EUROPEAN COMMISSION Brussels, 23.2.2021 SWD(2021) 37 final COMMISSION STAFF WORKING DOCUMENT



IMPACT ASSESSMENT

Accompanying the document Proposal for a COUNCIL REGULATION establishing the Joint Undertakings under Horizon Europe EU-Africa Global Health Partnership {COM(2021) 87 final} - {SEC(2021) 100 final} - {SWD(2021) 38 final}



Table of contents Part 1 - Common for all candidate institutionalised European Partnerships6 1.Background and context to European Partnerships in Horizon Europe and focus of the impact assessment– What is decided6 1.1.Focus and objectives of the impact assessment6 1.2.The political and legal context7 1.3.Why should the EU act10 2.The Candidate European Partnerships – What needs to be decided11 2.1.Portfolio of candidates for Institutionalised European Partnerships11 2.2.Assessing the necessity of a European Partnership and possible options for implementation12 2.3.Overview of the methodology adopted for the impact assessment16 2.4.Horizontal perspective on candidate Institutionalised European Partnerships20 Part 2 - The Candidate European Partnership on EU-Africa Global Health25 1.INTRODUCTION: POLITICAL AND LEGAL CONTEXT25 1.1.Emerging challenges in the field26 1.2.EU relative positioning in the field28 1.3.EU policy context beyond 202130 2.PROBLEM DEFINITION32 2.1.What are the problems?33 2.2.What are the key problem drivers?35

2.3.How will the problems evolve?39 3.WHY SHOULD THE EU ACT?39 3.1.Subsidiarity: Necessity of EU action39 3.2.Subsidiarity: Added value of EU action41 4.OBJECTIVES: WHAT IS TO BE ACHIEVED?42 4.1.General objectives of the initiative42 4.2.Specific objectives43 4.3.Intervention logic of the initiative44 4.4.What is needed to achieve the objectives – Key functionalities needed46 5.WHAT ARE THE AVAILABLE POLICY OPTIONS?55 5.1.What is the baseline from which options are assessed?55 5.2.Description of the European Partnership policy options57 5.3.Option discarded at an early stage62 6.HOW DO THE DIFFERENT POLICY OPTIONS COMPARE TO ACHIEVE THE EXPECTED IMPACTS?63 6.1.Effectiveness63 6.2.Efficiency70 6.3.Coherence72 6.4.Tabular comparison of options and identification of preferred option75 7.THE PREFERRED OPTION – HOW WILL ACTUAL IMPACTS BE MONITORED AND EVALUATED?77 7.1.The preferred option77

7.2.Objectives and corresponding monitoring indicators81 Acronyms AMR Anti-Microbial Resistance CD Communicable disease CSA Coordination and Support Action DIS Dedicated Implementation Structure EC European Commission EDCTP European and Developing Countries Clinical Trials Partnership EIT European Institute of Innovation & Technology EU European Union ERA European Research Area FTE Full Time Equivalent GA EDCTP General Assembly GHIT Global Health Innovative Technology Fund H2020 Horizon 2020 - EU Framework Programme of Research and Innovation - 2014-2020 HE Horizon Europe - EU Framework Programme for Research and Innovation 2021-2027 HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome ID Infectious disease IHI Innovative Health Initiative IMI Innovative Medicines Initiative

JU Joint Undertaking LMIC Low and Middle-Income Countries MDG Millennium Development Goals MOU Memorandum of Understanding MS EU Member States NCD Non-Communicable Diseases NGO Non-Governmental Organisations NTD Neglected Tropical Diseases OPC Open Public Consultation PDP Product Development Partnership PRND Poverty Related and Neglected Disease R&D Research and Development R&I Research and Innovation RIA Research and Innovation Action SDG Sustainable Development Goals SME Small- and Medium-Size Enterprises SRIA Strategic Research and Innovation Agenda SSA Sub-Saharan Africa TFEU Treaty of Functioning of the European Union TMA Training and Mobility Actions

