Provisions for Supervision of Drug Distribution
Commissioner of SFDA
Provisions for Supervision of Drug Distribution
(SFDA Decree No.26)
The Provisions for Supervision of Drug Distribution, adopted at the executive meeting of the State Food and Drug Administration on December 8, 2006, is hereby promulgated and shall go into effect as of May 1, 2007.
Shao Mingli
Commissioner of SFDA
January 31, 2007
Provisions for Supervision of Drug Distribution
Chapter I
Article 1 These Provisions are formulated for the purposes of strengthening drug supervision, regulating drug distribution order and ensuring drug quality in accordance with the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Drug Administration Law), the Regulations for Implementation of the Drug Administration Law of the People’s Republic of China (hereinafter referred to as Regulations for Implementation of the Drug Administration Law) and the requirements of the relevant law and regulations.
Article 2 Any institutions or individuals engaged in the purchase, sales and supervision of drugs in the People’s Republic of China shall abide by the Provisions.
Article 3 Drug manufacturers, distributors and medical institutions shall be responsible for the quality of the drugs that they produce, distribute or use.
Drug manufacturers and distributors shall carry out reforms and innovations in the direction of pharmaceutical logistics provided that drug quality is assured.
Article 4 The drug regulatory departments encourage individuals and organizations to involve in the social supervision on drug distribution. Individuals or organizations have the right to report or accuse of any violation of the Provisions to the drug regulatory departments.
Chapter II Supervision on Drug Purchase and Sales by Manufacturers and Distributors
Article 5 Drug manufacturers or distributors shall be responsible for their drug purchases and sales, and liable for the purchases and sales activities of their sales staff or offices in the name of their enterprise.
Article 6 Drug manufacturers or distributors shall train their purchase and sales staff on drug related laws, regulations and professional knowledge, and establish training records including time, venue, content and trainees.
Article 7 Drug manufacturers or distributors shall strengthen the management of the sales staff and set up specific rules for their sales behaviors.
Article 8 Drug manufacturers or distributors shall not store or spot trade drugs on the premises not approved by the drug regulatory departments.
Article 9 Drug manufacturers shall sell drugs that they produce in the name of themselves, and shall not sell any drug that they produce for contract manufacturing or any drugs produced by others.
Article 10 Where a drug manufacturer or wholesaler sells drugs, it shall provide the following materials:
(1) Copies of the Drug Manufacturing Certificate or Drug Supply Certificate, stamped with the seal of the enterprise, and the business license;
(2) Copies of the approval documents for the drug to be sold, stamped with the seal of the enterprise ;
(3) For import drug sales, relevant proof documents should be provided in accordance with the related provisions of the State.
Where a drug manufacturer or wholesaler sends any of its sales staff to sell drugs, it shall, in addition to the materials prescribed in the previous paragraph of this Article, provide a copy of the authorization letter with the seal of the enterprise. The original authorization letter shall contain the authorized drugs, regions and time of validity for drug sales, indicate the identity card numbers of the sales staff, and be stamped with the enterprise seal and legal representative seal (or signature). The sales staff shall show the original authorization letter and identity card for the check by drug purchasers.
Article 11 Where a drug manufacturer or wholesaler sells drugs, it shall provide sales document indicating supplier’s name, drug name, manufacturer, batch number, quantity, price, etc.
Where a drug retailer sells drugs, it shall provide sales document indicating drug name, manufacturer, quantity, price, batch number, etc.
Article 12 Where a drug manufacturer or distributor purchases drugs, it shall request, examine and retain the relevant certificates and documents of the supplier in accordance with the requirements set forth in Article 10 of the Provisions, and request and retain sales document in accordance with the requirements set forth in Article 11 of the Provisions.
The documents retained by the drug manufacturer or distributor in accordance with the previous paragraph of this Article shall be kept till one year after the date of expiry, but not less than three years.
Article 13 Where a drug manufacturer or distributor knows or should know that any person without certificates produces or distributes drugs, it shall not provide the person with any drug.
Article 14 A drug manufacturer or distributor shall not provide premises, qualifications documents, notes, etc. as conveniences for others to distribute drugs in its own name.
Article 15 A drug manufacturer or distributor shall not spot trade drugs by means of exhibition, exposition, trade fair, commodity fair or product promotion event.
Article 16 A drug distributor shall not purchase or sell pharmaceutical preparations prepared by medical institutions.
Article 17 A drug distributor shall not change its distribution mode without approval of the drug regulatory department.
A drug distributor shall operate within the approved distribution scope in the Drug Supply Certificate.
