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The War Against Counterfeit Medicne

My Story

Dora Nkem Akunyili

Publication Year: 2012

There is a general agreement that piracy; counterfeiting and passing off are unfair. However, there is often surreptitious ñ or even open ñ sympathy for, say, those who purchase counterfeit designer fashions or the latest technical gadgets. The pirate is even sometimes represented as a daring evil hero. In this book, Prof. Dora Nkem Akunyili, Director General of Nigeriaís National Agency for Food and Drug Administration and Control, presents a unique study of a global phenomenon in which lawbreaking and profiteering prevail at the cost of human health and life ñ and of the ways in which this can be fought by appropriate legislation, regulation and enforcement.

Published by: African Books Collective

Title Page, Copyright Page, Dedication

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pp. 2-7

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Foreword

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pp. vii-x

There is a general agreement that piracy; counterfeiting and passing off are unfair. However, there is often surreptitious – or even open – sympathy for, say, those who purchase counterfeit designer fashions or the latest technical gadgets. The pirate is sometimes represented as a dared evil hero who, like the historical pirate on the high seas, provides a kind of rough justice. ...

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Preface

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pp. xi-xviii

decided to write this book entitled: The War Against Counterfeit Medicine: My Story, to chronicle my experiences as the Director General (DG) of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), between April 2001 and December 2008. ...

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Acknowledgements

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pp. xix-xxii

My gratitude goes to Chief Olusegun Obasanjo, former President of the Federal Republic of Nigeria, who gave me the opportunity to serve as the Director General of Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC), despite stiff opposition from the political class. His support in this fight for life is immeasurable. ...

Contents

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pp. xxiii-xxv

Figures and Tables

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pp. xxvi-xxviii

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Prologue

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pp. xxix-xxxviii

As a child, I never thought of studying pharmacy. In the early 1970s in Nigeria, medicine and law were popular career choices for young people aspiring to enter a university for higher education. It was the vogue for students with excellent West African School Certificate (WASC) results in the sciences to study medicine. ...

Part I: Historical Background of Food and Drug Regulation

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Chapter 1. Evolution of Drug Production and Sale in Nigeria

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pp. 3-6

The development of pharmaceuticals in Nigeria has undergone significant evolution, from the concoctions infused from cocktails of leaves, fruits, barks and roots, to conventional Western medicine. Traditional remedies are still widely used, especially by the poor. ...

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Chapter 2 - Evolution of Drug Production and Sale in Nigeria

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pp. 7-8

Throughout history, society has been concerned with the quality of drugs, food and other health sensitive products. This prompted several societies to undertake some kind of regulation for the production and use of such products. For instance, in ancient Egypt, during the first century BC, physicians were required to administer their drugs in accordance with written laws. ...

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Chapter 3 - NAFDAC Mandate, Structure, Functions, Laws and Regulations

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pp. 9-14

NAFDAC is a parastatal under the Federal Ministry of Health. It was established by Decree No. 15 of 1993, to regulate and control the manufacture, importation, exportation, advertisement, distribution, sale and use of food, drugs, medical devices, cosmetics, detergents, chemicals and all packaged drinks. ...

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Chapter 4 - Definitions: Fake / Counterfeit / Adulterated / Substandard Drugs, Unwholesome Food and Other Substandard Regulated Products

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pp. 15-18

Despite the global nature of fake and counterfeit drugs, the international community has not given the problem the attention it deserves, as evidenced by it not having a harmonised definition. Consequently, various countries and organisations have different definitions, according to their perception of the problem. ...

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Chapter 5 - Global Trends in Drug Counterfeiting

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pp. 19-28

Counterfeiting of all products poses a great danger to every society. Almost all brands of commodities traded in international commerce are counterfeited. In most cases, it involves perfect copying of the original product. Some commonly known counterfeits are currencies, designer wristwatches, bags, perfumes, clothes, jewellery, ...

Part II - The NAFDAC I Met

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Chapter 6 - NAFDAC Before 2001

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pp. 31-38

When I assumed office in April 2001, I was faced with the arduous task of reactivating a food and drug regulatory environment which had failed for over three decades, resulting in a crisis situation characterised by massive copying of original brands of drugs and other regulated products. ...

