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Modest Meals Companies may provide modest meals incidental to the presentation of bona fide scientific, educational or business information. Meals may occur at the HCP’s place of business, or when such venues are not available, at a location conducive to such exchanges. Companies may provide meals only to those HCPs who have a professional interest in, and actually attend, the meeting. Travel Support for HCPs Where Code principles permit Companies to provide travel support for individual HCPs, the following additional provisions apply: The length of the trip must be commensurate with the bona fide scientific, educational or business purpose of the trip. Companies must not provide recreational activities, side trips, city tours, or any other activities that do not support the bona fide professional interest of the travel. Companies should adopt objective criteria to select locations and venues. Companies should consider local alternatives before sponsoring travel, and China-based alternatives before sponsoring international travel. Companies may provide for reasonable flights, hotels, meal and incidental expenses for individual HCP travel. Companies may not provide travel or other expenses for guests of Individual Health Care Professionals, or for any other person who does not have a bona fide professional interest in the activity requiring travel. Companies are encouraged to pay for flights/hotels directly where practical. Reimbursement of travel-related expenses over RMB 500 should not be made in cash. Educational Items and Branded Promotional Items Companies may provide items to HCPs that benefit patients or serve a genuine educational function. Other than medical textbooks or anatomical models used for educational purposes, the value of such items should be modest. Items should not be capable of use for non-educational purposes. Companies may provide HCPs branded promotional items related to the HCPs practice. Promotional items should have a value of 200 RMB or less. Transparency Companies are strongly encouraged to ensure that interactions with individual HCPs (or individual units within an institutional HCP) are appropriately disclosed to the institution or employer. If applicable laws, regulations or institutional rules require disclosure to a different body, then disclosure should be made in accordance with the applicable laws, regulations or rules. Sales & Marketing Intermediaries It is essential that Companies’ interactions with third party sales & marketing intermediaries (“SMIs”) as well as SMIs’ behavior on a Company’s behalf (including SMI interactions with HCPs and governmental officials) are conducted pursuant to all applicable legal and ethical principles. Companies are encouraged to adopt an SMI Management Compliance Program in addition to an overall compliance program. Code of Ethics Compliance Medical Technology Companies are strongly encouraged to adopt the Code and to implement an effective compliance program. Companies that adopt the Code may submit to AdvaMed an annual certification to that effect, and AdvaMed will publish an annual list of certifying Companies. Companies that are AdvaMed members shall, and non- member Companies may, supply contact information for their Compliance Department, which AdvaMed will publish on its website. Code of Ethics ON INTERACTIONS WITH HEALTH CARE PROFESSIONALS IN CHINA www.AdvaMed.org/chinacode What is the purpose of the code? The Code is an ethical guideline for companies that develop, produce, manufacture or market Medical Technologies in the People’s Republic of China (“Companies”). The Code provides principles that govern the interactions between Companies and Health Care Professionals, or HCPs.

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Page 1: Travel Support for HCPs Code of Ethics - AdvaMed · Code of Ethics Compliance ... China Code Certification; China Code Logo; medtech industry interaction with physicians; ethical

Modest MealsCompanies may provide modest meals incidental to the presentation of bona fide scientific, educational or business information. Meals may occur at the HCP’s place of business, or when such venues are not available, at a location conducive to such exchanges. Companies may provide meals only to those HCPs who have a professional interest in, and actually attend, the meeting.

Travel Support for HCPsWhere Code principles permit Companies to provide travel support for individual HCPs, the following additional provisions apply:

• The length of the trip must be commensurate with the bona fide scientific, educational or business purpose of the trip.

• Companies must not provide recreational activities, side trips, city tours, or any other activities that do not support the bona fide professional interest of the travel.

• Companies should adopt objective criteria to select locations and venues.

• Companies should consider local alternatives before sponsoring travel, and China-based alternatives before sponsoring international travel.

• Companies may provide for reasonable flights, hotels, meal and incidental expenses for individual HCP travel.

