ADVAMED CODE OF ETHICS ON INTERACTIONS WITH HEALTH

ADVAMED CODE OF ETHICS ON INTERACTIONS WITH HEALTH CARE PROFESSIONALS

IN INDIA

ADOPTED BY THE ADVAMED BOARD OF DIRECTORS

Effective October 1, 2021

SECTION I – INTRODUCTION

The Advanced Medical Technology Association (AdvaMed) is a global trade association of companies that develop, produce,

manufacture, and market medical devices and products, technologies, digital and software platforms, and related services,

solutions, and therapies used to diagnose, treat, monitor, manage, and alleviate health conditions and disabilities.

The AdvaMed India Executive Committee is an India-based AdvaMed governance group that consists of AdvaMed member

companies’ most senior company executives in India.

The India Executive Committee recognizes the obligation to facilitate ethical interactions between companies, health care

professionals and health care institutions involved in the provision of health care services and/or items to patients in India.

We are dedicated to advancing medical science; developing high quality, innovative medical technology; and improving

patient care.

The Value of Interactions with Health Care Professionals

A health care professional’s first and highest duty is to act in the best interests of their patients. Medical technology

companies help health care professionals meet this duty through necessary, collaborative interactions without interfering with

their professional autonomy and the autonomy of the medical institutions that the health care professionals may be

associated with.

Companies and health care professionals collaborate to advance medical care and clinical science through

research, product development, and product testing that results in new or improved, innovative medical

technology

Companies instruct, educate, and train health care professionals on the safe and effective use of complex

Medical Technology

Companies provide product service and technical support for health care professionals to help ensure the safe

and effective use of Medical Technology

Companies support health care professionals’ scientific and medical research, as well as the enhancement of

clinical skills and educational opportunities to improve patient care

Companies promote charitable giving of medical technologies and public awareness of medical and health

conditions through grants and donations in support of compassionate usage and patient education

The Purpose of the AdvaMed India Code & Its Cornerstone Values

The AdvaMed India Code (“the Code”) provides medical technology companies with guidance on ethical interactions and

relationships with health care professionals based on the following cornerstone values:

Companies should review all interactions with health care professionals in light of these values and should always avoid

interactions designed to circumvent the Code. The Code may be silent on a specific interaction or may not address all aspects

of an interaction with a health care professional. All interactions between companies and healthcare professionals should

comply with applicable laws, guidelines and codes. The Code is intended to help companies make reasonable and appropriate

decisions that align with the Code’s values.

Companies and their employees, agents and representatives should be mindful of their interactions and the perception of

their interactions with health care professionals. Companies should communicate company policies consistent with the Code

to their employees, agents and representatives with the expectation that they will comply.

Scope and Applicability of the Code

Legal Principles

The Code does not provide legal advice or create legal rights or obligations.

Geographic

Reach

The Code applies to all company interactions with India health care professionals, whether occurring

inside or outside India (such as at a conference or other event).

INNOVATION

EDUCATION

INTEGRITY

RESPECT

RESPONSIBILITY

TRANSPARENCY

Advance the development and availability of safe and effective medical

technology that health care professionals use to improve and save lives

Deliver high-quality training and education to help ensure that health

care professionals safely and effectively use medical technology

Conduct business with integrity at all times and avoid real or perceived

conflicts of interest with health care professionals

Respect the independent clinical judgment of health care professionals

to decide the best manner and method for treating patients

Promote socially and ethically responsible business practices that

protect patients, their rights and their safety

Conduct interactions with health care professionals fairly, openly and

transparently

Interactions

with Health Care

Professionals

The Code applies to a company’s interactions and a company’s employees’, representatives’, and

agents’ interactions with India health care professionals, even if an employee or representative or agent

pays for the interaction’s associated costs himself/herself.

Representatives

A company adopting the Code is required to communicate the Code’s provisions to its employees,

agents, representatives, dealers, distributors, vendors, independent consultants acting on a company’s

behalf and to any other health care professionals engaged by or affiliated with a company with the

expectation that they will adhere to the Code.

Multiple

Business Lines

Companies with different business lines (for example, medical devices, pharmaceuticals, biologics,

consumer items, and/or research-only products) may have other industry codes that apply to such

different businesses. This Code applies to companies’ interactions with the healthcare professionals

linked to medical technology.

Combination

Products

The Code also applies to all interactions with India health care professionals related to combination

products that include a medical technology component (for example, those that are both biologics and

devices or drugs and devices), which may also be subject to other trade association codes.

Complying with the AdvaMed India Code

The Code does not replace any applicable laws, regulations, or codes as notified from time to time that may contain stricter

requirements. The Code requires companies to comply with all applicable laws, regulations, and codes. Companies are strongly

encouraged to adopt an effective ethics and compliance program aimed at (1) promoting an organizational culture that

encourages ethical practices and a commitment to comply with the applicable law, guidelines and codes and (2) preventing

and detecting inappropriate conduct. Programs should be appropriately tailored for each company.

For assistance in evaluating a compliance program’s effectiveness, companies may consider referring to government-issued or

other industry guidance on what constitutes an effective compliance program. Elements of an effective compliance program

can include:

All medical technology companies doing business in India are strongly encouraged to adopt and certify to this Code and to

implement an effective compliance program.

A company that wishes to certify to the Code is required to submit to AdvaMed an annual certification that the company has

adopted the Code and has implemented a compliance program designed to uphold the principles of this Code. This

certification must be signed by the most senior executive responsible for the company’s medical technology operation in

India. For companies headquartered in India, this would be the Chief Executive Officer or individual with equivalent

responsibility within the certifying company. For companies headquartered outside of India, this would be the most senior

representative of the certifying company’s medical technology operation in India. This certification must additionally be signed

by the company’s Chief Compliance Officer for India or individual with equivalent responsibilities within the certifying

company.

