Der Gesetzentwurf zur Gesundheitsreform 2000 sieht vor, ab Mitte 2001 eine Positivliste für Arzneimittel einzuführen. Dieses Vorhaben wird von den betroffenen Interessengruppen abgelehnt, es ist aber auch wissenschaftlich umstritten. Wie ist die geplante Positivliste aus ordnungs- und...

The EC harmonized market entry regulation for pharmaceuticals from the early sixties on, but it achieved neither its goal of uniform national regulatory decisions nor that of automatic mutual recognition. Subsequent attempts to Europeanize the procedures themselves resulted in two alternatives...

We analyze the impact of national pharmaceutical regulation on the launch delay of new chemical entities approved by the EMEA's centralized procedure. We find that direct price control regimes have a significantly negative impact on the launch timing. These results cannot be found when...

The US and the EU recently introduced regulation to curb the extent of risky off-label drug use. It offers manufacturers a prolongation of patent protection or exclusivity if they invest in pediatric clinical tests. This paper shows that a reinforcement of physician liability for off-label use...

The basic principle of patent law is that once the term of a patent has expired, the protected subject matter becomes a part of the public domain. Hence, it can be freely used, including for commercial purposes, without the interference by the former patent owner. This allows competitors to...

"Viral hepatitis is an international public health challenge, comparable to other major communicable diseases, including HIV, tuberculosis and malaria. Despite the significant burden it places on communities across all global regions, hepatitis has been largely ignored as a health and...

This South Centre research paper by Dr. German Velasquez describes and analyses the mandate, programmes, strategies, and activities that different international organizations such as WHO, WTO, WIPO, UNCTAD, UNDP, UNAIDS, the UN Human Rights Council, and the UN Secretary-General's High Level...