Science and Technology CommitteeJoint written evidence submitted Andrew Russell and John Hughes, Patient & Public Member, UKCRC Board

Introductory Comment

We are the two Patient & Public Board members of the UK Clinical Research Collaboration, a partnership chaired by the Chief Medical Officer for England, which aims to improve the clinical research environment. The views expressed here are personal and are not necessarily shared by fellow Board members of the UKCRC. You will be aware that the Collaboration includes representatives from government, principal research and academic bodies, regulatory organizations, key charities and from industry, including the pharmaceutical industry.

The Scope of our Comments

We focus on the need for robust and independent regulation of the development process for new pharmaceutical products, currently by the Medicines & Health Products Regulatory Agency (MHRA), which is consulting on its draft Corporate Plan 2013–18.

The tone of the MHRA Corporate Plan is very much one of co-operation and compromise with the pharma industry. It places emphasis on the economic benefits of encouraging the industry to maintain a strong base in the UK and to carry out clinical trials here. Whilst we acknowledge the importance of this industry to the UK economy, we think there should be greater emphasis on regulation for the safety and benefit of the public, patient and taxpayer, in this Corporate Plan.

The need for Full Publication of Clinical Trial Results

The recent publication “Bad Pharma” by Dr Ben Goldacre makes a strong case that companies have failed routinely to publish trial results that have proved unfavourable to their products in development. This distorts meta-analyses in favour of the product, minimising evidence of side-effects and exaggerating health benefits. This serious charge signals a need for a strong and proactive regulator with an independent mind-set. Whilst the Medicines For Human Use (Clinical Trials) Regulations 2004 make registration and reporting mandatory, we question whether this requirement is always met by companies, and whether the MHRA sees it as its key role to enforce this aspect of the law.

The Case for Robust Regulation

Recent experience has shown that it is not in the best interests of an industry, nor of the public, for a regulator to be too close to that industry. The failure of the Financial Services Authority to guard against banks’ malpractices has proved disastrous for the whole UK population and to banks themselves. We believe that there is a lesson to be learnt in relation to pharmaceuticals, particularly in the light of the current lack of transparency in research findings, and the huge cost to the taxpayer of prescription drugs. We think that the MHRA, if it is to remain the principal regulator, should be less shy of asserting the need for strong regulation in its Plan.

The Clinical Practice Research Database (CRPD)

The CPRD, whilst a very valuable additional means of enhancing the safety and effectiveness of drugs in use, should not be relied upon as the primary protection for patients. Clinical trials, fully registered and reported, should remain the principal tool in the MHRA’s vital gatekeeper role.

Customers, Stakeholders and Conflicting Aims

Inevitably there is a potential degree of conflict between the stated function of the MHRA to promote and support innovation beneficial to prosperity by creating conditions favourable to the pharma industry, and its role as the key regulator of the industry’s products.

Whilst the term “customer” is not defined in the MHRA’s draft Plan, it appears to refer to bodies such as companies applying for products to be licensed. Satisfying them through a “faster, more efficient service” (p18) is desirable, and ensuring the MHRA’s financial viability through charges is important, but the requirements of the public, the most important stakeholder, should constitute the core aim of the agency.

The Plan’s approach to this is “proportionate regulation”. This phrase lacks clarity, and in view of the objective to reduce regulation (p17), we question whether this is a sufficiently transparent approach bearing in mind the high level of accountability essential for patient safety and proper use of taxpayers’ money. We would welcome more transparent criteria indicating the kind of risks which will merit regulatory attention.

Reference (p16) to reducing work which is not financially profitable to the agency, and to the increased pursuit of commercial opportunities, cause us concern. This indicates that the MHRA will see itself primarily as a business, rather than as a regulator acting for the public. At the extreme, a regulatory agency which prioritizes its own financial survival and success is unlikely to remain fit for purpose. Pharmaceuticals in development, under registered clinical trials, should be monitored to ensure that all trial results are made public in summary form.

The Risks of “Regulatory Capture” and “Revolving Door”

Whilst it is important for the regulatory authority to maintain clear communication with commercial companies and their representative bodies, we believe they should be wary of assuming that all the authority’s interests are held in common with companies.

In order to discourage personal conflicts of interest we suggest that contractual measures, if not already in place, be introduced to prevent senior MHRA staff accepting paid positions within the pharma or medical devices industries for a period of three years after the end of their employment in the MHRA.

Concluding Comment

We welcome the opportunity to make comment on this inquiry and hope that these views will be taken into consideration by the Commons Science & Technology Committee in determining its conclusions and advice.

February 2013

Prepared 16th September 2013