Originally published as Covington E-Alert on August 1st, 2012

On 17 July, the European Commission released the long-awaited proposal for a Regulation on clinical trials on medicinal products for human use (the Proposal). The future regulation will replace the Clinical Trials Directive 2001/20/EC, the revision of which has been advocated by the pharmaceutical industry, academia, and patients for years. Directive 2001/20/EC aims at harmonising the requirements throughout the EU but has not prevented divergent national requirements that, especially for multinational clinical trials, substantially hinder a swift handling of clinical trial applications and generate a very burdensome and costly administration. The Proposal primarily seeks to cut the red tape and to facilitate the conduct of multinational trials and restore competitiveness in clinical research in Europe.

The future Regulation will be more complete and detailed than Directive 2001/20/EC (more than 90 articles and five annexes) and will revise current rules, in particular as regards the authorisation procedures, and introduce new principles, such as co-sponsoring. Overall, the new regime should reduce administrative costs for industry and better reflect the variety of clinical trials. The Commission chose a Regulation as legislative instrument to ensure that identical rules will apply throughout European Union. This will increase harmonisation of the rules, but certain issues, such as ethics and sponsor liability, will remain governed by national law.

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Tags: Clinical Trials, EU Legislation, European Commission, Medicinal Products
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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in local litigation in Belgium. Peter’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

Chambers Global notes that a client said: “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions.” He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Peter’s prominent regulatory pharmaceutical and environmental practice. Legal 500 EME noted that he is “a superb lawyer who is very pleasant to work with.” Peter regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group and also served for fifteen years as Managing Partner of the firm’s Brussels office.

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Photo of Grant Castle Grant Castle

Grant Castle is a partner in the London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation.

His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling…

Grant Castle is a partner in the London office practicing in the areas of life sciences regulatory law, with an emphasis on pharmaceutical and medical device regulation.

His advice on general regulatory matters includes: adverse event and other reporting obligations, manufacturing controls, labeling and promotion, and product life cycle management.  He has also advised extensively on EC and national laws governing clinical research, data protection, and the regulatory status of borderline products.

He has developed considerable expertise in coordinating regulatory projects covering jurisdictions outside of Europe, including Canada, South America, Eastern Europe, Russia, Africa, the Middle East, Japan, and Australia.  His transactional work includes advice on regulatory aspects of mergers and acquisitions, licensing, and collaborative arrangements.

Grant is a visiting lecturer at the University of Surrey, on a course leading to a Master of Science in Pharmaceutical Medicine/Clinical Pharmacology; Cardiff University, on a course leading to a Master of Science/Diploma in Clinical Research and on the Postgraduate Course in Pharmaceutical Medicine; and, Cranfield University, on a course leading to Master of Science, Postgraduate Diploma, and Postgraduate Certificate in Medical Technology Regulatory Affairs.  Grant is recognized by Chambers UK, Life Sciences as “excellent,” “a knowledgeable lawyer with a strong presence in the industry,” who provides “absolutely first-rate regulatory advice,” according to sources, who also describe him as “one of the key players” in that area,” whilst Chambers Global sources report that “he worked in the sector for many years, and has a thorough understanding of how the industry ticks.”  He is praised by clients for his “absolutely first-rate” European regulatory practice.  Legal 500 UK notes that he is “‘highly competent in understanding legal and technical biological issues.”

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