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Regulation & Policy |
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US Drug Reimportation
Prospects & Opportunities
Publication Date May 2005
Publisher Espicom
Product Type Strategic Report
Pages 120
ISBN Number not applicable
Product Code ESP448
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Summary
Parallel trading in prescription pharmaceuticals is becoming an increasingly significant issue in the United States, as individuals and governments in the country look to ways of gaining cheaper pharmaceuticals. Although it is technically illegal for anyone other than a drug's manufacturer to bring pharmaceuticals into the US, recent years have seen an increase in prescription drugs entering the country through parallel trade.
The matter has gained increasing attention at a federal level, with several bills being introduced to both houses of Congress in recent years. As healthcare costs rise, so has the clamour to find a solution to curb the price of prescription drugs. Allowing parallel trading has become one of the most frequent calls!
This report addresses the key issues and questions which matter:
- Why has drug reimportation become such a major issue?
- Drugs entering the US through the mail have - to date - come officially via Canada, Ireland or the UK. However, many pharmaceutical shipments are really sourced further afield from countries such as India, the Philippines or Romania. Which sources of supply are acceptable to US consumers?
- Will the political stalemate, where neither the regulators, federal or state governments are able to agree the best way forward, ever be resolved?
- The volume of drugs estimated to be imported into the US on a daily basis is so great that neither the Customs and Border Protection (CBP) nor the FDA have mechanisms for keeping an accurate count.
- What is the likely outcome?
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Content
- Executive Summary
- Introduction
- The Existing Legal Situation
- The Food, Drug & Cosmetic Act
- Personal Importation policy
- The MEDS Act of 2000
- The Medicare Modernization Act
- The Case For Parallel Trading
- Legislative Action
- Federal legislation
- Summary of recent parallel trade legislation 2003
- Bill HR 2427, the Pharmaceutical Market Access Act of 2003
- Bill HR 780, Prescription Drug Price Reduction Act
- Bill HR 847, the Preserving Access to Safe, Affordable Canadian Medicines Act of 2003
- Bill HR 2497, Prescription Drug Parity for Americans Act
- Bill HR 2629, the New Aid for Trustworthy, Affordable Drugs Act (NAFTA Drugs Act)
- Bill HR 2769, the Save Our Seniors Act of 2003
- Bill S 1781, the Pharmaceutical Market Access Act of 2003 2004
- Bill HR 3710, To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs
- Bill S 2137, the Pharmaceutical Market Act of 2003
- Bill S 2307, Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004
- Bill S 2328, Pharmaceutical Market Access and Drug Safety Act of 2004
- Bill S 2493, Safe IMPORT Act of 2004
- Bill HR 4790, Drug Importation Promotion and Safety Act
- Bill HR 4923, Safe IMPORT Act of 2004 2005
- Bill S 109, the Pharmaceutical Market Access Act of 2005
- Bill S 16, the Affordable Health Care Act
- Bill HR 328, Pharmaceutical Market Access Act of 2005
- Bill S 184, the Safe IMPORT Act of 2005
- Bill HR 563, the Prescription Drug Affordability Act of 2005
- Bill HR578, the Prescription Drug Affordability Act
- Bill S 334, the Pharmaceutical Market Access and Drug Safety Act of 2005
- Us Drug Reimportation: Prospects & Opportunities
- ii May
- Bill HR 753, the Safe IMPORT Act of 2005
- H Con Res 75
- State-level initiatives
- Attorneys General issue letter to Tommy Thompson
- California
- Illinois
- I-SaveRx
- Iowa
- Kentucky
- Maine
- Maryland
- Montgomery County Council
- Massachusetts
- Boston
- Springfield
- Minnesota
- New Hampshire
- New York
- New York City
- Oklahoma
- Oregon
- Rhode Island
- Texas
- Vermont
- Washington
- Wisconsin
- The Case Against Parallel Trading
- Questions over the safety of imported drugs
- HHS
- FDA import blitzes
- PhRMA
- Pharmaceutical market pricing issues
- Congressional Budget Office
- Competitive Enterprise Institute
- John Calfee
- Hhs Task Force On Drug Importation
- Findings
- The current situation
- Limits on resources and authorities
- Potential impact on the pharmaceutical distribution system
- The role of foreign health agencies
- Potential savings
- Us Drug Reimportation: Prospects & Opportunities
- May 2005 iii
- Drug importation and intellectual property law
- Liability issues
- A REBEL IN THE RANKS
- THE US PUBLIC'S PERCEPTION OF PARALLEL TRADE
- Granite State Poll, University of New Hampshire
- Granite State Poll results
- The Luntz Research Companies
- The Luntz Research Companies poll results
- The Polling Company
- Polling Company poll results
- THE VIEW FROM CANADA
- The response of the drug companies
- The response of the government
- The response of others
- Voices of opposition
- Canadian Pharmacists Association (CPhA)
- National Association of Pharmacy Regulatory Authorities (NAPRA)
- Voices in favour
- Canadian International Pharmacy Association (CIPA)
- Not all Canadian drugs are cheaper
- Generic drug prices in Canada are more expensive than elsewhere
- Conclusion
- Alternatives?
- Medicare Prescription Drug Benefit
- New Manufacturers' Discounting Scheme announced, January 2005
- Appendix: Parallel Trade In The European Union
- Recent parallel trade issues in Europe
- EU enlargement
- LSE Report
- Restricting supplies to restrict parallel trading
- Legal cases
- Common origin not a prerequisite for parallel trade
- Adalat
- Parallel trade can continue after original product withdrawal
- Dual pricing
- Sources
- US DRUG REIMPORTATION: PROSPECTS & OPPORTUNITIES
- US Research-Based Pharmaceutical Manufacturers' Sales, 1990-2003 (US$ millions)
- Bill HR 2427, the Pharmaceutical Market Access Act of 2003
- Bill HR 780, Prescription Drug Price Reduction Act
- Bill HR 847, the Preserving Access to Safe, Affordable Canadian Medicines Act of 2003
- Bill HR 2497, Prescription Drug Parity for Americans Act
- Bill HR 2629, the New Aid for Trustworthy, Affordable Drugs Act (NAFTA Drugs Act)
- Bill HR 2769, the Save Our Seniors Act of 2003
- Bill S 1781, the Pharmaceutical Market Access Act of 2003
- Bill HR 3710, To amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs
- Bill S 2137, the Pharmaceutical Market Act of 2003
- Bill S 2307, Reliable Entry for Medicines at Everyday Discounts through Importation with Effective Safeguards Act of 2004
- Bill S 2328, Pharmaceutical Market Access and Drug Safety Act of 2004
- Bill S 2493, Safe IMPORT Act of 2004
- Bill HR 4790, Drug Importation Promotion and Safety Act
- Bill HR 4923, Safe IMPORT Act of 2004
- Bill S 109, the Pharmaceutical Market Access Act of 2005
- Bill S 16, the Affordable Health Care Act
- Bill HR 328, Pharmaceutical Market Access Act of 2005
- Bill S 184, the Safe IMPORT Act of 2005
- Bill HR 563, the Prescription Drug Affordability Act of 2005
- Bill HR578, the Prescription Drug Affordability Act
- Bill S 334, the Pharmaceutical Market Access and Drug Safety Act of 2005
- Bill HR 700, the Pharmaceutical Market Access and Drug Safety Act of 2005
- Bill HR 753, the Safe IMPORT Act of 2005 H Con Res 75
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