Expanding Extended Producer Responsibility: Challenges and Opportunities

EPR is an environmental policy principle that internalizes external environmental costs by holding producers accountable for the end-of-life management of their products. EPR serves as a fundamental pillar of environmental legislation worldwide, supporting the broader transition toward a circular economy.

As EPR policies continue to expand to new geographies and product categories, the pharmaceutical sector has gained increased attention. However, several product and demand characteristics distinguish pharmaceutical EPR from other sectors. For example, although pharmaceutical companies have long been subject to EPR for packaging, electrical and electronic waste, and unused drugs, new challenges are emerging with the increasing inclusion of medical devices, micropollutants in wastewater, and eco-modulation of EPR fees. EPR for urban wastewater treatment is unprecedented, as material recovery is technically not feasible. Furthermore, stringent regulations regarding human safety, hygiene, and sterility impose significant barriers to take-back, reuse, and material recovery.

Based on primary, secondary, and gray literature, this article examines the evolving landscape of both mandatory and voluntary EPR specifically in the pharmaceutical industry, highlighting EPR’s growing relevance, challenges, and opportunities.

Introduction

Pharmaceuticals play a crucial role in both medical and veterinary practices, significantly enhancing human and animal health, food production, and economic well-being. The summary of product characteristics1 provides specific guidance on the safe disposal of medicines to ensure environmental protection and public safety. However, leakage during production, spreading of sewage sludge, leaching after landfilling, or improper disposal of medicinal waste by end users can introduce active pharmaceutical compounds into natural ecosystems, potentially causing adverse effects on human health and the environment.2

Due to demographic, epidemiological, and lifestyle changes, pharmaceutical consumption has increased over the past two decades and is expected to continue rising. For instance, between 2000 and 2019, the consumption of antihypertensive drugs in Organisation for Economic Co-operation and Development (OECD) countries rose by 65%, lipid-modifying agents increased nearly 4-fold, and the use of antidiabetic and antidepressant drugs doubled.3 This rise in consumption has led, and will continue to lead, to increased waste volumes in the future.

Incentivizing and implementing circularity principles can help mitigate excessive resource consumption and potential pollution caused by pharmaceutical products and their residues. However, market demand for secondary products and raw materials alone is often insufficient to drive circular solutions. One of the main reasons is that external costs are not adequately factored into market prices. Various policy interventions can be implemented throughout the pharmaceutical product life cycle, including source-directed, user-oriented, or end-of-life measures, to prevent medicinal waste and reduce environmental leakage.

EPR is among the most effective and stress-tested policy principles for internalizing these external costs, rooted in the polluter pays principle,4 and a key pillar of environmental and circularity policy, particularly in the European Union.5 It shifts the responsibility for a product throughout the entire life cycle, including post-consumption treatment, from local authorities and municipalities upstream to producers.6^, 7^, 8 Pharmaceutical producers are defined as entities that engage in production, preparation, propagation, compounding, and processing of pharmaceuticals, which exclude repackagers, wholesalers, and other dispensing entities.9 EPR’s key rationale is to hold these producers operationally and/or financially accountable for the end-of-life management and environmental impact of their products.10 For the purpose of this article, we understand EPR in a broad sense from a full-value-chain perspective,11 encompassing both mandatory and voluntary instruments and mechanisms that interact in a policy mix.12

The most frequent approach to operationalize EPR is through take-back schemes, funded through advanced recycling or producer responsibility organization (PRO) fees, whereby producers pay for PRO services based on product weight, volume, or turnover. So-called eco-modulated fees refer to variable fees based on product characteristics and thereby incentivize, for instance, product recyclability or the use of mono-materials or recycled materials.8 Thereby, EPR can increase collection and material recovery, incentivize sustainable product design,13 and decrease primary material use and dependency.6^, 14^, 15 Since its creation, EPR has increased in complexity and has been extended, diffused, and transferred to new product groups, substances, sectors, and geographies.12^, 16

Historically, packaging and electronics were the first product groups to fall under EPR compliance. Nowadays, EPR has been applied to a wide range of products, including batteries, tires, oils, vehicles, mattresses, textiles, furniture, light bulbs, single-use plastics, and construction materials.

