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Pharmaceutical Counterfeiting in the EU: Where Are We Now?

Informa Healthcare
May 1, 2007
107 Pages - SKU: IFHC1693947

Abstract Table of Contents Search inside this report Related Reports

Countries covered: Europe

Pharmaceutical counterfeiting is widely accepted to be a serious, global problem. No longer just a scourge on the developing world, counterfeit drugs now affect industrialised nations including the member states of the European Union. This is an issue that must be faced by businesses worldwide.

Today, it is estimated that up to 10% of all drugs may be counterfeit. But international and national organisations, as well as governmental authorities, appear to be unanimous in their assertion that is it extremely difficult to establish reliable statistics regarding the size of the phenomenon -or even to determine what constitutes counterfeiting. So, as well as discussing the extent of the problem, this report explores the definitions -in itself an indication of the many varied forms counterfeiting can take.

This is a comprehensive guide and explores the problem from numerous angles and highlights the biggest threats facing the industry. It also explains what is being done to tackle the issue and suggests what companies themselves can do. It is essential reading for anyone concerned with the safe provision of medicines.

Use this report to:

Understand the problem
both the types and the scope of the threat
Protect your intellectual property rights
Know where to turn for help with this issue
Get ideas to how your company can tackle this problem
Keep up-to-date with the many anti-counterfeiting initiatives and laws
Tackle the threat posed by the internet
Ensure your packaging and labelling is compliant and tamper-proof
Find the best anti-counterfeiting solution

CHAPTER 1 INTRODUCTION DEFINITIONS, TYPES OF COUNTERFEITING & THE ISSUE OF IPR: 1.1 Definitions of a counterfeit drug; 1.2 Types of counterfeiting; 1.3 Intellectual property rights; 1.4 References
CHAPTER 2 THE EXTENT OF THE PROBLEM: 2.1 Introduction; 2.2 The WHO assessment of counterfeiting; 2.3 The assessment of the World Customs Organisation (WCO); 2.4 The global picture - region by region; 2.5 International initiatives; 2.5.1 International Medical Products Anti-Counterfeiting Taskforce; 2.5.2 EU initiatives; 2.6 References
CHAPTER 3 THE EUROPEAN LEGAL APPROACH: 3.1 Introduction; 3.2 The enforcement of intellectual property rights; 3.3 The second enforcement directive on IPR offences; 3.4 Framework decision on IPR offences; 3.5 The role of customs; 3.6 Heads of Medicines Agencies’ (HMAs) response to counterfeiting; 3.7 Counterfeiting and the role of the EMEA; 3.8 Working with China; 3.9 Working with India; 3.10 Working with the US; 3.11 Advertising and the internet; 3.12 The wholesale distribution of medicinal products for human use; 3.13 Labelling of medicinal products for human use and on package leaflets; 3.14 Good distribution practice of medicinal products for human use; 3.15 Electronic commerce; 3.16 References
CHAPTER 4 THE COUNCIL OF EUROPE AND COUNTERFEIT MEDICINES: 4.1 Introduction; 4.2 Why a convention?; 4.3 Single points of contact; 4.4 The Official Medicines Control Laboratories network; 4.5 The model procedure for managing counterfeit cases; 4.6 Counterfeit signal detection and evaluation; 4.7 The results of the Moscow conference; 4.8 References
CHAPTER 5 PARALLEL TRADE - THE VIEW FROM THE EUROPEAN ASSOCIATION OF EURO-PHARMACEUTICAL COMPANIES: 5.1 Introduction; 5.2 Parallel trade regulation in Europe; 5.3 The EAEPC standpoint; 5.4 References
CHAPTER 6 RFID AND OTHER CODING SOLUTIONS: 6.1 Introduction; 6.2 Stakeholders’ concerns; 6.3 Alternatives to RFID; 6.4 Overview of EU Member States’ coding initiatives (see note 11); 6.5 The view of the European Generic medicines Association; 6.6 References
CHAPTER 7 BIG PHARMA’S APPROACH: 7.1 Introduction; 7.2 AstraZeneca; 7.3 Lilly; 7.4 GlaxoSmithKline (GSK); 7.5 Merck & Co; 7.6 Novartis; 7.7 Pfizer; 7.8 References
CHAPTER 8 THE ROLE OF NATIONAL AGENCIES: 8.1 Introduction; 8.2 Austria; 8.3 Czech Republic; 8.4 Cyprus; 8.5 Irish Republic; 8.6 Latvia; 8.7 Lithuania; 8.8 Poland; 8.9 Portugal; 8.10 Slovakia; 8.11 Sweden; 8.12 UK
LIST OF TABLES: Table 1.1 Members of the Organisation Africaine de la Propriété Intellectuelle; Table 1.2 Members of the African Regional Industrial Property Organisation; Table 2.1 Top 10 countries per number of counterfeit medicines seized/discovered in 2005
LIST OF FIGURES: Figure 1.1 Types of counterfeit drugs; Figure 2.1 Breakdown of seizures at EU borders by country of origin, 2005; Figure 2.2 Breakdown of number of articles seized at EU borders by origin/provenance, 2005

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Pharmaceutical Counterfeiting in the EU: Where Are We Now?

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