Global Interactions Policy
Interacting with external stakeholders about our products, therapies, and services is essential to Baxter's mission to save and sustain lives. These interactions are subject to legal and regulatory requirements pertaining, but not limited to, anti-corruption, competition, transparency, privacy and product and scientific communications. We are committed to ensuring our interactions are legal, ethical and transparent. Building on the foundation of Baxter's Code of Conduct and applicable laws, this Global Interactions Policy (Policy) defines the principles and rules governing our interactions with Government Officials and members of the Medical Community (as defined below).
B. SCOPE AND APPLICABILITY
This Policy applies to all Baxter employees, directors, officers, contractors and Third Parties when interacting, virtually, in person or through any communications, with Government Officials and members of the Medical Community in the name or on behalf of Baxter.
C. DEFINITIONS AND CONVENTIONS
Key terms used in this Policy are defined in the table below. In addition, this Policy describes common interactions between Baxter and members of the Medical Community and Government Officials (Baxter Interactions). For ease of identification, these Baxter Interactions are capitalized in bold blue text throughout the document. Where possible, links have been provided for other policies and other cited documents.
Adverse Event (AE): Any untoward medical occurrence in a patient or animal administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom (e.g., rash, pain, discomfort, fever, dizziness, etc.), disease (e.g., peritonitis, bacteremia, etc.) or outcome of death temporally associated with the use of a medicinal product, whether or not considered related to this medicinal/therapeutic product.
Baxter Sponsored Research: Studies initiated and directed by Baxter, where Baxter is the owner of the protocol, to investigate drugs, biologics, devices, and/or combination products. Baxter is the sponsor of these studies.
Caregiver: A person who is not an HCP but gives care to Patients who need help taking care of themselves (e.g., family member, neighbor, hired home helper, or driver).
Collaborative Study: A research study where the institution acts as sponsor and manages the study. Baxter acts as a collaborator and provides financial and scientific support, as permitted by applicable law.
Fair Market Value (FMV): A price for services that is consistent with an amount unrelated parties would pay in an arms'-length transaction. Baxter's Fair Market Value Charts reflect approved hourly rates that may be paid to members of the Medical Community for services required by a Baxter legitimate need. In limited instances where a precise FMV calculation is unattainable, a commercially reasonable standard may be used.
Governmental Official (GO): Any individual who is currently acting in any of the listed capacities and has direct or indirect power over Baxter's business:
1. Any elected official, civil servant, military personnel, officer or employee of a government (including sub-national and local governments) or any department, agency or instrumentality thereof;
2. Any person acting in any official capacity on behalf of a government or any department, agency or instrumentality thereof;
3. Any officer or employee of any entity owned in whole or in part by a government;
4. Any officer or employee of a public international organization such as, but not limited to, the World Bank, World Health Organization, or the United Nations;
5. Any political parties, political party officials or candidates for political office in a government;
6. Any member of a royal family with official or unofficial power over any aspect whatsoever of a Non-U.S. Government, including its decision-making process, executive function, administration, or finances, including any direct or indirect power over Baxter’s business;
7. All close relatives of any of the above-described categories, including spouses, children, siblings or other immediate family members.
In many countries, HCPs are public employees and as such are considered Government Officials.
Healthcare Organization (HCO): Any entity or organization, directly or indirectly involved in the delivery of healthcare, that can purchase, order, prescribe, lease, recommend or use Baxter products, services and therapies. This includes, without limitation, universities/medical schools, hospitals, medical clinics, academic medical centers, physician groups, ambulatory surgery centers and hospice centers, as well as Patient and HCP support, advocacy or educational associations.
Healthcare Professional (HCP): Any individual, directly or indirectly involved in the delivery of healthcare, who can purchase, order, prescribe, lease, recommend or use Baxter products, services and therapies. This includes, without limitation, physicians, nurses, non-licensed healthcare professionals (e.g., CEOs, purchasing managers, hospital administrators), medical directors, specialty pharmacy representatives, physical therapists, dentists, and veterinarians.
Human Subject Research (HSR): HSR is defined as activities intended for generation of generalizable knowledge by obtaining information or biospecimens (whether the specimen has been de-identified or is connected to identifiable information, private information or other identifiable specimens) through intervention or interactions with the human subjects, and using, studying, or analyzing such information or biospecimens. Examples of HSR include, but are not limited to, surveys/questionnaires, focus groups, medical chart reviews, some Market Research, clinical studies, health economic and outcomes research, etc.
Investigator Initiated Research: Scientific/clinical research funded or supported by Baxter, initiated by a third party and conducted by an investigator. The third party is the sponsor of these studies.
Medical Community: The broad array of individuals and entities that deliver or receive healthcare. Collectively, it includes HCPs, HCOs, Caregivers, Patients, Patient Organizations, Payors, and contract research organizations.
Patient: Any individual that requires and/or receives medical care or treatment.
Patient Organization: Not-for-profit organizations (including the umbrella organizations to which they belong), mainly composed of Patients and/or Caregivers that represent and/or support the needs of Patients and/or Caregivers.
Payor: A private or governmental entity that pays for medical care expenses, such as an insurance company, national healthcare reimbursement system, managed care organization or self-insured employer.
Scientific Exchange: The non-promotional interaction and exchange of scientific information between Baxter and external communities in order to advance scientific and medical understanding.
Third Party: Any Third Party that interacts with the Non-U.S. Medical Community or Government Officials on Baxter's behalf. A Third Party under scope may be engaged in any of the following activities, for example:
1. Markets or promotes Baxter products;
2. Negotiates or executes Baxter agreements;
3. Lobbies or advocates for Baxter;
4. Provides regulatory consulting services;
5. Provides customs clearance services;
6. Remunerates or provides other benefits, such as congress registration, travel or accommodation, to HCPs on Baxter's behalf.
Transfer of Value: Payment or other benefit provided by Baxter to a Government Official, HCP or other covered member of the Medical Community, directly or indirectly. It can be a monetary payment (e.g., a fee in exchange for a service) or a non-monetary benefit (e.g., a meal, lodging, registration fee).
Worldwide Medical: A Baxter function that consists of GBU Medical Affairs, Regional Medical Affairs, Global Patient Safety and Strategy & Delivery teams.
This Policy establishes foundational requirements for several Baxter Interactions. Given the constantly evolving environment, this Policy cannot contemplate every potential interaction. When considering other transactions involving members of the Medical Community or Government Officials, Baxter employees should consult with their Ethics and Compliance business partner.
The Baxter Interactions described in this Policy are listed below. Each title is a clickable link. In addition, several Key Concepts apply across all interactions.
