European Pharmaceutical Regulation

Implications for Competitiveness, Innovation and a Single Market

Publication Date March 2004
ISBN 954112180
Pages 50
Tables n/a
Figures n/a

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Outlines the pressures the European pharmaceutical industry is under...

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.
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