Pharmaceuticals Policy and Law - Volume 12, issue 3-4
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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: Member States have adopted divergent rules and practices with regard to the provision of information, resulting in a situation of unequal access to information on medicinal products. In a system where the rules on key product information (Summary of products characteristics and package leaflet) are fully harmonised to ensure the same level of protection of public health across the Community, this objective is undermined if widely divergent national rules on the dissemination of such…key information are allowed. Moreover, national rules and practices on information may lead to restrictions to the free movement of goods in violation of Article 28 of the Treaty, impacting negatively on the completion of a single market of pharmaceuticals which the harmonised legal framework on medicinal products tries to achieve. The European Court of Justice has already found certain national provisions on information on medicinal products to be contrary to Article 28 of the Treaty . In the European Union, the Summary of Products Characteristics (SPC) provides the most impartial and complete information about prescription-only medicines. The SPC represents the agreed position on a medicinal product as approved during the course of an official assessment process. As such, its content cannot be changed except with the approval of the originating competent authority. The SPC is the basis of the information provided to health professionals on how to use the medicinal product safely and effectively. The patient's Package Leaflet (PL) must be drawn up in accordance with the SPC. The SPC forms an intrinsic and integral part of the product's marketing authorisation. The SPC is, therefore, the most complete and objective information about a medicinal product that a patient can access. The underpinning principle of any proposals directed to improve the current status of the legal framework on information to patients is that European citizens have the right to access the information on prescription-only medicines that would benefit them. Access to high quality medicines information approved and provided by the competent authorities is most desirable. The availability and the access to high-quality medicines information that can be understood by the average European citizen, available in all languages, via the internet, should be one of the principal objectives to achieve in this area. This information should be provided by the official website of the relevant competent authority in each Member State and by the websites of the EU competent authorities in the case of centrally authorised medicinal products. There is, therefore, no need to radically change the current legislation but there is a need to clarify the scope and implementation of the current provisions. The current rules governing the information, to be issued by the competent authorities, regarding authorised medicinal products, could be complemented with further rules facilitating the access to such documents for the "average" citizen.
Abstract: When a biopharmaceutical product patent expires, other manufacturers can produce copies of the original drug. These products, called biosimilars (follow-on biologics in the USA) are similar but not identical to the innovator drug due to the protein nature complexity. The article reviews the European regulatory basis for biosimilars approval and marketing. The current situation at USA is also analized as well as the harmonization perspectives at global level.
Abstract: The intention of this study lies in the analysis of the French efforts made so as to attain the strategy of the Rational Use of medecine. This concept has already been defended by the WHO, for many years. In a nutshell, this work consists on highlighting how the achievement of to Rational Use of the Medicament can be a solution for the populations to reach higher level of good health. So as to do so in France, a strategy has…been set up, leading to the adoption of two important measures. The first one known as the "Sanitary French Democracy, and the second one gets to modify the division of the territory allocated to each establisment." Finally, we will emphasize that the international help given in order to sustain the principle of development corresponds to a necessity of solidarity which is situated at the core of the French Republic. As a result, we need to highlight the essential role of non-governmental organizations (hereafter NGO) as well as the one of other French resources for development aid, such as strengthening the pharmacy policy in other countries.
Keywords: Rational use of the medicament, geographical planning of pharmacy, non-governmental organization, health policy, medicine