COMMON POSITION (EC) No 35/98 adopted by the Council on 30 April 1998 with a view to adopting Decision No . . ./98/EC of the European Parliament and of the Council of . . . adopting a programme of Community action on rare diseases within the framework for action in the field of public health (1999 to 2003) (98/C 227/01)

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 (1),

Having regard to the opinion of the Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions (3),

Acting in accordance with the procedure laid down in Article 189b of the Treaty (4),

(1) Whereas, for the purposes of this programme, rare diseases are life-threatening or chronically debilitating diseases which are of such low prevalence that special combined efforts are needed to address them so as to prevent significant perinatal and early morbidity or mortality or a considerable reduction in an individual's quality of life or socio-economic potential;

(2) Whereas, as a guide, low prevalence can be understood as meaning prevalence which is generally recognised as less than 5 per 10 000 in the Community;

(3) Whereas the very fact of the rarity of low-prevalence diseases and conditions and the lack of information about them may mean that people affected by such diseases and conditions do not benefit from the health resources and services which they need;

(4) Whereas the number of people affected by individual rare diseases is, by definition, relatively small in comparison with more commonplace disorders; whereas, however, these diseases taken together are quite prevalent and affect a significant percentage of the general population;

(5) Whereas rare diseases are considered to have little impact on society as a whole owing to their low prevalence individually; whereas, however, they pose serious difficulties for sufferers and their families;

(6) Whereas, in accordance with Article 3(o) of the Treaty, Community activities are to include a contribution to the attainment of a high level of health protection;

(7) Whereas Article 129 of the Treaty expressly provides for Community competence in this field insofar as the Community contributes 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 the competent international organisations in the sphere of public health; whereas Community action should be directed towards the prevention of diseases and the promotion of health education and information;

(8) Whereas, by helping to improve knowledge and understanding of rare diseases and foster a wider dissemination of information about them and by developing actions complementary to other Community programmes and actions and to initiatives which are of direct relevance to achievement of the objective of this programme, while avoiding unnecessary duplication, the programme will contribute to the achievement of the Community objectives set out in Article 129 of the Treaty;

(9) Whereas an action programme on rare diseases should be undertaken as part of a coherent overall approach which includes initiatives in the sphere of orphan drugs and medical research;

(10) Whereas rare diseases have been identified as a priority area for Community action in the Commission's communication of 24 November 1993 on the framework for action in the field of public health;

(11) Whereas, in its resolution of 16 January 1996 on the medium-term social action programme 1995- 97 (5), the European Parliament asked the Commission to present, under the proper procedures, the action programme for rare diseases provided for in that communication;

(12) Whereas, in accordance with the principle of subsidiarity, action on matters which do not fall within the exclusive competence of the Community, such as action on rare diseases, should be undertaken by the Community only if and insofar as, by reason of its scale or effects, its objectives can be better achieved by the Community;

(13) Whereas the Community is in a position to provide added value to the actions of Member States concerning rare diseases through the coordination of national measures, the dissemination of information and experience, the joint establishment of priorities, the development of networking as appropriate, selection of Community-wide projects and the motivation and mobilisation of all involved;

(14) Whereas cooperation with international organisations competent in the sphere of public health, in particular the World Health Organisation (WHO), and with third countries, should be fostered;

(15) Whereas the systematic collection of health data is carried out within the framework of the programme of Community action on health monitoring (1997 to 2001) adopted by Decision No 1400/97/EC of the European Parliament and of the Council (6); whereas a regular exchange of information and data must therefore be ensured between this programme and that programme of Community action on health monitoring;

(16) Whereas this programme should last five years in order to allow sufficient time to implement measures to achieve the objectives set;

(17) Whereas, in order to increase the value and impact of the programme, there should be continuous assessment of the measures taken, with particular regard to their effectiveness and the achievement of the objectives set;

(18) Whereas it should be possible to adjust or modify this programme in the light of its evaluation and of any developments that may take place in the general context of the Community framework for action in the field of public health;

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

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

(21) Whereas it is important that the Commission should ensure implementation of this programme in close cooperation with the Member States;

(22) Whereas a modus vivendi (7) between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was reached on 20 December 1994;

(23) Whereas this Decision lays down, for the entire duration of the programme, 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 (8), for the budgetary authority during the annual budgetary procedure,

HAVE DECIDED AS FOLLOWS:

Article 1 Duration and aim of the programme

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

2. The aim of this programme is to contribute, in coordination with other Community measures, towards insuring a high level of health protection in relation to rare diseases by facilitating access to information about these diseases, in particular for health professionals, researchers and for those affected directly or indirectly by these diseases, by encouraging cross-border cooperation of voluntary support groups for the last mentioned and by ensuring optimum handling of clusters.

3. The actions to be implemented under this programme are set out in the Annex.

Article 2 Implementation

1. The Commission shall ensure implementation of the actions set out in the Annex in close cooperation with the Member States, in accordance with Article 5.

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

Article 3 Consistency and complementarity

The Commission shall ensure that there is consistency and complementarity between the actions to be implemented under this programme and with those implemented under other Community programmes and actions, in particular in the sphere of public health, on the one hand, and initiatives in the sphere of orphan drugs and medical research, on the other.

Article 4 Budget

1. The financial framework for the implementation of this programme for the period referred to in Article 1 is hereby set at ECU 6,5 million.

2. The annual appropriations shall be authorised by the budgetary authority within the limits of the financial perspective.

Article 5 Committee

1. The Commission shall be assisted by a Committee consisting of two representatives of each Member State and chaired by a representative of the Commission.

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

(a) the Committee's rules of procedure;

(b) an annual work programme indicating the priorities for action;

(c) the arrangements, criteria and procedures for selecting and financing projects under this programme, including those involving cooperation with international organisations competent in the sphere of public health and participation of the countries referred to in Article 6(2);

(d) the evaluation procedure;

(e) the arrangements for dissemination and transfer of results;

(f) the procedures for coordination with programmes and initiatives which are of direct relevance to achievement of the aim of this programme;

(g) the arrangements for cooperating with the institutions and organisations referred to in Article 2(2).

The Committee shall deliver its opinion on the draft measures referred to above within a time limit which the Chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.

The Commission shall adopt measures which shall apply immediately. However, if these measures are not in accordance with the opinion of the Committee, they shall be communicated by the Commission to the Council forthwith. In that event:

- the Commission shall defer application of the measures which it has decided upon for a period of two months from the date of such communication,

- the Council, acting by a qualified majority, may take a different decision within the time limit laid down in the preceding indent.

3. In addition, the Commission may consult the Committee on any other matter concerning the implementation of this programme.

The representative of the Commission shall submit to the Committee a draft of the measures to be taken. The Committee shall deliver its opinion on the draft within a time limit which the Chairman 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 of the manner in which its opinion has been taken into account.

4. The representative of the Commission shall keep the Committee regularly informed of:

- financial assistance granted under this programme (amount, duration, breakdown and beneficiaries),

- Commission proposals or Community initiatives and the implementation of programmes in other fields which are of direct relevance to achievement of the objective of this programme, so as to ensure consistency and complementarity as referred to in Article 3.

Article 6 International cooperation

1. Subject to Article 228 of the Treaty, in the course of implementing this programme, cooperation with third countries and with international organisations competent in the sphere of public health, in particular the World Health Organisation (WHO), shall be encouraged and implemented as regards the actions covered by this programme in accordance with the procedure laid down in Article 5.

2. This programme shall be open to participation by the associated countries of central Europe, in accordance with the conditions laid down in the Association Agreements or Additional Protocols relating 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 countries of the European Free Trade Association (EFTA), in accordance with procedures to be agreed with those two 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 this programme, taking account of the aim set out in Article 1.

2. The Commission shall submit an interim report to the European Parliament and to the Council during the third year of this programme and a final report upon completion of this programme. It shall incorporate into these two reports information on Community financing in the various fields of action and on consistency and complementarity with the other actions referred to in Article 3, as well as the results of the evaluation referred to in paragraph 1 of this Article. The reports shall also be submitted to the Economic and Social Committee and the Committee of the Regions. The interim report should also take account of developments occurring within the framework for Community action in the field of public health.

3. On the basis of the interim report referred to in paragraph 2, the Commission may, if necessary, make appropriate proposals for modifications or adjustments to this programme.

Done at . . .

For the European Parliament

The President

For the Council

The President

(1) OJ C 203, 3.7.1997, p. 6.

(2) OJ C 19, 21.1.1998, p. 4.

(3) OJ C 64, 27.2.1998, p. 96.

(4) Opinion of the European Parliament of 11 March 1998 (not yet published in the Official Journal), Council common position of 30 April 1998 and Decision of the European Parliament of . . . (not yet published in the Official Journal).

(5) OJ C 32, 5.2.1996, p. 24.

(6) OJ L 193, 22.7.1997, p. 1.

(7) OJ C 102, 4.4.1996, p. 1.

(8) OJ C 102, 4.4.1996, p. 4.

ANNEX

ACTIONS

1. Promote the development of, and access to, a European information network on rare diseases, using the existing databases whenever possible. The information is to comprise entries listing the disease name, synonyms, a general description of the disorder, symptoms, causes, epidemiological data, preventive measures, standard treatments, clinical trials, diagnostic laboratories and specialised consultations, research programmes and a list of sources that can be contacted for further information about the condition. The availability of this information should be made as widely known as possible.

2. Encourage and support the drawing up of recommendations by professionals in order to improve early detection, recognition, intervention and prevention in the field of rare diseases.

3. Promote cross-border collaboration and networking between groups of persons directly or indirectly affected by the same rare conditions or volunteers and professionals involved and coordination at Community level in order to encourage continuity of work and transnational cooperation.

4. Support at Community level the monitoring of rare diseases in the Member States and early warning systems for clusters, and stimulate the networking and training of experts concerned with the handling of rare diseases and their clusters.

STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 26 May 1997 the Commission submitted a proposal for a Decision of the European Parliament and of the Council adopting a programme of Community action (1999-2003) on rare diseases within the framework for action in the field of public health, based on Article 129 of the EC Treaty (1).

2. The European Parliament delivered its opinion on 11 March 1998.

The Economic and Social Committee and the Committee of the Regions delivered their opinions on 29 October (2) and 19 November 1997 (3) respectively.

3. In the light of the European Parliament's opinion the Commission submitted an amended proposal on 16 April 1998.

4. On 30 April 1998 the Council adopted its common position in accordance with Article 189b of the Treaty.

II. OBJECTIVE

The Commission proposal concerns a programme on the rare diseases identified by the Commission, in its 1993 communication concerning the framework for action in the field of public health, as a priority area for Community action.

The aim of the proposed programme is to help ensure a high level of health protection in relation to rare diseases, by providing information about such diseases, encouraging and strengthening patient support groups and promoting the setting up of cluster response teams.

For achieving this objective the proposal provides for nine actions under the following headings:

1. Community information on rare diseases;

2. support for patient and family support groups;

3. handling of rare disease clusters.

III. ANALYSIS OF THE COMMON POSITION

1. Amendments made to the Commission proposal

Aims, framework and general content of the programme (Article 1)

In view of the reorganisation of the Annex, the specific objectives listed in paragraph 3 have been deleted and incorporated in more general terms in the description of the general aims in paragraph 2.

In addition the Council has inserted in paragraph 2 a reference to coordination with other Community measures in the field of rare diseases; it also chose to include such a reference in Article 3 (consistency and complementarity with, in particular, initiatives in the areas of orphan drugs and research).

Financial framework (Article 4(1))

The Commission proposed ECU 1,3 million for the first year of implementation of the programme, leaving it up to the budgetary authority to determine the financial framework for the last four years of the programme after the future financial perspective had been established.

In the interests of budgetary clarity, the Council set a financial framework for the whole duration of the programme: ECU 6,5 million, extending the allocation for the first year to cover the five-year implementation period.

Committee procedure (Article 5)

The Council departed from the procedure proposed, opting, as in programmes already adopted, for a mixed procedure combining the need for flexibility in certain aspects of the management of the programme and more active involvement of Member States in certain important decisions.

Monitoring and evaluation (Article 7)

The Council took the view that the interim report to be submitted during the third year of the programme should also take account of any developments occurring within the framework for Community action in the field of public health, and supplemented Article 7 accordingly.

Content of the programme (Annex)

By and large the common position incorporates the main thrust of the objectives in the Commission proposal.

The Council nevertheless felt it was appropriate to restructure and condense the actions set out in the Annex, taking account of the financial resources available, giving more emphasis to cross-border activities and those offering most Community added value.

The restructured text of the Annex may be summarised as follows:

Action 1 of the common position broadly incorporates the content of Action 1 and the first part of Action 2 as proposed. However, rather than a database, the Council considered it appropriate to refer to the setting up of a European information network using existing databases in the Member States.

In addition, the Council added certain items to the information to be included in the network and, following Parliament amendment 23, referred to the need for the availability of this information to be made widely known.

On the other hand, it felt there was no need for the programme to include support for the setting up and strengthening of networks at local, regional and national level.

Action 2, which broadly incorporates the proposed Action 3, has been recast to specify the purpose of the action ('drawing up of recommendations`) rather than means ('organising consensus meetings`).

Action 3 merges proposed Actions 4 and 5, focusing on cross-border collaboration and networking between groups of persons directly or indirectly affected by the same diseases.

Action 4 incorporates in more general terms the key points of proposed Actions 6, 7, 8 and 9 thereby allowing for a degree of flexibility in implementation.

2. European Parliament amendments

(a) Amendments incorporated by the Commission in its amended proposal

Of the 28 amendments adopted by Parliament at first reading, the Commission accepted 16, of which:

- one in its entirety (22),

- two with a slightly amended wording (3 and 5),

- thirteen in part (1, 2, 7, 8, 9, 12, 16, 17, 23, 25, 26, 27 and 28).

(i) Amendments accepted by the Council

The Council has incorporated in full Parliament amendments 2 and 3 in its common position (recitals 4 and 5 in the common position).

It has also incorporated part of the following amendments:

- amendment 7 (first part - recital 9),

- amendment 16 (first part - Article 1(2)),

- amendment 22 (in substance by inserting 'those affected directly or indirectly` in Article 1(2)).

The same wording has been inserted in Action 3 in the Annex relating to networking,

- amendment 23 (at the end of Action 1, in modified form for operational reasons).

(ii) Amendments not accepted by the Council

The Council has not been able to agree with the Commission on the following amendments proposed by the European Parliament:

- amendment 1 (new recital 1)

The Council considers that the spirit of this amendment is covered by recitals 1, 6, 7 and 13 in its common position,

- amendment 5 (recital 2a)

The Council considers that this text has no specific connection with the enacting terms,

- amendment 8 (recital 8)

The Council prefers to keep a general wording covering the widest spectrum (recital 13),

- amendment 9 (new recital 8a)

(to be seen in conjunction with amendment 21)

In the Council's view, this amendment would lie outside the scope of the programme,

- amendment 12 (new recital 10a)

The Council has not incorporated the recital covered by this amendment since, although its principle is not in dispute, it does not correspond to a specific provision,

- amendment 17 (Article 1(3) point 3)

The Council's restructuring of Article 1(2) and (3) has made this amendment superfluous. However, Action 4 (in the Annex) of the common position covers the substance of the amendment (see also amendments 25, 26, 27 and 28),

- amendments 25, 26, 27 and 28 (Annex, section III, objectives, Actions 6, 7 and 8)

The text of Action 4, as it stands following the restructuring of section III of the proposal, contains in more general terms the elements proposed and related amendments by the European Parliament.

The deletion of Action 8 (amendment 28) proposed by the Parliament matches the deletion made by the Council when restructuring the text.

(b) Amendments not accepted by the Commission in its amended proposal

(i) In general, the Council has accepted the reasons which led the Commission to reject some of Parliament's amendments, namely

- amendments 6, 10, 20 and 21 for reasons of conformity with the letter or the spirit of Article 129 of the Treaty or of consistency with similar provisions in other public health programmes,

- amendments 4, 15 and 24 which are of too precise or restrictive scope,

- amendments 11 and 13 which are covered elsewhere,

- amendment 18 which is not within the scope of the programme,

- amendment 19 which is not compatible with current availabilities and financial perspectives.

(ii) The Council has incorporated amendment 14 (deletion of recital 18) since it agrees with the Parliament's view that a financial envelope should be indicated for the full duration of the programme.

IV. CONCLUSIONS

While adopting a procedure for the implementation of this programme similar to the one in programmes already adopted and restructuring the actions and presenting them more succinctly, the Council has maintained the substance of the objectives and content of the programme proposed.

(1) OJ C 203, 3.7.1997, p. 6.

(2) OJ C 19, 21.1.1998, p. 4.

(3) OJ C 64, 27.2.1998, p. 96.