Dr Tayo Hamzat
WHO Health Systems Support Officer
Binta, a mother of two from Banjul, recalls the harrowing months of the acute kidney injury crisis in 2022 with a mix of relief and sorrow. Her children were spared, but her friend lost a child to the tainted cough syrup during the crisis that had gripped the country.
“It was a terrifying time,” Binta says. “We didn’t know which medicines were safe.”
In July 2022, The Gambia’s Ministry of Health alerted the public and WHO to a surge in acute kidney injury cases among children. Acute kidney injury (AKI), characterised by a sudden and rapid decline in kidney function, can be fatal if not promptly treated.
From July to September 2022, 78 cases were reported, with 66 confirmed deaths, a staggering 85% mortality rate.
WHO stepped in to provide support, issued a medical product alert, and started investigations into four potentially contaminated cough syrups. It collaborated closely with the Gambian Medicines Control Agency, a bastion of public health protection which plays a pivotal role in ensuring the safety, efficacy, and quality of medical products in The Gambia.
As a quick response, the Government recalled the syrups from all pharmacies and homes by implementing an urgent door-to-door campaign. It prohibited the consumption of all paracetamol or promethazine syrups and advised people to take pills instead, which limited further deaths. It also directed importers and retailers to stop selling all varieties of paracetamol syrups. Since The Gambia has no laboratory for testing, it shipped the medicines abroad for testing and the results revealed contamination.
The experience underscored the huge significance of a robust regulatory system to ensure that medicines and medical products are safe for the population to use. This is a crucial element of a strong health system, which is fundamental for achieving universal health coverage.
Robust regulation is essential for health
The crisis became a turning point for the Medicines Control Agency to implement meticulous scrutiny of every medical product entering The Gambia, replacing the previous practice of random sampling.
Over some years, WHO, through the UHC Partnership, has provided technical support to the Medicines Control Agency and Ministry of Health, facilitated partnerships, and invested in capacity building and training initiatives to support a stronger regulatory system for medical products. WHO accelerated actions and support during the acute kidney injury crisis to avert even greater loss of life across the nation and followed it up with increased technical support. Today the Medicines Control Agency is stronger than ever, backed up with amended legislation for a more efficient and safe system.
The UHC Partnership operates in over 125 countries, representing over 3 billion people. It is supported and funded by Belgium, Canada, the European Union, France, Germany, Ireland, Luxembourg, Japan, the United Kingdom of Great Britain and Northern Ireland, and WHO.
Building stronger institutions and systems
In 2017, with support from WHO, the Medicines Control Agency had embarked on an ambitious expansion, increasing its personnel and capacity. Without a fully-fledged quality control laboratory however, it relied on costly outsourcing of testing procedures to neighbouring countries like Ghana. The collaboration between the Medicines Control Agency and WHO marked a new era of regulatory efficacy and resilience. Leveraging WHO’s expertise, the Medicines Control Agency undertook a comprehensive overhaul of its regulatory framework, addressing a significant quality control deficit.
Following the acute kidney crisis, WHO played a crucial role in this transformation, facilitating partnerships with internationally accredited laboratories through strategic Memoranda of Understanding. These alliances with labs in key supply countries, including Ghana, India, and Pakistan, streamlined the testing process and ensured adherence to stringent pre-shipment testing protocols. With about 5,000 medical products circulating in the country, including orthodox and traditional medicines, this was a crucial step. As a result, The Gambia’s regulatory framework now upholds the highest standards of product safety and efficacy.
“The partnership between the Medicines Control Agency and WHO has been instrumental in transforming our regulatory capabilities. Through WHO’s expertise and support, we’ve enhanced our framework, ensuring the safety, efficacy, and quality of medical products in The Gambia. This collaboration has not only strengthened our operations but also empowered us to uphold the highest standards of public health protection. Together, we are paving the way for a safer and healthier future for our nation,” says Tijan Jallow, Director of Operations, Medicines Control Agency.
Despite these commendable strides, challenges persisted. Concerns arose regarding duplicative regulatory requirements for products from countries with stringent regulatory authorities. In response, the Gambian government, in consultation with WHO, enacted legislative amendments in October 2023 to harmonize import processes. This revised legislation allowed products from stringent regulatory authorities to bypass redundant testing requirements, expediting importation without compromising safety standards.
Following the events of the acute kidney injury crisis WHO’s investment in capacity building initiatives further empowered the Medicines Control Agency. Comprehensive training programs in Good Manufacturing Practice, Pharmacovigilance, and Risk-Based Post-Marketing Surveillance, funded by WHO, equipped the Medicines Control Agency personnel with the skills necessary to enforce regulatory compliance effectively. This strategic investment bolstered the Medicines Control Agency’s operational capabilities and paved the way for greater self-sufficiency in regulatory governance.
“The AKI crisis provided an opportunity to reassess The Gambia’s regulatory system. We identified weaknesses and leveraged strengths, including the commitment of the Medicines Control Agency’s management and the government’s favourable policies. In a few years, the Medicines Control Agency will achieve maturity level 3 in WHO’s Global Benchmarking of Regulatory Systems,” said Dr Tayo Hamzat, WHO’s Health Systems Support Officer.
Looking to the future, WHO remains a steadfast ally in the Medicines Control Agency ‘s quest for regulatory excellence. Together, they envision a healthcare landscape where every stakeholder is mobilized to uphold the highest standards of medical regulation. From community engagement initiatives to promoting international best practices, the collaborative efforts between WHO and the Medicines Control Agency serve as a beacon of hope for a safer, healthier future for The Gambia and beyond.
“Universal health coverage can only be achieved when there is affordable access to safe, effective, and quality medicines and health products. Ensuring that all medicines are safe, effective, and available to the entire population is foundational to ensure strong primary health care and health for all” said Dr Jane Maina, WHO Interim Country Representative to The Gambia.
As The Gambia continues to navigate the complexities of healthcare regulation in the 21st century, it is making solid steps towards achieving these health ambitions. A robust approach to health security is an essential part of ensuring a healthy future for all.
Health security
The Gambia has made significant strides in strengthening health security preparedness in recent years. In 2017, the country conducted a Joint External Evaluation (JEE) to assess its capabilities for preventing, detecting, and responding to health emergencies. Building on these insights, The Gambia has consistently completed the State Party Self-Assessment Annual Reporting Tool (SPAR) from 2018 to 2023, demonstrating its commitment to continuous monitoring and improvement in health security.
To further bolster its emergency response systems, The Gambia conducted a Simulation Exercise (SimEx) in 2019, enhancing its functional capabilities in managing public health emergencies. In 2021, the country performed two Intra-Action Reviews (IAR) to evaluate and learn from its Covid-19 response, aiming to refine future strategies. These efforts culminated in the development of a comprehensive National Action Plan for Health Security (NAPHS) in 2021, which outlines strategic actions to enhance the country’s preparedness and response mechanisms.
Through these coordinated efforts, The Gambia has significantly improved its health security framework, ensuring a robust and resilient system capable of addressing both current and future health threats.
This article is available online at https://extranet.who.int/uhcpartnership/story/bright-future-safe-medicines-gambia
