Marijuana: release of drugs hinders the medicinal market – 06/10/2023 – Panel SA

The Federal Supreme Court is preparing to discuss the suspension of an article of the Anti-Drug Law that prohibits the storage, planting and transport of drugs for personal use. Legalization, however, will hurt the medical marijuana industry.

This is what Bruna Rocha, executive president of BRCann (Brazilian Association of Cannabinoid Industries) defends. For her, this market has been attracting investments and is awaiting regulation by Anvisa to perpetuate the rules, which are currently transitory. By opening the discussion of recreational drug use, the Supreme Court will end up shifting the focus to recreational use.

In the first quarter of this year, the medical cannabis market grew 201% in sales in pharmacies, with the sale of 193 thousand units compared to just over 62 thousand in the same period of 2022. The trend, according to BRCann, is that the numbers follow doubling in size as Anvisa releases the entry of new products in the market.

Does the discussion of drug decriminalization by the STF help the cannabis pharmaceutical industry? There are several demonstrations against legalization on this side, precisely because of the implication that this may have on the credibility of the medicinal market. The industry awaits this judgment with caution and a certain apprehension. In order to talk about the decriminalization of drug possession, we would first have to go through a matter of public safety.

So the release harms the advance of the sector? It ends up confusing the fronts of action and puts the regulatory body against the wall. Anvisa is still in the process of structuring a medicinal market, rooted in public health, and which will be submerged, on account of the Judiciary, in a recreational market.

And how is the medical cannabis market in Brazil? It has existed since 2015 as a result of a court ruling in favor of a mother seeking treatment for her daughter. At the time, Anvisa released what we now call compassionate use, allowing the importation, directly by the patient, of cannabis-based products. Between 2015 and 2021, Brazil registered 70,000 import requests and, in the meantime, began to allow cannabis-based products to be sold in pharmacies and drugstores.

What are the rules? Once the company gets clearance, it has five years to become a pharmaceutical company and register its product as a drug. Otherwise, it is withdrawn from the market. Today we have 25 products approved for sale in pharmacies, but the queue for obtaining them is huge, there are hundreds of submissions. In the last interaction we had with Anvisa, one of the representatives indicated that they will need a year and a half to analyze the requests.

Are big pharmaceutical companies interested in this market? Yes. Abroad we have already had several strategic alliances and partnerships for the development of clinical research. Even merger and acquisition processes with efforts directed towards the sector. Outside, we have the manifestation of large pharmaceutical companies, such as Pfizer, Sanofi, Merck and Novartis. In Brazil, Hypera has already moved very clearly and today has products on the market. There are also funds with large capital reserves, investing in companies in this segment.

What are the prospects for this year? Some consultancies indicate that in the next five years, each measurement will have a multiplier of 2 [dobra a cada ano]. Then it gets more linear. Brazil is seen as the one that will grow the most in the medical cannabis market. Precisely because of the economic potential we have and the demographic dimension of our country. The number of patients who would have access to these products is very large. Not to mention a question that goes through agribusiness, with cultivation.

Where can you move forward? As Anvisa is still working with a test regulation, which has a start and end date, the question posed by the industry is ‘can I go as far as when?’ A resolution that defines the market in the medium and long term is extremely important for companies to establish themselves in the country.

And the cultivation? A bill is underway [para autorizá-lo] and, although it has approval in the committees, it needs to be voted on. Another point is the provision of cannabis-based products or medicines in the SUS. Today we have initiatives in states and municipalities, but nothing materialized in the federal government.

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