Industry bodies call for EU clinical trials directive changes
changes to be made to the European clinical trials directive in
order to bring about "harmonisation, transparency and consistency"
in this area across the member states.
The directive was first implemented by the European Commission in 2001 with in a bid to achieve these very things, however, because it is only a directive, much of it is open to interpretation and it is being implemented in different ways across the different member states, Francetta Carr, a spokesperson from the UK's BioIndustry Association (BIA) told Outsourcing-Pharma.com. Aisling Burnand, CEO of the BIA said: "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. 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." The BIA along with its European parent, EuropaBio, have been pushing to have certain amendments made to the directive in order to improve the situation. "We have submitted a paper and engaged in a lot of dialogue with the EC over this issue," said Carr. In response, the EC and the European medicines regulator, the EMEA, recently held a conference where stakeholder representatives could voice their concerns. At the meeting, BIA and EuropaBio submitted a proposal of five key areas for improving the directive, at the same time stressing that "the entire directive does not need to be repealed and replaced by a different legal instrument". The change they requested was a modification to the language used so that the provisions in the directive are less flexible: "Currently, the provisions are open to misinterpretation and misapplication of the law by Member States", they argued. In addition, they are asking for the current regulatory and ethics review processes should be streamlined; the roles and scope of responsibilities of National Competent Authorities (NCAs) and Ethics Committees need to be more clearly defined; and that mutual recognition of assessments carried out by NCAs should be introduced. Lastly the two organisations said they would like to see the mandate of the Clinical Trial Facilitation Group strengthened so mutual recognition of assessments and arbitration can occur between the member states. The EC will now go away and reflect on all the suggestions presented at the conference and is expected to produce a report on its findings in the next couple of months, said Carr.