Protocol
It is a great pleasure and honour for me to give this keynote speech on the 21st NECCI PR Roundtable. The topic of this address, “Fighting the scourge of illicit trade in the pharma industry: the role of communication” is very apt considering the expeditious need to promote local manufacturing of Active Pharmaceutical Ingredients (APIs) and to move Nigeria from an importer of Finished Pharmaceutical Products (FPPs) to a country where all classes of FPPs are manufactured. These connected activities are key agenda points of the current administration, for which success will engender economic diversification.
I would like to specially commend Mrs. Nkechi Ali-Balogun, the Founder/Convener of the NECCI PR Roundtable, for the diligent job she has done in pulling this calibre of speakers together because we are more than certain that the theme will be comprehensively deliberated upon.
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. 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.
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.
Illicit Trade.
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.
Substandard Medicines
The World Health Organization (WHO) defines a substandard medicine also called “out of specification”, as authorized medical products that fail to meet either their quality standards or specifications, or both (WHO, 2018).
They are essentially made by reputable manufacturers with no desire to deceive or scam the patient (Ghanem N, 2019).
Falsified Medicines
The WHO defines a falsified medicine as a medicine that is deliberately and fraudulently misrepresented in identity, composition, or source. Unknown manufacturers produce these medications under unhygienic and uncontrolled conditions. They might contain harmful contaminants, inactive components (such as chalk or corn or potato starch), the wrong API or the incorrect amount of the right API, and no API at all. Falsified medications frequently have virtually the same packaging as the genuine medication, making it difficult to distinguish between the two without conducting some detection tests on the medication’s ingredients (WHO, 2018).
Scale and impact of the problem of illicit trade in SF medicines
Due to high demand, pharmaceuticals are particularly susceptible to falsification. The enormous financial rewards from dealing in SF medicines have lured domestic and foreign criminal organisations into the illicit business.
According to the 2020 Organisation for Economic Co-operation and Development European Observatory on Infringements of Intellectual Property Rights (OECD/EUIPO) survey report, among the 97 documented product categories, medicines were the 10th most affected commodity between 2014 and 2016, based on records of customs seizures. The same report estimates that in 2016, the value of global commerce in SF/counterfeit drugs reached USD 4.4 billion. This accounts for 0.84% of all pharmaceutical product imports globally but excludes a sizeable amount of locally produced and consumed SF medicines.
According to INTERPOL data, the market for falsified medical products could be as high as 30% in some economies of Asia, Latin America, and Africa, as well as over 20% in those of the former Soviet Union (OECD/EUIPO, 2020).
In the meta-analysis of 96 studies that examined 50 or more samples, totalling 67, 839 drug samples, it was estimated that the incidence of SF medicines in low- and middle-income countries stood at 13.6%. The largest incidence was observed in Africa with 18.7% and 13.7% in Asia (Ozawa et al, 2018).
According to the WHO Global Surveillance and Monitoring System, the continent of Africa accounted for 42% of the 1,500 incidents of SF and counterfeit medical products recorded between 2013 and 2017. The most frequently reported products by member states were antibiotics and antimalarials, which accounted for about 36% of all the products (Ghanem N, 2019).
Currently, in Nigeria, the quality of medicines increased; SF antimalarials decreased from 17% to 10%
Available data seem to indicate that illicit trade in SF medicines may have been exacerbated by the COVID-19 pandemic, with a 5% surge in seizures reported in 2020 as against 2019 (OECD/EUIPO, 2021). Additionally, reports from the Pharmaceutical Security Institute (PSI) indicate a 38% increase in pharmaceutical crimes since 2020 (IFPMA)
Medications of all types and classifications are subject to falsification and counterfeiting. Generics, branded, OTCs, and Prescription only Medicines (POMs) are impacted. Even though lifestyle pharmaceuticals are typically the most targeted, SF medicines for life-saving purposes are growing at the fastest rate. The most common groups include medicines for treatments of severe conditions like cancer, HIV/AIDS, and malaria. They also include antibiotics, painkillers, and medications for the central nervous system, hypertension, and diabetes.
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. Even though it is more pronounced in developing nations than in developed ones, the illicit trade in SF medicines has a detrimental impact on the sales and profits of affected companies and long-term economic growth. 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, 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 SF 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).
