Image credits: Wikimedia Commons
/
Analysis

Medical Cannabis: Legal Status and Health Benefits

By Miriam Bello | Mon, 11/30/2020 - 11:27

Cannabis has been used for medicinal purposes for centuries. However, most countries prohibit its use, Mexico included. Making medical cannabis use a reality requires numerous areas to join efforts and solve the complexity of a large legal subject. There are several entities playing a key role in cannabis regulation, from the Ministry of Health and COFEPRIS to the Ministries of Trade, Economy, Agriculture, Finance and Pubic Credit, among others. It is a complicated subject that requires commitment and coordinated participation from Mexican authorities.

Mexico’s decriminalization and regulation initiative intended to pave the way for cannabis to become not just an option for therapy but an active market. According to studies made by Grand View Research, the global marijuana market will exceed US$76 billion by the end of 2027 and Mexico has a US$2 billion earning potential with the creation of 70,000 formal jobs, according to New Frontier Data. However, regulation is a must for this to become a reality.

According to an MBN interview with María Fernanda Arboleda, International Director of Medical Services at KHIRON Life Sciences Corp, “the lack of regulation creates a legal vacuum that causes illegal commercialization of the drug. Neglecting these regulations also endangers the patient as they are illegally accessing products with unknown quality standards.” Arboleda explains that the Cannabis plant is exposed to infections, fungi and other bacteria and its illegal distribution has resulted in severe health complications for some patients. 

Current Status of Regulations

The decriminalization of medical use of cannabis was granted in 2017 in Mexico. Later, in 2018, the Ministry of Health presented to COFEPRIS the Guidelines on Health Control of Cannabis and Its Derivatives, for pharmacological, medical and research purposes. The guidelines stablished the sanitary criteria to commercialize, export and import products for industrial use that contain derivatives of cannabis with THC concentrations of 1 percent or less. However, these were revoked after President López Obrador entered office and discussion resumed two years after.

The first submitted Guidelines on Health Control of Cannabis and Its Derivatives from 2018 indicated the legal sanitary guidelines for evaluation and authorization of such products. That was the first step towards a regulatory framework in the subject, which would allow the actual use of medical cannabis in Mexico. According to the then COFEPRIS’ Commissioner Julio Sánchez y Tépoz, the goal was to allow sowing, cultivation, harvest, elaboration, preparation, conditioning, acquisition, possession, trade, transport, medical prescription, supply, employment, use and consumption of cannabis, solely for medical and scientific purposes and with prior authorization from the Ministry of Health.

In 2019, already a couple months into the López Obrador administration, COFEPRIS revoked the 2018 guidelines as they were contemplating a broader use spectrum that allowed the commercialization of cannabis-derived products that were not contemplated under the mandate that reformed the General Health Law regarding the medical use of cannabis. Moreover, these initial guidelines contravened regulations regarding the establishment of non-tariff regulations on foreign trade, stated in the Foreign Trade Law, which should have been previously approved by the Foreign Trade Commission and published on the Federation’s Official Gazette to then modify the regulatory tariffs of the Ministry of Health regarding goods which were currently prohibited for commercial use.

Likewise, there is no evidence that such guidelines were introduced to the National Commission of Regulatory Improvement, whose approval should have been published on the Federation’s Official Gazette. COFEPRIS eliminated the possibility of products being marketed in national territory without authorization, in accordance with the current legal framework. “With this, the health of all Mexicans is protected and all processes are ensured to follow the legal framework and the rule of law,” stated the commission, during a press conference. COFEPRIS also called to reform several cannabis dispositions on the General Health Law, which are still pending.

After two years and a half (Sept. 2020), the Ministry of Health presented a second proposal for the Guidelines on Health Control of Cannabis to CONAMER. While this step was seen as an advancement, there was still much room to be addressed to set clear rules for a cannabis industry.

What do these guidelines allow?

  • The proposed law states authorities can monitor the production of cannabis for pharmacological and agronomic research purposes.
  • It regulates the prescription of drugs using barcode-controlled formats.
  • The regulation allows the importation of raw materials to Mexico, molecular complexes, pharmacological derivatives and medicines.
  • It supports strict management of the entire production chain, from obtaining seeds to distribution and marketing of drugs.
  • As for plant production, it establishes that production will be allowed at confined sites, which will be isolated from the population.

