natgillin/translations-raw huggingface dataset:
(e) The Executive Director, assisted by his secretariat, shall in particular:
(e) The Executive Director, assisted by his secretariat, shall in particular:
See Amendments 12, 13 and 14.
See Amendments 12, 13 and 14.
Annex, Article 6, paragraph 7, point (g)
Annex, Article 6, paragraph 7, point (g)
(g) submit to the Board his/her proposal(s) concerning the organisation structure of the Executive Office and organise, direct and supervise the staff of the IMI Joint Undertaking;
(g) submit to the Board his/her proposal(s) concerning the organisation structure of the Executive Office and organise, direct and supervise the staff of the IMI Joint Undertaking;
(g) direct and supervise the staff of the IMI Joint Undertaking;
(g) direct and supervise the staff of the IMI Joint Undertaking;
See Amendments 12, 13, 14 and 15.
See Amendments 12, 13, 14 and 15.
Annex, Article 7, paragraph 1
Annex, Article 7, paragraph 1
The Scientific Committee is an advisory body to the Board and it shall conduct its activities in close liaison and with the support of the Executive Office .
The Scientific Committee is an advisory body to the Board and it shall conduct its activities in close liaison and with the support of the Executive Office .
The Scientific Committee is an advisory body to the Board and it shall conduct its activities in close liaison and with the support of the Executive Director .
The Scientific Committee is an advisory body to the Board and it shall conduct its activities in close liaison and with the support of the Executive Director .
See Amendments 12, 13, 14, 15 and 16.
See Amendments 12, 13, 14, 15 and 16.
Annex, Article 7, paragraph 6, point (c)
Annex, Article 7, paragraph 6, point (c)
(c) advise the Board and the Executive Office on the scientific achievements described in the annual activity report;.
(c) advise the Board and the Executive Office on the scientific achievements described in the annual activity report;.
(c) advise the Board and the Executive Director on the scientific achievements described in the annual activity report;
(c) advise the Board and the Executive Director on the scientific achievements described in the annual activity report;
See Amendments 12, 13, 14, 15, 16 and 17.
See Amendments 12, 13, 14, 15, 16 and 17.
Annex, Article 11, title and paragraph 1
Annex, Article 11, title and paragraph 1
Financial Regulation
Financial Regulation
The IMI Joint Undertaking’s financial regulation shall be agreed and adopted by the Board.
The IMI Joint Undertaking’s financial regulation shall be agreed and adopted by the Board.
Financial Rules
Financial Rules
The IMI Joint Undertaking’s financial rules shall be adopted by the Board after having consulted the Commission.
The IMI Joint Undertaking’s financial rules shall be adopted by the Board after having consulted the Commission.
See Amendments 5, 8, 12 and 13.
See Amendments 5, 8, 12 and 13.
Annex, Article 11, paragraph 2
Annex, Article 11, paragraph 2
The purpose of the financial regulation is to ensure the sound financial management of the IMI Joint Undertaking.
The purpose of the financial regulation is to ensure the sound financial management of the IMI Joint Undertaking.
The purpose of the financial rules is to ensure the sound financial management of the IMI Joint Undertaking.
The purpose of the financial rules is to ensure the sound financial management of the IMI Joint Undertaking.
See Amendments 5, 8, 12, 13 and 20.
See Amendments 5, 8, 12, 13 and 20.
Annex, Article 11, paragraph 3
Annex, Article 11, paragraph 3
The IMI Joint Undertaking's financial rules may not depart from Regulation (EC, Euratom) No 2343/2002, unless necessary for its specific operating needs .
The IMI Joint Undertaking's financial rules may not depart from Regulation (EC, Euratom) No 2343/2002, unless necessary for its specific operating needs .
The prior consent of the Commission shall be required for the adoption of any rules which derogate from Regulation (EC, Euratom) No 2343/2002.
The prior consent of the Commission shall be required for the adoption of any rules which derogate from Regulation (EC, Euratom) No 2343/2002.
