On 17th July, in Brussels, the European Commission published their "Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (COM(2012) 369)", with the aim of boosting clinical research within the European Union (EU) by simplifying the rules for conducting clinical trials. Clinical trials, which are the process by which novel pharmacological compounds/treatments gain licences, are conducted in humans and initially give patients access to new medicines which otherwise would not be available to them. The Commission notes that clinical research within the EU, which currently is worth in excess of €20 million per year, makes a significant contribution to the growth policy of the Europe 2020 agenda. Clinical trials are vital to the development of new medicines and the data obtained is used by pharmaceutical companies when they apply for marketing authorisations, however, they also help improve and compare the use of already authorised medicines. In this instance the data is published widely in journals enabling clinicians to make informed decisions about which drugs to prescribe to which patient depending on individual circumstances.

Currently within the EU and the European Economic Area (EEA), "4,400 clinical trials are applied for every year. Approximately 60 % of clinical trials are sponsored by the pharmaceutical industry and 40% by other stakeholders, such as academics. Approximately 24% of all clinical trials applied for in the EU are multinational clinical trials, i.e. clinical trials intended to be performed in at least two Member States. While this seems a relatively small proportion, these 24 % clinical trials involve approximately 67% of all subjects enrolled in a clinical trial. This means that, on average, a clinical trial with more than 40 subjects is conducted in more than one Member State. Mono-national clinical trials are limited to small studies with low recruitment targets. Directive 2001/20/EC has brought about important improvements in the safety and ethical soundness of clinical trials in the EU and in the reliability of clinical trials data." (COM(2012) 369)

However, within the area of pharmaceutics, the EU legislation resulting from the Clinical Trials Directive has been criticised the most, by all stakeholders (patients, industry, and academic research), because of its disproportionate regulatory requirements. Primarily due to the high costs incurred, due to the implementation of the Clinical Trials Directive and the lack of harmonisation of the applicable rules necessary for multinational clinical trials. "This has contributed to a significant decline of clinical trials in the EU. Between 2007 and 2011 the number of clinical trials conducted in the EU fell by 25%. The number of clinical trials applied for in 2007 (5000) dropped to 3800 by 2011." (MEMO/12/566)

At a recent public consultation an academic researcher from the UK explained some of the problems being encountered on the ground:

Commercial Trials: Owing to the increased regulation the process of submitting a research protocol, for acceptance by an ethics committee, was becoming so protracted that by the time the requisite authorisation to recruit patients was obtained, countries such as China and India had already recruited the maximum number of patients required by the pharmaceutical company.

Academic Research: In the past many doctors studying for their MD conducted research on a small scale, through the hospital where they worked and in conjunction with the local University (which would process any grants awarded for financial support). However, in some instances the Clinical Trials Directive had made this virtually impossible.

It is for this reason that "the Commission is proposing new legislation to cut red-tape and bring patient-oriented research back to Europe. The objective is to restore European Union’s competitiveness in clinical research and the development of new and innovative treatments and medicines for the ultimate benefit of patients." (MEMO/12/566) The proposed Regulation will replace the 'Clinical Trials Directive' (2001/20/EC), which although has ensured a high level of patient safety its divergent transposition and application has led to an unfavourable regulatory framework for clinical research, with new legislation which will ensure that the rules for conducting clinical trials are identical throughout the EU. At the press release John Dalli, European Commissioner for Health and Consumer Policy, said: "Patients in Europe should have access to the most innovative clinical research. Clinical trials are crucial for developing new medicines and improving existing treatments. This is why today's proposal significantly facilitates the management of clinical trials, while maintaining the highest standards of patient safety and the robustness and reliability of trial data. 800 million euros per year could be saved in regulatory costs and boost research and development in the EU, thus contributing to economic growth." (IP/12/795)

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