药品推广行为准则(2006年版)医药销售必读

药品推广行为准则(2006 年版) Code of Practice on the Promotion of Pharmaceutical Products(2006 Revision) 中国外商投资企业协会药品研制和开发行业委员会 China Association of Enterprises with Foreign Investment R - The Implementation Regulation of the Drug Administration Law (effective September 15, 2002); - Drug Registration Regulation (revised May 1, 2005); - The Advertisement Law (effective February 1, 1995); - The Anti-Unfair Competition Law (effective December 1, 1993); - The Criminal Code (effective October 1, 1997); - Regulation for the Administration of Adverse Drug Reaction Report and Monitoring (effective March 4, 2004); - Temporary Regulation on the Administration of Prescription and OTC Drugs (effective January 1, 2000); - Regulation on Drug Insert Sheets and Labeling (effective June 1, 2006); - SFDA Notice to Further Standardize the Drug Name (effective June 1, 2006). RDPAC 准则准则 第第 1 条目标和范围条目标和范围 1.1 目标 (RDPAC 准则为向医疗卫生专业人士进行符合道德标准的药品推广订立标准和准 则以确保会员与医疗卫生专业人士所进行的互动交流行为正当和符合规范同时也被公 众认可为正当和符合规范。 1.2 范围 (RDPAC 准则的规范对象是针对医疗卫生专业人士进行的、处方药的推广活动。 1.2.1 定义 (a)“推广”指由某会员通过各种方式包括口头、书面、电子形式及互联网等进行的以 促进其药品的处方、推荐、供应、用于病人或为病人自用等为目的的针对医疗卫生专业 人士所进行的或组织、赞助的任何行为或活动。 (b)“医疗卫生专业人士”指医疗、牙科、药剂或护理领域中的专业人员或其他任何在其专 业活动中可能开具药品处方或推荐、采购、供应药品或将药品用于病人的其他人员。 (c)“药品”在RDPAC 准则下的含义同药品管理法第 102 条对“药品”的定义。 (d)“会员公司” (“会员”)指药品研制和开发行业委员会的会员而成为会员的条件之一就是 遵守本RDPAC 准则。 1.3 不适用情形 本准则不适用于下列活动： (a)直接针对一般公众的处方药推广(即 DTC 广告)(目前，中国法律禁止这类推广活动)， (b)不需开具处方的自我诊疗药品(OTC)的推广， (c)价格或其他有关药品供应的商务条款， (d)临床实验活动(见第 2 5 条)，及 (e)会员提供非推广类资讯比如旨在回答有关某个药品的具体问题的往来函件。 RDPAC Code ARTICLE 1 OBJECTIVE AND SCOPE 1.1 Objective The RDPAC Code sets out standards for the ethical promotion of pharmaceutical products to healthcare professionals to ensure that Member companiesinteractions with healthcare professionals are appropriate and perceived as such. 1.2 Scope The RDPAC Code covers the promotion to healthcare professionals of prescription-only pharmaceutical products. 1.2.1 Definitions (a) “Promotion”means any activity undertaken, organized or sponsored by a Member company which is directed at healthcare professionals to promote the prescription, recommendation, supply, administration or consumption of its pharmaceutical product(s) through all means, including oral, written, electronic, including internet communication. (b) “Healthcare Professional”means any member of the medical, dental, pharmacy or nursing professions or any other person who in the course of his or her professional activities may prescribe, recommend, purchase, supply, or administer a pharmaceutical product. (c) “Pharmaceutical product”as used in the RDPAC Code has the meaning of _Drugs_ set forth in Article 102 of the Drug Administration Law. (d) “Member company” (“Member”) means a member of RDPAC, one of the conditions of the RDPAC membership being compliance with this Code. 1.3 Exclusions This Code does not seek to regulate the following activities: (a) promotion of prescription-only pharmaceutical products directly to the public, i.e. direct to consumer advertising (currently such promotion not allowed by Chinese law); (b) promotion of self-medication products that are provided _over the counter_ without prescription; (c) pricing or other trade terms for the supply of pharmaceutical products; (d) the conduct of clinical trials (See Article 2.5); and, (e) the provision of non-promotional information by Members, one example being correspondence needed to answer a specific question about a particular pharmaceutical product. 