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 (EU). This issue 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 it is 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 and varied forms counterfeiting can take.

The report also pays special attention to how counterfeit medicines breach intellectual property rights (IPR) as the problem is compounded by originator companies' needs to protect their IPR.

Even in the EU, where protection of IPR is rigorously enforced, data gathered by EU medicines enforcement officers (EMEO) have revealed a startling number of fake drugs in the legal supply chain. And figures presented by the EU' s Directorate general for Tax and Customs show that in 2005, customs officers seized more than 500,000 counterfeit medicines.

As the counterfeiting of drugs in Europe threatens to spiral out of control, the European Commission (EC) has implemented stringent measures to deter and combat this type of fraud. Moreover, the European Medicines Agency and the Heads of Medicines Agencies have launched their own approaches to the problem, all of which are discussed in detail here.

In addition, this report contains a series of exclusive commentaries from selected EU countries which outline their opinions on the extent of the problem. This section details national measures that have been introduced to combat counterfeiting and highlights the efforts of the member states to move the fight onto an international stage.

And this report does not ignore the global scale of this problem. It gives an overview of the nature of the problem in countries around the world.

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