Mexican domestic law is silent about Data Package Exclusivity (DPE). Actually, the current Health Law allows the indirect reliance on innovators’ dossiers by approving generics through interchangeability tests with no period of protection for the information provided by the innovator.
Based on TRIPS and NAFTA and the hierarchy of the international treaties in our legal system, Olivares & Cía. devised, structured and executed a legal strategy to obtain the recognition of DPE for products that deserve this protection. We obtained the only two legal precedents by a court of law, recognizing and ordering the agency in charge to grant marketing authorizations, COFEPRIS, to observe and recognize DPE.
Now, on June 19, 2012, COFEPRIS published in their official website an internal decree providing guidelines to observe and protect DPE in Mexico with the following main principles and considerations:
* Information submitted in a process of regulatory approval is protected against unfair commercial use and disclosure.
* Five years maximum protection. During this period of time, no one can use information provided by the innovator for the commercialization of the drug.
* COFEPRIS would grant approvals for generics once the five years of protection lapses, unless the generic drug proves safety and efficacy independently.
* Protection for undisclosed and unpublished experiments and information, with the exception for publication of data necessary to protect the public or when confidentiality measures have been taken to protect unfair commercial use.
* Protection provided for new chemical entities only and for the information and data provided to prove safety and efficacy.
* The gathering of the data involves considerable research efforts.
These guidelines demonstrate that the current administration of COFEPRIS is willing to recognize and protect DPE pursuant to NAFTA and TRIPS and there is no doubt that the decree is positive as it provides a higher degree of confidence to innovators; however, certain issues are not clear and require further clarification, i.e. would the guidelines apply to biological products? There are other approvals which require considerable efforts such as new formulations and indications; are they protected? The decree is also silent about the proceedings and measures to enforce and observe DPE rights, providing uncertainty to all the involved parties.
Finally, the main question and test will be the weight and strength of an internal decree versus the lack of domestic statutory law recognizing DPE. According to our legal system and taking into consideration that this decree can be disregarded or changed by an eventual new administration of COFEPRIS after the coming Presidential elections, our efforts and suggestions will continue focused to obtain a clear and specific regulation of DPE in the statutory law or regulation.