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The idea for... biobank – just a few words

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EN
The use, collection and modification of human biological material/the human body is a difficult, controversial and challenging subject demanding deep analyses of all the ethical, social and legal aspects. Use of the human body for experimental purposes for or without the reward is often criticized. It is clear, however, that not all researches on new medicinal products, medical devices or cosmetics can be carried out on animals only. Contribution of a human being in experiments and clinical trials (including organs, tissues or cells) is the only way to verify safety and efficacy of a tested method or substance. Storage of human biological material intended for tests demands meeting conditions provided by legal standards and showing respect for the human body and human dignity; that is why biological material must be, as a rule, stored in cell and tissue banks (biobank). Any entity that wants to operate a biobank must meet a number of complex requirements before entering this narrow, difficult and demanding market. This is the result of legislative chaos and fragmentation of laws at the national and EU level, but also social, ethical or religious prejudice. However, biobanks are an indispensable research tool for understanding genetic or environmental grounds of many diseases, e.g. hereditary ones. Biobanks can undoubtedly revolutionize the health market and contribute to the further development of personalized medicine. However, the entity willing to establish a cell and tissue bank must meet and take into account several criteria. Any entity considering the foundation of a biobank wonders whether this activity will be profitable and whether it can be included in the chain of clinical trials.
EN
The paper in-question presents the theme of the modern utilitarianism with the release of J. Bentham, which is a crucial issue to discuss the concept of the public interest and understanding the background of axiological foundations of competition law and patent law. The idea of the eternal "conflict": the private interests versus the public interest, is presented in the literature frequently. J. Bentham in his principal work: "Introduction to the Principles of Morals and Legislation" made remarks on the interests of society. According to Bentham, however, there is no contradiction between the interests of individual and social interests because, as John Stuart Mill claimed later: the mutual kindness permeates society and the condemnation from the environment and gathering of suffering neighbor, cannot anyone give pleasure. The view of these two seem to be correct, especially through the prism of the present legislation and the case-law and their using the principle of proportionality, which is the key to resolving the alleged conflict between aforementioned interests. The rule of proportionality is exposed as a tool of the modern utilitarianism. In the light of primary understanding of competition law and industrial property law above-mentioned issues are presented in this paper.
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