EFPIA行为准则

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 to TABLE OF CONTENTS CHAPTER 1PROMOTION OF POM TO HCPsArticle 1Marketing authorization Article 2Information to be made availableArticle 3Promotion and its substantiation CHAPTER 2INTERACTIONS WITH HCPs, HCOs AND POsArticle 10Events and hospitality Article 11Prohibition of GiftsArticle 12Donations and Grants to HCOs and POs CHAPTER 3SPECIFIC REQUIREMENTS FOR INTERACTIONS WITH HCPs AND HCOsArticle 16Lifelong Learning in Healthcare Article 17Informational or Educational Materials, Items of Medical UtilityArticle 18Non-Interventional StudiesArticle 19Medical SamplesArticle 20Member Company Staff CHAPTER 4SPECIFIC REQUIREMENTS FOR INTERACTIONS WITH POsArticle 21Interactions with POs CHAPTER 5DISCLOSURE OF TRANSFERS OF VALUE FROM MEMBER COMPANIESArticle 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 REQUIREMENTSArticle 25 EnforcementArticle 26Amendments to, and guidance on compliance with, the EFPIA Code 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 Promotion 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, 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 Section 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 consequent 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 trials Healthcare Organisation (HCO):any legal person/entity (i) that is a healthcare, medical orscientific association or organisation (irrespective of the legal or organisational form) such asa hospital, clinic, foundation, university or other teaching institution or learned society (except for Healthcare Professional (HCP):any natural person that is a member of the medical, dental,pharmacy or nursing professions or any other person who, in the course of his/her professionalactivities, may prescribe, purchase, supply, recommend or administer a Medicinal Product andwhose primary practice, principal professional address or place of incorporation is in Europe.For the purpose of this Code, the definition of HCPs includes: (i) any official or employee of agovernment, agency or other organisation (whether in the public or private sector) that may Host Country Principle:refers to the primacy of the monetary threshold for a meal (food andbeverages) set by the relevant Member Association in its National Code. Informational or Educational Material:constitutes inexpensive material directly relevant to thepractice of medicine or pharmacy and directly beneficial to the care of patients. Item of Medical Utility:constitutes inexpensive item aimed directly at the education of HCPsenhancing the provision of medical services and patient care and that do not offset routine Life