WHO World Health Organisation Definitions For the purposes of the GHP/EDCTP3 impact assessment, the following definitions apply: Clinical trial: Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. Clinical trials may also be referred to as interventional trials. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiologic procedures, devices, behavioural treatments, process-of-care changes, preventive care, etc. Disease outbreak: The occurrence of disease cases in excess of normal expectancy. The number of cases varies according to the disease-causing agent, and the size and type of previous and existing exposure to the agent. Disease outbreaks are usually caused by an infection, transmitted through person-to-person contact, animal-to-person contact, or from the environment or other media. Health technology: The application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives. Health intervention: An act performed for, with or on behalf of a person or population whose purpose is to assess, improve, maintain, promote or modify health, functioning or health conditions. Infectious diseases: Those diseases caused by pathogenic microorganisms, such as bacteria, viruses, parasites or fungi; the diseases can be spread, directly or indirectly, from one person to another. Phases of a clinical trial: A trial of experimental drug, treatment, device or behavioural intervention may proceed through four phases: ·Phase I Clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects). ·Phase II Clinical trials study the biomedical or behavioural intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety. ·Phase III Studies investigate the efficacy of the biomedical or behavioural intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely. ·Phase IV Studies are conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

Zoonotic diseases: Infectious diseases of animals that can cause disease when transmitted to humans.

