MHRA-falsified medicine
False representation of identity, source or its history
Quality defects and intellectual property aren’t included
WHO- deliberately and fraudulently mislabelled in identity or source
Findings
Estimated 10% of the world’s medicine is counterfeit
According to impact: developed countries 1%, developing countries 25-50% and
Africa 60%
Value $75 billion
2009 11.4 million items seized at EU border
2007 2.1 million doses of counterfeit medicines imported to UK
700,000 doses then reached pharmacies and patients
10 recalls issued by the MHRA and 7 counterfeit medicines were withdrawn
from supply chain before reaching patients
UK ports are an international hub for counterfeits
Likely Counterfeits
Developing countries- lifesaving meds (antibiotics)
Developed countries- lifestyle meds (supplements)
Vaccines and APIs can be counterfeit
Effects of Counterfeits
Morbidity and mortality
Drug resistance and toxicity
Genuine manufacturers- damaged reputation and profits
Consumer- harm, damage to confidence to use meds, change in treatment
(worse) and loss of money
Government- affects reputation, increase cost to health service and loss in tax
Motives
Low risk of being caught
Up to 2000% profit
Weak penalties
Combating Counterfeits
Relates to integrity of packaging and inner labelling/leaflets
Authentication of product covert/overt technology
Medicine being identified at multiple stages so leaves a data trail
Online
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