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  1. 1. COMBATING COUNTERFEIT DRUGS IN INDONESIA First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta, 13-15 November 2007 National Agency of Drug and Food Control Indonesia
  3. 3. <ul><li>located between two continents and two oceans, which is easily accessible by land, sea, or air. </li></ul><ul><li>some problems are still being faced, including in the field of drug control. </li></ul><ul><li>problems may arise from borderline areas, which are susceptible to smuggled, counterfeit medicines. </li></ul><ul><li>Regarding counterfeit medicines they may be </li></ul><ul><ul><li>Illegally imported or </li></ul></ul><ul><ul><li>Locally manufactured by </li></ul></ul><ul><ul><li>illegal manufacturer </li></ul></ul>INDONESIA Distributed to illegal market
  4. 4. FREE TRADE ZONE <ul><li>Free Trade Zone BATAM, including Batam Island, Tonton Island, Setotok Island, Nipah Island, Rempang Island, Galang Island and Galang Baru Island. </li></ul><ul><li>Free Trade Zone BINTAN, including Galang Batang Industrial Estate, Maritim Industrial Estate, and Loban Island, Senggarang Industrial Estate and Dompak Barat Industrial Estate </li></ul><ul><li>Free Trade Zone KARIMUN, including number of Karimun Island, Karimun Anak Island </li></ul><ul><li>Free Trade Zone SABANG. </li></ul>NUMBER OF INTERNATIONAL PORT <ul><li>SEAPORT : 141 </li></ul><ul><li>AIRPORT : 10 </li></ul>
  6. 6. BORDER POST <ul><li>Efforts have been taken by establishing Border Posts in some areas, i.e : </li></ul><ul><ul><li>SKOU (Papua New Guinea) </li></ul></ul><ul><ul><li>MOTA AIN, NAPAN & META MAUK (Timor Leste ) </li></ul></ul><ul><ul><li>MARORE & MIANGAS ( Philipine ) </li></ul></ul><ul><ul><li>ENTIKONG & JAGOI BABANG (East Malaysia Land) </li></ul></ul><ul><ul><li>NUNUKAN (East Malaysia Ocean) </li></ul></ul><ul><ul><li>SUNGAI GUNTUNG (West Malaysia Ocean) </li></ul></ul><ul><ul><li>SAMBU BELAKANG, PADANG & TAREMPA (West Malaysia Ocean) </li></ul></ul><ul><li>Objective : </li></ul><ul><li>To control imported goods </li></ul><ul><li>To minimize illegal & counterfeit drugs entering the country </li></ul>
  7. 7. Definition <ul><li>Counterfeit Drugs (CD’s) definition in Indonesia based on Indonesian MoH Decree No. 949/2000 : </li></ul><ul><li>A medicinal product which is manufactured by illegal manufacturer or deliberately mislabeled with respect to identity of registered product. </li></ul>
  8. 8. Basic Law and Regulation related drug counterfeiting <ul><li>Law No. 1/1946 on Criminal Act </li></ul><ul><li>Law No. 23/1992 on Health </li></ul><ul><li>Law No. 8/1999 on Consumer Protection </li></ul><ul><li>Law No. 14/2001 on Patent </li></ul><ul><li>Law No. 15/2001 on Mark </li></ul>
  10. 14. COUNTERFEIT DRUGS FINDING FREQUENCIES PERIOD 2001-2007 (October) frequency * The data is made from finding frequencies > 3 times Counterfeit drugs
  11. 15. NUMBER OF CASES * a result of joint operation whereby an illegal warehouse was found filled with thousand of boxes of 26 items of counterfeit medicines, with an estimated value of up to 25 billion rupiahs Yes (injectable) Domestic 3 3 2005 No Domestic 1 1 2006 Yes Import and Domestic 2 2 * 2007 VITAL MEDICAL IMPORTED / DOSMETIC CONFIRMED SUSPECTED
  12. 16. HOW WHERE THESE CASES DETECTED 28,6% (2005), 20 % (2006), 4,16% (2007) Reported by affected manufacturer NO DATA AVAILABLE Routine checks NO DATA AVAILABLE Enforcement/investigation work NO DATA AVAILABLE Health professionals reports NO DATA AVAILABLE Patients complaints % or number of cases
  13. 17. NUMBER OF PROSECUTIONS / CONVICTIONS/PENDING NADFC DATA - 3 (2 Sentence penalty, 1 Wanted List) - - 2005 - 1 (in process) - - 2006 1 (in process) 1( in process) 2007 INFORMAL SECTOR RETAILER WHOLESALER / IMPORTER MANUFACTURER
  15. 19. Mechanism of national coordination Combating Counterfeit Drugs requires joint effort medicines Drug/National Regulatory Authority Healthcare & medicine providers Civil societies Patient Interest Groups Patients / consumers Drug manufacturers importers & wholesalers medicines Ministries, police, customs, Prosecutors Government
  16. 20. BENEFITS & LIMITATIONS OF COORDINATION <ul><li>BENEFITS </li></ul><ul><li>Technical support such as laboratory test, expert witness statement will be provided by NADFC if needed </li></ul><ul><li>If facing difficulties, force effort will be provided by the Police </li></ul><ul><li>Provided information of import-registered products for the custom </li></ul><ul><li>Several Laws and regulation as basic legal process to combat Counterfeit Drugs are available </li></ul><ul><li>LIMITATIONS </li></ul><ul><li>Lack of the reference standard available in NQCL </li></ul><ul><li>Lack of coordination among law enforcement agencies at all level (National-provincial-district) </li></ul><ul><li>On-line system is not in place </li></ul><ul><li>Weakness of Implementation of some Laws, such as need appeal from the manufacturing authorization holder of authentic drugs </li></ul>
