1. FIRST ASEAN – CHINA CONFERENCE ON COMBATING COUNTERFEIT MEDICINAL PRODUCTS JAKARTA, 13-15 NOVEMBER 07 COUNTRY PRESENTATION CAMBODIA Presented by Dr. Chhieng Phana Department of Drugs and Food Ministry of Health

2. LEGISLATIVE INFRASTRUCTURE Law on the management of medicinal products adopted by the National Assembly during the 6 th session of the first legislature in 1996 and this law has been amended with regards to current situation of pharmaceutical affaires in Cambodia. This amendment has been passed by the National Assembly last week by including the definition of counterfeit medicine and increasing the penalties. Furthermore the Health Inspector will become judiciary police, who have the right to confiscate or seize illegal transaction and prepare document for prosecution. National Drug Policy which has two main objectives: –To ensure the availability of drugs, which are safe, effective and of good quality to the whole population at an affordable price, –To rationalize the supply and use of the drugs throughout the country.

3. Cont Drug regulation: legislations and regulations for the management of pharmaceutical affaires have been developed and implemented namely: 1.Drug registration, 2.Drug inspection, 3.Quality control, 4.GMP Guidelines, 5.GPP Guidelines. Definition : a pharmaceuticals is one or any kinds of substance, which are primarily from chemicals, bio-products, plants combined in order to: 1.Use in the prevention or treatment of human or animal diseases, 2.Use in the medicinal or pharmaceutical research or diagnostic 3. change or support the functioning of the organs. Shall be also considered as medicinal product: 1.Serum and vaccines, 2.Blood or blood products, 3.Traditional medicines, 4.Products those are composed of poisonous substances, which are included in a list determined by Sub - Decree.

4. Definition of counterfeit medicines WHO definition: A counterfeit pharmaceutical product is a product that is deliberately and fraudulently mislabeled with respect to identity and /or source.This definition applies to both branded and generic products. Counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with incorrect quantity of active ingredients or with fake packaging. Cambodian definition: A counterfeit pharmaceutical product is a medicine: 1.Which is deliberately produced with the incorrect quantity of active ingredients, or with wrong active ingredients, or 2.A medicine that is either without active ingredients, or with amounts of active ingredients that are deliberately outside the accepted standard as defined in the standard pharmacopoeias, or 3.A medicine that is deliberately and fraudulently mislabeled with respect to identity and / or source, or one with fake packaging, or 4.A medicine that is repacked or produced by an unauthorized person. Substandard medicines: is a registered product, whose specifications are outside of accepted standard as defined in reference pharmacopoeias.

5. Penalties Shall be subject to penalize a fine of from 2,000.000 Riels to 10,000,000 Riels or to punishment to imprisonment from six days to one month or, both of these two punishments, for any person who obstructed the competent authority to prevent them from accomplishment their inspection duties, Shall be subjected to penalty to a fine from 20,000,000 Riels to 50,000,000 Riels or to punishment to imprisonment from five years to ten years or, both of the punishments, for any person who deliberately engaged in producing, importing, exporting or trading of pharmaceuticals containing addictives substances without authorization, counterfeit medicines, medicines with poor of quality, expired products which affected to the health or lives of the consumers. Shall also be punished with the same terms as set forth in the above for any public servant who is complicity or who commits an abuse of his/her own duties when during the inspection.

6. Insufficiencies in current legislation No consumer association and law on consumer protection, Lack of collaboration with others stakeholders involving in combating counterfeit medicines, controlling advertising through mass media and illegal transaction in pharmaceuticals. Effectiveness is still limited in the law enforcement. Public awareness on counterfeit medicines is still limited. Limitation of budget for Post Marketing Surveillance and airing of information dissemination. No National Surveillance Network. No effective coordination for proper actions against CD and substandard Big number of entry points along the borders between neighboring countries. Lack of public participation and manufacturers / distributors. Presence of unlicensed drug outlet and sale of products through unlicensed / unauthorized outlets. Delay in prosecution of offenders.

