Drug regulation: counterfeits experience of countries

1. Drug regulation: counterfeits experience of countries Workshop on GMP and Quality Assurance of Anti-malarial Medicines Bangkok, Thailand 18 -22 October 2004 Eshetu Wondemagegnehu Technical Officer & Focal Person for Counterfeit Drugs Quality Assurance & Safety:Medicines World Health Organization QSM/EDM

2. Framework of the presentation • How do countries define counterfeit drugs? • Examples of counterfeit drugs reported • Examples of measures taken by some countries to combat counterfeit drugs • What should governments, industry and other stakeholders do to address the problem? QSM/EDM

3. In pure legal terms a counterfeit medicine is: • A medicinal product made by someone other than the genuine/legitimate manufacturer • by copying/imitating a genuine product produced by legitimate manufacturer • without authority or right • to deceive/cheat • by passing the copy/forged medicinal product for that which is original QSM/EDM

4. The WHO definition of a counterfeit drug: • "A drug which is deliberately and fraudulently mislabelled with respect to its source and/or identity" • It applies to both generic and a branded products • A counterfeit product may include products: • with the correct ingredient (s) • with the wrong ingredient (s) • without ingredient (s) • with incorrect quantities of active ingredient (s) • with fake packaging • Could be an imitation or a copy of a genuine product or not QSM/EDM

5. In the United States, a counterfeit drug is: • "A drug which, or the container or labelling of which without authorisation bears the trademark, trade name, other identifying mark, imprint, or device or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is falsely represented, to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor. QSM/EDM

6. In Philippines it means: (1) • A drug deliberately & fraudulently mislabelled with respect to its source and/or identity (similar to WHO definition) • a product with incorrect amount of active ingredients • a product with wrong ingredients • A drug or the container or labelling bearing without authorisation trademark, trade name or other identification mark or imprint or any likeness to that registered (similar to the US definition) QSM/EDM

7. In Philippines it means: (2) • A product imported without being registered(specific to Philippines) • A product containing less than 80% of the labelled amount (specific to Philippines) • A product refilled in a container by unauthorized person if the legitimate labels or marks are used (specific to Philippines) QSM/EDM

8. In Australia-counterfeit therapeutic goods (medicines) are (1) • Goods containing false representation in any of the following: • any advertisement for the goods • any documentation or record relating the goods or their manufacture False representation involves: • The identity or the name of the goods, the formulation, composition or design specification of the goods • The presence or absence of any ingredient or component of the goods • The strength/size of any ingredient/component of the goods • The sponsor, source of manufacture, or place of manufacture of the goods, etc QSM/EDM

9. In China, the term includes any one of the following: (1) • The ingredients in the drug are different from those specified by the national drug standards • A non-drug substance is simulated as a drug or one drug is simulated as another • A product the use of which is prohibited by regulations by the regulatory department under the State Council • A product produced or imported without approval • A product marketed without being tested as required by law QSM/EDM

10. In China the definition includes: (2) • A product which has deteriorated • A product which is contaminated • A product produced by using a drug substance without approval number as required by law • A product bearing indications or functions which are beyond the specified scope QSM/EDM

11. In Viet Nam counterfeit drugs are products used for cheating purposes when: They do not have or have very little pharmaceutical ingredients They contain pharmaceutical ingredients that contradict to which stated on the label ( to mean different) Label & package are identical or nearly identical to those of other products ( to mean imitation/copy) QSM/EDM

12. In Cambodia a counterfeit drug is: A drug which is deliberately produced with incorrect or wrong active ingredients A drug without active ingredients or which contains quantities of active ingredients outside the defined pharmacopoeial standards A drug which is deliberately and fraudulently mislabelled with respect to identity or source or with fake packaging (similar to WHO) A drug repacked or produced by unauthorized person QSM/EDM

13. In Lao the definition applies to: • A modern or a traditional medicine which is deliberately produced to be fake, or copied from another product that has been produced and distributed and registered officially. In Thailand a counterfeit drug is: • Any modern/traditional medicine which is faked • An imitation of a drug which is produced, distributed and legally registered QSM/EDM

14. What do we learn from these definitions? • All countries consider counterfeiting a criminal activity • A counterfeit drug is: • a copy or imitation of a genuine product • a product which contains little or none of the active ingredient (s) mentioned on the label • a product which contains different ingredient from the one mentioned on the label • a product with fake packaging • Some countries do not differentiate substandard from counterfeit drugs QSM/EDM

