Master Thesis
Collaboration in the fight against counterfeit medicines
A situation analysis on definition, legislation and collaborationon a national, European and global level
Submitted by: Lars van Dorsselaer
Student ID: 1601598
Master: Master of Science in Crisis and Security Management
Mentor: Dr. Devroe
Second reader: Dr. Christiansen Date of submission: 11 August 2016 Date of defence: 16 August 2016
List of Abbreviations
ACTA Anti-Counterfeiting Trade Agreement CoE Council of Europe
DRA Drug Regulatory Authority
EC European Community
ECJ European Court of Justice EPE Europol Platform for Experts GDP Good Distribution Practice GMP Good Manufacturing Practice HMA Heads of Medicines Agencies
TRIPs Trade-Related Aspects of Intellectual Property Rights IFPMA International Federation of Pharmaceutical Manufacturers’
Associations
IGZ The Health Care Inspectorate (Inspectie Gezondheidszorg) IP Intellectual Property
IMPACT International Medical Products Anti-Counterfeiting Task Force JIT Joint Investigative Team
MoU Memorandum of Understanding MSF Médecins Sans Frontières NCA National Competent Authorities
OECD Organisation for Economic Co-operation and Development PSI Pharmaceutical Security Institute
SPOC Single Point of Contact
UN United Nations
UNODC United Nations Office on Drugs and Crime WCO World Customs Organization
WGEO Working Group Enforcement Officers WHA World Health Association
WHO World Health Organization WTO World Trade Organization
Table of Contents
LIST OF ABBREVIATIONS 2
LIST OF TABLES AND FIGURES 5
FIGURES 5
TABLES 5
1. INTRODUCTION TO THE RESEARCH SUBJECT 6
1.1 REASON FOR CHOOSING THIS SUBJECT 6
1.2 A BRIEF OUTLINE OF THE RESEARCH TOPIC 6
1.3 SCIENTIFIC RELEVANCE 7
1.4 SOCIETAL RELEVANCE 8
1.5 RESEARCH QUESTION 8
CHAPTER 2: THEORETICAL FRAMEWORK: BODY OF KNOWLEDGE 9
2.1 SAFETY, SECURITY AND PUBLIC HEALTH 9
2.2 COUNTERFEIT MEDICINES 10
2.2.1 HISTORICAL DEVELOPMENT 10
2.2.3 COUNTERFEIT MEDICINES ON THE CRIMINAL MARKET 12 2.2.4 COUNTERFEIT MEDICINES ON THE INTERNET 14 2.2.2 HISTORICAL DEVELOPMENT OF DEFINITION AND CONTROVERSIES IN TERMINOLOGY 15
2.3 CONCLUSION 18
2.4 PROBLEM SITUATION 19
2.4.1 DELINEATION OF TERMINOLOGY 20
2.4.2 COUNTERFEIT MEDICINES AS A CRIME 21
CHAPTER 3: METHODOLOGICAL FRAMEWORK 23
3.1 RESEARCH QUESTION 23
3.2 OPERATIONALIZATION TABLE 23
3.3 RESEARCH STRATEGY: QUALITATIVE RESEARCH 25
3.4 RESEARCH DESIGN: QUALITATIVE EXPLORATIVE DESIGN 26 3.2.1 JUSTIFICATION OF THE PHENOMENON COUNTERFEIT MEDICINES AND GLOBALIZATION 26 3.2.2 JUSTIFICATION FOR THE EXPLORATIVE DESIGN 27
3.5 DATA GATHERING 27
3.5.1 INTERVIEWS 27
3.5.2 INTERVIEW QUESTIONNAIRE 28
3.5.3 DESCRIPTION OF THE EXPERT INTERVIEW ORGANIZATIONS 29
3.5.4 DOCUMENT ANALYSIS 30
3.6 DATA EXPLOITATION 31
3.6.1 EXPERT INTERVIEWS 31
3.6.2 DOCUMENT ANALYSIS 31
3.7 VALIDITY & LIMITATIONS 31
CHAPTER 4: RESULTS 33
4.1 DEFINITION 33
4.1.1 INTRODUCTION 33
4.1.2 EXPERT PERCEPTION 33
4.1.3 FROM A DUTCH PERSPECTIVE 35
4.1.4 EU PERSPECTIVE: FALSIFIED MEDICINES BECAUSE OF A CONFLICT 35 4.1.5 INTERNATIONAL PERSPECTIVE: SSFFC MEDICAL PRODUCTS 37
4.1.6 SUB-‐CONCLUSION 37
4.2 LEGISLATION 38
4.2.1 INTRODUCTION 38
4.2.2 DUTCH LEGISLATION 39
4.2.3 INTELLECTUAL PROPERTY RIGHTS 39
4.2.4 INTERNATIONAL TREATIES ON INTELLECTUAL PROPERTY RIGHTS 40 4.2.5 PERCEPTION OF EXPERTS ON EU LEGISLATION 41 4.2.6 TREATY 211: THE MEDICRIME CONVENTION 41
4.2.7 SUB-‐CONCLUSION: LEGISLATION 43
4.3 COLLABORATION 44
4.3.1 INTRODUCTION 44
4.3.2 DUTCH COLLABORATION ON A NATIONAL LEVEL 44 4.3.3 COLLABORATION ON A EUROPEAN LEVEL 45
4.3.4 GLOBAL COLLABORATION 48 4.3.5 SUB-‐CONCLUSION COLLABORATION 55 5. CONCLUSION 56 5.1 DEFINITION 56 5.2 LEGISLATION 57 5.3 COLLABORATION 58
5.5 ANSWER TO RESEARCH QUESTION 59
6. DISCUSSION 60
ACKNOWLEDGMENTS 61
BIBLIOGRAPHY 62
APPENDIX 65
APPENDIX I: LIST WITH INTERVIEWS 65
APPENDIX II: INTERVIEW GUIDE 65
APPENDIX III: QUESTIONNAIRE 66
APPENDIX IV: TRANSCRIPTION OF INTERVIEW 1 68
APPENDIX V: TRANSCRIPTION OF INTERVIEW 2 76
APPENDIX VI: TRANSCRIPTION OF INTERVIEW 3, INTERVIEW QUESTIONNAIRE 84
APPENDIX VII: FIVE DUTCH CASES OF SELLING OF FAKE VIAGRA 87
List of tables and figures
Figures
Figure 1 Counterfeit drugs and their estimated availability on the black market
Page 16
Figure 2 Operationalization table Page 25
Figure 3 Explorative design drawn schematically Page 27
Figure 4 Pills seized during Operation Pangea Page 52
Figure 5 Countries participating in Operation Pangea Page 53
Tables
Table 1 Top products on the black market in estimated market values Page 13 Table 2 List of countries that signed, ratified and entered in to force the
MediCrime Convention
1. Introduction to the research subject
Counterfeit medicines are products that contain the exact opposite of what the term medicines is known to stand for. Medicines, known to help cure diseases, play an important role in the daily lives of many people. On the contrary, counterfeit medicines are making people less healthy or even have damaging effects to the physical or mental state of a human being. In addition, counterfeit medicines are generally produced under unhealthy circumstances and international criminal networks are engaged in making a profit from the sales, leading to a higher amount of economic resources for criminal organizations. Nevertheless, there is still a lot of controversy on the ways to stop these criminals. The “word cloud”1 on the front page
of this thesis illustrates the differences globally in an artistic way, using all sentences concerning terminology and definition issues applied in this thesis.
