Counterfeit medicines: Some frequently asked questions -May 2005
Which countries are the worst affected?
The problem affects many countries. Probably 60% of all cases are in developing countries, 40% in the West.
In the Western Pacific, it is particularly bad in the Greater Mekong area: Cambodia, the Lao People's Democratic Republic and Myanmar.
The problem is more common in countries where:
- the registration of medicines is ineffective;
- there is a large private (formal and informal) health sector that is insufficiently regulated or where regulations are weakly enforced, where most drugs can be bought without prescription and where many people self-treat;
- law enforcement is weak;
- there is a shortage or erratic supply of medicine;
- there is ineffective cooperation among different stakeholders;
- corruption is high;
- the population is poor and has little knowledge about health issues.
How much medicine on the world market is counterfeit?
Hard to calculate because:
- surveillance is not uniform;
- there is a lack of reporting;
- there is no common definition of “counterfeit”.
It has been estimated that probably more than 10% of the medicine on the global market is fake, and 25% of that in developing countries is counterfeit or substandard.
What are counterfeit medicines?
According to WHO’s definition, a drug/ medicine is counterfeit if it is produced with an intention to cheat. This can include mislabelling (including fudging expiry date), or no active ingredients, a wrong active ingredient, or the correct ingredient in an insufficient quantity. Both branded and generic products can be counterfeited.
What are substandard medicines?
Substandard medicines are genuine medicines produced by legitimate manufacturers that do not meet the quality specifications that the producer says they meet. For example, they may contain less (or more) active ingredient than written on the package. This may not be an intention to cheat, but may be due to problems with the manufacturing process.
How are the counterfeit drugs being distributed?
They are distributed through both legal and illegal drug channels. One factor helping counterfeiters is poor jurisdiction over pharmaceutical distribution, with wholesalers, distributors and pharmacies and village shops buying, selling and re-selling through unofficial channels, often with no proof of the medicines’ authenticity.
Who is buying counterfeits?
The main victims of this trade in this part of the world are usually the poor, particularly in rural areas. They buy these drugs because they are often cheaper than the genuine products. The public are often uneducated and do not give much thought to the quality of what they are buying.
Counterfeits are usually sold at little stores that stock a wide range of goods. The stallholders have no training in pharmaceuticals and often don’t know they are selling fake goods. They buy them from travelling salesmen who will explain the lower price by saying that they obtained the medicines wholesale or from cheaper sources, sometimes abroad.
How good are the counterfeits in terms of their ability to deceive?
Some counterfeiters have become very sophisticated. Looking at a drug, it is sometimes impossible to tell if it is a genuine product or not. In these cases, the packaging is also very well done, including faked holograms. However, there are also very simple counterfeit products on the market, with misspellings, etc. These are sometimes produced in cottage industries – in homes, sheds or even out in the open under trees. They are low profile and usually difficult to locate.
What genuine drugs are most copied?
Many drugs are copied, but one of the principal targets we currently have knowledge about in the Mekong region is the anti-malaria drug artesunate. It is exceptionally effective in treating malaria that is resistant to other commonly used antimalarials. The genuine product is manufactured mainly in China, but also to a lesser extent in Viet Nam.
Fake artesunate is on the market in most Greater Mekong region countries, suggesting a regional network of counterfeiters. In some countries in repeated surveys the % of counterfeits was above 20% of the examined batches.
Other commonly counterfeited drugs include antibiotics, vitamins, pain killers, hormones and steroids – products that are either popular or where the genuine product is too expensive for the poor.
What are the health consequences of taking counterfeit medicine?
At best, regular use of fakes can lead to the treatment simply not working. In some cases, as in the case of falciparum malaria, this can lead to death.
Why are the counterfeiters prospering?
- There is an enormous amount of money to be made (estimated worth of the global counterfeit and substandard drug trade: ~ US$35 billion), with very little risk of prosecution. Some narcotics dealers are now reported to be switching to counterfeit medicines.
- Lack of political will in some countries.
- Some governments are reluctant to report information as it may make them look bad.
- Some countries have weak regulatory systems and law enforcement, resulting in many unlicensed drug outlets.
- Manufacturers sometimes do not report copies of their drugs as it may affect their sales.
- Ignorance among the public.
- Many distribution channels, many intermediaries.
- Lack of access to affordable genuine medicines.
- Continuing rural poverty, lack of functioning health insurance schemes in many countries.
What would it take to wipe out the trade?
- Great political commitment
- Effective surveillance, investigation and law enforcement
- More human resources/better training.
- Fuller and fast exchange of information, within and across countries.
- Public education.
- Better access to affordable genuine medicines.
How bad is the situation in the Philippines?
The Bureau of Food and Drugs is committed to fighting the problem, but like many public services, it suffers from a lack of funds and a lack of manpower.
The principal problem is that surveillance and law enforcement of the counterfeit trade are poor. The major outlets such as Mercury Drugs are checked regularly – but that is not where the problem lies. The counterfeits are being sold in unlicensed outlets such as market stalls and sari-sari stores.
The government is carrying out a survey of these “high risk” outlets, and we do not yet have the results.
Another problem is the fact that many government health facilities have only 30% of the essential drugs they should have in stock. This is because of lack of funds. 30% is not acceptable for a country like the Philippines. Even in Cambodia, which is much poorer, the figure is more than 80%.
The result in the Philippines is that members of the public buy their drugs from unlicensed vendors – which is where the counterfeits are sold.
When I buy medicine from a stall in the market, what are the chances of it being fake?
We don’t know. But my advice would be to never to buy drugs from an unlicensed vendor. If it looks like you are getting a good bargain, you are almost certainly being offered fakes. The consequences could be serious.