European Generic Drug Markets - Growth to 2007

EXECUTIVE SUMMARY

1. THE EUROPEAN GENERICS MARKET

• Summary - the European market for generic drugs
• Introduction to the European generics industry
• Government cost-containment and the evolution of theEU generics sector
• Generic substitution
• Barriers to the Generics Industry
• Factors stimulating growth in the European generics market
• Measures needed to stimulate generic medicines
• The generics market in Europe
• Generic therapeutic categories
• Future generic blockbusters
• Generic market territories
• Regulatory issues – ten-year rule, MRP, bioequivalence
• Ten-year rule
• The Mutual Recognition Procedure (MRP)
• Bioequivalence
• Eurogenerics
• Recent regulatory issues
• Roche-Bolar – the European perspective
• Bolar provisions outside the EU
• Proposed changes to expedite the Mutual Recognition Procedure
• Recommendations from the generics industry
• Data Exclusivity versus Bolar provision: a Fair Trade Off?
• Recent European Commission proposals on data exclusivity include:
• Recent generics regulatory legislation in the US
• Intellectual property, patents and Supplementary Protection Certificates
• Intellectual property
• Patents
• Recent patent litigation – the case of AstraZeneca�fs Losec (Omeprazole)
• Schering-Plough – Claritin(loratadine) franchise
• Supplementary Protection Certificates (SPCs)
• EU Enlargement
• Multinationals and generics subsidiaries
• Pricing and patents develop an active generic market
• Pricing
• Expansion in the generics industry
• Impact of patent expiries of on the generics market
• Parallel Trade in Generics

2. UNITED KINGDOM

• The UK generics market
• Strengths of UK Generics Sector
• Generic Prescribing Trends in the UK
• Generic Pricing Issues
• Recent Pricing Issues
• The UK Government perspective – setting maximum generic prices
• Unfounded Generic Price Increases in the UK - A Case of Serious Fraud?
• Leading UK Generics Companies
• Major players
• Norton/IVAX
• APS-Berk
• Cox Pharmaceuticals
• Impact of Parallel Trade
• Impact of Patent Expiries
• Distribution Methods
• Direct pharmacy sales
• Wholesale distribution
• Short line wholesalers
• Regulatory Environment
• Intellectual Property and Patent Law

3. GERMANY

• Cost-containment measures
• Penalties for doctors
• Prescribing Trends
• Generic Prescribing
• Therapeutic Focus
• Pricing in Germany
• Reference pricing
• Generic pricing – effects of competition
• Impact of patent expiries
• Factors Affecting pricing of Generics in the Future
• Changes to the Reference Pricing System
• Positive List
• Physician Prescribing Budget
• Increased contributions to Statutory Health Insurers
• Distribution
• Impact of parallel trade
• Regulatory environment
• Intellectual property and patent law
• Leading Generics Players in Germany
• Ratiopharm
• Hexal
• Stada

4. FRANCE

• The French generics market
• Generic substitution
• The Répertoire
• Pharmacists and Generic Substitution
• Encouraging generic use among doctors
• Consumer Barriers to Substitution
• Recent market trends
• The French pricing system
• Distribution
• Regulatory Environment
• Intellectual property
• Impact of parallel trade
• Generics Companies in France
• The market leader
• Merck Génériques

5. THE NETHERLANDS

• The Dutch generics market
• Generic Prescribing Trends
• Leading generic companies in The Netherlands
• Pricing system
• Patent Expiry
• Regulatory environment
• Intellectual property
• Impact of Parallel Trade

6. BELGIUM

• The Belgian generics market
• Leading Generics Companies in Belgium
• Pricing System
• Distribution
• Regulatory Environment
• Intellectual Property
• Impact of parallel trade

• The Scandinavian Generic Drugs Market
• Denmark
• Pricing in Denmark
• Denmark and the Euro
• Parallel trade in Denmark
• Finland
• Norway
• Pricing in Norway
• Parallel Trade in Norway
• Sweden
• Pricing in Sweden
• Reference pricing
• Parallel Trade in Sweden

9. SPAIN

• The Spanish generics market
• Pricing in Spain
• The Pricing System in Spain
• Government cost-containment pressure
• Measures to encourage doctors
• Measures to encourage pharmacists through generic substitution
• Impact of patent expiries
• Distribution
• Regulatory environment
• Intellectual property
• Impact of parallel trade
• Generic Companies in Spain

9. OTHER EUROPEAN GENERICS MARKETS

• Austria
• Greece
• Italy
• Parallel export trade in Italy
• Portugal

10. FUTURE MARKET TRENDS AND OPPORTUNITIES

• Factors Facilitating Generic Growth to 2007
• Individual countries
• Future Generic Opportunities
• Patent expiry
• Parallel trade in generics
• Biogenerics
• Recent EU registration and regulation issues

11. GENERICS IN CENTRAL AND EASTERN EUROPE

• EU Enlargement
• Hungary
• Poland
• Former Yugoslavia
• Iceland
• Turkey

12. STRATEGIES FOR RESEARCH-BASED COMPANIES AND GENERICS MANUFACTURERS

• Strategies for research-based companies
• Litigation
• Reformulation
• New isomeric forms
• Changing the manufacturing process
• Releasing your own generic
• Strategies for generics manufacturers
• Exploiting patent rights
• Intellectual property protection
• R&D
• Protecting the manufacturing process
• Recognising and evaluating the rights protecting a commercial product
• Opposition to the Bolar exemption

BIBLIOGRAPHY

List of Tables

Table 1.1 Measures employed by governments and healthcare systems to save on pharmaceutical spending.

Table 1.2 Barriers to the generics drugs industry

Table 1.3 Key drivers of growth in the European generics sector

Table 1.4 Measures needed to stimulate the use of generic medicines

Table 1.5 Major western European Generic pharmaceutical markets, 2001-2007

Table 1.6 EC data exclusivity times as at mid-2000

Table 1.7 EGA position in response to research-based industry�fs claims on patent protection and data exclusivity

Table 1.8 Comparative prices of a basket of pharmaceuticals

Table 1.9 Price differentials between brand names and generics in Europe

Table 1.10 Patent expiries of leading drugs in Europe to 2004

Table1.11 Leading patented drugs, patent expiry dates and sales revenue, 2000-2005

Table 2.1 Estimations of UK generics market by value, 2001-2007

Table 2.2 UK rates of generic prescribing, 1987-2001

Table 2.3 Generic prescribing and dispensing rates in the UK, 2000-2001

Table 3.1 Estimates of Germany�fs generic market by value, 2001-2007

Table 3.2 German Sick Fund Drug Spending Trends, 1994-1999

Table 3.3 German prescribing rates for generically available substances (1998)

Table 3.4 A basket of drug prices in Germany, 1999-2000

Table 4.1 Estimates of the generic market in France by value, 2001-2007

Table 4.2 European average prices in 2000

Table 4.3 Leading generic molecules listed in August 2000 Répertoire

Table 4.4 Increase use of branded generics and decline of brands, 1998-2000

Table 4.5 European per capita drug consumption (1997)

Table 4.6 Revenue for leading French generic companies in 2001

Table 5.1 Estimates of the generic market in The Netherlands by value, 2001-2007

Table 5.2 Dutch generic prescribing rates 1998

Table 5.3 Leading Dutch generic firms, 1999

Table 6.1 Estimated generics market in Belgium, 2001-2007

Table 7.1 The Danish Generics Market, 2001-2007

Table 7.2 The Finnish Generics Market, 2001-2007

Table 7.3 The Norwegian Generics Market, 2001-2007

Table 7.4 The Swedish Generics Market, 2001-2007

Figure 7.1 Total generics market for Scandinavia, 2001-2007, US$bn

Table 8.1 Spanish Generic Market Estimations, 2001-2007

Table 8.2 European average prices, 2000

Table 8.3 Average price per prescription in Spain, 1997-2000

Table 8.4 Cost-containment measures introduced at government level in Spain since 1997

Table 8.5 Examples of Spanish generic companies

Table 9.1 The Generics Market in Austria, 2001-2007

Table 9.2 The Generics Market in Greece, 2001-2007

Table 9.3 The Generics Market in Italy, 2001-2007

Table 9.4 Generic companies in Italy

Table 10.1 Growth of the generic market in various European countries

Table 10.2 Major European patent expiries, 2000 to 2010

Table 10.3 Biopharmaceuticals Expected to Come off Patent by 2007

Table 10.4 Main EGA objections to EC proposals on improving the registration system for generics

Table 12.1 R&D companies and their subsidiaries involved with generics

Figure 1.1 Benefits of generic drugs

Figure 1.2 Key national factors stimulating generics growth in Europe

Figure 1.3 Penetration of generics in the EU by value and volume, 2001

Figure 1.4 Estimated market share by value of the European generics industry, 2002

Figure 1.5 Convergence of Eastern and Western generics manufacturers during EU enlargement

Figure 1.6 Prices of a basket of products at pharmacy level

Figure 2.1 Estimated market share by volume of leading UK generics companies, 2002

Figure 3.1 Leading German generics companies, 1999 (based on value DM million)

Figure 3.2 Top 10 generics companies by sales value, 1999

Figure 4.1 Market share of French generic companies by value, 2001

Figure 5.1 Estimated market share of leading generics firms in The Netherlands, 2000