Amendment to the Regulations on Health Supplies
The reform redefines the concept of a new molecule, strengthens patent linkage and regulatory data protection, introduces mechanisms to compensate for regulatory delays, and extends the renewal periods for marketing authorizations.
The reform introduces structural changes to Mexico’s marketing authorization framework and strengthens several mechanisms designed to protect intellectual property and pharmaceutical innovation.
The principal changes include the following:
The concept of a “New Molecule” is redefined to include any drug, biopharmaceutical or substance with therapeutic, preventive or rehabilitative activity that does not have a marketing authorization in Mexico. Accordingly, the absence of a marketing authorization becomes the principal criterion for determining whether a product qualifies as a new molecule.
The role of the New Molecules Committee is modified by eliminating the preliminary technical meeting with the applicant and incorporating the Committee’s opinion into the marketing authorization review process. When a product has previously been authorized by a recognized foreign authority, the Committee’s opinion will only be required if associated risks are identified, which may streamline the procedure in certain cases.
The patent linkage mechanism is strengthened and aligned with applicable legislation and the lists published by the Mexican Institute of Industrial Property (“IMPI”). Additional requirements are also introduced to demonstrate patent ownership or the existence of the corresponding licenses. For generic and biosimilar products, applicants may declare that no patents are infringed, while the authority may request a technical opinion from IMPI.
A mechanism is introduced to compensate for unreasonable delays attributable to the authority in granting marketing authorizations for allopathic medicines. When such delays affect the effective exclusivity period of a patent previously identified in the application, the patent holder may request an adjustment to the term of one of the patents covering the medicine through a supplementary certificate, which may not exceed five years.
With respect to regulatory data protection, a five-year exclusivity period is established for technical and scientific information concerning the safety, quality and efficacy submitted to obtain a marketing authorization for medicines containing new molecules. During this period, such information may not be used by third parties without the consent of the holder, directly affecting the timing of market entry for generic medicines.
The term of marketing authorization renewals is extended to align with the General Health Law. The first renewal period increases from five to ten years, and subsequent renewals will generally also be granted for ten-year periods.
Taken together, these changes are intended to reduce regulatory uncertainty, strengthen protection for pharmaceutical innovation and bring Mexico’s framework closer to international standards. The adjustments relating to patent linkage, regulatory data protection, compensation for regulatory delays and the duration of marketing authorizations are particularly relevant.
The scope of these provisions will need to be assessed on a case-by-case basis and, where appropriate, regulatory and intellectual property strategies associated with the development, registration, protection and commercialization of pharmaceutical products in Mexico should be reviewed.
Von Wobeser y Sierra is available to assess the implications of this reform and assist in defining regulatory and intellectual property strategies according to the needs of each product and transaction.
