The European Union's policy on medicinal products

Article type: Research Article

Authors: Valverde, José Luis

Affiliations: Jean Monnet Chair of EU law "Europe of Health", University of Granada, Spain

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.

Journal: Pharmaceuticals, Policy and Law, vol. 8, no. 0, pp. 103-113, 2005,2006