Patient Protection and Access to Innovative Medicinal Products in the European Union
- PDF / 16,704,763 Bytes
- 15 Pages / 612 x 792 pts (letter) Page_size
- 111 Downloads / 186 Views
281
Patient Protection and Access to Innovative Medicinal Products in the European Union
Markis Hartmain, PLD, MDRA European Consulting & Contracting in Oncologv. Trier. Germany Florence HartmannVareilles, Avoca? Academy of European Law, Trier. Germany
Protecting patients, either in medical interventions or as consumers of medicinal products or as participants in clinical trials, and facilitating access to innovative medicinal products are two distinct but interactingregulatg, processes. Through the implementation of the Pharmaceuticals Review 2001, taking the form of a package of revised pharmaceutical legislation that entered into force in November 2005, the European Union ( E V ) set new standards for both processesincluding a new European pediatrics regdation as part of the implementation measures.
Key Words European pharmaceutical law; Pharmacovigilance; Pediatrics; Clinical trials legislation: Access to medicines Corrrspondence Address Florence HarimannVareilles. Academy of European Law (ERA), Metzer Allee 4, D-54295 Triec Germany (email: fiarimann.era.prog1 @erain!).
I N T R O D U CTI 0 N In April 2004, the European Commission issued three key legislative proposals, which together constitute the core of a new European Union pharmaceutical legislation on human medicinal products, namely, Directives 2004/27 and 2004/24 "amending Directive 2001/83 on the Community code relating to medicinal products for human use" (1,2)and Regulation 726/2004 "amending the centralized Community procedure for the authorization and supervision of medicinal products and the role of the European Medicines Agency" (EMEA) (3).The new legislation came into force on November 20, 2005. The two directives and the regulation were introduced with a view to modifying the existing EU legislation to ensure a high level of public health protection and the completion of the internal market (4). To protect public health, the EU has adopted a dual strategy, consisting of robust regulation of medicinal products on the one hand and stimulation of innovation and competitiveness on the other hand. To make innovative, and in some cases, potentially lifesaving drugs available as quickly as possible to patients in line with an adequate level of patient protection,
One year on from the introduction of the new EU legislation, this article provides an overview of the most recent developments of pharmacovigilance and summarizes the ongoing political and legal activities intended to achieve an equal and rapid access to medicinal products across the EU. The review incorporates an analysis of the objectives and outcomes of the muchdiscussed Clinical Trials Directive as well as recent judgments of the European Court of Justice on patient mobility and health care services.
special high-level reflection processes were initiated. These discussed the major issues, defined priorities and possible agendas, and sought to strike the right balance between public health objectives and industry competitiveness in Europe (5,6). The new EU pharmaceutical legislation
Data Loading...
