COUNCIL REGULATION (EC) No 73/2008
of 20 December 2007
setting up the Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines
(Text with EEA relevance)
THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 171 and 172 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Parliament,
Having regard to the opinion of the European Economic and Social Committee (1),
Whereas:
(1)
Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007-2013) (2) (hereinafter referred to as the Seventh Framework Programme) provides for a Community contribution for the establishment of long-term public private partnerships in the form of Joint Technology Initiatives which could be implemented through Joint Undertakings within the meaning of Article 171 of the Treaty. These Joint Technology Initiatives result from the work of European Technology Platforms, already set up under the Sixth Framework Programme, and cover selected aspects of research in their field. They should combine private sector investment and European public funding, including funding from the Seventh Framework Programme.
(2)
Council Decision/2006/971/EC of 19 December 2006 concerning the specific programme ‘Cooperation’ implementing the Seventh Framework Programme of the European Community for research, technological development and demonstration activities (2007 to 2013) (3) (hereinafter referred as the Specific Programme Cooperation) underlines the need for ambitious pan-European public private partnerships to accelerate the development of major technologies, large research actions at Community level including, in particular, Joint Technology Initiatives.
(3)
The Lisbon Growth and Jobs Agenda underscores the need to develop favourable conditions for investment in knowledge and innovation in Europe to boost competitiveness, growth and jobs in the Community.
(4)
In its conclusions of 13 March 2003, of 22 September 2003 and of 24 September 2004, the Council highlighted the importance of further developing actions following the 3 % Action Plans, including the development of new initiatives aimed at intensifying cooperation between industry and the public sector in funding research to enhance trans-national public-private links.
(5)
In its conclusions of 4 December 2006 and of 19 February 2007, the Competitiveness Council and in its conclusions of 9 March 2007 the European Council invited the Commission to present proposals for the setting up of Joint Technology Initiatives for such initiatives that have reached an appropriate stage of preparedness.
(6)
The European Federation of Pharmaceutical Industries and Associations (hereinafter referred to as EFPIA) took the lead in establishing the European Technology Platform on Innovative Medicines under the Sixth Framework Programme. It developed a Strategic Research Agenda, based on an extensive consultation with public and private stakeholders. The Strategic Research Agenda described the research bottlenecks in the drug development process and recommends the scientific direction for a Joint Technology Initiative on Innovative Medicines.
(7)
The Joint Technology Initiative on Innovative Medicines responds to the Commission Communication of 1 July 2003‘A Stronger European-based Pharmaceutical Industry for the Benefit of the Patient - A Call for Action’ and in particular to the recommendation regarding access to innovative medicines to secure the development of a competitive innovative-based industry. This Communication was a response to the Report ‘Stimulating Innovation and Improving the EU Science Base’ adopted on 7 May 2002 by the High Level Group on innovation and provision of medicines - G10 Medicines. This Joint Technology Initiative also responds to the Commission Communication of 23 January 2002‘Life Sciences and Biotechnology - a strategy for Europe (2002)’.
(8)
The Joint Technology Initiative on Innovative Medicines also replies to the need for action as identified in the Report ‘Creating an Innovative Europe’ of January 2006. This report identifies pharmaceuticals as a key strategic area and it stresses the need for the Joint Technology Initiative on Innovative Medicines at European level.
(9)
The Joint Technology Initiative on Innovative Medicines should be a public private partnership aiming at increasing investments in the biopharmaceutical sector in Europe in the Members States and countries associated within the Seventh Framework Programme. It should provide socioeconomic benefits for European citizens, contribute to the health of European citizens, increase the competitiveness of Europe and help to establish Europe as the most attractive place for biopharmaceutical research and development.
(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 which identified efficacy, safety, knowledge management and training as important areas.
(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.
(12)
The Joint Technology Initiative on Innovative Medicines should deliver new approaches, methods and technologies, improve knowledge management of research results and data, and support the training of professionals. To this end, it is necessary to set up a Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines (hereinafter referred to as the IMI Joint Undertaking) as a legal entity.
(13)
The objective of the IMI Joint Undertaking should be achieved through support of research activities by pooling resources from the public and private sectors. To this end, the IMI Joint Undertaking should be capable of organising competitive calls for proposals for supporting the research activities. Such research activities should respect fundamental ethical principles applicable in the Seventh Framework Programme.
