title: Towards a sustainable system of drug development.
abstract: Drug development has become the exclusive activity of large pharmaceutical companies. However, the output of new drugs has been decreasing for the past decade and the prices of new drugs have risen steadily, leading to access problems for many patients. By analyzing the history of drug development and the pharmaceutical industry, we identified the main factors causing this system failure. Although many solutions have been suggested to fix the drug development system, we believe that a combination of reforms of the regulatory and patent systems is necessary to make drug development sustainable. These reforms must be combined with a larger, open-access role for public research institutes in the discovery, clinical evaluation and safety evaluation of new drugs.
authors.affiliation: Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Heidelberglaan 2, Utrecht NL-3584 CS, The Netherlands. Electronic address: e.h.m.moors@uu.nl.
authors.forename: Ellen H M
authors.initials: EHM
authors.lastname: Moors
authors.affiliation: Centre for Human Drug Research, Zernikedreef 10, Leiden NL-2333 CL, The Netherlands.
authors.forename: Adam F
authors.initials: AF
authors.lastname: Cohen
authors.affiliation: Innovation Studies, Copernicus Institute of Sustainable Development, Utrecht University, Heidelberglaan 2, Utrecht NL-3584 CS, The Netherlands; Department of Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, Utrecht NL-3584 CG, The Netherlands.
authors.forename: Huub
authors.initials: H
authors.lastname: Schellekens
mesh_terms: D003299:Cooperative Behavior; D055808:Drug Discovery; D004345:Drug Industry; D007880:Legislation, Drug; D010330:Patents as Topic; D014495:Universities