(Consultation procedure)

The European Parliament,

–   having regard to the Commission proposal to the Council (COM(2007)0241),

–   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 Articles 171 and 172 of the EC Treaty, pursuant to which the Council consulted Parliament (C6-0171/2007),

–   having regard to Rule 51 of its Rules of Procedure,

–   having regard to the report of the Committee on Industry, Research and Energy and the opinions of the Committee on Budgets and the Committee on the Environment, Public Health and Food Safety (A6-0479/2007),

1.  Approves the Commission proposal as amended;

2.  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 will be evaluated in the context of the negotiations for the next financial framework;

3.  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;

4.  Calls on the Commission to alter its proposal accordingly, pursuant to Article 250(2) of the EC Treaty;

5.  Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

6.  Asks the Council to consult Parliament again if it intends to amend the Commission proposal substantially;

7.  Instructs its President to forward its position to the Council and Commission.

Text proposed by the Commission   Amendments by Parliament Amendment 1 Recital 10 (10)  The objective of the Joint Technology Initiative on "Innovative Medicines" should be to foster collaboration between all stakeholders such as industry, public authorities (including regulators), organisations of patients, academia and clinical centres. The Joint Technology Initiative on "Innovative Medicines" should define a commonly agreed research agenda (hereinafter referred to as "Research Agenda"), closely following the recommendations of the Strategic Research Agenda developed by the European Technology Platform on "Innovative Medicines". (10)  The objective of the Joint Technology Initiative on "Innovative Medicines" should be to foster collaboration between all stakeholders such as industry, including small and medium-sized enterprises (SMEs), public authorities (including regulators), organisations of patients, academia and clinical centres. The Joint Technology Initiative on "Innovative Medicines" should define a commonly agreed research agenda (hereinafter referred to as "Research Agenda"), closely following the recommendations of the Strategic Research Agenda developed by the European Technology Platform on "Innovative Medicines". Amendment 2 Recital 11 (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. (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 into the tools and methodologies used in the drug development process generally, rather than in the process of developing any particular drug. Intellectual property arising under a Joint Technology Initiative on "Innovative Medicines" project should be licensed to third parties on fair and reasonable terms. Amendment 3 Recital 13 a (new) (13a)  In pursuit of the objectives of the Specific Programme Cooperation, the IMI Joint Undertaking should make provision for boosting SME participation, inter alia by improving administrative procedures, taking their requirements more fully into account and deploying support measures. Amendment 4 Recital 13 b (new) (13b)  In pursuit of the objectives of Council Decision 2006/974/EC of 19 December 2006 on the Specific Programme: Capacities implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013)1, the IMI Joint Undertaking should be attuned to investment in research for the benefit of SMEs and to enhancing their capacity for innovation and their ability to exploit the results of research. ____________________ 1OJ L 400, 30.12.2006, p. 298, corrigendum in OJ L 54, 22.2.2007, p. 101.. Amendment 5 Recital 14 (14)  The IMI Joint Undertaking should be set up for an initial period ending on 31 December 2017 to ensure the appropriate management of research activities initiated but not concluded during the Seventh Framework Programme (2007-2013). (14)  The IMI Joint Undertaking should be set up for an initial period ending on 31 December 2013. To ensure the appropriate management of research activities initiated but not concluded during the Seventh Framework Programme (2007-2013), work in progress should continue until 31 December 2017, if necessary. Amendment 6 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, taking into account a recommendation from the Council. Amendment 7 Recital 17 (17)  Founding members of the IMI Joint Undertaking should be the European Community and EFPIA. (17)  The founding members of the IMI Joint Undertaking are the European Community and EFPIA. Amendment 8 Recital 26 (26)  The research based pharmaceutical companies that are full members of EFPIA activities shall not be eligible to receive support from the IMI Joint Undertaking. (26)  The research based pharmaceutical companies that are full members of EFPIA activities shall not be eligible to receive direct or indirect support from the IMI Joint Undertaking. Amendment 9 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 regulation1 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. _______________________ 1 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 Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the budget of the European Communities, OJ L 357, 31.12.2002, p. 72; corrigendum in OJ L 2, 7.1.2003, p. 39. (27)  The financial rules applicable to the IMI Joint Undertaking should not depart from Commission Regulation (EC, Euratom) No 2343/2002 of 19 November 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities1, unless its specific operating needs so require, 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 is required for the adoption of any rules which depart from Regulation (EC, Euratom) No 2343/2002. The budgetary authority should be informed of any such derogation. _______________________ 1 OJ L 357, 31.12.2002, p. 72. Corrigendum in OJ L 2, 7.1.2003, p. 39. Amendment 10 Recital 28 (28)  