A bitter impression

The European Parliament recently approved a regulation on medicines for advanced therapies. It is aimed at creating a harmonized legislative framework for products designed for gene therapy, somatic cell therapy and tissue engineering. These products are based on gene and cell approaches to prevent and treat diseases and malfunctions of the human body, such as cancer, diabetes, Parkinson’s disease and other neuro-degenerative pathologies. The regulation may be considered definitively adopted and should therefore enter into force once the Ministers have formally approved it: this is expected to take place in the middle of next year. A procedure of single authorization is established. This will prevent pharmaceutical firms from having to request 27 national authorizations in EU member states. Strict regulations are also laid down in terms of evaluation and control of the therapies for which authorization for their marketing and sale is requested. Legal security and simplification of the procedures for firms and for hospitals, health and safety controls and better access to treatments for patients and for hospitals: that is the dual objective of the regulation adopted. There is one aspect, however, that has created many difficulties and that is likely to give rise to a heated debate. It concerns the removal of stem cells suitable for undertaking the therapies in question; as is well known, these cells may be removed either from adults or from embryos. In the latter case, the destruction of the embryo is inevitable. Moreover, the possibility of using material removed from germinal cells, which are those responsible for transmitting life, was not excluded. On these points, however, the parliamentary majority did not accept the amendments of those who asked for a clear ruling, thus protecting the embryo and not granting authorization to products that modify the human germinal line, or are derived from human hybrids or chimaeras.In this way the European Parliament – 403 votes in favour and 246 against – has deferred the ethical questions to the decision of the individual member states. This will give rise to confusion: the sale of a medicine will be permitted in one country but prohibited in the pharmacies of another, with the inevitable consequence that the former will be considered advanced, while the latter will be considered backward. The recent decision of the Parliament leaves a bitter impression. At Strasbourg the ethical concerns are increasingly less relevant, and the technical and economic ones count increasingly for more. Yet, such delicate questions are indivisibly scientific and moral.The Holy See, already in 1998, drew attention to the nerve point of our time: “The fact that unborn human beings and human embryos are not explicitly protected opens the door, especially in the field of genetic interventions, to discrimination and the violation of human dignity” (Observations on the Universal Declaration on the Human Genome and Human Rights). “Not everything that is technically feasible is also ethically permissible”. This is a fundamental principle of our time, even if, probably, it limits the interests of powerful pharmaceutical firms and research institutes. The European Parliament should reflect on that when it declares it wants to be on the side of citizens.