第第 2 条总则条总则 2.1 互动交流的基本原则 会员与医疗卫生专业人士建立联系的目的是造福患者和提高医疗水平。两者之间的互动 交流的重点应集中在由前者向后者传达药品信息、提供科学及教育方面的资讯、以及前者 为医学研究和教育提供支持等方面。 2.2 医疗卫生专业人士的独立性 会员不得向医疗卫生专业人士提供金钱利益或其替代物(包括捐赠、奖学金、补助、赞助、 咨询合同及教育或其他与其执业相关的名目)以换取后者对其药品的处方、推荐、采购、供 应及对病人使用或在将来继续进行上述活动的承诺，也不得以任何方式或条件承诺提供 或提供可能对医疗卫生专业人士的处方行为产生不正当影响的其他任何利益。 会员可以与医疗卫生专业人士签约由后者提供真实的咨询服务并向其支付合理的报 酬及食宿和差旅补偿，但此类咨询服务提供的方式或条件均不应当对有关医疗卫生专业人 士的处方行为产生不正当影响。 ARTICLE 2 GENERAL PRINCIPLES 2.1 Basis of Interaction Members_ relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing healthcare professionals about products, providing scientific and educational information and supporting medical research and education. 2.2 Independence of Healthcare Professionals No financial benefit or benefit-in-kind (including grants, scholarships, subsidies, support, consulting contracts or educational or practice related items) may be provided or offered to a healthcare professional in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so. Nothing may be offered or provided in a manner or on conditions that would have an inappropriate influence on a healthcare professionals prescribing practices. Healthcare professionals may be engaged to provide genuine consultancy services for reasonable compensation and reimbursement of reasonable travel, lodging and meal expenses, however, such services should not be offered or provided in a manner or conditions that would have an inappropriate influence on a healthcare professionals prescribing practices. 2.3 药品的正确及适当使用 药品推广活动应能通过客观介绍(而非夸大)药品的性能而促进药品的正确及适当使用。 2.4 中国法律法规及其他地方法规 在任何情况下会员应遵守中国现行的相关法律法规，而且在任何国家制作推广材料或 赞助、举办推广活动之前会员均应检索当地相关法律法规及行业准则的规定和要求 2.5 推广活动的透明性 会员不得对其推广行为和活动作任何形式的隐藏或掩饰不得将临床评估、药品上市后 的监测和反应项目及获得上市许可后的研究活动等转为变相的药品推广。上述评估、项目 以及研究均须以科学和教育为目的。对于由某公司赞助的、与药品及其使用相关的材 料无论其性质是否属于推广均应明示该材料系由某公司赞助。当公司以资助或其他方 式安排将其推广材料刊登在杂志上这些推广材料不得有使人误解其为独立的编者评论之 嫌。 2.6 药品获得上市许可之前的互动交流，及在药品标明的适用范围之外使用药品 会员在某药品获得中国药品主管部门颁发的上市(生产或进口)许可之前不得从事为在 中国上市使用该药品而进行的推广活动。 上述规定并不排斥科学界及一般公众对科技和医学发展动态的知情权。它既不限制就某 种药品的科学信息作充分适当的沟通的行为，包括通过科技专业媒体或普通媒体或在科学 交流会议上公布有关该药品的调研结果也不限制按相关法律法规的要求就某种药品向股 东或其他人作公开的信息披露。 2.3 Appropriate Use Promotion should encourage the appropriate use of pharmaceutical products by presenting them objectively and without exaggerating their properties. 2.4 Chinese Laws and other Local Regulations In all cases, all applicable Chinese laws and regulations (Chinese law) must be observed and Members have a responsibility to check all relevant laws, local regulations and industry codes in advance of preparing promotional material or sponsoring and organizing events in any specific country. 2.5 Transparency of Promotion Promotion should not be disguised. Clinical assessments, post- marketing surveillance and experience programs and post-authorization studies must not be disguised promotion. Such assessments, programs and studies must be conducted with a primarily scientific or educational purpose. Material relating to pharmaceutical products and their uses, whether promotional in nature or not, which is sponsored by a company should clearly indicate by whom it has been sponsored. Where a company pays for or otherwise secures or arranges the publication of promotional material in journals, such promotional material must not resemble independent editorial matter. 