Pharmaceutical Counterfeiting in the EU: Where Are We Now?

Table of Contents

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
  • 1.3.1 How IPR rights are breached by counterfeiters
    • 1.3.1.1 Patents and Supplementary Protection Certificates
    • 1.3.1.2 Trademarks
  • 1.3.2 TRIPS and patents in developing countries
• 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
  • 2.4.1 The European Union
  • 2.4.2 Commonwealth of Independent States (CIS) countries
    • 2.4.2.1 Russia
    • 2.4.2.2 The Ukraine
  • 2.4.3 Africa
    • 2.4.3.1 Angola
    • 2.4.3.2 Kenya
    • 2.4.3.3 Nigeria
  • 2.4.4 South America
    • 2.4.4.1 Colombia
    • 2.4.4.2 Mexico
    • 2.4.4.3 Peru
    • 2.4.4.4 The Dominican Republic
  • 2.4.5 Asia
    • 2.4.5.1 Cambodia
    • 2.4.5.2 China
    • 2.4.5.3 India
    • 2.4.5.4 Indonesia
    • 2.4.5.5 Lebanon
    • 2.4.5.6 The Philippines
• 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
  • 3.2.1 Points of interest in the preamble
  • 3.2.2 Articles of importance with regard to counterfeit drugs
    • 3.2.2.1 Article 8 - right of information - paragraph 1
    • 3.2.2.2 Article 10 - corrective measures - paragraph 1
    • 3.2.2.3 Article 11 - injunctions
    • 3.2.2.4 Article 16 - sanctions by member states
    • 3.2.2.5 Article 19 - exchange of information and correspondents
• 3.3 The second enforcement directive on IPR offences
  • 3.3.1 Points of interest relating to proposed articles
    • 3.3.1.1 Article 3
    • 3.3.1.2 Article 4
• 3.4 Framework decision on IPR offences
  • 3.4.1 Points of interest relating to proposed articles
    • 3.4.1.1 Article 2
    • 3.4.1.2 Article 3 - on extended powers of confiscation
    • 3.4.1.3 Article 4
    • 3.4.1.4 Article 5 - paragraph 1
    • 3.4.1.5 Article 5 - paragraph 2
• 3.5 The role of customs
  • 3.5.1 Points of interest in the preamble
  • 3.5.2 Articles of interest with regard to medicinal products
    • 3.5.2.1 Article 8 - paragraph 2
    • 3.5.2.2 Article 10
    • 3.5.2.3 Article 11 - paragraph 1
    • 3.5.2.4 Article 14 - paragraph 1
    • 3.5.2.5 Article 14 - paragraph 2
    • 3.5.2.6 Article 16
  • 3.5.3 Implementing regulation (EC) 1891/2004
  • 3.5.4 Articles of interest with regard to medicinal products
    • 3.5.4.1 Article 6
    • 3.5.4.2 Article 8 - paragraph 2
    • 3.5.4.3 Article 8 - paragraph 3
  • 3.5.5 Customs' response to counterfeiting and piracy
  • 3.5.6 Operation FAKE
• 3.6 Heads of Medicines Agencies' (HMAs) response to counterfeiting
  • 3.6.1 Enforcement
• 3.7 Counterfeiting and the role of the EMEA
  • 3.7.1 The Rapid Alert System
• 3.8 Working with China
• 3.9 Working with India
• 3.10 Working with the US
  • 3.10.1 Council Decision of March 30th, 2004 (2004/634/EC)
  • 3.10.2 Anti-counterfeit action programme
• 3.11 Advertising and the internet
  • 3.11.1 The distance selling directive
  • 3.11.2 The advertising of medicinal products for human use
  • 3.11.3 Misleading and comparative advertising
• 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
  • 4.6.1 Assessing the risk to public health
• 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
  • 5.3.1 Accusations
  • 5.3.2 Additional safety
  • 5.3.3 Good Parallel Distribution Practice Guidelines
• 5.4 References

CHAPTER 6 RFID AND OTHER CODING SOLUTIONS

• 6.1 Introduction
  • 6.1.1 RFID technology
  • 6.1.2 Towards an RFID Policy for Europe
• 6.2 Stakeholders' concerns
• 6.3 Alternatives to RFID
• 6.4 Overview of EU Member States' coding initiatives (see note 11)
  • 6.4.1 Belgium
    • 6.4.1.1 Aegate solution against counterfeiting
  • 6.4.2 France
  • 6.4.3 Italy
  • 6.4.4 Portugal
  • 6.4.5 Spain
• 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
  • 8.12.1 Legitimate UK supply chain to patient level:
  • 8.12.2 Legitimate UK supply chain to wholesale level but not beyond:
  • 8.12.3 Illegitimate supply chain (e.g. internet or through personal contacts):
• 8.13 Perspectives from non-EU countries
  • 8.13.1 Switzerland
  • 8.13.2 Russia

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