Barriers for Pharmaceutical Innovation With Focus in Cancer Drugs, the Case of Mexico:

Drug innovation does not only generate economic growth but also portrays a country’s efforts toward innovation. The article reviews the current status on the innovation of the Mexican pharmaceutical industry with a focus on cancer drugs. The authors examined the scientific and nonscientific literature in search of the origin of innovative cancer drugs, as well as the regulatory frames by which these drugs are approved in Mexico. The article presents a narrative analysis of the author’s experiences on the barriers that impede pharmaceutical innovation in Mexico. To the best of the authors’ knowledge, there was only 1 domestic approval by COFEPRIS, the Mexican health regulatory agency, of an anticancer product developed under a repositioning approach. Among the barriers impeding drug innovation in Mexico are, but not be limited to, insufficient funds for the discovery phase; unaffordable or limited capacity for performing preclinical studies under good laboratory practices (GLP); lengthy clinical trial appr...