The World Health Organisation has published new research showing that an estimated 1 in 10 medical products in circulation in low to middle income countries is substandard or falsified
The World Health Organisation has published new research showing that an estimated 1 in 10 medical products in circulation in low to middle income countries is substandard or falsified.
Since 2013, WHO has received 1,500 reports of cases of substandard or falsified products, which fail to prevent or treat disease and cause serious illness or even death.
Almost half of the reports (42%) came from the WHO African Region, where the issue puts increased financial strain on individuals and national health systems in countries’ already struggling with health-related epidemics.
The WHO America Region accounts for a further 21% of reports, and 21% also comes from the WHO European Region.
Many more cases, however, are likely to have remained unreported, according to WHO, as the Western Pacific, Eastern Mediterranean, and South-East Asia Regions account for the remaining 16% of reports.
Before WHO established the Global Surveillance and Monitoring System for substandard and falsified products in 2013, no global reporting of these cases occurred.
Now, many countries are actively reporting suspicious medicines, devices and vaccines, and WHO has trained 550 regulators from 141 countries to detect and advise on the issue.
Another study on the public health and socioeconomic impact of substandard or falsified medical products, conducted by WHO and the Member State Mechanism, estimated that low and middle income countries suffered a 10.5% failure rate in all medical products.
The study was based on over 100 research papers on medicine quality surveys completed in 99 countries and involving 48,000 medicine samples, though a lack of accurate data means these estimated figures can only indicate the scale of the problem.
Using the study’s findings, the University of Edinburgh developed a modelling exercise that estimates between 72,000 and 169,000 children may be dying from pneumonia a year due to falsified or substandard antibiotics.
The London School of Hygiene and Tropical Medicine similarly found that an estimated 116,000 additional deaths from malaria per year could result from inadequate anti-malarials in sub-Saharan Africa, costing patients and health care providers on average US$38.5 million on failed treatments.
Counterfeit products have been reported for both generic and patented products, from contraception to cancer treatment.
These products reach patients when manufacturing, supplying and distribution standards are not enforced correctly, or when regulations are flouted by the unethical practices of wholesalers, distributors, retailers and health care workers.
Countries with limited access to medicine reported a higher proportion of cases, whilst regulatory circumvention on modern purchasing models like online pharmacies impact higher-income countries.
Globalisation makes it more difficult to regulate medical products, as the manufacturing of product and packaging, shipping, assembling, and distributing can happen in different countries, and offshore bank accounts and companies can facilitate their sale.
WHO Director-General, Dr Tedros Adhanom Ghebreyesus, said: “Substandard and falsified medicines particularly affect the most vulnerable communities.
“Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die.
“This is unacceptable.
“Countries have agreed on measures at the global level – it is time to translate them into tangible action.”
Assistant Director-General for Access to Medicines, Vaccines and Pharmaceuticals at WHO, Dr Mariângela Simão, said: “Many of these products, like antibiotics, are vital for people’s survival and wellbeing.
“Substandard or falsified medicines not only have a tragic impact on individual patients and their families, but also are a threat to antimicrobial resistance, adding to the worrying trend of medicines losing their power to treat.”
