Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Die Zulassung von Arzneimitteln im Schweizer Heilmittelgesetz und seine Revision – ein Vergleich mit dem deutschen Arzneimittelgesetz ***

Dr. Madeleine Meusburger (Abschlußjahr: 2015)

Summary
Language: German
In Switzerland, the control and authorization of medicinal products falls under the Therapeutic Products Act (HMG), which was adopted in the year 2000 and came into force 2002. Though situated in the heart of Europe, Switzerland is not a member of the European Union and has no obligation to implement European Directives into national law. With the HMG being a very “young law”, it has only undergone one change since its first adoption. The so-called first part of the first revision was a high-priority revision performed earlier than originally scheduled. It had been realized that the Therapeutic Products Act in its original version might lead to a shortage of medicinal products in hospitals, since the law did not allow the fast manufacture of medicinal products in hospitals in sufficient amounts without going through the time-consuming marketing authorization process. The Therapeutic Products Act was adjusted accordingly in the year 2008.
Currently, the second part of the revision – the so called “ordentliche Revision” - of the Therapeutic Products Act is discussed by the Swiss legislative. This time, the changes are more profound and concern many different aspects. Among the officially declared objectives of the current revision are the facilitated access of the population to medicinal products (for example due to simplified marketing authorization procedures), the optimization of safety measures, an increase in transparency, and the elimination of legal loopholes.
In contrast, the German Medicinal Products Act (AMG, which was first adopted in 1961) has been adjusted on numerous occasions. In the last thirty years, new aspects have been integrated approximately every two to four years, often implementing European Directives into national law.
This master thesis compares the paragraphs and articles which regulate the authorization of medicinal products in Germany and Switzerland, namely paragraphs 21-37 of the AMG and articles 8-17 of the HMG. First, the paragraphs and articles currently in force are discussed. Differences were found in formal aspects such as authorization versus registration procedures, approval documents, and the renewal of marketing authorizations. Even more striking differences concern the handling of data exclusivity periods and simplified authorization procedures. Topics which have no corresponding counterpart in the other law are identified as well.
The second part highlights the changes which will be introduced by the revision of the Swiss Therapeutic Products Act. The official draft of the Swiss Federal Council and the proposed changes by the National Council and the Council of States are considered. In summary, the planned HMG revision changes in the chapter marketing authorization procedures can be divided into two parts: changes which will lead to an approximation to the German AMG, as current deviations are eliminated, and changes which will lead to an increase of already existing differences.
Pages: 61
Annexes: 1, Pages: 3