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Новости/Аналитика

Why is national hemp growing interested in the planned changes to the Brazilian regulatory framework?

25.08.2020

We can say that the beginning of 2021, if appropriate legislation is adopted, will be an impetus for the development of the industry in one of the most densely populated agricultural countries in the world. Is this not a reason to turn your attention to the market, where breeding and seed material will definitely be in demand, as well as the developments of national agricultural producers in the field of agronomy, processing, as well as the use of hemp raw materials and products made from it.

Historical reference

From the colonization of Brazil to the first quarter of the 20th century, citizens, as well as government enterprises, lawfully cultivated hemp in various regions of the country, mainly using the fiber of the plant for the production of textiles, and the grain for food or for the manufacture of cosmetics. Until 1932, hemp extracts were considered legal and recommended by doctors for the treatment of various types of diseases. The Brazilian hemp industry has been the leader among all agricultural sectors in the country for centuries. Initiated in the 30s of the XX century by the United States, a campaign to ban the cultivation and processing of hemp led to the virtual destruction of the hemp industry in the largest country in South America.

Modernity

At the moment, according to Ordinance 344/98 of the National Health Monitoring Agency (Agência Nacional de Vigilância Sanitária, ANVISA), the cultivation of any hemp plants is prohibited in the country. Despite this, since 2015, Brazil has allowed the import of medical cannabis for “compassionate use by patients” who are unresponsive to traditional treatments (terminally ill people or those who have exhausted other treatment options).  

Initially, hemp medicines could be imported only with the special permission of ANVISA, however, the legal framework in the country has made significant progress in matters related to the regulation of modern cannabis growing, mainly after the publication of the ANVISA RDC No. 327/19, which regulates the possibility of import, production and commercialization of hemp-based products for medical purposes, and sale of these products through pharmacies. Commodity items, which include raw materials with a tetrahydrocannabinol content of less than 0.2%, can be prescribed by physicians with minimal restrictions. In January 2017, Brazil issued its first cannabis drug license, authorizing the sale of Mevatyl oral spray (known worldwide as Sativex).

Current regulations already allow the import and sale of hemp-derived drugs to three categories of goods: 

1. Medicines registered as pharmaceuticals; 

2. Products with "sanitary approval" that do not require clinical trials; 

3. A “rational use” permit, which allows patients to import hemp products on an individual basis, 

cannabidiol is considered a “herbal medicine” product and is therefore classified as a “sanitary approval” requiring a prescription. In March 2020, the state of Pernambuco issued the first national license to legally grow psychoactive cannabis in the home for medicinal use. According to ANVISA, about 7,800 Brazilians are currently eligible to import hemp products for medical use.

Bills

Brazil is currently considering two bills to regulate the use of cannabis for industrial purposes.

In the Chamber of Deputies, there is bill 10549/2018, which regulates the production and commercial use of hemp, as well as various plant derivatives. It spells out the rules according to which the taxation of enterprises specializing in working with this crop will be similar to the taxation regimes applied to alcohol and tobacco.

The Senate is considering bill No. 5295/2019, which provides for regulation of the possibility of working with a plant for industrial and medical purposes. Conclusion 128/19, prepared on the basis of the review, states that “China is the largest hemp producer in the world, at the same time the European Union is the main producer of hemp products, as well as raw materials made from plants, and among other things, one of the main consumers of hemp products. are the countries of the EU. " It concludes that it would be extremely important for Brazil “to become one of the countries capable of creating hemp growing and processing chains, ultimately producing products with high added value”.

If any of the above regulations are adopted, Brazil could regulate the cultivation, processing, and industrial and medical uses of the plant, opening the market to nearly 210 million consumers. In particular, the production and marketing of products made from industrial hemp will be permitted unless they are intended for medical use or sold for “prophylactic, curative or palliative purposes”. This will “clear the way” for health and beauty, cellulose, fiber, and non-medical veterinary products as long as these products contain no more than 0.3% THC. So far, it is planned to permit the use of exclusively seeds as food products. The adoption of one of the bills does not imply the creation of new regulatory bodies.

It should be noted that the adoption of one of the draft laws will put enormous pressure on the Ministry of Agriculture and ANVISA, since government officials will face rather difficult tasks to adapt by-laws and their internal regulatory documents, taking into account the changes proposed by both draft laws.

Commentary of experts of the Association "Ukrainian technical hemp"

Some experts in the hemp market argue that, having the fourth largest pharmaceutical market in the world, the potential for the use of the hemp plant for medicinal purposes may increase dramatically with the adoption of new legislation and the volume of this sector of the economy will reach $ 4.7 billion within three years. market, several foreign and Brazilian companies have already created bridgeheads for the expansion of their products into the country. For example, “GW Pharmaceuticals” (UK) already sells its cannabidiol-based drugs in the country's pharmacy chains. The Brazilian pharmaceutical company Prati-Donaduzzi has also obtained the right to manufacture and distribute certain hemp products through pharmacy chains. The management of pharmaceutical giant Merck recently announced that it is considering opportunities to "provide the market with technical knowledge for research and development, quality control and biometric applications to enhance the potential of cannabis cultivation."

Based on good seeds, vocational training and quality soil characteristics, it can be argued that after the adoption of one of the draft laws, the work of small, medium and large agricultural cannabis growers will be actively developed in the country. Growing a hemp plant can help accelerate the country's recovery from a post-pandemic economic recession, create jobs in depressed agricultural regions of the country, and “launch” new sectors of the economy based on hemp raw materials. 

We can say that the beginning of 2021, if appropriate legislation is adopted, will be an impetus for the development of the industry in one of the most densely populated agricultural countries in the world. Is this not a reason to turn your attention to the market, where breeding and seed material will definitely be in demand, as well as the developments of national agricultural producers in the field of agronomy, processing, as well as the use of hemp raw materials and products made from it.

Обучение в рамках "Конопляного Университета"
13.10.2020

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