New rules for multinational clinical trials in the EU

Tresja Bolt is senior director and health care practice leader in APCO’s Brussels office. Co-author Riccardo Mezzasalma is a project consultant in Brussels.

Last week on 17 July, the European Commission finally released its proposal for a new legislative framework on clinical trials in the European Union.

The current Clinical Trials Directive is arguably the most criticised piece of EU pharmaceutical legislation, viewed by many stakeholders – including researchers, academics, industry and patients – as onerous, incurring unnecessary cost and delays for clinical trials in the EU. According to the European Commission, the number of clinical trials has fallen by 25 percent between 2007 and 2011, while the administrative burden to handle the clinical trial authorisation process has doubled. A key objective of the new proposed legislation, therefore, is to reduce the administrative costs and operational burden for sponsors and investigators, with a particular focus on trials carried out across different Member States (e.g., multinational clinical trials for rare diseases).

Today’s clinical trials system is a patchwork of 27 national laws, leading to differences in the approval and acceptability of clinical trials in the EU. The new proposal – a Regulation – will introduce a more detailed, single regulatory framework for planning and conducting clinical research, including the aforementioned multinational trials.

The proposed Regulation introduces a number of important changes:
• A simplified and faster authorisation procedure through a single portal for submitting authorisation applications, managed by the European Commission, and a mechanism to coordinate joint assessment of the “anticipated therapeutic and public health benefits” of a clinical trial application among different Member States
• Simplified reporting procedures, which remove the obligation of submitting largely identical information on the same clinical trial separately to various bodies and Member States
• The possibility for the Commission to carry out inspections in EU Member States and third countries, in order to monitor compliance with international Good Clinical Practice standards
• A risk-adapted approach to the regulation of clinical trials based on the level of risk for patient safety. As a result, the new Regulation removes certain regulatory requirements for low-risk medicinal products, such as the compulsory insurance and the annual safety report, which were previously mandatory.
Industry, academic research institutes, patient organisations and other third-party stakeholder groups will carefully assess the impact of the proposed Regulation over the summer. While the proposal is generally welcomed by policy-makers and policy influencers alike, its final impact will very much depend on the debate in Parliament and Council. This debate will see a lively discussion on a range of regulatory, ethical, procedural and technical issues. The proposal is likely to come into effect toward the end of 2016.