Rapid reporting of substandard and falsified medicines
One in every 10 medicinal products in low- and middle-income countries is substandard or falsified.
Astellas, AstraZeneca, GSK, Eisai, Novartis, Takeda
All diseases and patient populations
Promptly reporting sub-standard and falsified medicinal products
To address the public health risk of SF medicines
The World Health Organization (WHO) estimates that in low- and middle-income countries, one in every 10 medicinal products is substandard or falsified (SF).* WHO reports anti-malarial treatments as part of the most commonly found SF products in sub-Saharan Africa, with approximately 60% of the treatments circulating in the region potentially being SF, consequently leading to an estimate of 116,000 deaths per year.** This incidence of SF medicinal products represents a substantial threat to public health and the Index expects pharmaceutical companies to promptly report cases to national authorities and/or notify WHO’s global surveillance and monitoring system.
Companies ought to have policies in place to report any confirmed cases of SF medicines to the relevant health authorities in countries in scope as promptly as possible to mitigate the health risks. WHO, after validating and identifying the risk to public health, can then issue a rapid alert to warn states and populations and encourage increased vigilance and adequate regulatory action.***
GSK reports SF medicines within a maximum period of five days.
Where laboratory analysis is required for confirmation, a company’s policy should require reporting of cases as soon as possible and, following confirmation, within 10 business days. In the case of a SF medicine that needs only visual inspection for confirmation (such as the wrong packaging or batch number), it is good practice to commit to a shorter timeframe for reporting.
GSK's expedited reporting system
Of six companies leading in this area, GSK is stands out as its policy to report SF medicine has the quickest reporting timeframe with a maximum period of five days. It also applies the shortest timeframe of reporting in a consistent way, using the same process across all countries including those in scope of the Index. Its policy enables it to report to regulatory authorities, ministries of health and WHO and to quickly respond and take direct action in urgent situations where there is a significant risk of patient harm (for example, by withdrawing a product from market).
How do companies help safeguard the supply and quality of their products?
The achievement of the Sustainable Development Goals by 2030 brings a new sense of urgency to the challenges and inefficiencies posed by complex supply chains. Pharmaceutical companies have a crucial role to play in safeguarding the supply of high-quality medicines globally, especially in hard-to-reach populations where health systems may be weak. Access to such products is key in achieving Universal Health Coverage.
Public health factors taken into account
Five other companies, namely Astellas, AstraZeneca, Eisai, Novartis and Takeda, have policies in place to report SF cases to the relevant health authorities and/or WHO in less than 10 days. Each provides evidence of a policy to report SF medicine within a comparatively short timeframe. Astellas, AstraZeneca, Eisai and Takeda distinguish and differentiate cases that need only visual inspection for confirmation, while Novartis reports relying on packaging data verification and packaging testing. All demonstrate a policy based on public health considerations, allowing faster reporting to health authorities and quicker withdrawal of the potentially harmful SF medicine. One company in scope, Johnson & Johnson, also aims at reporting within five days, based on patient risk; however more details are not available. Novartis provides examples of robust collaborations with international and local authorities. In Egypt, it supports the local ministry of health to identify and tackle the circulation of falsified ophthalmology products and reports cases to the WHO. It has also worked with the Colombian government to tackle an illegal network manufacturing falsified medicine for patients needing critical care.