Protection of fundamental rights in the legal regulation of bio-banks

The theme of protection of fundamental rights is increasingly intertwined with that of legal regulation of human genetic material. The human genome is the fundamental entity that binds all humanity and at the same time represents the marker that is more expressive of belonging (such as territorial) to a certain community; it also defines humanity’s intrinsic dignity and preserves its diversity. In a symbolic sense, it is a heritage that belongs to everyone (Universal Declaration on the genome and human rights of UNESCO in 1997). The term bio-bank identifies the activity of collecting and storing organic biological material (tissues, blood, cells, fluids, micro-sequences of DNA). It is not restricted in a unitary interpretative context because it refers to a complex phenomenology. The bio-bank, as a form of biological safe, is able to preserve a genetic heritage of inestimable scientific value that has dual significance: from the clinical point of view, for the potential cure of certain pathologies and, from the scientific point of view, for non-medical research also. It contains precious information that allows us to predict the individual susceptibility of a given pathology, and, at the same time, helps us make a significant impact on the family group and extend it to future generations. The dual public and private value of the genetic data supports and reinforces the idea of building biological banks that are appropriately regulated by transparent and appropriate laws. In particular, the Recommendation of the Council of Europe R (94) 1 dated 14 March 1994 describes the human tissue bank as “a non-profit organisation that must be officially recognised by competent healthcare authorities of the member states”. Hence, there is need for detailed regulation that enables the management of such structures and the conservation and use of the genetic material stored therein in the individual EU Member States. In this regard, it is necessary to prepare an in-depth and detailed informative report, essential for establishing a correct relationship with the patient and making them participate in the experiment. This report must include: Analytical listing of the objectives being pursued, treatment outcomes, right of the donor to oppose the treatment, patient’s ability to limit access to data and transfer of biological material. From a different point of view, with the aim of protecting intellectual property rights, there is a proposal to attribute a common status to the genetic material stored in bio-banks; so that the biological materials transferred free of charge do not belong to the donors or to the bio-banks that guard them, but are the heritage of entire human race. In this way, it is the responsibility of the bio- banks to safeguard the privacy of donors; while researchers using this material would have a basic “right for use” these. Finally, the doctrine has also built a trust model, known as bio-trust, to entrust it with the responsibility of management of individual genetic heritage. In this area, this study will try to demonstrate the need for an in-depth legal analysis in view of the preparation of a uniform legislative framework that can regulate such a sensitive area of research.