1.1 Reason for choosing this subject
To stop the criminals that are indirectly profiting from other people’s health issues by tricking people in to buying these medicines is a real challenge for law enforcement agencies. The extent to which the goals of these challenges can be met depends on many factors. Not the least of which is the perception of stakeholders that are involved in the process of countering the counterfeit medicines. Researching the similarities and differences in perception on the definition of counterfeit medicines, as well as the legislation and collaboration issues, could contribute to a more comprehensive understanding of the problem. In turn, this could help the stakeholders in adjusting their strategy or deciding on what matters to prioritise in their fight against counterfeit medicines.
1.2 A brief outline of the research topic
Produced in countries such as China and India, counterfeit malaria drugs travel to African countries such as Uganda and Tanzania2, and counterfeit erectile dysfunction
1 Word Cloud (2016) Made with http://www.wordclouds.com on 4-8-2016
2 Guardian (2012) Retrieved from: https://www.theguardian.com/world/2012/dec/23/africa-counterfeit-2 Guardian (2012) Retrieved from: https://www.theguardian.com/world/2012/dec/23/africa-counterfeit-medicines-trade (last visited 23-07-2016)
and slimming pills are sent to the western countries, such as the UK3. This
transnational security problem demands a common strategy. Ideally, the fight against counterfeit medicines is lead by international health organizations and transnational law enforcement agencies. Transnational law enforcement agencies such as Interpol and the European Police Office (Europol) organize meetings to bring all parties together. On a daily basis, they build international expert networks from public and private sector and maintain contact with the national law enforcement units. Furthermore, they structure a flow of communication to keep the stakeholders informed on the status of their progress. Yearly, global operations are organized to target the criminal networks that are behind the sale of these counterfeit medicines. All these actions are meant for the purpose of preventing counterfeit medicines from entering the market. This is one main objective all stakeholders have in common. However, with so many different and active stakeholders and backgrounds, different perceptions could lead to constraints in the process of carrying out the strategy. Treating the research topic of the perception of counterfeit medicines among stakeholders focused on three main issues, namely definition, legislation and collaboration, should make the outcome of the research helpful to all stakeholders involved. And in turn, give insight into whether to keep or adjust their strategy in the fight against counterfeit drugs.
1.3 Scientific relevance
Counterfeit drugs are not only prevalent in unregulated sectors, such as the Internet or criminal markets, but also traditional healthcare settings, among others, because of faults in the supply chain. The scope of these medicines is expanding, resulting in a threat to a patient’s life and profiting criminal actors (Mackey and Liang, 2013). Through innovations, the pharmaceutical industry is rapidly changing. Therefore, sharing information between the public and private sector is an important facet for establishing an effective co-operation in tackling this crime.4 The phenomenon itself “… [h]as not gotten much attention amongst scholars in the field of criminology. The relatively rare scholarly work that has addressed this issue mainly comes from other
3 Guardian (2014) Retrieved from: https://www.theguardian.com/society/2014/dec/28/drugs-medicines-sold-illegally-online-internet (last visited 23-07-2016)
4 Europol Mandate Online (2015) https://www.europol.europa.eu/content/page/mandate-119 (last visited 2-10-2015)
disciplines, such as pharmacy, medicine or chemistry” (Lavorgna, 2015, p. 227). Scientific research in this area can provide new policy insights, expose the current state of research and give a clear picture of the perceptions of the several stakeholders.
1.4 Societal relevance
Next to being scientifically relevant, the societal relevance of this master thesis should also be explained. As this master thesis is part of crisis and security management, a study arisen from the need for specialization within the field of public administration, both disciplines are considered. Public administration aims to study the governance of a nation. Crisis and security management aims to put governance of a nation’s security and crisis in to perspective. As security is a socially contested concept, policy makers have to adjust their policies to the current laws. Subsequently, rules, regulations and laws are put together to serve the civil society. The sale of medicines is subject to strict rules and regulations. When people are selling fake medicines that do not comply with set standards, they are trespassing the law of a nation. Law enforcement has been put into practice to enforce these laws and regulations to ensure the safety and security of its citizens. It is thus in the interest of the government and the public that actors involved in the joint fight against counterfeit medicines share a common understanding of the issue, in order to align their objectives appropriately.
1.5 Research Question
And this same law enforcement has to work together with private actors in order to gain important information to tackle the phenomenon counterfeit drugs. A common understanding of counterfeit drugs is a prerequisite when dealing with the problem. Therefore, one of the objectives of this master thesis is to find a clear distinctive definition of the phenomenon of counterfeit drugs. On the other hand, this research aims to identify other obstacles for collaboration, such as differences in legislation. Additionally, theories for better collaboration will be examined. The main research question that embodies this thesis is:
How do key players perceive definition issues, legislation and collaboration in fighting counterfeit medicines and how can we explain this?
Chapter 2: Theoretical framework: Body of knowledge
This chapter deals with the problem situation. The body of knowledge has been explored to enhance the understanding of the primary concerns. Firstly, the broader concern on safety, security and public health are discussed. Secondly, these aspects are put in a historical perspective and the emergence of the phenomenon of counterfeit medicines is discussed. Third, a conclusion and a delineation of terminology used in the remainder of the master thesis.
2.1 Safety, security and public health
Safety, security and public health are pressing issues in today’s society. As many developed countries cope with an ageing population, advances in healthcare are a top priority of many governments. The healthcare and mainly the pharmaceutical industry come along with many safety and security issues. These concepts lie at the core of this master thesis.
First and foremost, counterfeit medicines are a threat to the public health. Since they do not comply with safety standards and do not respect health regulations in for example logistics, using cold chain transportation, counterfeit medicines can harm the public health. Moreover, the profits that criminals make by selling the counterfeit medicines can be invested in other criminal ventures, harming public security.
