On February 1, 2024, the Ministry of Environment, Water and Ecological Transition (MAATE) published Ministerial Agreement MAATE-2023-134 (hereinafter, the ‘Ministerial Agreement’) in Official Register No. 490, by which it issued the Technical Standard for the Application of the Extended Producer Responsibility Principle in the Comprehensive Management of Expired or Out-of-Specification Medicines and Pharmaceutical Products.

This instrument constitutes a key regulatory tool to ensure the environmentally sound management of these products throughout their entire life cycle, with special emphasis on the post-consumer phase.

It is worth noting that this provision complements the provisions of Articles 175 and 176 of the Organic Health Law, which establish that:

• Pharmacies and dispensaries must notify their suppliers at least 60 days before the expiration of the medicines; and

• Manufacturers or importers are responsible for their withdrawal, exchange, destruction, and disposal, under the supervision of the National Health Authority (Ministry of Public Health – MSP).

In this regard, the current legal framework establishes a shared responsibility between the health authority and the environmental authority, which must be addressed in a coordinated manner by all actors involved in the production, commercialization, and consumption chain of pharmaceutical products.

An important point to mention is that the Ministerial Agreement specifies that a Comprehensive Management Program must be submitted and implemented, which, in accordance with the First Transitory Provision of the Ministerial Agreement, must be submitted by August 1, 2025. This deadline is non-extendable, and failure to comply may result in administrative sanctions in accordance with the applicable environmental regulations. Therefore, this bulletin presents key points to consider:

1. Applicable Regulatory Framework

The Technical Standard is based on an intersectoral regulatory body, among which the following stand out:

• Organic Health Law: Articles 175 and 176.
• Organic Environmental Code (COA): Article 217.
• Regulations to the COA: Articles 650 and 652.

These provisions establish, among other aspects, the obligation of manufacturers, importers, and distributors to assume the management of expired or out-of-specification products, and to ensure their withdrawal, treatment, and final disposal in accordance with environmental and health regulations.

2. Scope of Application

The Technical Standard is mandatory for the following actors:

• Producers: Natural or legal persons who manufacture, import, or introduce for the first time medicines or pharmaceutical products into the domestic market, provided that they hold the sanitary registration issued by the competent authority.
• Distributors or Marketers: Natural or legal persons, whether domestic or foreign, responsible for the sale, marketing, or distribution of pharmaceutical products, subject to Extended Producer Responsibility in the domestic market.

The regulation also involves the following as co-responsible actors:

• Users or end consumers,
• Authorized environmental managers,
• Decentralized Autonomous Municipal or Metropolitan Governments (GADs).

3. Obligations of Producers:

Producers have the obligation to:

• Design, submit, and implement a Comprehensive Management Program (PGI) for expired or out-of-specification medicines, covering phases such as collection, transportation, treatment, and final disposal. This instrument includes the set of rules, actions, procedures, and means established for the proper reverse logistics process and subsequent comprehensive management of pharmaceutical products, so that they are sent to authorized facilities where they will undergo processes that prioritize their elimination and/or final disposal. This document shall be subject to approval by the National Environmental Authority.
• Obtain registration as a hazardous waste generator, in accordance with the Single Environmental Information System (SUIA) of MAATE.
• Implement an individual or collective management system in accordance with the established technical guidelines.
• Periodically report to the National Environmental Authority on quantities managed, collection points, and contracted operators.

4. Responsibility of Distributors and Retailers

According to the provisions of Article 4 of the Technical Standard and Article 652 of the Regulations to the COA, distributors and marketers share responsibility for the implementation of the PGIs approved by the producers. This co-responsibility implies:

• Actively collaborate in the collection processes of expired or out-of-specification products.
• Ensure the proper return and routing of these products to collection centers or authorized managers.
• Logistically coordinate with producers to facilitate the operation of the environmental management system.

We will be happy to provide you with more information on this matter. For further information, please contact us at the following email addresses:

Andrés Becdach Fierro: abecdach@bustamantefabara.com

Luis Rivadeneira Pinargote: lrivadeneira@bustamantefabara.com