by Ana Lúcia de Sousa Borda
February 06, 2020
The use of Cannabis products for recreational and medicinal purposes is already a reality in various countries. In Brazil, the discussions, which have been quite heated incidentally, revolve mainly around its use for therapeutic purposes.
Reports of significant improvement in some complex clinical situations, which, for example, are accompanied by convulsions, are becoming more and more frequent in our country and also abroad, following the use of Cannabis products and that before had not shown any satisfactory improvement from the treatments available on the market.
Far from ceasing to be a controversial issue in Brazil, a first and important step has been taken with respect to the use of Cannabis for medicinal purposes through ANVISA (National Health Surveillance Agency) Resolution (RDC no. 327, published on December 11, 2019).
Such Resolution will come into force on March 10, 2020, that is, 90 days after its publication.
Without wanting to wear the topic out, this article aims to reflect on some points and highlight others.
The first is related to the fact that Cannabis products for medicinal purposes can only be prescribed after all possibilities of conventional treatments already existing on the Brazilian market have been exhausted.
However, response to available conventional treatments will vary according to each individual. Patients with identical pathologies may have entirely different reactions, which should be taken into consideration, in order not to create barriers to the use of Cannabis products by those who may find, if not a cure, at least substantial relief in their symptoms from this treatment option.
RDC 327 lists all the requirements necessary for the granting of a Health Authorisation, an essential document for importing, manufacturing or marketing Cannabis products in Brazil. This Resolution also sets forth various prohibitions and parameters to be observed.
Among the prohibitions worthy of mention are those relating to advertising, the possibility of which has been totally ruled out. Trade names are also prohibited.
Word marks (only words), figurative marks (only designs) and word and device marks (words and designs) belonging to government institutions, philanthropic entities, associations representing the interests of consumers or health professionals also cannot appear on packaging, labels or brochures, etc. Quality certification seals are also included, except in cases where such seals must be used due to specific rules.
Particularly in the case of Cannabis products, certification marks are shown to be appropriate to fulfil their function of guiding the consumer with respect to the product to be purchased, especially with regard to compliance with certain manufacturing or storage standards, etc. It is important to make clear that a certification mark is not necessarily an indication of product excellence, but rather whether it meets certain standards to be followed throughout the manufacturing and marketing process. Such condition must be attested by an entity that cannot be directly or even indirectly commercially interested in the product’s marketing, in order to preserve the necessary impartiality of the certifying body.
What draws attention is that the Health Authorisation, if granted, will remain valid for an non-extendable period of five years, which raises doubts as to whether products that have proven to be effective and that will continue to be necessary for ongoing treatments will be discontinued.
Once the Health Authorisation has been granted, the party responsible for the product will have a term of 365 days to start marketing it, under penalty of it being cancelled. This provision is extremely strict, since the period of 365 days from the Sanitary Authorisation being granted may not be sufficient, at least in some cases.
Of even more concern is the provision that a Health Authorisation can be cancelled through a unilateral decision by ANVISA at any time, as a result of evaluations and on-site checks. Even assuming that the cancellation is justified for the safety of the users of Cannabis products, it is hoped that such a drastic measure will be adopted cautiously, in order to avoid harming ongoing therapies that are being undertaken with significant improvement of the patient.
The Resolution makes it unmistakably clear that the Health Authorisation will allow the import of pharmaceutical inputs in the form of plant derivatives, with the import of the plant itself or parts thereof being prohibited.
The characterisation of Cannabis products creates doubt, since the Resolution prohibits the use of terms such as “medicine” and “remedy” on packaging, labels and package inserts, and also states that the Cannabis product is not a medicine.
Nevertheless, the rule in question sets forth the cancellation of the Health Authorisation for those Cannabis products that are not appropriate for the category of medicines.
Like any new issue, the marketing of Cannabis products will continue to generate debate, but Resolution 327 clarifies a number of points – even if not all of them are agreed with. It is, as has been said, a first and important step and a light at the end of the tunnel for many health professionals, for those with diseases that can be treated with Cannabis products after all available treatment routes have been exhausted, and also for their relatives.