Explanatory Memorandum to COM(2013)495 - Innovative Medicines Initiative 2 Joint Undertaking - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)495 - Innovative Medicines Initiative 2 Joint Undertaking. |
|---|---|
| source | COM(2013)495  |
| date | 10-07-2013 |
In the context of the economic and financial crisis Europe is taking steps to find a path to sustainable growth. At the same time, Europe is faced with a series of important major challenges, such as climate change, finding sources of clean energy and improving the health and wellbeing of its citizens while containing the costs of healthcare.
One of the aims of Horizon 2020, Europe's flagship programme for research and innovation, is to strengthen European industry by taking action to support research and innovation across a range of industrial sectors. In particular, Horizon 2020 encourages public-private partnerships in research and innovation to help tackle some of the key challenges Europe faces, including in the public health sector.
The proposal for a public-private partnership builds on the Innovative Medicines Initiative Joint Undertaking (IMI JU) established under the 7th Research Framework Programme (‘FP7’) by Regulation (EC) No 73/2008 of the Council of 20 December 2007. IMI JU is a public-private partnership between the European Commission and the biopharmaceutical industry, and its objective is to improve the drug development process by supporting more efficient research and development cooperation among academia, small and medium enterprises (‘SMEs’) and the biopharmaceutical industry, in order to deliver better and safer medicines for patients.
This proposal is in line with the Commission Communication Public-private partnerships, in Horizon 2020: a powerful tool to deliver on innovation and growth in Europe '[1].
A Joint Undertaking in the area of innovative medicines is needed:
- Because the challenges it will tackle are vital for public health in Europe and for its citizens: improving their health and wellbeing by providing new and more effective diagnostics and treatments, while helping safeguard the future international competitiveness of the European biopharmaceutical and life-science industries such as diagnostics, vaccines, biomedical imaging and medical information technologies;
- Because it will help tackle a series of obstacles to effective research and innovation in this area: high risks of engaging in expensive and complex development of diagnostics and treatments, decreasing productivity of the drug and vaccine development processes and the lack of economic incentives to develop such interventions; high risks of supporting shared databases and networks that could speed up treatment development and help achieve lifelong health and wellbeing for all, particulary important in the context of an ageing population and the associated increase in chronic and degenerative diseases; the emergence and potential re-emergence of infectious diseases (including the increase in anti-microbial resistance); limited knowledge spill-overs due to a lack of open-innovation eco-systems among the various actors from academia, SMEs and industry; and the threat posed by zoonoses.
- Because industry on its own will not invest due to these obstacles, and because public support from the Member States acting alone is too fragmented and cannot achieve the coordinated, long-term, large-scale, transnational, cross-sectorial effort required.
- Because a JU at EU level can help the life-science industries to set a long-term research and innovation strategic agenda in a pan-European structure, create the necessary critical mass, leverage private investment, provide stable funding, facilitate knowledge sharing and reduce risk at lower costs. A JU will help create networks for open innovation, which bring together the main stakeholders along the entire drug development value chain.
- Because a JU can contribute to the EU's goal in other policy areas such as the Commission Communication on Combatting Antimicrobial Resistance, where the current IMI is one of the key implementation measures, the European contribution to the Global One Health Initiative, the European Innovation Partnership on Active and Healthy Ageing, the European Partnership for Action Against Cancer, as well as the European Pact for Mental Health and action related to the Commission Communication on Alzheimer's disease and other dementias.
Therefore, the new proposal aims to address bottlenecks in areas of public health interest, which are limiting the efficiency, effectiveness and quality of the drug development activities needed to bring innovative medicines to the market.
The proposed JU builds upon the achievements of the previous IMI JU set up under FP7.
IMI JU has mobilised resources by bringing together partners from the pharmaceutical industry, academia, SMEs, patient organisations and regulators in focused projects; it has stepped up cooperation between stakeholders in the health research and innovation field by opening access to other partners’ expertise and it has increase the collaboration between the pharmaceutical industry and other stakeholders in Europe. It has also fostered the development of comprehensive research agendas, and horizontal policy coordination.
