Cannabis and Narcotics for Medicinal Use in Mexico | PharmaBoardroom

Cannabis and Narcotics for Medicinal Use in Mexico

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Representatives of Olivares, one of the leading law firms in Mexico, explain the evolving status of cannabis and narcotics for medicinal use in the country. A new Bill authorizing the use of cannabis for medical treatments was passed by the Senate in December 2016, but there is still a long way to go before it, and other narcotics, are widely accepted by the Mexican government and society for medicinal use.

“The discussion among the Justices of the Mexican Supreme Court and the decision itself introduced the possibility of having approved clinical trials with cannabis, an eventual medicinal use of cannabis or pharmaceutical products with cannabis.”

Cannabis and Narcotics for Medicinal use still have an uncertain status in Mexico. Regarding the medicinal use of cannabis there is still debate since the Mexican General Health Law still contains a provision that forbids activities and conduct in Mexico related to cannabis and its derivatives; with respect with other narcotics, there is also a prohibition within our Health Law. However, there are some precedents introducing the medicinal use of cannabis, and for other narcotics there are some approvals granted with our current legislation which have been in force for many years now.

The prohibition stablished in the Health Law mainly forbids plantation, cultivation, harvesting, elaboration, preparation, conditioning, acquisition, possession, trade, transportation in any form, prescription, supply, employment, use, consumption and, in general, any act related with narcotics or any products that contains them. The Health Law specifically prohibits prepared opium, for smoking, diacetylmorphine or heroin, its salts and preparations, cannabis sativa, indica and american or marijuana or opium poppy papaver somniferum, papaver bactreatum and erythroxilon novogratense or cocaine, in any form, derivatives or preparations. Additionally, the Health Law establishes a list of narcotics for which approval is under the discretion of the Ministry of Health until they can be replaced in their therapeutic uses by other elements that, in their opinion, do not create dependency.

 

At the end of 2015, the Mexican Supreme Court of Justice debated whether “recreational” use of cannabis should be authorized by the Federal Commission for Protection against Sanitary Risk (COFEPRIS), the Mexican Health Regulatory Agency.

Four members of a Mexican non-governmental organization (NGO) contested the refusal of a petition filed before COFEPRIS to plant, cultivate, prepare, possess and transport cannabis for “recreational” use. They argued in part that the basis of the refusal and the corresponding provisions of the Health Law violated the civil right to express one’s personality and the rights of autonomy related to the human dignity that are recognized by the Mexican Constitution.

The District Court in charge of reviewing this Constitutional Action at the first stage dismissed the arguments. The NGO appealed and, due to the importance of the case, the appeal was taken up by the Mexican Supreme Court.

In brief, the Supreme Court Justices who decided the case declared certain articles of the Mexican General Health Law unconstitutional, as they foresee an extreme prohibition that is against these constitutional rights. The decision addressed that there is a minor health risk associated with cannabis, which is not severe and therefore does not require a strict prohibition like the one established by the related provisions of the Health Law.

The Supreme Court ordered COFEPRIS to issue the corresponding authorizations to these four members of the NGO, allowing them to plant, cultivate, prepare, possess and transport cannabis, but only for “recreational” use. The decision expressly excluded any act of commercialization, supply or any other activity that relates to disposal or distribution of cannabis. Finally, the Supreme Court‘s ruling considered that prohibiting the use of cannabis for “recreational” purposes is unconstitutional.

 

COFEPRIS complied with the decision on December 10, 2015, by granting to these four individuals the authorization to plant, cultivate, prepare, possess and transport cannabis for self-consumption on a “recreational” basis, excluding any commercial activity. The case is significant, but the ruling has limited impact at the moment, as it is directed only to these four contesting individuals. Although highly persuasive, the decision does not constitute binding jurisprudence to other Courts of Law.

Despite the fact that the case was mainly focused on “recreational use” of cannabis the discussion among the Justices of the Mexican Supreme Court and the decision itself introduced the possibility of having approved clinical trials with cannabis, an eventual medicinal use of cannabis or pharmaceutical products with cannabis.

Notwithstanding the foregoing, at the time, there was another relevant case, wherein the importation and personal use of a drug with cannabidiol as an active ingredient was approved by COFEPRIS. Also, at the end of 2015, as a result of a constitutional action filed before a Federal District Court by the parents of a girl who suffered several epileptic seizures, in fact around 400 seizures, during a day, COFEPRIS was ordered to approve the importation and personal use of a drug with cannabis. The story behind the legal case moved our regulatory authorities, who showed they were willing to help by facilitating the importation of the medicine with cannabis, but also that they were open to discussion on the medicinal use of cannabis.

These precedents have made a great introduction to relevant topics such as the medical use of cannabis and other narcotics. They have set an interpretation of the “prohibitionist system” established in the Health Law stating that the Law actually does prohibit the “recreational” use of narcotics, including cannabis, but such state prohibition shall not apply to a medicinal use.

The decisions by the Supreme Court and other Federal Courts have already had considerable impact on the Mexican legal system as it relates to the use of this drug. Various levels of the Mexican Federal Government have begun a serious and formal debate regarding the recreational and medical use of cannabis; thus, other narcotics.

On April 21, 2016 the Mexican President Enrique Peña Nieto submitted a legislative proposal aimed to authorize cannabis for medicinal use. The Bill is aimed to authorize cannabis for medicinal use (personal use), including investigational activities and granting marketing authorizations for medicines for which the active ingredient is THC. The legislative proposal should be materialized by some modifications to the Health Law and the Federal Criminal Code. For this purpose, the Mexican Congress has created a Technical Committee designed for the eventual issuance of regulations regarding cannabis.

The proposal by the Mexican President was approved by the Senate on December 13, 2016. Although, the Bill is still pending for approval by the lower chamber of the Mexican Congress; considering the judicial precedents by the Mexican Supreme Court of Justice and other Federal Courts, there are great probabilities that the Bill is also approved by this chamber as well.

On the other hand, although there is still debate and the regulation is still under interpretation on a case by case basis in most of the cases the “prohibitionist system” established in the General Health Law is applied.

Nevertheless, it is well known that there are approved pharmaceutical products which have a narcotic as an active ingredient. In one of the databases of COFEPRIS’ official website there are records of approved medicines with narcotics, such as Buprenorphine, Fentanyl, Sufentanil, Hydromorphone, Oxycodone, Tapentadol and Morphine. These are considered as narcotics in accordance to a list stated by a provision within the Health Law. Most of these substances are derived from opium, considered by our Health Law as a narcotic, and broadly included in the prohibition. Furthermore, in 2006, COFEPRIS granted an approval for a medicine containing nabilone, which is a synthetic cannabinoid.

Considering the nature of such substances the prohibition should have been considered prior to their approval, which did not happen. Therefore, the medicinal use was allowed under an exception to the rule, most probably due to the evidence of improvements and wellness that these substances provide to the patients.

“Any issue related to narcotics is still a very sensitive issue in Mexico at all the levels of government and society.”

In contrast, even though there is clinical evidence of the safe use of narcotics for medicinal use and that there are approved products using a therapeutic effect of a narcotics, any issue related to narcotics is still a very sensitive issue in Mexico at all the levels of government and society. Some of our authorities have spoken out against the medicinal use of cannabis or other narcotics in Mexico because they consider that narcotics represent a risk. They claim that our country does not have the required experience to govern and structure the legal framework to rule and enforce the use of narcotics and cannabis.

Although this approval of the Bill by the Senate and the precedents are a big step, we are only half way on having cannabis and other narcotics fully accepted and authorized for medicinal use in Mexico.

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