CAIRO, Egypt -Some 70% of countries globally have weak national medicines regulatory systems. But the launch of the African Medicines Agency should help address many of the shortcomings on the African continent, said speakers at the 6th Scientific Conference on Medicines Regulation in Africa (SCoMRA), convened here in mid-December. 

The conference, organized by the African Union Development Agency-NEPAD (AUDA-NEPAD) in partnership with the World Health Organization (WHO) and the African Medicines Regulatory Harmonization programme (AMRH) examined how stronger regulatory systems can increase equitable access to life-saving medicines.

“Since its inception we can say SCoMRA over the years has been instrumental in strengthening Africa’s harmonization efforts by promoting the regulation of medical products and propelling the continent towards equitable access to lifesaving medicines,” said WHO’s Andrea Keyter, reflecting on the theme of this year’s event.

Despite progress made, leadership changes, sustainable financing, human resource constraints, and infrastructure deficiencies, remain key challenges, said Keyter, a technical officer in WHO’s Department of Prequalification and Regulation.  

She referred to a 2021 WHO survey published in the Global Benchmarking Tool for Evaluation of National Regulatory Systems of Medical Products that found 70% of countries worldwide with weak national  regulatory systems for health products.

“There is the need for a more efficient use of the global regulatory resources to facilitate access to quality-assured medical products and to build capacity,” Keyter emphasized 

Battling Substandard and Falsified Medical Products

In another WHO report cited by Wanga Karim,  head of post market surveillance at the Kenyan Pharmacy and Poisons Board, substandard and falsified (SF) medicines are on the market in every country. At least one out of 10 tested samples in low- and middle-income countries are substandard or fake.

Unfortunately, public health officials in many countries fail to appreciate the burden of SF medicines. As this is better understood, officials will be able to make more informed choices about investments in regulatory systems that watchdog medicines quality.

On the persistent challenges of substandard and falsified medical products in Africa, Karim called for a concerted effort in utilizing available resources to curb the problems of SF on the continent.  

WHO describes substandard and fake medicines as medical products that have not undergone evaluation and /or regulatory approval for the market in which they are marketed, distributed, or used.

Increase in the marketing of contaminated cough syrups

In particular, the number of reported incidents of contaminated cough syrups has increased over the last 3 years, Karim said, noting. “Contaminated syrups have been detected in all regions – with exception of the WHO Region of the America.” As of Oct 2023, the highest number of reports of such incidents was in the African Region. 

According to Karim, some  22 incidents of cough syrup contamination with the chemicals diethylene glycol and ethylene glycol (DEG/EG) were reported to WHO in 18 member states involving 58 unique product batches between 2020 and 2023. Senegal, The Gambia, India and Cambodia topped the list.

In The Gambia, one of the biggest cases, DEG/EG contamination was “potentially” linked with acute kidney injury and 66 deaths among affected children, WHO Director General Dr Tedros Adhanom Ghebreyesus in October 2022.  Subsequent WHO-commissioned laboratory tests confirmed the presence of DEG/EG in four cough syrup products. The Haryana-based Maiden pharmaceuticals plant, which produced the syrups, was shut down temporarily by the Indian government as a result, while other products were recalled.  

In the period 2014 – 2023, Eritrea received about 2,400 alerts of suspected substandard or fake products, ultimately recalling more than 100, said Mulugeta Russom of the Eritrean Pharmacovigilance Centre, who presented a report on understanding, readiness and response in combating falsified medicine products in the country. 

“FS is a global threat because weak regulation and harmonization is a fertile ground for falsification hence in combating falsified medical products, understanding, knowledge and the political will is needed,” he concluded. 

International collaboration is critical 

Conference participants stressed the importance of international collaboration in the fight against substandard and fake products. 

“Unity in action is our strongest asset,” said AUDA-NEPAD’s Chimwemwe Chamdimba.   

Tamer Essam, Chairman of the Egyptian Drug Authority, highlighted the significance of improving the local legal frameworks and strengthening intersectional collaboration on the continent to maximize resources for the fight. “Improving the legal framework and strengthening intersectional collaboration are essential steps to combat SFMP effectively. We need a unified front in this battle,” he added.

Hiti Baran Sillon, a unit head in WHO’s Department of Regulation and Prequalification emphasized the crucial role of data and information sharing in the fight against fake and substandard medicines. 

“Enhancing data and information sharing on SF medical products among member states is crucial,” he said, adding, “collaboration is our strongest weapon against this menace.” 

African Medicines Agency – still waiting to begin operations

The African Medicines Agency is expected to help intensify the fight against fake medicines – expediting the sharing of data and information between countries, participants stressed. 

Some 55 countries have signed and/or ratified  the AMA Treaty, with Tanzania as the most recent, ratifying the treaty on 31 October 2023.” 

Aimed at facilitating sustained continental-wide harmonization of technical standards and processes, the AMA Treaty, which came into force in November 2021, was built on earlier AMRH efforts in regulatory harmonization. 

The AMA is expected to further support countries in  assessing complex medical products, provide scientific and regulatory advice in support of local pharma industry development, and expedite the removal of unnecessary technical barriers to trade in pharmaceuticals.

In June, the African Union signed an agreement with Rwanda to host the new AMA. The search for a director is meanwhile reportedly underway. But there has so far been no firm date fixed for the AMA to actually begin operations. Meanwhile three of Africa’s most powerful nations – Nigeria, South Africa and Ethiopia, have yet to sign the AMA treaty.  

The AMA is positioned not to replace but to coordinate and complement the work of national regulatory authorities and regional economic communities, stressed  Keyter.  However, in order to advance progress in regulatory strengthening, the importance of collaboration cannot be underestimated, she stressed. 

Conference participants also  highlighted the significant role of the African Medicines Regulatory Harmonization (AMRH) initiative, in the lead-up to the AMA’s creation. Said David Mukanga, chair of ARMRH Partnership Platform, “AMRH has been instrumental in implementing the African Vaccines Regulatory Forum (AVAREF) and the African Medicines Quality Forum (AMQF)  and has contributed to improved regulatory decisions, reduced registration timelines, and enhanced regulatory capacity.”

Image Credits: Jessica Ahedor , DIFD , Jessica Ahedor, AUDA/NEPAD, World Health Organization .