Recognising counterfeit medicines
When do we speak of counterfeit medicines?
Medicines are considered counterfeit if they have been deliberately and fraudulently mislabeled, i.e. if the information about their identity, ingredients and/or origin is incorrect. Counterfeit medicines contain either
- no active ingredient at all (e.g. consist only of baking powder)
- a harmful substance (e.g. a solvent)
- the stated active ingredient in an incorrect dosage (usually too little, i.e. ‘diluted’ in some way)
- the correct dosage, but are produced without patent rights and sold as originals
Although counterfeit medicines can often be recognised by their incorrect presentation or packaging, this is not easy especially for laypeopl. According to the World Health Organisation (WHO), the contents of 10 percent of medicines worldwide do not contain what is printed on the packaging; in Germany, experts estimate a counterfeiting rate of one percent, tendency rising.
High profit margins
Why are medicines counterfeited?
The production costs for counterfeit medicines are low. With simple machines and thanks to digital printing techniques, products that cannot be identified as counterfeit at first glance can be produced with little effort. Low production costs are met by enormous profit margins from the successful sale of counterfeit medicines. In addition, in many countries the regulations for the authorisation of medicines are not sufficient or are hardly enforced and criminal laws are weak or non-existent to prosecute such criminal offences. The personal risk for counterfeiters is therefore much lower and chances of profit are just as high as those for manufacturers and distributors of illegal drugs. On top of that, due to globalization and the increase of online pharmacies, the international distribution channels have become easier.
All of this makes the production and sale of counterfeit medicines an attractive business for ruthless people with fast and high profits. In Europe, for example, the profit margins of individual packs of particularly expensive cancer drugs are very high, but criminals can also make enormous profits from selling large quantities of widely used cheaper drugs. In September 2016, for example, a concerted operation by the World Customs Organisation and its partners in several African countries seized counterfeit medicines worth 52 million euros - all potentially lethal drugs!
Dangerous medicines
Why are counterfeit medicines so dangerous?
Doctors carefully use medicines to fight diseases. If the prescribed medication doesn`t contain enough, none or the wrong active components or even harmful substances, it always has negative consequences for the patient. At best, the healing process is simply delayed. However, the absence of the intended effect can also worsen the course of the disease or cause irreparable damage. Worst case, this can lead to the death of the patient.
For example: In some of our projects, malaria is one of the most common causes of death among young children. Sick children are often brought to the doctor late. Then, successful treatment is only possible with highly effective malaria medication. Even counterfeit products that contain the active ingredient, but not in the required dosage, lead directly to the death of the child. Unfortunately, medicines such as antimalarials or drugs against tuberculosis are among the most counterfeited pharmaceutical products. In addition to the high risk for individual patients, the epidemiological effects of counterfeit drugs can also be devastating. For example, patients suffering from tuberculosis who take incorrect doses of medication may develop resistance to active substances more quickly. At the same time, they pass these resistant germs on to many other people in their neighborhood due to the lack of effect of the tablets taken.
Information on distribution channels
How are counterfeit drugs distributed?
In the USA, Europe, Canada and Japan, counterfeit medicines are very rarely found in pharmacies: Only 1 per cent of preparations are counterfeit drugs, and drug safety via this distribution channel is very high. The situation is different for online pharmacies: Even in western industrialised nations, 50 percent of medicines from the internet are counterfeit.
However, the situation is far more dramatic in Africa, parts of Asia and Latin America. There, between 10 and 30 per cent of all medicines sold - both in recognised pharmacies and on the street or in unlicensed shops - are counterfeit medicines. No distribution channel meets the standards of drug safety of the Global North - with disastrous consequences for the health of entire nations.
Original vs. generic drug
What is the difference between propriety drugs, generic drugs and branded generics?
Propriety drugs or original preparations are medicines that are produced by recognised pharmaceutical manufacturers and marketed under a brand name (the best-known example is Bayer's Aspirin). Usually, the manufacturing companies developed the drug themselves and hold the patent rights.
