At the beginning of April, the Federal Commission for the Protection of Sanitary Risks (Cofepris) established new guidelines on the importation of drugs designed to facilitate the entry of medicines from overseas. Amid this, the Health Commission of the Business Coordinating Council (CCE) called for equity between international drugmakers and pharmaceutical companies operating in Mexico, while warning of the risks to citizens of a relaxation in these requirements. The government thus seeks to simplify the processes for health authorization by the Cofepris and drive down prices through more competition in the national industry.
The business chamber argues that the decree, published in the Official Gazette (DOF) March 29, should put both foreign and national participants of the sector on an equal footing. As it is, the guidelines establish the requirements, tests, evaluation procedures and other requirements that foreign regulatory agencies must comply with in order to import drugs and medical supplies into the country. According to Patrick Devlyn, president of the Health Commission of the CCE, this puts the local industry at a disadvantage, with it taking between seven months to a year to obtain a sanitary registration from Cofepris.
While the Council official highlighted the efforts of the Federal Executive branch to optimize public spending and extend health services to more Mexicans, he also requested the authorities safeguard the quality and safety of pharmaceutical products. For Devlyn it would be a mistake to omit the high standards of vigilance achieved for the marketing of health products, as it could affect people’s health and hurt Mexico’s reputation regionally and beyond. The government will seek to lower the costs of these goods and ensure access for the entire population, without impacting drug quality or safety in the process.