Article 18 A drug retailer shall, pursuant to the requirements of drug classification regulations set forth by the State Food and Drug Administration, sell prescription drugs in the presence of prescriptions.
Any drug retailer selling prescription drugs or Class A non-prescription drugs shall, in the absence of its licensed pharmacists and other qualified pharmaceutical professionals, put up a public notice and stop selling prescription drugs and Class A non-prescription drugs.
Article 19 For drugs that need low-temperature or cold storage as specified in drug insert sheets, the drug manufacturer or distributor shall transport and store the drugs with low-temperature or cold storage facilities in accordance with the relevant provisions.
When finding any drug manufacturer or distributor violates the requirements in the previous paragraph of this article, the drug regulatory department shall seal up or seize the drugs concerned immediately and deal with the matter in accordance with law.
Article 20 A drug manufacturer or distributor shall not provide the public with prescription drug or Class A non-prescription drug by means of tie-in sale, offering free drugs in association with sales of drug or commodity sale, etc.
Article 21 A drug manufacturer or distributor shall not sell prescription drugs directly to the public by post or over internet.
Article 22 Any illegal purchase of drugs is prohibited.
Chapter III Supervision on Drug Purchase and Storage by Medical Institutions
Article 23 The pharmacy established by a medical institution shall have the premise, equipment, storage facilities, hygienic environment, and pharmaceutical professionals required for drug dispensing. It shall also have the drug quality control units or personnel, and establish a system for drug storage.
Article 24 Where a medical insititution purchases drugs, it shall request, examine and retain the relevant certificates, documents and notes of the supplier in accordance with the requirements set forth in Article 12 of the Provisions.
Article 25 Where a medical institution purchases drugs, it shall establish and apply an examination and acceptance system, and keep authentic and complete purchase records. Purchase records shall indicate the adopted name of the drug in China, manufacturer (for Chinese crude drug, the origin should be noted), dosage form, date of expiry, drug approval number, supplier, quantity, price and date of purchase.
Drug purchase records shall be kept till one year after the date of expiry, but not less than three years.
Article 26 A medical institution shall establish and apply a system for drug storage and maintenance, and take necessary measures to ensure drug quality, such as cold storage, protection against freeze and humidity, ventilation, moisture proof, protection from direct light and fire, and avoidance of insects and rodents.
A medical institution shall store drugs and non-drug products separately; Chinese crude drugs, prepared slices of Chinese crude drugs, pharmaceuticals, and traditional Chinese medicine preparations shall be stored separately by category.
Article 27 A medical institution or family planning technical service institution shall not directly provide drugs for patients without diagnosis or treatment.
Article 28 A medical institution shall not sell prescription drugs directly to the public by post or over internet.
Article 29 Where a medical institution purchases drugs via a centralized tendering, it shall comply with the relevant requirements of the Drug Administration Law, Regulations for Implementation of the Drug Administration Law and the Provisions.
Chapter IV Legal Liabilities
Article 30 In any of the following circumstances, the drug manufacturer or distributor shall be instructed to rectify within a time limit and given a disciplinary warning; and if the drug manufacturer or distributor fails to do so, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan:
(1) any drug manufacturer or distributor in violation of Article 6 of the Provisions;
(2) any drug manufacturer or wholesaler in violation of the first paragraph of Article 11 of the Provisions;
(3) any drug manufacturer or distributor, in violation of Article 12 of the Provisions, failing to keep the relevant documents as required.
Article 31 Any drug manufacturer or distributor in violation of Article 7 of the Provisions shall be given a disciplinary warning and instructed to rectify within a time limit.
Article 32 In accordance with the provisions in Article 73 of the Drug Administration Law, in any of the following circumstances, the drugs illegally sold and the illegal gains therefrom shall be confiscated, and the drug manufacturer or distributor shall be fined not less than two times but not more than five times the value of the drugs illegally sold:
(1) any drug manufacturer or distributor, in violation of Article 8 of the Provisions, spot trading drugs on the premises not approved by the drug regulatory departments.
(2) any drug manufacturer in violation of Article 9 of the Provisions;
(3) any drug manufacturer or distributor in violation of Article 15 of the Provisions;
(4) any drug distributor in violation of Article 17 of the Provisions.
Article 33 Any drug manufacturer or distributor, in violation of Article 8 of the Provisions, storing drugs on the premises not approved by the drug regulatory departments，shall be punished pursuant to the provisions in Article 74 of the Regulations for Implementation of the Drug Administration Law.
