Source: EURLEX
Language: en
Format: md

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| INCEPTION IMPACT ASSESSMENT | |
| Inception Impact Assessments aim to inform citizens and stakeholders about the Commission's plans in order to allow them to provide feedback on the intended initiative and to participate effectively in future consultation activities. Citizens and stakeholders are in particular invited to provide views on the Commission's understanding of the problem and possible solutions and to make available any relevant information that they may have, including on possible impacts of the different options. | |
| Title of the initiative | European Partnership on Innovative Health |
| Lead DG (responsible unit) | DG Research and Innovation (RTD.E3) |
| Likely Type of initiative | Proposal for a Council Regulation for a European Partnership on Innovative Health under Horizon Europe |
| Indicative Planning | Q1 2020 |
| Additional Information | – |
| The Inception Impact Assessment is provided for information purposes only. It does not prejudge the final decision of the Commission on whether this initiative will be pursued or on its final content. All elements of the initiative described by the Inception impact assessment, including its timing, are subject to change. | |

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| A. Context, Problem definition and Subsidiarity Check |
| Context |
| The proposal for Horizon Europe, the future EU’s future research and innovation (R&I) programme for 2021-2027, outlines the approach (Article 8) and criteria (Annex III) for R&I partnerships under the umbrella term 'European Partnerships'. According to the political agreement between the Council and European Parliament, European Partnerships shall be established for addressing European or global challenges only in cases where they will more effectively achieve objectives of Horizon Europe than the Union alone and when compared to other forms of support of the Framework programme”. The overall financial framework for the upcoming partnerships still has to be agreed by the co-legislators. Different forms of partnerships can be implemented depending on needs and criteria. One such form is institutionalised partnerships set up under Article 185 or Article 187 of the Treaty on the Functioning of the European Union (TFEU). The draft legislation outlines possible areas in which institutionalised partnerships could be set up, including faster development and safer use of health innovations for European patients, and global health. In the course of the strategic planning, the Commission, in close cooperation with the Member States, has identified ‘Innovative Health’ as a candidate for such a partnership.  The partnership would build on the Innovative Medicines Initiative (IMI2), but would significantly revise its scope and expand its partners. IMI2 is an R&I partnership between the EU and the European pharmaceutical industry, established under Horizon 2020, as a continuation from its predecessor IMI established under FP7. The two successive initiatives are expected to have committed close to €5 billion between 2008 and 2020. They are seen as Europe’s exemplary flagship initiatives in this field, and the world’s largest public-private partnership to accelerate drug development. IMI2 successfully piloted a few cross-sectoral collaborations that can now be built upon to develop a larger-scale cross-sectoral partnership.  The partnership would strongly support the key strategic value chain on smart health, blending healthcare and digital technologies, digital media, mobile devices and biomedical engineering. |
| Problem the initiative aims to tackle |
| Health is a constant and major concern for many Europeans, as confirmed by Eurobarometer surveys. The EU has an ageing population and a rising burden of diseases. As a result, healthcare expenditure in EU countries is steadily increasing and now accounts for nearly 10% of Gross Domestic Product (GDP). This puts into question the sustainability of EU healthcare systems, which are under increasing financial and organisational pressure. Innovative health interventions can make a significant contribution to addressing these challenges. However, many innovations are slow to reach patients and healthcare professionals, or do not reach them at all if companies are unable to prove their safety and efficacy or if healthcare system funders cannot afford them. The European health industry is a highly research-intensive industrial sector that employs more than 1.3 million highly skilled employees (2016 figures) and that generates a very significant EU trade surplus. The industry represents a key asset in terms of generating the scientific progress required to address this problem.  An overarching organisational driver of the problem is the limited collaboration between the various health-related industrial sectors (including pharmaceuticals, diagnostics, medical devices, imaging, biotech and digital industries) due to competition, diverging business models and different development timelines, despite the increasing need to integrate technologies and health innovations along the healthcare pathway.  The following factors are the other key drivers of the problem, from an R&I point of view:  (a)Incomplete understanding of diseases, preventing the development of adequate prevention policies, timely and accurate diagnostics, and more targeted therapeutic interventions.  (b)Despite the EU being a strong global actor for health research, it is still relatively weak in translating research into tangible health products and services.  (c)Barriers limiting the transformative potential of digitalisation and data exchange for health R&I, including the lack of data interoperability and accessibility, inadequate or non-existing analytical methods and tools, and the need to tackle fundamental considerations concerning ethics, privacy and security.  (d)Market failure and lack of adequate business models discourage companies from investing in R&D, in particular in some areas of high, unmet public health needs with potentially low return on (significant) investment. Methodologies and models to demonstrate the market value of complex health interventions are lacking. |