According to Baldwin (1997), security is used to describe policy agenda’s concerning the protection of concepts such as human rights, economics, the environment, drug traffic, epidemics, crime, or social injustice next to the traditional concern with security from external threats. Other challenges for many developed countries are ageing populations, growing health-care costs, and the rising burden of chronic diseases posing challenges for health systems (Jambores, Nederland, Kaljouw, Van Vliet, Essink-Bot, Ruwaard, 2014). In today’s risk society, a term coined by Beck (1992), a stronger sense of insecurity is felt in society. The feeling of insecurity, a subjective sense and the actual insecurity, i.e. the risks we actually face, are equally important to us (Devroe, 2012, p. 56). Although feelings of insecurity related to terrorism are currently very prominent in public and political debate, risks related to environmental degradation, climate change and global diseases are far greater.
International organizations are aiming to tackle these challenges. An example is the World Health Organization (WHO), which has a special public health programme. The public health programme as described by the WHO is referring to “all organized measures (whether public or private) to prevent disease, promote health, and prolong life among the population as a whole. Its activities aim to provide conditions in which people can be healthy and focus on entire populations, not on individual patients or diseases.”5
2.2 Counterfeit medicines
The accessibility of alternatives for buying regular medicine over the Internet combined with the economic crisis causes citizens search for cheaper ways to get their medicines (Koenraadt & De Haan, 2016). Sometimes, the outcome is counterfeit medicines. In the best case, the medicines don’t have any effect, but in the worst case they are harmful.6 Criminals know this and anticipate on the demand by dealing in counterfeit medicines.7 This chapter aims to clarify the emergence and scale of the phenomenon of counterfeit medicines.
2.2.1 Historical development
In the early 19th century, industrialization was emerging in the Western world, better known as the industrial revolution. Since the industrial revolution, reducing scarcity of products that people needed on a daily basis was a major societal challenge (Beck, 1992, p. 21). Among others, medicines were found to reduce the scarcity of traditional plant-based remedies, during the middle of the 19th century.8
Meanwhile, this synthetic chemistry had evolved into a serious profession, leading to the emerging of the pharmaceutical industry. The need for better medicines caused the pharmaceutical industry to flourish with lots of new inventions during the 1930s to
5 WHO Online (2016) Retrieved from: http://www.who.int/trade/glossary/story076/en/ (last visited 7-3-2016)
6 Nederlands Dagblad Online (2009) Retrieved from https://www.nd.nl/nieuws/politiek/aanbieden-nepmedicijnen-wordt-strafbaar.193523.lynkx (last visited 7-3-2016)
7 NU.nl (2014) Retrieved from http://www.nu.nl/gezondheid/3889641/drugsdealers-handelen-vaker-in-nepmedicijnen.html (last visited 7-3-2016)
8 American Chemical Society (2005) Retrieved from:
the 1960s. Deaths in infancy were cut in half, while illnesses such as tuberculosis could be treated and cured for the first time in human history.
However, after these successes were booked, there was also some critique on the growing industry. In particular the pricing policies and sales approaches were put under investigation, leading to more strict regulations for drugs in the U.S. in the 1960s, and much later also in Europe. For example 16 years later, Germany implemented a more comprehensive drug law with formal premarket requirements for drug safety and efficacy.9
Parallel to the growing pharmaceutical industry, in 1945, states formed the United Nations (UN) in a bid to foster peace through multilateral collaboration on transnational issues. One of the topics they discussed was setting up a global health organization. The constitution of the WHO came into force in 1948.10 The WHO first appointed the issue of counterfeit medicines in 1984. The meeting, requested by the World Health Assembly (WHA), consisted of experts of the concerned parties, including governments, pharmaceutical industries, and patients’ and consumers’ organizations.
The main aim of that meeting was discussing the flow of information, national drug policies and marketing practices, focusing on developing countries. During the meeting, WHO was appointed to “[s]tudy the feasibility of setting up a clearing house to collect data and inform governments about the nature and extent of counterfeiting.”11 In the 1990s, the phenomenon got more attention and special international programs were set up for customs, health regulators, national police and the private sector to work together.12
9 American Chemical Society (2005) Retrieved from:
http://pubs.acs.org/cen/coverstory/83/8325/8325social.html (last visited 28-9-2015)
10 WHO (2016) Retrieved from: http://www.who.int/about/history/en/ (last visited 22-03-2015) 11 WHO (1985) Retrieved from http://apps.who.int/medicinedocs/documents/s17054e/s17054e.pdf (last visited on 20-8-2015)
12 The Royal Institute of International Affairs (2010) Retrieved from:
http://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/1110bp_co unterfeit.pdf (last visited 28-9-2015)
Next to industrialization, another characteristic of the late modern society (Garland, 2001; Beck, 1992; Young, 2007), namely globalization (Giddens, 1990) emerged. This basically means that “… [w]orldwide social relations are shaped by local events and vice versa”(Giddens, 1990, p. 64). Because of globalization and the impact of the Internet, the international market for medicines and counterfeit medicines grew extensively. The proof of this can be found in one of the international collaboration programs. Last year, globally more than 20 million units of counterfeit medicines were seized in the Pangea week of action. 13 Considering the volume of this seizure made in a limited time frame and taking into account the geographical scope, one can barely imagine the extent of counterfeit drugs flooding the global market on an annual basis.
