ON INTERACTIONS WITH CUSTOMERS
Our Mission is to make and sell devices that alleviate pain, restore health and extend life. We recognize that healthcare professionals – those best suited to understand the needs of their patients, the performance of medical devices in the clinical setting and unmet treatment needs – are critical partners in our ability to fulfill our Mission. We collaborate with physicians to create new products and therapies and to improve existing products. We provide world-class training and education on the safe and effective use of our products and therapies to healthcare professionals. We sponsor scientific research conducted by healthcare professionals to gather clinical evidence related to our products. All of these interactions are for the ultimate benefit of patients.
In no instance will Medtronic offer or provide a payment to a Customer as an unlawful inducement to purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe a Medtronic product. We define "Customer" to include any institution or individual, other than an individual patient, including any medical or healthcare professional or entity, in a position to purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Medtronic products. Medtronic also considers persons employed by a Customer, a close family member of a Customer (including spouse or life partner, their children and parents of the Customer) or an organization affiliated with a Customer (meaning that it is controlled by or under common control with the Customer or if the Customer is on the Board of the organization, receives material compensation from, or has an investment interest in the organization) to be within scope when determining whether an entity or individual should be treated as a "Customer" under our policies.
We are committed to adhering to applicable laws regarding physician-initiated use of our products and respect a physician's right to make independent medical decisions when treating patients. Our marketing, education and promotional activities are consistent with these commitments, and we comply with governing laws regarding appropriate promotion of our products.
Standard 1 | General Provisions
Standard 2 | Discounts and Evaluation Products
Standard 3 | Donations, Research and Educational Grants
Standard 4 | Educational Items and Gifts
Standard 5 | Business Meetings
Standard 6 | Services Arrangements
Standard 7 | Training and Education
Standard 8 | Third-Party Conferences
Standard 9 | Activities Benefiting Patient Care
Partnership between industry and its Customers must be based on solid ethical principles, as it presents the potential for conflicts of interest. These conflicts, both real and perceived, can affect patient and stakeholder confidence in clinicians, products, companies – and the entire industry. To sustain and enhance medical innovation through principled cooperation so that patients continue to benefit from advances in medical care, Medtronic is guided by two central principles:
Preserve the integrity of the physician-patient relationship
The relationship between physician and patient is a uniquely trusting one because of the special role that physicians play in saving and enhancing human life. Appropriate safeguards and regulations are necessary to ensure these relationships are not compromised by the cooperation between a physician and industry in the development and testing of new products, or the training and education of other physicians on the safe and effective use of products.
To provide patients and physicians with information to make informed treatment decisions, and to develop trust and minimize actual and perceived conflicts, Medtronic is committed to transparency and appropriate disclosure of policies regarding its relationships with Customers. We believe also that promoting greater transparency into collaboration with Customers will help people better understand the critical role that these interactions play in innovation, advancing patient care, and ultimately, saving and improving lives.
Medtronic has adopted and fully embraces certain local industry codes of ethics, for example, the AdvaMed Code, the Eucomed Code, and many others. The Medtronic Global Anti-Corruption Policy ("ACP") sets forth guiding principles across Medtronic for avoiding any corrupt interactions with Customers. The Medtronic Global Business Conduct Standards ("BCS") give more specific instructions for common categories of interactions with Customers. Where additional local requirements or exceptions are necessary for conforming this common approach to local rules, or additional information is needed for local operation of the BCS, those local provisions are provided in the BCS Playbook (in the U.S.) and the BCS International Procedures. Medtronic requires its employees, and others acting on its behalf to follow the ACP, BCS, and applicable BCS Playbook or BCS International Procedures, as well as all other applicable laws, regulations, company policies and industry standards whenever interacting with Customers. Medtronic will address violations of the BCS and related policies promptly and with appropriate corrective action. See the Global Code of Conduct and BCS Violations Procedure.
The BCS provides a framework to guide interactions across the globe with Customers that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Medtronic products. Because it cannot account for every situation, exceptions to this policy may be approved where the action contemplated does not raise legal, regulatory or ethical concerns.