  17. 21. STRATEGIC ACTION ON COMBATING COUNTERFEIT DRUGS (CDs) in INDONESIA ILEGAL MANUFACTURER ILLEGAL MARKET ILEGAL DISTRIBUTOR CONSUMER <ul><li>FACTS : </li></ul><ul><li>CDs are found, mostly in illegal market </li></ul><ul><li>Difficult to differenciate with the genuine one </li></ul><ul><li>Lack of public awareness (consumers buy drugs in the illegal market) </li></ul><ul><li>STRATEGIES : </li></ul><ul><li>Breaking up the Illegal chain </li></ul><ul><li>Sustainable law enforcement with deterrent penalties </li></ul><ul><li>Reveal modus operandi, identify the intellectual actors and their network </li></ul><ul><li>National Program ; </li></ul><ul><li>Comprehensive investigation and mopping-up what is already in circulation </li></ul><ul><li>National Joint Operation and joint investigatin with police (in ilegal market) </li></ul><ul><li>Strenghtening the infrastructure </li></ul><ul><li>Improvement collaboration and coordination with other law enforcement agencies </li></ul><ul><li>Increasing comprehensive drug distribution control </li></ul><ul><li>Increasing public awareness and law enforcement agencies </li></ul>
  18. 22. REGIONAL LEVEL <ul><li>Develop national tskforce on inter-sectoral coordination base on written procedures, clearly defined roles, adequate resources, and effective administrative and operational tools. </li></ul><ul><li>Increasing awareness on the harmful/impact of counterfeit drugs through seminar for the specific target groups such as Pharmaceutical Manufacturer, Health professionals, patients, training for Law enforcement Agencies, and DRA </li></ul><ul><li>Assist national authorities to develop risk communication and advocacy materials </li></ul><ul><li>Develop draft on counterfeit drugs Law </li></ul><ul><li>Need collaboration to get reference atandard assist by WHO </li></ul><ul><li>No comprehensive program on combating counterfeit drugs </li></ul><ul><li>No deterrent sanctions </li></ul><ul><li>No deterrent sanctions </li></ul><ul><li>The time line of lab result is not on schedule </li></ul><ul><li>Inter-sectoral coordination is not based on written procedure which are clearly defined roles, adequate resources and effective administrative and operational tools. </li></ul><ul><li>Lack of awareness about the severity of the problem among stakeholder. </li></ul><ul><li>No specific law on Counterfeit Drugs. </li></ul><ul><li>Limitation of reference standard on NQCL </li></ul>STRATEGY IMPLICATIONS GAPS
  19. 23. REGIONAL LEVEL <ul><li>Promote networking and collaboration among ASEAN DRA on counterfeit drugs </li></ul><ul><li>Develop TOR which are include discussion among ASEAN countries on : </li></ul><ul><ul><ul><li>the definition of counterfeit drugs. </li></ul></ul></ul><ul><ul><ul><li>Survey existing national and international legislation & requirements </li></ul></ul></ul><ul><ul><ul><li>Assess existing national best practices and develop model best practices </li></ul></ul></ul><ul><li>Promote secure exchange of information and alerts among ASEAN DRA </li></ul><ul><li>difficulties on contacting the person in charge </li></ul><ul><li>Different follow up action </li></ul><ul><li>difficulty to know the genuity of the suspected drug </li></ul><ul><li>Difficulty to trace the suspect if they escape to other countries </li></ul><ul><li>Lack of Information Exchange among countries, no designated person in charge at DRA </li></ul><ul><li>Different definition of Counterfeit Drugs among Countries </li></ul><ul><li>Lack of networking on Counterfeit drugs problem among ASEAN DRAs </li></ul>STRATEGY IMPLICATIONS GAPS
  20. 24. Proposed Project against Counterfeit Drugs <ul><ul><li>Development of common definition of counterfeit drug </li></ul></ul><ul><ul><li>within ASEAN Countries </li></ul></ul><ul><ul><li>Development ASEAN Scheme on tackling of counterfeit drugs </li></ul></ul><ul><ul><li>Development a Regional Strategy and Systematic Program </li></ul></ul><ul><li>OUTPUT </li></ul><ul><li>Exchange of information by designated unit of DRA </li></ul><ul><li>Develop data base of counterfeit drugs </li></ul><ul><li>Develop Alert System </li></ul>ASEAN Project on Strengthening Collaboration on Combating Counterfeit Drugs
  21. 25. CONCLUSION <ul><li>No adequate data on “how where the cases detected” showed that reported mechanism is not in place as well as awareness of severity of the cases </li></ul><ul><li>Weaknesses on inter sectoral coordination due to some factor i.e : no written standardized procedure, no specific law on counterfeit medical product. </li></ul><ul><li>Lack of networking on combating counterfeit medical product in regional, i.e : among ASEAN countries. </li></ul>
  22. 26. EXPECTATION <ul><li>Establish national and regional taskforce on combating counterfeit drugs </li></ul><ul><li>Combating counterfeit drugs need international support </li></ul>
  23. 27. still a long way to go!