Legal cannabinoid-based medicine in Mexico: challenges and perspectives

LEGAL CANNABINOID-BASED MEDICINE IN MEXICO: CHALLENGES AND PERSPECTIVES

Since last January 12, 2021, Mexico finally has a Regulation to prescribe Cannabinoid-Based Medicine (CBM) for thousands of patients and their families that have been waiting since 2017 for the publication of these so called “game rules”; that are nothing more than a set of rules and ordinances allowing them to access, via medical prescription, to drugs made from Cannabis and some of its more than 500 pharmacologically active compounds (including cannabinoids, terpenes, terpenoids and flavonoids).

We consider that the published regulations are a valuable instrument for the development of the national CBM industry and the clinical practice of this kind of therapy, as it lays the foundation for scientific research and medical use of the plant in our country. The regulation considers the production of Cannabis in our territory and ensures the exploitation and protection of the national Cannabis species’ genomics. The regulation also allows the importation of raw material for CBM as isolated cannabinoids (including psychotropic such as Tetrahydrocannabinol, THC), molecular complexes or herbal medicines, while preventing the importation of Cannabis flower.

With these rules, national farmers / producers are protected, and the opportunity arises to detonate the development of the Mexican fields. Additionally, these regulations allow the prescription of CBM by those professionals who are already prescribers, in accordance with the General Health Law (Mexican GHL) in force, i.e. physicians, homeopaths, dentists and veterinarians. In order to prescribe CBM, the use of the existing controlled drugs formulary and classified as Group I (narcotic drugs) according to Article 226 of the GHL (available to any of the aforementioned professionals at COFEPRIS) is proposed. The preparation of master formulas using CBM is also regulated which will allow from this moment on to have safe and affordable medicines, manufactured using good manufacturing practices and, what is most important from our patients’ point of view, available for immediate prescription.

The regulation is not, however, free of problems. For example, it does not differentiate psychotropic cannabinoids such as THC from non-psychotropic like CBD and CBG, or from the acidic forms of these (THCA, CBDA, CBGA) that also lack psychotropic activity and that, in addition, as is the specific case of CBD, have very promising therapeutic properties; a reclassification would allow this compounds to be used in the cosmetic industry and would also exempt them from being prescribed through the narcotics formulary, which in turn would make it more accessible for a greater number of patients. To be fair, the issue of cannabinoids’ reclassification is not in the scope of CBM regulations since it derives from the GHL current wording, specifically Articles 234 and 245. The opportunity to modify such articles is a power of the Legislative, who could modify the GHL while the General Cannabis Law is issued (whose controversial verdict was approved by the lower chamber representatives on March 8, the ratification or subsequent amendment corresponds to the Senate) in order to recognize the wide nature of cannabinoids, among which Δ8, Δ9 THC, CBN, and Δ9 THCV are the main psychotropics, and others like CBD, CBG, CBC, CBDV and non-decarboxylated acid forms like THCA, CBNA, THCVA, CBDA do not have a psychotropic effect and thus should not be considered narcotics. This reclassification is in line with the recommendation of the UN INCB, distinguishing between non-psychotropic Cannabis (better known as hemp, cultivated for the fiber to make textiles, among many other uses, and rich in CBD) and psychotropic Cannabis (which has been illegally cultivated to provide the highest possible effects, high in THC).

The published regulations do not allow the preparation of herbal remedies with Cannabis plant, requiring that such be registered instead as herbal medicines. Although this angle of the regulation is one of the most controversial in the public eye, our position is in favor of herbal medicines and against herbal remedies. The difference is significant: an herbal remedy can be labeled in such a way that the precise content of the active ingredients is not clearly specified, it is only enough to indicate the common names of the plants the remedy contains. As opposed to this, in an herbal medicine the concentration of the active ingredient must be precisely labeled. Especially in the case of CBM, it is neither desirable nor safe to ignore the contents of the active ingredients in the product, precisely because there are some cannabinoids psychotropic with potentially harmful effects for the patients. In the CBM, as with any other medicine or product intended for human use, we must demand traceability from the seed to the finished product, where each step is according good agricultural practices, which are the good manufacturing practices to elaborate herbal medicines and also with analytical controls to demonstrate the cleanliness and safeness of the medicine as to its level of microorganisms, absence of pesticides or herbicides, absence of heavy metals and other contaminants commonly found in Cannabis flowers. This represents a major challenge for the new CBM industry in Mexico, which must invest a substantial amount of financial and human resources to comply with these regulations. We believe this is the greatest challenge facing this nascent: the injection of resources to produce CBM must equal the investment to finance controlled, randomized, blind clinical trials, with the greatest number of participants; controlled clinical trials contributing to raise the quality of clinical evidence for the use of CBM in various pathologies; if we thoroughly analyze the evidence, it is not conclusive to recommend the use of CBM in many clinical contexts, where patients and physicians expect to see a positive effect of including these drugs in the clinical equation. The research cannot be ignored: critical steps cannot be overlooked if we aim to determine the efficacy and safety of these products for the Mexican population, with its genetic and geographic peculiarities that differentiate how we metabolize cannabinoids (or any other drug).

It would be unfortunate to repeat in Mexico the scenarios of Canada and Uruguay, where upon regulating the adult use of Cannabis, companies have focused their economic resources towards the production of CBM and have left forgotten to accompany such productive effort with a greater investment in high-quality clinical research, disguising the old pharmaceutical marketing model as “training” for healthcare professionals. Therefore, education becomes more of a talent recruitment for an industry that requires the medical profession to ensure the marketing of its products.

This leads us to another similar challenge for the new CBM industry in Mexico: ensuring that the training of healthcare professionals includes the endocannabinoid system, which as to date is not part of the health sciences curriculum; this training needs to be both academically and scientifically sound, as well as ethical and humanistic, in a relevant way for a country like Mexico, this meaning it should be free and available to most interested physicians and healthcare professionals.

In addition, it is necessary to invest considerable material and human resources in educating the Mexican society on the uses and limitations of Cannabis, both in the medicinal context and for adult use, since the stigma and misinformation still influence many of the opinions about the plant, and poorly informed society makes bad decisions.

It is our responsibility as physicians to demand from the Cannabis industry the level of safety and efficacy that we would demand from any other pharmaceutical industry, as well as sufficient investment in research to match the projected astronomical profits from the use of these products. As physicians, we are facing an invaluable opportunity to contribute to the education of our patients and their families with accurate, updated, and contextualized information on the use of this wonderful plant in the clinical context, and so contribute to destigmatize its adult use. Hopefully, we will know how to take advantage of it.

Luis David Suárez Rodríguez, M.D.

Specialist in Functional Medicine. Graduated from UNAM with a Medical Specialty in Acupuncture and Phytotherapy and another specialty in Physiological Regulation Medicine. He is a member of the American Conference for the Advancement of Medicine and of the Mexican and Spanish Association for Ozone Therapy. Since 2015, he has been part of the Scientific Advisory Committee of the International Scientific Committee in Ozone therapy. He has practiced functional medicine for over 12 years and has been working with medical Cannabis in his private practice for 8 years. Since 2011, he has been a member of the International Association of Cannabinoid Medicines (IACM). In 2018, together with other healthcare professionals, he founded the Mexican Association of Cannabinoid Medicine (AMMCann AC), a non-profit institution whose objective is the education of physicians and other healthcare professionals in the correct use of cannabinoid medicine in our country. He is currently the chair of the AMMCann AC. He is the author of several scientific articles on functional medicine and cannabinoid-based medicine, gives courses and conferences on these topics in both national and international forums.