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EAC’s bid to Curb Counterfeit Drugs

The presence of Counterfeit medicines is one of the long-term challenges still being faced in the African medical sector. Amidst the greater need of effective technology and specialized medical personnel in the health sector, the East African Community partner states are lately concerned on the status of readiness in curbing counterfeits.

The World Health Organization Global Surveillance and Monitoring for Falsified and substandard Medical products report states that 42% of all fake medicines reported to them between 2013 and 2017 were from Africa. While WHO estimated 1 in 10 medical products circulating in low and middle-income countries are either substandard or falsified, recent studies estimate that over 169,000 deaths of children under 5 suffering from pneumonia, and up to 116,000 deaths result from the use of falsified medicines to treat malaria. 

Counterfeit drugs have not only contributed to Antimicrobial Resistance, but also lead to a loss of confidence in medicines, health systems and healthcare providers. It is estimated that US$200 billion globally and US$30 billion in low- and middle-income countries annually is lost due to this challenge.

Through the East African Community(EAC) Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management managed under the University of Rwanda, two health personnel, from countries Rwanda, Tanzania, Kenya, Uganda, Burundi and South Sudan of National Medicines Regulatory Authorities (NMRAs) in the EAC Partner States were recently trained on the use of the Minilab technology, where Each EAC Partner State will received two Minilab kits, reference standards and reagents through its NMRA, and two Minilab kits will be reserved by the UR/EAC RCE-VIHSCM for teaching and training purposes.

Minilab technology is a portable and relatively low-cost tool designed to help screen the quality of medicines in resource-limited settings. It helps to quickly assess and detect counterfeit and substandard medicines anywhere any time without the lab.

This followed the Twenty-third Ordinary Meeting of the EAC Sectoral Council on Health, held on February 10th this year in Bujumbura, Burundi, which directed the EAC Secretariat in collaboration with EAC Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management (UR/EAC RCE- VIHSCM), to procure 16 Minilabs Test Kits as per the Implementation Agreement (EAC/SCHealth/23/Directive 060), and directed the UR/EAC RCE-VIHSCM to conduct regular trainings on the use of Minilab Test Kits (EAC/SCHealth/23/Directive061). 

Dr.  Raymond Muganga, the Rwanda Food and Drug Authority (FDA)’s Division Manager of Quality Control Laboratory admits how counterfeits have before been detected in Rwanda, especially entering from neighboring countries across the borders, an issue which has been earlier contained, “Health Centers receive, and are in more contact with people, so there is need to collaborate more on training and coordination with then so as to more monitor the progress in line with curbing of counterfeits,” Dr. Muganga adds. 

Rwanda has majorly previously relied upon first the visual inspection, and the lab technology, which is the advanced measure, a technical one which indeed incurs a cost too in expertise and infrastructure.

The Minilabs Project first phase is a result of a 400,000 Euros (USD435,660), grant by the Federal Government of Germany, Federal Ministry of Economic Cooperation and Development (BMZ) through German Development Bank (KfW). 

A Gap prevails 

With this technology to have been introduced in East Africa as a pilot project since 2002, its effectiveness in implementation has been deterred due to the cost, and lack of infrastructure and technical expertise. Around the region, Tanzania is leading with about 28 Minilab equipment earlier acquired by US Pharmacopeia, “But these aren’t enough, that each country needs to have one per hospital,” states Dr. Stephen Karengera, the Director of the East African Community, Regional Centre of Excellence for Vaccines, Immunization and Health Supply Chain Management (EAC RCE-VIHSCM). With about 700 hospitals countrywide in Rwanda, there is still a huge gap for this technology. 

With fake medicines resulting to Antimicrobial Resistance (AMR), which is a is an emerging global threat, AMR infections cause 700 000 deaths every year globally and is estimated to account for 10 million deaths each year by 2050 if no actions taken according to the 2016 O’Neill J. Tackling Drug-Resistance Infections Globally Report.

Burundi too presently has four equipment after the addition of two more, “We have at several times encountered counterfeit medicines through tracking it using the available measures, like visual identification, and limited technology,” states François Bayubahe, Quality Assurance and Quality Control Manager, Burundi national medical store (CAMEBU).The country needs at least five minilab equipment, which should majorly be stationed at border post so as to effectively operate, “But the technical expertise and availability of qualified staff is another challenge that needs to be addressed,” Bayubahe adds.

Kenya has Minilab technology since 2009, but before their entry, the presence of falsified drugs in the market was up to 30 percent, which has since then been curbed to 1% according to

Kenya Pharmacy and Poisons Board’s Michael Bugigi, who is the Principle Regulatory Officer in the Quality Controls Laboratory. With currently 20 minilab kits, there is still a need for this technology to be accessible at least each of its 45 counties.    

South Sudan currently has four equipment, from initially two. Although the country has before ever been faced by a major challenge arising from counterfeit drugs, which was contained ten years ago, amidst the lack of modern technology, no cases had lately been registered. Dr. Rita Gabriel Togba, the Quality Control and Quality Assurance Director General under the Drug and Food Control Authority, “We haven’t been using the testing technology for close to five years now due to the lack of necessary equipment to enable us to test,” she explains. There is a need for the allocation of a kit at each of its four entry border points according to Dr. Togba.

As a challenge, maintenance of the minilabs technology is a major one, since the equipment requires expertise in handling, and the right infrastructure to store them according to Dr. Karengera

Françoise Kayitare Tengera, the University of Rwanda Deputy Vice-Chancellor for Finance states that the EAC RCE-VIHSCM has already acquired catalytic funding of 2 million EUR and was approved the CEOs of National Medical Stores on August 8th this year, and EAC and 20th Ordinary Meeting of the EAC Sectoral Council on Health, “We are already in the process of setting up the EAC Digital Health Infrastructure to support both initiatives,” she adds.

By Andrew I. Kazibwe