Licensing of medicines

Finding flaws: the limitations of compulsory licensing for improving access to medicines--an international comparison.

Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers

OBJECTIVES Stratified medicine is often heralded as the future of clinical practice. Key part of stratified medicine is the use of predictive biomarkers, which identify patient subgroups most likely to benefit (or least likely to experience harm) from an intervention. We investigated how many and what predictive biomarkers are currently included in European Medicines Agency (EMA) licensing. S...

Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective

When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioe...

Out-licensing: a practical approach for improvement of access to medicines in poor countries.

VIEWPOINT There is much disagreement between the pharmaceutical industry and advocacy groups about how to provide patented medicines in poor countries. While everyone agrees that access to medicines in developing countries should be improved, too often this shared sensibility is submerged by an excess of timid incrementalism by industry, and demagoguery by activists. Neither contribution is con...

Licensing by Modification 217 Licensing by Modification 1. Modification and Direction of Licensing 1. Modification and Direction of Licensing 1. Modification and Direction of Licensing 1. Modification and Direction of Licensing 1. Modification and Direction of Licensing

This paper looks at the phenomena of licensing by modification, whereby an unacceptable noun phrase is redeemed by the presence of a modifier or an unavailable reading for a noun phrase is made available with the addition of a modifier. It argues that an optimal account of such phenomena should derive these effects from the interaction of the meanings of individual expressions in the sentence r...