One in 10 medical products in developing countries substandard or falsified: WHO

ISLAMABAD: An estimated one in 10 medical products circulating in low and middle-income countries is either substandard or falsified, according to new research from the World Health Organization (WHO).

The research report said that people are taking medicines that fail to treat or prevent diseases. Not only is this a waste of money for individuals and the health systems that purchase these products, but substandard or falsified medical products can cause serious illness or even death.

“Substandard and falsified medicines particularly affect the most vulnerable communities,” said Dr Tedros.

WHO Director-General Adhanom Ghebreyesus said: “Imagine a mother, who gives up food or other basic needs to pay for her child’s treatment, is 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 global level – it is time to translate them into tangible action.”

Since 2013, the WHO has received 1500 reports of substandard or falsified product cases. Of these, antimalarials and antibiotics are the most commonly reported. Most of the reports (42%) come from the African Region, 21% from the Americas, and 21% from the European Region.

This is likely just a small fraction of the total problem and many cases may be going unreported. For example, only 8% of reports of substandard or falsified products to WHO came from the Western Pacific Region, 6% from the Eastern Mediterranean Region, and just 2% from the South-East Asia Region, said the report.

“Many of these products, like antibiotics, are vital for people’s survival and well-being,” said WHO Access to Medicines, Vaccines and Pharmaceuticals Assistant Director-General, Dr Mariângela Simão.

“Substandard or falsified medicines not only have a tragic impact on individual patients and their families but are also a threat to antimicrobial resistance, adding to the worrying trend of medicines losing their power to treat,” she said.

Prior to 2013, there was no global reporting of this information. Since the WHO established the Global Surveillance and Monitoring System for substandard and falsified products, many countries are now active in reporting suspicious medicines, vaccines and medical devices.

WHO has trained 550 regulators from 141 countries to detect and respond to this issue. As more people are trained, more cases are reported. It has received reports of substandard or falsified medical products ranging from cancer treatment to normal diseases. They are not confined to high-value medicines or well-known brand names and are split almost evenly between generic and patented products.

In conjunction with the first report from the Global Surveillance and Monitoring System published, WHO is publishing research that estimates a 10.5% failure rate in all medical products used in low and middle-income countries.

This study was based on more than 100 published research papers on medicine quality surveys done in 88 low and middle-income countries involving 48,000 samples of medicines. Lack of accurate data means that these estimates are just an indication of the scale of the problem. More research is needed to more accurately estimate the threat posed by substandard and falsified medical products.

The report said that the 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.

“The bottom line is that this is a global problem,” said Dr Simão. “Countries need to assess the extent of the problem at home and cooperate regionally and globally to prevent the traffic of these products and improve detection and response.”