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

2. BACKGROUND 3.

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

INDONESIA Distributed to illegal market 4. 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.

NUMBER OF INTERNATIONAL PORT

SEAPORT : 141

AIRPORT:10

5. LEGISLATIVEINFRASTRUCTURE 6. BORDER POST

Efforts have been taken by establishing Border Posts in some areas, i.e :

• SKOU (Papua New Guinea)

• MOTA AIN, NAPAN & META MAUK (TimorLeste )

• 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

7. Definition

Counterfeit Drugs (CDs) 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.

8. 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

9. NUMBER OF CASES 10. 11. 12. 13. 14. COUNTERFEIT DRUGS FINDING FREQUENCIES PERIOD 2001-2007(October) frequency * The data is made from finding frequencies> 3 times Counterfeit drugs 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 rupiahsYes (injectable) Domestic 3 3 2005 No Domestic 1 1 2006 Yes Import and Domestic 2 2 * 2007 VITAL MEDICAL IMPORTED / DOSMETIC CONFIRMED SUSPECTED 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 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 18. NATIONAL COORDINATION 19. Mechanism of national coordination Combating Counterfeit Drugs requires joint effort medicines Drug/National Regulatory AuthorityHealthcare &medicine providers Civil societies Patient Interest GroupsPatients / consumers Drug manufacturers importers & wholesalers medicines Ministries, police, customs, Prosecutors Government 20. BENEFITS & LIMITATIONS OF COORDINATION

BENEFITS

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

21. STRATEGIC ACTION ON COMBATING COUNTERFEIT DRUGS (CDs) in INDONESIA ILEGAL MANUFACTURER ILLEGAL MARKET ILEGAL DISTRIBUTOR CONSUMER

FACTS :

CDs are found, mostly in illegal market

Difficult to differenciatewiththe genuine one

Lack of public awareness(consumers buydrugs in the illegal market)

STRATEGIES :

Breaking up the Illegal chain

Sustainable law enforcement with deterrent penalties

Reveal modus operandi, identify the intellectual actors and their network

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

22. REGIONAL LEVEL

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

No comprehensive program on combating counterfeit drugs

No deterrent sanctions

No deterrent sanctions

The time line of lab result is not on schedule

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

STRATEGY IMPLICATIONS GAPS 23. REGIONAL LEVEL

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

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

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

STRATEGY IMPLICATIONS GAPS 24. 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

OUTPUT

Exchange of information by designated unit of DRA

Develop data base of counterfeit drugs

Develop Alert System

ASEAN Project on Strengthening Collaboration on Combating Counterfeit Drugs 25. 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.

26. EXPECTATION

Establish national and regional taskforce on combating counterfeit drugs

Combating counterfeit drugs need international support

27. still a long way to go! 28. 29. 30. NUNUKAN ENTIKONG JAGAOI BABANG SKOU back 31. MIANGAS & MARORE SUNGAI GUNTUNG TAREMPA, SAMBU BELAKANG PADANG MOTA AIN, NAPAN, META MAUK back 32.