7. Implication of these gaps Consumers are at risk of using counterfeit medicines, which can lead to the treatment failure, development of drug resistance, worsening of the patients disease, and may even cause the death of patient, Poor people are mostly vulnerable to purchase medicines of unknown quality and safety from illegal drug outlet where most counterfeit and substandard are available and cheap. For manufacturers / distributors the confidence in their products is undermined. Smuggling from neighboring countries and unregistered products are still existed, Lack of confidence to the Regulatory Authority, health care system, health care professionals

8. What is being done to fill the gaps ? Based on the mounting evidence of the scale of the counterfeit medicine problem, the MOH established an Inter-ministerial Committee so called IMC against CD and illegal health service for the poverty reduction, which was signed by the Prime Minister on 5 th Dec. 2005, composed of : - Ministry of HealthChairman - Ministry of InteriorMember - Ministry of CommerceMember - Ministry of FinanceMember - Ministry of Agriculture Member - Ministry of InformationMember - Ministry of JusticeMember - Ministry of EducationMember - Deputy Governor of Phnom Penh cityMember - Department of HospitalMember - Department of Drug and FoodMember 20 Inter Department Committee at provincial level have also been formed with the same composition as the Inter Ministerial Committee Level.

9. Cont 3 days Workshop to be hosted by MOH on 29-31Oct. 06 to define the role and functions of the Inter Ministerial Committee and developed a strategic action plan with 24 components of activities among which 3 activities are prioritized to implement as followings: –Raise public awareness to the public on counterfeiting issue by taken experience from Kampong Cham Province, which is a leading province in eradication the number of illegal drug outlets and counterfeit medicines, –Application of sticker on registered products that make easy to the public by differentiation the registered and unregistered medicines, –Control of van importing and dispensing medicines to the province. Each provincial committee shall report the result every 3 months to the National Committee, which compile all report every 6 months to the council of Ministers for consideration and assessment. It is known that substandard and counterfeit medicines are in circulation in Cambodia and therefore PMS using the drug sampling and screening tests are considered to be the most effective means to detect them.

10. Cont Law on the management of quality and safety of products and services ( Code No 0600 / 001 dated 26 June 2000) Administration Order of the MOH No 616 dated 01-08 -03 on the prohibition of selling of CD Administration Order of MOH No 252 dated 15-03-05 on the sticking of vignette on the outer box of medicines. As result : minimized the number of illegal drug outlet and unregistered medicines.

11. Number of cases The failure rate is 21.13% ( 30 samples failed among 142 samples ). In addition to this testing the visual inspection and the investigation result allow us to find out 8 more products are being counterfeited and produced by unlicensed manufacturer after confirmation from the country of origin. In conclusion, this study has found 35 items of CD ( not registered and failed the test ) and 3 items of sub standard. Under USP-DQI project ( 2004 - 05 ) a survey was conducted in close collaboration with the National Center for Malaria, DDF and National Laboratory for Drug Quality Control ( NLDQC ) to establish a mechanism to detect substandard and counterfeit anti malaria such as Quinine, Artesunate,Mefloquine,Chloroquine,Tetracycline,Dihydriarte misine, Artemeter by using TLC testing

12. Number of cases First survey was funded by WHO and conducted in the year 2000/01. It showed that 13% among 230 samples randomly collected and tested were counterfeit and substandard. Second survey funded by AUSAID was conducted in 2004. 303 samples were collected in which 71 samples are registered and 232 are non registered. As the collect of sample was focused on suspected drug this figure can not represent the prevalent between registered and unregistered products. Due to lack of budget and limited testing among 303 samples, the committee decided choose only 142 samples for testing while the rest was kept for visual inspection and further investigation. Among 142 samples there are 114 unregistered products and 28 registered products. According to the result of quality testing, out of 114 samples, 27 samples ( 23.68% ) failed the test (API and DT) and out of 28 registered products, 3 samples ( 10.71% ) failed the test ( API slightly low than product claimed, 2 for DT)

13. Number of cases SuspectedConfirmedImported / Domestic Vital medicines 200414235Imported-Antibiotic -Anti malaria -Corticoides -Analgesic -Tetracycline 200518519Imported-Chloramphenicol: 6 -Dihydroartemisinine :1 - Phenoxy methyl PNC:7 -Tetracycline: 2 -Quinine: 3

14. How where these cases detected ? % or number of cases Patients complaints. Health professionals reports. Enforcement / investigation work.90% Routine checks.10% Reported by affected manufacturer. Others.

