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Medicines are of vital importance in health systems, and access to quality-assured medicines is part of the basic right to health. Nevertheless, substandard and falsified (SF) medical products, including vaccines, biologics, diagnostic tests and medicines, are widespread due to poor manufacture (substandard medicines) or deliberate falsification. SF medical products jeopardise national, regional and global attempts to improve access to effective health care because they lead to avoidable morbidity, waste financial resources and contribute to drug resistance.

Health worker giving medicine
Credit: Pippa Ranger DFID

Substandard medical products result from errors, corruption, negligence, or poor practice in manufacturing, procurement, regulation, transportation, or storage. In contrast, falsified products result from criminal fraud. Although they have been traded for many centuries, in the last few decades the problem has grown due to the increased complexity of the global pharmaceutical economy and internet sales. There have been reports of poor quality medicines and medical devices in both high and middle-income countries but many reports are from low-income countries. Many nations have inadequate surveillance systems, and SF medical products are often not detected or reported.

Little research has been done to date and existing data in this area are limited with many gaps, with improvements needed in data quality, collection and data sharing. The WHO estimates that 1 in 10 medical products circulating in low and middle-income countries are either substandard or falsified. However, the true scale of the problem is still unknown and this underlines the urgent need for wider, multidisciplinary research to build the evidence base globally and to use these data for informing interventions and policy to ensure that everyone has access to good quality medical products. SF medical products have far-reaching consequences, but the ability to tackle the problem is hampered by its complexity. The solution can only come from collaborative work between governmental authorities, pharmaceutical suppliers, healthcare professionals, national/international organisations, and research institutions.

IDDO’s Medicine Quality Research Group shares expertise and collates information to increase understanding of the prevalence and distribution of SF medical products around the world. It encourages discussion of poor quality medicine epidemiology, detection, prevention and investigation of criminal sources of falsified medicines; and aims to facilitate improvement in the quality of medicines that patients actually take.

The Medicine Quality Research Group has launched a new, free, online tool to help researchers and public health officials worldwide track what may be happening in their communities and countries in SF medical products. During the pandemic, the Group produced monthly reports from this tool collating information in the public domain on the quality of medicinal products that were in use, or that were being trialled for COVID-19’s prevention or treatment; and a separate regular report on falsified COVID-19 vaccines.

The Group led work on the Oxford Statement, in which over 150 representatives from governments, multilateral agencies, academia and civil society called for global action on medicine quality. which sprang from the Research Group’s successful 2018 event, the first-ever dedicated academic conference on Medicine Quality & Public Health.

For further information, please email medicinequality@iddo.org