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Opinion of the European Economic and Social Committee on the ‘Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions — A Stronger European-based Pharmaceutical Industry for the Benefit of the Patient — A Call for Action’

(COM(2003) 383 final)

(2004/C 241/02)

On 16 October 2003, the European Commission decided to consult the European Economic and Social Committee, under Article 262 of the Treaty establishing the European Community, on the ‘Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions — A Stronger European-based Pharmaceutical Industry for the Benefit of the Patient — A Call for Action’.

The Section for the Single Market, Production and Consumption, which was responsible for preparing the Committee's work on this subject, adopted its opinion on 4 May 2004. The rapporteur was Mrs O'Neill.

At its 409th plenary session of 2 and 3 June 2004 (meeting of 2 June), the European Economic and Social Committee adopted the following opinion by 164 votes to 1 with 10 abstentions.

1.   Background

2.   Purpose of the communication

3.   The text — general comments

4.   Proposed action from the Commission

4.1   Benefits to patients

4.2   Relative effectiveness

4.3   Pharmacovigilance

4.4   Developing a competitive European-based industry

4.5   Timing of reimbursement and pricing negotiations

4.5.4   Full competition for medicines neither purchased nor reimbursed by the State

4.6   Competitive generic market

4.7   Competitive non-prescription market

4.8   Strengthening of the EU science base

4.9   Incentives for research

4.10   Medicines in an enlarged European Union

4.11   Member States learning from each other

5.   Conclusion

Brussels, 2 June 2004.

The President

of the European Economic and Social Committee

Roger BRIESCH

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(1)  Enterprise papers No 1/2001.

(2)  Created by the High Level Committee on Health.

(3)  Internal Market Council Conclusions 18.5.1998.

(4)  European Commission High Level Group on Innovation and Provision of Medicines a Call for action. G10 Medicines 7.5.2002.

(5)  Council Resolution of 2.12.2003.

(6)  Opinion of the EESC on the proposal of a Regulation, OJ C 61/1 of 14.3.2003.

(7)  Opinion of the EESC on the proposal for a Decision OJ C 116/18 of 20.4.2001.

(8)  Ibid.

(9)  Ibid.

(10)  Benchmarking Pharmaceutical Expenditure published in 2001 by the Austrian Health Institute.

(11)  Council Directive 89/105/EEC, OJ L 40 of 11.2.1989.

(12)  Opinion of the EESC ‘A European Centre for Disease Prevention and Control’ — rapporteur Mr Bedossa — OJ C 32 of 5.2.2004.

(13)  Directive 2001/20/EC, OJ L 121 of 1.5.2001.

(14)  An ‘orphan’ disease is one which is very rare in Europe although it may be amongst the most common diseases in the world which occur largely, if not exclusively, in tropical countries with great poverty. For such diseases there is no well-developed market for competitively priced pharmaceuticals and hence little investment by the pharmaceutical industry to target these diseases. E.g. Malaria, schistosomiasis and leprosy.

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