Challenges responsible for illicit trade in SF medicines
The challenges, which constitute the factors responsible for the preponderance of illicit trade in the pharmaceutical industry are multifaceted, occurring globally, but predominant in developing countries like Nigeria. These challenges include, but are not limited to the following:
Absence of, or existence of weakened National Medicines Regulatory Authority (NMRA): In countries, particularly developing countries, where there is no functioning NMRA, or where the NMRA is weak, illicit trade in SF and counterfeit medicines will flourish, as SF medicines easily reach patients when there are breaches in / absence of medicines regulations, legislations and inspecting, testing, monitoring, vigilance, and issuance of marketing authorization capabilities. Internationally, the WHO uses the Global Benchmarking Tool (GBT) in objectively evaluating regulatory systems capabilities of NMRA of countries. On an established scale of WHO maturity levels 1 to 4, only four African countries, including Nigeria, operate within ML 3. This gives a lucid picture of the extent of the problem of illicit trade in SF and counterfeit medicines in Africa.
Abuse of free trade zones and other lawful trade facilitation mechanisms: Misuse of free trade zones facilitates trade in SF medicines by providing a secure location to package and repackage goods in ways that successfully conceal their real origin. It is frequently possible when business operations are subject to limited rules and reduced monitoring.
The issue is made worse when governments fail to appropriately govern the zones; this can happen when the zones are viewed as foreign units that fall outside the purview of local authorities or when zones are run by private entities whose cardinal objectives are at odds with national interests.
Evidence has shown that even where government agencies are monitoring the zones, appropriate coordination between them and private zone operators is lacking. This gives room for criminals to use zones for their illegal activities.
Uncoordinated drug distribution and supply chain system: Open drug markets and inadequate supply chain structures can be fingered as major factors that promote the supply and distribution of SF medicines. The drug distribution system in Nigeria cannot be said to be in good stead. To a very large extent, the success of criminals involved in the illicit trade of SF medicines has been possible due to weaknesses in the distribution and supply chain structure, which are frequently disjointed (OECD/EUIPO, 2020). The more hands/transit points between the manufacturer and the patient, the more openings there are for counterfeiters to come in. This is a major problem for us in Nigeria where the supply chain is vulnerable to penetration by counterfeiters. The continuous change of hands can give room for illicit activities like repackaging and the introduction of SF medicines. Our National Drug Distribution Guideline (NDDG) has not achieved its objective of eliminating the dominance of unregulated drug markets. The establishment of Mega Drug Distribution Centres (MDDCs) as its bedrock has still not materialized as only Kano State has established a Mega Drug Distribution Centre. This makes track and trace and other product anti-counterfeiting mechanisms difficult to implement.
Drug Hawking and Proliferation of Street / Open Drug Markets: Drug hawking is the illegal act of selling drugs by unlicensed vendors who move from place to place carrying drugs exposed to the vagaries of inclement weather. The chaotic drug distribution problem in Nigeria, as in many other developing countries, is further aggravated by the proliferation of street / open drug markets and drug hawkers. Drugs hawking has been a thorn in the flesh of the Agency and has continued to undermine efforts to sanitize the drug distribution channels in several parts of the country.
The Pharmacist Council of Nigeria has the mandate to register pharmaceutical premises. The Poison and Pharmacy Act Cap. 535 of 1990 regulates the supply, distribution, and sale of medicines in static outlets that are registered by the PCN. The Act prohibits the display, distribution, and sale of all categories of medicines in unregistered outlets. Drug hawkers, who are mobile vendors of drugs are not covered by this Act and their activities are therefore illegal and criminal.
Increasing use of postal / courier services for dispatch of small parcels of SF medicines: The rise in the usage of postal and courier services to move goods has fuelled e-commerce growth as well as the illicit trade in SF medications. Nearly 57% of all product categories that were confiscated between 2014 and 2016 came from postal mailings, while 12% came from rapid courier shipments. About 10% and 15% of the seizures were related to air and sea transportation, respectively (OECD/EUIPO, 2020). These postal firms lack the professional or technical expertise necessary to identify SF medications offered to them for shipping. Additionally, it is challenging to identify and halt products in domestic and transnational trade due to the lack of adequate details on shipments for postal/express courier despatch. NAFDAC is planning an awareness/sensitization workshop in the first quarter of 2024 on this as well as others relating to SF medicines.
Availability of advanced technologies: Detection of SF medical products requires expert examination, which can be costly. A critical factor in the success of counterfeiters is their capacity to package their goods in a manner that closely resembles the real products. Today’s readily accessible technologies have helped to make this possible. Even a smartphone with an app and a home printer is capable of amazing feats.
