Transcript PHAKE - Searching for Safety

The Deadly World of Falsified and
Substandard Medicines
ROGER BATE,
[email protected], Resident Scholar, AEI,
Washington, D.C.
August 14, 2012, USP
A rare successful prosecution
Abu Kasheh, Syria
Syrian customs warehouse:
destined for Iraq and recovered in Damascus
2,500+ drug samples from 19 cities
• 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)
• 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.
• 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.
• 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.
The Deadly World of Falsified and
Substandard Medicines
ROGER BATE,
[email protected], Resident Scholar, AEI,
Washington, D.C.
Are we discussing the same issues?
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
United
Nations
Office on
Drugs and
Crimes
International
Civilian
Aviation
Organization
1961
1968
Narcotic
Safety
Aircraft
Hijacking
International
Atomic
Energy
Agency
1976
Atomic
Energy
Safety
United
Nations
Environment
Program
World
Health
Organization
1980
2000
Chemical
Safety
Framework
Tobacco
Control