2.2.3 Counterfeit medicines on the criminal market
The global operation called Pangea, led by Interpol, targets criminal networks behind the sale of counterfeit medicines. The eighth operation of Pangea resulted in 156 arrests worldwide and the seizure of $81 million worth of counterfeit medicines. In total, more than 20 million units of counterfeit medicines were seized. From 9 to 16th of June 2015, the action was implemented in 115 countries. In the operation Pangea, 237 agencies participate. Among them are Interpol, the World Customs Organization (WCO), the Permanent Forum of International Pharmaceutical crime (PFIPC), the heads of Medicines Agencies Working Group of Enforcement Officers (HMA WGEO), the pharmaceutical industry and the electronic payments industry.14
As the operation Pangea revealed, counterfeit medicines is big business. In the Netherlands, the market for counterfeit medicines is estimated around $88 million in 2010. For Europe, this number was $11.7 billion in 2010.15 In 2000, the Organisation for Economic Co-operation and Development (OECD) estimated the scope of the total market for counterfeiting was at $110 billion.16 By 2005, the OECD estimated
13 Interpol Online (2015) http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea (last visited 27-10-2015)
14 Interpol Online (2015) http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea (last visited 27-10-2015)
15 Kassa Online (2010) Retrieved from: http://kassa.vara.nl/nieuws/markt-nepmedicijnen-goed-voor-79-miljoen-euro (last visited 27-10-2015)
the international market for counterfeit goods at $200 Billion.17 According to
Havocscope, this number is still valid in 2016. To illustrate, the top products on the black market and their estimated market values are presented in Table 1. In this table, values for corruption, money laundering, and organized crime are not included in this index due to its overlapping nature. Drugs such as marijuana, cocaine and heroin are not included in the market value of counterfeit drugs. Counterfeit drugs do include a whole range of fake medicinal products ranging from the counterfeit medicines version of cancer drug Avastin, abortion pills to lifestyle drugs such as Viagra and weight-loss pills.18
Table 1: Top products on the black market in estimated market values
1. Counterfeit Drugs $ 200 Billion
2. Prostitution $ 186 Billion
3. Counterfeit Electronics $ 169 Billion
4. Marijuana $ 141.8 Billion
5. Illegal Gambling $ 140 Billion
6. Cocaine $ 85 Billion
7. Prescription Drug Abuse $ 72.5 Billion
8. Heroin $ 68 Billion
9. Software Piracy $ 63 Billion
10. Cigarette Smuggling $ 50 Billion
11. Counterfeit Foods $ 49 Billion
12. Counterfeit Auto Parts $ 45 Billion
13. Oil Theft $ 37.23 Billion
14. Human Smuggling $ 35 Billion
15. Counterfeit Toys $ 34 Billion
Source: Havocscope Online, 201619
17 OECD (2007) Organisation for Economic Co-Operation and Development OECD (2007) The economic impact of counterfeiting and piracy: executive summary. Retrieved from
http://www.oecd.org/sti/38707619.pdf (last visited at 22-9-2015)
18 Havocscope (2016) Retrieved from: http://www.havocscope.com/data-sources/ (last visited 7-3-2016)
19 Havocscopre (2016) Retrevied from: http://www.havocscope.com/data-sources/ (last visited 7-3-2016)
Although the profit margins of counterfeit drugs are equal to hard drugs such as cocaine and heroin, the punishments are significantly lower. This makes the products interesting for organized crime.20 In addition, the potential market for counterfeit drugs is huge, as estimated numbers for the Netherlands, Europe and the rest of the world showed us.
2.2.4 Counterfeit medicines on the Internet
A recent study by Koenraadt & De Haan (2016) into the buying behaviour of online consumers in the Netherlands revealed that one out of ten Dutch citizens has purchased medicines online. Furthermore, the study claims that 1.6% of the Dutch population purchased medicines online outside the regulated supply chain such as prescription medicines without showing a prescription or unlicensed medicines. The medicines most prevalent medicines bought online are painkillers, slimming products, erectile dysfunction medicines and sleep- or tranquilizing medicines.
As counterfeit medicines are often sold online, the crime is linked to the online environment; and some label it as a cybercrime (Wall, 2008). In an article by Lavorgna (2015), it is argued that the online environment is a main facilitator for trade in counterfeit pharmaceuticals as well as for other counterfeit products. Lavorgna (2015) concludes that the Internet as a virtual marketplace provides a global platform for criminals to sell counterfeit medicines and thus have an enormous scope compared to local dealers. In addition, drugs have been prescribed online even though the prescriber did not even know the client, which is a crime in itself.
In Dutch law, it is stated in the Medicines Act that it is prohibited to prescribe medicines online, in the case that the client does not know the prescriber.21 Only recently, selling medicines online is prohibited in the Netherlands. After a check by the Inspectorate, the website gets a safe selling point logo.22 In May 2016, The Dutch
20 Radar Online (2012) Retrieved from: http://radar.avrotros.nl/columns/detail/online-medicijnen-levensgevaarlijke-gok/ (last visited
21 Wetboek Online (2016) Geneesmiddelenwet, Retrieved from: http://www.wetboek-online.nl/wet/Geneesmiddelenwet/67.html (last visited 16-4-2016)
22 Rijksoverheid Online (2016) Retrieved from:
https://www.rijksoverheid.nl/actueel/nieuws/2016/05/10/publiekscampagne-over-gevaren-vervalste-medicijnen (last visited 5-8-2016)
ministry of Health, Welfare and Sport started an online campaign with which citizens themselves can check whether the medicine is safe or fake on www.echt-of-nep.nl. Mavlanova and Benbunan-Fich (2010) study the way these websites are perceived by customers and how on-line buyers can distinguish websites selling fake products from legitimate business entities. For example universally wide recognizable labels are developed and other innovative ways of making sure the buyer can distinguish an authentic website from a counterfeit one. However, for making a universally wide recognized label, international authorities need to collaborate. Furthermore, national laws often differ and thus treaties are developed to make sure the crime can be fought on a transnational scale.
2.2.2 Historical development of definition and controversies in terminology Ever since the first transnational call for action by the WHA to combat “… [f]alsely labelled, spurious, counterfeited or substandard pharmaceutical preparations” 23, defining counterfeit medicines internationally has generated continuing controversy. The combination of counterfeiting, which is specifically related to intellectual property – with issues such as quality, safety and efficacy of medicines constitute the main controversy.
The first proposal for a universally recognized definition was coined by WHO in 1992. During a workshop of the WHO and the International Federation of Pharmaceutical Manufacturers’ Associations (IFPMA), participants had agreed upon the following definition:
“A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging (WHO, 1999, p. 8).”24
Although this definition was aimed to cover the product’s range of varieties, and broadly accepted by many stakeholders, it was not deemed sufficient to be adopted by
23 WHO (1985) Retrieved from: http://apps.who.int/medicinedocs/documents/s17054e/s17054e.pdf (last visited on 20-8-2015)
24 WHO (1999) Retrieved from:
WHO member states. For example, there is no mention of intellectual property laws on a national or international level.25 In the Counterfeit Drugs Guidelines by the
WHO (1999), a division of quality of counterfeit drugs was added. Furthermore, the percentage of their availability was estimated.
Figure 1: Counterfeit drugs and their estimated availability on the black market (WHO, 1999)26
In 2008, an International Medical Products Anti-Counterfeiting Taskforce (IMPACT) meeting elaborated the WHO definition, in response to concerns expressed by the generic pharmaceuticals industry. The new definition was more detailed in regards to generic medicines.
