Pharmaceuticals in the Environment
We are committed to understanding and managing the environmental impacts of our products throughout their life cycles—from discovery through manufacturing, use and disposal. This includes all products in our portfolio, whether they are small molecules, biologics or vaccines.
We conduct environmental risk assessments on our products (small molecules, biologics and vaccines), from the development phase through product launch, to understand and manage product impacts from manufacturing and patient use. We assess products in a manner consistent with the most stringent applicable global regulations, including the regulatory review processes of the U.S. Food and Drug Administration and the European Medicines Agency. Product environmental safety profiles are reassessed during periodic renewals of product filings, and risk-mitigation actions are implemented when needed.
We carefully monitor scientific research on the issue of pharmaceuticals in the environment (PIE), including studies that evaluate the potential effects pharmaceutical products may have on the aquatic environment and human health.
Pharmaceutical compounds have been found to enter the environment primarily through the use of medicines by humans and animals, and the subsequent excretion into wastewater treatment systems, water bodies or soil. Other potential environmental routes include manufacturing wastewater discharges and waste disposal.
Programs and initiatives
We use the information from our risk assessments to establish or update our internal, compound-specific Environmental Quality Criteria (EQCs), which are used to confirm that wastewaters discharged from our facilities do not contain levels of residual products that present a risk to human health or the environment. Our manufacturing facilities are required to use these EQCs, along with industry-accepted risk-assessment methods, to establish procedures for managing and controlling active pharmaceutical ingredients (APIs) in their wastewater.
We also provide EQC information to suppliers that manufacture pharmaceutical compounds for us and have initiated detailed assessments of our suppliers to better understand and address potential impacts. Our production facilities have, or will be provided with, API-treatment technology to ensure that our wastewater meets these EQCs after treatment. Our facilities are also required to incinerate any product-containing solid waste streams, unless restricted by local regulation.
We carefully monitor scientific research on the issue of PIE, including studies that evaluate the potential effects pharmaceutical products may have on the aquatic environment and human health. We support the use of science-based environmental risk assessments, and we will continue to collaborate with regulatory, academic, health care and research organizations to identify additional needs for data on pharmaceuticals in the environment.
Stakeholder engagement and advocacy
We participate in efforts to address PIE with various organizations, including the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). The EFPIA, Medicines for Europe, and the Association of the European Self-Medication Industry (AESGP) have worked together to develop the Eco-Pharmaco-Stewardship (EPS) initiative. The EPS initiative considers the environmental impacts of a medicine throughout its entire life cycle and addresses the roles and responsibilities of all parties in managing those impacts. This includes public services, the pharmaceutical industry, environmental experts, doctors, pharmacists and patients.
Our Public Policy Statement on Pharmaceuticals in the Environment contains additional details on this initiative and covers how we address environmental risks in our drug filings, within our manufacturing plants, and with our suppliers and patients.
Antimicrobial resistance (AMR)
The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) is spearheading the battle against antimicrobial resistance (AMR) for industry. Our company is helping to lead these industry efforts to minimize AMR risk from manufacturing while following a One Health approach to antimicrobial stewardship.
The AMR Industry Alliance has four commitments related to mitigating environmental impact for both environmental toxicity and contribution to resistance. These include assessing our sites and our suppliers and setting targets for each antibiotic manufactured.
As a member of the AMR Industry Alliance and signatory to the Industry Roadmap for Progress on Combating Antimicrobial Resistance, we are working to deliver on our commitments to reduce environmental impacts from the production of antibiotics. We have reviewed the operations of our third-party suppliers to assess their wastewater treatment controls and have recommended improvements where needed, which we will follow through to completion.
The AMR Industry Roadmap signatories have established and published a common framework for managing antibiotic discharges which will be the foundation for future assessments. Targets for assessing environmental discharges from antibiotic manufacturing have been developed using the most current scientific understanding in the published literature. We are evaluating our sites against these targets and identifying areas where improvement may be needed. We have developed a mechanism for transparently demonstrating that our supply chains meet the standards in this framework, which is presented in the AMR Industry Alliance 2020 Progress Report.