The pharmaceutical industry has been exposed to EPR via packaging and, to a lesser extent, electronic devices. Yet, the sector has recently drawn attention, as multiple areas of application—such as outdated and surplus medicines, micropollutants in wastewater, medical devices, or substances of concern (SoCs) —are now in scope of mandatory or voluntary schemes.

Pharmaceutical products show unique product and demand characteristics compared to other products traditionally associated with EPR, as outlined in a recent publication:9 First, they are consumables with strictly regulated and tested expiration dates. Second, they adhere to strict hygiene and safety regulations. Third, unused or expired drugs and residues can pose both public health and ecological risks, particularly in aquatic ecosystems, where potentially harmful substances can easily disperse.17

EPR is one means of generating political and economic incentives for recovery and sustainable product design, offering a market-based and more flexible approach compared to traditional command-andcontrol policies.

Existing EPR legislation and literature have focused primarily on nonconsumable products. The pharmaceutical industry is the first sector where consumables (in this case, a drug product containing microparticles) fall under compliance. Selected EPR studies focus on or at least include pharmaceuticals,9^, 14yet no study has explored the significance of EPR for the entire pharmaceutical industry and supply chain comprehensively. Here, we present key EPR concepts relevant to the pharmaceutical industry, based on a thorough review of both academic and gray literature. This study summarizes the latest developments, challenges, and opportunities associated with EPR in the pharmaceutical industry. We conclude by providing key implications and an outlook for pharmaceutical companies.

Key EPR Mechanisms and Functionalities

EPR is not a single instrument, nor is it a tax;9 rather, it is a policy principle. EPR is one means of generating political and economic incentives for recovery and sustainable product design, offering a market-based and more flexible approach compared to traditional command-and-control policies.10 EPR system designs vary considerably depending on country contexts, such as waste infrastructure and legislation, rule of law, and cultural aspects.18

A key distinction can be made between mandatory and voluntary EPR. Mandatory EPR legally requires producers to meet their EPR obligations, often through joining a PRO to collectively organize collection, sorting, and processing.14 Several studies have shown that collective EPR leads to higher environmental benefits than individual EPR.19 EPR systems can be organized either monopolistically, with a single centralized PRO, or competitively, with multiple PROs offering different fee models and slightly varying services. Furthermore, the level of involvement of PROs in operational activities, such as collection and sorting can vary. Systems where PROs have only financial responsibility are often found in monopolistic models. In contrast, systems where PROs are directly responsible for managing the collection, sorting, and treatment of products are typically found in competitive EPR models.20

Application of EPR to Pharmaceutical Products and Associated Waste Streams

Pharmaceutical Packaging

Pharmaceutical packaging—which includes paper, plastic, cardboard, glass, and metals—ensures pharmaceutical product safety and effectiveness. It contains, protects, transports, and identifies drug products until use by patients.21 Examples include blister packs, plastic bottles, pouches, trays, glass vials and ampules, and cardboard boxes. However, its production and end-of-life treatment often uses nonrenewable energy and, if not recycled, contributes to waste generation and pollution. The use of plastics is often preferred over other materials due to their cost-effectiveness and their lightweight, durability, and barrier characteristics. Plastic packaging can be easily sterilized, unlike cardboard or paper-based alternatives, and also supports efficient labeling. On the other hand, plastics can leak into natural environments, persist for extended periods, and degrade into microplastics, which then infiltrate organisms and enter food chains.

