‘fight against counterfeit goods and why i ?’it matters to...
TRANSCRIPT
‘‘Fight against Counterfeit Goods and why Fight against Counterfeit Goods and why i ?’i ?’it matters to us?’it matters to us?’
Tapan RayDirector General
Organisation of Pharmaceutical Producers of India
Seminar on Counterfeit Products & Their Impact on Consumer Safety
15th Sept, 2009 – New Delhi
C t tC t tContentContent
Counterfeit Medicines -
Definition
Perspective
CCCConcerns
The Way Forwardy
DefinitionDefinition
Counterfeit Medicines Counterfeit Medicines DefinitionDefinition
“A medicine, which is deliberately & fraudulently mislabeled with respect to identity and / or source source.
Can apply to both branded & generic products Can apply to both branded & generic products
Include products with correct / wrong ingredients; without active ingredients / with insufficient active ingredients / fake packaging”.
Source: WHO
PerspectivePerspective
Counterfeit MedicinesCounterfeit MedicinesVarious TypesVarious Types
Growing threat to Global Public
Health
Various TypesVarious Types
5050
60
3240
50
21.4 20.215.620
30
8.5
0
10
With t AI W I di t I tQ titi Ri ht titi f AI Hi h L l f M di i h dWithout AIs Wrong Ingredients Incorrect Quantities of AIs
Right quantities of AIs but in Fake Packaging
High Level of Impurities and Contaminants *
Medicines purchased from internet thru'
illegal sites
AIs – Active Ingredients *(Substituted ingredients could be from paracetamol t b i id t l d t i d i t)to boric acid, talcum powder, rat poison or road paint)
Source: WHO
Counterfeit Medicines Counterfeit Medicines f f
Growing threat to Global Public Health
Magnitude of the ProblemMagnitude of the Problem
Developed CountriesDeveloped Countries
New Products Hormones, Steroids, anti-asthma or anti-allergy medicinesanti-asthma, or anti-allergy medicines
WorldWorld
Developing CountriesDeveloping Countries
Malaria, Tuberculosis and HIV/AIDS
Magnitude of the ProblemMagnitude of the ProblemMagnitude of the ProblemMagnitude of the Problem
Hi h i id i t i h t Higher incidence in countries where access to medicines is poor.Less than 1% in developed countries like USA Less than 1% in developed countries like USA, EU, Japan, Australia, Canada and New Zealand.
M h 30% d l l k More than 30% in developing nations like parts of Asia, Latin American and Africa.
33-53% of artesunate for malaria are counterfeit in S.E. Asia.
Source: WHO IMPACT 2006
Growing threat to Global Public
HealthCounterfeit Medicines
15001600
- Incidence of Detection
12501200
1400
600
800
1000
150200
400
600
0
200
2000 2006 2007
Source: WHO Report
Counterfeit Medicines Counterfeit Medicines Seizures World overSeizures World over
Growing threat to Global Public
Health
Seizures World overSeizures World over
In 2005 and 2006, 2.7 million articles of counterfeit drug seizures took place which originated from the following seizures took place, which originated from the following countries:
India31%
China
Others18%
UAE31%
20%
Source: WHO IMPACT
Counterfeit Medicines Counterfeit Medicines Global ForecastGlobal Forecast
Growing threat to Global Public
Health
Global ForecastGlobal Forecast
7580
50
60
70
n
39.5
20
30
40
US$
Bill
io
0
10
20
200 2010
U
2005 2010
Source: Centre for Medicines in Public Interest - 2007
Counterfeit Medicines Counterfeit Medicines Growing threat
to Global Public Health
Factors Influencing Flourishing TradeFactors Influencing Flourishing Trade
Consumer push for cheaper drugs
High price Low probability EnablersLarge number
of smallParallel trading
DriversHigh price p y
of captureo s a
distributorstrading
Low penalties Internet pharmacies
Low risk/high returns on investment in counterfeit drugs
Counterfeit Medicines Counterfeit Medicines Ch ll f k ‘M d I d ’ dChina selling fake ‘Made in India’ drugs
Dented image of industry.
No regulatory control :Quality checks, data on the small scale units ymaking medicines, the location of such drug units, trade is growing unchecked.
Copies of well-known brands but contents deadly.
Drugs look genuine with good packaging so g g g p g gpassed on as genuine .
Counterfeit Medicines In Transit issuesIn Transit issues
InIn--transit issuestransit issuesInIn transit issuestransit issues
Monday, December 15, 2008In-Transit Pharma Consigments, IP Forum Proliferation and the WHO
A very well researched story from Lison Joseph of the Mint, which I reproduce in full y y J p pbelow (critical portions of the piece have been marked in bold).
