1. Combating Counterfeit Drugs in China Chen Xu Ph.D. (chenxu@sfda.gov.cn) Director of Division of Drug Supervision and Inspection Department of Drug Market Compliance State Food and Drug Administration People s Republic of China Department of Drug Market Compliance State Food and Drug Administration People s Republic of China

2. 2 What legislation is currently used for SFDA to combating counterfeit drug? China had first Drug Administration Law in 1985,which contained special articles for combating counterfeit drugs Drug Administration Law was revised in 2001, provided more specific Articles for combating counterfeit drugs. Regulations for Implementation of Drug Administration Law promulgated in 2002, and also contained special articles for combating counterfeit drugs. The State Council special regulation for strengthens food and drug security Surveillance was published and implemented on July 25, 2007,which contained special articles for combating counterfeit drug too.

3. 3 Article 48(Drug law) Production (including dispensing, the same below) and distribution of counterfeit drugs are prohibited. N ational definitions of counterfeit drug are followings: A drug is a counterfeit drug in any of the following cases: (1) the ingredients in the drug are different from those specified by the national drug standards; or (2) a non-drug substance is simulated as a drug or one drug is simulated as another. A drug shall be treated as a counterfeit drug in any of the following cases: (1) its use is prohibited by the regulations of the drug regulatory department under the State Council; (2) it is produced or imported without approval, or marketed without being tested, as required by this Law; (3)it is deteriorated; (4) it is contaminated; (5) it is produced by using drug substances without approval number as required by this Law; or (6) the indications or functions indicated are beyond the specified scope.

4. 4 Article 49(Drug law) Production and distribution of substandard drugs are prohibited. N ational definitions of substandard drug are followings: A drug with content not up to the national drug standards is a substandard drug. A drug shall be treated as a substandard drug in any of the following cases; (1) the date of expiry is not indicated or is altered; (2) the batch number is not indicated or is altered; (3) it is beyond the date of expiry; (4) no approval is obtained for the immediate packaging material or container; (5) colorants, preservatives, spices, flavorings or other excipients are added without authorization; or (6) other cases where the drug standard are not conformed.

5. 5 What are gaps in current legislation and how to meet gaps? In China, SFDA is responsible for administrative punishment on counterfeit drug including to investigate & penalize illegal activities of manufacturing, selling, using counterfeit drugs). But SFDA is not rresponsible for criminal punishment on counterfeiting. In China, SFDA is responsible for administrative punishment on counterfeit drug including to investigate & penalize illegal activities of manufacturing, selling, using counterfeit drugs). But SFDA is not rresponsible for criminal punishment on counterfeiting. In order to meet the gaps, SFDA cooperates with other government bodies. In order to meet the gaps, SFDA cooperates with other government bodies. –working with the Public Security Ministry for criminal punishment for manufacturing & selling counterfeit drugs, –working with the Public Security Ministry for criminal punishment for manufacturing & selling counterfeit drugs, –working with Postal Office for eliminating, closing of mail orders & mail boxes of counterfeit drugs. –working with Postal Office for eliminating, closing of mail orders & mail boxes of counterfeit drugs. –working with the Customs Office to control of smuggling counterfeit drug. –working with the Customs Office to control of smuggling counterfeit drug.

6. 6 What is being done to fill the gaps? Now we, SFDA has established regular and long term cooperation mechanisms with the above Depts. We have established fixed office, fixed meeting timetable, fixed hot line, and so on. Now we, SFDA has established regular and long term cooperation mechanisms with the above Depts. We have established fixed office, fixed meeting timetable, fixed hot line, and so on. For example, during March 25, to September 25,2003 SFDA carried out jointly by the Ministry of Public Security to combat the production and selling of counterfeit medicines in a nationwide scale. SFDA and the Ministry of Public Security had set up a special action leading group in charge of this special operation command coordination. The local DRA and public security also set up specialized agencies, responsible for organization and leadership work, and to identify hand, is responsible for the coordination of special action links. This special operation, the goal is to destroy key areas of production, selling of counterfeit medicines, and sales networks, and prosecute the illegal production and sale of counterfeit criminals, and to effectively check the manufacture and sale of counterfeit medicines. Establish a perfect anti-counterfeit long-term cooperation mechanism to purify medicine market order, and ensure the safety of the masses medication. For example, during March 25, to September 25,2003 SFDA carried out jointly by the Ministry of Public Security to combat the production and selling of counterfeit medicines in a nationwide scale. SFDA and the Ministry of Public Security had set up a special action leading group in charge of this special operation command coordination. The local DRA and public security also set up specialized agencies, responsible for organization and leadership work, and to identify hand, is responsible for the coordination of special action links. This special operation, the goal is to destroy key areas of production, selling of counterfeit medicines, and sales networks, and prosecute the illegal production and sale of counterfeit criminals, and to effectively check the manufacture and sale of counterfeit medicines. Establish a perfect anti-counterfeit long-term cooperation mechanism to purify medicine market order, and ensure the safety of the masses medication.

7. 7 If the case of counterfeit drugs accords with the demands of criminal punishment, DRA must promptly transfer it to the public security bodies according to the stipulation, positively coordinates the judicial bodies to develop pursues the punishment work, including collects and the production of evidence. Has a suspect clue of criminal case, SFDA must propose the public security bodies to involve ahead of time, the coordination investigation, prevented and avoids the criminal suspect as far as possible escaping, already escaped must assist the public security bodies to seize as soon as possible brings to justice. If the case of counterfeit drugs accords with the demands of criminal punishment, DRA must promptly transfer it to the public security bodies according to the stipulation, positively coordinates the judicial bodies to develop pursues the punishment work, including collects and the production of evidence. Has a suspect clue of criminal case, SFDA must propose the public security bodies to involve ahead of time, the coordination investigation, prevented and avoids the criminal suspect as far as possible escaping, already escaped must assist the public security bodies to seize as soon as possible brings to justice. The conditions for DRA to transfer counterfeit case to the public security body: The conditions for DRA to transfer counterfeit case to the public security body: (1) Individual illegal sale counterfeit drug amount 50,000 Yuan (RMB) above, or illegal obtained amount in 10,000 Yuan (RMB) above; (2) Unit illegal sale counterfeit drug amount 500,000 Yuan (RMB) above, or illegal obtained amount in 100,000 Yuan (RMB) above; (3) The production and sale of counterfeit drug, also sufficiently causes the human body serious harm, may directly carry on processing by the public security department according to the criminal law, not above amount limit. What is being done to fill the gaps?

8. 8 What are proposal for actions of IMPACT? (1) Measures to be taken: (a) Signing work cooperation document, making corresponding working routine. (b) Establishing special department, the personnel are responsible to coordinate the routine duties. (c) Establishing the platform of information exchange, is prompt, accurately the sharp related counterfeit information. (2) WHO should do it? (a) The coordination, management of IMPACT throughout member countries. (3)Transsmitting information to related country. (b)Providing the essential funds, and technical supports to the various countries.

9. 9 What are proposal for actions of IMPACT? (3)Critical factors to ensure success (a) The various countries' work develops and cooperates, WHO must establish in the equal and in the cooperation foundation, does not interfere the various countries' investigation work. (b) Information exchange provided by IMPACT system must be traceable according to the evidence which may look up. (c) Funds safeguard. (4)Realistic timeframe After completion of above work, all participates of IMPACT can be in motion together. (5) Cost estimate Needs 4 million US dollars funds budget every year in China.