This diploma thesis quite thoroughly deals with - at present a very topical - theme "liability for damage caused by a defective product"; thus, with an obligation to compensate for the damage caused by the defective product to its user (or third party), generally imposed on the person who is designated as the "producer" of the product, originally based on the Council Directive of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (85/374/EEC) (hereinafter 'Directive 85/374/EEC'). However, this work is not limited only to the (thorough) description of the currently valid and effective Czech implementing legislation. The thesis also compares the Czech legislation with the French implementing regulation, which is of a significantly higher legislative quality and much more faithful to its Union model. In fact, it was specifically France which shaped the final form of this responsibility regime, since it was the French transposition, and the French decision-making (judicial) practice, which was most often the subject of the Court of Justice's, as it ruled on the interpretation of the individual provisions and principles in the text of the previously mentioned directive contained. Nevertheless, France,...

Un niveau élevé de protection de la santé humaine est assuré dans la définition et la mise en oeuvre de toutes les politiques et actions de l’Union européenne. L’une des politiques les plus importantes, conformément aux enjeux de santé et au développement économique, est celle des médicaments. Leur sécurité est garantie par un cadre juridique donné par une législation pharmaceutique d’envergure présidant à l’octroi de l’autorisation de mise sur le marché et au suivi post-autorisation. Ce cadre juridique est supporté par un dispositif institutionnel d’exception, caractérisé par une interaction étroite entre l’Agence européenne des médicaments, la Commission européenne et les autorités nationales compétentes. Il a récemment été réformé à travers la nouvelle législation de pharmacovigilance. Le concept de sécurité sanitaire est ainsi devenu le principe directeur de la gestion du risque pharmaceutique. Toutefois, lorsque le risque inhérent à tout produit pharmaceutique se manifeste, le dommage médicamenteux se produit ainsi que la demande de réparation. Face à la nécessité d’indemniser les victimes de tels accidents, les réponses nationales des systèmes juridiques français et italien, par les biais de la responsabilité civile de droit commun et de la responsabilité du fait des produits défectueux issue de la directive 85/374/CEE, se révèlent inefficaces, car peu respectueuses de la spécificité du médicament. Ce constat conduit à plaider en faveur d’une dissociation entre responsabilité et indemnisation, en garantissant cette dernière à travers la création d’un fonds d’indemnisation général pour les dommages médicamenteux à participation mixte public-privé. Cette solution garantit une socialisation des risques justifiée par le caractère social du risque thérapeutique. Cela constitue le contrepoids aux dangers inhérents aux innovations de la science, tout en faisant profiter les malades des bénéfices thérapeutiques de demain. En prônant une approche holistique de la politique du médicament, la proposition de ce fonds constitue un instrument d’une politique de santé publique qui ne voit dans l’indemnisation des risques médicamenteux qu’un complément et un prolongement de la garantie de sécurité à la base de la législation pharmaceutique européenne. / The definition and implementation of the European Union’s policies and activities guarantee a very high level of human health protection. One of its most important policies, in accordance with the relative health and economic development issues, is that on medicinal products. Drug safety is guaranteed by a legal framework, constructed on the pharmaceutical legislation laying down rules and procedures for obtaining marketing authorisation and for post authorisation monitoring. This legal framework is supported by a special institutional system,which in particular ensures close interaction between the European Medicines Agency, the European Commission and the national competent authorities. This legal framework has recently been revised as a result of the new pharmacovigilance legislation. As such, health safety has become a key directive in managing pharmaceutical risk. Yet, whenever a risk relating directly to a particular pharmaceutical product becomes apparent, medical damages and compensation claims arise. The response of the national French and Italian legal systems to the application for compensation of the victims of such accidents, by way of the ordinary rules of civil liability and the liability for defective products as defined in Council Directive85/374/EEC, has proven ineffective: they fail to take into account the specific nature ofpharmaceutical products. Based on this observation, there is a sound case for separating liability from compensation: the latter can be guaranteed by setting up a general compensationfund for medical damages, with both public and private sector participation. This solutionwould guarantee a socialisation of risks that is justified by the social nature of therapeutic risk. It would provide a counterbalance to the dangers inherent in scientific innovation, whilst simultaneously allowing patients to benefit from future therapeutic developments. By advocating a holistic approach to drug policy, this proposed compensation fund would act as apublic health policy instrument, in the context of which compensation for medical risks would only be considered an addition to, and extension of, the security guarantee that constitutes the cornerstone of the European pharmaceutical legislation.