Brazil had no pending applications to register medical marijuana products as of the end of April, an indication that companies might be struggling to meet new pharmaceutical-level requirements introduced last December.
“So far, only one application for Sanitary Authorization has been received, and it was already published (approved) on April 22, 2020,” a spokesperson for National Sanitary Surveillance Agency (ANVISA) wrote in an email to Marijuana Business Daily.
ANVISA created the sanitary authorization category last December for the registration and commercialization of medical cannabis products that have not undergone clinical trials to prove their efficacy.
Brazil’s medical cannabis market has drawn keen attention for its potential, but regulatory hurdles under the new rules are high.
Companies unable to comply with the quality requirements to obtain a sanitary authorization might still sell medical cannabis in Brazil as “unregistered products,” a category for which entry barriers are much lower.
But this comes with disadvantages.
Unlike products with sanitary authorization, unregistered products cannot be imported in bulk or distributed to Brazilian pharmacies.
They can be imported only on a case-by-case basis for patients who obtained a special individual authorization from Brazil’s health agency.
Authorizations granted for these individual imports have been increasing rapidly since 2018.
Dirceu Barbano, former director-president of ANVISA, told MJBizDaily that he has been “alerting companies over the past years that there was a gap between the unregistered cannabis products coming from abroad and the quality requirements that normally apply to medicines.”
“All of them, without exception, preferred to work on expanding demand through the involvement of doctors and patients in Brazil with a view to selling what they had available instead of doing R&D.
“As a result, they now have a hard time registering products that fit into the quality requirements of medicines.”
The requirements of Brazil’s sanitary authorizations aren’t far from some European countries’ approaches to regulating medical cannabis. Those requirement mandate Good Manufacturing Practice (GMP) compliance and stability testing.
Emilio Figueiredo, a Brazilian lawyer specializing in cannabis regulations, said the 2019 regulations could be too high a bar for many businesses.
“Many entrepreneurs are frightened by the costs involved in the process of creating a company to work with cannabis along the lines proposed by ANVISA,” Figueredo said, referring to the pharmaceutical-level requirements.
One of the main barriers for most companies interested in applying for sanitary authorization is that production must be done in accordance with the principles of GMP.
In principle, only a GMP certification from ANVISA is allowed.
But, until December 2022, the agency might also accept GMP certifications issued by health agencies of PIC/S countries.
One of the companies preparing to submit an application for sanitary authorization in Brazil is Canada-based MediPharm Labs.
The Ontario company’s co-founder and president, Keith Strachan, told MJBizDaily that Brazil “poses a unique opportunity” for MediPharm because its manufacturing facility in Canada received its GMP certification from the Australian Therapeutic Goods Administration (TGA) for finished oral cannabis products.
“The TGA’s inspection was conducted in accordance to PIC/S GMP standards, which is important, as it means that our products will satisfy one of the primary ANVISA requirements for product registration in Brazil,” Strachan said.
However, GMP isn’t the only requirement. Stability studies are another important hurdle.
The main purpose of stability studies is to demonstrate that the quality of a product remains stable throughout its shelf life in the climatic conditions commonly found in the country where its commercialization is intended.
Stability studies are standard in the pharmaceutical industry, but they don’t always apply to medical cannabis. For instance, stability testing is not a requirement under the Good Production Practices (GPP) that govern medical cannabis production in Canada.
Strachan identified “zone IVb stability studies,” required by ANVISA, as one of the potential challenges.
Stability studies of products to be sold in colder regions of the world can be done under lower temperatures and humidity levels than studies for products to be sold in hot and humid places such as Brazil.
Higher temperatures and humidity typically mean faster degradation of the medicines.
For a sanitary authorization, the Brazilian agency requires long-term stability studies with a minimum duration of 12 months or, under certain circumstances, accelerated studies that could be done in a shorter period.
Rodrigo Mesquita, a Brazilian lawyer specializing in cannabis regulations, identified further difficulties.
He said only companies in the traditional pharmaceutical sector have the structural capacity already in place to comply with the new cannabis regulations.
Mesquita also pointed out the logistical complexities of a Brazilian market that requires major distribution operations.
“Deals between cannabis companies and companies that already have distribution logistics and access to the medical community in Brazil seem to me to be the solution,” he said.
José Bacellar, CEO of Toronto-based VerdeMed, a company focused on developing products for the Latin American medical cannabis markets, identified pharmacovigilance as a related challenge.
Pharmacovigilance is broadly defined as activities in place to detect, assess and act on adverse effects from a medicine.
“It requires operational capabilities that only large pharmaceutical companies have,” according to Bacellar, who questioned whether such a barrier was necessary for low-THC products.
Viviane Sedola, CEO of Dr Cannabis – a São Paulo company that provides consultancy services to businesses interested in the Brazilian market – told MJBizDaily that even the “basic” requirements that are common for pharmaceutical companies to operate in that country are often a challenge for unprepared marijuana firms.
She cited ANVISA’s Authorization to Operate (Autorização de Funcionamento de Empresa, AFE) and Special Authorization to Operate (Autorização Especial, AE), which are standard health-authority permits.
Both are requirements for companies that want to obtain a cannabis sanitary authorization.
“Obtaining these two permits, which is just one of the first steps toward a sanitary authorization, already requires investment and time,” she said.