(14)
The IMI Joint Undertaking should be set up for a period up to 31 December 2017 to ensure the appropriate management of research activities initiated but not concluded during the Seventh Framework Programme (2007 to 2013).
(15)
The IMI Joint Undertaking should be a body set up by the Community and discharge for the implementation of its budget should be given by the European Parliament, on the recommendation of the Council, in accordance with Council Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on the Financial Regulation applicable to the budget of the European Communities (hereinafter referred to as the Financial Regulation) (4) taking however into account the specificities resulting from the nature of joint technology initiatives as public-private partnerships and in particular from the private sector contribution to the budget.
(16)
Founding members of the IMI Joint Undertaking should be the Community and EFPIA.
(17)
EFPIA is a non-profit organisation representing the research based pharmaceutical industry in Europe. The aim of EFPIA is to ensure and promote the technological and economic development of the pharmaceutical industry in Europe. EFPIA is open for membership to national associations of research-based pharmaceutical companies, as well as directly to research-based pharmaceutical companies. It applies general principles of openness and transparency for membership ensuring a wide industrial involvement.
(18)
The IMI Joint Undertaking should be open to new members.
(19)
The rules for organisation and operation of the IMI Joint Undertaking should be laid down in the Statutes of the IMI Joint Undertaking as part of this Regulation.
(20)
A letter of commitment concerning the Statutes of the IMI Joint Undertaking has been signed by EFPIA and its research based pharmaceutical companies that are members of EFPIA.
(21)
The research activities should be covered by funding from the Community and at least on an equal level by resources from the research based pharmaceutical companies that are members of EFPIA. Further financing options may be available, inter alia, from the European Investment Bank, in particular through the Risk-Sharing Finance Facility developed jointly with the EIB and the Commission pursuant to Annex III to Decision/2006/971/EC.
(22)
The running costs of the IMI Joint Undertaking should be covered in equal amount by EFPIA and the Community.
(23)
To ensure an equal partnership, the research based pharmaceutical companies that are members of EFPIA activities should not be eligible to receive financial support from the IMI Joint Undertaking.
(24)
The IMI Joint Undertaking should adopt, in accordance with the Financial Regulation and subject to prior consent of the Commission, specific financial rules which take 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. In order to ensure a harmonised treatment between the participants of the Joint Undertaking research activities and those of the indirect actions of the Seventh Framework Programme, it is appropriate that value added tax should not be an eligible cost for Community funding, in accordance with Regulation (EC) No 1906/2006 of the European Parliament and of the Council of 18 December 2006 laying down the rules for the participation of undertakings, research centres and universities in actions under the Seventh Framework Programme and for the dissemination of research results (2007-2013) (5).
(25)
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 laid down in Regulation (EC, Euratom, ECSC) No 259/68 of the Council (6) to all staff recruited by the IMI Joint Undertaking.
(26)
As a body possessing legal personality, the IMI Joint Undertaking should be accountable for its actions. As regards the resolution of disputes in contractual matters, it should be possible that the contracts concluded by the Joint Undertaking provide that the Court of Justice of the European Communities has jurisdiction.
(27)
Appropriate measures should be taken to prevent irregularities and fraud and the necessary steps should be taken to recover funds lost, wrongly paid or incorrectly used in accordance with Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (7), Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (8), and the Regulation (EC) No 1073/1999 of the European Parliament and of the Council of 25 May 1999 concerning investigations concluded by the European Anti-Fraud Office (OLAF) (9).
(28)
In order to facilitate the setting up of the IMI Joint Undertaking, the Commission should be responsible for the establishment and initial operation of the IMI Joint Undertaking until it has the operational capacity to implement its own budget.
(29)
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.
(30)
Since the objective of this Regulation, namely the establishment of the IMI Joint Undertaking, cannot be sufficiently achieved by the Member States due to the trans-national nature of the great research challenge identified, which requires the pooling of complementary knowledge and financial resources across the sectors and borders and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set our in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve this objective,
HAS ADOPTED THIS REGULATION:
Article 1
Establishment of a Joint Undertaking
1. A Joint Undertaking for the implementation of the Joint Technology Initiative on Innovative Medicines is hereby set up for a period up to 31 December 2017 (hereinafter referred to as IMI Joint Undertaking).