Core Rule. In no instance will Medtronic offer or provide a payment or any other item of value to a Customer as an unlawful inducement to purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe a Medtronic product. To ensure that all Customer interactions are legal and ethical, they must be consistent with Medtronic's Business Conduct Standards.
Scope of Business Conduct Standards. The BCS are mandatory for interactions involving a transfer of anything of value from Medtronic to a Customer (a "Customer Interaction"). If you are unsure of the scope of the BCS, you must consult with Legal or Compliance before entering into a transaction or initiating a discussion with a Customer.
Business Conduct Standards are Country-Specific. Customers remain subject to the regulations of the country where they are located (healthcare organizations) or where they work (healthcare professionals), irrespective of where the interaction occurs. All Medtronic employees, distributors and agents are expected to become familiar with the BCS and other rules applicable to an individual Customer before initiating an interaction, regardless of the employee's geographic location. If you plan to enter into an agreement or other interaction with a Customer who works in a country outside your geography, please contact your compliance or legal contact prior to any negotiation with the Customer. Your compliance or legal contact will help you determine what is required before entering into such interaction.
Compliance with the BCS is required. All Medtronic employees involved in Customer interactions are expected to know and comply with the Global Anti-Corruption Policy, the BCS and the applicable BCS International Procedures (outside the U.S.) or BCS Playbook (U.S.), and any other applicable laws, regulations, company policies, procedures and interpretative guidance. As a requirement of working at Medtronic, all employees are expected to know and follow the BCS. Managers are responsible for ensuring that their reports comply with the BCS and any BCS-related requirements such as mandatory training. Medtronic distributors and agents must be required by contract to comply with the Medtronic Anti-Corruption Policy and with applicable principles of the BCS. See the Medtronic International Distributor and Sales Agent Appointment, Contracting and Management Policy.
If Medtronic is restricted from doing something, so are its employees and third party intermediaries. If these Standards restrict Medtronic's interactions with a Customer, Medtronic employees and third party intermediaries are likewise restricted, even if no reimbursement request is made to Medtronic. This means that Medtronic employees or agents may not give prohibited items to Customers even if they pay for them from their own personal funds.
BCS Violations. Employees who violate the BCS are subject to discipline, up to and including termination. See the Global Code of Conduct and BCS Violations Procedure.
Interpretation of Business Conduct Standards. Any employee with questions about the BCS should contact his/her Manager or Legal or Compliance. Distributors and agents should contact their Medtronic business contacts. Legal and Compliance are responsible for final interpretations of the BCS.
Reporting Concerns and Prohibition against Retaliation. Any employee, agent or business consultant who is concerned that others may be engaging in, or requiring that the employee, agent or business consultant engage in, conduct that is inconsistent with the BCS, should discuss the concern with a Manager, the Human Resources department, Legal/Compliance, or contact the confidential Medtronic Voice Your Concern Line at www.VoiceYourConcernLine.com. This website includes phone numbers for the Voice Your Concern Line in the U.S. (1-800-488-3125) and other countries. Reports can be made in many different languages. Retaliation against any individual for making a good faith report of a potential BCS violation is prohibited.
Method of Payment to Customers. Except as specified below, payments to, or on behalf of, or reimbursed to a Customer must be made by a Medtronic bank transfer only (except for countries where payments are made by check). Whenever possible and practical, payment for travel expenses incurred by a Customer (e.g. lodging, meals, or transportation) must be paid directly to the vendor (e.g., the hotel, airline and travel agency). When reimbursement is made to the Customer, original receipts or other supporting documentation are required. When a Customer is expected to pay directly for reimbursable travel expenses, the Customer should be provided with modest per-diem spending guidelines in advance.
Exceptions and Amendments to the BCS. Because the BCS cannot account for every situation, exceptions to the BCS may be approved where the action contemplated does not raise legal, regulatory or ethical concerns, following the appropriate Business Conduct Exceptions Process.