In my interview to the Mint for this story, I stated that the "in-transit" seizures of Indian consignments (of Pharmexcil member companies) in the EU appear g ( p ) ppto implicate "patent" rights of EU patent owners. And have nothing to do with trademark issues (since the exports were unbranded API's) or counterfeiting (as traditionally understood) or the WHO's recent moves to expand the definition of counterfeiting (under its IMPACT initiative). Nonetheless, there may g ( ) ybe cause to worry about the current trend towards more expansive IP enforcement measures worldwide (through ACTA etc) and the proliferation of international agencies that wish to jump into the IP bandwagon.
A Recent ReportA Recent Report
ConcernsConcerns
Counterfeit Medicines Counterfeit Medicines Emerging ViewsEmerging Views
1. Innovator Companies : Generic Industry & Drug R l k l h iRegulators not very keen to resolve the issue.
2. Generic Companies & Drug Regulators : Problem not as acute as projected by Innovator Companies. Exploiting situation to fight against generics & parallel Exploiting situation to fight against generics & parallel imports.
3 Other Group / NGOs : 3. Other Group / NGOs : Global Pharmaceutical Companies trying to extend IPR to patients’ safety issues and have gone to ACTA & WHO IMPACT.
IMPACT- International Medical Products Anti-Counterfeiting Task ForceACTA - Anti Counterfeiting Trade Agreement
Counterfeit Medicines Counterfeit Medicines Concerns
IPR being extended to the definition
Even in India “misbranded” drugs are considered gcounterfeit under - Section 17 of the Drugs & Cosmetics Act.
Estimated U.S.$ 30 billion - 6% of global turnover.*
* Albany Law Journal 2006 * Albany Law Journal 2006
turnover.
y Jy J
Counterfeit Medicines
Apprehension of Generic Pharma Industry
Counterfeit Medicines Concerns
Attempt being made to bring generic drugs under t f it m di i
Apprehension of Generic Pharma Industry
counterfeit medicines.
- No threat to non-patent infringing generics anywhere in the world.
- Generic Industry is growing much faster than - Generic Industry is growing much faster than patented drugs in the developed markets.
Counterfeit Medicines- Demands Immediate Action
Harmful effects on patients' health & can killHarmful effects on patients health & can killFrustrate efforts to deal with high burdens of diseaseUndermine health care systemsUndermine health care systems
Demands….I t ti l ll b tiInternational collaborationSimultaneous action on• legislation• regulations• enforcement• technology and technology and • communication strategies
Legislature in IndiaLegislature in India
The Way ForwardThe Way Forward
Combating CounterfeitingCombating CounterfeitingCorporate are part of the solution
Requires an integrated approach
Every company needs to protect :
Corporate are part of the solution
Make it difficult for its products to be counterfeited.Enable authentication of products and its source.Enable authentication of products and its source.Train sales staff to spot counterfeit productsRegular testing of samples from marketQuick redressal of consumer complaints Storm signal ( mismatch sales figures Internal with ORG/IMS )
|
ORG/IMS )Close liaison with regulatory authorities
Only 21% of large pharma companies had a dedicated Only 21% of large pharma companies had a dedicated anti-counterfeiting project team
Combating CounterfeitingCombating Counterfeiting Requires an integrated approach
Overt features: Covert features:
OPPI Recommendations:
Overt features:
embedded holograms,RFID….
FDA approved markers as excipients, invisible ink
Technical / Communications & PR /
LegalCommittees
Packaging Design Components controlOther considerations in design
Components control
Incident management
Combating CounterfeitingCombating Counterfeiting
P d t
OPPI Recommendations:
Product Systems
Anti-CounterfeitMeasures
Regulatory Public AAwareness
Counterfeit Medicines S P i t t P d– Some Points to Ponder
One in 5 medicines sold in India is fake.
75% f d li d ld h th i i i i 75% of drugs supplied world over have their origin in India.
As per Lancet 10 to 30% of medicines are counterfeit As per Lancet 10 to 30% of medicines are counterfeit in India.
< 1% of the drugs manufactured in India are tested. g
26 Government labs. Test 2,500 drugs samples annually. Each has backlog of 6-9 months.
WHO estimates that 200,000 of 1 million malaria death annually are due to fake drugs.
Source: The Times of India - 15th May, 2008
Combating CounterfeitingS Summing up
Counterfeit Medicines : Growing menace against Counterfeit Medicines : Growing menace against humanity.
All stakeholders to join hands to address this public health issue.
Technology and creation of awareness play a major role to address this public health menace.
