Transcript PHAKE

ROGER BATE
[email protected]
LEGATUM FELLOW IN GLOBAL PROSPERIT Y
AMERICAN ENTERPRISE INSTITUTE
WASHINGTON, D.C.
GMU May 03, 2012
Orson Welles as Harry Lime
Are your drugs safe?
• 100,000 annual deaths
• 1 out of every 10
medications in emerging
markets are ineffective
Drug samples from 19 cities worldwide
Online drug samples from 10 countries
Unregulated and often illegal
$10 billion USD market
Especially large in high-value BRICS markets
Emerging Markets
• Key variables
– income
– illiteracy
– political will
• Unlicensed, unmonitored, unofficial retailers
• Common medicines
– Antimalarial
– Antimycobacterials
– Antibiotics
Developed Countries
• Less danger in OECD, but problems still exist
– Internet sales
– Supply chain
•
•
•
•
Inferior API
Uncertain provenance of supply
Convoluted distribution networks
Criminal Networks
Fake Chinese packaging
I.
II.
III.
IV.
V.
Definitions
Research
Causes
Moving Forward
International Treaty
Definitions
Improperly stored or
transported
• Active Pharmaceutical Ingredients (API)
– Wrong dose
– Wrong ingredient
• Poorly formulated
• Contains lethal impurities
• Lacks Good Manufacturing Practices (GMP)
• Intentionally deceive patient
• Include counterfeit pharmaceuticals and
intellectual property violations
Are we discussing the same issues?
Research
Over 2,500 samples
– Malaria
– Tuberculosis (TB)
– Bacterial infections
Testing:
– MiniLab
– Raman
Spectrometer
NAFDAQ staff trained on Truscan
• 12% of total sample failed quality tests,
– 5% were falsified products
• many had zero API
– 7% substandard or degraded
• Vast majority breach trademark
• Substantial difference in price for
substandard products but not for fake ones
Average
0
Sao Paolo
6 4
Moscow
5
Istanbul
9
Beijing
12
Bangkok
11
Kolkata
15 16
Chennai
24
Delhi
29
Nairobi
9
Lusaka
Lubumbashi
Luanda
15 16
Lagos
24
Kigali
Kampala
Dar
Cairo
Addis
Accra
Percentage rate of failures (%)
49
27
12%
4 4
• 12% of total samples failed quality tests
• 5% of total samples were falsified products
– Many with zero-API (Active Pharmaceutical
Ingredient)
– 7% other
• Vast majority breach trademark
• Substantial difference in price for
substandard products but not for fake ones
• 12% of total samples failed quality tests
• 5% of total samples were falsified products
– Many with zero-API (Active Pharmaceutical
Ingredient)
– 7% other
• Vast majority breach trademark
• Substantial difference in price for
substandard products but not for fake ones
10
5
% Price Deviation
0
-5
-10
-15
-20
-25
-30
-35
-40
-45
Cheaper than quality
drugs by up to 40%
10
5
% Price Deviation
0
-5
-10
-15
-20
-25
-30
-35
-40
-45
No significant discount
By city GDP
60
Fake
Substandard
50
Total
40
30
20
10
0
0
-10
5000
10000
15000
20000
25000
30000
35000
40000
45000
50000
Origin and Causes
•
•
•
•
•
Inferior API
Non-GMP
Poorly formulated
Contain lethal impurities
Degraded
Avastin Case, March-April 2012
• European Avastin has the company label ‘Roche,’
whereas US brands do not
• Fakes had ‘Roche’ label
• 19 US medical practices across at least 3 states
purchased unapproved cancer medicines
Deaths
USA
USA
USA
Emerging Markets
Fake
Internet
Viagra
.
•Minimal
Fake Heparin
•149
Inferior API causing
shortages and dangerous
products
.
Substandard products due to
inferior API and excipients
.
Global
•Maybe hundreds
•Thousands**
Lethal impurities in falsified products
.
