The Legal Framework for Gene Therapy Treatments in Mexico
By Moeller IP Advisors
Gene therapy is a pioneering medical technique which consists in introducing genes or other genetic materials into a patient’s cells for therapeutic purposes. Genes are inserted to correct or replace abnormal or mutated genes into the patient’s body. Gene therapy has been developed to cure hereditary genetic conditions but late discoveries seem to give partial evidence that this technique could also have a promising role in treating acquired conditions like cancer.
However, since gene therapy is an extremely innovative technique, in its early stages, the legal framework has to effectively keep up with it, especially in developing countries like Mexico.
Patentability Issues in Mexico for Gene Therapy Treatments
It is clear that protecting the creation of gene therapy techniques can become pivotal for allowing the development of these treatments. Is gene therapy currently protected under Mexican Intellectual Property Laws?
Most of the time, gene therapy involves a surgical procedure for inserting the genetic materials into the patient’s body. This is particularly critical: indeed, it is well-known that Mexican Industrial Property law, in line with many other IP laws in South America, does not allow the patentability of medical methods.
Article 19 of the section 7 of the Ley de propiedad industrial establishes that “surgical, therapeutic and diagnostic treatment methods for the treatment of the human body and those related to animals” are not to be considered inventions.
This is particularly important. While gene therapies do not only involve innovative procedures, but also tangible components like modified cells or other materials, it is undeniable that the surgical method assumes a central role. Until the patentability is denied to the method, the whole therapy cannot be effectively protected by IP law in Mexico.
Legal Issues related to Health Safety of Gene Therapy Techniques in Mexico
Another criticality arises when the necessary health safety assessment comes into play. Indeed, although gene therapies can be considered as extremely promising techniques, they are still in most cases carried out under experimental conditions. To date, gene therapy has failed to prove its effectiveness in the totality of examined cases and its safety for use is also under scrutiny.
Moreover, the legal criteria for evaluating the safety and effectiveness of this new technique are still not properly defined in Mexico. Indeed, the Mexican General Health Law establishes that healthcare providers must be licensed and authorised by Cofepris, the Federal Commission for the Prevention of Health Risks, before they start experimental medical procedures.
But specific safety guidelines that the Cofepris can follow for granting approval to gene therapies currently do not exist.
The most immediate consequences of such an unclear legal framework is that, on the one hand, pharmaceutical and research companies are not encouraged to settle and invest in Mexico; on the other hand, the unclarity in the legal regime has created a panorama of clinics and providers that perform experimental treatments with little or no evaluation of the health risks by the competent authorities. Given its proximity to the US, Mexico could benefit from a flux of investments, companies, and, last but not least, patients – motivated by the relatively lower costs of the infrastructure and the personnel. However, the normative gap needs to be filled as soon as possible.