High proportion of counterfeit medicines in the Global South

High proportion of counterfeit medicines in the Global South

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/Gina Sanders, stock.adobe.com

Berlin Counterfeit medicines are a big problem, especially in the global south and the African Sahel region. In low-income countries, such as Africa, Asia or South America, the proportion is around 30 percent, explained Johannes Waltz, Chairman of the Global Pharma Health Fund (GPHF), recently before the Global Health Subcommittee of the Health Committee in the Bundestag. All medications are affected, but antimalarial medications or anti-infectives are most affected.

Up to 50 percent of pharmaceutical products in the Sahel region are of inferior quality, added Richard Neci Cizungu from the Ecumenical Pharmaceutical Network (EPN) in Nairobi. Another report showed that almost 23 percent of all antibiotics in Ethiopia, Kenya, Rwanda and Tanzania were counterfeit or ineffective, Neci Cizungu continued. Most of these products came from China, India but also from European countries such as Belgium or France. Waltz added that the proportion of counterfeit medicines in countries of the former Soviet Union is around 20 percent.

For Europe, the World Health Organization (WHO) assumes a proportion of less than one percent, said Oliver Onusseit, head of the drug approval department at the Federal Ministry of Health (BMG). I would never sign that number. It’s much less than one percent, he added. With 600 million prescription drug packs in Germany every year, one percent would be a terribly high number, says Onusseit.

Counterfeit medicines include not only medicines that do not contain any active ingredients, but also medicines whose origin is concealed, explained Onusseit. In this country, every medicine package has a randomized number, which is checked in pharmacies using the so-called Securpharm system. This way you can check whether it is a legal package. A double submission is also impossible, explained Onusseit.

Securpharm is the German contribution to the EU-wide EMVS network against counterfeit medicines. Implementation has been mandatory since February 2019. The system is supported by industry and wholesale and runs more or less smoothly, says Onusseit. However, stolen medicines will only be discovered via the system if the medicines and corresponding numbers are also reported as stolen.

Isolated scandals in Germany

In Germany, thousands of medicines were stolen during a major scandal in 2013/2014 and then fed back into the legal chain. These were originally produced by a drug manufacturer, but since we don’t know what happened to the drugs in the meantime, they are also considered unsafe and therefore counterfeit, says Onusseit.

After this scandal, a federal-state meeting was set up that meets about once a year. The Federal Criminal Police Office and customs are also represented there, says Onusseit. After the recent Ozempic scandal, there was another exchange in this round. In this incident, 200 pharmaceuticals were distributed to the United Kingdom by a German wholesaler. This would have been noticed if the Securpharm system had been used correctly. Unfortunately, that wasn’t the case, complained Onusseit.

There is no greater risk of obtaining counterfeit medicines through legal mail-order pharmacies in this country, as online pharmacies, like retail pharmacies, also purchase medicines from legal wholesalers, said Onusseit. The risk is more whether a patient recognizes whether he is ordering from a legal or illegal online pharmacy, says Onusseit. There needs to be more information about how to find a safe pharmacy and information about the dangers involved.

Laboratory studies are important in the global south

In countries in the global South there are no corresponding systems like Securpharm, said Yukiko Nakatani from the WHO. What is important, however, is the member state mechanism that brings WHO member states together on a platform to jointly develop strategies against counterfeit medicines and exchange best practices, said Nakatani.

Neci Cizungu emphasized that so-called minilabs are used to combat counterfeit medicines. These are produced and distributed by the GPHF association. The minilab is a suitcase weighing around 50 kilograms, explained Waltz, the head of GPHF. This includes laboratory equipment, reference materials and instructions in several languages. The suitcase costs around 8,000 euros, depending on the features.

In many countries it is the main means of combating drug counterfeiting, says Waltz. This allows medicines to be checked for contamination, for example. More than 1,000 of these minilabs are currently used in more than 100 countries, says Waltz.

Potentially affected drugs are also examined by other laboratories, and the data is sent to WHO laboratories, Neci Cizungu also explained. There is such a laboratory in Kenya. The data is used for international intelligence.

A big problem with counterfeits is that there are no or hardly any local production options for medicines in Africa. The African market is dependent on imports, says Neci Cizungu. Access to the relevant medicines is limited, so the (low) price is often the deciding factor. And: In crises, the availability of medication is much more important than the quality.

He continued to criticize that regulatory authorities and government agencies had ignored the problem for a long time and did not point out the difficult situation. Therefore, there is a need for better cooperation at all levels, more regulations for production and qualified staff who can distinguish between fake and real medicines.

Neci Cizungu emphasized that Germany could help and work with African authorities to clarify the relevant relevance and strengthen the resilience of African health systems. © cmk/aerzteblatt.de

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