The gaps in final disposal of cannabis-based products in Brazilian legislation
Trench Rossi Watanabe, São Paulo
Trench Rossi Watanabe, São Paulo
Adequate waste disposal is a historical problem in Brazil, albeit with recent improvement brought by the new legal framework for sanitation (Federal Law No. 14,026/2020). There are numerous gaps in the legislation currently in force on this subject, including the safe disposal of cannabis-based products, the medicinal usage of which was recently authorised by the National Health Surveillance Agency (ANVISA).
At the end of 2019, ANVISA issued Resolution No. 237, which authorises the manufacturing, import and commercialisation of such items. However, it ended up launching a legislative gap around potential risks in the environmental area, due to the lack of instructions regarding the proper treatment for the final disposal of cannabis-based products that are expired or in disuse, as well as their packaging and remaining waste.
ANVISA's Resolution details the procedures and requirements that shall be observed by companies interested in manufacturing and importing products that contain cannabis-derived plant actives and phytopharmaceuticals. However, when it comes to its safe final disposal, the resolution simply establishes that the procedures defined by the Brazilian National Policy on Solid Waste (Federal Law No. 12,305/2010) shall be observed within the scope of a take-back system.
Cannabis-based products may fall into limbo regarding their proper final disposal. They are not subject to the medicine take-back system recently approved by the Brazilian Ministry of the Environment, as such products are not considered medicine, although their usage is limited to medicinal purposes. Cannabis products do not fit into the general packaging take-back system either, as the remaining waste can cause adverse effects and potential food interactions, amongst other relevant consequences for the environment and human health.
The Brazilian National Policy on Solid Waste (Federal Law No. 12,305/2010) established shared responsibility for the products’ life cycle. This is similar to an extended producer responsibility (EPR) scheme. These require manufacturers, importers, distributors, sellers, consumers and holders of public urban cleaning services to have individualised and connected obligations to minimise the volume of solid waste, reducing the impacts caused to human health and to the environmental quality that may arise from the incorrect disposal of these products.
In this context, the take-back system is one of several economic and social development instruments established in order to assist in the implementation of shared responsibility. It consists of a set of actions and procedures designed to enable the collection and return of post-consumption solid waste to the respective business sector, promoting its reuse in its own cycle or in other productive cycles, or also other kinds of environmentally proper final destination.
In Brazil, the implementation of take-back systems is mandatory for a series of products – such as pesticides, batteries and tyres. They may be extended to products sold in plastic, metallic or glass packaging (considered as general packaging) and to other products and packaging (considering the degree and extent of their impacts on public health and the environment). Medicines in disuse or expired fall into the latter category, considering their potential to cause relevant impact to public health and to the environment.
Federal Decree No. 10,388/2020 was recently published to regulate the medicine take-back system. The scope of this new system encompasses medicines that are exclusively meant for domestic and human use, industrialised or manipulated, expired and/or in disuse and their packaging after their disposal by the consumer at collection points (in drugstores and pharmacies).
Since ANVISA does not consider cannabis-based products medicine, it is possible that drugstores and pharmacies may refuse to accept cannabis-based products at their medicine collection points, even though such products are sold exclusively by drugstores or pharmacies upon the presentation of a medical prescription.
The Brazilian Ministry of Health establishes that, whenever there is an interruption in the administration of medicines based on Cannabis sativum and tetrahydrocannabinol (THC), the physician who prescribed the medication or the local health authority must recommend its delivery to the competent health surveillance agency that shall be responsible for the appropriate destination – destruction or donation.
Therefore, even though ANVISA proposed in its latest Resolution that the safe disposal of cannabis-based products should be done through take-back systems, it seems possible these products could also be returned to the local health surveillance agency.
In addition, since ANVISA’s regulation provides that the safe disposal of cannabis-based products should be implemented through a take-back system, unless a specific Sectorial Agreement or Term of Commitment is negotiated with the Ministry of the Environment, which is very unlikely in the near future, an alternative would be for such products to be absorbed by the medicine take-back system. In other words, if ANVISA had equated these cannabis-based products to medicines since the beginning, these inconsistences in the legislation could have been simplified. Thus, with regards to the proper final disposal, it would have brought greater security and clarity to companies, consumers and the public administration.
Finally, considering that other sectors in Brazil are interested in the manufacturing and importing of products containing cannabis-derived plant actives and phytopharmaceuticals, such as the food, cosmetic and veterinary industry (which are currently not allowed in national territory), it seems relevant that public authorities reassess the social and environmental strategy for such products and their final destination.