The Regulatory Role of Patents in Innovative Health Research and Its Translation from the Laboratory to the Clinic
Dianne Nicol, Jane Nielsen
Abstract
Regulators must ensure that innovative health research is safe and undertaken in accordance with laws, ethical norms and social values, and that it is translated into clinical outcomes that are safe, effective and ethically appropriate. But they must also ensure that innovative health research and translation (IHRT) is directed towards the most important health needs of society. Through the patent system, regulators provide an incentive-based architecture for this to occur by granting a temporary zone of exclusivity around patented products and processes. Patents thus have the effect of devolving control over IHRT pathways to patentees and to those to whom patentees choose to license their patent rights.
Topics & Concepts
DiscretionScope (computer science)MonopolyIncentiveGovernment (linguistics)Law and economicsBusinessGovernment regulationRight to healthIntervention (counseling)Political sciencePublic economicsLawHealth careEconomicsMedicineComputer scienceMicroeconomicsMarket economyPhilosophyPsychiatryProgramming languageLinguisticsChinaBiotechnology and Related FieldsIntellectual Property and PatentsBiomedical Ethics and Regulation