Interacting in an Ethical and Legal Manner. We are all accountable for conducting Baxter's business with ethics and compliance in everything we do. Our interactions with the Medical Community and Government Officials must always occur in an ethical manner, in compliance with applicable anticorruption, antibribery and other laws, regulatory requirements and industry codes that Baxter has adopted. While this Policy establishes Baxter's global standards, when we interact with members of the Medical Community and Government Officials from different countries, we need to be aware of more restrictive country-specific laws and/or requirements. Ethics and Compliance will ensure that every country in which Baxter does business has a Local Country Annex that sets forth more restrictive and/or additional country-specific laws and/or requirements applicable to the interactions covered by this Policy. In case of conflict between local laws and/or regulations and this Policy, the more restrictive rule applies.
Baxter Does Not Buy Business. We sometimes provide members of the Medical Community and Government Officials with something of value that they may either have earned (like a Fair Market Value payment for services) or may have been given as a Business Incidental (like a Meal). We expect clinical decisions to be based entirely on sound medical judgment. No one at Baxter may offer or provide anything of value to a member of the Medical Community or a Government Official, either directly or indirectly, with the intent to improperly influence or reward his or her decision to prescribe, purchase, recommend and/or use a Baxter product, therapy or service.
We Value Privacy. Baxter Interactions with members of the Medical Community or Government Officials may involve Baxter receiving information that our stakeholders consider personal. We recognize and respect the privacy rights of individuals with regard to their personal information. Everyone at Baxter is accountable for following the requirements of applicable local laws and regulations.
Good Promotional Practices. The Medical Community relies on Baxter to provide accurate, balanced information to form sound clinical decisions about our products and therapies. Baxter fulfills this vital need by promoting our products, therapies, and services, and informing on disease states of interest to Baxter in an appropriate and lawful manner. That means ensuring that our product promotion and promotional sharing of product information is: (i) "on-label" and consistent with the product’s approved labeling (e.g., Summary of Product Characteristics (SPC), Product Information (PI) or Instructions for Use (IFU)); (ii) accurate and not misleading; (iii) appropriately substantiated and confirmed; (iv) provided with fair balance to address benefits as well as risks; and (v) pre-approved via Baxter's Advertising and Promotion Review Process (AdProm Process) to ensure it meets local legal and regulatory requirements.
Off-label Promotion is Strictly Prohibited. Where allowed by local regulations, trained professionals from Worldwide Medical may respond to unsolicited, requests for information from HCPs, HCOs and some Government Officials about off-label uses of Baxter products. These responses must be truthful and non-misleading, and should be clearly identified as containing information related to unapproved or uncleared uses of the product.
Appropriate Use of Scientific Exchange. Scientific Exchange may only be conducted by Worldwide Medical. Any presentations or information communicated to HCPs must be truthful, evidence-based, non-misleading and provided in a non-promotional manner. The information must be balanced and include both the product/therapy's benefits and risks associated with its use. Scientific Exchange can be proactive or reactive (unsolicited requests) and must be intended to foster unbiased scientific discussions.
No Indirect Transactions to Benefit an HCP or a Government Official. Circumventing Baxter's commitment to ethical interactions with HCPs and Government Officials by engaging in transactions that benefit a close relative of the HCP or Government Official (e.g., spouse, children, siblings, or other immediate family members) is prohibited.
Procedural Safeguards and Documentation Requirements. Baxter has created control processes to help ensure that anything of value provided to members of the Medical Community or Government Officials is appropriate and done in compliance with appliable laws and Baxter standards. Employees who interact with members of the Medical Community or Government Officials are responsible for using Baxter systems and processes to obtain prior approval where required and maintain accurate, correct and complete documentation to ensure a full understanding of the interaction and, where required by law or other regulations, disclosure of the interaction and its rationale can occur.
1. Product Promotion, Sales and Support
1.1 Promotional Interactions
Purpose: Members of the Medical Community rely on us to provide truthful, accurate and non-misleading product information, and to be forthright about a product’s risks as well as its benefits. Our product discussions must follow the laws and regulations applicable to promotion for countries where these products are sold.
Promotional Discussions: Discussions about products should be guided by our Key Concepts and follow local promotional rules. All materials used for Promotional Interactions must be reviewed, approved, and updated via Baxter's AdProm Process. Sales employees must be trained on all products they sell, use only approved messages and materials, and may not alter approved materials in any way. Off-Label questions must be referred to Worldwide Medical, who may engage in Scientific Exchange. Off-label promotion is strictly prohibited.
Discussing Reimbursement: We may provide reimbursement information that is timely, accurate and complete. Any reimbursement information that we provide must be for informational purposes only and not constitute advice or make any recommendations on medical necessity or clinical billing practices. This reimbursement information must support appropriate prescribing and billing practices, and shall not otherwise be prohibited by law. Sales employees must never suggest HCPs or HCOs (1) submit inappropriate claims for No Charge Goods, or products or services that are not medically necessary, (2) engage in fraudulent practices to receive an inappropriate payment, or (3) prioritize financial matters over patient care.
No Elimination of Overhead: Although it is appropriate to discuss how Baxter's products contribute to efficiencies, Baxter employees should not perform services for HCPs or HCOs that eliminate or reduce overhead or other expenses the HCP or HCO would ordinarily incur as part of their business operations.
Other: Promotional Interactions are multi-faceted. In addition to the items above, employees must follow all provisions of this Policy that apply to a particular Promotional Interaction.
1.2 Technical Service Support
Purpose: We stand behind Baxter's products by providing Technical Service Support to ensure our products are appropriately installed, maintained or repaired. Often, we have warranty or other contractual obligations regarding our products. Other times, the intricacy of our products and services require Baxter’s expertise to ensure proper installation occurs. Our Technical Service Support terms must be commercially reasonable, and we must abide by additional requirements when we go onsite to provide it.
Legitimate Need: Requests for Technical Service Support must be related to a product's attributes (e.g., complexity, intricacy, product under lease, warranty or covered by a service program). We do not provide free routine maintenance under circumstances where it would be commercially reasonable to expect payment. Baxter's provision of Technical Service Support may not be used to underwrite overhead costs that a member of the Medical Community would ordinarily be expected to incur.
Written Terms of Service: We provide Technical Service Support only in connection with a written agreement or other instrument that sets forth the terms of the services we will provide. Where we have determined our support has independent value (e.g., product off warranty, our expertise is optional, etc.), we establish a fee that reflects the Fair Market Value of Baxter providing the support. When we collaborate on implementing digital technologies, a collaboration agreement clearly establishing the equitable exchange of value and services among the parties must be executed.
No Connection to Product Sales: We provide Technical Service Support based on pre-determined, objective criteria, and offer the service on comparable terms to all purchasers who qualify. Technical Service Support that is provided as part of a larger product sale agreement, such as a tender, should be valued and documented in the context of the value analysis of the broader arrangement. Favorable terms for providing Technical Service Support may never be offered selectively to preferred purchasers, or otherwise be used to reward past, present or future business.
Onsite Technical Service Support: When necessary, we may send skilled personnel to an HCP or HCO facility to provide Technical Service Support that is related to the proper function of our products. Some circumstances where Baxter may offer onsite Technical Service Support include:
- Large capital equipment may require an initial installation.
