Comment on the Decision no. 1295/1999/EC, Official Journal L 155, 22/06/1999

The European Parliament, the Council and the Commission of the European Union jointly declare rare diseases as one of the most relevant issue among the priorities to deal with in the next public health programme.
Analysing, in fact, the whereases that introduce the Decision no. 1295/1999/EC of the European Parliament and of the Council of April 29th 1999 to adopt a programme of community action on rare diseases within the framework for action in the field of public health, it emerges that:

• The Community action should be able to contribute unique added value to analysis or intervention and, in order to improve the quality of life of all citizens of the Union, should be directed towards: the prevention of diseases and the promotion of health education and information through the co-ordination of national measures, the dissemination of information and experience, the joint establishment of priorities, the development of networking as appropriate, the selection of Community-wide projects and the motivation and mobilisation of all involved, in particular health professionals, researchers and persons directly or indirectly affected by such diseases;
  
• A public health approach is required. Rare diseases have been identified as a priority area for Community action (Commission's communication of 24 November 1993) and an action programme on rare diseases should be undertaken as part of a coherent overall approach that includes:
  • A 5 years lasting health monitoring programme within a continuous assessment of the measures taken in order to adjust or modify this programme in the light of its evaluation and of any developments that may take place;
  • co-operation with international organisations competent in the sphere of public health, in particular the World Health Organisation (WHO), and with third countries, should be fostered, as well as trans-national collaboration between voluntary support groups for those directly or indirectly affected by rare diseases;
  • initiatives in the sphere of orphan drugs and medical research;
• Interventions should be focused on improving life’s quality of people affected. Rare diseases, including those of genetic origin, are life-threatening or chronically debilitating diseases of such low prevalence that special combined efforts are needed to address them so as to prevent significant morbidity or perinatal or early mortality or a considerable reduction in an individual's quality of life or socio-economic potential, and make the people affected to benefit from the health resources and services they need;

Therefore, the Parliament and the European Council came to the:

DECISION No 1295/1999/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL

of April 29th 1999

adopting a programme of Community action on rare diseases within the framework for action in the field of public health (1999 to 2003)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION

have decided as follows:

• to adopt a programme of Community action on rare diseases for the period from 1st January 1999 to 31st December 2003 (art. 1, par. 1)
• to contribute, in conformity with this programme, to ensure a high level of health protection in relation to rare diseases improving knowledge by promoting the setting-up of: a European information network involving health professionals, researchers and patients’ associations and making the maximum use of means to spread information (including the Internet); a strengthen transnational co-operation between organisations concerned; a monitoring and surveillance system (art. 1, par. 2, 3; annex);
• to ensure implementation of the actions mentioned above, thanks to Commission’s co-operation with Member States, institutions and organisations active in the field of rare diseases (art. 2, par. 1, 2), attended by a nominated committee, whose tasks are settled in detail in art. 5;
• to ensure, thanks to the Commission, consistency and complementarity between actions to be implemented under this programme and with those implemented in the spheres of public health and orphan drugs (art. 3);
• to encourage and implement the co-operation with third countries, the associated countries of central Europe, Cyprus and Malta on the basis of settled rules (art. 6, par. 2) and with international organisations competent in the sphere of public health, in particular the World Health Organisation (WHO), in accordance with the procedure laid down in Article 5 (art. 6, par. 1);
• to adopt, through the Commission, the necessary measures to ensure monitoring and evaluation of this programme , taking into account the aim set out in Article 1 (art. 7, par. 1), and to submit an interim report and then a final report upon completion to this programme (art. 7, par. 2).