Among other provisions, the recent modifications to the Health Supplies Regulations, which came into force on February 1 2008, have resulted in dramatic changes to the practice of obtaining safety approvals for medicaments. They address the problem of inadequate definitions in the regulatory framework, which previously led to difficulties in enforcing the data protection provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) and the North American Free Trade Agreement (NAFTA).

The measure with the greatest impact on the general interpretation of the IP provisions in the TRIPs Agreement and NAFTA is the removal of a confusing classification: the 'interchangeable generic medicament'. This classification gave rise to the market for 'grey generics' or 'lookalikes' - generic versions of medicaments which were registered on the basis of questionable data, not on the basis of bioequivalence tests, as interchangeable generics are. On February 1 2008 the classification 'interchangeable generic' ceased to exist and was replaced by three new classifications: 'generic medicament', 'reference medicament' and 'new molecule'.  

The rationale behind the new regulations is to control the market by considering every product as being of one of two types: those that fall within the definition of a 'generic medicament' and those that do not. The regulations exclude from this definition all medicaments which contain or constitute:

  • new molecules;
  • combinations of drugs not previously used in Mexico;
  • new indications; and
  • new formulations

Furthermore, the definitions require that in order for a generic medicament to be recognized as such under the new regulations, prior health approval must be obtained for a medicament comprising or consisting of a new molecule if such a medicament is already on the market and can potentially be used as a reference medicament.

One of the most significant effects of the changes is that the new definitions are intimately related to other changes in the granting of health approval. The new Article 167(V) of the regulations explicitly exempts generic medicaments from the safety and efficacy information requirement; bioequivalence tests relating to a reference medicament must be submitted instead - precisely the condition that prohibits Mexico from granting health approval for generic medicaments for five years from the date on which corresponding approval for a new molecule is granted in Mexico.(1) Under these provisions, the five-year term starts on the date on which approval is first granted in Canada or the United States (if the data on safety and efficacy was based on an approval obtained by the same applicant in those countries).

Some commentators have claimed that the Mexican government may interpret the exemption for generic medicaments in a manner which is inconsistent with international treaties to which Mexico is a signatory and may consider that an application for health approval for a generic medicament is not deemed to be supported by the data provided by the recipient of the initial approval. Nevertheless, the prevailing opinion is that the new regulations and the existing provisions of the Law on Health, the Industrial Property Law and the international treaties are now sufficiently consistent to ensure that the government does not take this approach. The safety and efficacy of a generic medicament are first demonstrated by the party that obtains approval for the reference medicament; this prior demonstration by the first applicant is the only reason for the generic medicament's exemption from the requirement to submit data on safety and efficacy. Therefore, the approval of a generic medicament under the new rules is directly supported by the data of the party which obtained the initial registration.

The regulations were not modified expressly to require safety and efficacy information on medicaments containing or consisting of new molecules. The requirement to submit such information applies to all non-generic medicaments  - all other medicaments are subject to the safety and efficacy requirements, which raises the question of the kind of information that should be submitted for other medicaments. The new definitions effectively provide that any medicament that does not fall within with the definition of a 'generic medicament' is a new molecule medicament; otherwise, it would have to have the same main active ingredient, pharmaceutical form, concentration and formulation as a reference medicament. If a reference medicament does not exist, the medicament was not previously registered in Mexico and cannot be a generic; thus, it falls within the definition of the 'new molecule' classification.

If it differs in any respect from a reference medicament, a medicament is not a generic medicament, but rather a new molecule that, by definition, was obtained through health research activity. Health research activities must be conducted in accordance with the the implementing regulations of the General Law on Health Regulations on Health Research Matters, which have long been provided for in the interpretation of the Law on Health, but are particularly relevant in light of the new definitions of the Regulations on Health Supplies.

Article 65 of the implementing Regulations on Health Research Matters contains the most relevant provisions in this area. The administration of 'new molecules' (as defined in the new Health Supplies Regulations) in the context of human use falls within the definition of 'pharmacological research' in Article 65. Articles 66 to 68 specify the nature and contents of the data that must be provided and the protocols that must be complied with in order to demonstrate safety and efficacy. Such protocols cover subjects ranging from the administration of a product to humans for the first time to data for large population groups. Furthermore, the new definitions in the Health Supplies Regulations imply that if the relevant pharmacological research was conducted in Mexico, the holder of the first approval must have obtained authorization from the health authorities for the performance of the corresponding studies; otherwise, the information provided to the authorities is deemed to have been obtained in violation of the regulations on health research.

Consequently, the regime formally exempts health approvals for generic medicaments from the requirement to submit safety and efficacy data under the new Article 167(V), replacing it with a bioequivalence test. Therefore, the Mexican authorities cannot grant approval in respect of a generic medicament until at least five years after the date of first registration of the reference medicament, as the approval procedure for such products is shortened on the basis of bioequivalence and bioavailability studies. Under Article 1711(6) of NAFTA, such approval procedures are subject to data protection.

The new regulations have greatly reduced the confusion caused by interchangeable generics, which has led to abuses, the development of a grey market and the production of lookalikes. This positive development has in turn enhanced the authorities' ability to enforce the data protection provisions of key international treaties.

For further information on this topic please contact Héctor Elias Chagoya Cortes at Becerril, Coca & Becerril SC by telephone (+52 55 5263 8730) or fax (+52 55 5263 8731) or by email ([email protected]).


(1) Under various International treaties, notably NAFTA (Article 1711(6)).