Parallel Trade - US Lawmakers allow imported prescriptions drugs

发布时间：2007.6.21

内容介绍

"Parallel Trade acts as an important driving force for market integration where there are important differences in price between member states"

- European Commission Communication on the single market in pharmaceuticals

Parallel trade is on the verge of breaking its confines of the EU and diffusing into other global markets. This global practice is far from simple, and the loopholes that have made it possible refuse to close. Whether you think parallel trade is a benefit or a cost, the reality is that it is affecting the whole pharma industry on a wide scale. It started out a North-South divide but even this is changing. The European Commission and other trade regulation bodies won't protect the pharma companies pricing structures.

Although consumers may think that imported drugs into the US come from Canada, UK, or other Western European nations, it's impossible to definitively verify an imported drug's country of origin.

Do developing countries see parallel trade as a benefit for cheap drugs and if so will it remain a benefit?
This year how much will pharma companies' profits be threatened by parallel trade?
With individual drugs already being bought in Canada and Mexico will large scale parallel trade become a reality in the US as there are no price controls in place?
The US market is such an attractive market for parallel traders. How will the enlargement of the EU, to 27 affect parallel trade?
Patients, general practitioners, healthcare agencies and national governments are all benefiting from this gray market import. However, there are actual 'real' winners in this trade, parallel traders themselves. They gain the most benefit from such a trade, which is pure profit. On the other hand, pharma companies are blaming parallel trade, for huge losses in revenue, which in affect lowers innovation. Parallel trade is seen as a gateway for counterfeit drugs entering the supply chain.

"In the European Union, products pass freely from one member nation to another - through a system called 'parallel trade.' Consequently, drugs sold in England may actually have originated in a country with less rigorous safety standards, such as Cyprus or Latvia". Warwick News

The latest case of counterfeit drugs entering the UK supply chain was that of Eli Lilly's antipsychotic drug, Zyprexa and Sanofi-Aventis and Bristol Myers Squibb's Plavix. Three batches were recalled by the MHRA. Isn't this enough evidence that parallel trade is having a negative affect on the pharma industry? Find out by buying this report.

Does parallel trade diminish the quality and safety of drugs? Isn't repackaging a great issue when it comes to parallel trade? Isn't the Internet is a great medium for a form of parallel trade? Many important questions that need answers.

目录及图表

Chapter 1. Executive Summary: Parallel Trade, Benefiting or Breaking the Pharma Industry?
Chapter 2. Parallel Trade in Global Pharmaceutical Industry
2.1 What is Parallel Trade?
2.2 Effects of Parallel Trade
2.2.1 Innovation driving R&D
2.2.2 Profitability
2.2.3 Safety/Efficacy of Drugs
2.2.4 Easier Access for Counterfeit Drugs
2.2.4.1 Methods of Controlling Counterfeit Drugs

Chapter 3. Legal Aspects of Parallel Trade
3.1 Exhaustion of Rights
3.1.1 National Exhaustion
3.1.2 Regional Exhaustion
3.1.3 International Exhaustion
3.1.3.1 International Exhaustion and the Pharma Industry
3.2 Intellectual Property Rights
3.2.1 TRIPS
3.2.1.1 Controversy surrounding TRIPS
3.2.2 Doha Development Round
3.2.3 Pharmaceutical Patent Protection
3.3 Compulsory Licensing
3.3.1 Pharma Companies and Compulsory Licensing

Chapter 4. Price is the Principal Driver of Parallel Trade
4.1 Pricing in Pharma
4.1.1 Factors that Influence Pricing
4.2 Price Convergence
4.2.1 Arbitrage
4.2.2 The Impact of the Euro on Drug Prices
4.2.3 Price Convergence - a weak argument
4.3 Price Differential
4.3.1 Pricing is not the Only Factor in Determining the Parallel Trade Potential for a Drug
4.4 Pricing Control
4.4.1 Governments Link to Price Control
4.4.2 Parallel Trade is used as a Cost Containment Method
4.4.3 Cost Containment Methods have had Limited Effects
4.4.4 Price Controls May Affect Drug Launches
4.4.5 Price Control affects Innovation
4.4.5.1 Price Control Seen as Reason why Europe's Drug Innovation Falls Behind
4.4.6 Reference Pricing will Cause Drugs to be Priced Below the Market Line
4.4.7 A Single European Price for Pharma Drugs is Unlikely
4.5 Price Limiting
4.5.1 Price Sensitivity
4.5.1.1 Inelastic Market
4.5.1.2 Elastic Market
4.5.2 Factors That Affect Price Sensitivity