- Trainers may need to teach members of the Medical Community about the safe and effective use of our products.
- Our digital technologies may require us to collaborate with hospital technical teams on issues related to system connectivity, integration with electronic medical records, etc.
- Onsite Interactions: Employees who provide onsite Technical Service Support for an HCP or HCO must make clear they are Baxter employees acting in a Technical Service Support capacity. They must also follow all sites rules, especially those related to data privacy. When onsite, Baxter employees' activities must never interfere with an HCP’s independent clinical decision-making.
1.3 Product Price Concessions
Purpose: Interactions related to product pricing can be heavily regulated. Product Price Concessions offered in connection with sales must meet legal requirements and may need to be analyzed for government price reporting purposes. Additionally, Product Price Concessions must never interfere with an HCP's independent clinical decision-making or provide an inappropriate inducement to use a Baxter product, therapy or service.
Guidance: All Product Price Concessions must be approved through appropriate channels and reflected accurately in sales documentation (e.g., contract, invoice, purchase order, etc.). Non-standard Product Price Concessions that are part of a sales negotiation (e.g., rebates, free of charge goods, related services or technical support), must also be appropriate and reflected transparently. Baxter should not offer Product Price Concessions retroactively. All local laws requiring reporting or disclosure of pricing information must be followed. Product Price Concessions must never be disguised as unrelated transactions.
1.4 No Charge Goods Provided in Commercial Context
Purpose and Legitimate Need: Sometimes there is a legitimate need to provide No Charge Goods. For example:
- HCPs and HCOs may want to test a product before they commit to buying it, or have a model to use when educating Patients or HCPs on its proper use; and
- We may also provide No Charge Goods under a contract, either as a Product Price Concession or to fulfill our commitment to servicing the products we sell (e.g., loaners, products sold under warranty or with a service contract, etc.).
Providing No Charge Goods, however, can raise regulatory and legal concerns.
Guidance: To ensure our provision of No Charge Goods meets these requirements, we:
- Provide No Charge Goods in a commercial context only under narrowly defined circumstances that fulfill the intended purpose;
- Deliver reasonable quantities that reflect the trial basis of the use;
- Clearly inform recipients of applicable restrictions and prohibitions on billing others for No Charge Goods;
- Retain title and retrieve No Charge Goods that have been provided only for a limited time and purpose, such as capital evaluation equipment;
- Do not provide demonstration products for use by patients;
- Comply with all local government requirements for providing No Charge Goods, which may include regulations related to sampling, Product Price Concessions, transparency and reporting requirements; and
- Ensure our contracts and other documentation accurately reflect the purpose and execution of these activities.
Written Agreement: When providing No Charge Goods for a limited time and purpose, such as capital evaluation equipment, Baxter must execute a written agreement that reflects this Policy’s requirements.
No Inducement: No Charge Goods must never be offered in a manner where their monetary value serves as an inducement to use Baxter products or to reward individuals or organizations for past, present or future business.
2. Fee-For-Service Arrangements
When Baxter pays members of the Medical Community to provide valuable services, we consider these transactions "Fee for Service (FFS) Arrangements." FFS Arrangements require the following foundational elements: (1) a needs assessment (e.g., business purpose, detailed description of services, qualifications and rationale for obtaining the services from a member of the Medical Community); (2) an appropriate payment amount that reflects Fair Market Value; (3) a written agreement setting forth services, duration, payment and other relevant transaction elements; (4) absence of a conflict of interest; and (5) disclosure of payments where required by local law.
Purpose: We may engage Government Officials or members of the Medical Community as Consultants to provide needed services, such as speaking at or chairing meetings and events, providing training, serving on an advisory board or participating in a focus group or Market Research we directly conduct.
Legitimate Need: Baxter must have a pre-defined, documented and commercially reasonable business or scientific need for each use of a Consultant. The purpose of the consulting relationship is for Baxter to obtain the services and expertise of the Consultant. Consulting arrangements should never be used in lieu of Product Price Concessions. Consulting engagements may not be offered to promote products, therapies or services to the Consultants, or reward individuals or organizations for past, present or future business.
Additional Requirements for Non-HCP Government Officials: In general, non-HCP Government Officials should not be engaged. In exceptional circumstances, where Baxter requires Consulting services from a Government Official with unique qualifications, (1) the engagement must be allowed by local law; and (2) the rationale for why Baxter's needs cannot be met by engaging a different Consultant must be documented. Baxter's engagement of such a Government Official as a Consultant requires prior approval by the global head of the business unit that engages the Consultant, the global head of Government Affairs, and by Baxter’s Chief Compliance Officer.
Consultant Selection: Consultants must be selected based on their expertise and qualifications to satisfy the identified legitimate need. Baxter may only engage the number of Consultants necessary to meet the legitimate need. Local Country Annexes may place further restrictions on engaging Consultants.
Sales Involvement. Baxter Sales employees may provide input on a proposed Consultant's ability to meet a stated business need, but Sales personnel should not control decision to engage a particular member of the Medical Community or Government Official as a Consultant. In addition, Baxter Sales employees may not:
- Negotiate the terms of a Consultant's engagement or participate in the review and approval process;
- Deliver a Consultant's agreement; or
- Make any assurances or discuss the likelihood of consideration with a potential Consultant.
No Conflict of Interest: Baxter may not engage Government Officials or their family members if at the time of the engagement the Consultant or any member of the Consultant's family has any decision-making authority over Baxter products and/or therapies, including without limitation, purchasing, pricing, regulatory approval, custom clearance and/or bidding.
Speaking for Baxter: Consultants who speak on behalf of Baxter must understand the distinction between Scientific Exchange and promotion, and must follow the applicable Baxter rules. In most cases, Baxter's promotional rules will apply. Where necessary, Consultants should be trained in advance of speaking on behalf of Baxter. These requirements apply whether a Consultant uses Baxter's materials or their own.
Compensation: All compensation to Consultants for services must be reasonable, in accordance with the written agreement and reflect Fair Market Value for the services provided (consistent with any hourly or other compensation limitations set forth in the Fair Market Value Charts and Local Country Annexes). Consultants will be paid only for services actually provided, based on completion of required milestones. Payment must not be made before a written agreement is executed and documentation of services is received, or pre-determined milestones are achieved. Retainer fees or similar payments where money is provided to a Consultant to keep him/her available in case services are needed are not allowed. Consultant payments must be processed through Baxter's standard banking payment methods (e.g., checks, electronic transfers). Payment with cash, cash equivalents such as gift cards, money orders, coupons or other items of value is not allowed.
Travel Time: Travel time may be compensated at half the contracted Fair Market Value hourly rate if permitted under Local Country Annexes, with the total amount of travel time compensation not to exceed the amount paid for the actual service(s). Baxter does not reimburse Consultants additional amounts for preparation time spent during travel.
