Enterprise Directorate General

European Commission

The EU Framework for a Competitive Pharmaceutical Industry for the Benefit of the Patient

European Health Forum - 1 October 2003

James Copping

Summary of Presentation

• Overview of challenges

• Approach Commission is taking– Pharmaceutical Review

– G10 Medicines

• Next Steps

Pharmaceutical Policy

Objective:

To create the conditions that will allow the EU-based pharmaceutical industry to thrive so it can play a full role in ensuring that we can provide the highest level of health protection to European citizens.

Challenges

• EU-based industry losing ground to US– US has overtaken EU in development of

new chemical or biological entities

– Europe’s share of world market fallen to 26.7% - US grown to 40.2% since mid 96

– US R&D spending grown at twice the rate of EU

– NCEs as a %age of sales - US rose to 70% in 1995-99 - EU static at 18%

Pharmaceutical Review

Two key objectives:

Guarantee a high level of health protection for European Citizens

Increase availability of innovative medicines

Encouraging the development of generic competition.

Pharmaceutical Review

Key measures:

• Support innovation - data exclusivity

• Generic competition - “Bolar Provision”

• Access to market & patients – scope of Centralised Procedure– speeding up assessment times– fast-track

Pharmaceutical Review

Milestones:

29 September - Council adopts common position

8 October - Parliament starts 2nd Reading

Spring 2004 - Final adoption

G10 Medicines

“review the extent to which current pharmaceutical, health and enterprise policies achieve the twin goals of both encouraging innovation and competitiveness and ensuring satisfactory delivery of public health and social imperatives” (G10 Terms of Reference)

G10 Medicines - History

March 2001 - G10 Created

May 2002 - Report

July 2003 - Communication

December 2003 - Council Conclusions

2004 - Implementation

G10 Medicines - Communication

• Benefits to Patients

• Developing a Competitive European-based Industry

• Strengthening the EU Science Base

• Medicines in an Enlarged Union

• Member states Learning from Each Other

G10 Medicines - Implementation

Part 1 - Existing mechanisms

• Pharmaceutical Review

• Public Health Programme

• 6th Framework Programme

• Biotechnology Strategy

G10 Medicines - Implementation

Part 2 - Working with Member States

• Benchmarking

• EU reflection on pricing

• Information to Patients

• Relative Effectiveness

Conclusion

“The pharmaceutical sector makes a substantial positive contribution to the EU trade balance. It is a key source of high quality jobs which helps to sustain our science base. However, most importantly of all, a successful, thriving industry will deliver major benefits to patients.”

Erkki Liikanen: June 2002