Counterfeits, Knockoffs, Replicas:Parsing the Legal Implications
Counterfeits Kill
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Transcript of Counterfeits Kill
“Are They Real!?”
Counterfeits Can Kill!
Brought To You By….
Your Quality Assured Wholesaler1 (242) 393-4854 Fax 1 (242) 394-0533Email – [email protected]
“The Emerging Crime of the 21st Century”
Counterfeit Drugs!!
WHATS REAL AND WHATS NOT?
Can you really tell?
WHATS REAL AND WHATS NOT?
Can you really tell?
Counterfeit Medicine: A medicine that is
deliberately and fraudulently mislabelled with respect to identity
and source.
Counterfeit Products May Include Products With:
The correct ingredients, Wrong ingredients, Without active ingredients, With incorrect quantity of active
ingredient or With fake packaging
FACTS AND FIGURES
WHO survey between 1992 and 1994 revealed that 51% of counterfeit cases had no
active ingredient
25% of medicines used in developing countries are
counterfeit or substandard
Counterfeit medicines generate $32 billion a year in sales for Drug
Dealers
200,000 counterfeit bottles of Lipitor made their way onto
the US in 2003
5% of all antibiotics sold worldwide are
counterfeit!
The Extent of The Problem
WHO figures suggest that developing countries account for 60% of all
reported cases of counterfeit and
substandard drugs
Counterfeit drugs in developing countries are
generally life saving and not lifestyle drugs, such as
malaria, TB and HIV/AIDS
WHO survey of counterfeit medicines in 20 countries between January 1999 and October 2000 found that in60% of the 325 cases an
active ingredient was missing
pain killers, antimalarials, anti-asthma, anti-allergy, antibiotics, hormones and steroids
In 2003 WHO reported that fake drugs between 1999 and 2002 included:
51% of counterfeit cases had no active ingredient
17% contained the wrong ingredient 11% contained weaker than
recommended concentrations of active ingredient
WHO survey in 1992 and 1994 revealed that:
weak drug regulation control and enforcement,
scarcity or unreliable supply of basic medicines,
unregulated markets and high cost of medicines
Trade in counterfeit medicines is more prevalent in countries with:
Internet Purchasing
Internet Pharmacies have facilitated the sale of fake
medicines.
Some of these pharmacies do not require a
prescription to sell medicines and can
endanger the patient’s life
THE CONSEQUENCES Treatment Failures, Erosion of public confidence in health care, Prolonged illness, Unexpected and Dangerous side effects, Antimicrobial resistance Economic Hardship on Authorized and Ethical
Distributors Negative Effect on the countries Economy DEATH!
The Weakest Link in Pharmaceutical Counterfeiting
is………
The Supply Chain
Manufacturering Plant
Warehouse
Authorized Distributor
Retail Pharmacy
PATIENT
“Until the government takes action to restrict the number of times a prescription drug product is bought and sold among WHOLESALERS, the nation will continue to be susceptible to counterfeit drug problem.”
Eric Turkewitz, a New York City lawyer.
“A drug distribution system that includes thousands of wholesalers is like having "thousands of windows and doors for the criminals to get in….Especially when there are people inside the house who will be conveniently leaving the windows and doors open"
Eric Turkewitz
Major Problem…..
Current laws in many countries does not prevent anyone from bringing in a product to sell, that a distributor has been given exclusive distributorship to by the manufacturer.
This disrupts the safe distribution chain and increases the chance of sub-standard and/or counterfeit drugs entering the country.
Benefits of a Proper Chain of Distribution…….
Proper recall procedures Constant Supplies Proper Labeling Quality Control
(Storage/Packaging/Expiry) Positive Economic benefits for the
country e.g.. Authorized supplier paying taxes, duties, salaries, national insurance contributions etc.
Contributions of AUTHORIZED and reputable Wholesalers…….
Employment/Salaries National Insurance Contributions Customs Duties Real Property Tax Educational Seminars International Sponsorships Samples & Literature
Contributions of UNAUTHORIZED and disreputable Wholesalers…….
CHEAP BUT “QUESTIONABLE” DRUGS
TO THE RETAILER AND CUSTOMER
Questions to ask when purchasing a drug…. If this product is recalled, will you
be notified? If the answer is no, DON’T BUY IT! Will the government purchase this
product? If the answer is no, DON’T BUY IT
• Did it come to you through the authorized channels?
If the answer is no, DON’T BUY IT
Questions to ask when purchasing a drug…. Is the price too good to be true? If the answer is yes, DON’T BUY IT Is the label in English? (You owe
your patient the respect of having a label he/she can read!)
If the answer is no, DON’T BUY IT Is this drug being diverted? If the answer is yes, DON’T BUY IT!
Questions to ask when purchasing a drug…. Can the quality be guaranteed? If the answer is no, DON’T BUY IT!
Can you guarantee previous storage conditions or expiry date?
If the answer is no, DON’T BUY IT!
Do you have product liability from the authorized distributor?
If the answer is no, DON’T BUY IT!
Could this be a counterfeit or fake drug? If the answer is yes, DON’T BUY IT!
Remember!........The Weakest Link in
PharmaceuticalCounterfeiting is….
THE SUPPLY CHAIN
Purchase brands only from authorized Distributors!
Do not break the chain!
Your Quality Assured Wholesaler1 (242) 393-4854 Fax 1 (242) 394-0533Email – [email protected]
You are now eligible to enter and win $500 toward the educational
seminar of your choice!
Simply email us at [email protected] and complete the following sentence:
The Weakest Link in Pharmaceutical
Counterfeiting is….Note
This offer is restricted only to Pharmacists currently practing in The Bahamas
Deadline for Submission of Entry
June 30th 2005
Winner will be announced July 1st, 2005