Preliminary draft regulations for medical cannabis in Mexico
Author: Gala Menéndez
On June 19, 2017, the reform to the General Health Law and the Federal Criminal Code to regulate pharmacological derivatives of cannabis entered into force.
In order to operate, this reform requires a regulation that indicates the analytical parameters, as well as the commercialization, importation and distribution of the plant. The preparation of such a document is the responsibility of the Federal Commission for Protection against Health Risks (Cofepris). But instead, a series of guidelines were issued in 2018 that were removed a few months later.
In view of the lack of regulations, the Supreme Court of Justice of the Nation (SCJN) issued an order that obliges the Ministry of Health (SSa) and Cofepris to formulate them before June 30, 2020, a date postponed once again due to the COVID-19 pandemic contingency and rescheduled for September 9 of the same year.
Cofepris sent to the National Commission for Regulatory Improvement (Conamer) the preliminary draft of the "Regulation on sanitary control for the production, research and medicinal use of cannabis and its pharmacological derivatives", which was published on its website on July 27. This stage consists of making the process transparent; the regulatory impact is reviewed and, subsequently, a consultation period is opened in which it is submitted for public review; this in order to receive comments from the public.
Under the argument of improving the approach to regulatory impact, Conamer returned the document to Cofepris.
Analysis:
It is essential to identify the authority responsible for cannabis regulation in Mexico. According to the 2017 reform to the General Health Law (LGS), the Cofepris is the responsible authority. This is one of the particularities of our country in terms of cannabis legislation; in other countries, this is done by agricultural, law enforcement and/or tax authorities.
For this reason, the draft secondary rules for medical cannabis, as well as its application and management (except in areas outside its powers, which shall be defined in the regulations) depend on the Cofepris. It should be noted that it does not dictate the creation of new agencies, as proposed in other legislative discussions (such as the creation of a Mexican Cannabis Institute), nor does it propose a greater budget allocation.
The Regulations must be consistent with and comply with the provisions of the LGS, essentially the following articles:
General Health Law.
Article 28: professionals who may prescribe medicines.
Article 107: establishments providing health services.
Article 224: classification of drugs into magistral, officinal, specialties.
Article 234: cataloging of cannabis as a narcotic drug.
Article 235: industrial uses of pharmacological derivatives of cannabis (in particular THC).
Article 245 Bis: design and implementation of policies that regulate the use of pharmacological derivatives of cannabis.
Regulation of Health Supplies (RIS).
Article 46: Management of control books in the establishments.
Article 49: annual forecast of the amount of material to be used the following year.
Article 50: professionals who may prescribe and type of special prescriptions.
Article 51: bar codes for special prescriptions.
Article 54: Legal possession of medicines.
From the above list, art. 245 of the LGS stands out, as it establishes the regulation of products that lack therapeutic value, that are used in an industrial manner and with concentrations of less than 1% of THC. This would seem to indicate that it refers to industrial uses of hemp in fibrous or floury applications such as bioplastic, wood substitute, textiles, supplements, etc., however, this interpretation is incorrect, since the LGS only regulates those that belong to the industry of health inputs.
In turn, the Regulation provides a series of definitions related to the medical use of cannabis. This section is a novelty, as it does not appear in any other regulatory body. Without this precision, it is impossible to regulate the matter. The concepts that stand out are:
Cannabinoids
Hemp
CBD
THC
The actions governed by the Regulation are as follows:
Production: for the primary production of cannabis (cultivation).
Research: research for health.
Pharmacological research: scientific activities on the study of drugs for human use.
Agronomic research: scientific activities for cultivation, including evaluation and development of varieties, management and characteristics.
Industrial: production of molecular complexes, pharmacological derivatives and drugs.
Medical: diagnostic, preventive, therapeutic, rehabilitation and palliative care purposes.
I. Production
Planting permit (art. 20 to 28)
A permit issued by the Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria (Senasica) must be obtained for cultivation (either for research or drug production). The permit application must include the following information:
Name,
company name,
tax domicile,
use of raw materials,
quantity to be planted,
estimated harvest (including residues),
logbook, agricultural production authorization,
control book,
harvest cycle schedule,
location of the confined site.
Senasica will be in charge of the National Registry of Cultivation Permits (Registro Nacional de Permisos de Siembra). Interested parties must also declare the characteristics of the facilities where they intend to plant cannabis. It is important to point out that it must be a confined place, know the UTM coordinates, total surface, federal entity, single access door, among other provisions.
