Note on the Pharmaceutical Package for the EP Information Offices (EPIOs)

Studie 16-08-2010

The Pharmaceutical Package in this document refers to the initiatives taken by the European Commission under the "Communication on the future of the single market in pharmaceuticals for human use", setting out the EC's vision for the sector. It comprises three pieces of legislation put forward to the European Parliament on different aspects of medicinal products. The proposals cover: information to patients on prescription medicines, pharmacovigilance, and patient safety and falsified medicines. These legislative proposals have a direct impact on public health, as well as connections with internal market and industrial policies. In the European Parliament the Committee on Environment, Public Health and Food Safety-ENVI is leading these reports. The committees on the Internal Market-IMCO and Industry, Research & Energy-ITRE are responsible for opinions. This note provides a general overview of the present situation on public health policy and pharmaceutical products in the EU, taking into account its degree of implementation and impact. The note presents the three proposals from a public health perspective with regards to their present state of advancement inside the legislative process. Finally it mentions the main stakeholders for these subjects. The note includes an annex with the key officials responsible for this policy area in the EU institutions. IP/