Global Policy on Interactions with the Medical Community and Government Officials

Global Policy on Interactions with the Medical Community and Government Officials

Global Interactions Policy

Building on the foundation of Baxter's Code of Conduct and applicable laws, this policy defines the principles and rules governing our interactions with Government Officials (GO) and the Medical Community.  The Medical Community consists of Healthcare Professionals (HCPs), Healthcare Organizations (HCOs), patients, Patient Organizations, and Payors. Specifically, this policy covers five categories of interactions: (i) consultants; (ii) research activities; (iii) contributions; (iv) HCP education; and (v) business incidentals.

SCOPE AND APPLICABILITY

This policy applies to all Baxter employees, directors, officers, contractors and Third Parties when interacting with Government Officials and the Medical Community in the name or on behalf of Baxter.

DEFINITIONS

Baxter Sponsored Research: Research at all phases (clinical pre-market and post-market for drugs and devices as well as combinations) that is initiated and directed by Baxter’s Clinical, HEOR and Medical Affairs departments.

Governmental Official (GO): Any individual currently acting in any of the following capacities:

  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. 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, prescribe, lease, recommend or use Baxter products, services and therapies. This includes, without limitation, universities/medical schools, hospitals, medical clinics, contract research organizations, academic medical centers, physician groups and hospice centers, and 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, 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), medical directors, specialty pharmacy representatives, physical therapists, dentists, and veterinarians.

Investigator Initiated Research: Scientific/clinical research funded or supported by Baxter, initiated by a third-party and conducted by an investigator.

Patient Organizations: 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, managed care organization or self-insured employer.

Third Party: As defined in the Global Third Party Anticorruption Policy.

POLICY

I. Key Concepts

  • Interacting in an Ethical and Legal Manner. We are all accountable for compliance in everything we do and must ensure we do business the right way. Our interactions with the Medical Community and Government Officials must always occur in an ethical manner, in compliance with anticorruption, antibribery or other laws, regulatory requirements and industry codes. 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. Every country in which Baxter does business must prepare a Local Country Annex setting forth more restrictive and/or additional country-specific laws and/or requirements applicable to the interactions under this policy. In case of conflict between local laws and/or regulations and this policy, the more restrictive rule governs.
  • 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 treatment decisions to be based purely 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 through others, 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. 
  • 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, programs, therapies, services and informing on disease states in an appropriate manner. That means ensuring that our product promotion and 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 or confirmed; (iv) provided with fair balance to address benefits as well as risks; and (v) pre-approved through Baxter’s promotional review process.
  • Off-label promotion is strictly prohibited. Where allowed by local regulations trained professionals from the Medical Affairs department may respond to unsolicited, off-label questions from HCPs.
  • 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 the law and Baxter standards. This includes prior approval of interactions and accurate, correct and complete documentation to ensure a full understanding of the interaction and its rationale.

II. Interaction Requirements  

a. Consultants

We may engage 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.

To avoid a conflict of interest, Baxter may not engage Government Officials or their family members if at the time of the engagement they have any decision-making authority over Baxter products and/or therapies, including without limitation, purchasing, pricing, regulatory approval, custom clearance and/or bidding. 

  • Legitimate Need: Baxter must have a pre-defined and documented 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 services may not be used to promote products and/or therapies, or reward individuals or organizations for past, present or future business.
  • Choosing Consultants: Consultants must be selected based on their qualifications and expertise to satisfy the identified legitimate need. Baxter may only engage the number of consultants necessary to meet the legitimate need.  
  • Compensation: All compensation for consulting services must be reasonable and reflect fair market value for the services provided. Consultants will be paid only for services actually provided, based on completion of required deliverables. 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. Consulting payments must be processed through Baxter’s standard methods (e.g., checks, electronic transfers). Payment with cash, cash equivalents such as gift cards or other items of value is not allowed.
  • Travel Time: Travel time may be compensated at half the contracted fair market value hourly rate, with the total amount of travel time compensation not to exceed the amount paid for the actual service(s).   
  • 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, these must be made in advance of services starting.
  • Written Agreement: All consulting arrangements require a written agreement that is 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.

Facilitating Payments

Facilitating payments are prohibited. These are payments to Government Officials that are used to bribe, expedite or secure the performance of routine government services or activities to which Baxter is otherwise entitled to receive, such as regulatory approvals, processes related to product import or export, customs clearance, product registration and reimbursement. These payments should not be disguised as compensation for consulting services.

Facilitating payments do not include official and documented payments to obtain or expedite passports, visas or other government required travel documentation for employee and HCP 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 recorded. 

If you have any questions or are unsure about whether a payment is allowed or prohibited, please contact the Ethics and Compliance team.

b. Research Activities

Scientific research and discovery is essential to Baxter’s success. This includes both research initiated by Baxter (Baxter Sponsored Research) and research that is initiated by an external party and funded or supported by Baxter (Investigator Initiated Research or IIR). In addition to the requirements below, all scientific research must be conducted consistent with applicable established processes and compliant with local regulations. 