Article 34 Any drug retailer in violation of the provisions in the second paragraph of Article 11 of the Provisions shall be instructed to rectify and given a disciplinary warning; and if the drug retailer fails to do so within a time limit, it shall be fined not more than RMB 500 yuan.
Article 35 Where a drug manufacturer or distributor, in violation of Article 13 of the Provisions, knows or should know that any person without certificates produces or distributes drugs, but still provide the person with drugs, they shall be given a disciplinary warning, instructed to rectify and fined not more than RMB 10,000 yuan. If the circumstances are serious, they shall be fined not less than RMB 10,000 yuan but not more than RMB 30,000 yuan.
Article 36 Drug manufacturers and distributors in violation of Article 14 of the Provisions shall be punished pursuant to the provisions in Article 82 of the Drug Administration Law.
Article 37 Where a drug distributor, in violation of Article 16 of the Provisions, purchases or sells pharmaceutical preparations dispensed by medical institutions, it shall be punished pursuant to the provisions in Article 80 of the Drug Administration Law.
Article 38 Any drug retailer in violation of the first paragraph of Article 18 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so or the circumstances are serious, it shall be fined not more than RMB 1,000 yuan.
Where a drug retailer, in violation of the second paragraph of Article 18 of the Provisions, sells prescription drugs or Class A non-prescription drugs in absence of licensed pharmacists or other qualified pharmaceutical professionals, it shall be instructed to rectify within a time limit and given a disciplinary warning; if it fails to do so, it shall be fined not more than RMB 1,000 yuan.
Article 39 Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to transport drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be given a disciplinary warning and instructed to rectify within a time limit; if it fails to do as instructed, it shall be fined not less than RMB 5,000 yuan but not more than RMB 20,000 yuan. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Where a drug manufacturer or wholesaler, in violation of Article 19 of the Provisions, fails to store drugs under low-temperature or cold storage conditions as specified in insert sheets, it shall be punished pursuant to the provisions in Article 79 of the Drug Administration Law. Where the drugs concerned are legally proved to be counterfeit or substandard drugs, the drug manufacturer or wholesaler shall be punished in accordance with the relevant provisions of the Drug Administration Law.
Article 40 Any drug manufacturer or distributor in violation of Article 20 of the Provisions shall be instructed to rectify within a time limit and given a disciplinary warning; if the drug manufacturer or distributor fails to do so or the circumstances are serious, they shall be fined not more than two times the value of the free drugs offered, but not more than RMB 30,000 yuan.
Article 41 Any institution, in violation of Article 23 to Article 27 of the Provisions, shall be instructed to rectify within a time limit; if the circumstances are serious, it shall be announced.
Article 42 Where a drug manufacturer or distributor in violation of Article 21 of the Provisions or a medical institution in violation of Article 28 of the Provisions sells prescription drugs directly to the public by post, over internet, etc., they shall be instructed to rectify, given a disciplinary warning, and fined not more than two times the value of the drugs sold, but not more than RMB 30,000 yuan.
Article 43 Any illegal purchase of drugs, in violation of Article 22 of the Provisions, shall be punished pursuant to the provisions in Article 73 of the Drug Administration Law.
Article 44 Where a drug regulatory department or its staff that neglects its duty fails to stop or punish illegal activities that should be stopped or punished, administrative sanctions shall be imposed to the person directly in charge and other persons directly responsible. If a crime is constituted, criminal liabilities shall be investigated in accordance with law.
Chapter V Supplementary Provisions
Article 45 Spot trading of drugs in the Provisions refers to the activity that drug manufacturers, distributors or their appointed sales staff carry and sell drugs to unspecified objects on spot other than the premises approved by the drug regulatory departments.
Article 46 With respect to the supervision on the distribution of specially controlled drugs, vaccines, and military medicines, if otherwise provided by the relevant laws, regulations and provisions, they shall prevail.
Article 47 The Provisions shall come into force as of May 1, 2007. As of the date when the Provisions goes into effect, the Provisions for Supervision of Drug Distribution (Interim) (SFDA Decree No.7) implemented on August 1, 1999 shall be annulled therefrom.
