Medicines Regulatory System (Hansard, 4 February 2004)

§ Lord Warner
My Lords, in the United Kingdom human medicines are regulated by the Medicines and Healthcare products Regulatory Agency, in accordance with national and EU laws. The EU legislation has recently been changed to ensure that the system continues to protect public health in an enlarged Community and the Government are working on implementation. A value-for-money audit of the MHRA was conducted recently by the National 677 Audit Office and a Public Accounts Committee report on the agency was published in 2003. There are no plans for further wide-ranging reviews.

§ Lord Clement-Jones
My Lords, I thank the Minister for that very disappointing reply. Only yesterday it was discovered that the MHRA had not had full information about Seroxat from the drug company involved. There are great concerns about past delays preventing SSRIs being available for the treatment of children. There are also grave doubts about the yellow card scheme and about many other aspects concerned with the regulation of claims made about drugs, particularly in relation to Yasmin, the birth control pill, which the Minister may remember. That gives considerable grounds for an independent review. Will the Minister reconsider that?

§ Lord Warner
No, my Lords. An expert working group of the Committee on Safety of Medicines has undertaken a comprehensive independent scientific assessment of the available data on the safety of selective serotonin re-uptake inhibitors, which includes Seroxat. The full conclusions of that risk analysis, coming from the clinical trials in December, were published in public. The MHRA, in dealing with particular issues, has taken an open and above-board approach. The yellow card scheme, also mentioned by the noble Lord, is recognised as one of the best in the world, although to improve it I have asked for a review to be carried out to see whether there can be improved involvement of patients directly with the agency.

§ Lord Hunt of Kings Heath
My Lords, does my noble friend agree that the MHRA has an unrivalled reputation in the world as a robust regulator? Should we not be very cautious before starting to review legislation that might undermine that reputation which has brought so much credit to this country?

§ Lord Warner
My Lords, I am grateful to my noble friend for his remarks. From his own experience he knows how effective the MHRA is and what its standard is in Europe and across the world. The National Audit Office review recognised the international standing of the MHRA in a number of areas, particularly in the way in which it leads the field on the science of medicine safety.

§ Earl Howe
My Lords, what assessment have the Government made of the regulatory cost implications of the EU Clinical Trials Directive on publicly funded clinical trials? Have the Government estimated the impact of the directive on the development of medicines in the future?

§ Lord Warner
My Lords, we have estimated some of those impacts. We have communicated with the research community about them and we are in discussion, as I believe the noble Earl knows, with the research community on the implications of the Clinical Trials Directive for this country. That directive will 678 come into operation from 1 May 2004. When the Government bring forward regulations for that, they will also publish a regulatory impact assessment.

§ Lord Clement-Jones
My Lords, the Minister lauds the National Audit Office report, but does he recall that that the National Audit Office also drew attention to the conflict of interest between the MHRA's role in promoting the interests of the pharmaceutical industry and in protecting the health of the public?

§ Lord Warner
My Lords, I read the NAO report very carefully. My recollection of it is that it found no evidence that the potential—I emphasise the word "potential"—conflict of interest had led to questionable decision-making on the part of the MHRA when the NAO conducted the value-for-money study.