Packaging was the first sector to which EPR was applied. With the first schemes in Germany and Sweden in the early 1990s, packaging EPR is now mandatory in over 60 countries worldwide16 and six US states (California, Colorado, Connecticut, Maine, Maryland, and Oregon) (see Table 1). In many jurisdictions, primary medicinal packaging is exempt from EPR obligations (currently not in Oregon), but most secondary (e.g., trays) and tertiary packaging (e.g., transport packaging) are in scope. Primary or immediate packaging is in direct contact with the drug product. Secondary packaging protects and collates the product and carries information and branding. Tertiary packaging facilitates the protection, handling, and transportation of a series of sales units.22

A central demand of the ongoing global negotiations among more than 170 countries for a legally binding instrument on plastic pollution is that every country worldwide establishes an EPR system for packaging.23^, 24 The EU has already taken this step: With the revised Packaging and Packaging Waste Regulation enacted in 2025, packaging EPR will become mandatory across all EU countries by 2027. This is relevant for Denmark, Croatia, and Hungary, which previously did not have EPR take-back schemes in place.12 Globally, an increasing number of emerging countries are introducing packaging EPR or transitioning from voluntary to mandatory schemes, as seen in Kenya in May 2025.

Globally, significant differences in material collection and recovery rates exist depending on the type of material. Recovery rates are defined as the proportion of recyclable materials that are recovered from the total amount of recyclable waste generated. Paper and cardboard have the highest recovery rates, followed by glass and metals, solid plastics, and finally flexible plastics. Eco-modulation is an emerging trend and is becoming increasingly complex and granular. It incentivizes design for recyclability, use of recycled and mono-materials (e.g., polypropylene [PP]-only instead of polyvinyl chloride [PVC]-based and composite blister packaging), and the absence of SoCs. For example, the presence of PVC and polystyrene (PS) is already penalized in France and Portugal.25

In accordance with the EU’s “proximity principle,”4 France will also include a bonus fee if collection, sorting, recycling, and incorporation of recycled plastics takes place within 1,500 km around the barycenter of the French territory.21 It is possible that additional pharmaceutical-relevant substances, such as per- and polyfluoroalkyl substances, ethanol, or intentionally added microplastics (synthetic polymer microparticles), will be included into eco-modulation in the future, or at least added to reporting requirements, if they are not already restricted. It remains an open question whether future EPR modulation will also incentivize sustainable packaging trends like replacement of plastics with paper fiber, sustainable glass vials, fiber-based tamper-evident packaging, or electronic patient leaflets.22

Medical Devices

Medical devices are used either in medical centers and hospital settings (stand-alone injections) or at home, by either patients or medical staff. After use, many medical devices are discarded and processed in landfills or incinerated, leading to the loss of valuable materials (plastics, rubber, metals, glass) that could otherwise be reused.

Although many countries or regions have strict regulations regarding the safe disposal of medical devices, mandatory device EPR, including take-back of medical devices, usually from home application, is a niche instrument and most take-back schemes are voluntary industry initiatives. These experienced a strong international momentum in the post-pandemic years of 2022 and 2023.

Voluntary schemes cover prefilled syringes, self-injection devices (such as autoinjectors and pens), and other equipment, including sharps, inhalers, and pipettes. They are predominantly found in Europe and the US, but also exist in Brazil, Japan, Singapore, Malaysia, Thailand, and the Philippines. Common collection methods include drop-off points at pharmacies and retailers, or mail-in boxes and envelopes. Unlike deposit refund systems, one major challenge is the lack of financial incentives for patients to return devices, which often results in low return rates. Further challenges include lack of collection infrastructure, regulatory constraints, or economic feasibility. Electronic medical devices (e.g., electronic inhalers) are not covered by voluntary schemes and are typically regulated under EPR for waste electrical and electronic equipment.