(i) Baxter Sponsored Research 

  • Purpose: Baxter Sponsored Research (pre-market and post-market for drugs, devices and combinations) is initiated by Baxter and intended to answer legitimate scientific questions about the efficacy, safety, efficiency or utilization of Baxter products, or otherwise to advance the science in our therapy areas. Baxter Sponsored Research is not conducted as a means to promote Baxter’s products and/or therapies, or to reward individuals or organizations for past, present or future business.
  • Oversight: The Clinical, HEOR and/or Medical Affairs departments are responsible for Baxter Sponsored Research activities, and must ensure adherence to applicable regulations (Good Clinical Practices, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, etc.) and adequate oversight of the research relative to key milestones and the written research plan or protocol. The research results or other deliverables must be received and analyzed by or on behalf of Baxter’s Clinical & HEOR departments.
  • Written Agreement: The terms of all Baxter Sponsored Research must be documented in a written agreement (including the written research plan or protocol) and signed by all parties before the research starts and before any payment is issued.

(ii) Investigator Initiated Research (IIR) 

  • Purpose: Investigator Initiated Research (IIR) is research that is funded or supported by Baxter. For an IIR, an investigator who is not an employee of Baxter initiates the research and takes responsibility for the conduct and oversight thereof. 
  • Decision-Making Authority: Decisions regarding funding or support for IIRs must be made by and under the direction of Baxter’s Medical Affairs department, based upon the scientific merit of the proposed project and the potential clinical usefulness of the data expected to be generated by the study. Baxter does not support research that is without significant scientific merit, or as a means to promote Baxter’s products and/or therapies, or to reward individuals or organizations for past, present or future business.  Communication about the research between the Investigator(s) and Baxter should be done via Medical Affairs department.
  • Allowable Recipients: Only legal entities are eligible to receive IIR support from Baxter; individuals are not. 
  • Written Agreement: The terms of all Baxter supported IIR must be documented in a written agreement and signed by all parties before the research starts and before any payment is issued.
  • IIR Requests: All IIR support must be documented in a request from the investigator or research institution directly to the Medical Affairs department. There must be a written research plan (protocol) in English that addresses the essential elements of the research.
  • Allowable Funding/Support: Baxter may provide reasonable funding for, or support IIRs, by providing free products and therapeutics, and specialized services. Such funding or support can be used to cover: (i) direct study costs; (ii) indirect study costs; (iii) modest and reasonable travel expenses related to study updates and poster presentations, as long as they are budgeted and noted in the agreement; and (iv) equipment (provided by Baxter or leased through a third party) as long as it is returned once it is no longer needed for the study. 
  • Disclosure of Funding or Support: All Baxter funding or support of IIR must be fully and accurately disclosed in any publication or presentation of the research.

c. Contributions

Baxter may provide money, in-kind contributions (including non-Baxter products and/or services) to not-for-profit or charitable HCOs, for-profit HCOs and/or Patient Organizations, to support their missions, visions, goals and programs. 

  • Contribution Management Committees (“CMC”): For all contribution requests, the local (country, cluster or region) CMC has the decisionmaking authority. Each CMC has three voting members: a representative from Medical Affairs, Finance and Legal departments.
  • Legitimate Need: Contribution requests may be funded to advance medical science and/or patient care in therapeutic areas that Baxter serves. The 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.
  • No Connection to Sales: Contributions may not be given as a means to promote Baxter’s products and/or therapies, or to reward individuals or organizations for past, present or future business.
  • Appropriate Recipients: Contributions may not be given to individual members of the Medical Community or to Government Officials. 
  • Documentation: All contributions require written documentation between Baxter and the recipient, confirming the nature, purpose and amount of support.
  • 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 engages 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.
  • Product Donation: Donation of Baxter manufactured or distributed products does not fall under the scope of this policy and is governed by the Global Product Donation Policy.

d. HCP Education 

We may provide HCPs with the following types of education, as described below: (i) Baxter Educational Programs, and (ii) Third Party Organized Educational Programs.

(i) Baxter Educational Programs

Baxter Educational Programs mean educational and training activities related to our products and therapies that are planned, managed and/or executed by Baxter.

A written invitation letter or an agreement, confirming the purpose, type and amount of support, is required for Baxter educational programs. 

  • Baxter Promotional and Informational Educational Programs

Baxter educational programs which enable HCPs to get familiar with and form their independent opinion on the safe and effective use of our products, services and therapies, as well as disease state and diagnosis information, are promotional activities and must follow good promotional practices. They may be planned, managed and/or executed by several functions including Baxter’s Marketing, Sales, Government Policy, Advocacy and Reimbursement departments. Medical Affairs or other Baxter teams may participate in these activities and contribute as appropriate. 

