Activites

• 1999/06/22 Final act published in Official Journal
  • Decision 1999/1295
  • OJ L 155 22.06.1999, p. 0001
• 1999/04/29 Final act signed
• 1999/04/29 End of procedure in Parliament
• #2172
• 1999/04/22 Council Meeting
• 1999/04/14 Decision by Parliament, 3rd reading
  • T4-0299/1999 summary

    At third reading under codecision procedure, the European Parliament approved the joint text, approved by the Conciliation Committee, and the relevant joint declaration, for a European Parliament and Council decision adopting a programme of Community action on rare diseases in the context of the framework for action in the field of public health. The Parliament's rapporteur was Guido Viceconte (UPE,IT).�

• 1999/04/13 Debate in Parliament
  • Debate in Parliament
• 1999/03/25 Report tabled for plenary, 3rd reading
  • A4-0166/1999
• 1999/03/10 Joint text approved by Conciliation Committee co-chairs
  • 3602/1999
• 1999/02/04 Formal meeting of Conciliation Committee
• #2152
• 1998/12/17 Council Meeting
• 1998/10/08 Decision by Parliament, 2nd reading
  • T4-0566/1998 summary

    In adopting the recommendation for second reading by Mr Guido VICECONTE (UPE, I), the European Parliament approved the common position of the Council with numerous amendments: - it again proposed a total allocation of ECU 14 million over five years (whereas the Council had proposed an allocation of only ECU 6.5 million); - Parliament reaffirmed that a Community approach, rather than a national approach, was the only effective means of tackling a problem whose scale in individual countries was too small to allow the proper action; - it stressed that diseases which were currently rare might in future spread to the community as a whole, which made it necessary to adopt a range of measures, such as the establishment of a rapid detection and control system; pooling of knowledge acquired in Europe; extension of the programme to genetic disorders and diseases caused by aetiological agents; the setting-up of rapid response teams; the setting-up of databases accessible to all (wide dissemination of information, particularly over the Internet, telephone helplines and free information pamphlets, etc.); training of professionals; promotion of research, etc. The European Parliament also wished agreement to be reached with the Council that, in managing projects, the Commission would be assisted by an advisory committee comprising - and this would be a first - representatives of patient support groups and voluntary organisations.�

• 1998/10/07 Debate in Parliament
  • Debate in Parliament
• 1998/09/23 Vote in committee, 2nd reading
  • A4-0336/1998
• 1998/06/18 Committee referral announced in Parliament, 2nd reading
• #2102
• 1998/06/04 Council Meeting
• #2086
• 1998/04/30 Council Meeting
  • 06492/1/1998 summary

    In its common position on the programme of Community action on rare diseases, the Council extensively restructured the Commission proposal and condensed the presentation of the actions. More specifically, the Council rendered more succinct the description of the actions in the annex to the programme, concentrating on cross-border activities and those offering most Community added value. The Council particularly stressed the establishment of a European information network using existing databases rather than setting up a new one. It deleted support for the setting up and strengthening of information networks at local, regional and national level. The organisation of meetings of those working in the field ('consensus meetings') has been replaced with 'recommendations' to improve early detection, identification and prevention of the diseases concerned. The actions relating to patients' groups and their families are rationalised and concentrated on cross-border aspects. The actions concerning clusters of rare diseases are more general and stress Community monitoring of these diseases and early warning systems. Besides general rationalisation of the actions to be undertaken under the programme, the Council also modified other specific aspects of the programme: -commitology: the Council favours the mixed committee procedure over the advisory committee procedure, -budgetary aspects: the Council allocates ECU 6.5 m for the duration of the programme (5 years), -monitoring and evaluation of the programme: the Council considers that the interim report to be submitted by the Commission should also take account of developments which may occur in connection with Community action in the field of public health. The Council incorporated only 6 of the 28 amendments adopted by Parliament at first reading (the Commission had accepted 16 of them). The only amendments accepted by the Council concerned: -the considerable prevalence of these diseases and the fact that they affect a significant percentage of the population, -the serious difficulties they cause to sufferers, -the fact that the treatment of these diseases should be integrated into an overall policy which also relates to orphan drugs and research, -improving, by means of the programme, the knowledge of health professionals, researchers and people directly or indirectly affected by the diseases, -the widest possible public dissemination of information about the diseases. Among the most important of Parliament's amendments which were not accepted by the Council were those concerning the budget (Parliament had called for ECU 14 m), commitology and the establishment of a monitoring and surveillance system making it possible to respond rapidly and effectively to outbreaks of the diseases (establishment of networks and courses relating to their treatment).�

