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Clinical pharmacologist Michael Rawlins has headed up one of the United Kingdom’s most important medical institutions since it was founded in 1999. At the end of March, he is leaving the National Institute for Health and Clinical Excellence (NICE), which assesses which medicines the National Health Service in England and Wales can afford and produces guidelines for physicians. In the week following the UK government announcement that NICE will have a key role in a new scheme to pay pharmaceutical companies what medicines are determined to be worth — known as value-based pricing — he talked to Nature about the institute and his plans for the future.

You’ve been chairman of NICE for 14 years — did you expect the job to last that long?

I didn’t have any idea. I didn’t think about it. One of my close friends said that I was making the most serious mistake of my professional career. Five years later, he said 'get out now while you’re ahead'. I just thought, 'get it going and see what happens'.

What has been NICE’s greatest achievement?

Some people think survival. When we first started there were two complaints. One was the idea that looking at cost-effectiveness was immoral. It is now accepted by pretty well everybody that we have finite resources. We have to make the best use of the money that we have, the resources we have, and we therefore have to take cost into account.

The second complaint was the clinical guidelines, where I had doctors saying to me: ‘I’ve been practising medicine for 40 years; I don’t need you to tell me how to treat X, Y or Z.’ And that’s changed too. People realize that the medical literature is so massive that — as [former British Medical Journal editor] Richard Smith once pointed out — the average doctor would need to read between 18 and 20 peer-reviewed articles every day of the week to keep up to date. And none of us can do it. So guidelines bring together the guidelines on a particular area.

How has NICE’s relationship with the pharmaceutical industry changed?

In the early days it was tricky. The industry rather resented the fact we were looking at cost-effectiveness. The atmosphere has changed. All countries across the world are having to take cost into account, even in the United States. Just before JP Garnier left as chief executive of GlaxoSmithKline [headquartered in London], he told me, 'you’re not what we wanted but we have to recognize that all countries are going to be doing what you’re doing and I hope they’re as fair as you are'. That’s probably as good a compliment as I could ever have from the pharmaceutical industry.

How will NICE have to evolve to tackle value-based pricing?

I regard it as an evolutionary approach, not a revolutionary approach. Broadly speaking, there are three components to it. One is how you estimate the benefits, and everyone agrees we’re going to keep the quality-adjusted life year, the QALY [a value of 1 QALY represents a year lived in perfect health, 0 represents death].

The second component is the threshold. We normally say anything [such as a drug costing] less than £20,000 (US$30,000) per QALY should be a yes unless there are other factors. Above £30,000, there should be increasing reluctance to say yes except under special circumstances. The third component, which is I think the trickiest one, is what the economists call the economic perspective. We look at the costs and savings to the health service. You could take into account the costs for carers and families, or implications for employment. The government has indicated that it does want a more societal perspective. How far it will go, I don’t know — that’s a political decision, not a scientific one.

How does personalized medicine change the picture?

In some senses, personalized medicine is not new. For years we’ve been trying to make sure that we give the right antibiotic in relation to the sensitivity of the organisms, and we’ve been adjusting doses on the basis of renal function for drugs that are excreted in the urine.

In my ideal world, we will all have an electronic health record, with a real-time decision-support mechanism built in so it’ll tell your health-care provider what to do next — when should he or she be measuring your blood pressure, when was the last time you had a cholesterol test done — all that will be flagged up. And you’ll have your whole genome scan inside it too, so instead of having to do a genetic test for general things, it’ll all be there.

What are the biggest challenges for medical research?

It has become incredibly difficult to do clinical research. And there are three problems. One is the European Clinical Trials Directive, which is being replaced with a regulation that is actually a considerable improvement. The second is ethics arrangements [for giving the go-ahead to clinical trials]. The UK Health Research Authority is making great steps in bringing all the ethical approvals together. That’s good.

The third problem, which causes the greatest frustrations to everybody, is the research governance arrangements. I met a woman who was doing a [clinical] trial in 62 different hospitals and she’d had 62 CRB checks [Criminal Records Bureau checks for past criminal convictions]. It’s a nightmare. What is needed is a single sign-off, ideally a national sign-off.

What are you going to do next?

I’m president of the UK Royal Society of Medicine, I’m chairman of UK BioBank, and I’m going to become chairman of the Eastern Academic Health Sciences Network [a collection of researchers in universities, hospitals and other medical facilities in the east of England]. And doing good things there.