Short patent lives jeopardize drug and patient safety.
Exposure of patients to new medications carries potential safety hazards during widespread clinical practice. These are often detected only after a substantial period of use. Thus, there is considerable need for measures reducing drug-related morbidity and mortality, such as adequate, active postmarketing drug-safety surveillance systems with obligatory follow-up studies of suspected safety problems, or even an additional "Phase IV" safety study before marketing. However, drug development processes erode substantially into the useful patent life of a new drug. Therefore, we suggest that the potential benefits of patent life prolongation should be considered, under certain conditions for the sake of patient safety.
Department of Pharmacology, Catholic University of Leuven, Belgium. Luc.Hondeghem@ScreenQT.com
Luc M
LM
Hondeghem
Fred
F
De Clerck
John
J
Camm
D016907:Adverse Drug Reaction Reporting Systems; D000818:Animals; D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004353:Drug Evaluation, Preclinical; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D011358:Product Surveillance, Postmarketing; D013997:Time Factors