• 1998/04/15 Modified legislative proposal published
  • COM(1998)0232 summary

    In its amended proposal on the action programme on rare diseases, the Commission incorporated 16 of the 28 amendments adopted by the European Parliament at first reading. The amendments which it accepted concerned: -prevention of diseases at Community level, their treatment being too limited at Member State level, -the fact that the number of people affected by these diseases is not negligible, and that they pose serious difficulties for sufferers, -the importance of improving understanding of diseases, -the adoption of an overall policy on the subject including provision for orphan medicinal products and research, the compilation of a Community databank and the setting-up of detection and control systems, -the implementation of the programme by organizations representing sufferers and health professionals, -the extension of the programme to patients and health professionals, -clearer provisions concerning actions relating to rare-disease clusters: the actions concerned are to identify, handle and respond rapidly to such clusters, -as part of information measures, the provision of information about rare diseases to patients' families and maximum dissemination of the information gathered concerning these diseases, -as part of measures to treat clusters, having in place an effective system to monitor rare diseases, promote Community monitoring of rare diseases and make permanent organizational arrangements for providing appropriate responses for rare diseases (networking and training for their treatment). The amendments not incorporated related in particular to the budgetary provisions proposed by Parliament (increasing the allocation) and extending the scope of the programme (aetiological diseases).�

• 1998/03/11 Decision by Parliament, 1st reading/single reading
  • T4-0136/1998 summary

    In adopting the report by Mr Guido VICECONTE (UPE, I) on rare diseases, the European Parliament amended the programme proposed by the Commission, calling in particular for a commitment on the part of the Community to combat such diseases effectively. Although, all in all, the number of people affected by each individual rare disease was relatively small, Parliament considered that, taken together, they were quite prevalent and affected a significant percentage of the population. Accordingly it called for the programme to provide information about rare diseases (including genetic diseases and those caused by aetiological agents) to patients via self-help groups, to health professionals and to researchers. The programme should also foster a surveillance and monitoring system which would make it possible to respond rapidly and effectively when the diseases concerned appeared. Parliament also: -with regard to surveillance of rare diseases, called for action to be taken to ensure their rapid identification, assessment and treatment (it proposed, in particular, that rapid response teams be set up which could be mobilized readily in the event of an emergency); -called for the database provided for under the programme to be made widely accessible over the Internet and by means of telephone hotlines and free information pamphlets, -called for refresher courses for persons involved in dealing with rare diseases (it particularly suggested the setting-up of schools to deal with rare diseases). Lastly, Parliament: -in the field of commitology, called for the Commission to be assisted by representatives of patients or of voluntary organizations with relevant experience, -called for the appropriation for the programme for the period 1999-2003 to be increased to ECU 14 million.�

• 1998/03/10 Debate in Parliament
  • Debate in Parliament summary

    Commissioner Flynn considered that there was much the Community could offer in this area. Individual cases could be aggregated to form a larger group sharing the same characteristics which would provide the opportunity to undertake a wider range of interventions and to initiate coordinated actions with respect to patients who might otherwise be isolated. The Commissioner accepted 16 amendments out of the 29 tabled, either in their entirety – Nos 3, 5 and 22 – or partially – Nos 1, 2, 7, 8, 9, 12, 16, 17, 23, 25, 26, 27 and 28. However, the following amendments were not acceptable: Nos 6, 10, 20 and 21 (for legal reasons), Nos 4, 11, 13, 15, 24 and 29 (superfluous), No 18 (outside the scope of the programme), and Nos 14 and 19 (for budgetary reasons). Mr Flynn pointed out that the current financial perspectives did not allow for the sum requested by Parliament as the figure of ECU 1.3 million per year could not be exceeded.

