to play its full part in the new partnership called for in the review," said ABPI director general Richard Barker, "and in helping shape the Cooksey recommendations as they are further defined and implemented."
ABPI's director of science and technology, Philip Wright, added that the proposed structure is very similar to the submissions the association made to Cooksey. "The devil is in the details, and we need to maximize the ring-fenced funding on the NHS side," he said. "We will be working with the Department of Health and the Department of Trade and Industry to move things forward. But it is difficult to say what will happen until the budget [is approved] in March. With the government's current fiscal constraints, it will be interesting to see how things pan out."
Sarah Houlton is Pharmaceutical Executive's global correspondent. She can be reached at [email protected]