Heringa Jilles, Dute Joseph
Jilles - Consultancy in Health Care, The Netherlands.
Eur J Health Law. 2013 Sep;20(4):347-62. doi: 10.1163/15718093-12341284.
The Commission has proposed a regulation 'on clinical trials on medicinal products for human use' to introduce one regulatory framework for clinical trials in the European Union. This regulation should replace the current clinical trials directive (2001/20/EC). In this article we describe and critically review the main provisions of the proposed regulation. We assess the consequences for a sound authorisation procedure of clinical trials and the level of protection for human subjects. We note that the proposed regulation is inconsistent with applicable international legal documents, such as the Biomedicine Convention and the Declaration of Helsinki. We conclude that the proposed regulation does not ensure a "high level of human health protection"--required by its legal basis in the TFEU--because it may force Member States concerned to accept a reporting Member States' approval of--in their estimation--an unethical clinical trial.
欧盟委员会已提议一项“关于人用药品临床试验”的法规，以便为欧盟的临床试验引入一个监管框架。该法规应取代现行的临床试验指令（2001/20/EC）。在本文中，我们阐述并批判性地审视了该提议法规的主要条款。我们评估了其对健全的临床试验授权程序以及对人类受试者保护水平的影响。我们注意到，该提议法规与适用的国际法律文件，如《生物医学公约》和《赫尔辛基宣言》不一致。我们得出结论，该提议法规无法确保《欧洲联盟运行条约》法律基础所要求的“高水平人类健康保护”，因为它可能迫使相关成员国接受报告成员国对一项（据它们估计）不道德临床试验的批准。
