Country Presentation Myanmar First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta, 13-15 November 2007 Presented by Dr. Tun Zaw FDA, Myanmar

Legislative Infrastructure 1972 - Public Health Law 1992 October - National Drug Law 1993 August - Registration Notifications - Manufacturing - Sales and Distribution - Importation - Labelling and Advertisement 1995 January - Establishment of Food and Drug Administration (FDA)

The National Drug Law (1992) Chapter XI. Prohibitions 15(a) No one shall manufacture, import, export, store, distribute or sell the following drug; (i) a drug which has not been registered; (ii) a drug whose registration has been revoked temporarily or cancelled;

The National Drug Law (1992) (iii) fake drug, drug differing from standards, deteriorated drug, adulterated drug; (iv) a drug which has been manufactured with harmful substances; (v) a dangerous drug which is determined as not fit for utilization by the Ministry of Health by notification.

The National Drug Law (1992) (b) No one shall import or export a registered drug without permission under any existing law. 16. No one shall manufacture, store, distribute or sell a pharmaceutical raw material or drug without a licence.

The National Drug Law (1992) 17. A person who has obtained a licence – (a) shall not fail to abide by any condition of the licence; (b) shall not fail to abide by the orders and directives issued by the Ministry of Health or by the Board of Authority under this Law.

The National Drug Law (1992) Chapter XII. Offences and Penalties 18. Whoever violates any provision of section 15 shall, on conviction be punished with fine which may extend from a minimum of kyats 5,000 to a maximum of kyats 50,000 or with a imprisonment for a term which may extend to 7 years or with both. In addition, the exhibits involved in the offence shall also be liable to be confiscated.

The National Drug Law (1992) 19. Whoever violates any provision of section 16 shall, on conviction – (a) If it is an offence relating to an unregistered drug, be punished with fine which may extend from a minimum of kyats 5,000 to a maximum of kyats 50,000 or with imprisonment for a term which may extend to 7 years or with both;

The National Drug Law (1992) (b) If it is an offence relating to a registered drug, be punished with fine which may extend from a minimum of kyats 1,000 to a maximum of kyats 10,000 or with imprisonment for a term which may extend to 2 years or with both; (c) the exhibits involved in the offence shall also be liable to be confiscated.

The National Drug Law (1992) 20. A person who has obtained a licence and who violates any provision of section 17 shall, on conviction be punished with fine which may extend from a minimum of kyats 500 to a maximum of kyats 5,000 or with a imprisonment for a term which may extend to 1 years or with both.

National Definition of Counterfeit Drug 2 (d) Fake drug means the following; - (i) a drug the whole or part of the label of which is an imitation or resemblance by various means or is written similarly; (ii) a drug in respect of which the expiration date or manufacturer or distributor or place of manufacture or country of manufacture is fraudulently shown;

National Definition of Counterfeit Drug (contd.) (iii) a drug in respect of which it is fraudulently shown that it is manufactured according to the formula mentioned at the time of registration of the drug;

Legislative Infrastructure Gaps/ Insufficiencies Penalty for the offences pertaining to Counterfeit drugs is same as other offences pertaining to unregistered drugs, etc. It should be more harsh punishment for offences pertaining to Counterfeit drugs Revising The NDL and will be proposed to Attorney General’s Office

National Coordination

ORGANIZATIONAL STRUCTURE Cabinet of Ministers National Health Committee Ministry of Health Minister Myanmar Food and Drug Board of Authority (MFDBA) Central Food and Drug Drug Advisory Department of Health Supervisory Committee Committee Director General ( Central FDSC) (DAC) Food & Drug Administration Director State/Division Deputy Director (Drug) Deputy Director (Food) FDSC District Asst. Director Asst. Director Asst. Director Asst. Director Asst. Director Asst. Director FDSC Lab Service (Drug) Drug Control (Medical Devices & Lab. Service (Food) Food Control (Bio& Chemical Safety Lab) Safety Lab) Township

National Coordination Myanmar Food and Drug Board of Authority (MFDBA) is the highest authority for the control of food and drug affairs and is chaired by the Minister for Health MFDBA members come from various related departments and agencies e.g. General Administrative Dept., Myanmar Police Force, Custom, Trade, Development Affairs Dept. etc.

National Coordination Various levels of Food and Drug Supervisory Committees (FDSC) were formed – Central to Township level Members; Health General Affairs Police Force Development Affairs Livestock Breeding and Veterinary Dept.

National Coordination There is close collaboration between FDA (NRA) and other law enforcement agencies like Custom and Police Force in combating sub-standard, unregistered and counterfeit medical products. Benefits; The TFDSC was vested with the authority to inspect – routine and unannounced – drug retailers’ and wholesalers’ houses, and to issue licence

National Coordination Benefits; (contd.) The TFDSC has the right to conduct market surveillance and if there any counterfeit medical product has been detected, the committee might act upon the case according to the provisions of The NDL.

International Coordination Recent example of benefit: MPF, Chinese PF and Interpol coordinated and acted on information about fake artesunate trafficking across the trilateral border between Myanmar, PR china and Thailand at the end of Oct. 07. and seized two criminals with considerable amount of fake artesunate on Myanmar land, which was conducted with the name of Jupiter Operation.

Number of Cases 2006 - 0 / 25 Imported 2005 2 / 34 SUSPECTED CONFIRMED IMPORTED/ DOMESTIC VITAL MEDICINES 2006 - 0 / 25 Imported 2005 2 / 34

Number of Cases How these cases detected ? Detection of these cases rarely comes from patients complaints and Health professionals reports. It usu. come from enforcement/ investigation work, routine and periodic checks and reported by affected manufacturers

Number of Prosecutions/ convictions/ Pending Manufacturer Wholesaler/ Retailer Importer Informal sector 2006 - 8 / 0 / 0 2005 5 / 0 / 0

Proposals for Action Measures to be taken: Strengthening of coordination and cooperation between China and ASEAN countries in combating counterfeit medical products esp. cross-border trafficking. Strenghening of prompt and effective information exchange system among our countries Holding meeting at regular basis

Proposals for Action Who should do it? Every country should participate actively and all the stakeholders as well. Assignment of Focal Point for our region Establishment of contact point in each country NDRA should do most

Proposals for Action Critical factors to ensure success Effective intra-regional cooperation is of great importance Prompt information exchange between stakeholders is critical

Proposals for Action Realistic timeframe Ongoing process Cost estimate ? funding agencies

Thank You