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.
Hondeghem
Luc M
LM
Department of Pharmacology, Catholic University of Leuven, Belgium. Luc.Hondeghem@ScreenQT.com
De Clerck
Fred
F
Camm
John
J
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