• 1998/02/25 Vote in committee, 1st reading/single reading
  • A4-0074/1998
• #2056
• 1997/12/04 Council Meeting
  • 2056
• 1997/06/09 Committee referral announced in Parliament, 1st reading/single reading
• #2013
• 1997/06/05 Council Meeting
  • 2013
• 1997/05/26 Legislative proposal published
  • COM(1997)0225 summary

    OBJECTIVE: this proposal seeks to establish a programme on rare diseases for the period from 1 January 1999 to 31 December 2003, with the objective of: - improving information on rare diseases, - supporting patient support groups, - encouraging the creation of response and risk management teams in the event of rare diseases clusters. SUBSTANCE: Definition: rare diseases must be understood as life-threatening or chronically debilitating diseases which are of such low prevalence that specially combined efforts are needed (the generally accepted prevalence of rare diseases is less than 5 per 10 000 of the population - to date there are about 5 000 such diseases in this category). Actions eligible under this programme: 1) information actions on rare diseases to provide information to patients, health professionals and researchers: . creation of a data base on rare diseases, . creation of local, regional, national and Community information networks in order to improve access to information and coordination of existing information systems, . organization of meetings between health professionals in order to improve the identification and prevention of these diseases; 2) actions in support of patient and family support groups in order to establish and strengthen voluntary organizations involved in supporting people affected by these diseases: . aid for the establishment of groups of persons with the same rare conditions or those professionally involved, . establishment of networks of groups and the creation of umbrella bodies encouraging transnational cooperation; 3) actions on handling rare diseases clusters (temporal and physical concentrations or prevalence of rare diseases): . support for the monitoring (sentinel) of rare diseases in order to respond to the demands of detection and treatment of these diseases and the demands of statistical monitoring, . creation of rare diseases response teams and specialised training courses for those investigating clusters, . support for surveillance and early warning systems for clusters, . exchange of expertise in the evaluation and management of clusters of rare diseases that are associated with exogenic causes. Implementation: the Commission will ensure implementation of the programme in close cooperation with the Member States. It will cooperate with the institutions active in this field. In the management of this programme it will be assisted by an advisory committee consisting of representatives of the Member States; Consistency and complementarity: the programme must be implemented in consistency and complementarity with the other relevant Community actions; International cooperation: the programme is open to participation by the associated countries of central Europe and Cyprus and Malta; Monitoring and evaluation: the Commission will ensure the monitoring and continuous evaluation of the programme. It will present an evaluation report to the European Parliament and the Council during the third year of the programme. A final report will also be submitted to Parliament and the Council on completion of this programme; Budget: ECU 1.3 million for the first year (the financial framework for the following four years will be fixed after the establishment of the next financial perspective). �

Documents

• Legislative proposal published: COM(1997)0225
• Debate in Council: 2013
• Debate in Council: 2056
• Committee report tabled for plenary, 1st reading/single reading: A4-0074/1998
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 1st reading/single reading: T4-0136/1998
• Modified legislative proposal published: COM(1998)0232
• Council position published: 06492/1/1998
• Committee recommendation tabled for plenary, 2nd reading: A4-0336/1998
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 2nd reading: T4-0566/1998
• Joint text approved by Conciliation Committee co-chairs: 3602/1999
• Report tabled for plenary, 3rd reading: A4-0166/1999
• Debate in Parliament: Debate in Parliament
• Decision by Parliament, 3rd reading: T4-0299/1999
• : Decision 1999/1295
• : OJ L 155 22.06.1999, p. 0001

History

(these mark the time of scraping, not the official date of the change)