Few mandatory EPR schemes exist for end-of-life take-back of medical devices. For instance, Art. 8 of the EU’s Waste Framework Directive4 simply states that “Member States may take legislative or non-legislative measures to ensure that any natural or legal person who professionally develops, manufactures, processes, treats, sells or imports products […] has extended producer responsibility.”4

Although subsequent directives have applied the EPR principle to specific products or product groups, this has not been the case for medical devices. An exception at national level is the French DASTRI (Déchets d’Activités de Soins à Risques Infectieux), a national PRO that collects and treats waste from healthcare activities. Founded in 2016 and based on Art. 89 of the Public Health Code, DASTRI is entirely funded by health industry professionals, pharmaceutical companies, and medical device manufacturers. It provides patients who self-administer treatments and users of diagnostic self-tests with a local solution for disposing of medical waste they produce.26

Unused and Expired Medications

The use of human and veterinary pharmaceuticals for their intended purposes is accompanied by a complex network of routes by which they eventually gain entry to the environment. In particular, disposal of unused medicines can be a significant source of environmental contamination that would otherwise have been extensively metabolized. 27

Human medications can remain unused for various reasons. The primary causes include expired shelf lives, changes in therapy, nonadherence to prescribed treatment, or improved health conditions of the patient.28 Resale and redispensing of unused medicines remain limited due to concerns about counterfeits, quality assurance, and resulting legal constraints. Unused medications often end up in household waste streams and, in the absence of incineration infrastructure, are disposed of in landfills.

The use of human and veterinary pharmaceuticals for their intended purposes is accompanied by a complex network of routes by which they eventually gain entry to the environment. In particular, disposal of unused medicines can be a significant source of environmental contamination that would otherwise have been extensively metabolized.

The most common method for disposing of unused medications in households is through domestic waste.29 This practice poses fewer issues in regions where household waste is primarily incinerated with subsequent flue gas cleaning, as is the case in many EU countries. Incineration effectively neutralizes potentially harmful compounds, which may deter countries from investing in more expensive separate collection schemes.30 Unused medications are also frequently disposed of via the toilet. In a 2006 survey conducted in the US, over half of the participants (53.8%) reported flushing medications into public sewage systems,31 where wastewater treatment plants might not be equipped to effectively remove pharmaceutical compounds before discharge.2^, 29

Several countries have established EPR-inspired take-back schemes for unused or expired medication. Some programs are solely funded by the government, such as in Australia, whereas others receive financial support from the pharmaceutical industry or pharmacies, either voluntarily or through mandatory EPR (see Table 1).

Residents in Sweden, for instance, have a long tradition of returning unused medication to pharmacies. The system was introduced in 1971 by the Swedish pharmacy chain Apoteket AB, solely for safety reasons. Over the years, the focus has gradually shifted from safety to environmental concerns as research and discussions about pharmaceutical substances in the environment have increased.32 SIGRE (Sistema Integrado de Gestión y Recogida de Envases) in Spain, established in 2001, manages the safe disposal of expired or unused medicines and their packaging through a collaboration between the pharmaceutical sector, pharmacies, and the logistics sector, supervised by the regional ministries of environment. Finland and the Netherlands have similar systems of voluntary separate collection. In Germany, there is no uniform regulation for the disposal of medications and pharmaceuticals at federal level and disposal is managed at municipal or district level. Voluntary disposal of medications at pharmacies is available in half of all districts.33

In the United States, in 2012, Alameda County in California passed a jurisdiction to require pharmaceutical manufacturers to fund drug take-back programs, followed by King County, Washington, in 2013,14 and subsequently by New York, Massachusetts, and Vermont.

Australia’s government-funded National Return and Disposal of Unwanted Medicines Program (NatRUM) facilitates the safe disposal of expired and unwanted medicines by allowing individuals to drop them off at participating pharmacies at no cost, with the collected medicines primarily disposed of through incineration.34

Micropollutants in Urban Wastewater (EU Only)

Micropollutants, including residues of active pharmaceutical ingredients (APIs), their metabolites, and breakdown products from incomplete degradation, are natural or synthetic contaminants that can negatively impact humans and ecosystems.13 Some are hazardous even in small concentrations. If not captured and treated properly, these contaminants could be released into natural environments and may contaminate water sources, surface water, groundwater, and soil with adverse effects on human health and medical treatment options, such as antimicrobial resistance.15^, 17

