Pharmaceuticals Policy and Law - Volume 6, 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: The new regulation on pharmaceuticals, (EC) 726/2004 of the European Parliament and of the Council of 31 March 2004 reinforces the legal basis for a European database on medicinal products. Legislators and other stakeholders have great expectations of this database. This paper reviews the legal base for this database, lists other drivers for its implementation, and examines the benefits of such a database for the different stakeholders. It describes the scope of the database in terms…of data elements, data sources, data users and data usage. The paper discusses the current implementation plan and addresses technical and other challenges to its successful construction and routine use.
Abstract: The purpose of this paper is to discuss patent term extension strategies for pharmaceutical companies in the United States. Market exclusivity acquired through patents can yield higher prices and profits for pharmaceutical products. Therefore, pharmaceutical companies use a variety of strategies to increase market exclusivity of their products. Some of the strategies discussed in this paper include one-year extension of time to file for patent under the Paris convention, patent term restoration allowed by the…Waxman-Hatch Act, orphan drug exclusivity, pediatric exclusivity, the 30-month stay provision and so on. Even though, the strategies discussed in this paper are for the United States, they may be applicable to most European countries, Australia, New Zealand, Japan, and Canada with minor modifications as similar pharmaceutical regulations exist in these countries.
Keywords: patents, generics, pharmaceuticals, market exclusivity, Paris convention