Mexico defines orphan drugs, but leaves questions unanswered

Earlier this year, on 31 January, new provisions of Mexico's General Health Law (GHL) came into force, containing for the first time a definition of orphan drugs. Under Article 224 bis of the GHL, an orphan drug is defined as a drug "to diagnose, treat, or prevent a rare disease, affecting no more than 5 in 10,000 individuals". This definition, which was previously contained in the Mexican Pharmacopeia, is now a matter of Federal Law.

Under Article 224 Bis 1 the Health Ministry is given the power to implement such measures as are necessary to encourage and promote access to orphan drugs, including the making of recommendations to National Health Institutes with regard to research and development. Implementation of the new provisions lets the Health Ministry, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), issue marketing authorisations for orphan drugs, in place of the simple official communications which have been issued since 2009. However, the new provisions do not provide an exhaustive body of law on the subject, nor do they establish Data Package/Regulatory Exclusivity for them. This being so, recognition of these rights may require litigation.

Source: newsletter from Olivares & Cia., SC, Mexico