The need to ensure stable employment conditions and equal treatment of staff, and in order to attract specialised scientific and technical staff of the highest calibre, requires the application of the Staff Regulations of Officials of the European Communities and the Conditions of Employment of Other Servants of the European Communities, ("the Staff Regulation") to all staff recruited by the IMI Joint Undertaking. (28)  The requirement to ensure stable employment conditions and equal treatment of staff, and the need for specialised scientific and technical staff of the highest calibre, call for a degree of flexibility in the recruitment of staff for the IMI Joint Undertaking. The partnership should be balanced and each of the Founding Members should be in a position to recruit staff. The Commission should thus be free to second as many officials as it regards necessary to the IMI Joint Undertaking and the latter to recruit staff on a contractual basis in accordance with the employment law in force in the state where it has its seat. Amendment 11 Recital 33 (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. (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 the assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking. Amendment 12 Article 1, paragraph 1 1.  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. 1.  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 2013 (hereinafter referred to as "IMI Joint Undertaking"). Work in progress may nonetheless continue until 31 December 2017. The IMI Joint Undertaking is a body as referred to in Article 185 of the Financial Regulation and Point 47 of the IIA of 17 May 2006. Amendment 13 Article 3, point (b) (b) support the implementation of the research priorities as set out by the Research Agenda of the Joint Technology Initiative on "Innovative Medicines" (hereinafter referred to as "Research Activities"), notably by awarding grants following competitive calls for proposals; (b) support the implementation of the research priorities as set out by the Research Agenda of the Joint Technology Initiative on "Innovative Medicines" (hereinafter referred to as "Research Activities"), notably by awarding grants following competitive calls for proposals relating to research to be carried out exclusively in the Member States and the countries associated with the Seventh Framework Programme; Amendment 14 Article 6, paragraph 2 2.  The running costs of the IMI Joint Undertaking shall be financed by its Members. The Community and EFPIA shall contribute in equal part to such running costs. 2.  The running costs of the IMI Joint Undertaking shall be financed by its Members. The Community and EFPIA shall contribute in equal part to such running costs. The running costs shall not exceed 4% of the total budget of the IMI Joint Undertaking. Amendment 15 Article 7, point (a) (a) micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC; (a) micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC, in accordance with the specific objectives set for them in the Seventh Framework Programme; Amendment 16 Article 7, point (g) (g) qualified non-profit patients organisations. (g) legally established non-profit patients' organisations. Amendment 17 Article 8, title and paragraph 1 Financial Regulation Financial rules 1.  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. 1.  The financial rules applicable to the IMI Joint Undertaking shall not depart from Regulation (EC, Euratom) No 2343/2002, unless its specific operating needs so require and subject to the prior consent of the Commission. The budgetary authority shall be informed of any such derogation. Amendment 18 Article 8, paragraph 2 a (new) 2a.  The IMI Joint Undertaking may appoint an external auditor in order to verify the fairness and accuracy of the annual accounts drawn up by the IMI Joint Undertaking. Amendment 19 Article 8, paragraph 2 b (new) 2b.  The external auditor shall be responsible for ensuring satisfactory scrutiny of the annual accounts and the evaluation of the contributions made by the members and by the participants in the research projects. Amendment 21 Article 8, paragraph 2 c (new) 2c.  The IMI Joint Undertaking may make use of ad hoc external audits. Amendment 22 Article 8, paragraph 2 d (new) 2d.  The European Parliament shall be entitled to scrutinise the annual accounts of the IMI Joint Undertaking. Amendment 23 Article 9, paragraph 1 1.  The Staff Regulations of Officials of the European Communities, the Conditions of Employment of Other Servants of the European Communities and the rules adopted jointly by the Eeuropean Community institutions for the purpose of applying these Staff Regulations and Conditions of Employment shall apply to the staff of the IMI Joint undertaking and its Executive Director. 1.  The IMI Joint Undertaking shall rectuit its staff in accordance with applicable regulations of the host country. The Commission may second to the IMI Joint Undertaking as many officials as may be needed. Amendment 24 Article 9, paragraph 2 2.  In respect of its staff, the IMI Joint Undertaking shall exercise the powers conferred on the appointing authority by the Staff Regulations of Officials of the European Communities and on the authority empowered to conclude contracts by the Conditions of Employment of Other Servants of the European Communities. deleted Amendment 25 Article 9, paragraph 3 3.  The IMI Joint Undertaking shall, in agreement with the Commission, adopt the necessary implementing measures, in accordance with arrangements provided for in article 110 of the Staff Regulations of Officials of the European Communities, and the Conditions of Employment of Other Servants of the European Communities. 3.  The IMI Joint Undertaking shall, in agreement with the Commission, adopt the necessary implementing measures concerning the secondment of officials of the European Communities. Amendment 26 Article 13, paragraph 1 1.  