COMMITMENT

TO ETHICAL

CULTURE

✓ Board & senior

management are

knowledgeable

about and oversees

the compliance

program

✓ Individuals in

leadership with

overall

responsibility for

the compliance

program

✓ Compliance

personnel with day-

to-day program

responsibility,

including

appropriate Board

access and

reporting

✓ Retention of

personnel who

have not engaged

in conduct

inconsistent with

an effective

compliance

program

ELEMENTS OF AN EFFECTIVE COMPLIANCE PROGRAM

Effective training,

education and

communication

Appropriate

oversight and

management of

the compliance

program

Standards

enforced through

disciplinary action

Prompt

response to

detected problems

and corrective

action undertaken

Written policies

& procedures that

incorporate and

foster compliance

with the Code

Internal risk

assessments,

monitoring, and

auditing

Effective lines of

communication

(including an

anonymous

reporting

hotline)

AdvaMed will publish on its website a list of those companies that have submitted this annual certification. As part of this

certification, companies must supply contact information for the company’s compliance program or an anonymous hotline to

facilitate reporting of possible violations of the Code. AdvaMed will publish on its website the contact information supplied by

each company.

Glossary

Advertisements

Any activity undertaken, organized or sponsored by a company which is directed at health care

professionals to promote the safe and effective use of medical technology.

Commercial

Sponsorship

A payment or in-kind support provided to a third party in exchange for advertising or promotional

opportunities for a company (for example, a company exhibit at a third-party program).

Company

A company that develops, produces, manufactures and/or markets medical technology.

Educational Grant

A payment or in-kind support to a third-party entity (for example, a third-party program organizer,

training institution or health care organization) to reduce the costs of providing education. An

educational grant is not offered for commercial sponsorship opportunities.

Health Care

Professional

A health care professional is any person or entity (a) authorized or licensed in India to provide

health care services or items to patients or (b) who is involved in the decision to purchase,

prescribe, order, or recommend a medical technology in India. This term includes individual

clinicians (for example, physicians, nurses, and pharmacists, among others), provider entities (for

example, hospitals and ambulatory surgical centers), and administrative personnel at provider

entities in India (for example, hospital purchasing agents). This term does not include health care

professionals who are bona fide employees of a company, while acting in that capacity.

Medical Technology

Medical technology is a broad term that means medical devices and products, technologies, digital

and software platforms, and related services, solutions, and therapies used to diagnose, treat,

monitor, manage, and alleviate health conditions and disabilities. Some examples include:

• Implantable medical devices that are placed in or on the human body to replace, repair, or

strengthen a body part;

• Surgical devices used to perform procedures;

• Digital technology and software platforms that assist in monitoring, diagnosing, and treating

patients; and

• Non-invasive reagents, instrumentation, and/or software to aid in the diagnosis and treatment

of patients; among other technology.

Modest

Moderate value; may differ depending on the local standards and the purpose.

Occasional

An interaction is considered occasional if it occurs infrequently and not on a routine basis.

Satellite Symposium

A satellite symposium is a company-organized and funded program that is appended to a third-party

program agenda but that the third-party organizer does not control. These programs often take

place during meal breaks at the third-party program and may address education and training topics

that coincide with the third-party program’s focus.

A satellite symposium does not include a company-organized meeting, training, or educational

session (such as an advisory board, consultant meeting, or product education session) that (a) may

be held in close physical and temporal proximity to a third-party program and (b) is not appended to

or included in the third-party program’s official agenda.

Third-Party Program

A bona fide, independent health care-related educational, scientific, business, and/or policymaking

conference, meeting, or event put on by a third party other than a company. This term includes

programs that are accredited to provide continuing education credits and programs that are not

accredited.

Third-Party Program

Organizer

A third-party entity that organizes and/or oversees the development of the third-party program,

including the selection of presenters, attendees, topics, materials, and methods. A third-party

program organizer could include, for example, a health care professional society, institution,

association, medical trust fund, continuing medical education provider, hospital or other health care

entity.

Consigned Products

Medical technologies (a) that a company provides to a health care professional for use in and

storage at the health care professional’s patient care setting and (b) to which the company retains

title until the product is used.

Demonstration &

Evaluation Products

Products provided to health care professionals at no charge to assess the appropriate use and

functionality of the product and determine whether and when to use, order, purchase, or

recommend the product in the future. Company products that may be provided to health care

professionals for such assessment include single use (for example, samples of consumable or

disposable products) and multiple use products (sometimes referred to as capital equipment).

SECTION II – CONSULTING ARRANGEMENTS WITH HEALTH CARE PROFESSIONALS

A. Engaging a Health Care Professional to Provide Consulting Services

Companies engage health care professionals to provide a wide range of valuable, bona fide consulting services. Some

examples include arrangements for a health care professional to provide education and training, speaking services,

proctorships (evaluate), preceptorships (instruct), reference center or center of excellence services, participation on advisory

boards or focus groups, medical technology development and research services arrangements (such as research and

development, clinical studies, clinical investigator services, collaborative research, and post-market research), and

arrangements for the development or transfer of intellectual property.

Companies should apply the following principles to all consulting arrangements with health care professionals:

• Legitimate Need. Companies should enter a consulting arrangement with a health care professional only if the

company has identified a legitimate need for the health care professional’s services in advance.