Corruption: Government agencies have been accused of corrupt practices that have enabled illicit trade in SF medicines to thrive. Corruption has also contributed to the weakening of medicines regulatory structures as there are cases of aiding and abetting of these criminal elements through connivance, smuggling, and shielding from punitive measures.
Reduced risk of prosecution: According to WHO, there is little chance of being successfully prosecuted for counterfeiting pharmaceuticals (OECD/EUIPO, 2020). Most counterfeits are not discovered until they are in the hands of consumers or patients, and it is usually challenging to track them back through convoluted supply chains or to establish the precise location of illicit activity. Furthermore, in many African countries, the police are typically tasked with conducting criminal investigations, and they may lack substantial knowledge of the techniques occasionally required to investigate pharmaceutical crimes. This is however different with Nigeria, where NAFDAC is legally equipped to investigate pharmaceutical crime. In addition, a Proceeds of Crime Office (POCO) is being instituted in NAFDAC as part of response to the Proceeds of Crime Act (POCA), 2022.
Non-deterrent laws and weak penalties: Most nations impose much less severe penalties for falsifying medical items than they do for other crimes, such as drug trafficking, which carries the potential for lengthy prison terms and confiscation of the proceeds of crime. (OECD/EUIPO, 2020). Some of the proceeds from the SF drug business are channelled into terrorism financing.
Dealing in SF medical products is a very lucrative business since it entails little investment with maximum profit with few consequences when suspects are arrested. 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. 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 fifteen years or to both such fine and imprisonment. 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.
Profitability: Organised crime groups find the sale of SF medications very lucrative and attractive, especially if very little quantity of expensive API is used to produce the SF medicine which will be sold at a high profit margin. There are some drugs for which 80% of the cost of the generic can be accounted for by the API. In a case probed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), 100,000 pills of an SF medicine imported at a cost of roughly 0.25 GBP each were sold for up to 20 GBP a piece, yielding a profit margin of 7,900%. (OECD/EUIPO 2020).
Proliferation of rogue online pharmacies/unregulated sales of medicines online: Online sale of medicines is a veritable source of SF medical products. In Nigeria, there is no legislation to control the online marketing of drugs. For counterfeiters, online sale is especially appealing because it gives them the chance to conceal their identities and misrepresent their goods, making it relatively simple to access even the most tightly controlled markets.
Pfizer disclosed that between 2015 and 2018, it discovered and reported over 10,000 Facebook accounts or profiles that were involved in marketing SF Pfizer drugs. (Reddy, 2018).
Criminals in SF medicines have taken advantage of the growing number of people who surf the web for self-diagnosis and treatment, and consumers have repeatedly displayed a readiness to take a chance when purchasing pharmaceuticals over the internet without doing adequate checks to verify the source or the likelihood that the medicine is substandard or falsified.
Ignorance of the problem: Many consumers, mainly due to illiteracy are ignorant of the problem of counterfeiting of pharmaceuticals and can be easily deceived into thinking that the products they are purchasing are genuine. For instance, about 90% of Italian consumers who bought SF medicinal products did so inadvertently, thinking they were genuine (OECD, 2018).
Poverty and high cost of living: This is an oil that greases the wheels of illicit trade in SF medicines. Poverty and high cost of living are strong driving forces for many engaged in the purchase and use of SF medicines in Nigeria and other developing countries across the world. The disparity in prices between genuine and SF medicines in many cases is quite enormous, increasing consumer’s appetite for cheap medicines without regard for the consequences of purchasing and using products that are poorly manufactured. People knowingly pick SF medicines over genuine medicine because of cost.
Scarcity of Medicines: Scarcity and lack of access are a disruption in the supply chain of any product and provide an avenue for SF medicines to fill the gap.
Actions taken by NAFDAC to combat this trend in Nigeria.
The National Agency for Food and Drug Administration and Control (NAFDAC), established by Act Cap N1 LFN 2004, is mandated to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of Food, Drugs, Cosmetics, Medical Devices, Packaged Water, Chemicals and Detergents (collectively known as regulated products).
In the execution of this mandate, the Agency promotes the safety of the lives of Nigerians by ensuring that only safe and right quality food, medicines, cosmetics, medical devices, chemicals, detergents, and packaged water are manufactured, imported, exported, advertised, distributed, sold and used in Nigeria. This way, we are propelling the country towards the achievement of universal health coverage with improved access to safe, effective, quality, and affordable essential medicines and vaccines for all Nigerians.
