View
34
Download
0
Category
Tags:
Preview:
DESCRIPTION
ROGER BATE RBATE@AEI.ORG LEGATUM FELLOW IN GLOBAL PROSPERITY AMERICAN ENTERPRISE INSTITUTE WASHINGTON, D.C. GMU May 03, 2012. Orson Welles as Harry Lime. The Media. The Threat. Are your drugs safe?. The Problem. 100,000 annual deaths - PowerPoint PPT Presentation
Citation preview
GMU May 03, 2012
ROGER BATERBATE@AEI.ORGLEGATUM FELLOW IN GLOBAL PROSPERITYAMERICAN ENTERPRISE INSTITUTEWASHINGTON, D.C.
Orson Welles as Harry Lime
The Media
Are your drugs safe?
The Threat
• 100,000 annual deaths
• 1 out of every 10 medications in emerging markets are ineffective
The Problem
Drug samples from 19 cities worldwide
The Research
Online drug samples from 10 countries
The Research
Unregulated and often illegal $10 billion USD market
Especially large in high-value BRICS markets
The Market
• Key variables– income– illiteracy– political will
• Unlicensed, unmonitored, unofficial retailers
• Common medicines– Antimalarial– Antimycobacterials– Antibiotics
Emerging MarketsThe Market
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
The Market
Internet Sales
Fake Chinese packaging
I. DefinitionsII. ResearchIII.CausesIV.Moving ForwardV. International Treaty
Definitions
Improperly stored or transported
Degraded
• Active Pharmaceutical Ingredients (API)–Wrong dose–Wrong ingredient
• Poorly formulated• Contains lethal impurities• Lacks Good Manufacturing Practices
(GMP)
Substandard
• Intentionally deceive patient• Include counterfeit pharmaceuticals
and intellectual property violations
Falsified
Falsified
Falsified
Drug Types
Are we discussing the same issues?
Research
ResearchOver 2,500 samples
– Malaria– Tuberculosis (TB)– Bacterial
infections
Testing: –MiniLab – Raman
Spectrometer
Analysis
NAFDAQ staff trained on Truscan
Analysis
Analysis
• 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
Results
15169
2429
24
1516
49
11
27
125
96 4
04 4
12%
Perc
enta
ge r
ate
of
failu
res
(%)
Failure Rate by City
• 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
Results
• 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
Results
Cheaper than qualitydrugs by up to 40%
-50
-40
-30
-20
-10
0
10
% P
rice
Devi
ation
Substandard
Fake Products
-50
-40
-30
-20
-10
0
10
% P
rice
Devi
ation
No significant discount
Price Analysis
0 5000 10000 15000 20000 25000 30000 35000 40000 45000 500000
10
20
30
40
50
60FakeLogarithmic (Fake)SubstandardLogarithmic (Substandard)Total
By city GDP
Origin and Causes
• Inferior API• Non-GMP• Poorly formulated• Contain lethal impurities • Degraded
Causes
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
• Minimal
.
• 149
• Maybe hundreds
.
• Thousands**
.
• Tens of thousands
.
• Maybe 100,000
USA
USA
Emerging Markets
Global
Africa
USA
Fake Internet Viagra
Fake Heparin
Inferior API causing shortages and dangerous
products
Substandard products due to inferior API and excipients
Lethal impurities in falsified products
Poorly formulated medicines and fake medicines
Deaths
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…
* Phillipe Andre, European Auditor, School of Pharmaceutical Scienceand Technology at Tianjin University, China
but some subcontractor premises are “physically dirty”*
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”
Food and Drug Administration
Companies:
• The best line of defense• They should pool and deepen audits:
RX-360
Food and Drug AdministrationFood and Drug Administration
Good Manufacturing Practices (GMP)
• There are high quality as well as low quality companies: it’s hard to distinguish
Causes
Simplest Acetaminophen production
GMP Procedure
Simplest Acetaminophen production
GMP Procedure
Simplest Acetaminophen production
GMP Procedure
Simplest Acetaminophen production
GMP Procedure
Simplest Acetaminophen production
GMP Procedure
Final Producer
Role of Investigators
Processing
Role of Investigators
Storage
Role of Investigators
Roger and Suresh Sati in January, 2008
Role of Investigators
Moving Forward
Why and How to Make an International Crime of Medicine CounterfeitingBy Amir Attaran, Roger Bate and Megan Kendall
August 18, 2011Journal of International Criminal Justice
International Crime
Unregistered18% of total sample: 349 medicines
Registered82% of total
sample:1591 medicines
Drug Registration
Unregistered18% of total sample: 349 medicines
Drug Registration
What is the risk of having so many unregistered products
available in the market?
Unregistered drugs fail far
more often than registered ones.
5%
37%
RegisteredUnregistered
Failure Rate by Registration
Accra
Kampa
la
Luan
da
Nairob
i
Chenn
ai
Bang..
.
Istan
b...
São P
a...
Registered UnregisteredPe
rcen
tage
of f
ailu
res (
%)
Accra
Kampa
la
Luan
da
Nairob
i
Chenn
ai
Bang..
.
Istan
b...
São P
a...
020406080
100120
Registered Unregistered
Perc
enta
ge o
f fai
lure
s (%
)
37%
5%
Failure Rate by Registration
Medicine Regulation Authorities (MRAs): the FDA in the US
International Crime
Fake Coartem from Ghana
Nigeria’s NAFDAC
Dr. Paul Orhii
Dr. Dora Akunyili
International Crime
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
International Crime
50%30%
20%
Don’t have official anti-counterfeit medicine laws
Have laws and don’t fully
enforce them
Have laws and enforce them
Limits of National Law
BBC video here
• Most drugs (and fakes) are made in China and India
• Laws must – combat criminals and negligent
companies– not harm good producers
International Crime
Middle East Distribution Network
Middle East Distribution Network
International Crime
Amjad Markieh Raed Abu Markeih
In jail, awaiting trial in Syria
Prosecutions are rareInternational Crime
Abu Kasheh, Syria
Syrian customs warehouse: destined for Iraq and recovered in
Damascus
International Crime
International Crime
Does Price Reveal Poor-Quality Drugs? Evidence from 17 countries
By Roger Bate, Ginger Zhe Jin, Aparna Mathur
August 18, 2011Journal of Health Economics
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
Economics
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®
IP Success
• Overzealous EU enforcement led to seizures of legitimate Indian generic drugs en route to Africa and Brazil
• IP laws make no distinction
IP Shortcomings
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 isn’t enough
Intellectual Property
IP will remain the key determinant without international public health
law
International Treaty
International Treaty
1. UN Member States: negotiate treaty
2. Specialized UN agency: secretariat for oversight
3. National governments: responsible for enforcement
International Treaty
Aircraft Hijacking
International Civilian Aviation
Organization
World Health
Organization
Framework Tobacco Control
International Atomic Energy Agency
Atomic EnergySafety
United Nations
Environment Program
Chemical Safety
United Nations
Office on Drugs and
Crimes
Narcotic Safety
1961 1968 1976 1980 2000
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
International Treaty
Recommended