“Falsifiers are using sophisticated methods that make detection difficult,” Dr Nyassi said whilst speaking at the launching of the National Substandard and Falsified Medical Products Plan on Wednesday.
The rise of online purchases and informal markets makes it hard to monitor and control the distribution of these products, he said, adding that the vast number of medical products in circulation worldwide has made comprehensive regulation and monitoring a “significant” challenge.
He explained: “The key drivers include weak regulatory systems, insufficient regulatory oversight, lack of enforcement, punitive actions to deter offenders, inadequate inspection mechanisms, and supply chain complexity.
“Long and complex supply chains with multiple intermediaries increase the risk of product tampering and substitution. There is also lack of access to affordable medicines, and elevated prices and limited access to authentic medicines compel consumers to seek more affordable alternatives, often from unregulated and potentially unsafe sources (informal markets, online).”
According to him, in 2022, World Health Organisation (WHO) estimated that 10% of medicines worldwide were counterfeit, with figures as high as 30% in some developing countries.
He said substandard and falsified medical products (SFMP) is a burden on the economy and social life of people worldwide as WHO stated that countries spend an estimated US$30.5 billion per year on substandard and falsified medical products, which can have a serious budget implication for a developing nation like The Gambia. “ But the Government through its regulatory framework is committed to fighting SFMP in The Gambia,” he noted.
Director Nyassi indicated that this is manifested by the development of such a plan which has gone through the various stages of vetting by stakeholders and “we are about to witness its launching”.
Furthermore, he said, the Government’s National Health Policy 2021-2030 plays a vital role in combating substandard and falsified medical products, aligning with its core philosophy of building partnerships for quality healthcare accessible to all.
Further, he noted the policy is closely linked to The Gambia’s Development Plan, which emphasises equitable access to essential health services, including safe, effective, and quality medicines,
“This commitment to quality resonates throughout the policy document, addressing challenges like insufficient human resources, limited access to medical products, inadequate quality assurance systems, and the presence of unregistered medicines,” he said.
He added that a central policy objective focuses on establishing an efficient supply chain system to ensure the availability of medical products, consumables, and vaccines at all levels of healthcare.
“This objective aims to eliminate the presence of substandard, falsified, and unregistered medical products within the healthcare system,” he said. “The policy employs several strategic approaches to achieve this goal.”
He said one strategy involves strengthening the legislative and regulatory framework governing medical products. “This includes ensuring that medicines adhere to the standards and specifications outlined by the Medicines Control Agency (MCA),” he stated. “By enhancing regulations and enforcement mechanisms, the policy aims to prevent substandard and falsified medical products from entering the market.”
Additionally, he notes that the policy places emphasis on ensuring that medical product donations are in line with MCA approvals, further mitigating the risk of substandard donations.
“It is important to note that this National Action Plan resonates with the policy too and the Ministry of Health’s aspirations for the health sector especially in relation to the safety, efficacy and quality of medicines for the people,” he said
He commended the MCA and also thanked the benefactors Bill & Mellinda Gates Foundation for coming up with such a plan. “I also wish to solicit the support of all stakeholders either by funds or in kind towards the implementation of this national plan,” he appealed.
