Counterfeiting
A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/ or source.
Counterfeiting of medicines can apply to both branded and generic products. Generally, counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with in correct quantities of activities ingredients or with fake packaging
Counterfeit Medicines
Products marketed with intent to deceive
1– Counterfeit active/bulk ingredients
2– Counterfeit finished products
3– Unregulated diverted products
4– Counterfeit labeling
5– Mislabeled substances (e.g., generic anti-biotics)
Why are Medicines a Target?
- Fakes can be made relatively cheaply (at least as profitable as narcotics – lower risk).
- Many countries, especially in the developing world lack adequate regulation and enforcement
- Even in the industrialized countries, the risk of prosecution and penalties for counterfeiting are inadequate
- The way in which medicines reach the consumer is also different from other goods: the end-user has little knowledge of the product – a ‘credence’ good
What is Particular to Pharmaceutical Counterfeiting?
- Medicine counterfeiting is much more of a threat to public health than to company revenues
- Developing countries are the worst affected where regulatory structure is weaker and measurement and oversight is difficult; consumers in LDC’s often buy Rx drugs directly over the counter
- Non-branded generics are very widely counterfeited (e.g., ampicillin, paracetamol)
- Prices vary widely across the world, and parallel trade is widespread, allowing counterfeit medicines to enter the supply chain
- People will not knowingly buy a counterfeit drug, but consumer detection is extremely difficult: price is not an indicator in insured markets
Current and Future Risks
- Treatment failure in malaria, TB and HIV/AIDS
- Growth of resistance to existing anti-infectives from use of sub-par treatments
- Spread of drug resistant pandemics, including HIV and influenza
- Use of illegal funds to finance further illegal manufacture of medicines and even terrorism
- Globalization of pharmaceutical production know-how drives counterfeiting: supply-driven
- Counterfeit drugs are increasingly showing up in OECD countries
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- Fakes can be made relatively cheaply (at least as profitable as narcotics – lower risk).
- Many countries, especially in the developing world lack adequate regulation and enforcement
- Even in the industrialized countries, the risk of prosecution and penalties for counterfeiting are inadequate
- The way in which medicines reach the consumer is also different from other goods: the end-user has little knowledge of the product – a ‘credence’ good
What is Particular to Pharmaceutical Counterfeiting?
- Medicine counterfeiting is much more of a threat to public health than to company revenues
- Developing countries are the worst affected where regulatory structure is weaker and measurement and oversight is difficult; consumers in LDC’s often buy Rx drugs directly over the counter
- Non-branded generics are very widely counterfeited (e.g., ampicillin, paracetamol)
- Prices vary widely across the world, and parallel trade is widespread, allowing counterfeit medicines to enter the supply chain
- People will not knowingly buy a counterfeit drug, but consumer detection is extremely difficult: price is not an indicator in insured markets
Current and Future Risks
- Treatment failure in malaria, TB and HIV/AIDS
- Growth of resistance to existing anti-infectives from use of sub-par treatments
- Spread of drug resistant pandemics, including HIV and influenza
- Use of illegal funds to finance further illegal manufacture of medicines and even terrorism
- Globalization of pharmaceutical production know-how drives counterfeiting: supply-driven
- Counterfeit drugs are increasingly showing up in OECD countries
Please check out our Website
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