Chapter 5. Parallel Trade in US and Canada
5.1 Regulations in the US and Canada
5.2 Medicare Act Reducing Reliance on Cheaper Drugs from Canada
5.3 Safe Drugs are Only Imported from Canada
5.4 FDA's Approach to Personal Importation
5.5 The Future of Re-importation
5.5.1 Bill Allowing Imported Drugs Clears Senate
5.5.2 Effects of Allowing Reimportation in the US
5.6 Differences in Pricing between the US and Canada
5.7 Patented Drugs are Found to be Cheaper in Canada than in US
5.8 US Generic Drugs Cost Less than Canadian Drugs

Chapter 6. Parallel Trade in Europe
6.1 Parallel Trade Predominantly a European Activity
6.1.1 Trade Activity in the EU
6.1.2 EU Parallel Importation
6.2 Drug Prices in the EU
6.3 UK - One of the largest Importers of Parallel Trade
6.3.1 The Method of Parallel Importing into the UK
6.3.2 Regulation of UK Parallel Trade
6.3.3 Does the NHS Really Benefit from Parallel Trade?
6.3.4 UK Parallel Traders - Major Companies
6.4 Germany
6.4.1 German Parallel Distributors
6.5 France
6.6 Spain
6.7 Sweden
6.7.1 Parallel Distributors in Sweden
6.8 Norway
6.8.1 Norwegian Parallel Importers
6.9 The Netherlands
6.10 Denmark
6.10.1 Conditions for Parallel Import
6.11 Parallel Exporting Countries
6.12 GSK Wins Long Battle
6.13 EU Enlargement
6.14 Limitations to Growth

Chapter 7. The Role of the Internet in Parallel Trade
7.1 Internet Usage is Immense
7.2 Online Purchasing of Drugs
7.2.1 The World Online Drugs Market will Increase steadily
7.2.2 Benefits of Online Drug Sales
7.2.3 Concerns of Online Drug Sales
7.2.4 Consumers Point to Low Cost and Convenience as Reasons for Purchasing Drugs Online
7.2.5 Online Pharmacies Differ in their Operations
7.3 Verified Internet Pharmacy Practice Sites (VIPPS)
7.3.1 Certification of the VIPPS Programme
7.4 Regulations for International Sites
7.4.1 US Regulations
7.4.2 Australia
7.4.3 Fiji
7.4.4 India
7.4.5 Israel
7.4.6 New Zealand
7.4.7 UK
7.5 Canadian Internet Pharmacies
7.5.1 US Consumers Buying Less from Canadian Internet Pharmacies
7.6 Rogue Internet Pharmacies
7.6.1 UN Issues Warning About Rogue Internet Pharmacies
7.6.2 Continuing Challenges Faced in Counteracting Illegal Internet Pharmacies
7.7 Operation Cyber Chase - A Year Long Investigation
7.8 Online Pharmacies: Good or Bad?

Chapter 8. Counterfeiting is a Major Threat
8.1 An Immense Concern Due to Counterfeiting
8.2 Prevalence of Counterfeiting
8.2.1 Counterfeiting Incidents in Europe
8.3 PSI - Will it help?
8.4 Global Reports of Counterfeit Medicines
8.5 Counterfeit Lipitor Dispersed through the UK Supply Chain

