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The repeal of the clinical trials directive should make the EU a more attractive place to carry out this vital work, says Noel Wardle

The pharmaceutical industry is an important part of the UK economy, yet the clinical trials market is in decline. In 2000 the UK had the third biggest share of global trials (behind the US and Germany) but by 2006 it had dropped to ninth. This matters because the global market for outsourced trial services alone is expected to be worth £19bn next year and the clinical trials market an estimated £29bn.

Too much red tape

Part of the problem is the number of separate NHS and regulatory bodies from whom approval must be obtained before a trial can get off the ground. However the problem isn't just a UK one €“ it is EU-wide.

The EU Commission says the number of trial applications fell by 25 per cent from 2007 to 2011, while the costs for conducting trials have increased and the average delay for launching a trial has increased by 90 per cent to 152 days.

The 2001 EU clinical trials directive is at least partly to blame for this decline. Even the EU admits that it appears to have €hampered the conduct of clinical trials in Europe€. To sort out this sorry mess, the EU has now issued a new regulation to repeal and replace the clinical trials directive.

The regulation aims to harmonise the requirements for clinical trial approval and includes plans for an authorisation dossier that would be submitted to a single portal linked to an EU database in a nominated €reporting member state€.

This should help with cross-EU clinical trial applications, although individual member states would retain control of assessments that have particular national, local or ethical aspects.

Clear timelines

There will also be clear timelines for the approval of applications, with compliance ensured through a system of €tacit approval€ if an application has not been determined in time. This should help to speed up the process, or at least give some certainty over how long the approval process will take.

The regulation provides greater flexibility to submit, amend, extend and withdraw applications. It includes safeguards in relation to the selection of candidates and obtaining informed consent, as well as obligations to report outcomes and adverse reactions.

The new measures, which should come into force by mid-2016, will solve at least some of the problems in the clinical trials sector. But the big question remains €“ will they be enough to reverse the decline?

Noel Wardle is joint head of healthcare and a partner at Charles Russell LLP, specialising in healthcare and regulatory law.