Instituted by Law No. 12,305/10, the National Solid Waste Policy (PNRS) defined as one of its instruments reverse logistics systems for the application of shared responsibility for product’s life cycles. Such systems consist of a set of actions, procedures, and means, after the use of products, to make viable the collection and return of solid waste to the business sector for reuse in its cycle, in other production cycles, or for another environmentally appropriate final destination.

The PNRS lists products and sectors subject to the obligation to establish a reverse logistics system, leaving open the possibility of expanding this list, considering primarily the degree and extent of the impact of the waste generated on public health and the environment, in addition to the technical and economic feasibility of the system. According to article 15 of Decree No. 7,404/10, reverse logistics systems may be implemented through three instruments, which cover the regulations issued by the public authorities.

Thus, on June 5, Decree No. 10,388/20 instituted the reverse logistics system for drugs, limited to those for domestic use that have expired or are in disuse, exclusively for human use, industrialized, and handled, in addition to their packaging, after disposal by final consumers. A commercial establishments are defined by the decree as a legal entity that offers these home remedies, while manufacturer has been widely regarded as the legal entity that manufactures or has manufactured home remedies, on its behalf or under its brand name. Thus, brand owners are also considered manufacturers, regardless of who is responsible for the manufacturing process itself.

With these definitions, the decree, in its article 6, presents the situations of non-application of reverse logistics of medications. We highlight the health services waste generators whose activities involve the stages of waste management from services related to human or animal health care, acupuncture, piercing, tattooing, beauty and aesthetic salons, clinics and medical and dental offices and personal hygiene products, cosmetics, skin care products, perfumes, and sanitizers.

The decree also creates the obligation to establish a reverse logistics system and gives guidelines for its implementation, enabling the hiring or creation of a management entity, a separate legal entity, with the objective of structuring, implementing, and operating the system. Adhesion to the management entities will be voluntary, and more than one entity may be created to implement the system. The management entity is not to be confused with the representative entity, which represents the interests of the private sector for collaboration, support, and assistance to companies.

When the decree enters into force (180 days after the date of its publication), phase 1 of the structuring and implementation of the reverse logistics system will begin. Within 90 days, entities representing manufacturers, importers, distributors, and traders of home medicines will establish a performance monitoring group responsible for monitoring the implementation of the system. After the group is established, within 90 days a mechanism will be structured for the group to provide information, through an annual report, on the volume of medicinal products that have been delivered in an environmentally suitable manner.

Phase 2 will start 120 days after completion of phase 1 and will include qualification of service providers, preparation of a communication plan, and installation of fixed points for receiving medicines. For better effectiveness, it is provided that expired or unused household drugs are managed as non-hazardous waste during the stages of disposal, temporary storage, transportation, and sorting, until the transfer to the treatment unit and environmentally appropriate final destination, provided that there are no changes in their physicochemical characteristics and that they are kept in conditions similar to those of the products in use by the consumer. Likewise, the decree exempts the activities of receiving, collecting, storing, and transporting these medicines from environmental authorization or licensing. The transport may be carried out by the same vehicle that distributes the medicine for sale.

Due to the particularities and risks of the products and in view of the hierarchy imposed by the PNRS for solid waste handling and management, the decree provides that the environmentally appropriate final destination of expired or unused household drugs should be, as a priority, incineration, followed by co-processing and, finally, class I landfill for hazardous products.

Pharmacies and drugstores will be considered fixed waste reception points and will be obliged to acquire, make available, and maintain container dispensers, in the proportion of at least one fixed point for every 10 thousand inhabitants, in municipalities with a population of over 100 thousand inhabitants. In addition, they must record and report on the waste transportation manifest the mass of waste received and, if necessary, make available a place for primary storage at the commercial establishment. The decree also sets the schedule for the acquisition of the dispensers, such that in the first two years of phase 2 they should be made available only in cities with a population of over 500,000 inhabitants.

Manufacturers and importers are assigned the obligation to transport the expired or unused household medications discarded by consumers at the secondary storage points to the environmentally appropriate treatment unit and final destination. This transport should be funded in a shared manner by manufacturers, importers, and logistics operators. The environmentally appropriate destination of the drugs, on the other hand, should be financed directly by the manufacturers and importers.