UK government ministers are about to commence discussions with leaders of the pharmaceutical industry which, they hope, will lead to a voluntary agreement to replace the Pharmaceutical Price Regulation Scheme (PPRS), Dawn Primarolo, Minister of State for Public Health, told a Parliamentary Committee yesterday.

The government has not yet given its response to the Office of Fair Trading’s (OFT) report on the PPRS, which was published back in February and took industry by surprise with its conclusion that the scheme needed to be reformed, although an interim response from ministers on August 2 agreed with the OFT’s view that “it is time to develop a pricing system which is fit for purpose for the twenty first century.” Asked yesterday by MPs when the formal government response would appear, Ms Primarolo said it would be inappropriate to say anything further while the negotiations with industry were about to start, but added: “we will respond when we have the agreement.”

Commenting on the minister’s remarks, a spokesman for the Association of the British Pharmaceutical Industry told PharmaTimes World News that the industry had not yet made the decision to go into negotiations with the government and that the terms of reference were still under discussion.

Ms Primarolo was speaking at the final evidence session of the House of Commons Health Select Committee’s investigation into the National Institute for Health and Clinical Excellence (NICE). She defended NICE against criticisms from MPs over the considerably longer time which it takes to issue guidelines compared to the Scottish Medicines Consortium (SMC), the body that provides advice on the status of all newly-licensed medicines to the National Health Service (NHS) in Scotland.

Speed is an issue, she acknowledged, but this cannot be solved through cuts to the public consultation process and system of appeals which are central to NICE’s procedures; the SMC does not include such processes. Ministers believe NICE is the more robust and transparent process and it is internationally respected as the right way to proceed, said Ms Primarolo.

The SMC process operates on company applications, its statements are shorter than NICE’s and they perform a different function; you can’t simply compare the two systems, said Andrew Dillon, NICE’s chief executive. However, he acknowledged that a delay in getting new drugs to patients was a concern and said he was sure that more could be done. NICE’s public consultation progress takes about two months on average, and further time is taken up by appeals, which are launched against around 30% of the Institute’s guidelines. Then, if the appeal is upheld, it will go for advisory committee review, creating further delay, he told MPs.

NICE’s chairman Professor Sir Michael Rawlins said that, excluding the time taken for its public consultation and appeal processes, NICE guidances take an average of five and a half months to produce, compared with four and a half months for the SMC’s. Out of 73 treatment guidance “pairs” which have been produced by both agencies, 34 have come up with the same recommendations and for 39 they have differed. Of the latter group, 23 of NICE’s recommendations have been more restrictive than the SMC’s and 16 less restrictive, he said.

To suggestions from the Committee that NICE should be conducting speedy assessments of all drugs at the time of their launch, Sir Michael reply was that a “quick and dirty” assessment would be wrong and unfair to the NHS and patients. We rely on the rigour of the system to be fair to all who use it, he said. By Lynne Taylor