Product Stewardship

Patient Use

The work we do starts with the patient in mind. We are committed to making a positive impact on people, society and the planet. We aspire to develop products that are inclusive, trustworthy and sustainable to achieve the highest level of safety, user experience and patient outcomes with all of our products.

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 manufacturing reviews and an environmental development review process to evaluate potential environmental impacts during the scale-up of production to manufacturing levels.

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 to reduce our carbon footprint by continuing to increase the use of environmentally friendly materials and processes. Additionally, through our chemical management program, we work to reduce our use of materials, water and other natural resources when possible.

Manufacturing

We recognize that our manufacturing processes require the use of valuable natural resources. Our priorities include compliance with applicable HSE regulations, policies, procedures and standards as we work to continually improve our environmental performance related to energy efficiency, waste minimization and water management. We strive to reduce Lilly’s environmental impacts associated with our own manufacturing processes as well as our contract manufacturing organizations.

Product Transportation and Logistics

We consider many factors when selecting product packaging, including sustainability aspects such as materials reuse and recyclability. We have formed a green logistics team that seeks to optimize both shipment volumes and transportation methods to reduce packaging materials and greenhouse gas (GHG) emissions.

Product End-of-Life

Our product journey is circular and always comes back to where it started – the patient.

We work with stakeholders to ensure cost-effective approaches are available for product end-of-life disposal that balance environmental protection, patient safety and privacy, legal compliance and security.

We commit to understanding the potential effects of pharmaceuticals in the environment (PiE). We support using 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 continually work to further understand and proactively address any potential impacts from our products.

Green Chemistry

Green chemistry has been a focus at Lilly for many years. From the selection of candidate molecules through the identification of manufacturing processes, our development teams engage in a variety of activities during research and development to design sustainably, including:

eliminating or reducing the hazardous materials or chemicals of concern used to make a product
focusing on removal of substances of very high concern (SVHC) as classified by the European Chemicals Agency
shrinking the waste profiles of certain molecules through reduced solvent and water use
increasing the overall efficiency of material use
advancing the underlying green chemistry of medicine development and making production both safer and more environmentally friendly through a commitment to continuous process improvement
implementing new manufacturing technologies that minimize environmental impact, including continuous flow processes, which Lilly has worked to advance in the pharmaceutical industry.

By employing green chemistry, we have also been able 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 alternatives in our chemical synthesis operations.

We continue to advance green chemistry through our own research, and several of our findings were published in scientific journals. Highlights include:

Sustainable Oligonucleotide Manufacturing – Co-authored a paper examining the sustainability challenges and opportunities in oligonucleotide manufacturing, including minimizing waste and production costs.

Patent for Greener Medicine – Developed improvements in solvent efficiency and published a process patent and manuscript describing continuous chemistry for Lilly’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor.

Synthetic Molecule Design & Development – Co-authored a paper which captures the first systemic metrics study for synthetic peptides that warrants more environmentally friendly processes in peptide manufacturing.

Lilly actively pursues wider industry collaborations to help advance green chemistry through a combination of dialogue and leadership with peer companies, scientific partnerships and research sponsorship. We are actively engaged in collaborations with the American Chemical Society (ACS) Pharmaceutical Roundtable and the IQ Consortium’s Green Chemistry Working Group to promote the Green Aspiration Level (GAL) tool and support ongoing development of industry standards.

Since 2022, we have worked with industry peers to improve the iGAL metric. Yield, and convergence were added as new key sustainability indicators and include a new formula for convergence with potential applicability in computer assisted synthesis planning (CASP) algorithms. The improved statistical model of iGAL 2.0 represents a valuable extension to the common API process waste metrics, process mass intensity (PMI) and complete E factor (cEF). We believe that iGAL 2.0 can readily be adopted by pharmaceutical firms around the globe and thereby empower and inspire their scientists to make meaningful and significant contributions to sustainability.

Global Chemical Management

Governments around the world and across many of the regions where we operate have developed chemical management legislation, such as the REACH regulation in the EU that requires companies to collect and register information about certain chemicals they manufacture or use, unless those chemicals are exempt.

These regulations may require replacing chemicals identified as hazardous with safer alternatives, when available. To address these concerns, we have implemented a formal program and screening process to evaluate designated “chemicals of concern” throughout the pharmaceutical research and development process. Our process also addresses mitigation steps where new restrictions may impact our existing operations. This assists us with ensuring that our facilities and supply chain remain in compliance with chemical management laws.

During the scale-up of medicine production to manufacturing levels in our pharmaceutical business, we use an Environmental Development Review process to evaluate other potential environmental issues and opportunities. This process identifies and addresses potential impacts arising from manufacturing, suggests process improvements and facilitates learning as new medicines transition from the laboratory to the manufacturing facility.

