News published on: December 11, 2019
ANVISA approved new regulations for the roll-out of medicinal products derived from cannabis
The Brazilian Health Regulatory Agency (ANVISA) approved, at the beginning of December 2019, regulations that allow the sale in pharmacies of cannabis-based products for medical purposes. In these new proposals, the procedures for manufacturing and importing such products and the requirements for prescription, sale, and supervision are approved. Authorization does not include substance handling in pharmacies and is only allowed to sell – by prescription – products already formulated directly from the manufacturer. The approved guidelines will remain in force for 3 years, after which a new standard will be issued, considering the results obtained during this initial period.
This decision is a progress to the Brazilian health sector. We are seeing a worldwide trend of the rediscovery of Cannabis sativa properties beyond its recreational characteristics, therefore one of the most relevant discussions from the point of view of new drugs today is the substances derived from cannabis, called cannabinoids. The compounds extracted from the plant already contain more than 100 cataloged active substances that act on endocannabinoid receptors and are effective in various situations as medicines or as accessory substances, improving or eliminating side effects or enhancing the results of therapy.
In this scenario, Brazil has experienced a particular moment in which there is movement of society through patient associations, pressure from companies and the scientific environment to implement the legal framework for use for medicinal purposes. Participants in this chain live with high import costs and extensive legal process to approve the purchase, which reduces the availability of a tool with the potential to make significant advances in treating diseases such as epilepsy, sclerosis, anorexia, fibromyalgia, to name a few examples. In addition, there are already concrete cases, such as Canada, Israel, and the United States that have adopted legal models that have regularized the sale (including for recreational actions) and more closely, in Uruguay, Chile, and Colombia, which has been successful in their strategies.
With the subject so in vogue, it was very appropriate to hold the panel The Science of Cannabis for Healthcare Innovation during the BIO Latin America 2019 to discuss the perspectives. The speakers were handpicked: Gabriela Cezar (as moderator), CEO and Principal Partner of Panarea Partners, support institution to pharmaceutical innovation; Antoine Daher, President of Casa Hunter and of Brazilian Federation of Rare Disease Associations (Febrararas); Diego Olivera, Secretary General of National Drug Commission and President of Institute for Regulation and Control of Cannabis (Uruguay); João Paulo Perfeito, Manager of Low Risk, Herbal and Homeopathic Medicines and Medical Gases of the General Office of Drugs of ANVISA; Payton Palaia, Chief Science Officer of Olistica Lifesciences Group, which works with the development of new phytopharmaceuticals; and Sergio Lins Lima Braga Filho, PharmD – Director and Founder of Intrials, which offers Contract Research Organization (CRO) services for conducting clinical trials.
The panel was extremely rich in information and gave a clear notion that the discussion is not only relevant, but there are movements from the social sectors, private sector and investors to have it in greater volume. The ANVISA, in its turn, has also shown to be aware of these movements and has been working within the current possibilities of the legal framework and attentive to new developments, especially with two public consultations on the subject, about registration and monitoring and about the cultivation, completed in August 2019. More recently, in October 2019, regulatory proposals were evaluated, leading to the publication of the regulatory framework.
Just like the topic of usage of cannabis for healthcare innovation, the BIO Latin America Conference always hold debates about themes related to emerging biotechnologies and their potential to cure and transform healthcare. If you wish to keep updated with the latest researches that are designing how the sector will unfold a few years from now, save your spot for the 2020 edition!