See Amendments 5, 8, 12, 13, 20 and 21.
See Amendments 5, 8, 12, 13, 20 and 21.
Annex, Article 12, paragraph 5
Annex, Article 12, paragraph 5
The annual accounts and balance sheets for the preceding year shall be submitted to the Court of Auditors of the European Communities.
The annual accounts and balance sheets for the preceding year shall be submitted to the Court of Auditors of the European Communities.
An audit may be executed by the Court of Auditors in accordance with its standard procedures.
An audit may be executed by the Court of Auditors in accordance with its standard procedures.
The annual accounts and balance sheets for the preceding year shall be submitted to the Court of Auditors of the European Communities and to the budgetary authority .
The annual accounts and balance sheets for the preceding year shall be submitted to the Court of Auditors of the European Communities and to the budgetary authority .
Annex, Article 14, paragraph 1
Annex, Article 14, paragraph 1
The staff resources shall be determined in the establishment plan to be set out in the annual budget.
The staff resources shall be determined in the establishment plan to be set out in the annual budget.
The staff resources shall be determined in the establishment plan to be set out in the annual budget and to be forwarded by the Commission to the European Parliament and the Council together with the preliminary draft budget of the European Union.
The staff resources shall be determined in the establishment plan to be set out in the annual budget and to be forwarded by the Commission to the European Parliament and the Council together with the preliminary draft budget of the European Union.
Annex, Article 21, paragraph 2
Annex, Article 21, paragraph 2
Amendment to these Statutes shall be approved by the Board.
Amendment to these Statutes shall be approved by the Board.
If such amendment affects the overall principals and objectives of these Statutes, in particular any amendment to Article 1, first indent of Article 5(2)(c), Article 8(3) and Article 21 shall be subject to approval by the Council based on a proposal by the Commission.
If such amendment affects the overall principals and objectives of these Statutes, in particular any amendment to Article 1, first indent of Article 5(2)(c), Article 8(3) and Article 21 shall be subject to approval by the Council based on a proposal by the Commission.
If such amendment affects the overall principles and objectives of these Statutes, in particular any amendment to Article 1, the first indent of Article 5(2)(c), Article 8(3) and Article 21 shall be subject to approval by the Council based on a proposal by the Commission, and after consultation of the European Parliament.
If such amendment affects the overall principles and objectives of these Statutes, in particular any amendment to Article 1, the first indent of Article 5(2)(c), Article 8(3) and Article 21 shall be subject to approval by the Council based on a proposal by the Commission, and after consultation of the European Parliament.
Annex, Article 23 a (new)
Annex, Article 23 a (new)
Article 23a
Article 23a
Host Agreement
Host Agreement
A host agreement shall be concluded between the IMI Joint Undertaking and the host state.
A host agreement shall be concluded between the IMI Joint Undertaking and the host state.
Establishment of the Innovative Medicines Initiative Joint Undertaking
Establishment of the Innovative Medicines Initiative Joint Undertaking
Reimer Böge, Gérard Deprez, Valdis Dombrovskis, Brigitte Douay, James Elles, Salvador Garriga Polledo, Catherine Guy-Quint, Jutta Haug, Alain Lamassoure, Janusz Lewandowski, Vladimír Maňka, Margaritis Schinas, László Surján, Gary Titley, Kyösti Virrankoski
Reimer Böge, Gérard Deprez, Valdis Dombrovskis, Brigitte Douay, James Elles, Salvador Garriga Polledo, Catherine Guy-Quint, Jutta Haug, Alain Lamassoure, Janusz Lewandowski, Vladimír Maňka, Margaritis Schinas, László Surján, Gary Titley, Kyösti Virrankoski
The Innovative Medicines Initiative (IMI) is one of six so called "Joint Technology Initiatives" introduced by the Specific Programme “Cooperation” of the 7 th Framework Programme.
