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Resolution 371: Establishing the elements to be considered in the Management Plans for the Return of Pharmaceutical Products and Expired Medicines (in Spanish).

Title 6 of the Decree 1076 of 2015: Partially regulating the prevention and management of hazardous residues or waste under comprehensive management. Law 1333 of 2009 for environmental sanctions Article 28 of Law 344 of 1996: Allowing environmental authorities to charge for the services of evaluation and follow-up of the environmental licenses, authorizations, and other instruments of control and environmental management, established in the law or the regulations, The Resolution 1086 of 2012 of the ANLA which determines the fees for those services.

The inadequate management of pharmaceutical residues and unused/expired medications endangers both the health of the population and the environment. While the consumption of expired or falsified medications poses a direct health risk to consumers, the mismanagement of pharmaceutical residues can result in them entering the environment and becoming environmentally persistent pharmaceutical pollutants (EPPPs) that negatively impact ecosystems. As part of a national policy for regulating waste management from hazardous products, the Colombian Ministry of Environment and Sustainable Development (MESD) introduced Resolution 371, which contains compulsory requirements to regulate these products’ recollection and disposal. The Resolution’s remarkable feature is that it places the responsibilities and costs of implementation on the manufacturers and importers of pharmaceuticals and medications. By 2018, more than 930 tons of medicines had been disposed of, 2,593 take-back points were established to collect the medicines, and 711 manufacturers and importers participated in the policy. Moreover, the Resolution is a pioneer in the region and has inspired other neighbouring countries to develop similar approaches.

Our “Best Policies” are those that meet the Future Just Law-making Principles and recognise the interconnected challenges we face today. The goal of principled policy work is to ensure that important universal standards of sustainability and equity, human rights and freedoms, and respect for the environment are taken into account. It also helps to increase policy coherence between different sectors.

   Sustainable use of natural resources

• Tackles the problem of proper disposal of expired medication to protect the environment and human health.
• Protects population health, especially children, by reducing the possibility of poisonings and wrongful consumption of expired/falsified medication; prevents black market sales.
• Stimulates sustainable innovation alternatives for the disposal stage by industry players.
• Sustainably financed via fees paid by the producers and importers.

   Equity and poverty eradication

• Overall scope includes the medication-consuming population as well as the general population and environmental ecosystem.
• The national population coverage goal includes the entire population, in both urban and rural areas, to have access to take-back points.
• Acknowledges the responsibility to avoid future problems and thereby promotes the wellness of future generations, including children.
• Empowers consumers to take responsibility for safe consumption and disposal of medicines.

   Precautionary approach

• Prevents hazardous environmental impacts such as water and soil contamination, which can further harm population health; this is expected to worsen in the future unless preventive measures are taken.
• Places the responsibility on producers and importers to produce sustainable and safe products with proper disposal and waste management measures.
• Based on scientific evidence (the Basel Convention) for classification of hazardous products.

   Public participation, access to information and justice

• Supports the transparency of information to the public via public websites and mobile applications.
• Administrative process guarantees the participation of relevant stakeholders in the implementation, including public consultation.
• Promotes multistakeholder participation in the evaluation processes.
• Both the public and private sector are involved in consumer awareness-raising campaigns.

    Legal governance and human security

• Legal decision-making process involves consultations and feedback from stakeholders.
• Several government environmental agencies work in coordination in the implementation and monitoring of the Resolution.
• The ANLA monitors the implementation status annually; it is also in charge of imposing sanctions and fees, including in cases of non-compliance.

   Integration and interrelationship

• Reduces environmental exposure and thus supports environmental protection by promoting the proper disposal of pharmaceutical residues and expired/unused medications.
• Reduces risks associated with black market use and sales of expired/unused medications by reducing availability and thereby protecting the population health.
• Part of other complimentary environmental national policies (e.g. Law 1333 of environmental sanctions).
• Promotes collaboration between industry stakeholders by allowing them to manage the PPRMPs collectively.
• Application of the polluter-pays principle and the right-to-know principle.