音乐著作权侵权损害赔偿的若干法律问题
四川泰和泰律师事务所 熊永文律师
摘要：全国众多娱乐场所接到律师函，要求对其未经授权擅自使用音乐作品的侵权行为停止侵权并赔偿损失；业界产生了对音乐著作权侵权如何认定？证据制度怎么证明侵权构成？损害赔偿的计算方式和标准怎么样等音乐著作权侵权损害赔偿方面的法律问题，本文作了必要的法律介绍。
日前各媒体纷纷报道，国际唱片协会作为全球大型唱片公司的联盟，已委托全国50家律师事务所向全国120000家娱乐场所发出律师函，四川某律师事务所表示“成都几百家娱乐场所都会收到律师函，几乎不会有‘漏网之鱼’。”其中华纳唱片状告成都好乐迪量贩KTV侵犯著作权案件成为了成都首例音乐著作权官司，成都好乐迪量贩也成了被网住的第一条“鱼”。
华纳唱片状告好乐迪的理由是好乐迪在卡拉OK中使用了华纳出品的郑秀文的两首歌曲。而好乐迪认为，在卡拉OK和MTV中使用唱片公司的音乐，好乐迪每年都向文化部门交纳了费用，“每年5000元，一个子儿都不少，文化局发给我们的证明还挂在大厅。”（成都商报2004年3月2日A3版）。因此，好乐迪使用的每一首歌曲都经过文化部门审批，并不存在侵权问题。
那么我国音乐著作权侵权如何认定呢？好乐迪们如何合法使用音乐作品呢？有哪些可以抗辨的理由呢？侵权损害赔偿如何计算呢？本文对上述问题作律师实务上的探讨。
一、音乐电视、音乐录影和卡拉OK曲目是以类似摄制电影的方法创作的作品，应受到我国著作权法相应的保护。
《著作权法》保护的作品中包括了电影作品和以类似摄制电影的方法创作的作品（第三条第六项）。《著作权法实施细则》第四条明确规定电影作品和以类似摄制电影的方法创作的作品，是指摄制在一定介质上，由一系列有伴音或者无伴音的画面组成，并且借助适当装置放映或者以其他方式传播的作品；《著作权法》第十条第十项规定，著作权人对其作品享有放映权，“即通过放映机、幻灯机等技术设备公开再现美术、摄影、电影和以类似摄制电影的方法创作的作品等的权利”。著作权法第十五条规定：“电影作品和以类似摄制电影的方法创作的作品的著作权由制片者享有”。音乐电视（MTV）、音乐录影（MV）和卡拉OK曲目是以类似摄制电影的方法创作的作品，应受到我国著作权法相应的保护。
二、音乐作品的著作权权利人的著作权的基本内容有：
一般来讲，著作权包括下列人身权和财产权：
人身权包括：
1 、发表权，即决定作品是否公之于众的权利；
2 、署名权，即表明作者身份，在作品上署名的权利；
3 、修改权，即修改或者授权他人修改作品的权利；
4 、保护作品完整权，即保护作品不受歪曲、篡改的权利。
财产权包括使用权和获得报酬权，即以复制、表演、播放、展览、发行、摄制电影、电视、录像或者改编、翻译、注释、编辑等方式使用作品的权利；以及许可他人以上述方式使用作品，并由此获得报酬的权利。包括复制权（出版权、发行权、复制权、演绎权、翻译权一演绎权）、传播权（表演权、播放权、展示权、朗诵权）等权利。著作权法把“使用权”详细分列为复制权、发行权、出租权、展览权、表演权、放映权、广播权、信息网络传播权、摄制权、改编权、汇编权以及应当由著作权人享有的其他权利。涉及不同的使用权利，传播者对作者应该是分别受权、分别支付报酬。
在我国，音乐作品是受著作权保护的主要作品种类之一。音乐著作权人包括曲作者、词作者、音乐改编者、歌曲译配者、音乐作者的继承人以及其他合法方式获得音乐著作权的人，音乐出版者和录音者也可以通过音乐作者转让或通过开发音乐作品而享有音乐著作权。根据《中华人民共和国著作权法》规定，以印刷出版、录音发行、公开演奏演唱、公开放送录音、广播、编配和音像混成的方式使用音乐作品，都应征得音乐著作权人的许可。音乐著作权人有权授权他人使用其音乐作品并为此获得报酬。当然，他们也有权禁止他人使用其音乐作品。
（1）、机械复制权
（a）录音带、录像带及CD、VCD、LD、DVD、CD-ROM 等使用音乐作品的数字化制品
（b）影视作品的配音音乐
（c）广告音乐
（d）网上音乐
（e）使用音乐作品制作音乐作品
（2）、表演权
（a）现场表演（剧场、音乐厅）
