EFPIA行为准则

EFPIA CODE OF PRACTICE Adopted by the EFPIA Board on 22 March 2019, and ratified by the EFPIAStatutory General Assembly of 27 June 2019 FINAL CONSOLIDATED VERSION 2019Approved by the General Assembly of 27 June 2019 The EFPIA Code constitutes the collection of ethical rules agreed by EFPIA members for thePromotion of Medicinal Products to HCPs and the interactions with HCPs, HCOs and POs,with the intent of guaranteeing that these activities are conducted while respecting themost stringent ethical principles of professionalism and responsibility. This Code applies toall types of communication and interaction (traditional and digital). TABLE OF CONTENTS DEFINITIONSP. 05PREAMBLEP. 09INTRODUCTIONP. 11SCOPE OF THE EFPIA CODEP. 13APPLICABILITY OF THE EFPIA CODEP. 15 PROMOTION OF POM TO HCPsP. 16 Article 1Marketing authorizationArticle 2Information to be made availableArticle 3Promotion and its substantiationArticle 4Use of quotations in PromotionArticle 5Acceptability of PromotionArticle 6Distribution of PromotionArticle 7Transparency of PromotionArticle 8Promotional information provided during international EventsArticle 9Personal medical matters CHAPTER 2INTERACTIONS WITH HCPs, HCOs AND POsP. 19Article 10Events and hospitality Article 11Prohibition of GiftsArticle 12Donations and Grants to HCOs and POsArticle 13Contribution to Cost of Events and SponsorshipArticle 14Member Company fundingArticle 15Contracted services SPECIFIC REQUIREMENTS FOR INTERACTIONS WITH HCPs AND HCOsP. 23Lifelong Learning in Healthcare CHAPTER 3Article 16 Article 17Informational or Educational Materials, Items of Medical UtilityArticle 18Non-Interventional StudiesArticle 19Medical SamplesArticle 20Member Company Staff SPECIFIC REQUIREMENTS FOR INTERACTIONS WITH POsP. 27Interactions with POs CHAPTER 4Article 21 CHAPTER 5DISCLOSURE OF TRANSFERS OF VALUE FROM MEMBER COMPANIESP. 28Article 22Disclosure of ToVs to HCPs & HCOs and POs Article 23Disclosure of ToVs to HCPs and HCOsArticle 24Disclosure of support and services provided to POs CHAPTER 6PROCEDURAL REQUIREMENTSP. 32Article 25Enforcement Article 26Amendments to, and guidance on compliance with, the EFPIA CodeArticle 27Awareness and educationArticle 28Implementation and procedure rules ANNEXES DEFINITIONS Definitions of capitalised terms are included to ensure their consistent understanding. Applicable Codes: •in the case of Promotion or interaction that is undertaken, sponsored or organised by or onbehalf of, or with, a Member Company located within Europe, the Member Association NationalCode of the country in which such Member Company is located; or (ii) in the case of Promotionor interaction that is undertaken, sponsored or organised by or on behalf of, or with, a MemberCompany located outside of Europe, the EFPIA Code; and •the Member Association’s National Code of the country in which the Promotion or the interactiontakes place. In case of international Event for which a Member Company sponsors the attendance ofa HCP, if any funding is provided to such HCP in accordance with the provisions of Article 13, suchfunding is subject to the rules of the National Code where such HCP carries out his/her profession,as opposed to those in which the international Event takes place. In the event of a conflict between the provisions of the Applicable Codes set forth above, themore restrictive of the conflicting provisions must apply, except for the application of Section10.05, where the monetary threshold set in the country where the event takes place (i.e. the “hostcountry”) must prevail. Contribution to Costs related to Events:is a support providing or covering the costs of meals,travel, accommodation and/or registration fees to support the attendance of an individual HCP orPO Representative to an Event organised or created by a Member Company and/or a Third Party. Donations and Grants:collectively, mean providing funds, assets or services freely given forthe purpose of supporting healthcare, scientific research or education, with no consequentobligation on the recipient to provide goods or services to the benefit of the donor in return. European Federation of Pharmaceutical Industries and Associations (EFPIA):is therepresentative body of the pharmaceutical industry in Europe.EFPIA Code:TheEFPIA Code of Practice, including those Annexes which are expressly mentionedas binding and which form part of this Code. Europe:includes those countries in which the EFPIA Member Associations’National Codes apply1. Events:All professional, promotional, scientific, educational meetings, congresses, conferences,symposia, and other similar events (including, but not limited to, advisory board meetings, visits toresearch or manufacturing facilities, and planning, training or investigator meetings for clinical trialsand non-interventional studies) organised or sponsored by or on behalf of a Member Company. Healthcare Organisation (HCO):any legal person/entity (i) that is a healthc