Recently, the State of Sao Paulo Environmental Agency (“CETESB”), the State Secretariat of Infrastructure and Environment (“SIMA”) and 13 other entities from the pharmaceutical industry have signed a Commitment Term for the implementation of a reverse logistics system for household medicines that are expired or unused, as well as for its packaging, following disposal by the consumer, in the State of Sao Paulo.
The implementation of reverse logistics systems is established in the Solid Waste National Policy (Federal Law 12.305/2010), which aims to reintegrate the waste into new production cycles after its consumption, creating benefits to the environment, since it not only reduces the use of landfills, but also reduces the extraction of raw materials and the depletion of natural resources.
The regulation at the federal level specifically on medicines occurred through Federal Decree No. 10.388/2020, which institutes the reverse logistics system of expired or unused household medicine waste, classified as for human use, as industrialized and manipulated, as well as its packaging after it is discarded by consumers.
In accordance with the Federal Decree, each party to the product’s life cycle has different obligations. Producers and importers have the responsibility to (i) transport the disposed medicine from its secondary storage location to the treatment unit and to its final disposal location, at their own expense, as well as (ii) to bear the cost of the environmentally appropriate disposal of the collected medicine.
Distributors are responsible for (i) paying for the collection of the bags, boxes or receptacles containing expired or unused household medicine discarded by consumers, and for (ii) their transportation from the primary storage location to their secondary storage location, where they will be collected by producers or importers. The Decree also provides for the collection of disposed medicine by the same transportation methods that were used in the shipment of those medicines to merchants.
Merchants, defined as drugstores and pharmacies established as fixed collection points, are required to (i) provide a place for primary storage in their commercial establishments, and to (ii) register and inform, in the waste transportation declaration, the weight, in kilograms, of the expired or unused medicine for collection.
The Federal Decree further determines that consumers should discard their unused or expired household medicine and their packaging in compliance with the rules established by environmental agencies, in accordance with the instructions provided in the publicized material from educational initiatives.
With regard to its scope, the Federal Decree includes all state capitals and cities with a population of over 500 thousand inhabitants for the biennium of 2021 and 2022. From 2023 to 2025, these rules would also apply to all cities with a population of over 100 thousand inhabitants.
Returning to the State of Sao Paulo, the main goal involves the installation of 2,852 points for collection of medicine in the state by 2022, representing 1 collection point for every 10 thousand inhabitants, including, initially, cities with a population of over 200 thousand inhabitants.
This goal broadens the scope of cities that comprise the reverse logistics system for medicine and its packaging, compared to the criteria used in Federal Decree No. 10.388/2020 (500 thousand inhabitants).
In addition, the Commitment Term determines that the parties must, from January 1, 2023, be in full compliance with the conditions of Federal Decree 10.388/2020 with regard to the goals and objectives of the system.
Furthermore, the Commitment Term includes a requirement for the creation of a legal framework to ratify that the medicines subject to the system are not considered dangerous waste, in accordance with the established and appropriate guidelines.
In relation to the trackability and certifiability of implementation of the system, each step will be registered via a self-declaratory document that is unique and valid in all national territory.
Demarest’s Environmental Law team is available to provide support with further information and for the definition of measures to be adopted on a case-by-case basis.