Big Pharma companies have been lobbying UK ministers in an attempt to subvert the independent appraisal process and get their expensive new medicines approved for large-scale use in the NHS, the Guardian has revealed.
Over the eight months from October to May this year, senior executives from 10 drug companies met ministers to press for favourable decisions on their products. The executives were highly critical of the National Institute for Clinical Excellence (NICE), an independent expert body set up to decide which drugs are cost-effective for use in the NHS.
Documents obtained by the Guardian under Freedom of Information legislation reveal that:
· The world's biggest drug company, Pfizer, warned ministers that it could take its business elsewhere. "Pfizer ... noted that there is complacency in some quarters of Whitehall regarding their continued investment in the UK," the minutes of the meeting record.
Ministers later agreed to a special meeting where six companies could lobby for their drugs for Alzheimer's disease.
· Two companies lobbied ministers for wider access by patients to their drugs, both of which were later turned down by NICE on the grounds that they were not effective enough and too expensive.
The pharmaceutical industry is a major contributor to the UK economy. Its total investment in research and development was more than £3.4bn in 2004, which, a Whitehall briefing note points out, "represents around a quarter of the UK's total manufacturing industry expenditure".
Decisions by NICE, set up seven years ago, are crucial for the companies. It decides whether a drug should be universally available to patients in the NHS. Chaired by Prof Sir Michael Rawlings, NICE draws on scientific experts and consults doctors, patients, drug companies and the Department of Health. The government invariably accepts its final recommendations. Although ministers say they cannot influence NICE, the documents reveal a constant stream of high-level visitors from drug companies.
Manufacturers, led by Pfizer, have been complaining to ministers about Nice's position on their controversial Alzheimer's drugs. Originally NICE decided to allow them, then it reversed its position, saying they should be used only for a minority of patients with moderate disease.
At a meeting in October with the minister, Pfizer executives made it clear they "were unhappy with the NICE decision ... and thought their processes were flawed".
They requested a special meeting with ministers where all the companies making Alzheimer's drugs could put their case.
The documents prepared by civil servants for the Pfizer meeting outline the wealth and scale of the US company, which in 2004 had revenue of $52.5bn (£28bn) and a net income of over $11bn.
But, Pfizer executives warn the minister, it could always take its business elsewhere. "Pfizer ... noted that there is complacency in some quarters of Whitehall regarding their continued investment in the UK," the minutes record. "Pfizer asked for more public support from the government for a robust pharmaceutical industry in the UK and more consultation/dialogue with the government."
The subsequent meeting with all the companies took place in December. The minister, Jane Kennedy, was confronted by eight managing directors, vice-presidents and senior executives from six drug companies. The executives lobbied hard for the NICE ruling to be overturned by the government.