Ethics & Compliance

  • GRI

  • 2-27,

    Compliance with laws and regulations

  • 205-2,

    Communication and training about anti-corruption policies and procedures

  • 206-1,

    Legal actions for anti-competitive behavior, anti-trust, and monopoly practices

  • 417-1,

    Requirements for product and service information and labeling

  • 417-2,

    Incidents of non-compliance concerning product and service information and labeling

  • 417-3,

    Incidents of non-compliance concerning marketing communications

  • J&J22-3,

    Sites with animals that are accredited by AAALACi

  • J&J22-4

    Advance bioethics in decision making in R&D

The values that guide our decision-making are spelled out in Our Credo, which guides us to act ethically and within the laws that govern our businesses everywhere and at all times. Supported by comprehensive policies, procedures and training programs, everyone at Johnson & Johnson knows the value of doing the right thing.

We embed Our Credo values throughout our Company to ensure all employees and contingent workers know their responsibilities to act in accordance with applicable laws, regulations and industry codes, as well as the Company’s internal standards and expectations for ethical and compliant conduct. We use our biennial Our Credo Survey to assess how our values come to life across the Enterprise, which is supplemented in alternate years by the Our Voice Survey, which monitors employee sentiment related to many topics, including ethical business conduct.

Building on Our Credo values, Our Code of Business Conduct (CBC) and Health Care Compliance (HCC) policies list comprehensive ethical standards for decisions and actions in every market where we operate. Mandatory CBC training is conducted every two years, and HCC training is conducted each year. All new employees are assigned and required to complete CBC, HCC and other relevant required training.

Aspects of ethics and compliance we advanced in 2022 included:

Updating our compliance framework

We revised our HCC Framework to provide updated practical guidance on compliance with HCC guidelines based on the “Ten Hallmarks of an Effective Compliance Program” of the U.S. Department of Justice and to highlight specific focus on the role of our business leaders in setting a strong message at the top and continuing to drive a culture of accountability throughout our organization.

Annual compliance training

Our Enterprise HCC Annual Training encompasses the foundations of compliance using role-based topics and scenarios to drive training effectiveness. We design our training with the objective of ensuring learning is achieved, incorporating interactive challenges and a final assessment. We evaluate learning transfer using our proprietary methodology, and in 2022, our evaluation showed that learning transfer proved to be statistically reliable for a third year in a row. This indicates that critical thinking was required to answer the Enterprise HCC Annual Training assessment questions correctly and that passing the assessment was not simply the result of guesswork.

105,000

employees completed HCC training.

97 %

of sales and marketing employees completed HCC training.

In 2022, the Johnson & Johnson Enterprise HCC Annual Training Measuring Effectiveness methodology was awarded the prestigious Brandon Hall Gold Award for “Best Advance in Compliance Training,” along with a Silver Award for “Best Advance in Learning Measurement.”

Brandon Hall Gold Award for “Best Advance in Compliance Training” (logo)

Reinforcing our culture of accountability

Throughout 2022, our communication and training efforts focused on strengthening the culture of accountability with several initiatives, including communications from leadership; ethical leadership workshops using situational cases; and training to assist in preventing, detecting and correcting non-compliant behavior, as well as the Compliance Week 2022 Initiative containing interactive games, contests, and appealing communication materials to support culture-building initiatives under the tagline “People Follow People.”

Corporate Heroes Interactive Games strengthened our culture of accountability during Compliance Week 2022.

Corporate Heroes Interactive Games (photo)

Compliance-Related Investigations and Responsible Marketing Indicators

2022

2021

2020

Number of compliance-related allegations investigated

749

661

559

Percentage of compliance-related allegations investigated by category

Healthcare compliance

55%

48%

41%

Financial

36%

43%

51%

Other

9%

9%

8%

Number of warning letters or untitled letters issued by OPDP or APLB in the U.S.*

0

0

0

See PwC’s Report of Independent Accountants and Management's Assertion and PwC's Report of Independent Accountants in previous Health for Humanity Reports.

*

OPDP: Office of Prescription Drug Promotion; APLB: Advertising and Promotional Labeling Branch of the FDA Center for Biologics Evaluation and Research.

Inquiries and Complaints as Recorded With Our Credo Integrity Line by Category*

2022

2021

2020

Human Resources-related

71%

55%

51%

Business integrity-related

11%

14%

12%

Other (privacy, information security, general security, EH&S, etc.)

6%

9%

11%

General information questions

3%

8%

10%

Financial-related

4%

7%

14%

Human rights-related

1%

5%

Not reported

Product quality- and patient safety-related

3%

2%

2%

See PwC’s Report of Independent Accountants and Management's Assertion and PwC's Report of Independent Accountants in previous Health for Humanity Reports.

*

Johnson & Johnson Triage Committee and case investigators have the ability to change the issue type of the cases upon receipt in Our Credo Integrity Line. This for no more than 16% of cases in 2022.

