An in-depth assessment of how the Clinical Trials Directive (2001/20/EC) has been applied across the European Union is among the objectives set out by the European Commission in a recent communication accompanying its package of legislative proposals for the pharmaceutical sector.

A number of stakeholders have raised concerns about the Directive’s application by the EU member states and its impact on both academic and non-academic research, says the Communication on Safe, Innovative and Accessible Medicines: a Renewed Vision for the Pharmaceutical Sector. Points of contention have included divergence in interpretation of the relevant legislation and cumbersome procedures for multicentre clinical trials.

Shortcomings in the implementation of Directive 2001/20/EC were also identified at a joint meeting of the Commission and the European Medicines Agency in October 2007, the Communication points out. It therefore recommends that the Commission should present an assessment of the Directive’s application by 2010, “with a view to making, if appropriate, legislative proposals – while taking into account the global dimension of clinical trials”.

Another of the objectives established by the Commission’s communication is to submit – also by 2010 – a report on the use of ‘-omics’ technologies such as pharmacogenomics in pharmaceutical research and development. The question of whether new Community instruments are needed to support the development of these technologies should be explored with stakeholders, the Communication adds.

The measures cone against a background of faltering pharmaceutical innovation in Europe, it notes, stating: “The centre of gravity for research has moved to the US and Asia”. In the 1990s pharmaceutical R&D expenditure was €7.766 billion in Europe compared with €5.342 billion in the US. By 2006, however, R&D spend in Europe was running at €22.500 billion while in the US it had climbed to €27.053 billion.

Moreover, the Communication observes, between 2001 and 2006 18 research sites belonging to 22 pharmaceutical multinationals were shut down in Europe and only two opened. Over the same period, these companies opened 14 research sites in Asia (just one was closed) and six in the US (five were shut down).