In June ----, Mexico outperformed Brazil (for the first time) in terms of attracting investment from Germany. According to German Expo, German pharmaceutical companies rated investment opportunities in Mexico over the rest of Latin America due to its stability. ...In the same month, Pfizer also launched MXN---mn (USD--mn) in clinical research in Mexico. From September ----, Mexico s Federal Commission for Sanitary Risk Protection (COFEPRIS) will accept English-written documentation for the registration of innovative drugs, highlighting the theme of streamlined pharmaceutical regulation. The measure will apply to three of the five modules that make up the registration dossier, including sections that discuss results from preclinical and clinical trials. ...From September ----, Mexico s Federal Commission for Sanitary Risk Protection (COFEPRIS) will accept English-written documentation for the registration of innovative drugs, highlighting the theme of streamlined pharmaceutical regulation. The measure will apply to three of the five modules that make up the registration dossier, including sections that discuss results from preclinical and clinical trials.
...The lack of coordination between IMPI and the COFEPRIS has held back improvements in patent protection. Continued failure to enforce domestic patent law may continue to limit investment and product launches by multinationals. IMSS and ISSSTE bureaucracy has resulted in long waiting times for clinical trial approvals, representing a threat to investment in clinical development. Possible reduction of local manufacturing levels due to increasing competition from imports originated from lower cost bases such as China, India and Brazil. The establishment of a centralised public procurement mechanism in conjunction with other Latin American countries will have a negative effect on market values. ...Possible reduction of local manufacturing levels due to increasing competition from imports originated from lower cost bases such as China, India and Brazil. The establishment of a centralised public procurement mechanism in conjunction with other Latin American countries will have a negative effect on market values.
...Despite recent reforms, the enforcement of domestic patent law remains problematic. ...An inefficient coordination of regulatory and healthcare policies has contributed to high pharmaceutical prices. Law enforcement, particularly regarding counterfeit medicines, is sporadic and overshadowed by other major issues, including cartel-related violence. Red zones, or black markets, are known to the authorities and private security is a known overhead cost to manufacturers operating in Mexico. ...