“A medical product is counterfeit when there is a false representation in relation to its identity and/or source. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct components or with the wrong components, without active ingredients, with incorrect
25 The Royal Institute of International Affairs (2010) Retrieved from:
http://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/1110bp_co unterfeit.pdf (last visited at 16-10-2015)
26 WHO (1999) Retrieved from
http://apps.who.int/iris/bitstream/10665/65892/1/WHO_EDM_QSM_99.1.pdf (last visited 16-11-2015) Without active ingredients 32% With wrong ingredients 21% Incorrect quantities of active ingredients 20% With correct active ingredients but fake packaging 16% With high levels of impurities and
contaminants 9% Copies of an original product 2%
Counterfeit drugs
amounts of active ingredients or with fake packaging. Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit. Substandard batches or quality defects or non-compliance with good manufacturing practices/good distribution practices (GMP/GDP) in legitimate medical products must not be confused with counterfeiting.”27
The European Generic Association (EGA) accepted this definition, mostly because it clarified that patent status should not be confused with counterfeiting. Yet, it failed in satisfying many WHO delegates from developing countries in 2010. One of the main issues set out by the opponents from the developing countries was that counterfeiting in itself is an intellectual property concept, and should not be confused with issues concerning the safety, quality and efficacy of medicines.
In addition, they argue that the WHO, as a public health agency, should focus on quality, safety, and efficacy, and these issues should not be viewed through an intellectual property lens. According to them, IMPACT, the ‘seizures’ in the EU, and the anti-counterfeiting treaty (ACTA) are all manifestations of a Trade-Related Aspects of Intellectual Property Rights-plus, or “TRIPS-plus” agenda, on the part of developed countries together with pharmaceutical companies, aimed at harming the sales of legitimate drugs.28
Furthermore, in 2009, a distinction had been made between substandard medicines, falsified medicines and counterfeit medicines. Both definitions of substandard medicines and falsified medicines do not include the element of patent rights. The definition of substandard medicines focuses on the authorization of the national authorities responsible:
“Substandard medicines (also called out of specifications (OOS) products) are genuine medicines produced by manufacturers authorized by the National Medical
27WHO (2008) http://www.who.int/impact/news/BonnMeetingDraftPrinciples.pdf via The Royal Institute of International Affairs (2010) Retrieved from:
http://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/1110bp_co unterfeit.pdf (last visited at 16-10-2015)
28 The Royal Institute of International Affairs (2010) Retrieved from:
http://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/1110bp_co unterfeit.pdf (last visited at 16-10-2015)
Regulatory Authority (NMRA) which do not meet quality specifications set for them by national standards.”29
Falsified medicines is a third term that has evolved to overcome confusion created by the former two; substandard and counterfeit medicines. The EU distinguishes falsified medicines from counterfeit medicines in their new legislation and explains the difference on their website: “[F]alsified medicines are not to be confused with counterfeit medicines. The latter term refers to medicines that do not comply with EU law on intellectual and industrial property rights, such as registered trademarks or patent rights. The Directive on 'falsified medicines' does not deal with this aspect.”30
The main issue with the terminology is that there are many different stakeholders that have diverse interest in the process of accepting a recognized definition. Nevertheless, the importance of the definition is proven through all the conflicts so far. For example organizations such as Médecins Sans Frontières (MSF) have raised concerns that it might lead to threats in the trade of generic drugs of assured quality in developing countries to be labelled as counterfeit drugs.31 Subsequently, because of the controversy within the international community on a common term for counterfeit medicines, policy-making decisions of organizations dealing with the phenomenon are troubled.32
2.3 Conclusion
The purpose of this master thesis is to illuminate the collaboration in the fight against counterfeit medicines. This comes along with many concepts and questions. For example, why should there even be collaboration in fighting counterfeit medicines? And, what are counterfeit medicines? One could simply answer for the safety and security of the nations citizens it is important to fight fake medical products. But then again, what is the meaning of the concepts safety and security in this context and what
29 WHO (2015) Retrieved from http://www.who.int/medicines/regulation/ssffc/definitions/en/ (last visited 9-11-2015)
30 EC.Europa (2015) Retrieved from http://ec.europa.eu/health/human-use/falsified_medicines/index_en.htm (last visited 9-11-2015) 31 MSF Briefing (2012) Retrieved from
http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Briefing_ACTABlankC heque_ENG_2012.pdf (last visited 6-11-2015)
32 The Royal Institute of International Affairs (2010) Retrieved from:
http://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/1110bp_co unterfeit.pdf (last visited at 16-10-2015)
is understood by the term counterfeit medicine? These concepts and terminological issues were addressed as key concepts.
Looking back at history, one can conclude that the need for the large-scale production of medicines has emerged since the industrialization of the western society. Before this period, people were treated with plant remedies. However, as science developed, it was found that some diseases could be treated more effectively with the use of medicines. This caused for many diseases, which were formerly a lot more difficult to treat or even eradicated altogether. It was not until the commercial incentives started to play a role in the U.S. and eventually in Europe, that the production of medicines was bound to strict regulations. With the phenomenon of globalization, medicines have become more easily available than ever. And through sales over the Internet, medicines could even be bought online by patients themselves.
The developments over the last decade, and mainly that of individual medicines sales over the Internet, made it easier for people that are in need of medicines to buy it without a doctor’s prescription. At the same time, the phenomenon of counterfeit medicines had become an issue on the agenda of the WHO. The availability of counterfeit medicines on the black market grew to an estimated value of $200 billion, proving that it is most lucrative for criminals to deal in counterfeit medicines. In the meantime, law enforcement agencies joined forces and set up an annual operation Pangea, which had booked ever-growing results in the last eight years globally. Although this development seems to strengthen the fight against the criminalities of counterfeit medicines, there are still many alterations. At the core lies the conflict in terminology.
2.4 Problem situation
This conflict in terminology is in direct and indirect connection with two other components that are important aspects of fighting counterfeit medicines. The problem situation on reaching an agreement on terminology, reaching agreement in terms of legal aspects to the crime and the problem situation in collaborative efforts is a relatively unexplored phenomenon.
2.4.1 Delineation of terminology
Reaching agreement on definitions fails, because of the controversy within the international community on a common term for ‘counterfeit medicinal products’. According to some developing countries and organizations such as Médecins Sans Frontières (MSF), which are working with medicines in these developing countries, patented medicines are too expensive, and they are therefore keen to protect generic medicine producers in being accused of copying. They suggest that the term counterfeit medicines and its definition does not cover the extent of the problem, it rather hinders generic medicine producers. On the other hand, big Western pharmaceutical companies that invest money in research and development for patented medicines and are backed by their governments aim to protect their patents worldwide against copying. This controversy caused for other terms to emerge. For example, falsified medicines and substandard medicines are terms that were added in the debate to overcome confusion. Nevertheless, these terms caused more confusion along the way.
