By: Helmut Mahongo
The African Medicines Agency (AMA) and Medicines for Africa (MFA) signed a Memorandum of Understanding (MoU) on combating the rise in the use of substandard and falsified medical products.
The MoU, which was signed in Kigali, Rwanda, seeks to strengthen the continent’s collective response to a growing concern of substandard and falsified medical products.
Speaking at the signing of the MoU, the Director-General of the AMA, Dr Delese Mimi Darko, said, “The African Medicines Agency was established to strengthen regulatory cooperation and improve access to safe, quality and efficacious medical products across Africa.”
“Substandard and falsified medical products thrive on fragmented supply chains and regulatory oversight,” said Dr Darko.
Adding that, the collaboration between AMA and MFA will ensure that the regulatory excellence translates into safer outcomes for patients and stronger public confidence in medical products.
Dr Darko said this will be achieved by combining the strengthening of Substandard and falsified medical products advocacy by the AMA with the communication of these types of medical products public engagement led by the MFA.
According to a Taylor & Francis 2023 report, the absence of coherence in legislation was observed to be exacerbating the problem in South Africa.
The report revealed that “the lack of coordination between governmental departments, lack of stakeholder engagement and collaboration, especially between private/public partnerships, made the situation worse.
The lack of harmonisation on existing legislation, lack of capacity and resource mobilisation, which subsequently hampers effective law enforcement, were also identified by Taylor & Francis.
At the 78th World Health Assembly held in Geneva, Switzerland in 2023, Namibia indicated that it had submitted its first report to the Global Antimicrobial Resistance Surveillance System (GLASS).
Namibia at the same event revealed that it was developing a pilot antimicrobial stewardship program at healthcare facilities, aiming to reduce unnecessary antibiotic use.
On the need for raising awareness on this subject, Namibia pointed to the need for raising public awareness and fostering multi-sectoral engagements.
In 2023, the World Health Organisation (WHO) reported that as many as 267,000 deaths per year are attributed to substandard and falsified antimalarial medicines, according to the transnational organised crime threat assessment findings.
Trafficking these products, according to the WHO, is also taking a direct economic toll on affected countries.
The WHO estimates put the cost of caring for people who have used falsified or substandard medical products for malaria treatment in sub-Saharan Africa between N$192 million and N$720 million per year.
Drawing reference to the United Nations Office on Drugs and Crime UNODC investigations, the WHO said a variety of actors are involved in the illicit medical product trade.
Some of the traffickers, according to the UNODC, include pharmaceutical company employees, public officials, law enforcement officers, health agency workers and street vendors.
The WHO has also highlighted that the major contributing factors to substandard and falsified products globally are insufficient national medicine regulation, poor enforcement of existing legislation, and weak stakeholder collaboration.
In 2029, a WHO investigation raised alarms on the need for stronger regulations to combat substandard and falsified medications.
In 2014, in the Ituri district of the Democratic Republic of the Congo (DRC), several people, 60% of them children, became sick after taking a medicine believed to reduce shivering and fevers from malaria.
The medicine was later found to contain haloperidol, an antipsychotic substance used to treat schizophrenia.
The same WHO investigation found that the tablets people had been taking contained 13 mg of the same drug.
The dosage they said was about 20 times above the maximum recommended dose for a child, and by the time the source of the problem was identified, 930 people had been hospitalized, and 11 had been reported to have lost their lives as a result.
The first joint initiative of the partnership between AMA and MFA will co-convene the Africa Patient Safety Summit in Kigali, Rwanda, in September of this year.
The Summit will bring together regulators, researchers, and development partners, among others to help advance collective action on patient safety and the combating of substandard and falsified medical products across the continent.
