Explanatory Memorandum to COM(2007)241 - Innovative Medicines Initiative Joint Undertaking [SEC(2007) 568] [SEC(2007) 569] - Main contents
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| dossier | COM(2007)241 - Innovative Medicines Initiative Joint Undertaking [SEC(2007) 568] [SEC(2007) 569]. |
|---|---|
| source | COM(2007)241  |
| date | 15-05-2007 |
Joint Technology Initiatives (JTIs) are introduced in the Seventh Framework Programme i (FP7) as a new way of realising public-private partnerships in research at European level. JTIs are an expression of the EU's strong commitment to coordinating research efforts, so contributing to the realisation of the European Research Area and Europe's competitiveness goals.
JTIs arise primarily from the work of European Technology Platforms (ETPs). In a small number of cases, ETPs have achieved such an ambitious scale and scope that they will require the mobilisation of high public and private investments as well as substantial research resources to implement important elements of their Strategic Research Agendas. JTIs are proposed as an effective means of meeting the needs of this small number of ETPs.
In the Co-operation Specific Programme i six areas are identified where a JTI could have particular relevance: hydrogen and fuel cells, aeronautics and air transport, innovative medicines, embedded computing systems, nanoelectronics and GMES (global monitoring for environment and security).
Against this background, the Innovative Medicines Initiative Joint Undertaking (IMI JU) is the legal entity that will be responsible for implementation of the Joint Technology Initiative on Innovative Medicines (IMI JTI). This initiative will strengthen Europe’s position in pharmaceutical research. It will re-invigorate the European pharmaceutical sector, make Europe more attractive to research investment and, in the long term provide European citizens with faster access to better medicines.
Drug development is a very long and costly process. Having once been world leader in pharmaceutical research, Europe is now lagging in research investment, both public and private. The IMI JTI aims to improve this situation by a unique collaboration in the pharmaceutical sector. For the first time, competitor pharmaceutical companies will collaborate on research to improve the drug development process. Participation of academia and clinical centres, small and medium sized enterprises (SMEs), patient organisations and public authorities (including regulators) will be essential and will lead to faster uptake of results. Traditional EU collaborative research instruments cannot achieve the co-ordination of research efforts necessary to cope with the scale and complexity of the research challenges involved.
Competencies and resources from the private and the public sectors will be pooled in a public-private partnership to be founded as a Joint Undertaking by the European Commission (EC) and EFPIA (the European Federation of Pharmaceutical Industries and Association). The IMI JU will be set up as a Community body by a Council Regulation under Article 171 of the Treaty. It will have a total budget of EUR 2 billion. The EC will contribute with EUR1 billion from FP7. The other EUR1 billion will be contributed by EFPIA and the research-based pharmaceutical companies that are full members of EFPIA.
The IMI JU will support research activities conducted in the Member States and in the countries associated with FP7, following open calls for proposals. The Community contribution will be used exclusively to support academia and clinical centres, SMEs, patient organisations and public authorities (including regulators). The EFPIA member companies will carry the costs of their part of the research collaboration at a value equal to the Community contribution.
The pharmaceutical industry is important for the knowledge based economy. As a research-intensive sector, it contributes significantly to European innovation climate and economy. Investing around 15% of its turnover in research and development, it provides Europe with high-skill jobs (612,000 employees in 2004, of which 103,000 in research), high-value products, crucial to the health and well-being of European citizens, and benefits other economic sectors.
The impact of pharmaceutical sector to the economy is often discussed only in terms of costs to the public health system. However, it should be stressed that innovative medicines produce considerable economic benefits including:
· increased total economic production value (e.g. avoiding temporary disabilities, or decreasing their length),
· reinforced employment, through research, production, and distribution of innovative medications,
· added value through highly trained people,
· eased burden on public health (e.g. reducing hospital stays), and on pension systems (e.g. avoiding early pension eligibility),
· increased quality of life (e.g. reduced morbidity and mortality).
IMI addresses the issue of Europe's relative decline in pharmaceutical research by focussing on the main challenges to:
– improve prediction of the safety and the efficacy of new drug candidates in the early development phases, before the costly clinical trials begin;
– tackle the current multiplication of research efforts, both in the private and public sector, by jointly developed knowledge management systems;
– bridge gaps in training of professionals to ensure a more skilled workforce in Europe for this sector.
In addition, IMI will serve as a focal point to for developing synergies between research and collaboration with national, European and international activities and will contribute to establishing the European Research Area in this sector.
