A4-0336/98

Decision on the common position adopted by the Council with a view to adopting a European Parliament and Council Decision adopting a programme of Community action on rare diseases within the framework for action in the field of public health (1999-2003) (C4-0341/98 - 97/0146(COD))(Codecision procedure: second reading)

The European Parliament,

- having regard to the common position of the Council, C4-0341/98 - 97/0146(COD) ((OJ C 227, 20.7.1998, p. 1.)),

- having regard to its opinion at first reading ((OJ C 104, 6.4.1998, p. 127.)) on the Commission proposal to Parliament and the Council COM(97)0225 ((OJ C 203, 3.7.1997, p. 6.)),

- having regard to the amended Commission proposal COM(98)0232 ((OJ C 160, 27.5.1998, p. 8.)),

- having regard to Article 189b(2) of the EC Treaty,

- having regard to Rule 72 of its Rules of Procedure,

- having regard to the recommendation for second reading of the Committee on the Environment, Public Health and Consumer Protection (A4-0336/98),

1. Amends the common position as follows;

2. Calls on the Commission to support Parliament's amendments in the opinion it is required to deliver pursuant to Article 189b(2)(d) of the EC Treaty;

3. Calls on the Council to approve all Parliament's amendments, amend its common position accordingly and definitively adopt the act;

4. Instructs its President to forward this decision to the Council and the Commission.

(Amendment 1)

Recital -1 (new)

>Original text>

>Text following EP vote>

(-1) Whereas the European Union has a duty to take measures aimed at preventing all diseases and to protect the health of all citizens in the Union; whereas Community involvement is the only effective means of tackling a problem the scale of which in individual countries is too small to allow the necessary analysis or proper action;

(Amendment 2)

Recital 1

>Original text>

(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;

>Text following EP vote>

(1)

Whereas, for the purposes of this programme, rare diseases, which also include genetic diseases and those caused by aetiological agents, 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;

(Amendment 3)

Recital 5a (new)

>Original text>

>Text following EP vote>

(5a) Whereas understanding of rare diseases needs to be improved, since they constitute danger signs from a public health perspective to the extent that problems shown to affect a small section of the population could, in time, spread to the community as a whole if the incidence of the causes was to become more frequent;

(Amendment 4)

Recital 7

>Original text>

(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 organizations 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;

>Text following EP vote>

(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 organizations in the sphere of public health; whereas Community action should be directed towards the prevention of diseases, the promotion of health education and information and improving the quality of life for all EU citizens;

(Amendment 5)

Recital 9

>Original text>

(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;

>Text following EP vote>

(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; whereas a Community database should be compiled to store updated information on rare diseases, and whereas detection and control systems should likewise be set up;

(Amendment 6)

Recital 13

>Original text>

(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 mobilization of all involved;

>Text following EP vote>

(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 mobilization of all involved, in particular researchers, specialist doctors, general practitioners, and, above all, non-governmental associations that help sufferers in various ways, for example patients' and parents' and relatives' associations;

(Amendment 7)

Recital 13a (new)

>Original text>

>Text following EP vote>

(13a) Whereas, in accordance with the social and human rights model of disability supported in the Commission communication on equality of opportunity for people with disabilities (COM(96)0406), persons with rare diseases and their families should be fully involved in all aspects of the programme which benefit them;

(Amendment 8)

Recital 14

>Original text>

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

>Text following EP vote>

(14)

Whereas cooperation with international organizations competent in the sphere of public health, in particular the World Health Organization (WHO), and with third countries, should be fostered, encouraging the involvement of non-governmental associations working in the areas concerned;

(Amendment 9)

Recital 14a (new)

>Original text>

>Text following EP vote>

(14a) Whereas the high level of technology currently available can contribute significantly to the acquisition of better knowledge and understanding of, and the wider dissemination of information about, rare diseases, as stated above; whereas this technology should be used to enhance the achievement of the objectives and actions envisaged under the programme; whereas, because of the limited number of potential customers, rare diseases are of little interest to the pharmaceutical and biotechnological industries; whereas publicly funded research should therefore be encouraged;

(Amendment 10)

Article 1(1)

>Original text>

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.