Over the last couple of years, a new term has been coined by the WHO, which is aimed to cover the phenomenon rather than exclude certain terms. This term is called “Substandard, Spurious, Falsely labelled, Falsified and Counterfeit (SSFFC) Medical Products.” Nonetheless, there is currently no universally agreed definition on this term. Therefore, this master thesis will use “counterfeit medicines” as the main term to describe the phenomenon. Moreover, counterfeit medicine is still widely known to cover the phenomenon.33 The latest agreed definition of counterfeit medicines developed by the WHO is:
“A medical product is counterfeit when there is a false representation in relation to its identity and/or source. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct components or with the wrong components, without active ingredients, with incorrect amounts of active ingredients or with fake packaging. Violations or disputes concerning patents must not be confused with counterfeiting of medical products. Medical products (whether generic or branded) that are not authorized for marketing in a given country but authorized elsewhere are not considered counterfeit.
33 WHO (2016) Retrieved from: http://www.who.int/medicines/regulation/ssffc/ssffc_q-a_11-18/en/index4.html (last visited 15-04-2016)
Substandard batches or quality defects or non-compliance with good manufacturing practices/good distribution practices (GMP/GDP) in legitimate medical products must not be confused with counterfeiting.”34
Two legal scholars, Outterson & Smith (2006) present a quite controversial outlook. They argue that counterfeit medicines can also have social benefits, and therefore a distinction on the level of harmfulness of the drugs should be made. They make a distinction between the good, bad and ugly counterfeit drugs. Good, meaning medicines that are protected by US law. Secondly, bad drugs, meaning medicines that contain the right ingredients and that are legally available in other countries but not protected by US law because of minor regulation differences. Thirdly, ugly medicines, that are produced and/or distributed by organized crime. To conclude, their main argument is that the focus should be to protect the pharmaceutical supply chain from criminal counterfeiters that serve no positive social value, rather than serving the interest of drug company profits by forbidding safe, effective but less expensive drugs bought in Canada that violate some technical requirement of U.S. law.
2.4.2 Counterfeit medicines as a crime
In a recent study by Hemalatha and Srinivasa Rao (2015), it is found that important trends are the prevalence of erectile-dysfunction medication and doping substances, illicit narcotics. The available technologies to combat counterfeit drugs, such as barcodes and two-dimensional encryption have their limitations. They concluded that a fully secured supply chain solution can combat the problem. Counterfeit drugs pose a public health hazard and reduce the incentive to engage in research and development and innovation. Trafficking in counterfeits can be extremely profitable; detection of counterfeits is difficult, and the penalties are modest (Blackstone et al., 2014).
In legal terms, counterfeit medicines are often categorized as a violation of patent law, focusing on the patents or trademarks that are violated (Paun, 2011). Research in legislation on counterfeit medicines often comes down to intellectual property rights.
34The Royal Institute of International Affairs (2010) Retrieved from:
http://www.chathamhouse.org/sites/files/chathamhouse/public/Research/Global%20Health/1110bp_co unterfeit.pdf (last visited at 16-10-2015)
This is because patents can legally prevent others from manufacturing, using, selling and or importing pharmaceutical products that have the same or equivalent active ingredient or formulation (Foley & Lardner, 2008).
In addition, in some studies counterfeit drugs have been categorized as a source of income for organized crime. Moreover, in some cases it is even linked to financing terrorism (Pollinger, 2008; Pitkin, 2014). One study has proved that the sales of counterfeit products have financed terrorist group activities of Hezbollah (Arena, 2007). The U.S. Drug Enforcement Agency recognizes that Hezbollah and Hamas make counterfeit medicines that are distributed and sold by criminal networks throughout the Middle East and Latin America. This process produces revenues that feed terrorist activities. But perhaps a greater threat for the pharmaceutical sector is the online environment in which hackers are stealing intellectual property gained from research and development.35
According to Mackey and Liang (2013), there is a need for active, focused, and effective engagement against the criminal networks involved in this trade. Partnerships with the private sector of the WHO has gained harsh criticism, mainly from the incident where generic pharmaceutical products were seized in the Netherlands by customs on the route from India to Brazil. Mackey and Liang (2013) conclude that “[r]ecognition, coordination, and active engagement of key stakeholders are essential in combatting the global health crisis of dangerous counterfeit medicines.” It will be interesting to analyse if these factors, which are deemed essential in fighting counterfeit medicines, are perceived to be equally important by experts that participate in the current debate.
Chapter 3: Methodological framework
This paragraph aims to clarify and specify the methodological framework of the thesis. Firstly, the research question will be elaborated on. In this part, the question and sub-questions that have been derived from the main research question are posed. Secondly, the research design and a short description of the phenomenon are given. Third, the research method is explained. And fourth, the ways of data gathering and data exploitation are clarified. The chapter will close with a reflection on the validity and trustworthiness of the research results.
3.1 Research Question
On the one hand, the academic objective is to explore the perception on definition issues of the phenomenon of counterfeit drugs. On the other hand, this research aims to identify the causes for problems in legislation and collaboration and explain the differences in perception. This master thesis is an exploratory research, using qualitative and quantitative methods. The main research question that embodies this thesis is:
How do key players perceive definition issues, legislation and collaboration in fighting counterfeit medicines and how can we explain this?
3.2 Operationalization table
In order to better understand the main research question and to identify the key principles to be further explained for this research, an operationalization table is presented. This table presents the interview research questions and topics linked with the research question (see page 25). Next to using the expert interviews, document analysis and desktop research are used as important sources for the results the three topics.
First, the perception of definition issues will be questioned to the interviewees. It was clear from the theoretical framework that there are many issues with terminology. Therefore, next to the interview questions, document analysis and desktop research
should provide additional results on definition issues on a national, European and global level.
The second topic is legislation. From the theoretical framework in this research, it is clear that definition is also closely related to legislation. Often, counterfeit medicines are deemed an intellectual property crime. For the harmonization of this legislation, international treaties and EU legislation on counterfeit medicines are important topics and the perception of these are questioned in the interviews. Additionally, document analysis and desktop research should provide significant information for a better understanding of the legislative issues on a national, European and global level.
The third topic is collaboration, divided in the perceived coordination and perceived representation of stakeholders in collaboration. The interview questions in the operationalization table about coordination and representation of stakeholders are derived from a Public Private Partnership theory that was posed in a PhD study on transnational law enforcement collaboration in the field of Intellectual Property crime. In this PhD study, five factors are identified to be important for collaboration among public and private partners. The following factors and their influence on the PPP formation that Paun (2011) identifies are (1) Cooperation in the pursuit of resource gains, (2) Common ground (3) PPP Management, (4) Representation of stakeholders, (5) PPP policy. Two of these five, namely management and representation are highlighted below.
