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INDUSTRY SUPPORT FOR MEDICAL EDUCATION OF HEALTH CARE PROFESSIONALS IN CHINA A GUIDE FOR EDUCATIONAL CONFERENCE ORGANIZERS MEDICAL TECHNOLOGY COMPANIES MAY REQUEST POST-EVENT DOCUMENTATION AND INFORMATION VETTING EDUCATIONAL CONFERENCE ORGANIZERS Medical technology companies may vet conference organizers (and/or educational grant/donation recipients, if different) to determine if supporting an organization’s request for educational grant/donation funding would pose legal, compliance, or reputational risks. Companies may request information similar to the criteria listed below. This list is not exhaustive, and companies may give greater weight to some criteria over others. Examples include: 4 Whether the conference organizer or grant/donation recipient is an independent entity (via registration certification) 4 Whether the conference organizer or grant/donation recipient has provided documentation of official government registration, corporate certification, or other necessary qualifications and approvals 4 The size of the conference organizer or grant/donation recipient and date on which it was formed 4 Whether the conference organizer or grant/donation recipient operates independently from an individual HCP or is affiliated with or employs an individual HCP, including HCPs who work for hospitals or are influential in the industry 4 Whether the conference organizer, grant/donation recipient, or any of its subsidiaries or affiliated entities are under common control with, or otherwise related to, medical institutions 4 Whether the conference organizer or grant/donation recipient, including its principals and the immediate family of its principals, (a) is affiliated with, owned by, or partially owned by the government or government officials and/or (b) is recommended by government officials 4 Whether the conference organizer or grant/donation recipient appears on a list of industry-approved entities (if available) or a government list of restricted entities 4 Whether the conference organizer or grant/donation recipient has a history of bribery/corruption charges 4 Whether the conference organizer or grant/donation recipient has been subject to an official government audit regarding corruption, bribery, money laundering, or other fraud allegations and, if so, the results of the audit 4 Whether the conference organizer or grant/donation recipient is willing to submit to an audit of its books and records upon request 4 Whether the conference organizer or grant/donation recipient has organized a similar event, and if so, what are the event details and available feedback 4 Whether information about previous grants/donations provided to the conference organizer or grant/donation recipient raises concerns To help ensure companies review and fund educational grant/donation requests in a timely manner, it is important to respond promptly and fully to any request for additional information. To help ensure full transparency for conference funding, companies may seek information from conference organizers or educational grant/ donation recipients, if different, about how funds have been used. This could include, for example, requesting that a conference organizer or grant/donation recipient provide a medical technology company with an expense/fund usage report that details: 4 The total costs incurred by the conference organizer or grant/donation recipient to put together the educational conference; 4 The total educational grants/donations received to support the costs of the conference; and 4 A detailed breakdown of the costs incurred by the conference organizer or grant/donation recipient and covered by the medical technology company’s educational grant/donation. If a conference organizer or grant/donation recipient has received funds in excess of the costs incurred, a company may request that the organizer return its portion of excess funds. Companies intend to use this information for internal compliance purposes only in an effort to document how educational grants/donations were used. If a conference organizer or grant/donation recipient chooses not to provide requested information, a company may determine not to support the third-party educational conference in the future. this brochure has been designed to assist you in better understanding the rules and guidelines that medical technology companies follow to support medical education conferences in china.

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Page 1: MEDICAL TECHNOLOGY COMPANIES MAY REQUEST POST · PDF fileMEDICAL TECHNOLOGY COMPANIES MAY REQUEST POST-EVENT DOCUMENTATION AND INFORMATION VETTING EDUCATIONAL ... 4 The total costs

INDUSTRY SUPPORT FOR MEDICAL EDUCATION OFHEALTH CARE PROFESSIONALS

IN CHINA

A GUIDE FOR EDUCATIONAL CONFERENCE ORGANIZERS

MEDICAL TECHNOLOGY COMPANIES MAY REQUEST POST-EVENT

DOCUMENTATION AND INFORMATION

VETTING EDUCATIONAL CONFERENCE ORGANIZERS

Medical technology companies may vet conference organizers (and/or educational grant/donation recipients, if different) to determine if supporting an organization’s request for educational grant/donation funding would pose legal, compliance, or reputational risks. Companies may request information similar to the criteria listed below. This list is not exhaustive, and companies may give greater weight to some criteria over others. Examples include:

4 Whether the conference organizer or grant/donation recipient is an independent entity (via registration certification)

4 Whether the conference organizer or grant/donation recipient has provided documentation of official government registration, corporate certification, or other necessary qualifications and approvals

4 The size of the conference organizer or grant/donation recipient and date on which it was formed

4 Whether the conference organizer or grant/donation recipient operates independently from an individual HCP or is affiliated with or employs an individual HCP, including HCPs who work for hospitals or are influential in the industry

4 Whether the conference organizer, grant/donation recipient, or any of its subsidiaries or affiliated entities are under common control with, or otherwise related to, medical institutions

4 Whether the conference organizer or grant/donation recipient, including its principals and the immediate family of its principals, (a) is affiliated with, owned by, or partially owned by the government or government officials and/or (b) is recommended by government officials

4 Whether the conference organizer or grant/donation recipient appears on a list of industry-approved entities (if available) or a government list of restricted entities

4 Whether the conference organizer or grant/donation recipient has a history of bribery/corruption charges

4 Whether the conference organizer or grant/donation recipient has been subject to an official government audit regarding corruption, bribery, money laundering, or other fraud allegations and, if so, the results of the audit

4 Whether the conference organizer or grant/donation recipient is willing to submit to an audit of its books and records upon request

4 Whether the conference organizer or grant/donation recipient has organized a similar event, and if so, what are the event details and available feedback

4 Whether information about previous grants/donations provided to the conference organizer or grant/donation recipient raises concerns

To help ensure companies review and fund educational grant/donation requests in a timely manner, it is important to respond promptly and fully to any request for additional information.