Ensuring that our medicines have a smaller impact on the environment does not stop with green chemistry. We also focus extensively on water use, waste and Pharmaceuticals in the Environment (PiE). Learn more about our waste and water efforts.

Green Logistics

We consider many environmental sustainability factors in selecting product packaging, including material use and recyclability. Pharmaceutical packaging must meet stringent regulatory and internal standards. In some cases, this prevents us from using recycled content, as is the case with container closure systems that come into direct contact with our products. We continually seek to improve packaging design to reduce the amount of packaging used, use lower-impact materials and ensure recyclability. Examples of some of our packaging initiatives include:

EndeavAir Project – We are committed to improving the sustainability of packaging used for transporting medicines by air and sea freight. Historically, we used a single-use insulated package. After researching and testing alternatives, we arrived at a reusable shipping container that improves performance and increases capacity, thus reducing the number of shipments overall. We have implemented this new packaging solution at our sites in Japan and Spain and aim to expand use to other geographies in the coming years.
Recycling of Data Loggers – Every year, thousands of data loggers – small temperature measuring devices that ensure the quality of our pharmaceutical products – are used in logistics and then simply thrown away. We were able to develop a recycling program for these devices in cooperation with our manufacturer.

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 medicines are by nature, different. Public health regulations often prohibit the use of recovered materials from pharmaceutical products like those produced by Lilly. We continue to work with customers, industry partners and public health officials to address these product end-of-life issues.

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 syringes, needles and other sharps used in home settings. We communicate this information to patients through product user manuals and The Lilly Answers Center, a hotline that answers frequently asked questions about our products.

We are a member of the Pharmaceutical Product Stewardship Work Group (PPSWG), a U.S.-based membership association that coordinates pharmaceutical manufacturer efforts to respond to state and local household medicine and sharps takeback laws. We are a participating company in MED-Project USA and MED-Project LLC (“MED-Project”), owned by PPSWG, which serve 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 other industry stakeholders on these matters in the EU, such as European Federation of Pharmaceutical Industries and Associations (EFPIA), and in Canada Health Products Stewardship Association.

We are also committed to investigating ways to mitigate plastic waste by exploring potential new options to reduce end-product waste. Lilly is exploring opportunities individually and with industry collaborations that include:

efforts led by pharmaceutical associations

collaborations with other pharmaceutical and device manufacturing companies

supplier-led sustainability collaborations.

In addition, we are providing financial and resource support to potential partners for testing of newer recycling technologies that could lead to recycling and reuse of plastic after our devices are used by patients.

United States – Lilly is working with several recyclers in assessing the feasibility of their process to recycle Lilly devices. Once the feasibility is established, the goal is to scale up the technology for potential device recycling programs more broadly.

Germany – Lilly is conducting a device take-back pilot program in Germany. This effort was initially launched with a limited number of hospitals in 2020 and has since been expanded to include more than 150 health care offices and hospitals in Germany. The collected devices are being used in recycling pilots for assessing methods of recovering plastics and other materials. While still in its infancy, the pilot program is a step in our efforts to increase the circularity of our devices and minimize their environmental impact.

Denmark – Lilly has joined a collaborative effort with Novo Nordisk, Sanofi and Merck to pioneer the world's first cross-industry solution for recycling injection pens. This pilot program was launched in Denmark in May 2023 and is planned for 12 to 18 months, leveraging the existing recycling infrastructure in the country. The ambitious target for the pilot is for 25% of all injection pens distributed by the four companies in Denmark to be recycled.

France – Lilly, in collaboration with Sanofi, has joined RECYPEN, the first 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 for recycling insulin injection pens from Lilly and Sanofi is planned to launch in 2024 in four pilot regions: Auvergne-Rhône-Alpes, Grand Est, Hauts-de-France and Occitanie. The program will be tested for an initial one-year period and aims to collect 30% of pens used by patients in these regions.

UK – The Circularity in Primary Pharmaceutical Packaging Accelerator (CiPPPA) launched a new initiative with ambitions for waste reduction and environmental stewardship, such as the development of effective end-of-life product management of pharmaceutical packaging and diverting waste from landfill sites. Lilly, along with other leading pharmaceutical companies, global over-the-counter (OTC) brands and health care systems such as the NHS, has joined CiPPPA in this collaborative initiative focused on packaging solutions surrounding blisters, inhalers and injectables.

Spain – Lilly is evaluating alternate recycling technologies in addition to evaluating mechanical recycling. For this purpose, we are collaborating with a company in Spain offering enzymatic as well as pyrolysis technologies. Proof-of-concept studies are underway.