A paradigm shift in collaborative patterns will be necessary to meet these challenges. Traditionally, pharmaceutical companies work on a one-to-one basis with partners such as universities, SMEs to develop new drugs. The present challenges demand research and development on tools and methodologies that can be used by all companies active in the drug development process. Today industry investment in such research is very low, and collaboration between these highly competitive companies is rare. In addition, industry does not have all the necessary competencies to carry out this complex research alone. This is why a new approach at European level is needed, with academia and clinical centres, SMEs, patient organisations, public authorities (including regulators) working together with industry.
EFPIA, a non-profit organization representing the research-based pharmaceutical industry in Europe, took the lead in setting up the ETP on Innovative Medicines. Following consultation with a wide spectrum of stakeholders, the Innovative Medicines ETP developed a Strategic Research Agenda (SRA) detailing the challenges discussed above and ways to tackle them. The European Commission brought together representatives from the Member States and from the Countries associated to FP6. This group has met regularly and has actively supported the ETP by providing constructive comments, ideas and experiences based on national activities in the area.
The JTI is the most appropriate means of co-ordinating efforts given the scale and complexity of the research challenges. Therefore, the Commission proposed the implementation of the SRA on Innovative Medicines as a JTI in its proposal for FP7 confirmed through the co-decision by the Council and the European Parliament.
The proposed governance structure for the IMI JTI, which has been developed though a close collaboration between the Commission and EFPIA clearly reflects the public-private nature of the initiative. In their role as founders, the Commission and EFPIA will equally share the responsibilities and costs for the implementation of the IMI JTI. It will be governed by the IMI JU (Board, Executive Office and Scientific Committee) and by 2 additional groups (Member States Group and Stakeholder Forum).
The IMI JU will manage the implementation of the research activities outlined in the Research Agenda. The Executive Office, with its independent staff, will be responsible for the day-to-day management, including the call and evaluation process, grant agreements, etc. The Board, composed of the founding members, will have overall responsibility for the operations of the IMI JU, and decide on the annual implementation of the research activities following consultation of the Scientific Committee. It will also be responsible for communication and co-ordination between IMI and Member State activities (via the Member States Group). A Stakeholder Forum will be held annually to exchange views on the ongoing or planned research activities.
The research activities will be conducted through collaborative projects between public and private organisations selected though open calls for proposals and a peer review process. Any legal entity can participate in such projects provided the research is done in Member States or in the countries associated with FP7.
The research activities will be financed through contributions: with resources in kind (personnel, equipment, consumables, etc.) from the EFPIA member companies and with financial support for universities, public research organisations, SMEs, patient organisations etc. from the EC Contribution to IMI JU. All participating for-profit organisations that are not considered as SMEs are expected to carry the costs of participation in the research activities and will not receive any financial support from the IMI JU.
Grant agreements will govern the relationship between the selected consortia and the IMI JU. Such agreements will describe the implementation of the research activities, the appropriate financial arrangements and the rules relating to intellectual property rights on, the basis of the principles as set out in the Statutes of the IMI JU.
The intellectual property policy for IMI JU designed to be beneficial to the different participants: pharmaceutical companies want to have access to new methods and results; SMEs want to have their new techniques tested by users (i.e. pharmaceutical companies); universities want their research results validated and recognised; clinicians want to have rapid access to results and data; patients want more efficient medicines with less side effects, etc. The new collaborative partnership of IMI JU will provide legal and operational framework for a win-win situation for all. It should ensure the maximum utilization of research results and data, and rapid uptake into industrial, clinical and regulatory practice.
Through revitalisation of research in the pharmaceutical sector, Europe should become an attractive and dynamic environment for private investment.
No provisions exist today at a European level in this area.
However, the FP6-funded Integrated Project InnoMed (involving 43 partners, including 18 large pharmaceutical companies) serves as evidence of industry's willingness to cooperate with each other and with other stakeholders.
The proposed Regulation is consistent with Community policies in research. It is also consistent with the renewed Lisbon strategy i and the objectives of the EU to invest 3% of its GDP in research and development by 2010, with two-thirds coming from the private sector, as decided by the European Council in Barcelona 2002. The proposal is also consistent with the objectives of the previous G10 process i on public health and EU Pharmaceuticals policies, the ongoing policy reflection process of the EU Pharmaceutical Forum, and to the recent Aho report 'Creating an Innovative Europe' i.
