Brazil Edges Closer to Domestic Hemp and Medical Cannabis Cultivation
New draft legislation that would allow Brazilian farmers to cultivate cannabis and hemp domestically was submitted to the nation’s lower house of Congress, the Chamber of Deputies, last week.
If approved, the country could have an established regulatory structure for domestic production in place by early 2021, expert consultants say.
Last year, Brazil’s pharmaceutical regulator Anvisa rejected a proposal to allow for domestic medical cannabis cultivation, but now lawmakers from the chamber’s special commission for the regulation of medicinal cannabis believe that opening up domestic cultivation could be a major income boost for Brazil in a post-pandemic economic landscape.
What does the draft bill cover?
In essence, the draft legislation sets out a framework for who would be authorized to produce cannabis and hemp plants on domestic soil, with accompanying sets of criteria and conditions on how this material should be cultivated and processed. The legislation would in no way affect the current prohibition on cannabis cultivation for recreational use, religious use, or self-cultivation.
The full text of the proposed bill is available to read online, posted on lawmaker Paulo Teixeira’s website. Teixeria is the president of the lower house’s special commission for the regulation of medicinal cannabis.
Under the new legislation, legal entities with the prior authorization from the public authorities would be allowed to cultivate cannabis, provided they adhere to relevant cultivation quotas, production tracking, and safety plans. Legally constituted patient association would also be allowed to pursue cultivation and would be given two years to adapt to the new system. Finally, the government would be able to cultivate through the national health system.
Relating specifically to industrial hemp, the bill would:
- Authorize the production and marketing of hemp products, so long as they are not intended for medical, prophylactic, curative or palliative purposes.
- Allow cosmetics, personal care products, fibres, and non-medical veterinary products containing less than 0.3 percent THC to be legally produced and marketed.
- Permit the production and marketing of THC-free cannabis-derived food products and supplements.
- Allow industrial hemp to be grown outdoors, subject to fencing and containment guidelines.
Similarly, for medicinal cannabis, the legislation suggests that:
- Cannabis plants with more than 1 percent THC are to be considered psychoactive. Cannabis-based medicines will be considered psychoactive if they contain more than 0.3 percent THC.
- Products intended for veterinary use must contain less than 0.3 percent THC.
- Cannabis products for human use must be prescribed by authorized professionals as per the RDC 327/19 rules from Anvisa and the Ministry of Health.
- Products for human use would be regulated and authorized by Anvisa; the Ministry of Agriculture would be responsible for veterinary products.
The proposed bill also sets out guidelines for the transport of these materials, including a stipulation that the vehicles used for transporting any cannabis or hemp materials should not display “their company name, corporate name or any other name making it possible to identify the products transported there.”
Cannabis laws in Brazil
Current rules in Brazil do allow for access to medical cannabis through three distinct pathways.
Cannabis-derived medicines that are registered as pharmaceuticals are allowed. However, in Brazil there is only one such drug, GW Pharmaceutical’s Sativex, which is sold under the name Mevatyl and used for treating symptoms of multiple sclerosis.
Alternatively, patients can seek out products with “sanitary authorization.” Products in this new category, which was introduced under new rules created in December 2019, do not require immediate proven efficacy through clinical trials, but must follow strict quality guidelines. Similarly, only one product has been authorized in this category, a THC-free CBD product registered to Brazilian pharma giant Prati-Donaduzzi.
With a limited number of licensed options, the majority of medical cannabis patients in Brazil rely on authorizations granted for the “compassionate use” of imported non-registered cannabis products. According to Anvisa, around 7,800 Brazilians are currently importing their medical cannabis products in this way, though the real number of medical cannabis users is likely to be significantly higher. Such products are expensive, and so many patients find themselves relying on patient associations or on cheaper illicit market alternatives.
With the new legislation, lawmakers are hoping to make medical cannabis more affordable, so more patients can get the medicine they need.
“The price of medicines available in pharmacies is very high,” Teixeira told the Brazilian paper Folha de S.Paulo. “The two drugs available on the national market, Mevatyl and cannabidiol are around R$2,500 [approx. $450 USD] in pharmacies.”
“We talked to the companies and saw that 95 percent of the supplies are imported. We now have the chance to make supplies cheaper.”
If the legislation is enacted, Brazil would be able to end its reliance on imported cannabis products. This would mean no more dealing with the export costs and fluctuating exchange rates, which currently inflate the prices of cannabis-based medicines in Brazil.
Luciano Ducci, a lawmaker and fellow member of the special commission, also told Folha de S.Paulo that the bill could result in other economic benefits to Brazil.
“There are companies that are waiting for the law to enter Brazil, and we can bring income to Brazil post-pandemic,” he said. “This is the case of Canadian pharmaceutical companies that want to produce in our territory. If the country has the courage to pass the law, we will soon have a very good market.”
Cannabis in Latin America
The outlook looks positive for this new Brazilian bill; local hemp consultant Lorenzo Rolim da Silva told HempToday that he expects the proposal to be fast-tracked through the country’s legislature.
“I would not be surprised if we start 2021 with a functional regulation in place in Brazil, allowing the country to finally compete in the sector,” said Rolim da Silva.
“And trust me, we will give American and European hemp farmers a run for their money. Our costs in agriculture are overall lower and we have excellent climate conditions to become the most competitive player in the world.”
Elsewhere in Latin America, cannabis reform is also following a progressive path. In a press conference held on August 19, Mexican president Andrés Manuel López Obrador told reporters that cannabis legalization will be on the agenda when the nation’s Congress reconvenes next month.
Mexico is currently pursuing the legalization of cannabis after the nation’s Supreme Court found the drug’s prohibition to be unconstitutional. Initial progress on legalization was slow, but multiple senate commissions had approved a proposed legalization bill earlier this year before the coronavirus pandemic compelled the legislature to temporarily suspend its activities. With the Senate due to reconvene next month, progress on this reform bill will be allowed to continue.
Earlier this month, Uruguay signed two decrees with the intention of hastening the development of its medical cannabis and hemp industry, and encouraging international exports. The new rules simplify the export process, in a move which experts believe could help to attract fresh investment in the country’s cannabis sector.