2.6 Pre-Approval Communications and Off-label Use No pharmaceutical product shall be promoted for use in China until drug registration approval for marketing purposes has been granted by Chinese drug administration authorities. This provision is not intended to prevent the right of the scientific community and the public to be fully informed concerning scientific and medical progress. It is not intended to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination of investigational findings in scientific or lay communications media and at scientific conferences. Nor should it restrict public disclosure of information to stockholders and others concerning any pharmaceutical product, as may be required or desirable under applicable laws and regulations. 第第 3 条条 推广信息的标准推广信息的标准 3.1 产品信息的一致性产品信息的一致性 推广活动所传递的信息应与中国药品主管部门批准的药品标准相一致。中国的医疗卫生 专业人士应当获得与在发达国家传播的药品信息相类似的信息。 3.2 准确和不误导准确和不误导 推广信息应当清楚、易理解、准确、全面、公正、客观、完整足以使相对人能就有关 药品的治疗价值形成自己的观点。药品推广信息应以对所有相关证据所作的最新评估为依 据并清楚地反映出相关证据事实。推广信息不应通过曲解、夸大、过分强调、忽视、贬 低竞争对手或其他方式误导相对人。推广者应尽最大努力避免推广信息出现模糊不清的情 况避免使用绝对的和无所不包的论断，且一般应避免使用诸如“安全”、“无副作用”之类的 描述性词句如需使用则必须有充分的科学依据。 3.3 实证实证 药品推广信息应能通过对已经批准的药品说明书或科学证据的引用而得到证实。当医疗 卫生专业人士要求提供上述科学证据时推广者应向其提供。公司应以客观态度对待所有 要求获取有关药品信息的善意请求并应根据不同查询者的具体情况提供充分适当的药品 信息。 ARTICLE 3 STANDARDS OF PROMOTIONAL INFORMATION 3.1 Consistency of Product Information Promotion should not be inconsistent with pharmaceutical product information approved by Chinese drug administration authorities. Chinese healthcare professionals should have access to similar product information to that being communicated in developed countries. 3.2 Accurate and Not Misleading Promotional information should be clear, legible, accurate, balanced, fair, objective and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the pharmaceutical product concerned. Promotional information should be based on an up-to-date evaluation of all relevant evidence and reflect that evidence clearly. It should not mislead by distortion, exaggeration, undue emphasis, omission or disparaging the competitor(s) or in any other way. Every effort should be made to avoid ambiguity. Absolute or all-embracing claims should be avoided, and descriptions such as safeandno side effectsshould generally be avoided and should always be adequately qualified. 3.3 Substantiation Promotion should be capable of substantiation either by reference to the approved labeling or by scientific evidence. Such evidence should be made available on request to healthcare professionals. Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the inquiry. 第第 4 条印刷推广材料条印刷推广材料 4.1 内容要求内容要求 在遵守中国法律其他相关规定的前提下除 4 2 条所列情形外所有印刷推广材料均应 清晰易懂并包括以下必备内容： (a)药品名称(通常为药品的商品名)， (b)药物活性成份(应尽可能地使用经批准的名称)， (c)制药公司或药品代理公司的名称及地址， (d)广告制作的日期， (e)“处方信息概要”包括已经批准的一项或多项适应症、用法用量以及对禁忌症提示和 副作用的简要说明。 科学或医学文章的翻印本在单独使用时不构成药品推广材料因其非由制药公司制作， 但如果将它们连同由制药公司制作的其他文件一起发送到医疗卫生专业人士手中，则这些 翻印本就转变为药品推广材料。一旦某个推广材料中提及或者包含了科学或医学的论文或 研究报告或这些论文报告与推广材料一起被发送给相对人时推广人均应对论文或报告 的出处作清楚说明。 对任何选自于某论文或研究报告、并被包含在推广材料中或与推广材料一起被发送给相 对人的非文字信息(包括图表、示图、照片或者表格等)的翻印推广人均须清楚地注明出 处且翻印应忠实于原文。 4.2 提示性广告提示性广告 “提示性”广告是指仅包含药品名称和简要提示药品适应症的简短广告。“提示性”广告可以 省略上述 4 1 条中所提到的“处方信息概要”。 ARTICLE 4 PRINTED PROMOTIONAL MATERIALS 4.1 Content Requirements Subject to any additional requirements under Chinese law, all printed promotional materials other than those covered in 4.2 below must be legible and include: (a) the name of the product (normally the brand name); (b) the active ingredients, using approved names where they exist; (c) the name and address of the pharmaceutical company or its agent responsible for marketing the product; (d) date of production of the advertisement; (e) “abbreviated prescribing information” which should include an approved indication or indications for use together with the dosage and