A4-0074/98

Proposal for a European Parliament and Council Decision adopting a programme of Community action 1999-2003 on rare diseases in the context of the framework for action in the field of public health (COM(97)0225 - C4-0236/97 - 97/0146(COD))

The proposal was approved with the following amendments:

(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 -1a (new)

>Original text>

>Text following EP vote>

(-1a) 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;

(Amendment 3)

Recital 1a (new)

>Original text>

>Text following EP vote>

(1a) Whereas rare diseases are considered to have little impact on society as a whole due to their low prevalence individually; whereas, however, they pose serious difficulties for sufferers and their families;

(Amendment 4)

Recital 2

>Original text>

(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;

>Text following EP vote>

(2)

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

(Amendment 5)

Recital 2a (new)

>Original text>

>Text following EP vote>

(2a) 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 6)

Recital 4

>Original text>

(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 the prevention of diseases, and the promotion of health education and information;

>Text following EP vote>

(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 the prevention of diseases, and the promotion of health education and information, and improving the quality of life for all Union citizens;

(Amendment 7)

Recital 5a (new)

>Original text>

>Text following EP vote>

(5a) Whereas an action programme on rare diseases must be undertaken as part of a coherent, global policy which includes a European policy on orphan medicinal products and research into rare diseases; 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 8)

Recital 8

>Original text>

(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;

>Text following EP vote>

(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, 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 9)

Recital 8a (new)

>Original text>

>Text following EP vote>

(8a) 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 10)

Recital 9

>Original text>

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

>Text following EP vote>

(9)

Whereas cooperation with the international organizations competent in the field of public health and with third countries should be fostered, encouraging the involvement of non-governmental associations working in the areas concerned;

(Amendment 11)

Recital 9a (new)

>Original text>

>Text following EP vote>

(9a) Whereas Community action programmes should be launched with a view to setting up in the Member States training establishments specializing in rare diseases;

(Amendment 12)

Recital 10a (new)

>Original text>

>Text following EP vote>

(10a) 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, and 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 13)

Recital 12

>Original text>

(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;

>Text following EP vote>

(12)

Whereas this programme should last no more than 5 years in order to allow sufficient time for actions to be implemented to achieve the objectives set, without prejudice to a continuous review of the objectives and measures to be undertaken, as considered necessary, given the specific nature of the causes that can trigger rare diseases;

(Amendment 14)

Recital 18

>Original text>

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

>Text following EP vote>

Deleted

(Amendment 15)

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 1 January 1999 to 31 December 2003 in the context of the framework for action in the field of public health.

>Text following EP vote>

1.

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

(Amendment 16)

Article 1(2)

>Original text>

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.

>Text following EP vote>

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, especially for patients, health professionals and researchers, and by promoting and strengthening patient support groups (in particular patient self-help and relatives' groups) 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 17)

Article 1(3)(3)

>Original text>

(3) actions on handling rare diseases clusters.

>Text following EP vote>

(3)

actions concerning surveillance of rare diseases to ensure the rapid identification, assessment and treatment of rare diseases.

(Amendment 18)

Article 2(2)

>Original text>

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

>Text following EP vote>

2.

The Commission shall cooperate with institutions and organizations active in the field of rare diseases and also with persons with rare diseases and their families as appropriate.

(Amendment 19)

Article 3(1)

>Original text>

1. The financial framework for the implementation of the programme for the year 1999 shall be ECU 13 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.

>Text following EP vote>

1.

The total amount estimated to be necessary for the implementation of the programme for the period from 1999 to 2003 is ECU 14 million. This amount shall be divided into appropriations to be approved at the time of adoption of the 1999 budget and those to be covered by the future financial perspectives.

(Amendment 20)

Article 4

>Original text>

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

>Text following EP vote>

The Commission shall

take the necessary measures to ensure that there is consistency and complementarity between the Community actions to be implemented under the programme and those implemented pursuant to other relevant Community programmes and actions. It shall give notification of the measures no later than six months after the adoption of this Decision.

(Amendment 21)

Article 5(1)

>Original text>

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, and chaired by the Commission representative.

>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 the Commission representative.

(Amendment 22)

Annex (I), introduction

>Original text>

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

>Text following EP vote>

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

(Amendment 23)

Annex (I)(1)

>Original text>

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.

>Text following EP vote>

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. The information collected in this database will be made as widely available as possible, utilizing, among other means, the Internet, telephone hotlines, information pamphlets, and shall be accessible free of charge.

(Amendment 24)

Annex (I)(2)

>Original text>

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

>Text following EP vote>

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 and organizing specific refresher courses for the persons involved, especially general practitioners' associations and non-governmentalassociations that assist sufferers in various ways, for example patients' and parents' and relatives' associations

(Amendment 25)

Annex (III), introduction

>Original text>

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

>Text following EP vote>

Objective: to have in place an effective system of surveillance in order to ensure the rapid identification, assessment and treatment of rare diseases and rare disease clusters.

(Amendment 26)

Annex (III)(6)

>Original text>

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

>Text following EP vote>

6. Promoting a system of surveillance, monitoring and early warning to detect, assess and treat rare diseases, including birth defects, genetic disorders or diseases of different organ systems and the appropriate techniques for low-prevalence diseases, in order to meet, on the one hand, the demands or detection, treatment and research and, on the other hand, the demands of relevant statistical monitoring.

(Amendment 27)

Annex (III)(7)

>Original text>

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

>Text following EP vote>

7.

Promoting structures capable of responding rapidly to the appearance of rare diseases: by bringing together existing European expertise, rapid response teams can be quickly mobilized in the event of an emergency; promoting the creation of specialized training courses for those investigating clusters.

(Amendment 28)

Annex (III)(8)

>Original text>

8. Supporting surveillance and early warning systems for clusters.

>Text following EP vote>

Deleted

Legislative resolution embodying Parliament's opinion on the 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 (COM(97)0225 - C4-0236/97 - 97/0146(COD))(Codecision procedure: first reading)

The European Parliament,

- having regard to the Commission proposal to Parliament and the Council, COM(97)0225 - 97/0146(COD) ((OJ C 203, 3.7.1997, p. 6.)),

- having regard to Articles 189b(2) and 129 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C4-0236/97),

- having regard to Rule 58 of its Rules of Procedure,

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection and the opinion of the Committee on Budgets (A4-0074/98),

1. Approves the Commission proposal, subject to Parliament's amendments;

2. Calls on the Commission to alter its proposal accordingly, pursuant to Article 189a(2) of the EC Treaty;

3. Calls on the Council to incorporate Parliament's amendments in the common position that it adopts in accordance with Article 189b(2) of the EC Treaty;

4. Should the Council intend to depart from the text approved by Parliament, calls on the Council to notify Parliament and requests that the conciliation procedure be initiated;

5. Points out that the Commission is required to submit to Parliament any modification it may intend to make to its proposal as amended by Parliament;

6. Instructs its President to forward this opinion to the Council and Commission.

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