A generic drug, in the plural generics, is a medicinal product that is a copy of an original preparation. It is crucial that both products contain the same active ingredients in the same quantity. Differences may exist in the additives and in the technology used to manufacture the product. However, these must not have any effect on the efficacy of the product. The rights to manufacture generic drugs can be sold to generics` manufacturers by the owner of the patent rights of the original preparation. Alternatively, a sub company can take over production and distribution of the generic drug.
In both cases, it is sold under the international non-proprietary name (INN) in conjunction with the manufacturer's name. Branded generics are drugs that are manufactured from patent-free active ingredients (e.g. after patent expiry) and marketed under their own trade name.
Often lower prices for generic drugs
Partly because the companies producing generics do not invest in research and testing of medicines, they can often offer their products at a significantly lower price than the original preparation with the same active ingredient. This is precisely why they are often used in the field of humanitarian aid and development co-operation, as they are more cost-effective. This is an important point for many non-governmental organisations financed by donations. The prerequisite for this, however, is the guarantee that the medicine purchased actually contains the specified active ingredients in the prescribed dosage.
However, not only generics but also original preparations are affected by counterfeit medicines. While fraudsters in Europe, the USA and other developed markets make most of their profit from the sale of counterfeit, expensive original preparations, large profits are also made in other regions through the bulk business with counterfeit generics.
Our fight against counterfeit medicines
How does Swiss Doctors deal with the problem?
Generics play a major role in the supply of medicines to our patients, as they are generally cheaper and we can therefore use the donations entrusted to us more effectively. It is also one of our principles to buy medicines wherever possible on the local market in our regions of operation, as this also contributes to cost savings by eliminating transport and import costs. We also see it as a contribution to the economic development of the economies of our countries of operation. However, this also increases the risk of buying counterfeit medicines and thus using potentially lethal drugs.
Minilabs bring great success
In the years 2005 to 2016, thanks to the support of Celesio AG, we were able to actively tackle this issue in individual projects and reduce the counterfeiting rate of the medicines used in our Nairobi project from over 9 per cent to 0 per cent with the help of a mini-laboratory suitable for field use (now known as GPHF-Minilab®). In India, the success was even more powerful: in 2005, the counterfeit rate there was over 30 per cent; this was reduced to around 4 per cent. After the central pharmacy started in 2012, no more counterfeit medicines could be detected in our Calcutta project, which we run jointly with Swiss and German Doctors. This is a great success for our work on the ground and in particular for the many patients who now benefit from safe preparations. However, it remains a major challenge to guarantee these good results over a longer period of time.
Be careful when choosing your wholesaler
Therefore, where ever possible, we either use wholesalers specialising in NGOs with their own WHO-certified laboratory, such as in Kenya, or, if possible, we stick to distributors who have scored positively in the mini-lab tests. However, we are aware that the mini-lab's capabilities are limited and that only continuous monitoring can guarantee a certain degree of safety. However, the tests are time consuming and cost money, both of which are limited resources for NGOs. At present, we can only carry out spot checks.
In other countries where there is no functioning market for generics or where it is simply too expensive to buy locally, we obtain the medicines from recognised wholesalers who specialise in supporting humanitarian work - for example for our projects in the Philippines. These wholesalers use their own laboratories and mechanisms to guarantee quality. Bangladesh has successfully established its own controlled pharmaceutical industry since the 1980s. We therefore currently rely on effective medicines on the local market there.
The fight against counterfeit medicines continues
For a single aid organisation, however, the problem of counterfeit medicines ultimately remains a major challenge that it cannot tackle alone. Usually independent control authorities such as the Federal Institute for Drugs and Medical Devices (BfArM) do not exist in developing countries, which means that medical products and drugs are only tested insufficiently. International and national efforts must be made to ensure that patients throughout the world can be sure that they are actually taking (only) the active ingredients necessary for their treatment. There must be a worldwide effort be to improve the safety of medicines as there are still so many potentially deadly diseases in developing countries like tuberculosis, malaria, HIV/Aids and now also the Coronavirus.
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