The Director-General of the National Agency for Food and Drug Administration and Control (NAFDAC), Prof. Mojisola Adeyeye, says cancer, HIV/AIDS, and malaria medications are among the substandard and falsified medicines (SFM) that are being imported into the country.
The SFM also include antibiotics, painkillers, and medications for the central nervous system, hypertension, and diabetes, she said; adding that same also has catastrophic consequences on the local pharmaceutical industry.
Adeyeye spoke at the 21st NECCI Roundtable in Lagos, themed: “Fighting the scourge of illicit trade in the pharma industry: The role of communication”.
She decried penalties for convicted defaulters saying in Nigeria, the highest penalty, on conviction, in dealing with SF 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 15 years or both fine and imprisonment.
She said to make the penalties tougher, the 9th Assembly repealed the C34 Bill for the new Act on Prohibition and Control of Counterfeit Medical Products, Fake Drugs and Unwholesome Processed Foods and Other Related Matters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.
She explained that the menace of substandard and falsified medicines portends grave financial losses, possible divestment, and close of shop for the pharmaceutical industry and threatens the attainment of the United Nations Sustainable Development Goals, which strive for access to safe, effective, quality, and affordable essential medicines.
Even though lifestyle pharmaceuticals are typically the most targeted, the DG pointed out that SF 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 specialties, human drugs, vaccines, as well as vet drugs are impacted by the illegal trade in SF medications.
Prof Adeyeye said in today’s world of globalisation, innovations, technological advancement, exponential growth in e-commerce, and global trade facilitation, illicit trade in fake goods has continued to be a significant and growing threat to economies globally, adding that the socio-economic impact of this menace for any nation is enormous.
‘’In addition to harming the economy generally, it also has the potential to weaken the rule of law and erode public confidence in the government’’, she said, noting with dismay that when it comes to medicines, the proliferation of Substandard and Falsified (SF) medicines has even greater and significant dangerous public health ramifications as well as detrimental effects on the pharma industry.
Illegal trade involves the manufacturing, distribution, and sale of goods that are prohibited by domestic and/or international law. It includes dealing with products that, due to their characteristics, are illegal in all or some jurisdictions.
Due to high demand, she noted, pharmaceuticals are particularly susceptible to falsification, stressing that the enormous financial rewards from dealing in SF medicines have lured domestic and foreign criminal organisations into the illicit business. She put the value of global commerce in SF/counterfeit drugs in 2016 at $4.4 billion, accounting for 0.84% of all pharmaceutical product imports globally but excludes a sizeable amount of locally produced and consumed SF medicines.
Currently, in Nigeria, Prof Adeyeye said the quality of medicines has increased; SF antimalarials decreased from 17 percent to 10 percent.
Prof. Adeyeye warned that medications of all types and classifications of drugs are subject to falsification and counterfeiting, adding that generics, branded, OTCs, and Prescription-only Medicines (POMs) are impacted.
Even though it is more pronounced in developing nations than in developed ones, she said that the illicit trade in SF medicines 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 SF medicines, she added that these medicines also place a greater burden on the nation’s healthcare system and erode public confidence in it.
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 SF medicines, are identified as some of the challenges responsible for illicit trade in SF medicines.
