The World Health Organization (WHO) estimates from 2017 indicates that 10.5% of medical products available in low- and middle-income countries (LMICs) are “substandard or falsified” (SF). Substandard health products are approved by the national regulators, but they do not comply with adequate standards due to undetected errors, negligence, or poor practice in manufacturing, transportation, or storage. In some cases, they may be linked to corruption. Conversely, falsified medical products always result from criminal fraud. Current analyses from Oxford University suggest that the Covid-19 pandemic has seen a surge in SF health products, and particularly for vaccines.
The World Health Organization (WHO) estimates that 10.5% of medical products available in low- and middle-income countries (LMICs) are substandard or falsified (SF), and ongoing analyses from Oxford University suggest that the Covid-19 pandemic has seen a surge in SF health products, particularly for vaccines.
As a public health pharmacist, I am happy that building universal access to quality-assured health products is a priority for Belgium. For instance, the implementers of Belgium-funded medical programs overseas are explicitly required to ensure the quality of procured products, and Belgium is now actively promoting a similar approach for other European donors.
In 2020, Belgium promoted a resolution, approved by the Tenth Conference of State Parties of the United Nations Convention on Transnational Organized Crime, for preventing and combatting falsified medical products. And this year, on 17th May, Belgium sponsored a side-event at the thirtieth session of the Commission on Crime Prevention and Criminal Justice, with title ”Fighting poor-quality health products in times of COVID19 and beyond: the need for a multi-stakeholder approach”. The event was co-organised with ITM and ENABEL, and I was actively involved in planning and conducting it, with ENABEL colleagues.
Speakers from academia and from regulatory agencies in Africa stressed the importance of tackling SF through both regulatory and law-enforcement approaches.
As a speaker, I underlined the need of a public health–informed legal and regulatory environment, to prevent and detect SF health products. They arise from the interplay between societies, economies, and behaviors: thus, we need to disincentivise their production and supply, while supporting health systems to ensure access to affordable, quality-assured health products to all levels of society.
Paul Newton, a professor at the Centre for Tropical Medicine & Global Health, Oxford University, described the current knowledge about SF health products in the field of Covid-19, including cases of falsified remdesivir, contamination of hand sanitiser with methanol, and 94 reports of diverted or SF Covid-19 vaccines from 32 countries. He underlined that inequitable access is highly likely to fuel an increase in such incidents, and that vaccine falsification using harmful adulterants could cause outbreaks of unexpected side effects with dire consequences for vaccine hesitancy.
Mojisola Christianah Adeyeye, the Director General of the Nigerian National Agency for Food and Drug Administration and Control, reminded that while a reliable and well-developed health infrastructure is vital for every country, ensuring access to quality-assured health products is just as important. She presented the way Nigeria has been addressing the problem of SF health products for about twenty years now, by gradually reinforcing the national regulation and regulatory oversight within the country and in the countries from where about 70% of medicines are imported, and by promoting coordination across regulatory authorities, international organisations, manufacturers, public health and enforcement agencies.
Daphney Mokgadi Fafudi, Head of Regulatory Compliance at South African Health Products Regulatory Authority (SAHPRA - South African Health Products Regulatory Authority), presented the national statistics on SF medical products, and the stakeholders involved in tackling them. She stressed the need of live stream electronic system to detect warnings; the need for timely prosecutions of SF medical products (including unauthorized online sales); and the need of international collaboration, including timely sharing of lifesaving resources, information and associated skills transfer. She reminded that access to quality-assured health products is a moral requirement for humanity.
Aboubacry Amadou Ba, Director of Pharmacy and Laboratories in Mauritania, reminded that SF health products are harmful to individuals, communities and health systems, and that people in resource-limited countries are the first victims, due to lack of resources and limited international coordination to combat them. He wished that this event could be an opportunity to address the question of multi-stakeholders collaboration, as a way to find jointly sustainable solutions to the issue of poor-quality health products in times of Covid-19 and beyond.
We all strongly agreed that a stringent legal and regulatory framework is needed to mitigate the impact of SF health products. Regulatory authorities and law enforcement bodies have different mandates, skills and field of interventions, but there are also overlapping and complementarity in their work, thus information sharing and cooperation should be encouraged and promoted. We also hope that the Covid-19 crisis can trigger greater international collaboration and collective action on SF health products, including via harmonisation initiatives through African Medicines Regulatory Harmonization and the evolving African Medicines Agency; rigorous prosecution of falsified health products; greater coordination between international and UN agencies; and enhanced information-sharing.
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