Interdisciplinary Medical Law and Bioethics Research Centre was founded in 2013, on the basis of Rector’s order No. 106/2013. This entity is dedicated to the legal and ethical problems of medicine, biology and biotechnology. Activities of the centre are concentrated on research, education and popularization of issues connected with the development of medical technologies which is very rapid and bringing about difficulties and tensions stemming from both legal and ethical points of view. Interdisciplinary cooperation is very important for the evolution of the centre and that is why one of its main features is involvement in its activities of a group of lawyers, physicians and academics from different universities and research institutions.
The Department of Public International Law, after the Second World War was founded at the University of Wrocław in 1946. As the first head of this unit was appointed Prof. Stanisław Hubert, the former professor of the Jan Kazimierz University in Lviv. The Wrocław school of international law was grounded and developed by the team of four scientists and academic teachers: Stanisław Hubert, Karol Wolfke, Jan Kolasa and Kazimierz Kocot. In the 1990s the unit was changed into the Department of Public International and European Law as a consequence of the increasing role of the European Community law within the domain of international relations. At the moment the Department is headed by Prof. Krzysztof Wójtowicz. The team is now composed of 12 researchers and associated PhD students. To the main fields of interests of the Department belong issues of sources of international law, law of the treaties, international jurisprudence, institutional and material law of the EU, external relations in the EU, law of international organizations, international criminal law as well as international biomedical law.
Patentability of live forms, including that of human body, has been – and still is – the subject of attention of patent authorities and judicial practice. It is a controversial and disputable issue, as it concerns in particular treating a human being as a patentable subject matter. Therefore, patentability of human body has been exluded, even if Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions allows biological material which is isolated from its natural environment or produced by means of a technical process to be the subject of an invention even if it previously occurred in nature, i.e. the requirements of novelty and involvement of an inventive step have not been met. The author examines the current legal status of human embryo as a potential subject of invention under UE law, particularly in the context of the judgment of the Court of Justice of the European Union in the case Brüstle v. Greenpeace which is recognized as an essential element in the discussion on this issue, as well as an attempt to determine a possible direction of future development in this area in the EU law. The proper achievement of the tasks of the article depends mostly on the examination of the definition of human embryo proposed by the Court and its impact on EU law and domestic law of member states, and also an analysis of the status of the embryo in relation to the principle of respect to human dignity, patent law, scientific research in biomedicine, and the ban of use of human body for commercial purposes. In these areas, the legal status of embryo has a considerable importance.
This commentary evaluates the problem in assessing the role of a causal connection between damage and the use of a defective medical product, specifically a vaccine. The judgment of the Court of Justice of the European Union (CJEU) in the Sanofi Pasteur Case, which allowed the possibility of recognizing damage claims, even in cases where the prevailing scientific theory claims that there is no scientific evidence of a causal link between a vaccination and the disease, became a base for consideration. Consequently, procedural solutions (such as the standard of proof required, the admissibility of prima facie evidence reasoning and other solutions in cases of an uncertain causation) remain to be decided by national law. The authors assessed two legal systems: the French and Polish legal systems in the context of how to resolve these dilemmas and to describe the impact of the above-mentioned judgment on the case-law of French and Polish courts as regards the application of Directive 85/374/EEC. As a result, they concluded that the most important interpretative motive has become the individual interest of the vaccination’s victim as a consumer of medical services. It seems to be in accordance with Directive 85/374/EEC, which is motivated by the necessity of approximation of the laws of the Member States concerning the liability of the producer for damage caused by the defectiveness of his products. However, since the existing divergences may distort competition and affect the movement of goods within the common market and entail a differing degree of protection of the consumer against damage caused by a defective product to his health or property, in countries belonging to the European Union, the authors wonder how the commented judgment will affect the further development of consumers protection against defective vaccines.
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