  • Baxter Scientific Educational Programs

Baxter educational programs which provide scientific information to HCPs about research and clinical trials, disease state and diagnosis information, whether or not related to Baxter products and therapies, are non-promotional activities and must be: (i) medically and scientifically rigorous; (ii) objective, accurate, unbiased and appropriately validated; and (iii) provided with fair balance, complete and without material omissions of relevant information. They are planned, managed and/or executed under the oversight of Baxter’s Medical Affairs department. Other Baxter teams including Baxter’s Marketing, Sales, Government Policy, Advocacy and Reimbursement departments may participate in these activities and contribute as appropriate.

(ii) Third Party Organized Educational Programs

Baxter may support third party organized educational activities (i.e., sponsorship of the activity, direct or indirect sponsoring of HCPs to attend a medical or scientific congress). 

  • Independence: The educational program is independent of Baxter, meaning it is completely controlled by the organization carrying out the event. Baxter cannot control or influence the program objectives, program content, faculty or authors.   
  • Legitimate Educational Need: Events may be funded only on the basis of a legitimate scientific or medical educational need, as documented by the organizing third party, and in the therapeutic areas relevant to Baxter.
  • Direct Sponsorships of HCPs to Third Party Organized Educational Programs: In many countries either local laws and/or industry codes by which Baxter is bound do not allow direct sponsorship of HCPs to Third Party Organized Educational Programs. Where permitted by local law and/or industry codes, Baxter may directly sponsor HCPs’ attendance to a medical conference or congress related to Baxter’s products or therapy areas if there is a legitimate need for medical training/education. The selection process to choose HCPs to sponsor must be fair and transparent. Under no circumstances can the selection of HCPs be linked to prescription, recommendation, use or purchase of Baxter products or therapies.
  • Speakers at Third Party Organized Educational Programs: Baxter funding may be used by the organizing third party to cover reasonable travel, lodging and honoraria for moderators, speakers and presenters. Baxter may not directly pay for or arrange such honoraria, travel or lodging.   
  • Meals and Receptions: Any receptions or meals provided to attendees by the organizing third party must not take precedent 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.  

e. Business Incidentals

Business Incidentals are any benefit that Baxter may provide to members of the Medical Community or Government Officials in connection with the other interactions: consultants, research activities, contributions and HCP education; or as a standalone benefit. These include meals; travel and accommodation; and educational, scientific and therapy related items.

(i) General Principles of Business Incidentals

  • 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.

Baxter can organize consulting activities, HCP educational programs or research related activities 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.

 

  • 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 third parties. This includes sponsoring purely social activities such as holiday parties, sightseeing trips or social activities offered in conjunction with a Baxter supported event.

(ii) Types of Business Incidentals

Travel and Accommodation

  • We may, directly or through a third party, provide travel and accommodation as long as it is reasonable in cost, modest in appearance and provided no more than 24 hours before or after the duration of the event.
  • When making travel arrangements, the most economical option or 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 transcontinental flights longer than 6 hours; and (iii) standard single room in a business class mid-scale hotel which may be booked using prearranged conference rates or Baxter-preferred hotel rates. Reasonable travel expenses incurred are reimbursable upon evidence of the expense (receipt, paid invoice, etc.), including ground transportation to connect from an airport or train station to the hotel or meeting venue, and applicable mileage allowances when using personal vehicles at the rate established by Baxter’s Finance Department.
  • All travel arrangements or expenses to be reimbursed require a written agreement that is signed by all parties in advance of travel, and, if required, written approval from the traveler’s employer. Baxter does not invite, allow or pay for travel and accommodation of spouses or guests.

 

Meals

  • Attendance and ContentA representative from Baxter must be present at the meal, and the discussion must be primarily to promote, demonstrate, inform or discuss Baxter’s products, therapies, programs or services, or other topics relevant to Baxter’s business. The meal provided must be secondary to the business/educational discussion. 
  • Modest: Meals must be reasonable and modest in cost by local standards.
  • Frequency: Meals should occur infrequently (generally no more than once a month with any individual HCP). 
  • 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 business meal, unless such person has a valid business purpose for attending. In parts of the world where allowed, a patient’s 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 business meal.

 

Educational and Therapy Related Items  

  • Medically/Scientifically Related: Occasionally, we may give a member of the Medical Community a branded or unbranded item related to his or her area of treatment or practice, or a scientifically or medically related educational item.
  • Cost: Where permitted, educational or therapy related items provided to the Medical Community must be modest and inexpensive.
  • Prohibited Items: Providing gifts to members of the Medical Community and Government Officials is prohibited. Giving cash or cash equivalents, such as gift cards or certificates, personal gifts, holiday gifts, gift baskets and other similar items, is not permitted. Items that can be used independent of their educational or therapy related purpose, such as an iPad or other tablet, are also prohibited.

 

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.