Seed registration and production (art. 27 and 28)
It will be possible to apply for the registration or production of seeds in the National Catalogue of Plant Varieties before the National Seed Inspection and Certification Service (SNICS). A variety must be registered with the SNICS in the National Program for the Production of Qualified Seeds. The list of requirements is contained in the Regulations. The application must be accompanied by a series of requirements set out in the document.
II, III, IV. Research (art. 12 to 19)
In order to obtain the authorization of the Research Protocol,interested parties are required to submit the corresponding permit to Cofepris. The following must be declared: quantity of raw material, proof of origin, compliance with testing and traceability and research protocol. Researchers must have a professional license, accredited training and registration of clinical trials.
Research involving human subjects must be in accordance with Articles 41 Bis and 98 of the LGS, the LGS Regulation on Health Research and other provisions such as the internationally recognized Good Clinical Practices. In addition, considering the respect to Human Rights.
Annually, Cofepris will make an inventory of research centers, researchers, scientific publications and reports.
V. Industrial (art. 37 to 47)
The establishments that store and keep the raw material will be responsible for it and must have the documentation that proves its legitimate possession for at least three years. They must also have control books authorized by Cofepris and implement the Custody and Security Safeguard System.
The manufacture of the raw material must be recorded and signed by the laboratory manager and the requesting institution. The required data are: name of the raw material, lot number, quantity used, origin, use and destination, summary of the process. Cofepris will verify the above by means of a visit order.
From January to May, Cofepris must be informed of the estimated quantities required for the following year. National authorities are obliged to inform the International Narcotics Control Board (INCB) of the United Nations (UN).
Only establishments with a sanitary license will be allowed to sell the raw material.
IV. Physician (art. 29 to 33)
Article 29 states that only physicians, homeopaths and dental surgeons (for dental cases) may issue prescriptions with cannabis derivatives. There is no mention of the participation of veterinarians. This is one of the points that are contradictory, since in the LGS and the RIS these health professionals are recognized.
The procedure to obtain medical cannabis is that the professionals mentioned in Article 29 must request a bar code for special prescriptions from Cofepris. These must include, among other data, the number of days of treatment, presentation, dosage and date. The authorized professional must print the prescriptions on the spot.
In the case of establishments* authorized to supply medical cannabis: They must have a registry of professionals and patients with their personal data such as name, age, sex, conventional or fiscal address, the patient's diagnosis, their CURP, and the date of the prescription. The details of this item can be found in articles 30 and 33.
* Note: The 'establishments' considered are authorized drugstores, pharmacies or apothecaries, as mentioned in the LGS and the RIS. Statistics, data collection and control are the responsibility of these establishments (art.104 LGS).
Each facility will have a responsible person in charge of maintaining compliance with a list of obligations such as: reporting, security, control and record keeping. The prescription of cannabis medicines may be carried out in those health care services that give rise to the supply as long as they comply with the corresponding requirements for their operation.
Article 41 emphasizes that establishments must communicate to Cofepris the forecast of the quantities they will need the following year, information that will be communicated to the INCB. This notice must be made between January and May of each year. It will not be possible to acquire a greater quantity of the product until the next period.
Passengers on international trips (domestic and foreign) must carry and present a prescription with bar code and signature of the medical professional. Failing that, they must have the prescription issued by an authority of the nation of origin.
Other considerations to pay attention to:
Cannabis is prohibited in herbal remedies. In homeopathic medicines it will only be allowed when it is diluted or dynamized (art. 45 and 46).
Import authorizations (art. 50 to art. 54)
According to article 290 of the LGS, only drugstores and pharmaceutical laboratories may request the importation of raw materials, molecular complexes, pharmacological derivatives or drugs.
It will only proceed through authorized customs (not postal parcel services) when the country of origin also has a regulation on these substances, such as Canada, Colombia, Uruguay and some European countries. That is, authorized in accordance with the legislation of the country of origin, such as the Certificate under the Organization for Economic Cooperation and Development System.
Mexico is part of the INCB, which means that there is a maximum amount per country established for importing medical cannabis. The country has a quota of 14,015 grams.
Advertising and sales (art. 46, 86, 87 and 88)
Cannabis medicines may only be promoted to health professionals and not to the public. Additionally, they may not be presented in the form of a medical sample or original gift.
Sources:
Cofepris (2020). Reglamento en materia de control sanitario para la producción, investigación y uso medicinal de la cannabis y sus derivados farmacológicos. Recuperado de <PDF>, última consulta el 02 de septiembre de 2020.