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.
Informal or unofficial representation refers to the practice (more common in some European jurisdictions than in others), that persons not designed by a court or by the patient himself, make medical decisions on the patient's behalf in case of their incompetence. If the law provides for this, it is usually next of kin (spouse, children, brothers and sisters, etc.) who are allowed to act in such a capacity. Informal representation raises several questions. Are family members always familiar with what their relative would have wished, ready to take responsibility, and not too much reigned by their emotions? The basic legal concern is whether there are sufficient procedural and other safeguards to protect the incompetent patient from representatives who do not serve their best interests. In addressing these issues, after a brief survey of the law in the Netherlands as compared with that in Belgium, Germany and England/Wales, we will argue that informal representation as such is not at variance with international and European standards. However, an 'informal' approach to surrogate decision-making should always go together with sufficient protection of the incompetent patient, including procedural safeguards with regard to the decision that the patient is incompetent, limits to the decision-making power of informal representatives and effective forms of conflict resolution.
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