Part 1 - Common for all candidate institutionalised European Partnerships 1.Background and context to European Partnerships in Horizon Europe and focus of the impact assessment– What is decided 1.1.Focus and objectives of the impact assessment This impact assessment accompanies the Commission proposal for Institutionalised European Partnerships to be funded under Horizon Europe, the 2021-2027 Framework Programme for EU Research and Innovation (R&I). It sets out to help decide in a coordinated manner the right form of implementation for specific candidate initiatives based on a common approach and methodology according to individual assessments . It also provides an horizontal perspective on the portfolio of candidate European Partnerships to identify further efficiency and coherence gains for more impact. European Partnerships are initiatives where the Union, together with private and/or public partners (such as industry, public bodies or philanthropies) commit to support jointly the development and implementation of an integrated programme of R&I activities. The rationale for establishing such initiatives is to achieve the objectives of Horizon Europe more effectively than what can be attained by other activities of the Horizon Europe programme. Based on the Horizon Europe Regulation, European Partnerships may be set up using three different forms: “Co-funded”, “Co-programmed” and “Institutionalised”. The setting-up of Institutionalised Partnerships involves new EU legislation and the establishment of dedicated implementing structures based on Article 185 or 187 of the Treaty on the Functioning of the EU (TFEU). This requires an impact assessment to be performed. The Horizon Europe Regulation defines eight priority areas, scoping the domains in which Institutionalised Partnerships could be proposed . Across these priority areas, 13 initiatives have been identified as suitable candidate initiatives for Institutionalised Partnerships because of their objectives and scope. This impact assessment aims to identify whether 12 of these initiatives need to be implemented through this form of implementation and would not deliver equally well with traditional calls of Horizon Europe or other lighter forms of European Partnerships under Horizon Europe. This means assessing whether each of these initiatives meets the necessity test set in the selection criteria for European Partnerships in the Horizon Europe Regulation, Annex III. This assessment is done without any budgetary consideration, as the overall budget of the Multiannual Financial Framework of the EU – and hence of Horizon Europe – for the next financing period is not known at this stage. 1.2.The political and legal context 1.2.1.Shift in EU priorities and Horizon Europe framework European priorities have evolved in the last decades, and reflect the social, economic, and environmental challenges for the EU in the face of global developments. In her Political Guidelines for the new European Commission 2019 – 2024 , the new Commission President put forward six overarching priorities, which reach well beyond 2024 in scope . Together with the Sustainable Development Goals (SDGs), these priorities will shape future EU policy responses to the challenges Europe faces, and thus also give direction to EU research and innovation. As part of the Multi-annual Financial Framework (MFF) 2021-27 the new EU Framework Programme for Research and Innovation Horizon Europe will play a pivotal role for Europe to lead the social, economic, and environmental transitions needed to achieve these European policy priorities. It will be more impact driven with a strong focus on delivering European added value, but also be more effective and efficient in its implementation. Horizon Europe finds its rationale in the daunting challenges that the EU is facing, which call for “a radical new approach to developing and deploying new technologies and innovative solutions for citizens and the planet on a scale and at a speed never achieved before, and to adapting our policy and economic framework to turn global threats into new opportunities for our society and economy, citizens and businesses.” While Horizon Europe continues the efforts of strengthening the scientific and technological bases of the Union and foster competitiveness, a more strategic and impact-based approach to EU R&I investment is taken. Consequently, the objectives of Horizon Europe highlight the need to deliver on the Union strategic priorities and contribute to the realisation of EU objectives and policies, contribute to tackling global challenges, including the Sustainable Development Goals by following the principles of the Agenda 2030 and the Paris Agreement. In this context, at least 35 % of the expenditure from actions under the Horizon Europe Programme will have to contribute to climate action. Furthermore, a Strategic Plan is co-designed with stakeholders to identify key strategic orientations for R&I support for 2021-2024 in line with the EU priorities. In the Orientations towards the first Strategic Plan for Horizon Europe, the need to strategically prioritise and “direct a substantial part of the funds towards the areas where we believe they will matter the most” is emphasised. The Orientations specify, that actions under Pillar II of Horizon Europe “Global Challenges and European Industrial Competitiveness” will target only selected themes of especially high impact that significantly contribute to delivering on the political priorities of the Union. Most of the candidate European Partnerships fall under this Pillar. 1.2.2.Key evolutions in the approach to partnerships in Horizon Europe Since their start in 1984 the successive set of Framework Programmes uses a variety of instruments and approaches to support R&I activities, address global challenges and industrial competitiveness. Collaborative, competition-based and excellence-driven R&I projects funded through Work Programmes are the most traditional and long-standing approach for implementation. Since 2002, available tools also include partnerships, whereby the Union together with private and/or public partners commit to jointly support the development and implementation of a R&I programme. These were introduced as part of creating the European Research Area (ERA) to align national strategies and overcome fragmentation of research effort towards an increased scientific, managerial and financial integration of European research and innovation. Interoperable and integrated national research systems would allow for better flows of knowledge, technology and people. Since then, the core activities of the partnerships consist of building critical mass mainly through collaborative projects, jointly developing visions, and setting strategic agendas. Over 80% of respondents to the Open Public Consultation (OPC) indicated that a significant contribution by future European Partnerships is ‘fully needed’ to achieve climate-related goals, to develop and effectively deploy technology, and for EU global competitiveness in specific sectors/domains. Views converged across all categories of respondents, including citizens, industry and academia. Box 1 Key lessons from the interim evaluation of Horizon 2020 and R&I partnerships - The Horizon 2020 Interim Evaluation concludes that the overall partnership landscape has become overly complex and fragmented. It identifies the need for rationalisation, improve their openness and transparency, and link them with future EU R&I missions and strategic priorities. - The Article 185 evaluation finds that these public-public partnerships have scientific quality, global visibility and networking/structuring effects, but should in the future focus more on the achievement of policy impacts. From a systemic point of view, it found that the EU public-to-public cooperation (P2P) landscape has become crowded, with insufficient coherence. - The Article 187 evaluation points out that Public-Private Partnership (PPP) activities need to be brought more in line with EU, national and regional policies, and calls for a revision of the Key Performance Indicators. As regards the contractual PPPs (cPPPs) their reviews identified challenges of coherence among cPPPs and the need to develop collaborations and synergies with other relevant initiatives and programmes at EU, national and regional level. As analysed in the interim evaluation of Horizon 2020 , a considerable repertoire of partnership initiatives have been introduced over time, with 8 forms of implementation and close to 120 partnership initiatives running under Horizon 2020 - without clear exit strategies and concerns about their degree of coherence, openness and transparency. Even if it is recognised that these initiatives allow setting long-term agendas, structuring R&I cooperation between otherwise dispersed actors, and leveraging additional investments, the evaluation points to the complexity generated by the proliferation of instruments and initiatives, and their insufficient contribution to policies at EU and national level. Box 2 Key features of the revised policy approach to R&I partnerships under Horizon Europe based on its impact assessment üSimpler architecture & toolbox by streamlining 8 partnership instruments into 3 implementation forms (Co-Funded, Co-Programmed, Institutionalised), under the umbrella ‘European Partnerships’ üMore systematic and transparent approach to selecting, implementing, monitoring, evaluating and phasing out all forms of partnerships (criteria for European Partnerships): §The selection of Partnerships is embedded in the strategic planning of Horizon Europe, thereby ensuring coherence with the EU priorities. The selection criteria require that partnerships are established with stronger ex-ante commitment and higher ambition. §The implementation criteria stipulate that initiatives adopt a systemic approach in achieving impacts, including broad engagement of stakeholders in agenda-setting and synergies with other relevant initiatives to promote the take-up of R&I results. §A harmonised monitoring & evaluation system will be implemented, and ensures that progress is analysed in the wider context of achieving Horizon Europe objectives and EU priorities. §All partnerships need to develop an exit strategy from Framework Programme funding. This new approach is underpinned by principles of openness, coherence and EU added value. üReinforced impact orientation: §Partnerships are established only if there is evidence they support achieving EU policy objectives more effectively than other Horizon Europe actions, by demonstrating a clear vision and targets (directionality) and corresponding long-term commitments from partners (additionality). §European Partnerships are expected to provide mechanisms – based on a concrete roadmap - to join up R&I efforts between a broad range of actors towards the development and uptake of innovative solutions in line with EU priorities, serving the economy and society, as well as scientific progress. §They are expected to develop close synergies with national and regional initiatives, acting as dynamic change agents, strengthening linkages within their respective ecosystems and along the value chains, as well as pooling resources and efforts towards the common EU objectives. The impact assessment of Horizon Europe identifies therefore the need to rationalise the EU R&I funding landscape, in particular with respect to partnerships, as well as to re-orient partnerships towards more impact and delivery on EU priorities. To address these concerns and to realise the higher ambition for European investments, Horizon Europe puts forward a major simplification and reform for the Commission’s policy on R&I partnerships . Reflecting its pronounced systemic nature aimed at contributing to EU-wide ‘transformations’ towards the sustainability objectives, Horizon Europe indeed intends to make a more effective use of these partnerships with a more strategic, coherent and impact-driven approach. Key related changes that apply to all forms of European

