Product Stewardship

Lilly takes a broad approach to understanding and managing our HSE 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 requirements for assessing Lilly products across the value chain (see box below). Numerous Lilly business units and functional groups contribute to implementing this standard across the entire value chain—from product discovery and development; through manufacturing, sales and marketing, distribution and use; to final disposal. The scope covers both internal and external value chain elements globally. This approach is intended to integrate product stewardship deeply into Lilly’s business. See details in our 2012/2013 Lilly Corporate Responsibility Report.

We focus on the following areas:

  • 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;
  • Developing 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

In many industries, including pharmaceuticals, the majority of product environmental impacts are determined at the design stage. In the development of our human health pharmaceuticals, we consider environmental factors from the earliest phases of design and development. We take into account the materials and processes we will use to make products as well as how we will package those products to distribute to customers. This integrated approach enables us to identify opportunities to improve product environmental performance.

Innovations in Green Chemistry

In the early 1990s, Lilly was one of the first pharmaceutical companies to use green chemistry to transform our manufacturing processes to be inherently safer, more efficient, and more environmentally friendly.

Traditionally, pharmaceutical manufacturers viewed the use of hazardous materials as a necessary part of making medicine. Green chemistry, by contrast, works to reduce or eliminate the use of hazardous materials where possible so protection, controls, and treatment are reduced or are no longer needed.

The potential benefits of finding new and better ways to make pharmaceutical products are substantial. Lilly’s approach to green chemistry in our human health pharmaceuticals is twofold:

  • 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.
  • We strive to advance the underlying chemistry and engineering technologies used to make medicines through innovation, both internally and externally through partnerships.

To support these efforts, we have established guidelines for both the quantity of materials needed for the synthesis of a new product and the restricted use of materials that could significantly increase the environmental and safety risks of a process. Development teams incorporate these standards, along with other design criteria, as part of their Process by Design methodology when developing a new process and judging its suitability for future manufacturing. We then complete a review to evaluate success in implementing these standards and share feedback with the development teams.

 

Lilly uses an Environmental Development Review (EDR) process in our human health pharmaceutical business 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.

An EDR conducted in 2013 identified significant opportunities for the recovery and reuse of solvents for the manufacture of a product in our pipeline. Compared to incineration of these solvents, this reuse would decrease GHG emissions by more than 83 percent (equivalent to 4,300 metric tonnes CO2e per year), while recovering solvent worth up to $5 million annually. The review of production at a contract manufacturer that makes an intermediate for this same process uncovered additional solvent recovery opportunities that would decrease GHG emissions from incineration by 87% (equivalent to 3,700 metric tonnes CO2e per year) at that facility, while saving $3 million annually.

 

Global Chemical Management

Lilly, customers, and governments worldwide are increasingly focused on the chemical substances used in products. Governments across many of the regions where we operate have developed chemical management legislation, such as the European Union (EU) Registration, Evaluation, Authorisation, and Restriction of Chemical (REACH) Regulation, which requires 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.

We continue to assess the impact of these new and emerging global chemical management regulations on substances we manufacture and on our raw materials. We are committed to ensuring our facilities remain in compliance with all relevant laws.

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 contents from tampering or access by children. Packaging is also a source of cost and waste. Through our sustainable packaging efforts, we continually review packaging technologies and practices to reduce the amount of packaging used; to utilize lower environmental impact materials, including recycled content; to enhance recyclability; and to reuse or recycle packaging throughout the supply chain. During recent years, we’ve saved thousands of metric tonnes of packaging and millions of dollars through these efforts. We’re also collaborating with our distributors, retail pharmacies, and healthcare providers to better understand the overall pharmaceutical packaging footprint and ways to reduce it.

Our Product Stewardship Standard also supports these efforts. It requires that in our procurement processes we consider the use of post-consumer recycled materials, products from certified sustainable forests, and materials derived from renewable resources. Lilly’s paperstock suppliers in China, Europe, and the United States have certified that they source materials from sustainable forests as accredited by Forest Stewardship Council (FSC) or equivalent entities.

Recent examples of packaging innovation include the following:

  • We implemented several packaging-process improvements at our Giessen site in Germany in 2011 for the launch of one of our products. Through these efforts, we reduced the reject rate, decreased waste by nearly four metric tonnes per year, and achieved saving of an estimated $1.5 million annually.
  • In 2010, 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

Using advances in analytical testing technologies, scientists at locations around the world have measured trace amounts of residues of pharmaceutical products in the environment that were not previously detectable. These residues are widespread and found mainly in streams, rivers, and other water bodies. Reported concentrations are extremely low—as low as one part per trillion (equivalent to about one teaspoon of sugar dissolved in more than 3,300 Olympic-sized swimming pools). An estimated 90 percent of the medicines found in the environment are due to excretion from patients after normal use as prescribed.

At the levels currently present in the environment, risks to human health are considered to be very unlikely. This is consistent with findings of the World Health Organization (WHO), which evaluated selected investigations conducted in Australia, the United Kingdom, and the United States. Although acute effects on aquatic life are considered to be insignificant at current levels, the availability of data on the potential long-term impacts is increasing and varied, and chronic impacts on some aquatic life forms cannot be ruled out at this time. As part of our commitment in this area, we continually assess the emissions of active ingredients from all Lilly manufacturing facilities. Lilly is committed to understanding the potential effects of our products in the environment as well as in humans, and we support using science-based evaluations to assess and minimize related environmental risks. We collaborate with industry partners, academic researchers, and regulatory agencies to further proactively address any potential impacts from the production, distribution, use, and disposal of our products.

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 WHO, 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.

As a precautionary measure, pharmaceutical products are subjected to environmental and other testing as a part of registration protocols prior to marketing. Therefore, we test and assess our medicines for potential effects on the environment to meet current regulatory requirements and internal standards before launching new medicines. We regularly update our testing protocols for new and existing pharmaceuticals as knowledge and testing methods improve. We will continue to collaborate with regulatory, academic, and research organizations to advance knowledge in this area. See Lilly's Position 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 that are designed to capture value from products (such as paper, beverage containers, or electronic equipment) after use, do not apply to our industry. We continue to work 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 educating patients and caregivers on how to properly dispose of unused medicines because both groups have an important role to play. 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 PhRMA trade association support the SMARxT DISPOSAL™ program. Also, see Lilly’s Position Statement on the Disposal of Unused Medicines in the United States.

We also support the proper disposal of syringes, needles, and other sharps used in home settings to mitigate potential public health and environmental risks. Based on feedback from patients and healthcare providers, we believe that education offers the greatest opportunity to improve sharps’ disposal practices. We are working to more effectively communicate this information to patients through product user manuals, patient education programs, improved sales force awareness, and updated information at The Lilly Answer Center.