Why the licensing system for controlling the distribution of licences for the use of cannabis has proven ineffective
The parliament is discussing a bill that would allow patients to legally grow therapeutic cannabis at home.
The pages of the specialized electronic edition of Ukrainian hemp growers several years ago partially described the situation with "http://tku.org.ua/ru/news/3553">Cannabidiol in Brazil». What are the problems of Brazilian patients who have received from the state individual licenses for import of foreign drugs manufactured outside the country's territory that may be of interest to Ukrainian citizens, let's try to understand this material.
According to the former head of Brazil's National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, ANVISA), the mechanism for obtaining individual import authorizations for cannabis-based medicines is inadequate to meet the growing demand for such products in the country. Dirceu Barbano says that the continued increase in the number of medical cannabis import permits should force ANVISA to modify the current mechanism.
In 2018 alone, 2,180 new patients received permission from ANVISA to import medical cannabis for individual use into the country.
Since the launch of this mechanism in Brazil in 2014, a total of 4,870 patients have been granted permission to import cannabis-based medicines of this kind for one year. It should be noted that not all patients renew their authorizations, so the number of active users of this mechanism in Brazil may be lower than the number of authorizations issued since 2014.
Statistical indicators of ANVISA show that most of the products came from the United States, but that significant volumes of medical cannabis were imported from Switzerland, Canada and the United Kingdom. At the same time, Brazil's regulatory framework treats any cannabis drug as an unregistered drug, regardless of the amount of tetrahydrocannabinol it contains. The only registered medicinal product manufactured on the basis of hemp in Brazil is Sativex, which is sold in the country under the name Mevatyl.
After the representative of HempMeds Brazil said that the above mentioned medicine is the only registered medicine that can be sold in Brazilian pharmacies, it is impossible to find it on the shelves of pharmacy chains. It is this fact that leaves patients in need of these medicines the only legitimate way to access the therapeutic properties of cannabis – the direct import of products not registered in Brazil, which require not only a prescription, but also a special permission from ANVISA ».
Mr. Barbano argues that an increase in the number of patients is inevitable and expected by doctors, health authorities, and companies producing medicinal products based on the therapeutic properties of cannabis. As usual, the government agencies responsible for this process are not ready, so at the moment everything that is happening in this area resembles chaos. The efforts of a structure that supports the current model of individual permits will not be sufficient in the near future. The increase in the number of patients will jeopardize ANVISA's control system, particularly in terms of patient access to medicines, as well as the ability to verify the origin and quality of imported legal cannabis products.
Association Commentary on Ukrainian Technical Hemp
In 2015, HempMeds became the first company to legally import hemp products into Brazil, and MedReleaf was the first company to legally export medical cannabis to the country more than two years later. At the moment, the Parliament is discussing a bill that will allow patients to legally grow therapeutic cannabis at home. Since the launch of the above-mentioned programme, about 78,000 doses of cannabis used by patients within the framework of state prescriptions have been imported into the country. All imported cannabis products were prescribed by less than 1,000 doctors, and 2/3 of the patients who were prescribed these drugs received a prescription from a neurologist.