To help ensure full transparency for conference funding, companies may seek information from conference organizers or educational grant/donation recipients, if different, about how funds have been used.

This could include, for example, requesting that a conference organizer or grant/donation recipient provide a medical technology company with an expense/fund usage report that details:

4 The total costs incurred by the conference organizer or grant/donation recipient to put together the educational conference;

4 The total educational grants/donations received to support the costs of the conference; and

4 A detailed breakdown of the costs incurred by the conference organizer or grant/donation recipient and covered by the medical technology company’s educational grant/donation.

If a conference organizer or grant/donation recipient has received funds in excess of the costs incurred, a company may request that the organizer return its portion of excess funds.

Companies intend to use this information for internal compliance purposes only in an effort to document how educational grants/donations were used. If a conference organizer or grant/donation recipient chooses not to provide requested information, a company may determine not to support the third-party educational conference in the future.

this brochure has been designed to assist you in better understanding

the rules and guidelines that medical technology companies

follow to support medical education conferences in china.

Page 2: MEDICAL TECHNOLOGY COMPANIES MAY REQUEST POST · PDF fileMEDICAL TECHNOLOGY COMPANIES MAY REQUEST POST-EVENT DOCUMENTATION AND INFORMATION VETTING EDUCATIONAL ... 4 The total costs

MEDICAL TECHNOLOGY COMPANIES’ CONSIDERATIONS IN FUNDING

EDUCATIONAL GRANTS/DONATIONS MEDICAL TECHNOLOGY

COMPANY POLICIES

MEDICAL TECHNOLOGY COMPANY PROCEDURES

The AdvaMed Code of Ethics on Interactions with Health Care Professionals in China (AdvaMed China Code) provides compliance guidelines for medical technology companies. This includes information on how medical technology companies can support educational conferences.

Under the AdvaMed China Code, companiescan provide an educational grant or donation of funds to support bona fide independent, educational, scientific, and policymakingconferences that promote scientific knowledge, medical advancement and the delivery of effective health care.

4 Such educational grants/donations can be provided to (1) a Third-Party Conference Organizer or (2) another appropriate third party (such as a training institution, hospital, medical or other professional association, educational foundation, or similar entity that supports the training and education of Health Care Professionals (HCPs).

4 Such educational grants/donations can be used to reduce or defray legitimate conference costs, such as the cost of modest meals, registration, venue rental, and travel and lodging, among other costs.

4 Effective 1 January 2018, AdvaMed member companies do not directly pay for individual HCPs’ costs to attend a third-party educational conference. Instead, companies support educational conferences through educational grants/donations to the conference organizer or grant/donation recipient, as applicable.

Companies may also establish procedures to review and approve educational grant/donation requests. This could include:

4 A centralized portal or point of contact through which a conference organizer or training institution submits its request for educational grant/donation funding

4 Requesting the educational grant/donation request to include detailed information on the event, including agenda, content, venue, faculty, budgets, etc., and information about the conference organizer or grant/donation recipient (qualification, history of requests, and organizational structure, etc.)

4 A company may undertake a due diligence vetting or screening process before paying the educational grant/donation

4 A company may require direct payment of the educational grant/donation to the conference organizer or grant/donation recipient through wire transfer

4 Some companies may establish an internal, independent review committee to evaluate potential educational grant/donation support against objective criteria

4 Company agreements with conference organizers or grant/donation recipients, if different, may contain some standard provisions prohibiting the use of funds to support entertainment and recreation, requiring compliance with applicable laws, and requiring organizers to provide companies with fund usage details

Medical technology companies have internal policies and procedures that incorporate the principles of the AdvaMed China Code. This brochure summarizes some of these principles.

The AdvaMed Code criteria for medical technology companies’ support for these conferences include the following:

4 The event must be primarily dedicated to objective scientific and educational activities 4 The conference organizer or grant/donation recipient must be an organization with a genuine educational function

4 Conference organizers or grant/donation recipients (as applicable) should independently control and be responsible for the selection of program content, faculty, educational methods, and materials 4 Only the conference organizer or grant/donation recipient (if different) can select and invite the individual health care professionals who will receive support to attend the educational conference

4 A medical technology company cannot influence the selection of individual HCPs that benefit from the educational grant/donation

4 The venue must be conducive to the educational program

4 Companies cannot provide educational grants/donations as a quid pro quo or with the intention to influence any decision to purchase, order, recommend, or market a product

4 Requests for educational grants/donations should reflect the actual, fair market value costs of the intended educational activities

4 A company may not provide an educational grant/donation to influence the recipient’s decision to purchase, order, recommend, or market any product or medical technology

4 All support for third-party educational conferences should be appropriately documented

Please contact a company representative for additional information on how to submit a request to a specific company for an educational grant/donation.