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市場調查報告書
醫療改革和醫藥品業界：第111屆美國聯邦議會
The 111th U.S. Congress Tackles Healthcare Reform and the Pharmaceutical Industry
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醫療改革和醫藥品業界：第111屆美國聯邦議會 是由出版商Decision Resources, Inc.在2009年09月所出版的。
這份英文市場調查報告書包含35 Pages 價格從美金4600起跳。
報告書內容包括:美國的醫療改革及專利改革的動向分析、歐巴馬政權推動下的各種政策、生物學名藥市場的動向、今後的展望、內容綱要摘記如下:
實施摘要
進攻111屆議會的第一步
American Recovery and Reinvestment Act of 2009
生物學名藥：延續生物醫藥品
- 生物學名藥市場
- 資料獨佔性的相關議論
- 聯邦貿易委員會
- 歐巴馬政權的強化
- 未解決的生物學名藥法規範：2009年
Patent Reform Act of 2009
- national Academy of Science的見解
- 21世紀專利改革的聯盟
- 專利公平性之相關見解
- 司法相關參議院委員會的妥協案
醫療改革的高度注視度
今後的展望
Abstract
Introduction:
The stakes have never been higher or more serious for the pharmaceutical
industry - a perfect storm of legislation is moving through Washington, D.C.,
to address patent reform, healthcare reform, drug importation, authorized
generics, biosimilars, and much more. Does the 111th U.S. Congress have the
political will to fundamentally change the status quo? One certainty in these
uncertain times is that legislation that goes off the table this year is more
than likely to resurface next year and the years after that. In this report,
we discuss several of the legislative bills of 2009 and the potential impact
they could have on the biopharmaceutical industry.
Questions Answered in This Report:
- Alex M. Brill, CEO of Matrix Global Advisors and a research fellow at the
American Enterprise Institute, determined that a seven-year data exclusivity
period was sufficient to ensure adequate return on investment for a portfolio
of biologics. Why is data exclusivity a life or death issue for the
biopharma industry? Why does the CEO of the Generic Pharmaceutical Association
say that proposals for biosimilars data exclusivity by the biopharma industry
are excessive? Why does the general counsel of Eli Lilly argue that if the
biopharma industry relies solely on patent terms for protection that the
industry will have a survivability issue?
- John C. Lechleiter, Ph.D., Eli Lilly' s CEO, said that under certain
situations comparative effectiveness research will stop personalized medicine
in its tracks. How could this happen? What aspects of this research does
pharma support? Are industry stakeholders trying to co-opt the legislative
process and mold it accordingly?
- Kevin E. Noonan, J.D., Ph.D., a partner in a Chicago intellectual property
firm, says that the real driver for patent reform has come down to the issue
of damages. What started the movement to reform the U.S. patent system? Who
is pushing for reform? Why have perceptions changed over the last decade? What
is likely to happen if patent reform falls off the radar screen this year?
- The late Senator Edward M. Kennedy (D-MA) has said that healthcare reform
is the “cause of my life” and that Congress can adjust and improve
any healthcare reform program that is enacted for years to come. What is
the status of healthcare reform in the United States? Why is a bill likely to
be passed this year? What are the major issues?
Scope:
- Authorized generics and pay-for-delay deals: Reverse payment
settlements, Hatch-Waxman Act, gamesmanship, FDA Drug Safety bill, Federal
Trade Commission, Cephalon, Provigil, Teva Pharmaceutical Industries, Mylan,
Barr Pharmaceuticals, Ranbaxy Laboratories, antitrust laws.
- Biosimilars: Size of biologics markets, data exclusivity, Henry G.
Grabowski analysis, John E. Calfee, American Enterprise Institute, Matrix
Global Advisors, Alex M. Brill, Generic Pharmaceutical Association, Federal
Trade Commission' s input, biologic-biosimilar market dynamics,
interchangeability, reference product, mechanism of action.
- Comparative effectiveness research: Institute of Medicine report,
1,278 potential projects, 100 priority topics, conclusions in the aggregate,
Partnership to Improve Patient Care, clinical value, patient health outcomes,
coverage and payment decisions, Comparative Effectiveness Research Institute,
Patient-Centered Outcomes Research Institute.
