Search

The Convention on Human Rights and Biomedicine, the first legally binding international instrument in the field of bioethics, was adopted in November 1996. In the present paper, following a brief overview of some of the Convention's provisions likely to conflict with national enactments already in effect, we shall attempt, on the basis of the materials available in the International Digest of Health Legislation, to analyse the positions adopted by the different states involved and to identify foreseeable conflicts, focusing on the following four issues: human genome; protection of the embryo; scientific research; and protection of live organ donors. [ABSTRACT FROM AUTHOR]

This paper examines the right to health care. Various expressions of this right may be distinguished. These include both individual rights and social rights which could be based upon international treaties and constitutional rights. They may be found in national health legislation and, in some cases, in jurisprudence. To analyze the consequences of limiting the right to health care, a framework for judicial review has been developed which encompasses these expressions of the right to health care. The framework was used to examine legal and health policy developments in three Western and two Eastern European countries. In Italy and the Netherlands the right to health care is protected constitutionally (but on differing legal bases) while the United Kingdom does not have a written constitution. In contrast, Hungary and Poland have for many years seen the state take responsible for the provision, administration and allocation of health care services and the right to health care was guaranteed theoretically but not in practice because of the lack of (financial) means. However, the Polish Constitution explicitly anticipates possible limitations of the right to health care. What all these countries have in common is a cost containment perspective where the future will bring even tighter limits on what resources patients may consume. Despite differences in legal structure between these countries, where they seem to converge is on the consequences of putting limitations on the right to health care. The courts in Italy, the Netherlands and the UK have formulated conditions drawn from the acceptance that this right has to be judged within the context of limited resources. It may be concluded that finding a compromise between the right to health care and cost containment policies could also be an issue, Eastern European countries will have to face in the future. [ABSTRACT FROM AUTHOR]

From its conception the EU Clinical Trials Directive met with controversy. Some saw it as an unnecessary inhibitor to scientific research, introducing bureaucracy which was unduly expensive, slowing down the clinical trial approval system. The Directive however also enshrined respect for fundamental rights in relation to clinical trials decision-making and impacted upon the domestic law of member states facilitating the alignment of trial review processes. Nearly a decade after its implementation the EU is moving towards implementation of further reform in this area, from a Directive to a Regulation, from a system placing the research ethics system at the heart of the clinical trials approval committee to one which does not and which represents a see change in international and domestic approaches to research ethics. This article critically examines the proposed reform of the regulation of clinical trials on medicinal product through the introduction of a new EU Regulation and asks whether this can be seen as a natural streamlining of processes or a radical new agenda in EU health law and regulation. [ABSTRACT FROM AUTHOR]

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 condude 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. [ABSTRACT FROM AUTHOR]

Disagreement about matters of public policy concerned with moral issues is inevitable in pluralist democracies. One approach to the resolution of moral conflicts in society is the concept of deliberative democracies which emphasises the process or procedure which ultimately allows a political decision to be reached. The Republic of Ireland effectively has no legislative framework regulating human embryonic stem cell research (hESC research). This article proposes that Irish policymakers establish a procedural framework, similar to that used in other European democracies, to allow the development of appropriate regulations pertaining to hESC research in Ireland. In particular the article will consider how a three-tier model of procedural regulation has been used to achieve certainty in the area of hESC research in the United Kingdom and Germany and how this model might be applied to Ireland. [ABSTRACT FROM AUTHOR]

Abstract In 2011, the new law on organ transplants was voted by the Greek Parliament. Major changes include the selection of presumed consent system (opt-out) for organ transplants from dead donors. The system will take effect in 2013. In organ donations from living donors, a class of potential donors was added: a person with whom the organ recipient has a personal relationship and is emotionally connected. In this special case though, the truth of the altruistic motives is necessarily examined in court. Also, a detailed list of risks and consequences is part of the content of the obligation to inform a potential organ donor. [ABSTRACT FROM AUTHOR]

The author reflects on the utilization of health screening services for public consumption. He notes the differences in screening services being offered by the providers. He states that the jurisdictions in many European countries provide protection to consumers entering a service contract. The author also mentions the importance of common policy framework in the convergence of screening services.