The interim evaluation of the IMI Joint Undertaking has underlined that IMI enables mutual learning and has built understanding of rationales and approaches among the different stakeholders. This has benefit to all parties and has significantly contributed to the transition from a closed to an open innovation model in biopharmaceutical research, supported by a fair intellectual property regime. No other European programme has enabled cross-company collaboration within the pharmaceutical sector on the scale that has been achieved in IMI.
Contents
- RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENTS
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- General context
- Reasons for and objectives of the proposed Innovative Medicines Joint Undertaking
- Building on past experience
- Consultation of interested parties and use of expertise
- Impact assessment
- Summary of the proposed action
- Legal basis
- Subsidiarity and proportionality
Extensive consultations with stakeholders have been organised, including Member States, SMEs in the life sciences, medical imaging and information technology industries conducted through a series of dedicated meetings (Impact Assessment, Annex 1). The impact assessment report also draws on the results of the current JTI evaluation and the work of a group of experts. A public consultation was held from 11 July to 4 October 2012. In addition, an online consultation for participants of on-going IMI projects was conducted[3].
The proposed Regulation has been subject to a Commission impact assessment, which is attached to the proposal.
The proposal consists of a Council Regulation on the Innovative Medicines 2 Joint Undertaking. The IMI Joint Undertaking was initially established by Regulation (EC) No 73/2008 of the Council of 20 December 2007, which is to be repealed.
The proposal is based on Article 187 of the Treaty on the Functioning of the European Union.
The Rules for Participation and Dissemination of Horizon 2020 will apply. However, given specific operational needs of this initiative, derogations from these Rules are necessary. Nevertheless, these specific derogations are not included in the present proposal at this stage, in order not to prejudice the inter-institutional discussions concerning the appropriate legal basis/procedural modalities for their adoption, which are still pending in the context of the legislative works concerning the Commission proposal for a Regulation of the European Parliament and of the Council laying down the Rules for Participation and dissemination in Horizon 2020 (COM(2011) 0810 - 2011/0399 (COD). The specific derogations will be introduced at a later stage in view of the outcome of the abovementioned discussions.
A first derogation will allow to limit the eligibility for funding to entities such as SMEs, secondary and higher education establishments, non-profit organizations, and companies encountering difficulties to access finance, such as mid-caps or medium-sized companies. Secondly, in order to facilitate and speed up the delivery of innovative medicines to patients and to improve the drug research and development in Europe, IMI2 Joint Undertaking requires derogations from the intellectual property rules which concern relevant definitions, ownership, protection, exploitation, dissemination, transfer and licensing of results and access rights.
The proposal is designed to maximise EU added value and impact, focusing on objectives and activities that cannot be sufficiently achieved by Member States acting alone. The industrial challenge of bringing biomedical research and innovation to new products and thereby impacting the health of EU citizens is so large and complex that Member States acting alone do not have the necessary framework to set up transnational collaborative platforms for strategic industrial research.
Public intervention at EU level is necessary as only the EU is able to provide sustained, large-scale public sponsorship able to facilitate the kind of cross-border, cross-sector, interdisciplinary research and innovation consensus-building and implementation required. Intervening at EU level by supporting transnational cooperation between firms on long-term strategic research agendas produces the following added value over and above what Member States acting alone can achieve. Joint undertakings are the best set up to achieve the critical mass, in particular by implementation of joint agenda setting, mobilising of additional funding and having a larger leverage effect on industrial R&D investment.
In accordance with the principle of proportionality, the provisions of this regulation do not go beyond what is necessary to achieve its objectives.
The Legislative Financial Statement presented with this regulation sets out the indicative budgetary implications. The Union contribution shall be up to EUR 1 725 million i including EFTA contribution. The envelope is in current prices. The Union contribution shall be made from the ‘Health, demographic change and wellbeing’ challenge, DG Research & Innovation envelope, as part of the implementation of Horizon 2020 – The Framework Programme for Research and Innovation. The maximum amount of Union contribution for administrative costs shall be EUR 44,85 million.