August 14, 2012, USP

The Deadly World of Falsified and Substandard Medicines

ROGER BATE, RBATE@AEI.ORG, Resident Scholar, AEI, Washington, D.C.

Middle East Distribution Network

Abu Kasheh, Cairo

A rare successful prosecution

International Crime

Abu Kasheh, Syria

Syrian customs warehouse: destined for Iraq and recovered in

Damascus

International Crime

Storage, Processing Equipment

International Crime

Fakes destined for US?

2,500+ drug samples from 19 cities

The Research

• 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)

The Fake Problem

• 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.

Substandard Drugs

• 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.

Substandard Drugs

• 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.

Moving Forward

The Deadly World of Falsified and Substandard Medicines

ROGER BATE, RBATE@AEI.ORG, Resident Scholar, AEI, Washington, D.C.

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