Background

In the European Union ("EU") the conduct of clinical trials is tightly regulated. The rules for the conduct of clinical trials are currently contained in Directive 2001/20/EC (the "Clinical Trials Directive").

Since the Clinical Trials Directive was introduced in 2004, it has been widely criticised by patients, researchers and the pharmaceutical industry. The common opinion of such stakeholders is that the Clinical Trials Directive has reduced the attractiveness of the EU for conducting clinical trials. Concerns are that the Clinical Trials Directive has brought in unnecessary administrative and regulatory burdens and lacks clarity in certain aspects. Further, the Clinical Trials Directive has not been implemented uniformly by all Member States of the EU. Such reduced harmonisation has resulted in delays and increased costs for researchers conducting multinational trials.

Since the Clinical Trials Directive was introduced the costs of conducting a trial, the administrative burdens and the lead time in launching a trial have all increased.

Proposed Regulation

The European Commission now proposes to simplify the rules for the conduct of clinical trials and to harmonise them across the EU to ensure uniformity. Consequently, on 17 July 2012 the European Commission adopted a proposal for a European Regulation which will replace the Clinical Trials Directive and ensure that rules for conducting clinical trials are identical across the EU.

Issues addressed by the proposed European Regulation

  • Authorisation process
  • Reporting procedure
  • Co-sponsorship
  • "Low-intervention Clinical Trials"
  • Compensation for damages

Issues addressed by the proposed Regulation include:

  • Authorisation process: The Regulation will simplify and streamline the authorisation of clinical trials in the EU. It is proposed that there is to be a harmonised authorisation dossier and that all applications for clinical trials to be conducted in the EU (both single and multi-state) will be submitted through a single EU portal. With respect to multi-state trials, the submission will be assessed by all EU Member States involved and a single decision will be given.
  • Reporting procedure: There will be a more streamlined procedure. This will include reporting of serious adverse reactions being made direct to the EudraVilgilance database, the option to identify certain adverse events which do not need to be reported by the investigator to the sponsor, and simplified submission of the annual safety report by the sponsor (with an exemption for certain authorised investigational medicinal products).
  • Co-sponsorship: The Regulation will allow for co-sponsorship with the co-sponsors being able to divide responsibility for the clinical trial between them.
  • "Low-intervention clinical trials": The Regulation will introduce the concept of "lowintervention clinical trials", which is a clinical trial where the investigational medicinal product is authorised and used in accordance with its marketing authorisation and the additional risk posed by the trial compared to normal clinical practice is no more than minimal. Such trials will be authorised within shorter timeframes and subject to fewer burdensome regulatory requirements.
  • Compensation for damages: The Clinical Trials Directive introduced an 'obligatory insurance/indemnity' which has substantially increased the costs and administrative burden of conducting clinical trials. The proposed Regulation recognises that clinical trials do not always pose additional risk to the subjects over normal clinical treatment. Therefore in cases where there is no additional risk, or such risk is negligible, no specific damage compensation (insurance or indemnity) will be required. With respect to trials where there is additional risk and the sponsor is obliged to ensure compensation, the proposed Regulation puts EU Member States under an obligation to set up a national indemnification mechanism on a not-for-profit basis. This should be of particular value to noncommercial sponsors, for whom it has been difficult to obtain compensation coverage.

It is proposed that the provisions of the Clinical Trials Directive which are to be retained are to be clarified as needed, and where necessary the proposed Regulation will bring together the rules contained in the Good Clinical Practice Directive (Directive 2005/28/EC) and associated Commission guidelines. Ultimately, it is hoped that the proposed Regulation will restore the EU's competitiveness in clinical research.

Next steps

The proposal for the Regulation has been submitted to the Council and the European Parliament for consideration and adoption. It is expected that the new Regulation will come into effect in 2016.

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