   Common but differentiated responsibilities

• Potential to be adapted in other neighbouring countries, especially the progressive element of national coverage goals.
• Prices for medications are regulated by the state and cannot be increased to make the final consumers bear the costs of implementing the PPRMPs.

The Resolution tackles the problem of managing the disposal of pharmaceuticals and expired medications. Currently, Colombian wastewater treatment plants are not adequately equipped to filter out hazardous residues; waste is typically not incinerated, and the majority is disposed of in landfills. Although the concentration of pharmaceuticals active in the environment is shown to be low, negative impacts on the aquatic environment have been observed. The Resolution also addresses the health risks related to the consumption of expired medications. An estimated one in ten medical products in circulation in developing countries is falsified or substandard and consequently sold on the black market. In Colombia, medications are the substances most associated with chemical poisoning cases, accounting for almost 33 percent of reported cases. In 2005, the government published Decree 4741, which established a framework for a national environmental policy for the comprehensive management of hazardous waste and introduced the Post-Consumption Product Return Management Plans (PPRMP) for all hazardous products defined under the Decree. This Decree also included obligations for the private sector (e.g., producers, importers, and distributors) to take responsibility for each step in the product’s lifecycle, produce sustainable and safe products for consumption, and internalize all the costs of implementation. Consequently, in 2009 the MESD issued a detailed regulation for each type of product and thereby established Resolution 371, whose implementation commenced in 2011.

The main objectives of the Resolution are: 1) the proper waste management of pharmaceuticals and medications by making the producers and importers accountable for production and commercialization of their hazardous products; 2) establishing take-back points in various public locations for consumers to return such products, which are then collected for proper disposal by industry players; thereby supporting 3) the prevention and better control of the overall contamination and harm caused to public health and the environment through expired or falsified medications; and ultimately 4) to create awareness in consumers about the risk of such products by promoting proper waste management.