Employer and Other Notifications: If notifications to, or approvals from, regulatory authorities or the Consultant's employer or other organization are required by local laws or regulations, the Baxter employee engaging the Consultant must ensure all necessary disclosures are made/obtained by the Consultant in advance of the start of services.
Written Agreement: All consulting arrangements require a written agreement, even if no payment is made. The agreement must be signed by all parties before the start of the services and before any payment is issued. The written agreement must specify, at a minimum, the legitimate need, nature of the services, any deliverables, duration of the arrangement, Fair Market Value rates and payment terms. The written agreement should also address the fundamental elements of Baxter's relationship with the Consultant, including appropriate non-disclosure provisions if Baxter’s confidential information will be shared as part of the services.
2.2 HCP Education
Purpose: Choosing Baxter's products for appropriate Patients, and properly administering them once purchased, can require HCPs to have specific scientific understanding and technical skill. Baxter has a legitimate need to train and educate HCPs on its products, therapies or services and associated disease states. This Section applies to all education and training that Baxter provides directly to HCPs. HCP Education includes the following types of meetings and programs: (1) Promotional; (2) Non-Promotional; and (3) Jointly Conducted.
General Principles for All HCP Education
Baxter Organized and Controlled: HCP Education is planned, developed and executed by Baxter. Even though educational programs, or portions, may be delegated to vendors or Consultants, these educational programs are conducted under Baxter's control.
Content: The content for HCP Education, whether promotional or non-promotional, must be: (i) medically, technically and scientifically rigorous; (ii) objective, accurate, unbiased and appropriately validated; and (iii) provided with a fair balance of information to address a product's risks as well as its benefits.
Faculty: HCP Education may be delivered by Baxter personnel or external speakers. All speakers must have proper qualifications, education and expertise to conduct the program. External speakers must meet all requirements of the Consultants Section of this Policy.
No Reward for Business: Participation in HCP Education may not be used to reward speakers or attendees for past, present or future business. Where Meals are provided with HCP Education, the same attendees should not be invited to attend repeated programs covering the same topic absent a significant content change, or need for re-training.
Setting: Programs may be live or virtual. Settings must be selected on the basis of program suitability and be conducive to the effective transmission of information and scientific discussion. Additional requirements are contained in the Business Incidentals and Virtual Interactions Sections of this Policy.
Limitation of Scope: HCP Education does not include arrangements where Baxter engages HCPs to train Baxter staff. These arrangements should be analyzed and approved under the Consultant Section of this Policy.
Promotional HCP Education
In General: Promotional HCP Education is intended to promote various aspects of Baxter’s marketed products, procedures, or therapies. It includes information on safe and effective use of our products, as well as related disease areas.
Content: Promotional HCP Education must be consistent with approved labeling and good promotional practices. Materials should state clearly that the program is intended to promote Baxter’s products, irrespective of whether the program is delivered by Baxter or a third party. Materials used for Promotional HCP Education programs must be reviewed, approved, and updated per Baxter's AdProm Process.
Program Delivery: Promotional HCP Education may be delivered by Worldwide Medical, as well as Sales and Marketing. Educational events funded, developed, or provided by the Sales and Marketing organizations are presumed to be Promotional HCP Education.
Program Execution: HCPs must have a legitimate need to attend Promotional HCP Education (i.e., a need to obtain the education or training being offered). An HCP's staff should not attend unless they have a legitimate need for the training.
Non-Promotional HCP Education
In General: Non-Promotional HCP Education is intended to enhance HCPs' medical knowledge and scientific expertise through dissemination and discussion of scientific research or medical findings related to disease areas associated with Baxter's products, therapies or services. Where allowed by law and regulations, Worldwide Medical can prepare and present healthcare education sessions in a truthful, objective, fair and balanced manner.
Content and Delivery: Non-Promotional HCP Education is aimed at facilitating Scientific Exchange, and must not include content that promotes unlicensed use(s) of Baxter products.
Program Execution: Non-Promotional HCP Education programs are planned, developed and provided by Worldwide Medical. HCPs must have a legitimate need to attend Non-Promotional HCP Education (i.e., a need to obtain the education being offered). Content for Non-Promotional HCP Education programs must be reviewed and approved by Worldwide Medical. Other Baxter functions, including Sales and Marketing, may participate and contribute on a limited basis, only if such participation and/or contribution (1) is not linked to the promotion of Baxter's products; and (2) does not inappropriately influence the selection or compensation of any Consultants that may be involved.
Jointly Conducted HCP Education
In General: Baxter Sales and Marketing employees, in cooperation with Worldwide Medical, may jointly conduct HCP Education that contains both promotional and non-promotional content.
Content: The promotional and non-promotional components of Jointly Conducted HCP Education must adhere to the respective requirements set forth in this Policy.
Program Execution: The distinction between the promotional and non-promotional components of Jointly Conducted HCP Education must be clear. Scientific Exchange discussions must not be used to shift or "bridge" into commercial topics.
2.3 Market Research and Business Competitive Intelligence
Purpose: Market Research and Business Competitive Intelligence, whether conducted directly by Baxter or through vendors, provide us with important information and insights to better understand the market, competitive environment and/or key target audiences. The results inform decision making by many functions at Baxter.
Defined: Market Research involves collecting and analyzing information from members of the Medical Community to improve Baxter's understanding of the external environment in which its products are developed, marketed and sold.
Engagements: Market Research may be conducted by Baxter directly, or through a vendor (MR Vendor).
- Market Research Conducted Directly by Baxter: When Market Research is performed directly by Baxter, participants must be engaged under the Consultant Section of this Policy, and paid in accordance with applicable requirements (e.g., HCPs, Patients, Social Media Influencers, etc.).
- Market Research Conducted by MR Vendors: When Market Research is conducted through a MR Vendor that engages the participants, Baxter does not need to engage the participants separately as Consultants. MR Vendors that are engaged by Baxter must be qualified to perform the work and, if applicable, approved under the Third Party Process. MR Vendors must execute a written agreement that governs the terms of the arrangement and requires them to abide by this Policy and report compliance issues observed in the course of their work to Ethics and Compliance. MR Vendor compensation to participants must reflect Fair Market Value and be consistent with local standards.
Legitimate Need: Baxter must have a pre-defined and documented need to gather the information sought. Market Research may not be used to reward participants for past, present or future business.
No Promotion: Market Research questions should not be designed to promote a Baxter product. Baxter employees must never use information obtained to subsequently target participants with content tailored to their individual responses. Where privacy principles permit blinded studies, Market Research should be done in a manner that does not reveal the identity of Baxter or its products to participants.
Adverse Events: MR Vendors must commit to communicating any Adverse Events reported during these activities to Global Patient Safety within one business day.
Transparency Reporting: In regions with transparency reporting rules, the agreement must require MR Vendors to report participant payments as mandated by local law and regulations.
