The Regulations Implementing the Law on Production, Import, Marketing and Sale of Generic Medicines for Human Use has seen a recent reform, in particular through Executive Decree 1159, which removes the requirement that ‘reference medications’, once the patent expires, must modify their product marketing authorization to comply with the labelling requirements of a generic product. Instead, a reference medication must now modify its marketing authorization by changing the labelling in accordance with the new provisions of Decree 1159. This means specifically that upon expiry of the patent for a reference medication, the label must contain the International Nonproprietary Name with priority given to the words ‘Medicamento de Referencia’ (Reference Medication) above the name of the manufacturer. It is important to highlight that the regulation states “above the name of the manufacturer”, that is, it is understood that the trademark may still be predominant on the label.
In summary, the requirement that reference medicines be marketed as generics upon expiration of the patent is removed. However, instead of its complete removal, a new type of medication is created, a reference medication, not currently catered for by any other legal instrument.
Decree 1159 will enter into force once published in the Official Gazette. Notwithstanding this, its application will only be compulsory following 12 months from said publication.
13th September 2016