The MESD serves as the main environmental government actor and is in charge of providing the overall environmental regulatory framework and guidelines which the industry must follow, in accordance with the Resolution. It also supervises the different government agencies involved. The Resolution designates the responsibility of managing the proper disposal of expired pharmaceuticals and medications to the producers and importers. The industry stakeholders are in charge of presenting, implementing, and financing the PPRMPs. Furthermore, the Resolution defines the national population reach and coverage goals, the characteristics of safe recollection centres, data collection of the PPRMPs, matters of confidentiality and disclosure of information, follow-up and monitoring activities, restrictions, and sanctions. A PPRMP of expired pharmaceuticals and medications must contain information about 1) the type and quantity of medication produced, imported, or marketed on the national market; 2) the actors involved and their level of participation, including the resources and management tools used and the transparency of information exchange between them; and 3) the planning and monitoring of the implementation. In order to receive a license and registration to sell or import pharmaceuticals and medications, a PPRMP must be presented individually by a single company or collectively by two or more companies to the ANLA. Once a license is granted, and after the manufacturing/production and commercialization of the products are established, the implementation of proper disposal mechanisms via take-back centres can take place. The ANLA is the principal governmental agency in charge of overseeing and approving the plans proposed by the producers and importers. It also evaluates and monitors the plans and, under Law 1333 of environmental sanctions, imposes sanctions in case of non-compliance. Additionally, the PPRMPs contain the procedural measures that need to be followed by the companies. Companies may choose to carry out the plan themselves or through the use of operators in charge of the different logistical plan stages, such as collecting, sorting out, storage, and disposal. One of the largest PPRMP operators in Colombia is the Punto Azul Corporation, an industry association of 291 companies, representing the largest network of take-back points, with 1,726 Punto Azul-labelled disposal containers in Colombia. The Regional Environmental Authorities provide awareness-raising campaigns and inform consumers about the obligation to dispose of medications at take-back points set up by the producers. Consumers are then responsible for following the instructions for proper consumption and disposal of medicines set out by the Resolution. The Authorities are also in charge of the evaluation and follow-up of the companies involved, and they check whether returned medications are handled in environmentally friendly ways by monitoring the storage and management of products throughout the entire process of recollection and disposal. As for the containers, they cannot hold more than twenty tons and must be safely secured to both contain the hazardous products and prevent their removal and must be emptied within six months. The collected waste is then transported in sealed bags to avoid theft and taken to storage centres where waste is weighed and sorted out by manufacturers to control the amount collected from each company, and by product types, such as pills, syrups, and packaging. The Authorities check on all of these procedures and ensure the safe management of the process and also the compliance of security measures by workers in storage facilities. The waste is then taken for its final disposal, e.g., landfills, incineration, energy recovering systems, composting, or recycling. Other important actors are the distributors and merchandisers, such as pharmacies, drugstores, and healthcare centres. They must provide a safe space for the designated take-back points and accept returned medications by consumers. They are also responsible for informing consumers about the health and environmental risks associated with the consumption and improper disposal of expired medications and enforcing their safe disposal. The MESD also provides an app to help consumers find the nearest take-back points; further information can be accessed from the public websites of the MESD and the Punto Azul Corporation. The specified timeline goals for implementing the Resolution are: 1) in Year 1 (2011), the producers must present and carry out a pilot plan and include activities to raise awareness among consumers and chain actors; 2) in Year 2, the plan for returning expired medicines must cover 10 percent of the population; and 3) in Year 3, the plan must increase the national coverage of the population through annual increases of 10 percent, until reaching a total coverage of at least 70 percent of Colombia’s total population. Regarding implementation results, the findings of a collaborative evaluation project between the governments of Colombia, Chile, and Germany in 2012 showed a lack of public knowledge about the take-back programmes for hazardous products and an insufficient number of industry participants. Initially, this was due to the resistance to the added expenses to be incurred by the manufacturers and importers. However, the industry disclosed a positive view of the scheme, highlighting the straightforward relationship with the ANLA. In 2019, an evaluation by the MESD between 2007-2017 found that the actors involved viewed the Resolution as a profound contribution to the improvement of hazardous waste management. The evaluation also identified the issue of sufficient take-back points coverage; this is partly due to areas which are harder to reach and/or less populated leading to the necessity for more effective PPRMPs in these municipalities. The Resolution is continuously revised, and meetings with the industry are held regularly. An update has been considered to address some issues, such as expanding the geographical reach of the programme, re-evaluating the specifications on the methodology to calculate take-back goals, redefining which medications are covered by the Resolution, and strengthening information campaigns for consumers.

Leading up to 2018, 39 PPRMPs have been created, including 31 individual and 8 collective plans. Of 711 manufacturers and importers of medicines, 680 participate in collective plans, which corresponds to 95 percent of the market share. There are 2,593 take-back points and collection centres established in 1,102 municipalities. Since implementation, the goal of covering 70 percent of the population of Columbia with take-back centres has been reached and approximately 939,690 kilograms of used medications have been properly disposed of. Furthermore, the Resolution has positively impacted the industry to create sustainable disposal alternatives to traditional landfill and incineration methods, such as recycling, energy recovery systems, and composting. Regarding consumer awareness, in 2018, 78 percent of consumers of pharmaceuticals reported their knowing about the take-back programs for expired medications. Awareness raising campaigns by the government and the industry have also taken place in various locations such as supermarkets, private and public buildings, and educational institutions. Colombia is also a pioneer country in the development of the Ibero-American Network for Medical Post-Consumption Plans (REDIPPM), created in 2015 at the initiative of the pharmaceutical industry in Spain, Portugal, and Mexico to share experiences in the area of medicine waste management and to develop best practices for the development of post-consumption plans.