Partnerships encapsulated in Horizon Regulation are summarised in the Box below. Under Horizon Europe, a ‘European Partnership' is defined as “an initiative where the Union, prepared with early involvement of Member States and/or Associated Countries, together with private and/or public partners (such as industry, universities, research organisations, bodies with a public service mission at local, regional, national or international level or civil society organisations including philanthropies and NGOs), commit to jointly support the development and implementation of a programme of research and innovation activities, including those related to market, regulatory or policy uptake.” The Regulation further specifies that European Partnerships shall adhere to the “principles of Union added value, transparency, openness, impact within and for Europe, strong leverage effect on sufficient scale, long-term commitments of all the involved parties, flexibility in implementation, coherence, coordination and complementarity with Union, local, regional, national and, where relevant, international initiatives or other partnerships and missions.” 1.3.Why should the EU act 1.3.1.Legal basis Proposals for Institutionalised European Partnerships are based on: 1)Article 185 TFEU which allows the Union to make provision, in agreement with the Member States concerned, for participation in research and development programmes undertaken by several Member States, including participation in the structures created for the execution of those programmes; or 2)Article 187 TFEU according to which the Union may set up joint undertakings or any other structure necessary for the efficient execution of Union research, technological development and demonstration programmes. 1.3.2.Subsidiarity The EU should act only in areas where there is demonstrable advantage that the action at EU level is more effective than action taken at national, regional or local level. Research is a shared competence between the EU and its Member States according to the TFEU. Article 4 (3) specifies that in the areas of research, technological development and space, the EU can carry out specific activities, including defining and implementing programmes, without prejudice to the Member States’ freedom to act in the same areas.The candidate initiatives focus on areas where there is a demonstrable value added in acting at the EU level due to the scale, speed and scope of the efforts needed for the EU to meet its long-term Treaty objectives and deliver on its strategic policy priorities and commitments. In addition, the proposed initiatives should be seen as complementary and reinforcing national and sub-national activities in the same area. Overall European Partnerships find their rationale in addressing a set of systemic failures : ·Their primary function is to create a platform for a strengthened collaboration and knowledge exchange between various actors in the European R&I system and an enhanced coordination of strategic research agendas and/or R&I funding programmes. They aim to address transformational failures to better align agendas and policies of public and private funders, pool available resources, create critical mass, avoid unnecessary duplication of efforts, and leverage sufficiently large investments where needed but hardly achievable by single countries. ·The concentration of efforts and pooling of knowledge on common priorities to solve multi-faceted societal and economic challenges is at the core of these initiatives. Specifically, enhanced cross-disciplinary and cross-sectoral collaboration and an improved integration of value chains and ecosystems are among the key objectives of these instruments. In the light of Horizon Europe, the aim is to drive system transitions and transformations towards EU priorities. ·Especially in fast-growing technologies and sectors such as ICT, there is a need to react to emerging opportunities and address systemic failures such as shortage in skills or critical mass or cross-sectoral cooperation along the value chains that would hamper attainment of future European leadership and/or strategic autonomy. ·They also aim to address market failures predominantly to enhancing industry investments thanks to the sharing of risks. 2.The Candidate European Partnerships – What needs to be decided 2.1.Portfolio of candidates for Institutionalised European Partnerships –The new approach for more objective-driven and impactful European Partnerships is reflected in the way candidate Partnerships have been identified. It involved a co-design exercise aiming to better align these initiatives with societal needs and policy priorities, while broadening the range of actors involved. Taking into account the 8 areas for Institutionalised European Partnerships set out in the Horizon Europe Regulation , a co-design exercise as part of the Strategic Planning process of Horizon Europe lead to the identification of 49 candidates for Co-funded, Co-programmed or Institutionalised European Partnerships . Out of these, 13 were identified as suitable candidate Institutionalised Partnerships because of their objectives and scope . Whilst the Co-Funded and Co-Programmed Partnerships are linked to the comitology procedure (including the adoption of the Strategic Plan and the Horizon Europe Work Programmes), Institutionalised Partnerships require the adoption of legislation and are subject to an impact assessment. The Figure below gives an overview of all candidate European Partnerships according to their primary relevance to Commission priorities for 2019-2024. Figure 1 - Overview of the candidates for Co-Funded, Co-Programmed and Institutionalised European Partnerships according to Horizon Europe structure ·Source: Technpolis group (2020)

