Brazil postpones evaluation of CBD formulation for medical coverage

A government evaluation to include a specific CBD formulation in Brazil’s Public Health System (SUS) has been postponed.

The National Committee for Health Technology Incorporation (Conitec), a government agency, had been scheduled to take up the issue this week.

Instead, the evaluation will now occur in early 2021.

A decision by Conitec to include the CBD formulation in Brazil’s national health insurance scheme would be a game changer for the local industry, as it would make patients eligible to receive public health coverage for that product – effectively making it available for free to patients.

However, Tarso Araujo, chief business development officer for São Paulo, Brazil-based Entourage Phytolab told Marijuana Business Daily he’d be “surprised” if a product without finished clinical trials proving safety and efficacy is included in SUS coverage.

“Moreover, its high price doesn’t help pass the cost-benefit consideration that the Conitec must do,” Araujo said.

Some experts in Brazil also think the government move to include CBD in the SUS seeks to undermine a bill to allow in-country cannabis cultivation – a draft law which the government opposes.

Conitec could take up the issue again as soon as February, according to Brazilian cannabis news website Sechat.

The product set to be evaluated is manufactured by Brazilian pharmaceutical firm Prati-Donaduzzi with imported raw material.

It is the only medical cannabis product that has received “sanitary authorization” from the National Sanitary Surveillance Agency (ANVISA).

Because it has sanitary authorization, pharmacies are allowed to sell it under prescription.

But at a cost of 2,000 real ($392) or more, it remains unaffordable for many patients.

The only other cannabis-derived medicine locally available is GW Pharmaceuticals’ Sativex, sold in Brazil under the brand name Mevatyl.

But that also is largely unaffordable for most patients because it costs almost 3,000 real.

Earlier this year, Conitec provided a preliminary recommendation to not include Mevatyl in the SUS coverage.

The only other legal option for consumers is to import individually through a compassionate access scheme. Some patients have also obtained from the courts permits to grow at home, as also have two associations to supply their members.

In the past two years, almost 20,000 patients have been authorized to receive medical cannabis via the compassionate access scheme.

Alfredo Pascual can be reached at