| Basis for EU intervention (legal basis and subsidiarity check) |
| The legal basis for EU intervention is the Horizon Europe programme (based on Article 182 TFEU). In implementing the programme, the EU may make provisions for participation in research and development undertaken by several Member States or in programmes run jointly by several Member States (in accordance with Article 185 TFEU), or may set up joint undertakings (in accordance with Article 187 TFEU).  The nature and magnitude of the issues are such that action at EU level is needed, rather than the Member States acting alone. In particular:  §Effective engagement of industries in a cross-sectorial collaboration requires mobilising a very broad range of companies and other stakeholders, of expertise, of knowledge and resources, and of patients, all currently dispersed in Europe. No Member State alone could assemble the critical mass needed;  §Health R&I is increasingly a global endeavour, notably as regards digitalisation and data exchange. Joint action at EU level would foster coordination of stakeholders and would be more effective in reaching the objectives than running multiple smaller-scale initiatives at national level;  §Most health-related companies operate EU-wide and several of the targeted areas (medicinal products, medical devices and cross-border healthcare) are governed by EU-wide legal frameworks;  §Only a few Member States support public-private partnerships for health R&I, all more limited in scope and/or scale. No Member State alone would have the legal and financial framework to develop a multi-sectoral collaboration on the scale needed to bring pan-European long-term structural improvement;  §All Member States and their citizens would benefit from the proposed initiative. |
| B. Objectives and Mapping of Policy options |
| The problem requires large-scale knowledge and resource sharing and long-term, concerted R&I action involving academia, various industrial sectors (such as pharmaceuticals, diagnostics, medical devices, imaging and biotech), patients, healthcare payers, providers, professionals and regulators. The overall objective is to facilitate technology convergence and understanding of diseases in order to accelerate the development of safe, effective, patient-centred and cost-effective healthcare innovations that would directly respond to unmet public health needs, and that can be taken up by healthcare systems. More specific objectives, targeted to areas of public health interest (such as brain disorders or diabetes), will be to:  (a)Progress the understanding of health and disease by integrating technologies and sharing knowledge and resources across academia and industry;  (b)Accelerate the development of R&I into tangible products and services by developing tools, data, platforms, technologies and processes that help predict, prevent, intercept, diagnose and manage diseases and recovery more efficiently, meeting the needs of end users and payers. This includes in particular the combination of new products and services to provide innovative, patient-centred solutions throughout the whole continuum of care.  (c)Overcome the barriers that curb the full potential of digitalisation and data exchange, through standards, methods and tools providing interconnectivity and interoperability;  (d)Provide methodologies and models to better assess the market value of new complex health innovations, and lower the risk of investing in them.  The relevance of the priority and continuation of support under the Framework programme, including the form of support, will be subject to evaluations and assessments in line with the criteria set out in the Regulation of Horizon Europe.  Mapping the policy options:  Regular Horizon Europe calls for proposals (option 0)  Under the baseline scenario, priorities related to the faster development and safer use of health innovations for European patients and to global health would be implemented through collaborative R&I projects under Horizon Europe, coordinated loosely with the Member States through the Programme Committee. Under this scenario, it would be up to the stakeholders to coordinate R&I projects and investment and to draw up a joint R&I roadmap.    Compared with option 0 (calls for proposals), partnerships (options 1 and 2) allow to to jointly address priorities together with the Member States, the private sector, foundations and other stakeholders, following a joint strategy.  A co-programmed European Partnership (option 1) is based on drawing up memoranda of understanding or contractual arrangements with partners to align their research agendas. This option would run over a relatively longer-term perspective and would attract higher-level industry participation and additional in-kind and financial contribution from the partners, compared with option 0 to issue regular calls for proposals.  An institutionalised European Partnership (option 2) would allow deeper integration, engagement and up-front commitment from partners, by creating a long-term dedicated implementing structure.  Other forms of European Partnerships (co-funded, based on Article 185 TFEU) are discarded as they are designed for public authorities and are not suitable for industry partners. |
| C. Preliminary Assessment of Expected Impacts |
