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Market Research Report - 249503

Global Healthcare Policy Analysis 2012 - Regulatory, Pricing, and Reimbursement Assessment

Published by GlobalData
Published Content info 64 Pages
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Global Healthcare Policy Analysis 2012 - Regulatory, Pricing, and Reimbursement Assessment
Published: August 27, 2012 Content info: 64 Pages
Description

Summary

GlobalData's "Global Healthcare Policy Analysis 2012 - Regulatory, Pricing, and Reimbursement Assessment" provides an in-depth look at the policy initiatives and regulations shaping pharmaceutical markets around the world. Focusing on the global regulatory landscape in 2012, the report integrates in-depth research into the policies of major international markets with expert insight to reveal the opportunities and threats that the pharmaceutical industry is facing. Clients can use this report for strategic planning to tackle the challenges of developed markets and discover prospects in emerging markets. The report covers major healthcare policy initiatives, regulatory changes and key drug approvals, and examines the myriad of regulatory issues that are constantly affecting pharmaceutical and biotechnology players.

Scope

  • The report provides an in-depth look at changes in healthcare policy and regulations in key countries, including background information and a detailed look at the first half of 2012.
  • The report provides analysis of the key policy and regulatory changes employed by governments in different pharmaceutical markets and how they are affecting pharmaceutical companies.
  • The report contains case studies of regulatory issues that have cropped up in various countries and what these events mean for the industry at large.
  • The report includes analysis of important events in 2012 that will shape the global healthcare market into the future.

Reasons to buy

  • Be prepared for the challenges in the biopharmaceutical industry that are being created by changes in different countries' healthcare policy.
  • Understand current regulatory decisions or actions and upcoming regulatory changes to avoid unnecessary setbacks in the development, approval, and commercial launch of pharmaceutical products.
  • Identify the significant changes that are taking place in important pharmaceutical markets such as the United States, Japan, China, and India.
  • Organize your sales and marketing efforts by identifying the international markets that are poised for strong growth as well as the countries where market access will be more challenging.
Table of Contents

Table of Contents

1. Table of Contents

  • 1.1. List of Tables

2. Introduction

  • 2.1. Recent Related Reports
  • 2.2. Upcoming Related Reports

3. United States

  • 3.1. Overview
  • 3.2. Regulatory Update
    • 3.2.1. Evolving Guidelines for Biosimilars
    • 3.2.2. Merck & Co. Post-Marketing Study Warning
    • 3.2.3. FDA Guidance on Cargo Theft
    • 3.2.4. Moving Drugs from Prescription-Only to Over-the-Counter
    • 3.2.5. Notable US Drug Approvals
  • 3.3. Policy Update; Healthcare Reform
    • 3.3.1. Supreme Court Backs the Affordable Care Act
    • 3.3.2. Background on the Healthcare Supreme Court Case
    • 3.3.3. Affordable Care Act Provisions Already Implemented
    • 3.3.4. New in 2012: ACOs, W-2 Tax Reporting, and Addressing Disparities
    • 3.3.5. The Future of the Affordable Care Act: Taxes
    • 3.3.6. Update of the Prescription Drug User Fee Act
  • 3.4. Pricing and Reimbursement
  • 3.5. Intellectual Property
  • 3.6. Case Study - KV Pharmaceuticals

4. European Union

  • 4.1. Overview
  • 4.2. Regulatory Update
    • 4.2.1. UK NICE Updates
  • 4.3. Policy Update - Healthcare Reform
    • 4.3.1. Healthcare Reform in the United Kingdom
    • 4.3.2. 'Patent Box' to Encourage Pharmaceutical Investment in the UK
    • 4.3.3. German Healthcare Reform Challenges Drug Pricing
  • 4.4. Pricing and Reimbursement
    • 4.4.1. German Drug Pricing Determinations to Date
    • 4.4.2. Unintended Consequences of Strict Pricing Policies

5. Japan

  • 5.1. Overview
  • 5.2. Regulatory Update
    • 5.2.1. Notable Drug Approvals
  • 5.3. Policy Update; Healthcare Reform
  • 5.4. Pricing and Reimbursement
    • 5.4.1. Pricing for Newly Approved Drugs
    • 5.4.2. Pricing Policy for Generic Drugs
    • 5.4.3. Results of 2012 Price Revisions
  • 5.5. Intellectual Property

6. China

  • 6.1. Overview
  • 6.2. Regulatory Update
    • 6.2.1. Efforts against Counterfeit Drugs
    • 6.2.2. Crackdown on Ephedrine
  • 6.3. Policy Update; Healthcare Reform
    • 6.3.1. Introduction to the 12th Five-Year Plan
    • 6.3.2. Healthcare Reform
    • 6.3.3. Healthcare Reform Progress in 2012
  • 6.4. Pricing and Reimbursement
  • 6.5. Intellectual Property

7. India

  • 7.1. Overview
  • 7.2. Regulatory Update
    • 7.2.1. Drug Approvals Controversy
    • 7.2.2. Guidelines for Biosimilars
  • 7.3. Policy Update; Healthcare Reform
  • 7.4. Pricing and Reimbursement
    • 7.4.1. Pricing
    • 7.4.2. Intellectual Property Scuffle Prompts Pricing Changes
  • 7.5. Intellectual Property

8. Brazil

  • 8.1. Overview
  • 8.2. Regulatory Update
  • 8.3. Policy Update; Healthcare Reform
  • 8.4. Pricing and Reimbursement
    • 8.4.1. Background
    • 8.4.2. Update on Drug Prices in 2012
  • 8.5. Intellectual Property
  • 8.6. Mergers and Acquisitions Activity
    • 8.6.1. Valeant's Brazilian Spending Spree
    • 8.6.2. Merck & Co. Announces Brazilian Joint Venture
    • 8.6.3. Takeda Purchases Multilab
    • 8.6.4. UCB Acquires Controlling Interest in Meizler
    • 8.6.5. GE Healthcare Acquires Xpro

9. Appendix

  • 9.1. Bibliography
  • 9.2. Abbreviations
  • 9.3. Methodology
    • 9.3.1. Coverage
    • 9.3.2. Secondary Research
    • 9.3.3. Expert Panel Validation
  • 9.4. About the Authors
  • 9.5. About GlobalData
  • 9.6. Contact Us
  • 9.7. Disclaimer

List of Tables

  • Table 1: Provisions of the Affordable Care Act and Effective Dates
  • Table 2: Timeline of Seroquel Intellectual Property Case
  • Table 3: German Drug Reimbursement Decisions
  • Table 4: Flowchart for Determining New Drug Reimbursement
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