Some of the actions taken by the Agency in this regard are:
- Attainment of ISO 9001:2015 certification and WHO Maturity Level 3, which implies that NAFDAC has reached the level of a regulatory system operating as a stable, well-functioning, and integrated system for the regulation of medicines and imported vaccines, in an efficient, effective, and transparent manner, to achieve universal health coverage by making access to safe, effective, quality, and affordable essential medicines and vaccines for all Nigerians. This achievement has immensely strengthened the Agency’s regulatory system. It has attracted a lot of confidence in our noble effort and aspiration to confront the menace of SF medicines. However, no effort is spared in our quest to achieve the ML4/WLA status. We are currently undergoing WHO GBT evaluation to achieve WHO ML4 status.
- NAFDAC effectively operates four ISO-17025 re-certified drug control and food laboratories, giving the Agency the capacity to efficiently pronounce on the quality of regulated products. The agency also operates one ISO-17025 certified Vaccines, Biologics and Medical Devices (VBM) laboratory, which is the only in-house VBM Lab in Sub-Saharan Africa. The Central Drug Control Laboratory in Yaba has just received WHO Prequalification, another achievement of the Agency in the assurance of medicines quality.
- We have commenced phased implementation of a GS1-driven track and trace system, with in-country serialization capability, to secure the supply chain for pharmaceuticals, following a successful pilot study with Covid-19 vaccines. NAFDAC successfully developed and launched the national pharmaceutical traceability strategy, inaugurated the national traceability steering committee, and published the guidelines for master data requirements. The Agency also published the draft national traceability regulation that is being processed for gazetting. A pilot track and trace study is underway for narcotics to make the distribution more transparency and visible. More partner funding is capacitating the Agency in the deployment of hundreds of scanning devices to national and zonal cold stores while the personnel are being trained to use these scanners.
- Deployment of cutting-edge technologies like the TRUSCAN (handheld device built on Raman spectroscopy) for on-the-spot detection of SF medicines in circulation and at the ports of entry into the country. It has formed the basis of our Supply Chain Monitoring, which is a periodic but regular exercise, targeted at on-the-spot checks of medicines along the supply chain using the Truscan®.
This device has recorded immense success at identifying SF medicines that may have infiltrated the supply chain with the attendant consequences of impacting patient safety and security. We have successfully demonstrated that results from the Truscan® are comparable to those obtained from our wet chemistry laboratory.
- We also have a policy on the Establishment of New Pharmaceutical Plants in Nigeria. This enables companies to get their facility design right before commencing construction, in a bid to eliminate the potential for manufacturing SF medicines resulting from poorly designed manufacturing facilities. Local pharmaceutical companies have also begun setting up facilities for the manufacturing of Active Pharmaceutical Ingredients (APIs).
- The Centralized GMP Inspection Procedure. This ensures that local manufacturing facilities are assessed based on uniform and internationally accepted standards, and execution of unannounced routine inspections of local manufacturers of essential medicines to curb unethical practices and manufacture of SF medicines. This was initiated in 2018 through the GMP compliance road map for local pharmaceutical manufacturers to ensure effective implementation of GMP and GDP guidelines within the local pharma industry. In addition, the Centralized GMP inspection has resulted in the imposition of regulatory sanctions on several manufacturers ranging from outright shutdown and license revocation of non-compliant manufacturers as well as revocation of marketing authorization.
- The Clean Report of Inspection and Analysis (CRIA). This scheme is a Pre-shipment inspection arrangement set up as part of measures put in place by NAFDAC to curb the increasing rate of importation of fake, substandard, and unwholesome finished pharmaceuticals and other regulated products, raw materials, and chemicals from India and China. The scheme involves the appointment of independent laboratories in China and India to conduct quality testing of regulated products sampled by the CRIA agents on behalf of NAFDAC before the products are exported to Nigeria. The CRIA system has resulted in stopping of shipment of over 120 SF products from China and India.
- Strengthening our post-marketing surveillance. NAFDAC’s current strategy for tackling the circulation of SF medicines covers prevention, detection, and response mechanisms. Typical of these measures are multi-stakeholder engagement, education, and awareness, supply chain integrity, risk-based post-marketing surveillance, development of National Drug Distribution Guidelines, advocacy for the establishment of coordinated drug distribution centres, and access to laboratory and screening technologies.
- Comprehensive Legal Framework. Several regulations targeted at curbing SF medicines and safeguarding public health have been gazetted. These regulations (hoisted on the NAFDAC website) prescribed stiff sanctions for violators and peddlers of SF medicines.
- Investigation and Enforcement (I&E)/Federal Task Force on Counterfeit and Fake Drug and Unwholesome Processed Food. NAFDAC has strengthened its I&E directorate to carry out investigation and enforcement activities to deter the circulation of SF medicine.
One of the statutory responsibilities of I&E is to investigate pharmaceutical crime and to enforce compliance with the NAFDAC mandate. The main enabling legal instrument deployed by the Agency’s Investigation and Enforcement Directorate is the Counterfeit and Fake Drug and Unwholesome Processed Food (Miscellaneous provision) Act Cap C.34 LFN 2004 that is undergoing Amendment in the 10th Assembly. The Agency is collaborating with PCN to make the Federal Task Force more impactful through the Director of Pharmaceutical Services at the State levels. NAFDAC through the Investigation and Enforcement Directorate is also working to checkmate and disrupt the activities of illegal sales of medicines online.
- Deployment of the NAFDAC Greenbook. This is a database of all registered drugs in Nigeria. It will be available online (https://greenbook.nafdac.gov.ng) and on mobile (play stores). It will serve as the first line for authenticating the registration status of medicines registered by NAFDAC.
- Mobile Authentication Service (MAS): NAFDAC deployed the Mobile Authentication Service (MAS) as one of the anti-counterfeiting strategies to detect substandard and falsified (SF) medical products. MAS uses scratch codes and Short Messaging Service (SMS) to empower consumers to verify the authenticity of medicines at the point of purchase (putting the power of detecting counterfeits in the hands of consumers). The consumer scratches a panel on the product which reveals a unique, one-time-use PIN. The PIN is sent toll-free to a short code using any of the GSM operators and the consumer receives a response in the form of a text message (SMS) stating that the product is either genuine or suspected fake.
- Grassroots sensitization and awareness campaigns. To educate Nigerians about the effects of SF drugs, NAFDAC periodically organise grassroots sensitization and awareness campaigns around the country. These initiatives give consumers knowledge and skills to assist them in avoiding and protecting their health from the threat of SF and counterfeit medicines.
- Local and International Collaborations. NAFDAC has been engaged in a series of efforts with globally recognized bodies with the sole aim of joining the global fight against SF medicines. Chief among these include membership status of the International Coalition of Medicine Regulatory Authorities (ICMRA), having observer status of the International Council on Harmonization (ICH), active participation in the West Africa Medicine Regulatory Harmonization (WA-MRH), African Medicine Regulatory Harmonization (AMRH). In addition to all these, there has been bilateral and multilateral cooperation with technical partners notably UN agencies (WHO, UNICEF, UNOPS, UNITAID, UNODC, etc.), United States Agency for International Development (USAID), Bill and Melinda Gates Foundation (BMGF), etc.
NAFDAC is also collaborating with other NMRAs globally and the INTERPOL. We are actively involved in the sending of information on suspected cases of SF discovered in-country to the global community through the WHO Global Surveillance and Monitoring System and participate in various international initiatives aimed at eliminating sales and distribution of SF. These include the MEDICRIME Convention, WHO member state mechanism on SF medicines, operation PANGEA, etc.
- Successful launch and deployment of the Med Safety App, which is a mobile app for quick, efficient, and improved monitoring and reporting of adverse drug reactions, especially when compared to the traditional paper yellow form. It enhances patient safety and facilitates monitoring of adverse effects associated with SF medicines in circulation.
- NAFDAC has put in place some regulatory directives. One of these is the Five Plus Five Validity, which requires the importer of a drug, (for which local manufacturers can produce), to submit plans for migrating to local manufacturing or form partnership with local manufacturers during the renewal term, following the March 2019 directive date. Partnerships between importers and local manufacturers are increasing and new facilities are being built for those who decided to migrate to having physical facilities in Nigeria.
Another is scaling up the number of items covered in the NAFDAC Ceiling from 9 to 34 medical items, to prevent the importation of these drugs that are produced locally to meet local demand.
These policies will provide the Agency with a strong foothold for enhancing local regulatory oversight aimed at improving access to medicines that meet the requirements for quality, safety, and efficacy. With effective oversight of local manufacturing, the less we import, the less we are exposed to the import of SF medicines into the country. The policies are thus veritable means of curbing the influx of SF medicines into Nigeria.
The Role of Communication
Communication which involves information exchange has been extremely critical in our fight against illicit trade in SF medicines both within and outside Nigeria. Effective communication is part of the bedrock of the foundation of our success story in NAFDAC. Effective communication has made NAFDAC more efficient in the way we carry out our operations. Our communication tools double as productivity tools as they help us share information timely, making our work easier and leaving us with more time for other responsibilities.
