title: Will the EU Clinical Trials Regulation Support the Innovative Industry in Bringing New Medicines Faster to Patients?
abstract: A perspective from the innovative industry is provided in this article about the long awaited legal proposal for a Clinical Trial Regulation ("Proposal"), adopted in July 2012. With this Proposal, the European Commission reacted to a call by all stakeholders for more harmonization and streamlining of the provisions for conducting clinical trials in the EU. Discrepant approaches between Member States, a failure to respect legal timelines, and a lack of formal coordination mechanisms within and between Member States have resulted in an increased workload for the industry and contributed to a decline in Europe's attractiveness as a place to carry out research and development. The Proposal introduces a concept whereby the sponsor makes a single submission of the clinical trial application dossier to an EU portal, which is followed by a single assessment based on cooperation between Member States. A possibility for the sponsor to choose a 'reporting Member State' to take the lead on key aspects of the assessment is expected to support excellence building and work sharing of Competent Authorities in the EU. The Proposal respects the fact that certain aspects need to be reviewed nationally. The new process aims to lead to a single decision per clinical trial per concerned Member State. The rules are built on the principle of strict adherence to timelines for authorization. The timelines are ambitious but at the same time competitive, as the process builds in mechanisms that strengthen compliance. The rules have been designed to encourage sponsors to file complete submission packages, since any substantial modification to a trial would lead to delays in its commencement. Sponsors need to streamline their internal processes accordingly. In the end, streamlining is an effort that needs to be accepted by all parties involved. The Proposal does not detail how Member States organize the involvement of different bodies, such as Competent Authorities and Ethics Committees, because according to the EU Treaty, the EU cannot legislate on aspects falling into pure Member State competence. The Proposal, however, establishes the assessment objectives on the basis of Good Clinical Practices set by the International Conference on Harmonisation (ICH) and the Declaration of Helsinki by the World Medical Association. As such, the new legislation is likely to have implications on Member States' internal organization. In addition, Ethics Committees in Europe would benefit from an EU platform for best practice exchange-a concept that would need to be requested by the Council and the European Parliament through the legislative process. A single decision system for the entire EU per clinical trial has been discussed as an option, but such an approach was difficult to achieve while respecting national competencies. In this situation, the Proposal represents an acceptable compromise, provided its proposed mechanisms, processes, and timelines are retained upon implementation. As the Proposal is now on the table for discussion by the 27 Member States' governments and by the European Parliament, co-legislators and stakeholders should be aware that any dilution of these provisions would be detrimental to the objective to ensure patient access and make the conditions for clinical research in Europe attractive and fit for the future.
authors.affiliation: EU Regulatory Policies, F. Hoffmann-La Roche Ltd., Drug Regulatory Affairs, PDRA, Grenzacherstrasse 124, 4070 Basel, Switzerland.
authors.forename: Sabine
authors.initials: S
authors.lastname: Atzor
authors.forename: Surendra
authors.initials: S
authors.lastname: Gokhale
authors.forename: Michael
authors.initials: M
authors.lastname: Doherty