Chapter 9. The Issue of Repackaging
9.1 The Repackaging of Pharmaceuticals is an Important Aspect of Parallel Trade
9.2 Different Types of Packaging
9.3 What a Package Must Do
9.4 The EU Angle on Repackaging
9.5 FDA's Approach to Repackaging
9.6 Legal Case of Repackaging
9.6.1 Advocate General's Opinion on EU Repackaging of Pharmaceutical Products
9.6.2 Background to the Case
9.6.3 Advocate General's Main Conclusions
9.6.3.1 Overstickering
9.6.3.2 The Necessity Condition
9.6.3.3 Damage
9.6.3.4 Notice
9.6.3.5 Burden of Proof
9.6.4 Impact of Such a Legal Case
9.7 Repackaging Affects Quality

Chapter 10. Arguments for Parallel Trade
10.1 York Study Did Show Healthcare Costs to be Reduced by Small Amounts
10.2 Swedish Study Confirms Price Competitiveness in Parallel Trading of Drugs
10.3 University of Southern Denmark Agrees with York Methodology
10.4 EU Price Convergence Unlikely
10.5 The British Association of European Pharmaceutical Distributors Aim to Deliver Value

Chapter 11. Arguments Against Parallel Trade
11.1 Manufacturing Pharmaceutical companies Argument against Parallel Trade
11.1.1 Loss of Profits
11.1.2 Counterfeit Drugs
11.1.2.1 Batches of Two Blockbuster Drugs being Recalled After Counterfeits were Found
11.2 The Right to Maximise Returns
11.3 LSE Report Showed Negligible Savings

Chapter 12. Parallel Trade: Double Edged Sword
12.1 Benefits of Parallel Trade
12.2 The Costs of Parallel Trade
12.3 Global Growth of Parallel Trade
12.4 The Future

List of Tables
Table 2.1 R&D Expenditure in the UK ($m)
Table 4.1 Comparative Drug Prices in Selected Developed Countries
Table 4.2 All Factors that Influence Drug Prices
Table 4.3 Pricing Differentials for Leading Drugs (30 day supply)
Table 4.4 Another Example of Differential Pricing (price per pill)
Table 4.5 Advantages and Disadvantages of Single European Price
Table 5.1 Difference in Pricing of Selected Drugs
Table 5.2 U.S./Canadian Price Comparisons
Table 5.3 Price Per Standard Unit in the US Compared to Canada
Table 5.4 Price Per Standard Unit of Lipitor in the US and Canada
Table 5.5 Price Difference in Selected Generics
Table 6.1 Key Financials for the EU Pharmaceutical Industry ($m), 1990-2005
Table 6.2 EU Pharmaceutical Trade Balances ($m)
Table 6.3 Price Per Standard Unit in EU States
Table 6.4 Price Per Standard Unit of Lipitor in EU States
Table 6.5 NHS Saving Compared to Parallel Importers' Profit
Table 6.6 UK Parallel Distributors
Table 6.7 German Parallel Importers
Table 6.8 Swedish Parallel Traders
Table 6.9 Norwegian Parallel Importers
Table 7.1 Internet Usage World Wide
Table 7.2 Top 20 Countries in Regards to Internet Usage
Table 7.3 World Online Drug Market
Table 7.4 US Agencies and their Authorities
Table 7.5 Differences between Rogue and Quality Sites
Table 8.1 Top Ranked Countries where Counterfeits were Seized/Discovered
Table 10.1 Estimated Total Direct Savings from Parallel Trade in 2002
Table 10.2 Estimated Direct Savings in 2004

List of Graphs
Graph 1.1 Global R&D Expenditure and NME output
Graph 4.1 Incidents in Europe
Graph 5.1 World Internet Usage
Graph 5.2 Top 20 Internet Usage Countries
Graph 5.3 World Online Drug Market ($bn)
Graph 7.1 European Parallel Trade
Graph 7.2 EU Pharma Trade Balances
Graph 7.3 Share of Parallel Imports in Pharmacy Market Sales (%)
Graph 7.4 Estimated Share of Parallel Imports in Pharmacy Market Sales (%), 2007

List of Figures
Figure 1.1 Parallel Trading
Figure 3.1 Cost of Production
Figure 3.2 Inelastic Market
Figure 3.3 Elastic Market