According to expert opinions from Excelsior, this was a conservative measure that considered only pharmaceutical companies and research means for the plant because it solely allowed authorities to monitor cannabis production for pharmacological and agronomic research purposes. Moreover, the measure did not consider the creation of regulatory agencies. However, the guidelines served to keep pushing the matter toward the Senate to eventually expand its regulation and approval for other medicinal uses like those in the American or Mexican pharmacopoeia, the books on herbal remedies.

In March 2020, the Senate introduced a law initiative for the legal use and decriminalization of cannabis use for medical and recreational use but it was dismissed as it came right along the new Federal Law for Cannabis Regulation, which was not yet finished at the time. Months after, on Nov.19, the Senate approved the dictum on the Federal Law for the Regulation of Cannabis under the scope of public health, human rights and sustainable development. With this approval, the creation of the Mexican Institute for the Regulation and Control of Cannabis, as well as reforms to the current General Health Law are also foreseen. The Chamber of Deputies is now expected to vote on it and make the use of cannabis a reality in Mexico. Medicinal, palliative or pharmaceutical use, as well as scientific use, will be overseen by the General Health Law and its regulations, but other uses will be opened up as well.

What are the benefits of medicinal cannabis?

 “We have come to realize that medical cannabis is especially helpful for neuropathic chronic pain from a herniated disc, diabetic neuropathy or fibromyalgia. Right now, we are focusing on determining which component is the most helpful: THC or CBD,” Arboleda told MBN. According to her, it is hard to know the exact number of patients that can benefits from the uses of medicinal cannabis because not every patient is suited for those therapies. To know that, regulation to begin research is a must. However, Arboleda did say that at least in Latin America, medical cannabis could meet the needs of 68 million patients. “From that number, in Mexico, 11.7 million patients could benefit from medical cannabis treatments.”

The plant has around 400 chemicals called cannabinoids and CBD and THC are the ones available in the largest quantities. The American Academy of Neurology has analyzed the therapeutic vs the psychoactive effects of cannabis products in botanical and pharmaceutical preparations. According to Healthline, THC is the main psychoactive compound in cannabis. It is available in oils, edibles, tinctures, capsules and it can be consumed by smoking cannabis. CBD is shown to help with anxiety, depression and seizures. It is sold in the form of gels, gummies, oils, supplements, extracts and more. While Healthline mentions they both have similar medical benefits, THC has euphoric effects and CBD does not. CBD is used to help with other various conditions, such as seizures, inflammation, pain, psychosis or mental disorders, inflammatory bowel disease, nausea, migraine, depression and anxiety. THC, on the other hand, is used to help with pain, muscle spasticity, glaucoma, insomnia, low appetite, nausea and anxiety.

There are several therapeutic areas that could be favorable impacted by the use of cannabis:

  • An article by the Harvard Health Blog (HHB) highlights benefits in chronic or severe pain relief for diseases such as multiple sclerosis, nerve pain, post-surgical pain or broken bones. Also, cannabis can generate muscle relaxation, which can benefit Parkinson’s tremors.
    • THC and CBD oils are used to treat arthritis pain.
  • It can help with alcoholism and drug addiction. Clinical Psychology Review said that using marijuana may help people with alcohol or opioid dependencies to fight their addictions.
  • Cannabis can help with anxiety and can also be used to treat other mental health problems, such as depression and post-traumatic stress.
  • It can also reduce side effects of chemotherapy for cancer patients as it reduces nausea and vomiting.
  • The Medical Cannabis Network (MCN) says cannabis is linked to insulin regulation, blood sugar stabilization, lower blood pressure. Therefore, it can contribute to regulating or preventing diabetes.
    • Additionally, its properties on reducing blood pressure contribute to treating glaucoma.
  • MCN describes cannabis as a focusing agent, helping people with ADHD and ADD.
  • Cannabis has anti-inflammatory agents that can fight the brain inflammation that produces Alzheimer’s disease, according to MCN.
Photo by:   Wikimedia Commons
Miriam Bello Miriam Bello Journalist and Industry Analyst