The Innovative Medicines Initiative (IMI) is one of six so called "Joint Technology Initiatives" introduced by the Specific Programme “Cooperation” of the 7 th Framework Programme.
It is a novel kind of pan-European Public Private Partnership between universities, hospitals, public authorities, patient organisations, clinical centres and pharmaceutical companies with the aim to boosting biomedical research and the development of new therapies.
It is a novel kind of pan-European Public Private Partnership between universities, hospitals, public authorities, patient organisations, clinical centres and pharmaceutical companies with the aim to boosting biomedical research and the development of new therapies.
The IMI will create partnerships through open calls for tender in accordance with a permanently updated Research Agenda.
The IMI will create partnerships through open calls for tender in accordance with a permanently updated Research Agenda.
The main focus will be on the pre-competitive sector of pharmaceutical research, thus tools to make early and reliable predictions on the safety and efficiency of medicine candidates in order to deliver potential benefits faster to patients and with greater certainty about the use of therapies.
The main focus will be on the pre-competitive sector of pharmaceutical research, thus tools to make early and reliable predictions on the safety and efficiency of medicine candidates in order to deliver potential benefits faster to patients and with greater certainty about the use of therapies.
In addition, the IMI will focus research on priority diseases like cancer or Alzheimer, set out by the Research Agenda and foster the collaboration between private and public sectors.
In addition, the IMI will focus research on priority diseases like cancer or Alzheimer, set out by the Research Agenda and foster the collaboration between private and public sectors.
The total budget will be € 2 billion for the period 2007-2013.
The total budget will be € 2 billion for the period 2007-2013.
The contribution from the Community will be € 1 billion.
The contribution from the Community will be € 1 billion.
This public funding will be matched by equal contributions from research based pharmaceutical companies, in form of staff, laboratory equipment, clinical research etc.
This public funding will be matched by equal contributions from research based pharmaceutical companies, in form of staff, laboratory equipment, clinical research etc.
Community funding will go exclusively to SMEs, non-profit organisations, academia, authorities, clinical centres or patient organisations - not to big companies.
Community funding will go exclusively to SMEs, non-profit organisations, academia, authorities, clinical centres or patient organisations - not to big companies.
The draftsman warmly welcomes IMI Joint Undertaking which will speed up the development of innovative medicines that reach patients faster and are better fitted to their needs.
The draftsman warmly welcomes IMI Joint Undertaking which will speed up the development of innovative medicines that reach patients faster and are better fitted to their needs.
The Initiative will also result in less risk through human clinical trials.
The Initiative will also result in less risk through human clinical trials.
The scientific and technological progress combined with better knowledge of the human genome allows the development of entirely new approaches to battle diseases.
The scientific and technological progress combined with better knowledge of the human genome allows the development of entirely new approaches to battle diseases.
Future medicines and therapies will be more precisely targeted to individual patients and thus improve their living conditions considerably.
Future medicines and therapies will be more precisely targeted to individual patients and thus improve their living conditions considerably.
We know today that there is no single cure for a certain disease - the right therapy rather depends on a multitude of factors like gender, tolerability or specific genetic characteristics.
We know today that there is no single cure for a certain disease - the right therapy rather depends on a multitude of factors like gender, tolerability or specific genetic characteristics.
Europe urgently needs more investment into research and development in this field in order to deliver potential benefits quickly to patients.
Europe urgently needs more investment into research and development in this field in order to deliver potential benefits quickly to patients.
This is why enhanced public funding in pre-competitive research activities is particularly justified and will entail more private funding on the medium term and make Europe more attractive for talented scientist.
This is why enhanced public funding in pre-competitive research activities is particularly justified and will entail more private funding on the medium term and make Europe more attractive for talented scientist.
It has to be recognised that the development of a new therapy is a very costly and unpredictable undertaking.
It has to be recognised that the development of a new therapy is a very costly and unpredictable undertaking.
Only a small part of medicines candidates reaches the stage of a marketing authorisation.
Only a small part of medicines candidates reaches the stage of a marketing authorisation.