Part III - The War and the Strategies

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Chapter 7 - Declaring the War

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pp. 41-44

I received my letter of appointment as Director General of NAFDAC on April 11, 2001, and assumed office the following day. I asked Dr Dere Awosika, the then CEO of the National Programme on Immunisation (NPI), to accompany me to NAFDAC office in Abuja, to give me the much needed support. ...

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Chapter 8 - Strategy I: Restructuring and Reorganising NAFDAC

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pp. 45-55

Having been pressured into starting the public enlightenment campaigns, we quickly developed other strategies to support the fight. One strategy led to another. Staff reorientation and motivation were key, and the directorates needed to be restructured. We also needed to develop Standard Operating Procedures (SOPs) and Operational Guidelines. ...

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Chapter 9 - Strategy II: Operational Strategies

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pp. 56-76

The Agency identified poor monitoring and enforcement as the weakest links in the chain of our regulatory activities. To address these problems, the management evolved new operational strategies to eradicate counterfeit medicines and other substandard regulated products, and create a strong regulatory environment. ...

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Chapter 10 - Strategy III: Engaging Stakeholders

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pp. 77-110

Quite early on the job, I saw the need to take my message to the public, following the success we achieved with the pure water enlightenment campaign. It was clear to me that this strategy would help us sensitise the public to the high incidence of counterfeit medicines and engage the various stakeholders in frank and open discussions on the magnitude of the problem ...

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Chapter 11 - Strategy IV: Walking the Rough Road of Discipline

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pp. 111-122

In 2002, Chief Afe Babalola, a Senior Advocate of Nigeria (SAN) stated: “Until recently, all sorts of food, drugs and other products were imported into the country from all parts of the world, with little or no control and without due payment of the customs’ duties. Serious monitoring in the real sense of it was virtually non-existent. ...

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Chapter 12 - Special Cases

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pp. 123-180

NAFDAC received reports of frequent violations of our laws from different parts of the country. After investigations that usually follow such reports, the Enforcement Directorate and the Legal Division would work together to prosecute the offenders where applicable. In most cases, fines are imposed, but in the case of fake medicines, they are destroyed. ...

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Chapter 13 - Factors Militating Against Effective Food and Drug Regulation

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pp. 181-222

In our fight to safeguard public health in Nigeria, we encountered many challenges, but we were undeterred in our determination to rid Nigeria of the menace of counterfeit medicines and other substandard regulated products. The factors militating against effective food and drug regulation include corruption and conflict of interest, ...

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Chapter 14 - Institutionalising the Change

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pp. 223-236

When the new management came on board, the food and drug regulatory environment in Nigeria was characterised by total chaos and confusion. There were no procedures and guidelines for the performance of our duties, decisions were subjective, and members of staff did not have a clear-cut understanding of their roles. ...

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Chapter 15 - Focusing on Food

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pp. 237-248

Ensuring the safety and quality of food products in Nigeria is one of the key responsibilities of NAFDAC. The Agency works towards the fulfillment of this mandate through the regulation and control of local production, importation, exportation, manufacture, storage, advertisement and distribution of food products. ...

Part IV - Achievements, Support and Recognitions

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Chapter 16 - Gains and Achievements

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pp. 251-266

Transparency in our regulatory processes enhanced our communication with stakeholders, thereby making them comply with NAFDAC regulations and guidelines. This helped us win public trust and confidence. It also contributed to the international credibility of the Agency, resulting in NAFDAC being chosen by several international organisations ...

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Chapter 17 - Support, Appreciations and Recognitions From the Nigerian Government, Nigerians and the International Community

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pp. 267-296

The support we received from the Nigerian Government was immense. Favourable policies that enabled us to launch a successful fight against counterfeit medicines and substandard regulated products were established. The tremendous successes we recorded in the war are attributable in part to the remarkable support from all the Governors of the immediate past and present administrations, ...

Part V - Looking Into The Future

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Chapter 18 - Future Plans/Work In Progress Recommendations and Conclusion

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pp. 299-306

In charting a new course for the future, NAFDAC should consolidate on its present gains, work towards surmounting all outstanding constraints, improve on its administrative and operational capacities and explore new approaches to enhance efficiency and effectiveness. To achieve this, there is the need to consider the following critical areas: ...

References

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pp. 307-312

Abbreviations

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pp. 313-320

Appendices

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pp. 321-418

Index

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pp. 419-436

Back cover

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p. 476-476


E-ISBN-13: 9789788431565
Print-ISBN-13: 9789788431015

Page Count: 474
Publication Year: 2012