Data Purchase Agreements: Some Market Research activities involve Baxter purchasing data, or obtaining the right to access a third party's database. These transactions must be analyzed for a variety of issues related to the data (e.g., data privacy, licenses, Worldwide Medical's potential role, etc.). When data is purchased from a member of the Medical Community, the purchase must also meet the requirements of a bona fide FFS Arrangement, including demonstration of a legitimate need to purchase the data from the member of the Medical Community, Fair Market Value payment for the data or access rights and a written agreement.
Business Competitive Intelligence
Business Competitive Intelligence is any information about Baxter competitors (or potential competitors), potential acquisition targets, customers, and suppliers, as well as general business trends that can be used to assist Baxter employees in making business decisions.
2.4 Customer Experience Activities
Purpose and Legitimate Need: Sometimes Baxter's training for members of the Medical Community on Baxter products involves complex setup, or large, immovable equipment. In these instances, there may be a legitimate need for Baxter to conduct HCP Education at a centralized location where the equipment is installed. When these activities are necessary, the HCP Education Section applies, but we must also assess two other types of interactions with members of the Medical Community that apply: (1) visitors; and (2) site owners.
Types of Customer Experience Activities:
|Visits by Medical Community members or Government Officials to a site that Baxter owns or controls
|Visits by Medical Community members to a site that is owned by a Medical Community member
|Demonstrations performed at a laboratory site owned by a Medical Community member
Site Arrangements: Arrangements with sites owned by members of the Medical Community must meet the following requirements:
- The site must be qualified to meet Baxter's needs in conducting Customer Experience Activities.
- There must be an up-front written agreement setting forth key terms, including a legitimate need for Baxter to use the site, services to be provided, duration of agreement, and a Fair Market Value-based fee arrangement, etc.
- Payment to sites must not occur before a written agreement is executed and Baxter has received documentation the site has provided services. Site payments must be processed through Baxter's standard banking payment methods (e.g., checks, electronic transfers).
Participation Requirements: Participants in Customer Experience Activities must have a legitimate need to evaluate Baxter’s products and may not receive compensation for their time spent visiting the site. Based on geography, however, participants may qualify for reimbursement of travel-related expenses. All reimbursement must comply with the Business Incidentals Section of this Policy (including prohibitions on gifts, entertainment and participation by spouses or other guests). Where Baxter reimburses Travel and Accommodation for these activities, a written invitation letter or an agreement confirming the event and amount of reimbursement is required.
2.5 Scientific Research
Purpose: Scientific Research is essential to Baxter's ongoing growth and success. Baxter is committed to engaging in Scientific Research that is ethical in its design, implementation, and reporting.
Defined: Scientific Research interactions within the scope of this Policy include Baxter Sponsored Research, Investigator Initiated Research, Collaborative Studies and any other research conducted by R&D or Worldwide Medical that involves a member of the Medical Community or Government Official.
In General: Scientific Research must fulfill a legitimate research purpose, and be conducted consistent with established processes including, where applicable, and comply with all applicable local laws and regulations.
Written Agreement: Scientific Research requires a written services agreement that is signed by the parties before the start of services and before any payment is issued or product is supplied by Baxter. The written agreement should specify, at a minimum, the nature of the Scientific Research, deliverables, agreement duration, and compensation that is based on Fair Market Value for the Scientific Research services performed. Baxter's payments for Scientific Research services, including any collaborative work performed by Baxter, must not underwrite expenses that would ordinarily be incurred by the HCP (e.g., overhead, tasks that would typically be performed by the HCP’s office staff, etc.).
No Promotion: Baxter does not support Scientific Research as a means to promote Baxter's products and/or therapies, or to reward individuals or organizations for past, present or future business.
Eligible Entities: Only legal entities are eligible to receive Scientific Research support from Baxter; individuals are not eligible.
Additional Requirements for Human Subject Research:
- Decisions regarding funding or support for Human Subject Research must be made by or under the direction of Baxter's Worldwide Medical team, based upon the scientific merit of the proposed project and the potential clinical usefulness of the data expected to be generated by the study.
- Worldwide Medical should select all Investigators and conduct all investigator communications concerning Human Subject Research.
- All allegations of research misconduct involving Human Subject Research must be promptly investigated and addressed by Ethics and Compliance with expertise and support provided by Worldwide Medical.
2.6 Royalty Payments
Purpose: When members of the Medical Community improve Baxter's products, it may be appropriate to compensate them with Royalty Payments in exchange for their contributions to our intellectual property.
When Permitted: Royalty Payments are only appropriate where a member of the Medical Community has made a novel, significant or innovative contribution to the development of a Baxter product, technology, process or method. Royalty Payments are also only appropriate where permitted by local law.
No Interference with Medical Decision Making: Royalty Payment amounts must be based on factors that preserve the objectivity of the recipient's medical decision-making and avoid the potential for improper influence. These payments must not be conditioned on a requirement to: (1) purchase, order or recommend any Baxter product or medical technology; or (2) market the product or medical technology upon commercialization. Members of the Medical Community may not receive Royalty Payments for sales they can control. Baxter may, however, elect to enter into separate consulting arrangements with members of the Medical Community for marketing services if the engagement meets the requirements of the Consultant Section of this Policy.
Approval and Written Agreement: Any arrangement involving a Royalty Payment to a member of the Medical Community must be documented in a written agreement that has been approved in advance by the Legal Department.
Purpose: When preparing to launch a new product or service, or a new configuration of a commercialized product, Pilots can provide Baxter an opportunity to gain real world data by observing how the product or service will function in an actual hospital or patient care environment. Where permitted by local law, Pilots enable Baxter to gather important practical insights to refine the product or service, or adapt plans for broader commercialization.
General Requirements: Pilots must:
- Occur in the early stages of commercial launch in a given geographic area, or in connection with a recently launched new configuration of a commercialized product or service;
- Have a limited duration, and a plan for the return or destruction of No Charge Product at the Pilot's conclusion. If the Pilot site wishes to purchase the No Charge Product used in the Pilot, any discount must be assessed as a Product Price Concession;
- Be conducted based on a legitimate need to gather the real-world data sought, involve only the number of sites necessary to address the questions proposed, and have a plan to assess and implement the results; and
- Not be conducted repeatedly.
Pilots may be conducted by Marketing employees unless the nature of the Pilot requires expertise or oversight by another Baxter function (e.g., Worldwide Medical or R&D).
Written Assessment: All Pilots must have a written assessment outlining the Pilot's objectives and methods, Baxter function(s) involved in conducting the Pilot, site selection criteria, duration and plans for using the results. No work should begin in connection with a Pilot until the written assessment has been approved in accordance with local processes.
Site Selection: Sites must meet approved selection criteria. Sales employees may not select the sites, but may provide objective information relevant to identifying sites that might meet the selection criteria.
