Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Parallel import of generic medicinal products - Possible impacts of the Kohlpharma Case ***
Monika Frei (Abschlußjahr: 2006)
Language: English
All across Europe healthcare costs are rapidly increasing and reforming the health care system has become one of the main objectives in politics. Every possibility to control the healthcare budget, e.g. by lowering the pharmaceutical expenditure, is therefore in the interest of the Community.
In this respect, parallel imported medicinal products and generic medicinal products have the same goal - representing competitively priced therapeutic equivalents to originator pharmaceuticals. Despite of this common goal, parallel imported and generic medicinal products are based upon different principles and consequently are regulated differently, especially with regards to the requirements for a marketing authorisation.
However, when analysing the recent case on parallel imports, that was resolved by the ECJ in Luxembourg in April 2004, Kohlpharma vs. Federal Republic of Germany (C-112/02), the distinction between parallel import licence applications and generic licence applications seem to be blurred. Additionally, the question is raised, whether generic medicinal products can also be imported in parallel instead of having to take the route via a mutual recognition procedure.
In order to assess the possibility of such a scenario and the consequences, this paper first presents an overview of the regulatory framework for both generic and parallel imported medicinal products, especially comparing the situation before and after the Kohlpharma case. Furthermore, to gain a realistic picture of the practical consequences of the judgement, the guidelines on parallel importation of the various Member States, if available, are analysed with regards to the new requirements for a parallel import authorisation. Based on these results, it is finally evaluated whether a generic parallel import application could be successful.
Pages: 66