The coronavirus pandemic has accelerated the cannabis business around the world. However, the cannabis market in Brazil is cautious, quite different from the euphoria felt earlier this year. Just to remember: in January, some companies were boasting that they would have cannabis-based drugs on the shelves of national pharmacies in the first half of the year. Now the deadline for most of them was postponed to 2021.
The Brazilian market actually took off this year, after the first sign that Brazil would invest in the development of a medical cannabis industry. That was in December 2019, when Anvisa (Health Surveillance Agency) regularized the marketing and manufacturing of cannabis-based medicines.
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The pandemic and Anvisa’s complex rules hindered the Brazilian cannabis industry
Brazil is entering a business that saw its peak in Canada and the USA back in 2018. These nations have legalized the entire chain, from cultivation to the final product. The industry has created new jobs, taxes for the government, and large corporations with shares on the New York Stock Exchange.
The Brazilian businessmen have watched this process from afar. For no other reason, the regularization of Anvisa has created a generalized excitement, which has been decreasing over the last months. First, because of the advance of COVID-19 in the country, and with it, the climate of economic uncertainties – as well as much sadness for the lost lives. The challenge of capturing investments became even greater for cannabis startups.
In parallel, there was also an understanding of the complexity of the rules stipulated by Anvisa. They are pharmaceutical rules, very technical, taken from the specifications for medicines, in general. The problem is that few startups were set up to be laboratories.
“At the end of 2019, everyone thought we had won, but nobody took it,” said Jaime Ozi, who became partner and vice president of business at CanTera and OnixCann, shortly after the regulation was published. Before that, Ozi was regional director of Spectrum Therapeutics, the pharmaceutical arm of the multinational Canopy Growth in Brazil.
Pratti-Donaduzzi, a pharmacist from Paraná, is the first and only Brazilian to be able to register a cannabis drug at Anvisa. That was last month.
The other competitors are preparing the pharmaceutical dossiers they need to obtain the registration. Some have had to partner with third parties to get the job done. One example is OnixCann/Can Tera, by Ozi and Marcelo Galvão, which closed with Israel’s MGC Pharma in March.
Anvisa’s demands are difficult to meet
According to the companies, some of Anvisa’s requirements involve a lengthy process, such as the stability test. “It works as a guarantee of shelf life that goes into the medicine box. The proof attests that the product does not change within six months or a year and also warns in what conditions of temperature and humidity should be maintained,” explained José Bacellar, from the Canadian company VerdeMed, set up to operate in Latin America.
The stability test is only one of the 12 main points of this regulation. Anvisa has even published a manual to try to facilitate the understanding of the norms. Large pharmaceutical companies, such as Aché or Prati, have mastered these technical intricacies – unlike small companies that were not born with this DNA, but focused only on sales. In Aché’s case, the company reported that plans for medical cannabis are still embryonic.
The Anvisa regulation fell like a bomb also for the multinationals, which arrived with many plans in Brazil, the Canadian Canopy Growth case. In Canada, doctors prescribe medical cannabis as a herbal medicine. In the US, it is classified as a food supplement.
In Brazil, Anvisa classifies it as a phyto drug product and, after five years from the publication of the standard, it will become a medicine.
In the meantime, the companies have gained some time to adapt. The initial registration is for cannabis products. However, companies have until 2025 to conduct, for example, clinical trials – the costs of which advance by a million reais.
Cannabis companies in Brazil postponed the release of their cannabis-based drugs
The report listened to nine companies that operate in the domestic market to get an idea of what the consumer can expect in the second half of the year. Seven of them said that only next year they will be able to complete the process to meet the demands for the initial registration, which allows marketing. Two companies said they are battling to finish the dossier in the second half of the year. And even so, there is always “if Anvisa” approves the answers.
“We are finalizing the necessary documentation to file the request soon and, depending on the return of Anvisa, we will have the product on the shelves by December,” said Caio Abreu, CEO of Entourage Phytolab.
The agency can approve or ask for a complement – and that also depends on how long each company will wait for the result after submitting the paperwork. When Prati forwarded the request, the registration was issued in 40 days, which is considered a quick deadline.
In any case, this year the cannabis market is not yet consolidated as most imagined it would be – offering more product options and prices to consumers.
At the moment, there are only two cannabis-based drugs registered in drugstores. One imported, Mevatyl, from the English laboratory GW Pharma. The other one is Prati. Each one costs on average $462 (R$ 2,500).
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First published in Sechat, a third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.
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