Written Agreement: All sites must execute a written agreement that sets forth the terms of the Pilot and other essential transaction elements, including the terms of Pilot participation, duration of agreement, Fair Market Value for work performed in connection with the Pilot and other necessary payment terms.
No Inducement: Pilots must never be offered in a manner where the products provided, or opportunity to participate, serves as an inducement to use Baxter products or enter into future engagements with Baxter, or to reward individuals or organizations for past, present or future business.
2.8 Medical Community Influencer Interactions
Purpose: Social media is an important channel through which members of the Medical Community learn about health issues and available treatments. Education and information about Baxter and its products, therapies and services may sometimes involve communications by people who have large followings on social media (Social Media Influencers). When a Social Media Influencer is also a member of the Medical Community (Medical Community Influencer), this Policy also applies.
Engagements: Engagements with Medical Community Influencers must meet all requirements of the Consultants Section of this Policy and be permitted by local regulations regarding promotion. Work product is viewed by Baxter as a paid endorsement, and must be specifically defined in advance. Compensation to Medical Community Influencers must reflect Fair Market Value for the services provided. Baxter does not engage Medical Community Influencers as a reward for past, present or future business.
Content and Disclosure:
- All posts and endorsements must be (1) appropriate for the expected audience, and (2) reviewed and approved via the AdProm Process.
- All posts must clearly disclose Baxter's involvement and support, including both financial ties and any other free items supplied to the Medical Community Influencer.
- Medical Community Influencers must possess the necessary qualifications to support the opinions expressed in their posts.
- Baxter does not engage Medical Community Influencers to conduct Scientific Exchange.
Monitoring: Before engaging a Medical Community Influencer, and periodically afterwards, the Baxter employee who is accountable for the relationship (Relationship Owner) must confirm the Medical Community Influencer's overall activities are in keeping with our expectations, and do not independently promote Baxter or its products, therapies and services or mislead readers about their relationship with Baxter. If a Medical Community Influencer fails to meet Baxter's expectations, the Relationship Owner must ensure corrective action occurs, or terminate Baxter's relationship with that Medical Community Influencer.
3. External Funding Arrangements
Purpose: Baxter recognizes that external organizations play an essential role in the broader health care community. Among other things, these organizations advance medical education for HCPs, raise awareness of important health care topics and help underserved and indigent populations. Baxter may choose to fund the projects and programs of these entities. Baxter provides three types of External Funding: (1) Contributions; (2) Independent Medical Education; and (3) Sponsorships.
General Requirements for All External Funding
Ineligible Recipients: Each type of External Funding has its own eligibility requirements, but Baxter does not provide External Funding to individuals who are members of the Medical Community or Government Officials.
No Donation of Baxter Product: Donation of Baxter manufactured or distributed products does not fall under the scope of this Policy.
Documentation: All External Funding must include written documentation between Baxter and the recipient organization that confirms the nature, purpose, date, and amount of support.
Disclosure of Baxter Involvement: Baxter's involvement must be transparent to people who rely on the programs and materials generated through its External Funding. Recipients must commit to fully and effectively disclosing Baxter's support in externally facing materials (e.g., written works, websites, programs, etc.) and complying with local laws or reporting regulations.
Proper Classification: Organizations requesting External Funding may follow naming conventions that differ from Baxter's. For example, an organization may request a "Sponsorship" to fund a proposal that this Policy would classify as Independent Medical Education. Baxter employees who approve External Funding transactions must look beyond the requestor's naming convention and analyze the proposal under the appropriate Baxter rule(s). For example, a Sponsorship request that seeks funding beyond the tangible benefit (i.e., an Independent Medical Education program or separate Contribution) must be evaluated and approved under the more restrictive rules. When this occurs, the Sponsorship activity may be separated after a funding decision has been made so that Sales and Marketing employees may participate, as appropriate, in the activities associated with the approved Sponsorship portion.
Purpose and Legitimate Need: Non-profit organizations that do important work, such as providing Patient education and performing health-related services in the communities they serve, sometimes ask Baxter for Contributions to support their programs and activities. Baxter may fund Contribution requests based on a legitimate need to advance medical science and/or Patient care in therapeutic areas that Baxter serves.
Appropriate Recipients and Scope of Support: Where allowed by local law and/or industry associations, Baxter may provide money or in-kind Contributions (including non-Baxter products and/or services) to educational institutions, not-for-profit or charitable HCOs and Patient Organizations to support their missions, goals and programs.
Contribution Management Committees (CMC): For all Contribution requests involving members of the Medical Community, the local (country, cluster or regional) CMC has decision‐making authority. Each CMC has three voting members: a representative from the Worldwide Medical, Finance and Legal departments.
Scholarships: Baxter's funding may be used to support scholarships to attend an educational program for medical, pharmacy or nursing students, residents and fellows only. The request must be submitted by the HCO that selects the scholarship beneficiary or that plans the event. In such cases, Baxter may not directly or indirectly influence the selection of, or make payment to, the scholarship beneficiary.
Limitations of Allowable Funding: Each CMC has discretion to decide the best allocation of funding in the countries, clusters and regions it serves. Some Contributions, however, are specifically prohibited. These include:
- Baxter funding cannot cover activities that are expected to be covered by the recipient's regular budget.
- Baxter cannot fund requests to support purely social events, events that have already occurred, or fund requests to pay, offset or reimburse a particular Patient's care or treatment.
- Contributions may not be given, directly or indirectly, to promote Baxter's products, therapies or services, or to reward individuals or organizations for past, present or future business.
3.2 Independent Medical Education
Purpose and Legitimate Need: Independent Medical Education helps HCPs to obtain information and insights that can improve patient care. When Baxter determines an externally organized educational activity is worthwhile, it may choose to support the activity with External Funding. Events may be funded only on the basis of a legitimate scientific or medical educational need.
Appropriate Programs: Baxter funds bona fide Independent Medical Education programs that focus on therapeutic areas and disease states of interest to the company. If treatments will be discussed, the program should present a full range of options and must not focus solely on Baxter products, therapies or services.
Independence: The educational program must be independent of Baxter, meaning it must be completely controlled by the organization carrying out the event (Program Organizer). Baxter cannot control or influence the program objectives, program content, faculty or authors. Baxter should not provide advice or guidance on these matters, even if asked by the Program Organizer to do so.
Decision Making by Worldwide Medical: Decisions regarding whether an Independent Medical Education program qualifies for funding must be made by Worldwide Medical. Baxter employees who approve these programs should assess the quality of the proposed program and qualifications of the Program Organizer.
Role of Sales and Marketing: Sales and Marketing may provide advice on the broad categories of programs that may be of interest to Baxter, but should not be involved in decisions to fund particular Independent Medical Education programs. If the Program Organizer requests Baxter's support in informing potential attendees about the event, Baxter Sales may disseminate the Program Organizer's materials without discussing the content.
