Pharmaceuticals Policy and Law - Volume 8, issue 0
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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: Europe, traditionally, has been the leading power in the field of medicinal products. Over the last 20 years it has been gradually losing its competitiveness and, at the moment, needs urgent measures to be taken in order to relaunch its innovation, which forms the basis of the sector. Pharmaceutical policy needs a law on medicinal products which assures, every patient, that the medicinal products which are authorised onto the market are of a high quality, safe and efficient.…Medicinal products condition all areas of healthcare policy. Its efficient use poses a challenge for healthcare systems. However, in addition to the scientific and healthcare dimensions of medicinal products, there is an important economic element. In the member states of the EU there are systems of solidarity and social security which, in one form or another, assure collective funding. This adds complexity to the Governments' control over them, to which can be added industrial and investigation policies that are already in place. Without forgetting that in the complex world of medicinal products, developed democratic societies are strongly influenced by social judgements and prejudices which can seriously harm their development. Moreover there are increasing aggressive ascientific trends by a socio-political mentality which unbalances society, favouring alternative models, without any reasoning or rationale. They are simply based in a supposed personal freedom which, minorities are imposing on the majority of society. Anything done in one particular country has repercussions on the rest. The magnitude and weakness of medicinal products is that they are essential merchandise on a global level and are efficient tools in the preservation of human health. In this context we shall seek to summarise the essential elements of the law on medicinal products in the EU as a fundamental axis in the pharmaceutical policy of the EU. We shall then move on to examine the economic, social and ascientific aspects that condition it.