• Consultant Selection. Companies should select only duly vetted health care professionals to serve as consultants,

based on the health care professional’s qualifications to meet the identified need. Some examples of these

qualifications include the health care professional’s specialty, years of experience, location, practice setting, clinical

research experience, podium presence, speaking and publication experience, or experience with, usage of, or

familiarity with a specific medical technology, among other qualifications. Companies may not select or compensate

consultants as a reward for past usage or as an unlawful inducement for future purchases. Companies should

implement safeguards so that consultants are not selected based in whole or in part on sales considerations.

• Number of Consultants. Companies should engage only as many consultants as are necessary to fulfill the

requirements for the bona fide services.

• Fair Market Value Compensation. Companies should compensate consultants consistent with the fair market value in

an arm’s length transaction of the services provided. Companies should not base compensation on the volume or

value of the consultant’s business generated by the consultant in the past, present or expected in the future.

Companies should confirm that the services performed by the consultant are in accordance with the agreement.

• Expenses. Companies may pay for documented, reasonable, and actual expenses incurred by a consultant that are

necessary to carry out the consulting arrangement, such as costs for travel, lodging, and modest meals. See Sections VI

and VII of the Code for information on providing travel, lodging, and meals to health care professionals.

• Written Agreement. Companies should enter into written agreements that describe all consulting services to be

provided and the compensation to be paid in exchange for the services. Such agreements with the healthcare

professionals should be fully transparent and disclosed (when required to do so by the appropriate authority), should

ensure that the professional integrity and freedom of the health care professionals are maintained and that the patients’

interest is not compromised. When a company contracts with a consultant to conduct clinical research services, there

should also be a written research protocol.

• Sales Involvement. Sales personnel cannot control or unduly influence the decision to engage a particular health care

professional as a consultant. Companies’ sales personnel may provide input about the qualifications of a proposed

consultant. Companies should consider implementing appropriate controls to promote compliance with this section.

B. Royalties

Arrangements involving the payment of royalties to health care professionals should meet the standards listed in this section

of the Code.

Health care professionals often make valuable contributions that improve products or medical technologies. They may

develop intellectual property (for example, patents, trade secrets, or know-how), under a product or technology development

or intellectual property licensing agreement.

Companies should enter a royalty arrangement with a health care professional only if the health care professional (individually

or as part of a group) makes a novel, significant, or innovative contribution to the development of a medical technology or a

combination product, process, or method, subject to intellectual property protections. A significant contribution by an

individual or group, if it is the basis for compensation, should be appropriately documented.

Companies should base the calculation of royalties payable to a health care professional in exchange for intellectual property

on factors that preserve the objectivity and autonomy of medical decision-making and avoid the potential for improper

influence. For example, a company should not condition royalties paid in exchange for intellectual property on: (1) a

requirement that the health care professional purchases, orders or recommends any use of medical technology of the

company or technology produced as a result of the development project; or (2) a requirement to market the technology upon

commercialization.

Companies are strongly encouraged to consider whether it is appropriate and practicable to exclude from the calculation of

royalties the number of units purchased, used, or ordered by the individual health care professional and/or members of the

health care professional’s practice.

C. Clinical Studies & Research Arrangements

Arrangements that involve clinical research services by a health care professional in return for compensation are also a type of

consulting arrangement, subject to the principles in this section of the Code. The clinical program for which the services are

being provided should fulfill a legitimate research purpose, should have due permissions from the competent authorities, and

should be transparent. A written services agreement should govern these arrangements, and companies should base

compensation on the fair market value of the services provided.

A clinical study agreement typically is entered between a company and a health care professional that is a facility, institution,

or practice group, and compensation for the clinical research services is paid to that entity. An individual health care

professional may act as a study investigator but also provide related services in his or her individual capacity that is outside the

scope of the services covered in the clinical study agreement (e.g., protocol development, delivering education and

presentations on the company’s behalf, etc.). In that case, companies are strongly encouraged to enter a separate consulting

arrangement with that individual health care professional.

SECTION III – COMPANY-CONDUCTED PROGRAMS & MEETINGS WITH HEALTH CARE

PROFESSIONALS

Companies have a legitimate need to conduct training and education for health care professionals and to hold other important

business meetings with health care professionals.

A. Company-Conducted Training & Education

Companies have a responsibility to train and educate health care professionals on their medical technologies, the procedures

in which these medical technologies are used, and other related information:

✓ Medical technology may involve complex equipment, devices, and/or sophisticated software platforms that require

technical instruction.

✓ Medical technology may have a new procedure of insertion and deployment technique and may require sufficient

hands-on experience before application on patient.

✓ Medical technology may require analysis of new monitoring parameters.

✓ Medical technology may include breakthrough innovations.

✓ Procedures in which medical technologies are used may be complex and require skilled clinical instruction.

✓ Health care professionals need training and education on disease states and treatment options, patient selection

criteria, clinical treatment standards and outcomes, care pathways, and how medical technologies benefit certain

patient populations, among other important topics.

All of this information contributes to the safe and effective use of medical technology.

Companies should apply the following principles when conducting training and education programs concerning medical

technologies for health care professionals:

• Setting. Companies should conduct live or virtual training and education programs in modest settings that are

conducive to the effective transmission of information. These may include clinical, educational, conference, or other

center of excellence developed by the company for such purposes, either in country, offshore, or other settings such

as hotels or other commercially available meeting facilities. It could also include the health care professional’s

location. Programs providing hands-on technical training and instruction on medical technologies (for example, a

cadaver lab) should be held at training facilities, medical institutions, laboratories, or other appropriate facilities.

