Pharmaceuticals Policy and Law - Volume 12, issue 3-4

Article Type: Other

DOI: 10.3233/PPL-2010-0295

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 171-178, 2010

Authors: Cabezas, Maria Dolores

Article Type: Research Article

DOI: 10.3233/PPL-2010-0304

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 179-192, 2010

Authors: Valverde, Jose Luis

Article Type: Research Article

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. Show more

DOI: 10.3233/PPL-2010-0307

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 193-204, 2010

Authors: Calvo, B. | Zuñiga, L.

Article Type: Research Article

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.

Keywords: Biopharmaceuticals, biosimilars, follow-on biologics, similar biotherapeutic products, regulatory basis, harmonization

DOI: 10.3233/PPL-2010-0299

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 205-215, 2010

Authors: Barranco Vela, Rafael

Article Type: Research Article

DOI: 10.3233/PPL-2010-0297

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 217-228, 2010

Authors: Pérez, Francisca Villalba

Article Type: Research Article

DOI: 10.3233/PPL-2010-0301

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 229-239, 2010

Authors: Bombillar, Francisco

Article Type: Research Article

DOI: 10.3233/PPL-2010-0298

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 241-257, 2010

Authors: Querci, Agnese

Article Type: Research Article

DOI: 10.3233/PPL-2010-0296

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 259-273, 2010

Authors: Baes, Céline

Article Type: Research Article

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. Show more

Keywords: Rational use of the medicament, geographical planning of pharmacy, non-governmental organization, health policy, medicine

DOI: 10.3233/PPL-2010-0300

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 275-295, 2010

Authors: Leopardi, Onorevole Giacomo

Article Type: Research Article

DOI: 10.3233/PPL-2010-0303

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 297-301, 2010

Authors: Cicconetti, Pierandrea

Article Type: Research Article

Abstract: List of the new health (professional) and social (administrative) services provided by pharmacy according to new Italian law and National Health Service Authority; weak and strength points, examination of all the aspects. New health services are important to give effort to the pharmacist role, on the other hand the social ones need time and human resources to run. Some pharmacy provides a wide range of services for free already and small pharmacies cannot compete …due to problems dealing with the surface of the shop or with the number of employees. New strategies oriented to help and protect small pharmacies are vital, but the most important thing is to create a network of pharmacies that will offer new services; everyone must join it, we do not want pharmacies lack in knowledge in the future and not professional. Show more

Keywords: National health service, region, pharmacy, health (professional) service and social (administrative) service

DOI: 10.3233/PPL-2010-0306

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 303-306, 2010

Authors: Gillard, Juan | Escudero, Concepción

Article Type: Research Article

DOI: 10.3233/PPL-2010-0302

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 307-311, 2010

Authors: Ripari, Nadia Vanina | Vega, Elena Maria | Elorza, María Eugenia | Moscoso, Nebel Silvana | Santiago, Daniel Palma | Budassi, Nadia

Article Type: Research Article

Abstract: In the last decades the pharmacist has played a main role in the policies of costs containment in the health sector. The present study has been designed to assess this role in the costs containment of the pharmacological treatments of patients at a Coronary Care Unit (CCU) of a public hospital in Argentina, through an analitic and retrospective study. It has been observed that the pharmacist could determine in all the service a saving of $ 3,393.03 buying …the prescriptive drugs at minimum prices during the analized period. However, it has been proved that there are costs which the pharmacist cannot modify, as in the case of certain risk factors that may increase the pharmacological costs in the treatment of a pathology. This cost variation has been proved in ischemic cardiopathy patients with smoking habits. Show more

Keywords: Role of the pharmacist, costs containment, ischemic cardiopathy, smoking habits

DOI: 10.3233/PPL-2010-0305

Citation: Pharmaceuticals, Policy and Law, vol. 12, no. 3-4, pp. 313-319, 2010