2. The seat of the IMI Joint Undertaking shall be located in Brussels, Belgium.
Article 2
Objectives
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 overcome the 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.
Article 3
Legal status
The IMI Joint Undertaking shall be a Community body and shall have legal personality. In each of the Member States of the European Community, it shall enjoy the most extensive legal capacity accorded to legal persons under the laws of those States. It may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings.
Article 4
Statutes
The Statutes of the IMI Joint Undertaking, as set out in the Annex hereto, shall constitute an integral part of this Regulation and are hereby adopted.
Article 5
Community contribution
1. The maximum Community contribution to the IMI Joint Undertaking covering running costs and Research Activities shall be EUR 1 000 million. The contribution shall be paid from the appropriation in the general budget of the European Union allocated to the ‘Health’ theme of the Specific Programme Cooperation implementing the Seventh Framework Programme according to the provisions of Article 54(2)(b) of the Financial Regulation.
2. The arrangements for the Community financial contribution shall be established by means of a general agreement and annual financial agreements to be concluded between the Commission, on behalf of the Community, and the IMI Joint Undertaking.
3. The Community contribution to the IMI Joint Undertaking for the funding of the Research Activities shall be granted following open and competitive calls for proposals.
Article 6
Financial rules
1. The IMI Joint Undertakings shall adopt specific financial rules in accordance with Article 185(1) of the Financial Regulation. They may depart from Commission Regulation (EC, Euratom) No 2343/2002 (10) on the framework Financial Regulation for the bodies referred to in Article 185 of the Financial Regulation where the specific operating needs of the IMI Joint Undertaking so require and subject to prior consent of the Commission.
2. The IMI Joint Undertaking shall have its own internal audit capability.
Article 7
Staff
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 institutions of the European Communities 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.
2. Without prejudice to paragraph 3 of this Article and Article 6(3) of the Statutes, 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 in respect of its staff.
3. The Governing Board shall, in agreement with the Commission, adopt the necessary implementing measures referred to 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.
4. The staff resources shall be determined in the establishment plan of the IMI Joint Undertaking that will be set out in its annual budget.
5. The staff of the IMI Joint Undertaking shall consist of temporary agents and contract agents engaged for a fixed period that may be renewed no more than once for a fixed period. The total period of engagement shall not exceed seven years and shall not in any case exceed the lifetime of the Joint Undertaking.
6. All cost related to the staff shall be borne by the IMI Joint Undertaking.
Article 8
Privileges and immunities
The Protocol on the Privileges and Immunities of the European Communities shall apply to the IMI Joint Undertaking and its staff.
Article 9
Liability
1. The contractual liability of the IMI Joint Undertaking shall be governed by the relevant contractual provisions and by the law applicable to the agreement or contract in question.
2. In the case of non-contractual liability, the IMI Joint Undertaking shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its staff in the performance of their duties.
3. Any payment by the IMI Joint Undertaking in respect of the liability referred to in paragraphs 1 and 2 and the costs and expenses incurred in connection therewith shall be considered as expenditure of the IMI Joint Undertaking and shall be covered by the resources of the IMI Joint Undertaking.
4. The IMI Joint Undertaking shall be solely responsible for meeting its obligations.
Article 10
Jurisdiction of the Court of Justice and applicable law
1. The Court of Justice shall have jurisdiction:
(a)
in any dispute between the Members which relates to the subject matter of this Regulation and/or the Statutes referred to in Article 4;
(b)
pursuant to any arbitration clause contained in agreements and contracts concluded by the IMI Joint Undertaking;
(c)
in actions brought against the IMI Joint Undertaking, including decisions of its bodies, under the conditions provided for in Articles 230 and 232 of the Treaty;
(d)
in disputes related to compensation for damage caused by the staff of the IMI Joint Undertaking in the performance of their duties.
2. For any matter not covered by this Regulation or by other acts of Community law, the law of the State where the seat of the IMI Joint Undertaking is located shall apply.
Article 11
Report, evaluation and discharge
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. This report shall contain details of implementation including number of proposals submitted, number of proposals selected for funding, type of participants, including SMEs, and country statistics.
