Proposal for a European Parliament and Council Decision adopting a programme of Community action 1999 to 2003 on rare diseases in the context of the framework for action in the field of public health (97/C 203/06) (Text with EEA relevance) COM(97) 225 final - 97/0146(COD)

(Submitted by the Commission on 26 May 1997)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION

Having regard to the Treaty establishing the European Community, and in particular Article 129 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the Economic and Social Committee,

Having regard to the opinion of the Committee of the Regions,

Acting in accordance with the procedure referred to in Article 189b of the Treaty,

(1) Whereas, the very fact of the rareness of the low-prevalence diseases and conditions and the consequent lack of information about them can lead to people affected by these conditions not receiving the health resources and services they need;

(2) Whereas, for the purposes of this programme rare diseases will be defined as life-threatening or chronically debilitating diseases which are of such low prevalence that special combined efforts are needed to address them;

(3) Whereas, in accordance with point (o) of Article 3 of the Treaty, Community action shall include contribution towards the attainment of a high level of health protection;

(4) Whereas Article 129 expressly provides for Community competence in this field in so far as the Community contributes to it by encouraging cooperation between the Member States and, if necessary, lending support to their action; promoting coordination of their policies and programmes and fostering cooperation with third countries and international organizations competent in the sphere of public health; whereas Community action should be directed towards to prevention of diseases, and the promotion of health education and information;

(5) Whereas rare diseases have been identified as a priority area for Community action within the framework for action in the field of public health (1);

(6) Whereas in its resolution A4-0311/95 on the medium-term social action programme 1995 to 1997 (2) the Parliament asked the Commission to present, under the proper procedures, the action programme for rare diseases foreseen in the Commission's framework communication on public health;

(7) Whereas, in accordance with the principle of subsidiarity, action on matters not under the exclusive competence of the Community, such as action on rare diseases, must be undertaken by the Community only if and in so far as, by reason of its scale or effects, it may be better achieved at Community level;

(8) Whereas, the Community can provide added-value to the actions of Member States concerning rare diseases through the coordination of national measures, the dissemination of information and experiences, the joint establishment of priorities, the development of networking as appropriate, selection of Community-wide projects and the motivation and mobilization of all involved;

(9) Whereas cooperation with the international organizations competent in the field of public health and with third countries should be fostered;

(10) Whereas, by providing support for acquiring better knowledge and understanding of, and wider dissemination of information about rare diseases and by developing actions complementary to existing Community programmes and actions, while avoiding unnecessary duplication, the programme will contribute to the achievement of the Community objectives set out in Article 129;

(11) Whereas, in order to increase the value and impact of the programme, a continuous assessment of the actions undertaken should be carried out, with particular regard to their effectiveness and the achievement of the objectives set and, with a view where appropriate, to making the necessary adjustments;

(12) Whereas this programme should be of five-year duration in order to allow sufficient time for actions to be implemented to achieve the objectives set;

(13) Whereas the introduction of specific Community arrangements will help to ensure that all Member States are swiftly informed in the event of an emergency situation, so that the protection of the population can be ensured;

(14) Whereas these Community arrangements for the rapid exchange of information do not affect the Member States' rights and obligations under Treaties or bilateral and multilateral conventions;

(15) Whereas an agreement on a modus vivendi between the European Parliament the Council and the Commission concerning measures for the implementation of acts adopted pursuant to the procedure laid down in Article 189 b of the Treaty was reached on 20 December 1994;

(16) Whereas this Decision lays down, a financial framework constituting the principal point of reference, within the meaning of point 1 of the declaration of the European Parliament, the Council and the Commission of 6 March 1995, for the budgetary authority during the annual budgetary procedure;

(17) Whereas the Community's financial perspective is valid up until 1999 and will have to be revised for the period beyond that date;

(18) Whereas the financial framework for the last four years of the programme (2000 to 2003) shall be determined after the establishment of the future financial perspectives,

HAVE DECIDED AS FOLLOWS:

Article 1

Establishment of the programme

1. A programme of Community action on rare diseases hereinafter referred to as 'this programme`, is hereby adopted for the period 1 January 1999 to 31 December 2003 in the context of the framework for action in the field of public health.

2. The aim of this programme is to contribute towards ensuring a high level of health protection in relation to rare diseases by providing knowledge about these diseases by promoting and strengthening patient support groups and by fostering the setting-up of cluster response teams.

3. The actions to be implemented within the meaning of this programme and their specific objectives are set out in the Annex under the headings:

(1) actions on Community information on rare diseases,

(2) actions in support of patient and family support groups,

(3) actions on handling rare diseases clusters.

Article 2

Implementation

1. The Commission shall ensure implementation, in close cooperation with the Member States, of the actions set out in the Annex.

2. The Commission shall cooperate with institutions and organizations active in the field of rare diseases.

Article 3

Budget

1. The financial framework for the implementation of the programme for the year 1999 shall be ECU 1,3 million, in keeping with current financial perspectives. The financial framework for the final four years of the programme (2000 to 2003) shall be determined in detail after the establishment of the future financial perspectives.

2. The annual appropriations shall be established by the budgetary authority in accordance with the financial perspectives.

Article 4

Consistency and complementarity

The Commission shall ensure that there is consistency and complementarity between the Community actions to be implemented pursuant to this programme and those implemented pursuant to other relevant Community programmes and actions.

Article 5

Committee

1. In implementing this action plan, the Commission shall be assisted by an advisory committee, hereinafter referred to as 'the Committee`, consisting of two representatives from each Member States, and chaired by the Commission representative.

2. The representative of the Commission shall submit to the Committee a draft of the measures to be taken concerning, in particular:

(a) the criteria, and procedures for selecting and financing projects pursuant to this programme;

(b) the evaluation procedure.

The Committee shall deliver its opinion on the draft, within a time limit which the chairperson may lay down according to the urgency of the matter, if necessary by taking a vote.

The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.

The Commission shall take the utmost account of the opinion delivered by the Committee. It shall inform the Committee on the manner in which its opinion has been taken into account.

The representative of the Commission shall keep the Committee regularly informed about Commission proposals or Community initiatives and the implementation of programmes in other policy areas which are relevant to the achievement of the objectives of this programme.

Article 6

International cooperation

1. In the course of implementing this programme, cooperation with third countries and with international organizations competent in the field of public health shall be fostered.

2. This programme shall be open to participation by the associated countries of Central and Eastern Europe (CEECs), in accordance with the conditions laid down in the Association Agreements or additional protocols related thereto concerning participation in Community programmes. This programme shall be open to participation by Cyprus and Malta on the basis of additional appropriations in accordance with the same rules as those applied to the EFTA countries, in accordance with procedures to be agreed with those countries.

Article 7

Monitoring and evaluation

1. In the implementation of this Decision, the Commission shall take the necessary measures to ensure the monitoring and continuous evaluation of the programme taking account of the general and specific objectives referred to in Article 1 and in the Annex.

2. During the third year of this programme, the Commission shall present to the European Parliament and to the Council an evaluation report.

3. The Commission shall submit to the European Parliament and the Council a final report on completion of this programme.

4. The Commission shall incorporate into these two reports information on Community financing in the various fields of action and on complementarity with the other actions referred to in Article 4, as well as the results of the evaluations. It shall also send them to the Economic and Social Committee and the Committee of the Regions.

(1) COM(93) 559 final.

(2) OJ No C 32, 5. 2. 1996, pp. 15 to 24.

ANNEX

SPECIFIC OBJECTIVES AND ACTIONS

I. Actions on Community information on rare diseases

Objective: to provide knowledge about rare diseases especially for patients, health professionals and researchers

1. Encouragement and support for the establishment of a European rare diseases database, with entries listing the disease name, synonyms, a general description of the disorder, symptoms, causes, affected population, standard treatments, investigational treatments (when available) and a list of resources that can be contacted for further information about the condition

2. Promoting access to information and coordinating existing information systems and services by supporting the setting up and strengthening of networks at local, regional, national and Community level

3. Organizing consensus meetings among health professionals in order to improve the early detection, recognition, intervention and prevention of rare diseases.

II. Actions in support of patient and family support groups

Objective: to establish, foster and strengthen voluntary organizations involved in supporting people directly or indirectly affected by rare diseases

4. Promoting the establishment of groups of persons with the same rare conditions or those professionally involved in order to disseminate their experience, to facilitate training and to coordinate their activities at national and Community level

5. Promoting the groups' collaboration and networking and the setting-up and fostering of umbrella bodies, focusing particularly on efforts to encourage the continuity of work and cross-national cooperation.

III. Actions on handling rare diseases clusters

Objective: to ensure an efficient handling of the problem of clusters, which is of key importance for rare diseases

6. Supporting the monitoring (sentinel) of rare diseases, including birth defects, genetic disorders or diseases of different organ systems and the appropriate technique for low-prevalence diseases, in order to meet, on the one hand, the demands of detection, treatment and research and, on the other hand, the demands of relevant statistical monitoring

7. Promoting the creation of rare diseases response teams and of specialized training courses for those investigating clusters

8. Supporting surveillance and early warning systems for clusters

9. Encouraging the exchange of expertise in the evaluation, assessment, communication and management of clusters of rare diseases that are associated with exogenic causes.