The proposed initiative is part of a broad ambitious Community strategy aimed at tackling the innovation gap which includes, inter alia, the proposal to establish a European Institute of Technology.
Consultation of interested parties and use of expertise
Stakeholders (pharmaceutical industry, academia and clinical centres, SMEs, patient organisations, public authorities (including regulators)) have been widely consulted. The key forum for discussion with representatives of the Member States has been the IMI Member States Contact Group. The European Medicines Evaluation Agency (EMEA) has contributed through consultations of their scientific committees. In addition, comments have been received following the publication of the draft SRA on the web and presentations at European and International level.
The proposed Regulation has been subject to a Commission Impact Assessment, which is attached to the proposal.
Summary of the proposed action
The present proposal concerns setting up the Innovative Medicines Initiative Joint Undertaking (IMI JU) under Article 171 of the Treaty for the implementation of the Joint Technology Initiative on Innovative Medicines (IMI JTI).
The IMI JU should be considered as a Community body and be established for a period ending on 31 December 2017. It will have its seat in Brussels, Belgium.
It will be founded by the European Community, represented by the EC, and the European Federation of Pharmaceutical Industries and Associations, EFPIA. The activities of the IMI JU will be jointly funded by its founders. The European Community and EFPIA will contribute in equal parts to the running costs of the IMI JU. The research activities will be jointly funded through contributions by the EFPIA member companies with resources (personnel, equipment, consumables, etc.), and a matching contribution of the European Community.
The IMI JU will be open to new members, provided that they contribute with funds to achieve its objectives.
The European Commission will be represented on the Board. Any decision by the Board shall require the positive vote of the European Commission.
The legal basis of the proposal is Article 171 of the Treaty establishing the European Community.
The proposal concerns an area in which the Community does not have exclusive competence, which is why the principle of subsidiarity applies.
The policy objective underlying the proposal can only be achieved through Community action and this for the following reasons:
The trans-national nature of the great research challenge identified, which requires the pooling of complementary knowledge and financial resources across sectors and borders. No single Member State, company or stakeholder can in and by itself resolve the problem.
The co-ordination effort and the resources required are of such a large scale that they can only be credibly implemented at European level.
In view of similar and competing initiatives being launched in other leading economies (e.g. Critical Path Initiative in the US), only a large-scale action implemented at European level is sufficiently attractive for the globally acting pharmaceutical industry.
In accordance with the principle of proportionality, the provisions of this regulation do not go beyond what is necessary to achieve its objectives.
The proposed Regulation will boost the public and private investment in research aiming at improving the competitiveness of the European pharmaceutical sector. The Joint Undertaking option offers a potential leverage effect of Community funds with private resources that cannot be achieved with the traditional instruments of the Framework Programme, i.e. each EUR 1 of Community funds will generate research investments worth at least EUR 2.
Increased research investments will stimulate further investments in other industrial sectors. In addition, more public funds will be available for non profit stakeholders in the research activities, and the total research investment is expected to be higher than with the traditional EU collaborative research scheme.
Contents
- BUDGETARY IMPLICATIONS
- Grounds for and objectives of the proposed Innovative Medicines Initiative Joint Undertaking
- General Context
- Existing provisions in the area of the proposal
- Consistency with other Union policies and objectives
- 2. CONSULTATION AND IMPACT ASSESSMENT
- Impact assessment
- 3. LEGAL FRAMEWORK OF THE PROPOSAL
- Legal basis
- Subsidiarity and Proportionality
- Choice of instrument
- 5. ADDITIONAL INFORMATION
- Review
The total budget of the IMI JU will be EUR 2 billion.
The maximum contribution from the European Community will be EUR 1 billion paid from the budget appropriation allocated to the Theme Health of the Specific Programme Cooperation implementing FP7.
The running costs of the IMI JU will be financed in equal parts by EFPIA and the European Community. The running costs will not exceed 4% of the total budget for the period ending on 31.12.2017.
The Research Activities will be jointly funded through a financial contribution of the European Community, and contributions by the research based pharmaceutical companies that are full members of EFPIA, with resources in kind (such as personnel, equipment, consumables, etc.) at least equal to the financial contribution of the European Community.
Transitory period
In order to facilitate the setting up of the IMI JU, the Founding Members, the EC and EFPIA, should take all necessary preparatory actions until the bodies responsible for its operations have been set up.
The EC will present an annual report on the progress achieved by the IMI JU
Discharge for the implementation of the budget of the IMI JU will be given by the European Parliament, upon 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.