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,
