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Published by: Datamonitor
Published: Apr. 21, 2006 - 100 Pages
Table of Contents
- CHAPTER 1 OVERVIEW OF PARALLEL TRADE
- What is parallel trade?
- Conditions for parallel trade
- Implications of parallel trade
- Price convergence of drugs
- Parallel trade drives down pharmaceutical companies’ profitability
- Does parallel trade compromise the safety of drugs?
- CHAPTER 2 DRUG IMPORTATION IN THE US
- Introduction
- Further legislation has been passed to legalize drug importation, but implementation is no closer
- US consumers are evading the law and importing prescription drugs from abroad
- Route of illegal importation
- Key drivers of drug importation - the search for cheaper drugs
- State initiatives to drive importation of prescription drugs
- Driving factors for drug importation from Canada
- Key resistors of drug importation - the safety of drugs is being compromised
- Many foreign Internet phamacies operate in a regulatory loophole
- Rogue Internet pharmacies - a high percentage of Internet phamacies that claim to be Canadian are not really Canadian
- Counterfeits entering the supply chain
- Strategies for manufacturers to tackle drug importation
- Supply management strategies
- Anti-counterfeiting technologies
- Pricing strategies
- Legal challenges
- Programs for the uninsured
- Public awareness campaigns
- Use of different packaging
- Use of different brand names
- Datamonitor’s recommendations
- Future outlook for drug importation
- Drug importation is expected to decline
- Legalization of drug importation unlikely
- CHAPTER 3 PARALLEL TRADE IN EUROPE
- Introduction
- Legal and regulatory framework
- Regulatory framework
- Repackaging and relabeling
- The derogation of accession states
- Country-level trends in parallel trade in Europe
- Present situation
- The future outlook of parallel trade in Europe
- Strategies for manufacturers to tackle parallel trade in the EU
- Supply management is the most effective approach
- Pricing strategies are unlikely to be profitable moves, although Pfizer’s dual pricing system may change this
- Legal challenges by drug manufacturer’s rely on intellectual property rights
- Use of different packaging and brands in member states may deter parallel trade - but the effect is limited
- The ‘do nothing’ approach is risky
- CHAPTER 4 APPENDIX : SUPPORTING DATA
- Definitions
- Glossary of terms
- Supporting data
- Conferences attended
- Reference
- Exchange rate
- LIST OF TABLES
- Table 1: Evaluation of three generics bought by the FDA from an Internet pharmacy failed on a number of tests
- Table 2: Product patents were introduced in eight of the accession states between 1991 and 1994
- Table 3: Incentives for parallel importation in the six main parallel importing European countries
- Table 4: Summary of the economic impact of parallel trade, based on the ESRC, LSE and YHEC studies
- Table 5: EEA countries
- Table 6: Exchange rates*, 2004
- LIST OF FIGURES
- Figure 1: Generalized distribution chain for parallel traded pharmaceutical products
- Figure 2: The number of state and federal bills introduced in Congress proposing the legalization of parallel drug importation has dramatically risen over the last four years
- Figure 3: Foot traffic traditionally accounted for the majority of cross border sales of prescription drugs from Canada to the US, however, foreign Internet pharmacies have become more popular after their emergence
- Figure 4: Average ratio of Canadian prices to Median International Prices of patented drugs, 1987-2004
- Figure 5: Ratio of average Canadian patented drug prices to foreign drug prices, 1987, 1997, 2004
- Figure 6: The high level of competition for major generic products in the US drives the price down
- Figure 7: Main strategies available to drug manufacturers to tackle the current illegal importation of prescription drugs in the US
- Figure 8: A large section of LillyAnswers’ website discusses the risks of drug importation
- Figure 9: Lilly ICOS devotes a whole section on its Cialis website on how customers can avoid counterfeit Cialis drugs
- Figure 10: Benchmarking anti-drug importation strategies
- Figure 11: Although Medicare D provides some coverage of prescription drug costs, beneficiaries will still have to contribute
- Figure 12: Legal framework of EC law supporting parallel trade in the EU
- Figure 13: Parallel trade rose substantially in Europe between 1998 and 2002, particularly in the UK, Sweden and Germany
- Figure 14: Parallel import penetration across selected European countries in terms of value in 2004
- Figure 15: Parallel import penetration in Germany, 1997-2004
- Figure 16: ARB case study: selective use of PPRS price cuts to UK packs with high parallel import penetration drove down parallel importation
- Figure 17: Sales of locally-sourced Aprovel and Amias rose sharply in 2005, while parallel imports fell
- Figure 18: The accession countries have a high penetration of generics, compared to some of the most common parallel exporter countries
- Figure 19: Wholesalers are vertically integrating into offering pre-wholesale and pharmacy activities
- Figure 20: Main actions that drug manufacturers can take to limit parallel trade in Europe
AbstractIntroduction
Since the beginning of this decade, parallel trade levels of pharmaceutical drugs in the US and Europe have risen to some of the highest levels ever seen, exerting additional pressure on the profitability of pharmaceutical companies. As a result, it has become ever more important for pharmaceutical companies to take action to limit the impact of this.
Scope of this report
- In-depth analysis of the present situation of parallel trade in Europe and the US, including an examination of the impact of the new accession states
- Evaluation of the future of parallel trade in Europe and the US, including analysis of the key factors that impact this
- Case studies examining strategies used by the leading pharmaceutical companies to restrict parallel trade
- Recommendations on how companies can optimize their strategy to tackle parallel trade effectively
Research and analysis highlights
Illegal drug importation into the US is in decline. Pharmaceutical companies have successfully restricted the supply of drugs to the main culprits in Canada who have been selling drugs to Americans, and the recent introduction of Medicare Part D has reduced the number of people without drug coverage.
The legal framework supporting parallel trade in the EU has restricted the actions pharmaceutical companies' can take to restrict parallel trade, but Bayer's legal victory on the Adalat case in 2004 has provided companies with an opportunity to take action that can effectively restrict parallel trade without infringing EU law.
The 2004 EU enlargement has not caused a rise in parallel trade yet, mainly because of the derogation that prevents parallel exportation of many branded drugs from 8 of the new countries. The effect of this on new accession states and future accession countries will erode over time, which is expected to cause a gradual rise in EU parallel trade.
Key reasons to read this report
- Assess the commercial implications for your business of parallel trade in the US and EU
- Get up to speed with recent development in the parallel trade situation in Europe and the US
- Understand how to optimize your strategies to tackle parallel trade
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