Our responsibilities to patients, consumers, HCPs HCPs Healthcare professional , employees, communities and shareholders are embedded in Our Credo. Our comprehensive policies, procedures and training programs help our employees and contingent workers comply with applicable laws, regulations and industry codes as well as the Company’s internal standards and expectations for responsible conduct. We use our biennial Our Credo Survey to assess how our values come to life across the Enterprise. Our next Our Credo Survey is in 2022.
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. In our policies, we comprehensively address anti-corruption and anti-bribery, following the U.S. Foreign Corrupt Practices Act, the UK Bribery Act 2010, and other applicable local anti-bribery and anti-corruption laws and regulations. Similarly, we value transparency as a key component of building trust with all those engaged with our business and aim to comply with multiple regulatory reporting requirements in different jurisdictions around the world as well as publishing a wide range of voluntary disclosures to meet the information needs of our diverse stakeholder groups.
Health Care Compliance (HCC) Training Completion
Aspects of ethics and compliance we advanced in 2021 include:
Enhancing the effectiveness of HCC training: As part of our process of continuously improving our training tools to further enhance compliance across the Enterprise, we introduced a new interactive platform to deliver HCC training in a virtual setting. The platform includes 64 new HCC situational business/compliance case study discussions. We also introduced new methods to evaluate the effectiveness of our mandatory annual Enterprise HCC training. The methods evaluate learning and learning transfer by providing statistical evidence that employees understand the content of the training. Our 2021 final assessment indicates that the results of the test are the product of consistent learning behavior, that they are highly defensible, and that learners demonstrated mastery of the subject matter.
Revising Our Credo escalation procedure: At Johnson & Johnson, one way we build our culture of integrity and accountability is by requiring employees to report actual or potential violations of our policies or the law as well as risks that could jeopardize our reputation. The escalation procedure outlines those responsibilities, including what should be reported, in what timeframe, and the process for reporting. In 2021, we revised our escalation procedure and communicated it broadly to all employees, emphasizing that every employee is empowered to speak up on any matter relating to ethical conduct or compliance.
Spotlighting compliance and ethics: Our annual Compliance and Ethics Week offers an opportunity to reinforce an overall culture of compliance across our organization. During this week, among activities in all our regions, we launched a bespoke initiative themed “2021 Ignite Compliance—Doing the right thing the right way” across Southeast Asia (SEA), with multiple interactive sessions and interviews with senior leaders, tailored to the needs of each market in the region. Additionally, we expanded our efforts to external business partners, continuing to increase awareness of HCC, anti-corruption laws and conflicts of interest across Third Party Intermediaries (TPIs). Our focus on TPI compliance extends well beyond SEA; however, in 2021, we adapted the Advanced Medical Technology Association (AdvaMed) Distributor Toolkit to create a proprietary, broader Johnson & Johnson TPI Compliance Toolkit for global use, with the purpose of enabling TPIs to better self-assess the maturity and completeness of their own compliance programs and to strengthen their programs where needed.
New anti-corruption benchmark: We completed the Transparency International UK (TI-UK) Corporate Anti-Corruption Benchmark, which is designed and verified by independent experts selected by TI-UK and includes meeting the legal requirements of the UK Bribery Act and the U.S. Foreign Corrupt Practices Act. Our participation required a comprehensive review of our anti-corruption program, including governance and controls in our HCC program as well as in the areas of supply chain, finance, procurement, mergers and acquisitions, and human resources across all sectors and business functions. While our overall score ranked highly in the benchmark relative to other industry participants, we took the opportunity to engage in discussion and learn of possible additional best practices that could be relevant for Johnson & Johnson.
Maintaining our focus on bioethical decision making: To address the complex ethical questions arising in the field of biological research, science and medicine, our global Johnson & Johnson Bioethics Committee (JJBC) serves as an advisory body to our global teams on ethical issues. In 2021, JJBC provided guidance to multiple teams on ethical questions related to research, access to investigational medicines, data transparency and more. JJBC also conducted workshops covering bioethics principles and mentoring sessions for colleagues interested in bioethics careers. We continued to actively engage externally to discuss important bioethical issues. For example, we sponsor the Harvard Multi-Regional Clinical Trials Bioethics Collaborative and an innovative, multistakeholder bioethics colloquium convened by New York University (NYU) and the New York Academy of Sciences.