• Faculty. Companies should only engage faculty that have the proper qualifications and expertise to conduct the training

or education. This may include health care professionals or qualified company employees (including field sales staff)

who have the technical expertise and experience necessary to perform the training.

• Attendees. Health care professionals must have a legitimate need to attend a company-conducted training or

education program (for example, the need to obtain technical instruction on how to use a new medical technology

• Travel & Lodging. See Section VI of the Code for more information on providing travel and lodging to health care

professionals to attend a company-conducted training or education program.

• Meals & Refreshments. See Section VII of the Code for information on providing meals and refreshments to health

care professionals attending a company-conducted training or education program.

• Documentation. Companies are required to maintain documentation of the training to demonstrate that the purpose

of the training has been sufficiently met. Documentation may include copies of the agenda, training content,

photographs, attendees and any other such record.

B. Company Business Meetings

Companies may identify a legitimate need to conduct other types of business meetings with health care professionals to

discuss, for example, medical technology features, sales terms, company service offerings and their impact on health care

delivery, product line offerings, health economics information, feedback and advice on medical technologies or purchase

contract arrangements. Other examples could include plant or facility tours, meetings to demonstrate equipment, or meetings

to explore product development or clinical testing needs.

Companies should apply the following principles when organizing and conducting business meetings:

• Legitimate Need. Companies must have a legitimate need to conduct the meeting. For example, a company may

identify a need to show health care professionals how they make medical technologies, their quality control systems,

or other aspects of their manufacturing processes through a plant tour.

• Setting. Companies may hold meetings at or close to a health care professional’s place of business or facility; another

centralized location; or at a company’s own facility or business centers that may be a more appropriate setting for the

meeting, depending upon the topics discussed. In all instances, the setting for a company-conducted program or

meeting must be conducive to the discussion of relevant information.

• Attendees. Each health care professional in attendance must have an objective, legitimate need to attend a company’s

business meeting.

• Travel & Lodging. See Section VI of the Code for information on providing travel and lodging to health care

professionals attending a company’s business meeting.

• Meals & Refreshments. See Section VII of the Code for information on providing modest meals and refreshments to

health care professionals attending a company’s business meeting.

• Documentation. Companies are required to maintain documentation of the meeting to demonstrate that the purpose

of the meeting has been sufficiently met. Documentation may include copies of the agenda, meeting content,

photographs, attendees and any such record.

SECTION IV – EDUCATIONAL & RESEARCH GRANTS, CHARITABLE DONATIONS, COMMERCIAL

SPONSORSHIPS

Companies provide monetary, in-kind, and other contributions to third parties in support of their educational, scientific,

charitable, and research programs.

Companies can support these programs for many valid reasons, such as advancing medical education and training for health

care professionals, raising patient and public awareness on important health care topics, helping underserved or indigent

populations through bona fide charitable programs, or funding independent scientific or clinical research.

A. Supporting Third-Party Programs Through Educational Grants and Commercial Sponsorship

Third-party programs allow companies to support health care professional- and patient-related training and education to

participate in clinical, research and scientific exchanges related to their medical technologies and to demonstrate the safe and

effective use of their products, services and technologies.

Companies should apply the following principles when supporting third-party programs through educational grants and/or

commercial sponsorship:

SUPPORTING

THIRD-PARTY

PROGRAMS

THROUGH

EDUCATIONAL

GRANTS

Companies may provide an educational grant in support of a third-party program directly to the third-

party program organizer or, in some instances, to a training institution, health care professional

association or other entity designated by the third-party program organizer.

A third-party program organizer (or training institution or designee) may use an educational grant in a

transparent manner:

✓ To defray or reduce the costs of conducting the educational components of a third-party

program

✓ To allow health care professionals-in-training (for example, medical and nursing students,

residents, and fellows) to attend the third-party program, provided that the company does not

select or control the selection of the specific health care professionals-in-training who will

benefit

✓ To cover the reasonable compensation, travel, lodging, and modest meals of health care

professionals who serve as bona fide faculty at the third-party program.

✓ To provide health care professionals attending the third-party program with items of value

permissible under the Code, such as modest meals, refreshments, and educational items.

Sales personnel should not control or unduly influence the decision of whether a particular entity will

receive an educational grant or the amount of the grant.

SUPPORTING

THIRD-PARTY

PROGRAMS

THROUGH

When companies provide commercial sponsorship in support of a third-party program, the level of

commercial sponsorship should reflect the fair market value of the benefits received by the company,

such as signage, display/ exhibit space, electricity/ audio-visual equipment/ furniture to be used in

display/ exhibit space or other opportunities to communicate/ display company specific products/

• No Support to Individuals. Companies may not provide any contribution (whether monetary or in-kind) directly to an

individual health care professional or pay directly for an individual health care professional’s registration, fees, or

travel or lodging expenses to attend a third-party program.

• Adherence to Program Standards. Companies should adhere to all standards established by the third-party program

organizer or the body accrediting the third-party program, as applicable.

• No Direct Sponsorship. Direct sponsorship of a health care professional to a third-party program is not permitted.

Companies are not permitted to pay, offer to pay or offer to reimburse any expense (e.g., travel, stay, local travel,

honorarium etc.) in support of attendance of health care professionals to third-party programs as faculty. Companies

must also preserve the independence of third-party programs and must not select or influence selection of health care

professional attendance to third-party program. Companies may engage health care professionals under a

professional services agreement for a company-conducted satellite symposium held alongside third-party programs

and may compensate in accordance with fair market value. Travel and lodging should be considered only if the health

care professional is travelling solely for the satellite symposia.

