natgillin/translations-raw huggingface dataset:
Against this background, the Innovative Medicines Initiative Joint Undertaking (IMI JU) is the legal entity that will be responsible for implementation of the Joint Technology Initiative on Innovative Medicines (IMI JTI).
Against this background, the Innovative Medicines Initiative Joint Undertaking (IMI JU) is the legal entity that will be responsible for implementation of the Joint Technology Initiative on Innovative Medicines (IMI JTI).
The present proposal relates to the setting-up of the IMI JU under Article 171 of the Treaty.
The present proposal relates to the setting-up of the IMI JU under Article 171 of the Treaty.
The IMI JU should be considered as a Community body and be established for a period ending on 31 December 2017.
The IMI JU should be considered as a Community body and be established for a period ending on 31 December 2017.
It will have its seat in Brussels, Belgium.
It will have its seat in Brussels, Belgium.
It will be founded by the European Community, represented by the EC, and the European Federation of Pharmaceutical Industries and Associations, EFPIA.
It will be founded by the European Community, represented by the EC, and the European Federation of Pharmaceutical Industries and Associations, EFPIA.
The activities of the IMI JU will be jointly funded by its founders.
The activities of the IMI JU will be jointly funded by its founders.
The European Community and EFPIA will contribute in equal parts to the running costs of the IMI JU.
The European Community and EFPIA will contribute in equal parts to the running costs of the IMI JU.
The research activities will be jointly funded through contributions by the EFPIA member companies with resources (personnel, equipment, consumables, etc.), and a matching contribution from the European Community.
The research activities will be jointly funded through contributions by the EFPIA member companies with resources (personnel, equipment, consumables, etc.), and a matching contribution from the European Community.
The IMI JU will have a total budget of EUR 2 billion.
The IMI JU will have a total budget of EUR 2 billion.
The EC will contribute with EUR 1 billion from FP7.
The EC will contribute with EUR 1 billion from FP7.
The remaining EUR 1 billion will be contributed by EFPIA and the research-based pharmaceutical companies that are full members of EFPIA.
The remaining EUR 1 billion will be contributed by EFPIA and the research-based pharmaceutical companies that are full members of EFPIA.
Two new budget lines will be created for the EU contribution:
Two new budget lines will be created for the EU contribution:
08.02 01 10 "Operational expenditures for research activities of the IMI Joint Undertaking"
08.02 01 10 "Operational expenditures for research activities of the IMI Joint Undertaking"
08.02 01 20 "Support expenditures for running costs of the IMI Joint Undertaking"
08.02 01 20 "Support expenditures for running costs of the IMI Joint Undertaking"
with the following expenditure profile:
with the following expenditure profile:
Section no.
Section no.
Year 2008
Year 2008
2013 and later
2013 and later
Expenditure 08.02 01 10 "Operational expenditures for research activities of the IMI Joint Undertaking"
Expenditure 08.02 01 10 "Operational expenditures for research activities of the IMI Joint Undertaking"
122 700
122 700
76 800
76 800
95 800
95 800
155 400
155 400
294 300
294 300
215 000
215 000
960 000
960 000
Administrative expenditure
Administrative expenditure
Expenditure 08.02 01 20 "Support expenditures for running costs of the IMI Joint Undertaking"
Expenditure 08.02 01 20 "Support expenditures for running costs of the IMI Joint Undertaking"
Technical & administrative assistance (NDA)
Technical & administrative assistance (NDA)
2 300
2 300
3 200
3 200
4 200
4 200
4 600
4 600
5 700
5 700
20 000
20 000
40 000
40 000
TOTAL REFERENCE AMOUNT
TOTAL REFERENCE AMOUNT
125 000
125 000
80 000
80 000
160 000
160 000
300 000
300 000
The draftswoman's amendments are mainly based on two concerns:
The draftswoman's amendments are mainly based on two concerns:
1) The JU is established for an initial period ending on 31 December 2017 (which may even be extended to a later date), whereas the MFF only covers the period up to 2013.