Advanced wastewater treatment processes, including adsorption, ozonation, and filtration through nanofiltration or reverse osmosis membranes, have proven effective in removing most pharmaceuticals.29 However, more persistent and mobile contaminants can only be removed via quaternary treatment, that is, nutrient removal. Costs of tertiary and quaternary treatment are significantly higher than secondary treatment.38

Pharmaceuticals in the environment have emerged as a critical regulatory focus due to their potential ecological and human health impacts as micropollutants. The Urban Waste Water Treatment Directive (UWWTD) in the European Union, particularly through the revised Directive (EU) 2024/3019 mandates the removal of micropollutants—including pharmaceutical residues—from urban wastewater. A study by Bio Innovation Service39 claims that 92% of the micropollutant toxic load (based on potential no-effect concentrations) originated from the use of pharmaceutical and cosmetics products. Although the underlying data model has been contested,40 the revised EU UWWTD, effective as of January 2025, requires pharmaceutical and cosmetics industries to contribute at least 80% of the full costs of quaternary wastewater treatment via EPR schemes.41

The UWWTD is currently being transposed and implemented by EU member states into national legislation. By 2027, pharmaceutical and cosmetics companies operating in the EU will be required to pay EPR fees. There are ongoing discussions regarding definitions (e.g., rapid biodegradability), cost coverage, implementation processes (standardized fee calculation method), oversight mechanisms, eco-modulation (e.g., hazardousness, toxicity), stormwater management, and the establishment of national PROs.

Experience has shown that for new EPR schemes, single, centralized, not-for-profit PRO systems should be prioritized over multi-PRO competitive schemes because they yield benefits in terms of transparency, administration costs, and oversight. Responsibility for quaternary treatment upgrades will remain with wastewater authorities. Because the required upgrades are clearly defined, it is difficult to envision for-profit PRO systems differentiating through varied services or fee models. Micropollutants in wastewater represent a new product category under EPR, marking the first instance of an EPR scheme without the goal or possibility of material recovery. This introduces a new dimension to EPR, aligning with the ongoing extension and evolution of EPR mechanisms worldwide.

Discussion and Conclusion

Global EPR Trends

The number of countries, regions, and states applying the wide toolbox of EPR mechanisms and instruments across industries is growing, and the pharmaceutical sector is no exception. The policymaker’s role is to level the playing field. This would not only enable the funding of recycling infrastructures but also allow industry take-back programs and other circularity initiatives to evolve from mere environmental compliance to competitive advantages. Although it has been argued that “it is difficult to imagine that EPR will lead to recyclable or reusable pharmaceutical product designs.”14 the global regulatory landscape has evolved and eco-modulated fees, in particular, provide incentives for packaging and device designs to reduce environmental externalities and end-of-life treatment costs. The increasing global adoption of EPR suggests that it is becoming the preferred policy principle for managing pharmaceutical packaging, unused drugs, and medical devices.9

There are conflicting trends for mandatory EPR: there’s a supranational effort to standardize and harmonize minimum criteria for effective EPR while complexity and granularity of system designs continue to increase. Mandatory and voluntary EPR, centralized and competitive EPR, as well as financial and operational EPR, differ significantly in their design, implementation, and functioning. As we’ve seen,,9^, 12 preferred EPR models from other industries should not be blindly applied to the pharmaceutical setting, mainly due to demand structures and the consumable nature of pharmaceuticals. Instead, when transferred to new sectors or countries, EPR building blocks must always be translated into and carefully weighed against existing legislation, critical infrastructure, business climate, market conditions, cultural aspects, and the informal sector.12

