Patient Safety

Management Approach

From early discovery through drug development, as well as while a product is on the market, Lilly works to ensure the safety and effectiveness of our medicines.

The safety and integrity of our products begins with the procurement of materials and extends throughout the production process. This includes strong health, safety and the environment (HSE) practices with suppliers who provide us with materials for research and development, as well as with the contract manufacturers who make our medicines and other pharmaceutical products. We continue to work to stem the tide of counterfeit medicines and we partner with other organizations aligned with upholding patient safety and deterring counterfeiting.

Global Patient Safety

Beginning with the discovery of a potential new medicine, and for as long as it is available to patients, our goal is to ensure that the benefits and risks of a medication are continuously monitored and well-understood by regulators, health care providers and patients.

Our Global Patient Safety organization, consisting of more than 300 physicians, pharmacists, nurses and other healthcare professionals is dedicated to the collection, monitoring, evaluation and reporting of safety information. Lilly collects adverse event reports and other safety information from around the world in an adverse event database and new safety findings are communicated to patients, health care professionals and regulators. In addition, Lilly Global Patient Safety physicians partner with Global Manufacturing and Global Quality colleagues to ensure the safety of our medicines through the evaluation of manufacturing specifications, manufacturing changes and deviations.

Lilly’s Global Patient Safety organization also maintains a robust system to monitor and ensure our devices are acceptably safe and effective from development to end of life cycle. 

Read additional information about our patient safety efforts.

Reliable Product Availability

The mission of our Global Manufacturing organization is to provide a reliable supply of high-quality medicines. Because we manufacture medicines that people rely upon and that can be critical for health, we know that we have a responsibility to safeguard the materials needed to manufacture these medicines and the supply chain logistics that help ensure their availability.

Our Manufacturing Policy Committee oversees the maintenance of Lilly’s inventory of essential raw materials. Before these materials are received by Lilly, our raw material and component suppliers are evaluated for technical competence and their ability to provide high-quality, efficacious raw materials. Learn more about our third-party risk management.

As an additional safeguard, we have mitigation plans in place for our drug product components, which include the active pharmaceutical ingredient and all other components used to manufacture finished drug products. Our manufacturing, packaging and distribution capabilities also help safeguard the supply of Lilly medicines and our ability to provide safe and effective finished drug products, or the final packaged medicines, to patients and health care providers. Our product serialization solution, first implemented in the U.S. in 2018, and with ongoing implementation in other countries, adds an additional level of security to our distributed products.

Safety of Clinical Trial Patients

We work to find new and improved medicines through rigorous research, including clinical trials. We believe diverse representation in clinical trials is critical and helps our researchers ensure we develop medicines that can be as effective as possible for the patients who use them. Many factors impact how someone will respond to a treatment, including their genetic background, ethnicity, gender and lifestyle, so it’s important to enroll a diverse range of people in clinical trials for our medicines. Learn more about how we approach diversity in our trials.

One of the primary responsibilities of Lilly researchers and the medical professionals who conduct our clinical trials is the safety of study participants. Participant safety and well-being is monitored throughout each clinical trial. In addition, Ethics Review Boards and a team of people independent from the research review every clinical trial to ensure appropriate steps are taken to protect the rights and welfare of participants before enrollment, as well as maintaining independent oversight over each clinical trial throughout its duration.

Before enrolling in a clinical trial, participants are given information about the study through a process called informed consent, which continues throughout the duration of the study. The informed consent document describes the study’s purpose, length, procedures, risks and benefits, and other information that all participants should know. This document is not a contract, and participants may withdraw from a study at any time, for any reason.

Lilly sponsors clinical trials but relies on a variety of partners to conduct the trials. In addition to the medical professionals at research sites, called clinical trial investigators, we partner with service providers, technology providers, research monitors and other providers, as needed, to effectively conduct our research. These partnerships are essential for appropriate oversight. For example, research monitors work with investigator sites to validate and confirm clinical trial data, and technology providers deliver items such as electronic trial diaries or digital devices to collect biomarker data (for example, pulse, breathing rate, body temperature, etc.). We conduct robust assessments of these parties to ensure they meet Lilly standards for research and data privacy, and we oversee their activities throughout the clinical trial to ensure quality and data integrity.