2. By 31 December 2010, as well as by 31 December 2013, the Commission shall carry out interim evaluations of the IMI Joint Undertaking with the assistance of independent experts on the basis of terms of reference established after consultation of the IMI Joint Undertaking. These evaluations 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 and, where appropriate, proposals to amend this Regulation, including the possible early termination of the IMI Joint Undertaking, to the European Parliament and the Council.
3. Not later than six months after the end of the Joint Undertaking, 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 to the Council.
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 rules of the IMI Joint Undertaking referred to in Article 6.
Article 12
Protection of the financial interests of the Members and anti-fraud measures
1. The IMI Joint Undertaking shall ensure that the financial interests of its Members are adequately protected by carrying out or by allowing the carrying out of appropriate internal and external controls.
2. In case of irregularities committed by the IMI Joint Undertaking or its staff, the Members shall reserve the right to recover amount unduly spent or to reduce or suspend any subsequent contribution to the IMI Joint Undertaking.
3. For the purposes of combating fraud, corruption and other illegal acts, Regulation (EC) No 1073/1999 shall apply.
4. The IMI Joint Undertaking shall carry out on-the-spot checks and financial audits among the participants of the Research Activities funded by the IMI Joint Undertaking.
5. The Commission and/or the Court of Auditors may, if necessary, carry out on-the-spot checks among the recipients of the IMI Joint Undertaking's funding and the agents responsible for allocating it. To that end, the IMI Joint Undertaking shall ensure that grant agreements and contracts provide for the right of the Commission and/or the Court of Auditors to carry out the appropriate controls and, in the event of the detection of irregularities, to impose dissuasive and proportionate penalties.
6. The European Anti-Fraud Office (OLAF) established by Commission Decision 1999/352/EC, ECSC, Euratom (11) shall enjoy the same powers in respect of the IMI Joint Undertaking and its staff as it enjoys in respect of Commission departments. As soon as the IMI Joint Undertaking is established, it shall accede to the Interinstitutional Agreement of 25 May 1999 between the European Parliament, the Council and the Commission of the European Communities concerning internal investigations by the European Anti-fraud Office (OLAF) (12). The IMI Joint Undertaking shall adopt the necessary measures needed to facilitate internal investigations conducted by OLAF.
Article 13
Confidentiality
Without prejudice to Article 14, the IMI Joint Undertaking shall ensure the protection of sensitive information, the disclosure of which could damage the interests of its Members or of participants in the activities of the IMI Joint Undertaking.
Article 14
Transparency
1. Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding access to European Parliament, Council and Commission documents (13) shall apply to documents held by the IMI Joint Undertaking.
2. The IMI Joint Undertaking shall adopt the practical arrangements for implementing Regulation (EC) No 1049/2001 by 7 August 2008.
3. Decisions taken by the IMI Joint Undertaking pursuant to Article 8 of Regulation (EC) No 1049/2001 may form the subject of a complaint to the Ombudsman or of an action before the Court of Justice, under the conditions laid down in Articles 195 and 230 of the Treaty respectively.
Article 15
Intellectual property
The IMI Joint Undertaking shall adopt distinct rules governing the protection, use and dissemination of research results based on the principles of Regulation (EC) 1906/2006 as set out in Article 22 of the Statutes which ensure that, where appropriate, intellectual property generated in Research Activities under this Regulation is protected, and that research results are used and disseminated.
Article 16
Preparatory actions
1. The Commission shall be responsible for the establishment and initial operation of the IMI Joint Undertaking until the IMI Joint Undertaking has the operational capacity to implement its own budget. It shall carry out, in accordance with Community law, all necessary actions in collaboration with other Founding Members and the involvement of the Governing Board.
2. For that purpose, until such time as the Executive Director takes up his/her duties following his/her appointment by the Governing Board in accordance with Article 6(3) of the Statutes, the Commission may assign a limited number of its officials, including one to fulfil the functions of the Executive Director, on an interim basis.
3. The interim Executive Director may authorise all payments covered by the credits provided in the budget of the IMI Joint Undertaking once approved by the Governing Board and may conclude contracts, including staff contracts following the adoption of the IMI Joint Undertaking establishment plan. The Commission authorising officer may authorise all payments covered by the credits provided in the general budget of the IMI Joint Undertaking.
Article 17
Support from the host State
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.
Article 18
Entry into force
This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 20 December 2007.