BCS Spending Limits. Spending limits are established for business-related expenditures on modest meals, refreshments and lodging; reasonable travel and occasional educational items provided to Customers. In addition, employees are expected to follow any applicable Customer-related restrictions. These include, for example, more restrictive laws or employer policies. See the Authorization Levels in the Worldwide Finance Manual to determine the level of authorization necessary to approve payments. For specific spending limits, see the BCS International Procedures or Playbook.
Proper Reporting of Expenses. Payments and all other benefits transmitted to Customers or on behalf of Customers must be timely reported to Medtronic using the applicable expense reporting system and attributed to individual Customers accurately and completely.
Modest Meals and Refreshments. We may provide modest meals as an occasional business courtesy so long as the meal is incidental to the purpose of the business interaction, provided in a manner and setting conducive to the exchange of information and attended by a Medtronic representative. We will not pay for meals for an individual Customer not in attendance at the meeting. We will not pay for or provide excessive alcohol at business meetings, as excessive alcohol undermines the legitimacy of the business meeting. Such meals or refreshments may be provided to Customers in conjunction with:
No Entertainment. Medtronic does not provide or pay the costs for a Customer's participation in entertainment or recreational events.
No Subsidy of Spouses, Partners or Guests. Medtronic may not pay for meals, other hospitality, travel or lodging for a spouse, partner or other guest of a Customer.
Reasonable Travel. Depending on the local rules, Medtronic may be able to pay reasonable travel costs for Customers in conjunction with:
As a general rule, economy class travel should be used on all flights. The appropriateness of business class travel for Customers, according to Medtronic policy, shall only be considered for certain longer flights in accordance with local policy (see the International Procedures or BCS Playbook). Medtronic will not pay for upgrades, provide Customers cash in lieu of a ticket or pay any costs associated with a private plane.
Locations and Lodging for Customer Interactions. Depending on the local rules, Medtronic may be able to provide modest lodging for Customers in conjunction with the following interactions:
When Medtronic is responsible for selecting location and lodging for a Customer interaction, it must be selected based upon program requirements, convenience of attendees, and cost savings to Medtronic. Where most or all of the Customer attendees are from the same country, the interaction should be held in that country unless there is a legitimate business purpose to hold the meeting elsewhere.
Requisition and BCS Approval Procedure. Approval processes involving evaluation by qualified, non-sales personnel are required for many Customer interactions (for example consulting agreements, donations and grants all require advance approval according to local processes). See the International Procedures or Playbook for more information. Where an approval process is required by these Standards, Medtronic personnel may not proceed or make a commitment to a Customer before obtaining all required approvals. Failure to obtain the necessary approval may result in a BCS violation.
Training on anti-corruption and the Business Conduct Standards is mandatory for all Medtronic employees interacting with Medtronic's Customers. Third Party Intermediaries, such as distributors, consultants or agents are also subject to training requirements. Minimum training requirements are specified on the Legal/Compliance website. Such training may occur at the time of hire, annually, or at such other times as may be required. For questions about required training, contact Legal or Compliance.
With proper documentation and in compliance with applicable legal and regulatory requirements and other Medtronic policies and guidelines such as pricing and rebate guidelines, Medtronic may provide products to Customers at a reduced or no charge, including:
Notification to Customers should be provided when a product or accessory is sold at a discount or provided or loaned to a Customer at no charge. This requirement can be met through a purchase agreement, invoice or other notice that reflects the discounted price or zero charge and is provided to the Customer.
For evaluation purposes, only a reasonable number of single-use or disposable products should be provided to a Customer. Products that are covered by pricing arrangements such as discounts, rebates, and warranties are not “evaluation” products.
Provision of capital equipment or multiple-use products free of charge must be accompanied by a written agreement addressing, among other things, term of use and return or purchase of the equipment at the end of the term, if less than the useful life of the equipment. This requirement does not apply to equipment or products that have been determined by Legal to have “no independent value.” Be sure to check BCS International Procedures and Playbook for additional local requirements.
Discounts, warranties, multi-line discount programs, no-charge products and accessories and other pricing arrangements should adhere to local pricing policies and procedures or be reviewed by Medtronic legal counsel before being offered.
