Overview of the cannabis reform in Mexico and its implications in patent protection
For the last three years and in response to the changing needs, a lot of work has been put into developing a solid legal framework that addresses the rapidly changing concerns regarding cannabis in Mexico. Specifically, the General Health Law and the Federal Penal Code have been reformed.
These laws involve the regulation of the plant (Cannabis sativa, indica, americana or commonly known as marijuana), its pharmacological derivatives, its cannabinoids and specifically the psychoactive substance denominated tetrahydrocannabinol (THC), its isomers and stereochemical variants.
The reformed Federal Penal Code contains an amendment on article 198 which states that the sowing, cultivation or harvesting of marijuana plants will not be punishable when these activities are carried out for medical or scientific purposes.
However, it was the General Health Law the one with the most relevant changes. Firstly, Article 235 bis was added, which establishes that the Ministry of Health must design and execute public politics that regulate the medical use of the pharmacological derivatives of Cannabis sativa, indica and americana, including tetrahydrocannabinol, its isomers and stereochemical variants as well as to regulate the investigation and national production thereof.
Also, the recitation of cannabis was eliminated from the list recited in Article 237 of the General Health Law which prohibited all activities related to the chain of production, conditioning, possession and consumption of cannabis, resulting now in the stipulate that the plant and its derivatives can be used for medical and scientific purposes.
Furthermore, Article 245 of the General Health Law, was also modified. Article 245 refers to the classification of psychotropic substances in five groups. THC was deleted from group I which refers to psychotropic substances with null therapeutic action and susceptible to be a specially serious problem in public health; group II now lists THC by referring to it as a psychotropic substance that has a therapeutic action but also constitutes a serious problem for public health when it is in a concentration of 1% or more; it is further included in group IV which is directed to psychotropic substances that have therapeutic action but do not constitute a serious problem for public health when THC is in concentrations less or equal to 1%. Finally, it was also included in group V stating that derivatives of cannabis in concentrations of 1% or less of THC with broad industrial uses are allowed to be commercialized, exported and imported.
Finally, Article 290 of the General Health Law which authorizes import of psychotropic substances is also amended now to include pharmacologic derivatives of Cannabis sativa, indica, and americana, including tetrahydrocannabinol its isomers and stereochemical variants.
Now then, the Transitory articles in the Decree by which the General Health Law was reformed in 2017 stipulated that the Ministry of Health had 180 days starting from June 20th, 2017 to harmonize the regulations on the therapeutic use of tetrahydrocannabinol (THC) and its stereochemical variants.
The deadline arrived on December 17th, 2017, but it was not until the end of October 2018 that the Ministry of Health via the Federal Commission for Protection against Health Risks (COFEPRIS) issued the “Guidelines for Health Control of cannabis and its derivatives”.
However, only a few months later, at the end of March 2019, a press release issued by the Ministry of Health in conjunction with the Ministry of Economy reported that these Guidelines had been revoked on the basis of three main reasons: (i) the Guidelines included contraventions to the Reform of the General Health Law, (ii) there were omissions in matters of non-tariff foreign trade regulations and (iii) violations of the Federal Law of Administrative Procedure and the General Law of Regulatory Improvement.
The Guidelines were against the provisions of the Decree by which the General Health Law was reformed in 2017 because they had authorized the marketing of various products (herbal remedies, foods, nutritional supplements, non-alcoholic beverages and alcoholic beverages) comprising THC for purposes that are not therapeutic or scientific.
The Ministry of Economy ruled that the guidelines contravene the Foreign Trade Law and its Regulations, since they lacked the approval of the Foreign Trade Commission. Additionally, the merchandise that was supposedly approved in these Guidelines remains prohibited in the Tariffs of the Law of General Import and Export Taxes.
Finally, there was no evidence that the aforementioned Guidelines and their corresponding Regulatory Impact Analysis were ever submitted to the National Commission for Regulatory Improvement, in accordance with Article 71 of the General Law on Regulatory Improvement, in addition to not having been published in the Official Gazette of the Federation as ordered by articles 4 of the Federal Law of Administrative Procedure and 76 of the General Law of Regulatory Improvement, therefore the Guidelines did not produce any legal effect whatsoever.
Thereby, the above-mentioned revocation includes important challenges for Mexican lawmakers in the immediate future, for example, to successfully achieve the harmonization of the regulations applicable to matters of cannabis within all the government ministries involved in said matter and last but not least, to review the “authorizations” previously granted by COFEPRIS for cannabinoid-containing products (which currently ascend to 38).
It is clear that the cannabis industry is emerging to be one of the strongest in the coming years. In the period from 2015 to 2019, approximately 120 patent applications related to cannabis have been filed in Mexico and the Mexican Gazette of Pharmaceuticals (similar to the US Orange book) already includes the cannabis-related patent 277949. Said patent protects a pharmaceutical formulation that comprises both tetrahydrocannabinol (TCH) as well as cannabidiol (CBD), thus confirming that it is possible to obtain patents for products comprising cannabinoids. Notwithstanding, in view of the conclusions of the revocation, it seems that the products with the best potential of being granted and marketed are those destined for medical uses which provide a much needed solution to typically painful diseases such as cancer and HIV/AIDS, but also to orphan diseases such as Lennox-Gastaut and West syndromes.
It is important to bear in mind that food, nutritional supplements and cosmetic uses could also fall within the scope of medical purposes accepted for cannabinoids.
It is expected that with the changes in the law above mentioned together with a soon and complete harmonization of the institutions involved, patented products related to cannabinoids having a medical use will have a prompt approval of the Federal Commission for Protection against Health Risks (COFEPRIS) to be commercialized in our country, making Mexican market attractive for industries and investment in this field.
by Erika Paz and Anna Arroyo