1) The JU is established for an initial period ending on 31 December 2017 (which may even be extended to a later date), whereas the MFF only covers the period up to 2013.
Therefore, any request for Community funding for the IMI JU after 2013 has to be newly evaluated in the context of the negotiations for a new financial framework.
Therefore, any request for Community funding for the IMI JU after 2013 has to be newly evaluated in the context of the negotiations for a new financial framework.
As for the current period, the proposal - although falling under Heading 1a with its dwindling margins - is compatible with the MFF, for the simple reason, that the EU contribution required is taken from the FP7 and has as such already been included in the Commission's financial programming.
As for the current period, the proposal - although falling under Heading 1a with its dwindling margins - is compatible with the MFF, for the simple reason, that the EU contribution required is taken from the FP7 and has as such already been included in the Commission's financial programming.
Nevertheless, your draftswoman would like to point out that no financial commitments can be made for the time after the current MFF (Amendment 1).
Nevertheless, your draftswoman would like to point out that no financial commitments can be made for the time after the current MFF (Amendment 1).
2) By analogy with the negotiations on the ITER Joint Undertaking at the beginning of 2007 which led to the Conclusions agreed at the Trilogue of 7 March 2007, the IMI JU has to be considered as an agency within the meaning of Article 185 of the Financial Regulation and is therefore subject to an agreement by the budgetary authority on its financing (Amendments 2, 3, 7 and 11).
2) By analogy with the negotiations on the ITER Joint Undertaking at the beginning of 2007 which led to the Conclusions agreed at the Trilogue of 7 March 2007, the IMI JU has to be considered as an agency within the meaning of Article 185 of the Financial Regulation and is therefore subject to an agreement by the budgetary authority on its financing (Amendments 2, 3, 7 and 11).
At the same time, if the basic assumption is that the IMI JU is to be treated as an agency for budgetary purposes, it has to be consistent with the general approach on agencies that the Committee on Budgets has developed over the past years.
At the same time, if the basic assumption is that the IMI JU is to be treated as an agency for budgetary purposes, it has to be consistent with the general approach on agencies that the Committee on Budgets has developed over the past years.
Your draftswoman therefore presents a series of amendments which guarantee such a consistent approach (Amendments 4-6, 8-10 and 12-26).
Your draftswoman therefore presents a series of amendments which guarantee such a consistent approach (Amendments 4-6, 8-10 and 12-26).
The Committee on Budgets calls on the Committee on Industry, Research and Energy, as the committee responsible, to incorporate the following amendments in its report:
The Committee on Budgets calls on the Committee on Industry, Research and Energy, as the committee responsible, to incorporate the following amendments in its report:
Considers that the reference amount indicated in the legislative proposal must be compatible with the ceiling of heading 1a of the current multiannual financial framework 2007 - 2013 and with the provisions of Point 47 of the Interinstitutional Agreement (IIA) of 17 May 2006; notes that any financing beyond 2013 shall be evaluated in the context of the negotiations for the next financial framework;
Considers that the reference amount indicated in the legislative proposal must be compatible with the ceiling of heading 1a of the current multiannual financial framework 2007 - 2013 and with the provisions of Point 47 of the Interinstitutional Agreement (IIA) of 17 May 2006; notes that any financing beyond 2013 shall be evaluated in the context of the negotiations for the next financial framework;
Paragraph 1 b (new)
Paragraph 1 b (new)
Recalls that the opinion delivered by the Committee on Budgets does not pre-empt the outcome of the procedure laid down in Point 47 of the IIA of 17 May 2006 which applies to the setting up of the Innovative Medicines Initiative Joint Undertaking;
Recalls that the opinion delivered by the Committee on Budgets does not pre-empt the outcome of the procedure laid down in Point 47 of the IIA of 17 May 2006 which applies to the setting up of the Innovative Medicines Initiative Joint Undertaking;
Citations 1 a and 1 b (new)
Citations 1 a and 1 b (new)
Having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities 1 (Financial Regulation), and in particular Article 185 thereof,
Having regard to Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the general budget of the European Communities 1 (Financial Regulation), and in particular Article 185 thereof,
Having regard to the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management 2 (IIA) , and in particular Point 47 thereof,
Having regard to the Interinstitutional Agreement of 17 May 2006 between the European Parliament, the Council and the Commission on budgetary discipline and sound financial management 2 (IIA) , and in particular Point 47 thereof,
