Taking stock of the MHRA

The UK’s top medicines regulator, the chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA), has for many years declared a recreational interest in the stockmarket (and golf) – not to his colleagues, but in a reference book to the great and good, Debrett’s People of Today.

As the linked correspondence tersely details, the MHRA chairman has taken great care to avoid investing in companies linked to the pharmaceutical industry. He considered such measures sufficient to relieve him of any responsibility to inform his colleagues of his interest in the stockmarket and the steps he took to avoid any possible conflicts. This also satisfied his obligations under the relevant government code: "Recreational interests are not required to be disclosed unless the person believed that it could be regarded as influencing his advice".

So what’s the problem? The issues here are not to do with the judgment or probity of the individual concerned, but with institutional standards, perspective, sensitivity, responsiveness and effectiveness. Under present guidelines, half the staff of the MHRA could be playing the stockmarket and, provided they didn’t invest in regulated companies, everyone (officially) should be happy – alarming as that might seem.

The central issue here comes closer to what accountants regard as ‘material’, rather than to codes of practices about possible conflicts of interest. The difference is between what users (prescribers and patients) would make of the situation, rather than the chairman’s colleagues: "In an accounting sense...a matter is material if knowledge of the matter would be likely to influence the user of the financial or other statements under consideration." (Blakemore J, Pain B: Materiality in accounting, ACCA (the Association of Chartered Certified Accountants), May 1998.

The record of the MHRA/CSM in regulating medicines is also relevant. Had the Agency excelled, the chairman’s recreational interest in the stockmarket might hardly raise an eyebrow, but its performance has been exceptionally poor. The MHRA/CSM have disappointed and many people have been badly hurt.

The recent report of the House of Commons Health Committee underlines this. The Committee referred to "serious weaknesses in the MHRA", found that it "seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings", and identified "some complacency and a lack of requisite competency". On these and related grounds, the Health Committee (paragraph 376) called for an independent review of the Agency – a recommendation that will be fiercely resisted, of course.

The MHRA has been busily preparing its defence and the Department of Health is expected to publish a definitive response to the Health Committee report very soon. One of the main issues the Department will address again has some bearing on the MHRA chairman’s recreational interest in the stockmarket. This is the Committee’s recommendation that responsibility for representing the interests of the pharmaceutical industry should be moved to the Department of Trade and Industry "to enable the Department of Health to concentrate solely on medicines regulation and the promotion of health". The same surely applies to the MHRA:

"During this long inquiry we have become concerned that there is a fundamental weakness in the Government’s dealings with the pharmaceutical industry: that is the Department of Health’s dual role in promoting health and acting as ‘sponsor’ of the industry. These roles have not proved compatible. Health and trade priorities are not always identical and their combination leads to a lack of clarity of focus and commitment to health outcomes …" (Paragraph 392).


Charles Medawar
14 June 2005

Declaration of interest: The author was engaged as one of four specialist advisers to the House of Commons Health Committee, on its recent enquiry into "The Influence of the Pharmaceutical Industry". He has previously made clear his view that the credibility of the MHRA would be enhanced by the departure of its chairman.