(3) PPP Management: a defining characteristic is that the PPP is set up for a long period of time. This requires a day-to-day management, so the PPP can exist between meetings. For transnational PPPs, the most common provider of such management services is a public international organization. To continuously exist, a public international organization needs the approval from the member states, rather than the approval of many stakeholders. For reasons of discretion, the public international organization might be interested in providing the PPP management service. This PPP management will be referred to as “coordination”
(4) Representation of stakeholders: if stakeholders are not adequately represented in the PPP, they may choose to oppose it from the outside. Things that are further
complicated by the fact that states are not always uniform actors as assumed in realist and institutionalist International Relations theory. Different agencies of a state can pursue different policies and therefore it matters not only if a state is represented, but also by which government agency it is represented.
Furthermore, document analysis and desktop research should provide additional insight on the collaboration, coordination and representation of stakeholders on a national, European and global level.
Figure 2: Operationalization table. Source: Own presentation (Devroe, 2015 research design course).
3.3 Research strategy: qualitative research
In order to answer the main research question of this master thesis, a qualitative approach will be applied as research strategy. The most obvious difference with a quantitative research strategy is that qualitative research tends to be concerned with words rather than numbers. Moreover, qualitative research is taking an epistemological position, meaning that, in contrast to the adoption of a natural scientific model in quantitative research, the stress is on understanding the social
world through an examination of the interpretation of that world by its participants (Bryman, 2012, p. 380). Since the perceptions of the key players in the fight against counterfeit medicines are important for answering the research question, a qualitative research strategy is most suitable.
Qualitative data collection-methods are applied. In this research, two methods are applied; (a) a literature study in combination with a document analysis and (b) interviews with key experts in the field. According to Devroe (2014), a triangulation of methods prevents that a “one sided subjective interpretation of empirical results will take place”.
3.4 Research design: Qualitative Explorative Design
The research design for this research is qualitative explorative study. The aim is to explore a social setting or phenomenon that has yet not being explored. By exploring the phenomenon on issues such as definition legislation and collaboration, a comprehensive overview of the phenomenon in relation to these topics emerges.
Figure 3: Explorative design drawn schematically
3.2.1 Justification of the phenomenon counterfeit medicines and globalization The distinctive need of this case study is arisen out of the desire to understand the complex phenomena of counterfeit medicines within different stages of globalization. As the phenomenon of globalization is described as social relations that are shaped by
Definition Legislation Collaboration
Counterfeit medicines
Global level
European level
Dutch (national level)
local events and vice versa, the layers from national, European an global should give more insight in how these are related. There have only been a few studies in to the phenomenon of counterfeit medicines and therefore it aims to explore the boundaries of research on this topic. Starting with a Dutch perspective, the three topics definition, legislation and collaboration will be analysed on a European level and an international, global outlook on the three topics.
3.2.2 Justification for the explorative design
Explorative research intends to explore the research questions and it does not intend to offer final and conclusive solutions to existing problems. As exploratory research aims to determine the nature of the problem, this type of research is not indented to provide conclusive evidence, but helps us to have a better understanding of the problem. Explorative research can result in schemes for new theoretical building blocks, relevant mechanisms, or for new conceptual definitions or adjusted analytical frameworks. As explorative research is not founded in theories, you are not testing hypotheses or search for causality. When conducting exploratory research, one should be willing to change his/her direction as a result of revelation of new data and insights.36 Within the limitations of time and resources, these changes direction have taken place and are part of this research.
3.5 Data gathering
In this case study, different sources will be used. Data for this research will be gathered through interviews, document analysis and desktop research. The data gathered through interviews is the main source in answering the research question. The data gathered through document analysis and desktop research should serve as additional insight in to the broader Dutch national, European and global scope.
3.5.1 Interviews
The first research method is interviews. This research uses a specific type of interview called elite interviewing (Aberbach and Rockman, 2002). In this form of interview, key persons are questioned. Exploratory research tends to tackle new problems on
36 Research Methodology Online (2016) Retrieved from http://research-methodology.net/research-methodology/research-design/exploratory-research/ (last visited 23-7-2016)
which little or no prior research has been done. Unstructured interviews are the most common primary data collection method with this type of research.
Expert interviews will be conducted with an expert and the head of the Europol counterfeiting team, an expert of the pharmaceutical private industry and a national expert that is a member of the Working Group Enforcement Officers (WGEO). Two interviews will be held in Dutch; one interview will be held in English. The interviews are numbered from 1 to n and can be found in the appendix.
The interview with the Cluster manager IPC3 at Europol will lead to the contacts of other the other experts. This use of sampling is snowball sampling, starting with one interviewee leading to other contacts (Bryman, 2012, p. 351). This resulted in a total of three interviews with key experts, which should give a short but clear overview with different perspectives. For the interviews, a semi-structured interview will be chosen to cover a fairly specific set of topics, also called an interview guide (Bryman, 2012, p. 471). When engaging in the interview, the researcher takes an interview guide to the interview. In this interview guide, the research question and questions elaborating on the three main topics, definition, legislation and collaboration are stated.
The interviews will be recorded using a recorder, and transcribed afterwards. The transcribed text is sent to the interviewees to give them a chance to review and if necessary re-formulate certain statements. In the phase hereafter, the interviews will be screened per topic. The interviews and their transcription will be held in June and July 2016. After the interviews are commenced, the recordings will be transcribed in the original spoken language to written documents, which will be sent to the respondents. The interviews will hereafter be translated in English, when recorded in Dutch.
3.5.2 Interview questionnaire
An exception is made for the respondent of the pharmaceutical company. Since this respondent is situated in Paris, the setting up of an interview in the form of a physical encounter cannot be planned since it exceeds the limited resources of the researcher. Therefore, a questionnaire (Appendix III) will be sent to this respondent. The
questions and introductions are almost similar to the interview guide. In order to keep the highest possible equality with a face-to-face interview, each questions is introduced.
