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Thanks to Butterworths.co.ukImpact of Clinical Trials DirectiveThe EU�s Clinical Trials Directive, due to be introduced in the UK next year, requires legal sponsorship for trials and introduces `onerous' reporting and legal obligations. Cameron Firth, lawyer with SJ Berwin�s Pharmaceuticals and Biotechnology group, talks to Greg Bousfield about its impact� Academic and non-commercial clinical researchers in the UK say that the EU�s Clinical Trials Directive (2001/20/EC) will burden them with onerous reporting standards and legal obligations, and may deter important research. The current Medicines Act 1968 requires that anyone who wishes to supply a medicinal product for a clinical trial, or to procure the supply of such product, must obtain a clinical trial certificate (CTC). The Act, however, provides for various exemptions and most trials in the UK are conducted under exemption schemes, except those that pose an unusually difficult risk to benefit decision. Such exemptions will be ended by the Directive. The Directive will introduce good administrative standards and encourage greater discipline in the UK, which may well have an up side for non-commercial researchers, according to Cameron Firth, lawyer with SJ Berwin�s Pharmaceuticals and Biotechnology group. "If some of the trials carried out by commercial researchers do not show the results that they want, they are not published and the trial will be done in some other way. I think one of the aims of the Directive is to help some charities be sure they are not funding research which has already been done." However, elsewhere in the process, expanded reporting requirements may impede research, complain non-commercial researchers. For example, the removal of exemptions for trials � particularly �phase one� of trials where testing is aimed at eliciting side effects and dose range of drugs before testing for more specific effects on the illness being treated � will mean that �all adverse effects� must now be reported to trial sponsors as well as an annual report covering �all serious adverse reactions�. These requirements may mean, for example, that "every case of nausea, which cancer treatment always causes," must be reported, in the words of one cancer researcher. A second major issue raised by charities and non-commercial researchers is that the Directive requires appointment of a �legal sponsor� for trials. "I agree that this imposes new conditions on the directors of charities, the Directive makes no distinction between commercial and non-commercial in this respect," Firth says. "Legal sponsorship means civil and criminal liability will apply. The UK may include some criminal penalties and it could also have an influence on things like insurance costs," he says. The Directive has its origins in concerns about patient rights, an exaggerated reaction to a number of medical scandals in the 1990s, say some researchers. The UK office of the European Agency for the Evaluation of Medical Products� (EMEA) promotes the Directive as a breakthrough for the patients who are the test subjects or research trials because researchers will in future need to obtain proper informed consent from them. This will include patients right to withdraw from trials at any point, "which is not always explained", the Agency contends. The Directive also includes detailed procedures for trial subjects who are not in a position to give informed consent. At the moment, under the Medicines Act 1968, studies on healthy volunteers are exempt from CTC provisions because the definition of a clinical trial does not include studies on subjects where there is no evidence that the medicinal product will have effects which may be beneficial to the subject. Under the directive, these studies would be considered to be clinical trials and would require an authorisation. "There were quite wide exemptions if you were testing on healthy human volunteers but now the same level of consent would be required for that as for testing on people who are ill," Firth comments. The Directive (�relating to implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use�) will be introduced into UK law as a Regulation next year, amending the Medicines Act 1968. Currently, it is in the form of a consultation letter �on the medicines for human use (clinical trials) Regulations 2003�. (15/10/03) If you have any comments about this or any other news item or feature, please respond via e-mail to: [email protected] Legislative annotations in other services:- |