3INDONESIAlocated between two continents and two oceans, which is easily accessible by land, sea, or air.some problems are still being faced, including in the field of drug control.problems may arise from borderline areas, which are susceptible to smuggled, counterfeit medicines.Regarding counterfeit medicines they may beIllegally imported orLocally manufactured byillegal manufacturerDistributed to illegal market
4NUMBER OF INTERNATIONAL PORT SEAPORT : 141AIRPORT : 10FREE TRADE ZONEFree Trade Zone BATAM, including Batam Island, Tonton Island, Setotok Island, Nipah Island, Rempang Island, Galang Island and Galang Baru Island.Free Trade Zone BINTAN, including Galang Batang Industrial Estate, Maritim Industrial Estate, and Loban Island, Senggarang Industrial Estate and Dompak Barat Industrial EstateFree Trade Zone KARIMUN, including number of Karimun Island, Karimun Anak IslandFree Trade Zone SABANG.
6BORDER POST To control imported goods Efforts have been taken by establishing Border Posts in some areas, i.e :SKOU (Papua New Guinea)MOTA AIN, NAPAN & META MAUK (Timor Leste)MARORE & MIANGAS (Philipine)ENTIKONG & JAGOI BABANG (East Malaysia Land)NUNUKAN (East Malaysia Ocean)SUNGAI GUNTUNG (West Malaysia Ocean)SAMBU BELAKANG, PADANG & TAREMPA (West Malaysia Ocean)Objective :To control imported goodsTo minimize illegal & counterfeit drugs entering the country
7DefinitionCounterfeit Drugs (CD’s) definition in Indonesia based on Indonesian MoH Decree No. 949/2000 :A medicinal product which is manufactured by illegal manufacturer or deliberately mislabeled with respect to identity of registered product.
8Basic Law and Regulation related drug counterfeiting Law No. 1/1946 on Criminal ActLaw No. 23/1992 on HealthLaw No. 8/1999 on Consumer ProtectionLaw No. 14/2001 on PatentLaw No. 15/2001 on Mark
14COUNTERFEIT DRUGS FINDING FREQUENCIES PERIOD 2001-2007 (October) frequency* The data is made from finding frequencies > 3 times
15NUMBER OF CASES SUSPECTED CONFIRMED IMPORTED / DOSMETIC VITAL MEDICAL 20072 *2Import and DomesticYes20061DomesticNo20053Yes (injectable)* 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
16HOW WHERE THESE CASES DETECTED % or number of casesPatients complaintsNO DATA AVAILABLEHealth professionals reportsEnforcement/investigation workRoutine checksReported by affected manufacturer28,6% (2005), 20 % (2006), 4,16% (2007)
17NUMBER OF PROSECUTIONS / CONVICTIONS/PENDING NADFC DATAMANUFACTURERWHOLESALER / IMPORTERRETAILERINFORMAL SECTOR20071( in process)1 (in process)2006-20053 (2 Sentence penalty, 1 Wanted List)
20BENEFITS & LIMITATIONS OF COORDINATION Technical support such as laboratory test, expert witness statement will be provided by NADFC if neededIf facing difficulties, force effort will be provided by the PoliceProvided information of import-registered products for the customSeveral Laws and regulation as basic legal process to combat Counterfeit Drugs are availableLIMITATIONSLack of the reference standard available in NQCLLack of coordination among law enforcement agencies at all level (National-provincial-district)On-line system is not in placeWeakness of Implementation of some Laws, such as need appeal from the manufacturing authorization holder of authentic drugs
21STRATEGIC ACTION ON COMBATING COUNTERFEIT DRUGS (CDs) in INDONESIA CONSUMERILEGAL MANUFACTURERILLEGAL MARKETNational Program ;Comprehensive investigation and mopping-up what is already in circulationNational Joint Operation and joint investigatin with police (in ilegal market)Strenghtening the infrastructureImprovement collaboration and coordination with other law enforcement agenciesIncreasing comprehensive drug distribution controlIncreasing public awareness and law enforcement agenciesILEGAL DISTRIBUTORSTRATEGIES :Breaking up the Illegal chainSustainable law enforcement with deterrent penaltiesReveal modus operandi, identify the intellectual actors and their networkFACTS :CDs are found, mostly in illegal marketDifficult to differenciate with the genuine oneLack of public awareness (consumers buy drugs in the illegal market)
22REGIONAL LEVEL GAPS IMPLICATIONS STRATEGY Inter-sectoral coordination is not based on written procedure which are clearly defined roles, adequate resources and effective administrative and operational tools.Lack of awareness about the severity of the problem among stakeholder.No specific law on Counterfeit Drugs.Limitation of reference standard on NQCLNo comprehensive program on combating counterfeit drugsNo deterrent sanctionsThe time line of lab result is not on scheduleDevelop national tskforce on inter-sectoral coordination base on written procedures, clearly defined roles, adequate resources, and effective administrative and operational tools.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 DRAAssist national authorities to develop risk communication and advocacy materialsDevelop draft on counterfeit drugs LawNeed collaboration to get reference atandard assist by WHO
23REGIONAL LEVEL GAPS IMPLICATIONS STRATEGY Lack of Information Exchange among countries, no designated person in charge at DRADifferent definition of Counterfeit Drugs among CountriesLack of networking on Counterfeit drugs problem among ASEAN DRAsdifficulties on contacting the person in chargeDifferent follow up actiondifficulty to know the genuity of the suspected drugDifficulty to trace the suspect if they escape to other countriesPromote networking and collaboration among ASEAN DRA on counterfeit drugsDevelop TOR which are include discussion among ASEAN countries on :the definition of counterfeit drugs.Survey existing national and international legislation & requirementsAssess existing national best practices and develop model best practicesPromote secure exchange of information and alerts among ASEAN DRA
24Proposed Project against Counterfeit Drugs Development of common definition of counterfeit drugwithin ASEAN CountriesDevelopment ASEAN Scheme on tackling of counterfeit drugsDevelopment a Regional Strategy and Systematic ProgramProposed Project against Counterfeit DrugsASEAN Project on Strengthening Collaboration on Combating Counterfeit DrugsOUTPUTExchange of information by designated unit of DRADevelop data base of counterfeit drugsDevelop Alert System
25CONCLUSIONNo adequate data on “how where the cases detected” showed that reported mechanism is not in place as well as awareness of severity of the casesWeaknesses on inter sectoral coordination due to some factor i.e : no written standardized procedure, no specific law on counterfeit medical product.Lack of networking on combating counterfeit medical product in regional, i.e : among ASEAN countries.
26EXPECTATIONEstablish national and regional taskforce on combating counterfeit drugsCombating counterfeit drugs need international support