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Two major bioscience industry trade associations have called for 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.
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