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Department of Health

Yes, it does. It should concern us all, and it should concern the pharmaceutical industry more than any of us, because it is directly responsible for ensuring that we have as much information as is necessary. The Committee recommended closer working between the MHRA and the industry to ensure that trial design benefits patients. No changes or additional work by the MHRA to improve the design of trials to reflect clinical improvements is suggested in the report, which I think is a shame. Guidance on"““the type of clinical trial required for marketing authorisation””" is said to be already in place, but that does not apply to guidance on the types of trial likely to prove therapeutic gain. That is one of the issues raised by the hon. Member for Windsor (Adam Afriyie). No additional funding for NICE to address the issue has been agreed, and the report does not mention changes in the way in which research ethics committees review and approve clinical trials. I think that that is wrong. As I have said, the issues should concern us all. On the few occasions that such matters do come into the public domain and drugs are removed from the market, we should establish why that has happened. When drugs come on to the market, we should do our best to ensure that that is dealt with as safely as possible. The report highlights the problem of ““me-too”” drugs—medicines that add little to the clinical effects of chemically similar drugs that are already on the market. The Government recognise the problem, and the response states that additional work by the National Prescribing Centre may be considered to address it. The Government agree with the Committee that impediments to generic drugs entering the market should be prevented, and will consider an initiative to investigate the problem.