By Leonardo Sforza, Managing Director, Brussels, MSLGROUP EMEA

Earlier in June, at our healthcare seminar in Geneva, we discussed the European Commission‘s compelling new regulation that is due to replace the cumbersome statutory requirements for clinical trials currently in place.

The New Regulation

The new legislation proposed by the Commission will take the form of a ‘regulation’ rather than a ‘directive’ with a view to ensure that the rules for conducting clinical trials are identical throughout the EU and are not put in jeopardy when implemented at the national level.

Clinical Trials | Courtesy: Goldmund100 on Flickr

Some concrete proposals included in the revision are:

• Authorisation procedure for fast and thorough assessment of the application by all Member States concerned will be created, to ensure a single assessment outcome. The authorisation procedure allows the individual Member State to appoint the body or bodies in charge of the assessment, on the condition that the assessment is fully independent and based on expertise;
• Simplified reporting procedures which will spare researchers from submitting similar information on trials separately to various bodies and Member States;
• More transparency on whether recruitment for participating in a clinical trial is still ongoing, as well as the results of the clinical trial;
• Controls: The possibility for the Commission to ensure supervision and enforcement of rules in Member States and non-EU countries.

The Rationale Behind The Revision

The current requirements for clinical trials have been widely (and rightly) criticised by patients, researchers and the industry alike. It has disproportionate regulatory requirements, high costs and a lack of harmony among the applicable rules necessary for multinational trials.

So finally, at one of its meetings before the summer break, the Commission agreed on the new draft legislation and opened the way to the EU decision-making process. The key reason:

The rationale behind the revision of the policy is to facilitate the management of clinical trials while maintaining the highest standards of patient safety and the robustness and reliability of trial data.

The Advantages

The advantages, according to the European Commission, are clear. As much as 800 million euros per year could be saved in regulatory costs. The new provision will also enhance R&D activities in the sector.

What Next

For the final text, we need to wait for the results of a complex scrutiny by the European Parliament and the EU Council. The examination of a draft law in that context often leads to amendments that reflect the range of policy orientations and national sensitivities represented in the Parliament and the Council.

They need to jointly agree about every comma of the new regulation and there is always a risk of jeopardising the initial good intentions of the EU legislator. The Commission’s outstanding proposal is a good opportunity for improving the regulatory environment of the health care industry. This opportunity merits close monitoring. It could also be enriched with contributions by key stakeholders pleading for a positive and ‘quick’ legislative outcome fit for purpose.

Leonardo Sforza, MSLGROUP

Leonardo has 25 years of Brussels-based experience in addressing European Union policy issues and corporate strategies. Until March 2012 Leonardo was the Head of Research and EU Affairs at Aon Hewitt were he has been advising global multinationals and the European Commission on financial service institutions, human capital and governance. Before that Leonardo worked for several departments of the European Commission where he led numerous initiatives supporting job creation and business competitiveness in the service industry.