Ethics, safety and quality

We are committed to conducting our research and business with the highest standards of ethics, and to delivering medicines reliably, with the quality and safety patients can trust.

Ethics in business and research

Acting with Integrity is one of our fundamental principles and an important part of our culture.

We set clear expectations for employee behavior, beginning with our Code of Business Conduct, which applies to all employees globally and is available in 31 languages. Each year all employees receive interactive training and must certify to abide by the Code. We extend our expectations to suppliers through our Supplier Code of Conduct.

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Our comprehensive global ethics and compliance program includes robust training and monitoring. Beyond the Code of Conduct, the program includes:

The Office of Ethics and Compliance, which oversees the program
Policies and procedures describing clear requirements for fair and balanced product promotion and review and approval of promotional materials
Leading with Integrity, guidance for managers on setting the tone for our culture of integrity, leading by example, and supporting employees in making good decisions
A dedicated Ethics and Compliance Helpline, available 24/7
A no-retaliation policy for good-faith reports of potential violations
A mandatory training program with topics assigned to employees based on their roles, including: anti-corruption and anti-bribery, recognizing and reporting safety information and appropriate interactions with health care providers and patient groups
Structured ethics and compliance monitoring and reporting

Learn more about our Ethics & Compliance Program.

We engage with external stakeholders with the goal of advancing care for patients. We strive to be transparent in these interactions. Learn about our disclosures:

Our ethics program extends to the laboratory and the clinic. Read more about our approach to ethical research:

Principles of ethical research
AbbVie's bioethical principles are consistent with the World Medical Association Declaration of Helsinki. We adhere to our strict principles and policies—even when local law stipulates a less robust approach. Learn more about Our Commitment to Bioethics.

Responsible laboratory practice
As a science-based company committed to innovation, AbbVie explores cutting-edge laboratory techniques. We are committed to ensuring that as science evolves, our work remains consistent with our bioethical principles. Leare more about Our Commitment to Responsible Use of Stem Cells.

Humane care and use of animals
Major regulatory agencies across the globe require new medicines to be evaluated in animals and humans. Humane animal care is an essential aspect of high quality science. We voluntarily maintain accreditation from AAALAC International for our animal programs, and actively employ the internationally accepted 3Rs framework to minimize animal use in our research. Learn more about Our Commitment to Humane Care and Use of Animals.

Patient safety

Every year, tens of thousands of patients worldwide participate in clinical trials of potential AbbVie medicines. It’s because of these participants that we are able to eventually bring new medications to
more patients.

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From our clinical trials to our marketed products, we are deeply committed to patient safety:

AbbVie was a leading adopter of the 2015 FDA Safety Assessment Committee recommendations for clinical trials, establishing an internal safety committee to advise and monitor two strategic clinical development programs.
We comply with Good Clinical Practice, a global standard that helps assure the safety, integrity, and quality of trials across trial design, implementation, and outcomes reporting.
Our product labeling and packaging is developed with patients’ needs in mind. We conduct in-depth research to understand patient preferences and behaviors to ensure that dosage instructions are clear to prevent accidental misuse. Learn more about how we are evolving our packaging for our patients.
We use advanced post-marketing surveillance systems to detect and address potential safety signals quickly.

At AbbVie, scientific advancement doesn’t stop with our medicines. Our safety scientists are continually advancing both theory and practice in the field of patient safety. See some of their recent contributions:

Teaching tools
AbbVie safety experts edited and made major contributions to the book “Pharmacovigilance: A Practical Approach,” which focuses on principles and practice of pharmacovigilance.

Research papers
Our safety scientists regularly publish papers in peer-reviewed journals. Some recent examples:

Process improvement

Our teams are using technology to increase both efficiency and accuracy in pharmacovigilance. “Ditto” is a robot that automates the cumbersome process of checking for duplicate adverse events. Ditto allows us to increase efficiency and accuracy, and deploy valuable human resources for more complex pharmacovigilance tasks.

Product quality

We are focused on making medicines that are of high quality and available when patients need them.

The Quality Council oversees our quality strategy and is directly accountable to our CEO. Highly skilled and experienced teams oversee every aspect of our manufacturing processes, from the suppliers who provide the inputs to the medicines that are delivered to pharmacies.

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Our quality processes are reviewed and certified by multiple external parties:

Standards organizations
We use an integrated enterprise quality management system that complies with applicable standards from the International Organization for Standardization (ISO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use (ICH).

Regulatory authorities
AbbVie manufacturing sites receive dozens of internal audits and outside inspections
each year.

Our assurance of supply program is designed to help us maintain supply of medicines even in unpredictable circumstances, such as natural disasters or surges in demand:

This includes identifying and qualifying backup suppliers, scanning the environment for potential risks, and scenario planning.
After Hurricane Maria devastated Puerto Rico in 2017, a high level of preparedness allowed us to maintain production at all three of our local plants with no impact
to patients.

To ensure the quality and integrity of our supply chain, we have a supply chain management system that includes criticality assessment, controls, relationship management and continuous monitoring.

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