Abstract

The European Clinical Trial Directive (2001/20/EC) was implemented into the Belgian legal system by the Law of 7 May 2004 concerning experiments on the human person (LEH). Apart from implementing the European Directive, this law also broadens the scope of the Directive from interventional clinical trials to all medical experiments involving human persons. This article offers an overview of the requirements for involving minors in medical experiments that are captured in the LEH, illustrates the process of protocol review by an ethics committee, and discusses the dissimilarities between the LEH and the European Directive.

In: European Journal of Health Law

Abstract

The European Convention on Human Rights and Biomedicine of the Council of Europe provides in article 6 for special protection of persons who are not able to give free and informed consent to an intervention in the health field, e.g. minors. According to the second paragraph of this article it is up to domestic law to decide whether and under which conditions a minor is capable of taking autonomous decisions in the health field.In the present article an overview is given of the legal regulations in place regarding the position of minors in a health care setting in the EU Member States that have ratified the European Convention on Human Rights and Biomedicine namely Cyprus, Czech Republic, Denmark, Estonia, Greece, Hungary, Lithuania, Portugal, Slovakia, Slovenia and Spain. As the overview will show, the legal position of minor patients in a health care setting varies from country to country. This in view of the system they have opted for as well as the age and circumstances under which minors are allowed to take health care decisions autonomously.

In: European Journal of Health Law