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(2004/C 78 E/0513)

WRITTEN QUESTION E-3218/03

by John Bowis (PPE-DE) to the Commission

(31 October 2003)

Subject:   Rare diseases: Evans syndrome

Is the Commission aware of the problems of children suffering from Evans syndrome and of the extreme and alarming difficulties faced in financing even modestly budgeted medical research projects for non-genetic rare diseases (including Evans syndrome) in Europe?

Is the Commission prepared to provide financial support to research projects related to the Evans syndrome (including projects sponsored by the ‘Association Française du Syndrome d'Evans (AFSE)’ in France and by ‘People in Search of a Cure for Evans Syndrome’ in the UK)?

Given that the EC Pharmaceutical Policy Regulation on Orphan Drugs requires a prior fundamental understanding of physiopathological aspects of diseases (which is presently absent in the case of the Evans syndrome) and that the Community's action on rare diseases is not linked to criteria such as the mortality rate or the impact of a disease on children (and is in practice too selective, excluding diseases which have not been researched earlier), could the Commission envisage the creation of a ‘universal fund for rare diseases’, such as the one that exists in other sectors, to help guarantee the rights of the weakest?

Answer given by Mr Busquin on behalf of the Commission

(10 December 2003)

Rare diseases research is covered under the Priority 1 Programme ‘Life sciences, genomics and biotechnology for health’ of the 6th Framework Programme. Competitive calls for projects, involving at least three independent legal entities established in three different Member States or associated States, are issued regularly within the context of the work programmes of this priority.

Although this Priority Programme is focused on genomics and biotechnology research, and even though the Evans syndrome seems to have no genetic basis, the disease may benefit from research undertaken in this Priority.

Two calls have already been published in 2003.

Although Evans syndrome has not been specifically mentioned in the work programmes of these two first calls, researchers interested in Evans syndrome may have taken the opportunity to participate in consortia applying for topics relevant to their research field, such as:

Other calls for proposals will be published in 2004 and 2005. The topics for these calls will be elaborated through consultation of the scientific community, with the support of the scientific advisory committee and the Programme Committee of the Priority 1 Programme. Researchers interested in Evans syndrome may check, once the calls will be published, the opportunity for them to participate in projects relevant to their field.

Rare Diseases are also given importance in the new Programme of Community action in the field of Public Health (2003 — 2008). As per Annex 2.3 of the new Programme, activities related to rare diseases include the development of strategies and mechanisms for the exchange of information and prevention. According to the 2003 and 2004 Work Plans, the two main pillars of actions is the exchange of information using a European information network on rare diseases as well as the development of strategies and mechanisms for exchange of information and coordination at Community level to encourage continuity of work and transnational co-operation as such. In this context, projects, which could be relevant to the Evans syndrome community, may also be supported.

The creation of a universal fund for rare diseases is not envisaged by the Commission.

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