Drug companies should release data from all trials of licensed drugs, say MPs

BMJ 2013; 346 doi: (Published 16 January 2013) Cite this as: BMJ 2013;346:f321
  1. Nigel Hawkes
  1. 1London

The drug industry should be obliged to release in a publicly accessible form all the information it possesses about trials of licensed drugs, the House of Commons Health Committee has said in a new report on the functioning of the National Institute for Health and Clinical Excellence (NICE).1

It should be “neither legal nor ethical” to withhold such data, said the committee. It was concerned that failure to observe this simple principle undermined the effectiveness of NICE, because the institute was forced to appraise drugs without having access to all relevant data.

“This situation cannot be allowed to continue,” said Stephen Dorrell MP, the Conservative chairman of the Health Committee. At a press conference in London to launch the report he called for a “duty of candour” to apply to drug companies, citing remarks made to the committee by David Haslam, who in April will replace Michael Rawlins as chairman of NICE. Haslam told the committee that he found it “impossible to come up with any good argument that all data should not be released.”2

To bring about the necessary changes, the committee recommended that the drug industry introduce a new code of practice and that the General Medical Council reiterate its guidance to doctors on the conduct of drug trials, to remind them that a failure to comply could lead to fitness to practise proceedings being brought against them.

The committee was also exasperated by the failure of the government to make it clear how its value based pricing system for new drugs would actually work. Although the government had been in power for over two and a half years it had provided “very little detail” about value based pricing, a delay the committee described as unacceptable. “We are increasingly surprised that we haven’t had more information,” Dorrell said. “We’re looking for greater clarity.”

The evidence it took indicated that the drug pricing changes might be more modest than first suggested. At present, manufacturers are entitled to set their own price, and NICE then makes cost effectiveness calculations on the basis of that price. NICE has no formal role in negotiating lower prices, but in practice, the report said, discussions do take place between the manufacturers and NICE about the price at which the drug would satisfy cost effectiveness criteria. “Against that background it is even less clear what substantive change is implied by the concept of value-based pricing,” says the report.

The principal change is that the negotiations would be formalised and undertaken by (it seems) the Department of Health. But given that the system was supposed to be in place from April 2014 for newly approved drugs, and that the existing scheme needed to be extended for existing drugs, greater clarity was overdue, the committee said. It has urged the health department to end the uncertainty no later than March this year.

The committee also made recommendations on the £200m (€240m; $320m) cancer drugs fund, introduced by the present government to provide expensive drugs not cleared (or not yet cleared) by NICE to be made available in the period before value based pricing began. It called for an assessment to be made of outcomes in patients treated with those drugs.

Valerie Vaz, a member of the committee, said, “I hope there is somewhere in the Department of Health where the outcomes have been measured.” She said that where such evidence of benefit existed it should be fed into the value based pricing scheme and applied to treatments other than for cancer. Ways need to be devised for drugs paid for under the fund to continue to be made available to individual patients once the fund ended in April 2014.3


Cite this as: BMJ 2013;346:f321