Glaxo Wellcome has called for a reappraisal of how the National Institute for Clinical Excellence works and of its procedures.
It has done this because, it says, the institute's guidance to the National Health Service on Relenza contradicts an assurance given by the Government earlier this year.
The consultation document on the institute "Faster access to modern treatments" said: "Transitional arrangements will be needed over the next few years, in particular for medicines, since any clinical research needed to satisfy the licensing requirements will already be underway. Under these circumstances it would be unreasonable to require information which was not obtainable from the research already underway, since that would imply new research and might delay, perhaps by several years, the launch of the product. We believe that this would be unrealistic for many companies, especially those with international markets."
Glaxo Wellcome has also pointed out that Relenza has not been banned on the National Health Service.
"The advice of the National Institute for Clinical Excellence is only guidance and does not override doctors' professional responsibility to make appropriate decisions in the interests of their patients," the company said on the same day that the NICE announced its decision that doctors should not prescribe Relenza.
The company pointed out that Relenza had been approved by the Medicines Control Agency as a safe and effective influenza treatment.
Glaxo Wellcome criticised the NICE for saying that the company should gather more data on the cost of Relenza to the NHS. The company said that these data could only be collected if Relenza were actually available in clinical practice and that it had repeatedly made this point to the Department of Health and the NICE.
"Having proved to the satisfaction of regulators world-wide that Relenza is safe and effective, we are now being asked in the UK for additional data which it is impossible to collect without the product being available by NHS prescription," Sir Richard Sykes (chairman, Glaxo Wellcome) said.