The Commission shall present to the European Parliament and to the Council an annual report on the progress achieved by the IMI Joint Undertaking. 1.  The Commission shall present to the European Parliament and to the Council an annual report covering, in particular, the progress achieved by the IMI Joint Undertaking. Amendment 27 Article 13, paragraph 2 2.  Two years after the establishment of the IMI Joint Undertaking, but in any case no later than 2010, the Commission shall conduct an interim evaluation of the IMI Joint Undertaking with the assistance of independent experts. This evaluation shall cover the quality and efficiency of the IMI Joint Undertaking and progress towards the objectives set. The Commission shall communicate the conclusions thereof, accompanied by its observations to the European Parliament and to the Council. 2.  No later than 31 December 2011, the Commission shall present to the European Parliament and to the Council an interim evaluation of the IMI Joint Undertaking prepared with the assistance of independent experts. This evaluation shall cover the quality and efficiency of the IMI Joint Undertaking and progress towards the objectives set. Amendment 28 Article 13, paragraph 3 3.  At the end of 2017, the Commission shall conduct a final evaluation of the IMI Joint Undertaking with the assistance of independent experts. The results of the final evaluation shall be presented the European Parliament and to the Council. 3.  By 31 December 2013 or, if work in progress continues beyond that date, by 31 December 2017, the Commission shall conduct a final evaluation of the IMI Joint Undertaking with the assistance of independent experts. The results of the final evaluation shall be presented to the European Parliament and the Council. Amendment 29 Article 13, paragraph 4 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. 4.  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. Amendment 30 Article 16 The IMI Joint Undertaking shall adopt rules governing the use and dissemination of research results which ensure that, where appropriate, intellectual property generated in Research Activities under this Regulation is protected, and that research results are used and disseminated. The IMI Joint Undertaking shall adopt rules governing the use and dissemination of research results which ensure that, where appropriate, intellectual property generated in Research Activities under this Regulation is protected, and that research results are used and published by the IMI Joint Undertaking. Amendment 31 Article 18 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 assistance with regard to office accommodation, privileges and immunities and other support to be provided by Belgium to the IMI Joint Undertaking. Amendment 32 Article 19, paragraph 1 This Regulation shall enter into force on the third day of its publication in the Official Journal of the European Union. This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union. Amendment 33 Annex, Article 1, paragraph 3 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. 3.  The IMI Joint Undertaking shall be established as from the publication of these Statutes in the Official Journal of the European Union for a period ending on 31 December 2013. Amendment 34 Annex, Article 1, paragraph 4 4.  The initial period may be extended by amending these Statutes in accordance with the provisions of Article 21, taking into account the progress made towards achieving the objectives of the IMI Joint Undertaking and provided that financial sustainability is ensured. deleted Amendment 36 Annex, Article 2, paragraph 2, point (i) (i) to organise an annual meeting, hereafter referred to as a Stakeholder Forum, with interest groups to ensure openness and transparency of the Research Activities of the IMI Joint Undertaking with its stakeholders. (i) to organise an annual meeting, hereafter referred to as a Stakeholder Forum, an open meeting for relevant organisations with an interest in biomedical research to provide feedback on IMI activities, with interest groups to ensure openness and transparency of the Research Activities of the IMI Joint Undertaking with its stakeholders. Amendment 35 Annex, Article 2, paragraph 2, point (k) (k) to publish information on the projects, including the name of the participants, and the amount of the financial contribution of the IMI Joint Undertaking. (k) to publish, inter alia on its website, information on the projects, including the name of the participants, and the amount of the financial contribution of the IMI Joint Undertaking. Amendment 37 Annex, Article 4 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. Amendment 38 Annex, Article 5, paragraph 1, point (b) (b) the voting right of any new Member shall be determined in proportion to its contribution towards the total contributions to the activities of the IMI Joint Undertaking; (b) the voting right of any new Member shall be determined in proportion to its contribution towards the total contributions to the activities of the IMI Joint Undertaking. However, the total number of votes held by new Members may not exceed the total number of votes held by the Founding Members; Amendment 39 Annex, Article 5, paragraph 1, point (c) (c) the vote of each Member shall be indivisible; (c) the vote of each Member shall be indivisible; there shall be no proxy voting; Amendment 40 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 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 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; Amendment 41 Annex, Article 5, paragraph 3, subparagraph c a (new) (ca)  Three Members of the European Parliament may attend meetings as observers and shall be invited by the Board. Amendment 42 Annex, Article 5, paragraph 3 a (new) 3a.  The Board shall inform the Member States of decisions concerning the Research Agenda of the Joint Technology Initiative on "Innovative Medicines". Amendment 43 Annex, Article 6, title and paragraph 1 Executive Office Executive Director 1.  