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Compliance & Bioethics

Compliance & Bioethics

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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 (results for the 2020 – 2021 CBC training cycle will be published in the 2021 Health for Humanity Report), and HCC training is conducted each year.

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. See our Positions on Ethics and Compliance and Anti-Corruption. 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. Beyond meeting our regulatory reporting requirements, we also publish a wide range of voluntary disclosures. See our Position on Transparency.

Johnson & Johnson was named in 2020 for the third consecutive year to the CPA-Zicklin Index of Corporate Political Disclosure and Accountability with trendsetter status, indicating model corporate governance best practices.
81,000
employees and 96% of sales and marketing employees completed HCC training in 2020.
100%
of senior leaders certified* the compliance of their organizations with the CBC.

* Certifiers include senior leaders at VP2 level and above, selected Managing Directors and General Managers based on country or business segment risk profile, and executives of recently acquired companies.

Aspects of compliance and transparency we advanced in 2020 include:

  • Third Party Intermediary (TPI) compliance: We continued to enhance end-to-end TPI Risk Management processes leaning on updated risk segmentation to drive a risk-based TPI Due Diligence process and background checks, red flag management, monitoring, and risk mitigation. All employees are directed to utilize these standards when selecting and managing TPIs and other intermediaries.
  • Supporting distributor compliance: In collaboration with the Advanced Medical Technology Association (AdvaMed) and member industry partners, the AdvaMed Distributor Capability Working Group completed the development of a Global Compliance Distributor Toolkit. This publicly available Toolkit offers access to compliance guidance, training and other resources to help third-party distributors formalize and strengthen their compliance program to meet the expectations and standards for doing business in the medical devices and diagnostics industry.

We continued to adhere to strict bioethics principles and practices in 2020:

  • To address the complex ethical questions arising in the field of biological research, science and medicine, our Enterprise Johnson & Johnson Bioethics Committee (JJBC), sponsored by OCMO OCMO The Johnson & Johnson Office of the Chief Medical Officer View entire glossary , serves as an advisory body to our worldwide teams on bioethical issues, advocating adherence to bioethical principles, providing an expert forum for teams to obtain guidance on bioethical issues, and championing our commitment to bioethical decision-making across the Enterprise. The JJBC is guided by the fundamental principles of bioethics, including beneficence, non-maleficence, autonomy and justice, and our Ethical Code for the Conduct of Research and Development. See also our Position on Bioethics.

  • As part of our COVID-19 response, OCMO OCMO The Johnson & Johnson Office of the Chief Medical Officer View entire glossary convened a working group of internal and external experts to develop an ethical framework to guide the allocation of donated supplies of PPE globally. The working group also established guidance on ethically balancing a drug’s current approved use and its potential usefulness in fighting COVID-19 in the absence of peer-reviewed data from randomized clinical trials. See the United in Defeating COVID-19 section.

  • 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 2020, 206 research proposals have been reviewed and 41 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.

  • We continued to uphold the ethical treatment of animals used in laboratory settings to advance patient safety and well-being. Johnson & Johnson companies have policies and guidelines in place to assure the ethical and humane treatment of the animals and promote the use of non-animal alternatives whenever feasible. We support and participate in efforts to obtain regulatory acceptance of alternative testing methods. See our Humane Care and Use of Animals Policy.

Since 2015, we have collaborated with New York University (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), comprised of ethicists, physicians and patient representatives independently selected by NYU, provides guidance 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. See our Position on Pre-Approval Access and Compassionate Use.

Inquiries and Complaints as Filed with Our Credo Integrity Line by Category*

Inquiries and Complaints as Filed with Our Credo Integrity Line by Category*

2020 2019 2018
Human Resources-related 51% 60% 58%
Financial-related 14% 13% 11%
Business integrity-related 12% 6% 6%
Other 11% 8% 10%
General information questions 10% 11% 13%
Product quality and patient safety-related 2% 2% 2%
See PwC's Report of Independent Accountants.
* Changes to Our Credo Integrity Line complaint categories were made in December 2020 as part of a broader project to enhance the overall user experience of and accessibility to Johnson & Johnson’s anonymous reporting mechanism. As such, certain inquiries and complaints received in December 2020 under newly created or updated categories are excluded. These exclusions comprise less than 0.49% of total inquiries and complaints made in 2020. These changes will be included in next year’s 2021 Health for Humanity Report.

Compliance-Related Investigations and Responsible Marking

Compliance-Related Investigations and Responsible Marketing Indicators

2020 2019 2018
Number of compliance-related allegations investigated through Triage Committee 559 738 707
Percentage of compliance-related allegations investigated through Triage Committee, by category
Healthcare compliance 41% 40% 46%
Financial 51% 50% 40%
Other 8% 10% 14%
Number of warning letters or untitled letters issued by OPDP or APLB in the U.S.* 0 0 Not reported
See PwC's Report of Independent Accountants.
* OPDP: Office of Prescription Drug Promotion and APLB: Advertising and Promotional Labeling Branch of the FDA Center for Biologics Evaluation and Research.

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