New European Regulations Pose Serious Threat to Life Saving Clinical Trials

Draconian new European regulations are likely to derail life saving clinical trial work in all areas of medicine throughout Britain. The new regulations, first conceived by the EU two years ago, were intended to harmonise and improve the quality and safety of clinical trials throughout Europe. Instead they threaten to bring about a collapse of the significant lead that Britain enjoys in this important area of research and put lives at stake.

Particularly badly hit will be clinical trials in children that are almost wholly dependent on charitable or public funding. Unless something is done to take into account in the needs of charities, academics and institutions whose excellent work has led to innovative new treatments, then the likelihood is that this work will not continue" commented Dr David Flavell, Honorary Scientific Director of the childrens leukaemia research charity Leukaemia Busters, the Southampton charity pioneering new treatments for children with currently incurable forms of leukaemia. The problem with the new EU Directive is that it is based on the model developed by the pharmaceutical industry and was developed in consultation with that industry without any invited input from the non-commercial sector. Unlike under the old British system the new regulations will make absolutely no distinction between clinical trials run by multinational pharmaceutical companies and those run by non-profit making organisations such as charities & the NHS".

Under the old system that will be thrown out of the window on 1st May 2004, small non-profit making clinical trials run by individuals and organisations whose pure aim is to discover treatments that would be beneficial for patients were exempted from many of the rules and regulations that were applied to the pharmaceutical industry. Dr David Flavell commented This system worked very well, was equally safe for patients and allowed studies to proceed at a cost that was affordable." Dr Flavell went on to say A solution to the current crisis would be for the MHRA to incorporate a similar exemption for the non-commercial sector into the new legislation so that they can continue with their good work for the benefit of patients. Without such an exemption its entirely possible that lives will be lost in the future"

Many of the trials undertaken by charities and non-profit making institutions are for patients with diseases which the pharmaceutical industry has little interest in because of the relatively small numbers and subsequent lack of profitability. One such example is childhood leukaemia. If the non-commercial sector is no longer able to conduct trials for these patients then they will probably never get done at all and new improved treatments will likely never be developed in Britain at least.

While we all welcome regulations that improve quality and safety for patients the vast majority in the medical community believe that these new regulations will not substantially improve either of these for patients participating in their trials. Instead we will see a spiralling increase in bureaucracy and cost of clinical trials that are conducted by the non-profit making sector (including charities, NHS hospitals, medical schools and universities). The end result will be that non-commercial clinical trial work that has in the past made significant contributions will grind to a halt. Britain has developed a very high reputation over the decades in this very important area of research and now stands to lose this if the draft regulations are implemented as they stand.

The Medicines and Healthcare Regulatory Authority (MHRA), the government agency responsible to the Department of Health has been charged with implementing the new EU regulations in the UK. In a recent consultation exercise undertaken by the MHRA, the vast majority of the 147 organisations that responded to the agencys call for comments on the proposed new regulations expressed their serious concerns about the impact that these will have on clinical studies beyond May 2004. Despite this & the serious consequences that the new legislation is likely to have there is generally a poor awareness of this, not just amongst the general public but also amongst members of the medical community. There has also been scant coverage of this important issue in the media.

We are now in the fifty ninth minute of the eleventh hour before the new legislation is put before parliament in October" said Dr Flavell, there is still time to have an influence and win concessions for the publicly funded non-profit making sector before its too late". He went on to say, If we dont win on this then the effects of developing future healthcare in Britain will be incalculable. One cant help thinking that our excellence in academic clinical studies in Britain might go the same way that our fishing industry went twenty years ago as yet another casualty of EU issued Directives. We must remember that in this instance that its not just a few fish at stake but the lives of future patients in the UK."

For more information and to join in the campaign, log on to the Leukaemia Busters Website (www.leukaemiabusters.org.uk) or contact Nigel Impey on 023 8063 6607, or write to The Leukaemia Busters Clinical Trials Campaign, Leukaemia Busters, c/o Southampton General Hospital, Southampton, SO16 6YD.

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Notes for Media

·         Leukaemia Busters is the UK's children's leukaemia research charity, based in Southampton. Its mission is to conduct research into and develop new, improved and safer treatments for leukaemia and related conditions.

·         Leukaemia Busters' Cure for ALL fund is used to develop new antibody-based drugs for children with currently incurable forms of leukaemia. Clinical trials with two drugs developed in the past with Leukaemia Busters funding are now underway in 13 cancer centres around Britain.

·         Leukaemia Busters is a registered charity (1010957) that relies on public support. Donations to the Cure for ALL campaign can be made on-line by visiting Leukaemia Busters website www.leukaemiabusters.org.uk or by post to Leukaemia Busters, c/o Southampton General Hospital, Southampton SO16 6YD.

For further information contact:

Nigel Impey, Leukaemia Busters Fundraising Manager

E-mail: nigeli@leukaemiabusters.org.uk Tel: 023 8063 6607 Fax: 023 8063 6609