1 OJ L 248, 16.9.2002, p.
1 OJ L 248, 16.9.2002, p.
Regulation as amended by Regulation (EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p.
Regulation as amended by Regulation (EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p.
2 OJ C 139, 14.6.2006, p.
2 OJ C 139, 14.6.2006, p.
Recital 16
Recital 16
(16) The IMI Joint Undertaking should be a body set up by the Communities and discharge for the implementation of its budget should be given by the European Parliament, on the recommendation of the Council, taking however into account the specificities resulting from the nature of JTIs as public-private partnerships and in particular from the private sector contribution to the budget.
(16) The IMI Joint Undertaking should be a body set up by the Communities and discharge for the implementation of its budget should be given by the European Parliament, on the recommendation of the Council, taking however into account the specificities resulting from the nature of JTIs as public-private partnerships and in particular from the private sector contribution to the budget.
(16) The IMI Joint Undertaking should be a body set up by the Communities and discharge for the implementation of its budget should be given by the European Parliament, taking into account a recommendation from the Council.
(16) The IMI Joint Undertaking should be a body set up by the Communities and discharge for the implementation of its budget should be given by the European Parliament, taking into account a recommendation from the Council.
Recital 27
Recital 27
(27) The IMI Joint Undertaking should have, subject to prior consultation with the Commission, a distinct Financial Regulation based on the principles of the framework financial regulation which takes into account its specific operating needs arising, in particular, from the need to combine Community and private funding to support research and development activities in an efficient and timely manner.
(27) The IMI Joint Undertaking should have, subject to prior consultation with the Commission, a distinct Financial Regulation based on the principles of the framework financial regulation which takes into account its specific operating needs arising, in particular, from the need to combine Community and private funding to support research and development activities in an efficient and timely manner.
(27) The financial rules applicable to the IMI Joint Undertaking should not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of the Financial Regulation 1 , unless specifically required for its operating needs , in particular the need to combine Community and private funding to support research and development activities in an efficient and timely manner.
(27) The financial rules applicable to the IMI Joint Undertaking should not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of the Financial Regulation 1 , unless specifically required for its operating needs , in particular the need to combine Community and private funding to support research and development activities in an efficient and timely manner.
The prior consent of the Commission should be required for the adoption of any rules which derogate from Regulation (EC, Euratom) No 2343/2002.
The prior consent of the Commission should be required for the adoption of any rules which derogate from Regulation (EC, Euratom) No 2343/2002.
The budgetary authority should be informed of such derogations.
The budgetary authority should be informed of such derogations.
1 OJ L 357, 31.12.2002, p.
1 OJ L 357, 31.12.2002, p.
Recital 33
Recital 33
(33) The IMI Joint Undertaking should be established in Brussels, Belgium.
(33) The IMI Joint Undertaking should be established in Brussels, Belgium.
A host agreement should be concluded between the IMI Joint Undertaking and Belgium concerning office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
A host agreement should be concluded between the IMI Joint Undertaking and Belgium concerning office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
A host agreement should be concluded between the IMI Joint Undertaking and Belgium concerning the host country's assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
A host agreement should be concluded between the IMI Joint Undertaking and Belgium concerning the host country's assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
For the implementation of the Joint Technology Initiative on Innovative Medicines, a Joint Undertaking is hereby set up for a period ending on 31 December 2017 (hereinafter referred to as "IMI Joint Undertaking").
