Part 1General Themes

Chapter 1Introduction

The problem of counterfeit drugs is not a new one, but it is a growing issueand one that cannot be ignored. Of course, this book does not review allof the possible situations or contain all the answers necessary to solve theproblem. Nevertheless, I hope that it provides some guidance on the prin-ciples of anti-counterfeiting and gives some food for thought on strategyand technology choices. Counterfeit medicines cannot be tolerated–we allhave an urgent obligation to do something about it. It is not just a fewtechnical specialists or even the whole pharmaceutical industry that needsto take action: counterfeit medicines are everybody’s problem. We maynot be able to stop fake drugs entirely, but we have to keep that as ouraim. One life lost because of a counterfeit medicine is a death too many.

WHY WRITE THIS BOOK?

Counterfeiting is a growing, worldwide criminal trend that affects us all.1

It is now present in almost all industry sectors, not just consumer goods,and fake products are getting ever harder to avoid. We can choose not tobuy obviously counterfeit “designer” items sold at bargain prices by streettraders. By buying only from authorized outlets, we consider ourselvessafe from being ripped off. But in many cases, fakes are not so easy to

Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs,First Edition. Mark Davison.© 2011 John Wiley & Sons, Inc. Published 2011 by John Wiley & Sons, Inc.

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4 INTRODUCTION

spot, however vigilant we are. The same profit motive that has led torip-offs in the consumer goods industry has caused an alarming rise incounterfeit medicines. These are very difficult for the average consumerto spot and they are starting to turn up in local pharmacies around theworld. They are already endemic in developing countries and evidencesuggests that they kill hundreds of thousands of people every year.2

Almost everyone on the planet will take pharmaceutical drugs at somepoint during their lifetime. Some people must take dozens of pills everyday just to stay alive. Every time we take a painkiller for a headache or getour children immunized, we are placing our safety or that of our lovedones in the hands of the drug supply chain. We rightly anticipate thatour sore head will benefit from analgesic drugs and our children’s futurehealth will benefit from vaccinations. We do not expect our immediate orfuture well-being to be harmed by toxic effects or by ineffective medicinesthat expose us to preventable danger.

Twenty years ago that may have been a relatively safe assumption,but today, the activities of organized criminals have turned counterfeitmedicines and medical products into a global parallel industry, with thepotential to undermine progress in healthcare if its growth is not checked.

The reasons why drug counterfeiting occurs are many, varied and com-plex. These subjects are well covered elsewhere and I have includedreferences for those interested in these issues. I have spent the last fewyears working as part of a small industry that is trying to use technologyfirst to control and eventually to prevent the spread of counterfeit prod-ucts. My work has taken me around the world and into several differentindustries. Although I will give an overview of the counterfeiting prob-lem, this book is deliberately and specifically about anti-counterfeiting .Whether we like it or not, counterfeit drugs have gained a foothold. Thisbook is a primer for those who want to know more about the problemand how to deal with it.

DOESN’T THIS BOOK JUST HELP THE CRIMINALS?

The paradox of writing about anti-counterfeiting is that it runs the risk ofeducating the very people we are trying to thwart. I therefore took severalkey decisions when planning this book.

Firstly, this book is not a technical manual or a directory of securitysuppliers and their capabilities. None of the technical information or real-world examples given is based on privileged information and this bookdoes not discuss specific details of the proprietary technologies used byany brand owner or vendor. All of the technical information given is

WHO IS THE BOOK AIMED AT? 5

available elsewhere in the public domain and I neither endorse nor crit-icize any of the technologies discussed. I explain the general principlesof various techniques, but in general, the book focuses on policy andstrategy issues—which in any case are often far more critical to suc-cess than the technology employed. There are also some technical subjectareas which I have deliberately covered in less detail to avoid giving helpto counterfeiters. In particular, these areas relate to specific covert andforensic technologies, which are confidential and not publicly disclosed.Pharmaceutical product protection, like all security functions, should fol-low the need-to-know principle. In the interests of transparency, I shouldagain point out that I was previously employed by a leading security ven-dor, but of course none of the confidential aspects of my work there arementioned in this book. There are many excellent technology providersand sources of independent advice, and I encourage the reader to contactme privately or to seek other expert guidance when assessing technol-ogy choices. The “Further Resources” section contains contact details forvarious trade associations.

Secondly, with only one or two well-studied exceptions, I have chosennot to use illustrations and case studies which involve specific brands. Thepragmatic reason is that drug companies are often reluctant to give permis-sion for photographs of their products to be used, but the main argumentis that it is unfair to single out individual corporations. All manufacturersand all price levels of products are now vulnerable to counterfeiting. Vig-ilant and transparent companies often have a higher apparent incidenceof counterfeits only because they look harder and report fully. Therefore,in most cases, I have used illustrations of generic types of counterfeitingto show the methods used, with links to public domain information aboutreal examples where appropriate.

WHO IS THE BOOK AIMED AT?

Pharmaceutical company executives, in all disciplines, need to be conver-sant with the issue of counterfeit drugs and with the technical and policyapproaches required to combat them. Other pharmaceutical employees,from R&D scientists to sales representatives to manufacturing supervi-sors, should also have a working knowledge of the issues discussed inthis book. Only by involving all levels and functions in constant vigilancecan we begin to get on top of the counterfeiting and diversion problem.More specifically, most drug companies and other organizations involvedin the production, distribution, or monitoring of drug supplies now haveindividuals with responsibility for anti-counterfeiting and supply chainsecurity. I hope this book will provide them with some fresh insights.

6 INTRODUCTION

Pharmacists and doctors are key arbiters of drug quality and providethe final professional link in the chain of custody from drug manufac-turer to patient. Many of the drug tracking and anti-counterfeiting systemscurrently being piloted are heavily reliant on pharmacists’ participation.This volume is an ideal primer on these issues for trainee and qualifiedpharmacists and doctors.

Many governments and non-government institutions have createdagencies and appointed individuals to monitor and combat fake drugs.Resources are usually limited and these organizations are lobbiedhard by technology vendors, pharmaceutical companies, and tradeassociations representing often conflicting views from various supplychain stakeholders. This book provides a neutral view of the issues tohelp civil servants to take informed judgements.

Although technical issues are discussed, I have also tried to ensure thatthe book remains accessible to the interested layman. We are all customersof the medical system and the more the general public is informed aboutcounterfeit drugs, then the more vigilant society will become.