Use of Baxter Funding: Baxter funding may be used by the Program Organizer to cover reasonable expenses including travel, lodging and honoraria for moderators, speakers and presenters. Baxter may not directly pay for or arrange such honoraria, travel or lodging for speakers and presenters, or pay for entertainment.
Meals: Any food and beverage provided to attendees by the Program Organizer must be modest and must not take precedence over the educational component of the program. Such expenses must be part of the costs set out in the budget submitted with the funding request.
Baxter Support for HCP Attendance: Baxter aims to fund programs, not participants, and its support is expected to be used by the Program Organizer to defray costs for all attendees. In limited circumstances, Baxter support may be used to fund individual HCP attendees either directly or indirectly. Whether this support is permitted is a question of local law and industry practice.
Direct HCP Support: Where permitted by and consistent with local law and/or industry codes, and supported by a legitimate need for an HCP to receive medical training/education, Baxter may directly support HCPs' attendance at an Independent Medical Education program related to disease states of interest to Baxter. The selection process to support HCPs must be conducted by Worldwide Medical. Under no circumstances can the selection of HCPs be linked to prescription, recommendation, use or purchase of Baxter products or therapies.
Indirect Support: Where direct HCP support is prohibited by local law and/or industry codes, Baxter funding may be used to allow qualified HCPs to attend the Independent Medical Education, provided that Baxter does not select or control the selection of the specific HCPs who will benefit.
Purpose and Legitimate Need: Some External Funding opportunities involve more than a simple Contribution from Baxter. Sponsorships are worthwhile External Funding opportunities where Baxter receives something of value in exchange for its support. To qualify for Sponsorship funding, the requestor’s proposal must advance a legitimate Baxter funding purpose (e.g., advancing medical education, training HCPs, raising Patient and public awareness on important health care topics, helping underserved or indigent populations, etc.).
Tangible Benefit: The value Baxter receives in exchange for its Sponsorship may include access to data, participation rights, a promotional or other public relations opportunity, etc. For example, a Sponsorship may promote or advance a valid Company interest, allow Baxter to participate in an organization, give Baxter access to information or data, or permit Baxter to educate customers about our products, therapies, and services through advertising, exhibit space, satellite symposia, etc.
Appropriate Recipients: Baxter can provide Sponsorship funding to both for-profit and not-for-profit entities.
Sponsorship Amount: The support provided by Baxter should reflect a commercially reasonable fee in exchange for the tangible benefits Baxter receives in exchange for its support.
Commercial Involvement: Because Sponsorships can include commercial rights, Sales and Marketing employees may participate in funding decisions, and might be invited to participate in the funded activity. This participation is governed by Baxter's established commercial practices, including:
- No Inappropriate Promotion: Baxter may not provide Sponsorship funding to support the recipient having discussions or taking other actions in which Baxter could not directly engage.
- Sharing Materials: Materials shared in connection with a commercial Sponsorship must be appropriate for promotional use, and interactions must comply with Baxter’s local standards for promotion.
- Materials Created by Recipient: When a Sponsorship involves the creation of written materials and Sales and Marketing employees have been involved, AdProm Process review may be necessary to ensure any references to Baxter products are appropriate or to confirm the materials do not contain promotional content.
4. Patient Interactions
Purpose: As Patients become more active in their own care, Baxter Interactions with Patients, Caregivers and Patient Organizations have become increasingly important. Together, these activities are considered "Patient Interactions." All Patient Interactions must be ethical, transparent, and compliant with local rules and regulations.
Types of Patient Interactions: Patient Interactions may involve:
- Promotion and Education. Where allowed by local law, Baxter may speak directly with Patients and Caregivers about Baxter products therapies and services, and the diseases or conditions they treat.
- Engagements. Baxter may engage with Patients, Caregivers, or Patient Organizations for a variety of reasons, such as obtaining a better understanding of Patients’ or Caregivers’ experiences, gathering practical information about a disease or treatment, or performing services on behalf of Baxter.
- Collaborations. Baxter may work together with Patients or Patient Organizations to achieve government or commercial payor coverage, guidelines, policies, and adequate reimbursement levels that allow Patients to access its products, therapies and services.
Content Requirements for Patient Interactions: Because Patient Interactions involve communications directly with lay persons, materials we use for HCP communications may be inappropriate. For Patient Interactions, the following content restrictions apply:
- Written materials must be approved via the AdProm Process for use with Patients.
- Promotional product topics, and disease state discussions that do not mention treatments are permissible.
- Scientific Exchange discussions are not permitted.
- When conducting promotion and education directly with Patients and Caregivers, Baxter employees should be clear that the communication is promotional.
- For engagements and collaborations, the Baxter employees involved should not promote Baxter's products, therapies or services to the participants. All work product must meet local promotional standards and be approved via the AdProm Process. Participants who create content may need to be trained on Baxter’s promotional requirements.
Additional Requirements for Engagements and Collaborations: Engagements for Patients and Patient Organizations to provide services must meet the requirements of the Consultants Section of this Policy. For collaborations, the agreement should involve an equitable exchange of goods and services among the collaborators, and Baxter’s contributions must be documented and accounted for in the valuation. Where these arrangements involve an activity that is separately set forth in this Policy (e.g., Market Research, Medical Community Influencers), the requirements relevant to the specific activity also apply.
External Funding: Baxter may provide funding support to Patient Organizations in the form of Contributions and Sponsorships. These arrangements are governed by the applicable External Funding Section of this Policy, which includes a requirement that the recipient fully and effectively disclose Baxter's support in externally facing materials (e.g., written works, websites, programs, etc.), as required by local law or regulation.
Independence: When Baxter shares common interests and goals with a Patient Organization, our size, expertise and resources can enable us to contribute great value to Patient Interactions. These factors, however, can also create an atmosphere of undue influence. In all Patient Interactions, Baxter employees should maintain the independence of the funded entities and effectively manage any conflicts of interest. Each situation will be unique, but in general:
- Baxter should avoid being the sole funder of a Patient Organization.
- Baxter may not fund a Patient Organization for the purpose of having that Patient Organization conduct activities that Baxter would be prohibited from engaging in directly.
- When participating in Patient Interactions associated with Baxter's funding, Baxter employees must preserve the independence of a Patient Organization's decision making. Where Baxter or its products, therapies or services are being discussed, employees should exercise judgment and may need to recuse themselves.
Information Baxter Receives: Some Patient Interactions may result in Baxter receiving information that requires special care:
- Sensitive or Personal Information: Baxter must comply with all applicable data privacy laws and regulations. Employees must obtain explicit consent from the Patient or Caregiver prior to accepting or handling any Patient or Caregiver information, and take the necessary steps to protect it.
- Adverse Events: Patient Interactions may be more prone to participants inadvertently sharing Adverse Events. Baxter employees who engage in these activities should remain alert to ensure they meet their obligation to transmit these reports to Global Safety within one business day.