For the implementation of the Joint Technology Initiative on Innovative Medicines, a Joint Undertaking is hereby set up for a period ending on 31 December 2017 (hereinafter referred to as "IMI Joint Undertaking").
This period may be extended by the Council .
This period may be extended by the Council .
This period may be extended by a revision of this Regulation .
This period may be extended by a revision of this Regulation .
The IMI Joint Undertaking is a body set up in accordance with Article 185 of the Financial Regulation and Point 47 of the IIA of 17 May 2006.
The IMI Joint Undertaking is a body set up in accordance with Article 185 of the Financial Regulation and Point 47 of the IIA of 17 May 2006.
For any extension of the Joint Undertaking's lifetime, the respective legislative procedure has to be followed.
For any extension of the Joint Undertaking's lifetime, the respective legislative procedure has to be followed.
The IMI Joint Undertaking's Financial Regulation shall be based on the principles of the Framework Financial Regulation.
The IMI Joint Undertaking's Financial Regulation shall be based on the principles of the Framework Financial Regulation.
It may depart from the Framework Financial Regulation where the specific operating needs of the IMI Joint Undertaking so require and subject to prior consultation with the Commission.
It may depart from the Framework Financial Regulation where the specific operating needs of the IMI Joint Undertaking so require and subject to prior consultation with the Commission.
The financial rules applicable to the IMI Joint Undertaking may not depart from Regulation (EC, Euratom) No 2343/2002, unless specifically required for its operating needs and subject to prior consent of the Commission.
The financial rules applicable to the IMI Joint Undertaking may not depart from Regulation (EC, Euratom) No 2343/2002, unless specifically required for its operating needs and subject to prior consent of the Commission.
The budgetary authority shall be informed of such derogations.
The budgetary authority shall be informed of such derogations.
See Amendment 5.
See Amendment 5.
Article 13, paragraph 4
Article 13, paragraph 4
Discharge for the implementation of the budget of the IMI Joint Undertaking shall be given by the European Parliament, upon recommendation of the Council , in accordance with a procedure provided for by the Financial Regulation of the IMI Joint Undertaking.
Discharge for the implementation of the budget of the IMI Joint Undertaking shall be given by the European Parliament, upon recommendation of the Council , in accordance with a procedure provided for by the Financial Regulation of the IMI Joint Undertaking.
Discharge for the implementation of the budget of the IMI Joint Undertaking shall be given by the European Parliament, taking into account a recommendation from the Council.
Discharge for the implementation of the budget of the IMI Joint Undertaking shall be given by the European Parliament, taking into account a recommendation from the Council.
A host agreement shall be concluded between the IMI Joint Undertaking and Belgium concerning office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
A host agreement shall be concluded between the IMI Joint Undertaking and Belgium concerning office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
A host agreement shall be concluded between the IMI Joint Undertaking and Belgium concerning the host country's assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
A host agreement shall be concluded between the IMI Joint Undertaking and Belgium concerning the host country's assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking.
Annex, Article 1, paragraph 3
Annex, Article 1, paragraph 3
The IMI Joint Undertaking shall be established as from the publication of these Statutes in the Official Journal of the European Union for an initial period ending on 31 December 2017.
The IMI Joint Undertaking shall be established as from the publication of these Statutes in the Official Journal of the European Union for an initial period ending on 31 December 2017.
It is a body set up in accordance with Article 185 of the Financial Regulation and Point 47 of the IIA of 17 May 2006.
It is a body set up in accordance with Article 185 of the Financial Regulation and Point 47 of the IIA of 17 May 2006.
See Amendment 7.
See Amendment 7.
Annex, Article 4
Annex, Article 4
The bodies IMI Joint Undertaking shall be the Board, the Executive Office and the Scientific Committee.
