Prospects for Legalizing Drug (Re-)Importation to the United States

Content

• Executive Summary
• 1. Background to Importation
  • 1.1 Healthcare Coverage in US
    • 1.1.1 Employers
    • 1.1.2 Medicare
    • 1.1.3 Medicaid
  • 1.2 US Drug Prices
  • 1.3 Cost Burden
  • 1.4 Why Importation?
  • 1.5. Current Legal Situation with Importation
    • 1.5.1 Importation by Manufacturers
    • 1.5.2 Enforcement Discretion with Personal Importation
• 2. The Rise, Fall and Partial Recovery of International Pharmacies
  • 2.1 Channel Development in Canada
    • 2.1.1 Standards
    • 2.1.2 Customers
    • 2.1.3 Products
    • 2.1.4 Savings
    • 2.1.5 International Pharmacies in Other Countries
    • 2.1.6 Canadian Backlash
  • 2.2 Canadian-Foreign Pharmacy Partnership
  • 2.3 Preventing Seizures at US Border
  • 2.4 Sales Evolution
  • 2.5 Factors Contributing to Decline
    • 2.5.1 Strengthening Canadian Dollar
    • 2.5.2 Patient Assistance/Drug Discount Programmes
    • 2.5.3 Non-reimbursement in US
    • 2.5.4 Manufacturers' Supply Limitations
    • 2.5.5 Increased Safety Warnings
    • 2.5.6 Failure of State-sponsored Importation Schemes
    • 2.5.7 Greater Generic Use
    • 2.5.8 Introduction of Medicare Part D
    • 2.5.9 Stepped-up Seizures at US Entry Ports
  • 2.6 Current Situation
• 3. Protagonists in the Importation Debate and their Arguments
  • 3.1 Views of the Various Stakeholders
  • 3.2 Arguments
    • 3.2.1 For Importation
    • 3.2.2 Against Importation
  • 3.3 HHS Importation Task Force
  • 3.4. Congressional Budget Office
  • 3.5 Miscellaneous Comment
  • 3.6 Access by Counterfeits
• 4. Past Legislative and Other Importation Initiatives
  • 4.1 Initiatives by Members of Congress
    • 4.1.1 Bills Tabled by Senator Dorgan
    • 4.1.2 Amendments to Appropriation Bills
  • 4.2 Initiatives by States and Municipalities
    • 4.2.1 FDA Reaction
    • 4.2.2 Response by States
    • 4.2.3 Patient Uptake
  • 4.3 Initiatives by Seniors Groups
• 5. Pharmaceutical Market Access and Drug Safety Act of 2009
  • 5.1 Principles
  • 5.2 Main Features
    • 5.2.1 Qualifying Products
    • 5.2.2 Permitted Countries
    • 5.2.3 Relationship to FDA Approval
    • 5.2.4 Registration
    • 5.2.5 Exporters
    • 5.2.6 Importers
    • 5.2.7 Chain of Custody/Anti-counterfeit Measures
    • 5.2.8 Labelling
    • 5.2.9 User Fees
    • 5.2.10 Information to Consumers/Transparency
    • 5.2.11 Preventing Countermeasures by Manufacturers
    • 5.2.12 Patent Exhaustion
    • 5.2.13 Internet Sales
    • 5.2.14 Savings
• 6. Prospects
  • 6.1 Position of Administration and Legislature
  • 6.2 Legislative Hurdles
  • 6.3 Current Status of Dorgan Bill
  • 6.4 Opposition Strategy
  • 6.5 If Passed, Would the Act Work?
    • 6.5.1 Lower Price Opportunity Overseas?
    • 6.5.2 Where Might Supplies Come From?
      • 6.5.2.1 Canada
      • 6.5.2.2 Europe
      • 6.5.2.3 Japan
      • 6.5.2.4 Australia/New Zealand
    • 6.5.3 Who Might Supply the US?
    • 6.5.4 Regulatory Issues
      • 6.5.4.1 Manufacturer Notices
      • 6.5.4.2 User Fees
      • 6.5.4.3 Chain of Custody
      • 6.5.4.4 Preventing Countermeasures
      • 6.5.4.5 IP Rights Exhaustion
  • 6.6 Who Would Use Commercial Imports?
  • 6.7 Will Savings Reach Patients?
  • 6.8 Conclusion
• List of tables
  • 1.1 Average foreign-to-Canadian MSP ratios
  • 1.2 International comparison of basket of MSPs in UK
  • 1.3 US formulary tiered drug plans
  • 2.1 Top-10 drug classes sold by Canadian international pharmacies
  • 2.2 Declared drug sources offered by Canadian international pharmacies
  • 2.3 Sales into Canadian international pharmacies by province
  • 2.4 Sales into Canadian international pharmacies by quarter, 2002-08
  • 2.5 Value of $US in $CDN, 2002-09
  • 2.6 Drugs not genericized in US sold as generic versions from Canada
  • 2.7 Consumer costs for 3-months' supply of common drugs, Q4 2008
  • 6.1 Canadian MSPs as % of US prices
  • 6.2 Specimen WAC differentials between US and EU countries, 2009
  • 6.3 Specimen WAC evolution US vs Europe, 2002-09
  • 6.4 Drug sales through retail pharmacies in US and permitted countries
  • 6.5 Examples of European variability of originator brand names
  • 6.6 Examples of variability of European pack sizes
• Glossary of Acronyms and Abbreviations
• References
  • Appendix 1: Bills tabled in US Congress since 1999 relating to drug importation
  • Appendix 2: House and Senate co-sponsors of the Pharmaceutical Market Access and Drug Safety Act of 2009