Product Stewardship

Managing Environmental Performance Across the Product Life Cycle

Our circularity-based strategy integrates sustainability across the value-chain, toward the ultimate goal of fostering positive impact on patients and the planet.

Patient Use

The work we do begins and ends with the patient in mind. We aspire to develop products that promote inclusivity, trust and sustainability to support the highest level of safety, user experience and patient outcomes.

Research and Development

We consider environmental factors beginning with the earliest stages of design and development. We use the 12 principles of green chemistry, environmental risk assessments, packaging and manufacturing reviews and an environmental development review process to evaluate potential environmental impacts as products scale from development to manufacturing.

Materials and Natural Resources

Our stakeholders, including customers, governments and suppliers worldwide, are increasingly focused on the materials and chemicals used to make pharmaceutical products. A key component of our sustainability strategy is reducing our environmental footprint, including our carbon footprint, by continuing to increase the use of more environmentally friendly materials and processes. Additionally, we work to reduce our use of raw materials, water and other natural resources, where feasible.

Manufacturing

Our manufacturing processes require the use of valuable natural resources. We comply with applicable HSE regulations, policies, procedures and standards, and seek to go beyond by continuously working to improve how we use energy, manage waste, and conserve water. These efforts to reduce Lilly’s environmental impacts extend to both our own manufacturing operations and the contract manufacturing organizations we work with.

Product Transportation and Logistics

We consider many factors in transportation and logistics related to supply and distribution of our products, including sustainability aspects such as material minimization, reusability and recyclability. We have formed a green logistics team that seeks to optimize shipment volumes, packaging design and transportation methods.

Product End-of-Life

Our product journey is circular and always comes back to where it started – the patient. We work with stakeholders to help identify where responsible and cost-effective approaches are available for product end-of-life disposal that balance environmental protection, patient safety and privacy, legal compliance and security.

We believe the discharge of pharmaceuticals into the environment should be minimized. We strive to ensure our internal and external manufacturing operations do not adversely impact waterways due to discharges of pharmaceuticals. We support science-based evaluations to assess and reduce the environmental risks of our pharmaceutical products. Through collaborations with industry partners, academic researchers and regulatory agencies, we continue working to better understand and proactively address potential environmental impacts associated with our products.

Green Chemistry

Green chemistry is an approach to chemical design that aims to reduce or eliminate the use and generation of hazardous substances throughout the lifecycle of a chemical product or process. Green chemistry has been a focus of ours for many years. From the selection of candidate molecules to the development of manufacturing processes, our teams engage in a variety of activities during research and development to support sustainable design, including:

• eliminating or reducing hazardous materials and chemicals of concern used to make a product, where feasible,

• prioritizing the removal of substances of very high concern (SVHC) as classified by the European Chemicals Agency,

• reducing waste profiles of certain molecules through lower solvent and water use, increasing the overall efficiency of material use,

• advancing green chemistry approaches throughout medicine development and making production both safer and more environmentally friendly through a commitment to continuous process improvement, and

• implementing new manufacturing technologies that minimize environmental impact, including continuous flow processes, which Lilly has helped advance within the pharmaceutical industry.

By employing green chemistry, we strive to enhance the safety profile of manufacturing processes by reducing the risk of the most hazardous manufacturing steps. We are also focused on the adoption of greener and safer solvents, where possible. For example, we have replaced several hazardous solvents and hazardous air pollutants with safer alternative solvents in our chemical synthesis operations.

Lilly Research

We continue to advance green chemistry through internal research and external collaborations, with several recent publications in peer-reviewed journals. Highlights include:

• Co-authored a manuscript which describes an alternative synthesis of the C-terminus of tirzepatide using liquid-phase peptide synthesis (LPPS), eliminating the need for highly wasteful solid-phase peptide synthesis (SPPS). The approach replaces highly waste-intensive SPPS steps, helps enable removal of certain chemicals of concern and reduces process mass intensity (PMI) of the peptide production process. The work was published in Organic Process Research & Development.

• Co-authored a paper presenting the first systemic metrics study for synthetic peptides, highlighting opportunities for more environmentally sustainable approaches in peptide manufacturing.

• Developed improvements in solvent efficiency and published a process patent and manuscript describing the application of continuous chemistry in the manufacturing of Lilly’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor.

External Collaborations

We actively pursue broader industry collaborations to advance green chemistry through dialogue with peer companies, scientific partnerships and research sponsorships. We are collaborating with the American Chemical Society (ACS) Pharmaceutical Roundtable and the IQ Consortium’s Green Chemistry Working Group to promote sustainable chemistry including the application of the Green Aspiration Level (GAL) tool and the continued development of industry standards.

