Masterstudiengang "Drug Regulatory Affairs"
Intellectual Property Rights for Medicinal Products in an Enlarged European Union ***
Dr. Andrea Derix (Abschlußjahr: 2002)
Five years by now have been passed since the introduction of the enlargement process, which, with reason, can be seen as historical challenge and opportunity for Europe. During these years a lot has been discussed about the chances and risks involved, for the European Union (EU) and the potential new members - in the governments, in the government offices, in the industry and in the population. This also applies for the healthcare and the pharmaceutical sector which have played a crucial role in the preparation process.
Common sense and insight of all shared parties is, that the availability of high quality and affordable medicines to patients across Europe must be ensured also in the future. But how can this be achieved? Two main topics have been in the focus of discussions
the achievement and maintenance of the high regulatory standards which are currently valid for the EU and match the highest international standards
ensuring a high level of health care protection in Europe
the need for a 'level playing field in the Intellectual Property Right in order to reinforce innovative strength in the European pharmaceutical industry and its competitive strength in the international pharmaceutical market.
The focus of the present thesis is on the third topic, the development of Intellectual Property Rights in an enlarged EU. Intellectual Property Rights which are important for medicinal products involve the Patent and Trademark Law in general, some specific regulations like the Supplemental Protection Certificate and the Roche-Bolar provisions as well as Data exclusivity for regulatory data.
The development of Intellectual Property Rights in an Enlarged EU can be regarded from two sides: from the viewpoint of the current EU and its Member States as enlargement process and from the viewpoint of the Candidate Countries as accession process. Accordingly, in a first step the Intellectual Property Rights of the EU as written down in the acquis communautaire are described and discussed.
In a second step the process of adoption and implementation of these rules by the Candidate Countries is analysed. This part describes where problems occur and where special arrangements and solutions will have to be defined as part of the future accession treaties with each individual Candidate Country.