Responsible Marketing and Promotion

KEY POINTS

• Medtronic strongly believes in the integrity of its business practices and is proud of the global compliance programs we have in place today.  Medtronic’s Code of Conduct (“The Compass”) commits all of our employees and those acting on our behalf to ethical behavior and requires employees to follow applicable laws and regulations, including those governing promotion of our products.
• Our Global Ethics & Compliance program, established by our Board of Directors in conjunction with Medtronic senior management, is one of the key components of our commitment to the highest standards of ethical practice.
• Medtronic’s Global Anti-Corruption Policy requires compliance with all applicable anti-corruption laws and regulations, including the U.S. Foreign Corrupt Practices Act (FCPA) and anti-corruption laws of other countries where we or our partners do business.
• While physicians are free to use medical devices as they see fit based on their medical judgment (including “off-label” use), our Code of Conduct limits sales representatives to promotion of our products solely based on approved labeling consistent with specific requirements for the marketing, sale, and promotion of products in their respective countries.
  

Overview

1. Our Global Ethics & Compliance Program
   
   

   Our Global Ethics & Compliance program, established by our Board of Directors in conjunction with Medtronic senior management, is one of the key components of our commitment to the highest standards of ethical practice. This program involves not only a framework of policies, procedures and programming activities, but also the commitment of senior management, and the support of all employees, contractors, distributors, and agents to make the program effective. We regularly review and enhance our compliance program to meet our evolving compliance needs. The program includes: (1) written standards, including Medtronic’s Code of Conduct;¹ (2) a leadership structure incorporating a Global Chief Ethics & Compliance Officer and Executive Compliance Committee; (3) education and training; (4) auditing and monitoring; (5) corrective action procedures; (6) disciplinary processes standards for violations, and (7) a compliance hotline, available around the globe in dozens of languages, which allows individuals to confidentially raise any compliance concerns.

   We also have programs designed to foster a culture of compliance and commitment to the law and our ethical standards, including making ethical behavior a mandatory component of the performance review of every employee. Medtronic invests in robust programs for training our employees and agents globally on their responsibilities under these policies, and we take instances of non-compliance very seriously.

2. Our Code of Conduct
   
   

   Medtronic strongly believes in the integrity of its business practices and is proud of the compliance programs we have in place today. Medtronic’s Code of Conduct (“The Compass”) commits all of our employees and those acting on our behalf to ethical behavior and requires employees to follow applicable laws and regulations, including those governing promotion of our products. As reflected in our Code of Conduct, behaving ethically and in compliance with the law is an important part of safeguarding Medtronic’s reputation: “We all benefit from the Company maintaining a reputation for conducting business ethically and with integrity. It’s a valuable Company asset earned through the behavior of employees past and present. We all have a responsibility to maintain and enhance this legacy through our daily interactions.”¹

3. Our Global Anti-Corruption Policy, Conflicts of Interest Policy, and Supplier Code of Conduct
   
   

   Medtronic’s Global Anti-Corruption Policy requires compliance with all applicable anti-corruption laws and regulations, including the U.S. Foreign Corrupt Practices Act (FCPA) and anti-corruption laws of other countries where we or our partners do business. Our policies and contracts with our global distributors require compliance with anti-corruption laws, regulatory requirements around lawful promotion and label requirements, and other laws and regulations relating to the distribution of our products. We conduct background checks on distributors, we provide local compliance training to distributors, we require them to have compliance policies and standards, and we insist they annually certify compliance as a condition of working with us.

   Our Global Conflicts of Interest Policy, applicable to all Medtronic employees worldwide, prohibits engaging in activities that create a conflict between personal interests and the business interests of the company. Designed to supplement our Code of Conduct, this policy provides employees with practical guidance on how to avoid or disclose real or potential conflicts of interest with business partners, suppliers, vendors and colleagues. We also have a global anti-retaliation policy, which prohibits Medtronic employees or agents from taking any adverse action against an individual because that person reported a possible violation of law or policy. Medtronic implements robust programs for training our employees and agents globally on their responsibilities under these policies, and we take instances of non-compliance seriously. If an employee or partner is alleged to be in violation of these policies, Medtronic thoroughly investigates and issues the appropriate corrective actions, up to and including termination.

   Medtronic also has a Supplier Code of Conduct which, among other things, commits our suppliers to comply with ethical labor practices and associated standards and laws.

4. Our Commitment to Responsible Promotion
   
   

   While physicians are free to use medical devices as they see fit based on their medical judgment (including “off-label” use), our sales representatives are not permitted to promote the use of any of our products in a manner that is at odds with the approved labeling in a given geographic region. Medtronic educates its direct sales force on appropriate communications and to implement compliance programs that ensure any promotion or sale of its products is consistent with labeling, as well as all applicable laws and regulations governing relationships with government and private customers.

See also:

• Medical Device Regulations and Pricing
• Collaboration with External Experts