The proposed rules for drug clinical trials in the EU: 'this time we have to get it right'

摘要

On 17 July this yean the European Commission finally released its long-awaited proposal for a revised legislation governing drug clinical trials in the EU. The commission's proposal revises and replaces the unpopular Clinical Trials Directive (Directive 2001/20/EC), which for many years has been criticised for producing a regulatory framework detrimental to clinical research in the EU.The proposal seeks to replace the directive with a regulation, a legislative instrument that, unlike a directive, will ensure the application of identical rules throughout the EU.The proposed regulation is more complete and detailed than its predecessor; it contains more than 90 Articles and five Annexes. As well as revising the clinical rules in general, it makes significant changes to trial authorisation procedures, codifies commission guidelines and introduces new principles. The proposal has been submitted to the European Parliament and Council for review as the first step of the legislative process. It will likely be heavily debated and substantially amended. If adopted, the regulation will apply for many years before it is revised. Scientific and technological developments evolve quickly and will continue to do so. We must anticipate the challenges that these scientific and technological developments will raise and ensure that we can respond to them rapidly and uniformly on the legislative and regulatory fronts. As per the comment on the proposed regulation by EU health and consumer policy commissioner John Dalli:"This time we have to get it right". This article examines selected features of the proposal and suggests amendments that would clarify certain provisions or further increase the harmonisation of the clinical trial rules in Europe.