The National Institute for Health and Care Excellence (NICE), an organization given the responsibility of setting the standards for high quality healthcare in the UK, has come under fire for being too conservative and resource-intensive. In a recent opinion piece in The Times of London, business editor Ian King cautioned that the pharmaceutical industry could abandon drug development in the UK if NICE doesn’t ease its practice of restricting access to drugs based on expense or side effects.
Quoting Jonathan Emms, Pfizer UK managing director, King said that NICE turned down 40 percent of new medicines last year, advising the National Health Service (NHS) that it cannot use them or restricting their use. Enns pointed out that “19 out of 20 attempts fail before they reach the patient – even before any NICE review,” and added, “NICE is denying patients access to some of the best treatments available today.”
Drug Developers and the Cost of Bringing a Drug to Market
NICE CEO Andrew Dillon said that his agency is chartered with providing the NHS the best medicines available at affordable prices. He added, “NICE is, quite properly, scrutinized closely on its decisions and the methods we use to arrive at them. We have changed and improved over the decade and more that we have been advising the NHS. We are not perfect, but we are respected throughout the world for our quality of work.”
Dillon added, “Companies are entitled to expect a return on their investment, but health services have to be confident that the extra benefit to patients justifies the price. It mostly does so, though sometimes at a stretch. If we are not sure, we have to say so, in the interests of all those of us who expect the NHS to apply its resources equitably across all of the demands we make of it.” Using the widely-quoted estimate that it now costs 1.2 billion pounds (approximately $1.9 billion) to bring a new drug to market, NICE CEO Andrew Dillon countered, “if it really does cost 1.2 billion pounds to develop a new drug, the question the pharmaceutical industry must be able to answer is this: Are you absolutely confident that it needs to.” Dillon contends that the “research and clinical environment (in the UK) holds too many advantages for companies” to abandon the country.
Are the UK Market Advantages Enough to Keep Drug Developers Interested?
Stephen Whitehead, CEO of ABPI, the industry body negotiating on behalf of the branded pharmaceutical industry, warns that this “advantage” in biopharmaceutical R&D is “fragile and under constant challenge,” citing that UK’s share of global clinical trials fell from 6% to 1.4% in just 10 years. He says, “The consequences of this is the closure of six research sites in the UK over the past six years.”
Whitehead concluded, “The biopharmaceutical industry has proven that it delivers solutions to healthcare challenges but the conservative and resource-intensive approach taken by NICE adds significant cost to the development of medicines. Through its decisions, NICE has a role in repeatedly denying patients in the UK access to medicines that are routinely available in other countries.”