Owing to the proliferation of substandard and falsified medicines in the country, which portends grave consequences on public health and national security, the Director General, National Agency for Food and Drug Administration and Control (NAFDAC) Prof. Mojisola Adeyeye, has advocated tougher sanctions for peddlers of substandard and falsified medicines.
She regretted that sanctions against dealers of substandard and falsified medicines are ridiculously light, in comparison to penalties for other crimes such as drug trafficking, which carries the potential for lengthy prison terms and confiscation of the proceeds of crime, noting that some of the proceeds from substandard and falsified drug business are channelled into terrorism.
The NAFDAC DG who spoke in Lagos recently on “Fighting the scourge of illicit trade in the pharma industry”, affirmed that the menace of substandard and falsified medicines presents huge financial losses, possible divestment, close of shop for the pharmaceutical industry and threatens the attainment of the United Nations Sustainable Development Goals, (SDGs), hence the need for the formulation of stiffer penalties to serve as deterrent for perpetrators.
She also called for a multifaceted approach in tackling substandard and falsified medicines, stressing that experiences have shown that no single agency or country can go on this battle alone, except with concerted efforts and collaboration among all stakeholders to curb the menace.
Prof. Adeyeye further noted with dismay that dealing in substandard and falsified medical products is a very lucrative business since it entails little investment with maximum profit with few consequences when suspects are arrested, stressing that this is more so since the world powers expend so much time, energy, effort, and money in fighting narcotic and psychotropic crimes while they pay little attention to pharmaceutical crime.
According to her “In Nigeria, the highest penalty, on conviction, in dealing with substandard and falsified medicine is that the suspect will be liable on conviction to a fine not exceeding five hundred thousand naira (N500,000.00) or imprisonment for a term of not less than five years or more than fifteen years or to both such fine and imprisonment”.
To make the penalties tougher, she said the 9th Assembly repealed the C34 Bill for the new Act on Prohibition and Control of Counterfeit Medical Products, Fake Drugs and Unwholesome Processed Foods and Other Related Matters that will be signed into law in the 10th Assembly.
The NAFDAC helmsperson further decried the negative impacts of illicit trade in substandard and falsified medicines on the nation, saying it has a detrimental impact on the sales and profits of affected companies and long-term economic growth. She added that It also poses a serious threat to public health because these medications are frequently improperly formulated and may contain dangerous ingredients that will harm patients' health (kidney and other organ failures), cause treatment failures, drug resistance (especially with antimicrobials and antibiotics), and death.
In addition to increasing the cost of treating individuals who have experienced negative health effects because of using substandard and falsified medicines, she said these medicines also place a greater burden on the nation's healthcare system and erode public confidence in it.
“In general, the illegal trade in substandard and falsified medicines, medicines has a multitude of negative effects on health, society, and the economy, making it more difficult to meet the Sustainable Development Goals (SDGs), especially those that deal with poverty and health outcomes (WTO, 2022)”.
She however identified pharmaceuticals as most susceptible to falsification, due to high demand, stressing that the enormous financial rewards from dealing in substandard and falsified medicines have lured domestic and foreign criminal organisations into the illicit business. She put the value of global commerce in substandard and falsified drugs in 2016 at USD 4.4 billion, accounting for 0.84% of all pharmaceutical product imports globally but excludes a sizeable amount of locally produced and consumed substandard and falsified medicines.
Although lifestyle pharmaceuticals are typically the most targeted, the DG pointed out that substandard and falsified medicines for life-saving purposes are growing at the fastest rate with medicines for treatments of severe conditions like cancer, HIV/AIDS, and malaria being the most common groups.
‘’They also include antibiotics, painkillers, and medications for the central nervous system, hypertension, and diabetes’’, she said, stressing that all nations, patients of all ages, all therapeutic specialities, human drugs, vaccines, as well as vet drugs are impacted by the illegal trade in substandard and falsified medications.
“Absence of, or existence of weakened National Medicines Regulatory Authority (NMRA), abuse of free trade zones and other lawful trade facilitation mechanisms, uncoordinated drug distribution and supply chain system, drug Hawking and proliferation of Street / Open Drug Markets, increasing use of postal / courier services for dispatch of small parcels of substandard and falsified medicines”, were highlighted by the DG as some of the challenges responsible for illicit trade in substandard and falsified medicines in the country.
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