15. Examples of counterfeit drugs reported (1) • Diethylene glycol poisoning in USA (1936), Nigeria, (1990), Haiti (1996/97), India, (1998)…..etc • Dummy contraceptive pills in Brazil. About 200 unwanted pregnancies(1998) • Fake Tarivid (ofloxacin) in Hong-Kong contained-glucose and penicillin (1998) • Counterfeit artesunate and mefloquine in Cambodia (1999) QSM/EDM

16. Examples of reported counterfeit cases(2) • 240,000 packs of medicines and 2 tonnes of raw materials worth 1 million US$ seized in Italy (2000) • Counterfeit ampicillin in Tanzania, (2000) • Counterfeit Serostim (Somatropin) , Neupogen (Filgrastim) and Nutropin AQ (Somatropin) in USA (2001) • In India, in one factory police found 660 kg of fake drugs, 1000 kg of raw materials & boxes bearing the logo of a reputable firm (2001) • 2001-2002 in Shantou, Pu Ming and Chengzhou cities several counterfeit drugs were detected including Sandostatin and Neoral QSM/EDM

17. Examples of reported counterfeit cases (3) • Russia MOH reported 80 cases of counterfeit drugs, 2002 • Counterfeit Combivir, Ziagen, Gamimmum, Epogen reported in USA (2002) • Counterfeit Lipitrol (atorvastatine) and Procrit (epoetin alfa) detected in USA (2003) • Counterfeit Reductil (sibutramine) and Cialis (sildenafil) found by UK Medicines and Healthcare products Regulatory Agency (2004) QSM/EDM

18. QSM/EDM

19. Cases detected in USA QSM/EDM

20. Counterfeit artesunate-contained no active ingredient (2003) QSM/EDM

21. Counterfeit Neupogen - no active ingredient QSM/EDM

22. Counterfeit Viagra - no active ingredient QSM/EDM

23. Counterfeit anti-malarial-hard to differentiate QSM/EDM

24. Chloramphenicol – unknown manufacturer (it is not only branded products that are affected) QSM/EDM

25. Illegal manufacturing–a good source of counterfeit drugs Making capsules in a private house QSM/EDM

26. Repacking to hide the identity and true source

27. Medicines sold in market places with bananas, fish,.. etc QSM/EDM

28. Smuggling - a source of counterfeit drugs QSM/EDM

29. Examples of measures by some counties to address the problem USA • Established special task-force to combat counterfeit drugs • Posted cases of counterfeit drugs detected on web site • Tightened control system at ports of entry • Initiated public awareness and education programme • Established a rapid alert system Nigeria • Passed a special act against fake and counterfeit drugs • Established taskforce against counterfeiting • Barred importation from suspected/black listed countries and manufacturers QSM/EDM

30. Australia and UK • Created special enforcement unit - police/criminal investigators within their national drug regulatory systems • Enacted penal sanctions • Strengthened surveillance and enforcement China: • Enacted a new Drug Administration Law with penal sanctions against counterfeiting of drugs • Established the State Food and Drug Administration • Created a special programme on cracking counterfeiting of drugs • Special website for online complaint on counterfeit drugs • Public awareness programme using radio and TV QSM/EDM

31. Measures that need to be taken National level • Increase awareness of government decision-makers to gain political support for strong drug regulation • Enact special drug legislation on counterfeit drugs with deterrent penal sanctions • Control the manufacture, importation, exportation and distribution of drugs-regular inspection and quality surveillance programme • Improve enforcement by cooperating with other national law enforcement agencies - customs, police and prosecutors QSM/EDM

32. Measures that need to be taken National level • Sensitise the public to prevent buying drugs from unauthorized premises and peddlers • Disclose names of individuals & companies that have been prosecuted and convicted • Stop trade of drugs through free-ports & Internet • Promote cooperation with stakeholders-DRA, manufacturers, distributors, health professionals, civil societies, etc to combat counterfeit drugs • Seek international cooperation e.g. WHO, INTERPOL, the World Customs Organization QSM/EDM

33. Measures that need to be taken Inter-country and region level • Promote cooperation between countries sharing common boarders to prevent smuggling and cross-boarder trade • Promote inter-country, sub-regional, regional co-operation in the fight against counterfeit drugs • Ensure that export-drugs are regulated to the same standard as drugs domestically used QSM/EDM

34. Measures that need to be taken Global level • Cooperation between countries to develop common definition and harmonized measures • Global framework to control trade in counterfeit drugs • Timely exchange of information between countries and international organizations such WHO, Interpol, World Custom Organization QSM/EDM

35. Counterfeit drugs Thank You QSM/EDM