The Clinical Trials Directive should be reviewed to improve the harmonisation, transparency and consistency of trial approval and conduct across the European Union, the UK's BioIndustry Association (BIA) argued at a recent joint meeting of the European Medicines Agency (EMEA) and the European Commission.

The Clinical Trials Directive (2001/20/EC) aims to facilitate the internal market, protect public health, and to simplify and harmonise administration by establishing clear, transparent procedures. However, in December 2006, the European Commission’s Pharmaceutical Committee endorsed a report which found that while the impact of some of the guidance could not be assessed fully, administrative obstacles and implementation of the legislation varied between Member States.

So, on 3 October, the EMEA and the European Commission held a “stocktaking” conference, involving EU Member States and major stakeholders, to determine whether further work on implementation would resolve the problems and whether the Directive should be revised. At the meeting, the BIA supported a revision.

The association emphasised that the entire Directive did not need to be repealed and replaced. However, the BIA, working with EuropaBio, the European association for the bioscience industry, identified five key areas for improvement:

- Modifying the Directive's language to make it more specific. “Currently, the provisions are open to misinterpretation and misapplication of the law by Member States,” the associations argued.

- Streamlining regulatory and ethics review processes “to accelerate the initiation of trials and allow patients faster access to innovative treatments”.

- Defining more clearly the roles and responsibilities of National Competent Authorities (NCAs) and Ethics Committees.

- Introducing mutual recognition of assessments performed by NCAs.

- Strengthening the mandate of the Clinical Trial Facilitation Group to promote mutual recognition of assessments and facilitate arbitration between Member States.

Significant impact

“Differences in the implementation of the Directive by Member States have adversely impacted on the ability of companies to carry out multinational trials across Europe," said Aisling Burnand, Chief Executive of the BioIndustry Association and Chair of EuropaBio’s National Associations Council. "The impact on small and medium-sized companies is particularly significant because they do not have sufficient financial and manpower resources to deal with the additional administrative burden and consequent delays."

“We look forward to continuing to work with the European Commission, National Competent Authorities and EMEA to address the issues highlighted, which would have a direct benefit of improving patient access to innovative medicines," Burnand added.