1. August 14, 2012, USP The Deadly World of Falsified and Substandard Medicines ROGER BATE, RBATE@AEI.ORGRBATE@AEI.ORG, Resident Scholar, AEI, Washington, D.C.

4. A rare successful prosecution Abu Kasheh, Syria

5. Syrian customs warehouse: destined for Iraq and recovered in Damascus

9. 2,500+ drug samples from 19 cities

10. Half of 100,000 + annual deaths (most in nations with income under $5,000 pp/py) are from fakes At least 1 out of every 20 medications in poorer emerging markets are fake Unregulated, often illegal market, perhaps worth US$10 billion (high value in BRIC) Efforts improving to combat fakes. Improvement in laws and their enforcement. Definitional differences still exist, with no immediate resolution in sight. Poor regional enforcement in key countries (India and China)

11. Registered products five times less likely to be substandard (roughly half deaths from substandards) SRA/WHO approved products far less likely to be substandard than non-approved products. RRTM studies (8% v. 40% of antimalarials). WHO is not a regulator. Some companies may be taking advantage of its lack of market surveillance. WHO has launched an investigation (based on RRTM studies). Few want results discussed – including certain aid/academic interests.

12. Politics of substandards makes them hard to combat - not everyone agrees what a substandard drug actually is (pharmacology vs development realities) Local producers more likely to win tenders, often regardless of (consistent) quality of products MRAs often lose out to “Commerce” Ministry if/when try and combat dodgy local producers (API problem?). Commerce Ministry and western interests focus on IP (often antagonistically) and substandards get little focus.

13. Combating substandards important. Strengthening MRAs is vital (and to help find fakes too - Nigeria) Harmonizing regulation is important to assist MRAs in LDCs – also helpful to us if large API suppliers Western auditing of suppliers needs to be deeper rather than simply repetitive (Rx 360 a good start) International Convention against fakes is important. G8 discussion of fakes a start (IP focus problematic) Standardization of methods for testing and evaluation are important too, so data (of fakes and substandards) are not simply ignored.

14. The Deadly World of Falsified and Substandard Medicines ROGER BATE, RBATE@AEI.ORGRBATE@AEI.ORG, Resident Scholar, AEI, Washington, D.C.

15. Are we discussing the same issues?

16. Why and How to Make an International Crime of Medicine Counterfeiting By Amir Attaran, Roger Bate and Megan Kendall August 18, 2011 Journal of International Criminal Justice

17. Aircraft Hijacking International Civilian Aviation Organization World Health Organization Framework Tobacco Control International Atomic Energy Agency Atomic Energy Safety United Nations Environment Program Chemical Safety United Nations Office on Drugs and Crimes Narcotic Safety Framework Convention Against Falsified Medicines United Nations Office on Drugs and Crimes World Health Organization 19611968197619802000 ?