The bodies IMI Joint Undertaking shall be the Board, the Executive Office and the Scientific Committee.
The bodies of the IMI Joint Undertaking shall be the Board, the Executive Director and the Scientific Committee.
The bodies of the IMI Joint Undertaking shall be the Board, the Executive Director and the Scientific Committee.
Annex, Article 5, paragraph 2, point (c), indents 9 to 13
Annex, Article 5, paragraph 2, point (c), indents 9 to 13
– approve the guidelines on evaluation and selection of project proposals as proposed by the Executive Office ;
– approve the guidelines on evaluation and selection of project proposals as proposed by the Executive Office ;
– approve the guidelines on evaluation and selection of project proposals as proposed by the Executive Director ;
– approve the guidelines on evaluation and selection of project proposals as proposed by the Executive Director ;
- approve the list of selected project proposals;
- approve the list of selected project proposals;
- appoint the Executive Director, provide guidance and direction to the Executive Director, monitor the Executive Director's performance and, if necessary, replace the Executive Director;
- appoint the Executive Director, provide guidance and direction to the Executive Director, monitor the Executive Director's performance and, if necessary, replace the Executive Director;
– approve the organisational structure of the Executive Office based on recommendations of the Executive Director;
– approve the organisational structure of the Executive Office based on recommendations of the Executive Director;
– approve the financial regulation of the IMI Joint Undertaking in accordance with Article 11;
– approve the financial regulation of the IMI Joint Undertaking in accordance with Article 11;
– approve the financial rules of the IMI Joint Undertaking in accordance with Article 11, after consulting the Commission ;
– approve the financial rules of the IMI Joint Undertaking in accordance with Article 11, after consulting the Commission ;
See Amendments 5, 8 and 12.
See Amendments 5, 8 and 12.
Annex, Article 6, title and paragraph 1
Annex, Article 6, title and paragraph 1
Executive Office
Executive Office
The Executive Office shall be composed of an Executive Director and supporting staff.
The Executive Office shall be composed of an Executive Director and supporting staff.
Executive Director
Executive Director
See Amendments 12 and 13.
See Amendments 12 and 13.
Annex, Article 6, paragraph 2, introductory part, points (a) to (d) and point (e), introductory part
Annex, Article 6, paragraph 2, introductory part, points (a) to (d) and point (e), introductory part
The tasks of the executive office are the following:
The tasks of the executive office are the following:
The tasks of the Executive Director are the following:
The tasks of the Executive Director are the following:
(a) The Executive Office shall be in charge of the day-to-day management of the IMI Joint Undertaking;
(a) The Executive Office shall be in charge of the day-to-day management of the IMI Joint Undertaking;
(b) The Executive Office shall be responsible for the operational aspects of the IMI Joint Undertaking;
(b) The Executive Office shall be responsible for the operational aspects of the IMI Joint Undertaking;
(b) The Executive Director, assisted by his secretariat, shall be responsible for the operational aspects of the IMI Joint Undertaking;
(b) The Executive Director, assisted by his secretariat, shall be responsible for the operational aspects of the IMI Joint Undertaking;
(c) The Executive Office shall be responsible for the communication activities related to the IMI Joint Undertaking;
(c) The Executive Office shall be responsible for the communication activities related to the IMI Joint Undertaking;
(c) The Executive Director, assisted by his secretariat, shall be responsible for the communication activities related to the IMI Joint Undertaking;
(c) The Executive Director, assisted by his secretariat, shall be responsible for the communication activities related to the IMI Joint Undertaking;
(d) The Executive Office shall manage appropriately the public and private funds;
(d) The Executive Office shall manage appropriately the public and private funds;
(d) The Executive Director, assisted by his secretariat, shall manage appropriately the public and private funds;
(d) The Executive Director, assisted by his secretariat, shall manage appropriately the public and private funds;
(e) The Executive Office shall in particular:
(e) The Executive Office shall in particular: