FEDERAL REPUBLIC OF NIGERIA

1. FEDERAL REPUBLIC OF NIGERIA

2. ANTICOUNTERFEITING ACTIVITES: THE CASE OF NIGERIA PROF. DORA N. AKUNYILI DIRECTOR-GENERAL NATIONAL AGENCY FOR FOOD AND DRUG ADMINISTRATION AND CONTROL (NAFDAC), NIGERIA. PRESENTATION TO WORKING CUSTOMS SEMINAR ON THE FIGHT AGAINST FRAUD AND COUNTERFEITING IN WESTERN AFRICA ORGANISED BY AFRICAN INDUSTRAL ASSOCIATION IN PARTNERSHIP WITH WESTAFRICAN ECONOMIC AND MONETRY UNION (WAEMU) & THE EUROPIAN COMMISSION AT OUAGADOUGU, BURKINA FASO NOVEMBER 28th – 30th, 2005 .

3. OUTLINE • Introduction. • What is a Counterfeit Medicine • Implications of Counterfeit Drugs • Scope of the Problem of Fake/Counterfeit Drugs in Nigeria Prior 2001. • Factors that encourage drug counterfeiting. • Strategies employed by NAFDAC to Combat Drug Counterfeiting in Nigeria. • Government Support • Some of the Achievements and Gains Recorded so Far. • Conclusion

4. INTRODUCTION BACKGROUND INFORMATION Nigeria is a country in west Africa bordered to the East by Cameroun, the West by Benin Republic, the North by Niger Republic, North East by Chad and South by Atlantic Ocean. • POPULATION: Approx.150million • TOTAL AREA: 923,768Sq/Km • LAND AREA: 910,768Sq/Km • WATER : 13,OOOSq/Km • GEO-POLITICAL ZONES:Six(6) • NO. OF STATES:36 • CAPITAL: Abuja • OFFICIAL LANGUAGE: English

5. INTRODUCTION CONTD • I am excited to have been invited to address this distinguished audience on a global burning issue, that is of interest not only to Drug regulatory authority but also the custom organizations. • I have also been privileged to participate in the 1st and 2nd Global Fora on Pharmaceutical anti-counterfeiting, organized by Reconnaissance International in Geneva and Paris, September 2002 and March 2005, respectively. More recently we have equally shared our experience of anticounterfeiting activities with regulatory authorities from francophone west African countries in Senegal in October 2005 • I use the opportunities of such meetings to tell the world that drug counterfeiting is a reality, • Share strategies that we have used in combating it, - So that countries that have already been invaded by drug counterfeiters will learn from our experience and know that it is possible to fight and defeat them despite the daunting constraints, - And countries without reports of counterfeit drugs to be proactive so as not to give drug counterfeiters the opportunity to come in and establish their network.

6. INTRODUCTION CONTD • Drug counterfeiters have succeeded in the past three decades largely because of lack of awareness and lack of cooperation among stakeholders nationally and internationally. • The increasing worldwide reports of counterfeit medicines and the number of international fora focusing on drug counterfeiting, have sensitized all stakeholders including security operatives as yours to collaborate on the need to work together in order to make it difficult for drug counterfeiters to continue thriving in their nefarious activities. • The negative impact of counterfeit drugs knows no boundaries and affects the health, social and economic life of all nations, therefore a forum such as this with officers versed in investigative skills is ideal for pooling resources to frustrate drug counterfeiters. • At the end of this presentation I expect that we would all have learnt and imbibed the need for collaborative effort between customs and regulatory authorities, also between Nations of the world especially in the sub-region.

7. WHAT IS A COUNTERFEIT MEDICINE NAFDAC identified forms of fake/counterfeit drugs: • Drugs with no active ingredient(s) • Drugs with insufficient active ingredients • Drugs with active ingredient(s) different from what is stated on the packages • Clones of fast moving drugs - these are drugs with the same quantity of active ingredients as the genuine original brand. • Herbal Preparations that are toxic, harmful, ineffective or mixed with orthodox medicine. • Expired drugs or drugs without expiry date, or expired and re-labelled with the intention of extending their shelf-life. • Drugs without full name and address of the manufacturer. • Drugs not registered by NAFDAC

