Pharmaceuticals Policy and Law - Volume 20, issue 1-4
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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: This paper aims at describing the different liability regimes applicable to damages caused by pharmaceutical products. Special attention is paid to the strict liability regime foreseen in the European Directive 85/374/CEE, on the liability of the manufacturer for defective products. It also deals with some of the main characteristics of the Spanish procedural system, when referred to tort liability procedures aimed at compensating damages caused by defective products.
Abstract: The EC Product Liability Directive includes an optional development risk defence whose requirements are not entirely clear under the directive’s wording. The Court of Justice of the EU has so far had no opportunity yet to clarify its meaning. This article gives a brief overview of the various aspects of this defence.
Keywords: Product liability, development risk, state of the art