15. Number of prosecutions / convictions / pending ManufacturersWholesaler / importer RetailerInformal sector 2004 2005 Notes: As all number of cases relating to imported products, the MOH has jointly investigated with the country of origin to confirm whether those products have been produced by the licensed manufacturers. Some delay in getting confirmation from DRA in the country of origin, therefore delay in taking measure or informed to the public. So far there is only round table for discussion among stakeholders to find an appropriate way to stop selling CD medicines, which have been printed in brochure / booklet. Prosecution / conviction / pending will be undertaken through the inter ministerial committee when the amended law will be adopted.

16. Proposals for action Measures to be taken Who should do it ? Critical factors to ensure success Realistic timeframe Cost estimate - Promulgating appropriate legislation DRA-Power and responsibilities of DRA -Regulate authorized premises under the supervision of qualified persons -Eradicate unlicensed outlets -Revoke license for illegal performance against the law/regulations -Prosecution and severe penal sanctions 3 years.USD 20,000.00

17. Proposals for action Measures to be taken What should do it ? Critical factors to ensure success Realistic timeframe Cost estimate Promulgating appropriate legislation DRA-Investigate the location of clandestine manufacturer, warehouse of trafficker. -Control of illegal entry point 3 years Developing SOP and guidelines for drug inspectors DRA-SOP and Guidelines for inspection of suspected CD: smuggled medicines, unregistered, mislabeled, plastic bag medicines. 1 yearUSD 3,000.00

18. Proposal for action Measures to be taken Who should do it ? Critical factors to ensure success Realistic timeframe Cost estimate - Developing SOP and guidelines for drug inspectors DRA-Strengthening the basic TLC testing, - Random sampling. 1 year

19. Proposal for action Measures to be taken Who should do it ? Critical factor to ensure success Realistic timeframe Cost estimate - Monitoring and evaluation DRA-Monitor regularly progress in implementing all aspect of action plan: factors contributing to success and to failure should be identified, - Empower the drug enforcement officers to examine the plant and commercial documents, -Regular meeting with agencies involved. Every 3 months. 10,000.00 USD

20. Proposal for action Measures to be taken Who should do it ? Critical factors to ensure success Realistic timeframe Cost estimate Empowering judiciary MOH and Ministry of Justice -Consider counterfeiting is a crime, -judiciary should be empowered to impose severe penalties with the nature of the contravention, -Counterfeiting case should be given priority and handled speedily in the court system All counterfeiting cases 20,000.00USD

21. Proposal for action Measures to be taken Who should do it ? Critical factors to ensure success Realistic timeframe Cost estimate Fostering partnerships MOH / DRA- Pharmaceutical industries, - Importers, - Wholesalers and retailers, - Health professionals, - Community, - Consumers. - Regular meeting 3 years.10,000USD

22. Proposal for action Measures to be taken Who should do it ? Critical factors to ensure success Realistic timeframe Cost estimate Sharing responsibilities MOH / DRA-National level, -Sub regional / regional level, -International cooperation. 10,000.00USD

23. Conclusion Effectiveness of the elimination of counterfeit medicines depend on: 1-the existing of adequate and sufficient Legislation Regulation. 2-the conducting of inspections according to the agenda 3-the punishment according to the prescribed penalty. 4-high Responsibility and Professional ethic of drug manufacturers, importers, wholesalers, retailer and health providers. 5-close cooperation and good coordination between relevant ministries and stakeholders. 6- the provision of adequate financing support. 7- fast action to be taken for products found to be counterfeited: disqualified the manufacturers, recall the products and warning or filing the person who is being violated the drug law and regulations.

24. Thank for your kind attention