Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
The European Commissions "Pharmaceutical Package": An Analysis ***
Dr. Stephanie Mondabon (Abschlußjahr: 2009)
Language: English
During the last years, the activities of the EU Commission had been focused on how to meet new challenges, such as globalisation, the assurance of a smooth functioning of the internal market in a widening Europe and the progress in science and technology. It has always been the most important task to protect public health without preventing an environment that stimulates innovation and supports the competitiveness of the European industry.
Globalisation was expected to not only bring opportunities in the years to come but also challenges like worldwide health threats, e.g. increasing numbers of counterfeit medicines. Structural factors were considered to be an issue as well, since there was a shifting of markets to the USA and Asia, especially in the field of pharmaceutical innovation. To take up these challenges, two specific objectives were outlined in a broad public debate the EU Commission launched in July 2007: to better protect public health of the European citizens and to strengthen the competitiveness of European companies, which shall be realised by removing regulatory and non-regulatory barriers. In this regard, also a need to strengthen and streamline the European pharmacovigilance system was revealed and based on the patients' growing demand for information and the recent technological advances, the Commission also considered it necessary to harmonise and improve the rules for information provision on medicinal products accross the EU to assure that patients have equal access to high-quality information.
Single initiatives in the fields of pharmacovigilance, counterfeit medicines and information to patients finally resulted in the adoption of the EU Commission's "Pharmaceutical Package" on December 10, 2008.
This master thesis gives an insight into the three legislative proposals in the context of the "Pharmaceutical Package". The reader will get an historical overview of the three initiatives, followed by descriptions of the proposed legislative changes on pharmacovigilance, counterfeit medicines and information to patients. The proposed changes are being thoroughly discussed in the context of the respective current legislative environment and based on whether the stakeholders' major comments from the respective public consultations held prior to the publication of the legislative proposals have been taken into consideration. Furthermore, Member States' comments from the ongoing debates in the Council Working Party are included in the discussion to show which further changes might be expected in respect of the final implementation of the legislation. Aside from that, the possible implications for the pharmaceutical industry and health authorities are evaluated.
Pages: 144