8. IMPLICATIONS OF COUNTERFEIT DRUGS • Counterfeiting of medicines is one of the greatest atrocities of our time. It is also a form of terrorism against public health, as well as an act of economic sabotage. Counterfeit drugs violate the right to life of innocent victims. • The evil of fake drugs is worse than the combined scourge of malaria, HIV/AIDS and armed robbery put together. This is because malaria can be prevented, HIV/AIDS can be avoided and armed robbery may kill a few at a time, but counterfeit/fake drugs kill en mass. • The social problem posed by hard drugs, cocaine, heroine etc. cannot also be compared with the damage done by fake drugs, because illicit drugs are taken out of choice, and by those that can afford them, but fake drugs are taken by all and anybody can be a victim. • Treatment failures, drug resistance, organ dysfunction/damage, worsening of disease conditions and death.

9. SCOPE OF THE PROBLEM OF FAKE/COUNTERFEIT DRUGS IN NIGERIA PRIOR 2001. NIGERIAN EXPERIENCE Counterfeit drugs are most prevalent in developing countries. Developed countries are beginning to experience increase in reported cases, which are worsened by increasing sale of medicines on the Internet. AFRICA Prevalence of fake and counterfeit drugs in Africa worsens the existing burden of debt, poverty, illiteracy, diseases, wars, etc. • Essential Drug Monitor (EDM) report on transforming drug supply in Dar es Salaam Tanzania, sums up the picture in most African countries as follows, • “There was chronic shortage of drugs at health facilities, supplies were erratic, as was government funding, poor drug supply management and irrational use of drugs. • Drug quality was questionable and pharmacy premises were often unsuitable, hot, humid and cluttered with piles of drugs, some of them expired. • Pharmacists have low professional visibility. This clearly mirrors the situation in many African countries, Nigeria not being an exception. • In view of flow of trade on pharmaceutical products between Nigeria and neighbouring countries, the situation in Nigeria naturally reflects that of most African countries.

10. SCOPE OF THE PROBLEM CONT’D When the present management of NAFDAC came on board in April 2001, we were faced with an enormous task of reactivating a failed regulatory environment of over two decades. • Fake/counterfeit/expired/unregistered drugs, substandard cosmetics, unwholesome food products and other regulated products were dumped into Nigeria. • Nigeria was rated as one of the countries with the highest incidence of fake/counterfeit drugs. Consequently, made in Nigeria drugs were officially unaccepted in other West African countries. • Fake drugs embarrassed our healthcare providers and eroded the confidence of the public on our healthcare delivery system. • Due to unfair competition, local drug manufacturing became unattractive, and many multinational companies left Nigeria out of frustration e.g. Boehringer, ICI, Sandoz, Merck, Ciba – Gaeigy, Boots, etc.

11. SCOPE OF THE PROBLEM CONT’D • Estimates of the extent of counterfeit medicines in circulation in Nigeria ranged from 48% to 80% from various studies before 2001. • A study by Poole in Nigeria in 1989 indicated that 25% of samples studied were fake, 25% genuine and 50% inconclusive. • In 1990, Adeoye Lambo, a former WHO Deputy Director reported that 54% of drugs in every major pharmacy in Lagos were fake, and that the figure had risen to 80% in the subsequent year. • Taylor et al reported that 48% of drugs tested were fake and substandard.

12. SCOPE OF THE PROBLEM CONT’D • Antimalarials, antibiotics and vitamins are among the most used drugs in Nigeria. Out of the three, antimalarials as a group had the least proportion of products with standard active ingredients. Proportion of drugs with standard active ingredients. Adapted from: Adenika FB. Pharmacy in Nigeria 1998

13. SCOPE OF THE PROBLEM CONT’D • In 2001, NAFDAC carried a baseline study to ascertain the level of incidence of fake drugs in Nigeria. • This study measured the level of compliance to drug registration, and we found that 67.95% of drugs in circulation were unregistered. • This study was repeated in 2003 and 2004. • The second phase of the study is being conducted in collaboration with WHO and DFID, and this involves laboratory testing.

14. REPORTED CASES In Nigeria due to poor reporting system, cases of worsening disease conditions or deaths due to fake drugs abound, but unfortunately we don’t have much statistics to support them. In addition, due to cultural cleavages, deaths are sometimes attributed to witchcrafts from the “wicked ones” or “enemies”. This again does not help our reporting system. A few examples of the reported cases of effects of counterfeit and substandard drugs are as follow: • In the early 80’s, poorly compounded Chloroquine syrup killed several children in University of Nigeria Teaching Hospital (U.N.T.H),Enugu of which there is no statistics, partly because many of the deaths were not even reported.

