Resources made available to the Joint Undertaking in 2009

Competences of the Joint Undertaking as defined in Regulation (EC) No 73/2008

Treaty on the Functioning of the European Union Title XIX ‘Research and Technological Development and Space’. Article 187 (ex Article 171 EC) states: The Union may set up joint undertakings or any other structure necessary for the efficient execution of Union research, technological development and demonstration programmes. Article 188(1) (ex Article 172(1) EC) states: The Council, on a proposal from the Commission and after consulting the European Parliament and the Economic and Social Committee, shall adopt the provisions referred to in Article 187.

Objectives Article 2 of Regulation (EC) No 73/2008 states: The IMI Joint Undertaking shall contribute to the implementation of the Seventh Framework Programme and in particular the Theme ‘Health’ of the Specific Programme Cooperation implementing the Seventh Framework Programme. It shall have the objective of significantly improving the efficiency and effectiveness of the drug development process with the long-term aim that the pharmaceutical sector produce more effective and safer innovative medicines. In particular it shall: (a) support ‘pre-competitive pharmaceutical research and development’ in the Member States and countries associated with the Seventh Framework Programme via a coordinated approach to overcomethe identified research bottlenecks in the drug development process; (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; (c) ensure complementarity with other activities of the Seventh Framework Programme; (d) be a public-private partnership aiming at increasing the research investment in the biopharmaceutical sector in the Members States and countries associated to the Seventh Framework Programme by pooling resources and fostering collaboration between the public and private sectors; (e) promote the involvement of small and medium-sized enterprises (SME) in its activities, in line with the objectives of the Seventh Framework Programme.

Tasks Article 1 of the Statutes annexed to the Council Regulation states: The main tasks and activities of the IMI Joint Undertaking shall be: (a) to ensure the establishment and sustainable management of the Joint Technology Initiative on ‘Innovative Medicines’; (b) to define and carry out the annual implementation plan referred to in Article 18 via calls for project; (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; (d) to mobilise the public and private sector resources needed; (e) to establish and develop close and long-term cooperation between the Union, industry and the other stakeholders such as regulatory bodies, patients organisations, academia and clinical centres, as well as cooperation between industry and academia; (f) to facilitate coordination with national and international activities in this area; (g) to undertake communication and dissemination activities; (h) to communicate and interact with the Member States and the countries associated within the Seventh Framework Programme via the IMI States Representatives Group, specifically established for this purpose; (i) to organise at least an annual meeting (hereinafter 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; (j) to notify legal entities that have concluded a grant agreement with the IMI Joint Undertaking of the potential borrowing opportunities from the European Investment Bank, in particular the Risk Sharing Finance Facility set up under the Seventh Framework Programme; (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 per participant; (l) to ensure the efficiency of the Joint Technology Initiative on ‘Innovative Medicines’; (m) to carry out any other activity needed to achieve the objectives referred to in Article 2 of the Regulation.

1 — Governing Board The Governing Board is the main decision-making body of the IMI JU and shall be responsible for the supervision of the Joint Undertaking in the pursuit of its objectives. It ensures close collaboration between the Joint Undertaking and its Members in the implementation of its activities. It therefore guarantees the fulfilment of the objectives set by the IMI JU, namely overcoming bottlenecks in European pharmaceutical R & D and supporting biomedical research for the benefit of patients. 2 — Executive Director The Executive Director — appointed by the Governing Board — shall be the chief executive responsible for the day-to-day management of the IMI Joint Undertaking in accordance with the decisions of the Governing Board. In that context, he/she shall regularly inform as well as respond to any specific ad hoc requests for information from the Governing Board and the Scientific Committee. The Executive Director shall be the legal representative of the IMI Joint Undertaking. He/she shall perform his/her tasks with complete independence, and shall be accountable to the Governing Board. 3 — Scientific Committee The Scientific Committee is an advisory body to the Governing Board and conducts its activities in close liaison with the support of the Executive Office. The Scientific Committee shall advise on the Research Agenda on the scientific priorities for the annual implementation plan proposal and on the scientific achievements described in the annual activity report. IMI JU is also supported by 2 external advisory bodies: 4 — IMI States Representatives Group The IMI States Representative Group consists of one representative of each Member State and of each country associated to the Framework Programme. It has an advisory role for the IMI Joint Undertaking and acts as an interface between the IMI Joint Undertaking and the relevant stakeholders within their respective countries. 5 — Stakeholder Forum The Stakeholder Forum is a meeting opened to all stakeholders to provide comments and convened at least once a year by the Executive Director. 6 — External Audit Court of Auditors. 7 — Discharge Authority Parliament on a recommendation of the Council.

Budget 81,9 million euro funded by Union contribution and 50 % of the running costs received form EFPIA (0,5 million euro) Staff at 31 December 2009 29 posts in the annual establishment plan of which 12 occupied at 31.12.2009 and assigned to the following duties: — Executive Director: 1, — scientific: 3, — operational tasks: 5, — administration tasks: 3.