Purpose. Medtronic may make monetary and product donations for appropriate scientific, educational, health care, or other charitable purposes. Donations are limited to certain institutions or organizations and are not always allowed for individuals who are Customers; see the appropriate country-specific guidance for more detail.
The donation or grant may not be connected to the purchase of Medtronic products and cannot be made to influence the judgment of an individual Customer related to the institution.
Educational Grants. Medtronic makes a variety of charitable contributions, including educational grants. Educational grants can include supporting an endowed chair at an academic institution, the education of fellows in recognized medical training programs, programs that educate the public on health care topics, and support for educational and policy making conferences and meetings. Educational grants are provided to institutions; not individual people. Refer to Third Party Conferences (BCS 8) for the support of medical congresses or conferences that relate to Medtronic products and therapies.
Fellowships / Scholarships. Medtronic may provide educational donations to recognized medical training institutions or professional societies for fellowships and scholarship awards (to underwrite appropriate related costs such as travel, tuition, lodging, meals, etc.) in fields associated with Medtronic products and therapies, so long as they relate to a bona fide educational need of the fellow and his or her institution.
The selection of fellows should be within the discretion of the teaching institutions at which they will be trained. Donations must be provided to either the teaching institution or the fellow's home institution (where and to the extent that the teaching institution charges tuition or costs to the home institution for the fellowship program), not to individual fellows. Grants may not be tied to an institution's purchase of Medtronic's products, or otherwise be based on an institution's past or potential future, undefined use of Medtronic's products or services.
Scientific Research Grants. Medtronic funds scientific research including, for example, donations to support basic scientific research and general research grants to study new therapeutic uses of approved devices. However, Medtronic will not use such research for the purpose of unlawfully promoting uses of our products and therapies that have not been approved. Generally, the funding of research protocols related to Medtronic products and therapies should be carried out as an agreement under BCS 6 rather than a donation under this Business Conduct Standard. Other guidelines and requirements may apply to decisions for funding such research protocols, such as the need for review by appropriate Medtronic scientific personnel or an External Research Program board.
Fundraising Events. Medtronic may support a healthcare organization's fundraising event (for example, a golf outing or a formal gala) when the grantee is a registered charity and at least a portion of the donation qualifies for a charitable tax deduction. The tickets may be used by Medtronic employees or Medtronic guests who are not Customers, or they may be given back to the charity. See the International Procedures or U.S. BCS Playbook for more details.
Prior Approval. All Customer-related grants and donations require prior approval under BCS approval procedures before a commitment may be made to the recipient. Donation / grant requests must be reviewed to ensure that a funding proposal has a permissible purpose, regardless of the volume or value of purchases made by, or anticipated from, the recipient and that funding is not used as a reward for prior sales or inducement for future sales. In general, it is not appropriate to provide retrospective financial support for research, educational or other projects already completed. Donations made to privately owned medical institutions require careful review to ensure appropriate project budgeting for use of funds.
Except in the very limited circumstances below, the giving of gifts to Customers is generally prohibited. Medtronic may occasionally provide items that have a genuine educational function or benefit patients, such as textbooks or anatomical models, if they are modest in value and in accordance with the national and local laws, regulations and industry and professional codes of conduct of the country where the Customer is located. It is never appropriate to give items such as cash or cash equivalents, or personal items (e.g., clothing, perfume, iPods, iPads, iPhones, etc.).
Medtronic adheres to industry codes of ethics regarding whether it is appropriate to provide gifts to a Customer or a Customer's close family member. Consult the BCS International Procedures or Playbook for country-specific standards on items that may be appropriate to give to Customers as well as monetary limits on such gifts.
The description and purpose of items given to Customers should be documented and approved on an expense report or through a comparable authorization process.
We conduct business meetings with Customers to discuss features or other important aspects of Medtronic products or therapies, product-related service concerns, sales terms, contracts, patient access to therapies and other business topics. We do not use business meetings to promote our products or therapies in a manner that would be inappropriate under local law.