| The impact of the partnership will be fully assessed during the impact assessment. It will take into account its ability to contribute to the scientific, technological and societal impact outlined in Article 3 of the draft Horizon Europe programme, and to the impacts targeted under other corresponding EU priorities and objectives. |
| Likely scientific and economic impacts |
| The partnership is likely to advance science and develop innovative health solutions by sharing expertise, resources and knowledge among academia and industrial players. It could also contribute to bringing innovation to the healthcare systems and to increasing their efficiency.  The partnership is likely to strengthen the competitiveness of Europe’s health tech industry, a cornerstone of Europe’s knowledge-based economy, by bringing in new business models and lowering the risk of investing in the development of new products and services. It is likely to yield efficiency gains and to shorten the time-to-market of innovative products and services. It could directly and indirectly create highly skilled jobs, both in academia and industry. Its contribution to improving the health of EU citizens could also yield economic gains. |
| Likely social impacts |
| The partnership is likely to contribute to improved health outcomes for European citizens, expressed as more life-years in good health, a lower burden of disease, improved patient experience of care, better diagnoses and more efficient therapies. It is expected to constitute an incentive for industry to invest in unmet public health needs, such as brain disorders and antimicrobial resistance. Moreover, the partnership could contribute to the sustainability of healthcare systems and make innovative health interventions accessible to a broader population. |
| Likely environmental impacts |
| The partnership may cover ecotoxicology of medicines and safer drug disposal, and/or may contribute to reducing, refining and replacing animal testing, which would have an impact on animal welfare. By developing medical technologies for remote testing and monitoring, it may contribute to reducing travelling and greenhouse gas emissions. |
| Likely impacts on fundamental rights |
| This partnership is expected to facilitate the delivery of patient-centric healthcare interventions that respect patient privacy. It should also facilitate the timely delivery of interventions that are accessible, suitable and affordable for patients and payers, thus improving health, a fundamental right of every human being. |
| Likely impacts on simplification and/or administrative burden |
| A simpler, more strategic and coordinated approach to the setting-up and implementation of European Partnerships under Horizon Europe will significantly reduce the administrative burden for applicants and beneficiaries. Horizon Europe legal basis requires thorough assessment as to the necessity for establishing institutionalised partnerships, and whether other, more flexible partnership forms could achieve the identified objectives. In addition, it lays down requirements (e.g. related to central management of financial contributions, access to data, and links with the monitoring and evaluation framework of Horizon Europe etc.) that support further simplification, harmonisation and more effective implementation. |
| D. Evidence Base, Data collection and Better Regulation Instruments |
| Impact assessment |
| An impact assessment is being prepared to inform the Commission's decision on whether to propose the establishment of an institutionalised European Partnership and to support the preparation of this initiative. If this decision is positive, the impact assessment is likely to be made available in the first quarter of 2020. |
| Evidence base and data collection |
| A full impact assessment is required for all partnerships, which might be institutionalised based on Articles 185 and 187 TFEU. In this context, an external study will provide coordinated input for the preparation of impact assessments, which could lead to and would accompany the proposals for institutionalised partnerships (based on Articles 185 and 187 TFEU). The study will be based on desk research, Commission and stakeholder consultation, quantitative and qualitative data collection and analysis and inputs from panels of experts. It will develop a single common methodology to ensure coordinated inputs to individual impact assessment studies of each envisaged partnership. |
| Consultation of citizens and stakeholders |
| In line with the Better Regulation guidelines, the Commission seeks to consult stakeholders as widely as possible. The consultation strategy aims to involve a broad range of stakeholders, including national authorities, the research community across the EU, industry, EU institutions and bodies, and others.  A structured consultation of Member States in the Shadow Strategic Configuration of the Programme Committee Horizon Europe in May-June 2019 provided early input into the preparatory work.  A single open public consultation from mid-2019 (in English, French and German) will cover all 12 potential institutionalised partnerships based on Articles 185 and 187 TFEU. It will collect input from a broad range of stakeholders, on both the overall approach and the individual candidates for institutionalised partnerships based on Article 185 or Article 187 TFEU. It can be accessed via the Commission's Have Your Say web portal. As the results are expected to inform debate during the ‘R&I days’ (Brussels, 24-26 September), it might be necessary to shorten slightly the 12 week consultation period.  Once all consultation activities are closed, the Commission will publish a synopsis report (summarising the results) on the consultation page. |

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