B. Supporting Other Third-Party Programs through Educational Grants

Companies may provide educational grants to training institutions (such as medical schools and teaching hospitals) and to

other third-party entities in support of their legitimate scientific, educational and training programs and other activities. This

includes, but is not limited to, educational grants to support the education and training of health care and medical personnel

(for example, physicians, medical students, residents, fellows, or other health care professionals-in-training or in practice),

patients, government officials and regulators (per approval from respective institutions and as per applicable laws and

applicable service rules), and the selected patient group/public about important health care topics.

Companies may not make an educational grant to individual health care professionals or individual health care professionals-

in-training, and companies may not select or influence the selection of the individual health care professionals who might

benefit from the company’s support.

Sales personnel should not control or unduly influence the decision of whether a particular institution will receive support or

the amount of the support.

C. Supporting Independent Third-Party Research

Supporting third-party research programs and partnering with health care professionals to advance independent research can

provide valuable scientific and clinical information, improve clinical care, lead to promising new medical technologies,

promote improved delivery of health care, and otherwise benefit patients. To help meet these objectives, companies may

provide in-kind or monetary research grants in support of independent research with scientific merit.

• Objectives & Milestones. Companies may provide support for research that has defined goals, objectives, and

milestones. Requests for research grants should be accompanied by clinical protocols that outline these objectives and

milestones. Requests for research grants should also transparently document the nature and scope of the research

COMMERCIAL

SPONSORSHIPS

technologies/ services. Companies may provide commercial sponsorship even if the company determines

not to provide the third-party program organizer with an educational grant.

activity, the budget, the approximate duration of the research, and where applicable, the requirements for

independent authorizations or approvals.

• Limitations. Research grants may include in-kind or monetary support for legitimate, study-related, documented

expenses or services and/or reasonable quantities of no-charge product for the limited duration of the research.

• Company Involvement. The recipient of a company’s monetary or in-kind research support should retain independent

control over the research.

• Company Review Processes. Companies should establish controls for reviewing requests for research grants and

ensuring that there is compliance with applicable laws, guidelines and codes and applicable service rules, if any.

• Sales Involvement. Sales personnel should not control or unduly influence the decision of who will receive support or

the amount of the support.

Company-initiated or directed research involving a company’s medical technology (such as clinical study agreements) is

addressed separately in Section II of the Code.

D. Supporting Charitable Programs through Charitable Donations

A company may make monetary or in-kind charitable donations of product or equipment for charitable purposes, such as

compassionate usage, patient or public education.

• Charitable or Philanthropic Mission. Donations should be made for bona fide charitable purposes and should be made

only to charitable organizations or other non-profit entities with bona fide charitable and/or philanthropic purposes.

Companies should exercise diligence to ensure the charitable organization or charitable purpose is bona fide. Relevant

factors to consider may include (1) the entity’s tax status, (2) the entity’s corporate status under local law, (3) whether

the organization has a charitable mission or purpose, and (4) local laws and regulations [for example the Foreign

Contributions (Regulation) Act, 2010 and the Rules made thereunder], among other factors.

• Use of Funds. Companies must require that any donation is used only towards charitable or philanthropic purposes.

• Compassionate Usage. Companies may make charitable donations of product for compassionate usage, provided that

these donations serve exclusively to benefit patients and are permitted under applicable laws [for example, Drugs and

Cosmetics Act, 1940 and the Rules (Medical Devices Rules, 2017, New Drugs and Clinical Trials Rules 2019 & Drugs &

Cosmetics Rules, 1945) made thereunder]. Companies should consider making product donations for compassionate

usage cases contingent upon a hospital’s agreement that no third parties will be billed for the donated product.

• Charitable Events. Companies may not pay for or provide tickets to health care professionals or their spouses or

guests to attend charitable events, such as galas and golf outings.

• Sales Involvement. Sales personnel should not control or unduly influence the decision of whether a particular entity

will receive support or the amount of the support.

SECTION V – JOINTLY CONDUCTED EDUCATION & MARKETING PROGRAMS

Companies may partner with health care professionals to jointly conduct education and marketing programs. These programs

serve an important purpose by allowing companies and health care professionals to educate fellow health care professionals

on medical conditions and the range of testing or treatment options available, including the availability of medical technology

and the health care professional’s ability to diagnose or treat related medical conditions.

Companies should apply the following principles:

• There must be a bona fide, legitimate need for the company to engage in the activity.

• Companies should establish controls to help ensure that decisions to engage in these arrangements are not made as

an unlawful inducement. Companies should also require health care professionals participating in these arrangements

to comply with company guidelines and local regulatory guidelines on providing all relevant regulatory and clinical

information related to the product’s labeling, safety, quality, instructions for use, performance, safety, side-effects

and potential adverse-effects among other controls. Such programs shall be subject to the local law including but not

limited to registration of the product by the relevant regulatory authority.

• Jointly conducted programs should be balanced to disseminate and exchange information to the health care

professional and the range of services offered by the industry, the treatment of related medical conditions in that

disease area as well as the range of technologies and services which are available in the competitive market.

• The company and the health care professional should serve as bona fide partners in the program. The arrangement

should be documented in a written agreement that describes the purpose of the arrangement and the roles,

responsibilities, and mutually agreed contributions of each party, including payment of costs.