method of use; and a succinct statement of the contraindications precautions and side effects. Reprints of scientific and medical articles, when used as stand-alone documents, are not developed by pharmaceutical companies and as such cannot be considered as promotional materials. If, however, they are presented to a healthcare professional together with other, company originated documents, they then become promotional materials. In all cases, where promotion refers to, includes, or is presented together with scientific or medical articles or studies, clear references should be provided. Any reprint of artwork (including graphs, illustrations, photographs or tables) taken from articles and included or presented with promotional materials should clearly indicate the source of the artwork and be faithfully reproduced. 4.2 Reminder Advertisements A“reminder” advertisement is defined as a short advertisement containing no more than the name of the product and a simple statement of indications to designate the therapeutic category of the product. For“reminder” advertisements, “abbreviated prescribing information” referred to in Article 4.1 above may be omitted. 第第 5 条电子版推广材料，包括音像制品条电子版推广材料，包括音像制品 电子版推广材料应遵守与印刷形式推广材料相同的各项要求。就与药品有关的网页而言： (a)制药公司的名称以及网页推广所针对的受众应一目了然， (b)内容应当适合于其所针对的受众， (c)其制作(内容、链接等)对其所针对的受众而言应适当、醒目， (d)针对某个国家市场的信息应符合当地的法律法规。 第第 6 条与医疗卫生专业人士的互动交流条与医疗卫生专业人士的互动交流 6.1 互动交流活动 6.1.1 以科学和教育为目的 对任何由会员组织或赞助的、针对医疗卫生专业人士所进行的各种座谈会、代表大会及 其他推广的、科学的或专业的会议(以下统称“互动交流活动”)而言其目的和重点都只能是 向后者传递有关药品信息以及提供科学或教育方面的资讯且应严格遵守本准则 2.2 条 的规定。 6.1.2 涉及到出国的互动交流活动涉及到出国的互动交流活动 会员只可在理由充分的情况下组织或赞助医疗卫生专业人士赴中国境外参加互动交流活 动，所谓“理由充分”是指： (a)有关活动所邀请的大部分医疗卫生专业人士都来自境外且出于会议安排及安全的考 虑在境外举办该活动更为合理，或者 (b)作为有关活动主题的相关资源或专家均在中国境外。 6.1.3 互动交流活动中的药品推广互动交流活动中的药品推广 信息 如果推广者在国际的科学大会或座谈会上需要通过展示窗或直接分发材料的方式向出 席者传送某个，些尚未在会议所在国注册、或虽注册但内容和条件与其他国家有所不同的 药品的推广信息则该推广行为还须同时满足以下几个条件： (a)会议本身应当是真正意义上的国际科学会议其中大多数讲演者和出席者都应来自会 议所在国，地区以外的其他国家， (b)尚未在会议所在国，地区注册的药品的推广材料(不包括推广辅助用品)中应包含该药品 已在哪些国家获得注册的说明同时声明该药品尚未在会议所在国，地区获得注册， (c)如某药品虽然在会议所在国，地区获得上市许可但其推广材料中含有经会议所在国， 地区以外的其他国家批准的新的处方信息(适应症、警告等)则推广材料应同时声明该药 品的注册内容和条件在各国之间有所不同， (d)推广材料中应明示药品已获注册的国家、及药品尚未在会议所在国，地区获得注册的 事实。 6.2 赞助赞助 会员在满足以下条件的情况下可赞助医疗卫生专业人士出席互动交流活动： (a)有关互动交流活动符合本准则 6.5 条关于招待活动的规定， (b)对医疗卫生专业人士赞助应限于对旅行、餐费、住宿及会议注册费的支付， (c)不得对医疗卫生专业人士出席会议的时间作任何补偿， (d)对医疗卫生专业人士提供赞助不得以其对某药品的处方、推荐或推广等义务为条件。 ARTICLE 5 ELECTRONIC MATERIALS, INCLUDING AUDIOVISUALS The same requirements shall apply to electronic promotional materials as apply to printed materials. Specifically, in the case of pharmaceutical product related websites: (a) the identity of the pharmaceutical company and of the intended audience should be readily apparent; (b) the content should be appropriate for the intended audience; (c) the presentation (content, links, etc.) should be appropriate and apparent to the intended audience; and (d) country-specific information should comply with local laws and regulations. ARTICLE 6 INTERACTIONS WITH HEALTHCARE PROFESSIONALS 6.1 Events 6.1.1 Scientific and Educational Objectives The purpose and focus of all symposia, congresses and other promotional, scientific or professional meetings (an“Event”) for healthcare professionals organized or sponsored by a company should be to inform healthcare professionals about products and/or to provide scientific or educational information and should be conducted in full compliance with Article 2.2. 