The Road to Public Market For New Medicines

Drug regulation remains a complex process. In order to reach the Mexican public market, new medicines must pass through a number of processes. Drug development and import require separate processes, but both new local medicines and imported drugs are subject to COFEPRIS approval and to General Health Council (GHC) evaluation. The drug must then be included on the National Formulary before being evaluated by public institutions, and finally being made available to hospitals.

A 2014 survey conducted by IMS Health found that the process took an average of 4.3 years. Despite COFEPRIS speeding up the overall process to 3.1 years, Mexico’s regulatory processes lag far behind the UK, Japan (two years each), France (1.8), and the US (1.1). Indeed, the development of particular drugs is a complex process in its own right. From discovering a molecule to conducting in vitro tests, from preclinical studies to clinical trials, the early life of a new drug can last between eight and 12 years. The number of molecules that become safe and effective medicines remains somewhere around one out of every 10,000.

Changes to the COFEPRIS administration have streamlined the process, but difficulties remain. In the past, the transfer from GHC approval to the National Formulary could take up to 1.3 years, followed by examination periods of eight months as the relevant public institutions examine the drug’s case for incorporation in their formularies. Indeed, the number of new medicines included in IMSS’ register has dropped from 24 to four between 2011 and 2013. ISSSTE’s register included 23 new drugs in 2011. In 2013, none were added.

ISSSTE’s rate of rejection stands at 24%, with that of IMSS’ rising to 71%. Question marks over economic valuation led to 62% of IMSS rejections. Where the remainder of rejected substances is concerned, 15% were of uncertain safety and effectiveness, 8% failed to reach a population study sufficient to be considered, – and the remaining 15% of reasons were not disclosed. The problem is reciprocal. Pharmaceutical companies must be prepared to submit proper scientific, clinical, and economic evidence data. Meanwhile, the burden is on public institutions to streamline processes so that medicines are made available to patients within a shorter space of time.