Mexico defines orphan drugs, but questions remain; US patent deal

Earlier this year, on January 31, new provisions of the Mexican General Health Law (GHL) came into force, containing for the first time a definition of orphan drugs, explains law firm Olivares & Cia in a posting on the IP Tango blog.

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 five 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 R&D. Implementation of the new provisions lets the Health Ministry, through the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), issue marketing authorizations 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, says Olivares & Cia.