6.1.2 Events Involving Foreign Travel A Member can only organize or sponsor an event for healthcare professionals outside China if it is justified, i.e.: (a) a significant proportion of the invited healthcare professionals are from outside China, and it makes greater logistical or security sense to hold the event in another country; or (b) the relevant resource or expertise that is the object or subject matter of the Event is located outside of China. 6.1.3 Promotional Information at Events Promotional information which appears on exhibition stands or is distributed to participants at international scientific congresses and symposia may refer to pharmaceutical products which are not registered in the country where the Event takes place, or which are registered under different conditions, provided that the following conditions are observed: (a) The meeting should be a truly international, scientific Event with a significant proportion of the speakers and attendees from countries other than the country where the Event takes place; (b) Promotional material (excluding promotional aids) for a pharmaceutical product not registered in the country of the Event should be accompanied by a suitable statement indicating the countries in which the product is registered and make clear that such product is not available locally; (c) Promotional material which refers to the prescribing information (indications, warnings, etc.) authorized in a country or countries other than that in which the Event takes place but where the product is also registered, should be accompanied by an explanatory statement indicating that registration conditions differ internationally; and (d) An explanatory statement should identify the countries in which the product is registered and make it clear that it is not available locally. 6.2 Sponsorship Members may sponsor healthcare professionals to attend Events provided such sponsorship is in accordance with the following requirements: (a) the Event complies with the hospitality requirements in this Code as described in Article 6.5; (b) sponsorship to healthcare professionals is limited to the payment of travel, meals, accommodation and registration fees; (c) no payments are made to compensate healthcare professionals for time spent in attending the Event; and, (d) any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend or promote any pharmaceutical product. 6.3 客人客人 会员不得支付与所邀请的医疗卫生专业人士随行客人的任何费用。 6.4 向讲演者付费向讲演者付费 如果医疗卫生专业人士按照其与公司就某互动交流活动签订的书面合同提供了真实的讲 演服务则公司可以向其支付合理的报酬并补偿其包括旅行费和住宿费在内的、实际发 生的合理费用。 6.5 招待招待 6.5.1 适当的地点适当的地点 互动交流活动均应在适当的地点举办以有助于实现科学教育的目标及会议本身的目的。 公司应避免选择名胜或铺张奢侈的地点举办会议。此外本准则第 6 条的其他规定也同时 应适用于本条。 6.5.2 招待的限制条件招待的限制条件 招待活动应限于那些附属于互动交流活动主题的餐饮活动且： (a)只能向互动交流活动的参加者提供而不能向其客人提供， (b)按当地标准衡量应是中等水平的和合理的。 6.5.3 娱乐娱乐 会员不应提供或支付任何单独进行的娱乐或其他休闲社交活动。在互动交流活动中可 以提供附属于相关活动主题的、适度的娱乐或其他休闲社交活动。 6.3 Guests Members should not pay any costs associated with individuals accompanying invited healthcare professionals. 6.4 Payments for Speakers and Presenters Payments of reasonable fees and reimbursement of out-of-pocket expenses against receipt, including travel and accommodation, may be provided to healthcare professionals who are providing genuine services as speakers or presenters on the basis of a written contract including reasonable compensation terms with the company at the Event. 6.5 Hospitality 6.5.1 Appropriate Venue All Events should be held in an appropriate venue that is conducive to the scientific or educational objectives and the purpose of the Event or meeting. Members should avoid using renowned or extravagant venues. The additional require