COMBATING COUNTERFEIT DRUGS IN INDONESIA National Agency of Drug and Food Control Indonesia First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta, 13-15 November 2007

BACKGROUND

INDONESIA located 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 be Illegally imported or Locally manufactured by illegal manufacturer Distributed to illegal market

NUMBER OF INTERNATIONAL PORT SEAPORT : 141 AIRPORT : 10 FREE TRADE ZONE Free 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 Estate Free Trade Zone KARIMUN, including number of Karimun Island, Karimun Anak Island Free Trade Zone SABANG.

LEGISLATIVE INFRASTRUCTURE

BORDER 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 goods To minimize illegal & counterfeit drugs entering the country

Definition Counterfeit 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.

Basic Law and Regulation related drug counterfeiting Law No. 1/1946 on Criminal Act Law No. 23/1992 on Health Law No. 8/1999 on Consumer Protection Law No. 14/2001 on Patent Law No. 15/2001 on Mark

NUMBER OF CASES

COUNTERFEIT DRUGS FINDING FREQUENCIES PERIOD 2001-2007 (October) frequency * The data is made from finding frequencies > 3 times

NUMBER OF CASES SUSPECTED CONFIRMED IMPORTED / DOSMETIC VITAL MEDICAL 2007 2 * 2 Import and Domestic Yes 2006 1 Domestic No 2005 3 Yes (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

HOW WHERE THESE CASES DETECTED % or number of cases Patients complaints NO DATA AVAILABLE Health professionals reports Enforcement/investigation work Routine checks Reported by affected manufacturer 28,6% (2005), 20 % (2006), 4,16% (2007)

NUMBER OF PROSECUTIONS / CONVICTIONS/PENDING NADFC DATA MANUFACTURER WHOLESALER / IMPORTER RETAILER INFORMAL SECTOR 2007 1( in process) 1 (in process) 2006 - 2005 3 (2 Sentence penalty, 1 Wanted List)

NATIONAL COORDINATION

Mechanism of national coordination Combating Counterfeit Drugs requires joint effort Drug/National Regulatory Authority Healthcare & medicine providers Civil societies Patient Interest Groups Patients / consumers Drug manufacturers importers & wholesalers medicines Ministries, police, customs, Prosecutors Government medicines

BENEFITS & LIMITATIONS OF COORDINATION Technical support such as laboratory test, expert witness statement will be provided by NADFC if needed If facing difficulties, force effort will be provided by the Police Provided information of import-registered products for the custom Several Laws and regulation as basic legal process to combat Counterfeit Drugs are available LIMITATIONS Lack of the reference standard available in NQCL Lack of coordination among law enforcement agencies at all level (National-provincial-district) On-line system is not in place Weakness of Implementation of some Laws, such as need appeal from the manufacturing authorization holder of authentic drugs

STRATEGIC ACTION ON COMBATING COUNTERFEIT DRUGS (CDs) in INDONESIA CONSUMER ILEGAL MANUFACTURER ILLEGAL MARKET National Program ; Comprehensive investigation and mopping-up what is already in circulation National Joint Operation and joint investigatin with police (in ilegal market) Strenghtening the infrastructure Improvement collaboration and coordination with other law enforcement agencies Increasing comprehensive drug distribution control Increasing public awareness and law enforcement agencies ILEGAL DISTRIBUTOR STRATEGIES : Breaking up the Illegal chain Sustainable law enforcement with deterrent penalties Reveal modus operandi, identify the intellectual actors and their network FACTS : CDs are found, mostly in illegal market Difficult to differenciate with the genuine one Lack of public awareness (consumers buy drugs in the illegal market)

REGIONAL 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 NQCL No comprehensive program on combating counterfeit drugs No deterrent sanctions The time line of lab result is not on schedule Develop 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 DRA Assist national authorities to develop risk communication and advocacy materials Develop draft on counterfeit drugs Law Need collaboration to get reference atandard assist by WHO

REGIONAL LEVEL GAPS IMPLICATIONS STRATEGY Lack of Information Exchange among countries, no designated person in charge at DRA Different definition of Counterfeit Drugs among Countries Lack of networking on Counterfeit drugs problem among ASEAN DRAs difficulties on contacting the person in charge Different follow up action difficulty to know the genuity of the suspected drug Difficulty to trace the suspect if they escape to other countries Promote networking and collaboration among ASEAN DRA on counterfeit drugs Develop TOR which are include discussion among ASEAN countries on : the definition of counterfeit drugs. Survey existing national and international legislation & requirements Assess existing national best practices and develop model best practices Promote secure exchange of information and alerts among ASEAN DRA

Proposed Project against Counterfeit Drugs Development of common definition of counterfeit drug within ASEAN Countries Development ASEAN Scheme on tackling of counterfeit drugs Development a Regional Strategy and Systematic Program Proposed Project against Counterfeit Drugs ASEAN Project on Strengthening Collaboration on Combating Counterfeit Drugs OUTPUT Exchange of information by designated unit of DRA Develop data base of counterfeit drugs Develop Alert System

CONCLUSION 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 Weaknesses 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.

EXPECTATION Establish national and regional taskforce on combating counterfeit drugs Combating counterfeit drugs need international support

still a long way to go!

ENTIKONG NUNUKAN SKOU JAGAOI BABANG back

MOTA AIN, NAPAN, META MAUK TAREMPA, SAMBU BELAKANG PADANG MIANGAS & MARORE SUNGAI GUNTUNG MOTA AIN, NAPAN, META MAUK TAREMPA, SAMBU BELAKANG PADANG back