15. REPORTED CASES CONTD. • In 1990, the “Paracetamol syrup disaster” occurred when 109 children died in Ibadan and Jos, (Nigeria) after taking paracetamol syrup produced with the toxic ethylene glycol solvent instead of propylene glycol. • This tragedy occurred more than fifty years after that of U.S.A. • In 1996, without authorization from NAFDAC, clinical trial of a new antibiotic Trovan was carried out by Pfizer on 200 children in Kano Northern Nigeria during an epidemic outbreak of meningicoccal meningitis. • Several (the exact number is disputed) of the sick children given the experimental drug died. Many more suffered lasting injuries. One Samaila Musa now a teenager was struck deaf and dumb. The case is currently in a U.S.A. court. • In 2002, 3 patients reacted adversely to infusions manufactured by a Nigerian company. Investigations by NAFDAC on the offensive infusions collected from the hospital revealed that three (3) batches were heavily contaminated.

16. REPORTED CASES CONTD. • Fake cardiac stimulant (Adrenaline) was reported to have contributed to the death of 3 children during open-heart surgery in Nigeria in 2003. • Further investigations by NAFDAC revealed that the muscle relaxant (suxametonium) had low potency and some of the infusions used for the surgery were contaminated. • In 2004, 3 Nigerian hospitals reported cases of adverse reactions from the use of contaminated infusions produced by 4 Nigerian companies. • Consequently we sampled infusions and water for injection from all over the country. • Our results confirmed that some batches of infusions produced by the indicted companies were heavily contaminated with microorganisms. • 147 of the 149 brands of water for injection screened were also not sterile.

17. CAUSES OF PHARMACEUTICAL COUNTERFEITING • CORRUPTION AND CONFLICT OF INTERESTS The first line of action by drug counterfeiters is to compromise regulators. When this fails, they resort to Intimidation, harassment, blackmail, threats and physical attacks.

18. INSECURE AND UNFRIENDLY ENVIRONMENT At some point, when all the other antics of drug counterfeiters failed, they resorted to physical attacks, vandalism, and arson against NAFDAC facilities and staff. This culminated in a shooting attack on my person on December 26, 2003. My family members and some NAFDAC staff remain constantly under threat. • Gunmen fired at the vehicle I was travelling in, the back windscreen was shattered by bullets which pierced through my head scarf and burnt my scalp. • During the shooting, a commercial bus was riddled with bullets and the driver died instantly.

19. ASSASSINATION ATTEMPT- Car rear shattered wind shield.

20. ASSASSINATION ATTEMPT- Head Scarf showing bullet holes

21. ASSASSINATION ATTEMPT - Car front wind shield with bullet hole

22. ARSON ON NAFDAC Operational Headquarters Lagos (Outside view)

23. Wreckages of NAFDAC Operational Headquarters Lagos destroyed by fire (Inside view).

24. Wreckages of NAFDAC Kaduna Laboratory destroyed by fire (Outside view)

25. Wreckages of NAFDAC Kaduna Laboratory destroyed by fire(Inside view)

26. DISCRIMINATORY REGULATION BY EXPORTING COUNTRIES • Some countries have strong regulations for drugs consumed internally and little or no regulation for drugs meant for export. • Discriminatory regulation Informed the decision of the NAFDAC management to prohibit the importation into Nigeria of products marked “FOR EXPORT ONLY.” • Any product that cannot be used in the country of manufacture is officially unacceptable in Nigeria. • Presently, there are 92 pharmaceutical manufacturing companies producing about 30% of Nigeria’s drug need while the rest are imported. • Most of the fake/counterfeit drugs in Nigeria are imported from Asia, particularly India and China. • From 2001 till date, we banned thirty Indian and Chinese companies and one Pakistani company (confirmed to be fake drug producers) from exporting drugs into Nigeria.

