Lilly is committed to reducing environmental impacts across the product life cycle. This improves our own performance and demonstrates our values, while also meeting the expectations of customers and other stakeholders who are increasingly focused on Lilly’s progress in this area.
Lilly’s Product Stewardship Standard defines our health, safety, and environment (HSE) requirements for assessing Lilly products across the value chain. The scope covers both internal and external value-chain elements globally, and distributes accountability to numerous Lilly business and functional groups, to integrate product stewardship deeply into Lilly’s business. See details in our 2011/2012 Lilly Corporate Responsibility Update.
Our main areas of focus in product stewardship include the following:
- Using green chemistry to reduce the use of energy, water, and hazardous materials in our development and manufacturing processes;
- Reviewing materials used in devices to reduce their environmental footprint;
- Reducing the environmental impact of product manufacturing;
- Develop more sustainable packaging practices;
- Using science-based environmental risk assessments to evaluate the potential impact of our products in the environment; and
- Disposing of products responsibly at end-of-life.
Design for Environment
Across many industries, the majority of product environmental impacts are determined at the discovery and development stage. The pharmaceutical industry is no exception. For this reason, we consider the materials and processes we use to make products, as well as packaging.
Green Chemistry
Lilly was one of the first pharmaceutical companies to recognize the potential of green chemistry to transform our manufacturing processes to be inherently safer, more efficient, and more environmentally friendly in the early 1990s. Green chemistry works to reduce or eliminate the use of hazardous materials where possible so protections, controls, and treatment are reduced or no longer needed.
Lilly’s approach to green chemistry is twofold. First, we seek improvements by reducing the amount of hazardous material used to make a product, increasing overall materials efficiency, evaluating chemical alternatives, and avoiding use of the riskiest substances. Second, we’re striving to advance the underlying chemistry and engineering technologies used to make medicines through innovation, both internally and through partnerships. The potential benefits of finding new and better ways to make pharmaceutical products are enormous.
We have developed several continuous processes that improve environmental performance and enhance process safety by reducing the operational scale of the most hazardous manufacturing steps more than one hundredfold. Lilly has also been a key contributor to the Pharmaceutical Roundtable and co-chairs its work group on Green Chemistry. One focus area in 2012 has been developing a $100,000 research grant to produce safer solvents. We have also contributed to the creation and public release of a harmonized solvent selection guide by the organization that capitalizes on several companies’ best practices.
Lilly uses an Environmental Development Review (EDR) process to evaluate potential environmental issues and opportunities during the scale-up of medicine production to manufacturing levels. The EDR process helps us identify and address potential impacts of manufacturing and waste treatment, suggest process improvements, and share learning as new medicines come through the pipeline and transition into manufacturing.
One EDR identified significant opportunities for recovery and reuse of solvents for the manufacture of a product that could begin in 2019, depending on the approval of the product by regulatory authorities. Compared to disposing these solvents, this would decrease GHG emissions associated with waste incineration by more than 75 percent while saving tens of millions of dollars annually. See more information about our environmental performance in manufacturing.
We have developed several continuous processes that improve environmental performance and enhance process safety by reducing the operational scale of the most hazardous manufacturing steps more than one hundredfold. Lilly has also been a key contributor to the Pharmaceutical Roundtable and co-chairs its work group on Green Chemistry. One focus area in 2012 has been developing a $100,000 research grant to produce safer solvents. We have also contributed to the creation and public release of a harmonized solvent selection guide by the organization that capitalizes on several companies’ best practices.
Global Chemical Management
Lilly, customers, and governments worldwide are increasingly focused on the chemical substances used in products. Various governments across many of the regions where we operate have developed chemical management regulations which generally require manufacturers and importers of chemicals to collect and register information about the chemicals they manufacture or use. These regulations may also require replacing the most hazardous chemicals with safer alternatives when available.
For example, the European Union (EU) Registration, Evaluation, Authorisation, and Restriction of Chemical (REACH) Regulation, requires manufactures and importers of chemicals to collect and register information about the chemicals they use, and to replace the most dangerous chemicals when safer alternatives are available. Teams atcorporate and at our local manufacturing sites work together to assess the impact of these new and emerging global chemical management regulations on substances we manufacture and on our raw materials. Our goal is to ensure our facilities remain in compliance within this growing regulatory space.
Packaging
Pharmaceutical packaging is highly regulated and must fulfill many functions, including protecting product integrity during transit and storage, providing information, resisting counterfeiting, and protecting the contents from tampering or access by children.
Packaging is also a source of cost and waste. To address this, Lilly operations worldwide have developed innovative packaging approaches that contribute to the bottom line while improving our environmental performance.
Recent examples of packaging innovation include the following :
- Several packaging-process improvements were implemented at our Giessen site in Germany in 2011 for the launch of one of our products. We reduced the reject rate, decreased waste by nearly four metric tons per year, and achieved saving of an estimated $1.5 million annually.
- A joint effort by our packaging engineers and brand teams in Indianapolis, Indiana, resulted in simplifying product sample packaging for two products. Redesigning the blister (the protective plastic sleeve that covers each individual pill) for one product sample, removing the external carton for the sample bottle for another product, and eliminating the wallet (the protective cardboard sleeve for blister packs) for both products will save an estimated $1.3 million yearly.
Pharmaceuticals in the Environment
Lilly is committed to understanding the potential effects of pharmaceutical products in the environment as well as in humans. We support using science-based evaluations to assess and minimize the environmental risks of our pharmaceutical products. We collaborate with industry partners, academic researchers, and regulatory agencies, to further understand and proactively address any potential impacts from the production, distribution, use, and disposal of our products.
As part of our involvement in this area, Lilly supports industry efforts to make information about pharmaceuticals in the environment and the environmental characteristics of medicines readily available. Our scientists have published articles and presented on these topics, and have participated in discussions about the safety of pharmaceutical residues in water at scientific meetings held by the U.S. National Academies National Research Council, the World Health Organization, the U.S. Environmental Protection Agency, and European governmental sponsors. Summary results from environmental fate and effect studies are available in our Material Safety Data Sheets and are routinely updated.
See Lilly’s Position Statement on Pharmaceuticals in the Environment.
Product End-of-Life
Medicines are intended to be used in their entirety by patients. As a result, typical models of take-back, reuse, and recycling in other sectors, designed to capture value from products (such as paper, beverage containers, or electronic equipment) after use, do not apply to our industry. We're working with customers and partners to better understand and ensure an effective approach to product end-of-life issues.
In cases where patients do not finish their medication, reuse or recycling is not a safe option due to the nature of our products. Therefore, we support nationally sanctioned disposal guidelines for patients’ unused medicines. In the United States, we promote efforts to educate the public about proper drug disposal methods for unused medicines. For example, both Lilly and the Pharmaceutical Research and Manufacturers of America (PhRMA) trade association sponsor the SMARxT DISPOSAL™ program.
See our 2011/2012 Lilly Corporate Responsibility Update for information about our approach to disposal of syringes, needles, and other sharps to mitigate potential public health risks.