Other medicine disposal management plans with a focus on producer responsibility exist in Mexico and Europe.  The REDIPPM is a key player for transferability as it organizes congresses and meetings to share experiences and advises the industry and other countries to participate. In 2019, they created the Post-Consumer Medicine Platform (PPM) with the support of the Ibero-American Medicines Authorities Network  to promote the creation of more medicine disposal management plans in the region. The Punto Azul Corporation is currently working with Ecuador to expand their services of safe disposal mechanisms, although Ecuador has yet to establish the coverage goals and compliance mechanisms. Other countries in the region, like Brazil, Chile, Honduras, Costa Rica, and Peru, are also in the process of developing pharmaceutical and medicines PPRMPs.

1. Chilean Government and Ministries and Colombian MESD and Sustainable Development (2014). Triangular Cooperation between Colombia/Chile/Germany: Strengthening of Waste Management Project.
2. Colombia currently has regulations for seven different product types, including used lead-acid batteries (2009), expired pharmaceuticals or medication (2009), disused computers and printers (2010), normal batteries (2010), fluorescent lightbulbs (2010), disused pesticides, their containers or packaging, and packaging that has been contaminated with pesticides (2013), and tires (2017).
3. Decree 1076 of 2015 is a compilation of many decrees, including the Decree 4741 of 2005. Government of Colombia. The MESD (2015). Decree 1076 of 2015. https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=78153.
4. Email from Diego Escobar Ocampo on 31 August 2020.
5. Gómez, A.P.D. (2017). Event Report: Chemical Poisoning; Version 03. The National Institute of Health: Process Surveillance and Analysis of Risk in Public Health. https://www.ins.gov.co/buscador-eventos/Informesdeevento/INTOXICACIONES%202017.pdf.
6. Government of Colombia (1996). Article 28 of the Law 344 of 1996: by which regulations are issued to rationalize public spending, extraordinary powers are granted, and other provisions are issued. http://www.suin-juriscol.gov.co/viewDocument.asp?ruta=Leyes/1658481#:~:text=LEY%20344%20DE%201996&text=(diciembre%2027)-,por%20la%20cual%20se%20dictan%20normas%20tendientes%20a%20la%20racionalizaci%C3%B3n,y%20se%20expiden%20otras%20disposiciones.
7. Government of Colombia (2009). Law 1333 of 2009: by which the environmental sanctioning procedure is established and other provision are issued. https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=36879.
8. Government of Colombia. ANLA (2012). Resolution 1086 of 2012 of the ANLA: establishes the fees for the collection of evaluation and monitoring of licenses, permits, authorizations and other instruments of control and environmental management, and other provisions. http://portal.anla.gov.co/documentos/institucional/11802_2014-04-03_-_MODIFICACI%C3%93N__RESOLUCI%C3%93N_1086_DE_2012.pdf.
9. Government of Colombia. The MESD (2005). Decree 4741, http://www.ideam.gov.co/documents/51310/526371/Decreto+4741+2005+PREVENCION+Y+MANEJO+DE+REIDUOS+PELIGROSOS+GENERADOS+EN+GESTION+INTEGRAL.pdf/491df435-061e-4d27-b40f-c8b3afe25705.
10. Government of Colombia. The MESD (2009). Resolution 371: Establishing the elements to be considered in the Management Plans for the Return of Pharmaceutical Products and Expired Medicines.
11. Government of Colombia. The MESD (2013, April 15). Post-consumer programs: expired medications [Video]. Youtube. https://youtu.be/6UgYWuFRcbI; The MESD (2014, June 10). Post-consumer campaign “Medications” [Video]. Youtube. https://youtu.be/6q7MDyyiln0.
12. Government of Colombia. The MESD (2017, September 01). Post-consumer waste collection day in the Amazon [Video]. Youtube. https://youtu.be/KF9-1COpgdw.