Africa
Poorly formulated medicines and fake medicines
•Tens of
thousands
•Maybe
100,000
Active Pharmaceutical Ingredients (API)
Intentional contamination
– Chinese Heparin caused 149 deaths in the US
Most problems are unintentional
– non-certified plants making chemicals
Over 70% of API is made in India and China
They have many high quality suppliers…
but some subcontractor premises are
“physically dirty”*
* Phillipe Andre, European Auditor, School of Pharmaceutical Science
and Technology at Tianjin University, China
Auditor Phillipe Andre:
“Drug companies misinformed about source of
39% of drug substances purchased from
China.”
“Only 6% of Chinese companies provide
impurity profiles of chemicals exported.”
“Residues of solvents and potentially genotoxic
catalysts are rarely controlled.”
“94% of audits of Chinese drug substances
bought by overseas firms are conducted
after purchase.”
FDA is increasing inspections:
– Once every 30 months in the US
– At best once every 13 years in China;
sometimes “staged”
Companies:
• The best line of defense
• They should pool and deepen audits: RX-360
Good Manufacturing Practices (GMP)
• There are high quality as well as low quality
companies: it’s hard to distinguish
Simplest Acetaminophen production
Simplest Acetaminophen production
Simplest Acetaminophen production
Simplest Acetaminophen production
Simplest Acetaminophen production
Final Producer
Processing
Storage
Roger and Suresh Sati in January, 2008
Moving Forward
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
Unregistered
18% of total sample:
349 medicines
Registered
82% of total sample:
1591 medicines
Unregistered
18% of total sample:
349 medicines
What is the risk of having so many
unregistered products available in
the market?
37%
Unregistered drugs
fail far more often
than registered
ones.
5%
Registered
Unregistered
Percentage of failures (%)
120
100
80
60
40
20
0
Percentage of failures (%)
Registered
Registered
Unregistered
Unregistered
37%
5%
Medicine Regulation Authorities (MRAs):
the FDA in the US
Fake Coartem from Ghana
Nigeria’s NAFDAC
Dr. Paul Orhii
Dr. Dora Akunyili
According to the World Health Organization
(WHO), fewer than 50% of countries have
adequate anti-counterfeit laws
– Some anti-counterfeit laws (like Kenya’s) may
conflate fakes with generics
Have laws and
enforce them
Don’t have official
anti-counterfeit
medicine laws
20%
50%
30%
Have laws and
don’t fully
enforce them
BBC video here
• Most drugs (and fakes) are made in China
and India
• Laws must
– combat criminals and negligent companies
– not harm good producers
In jail, awaiting trial in Syria
Amjad Markieh
Raed Abu Markeih
Prosecutions are rare
Abu Kasheh, Syria
Syrian customs warehouse:
destined for Iraq and recovered in Damascus
Does Price Reveal PoorQuality Drugs?
Evidence from 17
countries
By Roger Bate, Ginger Zhe Jin,
Aparna Mathur
August 18, 2011
Journal of Health Economics
Enforcing higher quality standards can cause:
– Drug Shortages
• In the US: “number of prescription drug shortages
nearly tripled between 2005 and 2010”
• Children’s hospitals ran short of leukemia drug
after principal supplier, Ben Venue Laboratories,
failed FDA inspection and was shut down
– Variable Prices
Federal Drug Administration (FDA); the White House, Executive Order 13588; NPR
•
•
•
•
India and China
Emphasize the harm to consumers
Save thousands of lives
Western companies enforcing IP is the
reason for Syrian ring shut down
– E.g. Novartis and Glivec®
• Overzealous EU enforcement led to seizures of
legitimate Indian generic drugs en route to Africa
and Brazil
• IP laws make no distinction
Unlike most other fake products, there’s no demand for fake
medicines
• Intellectual Property laws can be abused
• Due to IP accusations, non-regional nations
are unlikely to adopt regional treaties
• Europe: CoE Medicrime
• There is little chance of extradition without
inter-jurisdictional agreement
IP will remain the key determinant
without international public health law
International Treaty
1. UN Member States: negotiate
treaty
2. Specialized UN agency:
secretariat for oversight
3. National governments:
responsible for enforcement
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
Role and benefits of UN treaty:
– Increase MRA funding to
• Build labs
• Enable authorities to spot fakes
• Oversee GMP
– Share criminal evidence
– Train customs staff to spot fakes
– Improve cooperation between police and
prosecutors