The Executive Office shall be composed of an Executive Director and supporting staff. Amendment 44 Annex, Article 6, paragraph 2, introductory part, points (a) to (d) and point (e), introductory part 2.  The tasks of the executive office are the following: 2.  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; (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; (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; (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; (e)  The Executive Office shall in particular: (e)  The Executive Director, assisted by his secretariat, shall in particular: Amendment 45 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, after consulting the Scientific Committee and the Stakeholder Forum; Amendment 46 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) direct and supervise the staff of the IMI Joint Undertaking; Amendment 47 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. 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 Director. Amendment 48 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 Director on the scientific achievements described in the annual activity report; Amendment 49 Annex, Article 8, paragraph 6 a (new) 6a.  The evaluation of proposals shall establish whether the funds requested are commensurate with the work involved in carrying out the project. Amendment 50 Annex, Article 11, title and paragraph 1 Financial Regulation Financial rules 1.  The IMI Joint Undertaking's financial regulation shall be agreed and adopted by the Board. 1.  The IMI Joint Undertaking's financial rules shall be adopted by the Board after consulting the Commission. Amendment 51 Annex, Article 11, paragraph 2 2.  The purpose of the financial regulation is to ensure the sound financial management of the IMI Joint Undertaking. 2.  The purpose of the financial rules is to ensure the sound financial management of the IMI Joint Undertaking. Amendment 52 Annex, Article 11, paragraph 3 3.  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. 3.  The IMI Joint Undertaking's financial rules shall not depart from Regulation (EC, Euratom) No 2343/2002, unless its specific operating needs so require and subject to the prior consent of the Commission. The budgetary authority shall be informed of any such derogation. Amendment 53 Annex, Article 12, paragraph 5 5.  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. 5.  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. An audit may be executed by the Court of Auditors in accordance with its standard procedures. Amendment 54 Annex, Article 13, paragraph 2, subparagraph 1 a (new) The Executive Director shall present the annual activity report to the European Parliament. Amendment 55 Annex, Article 14, paragraph 1 1.  The staff resources shall be determined in the establishment plan to be set out in the annual budget. 1.  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 general budget of the European Union. Amendment 56 Annex, Article 14, paragraph 2 2.  The members of the staff of the IMI Joint Undertaking shall be temporary agents and contract agents and shall have fixed term contracts extendable once up to a maximum total period of seven years. deleted Amendment 57 Annex, Article 17, paragraph 5, point (a) (a) micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC; (a) micro, small and medium-sized enterprises within the meaning of Commission Recommendation 2003/361/EC, in accordance with the specific objectives set for them by the Seventh Framework Programme; Amendment 20 Annex, Article 17 a (new) Article 17a Scientific and financial reports Annual scientific and financial reports on the projects supported shall be submitted to the IMI Joint Undertaking by the participants. Such reports shall give details of the research activities carried out and the costs of such activities. Statements of expenditure shall be accompanied by an audit certificate. The external auditor shall examine the audit certificates and determine whether the in kind contributions match the contributions from public funds to the project. Amendment 59 Annex, Article 21, paragraph 2 2.  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. 2.  Amendment to these Statutes shall be approved by the Board. 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 consulting the European Parliament. Amendment 60 Annex, Article 22, paragraph 3, point (a) (a)  Each participant in a project shall remain the owner of the intellectual property that it introduces into a project, and shall remain the owner of the intellectual property that it generates in a project unless otherwise mutually agreed by the participants in a project. The terms and conditions of access rights and licenses with regard to the intellectual property introduced into or generated by participants in a project, shall be defined in the Grant Agreement and the Project Agreement of the project concerned. (a)  Each participant in a project shall remain the owner of the intellectual property that it introduces into a project, and shall remain the owner of the intellectual property that it generates in a project unless otherwise mutually agreed by the participants in a project. The terms and conditions of access rights and licenses with regard to the intellectual property introduced into or generated by participants in a project, shall be defined in the Grant Agreement and the Project Agreement of the project concerned. Project participants should establish any cases of co-ownership of intellectual property arising from projects. Amendment 61 Annex, Article 23 a (new) Article 23a Host Agreement A host agreement shall be concluded between the IMI Joint Undertaking and the Kingdom of Belgium.

(1) OJ L 248, 16.9.2002, p. 1. Regulation as amended by Regulation (EC, Euratom) No 1995/2006 (OJ L 390, 30.12.2006, p. 1). (2) OJ C 139, 14.6.2006, p. 1.