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WHO says 1 in 10 medical products in developing countries substandard, falsified

The World Health Organization has urged governments to take action after its research found that about 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified.

The WHO said people are taking medicines that fail to treat or prevent diseases and the substandard or falsified products can cause serious illness or even death.

Since 2013, WHO received 1,500 reports of cases of substandard or falsified products, of which the most commonly reported were anti-malarials and antibiotics.

The cases ranged from products related to cancer treatment to contraception. The report stated that substandard or falsified medical products were split almost evenly between generic and patented products.

The WHO added that globalization is making it harder to regulate medical products. Many falsifiers manufacture and print packaging in different countries, shipping components to a final destination where they are assembled and distributed, and sometimes offshore companies and bank accounts have been used to facilitate the sale of falsified medicines.

The data is from WHO's Global Surveillance and Monitoring System for substandard and falsified medicines, vaccines and in-vitro diagnostic tests, which was launched in July 2013 and collected data over four years till June 30, 2017.

In addition, the WHO also published research based on 100 literature reviews and two peer-reviewed models developed by the University of Edinburgh and the London School of Hygiene and Tropical Medicine, which estimates a 10.5% failure rate in all medical products used in low- and middle-income countries.

Based on the 10% estimates of substandard and falsified medicines, a modeling exercise developed by the University of Edinburgh estimates that 72,000 to 169,000 children may be dying each year from pneumonia due to substandard and falsified antibiotics.

A model done by the London School of Hygiene and Tropical Medicine estimates that 116,000, ranging between 64,000 and 158,000, additional deaths from malaria could be caused every year due to such products in sub-Saharan Africa, with a cost of $38.5 million, ranging between $21.4 million and $52.4 million, to patients and health providers for further care due to failure of treatment.

About 42% of the cases of substandard or falsified products were reported from the WHO African Region, 21% from the WHO region of the Americas, and 21% from the WHO European region.

The WHO said it is likely that the cases reported are just a small fraction of the total problem and many cases could be going unreported. The WHO's assumption is based on the fact that only 8% of reports came from the WHO Western Pacific region, 6% from the WHO Eastern Mediterranean region and just 2% from the WHO South-East Asia region.