27. CHAOTIC DRUG DISTRIBUTION SYSTEM • Drug distribution in Nigeria is very chaotic with drugs marketed like any other commodity of trade. • Due to poor regulation over the years, drug markets evolved and got deeply established all over the country despite the illegality of such activities. Almost all drug manufacturers and importers supply to these drug markets. • Drug sellers and even health professionals patronize the drug markets, which also service the hawkers that sell in streets and commercial buses. • Efforts made by NAFDAC to create an orderly Drug Distribution System so as to enable us phase out the existing disorganized Drug Markets, suffered a set back due to its unacceptability by some Pharmacists who are the major stakeholders in drug matters.

28. FALSE DECLARATION BY IMPORTERS • Some drug importers, in order to evade inspection and detection, make false declarations about the nature and contents of the products in their containers. • They employ unimaginable concealment methods for their nefarious activities, such as stacking drugs in the inner part of containers containing other items like clothings, hair products, motor spare parts or household items, or wrapping the drugs inside clothings. • We have made several seizures of drugs concealed inside t-shirts or baby wears

30. SOPHISTICATION IN CLANDESTINE DRUG MANUFACTURE. Sophistication in drug production has made it difficult for even brand owners to tell the difference between their brands and counterfeits.

31. FAKE ORIGINAL AMOXIL GENUINE FAKE • Blister has grey and red diagonal lines only • There is no company Identification on the blister • Counterfeit product with copied NAFDAC # • Not registered by NAFDAC • Blister has grey, red and white diagonal bands. • Each blister has”SB102M” embossed on the edge • Registered by NAFDAC • NAFDAC #04-2481Printed on the pack

32. SIMILAR SOUNDING NAMES/LOOK-ALIKE COUNTERFEITS DETECTED BY NAFDAC ORIGINAL FAKE CIALIS Look –alike and sound-alike GENUINE FAKE • Copied the name and address on the original product • No colour change on brown hologram • Date markings are stated in numbers i.e. M05 03 E 08 05 • Counterfeit product notregistered by NAFDAC • Has no NAFDAC # • Address on product: • Eli Lilly CompanyLimited Basingstoke, England • Colour changes on brownhologram on exposure to light at different angles •  Date markings are statedin words i.e. MAY 04 Jun 06 • Registered by NAFDAC • NAFDAC # 04-5196 Printed on the pack •   No location address of manufacturer •  Hologram absent •  Date markings are stated in numbers • Look –alike and sound-alike fake product not registered by NAFDAC.

33. LACK OF OR INADEQUATE LEGISLATION • Almost in all countries, laws against drug counterfeiting are very weak. Consequently, criminals are shifting from smuggling of narcotics and running of weapons to counterfeiting of drugs because it is financially lucrative and of relatively low risk. • The penalties for importing, producing or distributing fake and counterfeit drugs in Nigeria ranges from imprisonment for between three months and five years with the option of fine of USD70 - USD3600. • In the interim we have strengthened our regulatory processes by putting in place some administrative guidelines within the law. • Using the press to disgrace identified drug counterfeiters.

34. STRATEGIES EMPLOYED BY NAFDAC TO COMBAT DRUG COUNTERFEITING IN NIGERIA. NAFDAC’S VISION, MISSION, GOAL AND STRATEGIES • Our VISION is to safeguard public health • MISSION is to safeguard public health by ensuring that only the right quality products are manufactured, imported, exported, advertised, distributed, sold and used in Nigeria. • Current GOAL is to eradicate fake drugs and other substandard regulated products.

35. Strategies employed Contd. • Staff Re-Orientation and Motivation At the inception of this administration, the inevitable need for staff re- orientation was glaring. Total change of mind-set and in fact, an organizational cultural revolution. • Measures undertaken to reposition staff for better effectiveness: • Retrenchment of corrupt, redundant and incorrigible staff. • Staff training and re-training. • Effective delegation of duties and Staff empowerment. • To encourage staff, hard work, dedication and integrity are adequately compensated while any form of laxity or corruption is severely sanctioned. • When hard work and integrity are not recognized and rewarded, corruption and ineptitude are promoted. • Leadership by example is highly emphasized.

