The Clinical Trials Regulation also allows for a single submission within Europe and an overall streamlined assessment process, rather than country-by-country requirements, thus making larger multi-country trials much easier to conduct. This will allow for ‘a more harmonized approach to clinical trials in the EU’, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA).

EFPIA also welcomed the legislation’s approach to transparency, which respects the need to protect personal patient data and commercially confidential information. European legislators, however, state that ‘clinical trial data should not be considered commercially confidential once a marketing authorization has been obtained. For the sake of transparency, once a clinical trial has led to marketing authorization, data generated during the clinical trial should be fully accessible.’

According to Health Commissioner Tony Borg ‘the new measures should save research institutions and companies conducting clinical trials in the EU 800 million Euros per year in regulatory costs – removing the most significant barrier to keeping clinical research within EU borders.’

Some originator companies have not been too happy about the introduction of such legislation. AbbVie sued the European Medicines Agency (EMA) to stop it releasing information from clinical trials of its drugs, as did InterMune. However, EMA confirmed on 3 April 2014 that AbbVie had withdrawn both its court cases brought against EMA concerning access to clinical trial data.

The legislation approved by the European Parliament is expected to take effect in 2016 and will require the results of all new clinical trials to be published within a year of the trial ending.

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