Key Challenges

Packaging EPR systems, although sometimes exempted for primary pharmaceutical packaging, face challenges such as limited oversight and inadequate enforcement, potentially leading to free riding. This refers to actors who place products on the market, benefiting from waste treatment infrastructure, without paying the required EPR fees. They thereby distort competition and rarely invest in improved product design.9^, 42 Patients play a crucial role in the success of EPR take-back schemes for medical devices and unused drugs. These programs largely depend on patient awareness and their willingness to return used or unused products without immediate financial compensation, as would be the case in deposit refund schemes. Another risk is that additional fees, such as a malus applied to composite or PVC packaging, may be passed on to patients through increased drug prices, thereby undermining the intended incentive for companies to invest in more sustainable product development. Major barriers at the company level include limited-scale economies, complexities in reverse logistics, and high operational expenses (OPEX).17 Consequently, companies with large medical device portfolios are more likely to drive these initiatives forward.

Patients play a crucial role in the success of EPR take-back schemes for medical devices and unused drugs. These programs largely depend on patient awareness and their willingness to return used or unused products without immediate financial compensation, as would be the case in deposit refund schemes.

There is also a metrics challenge: standardized, reliable, and comparable effectiveness metrics (e.g., return, sorting, and recycling rates) and EPR fee calculation benchmarks are often missing. Given that setting up and operating packaging EPR systems can be resource-intensive, plastic credits have been proposed as an “EPR-light” alternative. However, this approach has faced severe criticisms: companies that voluntarily use plastic credits to offset their environmental impacts are not required to establish long-term collection or treatment infrastructures. These companies might also lobby against the introduction of EPR systems, as plastic credits might appear more cost-effective and impose less administrative burden.42

Implications for Pharmaceutical Companies

The importance of EPR and EPR-inspired legislation and initiatives is set to grow. This creates new investment needs for pharmaceutical companies but also offers potential for cost savings. The application of EPR to new products and services, along with the increasing complexity and reporting requirements of existing schemes, will necessitate pharmaceutical manufacturers to further invest in regulatory compliance, analytical, and data resources. An emerging market for outsourcing EPR benchmarking, specifically for tools that integrate regulation and fee calculation, to external consultancies is already developing.

At the same time, EPR will increasingly influence decisions regarding drug formulation and device and packaging design. Due to EPR, a device or packaging product currently under development made from mono-material, containing recycled material, or being recyclable may reduce OPEX and thereby present a more viable business case than its nonsustainable counterpart. For example, recyclable PP mono-blisters might already present such a viable business case compared to conventional PVC/aluminum blisters. Additionally, there are opportunities for pollution prevention and source reduction in pharmaceutical accumulation and disposal. Key approaches include unit dosing, appropriate sizing of drug packaging, trial scripts, increased patient monitoring, and implementing concordance practices to minimize drug wastage and improve compliance.27^, 43

Alignment and cooperation throughout the entire pharmaceutical supply chain are crucial. These include suppliers, contract manufacturers, healthcare entities, waste management organizations, logistic companies and distributors, end users, patient advocacy groups, as well as regulatory bodies. Industry consortia play a vital role in facilitating standardization, regulatory alignment, cost efficiency, and effective knowledge-sharing across sectors. For example, in 2012, the Pharmaceutical Product Stewardship Work Group was established in the United States to address the collection and disposal of unwanted household pharmaceutical products and sharps.44 Another example is the United Kingdom–based Circularity in Primary Pharmaceutical Packaging Accelerator (CiPPPA), a not-for-profit initiative that focuses on connecting stakeholders across the pharmaceutical supply chain to develop and implement collection, recycling solutions for primary pharmaceutical packaging, for example, blister, inhaler, and injectable packaging.45

Conclusion

Given the limited literature regarding the role of EPR in the pharmaceutical sector, we hope that the results presented and discussed in this article will inspire further research on the evolving role of take-back schemes, eco-modulation, and deposit refunds in the pharmaceutical industry. Important avenues for follow-up studies could be either to address existing quantitative data gaps or to empirically analyze, either ex ante or post hoc, which EPR models are most suitable for various applications and geographical locations.