3.5.3 Description of the Expert Interview Organizations
The European Police Office (Europol) is an organization that was established in 1994. It is one of the few EU agencies that have been formed to enforce EU laws and coordinate EU actions in the area of crime and justice. The idea for a Europe-wide police agency was proposed in 1991 by German chancellor Helmut Kohl, founded with a structure similar to that of the Bundeskriminalamt (German Federal Criminal Police). In 1993, the Maastricht Treaty the instituted Europol with limited operations, which started its activities in January 1994 in The Hague, the Netherlands. In the beginning the focus was solely on international drug crimes. In the following years, the European Union increased. Simultaneously, the capacities of Europol increased and a legal framework was established for Europol to become an EU Agency, which entered in to force in 2010. 37 In 2014, Europol had 912 employees.38 In addition, Europol holds many partnerships with other global public organizations such as WHO, Interpol and WCO. Also, Europol has partnerships with private industry companies to exchange information on intellectual property crime matters among others. The intellectual property crime unit of Europol supports international IPC investigations with law enforcement and private sector partners, to protect consumers and identify the criminals behind the networks of the counterfeiting industry.39 This unit, operating from the headquarters in The Hague consists of 30 specialists. On the 12th of July 2016, a new centre was opened, named the Intellectual Property Crime Coordinated Coalition (IPC3).40
The members of the Working Group Enforcement Officers (WGEO) are appointed on the basis of their expertise and experience in medicines enforcement in the field of human or veterinary medicines. Members are designated by the National Competent
37 Europol (2016) Retrieved from: https://www.europol.europa.eu/content/page/history-149 (last visited 22-03-2016)
38 Europol (2016) Europol Review 2014. Retrieved from:
https://www.europol.europa.eu/content/europol-review-2014 (last visited 21-03-2016)
39 Europol (2016) Retrieved from: https://www.europol.europa.eu/content/page/mandate-119 (last visited 22-03-2016)
40 Europol (2016) Retrieved from: https://www.europol.europa.eu/content/launch-ipc3-europe’s-response-intellectual-property-crime (last visited 8-8-2016)
Authorities. At present, Ron van Geffen of the Dutch Healthcare Inspectorate (IGZ) chairs the WGEO.41
The Health Care Inspectorate (IGZ) is a Dutch public organization that promotes public health through effective enforcement of the quality of health services, prevention methods and medical products. As IGZ describes their tasks on their website; it gives advice to the responsible ministers and applies several measures, including advice; encouragement, pressure and coercion, to ensure that health care providers offer only 'responsible' care. The Inspectorate investigates and assesses in a conscientious, expert and impartial manner, independent of party politics and unaffected by the current care system.42
Sanofi is a global pharmaceutical company that researches, develops, and manufactures prescription pharmaceuticals and vaccines. The Company develops cardiovascular, thrombosis, metabolic disorder, central nervous system, internal medicine and oncology drugs, and vaccines.43 Sanofi is encouraging governments to implement stronger legal measures to fight counterfeit medicines and is subscribed to international collaborative efforts.44
3.5.4 Document analysis
Relevant documents, as a second method next to interviews, will be sought. An extensive review of these documents on the definition, legislation and collaboration issues should give insight in the Dutch national, European and global perspectives. The documents that are analysed date back from 1984, the minutes of a WHO meeting, when counterfeit medicines were first addressed, to more current times such as a press release on the most recent operation Pangea, released in June 2015.45 The
41 WGEO (2016) Retrieved from: https://medregeu2016.nl/calendar/working-group-of-enforcement-officers-wgeo/ (last visited 23-7-2016)
42 IGZ (2016) Retrieved from: http://www.igz.nl/english/ (last visited 23-7-2016)
43 Bloomberg Online (2016) Retrieved from http://www.bloomberg.com/quote/SAN:FP (last visited 23-7-2016)
44 Sanofi Press Release (2016) Retrieved from: http://en.sanofi.com/Images/33151_DP_Counterfeit.pdf (last visited 4-8-2016)
45 WHO (1985) Retrieved from http://apps.who.int/medicinedocs/documents/s17054e/s17054e.pdf (last visited on 20-8-2015)
Interpol Online (2015) http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea (last visited 27-10-2015)
documents that are selected are academic literature, newspaper articles, press releases, web-pages, legislation texts, treaties.
3.6 Data exploitation
The data that will be gathered will be asked the questions from the operationalization table. Each document, whether a transcription of an interview, or a policy document, will be asked the same questions. These questions can be linked back to the sub research questions and eventually back to the main research question.
3.6.1 Expert interviews
The data that is gathered through interviews will be analysed for relevant information on the three main topics; definition, legislation and collaboration in the fight against counterfeit medicines. Moreover, the information relevant for the analysis will serve as data for answering the main research question. Secondly, it will also serve to gather non-factual information that the literature study and document analysis cannot provide, such as opinions and perceptions.
3.6.2 Document analysis
The document analysis serves as a starting point to get a comprehensive understanding of all relevant concepts such as counterfeit medicines and intellectual property rights. This also holds for the international legal frameworks and the competences and authorities of all involved actors. For the documents that could be found on the Internet are cited using footnote, the link has been placed in the footnote. The documents will be explored per topic, namely definition, legislation and collaboration. By taking the same division in topics, the structure will remain the same as with the interviews.
3.7 Validity & limitations
As described above, the data that the documents and interviews supply are analysed to answer the main research question. In a qualitative approach, the researcher is seen as the primary instrument for data collection and analysis (Punch, 2006, p. 59). As with any research within the social sciences, the outcomes have their limitations. This paragraph aims to underscore the validity and limitations of this research.
According to Yin (2009), by applying a triangulation of methods, internal validity and reliability issues can be reduced. This research makes use of a triangulation of methods by combining desktop research, document analysis of documents such as policy documents, parliamentary papers, press statements, academic literature and interview transcriptions. The external validity knows its boundaries. External validity refers to the degree to which findings can be generalized across social settings.
According to Bryman (2012), unlike internal validity, external validity represents a problem for qualitative researchers because of their tendency to employ case studies and small samples. Because of the limited amount of experts and thus perspectives and, as counterfeit medicine represents a very specific type of phenomenon, the outcomes cannot be generalized. The outcomes of this study stay limited to the phenomenon of counterfeit medicines and thus cannot be generalized for other counterfeit products.
Chapter 4: Results
In this chapter, the results of the interviews and document analysis are presented. It aims to explain the evolution of counterfeit medicines taking different perceptions in to consideration, starting with a Dutch perspective and exploring other international stands. Firstly, the issues around terminology and the perception on this issue from three experts are discussed. The results from documents analysis complete the debate. Secondly, the perception of key experts in the field on the legislation issues within the Netherlands and in the EU is analysed and a document analysis aims to add to that data. Thirdly, the results on collaboration in the fight against counterfeit medicines are discussed and an overview of collaborative initiatives is given, including the perception of key experts on the issue.
4.1 Definition
This chapter is presenting the results of the interviews, document analysis and desktop research on definition issues. It aims to give a full overview on the available different perceptions on terminology and definitions that are used worldwide and change in the use of these definitions.
4.1.1 Introduction
As the foundation of understanding of the problem was elaborated on in the theoretical framework of this thesis, this analysis aims to further analyse the perceived issues and include many perceptions and perspectives on the issue. Starting with the expert perceptions on the issue, we will continue analysing other international perspectives on the term counterfeit medicine and its definition.
4.1.2 Expert perception
For the topic of definition, the following interview research question was formed: What is your perception of definition issues? Not surprisingly, all three respondents confirmed that there are and have been definition issues among key players. Nonetheless, they all perceive definition issues differently.
One respondent described that in the past, there was a tendency to lose perspective because of definition issues:
