Pharmaceuticals Policy and Law - Volume 12, issue 1,2
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: Modern paediatric intensive care became organized in Europe in 1970s. Since that, time medical and technological advances resulted in a significant improvement of the treatment for infants, children and adolescents admitted to the Paediatric Intensive Care Units (PICUs) with a wide range of medical and surgical conditions. Now numerous conditions that were previously considered fatal have become treatable with an overall survival rate of 85–98%. However, the profile change of patients and the appearance of new…conditions (CLD, VAP, VILI) have caused new problems, together with the consideration that 90% of medicinal products used in PICUs are still unauthorised or administered off-label. PICU constitutes a unique setting for pharmacotherapy, as the patient is often characterised by respiratory or multiorgan failure, with an underlying pathology, and for which drug interaction, mode of administration and organ maturation are not properly taken into account.