Pharmaceuticals Policy and Law - Volume 6, issue 0

Article Type: Other

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 1-2, 2005

Authors: Valverde, José Luis

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 3-21, 2005

Authors: Weissenberg, Paul

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 23-27, 2005

Authors: Grossetete, Françoise

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 29-32, 2005

Authors: Brunet, Philippe | Alberola, Clara Martinez

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 33-45, 2005

Authors: Sauer, Fernand | Delaney, Frances | Fernandez-Zincke, Eduardo

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 47-58, 2005

Authors: Wahlroos, Hannes

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 59-67, 2005

Authors: Lönngren, Thomas

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 69-72, 2005

Authors: Badescu, Rodica

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 73-80, 2005

Authors: Wagner, Hans-Georg

Article Type: Research Article

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. Show more

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 81-93, 2005

Authors: Cranz, Hubertus

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 95-103, 2005

Authors: Nisticò, Giuseppe

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 105-107, 2005

Authors: Bhat, Vasanthakumar N.

Article Type: Research Article

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. Show more

Keywords: patents, generics, pharmaceuticals, market exclusivity, Paris convention

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 109-122, 2005

Authors: Ma Suñé Arbussà, José

Article Type: Research Article

Citation: Pharmaceuticals, Policy and Law, vol. 6, no. 0, pp. 123-137, 2005