• Companies may not provide travel or other expenses for guests of Individual Health Care Professionals, or for any other person who does not have a bona fide professional interest in the activity requiring travel.

• Companies are encouraged to pay for flights/hotels directly where practical. Reimbursement of travel-related expenses over RMB 500 should not be made in cash.

Educational Items and Branded Promotional ItemsCompanies may provide items to HCPs that benefit patients or serve a genuine educational function. Other than medical textbooks or anatomical models used for educational purposes, the value of such items should be modest. Items should not be capable of use for non-educational purposes. Companies may provide HCPs branded promotional items related to the HCPs practice. Promotional items should have a value of 200 RMB or less.

Transparency Companies are strongly encouraged to ensure that interactions with individual HCPs (or individual units within an institutional HCP) are appropriately disclosed to the institution or employer. If applicable laws, regulations or institutional rules require disclosure to a different body, then disclosure should be made in accordance with the applicable laws, regulations or rules.

Sales & Marketing IntermediariesIt is essential that Companies’ interactions with third party sales & marketing intermediaries (“SMIs”) as well as SMIs’ behavior on a Company’s behalf (including SMI interactions with HCPs and governmental officials) are conducted pursuant to all applicable legal and ethical principles.

Companies are encouraged to adopt an SMI Management Compliance Program in addition to an overall compliance program.

Code of Ethics ComplianceMedical Technology Companies are strongly encouraged to adopt the Code and to implement an effective compliance program. Companies that adopt the Code may submit to AdvaMed an annual certification to that effect, and AdvaMed will publish an annual list of certifying Companies. Companies that are AdvaMed members shall, and non-member Companies may, supply contact information for their Compliance Department, which AdvaMed will publish on its website.

Code of EthicsON INTERACTIONS WITH HEALTH CARE

PROFESSIONALS IN CHINA

www.AdvaMed.org/chinacode

What is the purpose of the code?

The Code is an ethical guideline for companies that develop, produce, manufacture or market Medical Technologies in the People’s Republic of China (“Companies”). The Code provides principles that govern the interactions between Companies and Health Care Professionals, or HCPs.

国道德行为规范

准则拥护者

美国先

进医疗技术协会

Page 2: Travel Support for HCPs Code of Ethics - AdvaMed · Code of Ethics Compliance ... China Code Certification; China Code Logo; medtech industry interaction with physicians; ethical

Company-Conducted Product Training and EducationCompanies may provide HCPs training on the safe and effective use of their products, and education regarding disease states and the benefits of their technologies.

• Programs should be conducted in clinical or educational settings that are conducive to scientific exchange, like clinical, educational or conference centers.

• “Hands on” training should be held at suitable facilities, and instructors should be qualified and have the technical expertise to conduct the training.

• Meals and refreshments may be provided only to attendees and must be modest in nature and subordinate to the training and/or education.

• Companies may only pay for necessary and reasonable travel, and modest lodging for HCP attendees. It is inappropriate for Companies to pay for meals, refreshments, travel or lodging for any person who does not have a bona fide professional reason to attend the training or education.

Evaluation and Demonstration ProudctsCompanies may provide reasonable quantities of products to HCPs at no charge for evaluation and demonstration purposes.

• Evaluation products are typically intended for human use to permit HCPs to use and assess the product in order to decide whether to purchase or recommend the product. Companies may provide single-use products only in

quantity necessary for adequate evaluation, and capital equipment only for a reasonable period of time sufficient for evaluation.

• Demonstration products are typically unsterilized, single-use products used for HCP and patient awareness, education and training. Such products are not intended for patient care and are typically identified as “Sample,” “Not for Human Use,” or similar designation on the product, packaging or accompanying documentation.

The provision of evaluation and demonstration products should not be linked to purchase requirements or anti-competitive conditions. Companies should provide institutional HCPs with documentation and disclosure regarding the no-charge status unless applicable laws, regulations or institutional rules require disclosure to a different body (in which case such disclosures should be made in accordance with such laws, regulations or rules).

