Parallel Trade in Pharmaceuticals

Content

• Marketing Brochure
• Executive Summary
• Foreword
• Introduction
• 1: Background To Parallel Importation
  • The concept of parallel importation
  • The view of pharmaceutical manufacturers
  • The view of parallel importers
  • Legalities of parallel trade
  • Exhaustion of intellectual property rights
  • Consumer views of intellectual property rights
  • Repackaging and re-labelling of products
  • The definition of price
  • Consumers and pricing
  • Therapeutic efficacy
  • Second-generation products and price increases
  • Influences on prices
  • Pricing strategies and parallel imports
  • Skimming
  • Prestige pricing
  • Penetration pricing
  • Extinction pricing
  • Pricing freedom
  • Pricing differentials
  • Differentials created by price discounts
  • Price differentials resulting from variations in pricing regulations
  • Creation of post-patent price differentials
  • Pricing within a single price band
  • Patents
  • Strategies to extend effective patent life
  • Cost containment and pharmaco-economics
  • Generic drugs
  • Parallel importation of generics
  • Counterfeit products
  • Internet trading
• 2: Parallel Importation in Europe
  • Introduction to European parallel trade issues
  • The European pharmaceutical market
  • European pharmaceutical spending controls
  • Is spending really the issue?
  • The EU
  • History of the EU
  • Philosophy of the EU
  • The set-up of the EU
  • EU law
  • Primary legislation
  • Secondary legislation
  • Case law
  • Decision making in the EU
  • European integration
  • The institutions of the EU
  • The Court of Justice
  • EU law and parallel importation
  • The European Economic Area (EEA)
  • The creation of the EEA
  • EU enlargement and the EEA
  • The euro
  • The euro and the pharmaceutical industryThe value of parallel trade in Europe
  • The legalities of parallel trade in the EU
  • Pharmaceutical manufacturers and parallel trade
  • Repackaging of parallel imports
  • Protection of products from parallel importation
  • Wholesalers in the EU
  • European hospitals and parallel importer
• 3: Enlargement of the EU
  • EU expansion and the pharmaceutical market
  • EU expansion and parallel trade - the view of the pharmaceutical industry
• 4: Parallel Trade by Country & Significant Legal Battles
  • The UK
  • Parallel trade and the Pharmaceutical Price Regulation Scheme (PPRS)
  • Ireland
  • France
  • The Netherlands
  • Germany
  • Denmark
  • Sweden
  • Belgium
  • Spain
  • Italy
  • Austria
  • Switzerland
  • Norway
  • Future trends for parallel trade in Europe
• 5: Parallel Importation Issues in a Global Context
  • The pharmaceutical industry and globalisation
  • Maximising revenue worldwide
  • The World Trade Organisation (WTO) and its objectives
  • Organisation of the WTO
  • The WTO philosophy
  • The WTO's viewpoint on intellectual property rights
  • Trade-related Aspects of Intellectual Property Rights (TRIPS)
  • Limitations of TRIPS and trade disputes
  • The WTO and the access-to-medicines issue
  • Possibilities for international parallel trade
  • The concept of international exhaustion
  • The WTO and parallel imports
  • Exporting to the EU from outside Europe
• 6: Parallel Importation Outside Europe
  • Drug pricing in the US
  • The views of the US pharmaceutical industry
  • US political debates over pricing and parallel importation
  • Canada
  • Mexico
  • Kenya and parallel trade
  • Philippines
  • US reaction to developments in the Philippines
  • Singapore
  • Discounted drugs in Taiwan
  • Japan
  • New Zealand
  • Australia
  • India
  • The concept of compulsory licensing
  • The grounds for using a compulsory licence
  • The AIDS crisis
  • HIV drug pricing becomes an issue
  • South Africa and HIV drug pricing
  • Brazil and HIV drug pricing
  • Future implications of compulsory licensing
  • Compulsory licensing in North America
  • Compulsory licensing, parallel importation and unscrupulous traders
• 7: Analyses of Parallel Importation
  • Pharmaceutical R&D investment and parallel trade
  • Innovation and new drug development
  • Why intellectual property matters to pharmaceutical companies
  • Consumer views
  • Tax benefits on pharmaceutical R&D
  • Parallel traders and pharmaceutical R&D 'myths'
  • Better management of R&D investment
  • An economic viewpoint on parallel trade issues
  • Market structure
  • Demand elasticity
  • Pricing regulations
  • Competition policies
  • Using parallel importation as a negotiation tool
  • The process of parallel importation
  • How to bring parallel imports to market
  • The effect of parallel trade channels
  • Defensive measures for parallel trade
  • Conclusions
• References
• Parallel Trade Organisations
• List of Figures
  • Figure 1.1 Fundamental reasons for parallel trade in the EU
  • Figure 1.2 Breakdown of retail medicine price in Europe, 2000
  • Figure 1.3 The global price corridor
  • Figure 1.4 Estimates of annual cost of CHF treatment with ACE-inhibitors, 2000
  • Figure 1.5 Average approval time for generic drugs according to the FDA
  • Figure 1.6 Estimated European generics market by volume, 2000
  • Figure 2.1 Breakdown of European pharmaceutical R&D
  • Figure 2.2 Cost-containment strategies: price controls
  • Figure 2.3 Cost-containment strategies: spending controls
  • Figure 2.4 Cost-containment strategies: volume controls
  • Figure 2.5 Informedica pricing analyses, 1998/99: Neoral treatment costs
  • Figure 2.6 Informedica pricing analyses, 1998/99: AmBisome treatment costs
  • Figure 2.7 Share of pharmaceutical parallel imports by value
  • Figure 2.8 Share of parallel imports in total European pharmaceutical market sales (industry estimates, 2001)
  • Figure 2.9 Parallel importation of Norvir, 1999
  • Figure 2.10 Parallel importation of Epivir, 1999
  • Figure 2.11 Parallel importation of Retrovir, 1999
  • Figure 2.12 HIV drug prices, 1999
  • Figure 4.1 Market share of parallel imports in Germany
  • Figure 4.2 Factors influencing the future of parallel trade in Europe
• List of Tables
  • Table 1.1 Price variations in the EU (public prices in euros)
  • Table 1.2 Some parallel imports options offered to European hospitals in 1997
  • Table 1.3 Types of prescription drugs
  • Table 2.1 Market share of parallel imports in key European markets in selected years
  • Table 2.2 Estimated penetration of parallel imports (%) in main importing states, 1999
  • Table 2.3 Summary of pharmaceutical company options to counter parallel importing
  • Table 2.4 Summary of what is permissible and not permissible for parallel importers repackaging an original manufacturer's products in the EU
  • Table 2.5 Summary of key European pharmaceutical parallel trade cases
  • Table 4.1 Summary of parallel trade in the UK, 1997 and 2001