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The Law firm representing the two most seriously affected victims of the Northwick Park drugs trial, today condemned the report of the regulatory body investigating the aborted clinical trial as "totally inadequate". She called for an independent Inquiry into the conduct of the trial and said that she would be making her concerns about the MHRA known to the Secretary of State for Health. She said she would also be notifying the Parliamentary Select Committee on Health whose report published exactly a year today found "serious weaknesses" in the MHRA.

"The MHRA's report gives no detailed information about the pre-clinical trials, about which there has been conflicting information since the trial was suspended", said the spokesperson. "How long did it last, what animals were involved, what were the effects, and had these trials been completed? My clients and the general public are entitled to answers to these questions"

"The Lancet has already condemned the drugs companies for not releasing this information. This omission has now been compounded by a regulatory authority which is supposed to be acting in the public interest and has manifestly failed to do so".

"We note with interest the conclusions of last year's Health Select Committee report on the influence of the Pharmaceutical Industry. It found a lack of transparency in the MHRA and complained that there was no public access to data. It also concluded that there was a "major failing in the regulatory system" and drew attention to the fact that the MHRA is "entirely funded by fees from those it regulates".

"The concerns of the Select Committee seem to have been confirmed by the MHRA's investigations. I now have little faith in the MHRA's ability to seek, obtain or make public detailed and relevant information about the clinical history of this trial or the manner in which it was conducted. I believe that an independent Inquiry is now essential, and I will be making my views known to the Secretary of State and to the Chair of the Health Select Committee".

Ends.

Some relevant extract from Select Committee report:

362. Our inquiry revealed major failing in the regulatory system. The organisation, process and techniques of the MHRA are focussed on bringing drugs to market fast. The stated rationale, that patients benefit from new drugs, is insufficiently qualified by considerations of relative merit or value, or therapeutic need. We have concerns about the licensing process, including the evaluation of clinical trials; the control of marketing; staffing levels, particularly in relation to post-marketing evaluation; the withdrawal of drugs; the Yellow Card system; and licensing related to generics.

363. The process by which drugs are licensed is far from transparent. There is no public access to the data presented by the pharmaceutical companies nor to the assessments undertaken by the MHRA. There is not enough involvement of patients, the public and the wider scientific community, and the Agency does not listen or communicate well. After years of intense secrecy surrounding UK drug regulation, we welcome the MHRA's commitment to improve external communications, and to give patients a greater voice, but we are not convinced that these changes will be sufficient to counter the current inadequate state of affairs. We recommend that the MHRA publishes, in some form of useable database, the material it receives from drug companies and the assessments it sends to advisory bodies at the time it sends them. We welcome the MHRA's plans to include lay members on every MHRA advisory committee, and recommend that these members receive sufficient training and support to allow them to fully contribute to decision making.

375. The MHRA, like many regulatory organisations, is entirely funded by fees from those it regulates. However, unlike many regulators, it competes with other European agencies for fee income. This situation has led to concerns that it may lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies. No evidence was submitted with proposals for a better system for funding the MHRA, but it is important to be aware of the dangers of the present arrangements. These dangers make our other recommendations for improving the regulatory system all the more important.

376. During this long inquiry we became aware of serious weaknesses in the MHRA. Worryingly, in both its written and oral evidence the Agency seemed oblivious to the critical views of outsiders and unable to accept that it had any obvious shortcomings, except those that could be remedied by more transparency. The Agency's attitude to its public health responsibilities suggested some complacency and a lack of requisite competency, reducing our confidence in its ability to undertake the reforms needed to earn and deserve public trust. Nor did we conclude that the MHRA provides the discipline and leadership that this powerful industry needs. We recommend that there be an independent review of the MHRA. The earlier review by the National Audit Office was designed expressly to assess the public expenditure aspects of the work of the agency; a more wide-reaching and in-depth review needs to be carried out to determine whether the processes now used for decision-making are adequate and reflect patients' health needs and society's expectations. The following principles should govern the
review:

The need for greater independence from Government The need for greater independence from the pharmaceutical industry The need for policies of greater transparency and accountability in light of recent freedom of information legislation The effectiveness of the post-licensing department and the need for the MHRA to become pro-active rather than re-active Scrutiny of the regulatory standards underpinning clinical and non-clinical new drug review The reporting and evaluation of adverse drug reactions The prioritisation of new marketing applications Inclusion of the public in policy-making and implementation

377. Major changes in the functioning of the MHRA after the review has been conducted and its findings implemented should enable it to make the improvements that we have recommended in this report.

Notes to editor

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