This article discusses a number of changes to the cannabis legal landscape which have taken place in Mexico over the past few weeks.
COFEPRIS issues guidelines for drug and industrial products
The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) recently published on its website guidelines on the sanitary control of cannabis and cannabis derivatives. These guidelines do not substitute the legal mandate for specific regulations, but rather aim to inform companies which are interested in the Mexican market of how the COFEPRIS intends to address permit requests regarding cannabis.
These guidelines will regulate the following matters.
Research protocols The guidelines specifically refer to the need for prior authorisation for protocol-related activities. Notably, the guidelines list planting and growing cannabis as protocol-related activities that can be approved.
Further, the guidelines state that any company requesting protocol approval must be registered in the newly created National Cannabis Research Inventory.
Medical use According to the 2017 legal reform, the definition of 'medical use' is subject to drug marketing authorisations. The guidelines stipulate that planting and growing cannabis are permitted activities that can be approved via an authorisation process.
The import of previously authorised drug products is allowed, as long as the importing company has a facility licence for narcotics.
For products that are not approved in Mexico, the guidelines confirm that individual patients with a valid prescription can obtain an import permit.
Products used in industry Products (eg, cosmetics, insect repellents and hemp), raw materials and substances with a tetrahydrocannabinol (THC) concentration of less than 1% can be imported, manufactured and marketed following a prior sanitary evaluation by the COFEPRIS. The guidelines set out the requisites for such an evaluation.
Food, supplements and alcoholic and non-alcoholic beverages Food, supplements and alcoholic and non-alcoholic beverages with a THC concentration of less than 1% are subject to prior authorisation.
Herb-based medicines The guidelines set out the rules for obtaining the relevant approval for herb-based medicines.
Supreme Court decision regarding prohibition on adult use
In November 2018 the Supreme Court issued its fifth decision granting constitutional protection against the adult use prohibition. In these decisions, the court had prohibited the plaintiffs from establishing businesses or marketing cannabis, but determined that they could not be prosecuted for using recreationally, possessing or growing cannabis.
This latest decision is mandatory for all judges. Now, if any party files a request for an adult-use permit and this is refused by the COFEPRIS, a judicial challenge would be immediately successful.
Under a strict human rights interpretation, sanitary authorities should also observe the decision, although their approach has usually been to wait for changes to the law before adapting their decisions to follow court jurisprudence. In this regard, the below legal changes are expected shortly.
Bill implementing General Law for Cannabis Control
Congress was recently presented with a bill to implement the General Law for Cannabis Control. The bill concerns the concepts referred to in the new COFEPRIS guidelines, as well as other concepts, activities and products relating to cannabis that will be legalised and regulated.
If passed by Congress, the General Law for Cannabis Control will regulate the growing, cropping, production, transformation, packaging, promotion and marketing, publicity, transportation, sale and consumption of cannabis whether for recreational, industrial, medical, research or other purposes.
The bill also proposes that a new regulating entity under the Ministry of Health be created to enforce the applicable provisions regarding cannabis and its derivatives.
In addition to this law, it will be necessary to amend a considerable number of laws in order to reflect the change from a total prohibition to the full recognition of the possible activities and products deriving from cannabis. It will also be necessary to amend a range of laws, regulations and guidelines with regard to the use of cannabis in food, dietary supplements, cosmetics, medicines and other industrial products, as well as provisions governing its use in public and private spaces.
Certain provisions regarding the above products, as well as tobacco products and alcoholic beverages, are expected to form the basis of the new provisions.
Laws and provisions regarding agricultural issues must also be amended once the General Law for Cannabis Control has been implemented.
Finally, Mexico has executed a range of international agreements and treaties regarding the limitations on the use of cannabis. These must undergo review to ensure that they complement the proposed new law.
For further information on this topic please contact José Alberto Campos Vargas or Juan Luis Serrano-Leets at Sanchez-DeVanny Eseverri SC by telephone (+52 55 5029 8500) or email ([email protected] or [email protected]). The Sanchez-DeVanny Eseverri SC website can be accessed at www.sanchezdevanny.com.
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