Business Purpose. A business meeting is defined as a meeting held with one or more Medtronic employees or independent sales representatives and a Customer for one of the following business purposes:
Often, these meetings occur at or close to the Customer's place of business and require either time away from the clinic or a commitment of the Customer's non-working time. We host such business meetings only at settings that are conducive to bona fide scientific, educational or business discussions. In addition to providing occasional modest meals and refreshments in connection with such meetings, when necessary we may pay for reasonable travel costs and modest lodging of meeting attendees. Costs for such meetings must be in accordance with the respective country limits.
Plant tours and other such product- or manufacturing-oriented business meetings with Customers must follow the processes that have been previously reviewed and approved by Compliance/Legal. See the applicable BCS International Procedures or Playbook for more detail.
For more guidance on meals provided in the context of a third-party conference or training session, see BCS 7 or BCS 8, as appropriate.
Entertainment. Medtronic may not provide or pay for any entertainment or recreational event, such as golfing, attendance at sporting events, theatre, etc. for a Customer. This includes paying for, contributing to or holding parties for Customers for the purpose of celebrating a non-business event, such as a holiday, retirement, promotion, etc.
Expense Reporting. For payment of meals/transport, it is the responsibility of the involved employee and the employee's manager to confirm the appropriateness of the type and amount of the event. The description and purpose of meals and related transportation should be documented and approved on an expense report or through a comparable authorization process.
BCS Spending Limits. For detailed information on meal limits, please see the BCS International Procedures or Playbook.
Business Purpose and Need. Services agreements with Customers must be entered into only where a specific, legitimate business purpose and need for services in the areas of training and education; product research and development; advisory services; or clinical research is identified in advance and documented. For example:
Limitations. The use of Customer service providers is limited:
See the BCS International Procedures and Playbook for more detail on the process required to be followed in advance of entering into discussions with a Customer about a potential agreement.
Selection of Customer service providers must be on the basis of the Customer's qualifications, expertise and capacity to address the identified purpose. While it is possible that the qualifications for a task could include experience with, usage of, or familiarity with a Medtronic product or therapy, the selection of a Customer service provider may not be used to reward past usage or constitute an unlawful inducement.
Compensation may not exceed the fair market value of services provided. Fair market value must be assessed in accordance with requirements of the country where the Customer normally practices (in the case of an individual Customer) or is located (in the case of an institutional Customer). Compensation must be structured on a measurable basis, such as payment based on a daily, hourly or per-project rate, deliverables or milestones. Compensation paid to a Customer service provider may not be based on the volume or value of the Customer's past, present or anticipated business.
Services agreements must be in writing, must describe all services to be provided, must be approved in advance following the appropriate process and signed by the parties, including an appropriate Medtronic approver as indicated in the BCS International Procedures or Playbook, and entered into prior to the start of services and payment. Agreements providing for general services or services on an as-needed basis with payment prior to receipt of services ("retainer agreements") are prohibited. In addition to the written agreement, the responsible business person must maintain accurate files documenting the services or intellectual property received in exchange for Medtronic's payments.
Any reimbursement for reasonable travel expenses should be paid, whenever possible and practical, directly to the hotel, airline, and travel agency and not to the Customer. If not paid directly, any reimbursement should be supported by original receipts or other supporting documentation. No payments for the Customer's family members are permitted. Medtronic should not arrange for the travel or lodging of a Customer's guests or family members.
Consultant Meetings. The venue and circumstances for meetings with consultants should be appropriate to the subject matter of the consultation. Hospitality that occurs in conjunction with a consultant meeting should be modest, in accordance with the respective country limits, and should be subordinate in time and focus to the primary purpose of the meeting.
Medtronic must comply with applicable national and local laws with regard to the disclosure, transparency or approval requirements to any third parties associated with engaging Customers as service providers. See the BCS International Procedures and Playbook for local requirements as well as the detail on compensating for travel time.
Purpose. Medtronic may organize sessions with Customers for the purpose of instruction, education and training to explain the safe and effective use of Medtronic products. This education and training includes "hands on" product training as well as education on topics associated with the appropriate use of our products, therapies and related services and support programs. This may involve training and education on:
Training and education must generally constitute a substantial majority of the program on each program day.