–There are only three partnerships for which implementation as an Institutionalised Partnership under Article 185 is an option, i.e. European Metrology, the EU-Africa Global Health partnership, and Innovative SMEs. Ten partnerships are candidates for Institutionalised Partnerships under Article 187. Overall the initiatives can be categorised into ‘horizontal’ partnerships and ‘vertical’ partnerships. –The ‘horizontal’ partnerships have a central position in the overall portfolio, as they are expected to develop methodologies and technologies for application in the other priority areas, ultimately supporting European strategic autonomy in these areas as well as technological sovereignty. These ‘horizontal’ partnerships are typically proposed as Institutionalised or Co-programmed Partnerships, in addition to a number of EIT KICs, they cover mainly the digital field in addition to space, creative industries and manufacturing, but also the initiative related to Innovative SMEs. ‘Vertical’ partnerships are focused on the needs and development of specific application areas, and are primarily expected to support enhanced environmental sustainability thereby addressing Green Deal related objectives. They also deliver on policies for more people centred economy, through improved wellbeing of EU citizen and the economy, like health related candidate European Partnerships. 2.2.Assessing the necessity of a European Partnership and possible options for implementation Horizon Europe Regulation Article 8 stipulates that Institutionalised European Partnerships based on Article 185 and 187 TFEU shall be implemented only where other parts of the Horizon Europe programme, including other forms of European Partnerships would not achieve the objectives or would not generate the necessary expected impacts, and if justified by a long-term perspective and high degree of integration. At the core of this impact assessment is therefore the need to demonstrate that the impacts generated through a Partnership approach go beyond what could be achieved with traditional calls under the Framework Programme – the Baseline Option. Secondly, it needs to assess if using the Institutionalised form of a Partnership is justified for addressing the priority. For all candidate Institutionalised European Partnerships the options considered in this impact assessment are the same, i.e.: ·Option 0 – Baseline option – Traditional calls under the Framework Programme ·Option 1 – Co-programmed European Partnership ·Option 2 – Co-funded European Partnership ·Option 3 – Institutionalised Partnership oSub-option 3a Institutionalised Partnerships based on Art 185 TFEU oSub-option 3b Institutionalised Partnerships based on Art 187 TFEU 2.2.1.Option 0 - Baseline option – Traditional calls Under this option, strategic programming for R&I in the priority area will be done through the mainstream channels of Horizon Europe. The related priorities will be implemented through traditional calls of Horizon Europe covering a range of actions, mainly R&I and/or innovation actions but also coordination and support actions, prizes or procurement. Most actions involve consortia of public and/or private actors in ad hoc combinations, while some actions are single actor (mono-beneficiary). There will be no dedicated implementation structure and no support other than what is foreseen in the related Horizon Europe Work Programme. This means that discontinuation costs/benefits of predecessor initiatives should be factored in for capturing the baseline situation when relevant. Under this option, strategic planning mechanisms in the Framework Programme will allow for a high level of flexibility in the ability of traditional calls to respond to particular needs over time, building upon additional input in co-creation from stakeholders and programme committees involving Member States. The Union contribution to addressing the priority covers the full duration of the initiative, during the lifetime of Horizon Europe. Without a formal EU partnership mechanism, it is less likely that the stakeholders will develop a joint Strategic Research Agenda and commit to its implementation or agree on mutual commitments and contributions outside their participation in funded projects. 2.2.2. European Partnerships Under this set of options, three different forms of implementation are assessed: Co-funded, Co-Programmed, Institutionalised European Partnerships. These have commonalities that cannot serve as a distinguishing factor in the impact assessment process. They are all based on agreed objectives and expected impacts and underpinned by Strategic Research and Innovation Agendas / roadmaps that are shared and committed to by all partners in the partnership. They all have to follow the same set of criteria along their lifecycle, as defined in the Horizon Europe Regulation (Annex III), including ex ante commitment from partners to mobilise and contribute resources and investments. The Union contribution is defined for the full duration of the initiative for all European Partnerships. The Horizon Europe legal act introduces few additional requirements for Institutionalised Partnerships, e.g. the need for long-term perspective, strong integration of R&I agendas, and financial contributions. Figure 2 - Key differences in preparation and implementation of European Partnerships Type Legal form Implementation Co-Programmed Contractual arrangement / MoU Division of labour, whereby Union contribution is implemented through Framework programme and partners’ contributions under their responsibility. Co-Funded Grant Agreement Union provides co-funding for an integrated programme with distributed implementation by entities managing and/or funding national research and innovation programmes Institutionalised based on Article 185/187 TFEU Basic act (Council regulation, Decision by European Parliament and Council) Integrated programme with centralised implementation The main differences between the different forms of European Partnerships are in their preparation and in the way they function, as well as in the overall impact they can trigger. The Co-Programmed form is assessed as the simplest, and the Institutionalised the most complex to prepare and implement. The functionalities of the different form of Partnerships – compared to the baseline option – are presented in Figure 3. They relate to the types of actors Partnerships can involve and their degree of openness, the types of activities they can perform and their degree of flexibility, the degree of commitment of partners and the priority setting system, and their ability to work with their external environment (coherence), etc. These key distinguishing factors will be at the basis of the comparison of each option to determine their overall capacity to deliver what is needed at a minimised cost.

