Water

Management Approach

Water is essential to our operations and the facilities where we discover and manufacture our medicines, and we’re committed to using this critical resource efficiently. We aim to manage water more sustainably by minimizing our water footprint and avoiding potential risks related to pharmaceuticals in the environment (PiE).

We continuously assess our water risks, and while we generally operate in locations where the risk of water scarcity and poor quality are low, we continue to focus on conserving and reducing water use and improving the quality of the water we discharge from our facilities. We work with our sites around the world to identify water-saving opportunities and wastewater treatment technologies to support our environmental goals. In 2022, our efforts received an A-minus rating from CDP’s water program, which is above average for the biotech and pharmaceutical industry sector. View our 2022 CDP Water Security response.

Water Use

Manufacturing operations account for the majority of our water use. The production of injectable medicines requires exceptionally high-quality water, and our sites rely on utility operations to make purified water as well as water for cooling systems and steam boilers. To reduce our water consumption, we use reclaimed water when possible, and we have optimized our cooling systems to reduce water usage. In 2022, our facilities recycled or reused 279 billion liters of water, representing 97.9% of our total water demand.

In 2022, 7.7% of our total water intake occurred at sites in geographies that are defined as “water stressed,” a decrease from 2021 primarily due to changes in production rates and benefits seen from projects to recover clean water for reuse at some of our manufacturing sites. Potential future regional water risk, unpredictable costs and climate change concerns have further strengthened our commitment to using water more efficiently or improving water quality based on local needs. This is why we established a 2030 goal that requires water management plans for Lilly sites in water-stressed areas.

Each of our manufacturing sites that operate in water-stressed areas started conducting water stress assessments in 2021. In 2022, they are developing and documenting water stress management plans. Each water stress plan is expected to have “context-based” targets with specific delivery dates related to reducing water stress where these sites operate. These plans are being developed based on guidance in the Alliance for Water Stewardship International Water Stewardship Standard V2.0 (AWS Standard). The AWS Standard has five outcomes that represent fundamental aspects of water. The intent of these outcomes is to act as fundamental “pillars” of water stewardship – or themes that are reflected in all water stewardship efforts.

1. How humans are responsible and accountable for water (governance)

2. Quantities and timing of water (water balance)

3. Properties of the water (water quality)

4. Spatial aspects of areas that may or may not contain water at a given time, but that are critical to maintaining the human-derived benefits of water including the ecosystem services from Important Water-Related Areas (IWRAs)

5. Provision of safe water, sanitation and hygiene for all.

Pharmaceuticals in the Environment (PiE)

The active ingredients of medicines, have been found in surface waters, groundwater, sediment and soil. Reported concentrations of pharmaceuticals detected in the environment are usually extremely low. Pharmaceuticals may enter the environment as effluents from pharmaceutical manufacturing or through excretion by patients after therapeutic use of a medicine. They may also enter the environment through improper disposal of unused medicines.

There are various public and stakeholder concerns regarding pharmaceuticals in the environment (PiE). The detection and biological potency of pharmaceuticals raise questions about potential risks to the environment. Additionally, there are concerns about the impact of the pharmaceutical supply chain on human health, especially in countries that may lack rigorous environmental protection standards. The World Health Organization, the U.S. Environmental Protection Agency and the U.S. Geological Survey have all concluded that the presence of pharmaceuticals in drinking water is unlikely to have a direct impact on human health. Recent publications by Gunnarsson et al. (2019) and Wilkinson et al. (2022) conclude that for most pharmaceuticals, presence in surface water presents a low risk to environmental species, whether based on predicted or measured environmental concentrations.

We believe the discharge of pharmaceuticals in the environment should be minimized. We are committed to ensuring our internal and external manufacturing operations do not adversely impact waterways as a result of discharges of pharmaceuticals.

Due to the importance of the topic of pharmaceuticals in the environment (PiE) to Lilly and our stakeholders, Lilly has a PiE Governance Committee that sets strategic direction related to PiE and provides long-term oversight of Lilly’s Aquatic Exposure Guideline (LAEG) program that controls the discharges of active pharmaceutical ingredients from manufacturing sites. The PiE Governance Committee reports directly to our Global HSE Committee. Read more about our HSE governance.

We assess the active pharmaceutical ingredients in our medicines for potential environmental impacts, ensuring that they meet regulatory requirements and internal standards before introducing a medicine to market. We use procedures recommended by U.S., Canadian and European regulatory agencies to assess risks from residues of our active pharmaceutical ingredients in the environment. We assess the environmental risk posed by patient use of our medicines – based on a Predicted No Environmental Concentration estimate – as part of the approval process for new medicines in the U.S. and Europe.

