1. Combating counterfeit medicines in Vietnam

2. Issues Definitions of counterfeit medicines and concerned legal documents National coordination Number of counterfeit cases detected

3. As indicated in the Pharmaceutical Law - 2005 Definitions of counterfeit medicines Counterfeit medicines are products manufactured in the forms of medicines on intention of fraudulence, falling in one of the following cases : Without active pharmaceutical ingredient Containing API but with a different dosage from what has been registered Containing different API from the one printed on the label Imitating name and industrial design of anothers manufacturers product registered for industrial property right protection

4. LEGISLATION ON COUNTERFEIT DRUGS Pharmaceutical Law (2005) Law on Peoples Health Protection (Chapter VI) Criminal Law (Article 156 and 157) Ordinance on Private Medical and Pharmaceutical Practices Decree No. 45/2005/NĐ-CP on administrative punishments related to health practices Medicine quality management regulations – medicine registration regulations – regulations on sampling medicines for quality validation Circular instructing medicine and cosmetic labelling – Circulars instructing medicine import, export

5. LEGISLATION ON COUNTERFEIT DRUGS Joint -Circular No. 27/TTLT on combating counterfeit medicines and rearranging medicine market (1990) Directive No. 31/1999/CT-TTg by the PM on combating against production and trading of counterfeit goods Joint Circular No. 10/1999/TTLB instructing the execution of Directive No. 31/1999/CT-TTg on combating against production and trading of counterfeit goods

6. LEGISLATION ON COUNTERFEIT DRUGS Pharmaceutical Law Article 9 : Strictly forbidden acts: 1-Conducting drug trade without Certificate of SDTC 2- Conducting drug trade without Certificate of PP 3- Trading in drugs of unclear origin, counterfeit drugs, substandard drugs, expired drugs, drugs in the banned list of import, drugs for clinical trials, drugs which are not permitted for marketing, sample drugs used for registration or for promotion to physicians

7. LEGISLATION ON COUNTERFEIT DRUGS Pharmaceutical Law -Article 9: Strictly forbidden acts: 4- Counterfeiting, renting, borrowing, leasing, lending certificates of pharmaceutical practice, certificates of satisfaction of drug trading conditions 6- Selling drugs at places which are not lawful drug selling establishments

8. CRIMINAL ACT - Persons who produce, trade in counterfeit products that are food, drugs shall be liable to an imprisonment of 2 to 7 years - Committing the offences (depending on consequences) shall be liable an imprisonment of 5 to 20 years, or live imprisonment or death penalty - Guilty persons shall be liable to a fine from 5 million to 50 million VND; their properties shall be partly or totally confiscated;…;be prohibited from professional practices or operating certain jobs for a period of 1 to 5 years. Article 156 Production, trade in counterfeits Article 157 Production, trade in food and drug counterfeit - Persons who produce, trade in counterfeit products shall be liable to an imprisonment

9. 9 The inconsistency of existing laws and regulations of Vietnam on counterfeits 1. There exists the conflict between Pharmaceutical Law and Intellectual Property Law since the IP Law does not consider the act of imitating industrial design of certain product as counterfeiting. So the punishment is administrative and financial activities To resolve it: Add the regulations which classify more details the indices of counterfeit drugs. 2. The sample collected on the market is only legal if the sampling process is conformed to the regulations on collecting sample and the sampling process is official. So that, drug regulators is not capable to capture the counterfeit drugs. To resolve: implementation of buying the sample. And add the quality controllers.

10. 10 Intellectual Property Law 2005 Article 213. Intellectual property counterfeit goods 1. Intellectual property counterfeit goods include counterfeit mark goods or counterfeit geographical indication goods... 2. Counterfeit mark goods are goods or their packaging bearing a mark or a sign which is identical with or substantially indistinguishable from a mark or geographical indication which is protected for such goods without consent of the owner of such mark or the management organization of such geographical indication respectively.

11. Systems of Agencies on Combating CD Steering Committee No 127 Head by Minister of Trade and Industry Vice Ministry of Police Vice Ministry of Finance Provincial Committee 127 Vice Ministry of Health Vice Ministry of Trade and Industry Economic Police (A-counterfeit Section) DAV- Inspectorate Control Lab Market Control Customs (Anti- Smuggling) Other Department Sub Market Control Department Police Service Health Service Permanent Standing Customs Department

12. Functions of Steering Committee No. 127 Assist the PM to direct and coordinate the collaboration the anti counterfeit inter-sectoral activities of Ministries and Bodies Monitoring, supervising and speeding up the anti counterfeit of Ministries, Provincial Directly settling the difficulty counterfeit cases, concerning many Ministries, or bodies, or inter- areas Synthetizing the situation and the results of anti counterfeit activities Give the petition to PM of measures to improve anti counterfeit activities.

13. Process Flow Receives alert DAV, Police MC, Cust Confirms alert DAV, Police MC, Cust Investigations Police ProsecutionsTribunal Recall Case closed & archived Reporter report (Lot of sources) Lot of Source DAV, Police, MC, Customs

14. Number of CD Cases Detected SuspectedConfirmedImported/ domestic Vital Medicines 2006 8 drugs 42No- identified source 1 Antibiotic, 1 Artesunate 2005 17 drugs 463/ 3 + 4 No- identified source Some antibiotic, Clamoxyl : 20 000 sachets Postinor: 30.000 tablets Acetaphen : 24.500 ampouls Cefuroxim : 1400 vials

15. Number of CD Cases Detected Number of Case Patient Complaints2 Health professional reports0 Enforcement/Investigation works 3 Routine Check2 Reported by affected manufacturer 10 Other