/Gina Sanders, stock.adobe.com
Berlin Counterfeit medicines are a major problem, especially in the global south and the Sahel region of Africa. In low-income countries such as Africa, Asia or South America, the proportion is around 30 percent, explained Johannes Waltz, President 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 or anti-infective medications are most affected.
Up to 50 percent of pharmaceutical products in the Sahel region are of inferior quality, added Richard Neci Cizungu of 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 the countries of the former Soviet Union is about 20 percent.
For Europe, the World Health Organization (WHO) takes a share of less than 1 percent, said Oliver Onusseit, head of the drug approval department at the Federal Ministry of Health (BMG). I would never subscribe to that number. It’s much less than one percent, she added. With 600 million packages of prescription medicines in Germany every year, 1% 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 hidden, Onusseit explained. In this country, each medicine package has a random number, which is checked in pharmacies by the so-called Securpharm system. This way you can check if it is a legal package. A double submission is also impossible, Onusseit explained.
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 works more or less smoothly, says Onusseit. However, stolen medicines will only be discovered through 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 reintroduced into the legal chain. These were originally produced by a drug manufacturer, but because 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 created that meets about once a year. The Federal Criminal Police and customs are also represented there, says Onusseit. After the recent Ozempic scandal, there was another switch in this round. In this incident, 200 pharmaceutical products were distributed to the United Kingdom by a German wholesaler. This would have been noticed if the Securpharm system had been used correctly. Unfortunately, this was not 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, Onusseit said. The risk is greater if the patient recognizes whether they are 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 of 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, Nakatani said.
Neci Cizungu emphasized that so-called mini-laboratories are used to combat counterfeit medicines. These are produced and distributed by the GPHF association. The mini-laboratory is a suitcase that weighs about 50 kilograms, explained Waltz, head of the GPHF. This includes laboratory equipment, reference materials, and instructions in multiple languages. The suitcase costs around 8,000 euros, depending on the characteristics.
In many countries it is the main means of combating counterfeit medicines, says Waltz. This makes it possible, for example, to check whether medicines are contaminated. More than 1,000 of these minilabs are currently used in more than 100 countries, says Waltz.
Potentially affected medicines 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 almost no options for local production of medicines in Africa. The African market depends on imports, says Neci Cizungu. Access to relevant medicines is limited, so (low) price is often the deciding factor. E: In crises, the availability of medicines is much more important than quality.
He continued to criticize the fact that regulatory authorities and government agencies 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 personnel who can distinguish between fake and real medicines.
Neci Cizungu emphasized that Germany could assist and work with African authorities to clarify the relevant relevance and strengthen the resilience of African health systems. © cmk/aerzteblatt.de