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Innovation
Advancing Human Health and Innovation Excellence: Spotlight on Johnson & Johnson’s Bioethics Efforts
A Q&A with Ed Kuffner, M.D., Chief Medical Officer, Johnson & Johnson Consumer Inc.

ioethics is an applied discipline that facilitates how we address ethical questions that arise in scientific research and medicine. As a patient-centered and ethics-driven company, Johnson & Johnson is committed to the highest ethical standards for our work in healthcare innovation. We strive to do what is right for patients and consumers, and we use the lens of bioethics to help us solve some of the most complex challenges in research, science and medicine today.

Bioethics can guide us on critical questions that we encounter in our work, such as how we should design clinical studies, how and when we should share our research findings, or how we can make medicines available to people who can’t access them. Bioethics provides a framework for making decisions around complicated issues or dilemmas. For example, how can we be fair and equitable in making a potentially lifesaving investigational drug, that is in short supply, available to someone who might desperately need it and might otherwise die? Or how can we design research studies to evaluate the safety of medicines without compromising the safety of patients who are in the studies?

Bioethics provides structured ways to navigate these complex questions and helps us make decisions that are fair, transparent and respectful of the rights and welfare of all people.

Across Johnson & Johnson, bioethical principles are at the heart of all of our efforts to advance human health and well-being. We aspire to be an industry leader by championing bioethical initiatives and policies that strive for excellence in scientific innovation and medical research.

This can be seen through our efforts in compassionate use through the CompAC initiative—an innovative approach that the Janssen Pharmaceutical Companies of Johnson & Johnson employs globally to help provide a fair, ethical evaluation of compassionate use requests, developed in collaboration with New York University Langone Health. In addition, we are a leader in initiatives to improve clinical trial data transparency through the Yale Open Data Access (YODA) Project, a data-sharing model that provides a fair and unbiased approach for assessing external requests for the use of our data.

Ed Kuffner, M.D., Chief Medical Officer at Johnson & Johnson Consumer Inc., Office of the Chief Medical Officer Leadership Team member and Chair of the Johnson & Johnson Bioethics Committee, describes our ethics-driven mission and its role in healthcare innovation.

Q:

Why is bioethics important to Johnson & Johnson?

A:

We believe that following bioethical principles is consistent with Our Credo and our values as an ethical healthcare company. Our Credo states that our first responsibility is to the patients and consumers who use our products and services. We believe bioethical behavior and decisions are central to our mission and the trust we earn with society.

Our first priority is always to serve the interests of patients and their families, and one step that we take to support this is to always be listening to patients and what they truly need of us. For example, compassionate use is an issue that has become more important to patients and society in recent years. We heard that directly from patients. As a result, we made the ethical decision to stand up and take a leadership role to improve and pioneer new ways to assess and make investigational medicines available to patients, many of whom desperately needed lifesaving treatment.

Providing new, ethics-driven guidance and leadership in this area has supported the needs of patients, and we believe it is the right thing to do.

Q:

How is the approach of bioethics built into the fabric of Johnson & Johnson?

A:

Our leadership role in bioethics is rooted in Our Credo, which supplies the foundation and values for our ethical decision-making. It provides standards and codes of conduct that guide ethical decision-making throughout our company and in our work on behalf of the patients, consumers and healthcare providers we serve.

Our approach is interwoven throughout Johnson & Johnson in a number of respects, and we take an end-to-end approach to bioethics at Johnson & Johnson. Our commitment to ethical decision-making and adherence to ethical principles applies across the work of every single employee and around the world.

We have also established state-of-the-art policies and invested in building dedicated bioethics expertise. We also champion and advocate for the application of bioethical principles both within our company and more broadly in industry. We regularly engage with scientific and business leaders, policy makers and advocacy groups on bioethical questions because we believe it is critical to have an open dialogue with all stakeholders to do what’s best for patients and society. For these reasons, we are considered a leader in this arena.

Finally, we also take a long-term view as Johnson & Johnson: We believe that making ethical decisions every day will help to earn the long-term trust of patients, society, innovators and others working to advance health for humanity.

Q:

What is the Johnson & Johnson Bioethics Committee?

A:

The Johnson & Johnson Bioethics Committee is a formal body that takes responsibility for providing guidance to our company on bioethical issues. It comprises leaders from throughout our organization who have expertise in research and development, science, medicine and regulatory affairs, as well as experience applying ethics to decision-making in healthcare. By design, the committee brings together a diverse group of approximately 25 multidisciplinary experts from across our global business who bring a dedicated focus to our mission in bioethics that is centered on patients first and foremost.

Because of the breadth and depth of skills and expertise represented in our Bioethics Committee, we have the ability to both draw on the best expertise internally and obtain consultation from external experts when topics arise that call for further specialized focus, expertise or partnership.

Finally, the Bioethics Committee facilitates education on bioethical behavior to Johnson & Johnson employees around the world so that every employee can embody and champion ethical decision-making on behalf of our patients.