36. Strategies employed Contd. • Restructuring NAFDAC and Modernization of our Regulatory Processes • NAFDAC was restructured into eight functional directorates as against the previous six. • The two new directorates created, the Ports Inspection and Enforcement further positioned the agency to effectively tackle the problems emanating from inspection lapses and poor enforcement activities. • Other six Directorates are: • Laboratory Services • Narcotics and Controlled Substances • Establishment Inspection • Registration and Regulatory Affairs • Administration and Finance • Planning, Research and Statistics

37. Strategies employed Contd. • Restructuring Cont’d • Ten new state offices were established and the existing twenty-seven were strengthened to cover the thirty-six states and Federal Capital Territory. -Three special inspectorate offices were also established in the three towns with the biggest drug markets, Onitsha, Aba and Kano. • Four laboratories are continuously upgraded, and two new ones are under construction. • Constructed new warehouses and land border offices at some of our ports. • New Standard Operating Procedures (SOPs) and Guidelines were developed. • Automation of all our regulatory processes.

38. Strategies employed Contd. • Public Enlightenment Campaign • Our most effective strategy in combating products’ counterfeiting, and creating effective regulation. • Involves dialogue, education and persuasion because this addresses the fundamental issue at stake, which is BEHAVIOURAL CHANGE. • Sustained using: • Print and electronic media such as jingles, alert notices, erection of billboards, publication of differences between identified fake and genuine products in the national dailies, etc. • Workshops, seminars and meetings have been conducted for most stakeholders ranging from pharmacists, patent medicine dealers, traditional rulers, religious leaders, manufacturers, importers, transporters and even consumers. • Grassroots mobilization campaign for rural areas is on- going. • We have produced many publications, fliers, leaflets, posters (both in English and vernacular languages).

39. Strategies employed Contd. • Public Enlightenment Campaign Cont’d • Extended to Nigerian High schools in order to catch them young, by organizing annual competitions and prize giving ceremonies on their understanding of the ill effects of fake drugs and other substandard products on the society. • Also established NAFDAC Consumer Safety Clubs in most of these schools . • These activities are geared towards educating the young ones on the dangers of fake drugs, inculcating in them the value of quality and encouraging them to join NAFDAC in the fight against counterfeit medicines. • Our enlightenment campaigns have greatly empowered the public to recognize and reject expired, fake/substandard drugs and unwholesome food. • In any country we visit, we hold meetings with exporters of drugs, food, cosmetics and other NAFDAC regulated products. Convinced many of them to set up industries in Nigeria.

40. Strategies employed Contd. • Stopping the Importation of Counterfeit Medicines and Other Substandard Products to Nigeria at Source In a bid to stop the importation of fake drugs from the countries of production to Nigeria, NAFDAC has put in place some administrative guidelines which include the following: • A factory must be GMP certified before it can export drugs, cosmetics or any other NAFDAC regulated product to Nigeria. • NAFDAC officials must inspect factories anywhere in the world before we register or renew registration for their drugs, cosmetics, food and other regulated products. • NAFDAC has appointed analysts in India and China who re-certify any drug from the two countries before importation into Nigeria. • For drugs imported from any country, NAFDAC requires mandatory pre-shipment information to be provided by all importers before the arrival of the drugs. • Nigerian banks insist on NAFDAC clearance before processing financial documents for drug importers. This agreement is now a government policy because of its adoption by Central Bank of Nigeria.

41. Strategies employed Contd. • Beefing Up Of Surveillance At All Ports Of Entry • NAFDAC has re-enforced the two new directorates of Ports Inspection and Enforcement for more effective surveillance at all ports of entry, and better enforcement activities respectively. This has resulted in increased seizures of fake/counterfeit drugs and other substandard regulated products at the ports. • Hitherto, land and sea borders were major routes of importation. The Agency, having considerably intensified surveillance at these borders, and the merchants of fake drugs resorted to the use of airlines. Consequently, NAFDAC issued a new guideline that any aircraft that lifts drugs to Nigeria without obtaining the Agency’s authorization from their clients will be grounded. • Due to NAFDAC’s strong surveillance at the borders, and government’s ban on importation of drugs and other regulated products through land borders, these criminals have resorted to the use of speedboats and other water transports.

42. Strategies employed Contd. • Mopping Up Substandard and Fake Products Already In Circulation • Cognizance of our many porous borders, NAFDAC embarks on planned, systematic, continuous and sustained surveillance at all markets and retail outlets for drugs. • This has given rise to sealing of pharmacy retail outlets involved in selling counterfeit, unregistered or expired drugs, and also drug manufacturing factories, whose GMP status were found to be unsatisfactory. • Closure of 2 major drug markets for between 3 – 6 months. To achieve high level of success with our mopping up exercise, NAFDAC has put in place the following administrative guidelines: • Confiscation and subsequent destruction of drugs of sellers who fail to provide a proper invoice of purchase with full name and address. • This is to enable us trace the big time importers and distributors of fake drugs.

