New challenges for the information on medicines in the EU

Article type: Research Article

Authors: Valverde, Jose Luis

Affiliations: University of Granada, Granada, Spain. E-mail: jlvalver@ugr.es

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.

DOI: 10.3233/PPL-2010-0307

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