The Our Credo Integrity Line provides a channel for all employees, contractors, customers, third-party agencies and other partners to report potential violations of the CBC, other Company policies or the applicable laws and regulations in the countries of operation. The 2022 increase in Human Resources inquiries and complaints to Our Credo Integrity Line is a result of a period of significant organizational change.

Continuous improvement in anti-corruption controls

We aim to achieve continuous improvement vigilance, governance, controls and processes to prevent corruption in any part of our business. Following our completion of the Transparency International UK (TI-UK) Corporate Anti-Corruption Benchmark in 2022, a comprehensive self-assessment tool that measures and compares the performance of anti-corruption programs across companies, we continued to engage in quarterly meetings with TI-UK and other companies participating in the benchmark to share insights and discuss best practices.

Learn more about our anti-corruption disclosures (NBIM) in our 2022 ESG Disclosure Index.

Johnson & Johnson was named in 2022 for the fifth consecutive year to the CPA-Zicklin Index of Corporate Political Disclosure and Accountability with Trendsetter status.

Independent assessment of external research proposals

Since 2014, we have been working with the Yale University Open Data Access (YODA) Project to enable a consistent approach for the independent assessment of external research proposals requesting the use of clinical trial data generated by Johnson & Johnson companies. As of 2022, 301 research proposals have been reviewed and 85 articles published using data shared through the YODA Project, enabling researchers to create new insights that advance science and medicine and lead to improvements in public health. Johnson & Johnson continues to demonstrate its support of expanding the reach of clinical trial data and, in 2022, joined the Vivli Antimicrobial Resistance Surveillance Data Register (see section: Antimicrobial Resistance).

We collaborate with NYU School of Medicine to support Janssen decision making for investigational medicine requests, also known as “compassionate use” or “pre-approval access.” The Compassionate Use Advisory Committee (CompAC), comprising ethicists, physicians and patient representatives independently selected by NYU, provides recommendations to Janssen on pre-approval access plans and individual requests received at Janssen. CompAC affirms Johnson & Johnson’s commitment to ensuring a transparent, ethical and objective approach to reviewing compassionate use requests. Since 2015, Janssen has provided access to almost 8,000 patients globally through its Pre-Approval Access (PAA) Program. In 2022, we further advanced transparency by providing, for the first time, a list of potential treatment options available per country or territory on Janssen.com.

Keeping bioethics on the agenda

Our Office of the Chief Medical Officer (OCMO) sponsors the Johnson & Johnson Bioethics Committee (JJBC), which advises our global teams on ethical issues, in alignment with our Ethical Code of Conduct for R&D. In 2022, the JJBC continued to advise many Johnson & Johnson teams on ethical questions related to research, access to investigational medicines and data transparency; conducted workshops on bioethics principles; and launched a bioethics-related mentoring program for employees. JJBC members undertook professional ethics training with Fellowships at Auschwitz for the Study of Professional Ethics (FASPE). In addition, OCMO sponsored the Harvard Multi-Regional Clinical Trials Bioethics Collaborative; a bioethics colloquium convened by NYU and the New York Academy of Sciences; and co-founded and co-chairs the Bioethics Community within DIA, a global organization advancing life sciences networks.

Promoting animal welfare

Research involving animals has led to major medical advances and will continue to be an important part of further discoveries until viable non-animal alternatives are developed and accepted. Year after year, we utilize non-animal alternatives whenever possible and work with regulatory bodies to gain acceptance of appropriate non-animal alternatives. Johnson & Johnson is committed to the 3Rs principles for the ethical treatment of animals involved in biomedical research—replacing, reducing and refining their use whenever possible. Our Global Animal Welfare Officer is responsible for ensuring adherence to and monitoring our animal welfare standards, supported by many R&D professionals who are certified in different aspects of veterinary medicine and animal welfare.

As part of our commitment to the ethical and humane treatment of laboratory animals under our care, we hold an annual 3Rs awards program to recognize our teams’ outstanding achievements in replacing, reducing and refining the use of animals in the fields of biomedical research, education or training. In 2022, the winning innovation advanced the use of donated human cadavers to avoid animal use in HCP training on medical devices.

We are transparent about our animal welfare practice and engage widely to inform, share and work toward improving public policy on animal testing. For example, in 2022, Janssen’s Beerse site in Belgium welcomed the Animal Welfare Committee from the Flemish Parliament and a number of other stakeholders from the life sciences ecosystem. Visitors toured the animal facilities and engaged in discussions around Janssen’s animal welfare policy and alternatives that could reduce animal testing.

100% of facilities with animals have veterinary oversight. 100% of sites with animals are accredited by AAALAC International.

AAALAC
Global nonprofit that promotes the humane treatment of animals in science. Formerly Association for Assessment and Accreditation of Laboratory Animal Care International
HCP
Healthcare professional(s)
NBIM
Norges Bank Investment Management (NBIM) and Basel Institute on Governance's "Measuring effectiveness of anti-corruption programmes" reporting framework, adding disclosures against this set of 17 indicators