Supporting Third-Party Educational ConferencesCompanies may support independent educational or scientific conferences as follows:

• Grants to conference sponsors to reduce conference costs or to training institutions to allow attendance of HCPs in training. Grants should be paid only to reimburse legitimate expenses for the educational activity, and the conference sponsor is solely responsible for the program content, faculty, educational methods and materials.

• Meals and refreshments to all attendees consistent with standards established by the conference sponsor. Meals or refreshments should be modest in value,

subordinate in time and focus to the purpose of the conference, and clearly separate from the education portion of the conference.

• Grants to conference sponsors for reasonable honoraria, travel, lodging and modest meals for HCPs who are bona fide conference faculty members.

• Companies may sponsor individual HCPs to attend third-party educational conferences, but should not reimburse travel expenses directly to the HCP. Companies should establish internal controls to ensure sponsored HCPs are selected for sponsorship based upon appropriate qualifications, and to evaluate and qualify travel agents and other third parties to be reimbursed for meeting-related expenses.*

• Purchasing advertisement and leasing booth space for company displays at conferences.

Sales, Promotional and Other Business MeetingsCompanies conduct business meetings with HCPs to discuss product features, sales terms or contracts, and may pay for occasional modest meals in connection with such meetings. In addition, in cases where it is necessary to demonstrate non-portable equipment, or conduct plant tours, Companies may pay for reasonable travel costs, lodging and modest meals of attendees (but not their guests).

Consulting Arrangements with HCPsConsulting agreements should be for bona fide services and should describe all the services that are to be provided (and should include a written research protocol when clinical research services are being provided). There should be a legitimate need for the services identified and documented in advance. Consultants should be selected based upon their qualifications relative to the defined need. Compensation should be at fair market value without regard to the value of the consultant’s past or anticipated business. Compensation should not be paid in cash. Companies may

pay for reasonable and actual expenses of consultants, including travel, modest meals and lodging. The venue and circumstances of any meetings should be conducive to the exchange of information, and any meals or refreshments provided by Companies should be modest in value and subordinate in time and focus to the purpose of the meeting. Companies should not provide recreation or entertainment.

Company’s sales personnel should not control or unduly influence the selection of HCP consultants.

The Code also addresses other areas related to consulting arrangements, including royalties.

Research and Educational Grants and Charitable DonationsCompanies may provide research and educational grants and charitable donations to institutional HCPs. Companies should adopt:

• Objective criteria for grants and charitable donations that do not take into account purchasing criteria;

• Implement appropriate procedures to ensure grants and charitable donations are not used as an unlawful inducement;

• Ensure that grants or donations are made to the legal entity of the institution, handled by its financial department, used according to the grant agreement for bona fide nonprofit activities, and not linked to purchase requirements or anti-competitive conditions.

Company’s sales personnel should not control or unduly influence grant decisions. Grants may not be made to individual HCPs.

Prohibition on Entertainment and RecreationAll interactions between Companies and HCPs should be professional and facilitate exchange of information beneficial to patient care. Companies should not provide or pay for any entertainment or recreation of HCPs.

* This section of the Code is subject to additional review and re-evaluation.

Compliance with LawThe Code should not be construed as legal advice. Companies have an independent obligation to comply with all applicable laws, regulations and government guidelines. This Brochure summarizes key points of the Code. For a complete copy of the Code, please visit www.advamed.org/chinacode.

What are HCPs?“Health Care Professionals” or “HCPs” includes individuals and institutions. Institutional Health Care Professionals are institutions involved in the provision of health care services and/or items to patients, which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Companies’ Medical Technologies in China. Individual HCPs are persons employed by institutional HCPs involved in the provision of health care services and/or items to patients and who also purchase, lease, recommend, use, or arrange for the purchase or lease of, or prescribe Companies’ Medical Technologies.