（b）机械表演（背景音乐）使用场所有：饭店、商场、歌舞厅、卡拉 ok 厅、餐厅等
（c）网上浏览、试听等
（3）、广播权：电台、电视台、有线电视台、卫星电视台等
（4）、出版权：以印刷出版的形式使用音乐作品
三、音乐著作权侵权若干案例
1、播放ＭＴＶ音乐侵犯著作权案
2003年11月24日，北京市法院首次对卡拉ＯＫ歌厅中播放ＭＴＶ音乐作品是否支付著作权使用费作出判决。法院判决：北京纯音歌舞娱乐有限公司立即停止侵权播放陈慧琳三首ＭＴＶ作品行为，以书面形式向原告香港正东唱片有限公司公开赔礼道歉，并赔偿原告经济损失及各项诉讼合理支出共计56376元。这也是法院首次就歌厅播放ＭＴＶ音乐是否构成侵权作出判决。
2003年6月，香港正东唱片有限公司向北京市一中院递交起诉书，称北京纯音歌舞娱乐有限公司的自助式ＫＴＶ歌厅以营利为目的，擅自将正东唱片公司享有著作权的ＭＴＶ作品以卡拉ＯＫ的形式向公众放映。香港正东唱片有限公司认为对方侵犯了其专有著作权，要求法院判令对方立即停止侵权行为，公开赔礼道歉，赔偿原告经济损失及诉讼支出共计35万元。
北京市一中院经审理查明：纯音歌舞公司未经正东唱片公司许可，在ＫＴＶ点歌系统及歌曲库中提供了正东唱片公司享有著作权的三首歌曲ＭＴＶ作品。法院认为，该歌厅侵犯了著作权人的著作权，应承担停止侵害、消除影响、赔礼道歉、赔偿损失的民事责任。
2、背景音乐播放侵犯著作权案
2003年11月1日，中国音乐著作权协会以商场背景音乐侵犯著作权为由，把北京长安商场告上了法庭，要求长安商场支付20万元音乐使用费。这是我国新《著作权法》颁布以来，第一起因为背景音乐侵权而走上法庭的官司。
3、手机音乐侵犯著作权案
2003年11月，中国音乐著作权协会以手机内置铃声音乐侵犯该协会会员的著作权为由，将ＴＣＬ告上法庭，并索赔1200万元，这是目前国内最大的一起音乐著作权纠纷案。
4、mp3格式音乐侵权案
一九九六年窜起的网络音乐格式－MP3，已经成为颠覆传统唱片通路的杀手。按MP3的全名是MPEG Audio Layer 3，是一种以计算机播放、储存数字音乐的格式。MPEG是Moving Picture Experts Group(动态影象专业团体)的缩写，此国际团体所制定的MPEG标准已被广泛地应用在各种多媒体产品中(例如VCD、DVD影片等)。
一九九九年九月，十九岁的Shawn Fanning和二十岁的Sean Parker在美国加州创立了Napster公司，该公司发布的Napster软件使得寻找和共享MP3变得异常容易。Napster公司是美国是当时影响最大的音乐在线公司，Napster公司在广大的使用者群中构造了一个庞大的虚拟音乐社区。Napster公司积聚了强大的搜寻、聊天、文件传输以及播放功能，每一个使用Napster的使用者既是内容的提供者，也是内容的使用者。Napster令使用者之间能方便地交流各自的MP3。
一九九九年十二月七日，RIAA代表新力、华纳、维京、BMG、Motown等七家唱片公司，以违反著作权法为由，对Napster公司提起诉讼，称Napster向网络族提供MP3档案共享软件侵犯了音乐著作权，要求法院关闭该公司并赔偿损失一亿美元。
此次官司风波的影响，美国Napster公司已被迫关闭其30万在线音乐帐户，因部分大学生使用该软件而遭致侵权控告，故目前部分美国大学已禁止其学生再行使用Napster
5、卡拉ok播放音乐侵权案
2003年11月，华纳唱片有限公司诉北京唐人街餐饮娱乐有限公司侵犯著作权纠纷案称，该公司是郭富城演唱的《爱的呼唤》、《有效日期》、《听风的歌》3首歌曲MTV作品的著作权人。而外资企业北京唐人街餐饮娱乐有限公司未经其许可，以卡拉OK的形式向公众播放这三首作品，侵犯了其所享有的著作权中的放映权，故诉至法院，请求判令唐人街餐饮娱乐公司停止侵权、公开赔礼道歉并赔偿经济损失35万元。
北京市第二中级人民法院12月5日作出一审判决：被告北京唐人街餐饮娱乐有限公司赔偿原告华纳唱片有限公司经济损失2．3万元和因诉讼而支出的合理费用1．5万元。