SECTION VI – TRAVEL, LODGING & VENUE

There may be educational/training programs or other scientific meetings for which a company determines it is appropriate to

pay for health care professionals’ travel and lodging costs. This section of the Code provides companies with guidance on

paying for a health care professional’s travel and lodging costs. Companies should apply the following principles:

• Legitimate Need. There must be objective, legitimate reasons that support the need for out-of-town travel, such as

the need to deliver training and education concerning medical technologies (for example, the non-availability of health

care professionals who may not require travel, established expertise in a particular field/therapy/practice, the inability

to effectively deliver the content of the program through means other than an in-person meeting, or the need to

demonstrate equipment). Companies are encouraged to document the legitimate need for travel.

• Modest & Reasonable. Travel and lodging accommodations and costs must be modest and reasonable under the

circumstances. Companies are encouraged to establish controls on the appropriate class of travel service and the

appropriate level of lodging accommodations.

• Travel Time & Destination. Companies are also encouraged to ensure criteria’s are established and taken into

consideration while making such arrangements for healthcare professionals (for example, travel dates to be -/+ 24

hours from the start and end of the event date(s), respectively, or travel to and from the place of the healthcare

professionals’ official residence/practice unless there is a justified need to make arrangements from some other

place).

• Guests. Companies may not pay for or otherwise subsidize the travel or lodging of spouses or guests of health care

professionals or for any other person who does not have a bona fide professional interest in the information being

shared at the company’s meeting.

• Personal Travel & Lodging. Companies may not pay for a health care professional’s personal travel or lodging costs

that are not connected to such company-conducted program.

• Setting. The setting for a company-conducted program or meeting of health care professionals should always be

conducive to the exchange of information, suit the particular purpose of the program/ training/meeting, and should

not be the main attraction of the event. Companies should consider the following principles when choosing a setting:

✓ The setting should be in a business/ clinical environment as deemed suitable for the purpose, centrally located

and easily accessible (for example, considering proximity to airports and highways) in relation to the place of

origin of the invited participants.

✓ Companies should not select a setting because of its entertainment or recreational facilities (considering, for

example, the season or time of year of the event).

✓ Companies should avoid top category or luxury hotels or resort facilities without an appropriate justification.

• Other Laws. Companies should be aware that other laws or regulations may apply to paying for health care

professionals’ travel and lodging, including potentially more restrictive local laws, institutional rules and service rules

applicable to the health care professionals.

SECTION VII – PROVIDING MODEST MEALS & REFRESHMENTS TO HEALTH CARE PROFESSIONALS

Companies may occasionally provide health care professionals with modest meals and refreshments subject to the following

principles:

• Purpose. The meal or refreshments should be subordinate in time and in focus to the bona fide discussion and

presentation of scientific, educational, or business information. Companies should only provide meals and refreshments

in a manner conducive to the presentation or discussion of such information. The meal or refreshments should not be

part of an entertainment or recreational event.

• Setting & Location. Meals and refreshments should be provided in a setting that is conducive to bona fide scientific,

educational, or business discussions. This may include, for example, the health care professional’s place of business, the

company’s office or an off-site space that is conducive to the discussion, such as a restaurant or business center.

• Participants. Companies may provide a meal or refreshments only to health care professionals who actually attend and

have a bona fide purpose for attending the meeting.

Companies may not provide a meal or refreshments:

✓ For an entire office staff where everyone does not attend the meeting;

✓ If a company representative is not present; or

✓ For guests of health care professionals or for any other person who does not have a bona fide professional interest in

the information being discussed at the meeting.

• Documentation. Companies should establish controls to ensure the purpose and execution of the meeting is reasonably

documented.

• Frequency. Companies should establish controls to reasonably monitor and track the frequency of meetings with health

care professionals involving meals and refreshments.

SECTION VIII – EDUCATIONAL & PATIENT BENEFIT ITEMS; PROHIBITION ON GIFTS

Companies may occasionally provide modest, appropriate educational items to health care professionals that benefit patients

or serve a genuine educational function for health care professionals. Educational items can include but are not limited to

product manuals and anatomical models.

Companies may not provide gifts to health care professionals. This means that companies may not provide health care

professionals with the following:

✓ Items that the health care professional (or his or her family members, office staff, or friends) can use for non-

educational or non-patient-related purposes (for example, office supplies, scrubs, a tablet, smart phone, laptop, or

other mobile device capable of personal use)

✓ Non-educational promotional items, even if the item is of minimal value, related to the health care professional’s

work, or for the benefit of patients (for example t-shirts, hats, mugs, and other items with a company or product name

or logo)

✓ Gifts such as wine, gift baskets, holiday gifts or cash or cash equivalents (for example, gift cards)

Other important principles include:

✓ Any item given to a health care professional’s staff should be treated as though it is given to the health care

professional and is subject to all applicable provisions of the Code.

✓ Companies may not raffle or give away an item that it could not otherwise give a health care professional under the

Code.

SECTION IX – PROHIBITION ON ENTERTAINMENT & RECREATION

Companies should not provide or pay for any entertainment or recreational event for a health care professional, their staff or

their family.

Some examples of entertainment and recreational activities include, among others, theater, live comedy or musicals, sporting

events, golf, skiing, cruises, spas, or vacation trips.

This prohibition applies regardless of (1) the value of the activity; (2) whether the company engages the health care

professional as a consultant; or (3) whether the entertainment or recreation is secondary to an educational purpose.

SECTION X – PROVISION OF HEALTH ECONOMICS & REIMBURSEMENT INFORMATION

As medical technologies become increasingly complex, so do payor coverage and reimbursement policies. Patient access to

necessary medical technology depends on health care professionals and/or patients having timely and complete coverage,

reimbursement, and health economic information. To promote patient access to medical technologies:

• Companies may provide this information to health care professionals regarding its medical technologies if it is

accurate and objective.