The vast majority of research activities ends due to safety or efficiency concerns after hundreds of millions of Euros have been spend during the development process.
The vast majority of research activities ends due to safety or efficiency concerns after hundreds of millions of Euros have been spend during the development process.
At the same time, the investment into biopharmaceutical research in Europe is loosing pace with other parts of the world like the US or Japan.
At the same time, the investment into biopharmaceutical research in Europe is loosing pace with other parts of the world like the US or Japan.
Therefore, the IMI starts from the right point by using public and private money to boost large scale pan-European research in order to identify at the earliest possible stage whether a medicine candidate has the potential top become a safe and effective cure and to foster the collaboration between industry, academia and the non-profit sector for the benefit of the whole society.
Therefore, the IMI starts from the right point by using public and private money to boost large scale pan-European research in order to identify at the earliest possible stage whether a medicine candidate has the potential top become a safe and effective cure and to foster the collaboration between industry, academia and the non-profit sector for the benefit of the whole society.
IMI-projects will ensure that the substantial research needed to develop and validate new tools for drug discovery and development is well coordinated and will avoid the duplication of work.
IMI-projects will ensure that the substantial research needed to develop and validate new tools for drug discovery and development is well coordinated and will avoid the duplication of work.
Through the cooperation with big companies small scale research centres will also get the chance to get their ideas up and running.
Through the cooperation with big companies small scale research centres will also get the chance to get their ideas up and running.
The draftsman proposes a few amendments to the Commission's proposal, mainly aiming at ensuring an up-to date research agenda and an effective dissemination of the results to the public and private sector.
The draftsman proposes a few amendments to the Commission's proposal, mainly aiming at ensuring an up-to date research agenda and an effective dissemination of the results to the public and private sector.
In addition, improved transparency through a closer involvement of the European Parliament should be ensured by appointing independent EP representatives to the IMI Board.
In addition, improved transparency through a closer involvement of the European Parliament should be ensured by appointing independent EP representatives to the IMI Board.
Whilst the proposal gives a prominent role to one research based pharmaceutical association, it should be noted that there are also research activities with known substances, e.g. in the area of herbal or non-prescription medicines.
Whilst the proposal gives a prominent role to one research based pharmaceutical association, it should be noted that there are also research activities with known substances, e.g. in the area of herbal or non-prescription medicines.
The participation of these companies and the relevant trade association in the IMI JU must be possible.
The participation of these companies and the relevant trade association in the IMI JU must be possible.
Finally, it should be emphasised that beside evident benefits for Europe's competitiveness and diminished risk through human clinical trials, IMI projects will as well have a positive effect on the need for animal tests.
Finally, it should be emphasised that beside evident benefits for Europe's competitiveness and diminished risk through human clinical trials, IMI projects will as well have a positive effect on the need for animal tests.
Unnecessary tests will be avoided if a potential failure of a medicine candidate is recognised at an early stage and new tools in the drug development process will mostly not rely on animal tests but on new in-vitro techniques or computer based technologies.
Unnecessary tests will be avoided if a potential failure of a medicine candidate is recognised at an early stage and new tools in the drug development process will mostly not rely on animal tests but on new in-vitro techniques or computer based technologies.
The Committee on the Environment, Public Health and Food Safety calls on the Committee on Industry, Research and Energy, as the committee responsible, to incorporate the following amendments in its report:
The Committee on the Environment, Public Health and Food Safety calls on the Committee on Industry, Research and Energy, as the committee responsible, to incorporate the following amendments in its report:
(11) The Joint Technology Initiative on "Innovative Medicines” should propose a coordinated approach to overcome identified research bottlenecks in the drug development process, and to support 'pre-competitive pharmaceutical research and development', in order to accelerate the development of safe and more effective medicines for patients.
(11) The Joint Technology Initiative on "Innovative Medicines” should propose a coordinated approach to overcome identified research bottlenecks in the drug development process, and to support 'pre-competitive pharmaceutical research and development', in order to accelerate the development of safe and more effective medicines for patients.
