The current review of the European Union’s much-maligned Clinical Trials Directive could result in the partial replacement of Directive 2001/20/EC with a new Regulation.

After receiving more than 100 responses to the public consultation on the Directive it launched last October, the European Commission has published a ‘roadmap’ setting out the options for a Legislative proposal on a Regulation/Directive amending the Clinical Trials Directive 2001/20/EC. This initiative is expected to be adopted by October 2011.

The document released by the Commission’s health directorate, DG SANCO, describes Directive 2001/20/EC as “arguably the most criticised piece of legislation” in the whole body of legal provisions for medicines in the European Union.

The roadmap is part of a broader impact assessment, promised in the European Commission’s December 2008 Communication on ‘Safe, Innovative and Accessible Medicines: a renewed vision for the Pharmaceutical Sector’.

Started in spring 2009 , this work is considering in particular “various options for improving the functioning of the Clinical Trials Directive with a view to making legislative proposals, if appropriate, while taking the global dimension of clinical trials into account”, DG SANCO notes.

It says the public consultation has provided “very useful quantitative and qualitative information”, establishing “a useful baseline of administrative burden, and the consequent measurement of reductions through the EU Standard Cost Model”.

The Commission will now gather additional information on the benefits of clinical research to human health, through in-house expertise and dedicated meetings with expert stakeholders over the course of the year.

The main policy objectives of the initiative to improve the operation of Directive 2001/20/EC are set out as:

- A modern regulatory framework for clinical trials that takes into account the multinational research environment and “the needs of the highly innovative, research-based pharmaceutical sector”.

- Regulatory requirements “which are adapted to practical requirements, constraints and needs, without compromising the safety, well-being and rights of clinical trial participants”.

- Addressing the global dimension of clinical trials “in terms of global alignment and enduring respect of Good Clinical Practice”.

Among the policy options on the table for achieving these ends are:

- A streamlined mechanism for clinical trial authorisation, based on joint assessment and follow-up by the Member States.

- Clarifying certain provisions in Directive 2001/20/EC, “in order to reduce divergencies in assessment by Member States”.

- Adopting the Clinical Trials Directive as a Regulation to smooth out the disparities in its transposition into national legislation.

- Revising/amending the existing Directive.
- Replacing the Directive (partly) with a Regulation.

- Revising the current implementing guidelines and infringement procedures.
- Strengthening international dialogue and co-operation, including capacity-building in certain third countries.

- Closer scrutiny of the results of clinical trials conducted in third countries, “if these are referred to in the regulatory setting of the Union”.

According to DG SANCO, some of these options, and in particular a review of the Directive or its partial replacement by a Regulation, “have considerable potential for simplifying” the regulatory framework for clinical trials in the European Union, as well as for reducing the associated administrative burden.