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Pharmaceutical Counterfeiting in The Eu

Where Are We Now?

Publication Date   January 2007
Publisher   Scrip Reports
Product Type   Report
Pages   not applicable
ISBN Number   not applicable
Product Code   SCR018
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Price £1,095.00

approximately: $1,633 | €1,304

Summary


The first edition of Clinica's Medical Technology Company League Tables presents the financial information necessary to assess the performance of leading medical technology manufacturers and suppliers worldwide. The market changes rapidly and industry news is dominated by mergers and acquisitions, making it more important than ever to keep up-to-date with what is happening in this $260 billion industry. The report offers the knowhow required to accurately assess the medical technology market, its segments and major players, thus providing invaluable competitor intelligence for senior executives and other decision makers. The information contained in this report originates from disparate sources including annual reports and SEC filings, analyst reports, questionnaires, personal correspondence and conference material.

A wide spectrum of companies is involved in the market and their output ranges from the production of components to complete instruments.

Clinica's League Tables aims to compare the companies working in the major therapeutic areas: cardiology; diagnostics; dialysis; electromedical; ophthalmology; orthopaedics/prostheses; radiology therapy; respiratory; surgery; and wound care.

Financial data is presented in a series of tables according to medical technology sales value, sales growth, export sales, research and development (R&D) expenditures (by percentage of sales and by nominal value), profitability and number of employees. To present the financial data in a comparable format, figures are converted from their local currencies to US dollars. The exchange rates used are based on the average conversion rates for 2005 and it should therefore be kept in mind that exchange rate movements may influence the financial figures.

Most companies report their year end results on 31 December. Some companies, however, report on different dates with the majority of Japanese companies reporting on 31 March. The League Table does not take into account the different year ends and, for the purpose of the League Tables, and to be as up-to-date as possible, 2005 figures are defined as fiscal years ended by July 2006.

Many of the companies featured in Clinica's League Tables deal purely in medical devices or diagnostics. In a number of cases, however, medical devices represent only a proportion of business within a diverse conglomerate, as is the case with Siemens and General Electric (GE).

Companies are not required to report details of financial figures for divisions below a certain size so estimates provide the basis for its overall ranking.

These figures are not random guesses, though, but educated predictions based on a varied and disparate set of sources. Some provide sales figures but no breakdowns beyond that. In these cases the companies received an overall ranking based on revenues while being omitted from the remaining league tables.

Companies acquired last year while still reporting 2005 results have been included in the league with a separate entry. Details of their new ownership status and parent company appear in the footnotes and company profiles.

The report surveys the results of the 200 companies whose data were available at the time of publication. While the list is representative of the leading companies, it does not claim to be exhaustive. Several privately owned concerns, which are not legally obliged to disclose their results, politely declined to provide them for this report. We should like to thank all the companies which contributed to the contents of this report and hope the publication of the first edition of Clinica's League Tables will encourage more companies to disclose figures on their medical technology activities for the next edition.

Exchange rates

$1 = 110.580 0.550 €0.806 Aus$1.30947 SEK7.4731 C$1.2118 CHF1.2452 DKK5.9969 NZ$1.634788 Source: IMF, World Bank, OECD, http://fx.sauder.ubc.ca/etc/USDpages.pdf

The following notes apply to all of the tables contained within this report: AFP Imaging - year ended June 2006 Agfa Healthcare - all figures are for the Healthcare division only Alcon Laboratories - surgical sales only Aloka - year ended March 2006 Analogic - year ended July 06, medical imaging sales only Cantel Medical - Subsidaries include Minntech and Carsen Carl Zeiss - medtech and surgical combined, new entity in 2006 with sales of €500m Celera Genomics - part of Applera and includes Celera Diagnostics Chiron - now part of Novartis Coloplast Group - fiscal year ends September 2005 Compex Technologies - fiscal year ends June 2006 Copper Surgical - subsidiary of coopercos, financial year end October 2005 CYTYC - whole company Dade Behring - whole company Eastman Kodak - Healthgroup segment only Edwards Lifesciences - whole company E-Z-EM - Financial year end June 2006 Genzyme - Biosurgery and diagnostics only Getinge - Medical systems business Guident - aquired by J&J in 2006 Haemonetics - year ended March 06 Hill-Rom - year ended September 2005, healthcare sales only Hitachi Medical - year ended March 2006 Inamed - aquired by Allergan in 2006 Intermagnetics - year ended May 06 Inverness Medical Innovations - Other values take into account total net product sales J&J - Subsidaries include: Biosense Webster; Codman & Shurtleff; Cordis; DePuy; Ethicon; Ethicon Endosurgery; Ortho Clinical Diagnostics Kimal - private company MDS Nordion - converted from Canadian $

nihon Kohden - fiscal year ended March 2006 Schick Technologies - year ended March 2006 Shimadzu - medical systems sales, year ended March 2006 Steris - Healthcare sales only, year ended March 2006 Stratagene - Clinical diagnostics sales only Thermo Electron - estimate of clinical sciences and diagnostics sales Urologix - year ended June 2006 Viasys Healthcare - sales are for scientific instrument segments only but R&D given for whole company Vital Signs - year ended September 2005 Wilson Greatbatch - makes components for medical device companies, not a medical device manufacturer itself

Content


  • 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
    • 3.2.2.2 Article 10 - Corrective Measures - Paragraph
    • 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
    • 3.3.1.2 Article
    • 3.4 Framework Decision on Ipr Offences
    • 3.4.1 Points of Interest Relating to Proposed Articles
    • 3.4.1.1 Article
    • 3.4.1.2 Article 3 - on Extended Powers of Confiscation
    • 3.4.1.3 Article
    • 3.4.1.4 Article 5 - Paragraph
    • 3.4.1.5 Article 5 - Paragraph
    • 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
    • 3.5.2.2 Article
    • 3.5.2.3 Article 11 - Paragraph
    • 3.5.2.4 Article 14 - Paragraph
    • 3.5.2.5 Article 14 - Paragraph
    • 3.5.2.6 Article
    • 3.5.3 Implementing Regulation (Ec) 1891/2004
    • 3.5.4 Articles of Interest with Regard to Medicinal Products
    • 3.5.4.1 Article
    • 3.5.4.2 Article 8 - Paragraph
    • 3.5.4.3 Article 8 - Paragraph
    • 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 Proprit 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 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