We currently hold a leadership role within the ACS Pharmaceutical Roundtable, which serves as a primary forum for advancing pre-competitive sustainability initiatives across the pharmaceutical industry. In collaboration with industry peers, we have also contributed to the development and public dissemination of several widely used sustainability resources, including process mass intensity (PMI) benchmarks, reagent guides, solvent selection guides, and lifecycle assessment tools, helping to make these resources available to both industry and academia.

Global Chemical Management

Governments around the world, including in many of the regions where we operate, have developed chemical management legislation, such as the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation in the EU that requires companies to identify, manage risks, and register information about certain substances they manufacture or use, unless those chemicals qualify for specific exemptions.

These regulations may require replacing chemicals identified as hazardous with safer alternatives, where available. To implement these requirements, we have implemented a chemical management program and screening process to evaluate designated “chemicals of concern” throughout the pharmaceutical research and development process. Our process also identifies mitigation steps where new restrictions may impact our existing operations, helping ensure that our facilities and supply chains remain in compliance with chemical management regulations.

During the scale-up of medicine production to manufacturing scale, we use an Environmental Development Review process to evaluate additional potential environmental risks and opportunities. This process identifies and addresses potential impacts arising from manufacturing, supports identification of process improvements and facilitates learning as new medicines transition from the laboratory to the manufacturing facilities.

Product End-of-Life

Unlike many consumer products that can be recycled or are composed of materials that can be reclaimed at the end of their usefulness, many of our products are, by design and regulation, different. Public health regulations often prohibit the use of recovered materials from pharmaceutical products, such as those produced by Lilly. We continue to work with customers, industry partners and public health officials to responsibly address these product end-of-life considerations.

We promote policy decisions that are efficient, effective and protect both human health and the environment. We also support educating patients and caregivers on proper disposal of medicines and delivery devices, including syringes, needles, autoinjectors and other sharps used in home settings. We communicate this information to patients through product user manuals and the Lilly medicine resources website.

We are a member of the Pharmaceutical Product Stewardship Work Group (PPSWG), a U.S.-based membership association that coordinates pharmaceutical manufacturer and supplier efforts to respond to state and local household medicine and sharps safe disposal laws. We are a participating company in MED-Project USA, which serves as the stewardship organization designated by PPSWG members to implement and operate mandated household unwanted medicine and sharps take-back programs. The MyOldMeds.com website is provided by PPSWG as an easy way for patients to find a site near them to dispose of unwanted, unused or expired medicines from households. We also engage with industry and regulatory stakeholders on these matters in the EU, such as the European Federation of Pharmaceutical Industries and Associations (EFPIA), and in Canada with the Health Products Stewardship Association.

Device Take-back and Recycling

We are continuing to investigate pathways to mitigate plastic waste by exploring potential new options for minimizing end-product waste. Lilly is exploring opportunities both independently and with industry collaborations that include:

• Pharmaceutical industry association-led efforts

• Cooperations with other pharmaceutical and device manufacturing companies

• Supplier-led sustainability collaborations.

In addition, we are working with third-parties on the testing of newer technologies that could lead to recycling and reuse of plastic after our devices are used by patients.

• United States – We are working with several recyclers in different regions of the country to assess the feasibility of their processes and technologies for recycling Lilly devices. Once feasibility is established, the goal is to pilot and scale up the technology for potential device recycling programs more broadly.

• Denmark – We are an active member of returpen™, a collaborative effort with several other pharmaceutical companies, pioneering a cross-industry solution for recycling injection pens. This pilot program was launched in Denmark in 2023, leveraging the country’s existing recycling infrastructure and has since grown its reach to include most Danish pharmacies.

• France – In collaboration with Sanofi, we are an active participant in RecyPen, a recycling effort for insulin injection pens in France. RecyPen is an initiative led by DASTRI, the national eco-organization approved to collect and treat waste from health care activities. This pilot program involves recycling insulin injection pens from Lilly and Sanofi at pharmacies in four pilot regions: Auvergne-Rhône-Alpes, Grand Est, Hauts-de-France and Occitanie. The program is expected to expand its reach within France in 2026.

• Germany – We are conducting a device take-back pilot program in Germany. This effort collects devices at select hospitals and health care offices in Germany, which are then used in recycling studies to assess methods of recovering plastics and other materials, or safely disposed of if not needed for recycling studies.

Related Topics:

• Climate

• Waste

• Water

• HSE Governance

• Product Stewardship

• Bioethics