• Companies may also collaborate with health care professionals, health economists, reimbursement experts and

organizations representing their interests to achieve government and commercial payor coverage decisions,

guidelines, policies, and adequate reimbursement levels that allow patients to access its medical technologies.

Permissible activities involving the provision of coverage, reimbursement, and health economic information may include, but

are not limited to:

• Identifying the clinical value of the company’s medical technologies and the services and procedures in which they are

used.

• Collaborating with health care professionals, their professional organizations, health economists, reimbursement

experts and patient groups to conduct joint advocacy on coverage, reimbursement, and health economics issues.

• Supporting health care professionals and their professional organizations in developing materials and otherwise

providing direct or indirect input into payor coverage and reimbursement policies.

• Promoting accurate payor claims by providing accurate and objective information and materials to health care

professionals regarding the company’s medical technologies, including identifying coverage, codes, and billing options

that may apply to those medical technologies or the services and procedures in which they are used.

• Providing accurate and objective information about the economically efficient use of the company’s medical

technologies, including where and how they can be used within the continuum of care.

• Providing information related to the company’s medical technologies and available reimbursement and associated

costs.

• Providing information relating to changes in coverage or reimbursement amounts, methodologies and policies and the

effects of such changes to help a health care professional in the decision to use or recommend use of the company’s

medical technologies.

• Providing accurate and objective information designed to offer technical or other support intended to aid in the

appropriate and efficient use or installation of the company’s medical technologies.

• Providing accurate pricing and payment documentation on the company’s medical technologies to the hospital and

maximum retail prices to the relevant authorities and health care professionals.

• Facilitating patient access to a company’s medical technologies by providing health care professionals with assistance

in obtaining patient coverage decisions from payors, including providing information on payor policies and training on

procedures for obtaining prior authorization, providing sample letters and information on medical necessity and

appeals of denied claims.

In addition, at the request and recommendation of a health care professional to facilitate patient access to the

company’s medical technology and subject to appropriate privacy safeguards, the company may assist the patient by

facilitating the preparation and submission of requests for coverage determinations, prior authorizations, pre-

certifications and appeals of denied claims relating to a company’s own medical technology, however, such assistance

should not be provided as an unlawful inducement.

Companies may not interfere with a health care professional’s independent clinical decision making or provide coverage,

reimbursement, and health economics support as an unlawful inducement. For example, companies should not provide free

services that eliminate an overhead or other expense that a health care professional would otherwise have incurred as part of

its business operations. Further, companies should not suggest mechanisms for billing for services that are not medically

necessary, or for engaging in fraudulent practices to achieve inappropriate payment.

If a company comes across information on any patients’ medical records while collaborating with a health care professional or

patient in obtaining reimbursement, the company should maintain the privacy of the data as per applicable laws, regulations,

guidelines, codes and applicable global standards. Similarly, the company should fulfil its other regulatory obligations such as

initiating field corrective measures and/or informing the relevant regulatory authority.

SECTION XI – DEMONSTRATION, EVALUATION & CONSIGNED PRODUCTS

A. Demonstration & Evaluation Products

Providing products (approved medical technologies) to health care professionals at no charge for evaluation or demonstration

purposes can improve patient care, facilitate the safe and effective use of products, enhance patient awareness, and educate

health care professionals regarding the use of products. Under certain circumstances including tendering processes, a

company may provide reasonable quantities of products to health care professionals at no charge to allow health care

professionals to assess the appropriate use, safety and performance of the product.

Company products that may be provided to health care professionals for evaluation include single use (for example, samples

of consumable or disposable products) and multiple use products (sometimes referred to as capital equipment).

Company products provided for evaluation are typically expected to be used in patient care. Companies should provide health

care professionals with appropriate documentation to allow the health care professional to address any reimbursement

reporting obligations, including providing information on the no-charge status of these products.

• Single Use/Consumables/Disposables. The number of single use products provided at no charge should not exceed

the quantity reasonably necessary for the adequate evaluation of the products.

• Multiple Use/Capital. Multiple use products provided without transfer of title for evaluation purposes should be

furnished only for a period of time that is reasonable under the circumstances to allow an adequate evaluation.

o The length of time necessary for a health care professional to evaluate a multiple use product can vary among

products and may depend on the frequency of anticipated use, the duration of required training, the number

of health care professionals who need to evaluate the product, the length of time needed to evaluate

different product features, and other considerations such as local laws, standards and regulations.

o The terms of evaluation of such multiple use products should be set in advance in writing, specifying the

length of the evaluation period and documenting legitimate reasons for products that would not be returned

within the evaluation period.

o Companies should retain title to multiple use products during the evaluation period and should have a process

in place for promptly removing multiple use products from the health care professional’s location at the

conclusion of the evaluation period unless the health care professional purchases or leases the products.

• Demonstration. Company demonstration products are sometimes unsterilized single use products or mock-ups that

are used for health care professional and patient awareness and education. For example, a health care professional

may use a demonstration product to show a patient the type of device that will be implanted in the patient.

o Company demonstration products are typically identified as not intended for patient use through designations

like “Free Sample - NOT FOR SALE” or “Not for Human Use” on the product, the packaging, or documentation

that accompanies the product. Sterilized products may be used in live demonstration only if done in an

educational setting with company controls in place.

