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Regulatory Regulatory
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Title European Pharmaceutical Regulation
Sub title Implications for Competitiveness, Innovation and a Single Market
Author Patrick Brennan
Publication date March 2004
ISBN 0954112180
Pages 50
Price pdf £150   |   print £175 currency coverter link
Summary

The nature of the European pharmaceutical sector results in conflicting industry and health policy objectives, the complexity of which are compounded by the varied macroeconomic, regulatory and social conditions across the European Union including issues such as cost containment in healthcare, parallel trade and EU enlargement. Of particular importance is the declining competitiveness of the pharmaceutical industry inn comparison to the US. This is now recognised by the authorities who anxious to encourage pharmaceutical R&D may have to change the regulatory landscape in which both biotechnology and pharmaceutical companies operate.

European Pharmaceutical Regulation - Implications for Competitiveness, Innovation and a Single Market is a unique report that succinctly outlines the major issues currently affecting pharmaceutical companies and the industry regulators. The report will provide insight into:
  • Cost containment policies used by governments to control health care expenditure
  • The decline in competitiveness of the European research-based pharma industry
  • The effect of parallel trade in pharmaceuticals
  • Whether there will be single European market for pharmaceuticals
  • The challenges that face the industry with enlargement of the EU.

    This report is essential reading for anybody needing a top level view of the key drivers within pharmaceutical regulation.

  • TABLE OF CONTENTS
    Content

    Executive Summary

    1. The Pharmaceutical Industry: Extraordinary Economic Dilemmas and Health Policy Implications
    Reconciling Health Policy and Industrial Policy
    Pharmaceuticals in Europe
    Conclusion

    2. European Regulatory Structures
    Supply-Side
    Free Pricing
    Direct Price Controls
    Cost-Plus Pricing
    Reference Pricing
    Average Pricing and International Comparisons
    Profit Control
    The 'Fourth Hurdle': Cost-Effectiveness Analyses
    Positive and Negative Lists
    Proxy-Demand Side
    Prescription Budgets
    Encouraging Generic Competition
    Demand-Side
    Increased Co-Payments
    De-listing Schedules
    Conclusion

    3. European Competitiveness in the Global Pharmaceutical Industry
    G10 Medicines - High Level Group on Innovation and Provision of Medicines
    Competitiveness and Innovation
    Access to Medicines
    Conclusion

    4. A Single Market for Pharmaceuticals
    Differential Pricing
    Conclusion

    5. European Enlargement: Impact on Health care & Pharmaceuticals
    Challenges of Enlargement
    Economic Disparities
    Health care System Reform
    Reform of Pharmaceutical Regulation in CEE: Progress to Date
    Controlling the Costs: Pharmaceutical Pricing & Reimbursement in CEE
    Countering the Negative Effects of National Drug Policies in an Enlarged Europe
    Transparency of Pricing and Reimbursement Policies
    Intellectual Property Protection
    Parallel Trade
    CEE Enlargement: Opportunities for the Global Pharmaceutical Industry
    Conclusion

    6. Pharmaceuticals in an enlarged Europe

    Biblography

    List of Figures
    Figure 1 Pharmaceutical R&D Expenditure in Europe
    Figure 3 Approximate number of EMEA centralised marketing authorisations


    List of Tables
    Table 1 Global Pharmaceutical Sales by Region, 2002
    Table 2 Comparative Pharmaceutical Industry Data
    Table 4.1 Differiential Pricing
    Table 5.1 GDP of CEECs (in € PPP), 1999
    Table 5.2 Total Health care Expenditure as % of GDP
    Table 5.3 Total health expenditure, PPP$ per capita
    Table 5.4 Average Incomes and Drug Expenditure Levels in CEE (1999)
    Table 5.5 Pricing and Reimbursement Regulation in CEE

    Regulatory Regulatory
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