- Drug importation: Pharmacoeconomics, risks of drug safety,
MAPLight.org.
- Healthcare reform: Obama' s eight key principles, glide path to
reform, need for reform, Congressional Budget Office cost projections,
individual mandate, public plan, healthcare cost curve.
- Patent reform: National Academies, Federal Trade Commission,
damages, crossroads, fundamentally different approaches, non-obviousness
standard, consistency, postgrant opposition procedure, best mode,
harmonization, Coalition for 21st Century Patent Reform, choice of venue,
apportionment of damages, objective recklessness, interlocutory appeals.
- Privacy of personal health information: BBC World News America/The
Harris Poll, electronic medical records, Coalition for Patient Privacy, The
Healthcare Leadership Council, Confidentiality Coalition, notifications of a
breach of protected health information, penalties for violating personal
privacy, New Hampshire' s Prescription Information Law, prescriber-identifiable
data.
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Aggressive First Steps by the 111th Congress
- American Recovery and Reinvestment Act of 2009
- Comparative Effectiveness Research
- The Comparative Effectiveness Research Act of 2009 (H.R. 2502)
- The Patient-Centered Outcomes Research Act of 2009 (S. 1213)
- Privacy of Personal Health Information
- Health Information Technology for Economic and Clinical Health Act
(HITECH Act)
- New Hampshire' s Prescription Information Law
- Importation of Drugs
- Authorized Generics and Pay-for-Delay Deals
- Reverse Payment Patent Settlements - Pay-for-Delay Deals
- Authorized Generics
- Biosimilars: Follow-On Biologics
- Biosimilar Markets
- Data Exclusivity Arguments
- Fuqua School of Business at Duke University: Henry G. Grabowski
Analysis
- Matrix Global Advisors: Alex M. Brill Critique
- Federal Trade Commission Gives Input
- The Obama Administration Weighs In
- Pending Biosimilars Legislation, 2009
- Promoting Innovation and Access to Life-Saving Medicine Act, H.R. 1427
- Promoting Innovation and Access to Life-Saving Medicine Act, S. 726
- Pathway for Biosimilar Act, H.R. 1548
- Patent Reform Act of 2009
- National Academy of Sciences View
- Coalition for 21st Century Patent Reform
- Coalition for Patent Fairness View
- Breakthrough Compromise in the Senate' s Committee on the Judiciary
- All Eyes Turn to Healthcare Reform
- Need for Healthcare Reform in the United States
- Components of Healthcare Reform
- Outlook
Expert Commentaries
- “Nothing Is Agreed to Until Everything Is Agreed To”
- by Alex M. Brill, CEO of Matrix Global Advisors and a research fellow at
the American Enterprise Institute
Tables
- 1. American Recovery and Reinvestment Act of 2009 - A $787 Billion
Economic Stimulus Bill
- 2. New Hampshire' s Prescription Information Law
- 3. Legislation to Provide for Drug Importation
- 4. Legislation to Prohibit Authorized Generics and Reverse Payments
(Pay-for-Delay Deals)
- 5. Patent Expiries and Anticipated Biosimilar Entry Dates of Key Biologic
Brands
- 6. Henry G. Grabowski, Duke University Fuqua School of Business: Data
Exclusivity Assumptions
- 7. Alex M. Brill: Data Exclusivity Analysis Favored by the Generic
Pharmaceutical Association
- 8. Provisions of the Hatch-Waxman Act of 1984 for Small-Molecule Generics
- 9. Biosimilars Legislation as Introduced: H.R. 1427 Promoting Innovation
and Access to Life-Saving Medicine Act
- 10. Biosimilars Legislation as Introduced: H.R. 1548 Pathway for
Biosimilars Act
- 11. Legislation to Amend Title 35 of the United States Code to Provide
Patent Reform
- 12. President Barack Obama' s Eight Key Principles for Guiding Healthcare
Reform Efforts in the United States
- 13. Legislation to Provide Healthcare Reform
Figures
- 1. Handling Personal Information: A Survey by BBC World News America/The
Harris Poll, March 2009
- 2. Factors Explaining Future Federal Spending on Medicare, Medicaid, and
Social Security
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