Promoting animal welfare: As an important part of our bioethical approach and policies, we continued to uphold the ethical and humane treatment of animals used in laboratory settings and promote the use of non-animal alternatives whenever feasible, including through regulation. Within our organization, we run annual 3Rs Awards that recognize the commitment of Johnson & Johnson teams to 3R principles for ethical use of animals in testing—reducing, refining and replacing their use whenever possible in R&D. In 2021, for example, via our Best of Sector 3Rs Award, we recognized our Consumer Health team in China for successfully engaging with Chinese Health Authorities on alternative in vitro models that could help reduce animal testing of cosmetics in the country. Through close collaboration with industry, the Consumer Health team created training materials, consolidated validation data on animal alternative models, and helped shape regulatory acceptance to permit alternative models for cosmetics in China. In 2021, the China Cosmetic Product Safety Evaluation Guidance was published and included in vitro methodologies and other safety assessment approaches, enabling Chinese producers to waive animal studies in the cosmetic registration process and paving the way to reduce animal testing for cosmetic products in China.
Collaborating on external research assessments: Since 2014, we have been working with the Yale University Open Data Access (YODA) Project to enable a consistent approach for assessing external research proposals requesting the use of clinical trial data generated by Johnson & Johnson companies. As of 2021, 252 research proposals have been reviewed and 56 articles published using data shared through the YODA Project, enabling researchers to build on existing findings to accelerate research that leads to improvements in public health.
Nationwide opioid settlement agreement: In July 2021, we announced the finalization of a nationwide settlement agreement to resolve opioid-related claims and litigation in the U.S. Johnson & Johnson confirmed its contribution of up to $5 billion to the settlement, depending on the number of state and local governments that elect to opt in to the agreement. In February 2022, we confirmed that there was a sufficient level of participation to move forward with the nationwide settlement agreement to resolve opioid-related claims and litigation by states, cities, counties and other subdivisions in the U.S. Johnson & Johnson no longer sells prescription opioid medications in the U.S. as part of our ongoing efforts to focus on transformational innovation and serving unmet patient needs.
Political giving: At the beginning of the 117th Congress (2021 – 2022), Johnson & Johnson paused all political contributions for a further review of our giving policies and criteria. While we have always maintained stringent political giving criteria to govern our contributions, in 2021, we undertook an extensive review of our corporate political giving program and the Johnson & Johnson Political Action Committee (Johnson & Johnson PAC) to ensure that both are positioned to fulfill their mission in support of Our Credo by including a revised giving criteria for agile decision making. With revised giving criteria in place, we reinstated our corporate political giving program and Johnson & Johnson PAC contributions.
Supporting voting rights: We believe that all eligible Americans should be able to exercise freely, fairly and safely their right to vote, regardless of their race or ethnicity. The act of voting remains a fundamental way to make our voices heard on the most important issues of our time, and there cannot be laws that implement barriers to exercising this most basic right. Johnson & Johnson fully supports an inclusive democratic process that facilitates safe access to voting, and as both an employer and a member of the communities we serve, we actively support and encourage participation in the voting process. In the spring of 2021, we were proud to join hundreds of corporations and others in signing a statement in support of democracy, opposing legislation that would make it harder for people to vote. The statement was published in leading media outlets in the U.S.
Compliance-Related Investigations and Responsible Marketing Indicators
|Compliance-Related Investigations and Responsible Marketing Indicators||2021||2020||2019|
|Number of compliance-related allegations investigated||661‡||559+||738|
|Percentage of compliance-related allegations investigated by category||
|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 in the 2020 Health for Humanity Report.
* OPDP: Office of Prescription Drug Promotion; and 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*
|Inquiries and Complaints as Recorded With Our Credo Integrity Line by Category*||2021||2020||2019|
|General information questions||8%‡||10%+||11%|
|Human rights-related||5%‡||Not reported||Not reported|
|Product quality- and patient safety-related||2%‡||2%+||2%|
+ See PwC's Report of Independent Accountants in the 2020 Health for Humanity Report.
* Johnson & Johnson Triage Committee and case investigators have the ability to change the issue type of cases upon receipt in Our Credo Integrity Line. This occurs for 5% or fewer of cases.