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

Abstract

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

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.

TOC

1 Table of Contents

1 Table of Contents 3

  • 1.1 List of Tables 4

2 Introduction 5

  • 2.1 Recent Related Reports 6
  • 2.2 Upcoming Related Reports 6

3 United States 7

  • 3.1 Overview 7
  • 3.2 Regulatory Update 7
    • 3.2.1 Evolving Guidelines for Biosimilars 7
    • 3.2.2 Merck & Co. Post-Marketing Study Warning 10
    • 3.2.3 FDA Guidance on Cargo Theft 11
    • 3.2.4 Moving Drugs from Prescription-Only to Over-the-Counter 12
    • 3.2.5 Notable US Drug Approvals 13
  • 3.3 Policy Update; Healthcare Reform 14
    • 3.3.1 Supreme Court Backs the Affordable Care Act 15
    • 3.3.2 Background on the Healthcare Supreme Court Case 15
    • 3.3.3 Affordable Care Act Provisions Already Implemented 16
    • 3.3.4 New in 2012: ACOs, W-2 Tax Reporting, and Addressing Disparities 17
    • 3.3.5 The Future of the Affordable Care Act: Taxes 18
    • 3.3.6 Update of the Prescription Drug User Fee Act 19
  • 3.4 Pricing and Reimbursement 23
  • 3.5 Intellectual Property 25
  • 3.6 Case Study - KV Pharmaceuticals 26

4 European Union 28

  • 4.1 Overview 28
  • 4.2 Regulatory Update 28
    • 4.2.1 UK NICE Updates 28
  • 4.3 Policy Update - Healthcare Reform 32
    • 4.3.1 Healthcare Reform in the United Kingdom 32
    • 4.3.2 'Patent Box' to Encourage Pharmaceutical Investment in the UK 34
    • 4.3.3 German Healthcare Reform Challenges Drug Pricing 34
  • 4.4 Pricing and Reimbursement 36
    • 4.4.1 German Drug Pricing Determinations to Date 36
    • 4.4.2 Unintended Consequences of Strict Pricing Policies 37

5 Japan 39

  • 5.1 Overview 39
  • 5.2 Regulatory Update 39
    • 5.2.1 Notable Drug Approvals 39
  • 5.3 Policy Update; Healthcare Reform 40
  • 5.4 Pricing and Reimbursement 42
    • 5.4.1 Pricing for Newly Approved Drugs 43
    • 5.4.2 Pricing Policy for Generic Drugs 44
    • 5.4.3 Results of 2012 Price Revisions 44
  • 5.5 Intellectual Property 45

6 China 46

  • 6.1 Overview 46
  • 6.2 Regulatory Update 46
    • 6.2.1 Efforts against Counterfeit Drugs 46
    • 6.2.2 Crackdown on Ephedrine 46
  • 6.3 Policy Update; Healthcare Reform 46
    • 6.3.1 Introduction to the 12th Five-Year Plan 46
    • 6.3.2 Healthcare Reform 47
    • 6.3.3 Healthcare Reform Progress in 2012 48
  • 6.4 Pricing and Reimbursement 49
  • 6.5 Intellectual Property 49

7 India 51

  • 7.1 Overview 51
  • 7.2 Regulatory Update 51
    • 7.2.1 Drug Approvals Controversy 51
    • 7.2.2 Guidelines for Biosimilars 52
  • 7.3 Policy Update; Healthcare Reform 52
  • 7.4 Pricing and Reimbursement 52
    • 7.4.1 Pricing 52
    • 7.4.2 Intellectual Property Scuffle Prompts Pricing Changes 53
  • 7.5 Intellectual Property 53

8 Brazil 54

  • 8.1 Overview 54
  • 8.2 Regulatory Update 54
  • 8.3 Policy Update; Healthcare Reform 55
  • 8.4 Pricing and Reimbursement 55
    • 8.4.1 Background 55
    • 8.4.2 Update on Drug Prices in 2012 56
  • 8.5 Intellectual Property 56
  • 8.6 Mergers and Acquisitions Activity 57
    • 8.6.1 Valeant's Brazilian Spending Spree 57
    • 8.6.2 Merck & Co. Announces Brazilian Joint Venture 57
    • 8.6.3 Takeda Purchases Multilab 57
    • 8.6.4 UCB Acquires Controlling Interest in Meizler 57
    • 8.6.5 GE Healthcare Acquires Xpro 58

9 Appendix 59

  • 9.1 Bibliography 59
  • 9.2 Abbreviations 61
  • 9.3 Methodology 62
    • 9.3.1 Coverage 62
    • 9.3.2 Secondary Research 63
    • 9.3.3 Expert Panel Validation 63
  • 9.4 About the Authors 63
  • 9.5 About GlobalData 64
  • 9.6 Contact Us 64
  • 9.7 Disclaimer 64

List of Tables

1.1 List of Tables

  • Table 1: Provisions of the Affordable Care Act and Effective Dates 16
  • Table 2: Timeline of Seroquel Intellectual Property Case 25
  • Table 3: German Drug Reimbursement Decisions 36
  • Table 4: Flowchart for Determining New Drug Reimbursement 43
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