A pilot project between a drug company and the National Institute for Health and Clinical Excellence (NICE) is the first attempt to change the relationship between the drugs industry and the watchdog that decides which medicines should be available on the NHS.

Richard Barker, director-general of the Association of the British Pharmaceutical Industry (ABPI), says that the drug company, Novartis, is testing “early dialogue” during the development of a medicine to find out what information NICE needs and whether this can be proven during the early stages of clinical trials. The aim is to get agreement about what data needs to be collected. Both sides are enthusiastic about it, says Dr Barker, “so that we can be clear in advance what you have to prove and then, of course, the onus is on the company to collect the data and to make the case.”

Problems can arise when testing new drugs, as with the trial of TGN 1412, which left six young men seriously injured and bankrupted the developing company TeGenero. The ABPI is working with the Government on insurance guidelines to cover these situations. While insurance would not be an issue for most companies that have significant financial resources, TeGenero was an early-stage company and this was its only product. Dr Barker says it won't be too long before the guidelines are available, but adds: “We need to find a solution that's European in nature, and that always takes a bit longer.”

Access to new medicines is “significantly worse” in Britain than elsewhere in Europe and falls well behind the US. Products launched in the past five years represent just 14 per cent of the UK market, compared with 26 per cent in the US. While our regulatory processes are “pretty slick” - the European Medicines Agency and the Medicines and Healthcare Products Regulatory Agency are quite efficient in getting new medicines approved - “the problem is how quickly the NHS takes those medicines up”.

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NICE is the first barrier, says Dr Barker. “The industry accepts the need for an agency like NICE [but] we think that [it has] become unduly focused on a single number, the cost per quality-adjusted life year. We need more judgment and less arithmetic.”

A second barrier is that even when NICE says yes to a medicine, many primary care trusts (PCTs) say no. Dr Barker wants national standards to be defined by NICE and for PCTs to be monitored on their compliance. “If we've gone to the trouble of assessing a treatment as cost-effective then the discretion that the PCTs have to fund it or not is a luxury we can't afford.”

NHS attitudes to innovation are also holding back the UK. “There is a general feeling that innovation is something that other people try and when it's been proven for ten years we'll do it here,” says Dr Barker. “I think there is this longstanding feeling that people should be grateful for any treatment well delivered, and not enough pride in making sure that the right medicine reaches the right patient at the right time. And pride in being the best in the world, not just being good enough, or better than last year.”

He adds that there is a “very significant seismic shift” in the way the industry views the NHS as a customer. It's a recognition of the reality that prescribing decisions are not just down to individual GPs. “We need to get beyond this feeling that the medical representatives are out there pushing particular medicines and that the job of the PCTs is to stop that happening. Companies have recognised that they need to [reorientate] themselves from simply working with the prescribers to working more broadly with the NHS to advance health.”

Richard Barker

Born: October 18, 1948, in London.

Career: Prior to becoming director-general of the ABPI, he was chairman and CEO of Molecular Staging, a US company. Past roles include chief executive of Chiron Diagnostics and general manager of IBM's worldwide healthcare solutions business. He also led McKinsey's European pharmaceuticals and healthcare practice. His academic research was in biological magnetic resonance, at Oxford, Leeds and Munich.

What he says: “We need the NHS to be a much more innovative customer, because you can't really have an innovative industry without an innovative customer.”

Little-known fact: He enjoys Wagner operas.

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