title: Medicinal products in the European Union--between harmonization and divergence.
abstract: The rules governing the manufacture and trade in medicinal products in the European Union are, to a large extent, harmonized covering almost the entire life cycle of a medicinal product, starting from the conduct of clinical trials (Directive 2001/20, 2005/28), through manufacture (Directive 2003/94), registration, distribution and pharmacovigilance (Directive 2001/83) to the principles concerning pricing and reimbursement (Directive 89/105). A unified registration procedure has been established with respect to highly innovative medicinal products (Regulation 726/2004). There is also abundant case law of the European Court of Justice concerning medicinal products. The harmonization both judicial and legislative--took place in spite of the lack of explicit competence of the EU as regards healthcare and was based to a large extent on the provisions of economic nature, whose aim was to ensure the unfettered functioning of the internal market. In spite of those harmonization efforts, national rules governing pharmaceuticals are still to a large extent divergent, in particular as regards financing and distribution of medicinal products. This paper explores the level of harmonization of pharmaceutical market in Europe, in particular in the light of the primary competence of the Member States in the field of healthcare and discusses its implications.
authors.affiliation: Pharmaceutical and IP Group at Baker & McKenzie, Warsaw Office, Rondo, Warsaw, Poland.
authors.forename: Natalia
authors.initials: N
authors.lastname: Lojko
mesh_terms: D003431:Cross-Cultural Comparison; D003695:Delivery of Health Care / Q000191:economics / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence*; D005060:Europe; D005062:European Union / Q000191:economics / Q000458:organization & administration*; D006801:Humans; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000191:economics* / Q000600:supply & distribution
chemical_list: D004364:Pharmaceutical Preparations