• Documentation. Company should maintain a system of control in respect of such demonstration products including

traceability (such as product name, product code, quantity, batch number, lot number and, name of the healthcare

professional to whom such demonstration products are given etc.).

B. Consigned Products

Consigned products are medical technologies (a) that a company provides to a health care professional for use in and storage

at the health care professional’s patient care setting and (b) to which the company retains title until the product is used.

• Consignment arrangements should generally be subject to an agreement that addresses the terms of consignment, for

example, the number of products, any requirements to segregate consigned products from other products, and

storage conditions and responsibility of ensuring the storage conditions of the products.

• Companies are encouraged to consider implementing appropriate controls. This could include (among other

measures) taking periodic inventory of consigned devices for purposes such as billing and restocking; reconciling

discrepancies between the company’s records and the number of products used or verified during inventory; and

return or removal of expired product.

SECTION XII – COMPANY REPRESENTATIVES PROVIDING TECHNICAL SUPPORT IN THE CLINICAL

SETTING

Company representatives may play an important role in the clinical setting by providing technical support on the safe and

effective use of medical technology. Some examples include:

• Company representatives may need to explain how a medical technology’s unique settings and technical controls

function and may make recommendations.

• Company representatives may assist the clinical/operating room team to ensure that the appropriate range of

necessary devices and accessories are available during a procedure, especially when dealing with medical technology

that involves multiple devices and/or accessories.

Companies should apply the following principles:

1. Company representatives should enter and be present in the clinical setting only at the request of and under the

supervision of a health care professional.

2. Company representatives should be transparent that they are acting on behalf of the company in a technical support

capacity only. The primary patient care responsibility lies exclusively with the health care professional.

3. Company representatives should ensure that the professional autonomy of the health care professional and/or

autonomy of the medical institution is maintained by not interfering with a health care professional’s independent

clinical decision-making.

4. Company representatives should comply with applicable hospital or facility policies and requirements, including

patient privacy and credentialing requirements as per the applicable laws, guidelines and codes.

5. A company’s technical support should not cover an overhead or other expense that the health care professional would

otherwise incur while providing patient care. For example, a company representative providing technical support for a

procedure with regard to the company’s medical technology may not function as a surgical technician for a hospital.

6. Company representatives may provide their personal contact details where required if the product requires consistent

monitoring, programming or adjustment, but such support can only be provided per the health care professional’s

direction.

SECTION XIII – RELATIONSHIPS WITH THIRD-PARTY INTERMEDIARIES

Companies are encouraged to adopt a third-party intermediary management compliance program in addition to an overall

compliance program. Taking into account a variety of risk-based factors, as well as local applicable laws, such programs should

include the following elements:

1. Written Anti-Bribery Policy/Procedure: Companies should adopt and implement internal policies prohibiting all forms

of bribery by any person or entity acting on a company’s behalf, including company personnel, third-party

intermediary representatives, health care professionals and other agents. Such policies should include more detailed

measures for common risk areas such as travel, gifts, hospitality, entertainment, grants or donations, research, and

capital equipment. Companies should consider communicating to health care professionals and other stakeholders

their ethical business practices concerning third-party intermediaries.

2. Risk Assessment: Companies should evaluate the risk profile for proposed and utilized third-party intermediary

arrangements including, for example:

• Companies should assess (1) the local risk through published corruption indices as well as specific risk profiles

of planned or utilized Third-party intermediaries; (2) international, national and local legal requirements, (3)

information from third-party intermediaries for potentially unusual arrangements, such as unusually high

commissions paid to sub-intermediaries, high degree of interaction with government officials or health care

professionals associated with Government hospitals, marketing budgets, health care provider corporate

affiliation or ownership, and/or off-shore payment accounts, and (4) information available from public sources

or employees for potential issues associated with a third-party intermediary.

• Third-party intermediaries should (1) support companies’ risk assessments prior to and throughout

engagement in activities conducted on the company’s behalf, (2) assess and comply with international,

national and local legal requirements, (3) disclose potentially unusual arrangements, and (5) maintain accurate

records for review.

3. Diligence Program: Companies should establish a risk-based, pre-engagement and renewal due diligence program to

identify, prevent, and mitigate risks relating to the market in which the third-party intermediaries is engaged to

operate, as well as any specific activities the third-party intermediary deploys on behalf of the company. Companies

are encouraged to engage with local industry associations to advance compliance training and best practices sharing.

4. Written Contract: Companies should reach contract terms with third-party intermediaries that implement anti-

corruption policies including but not limited to:

a. Compliance with international, national and local laws, ethical principles, and company policies;

b. The ability to conduct independent audits and monitoring, including access to relevant books and records;

c. The ability to terminate an engagement for failure to comply with international and local laws, ethical

principles, and company policies; and

d. Diligence rights upon renewal.

5. Training and Education: Companies should undertake initial and provide regular training and education for relevant

third-party intermediary personnel on international and applicable national anti-corruption and anti-bribery laws, data

privacy principles and other laws and regulations that may be relevant for third-party intermediaries to conduct their

business per ethical principles and company policies. Training should be conducted in the language most appropriate

to the audience.

6. Monitor/Audit: Companies are encouraged to undertake risk-based, routine monitoring, auditing, and other

assessments of their relationship for compliance with international and applicable national and local laws, ethical

principles, and company policies as well as relevant contract terms.

7. Appropriate Corrective Action: Companies should take appropriate corrective action, consistent with applicable

international and applicable national and local laws, if a third-party intermediary representative fails to comply with

such international and applicable national and local laws, ethical principles, company policies, relevant contract terms,

or engages in other impermissible or unethical conduct.