Parallel Trade - US Lawmakers allow imported prescriptions drugs
"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.
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. Why You Must Buy This Report: This 130+ paged report features key figures, including graphs and charts, important tables, news, insights, the latest developments in the parallel trade market with up-to-date analysis. This report will give you the understanding you require to gain that competitive edge in the parallel trade market. This controversial practice is a hot topic in the pharma industry. Therefore, it is vital that the latest parallel trade report is brought without fail. With in depth analysis of key markets, and the latest information on parallel trade, this report is vital to grasp an understanding of parallel trade. Key questions that this report answers:
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Table of Contents
- 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
- 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
- 3.2.1 TRIPS
- 3.3 Compulsory Licensing
- 3.3.1 Pharma Companies and Compulsory Licensing
- 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
- 4.5.1 Price Sensitivity
- 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
- 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
- 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?
- 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
- 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
- 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
- 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
- 12.1 Benefits of Parallel Trade
- 12.2 The Costs of Parallel Trade
- 12.3 Global Growth of Parallel Trade
- 12.4 The Future
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