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: The European Union, the United States Japan and Brazil have developed different product liability rules which, in spite of showing some trends towards harmonisation, still make it impossible for manufacturers of pharmaceuticals to implement globally acceptable product designs, manufacturing processes and labelling. In the products liability rules for pharmaceuticals there are still differences as regards the contract/tort approach, the use of alternative instruments of no-fault compensation schemes, the need to establish specific rules for some sort of pharmaceuticals and the understanding of some of the core elements of products liability such as the notions of product, defect, causation and defences.…This paper deals with some of these questions from a comparative prospective trying thereby to establish a general framework for some of the problems that will be dealt with in more detail in the other papers included in this issue.
Keywords: Liability for pharmaceutical products, comparative law, contract/tort rules, no-fault compensation schemes, specific rules for pharmaceuticals, product, defect, causation, defences
Abstract: Pharmaceutical claims are arguably the most significant type of product liability cases in the United States. Failure to warn is the primary theory used against pharmaceutical manufacturers, and it can be brought under strict product liability or negligence; the standard is essentially the same under either doctrine. In this descriptive overview of United States law, the authors discuss theories of recovery, causation, damages, defences, procedure, and alternative regulations and remedies.
Keywords: Product liability, pharmaceuticals, failure to warn
Abstract: The Japanese liability system regarding pharmaceutical products consists of two basic categories: the general fault-based liability is accompanied by the liability system based on the Product Liability Act (PLA), which is established under the influence of American doctrine and the EC directive. The PLA liability is originally supposed to be a strict liability, but this characterisation is recently more and more doubted. The other features of Japanese law relating to pharmaceutical products liability include some state-operated compensation schemes, several measures to facilitate proof, development risk defence, lack of market share liability and class action.
Keywords: Strict liability, manufacturing defect, design defect, information or warning defect, facilitation of proof, development risk, alternative dispute resolution (ADR), non-pecuniary damage
Abstract: This article will address the issue of pharmaceutical liability in Brazilian law. At first, the article will describe the general lines of product liability in Brazilian law, addressing the main requirements for victims’ compensation, as well as the main defenses that product suppliers can use. Subsequently, this article will show the specific characteristics of pharmaceutical liability, addressing mainly the specificities of inherently dangerous products. Finally, the most important and current jurisprudence on the subject will be commented
Abstract: In 1976 Germany introduced a special strict liability regime for personal injuries through pharmaceuticals for human consumption. This was in reaction to the Thalidomide-catastrophe in the 1950ies and 1960ies. Since then, Germany disposes of a two lane-system of liability in this field: traditional fault liability under general tort law and strict liability under the special Medicinal Products Act. The following article examines in detail the conditions of liability under either regime. Also, possible defences and procedural matters are being dealt with as well as the question of insurance and the accessibility of funds established for victims.
Keywords: Liability for defective medicinal products, special statutory regulation in Germany, strict liability, causation and damages, fund solutions, producers’ defences and time limits
Abstract: This short article addresses a series of questions regarding pharmaceutical products liability in the United Kingdom. Issues in both the relevant substantive and procedural law are discussed. The overall picture that emerges is that claims for damage caused by pharmaceutical products are exceptionally challenging. This is due not only, in particular, to a general reluctance on the part of judges to find fault in the design of pharmaceutical products but also the exceptionally high cost of litigation in the United Kingdom.
Keywords: Product liability, pharmaceuticals, consumer protection, failure to warn, defences
Abstract: The article discusses product liability law in Poland with regard to liability for pharmaceutical products. The author describes substantive law provisions and their interpretation by Polish and EU courts, procedural issues as well as the impact of safety regulations on civil law liability.