52003XG1018(01)

Council Conclusions

of 22 September 2003

on reinforcing the competitiveness of the European-based pharmaceutical industry

(2003/C 250/01)

THE COUNCIL OF THE EUROPEAN UNION,

RECOGNISING that the European-based pharmaceutical industry plays a vital role in both the industrial and health sectors, as well as in the science base;

WELCOMES the response given by the Commission to the report of the "G10 High Level Group on innovation and the provision of medicines" in its Communication on "A stronger European-based pharmaceutical industry for the benefit of the patient"(1);

REAFFIRMS the need for a balance between competitiveness and public health policies, while fully respecting the Community and national competencies involved;

UNDERLINES the need to reinforce the competitiveness of the European-based pharmaceutical industry vis-à-vis its competitors, particularly by enhancing Europe's attractiveness as a location for innovative high tech industry and for maintaining a high quality science base; this should be accompanied by measures to facilitate the development of competitive generic and non-prescription sectors in the EU;

RECOGNISES that establishing the framework for a sustainable improvement of the competitiveness of the pharmaceutical industry requires action to be taken at both national and EU levels;

NOTES that the industrial landscape in the European pharmaceutical sector is made up of complementary relations between big and small/medium enterprises spread over all the regions in Europe and UNDERLINES that this interrelationship should be developed and enhanced;

HIGHLIGHTS the importance of stimulating new and more integrated forms of cooperation, including public-private partnerships, in Europe among governments, academia, scientific institutions, pharmaceutical and biotechnology companies to improve and speed up the transfer of scientific knowledge and the availability of innovative medicines;

WELCOMES:

- the benchmarking exercises proposed by the Commission on both health and competitiveness issues as a guide to policy-making over time, and UNDERLINES in this context that new developments, such as the enlargement of the European Union, should be duly taken into account in the collection of data,

- the concept behind the European Virtual Institutes of Health, outlined by the Commission, in order to promote clinical, pharmacological and pharmaceutical research, including research on medicines with smaller markets, through linking centres of fundamental and clinical research into a European network of excellence;

INVITES Member States to:

- actively participate in the implementation of the key actions set out in the Commission's communication, in particular benchmarking, by providing appropriate information on legislative and non-legislative measures that could have an impact on the pharmaceutical sector,

- consider the Commission's suggested implementing actions for:

(a) competition concerning authorised medicines that are neither purchased nor reimbursed by the State;

(b) the rapid launch of medicines on the market after granting a marketing authorisation;

INVITES the Commission to:

- organise an EU-wide reflection together with all interested Member States and stakeholders on different approaches to pricing and reimbursement for pharmaceutical products, exploring the scope of more competitive and dynamic market mechanisms, aimed at ensuring the equitable and rapid access of patients throughout the EU to medicines, in order to improve the integration of the European market in this field, while respecting Member States' competencies and the differences in their health care systems, including the assessment of the added therapeutic value,

- report regularly to the Council, on the state of competitiveness of the pharmaceutical sector on the basis of the results of the benchmarking exercises on competitiveness and public health and of information supplied by Member States.

(1) Document 11165/03 ECO 147 SAN 152 COMPET 38 IND 103 MI 167 RECH 119.