Appropriate Setting. Training and education programs are to be conducted in appropriate settings - places that are conducive to the program's training and education purpose, convenient for the attendees and reasonable in cost. See the BCS International Procedures or Playbook for more detail on appropriate training locations.
Travel Expenses. Where appropriate, we subsidize Customers' expenses to travel to Medtronic-conducted training and education programs. Lodging, setting, meals and refreshments provided in conjunction with training and education programs must be modest and in accordance with the applicable country limits and must not overshadow the training and education purpose of the program.
Payments to Customers to conduct Medtronic training and education sessions and reimbursement of travel expenses must be under a written agreement and in accordance with BCS 6. Medtronic may not pay an honorarium fee for simply attending a Medtronic training and education event.
Prior Approval. Training and education programs involving Customer travel must be reviewed and approved according to a written process that requires prior approval of the course content, agenda (covering all events from arrival to departure), budget, location/venue types and numbers of attendees and faculty. Agenda items may not include uses of our products or therapies that would be inappropriate under local law, nor may agendas include entertainment or recreation.
Faculty may include qualified Medtronic sales personnel, other Medtronic technical experts, as well as healthcare professionals with the proper qualifications and expertise to conduct the training and education.
Purpose. Medtronic may support independent educational, scientific and policymaking conferences and professional meetings that promote scientific knowledge, advance the practice of medicine and enhance the delivery of effective healthcare if they are generally recognized and respected within the medical community and relate to our products and therapies. The rules and practices in supporting third party conferences vary greatly by geography, but regardless of region, Medtronic never provides funding support for purposes of rewarding a Customer's past purchases or improperly influencing future ones.
Conferences in the U.S. – Medtronic's funding must be consistent with the rules of the body accrediting the educational activity. This means:
However, Medtronic may provide grants to conference organizers to reduce overall conference costs, defray faculty costs and expenses, support modest meals or receptions and allow attendance by healthcare professionals-in-training, or Medtronic may give a grant to a training institution to allow an HCP-in-training to attend a third-party conference or professional meeting.
Conferences outside the U.S. – Proposed sponsorship of such conferences requires review under the BCS process in the geography of the conference site. See the BCS Playbook for further detail, including the rules on U.S. Customers attending third-party conferences occurring outside the U.S.
Where permitted under national and local laws, regulations and professional codes of conduct, and with prior approval, Medtronic may provide financial support to cover the cost of conference attendance by individuals who are Customers. Such financial support should be limited to the conference registration fee and reasonable travel, meals and accommodation costs relating to attendance at the event. Medtronic must ensure full compliance with national and local laws with regard to the disclosure or approval requirements associated with such sponsorship and where no such requirements are prescribed, shall nevertheless maintain appropriate transparency, for example, by requiring prior written notification of the sponsorship is made to the hospital administration, the individual Customer's superior or other locally-designated competent authority.
Note that Eucomed has established a process to approve conferences occurring in Europe which Medtronic will use as a guide for determining conference support. See the International Procedures for further detail.
Reimbursement Support. Patient access to our products and therapies depends on the availability of timely and complete coverage, reimbursement, and health economic information. Where appropriate, Medtronic may provide this information to Customers, payors and patients, provided such reimbursement support is accurate, objective and related to Medtronic products, therapies, procedures and services. We may also collaborate with Customers, patients and organizations representing their interests, to achieve government and commercial payor coverage and adequate reimbursement levels that allow patients to access Medtronic products and therapies.
Medtronic-provided reimbursement support may never suggest mechanisms for either billing for services that are not medically necessary or that facilitate fraudulent practices to achieve inappropriate reimbursement.
Other Activities to Support Patient Access. Medtronic also undertakes other activities to support patient access to our products and therapies to improve patient outcomes. Medtronic may engage in market development activities and conduct educational and awareness programs with its customers. In addition, Medtronic may provide health and disease management programs that include the provision of items, services and provider and patient health management tools such as critical pathways, remote monitoring and patient compliance and education support.