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It’s time for Brazil to change its perception of medical cannabis

Latin Lawyer, 29.01.2020

The benefits are plain to see

Discussion about the legalisation of cannabis for medical, recreational and industrial use is a trending topic around the world, but there is still a lot of misinformation and stigma about the use of the plant. In medical use, cannabis-based medication (either in oil or capsule/edible form) can contain none or very low levels of psychoactive THC (so no, it will not get you high). It has largely been used in the treatment of epilepsy, eliminating or drastically reducing convulsions and allowing thousands of epileptic children to have a normal childhood.

Among other things, it has also been used to ease schizophrenia symptoms and Crohn’s disease, and to reduce pain for cancer patients. Medical cannabis is said to be clearly safer than opiates (since it is impossible to overdose on and far less addictive) and may be a substitute for non-steroidal anti-inflammatory drugs (such as Advil or Aleve) for people who have problems with their kidneys or ulcers.

This likely explains why legalisation of medical cannabis is sweeping throughout Europe, Asia, North America and Latin America. In South America, Uruguay, Mexico, Colombia and Peru are facing (and overcoming) their demons from the past admirably, legalising the cultivation and distribution of cannabis-based medication. Brazil, however, seems preoccupied with preconceptions, preventing thousands of patients from benefiting from access to cannabinoid treatments.

From criminalisation to legalisation

Partly influenced by the war on drugs (policies enacted by President Nixon in the 1970s and reinforced by President Reagan), most countries around the globe, including Brazil, prohibited the cultivation and commercialisation of cannabis.

But in the 21st century – after scientific investigation proved the benefits of cannabis – there was a radical shift in legislation. Canada legalised medical cannabis in 2001, and recreational cannabis was legalised in 2018. Israel has been considered the cannabis research capital of the world for decades. The country not only authorises medical use, but recently decriminalised the drug and approved export of medical cannabis (the government estimates that exports could generate US$273 million in taxes). In the US, 34 states have authorised the use of medical cannabis, and hemp was legalised by the Agriculture Improvement Act of 2018. More than 50 countries have approved the use of medical cannabis, including the UK, Italy, France, Portugal, the Netherlands, Australia, South Africa, South Korea and Thailand.

In Latin America, Uruguay was the first country to explicitly legalise cannabis for medical and recreational use in 2013 and Colombia was the first country to regulate medical cannabis in 2016. Mexico, Peru, Paraguay, Argentina and Chile have all approved the use of medical cannabis (Chile is currently the largest producer of hemp in Latin America).

In Brazil, the recreational use of cannabis is illegal. In 2006, the government passed the Anti-drug Law (Law 11,343/2006), which intended to be more flexible with possession of small quantities of the drug or cultivation for personal use. Personal consumption was still classified as a crime, but subject to milder penalties. A much criticised aspect of the law is that it does not define what a “small quantity” is and does not distinguish that from drug trafficking, so ultimately it is at the authorities’ discretion to decide, on a case-by-case basis. Studies point out that this has led to a highly subjective and unjust drug control system.

As to medical use, the Anti-drug Law states that the federal government can authorise the plantation and cultivation of – and extraction from – drug plants exclusively for medical and scientific use. It is up to ANVISA (Brazil’s national health agency) to regulate the medical use of the plant.

So far, cultivation of medical cannabis has not been regulated, and registration requirements are based on a generic regulation. Only one medication (Mevatyl) has been registered before ANVISA. In practice, local patients who are prescribed cannabis-based treatments must individually request authorisation for the import of the medication from ANVISA, which approves imports case by case. The agency is currently overwhelmed with requests for individual import permits, and the number of patients going to court to demand access is growing significantly. The cost and bureaucracy involved have interrupted or prevented the treatments of thousands of patients.

A turning point

On 13 June 2019, ANVISA conducted two public consultations that concluded 60 days later. In one – RDC 654 – it invited the public to comment on a draft resolution by the agency to review the registration procedures specifically for medicines manufactured with cannabis, its derivatives or synthetic analogues. The proposed regulation could allow the commercialisation of products that have completed the second (as opposed to the third) phase of clinical trials.

In the other consultation, CP 655, it invited the public to comment on a draft resolution to regulate the domestic cultivation of cannabis exclusively for medical and scientific purposes.

The possibility of allowing registration of cannabis-based medication before the conclusion of the third phase of clinical trials has been praised. But a relevant criticism is that the proposed regulation only applies to rare diseases that can only be treated with cannabis-based medication. Also, the regulation does not distinguish between medication containing only CBD and one that also contains THC. CBD, or cannabidiol, is the part of the plant that contains no psychoactive principles. THC, or tetrahydrocannabinol, is the natural chemical produced by the plant that contains psychoactive effects. Many treatments use CBD only, while others use CBD and a low concentration of THC. ANVISA could have proposed more flexible rules for medication containing CBD only.

Approval of cultivation would boost research and help build a regulatory framework for cannabis in Brazil. Many have commended the traceability requirements (the capacity to trace the plant from the acquisition of the seed until final processing and discarding), which are very important to ensure quality and safety. One criticism is that cultivation is restricted to legal entities, which will probably lead to elevated treatment costs. Also, obtaining a licence to cultivate the plant for medical and research purposes may be excessively bureaucratic and take unreasonably long.

The agency’s collegiate board of directors approved a new regulation for products derived from cannabis on 3 December, providing rules governing medical use, but the board postponed a decision on the cultivation of cannabis. Rumours suggested this was due to pressure from parts of the government.

The rest of the world – including other countries in Latin America – is legalising the cultivation and commercialisation of medical cannabis and, in doing so, stimulating research and the development of new medication and treatments that improve the health of thousands of patients. By contrast, Brazil is timidly discussing the registration of cannabis-based medication and cultivation by legal entities.

We are at an inflection point and it is time for careful thought. Brazil is the tenth-largest economy in the world with a population of more than 200 million, and it has the right climate – as well as highly successful agriculture and technology sectors – for the cultivation of cannabis.

The industry is moving forward rapidly, right before our eyes. Governments and stakeholders around the world are shaping their legal frameworks for cannabis. There is a great opportunity for Brazil to place itself among world leaders in the cultivation and distribution of cannabis-based medication – participating in a multibillion-dollar market, generating jobs, increasing tax collection and allowing access to treatment by thousands of patients.

It would be irresponsible to choose to be excluded from this multibillion-dollar market amid the country’s current efforts to boost its economy and, most importantly, to prevent thousands of individuals from accessing life-saving or easing treatments based on misinformation and stigma.

Either we march in the same direction as the rest of the world and properly regulate medical cannabis, or we opt to fall behind.

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Natalie Sequerra

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