In the present context 'pre-competitive pharmaceutical research and development' should be understood as research on the tools and methodologies used in the drug development process.
In the present context 'pre-competitive pharmaceutical research and development' should be understood as research on the tools and methodologies used in the drug development process.
Intellectual property originating from an Innovative Medicines Initiative (IMI) project should be licensed to third parties on fair and reasonable terms.
Intellectual property originating from an Innovative Medicines Initiative (IMI) project should be licensed to third parties on fair and reasonable terms.
It should be clarified that the intellectual property necessary to make use of the research tools developed by the partners of an IMI project, will be made available to third parties on fair and reasonable terms.
It should be clarified that the intellectual property necessary to make use of the research tools developed by the partners of an IMI project, will be made available to third parties on fair and reasonable terms.
Article 7, point (g)
Article 7, point (g)
(g) qualified non-profit patients organisations.
(g) qualified non-profit patients organisations.
(g) qualified non-profit patients organisations according to criteria to be established and defined by the Commission.
(g) qualified non-profit patients organisations according to criteria to be established and defined by the Commission.
There is a clear need for the Commission to establish certain criteria for non-profit patients organisations in terms of transparency and accountability to qualify for this particular funding.
There is a clear need for the Commission to establish certain criteria for non-profit patients organisations in terms of transparency and accountability to qualify for this particular funding.
Annex, Article 2, paragraph 2, point (c)
Annex, Article 2, paragraph 2, point (c)
(c) to make any necessary adjustments to the Research Agenda of the Joint Technology Initiative on "Innovative Medicines" in light of scientific developments occurring during its implementation;
(c) to make any necessary adjustments to the Research Agenda of the Joint Technology Initiative on "Innovative Medicines" in light of scientific developments occurring during its implementation;
(c) to regularly review and make any necessary adjustments to the Research Agenda of the Joint Technology Initiative on "Innovative Medicines" in light of scientific developments occurring during its implementation and in order to ensure that the health care priorities and the needs of patients are adequately addressed in Europe ;
(c) to regularly review and make any necessary adjustments to the Research Agenda of the Joint Technology Initiative on "Innovative Medicines" in light of scientific developments occurring during its implementation and in order to ensure that the health care priorities and the needs of patients are adequately addressed in Europe ;
The Research Agenda should be systematically reviewed in order to ensure that scientific progress and the benefit for patients in Europe are permanently taken into account.
The Research Agenda should be systematically reviewed in order to ensure that scientific progress and the benefit for patients in Europe are permanently taken into account.
Annex, Article 5, paragraph 1, point (f a) (new)
Annex, Article 5, paragraph 1, point (f a) (new)
(fa) the European Parliament shall appoint two independent representatives and two substitutes to the Board.
(fa) the European Parliament shall appoint two independent representatives and two substitutes to the Board.
Given the role of the European Parliament as part of the Budget Authority, it should be represented in the Board.
Given the role of the European Parliament as part of the Budget Authority, it should be represented in the Board.
Annex, Article 6, paragraph 2, point (e), indent 6
Annex, Article 6, paragraph 2, point (e), indent 6
- prepare the annual budget proposal, including the staff establishment plan;
- prepare the annual budget proposal, including the staff establishment plan;
- prepare the annual budget proposal, including the staff establishment plan, after consultation with the Scientific Committee and the Member States Group ;
- prepare the annual budget proposal, including the staff establishment plan, after consultation with the Scientific Committee and the Member States Group ;
Annex, Article 6, paragraph 7, point (i)
Annex, Article 6, paragraph 7, point (i)
(i) call the annual meeting of the Stakeholder Forum, to ensure openness and transparency of the activities of the IMI Joint Undertaking with its stakeholders;
(i) call the annual meeting of the Stakeholder Forum, to ensure openness and transparency of the activities of the IMI Joint Undertaking with its stakeholders;