>Text following EP vote>

1.

A programme of Community action on rare diseases, which also include genetic diseases and those caused by aetiological agents, 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.

(Amendment 11)

Article 1(2)

>Original text>

2. The aim of this programme is to contribute, in coordination with other Community measures, towards ensuring 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.

>Text following EP vote>

2.

The aim of this programme is to contribute, in coordination with other Community measures, towards ensuring a high level of health protection in relation to rare diseases by improving knowledge about and 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 and strengthening national and international cooperation of voluntary support groups for the last mentioned, in particular patient self-help and relatives' groups, by ensuring optimum handling of clusters and by fostering the setting up of a system of surveillance and monitoring for rare diseases so that a rapid and effective response can be made.

(Amendment 12)

Article 2(1)

>Original text>

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.

>Text following EP vote>

1.

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

(Amendment 13)

Article 3

>Original text>

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.

>Text following EP vote>

The Commission shall

take the necessary measures to 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. It shall give notification of the measures no later than six months after the adoption of this Decision.

(Amendment 14)

Article 4(1)

>Original text>

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.

>Text following EP vote>

1.

The financial framework for the implementation of this programme for the period referred to in Article 1 is hereby set at ECU 14 million.

(Amendment 15)

Article 5

>Original text>

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.

>Text following EP vote>

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 State, one of whom is to be drawn from a patient support group or to be an expert/representative of voluntary organizations with relevant experience, and chaired by a representative of the Commission.

>Original text>

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

>Text following EP vote>

2.

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

>Original text>

(a) the Committee's rules of procedure;

>Text following EP vote>

(a)

the criteria, and procedures for selecting and financing projects under this programme;

>Original text>

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

>Text following EP vote>

(b)

the evaluation procedure.

>Original text>

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

>Text following EP vote>

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.

>Original text>

(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 organizations referred to in Article 2(2).

>Text following EP vote>

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.

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

>Original text>

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.

>Text following EP vote>

>Original text>

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:

>Text following EP vote>

>Original text>

- 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;

>Text following EP vote>

>Original text>

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

>Text following EP vote>

>Original text>

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

>Text following EP vote>

>Original text>

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.

>Text following EP vote>

>Original text>

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.

>Text following EP vote>

>Original text>

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.

>Text following EP vote>

>Original text>

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.

>Text following EP vote>

(Amendment 16)

Article 6(1)

>Original text>

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

>Text following EP vote>

1.

In the course of implementing this programme, cooperation with third countries and with international organizations competent in the sphere of public health, in particular the World Health Organization (WHO), shall be encouraged and implemented as regards the actions covered by this programme.

(Amendment 17)

ANNEX (1)

>Original text>

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 specialized consultations, research programmes and a list of sources that can be contracted for further information about the condition. The availability of this information should be made as widely known as possible.

>Text following EP vote>

1.

Promote the development of, and access to, a European information network on rare diseases, using the existing databases, among other things. 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 specialized consultations, research programmes and a list of sources that can be contracted for further information about the condition. The availability of this information should be made as widely known as possible and such information should be made as widely available as possible, utilizing, among other means, the Internet, telephone helplines and information pamphlets, and shall be accessible free of charge.

(Amendment 18)

ANNEX (2)

>Original text>

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.

>Text following EP vote>

2.

Encourage and support training and refresher courses for professionals in order to improve early detection, recognition, intervention and prevention in the field of rare diseases.

(Amendment 19)

ANNEX (3)

>Original text>

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 trans-national cooperation.

>Text following EP vote>

3.

Promote national and international 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 trans-national cooperation.

(Amendment 20)

ANNEX (4)

>Original text>

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.

>Text following EP vote>

4.

Support at Community level the monitoring of rare diseases in the Member States and early warning and rapid response systems for clusters, by stimulating the networking and training of experts concerned with the handling of rare diseases and their clusters: existing European expertise can be used to mobilize rapid response teams quickly in the event of an emergency.