Pharmaceuticals Policy and Law - Volume 3, 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 European Parliament and the Council have recently adopted a legal framework which aims to foster research and promote the development of new therapies for the treatment of rare diseases. It has been well recognised that the US Orphan Drug Act has been a major breakthrough in promoting product development for patients suffering from rare disorders and now after 17 years of experience it is regarded as an essential tool to promote and preserve public health.…Several sources indicate that almost 8000 different severe and incapacitating conditions may exist affecting as many as 25--30 million European citizens. Of these disorders about 4000 have a genetic origin affecting primarily neonates and children. The European Agency for the Evaluation of Medicinal Products (EMEA) is responsible for putting in place a community procedure for the evaluation of the applications orphan medial product designation through the creation of a new scientific body, the Committee for Orphan Medicinal Products (COMP). This paper reviews the role and the objectives of the COMP and the EMEA in the development of medicinal products for rare disorders and the key elements for submitting an application for the designation which if successful leads to several incentives.
Abstract: The legislative framework for orphan medicinal products has recently been laid down in the European Union, with the adoption of Regulation (EC) No 141/2000 of 16 December 1999 and Commission Regulation (EC) No 847/2000 of 27 April 2000. The European Agency for the Evaluation of Medicinal Products (EMEA) with its new committee, the Committee for Orphan medicinal Products, now plays a major role in implementing the new legislation. A Community procedure has been established which will…clearly identify orphan medicinal products eligible for incentives. Incentives for sponsors developing orphan medicinal product available in the European Union include, amongst others, a 10 year period of market exclusivity, protocol assistance from the EMEA, and the possibility to request reduction of fees for all types of activities linked to the centralised marketing authorisation procedure.