Patient Expense Reimbursement: If Patient Interactions involve Meals or Travel and Accommodation, Baxter may cover reasonable expenses of a Patient, Caregiver, or a representative of a Patient Organization under the Business Incidentals Section of this Policy.
5. Business Incidentals
Purpose: Sometimes Baxter Interactions involve meeting over a meal, or travel to a different location. Business Incidentals are any benefit that Baxter may provide to members of the Medical Community or Government Officials in connection with the Baxter Interactions outlined in this Policy. Under appropriate circumstances, the following types of Business Incidentals are permitted: (1) Meals; (2) Travel and Accommodation; and (3) Educational and Therapy-Related Items.
General Principles of Business Incidentals
Legitimate Need: Business Incidentals must be related, and secondary, to an appropriate Baxter Interaction.
Location and Venue: Location must be business appropriate. In general, Baxter does not support the use of any venue that is: (i) renowned for its entertainment facilities; (ii) associated solely or primarily with leisure, recreation or sporting activities; (iii) a tourist location in peak seasons; or (iv) extravagant or viewed as luxury. In case of doubt, approval should be sought by the line management VP or above.
Country Selection: If a Baxter Interaction involves HCPs from more than one country, Baxter can organize that interaction in a given country only when it makes logistical sense to do so because:
- Most of the invitees are based in the country where the event will be held; or
- The relevant facility or expertise center is found in the country where the event will be held.
Most Restrictive Rules Apply: Sometimes Government Officials and members of the Medical Community are subject to more restrictive rules regarding Business Incidentals. When this is the case, the most restrictive rule applies. Employees must ensure that all relevant restrictions on providing Business Incidentals are followed.
Entertainment Prohibition: Providing members of the Medical Community or Government Officials with entertainment or recreation is prohibited. Additionally, Baxter funding may not be used to support entertainment activities offered by others. This includes sponsoring purely social activities such as holiday parties, sightseeing trips or social activities offered in conjunction with an event Baxter has supported with External Funding.
5.1 Travel and Accommodation
Legitimate Need: We may, directly or through a vendor, provide Travel and Accommodation as long as it is objectively necessary for a Baxter Interaction, reasonable in cost, modest in appearance and occurs no more than 24 hours before or after the event.
Class of Service: When making arrangements for Travel and Accommodation, the most economical class of service must be selected: (i) standard or first class for rail service; (ii) economy class for air travel, with the option of upgrading up to business class for non-stop flights longer than 6 hours per segment; and (iii) standard single occupancy room in a modest business class hotel that may be booked using prearranged conference rates or Baxter-preferred hotel rates.
Expense Detail: Reasonable Travel and Accommodation expenses incurred are reimbursable upon evidence of the expense (i.e., receipt, paid invoice), including ground transportation to connect from an airport or train station to the hotel or meeting venue and reasonable business-related food and beverage expenses incurred in transit. When personal vehicles are used, the mileage allowances established by Baxter's Finance Department apply.
Written Documentation: All expenses to be reimbursed require a signed written agreement or an invitation letter in advance of travel, and, if required, prior written approval from the traveler's employer. Baxter does not invite, allow or pay for Travel and Accommodation of spouses or guests.
Defined: A Meal includes all food and beverage expenses incurred in connection with a Baxter Interaction.
Attendance and Content: A representative from Baxter must be present, and the discussion must be primarily to promote, demonstrate, inform or discuss Baxter's products, therapies or services, or other topics relevant to Baxter's business. The Meal provided must be secondary to the business/educational discussion. The most senior Baxter employee present must pay for the Meal.
Virtual Interactions: Where allowed by local law and/or industry code, Meals may be provided to HCPs during Virtual Interactions or events.
Modest: Meals must be reasonable and modest in cost by local standards.
Frequency: Meals should occur infrequently.
Alcohol: In countries allowing alcohol to be served during business Meals, consumption should be minimized, as appropriate. Accountability lies with the most senior Baxter attendee. Alcohol may never be served in a hospital or clinic setting.
Guests: Baxter does not invite, allow or pay for spouses or guests to attend a Meal, unless such person has a valid business purpose for attending. In parts of the world where allowed, a Caregiver, spouse or other family member involved in the Patient's care is considered to have a valid purpose for attending a Patient event and may partake in a Meal.
5.3 Educational and Therapy-Related Items
Permitted Items: Occasionally, and where permitted by law or applicable industry codes, we may provide an HCP a branded or unbranded item related to his or her area of treatment or practice, or a scientifically or medically related educational item.
Cost: Educational and Therapy-Related Items provided to Government Officials or members of the Medical Community must be modest and inexpensive. Check the Local Country Annex to see if further restrictions apply.
Gifts are Prohibited: Other than permitted Educational and Therapy-Related Items, no items of value may be given to members of the Medical Community or Government Officials. This includes providing any of the following:
- Goods that are not Educational and Therapy-Related Items, such as clipboard, pens, mugs or similar items with or without company logo.
- Items that can be used independent of their educational or therapy-related purpose, such as an iPad or other tablet.
- Cash or cash equivalents (e.g., such as gift cards or certificates), personal gifts, holiday gifts, gift baskets and other similar items.
Other: Any item given to an HCP’s office staff should be treated as though it was given to the HCP.
6. Facilitating Payments
Defined: Facilitating Payments are payments to Government Officials that are intended to expedite or secure the performance of routine government services or activities that Baxter is otherwise entitled to receive, such as regulatory approvals, processes related to product import or export, customs clearance, product registration and reimbursement.
Prohibition: Facilitating Payments are prohibited. These payments may not be disguised as compensation for goods, consulting or other services.
Facilitating Payments Do Not Include:
- Official and documented payments to obtain or expedite passports, visas or other government required travel documentation for Baxter employees’ and Consultants' use.
- In the extreme case of personal danger or duress, a payment to a Government Official may be made to prevent undue physical harm. Any such payment to ensure safety must be brought to the attention of the Ethics and Compliance team as soon as possible once safety is assured and must be documented accurately.
If you have any questions or are unsure about whether a payment is allowed or prohibited, please contact the local Ethics and Compliance business partner.
7. Virtual Interactions
Defined: When members of the Medical Community or Government Officials are physically present in different locations and use technology to connect, communicate, and/or deliver services to Baxter, the activity is considered a Virtual Interaction.
Documentation and Approval: Where Transfers of Value occur, Virtual Interactions are subject to the same documentation and approval requirements as in-person interactions.
Use of Devices: Baxter employees must use Baxter devices and approved IT platforms for conducting Virtual Interactions and must comply with applicable Baxter policies.
8. Exceptions to This Policy
Exceptions to this Policy require the approval of the Ethics and Compliance team and must be accurately documented.
This is a public version of Baxter’s Global Policy on Interactions with the Medical Community and Government Officials (Global Interactions Policy) which has been condensed to ensure compliance with Data privacy laws and to prevent disclosure of sensitive information.