We also assess the potential for environmental risk posed by manufacture of our medicines as part of our internal Lilly Aquatic Exposure Guideline (LAEG) program. The results drive appropriate treatment and containment strategies at our manufacturing sites to protect aquatic species in downstream surface waters, and the communities and wildlife using these waters. While the LAEG program has been in place for more than three decades at Lilly facilities, we are now fully implementing LAEG assessments at contract manufacturers across our supply chain. Lilly has committed to 100% compliance with LAEG requirements at our manufacturing facilities and to ensure controls are in place at our contract manufacturers to prevent harmful discharge of our active pharmaceutical ingredients.

We continue to partner with industry, academia and governments to improve both our understanding of and response to pharmaceuticals in the environment (PiE). Lilly scientists and technical experts have been engaged in the following efforts:

Improving PiE Risk Assessments – We participated in the Intelligence Assessment of Pharmaceuticals in the Environment (iPiE) project, part of the Innovative Medicines Initiative (IMI). The five-year iPiE project consisted of a consortium of universities, pharmaceutical companies and other research institutions that developed frameworks, methods and database tools to support environmental testing for new pharmaceuticals and prioritized the testing of legacy pharmaceuticals with incomplete environmental data sets.

Collaborating on Novel PiE Assessment – We are currently engaged in a second IMI consortium project, the Prioritization and Risk Evaluation of Medicines in the EnviRonment (PREMIER). This six-year project aims to deliver a novel assessment system for characterizing the environmental risks of pharmaceuticals while addressing several of the actions stated in the EU’s published Strategic Approach to PiE. As part of this project, we are collecting environmental data on prioritized legacy pharmaceuticals and contributing to the evaluation of the relationship of external and internal concentrations of pharmaceuticals in fish.

Assessing the potential for designing environmentally biodegradable pharmaceuticals – We participate in the American Chemistry Society’s Green Chemistry Institute Pharmaceutical Roundtable in which a consortium of companies is considering the biodegradation potential of pharmaceuticals in the environment.

Advancing the Science of PiE – We continue to support efforts to advance PiE-related research by authoring papers, serving as reviewers for journals, presenting at conferences and workshops, and participating in meetings concerning the safety of pharmaceutical residues in water.

Partnering on Take-Back Programs – In collaboration with regulators and other pharmaceutical companies, we are key partners in take-back programs for unused medicines such as MedsDisposal in Europe and Med-Project in the U.S.

Engaging in Industry Initiatives – We participate in several industry PiE initiatives, such as Eco-Pharmaco-Stewardship, a multi-faceted program developed with several pharmaceutical trade organizations (EFPIA, AEGSP, MFE).

Developing PiE Tools and Resources – We are also actively engaged in creating tools and resources to share with industry peers, including in-person and on-line training on risk-based approaches to managing effluents, a user-friendly tool to calculate discharge limits for pharmaceuticals, an industry guidance document on controlling pharmaceutical discharge and audit protocols to evaluate PiE supply chain risks.

Water Performance Data

Water Use	2019	2020	2021	2022
Water Intake (billion liters)¹	2019: 6.27	2020: 6.10	2021: 5.92	2022: 6.05
Water Recycle Rate (%)²	2019: 97.8%	2020: 98.4%	2021: 98.0%	2022: 97.9%
Percent of Water use in Water-Stressed Areas	2019: 8.0%	2020: 8.1%	2021: 8.9%	2022: 7.7%

Water Goals	Target	2022 Performance
Establish and implement water management plans for sites in water-stress geographies	Target: Develop and implement water management plans for sites in water-stressed geographies	2022 Performance: 100% of plans were developed on time, and the implementation phase has started
Ensure 100% of Lilly sites meet predicted no-effect concentrations (PNEC) for pharmaceuticals in the environment	Target: 100%	2022 Performance: 100%
Ensure appropriate controls are in place with Lilly contract manufacturers to prevent discharge of pharmaceuticals in wastewater above applicable predicted no-effect concentrations (PNEC)	Target: 100%	2022 Performance: 85% complete; 15% assessments in progress;
Percent of assessed external partners meeting PNEC limits	Target: 100%	2022 Performance: 100%

Footnotes

Note: Bureau Veritas was engaged by Lilly to provide limited assurance in relation to specified 2022 environmental performance data presented.

“Water intake” is the total amount of water coming into a site, including water pumped from bodies of surface water and groundwater, as well as water provided by a utility. It includes water used in processes, utilities and other ancillary operations, such as irrigation. The term does not include groundwater pumped solely for treatment to satisfy regulatory actions or requirements (e.g., remediation activities where the water is not used for another purpose). Values do not include the water extracted from wells solely for the purpose of lowering the groundwater table(s) to maintain the physical and structural integrity of building foundations. Totals include a small amount of rainwater intake not included in other water intake subcategories. Lilly does not generally collect water data from small locations that house primarily administrative activities such as sales and marketing offices unless they are co-located at a Lilly manufacturing or research facility.
“Water recycle rate” is calculated as the total annual volume of water recycled/reused divided by the sum of total annual water intake plus the total annual volume of water recycled/reused.

View Lilly’s environmental data from 2020, including our previous goals and progress through 2020. Additional historical data are available in our reporting archives.