The Brazilian government, through its regulatory agency ANVISA, failed to deliver a decision on two proposals that would expand access to cannabinoid-based medicines in Brazil, and open doors to a national medical cannabis industry.
The first proposal would create guidelines for the cultivation of cannabis solely for scientific research and the manufacture of medicines. Pharmaceutical companies and research institutions would have to comply with ANVISA’s security standards, such as biometric authentication in the facilities. The second would establish rules for the registration of cannabis-based medicines and products available in the international market. So far, under the current limited system, only one product has been registered and is sold in pharmacies in Brazil.
The voting was to take place on the morning of October 15, at ANVISA’s headquarters in Brasilia, and led by President/Director William Dib, who is publicly in favor of both proposals. However, two of ANVISA’s directors requested further examination, which postponed the voting for the second time this month.
Director Antônio Barra Torres, who was appointed by President Jair Bolsonaro, the nationalist who has led Brazil since January, asked for more time to review the proposal regarding the cultivation of cannabis by pharmaceutical companies and research institutes. The Bolsonaro administration is openly against this proposal.
President/Director Dib gave an emotional statement before inviting his fellow directors to vote. “This is not ANVISA’s most important theme, but it is by far the most controversial,” he said. “It has brought exterior differences to our house, and divided us.”
In July, the Citizenship Minister, Osmar Terra, spoke of the possibility that ANVISA, an autonomous agency subordinated to the Ministry of Health, might be “shut down” if it legalized cultivation. He told the website Jota that allowing cultivation would “open the doors for general consumption of cannabis.” Bolsonaro has extinguished or transformed a number of ministries or government bodies that he associates with liberal causes.
Director Fernando Mendes Garcia Neto, meanwhile, requested time to examine the second proposal—the one to register cannabinoid-based medicines that are available in the international market. The proposal would allow the government to import products in higher quantities and at a lower cost, and provide them for free through its universal healthcare system, SUS. ANVISA estimates that 13 million people in Brazil could benefit from access to tetrahydrocannabinol and CBD-derived drugs. However, under the current system, less than 8,000 have ANVISA’s authorization to import those medications.
The proposal would also expedite the approval and registering of the medicines. It currently takes two years for a new drug that follows the formal requirements to be registered within ANVISA. Under this new proposal, the agency would shorten that period by allowing in medications that haven’t completed a Phase 2 clinical trial, as long as manufacturers can prove positive results had been obtained during treatment.
Before submitting the final proposals to vote on these two proposals, ANVISA hosted a series of public consultations and hearings—in its headquarters, in the Senate, and in the Congress. According to Dib, more than a thousand comments were collected over two months, from representatives, common citizens, and public and private entities.
A new voting session will likely be scheduled before the end of the year, before Dib finishes his term at ANVISA, although it is unclear if final decisions on the proposal would be made at that time
A five-year battle
Cannabidiol (CBD) was removed from ANVISA’s list of forbidden substances only in 2015, when the agency offered a path for patients to personally import medicines.
Since then, Brazilians who can prove exceptional need for cannabis-based medications have been able to apply for authorization from ANVISA to import them legally. As of September, almost 8,000 people had obtained medications this way to treat conditions including epilepsy, autism, chronic pain, Parkinson’s disease, and anxiety disorders.
The demand has been growing fast. In 2017, when Sativex, the only cannabis-based medication ever registered by Anvisa, became available to multiple sclerosis patients, the agency saw the number of new petitioners double, to 1,392. In 2018, applications to import increased 70 percent over 2017, with 2,371 new patients filing.
According to Dib, patients importing medications are reimbursed by SUS, which puts cannabis-derived medications in the top ten products with the highest cost for the government.
“We are talking about millions in taxpayer’s money being used to supply medications that are not registered by us and may not abide to our standards,” he said. “The recent budget cuts urge us, decisionmakers, to offer solutions that will spare our health system.”
According to a 2018 report by IQVIA Institute, a U.S. based consultant company serving the health industry, the Brazilian market for pharmaceuticals is also growing faster than the biggest markets in the world. From 2013 to 2017, it grew by 11.5% compared to an average growth of 4.4% in the top five European Union markets and 7.3% in the U.S.
“Two decades from now, one fourth of the Brazilian population will be at least 65 years old,” Dib said. “Many cannabis-based medications help with elderly health issues such as Parkinson’s. We are here today to create policies for those people, too.”
