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Department of Health

Vioxx is an issue for everyone here, and the Health Committee asked for a public inquiry into the matter, saying that, when a drug is withdrawn in the way that Vioxx was, there should be a public inquiry. The Government did not agree, and I have to say that I have some sympathy with the Government on that. However, the public should have more information on the way in which the drug was licensed and came into use, so that they can be satisfied that we understand the issues surrounding it. My hon. Friend mentioned half a dozen cases. He will be aware that there is the potential for litigation on this matter either in this country or the United States. Reports in The Lancet have put the number of cases in this country of people who have been affected long-term in relation to taking Vioxx at far higher than half a dozen. Perhaps my hon. Friend the Minister will comment on this when he speaks later in the debate. The lack of transparency in the MHRA and the industry means that health care professionals do not always have all the information that they need to make appropriate prescribing decisions. The report welcomed the introduction of a register for clinical trials, which will allow professionals and the general public to access information about the development of drugs. The Committee’s proposal for maintenance of the register by an entirely independent body was rejected, as was the recommendation that information regarding clinical trials be available at drug launch, so that prescribers could access information during the period when the promotion of a new medicine was at its most concentrated. The Government believe that the publication of such trials within one year of launch is appropriate. The Government’s response reiterates the importance of a close relationship between the Government and the pharmaceutical industry, citing as a reason the need to ensure transparency in the way in which medicines are brought to the public. The response stresses the role of the ministerial industry strategy group—the MISG—in this respect. Importantly, the response agrees that"““there is a need to look at whether there is a safer way of introducing new drugs””," and this is one of the aspects that will be considered by the MISG. I hope that, in doing so, it will consider the issues around Vioxx that my hon. Friend mentioned. Corrective statements will not be issued in every case of a breach of legislation, as was recommended by the Committee. However, the MHRA is considering publishing the correspondence with companies relating to the promotion of medicines. The agency will also publish an annual advertising regulations outcome report. Contrary to the Committee’s recommendation, information received by the MHRA will remain confidential until a licensing decision has been made. However, upcoming legislation will require a public assessment report of a medicine’s licensing history to be published shortly after a licence is granted. The MHRA has undertaken to publish assessment reports for licence renewals and safety update reports. Such safety reports will also be issued more frequently. One of the Committee’s main recommendations was for a large-scale, independent review of the MHRA to be conducted. The suggested governing principles included the agency’s need for independence from the Government and the industry, greater transparency, greater proactiveness in post-marketing surveillance, the prioritisation of new marketing applications, and the inclusion of lay members in policy-making decisions. That recommendation was rejected by the Government, although they stated, on page 18 of their response, that perhaps a four-yearly review of the operations of the MHRA should take place. If that were to happen, the terms of reference would remain to be decided. I remind the House that the terms of reference should consider methodology, timing and other issues. If the Government adopt that approach, as I think they should, it would be useful if there were a parliamentary input into exactly what the terms of reference should be, either on the Floor of the House or at least from the Health Committee. I am sure that members of the Committee would be more than happy to consider the issue. Both the report and the response stressed the importance of research and development for patients and the economy, and the need to maintain levels of investment by drug companies in the United Kingdom. However, the Government agreed with the Committee that there were occasional deficiencies in the design and conduct of clinical trials. Poorly designed trials have significant consequences for patient safety, as is shown by the tragic consequences of widespread prescription of the anti-arthritis drug Vioxx, mentioned by my hon. Friend the Member for Newport, West.