43. Strategies employed Contd. • Mopping Up Fake Drugs Contd • Faced with the frustrations of evacuating many lorry loads of fake drugs from warehouses on tip off without anybody accepting ownership, NAFDAC has notified the public that whenever the importer cannot be traced, the landlord of the premises used for the storage of fake drugs will be arrested, with a view to tracing the fake drug importer for necessary sanctions. • In one occasion in Lagos, it was only after the landlord of the warehouse was arrested that the owner of the fake drugs gave himself up. • Raids are regularly carried out on drug hawkers, and their drugs are confiscated and destroyed. • We also trace fake drug dealers through reports from health professionals or victims and constant tip-off from the public. • Routine sampling, checking and testing of all NAFDAC registered drugs in circulation.

44. Strategies employed Contd. COUNTERFEITING-A REALITY! • Destruction of Seized Counterfeit Drugs by NAFDAC. (Health risk, national economic loss.)

45. Strategies employed Contd. • Monitoring GMP of Local Manufacturers • NAFDAC monitors local manufacturers of drugs routinely. • Compliance directives are issued and enforced to the letter when lapses are observed. • Prosecution is carried out as a last resort when necessary.

46. Strategies employed Contd. • Streamlining and Strict Enforcement of Registration Guidelines NAFDAC has strengthened its registration processes with some administrative guidelines to ensure a strong and effective regulation, which is the most sustainable solution to dumping of fake products. These guidelines include: • All drugs must comply with laboratory standards and inspection requirements before they are registered. • Renewal of registration of any drug is every five years. • Renewal of Herbal Medicine registration is every year. • NAFDAC insists on fixing of NAFDAC REGISTRATION NUMBER on the label of all products to enable the public identify drugs certified by the Agency. • Drugs can be imported for only ten years, after which the importer must start producing locally.

47. Strategies employed Contd. OTHER INTERVENTIONS • INTERNATIONAL: • Established cooperation with food and drug regulators of almost all continents. • Constant dialogue with other West African countries’ Food and Drug Regulatory Authorities with a view to sharing strategies and carrying them along, so that the counterfeiters will not find a safe haven any where in the sub region. • In 2002 in Hong Kong, NAFDAC originated the campaign for the setting up of an international convention on counterfeiting of pharmaceuticals just as we have for narcotics and psychotropic substances. We have continued to aggressively pursue this campaign in all international meetings and it is catching on.

48. Strategies employed Contd. • DRUGS SAFETY MONITORING • Established the National Pharmacovigilance Centre and admitted as the 74th member of National Centres, participating in the WHO Drug Safety Monitoring Programme. • ACCESS TO ETHICAL DRUGS STRICTLY ON PRESCRIPTION • It is common practice in Nigeria for prescription drugs to be purchased without prescription. This fuels irrational drug use which sustains drug counterfeiting. • NAFDAC has started enforcing that ethical drugs are obtained strictly on prescription. In agreement with other stakeholders, we started with all injectables in addition to the sedatives that are already being enforced.

49. GOVERNMENT SUPPORT • We enjoy tremendous support from government under the able leadership of President Olusegun Obasanjo. • Nigerian government banned importation of drugs through land borders and designated two airports and two seaports for drug importation. • Recently, government also banned 17 drugs that our local manufacturers have capacity for.

50. SOME OF THE ACHIEVEMENTS AND GAINS RECORDED SO FAR • Sanitized the food and drug industry and created a reasonably well regulated environment which has saved the lives of millions of Nigerians and boosted our economy by encouraging local industries, genuine importers and foreign investors. • Immense public awareness resulted in the participation of all stakeholders in the promotion of food and drug regulation in Nigeria. • Awakened the international consciousness that Nigeria is no longer a dumping ground for fake drugs. • The level of incidence of fake drugs has been reduced by over 80% from what it was in 2001. • The production capacities of our local pharmaceutical industries have increased tremendously. • 22 new drug manufacturing outfits were established in the last four and half years.