Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Skinny labelling ***

Dr. Andrea Abele (Abschlußjahr: 2015)

Summary
Language: English
Finding new uses for known substances makes an important contribution to improving public health. Patents in form of second medical use claims were established to promote and incentivise this kind of research. Since 2004, it is possible in Europe to market generic medicinal products with carve-outs of patent protected indications or other new uses in their labelling (so-called “skinny labelling”). Many countries have introduced generic substitution to increase the use of generic medicines and thereby reduce health care costs. Thus, the generic medicinal products with a skinny label approved only for non-protected indications/uses are actually dispensed for all indications/uses of the brand medicinal product.
This procedure leads not only to a weakening of patent law but has also an impact on patient’s safety and creates an area of conflict for all stakeholders. Further regulatory legislation/guidance is needed.
In this master thesis on overview of the current system regarding skinny labelling and second medical use claims is presented. Problems arising out of the current practices are discussed and opportunities for an improvement are proposed by a comparison to the US system and by taking into account the recent jurisprudence concerning second medical use claims.
Pages: 55