13. Government of Colombia. The MESD (2018). The Red Posconumo app expands to more than 8,000 points throughout the country. https://www.minambiente.gov.co/index.php/noticias-minambiente/3762-la-app-red-posconsumo-se-amplia-a-mas-de-8-000-puntos-en-todo-el-pais.
14. Government of Colombia. The MESD (2019). Evaluation of the implementation of the Environmental Policy for Integrated Hazardous Waste Management 2007-2017. https://www.minambiente.gov.co/images/AsuntosambientalesySectorialyUrbana/pdf/sustancias_qu%C3%ADmicas_y_residuos_peligrosos/A-EVALUACI%C3%93N_POL%C3%8DTICA_RESPEL_30-03-2020.pdf.
15. Government of Colombia. The MESD (2019). Evaluation of the implementation of the Environmental Policy for Integrated Hazardous Waste Management 2007-2017. https://www.minambiente.gov.co/images/AsuntosambientalesySectorialyUrbana/pdf/sustancias_qu%C3%ADmicas_y_residuos_peligrosos/A-EVALUACI%C3%93N_POL%C3%8DTICA_RESPEL_30-03-2020.pdf.
16. Government of Colombia. The MESD. Expired Medications. https://www.minambiente.gov.co/index.php/asuntos-ambientales-sectorial-y-urbana/programas-posconsumo-existentes/medicamentos-vencidos.
17. Ibero-American Medicines Authorities Network. https://www.redeami.net/.
18. Ibero-American Network of Post-consumer Drug Programs. https://www.redippm.org/.
19. In Europe such schemes exist in: Spain, Portugal, Austria, France, Belgium, Finland, Sweden, Croatia and Slovenia. European Commission – DG Environment (2014). Final Report. Development of Guidance on Extended Producer Responsibility (EPR). https://ec.europa.eu/environment/waste/pdf/target_review/Guidance%20on%20EPR%20-%20Final%20Report.pdf.
20. Interview with Diego Escobar Ocampo and Natalia Uscategui on 20 November 2020
21. Interview with Jorge Enrique Trujillo Sánchez on 27 November 2020.
22. Interview with Oscar Javier Suárez Medina on 5 November 2020.
23. Interviews with: Diego Escobar Ocampo and Natalia Enrique Trujillo Sánchez on 27 November 2020.
24. National Environmental Permit Authority (ANLA), Government of Colombia. http://www.anla.gov.co/.
25. National Environmental Permit Authority (ANLA): Management Plans for the Post-Consumption Return of Expired Drugs or Medicines. http://portal.anla.gov.co/planes-gestion-devolucion-posconsumo-farmacos-o-medicamentos-vencidos.
26. Punto Azul Corporation. Post-use Human Medicines Program. https://www.puntoazul.com.co/medicamentos-humanos/.
27. Ibero-American Network of Post-consumer Medicine Programs. Post-consumer Medicine Platform (PPM). https://www.redippm.org/plataforma-posconsumo-de-medicamentos-ppm/.
28. The categorization of hazardous products in Colombia is based and updated according to the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal of 1989. UNEP. Basel Convention: Controlling transboundary movements of hazardous wastes and their disposal. http://www.basel.int/TheConvention/Overview/TextoftheConvention/tabid/1275/Default.aspx.
29. The MESD, Government of Colombia. (2019). Evaluation of the implementation of the Environmental Policy for Integrated Hazardous Waste Management 2007-2017. https://www.minambiente.gov.co/images/AsuntosambientalesySectorialyUrbana/pdf/sustancias_qu%C3%ADmicas_y_residuos_peligrosos/A-EVALUACI%C3%93N_POL%C3%8DTICA_RESPEL_30-03-2020.pdf.
30. The Red-EAMI Network is formed by the Agencies or Directorates of medicines linked to the Ministries of Health or public health research institutions in twenty-two Latin American countries: Andorra, Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Portugal, Dominican Republic, Uruguay and Venezuela.
31. The scheme in Mexico is however a voluntary system and lacks compliance, demonstrating the importance of enforcement mechanisms.
32. WHO (2017). Drug Information, 31, No. 4. https://www.who.int/medicines/publications/druginformation/issues/WHO_DI_31-4.pdf.