NAFDAC has a communication strategy aimed at ensuring all our processes, procedures, laws, regulations, policies, etc are promptly and effectively communicated to our staff, our stakeholders, and the public. We have developed an Agency-wide Communication Matrix that outlines our communication management plan for efficient and improved intra and inter-agency communication. We have identified our internal and external stakeholders, as well as the means and frequency of communicating with them. We employ various forms of communication including electronic media, broadcast media, print as well as digital media.
We have television and radio programs such as NAFDAC and Your Health, we have IEC materials like posters, flyers, brochures and magazines, newspaper publications, NAFDAC Info and NAFDAC news, Dear Healthcare Provider letter; we conduct press briefings, press statements, media campaigns, sensitization and awareness programs and campaigns, townhall meetings, workshops and conferences, video conferencing, virtual meetings and we are online via our interactive website, www.nafdac.gov.ng. Additionally, we utilize emails, SMS, WhatsApp, phone calls, and social media platforms like Instagram – @nafdac_ng; X formerly Twitter – @NafdacAgency; and Facebook – @NAFDACNIGERIA.
We have a digital communication team that plans, develops, implements, and manages strategies for our social media accounts.
The Agency also has a feedback mechanism for receiving information from clients, stakeholders, and the public.
NAFDAC conducts sensitization campaigns across the country to raise awareness and drive home the message against SF medicines and their deleterious effects. The Agency attends local and international meetings and conferences to share ideas and knowledge and build networks and partnerships in the fight against illicit trade in SF medicines.
Today, I am here with this auspicious audience, once more, communicating this agenda.
With our communication strategy, we have been informative by providing correct and unbiased information on SF medicines including methods of identifying SF medicines and the need to purchase medicines from registered pharmacies. We have also been persuasive with our messages in our grassroots sensitization campaigns, to get people to do the right things through attitudinal change, like stopping patronage of drug hawkers and shunning the lure to indulge in illicit trade in SF medicines.
Conclusion
Illicit sales and distribution of substandard and falsified medicines are a global threat that presents huge public health challenges to National Medicines Regulatory Authorities in both developed and developing countries. It 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.
Our experiences in tackling SF medicines have shown that no single Agency or country can go on this battle alone. The approach must be multifaceted. This therefore calls for concerted efforts and collaboration among all stakeholders. Efforts, through various regulations, programs, policies, technological deployment, and local and international collaborations must be supported with effective communication, which guarantees transparent and efficient dissemination and sharing of information to curb the menace of SF medicines.
Effective communication has helped NAFDAC build trust with our stakeholders. It has further helped in clarifying and providing regulatory direction in the fight against illicit pharmaceuticals in Nigeria.
The array of aforementioned activities, programs, policies, collaborations, and interventions, coupled with our effective communication strategy has resulted in improved monitoring and control of SF medicines and improved foreign direct investment with massive technology transfer into the local pharmaceutical manufacturing industry in Nigeria. Our most recent survey indicates that SF antimalarials in circulation have decreased from 17% to 10%.
We now have a huge array of local manufacturers who are building brand-new pharma manufacturing plants and retrofitting old facilities to meet global standards. In addition, we now have some of our local drug producers in manufacturing contract arrangements with some well-known multinational companies who are synonymous with high-quality products meaning our manufacturers can churn out products that meet international quality standards.
I once more congratulate the NECCI PR for the successful hosting of this program and express my desire for such result-oriented programs to continue to be hosted for the foreseeable future.
Thank You
References
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IFPMA – International Federation of Pharmaceutical Manufacturers and Associations
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OECD – Organization for Economic Cooperation and Development
EUIPO – European Union Intellectual Property Office
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Ozawa. S. et al (2018). Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systemic Review and Meta-analysis. Available at Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis | Global Health | JAMA Network Open | JAMA Network. (accessed on October 16, 2023)
Reddy, S. (2018), “The uphill fight against fake prescription drugs”, Wall Street Journal, 8 October. Available on www.wsj.com/articles/the-uphill-fight-against-fake-prescription-drugs-1539009351. (accessed on October 22, 2023)
World Health Organization (WHO) (2018), Substandard and falsified medical products. Available at: https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products (accessed October 12, 2023)
World Trade Organisation (WTO) (2022), Leveraging WTO Rules to Combat Illicit Trade in Medical Products. Available on https://www.wto.org/english/tratop_e/markacc_e/illicit_trade_working_paper.pdf. Accessed on October 24, 2023)