During the clinical trial, researchers monitor patient safety by collecting any adverse events that occur to identify potential safety concerns. Lilly reviews these adverse events across trial participants to help inform researchers, participants and regulators how to appropriately manage the care of the research volunteers, and to inform the benefit-risk profile of our products in development.

Upholding Product Quality

Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is a high priority. We take our obligations seriously and have rigorous quality systems in place to ensure compliance with regulatory requirements.

Our Global Quality team is an independent organization within Lilly composed of about 2,900 scientists, pharmacists and other quality professionals. The most senior Quality leader reports directly to our CEO to ensure independence and objectivity. Global Quality is involved throughout the product life cycle, working across all phases of drug development and manufacturing. The goal of the team is to provide effective guidance and quality oversight, collaborating with colleagues in R&D and manufacturing to comply with applicable regulatory and internal standards and controls.

Global Quality manages and updates the Lilly Quality System, an integrated system of standards, business processes, organizational controls and oversight designed to help assure high-quality medicines are delivered to patients. The Lilly Quality System, which also includes sales and marketing activities for the U.S., maintains standards that support delivering balanced, objective, substantiated and current information to our customers. The Lilly Quality System, supports and reinforces the Lilly values and our commitment to operating ethically and responsibly. In addition, Lilly places an emphasis on the culture of quality and has implemented a program focusing on culture. Aspects of the program include both leadership training and employee engagement. Lilly performs quality culture assessments of the manufacturing sites to reinforce cultural strengths and operational excellence. We work to create an environment where employees are empowered to speak up and share concerns. Learn more about our Business Ethics.

Lilly regularly hosts inspections by global regulatory bodies of our manufacturing facilities, as well as inspections in our marketing affiliates and clinical areas. These inspections examine our adherence to regulations such as Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and quality standards. The successful outcome of these inspections support continued reliable supply to patients, while driving continuous improvement to meet regulatory expectations based on learnings from the inspections.

Lilly utilizes a robust process to evaluate possible quality defects and safety issues that may be identified through internal testing, an event that potentially impacts product, quality, or a complaint. Any such incident that poses a risk to the patient is escalated, promptly investigated and triaged by technical subject matter experts, quality management and patient safety physicians. Investigation outcomes are utilized for continuous improvement of our processes.

Global Quality also oversees the following activities to safeguard product quality:

• Testing and Assurance Checks – Testing and assurance checks are performed throughout the manufacturing process, starting with testing raw materials and components to in-process testing of active pharmaceutical ingredients to final product testing to conform to regulatory and internal specifications.

• Authorization and Regulation of Products – The Lilly Regulatory Affairs organization is responsible for the content of product submissions and any communications related to review and approval of products. Regulatory Affairs also manages post-approval product registrations, labeling, promotional materials and associated regulatory policy.

• Quality Management Training - At Lilly, employees routinely receive training to ensure they adhere to the applicable enterprise quality policies. For our employees working in GMP areas, we have a robust CGMP (current good manufacturing practices) training program to ensure that they are prepared to perform their responsibilities effectively. This includes an annual CGMP update training that covers current quality-related topics, industry trends and regulatory updates. See Business Ethics for more information.

• Medical Device Certifications – For our medical devices, we maintain certification to the current ISO 13485 standard and participate in the Medical Device Single Audit Program (MDSAP). In this program, multiple regulatory authorities can accept the audit from a notified body on their behalf.

Preventing Counterfeit Medicines

Counterfeit or illegitimate medicines are a threat to patient safety around the world and often undermine the regulated supply chains from which patients expect to receive safe, Lilly-manufactured products. Our product protection strategy was formally established in the early 2000s. Since that time, we have emerged as a leader and trusted partner in product protection, both within the industry and with government and law enforcement agencies worldwide. Lilly’s product protection strategy has evolved to address various threats to products and issues that emerged around the globe such as counterfeiting, tampering, theft and diversion.

Read additional details on the counterfeit or illegitimate medicine problem and the roles of Lilly, patients and governments in combating this issue.

See important information about our ESG report.