Figure 3 Overview of the functionalities provided by each form of European Partnerships, compared to the traditional calls of Horizon Europe (baseline) Baseline: Horizon Europe calls Option 1: Co-Programmed Option 2: Co-Funded Option 3a: Institutio-nalised Art 185 Option 3b: Institutionalised Art 187 Type and composition of actors (including openness and roles) Partners: N.A.,

no common set of actors that engage in planning and implementation Priority setting: open to all, part of Horizon Europe Strategic planning Participation in R&I activities: fully open in line with Horizon Europe rules Partners: Suitable for all types: private and/or public partners, philanthropies Priority setting: Driven by partners, open stakeholder consultation, MS in comitology Participation in R&I activities: fully open in line with Horizon Europe rules Partners: core of national funding bodies or govern-mental research organisations Priority setting: Driven by partners, open stakeholder consultation Participation in R&I activities: limited, according to national rules of partner countries Partners: National funding bodies or governmental research organisation Priority setting: Driven by partners, open stakeholder consultation Participation in R&I activities: fully open in line with Horizon Europe rules, but possible derogations Partners: Suitable for all types: private and/or public partners, philanthropies Priority setting: Driven by partners, open stakeholder consultation Participation in R&I activities: fully open in line with Horizon Europe rules, but possible derogations Type and range of activities (including additionality and level of integration) Activities: Horizon Europe standards that allow broad range of individual actions Additionality: no additional activities and investments outside the funded projects Limitations: No systemic approach beyond individual actions Activities: Horizon Europe standard actions that allow broad range of individual actions, support to market, regulatory or policy/ societal uptake Additionality: Activities/investments of partners, National funding Limitations: Limited systemic approach beyond individual actions Activities: Broad, according to rules/programmes of participating States, State-aid rules, support to regulatory or policy/ societal uptake Additionality: National funding Limitations: Scale & scope depend on participating programmes, often smaller in scale Activities: Horizon Europe standards that allow broad range of individual actions, support to regulatory or policy/societal uptake, possibility to systemic approach Additionality: National funding Activities: Horizon Europe standards that allow broad range of individual actions, support to regulatory or policy/societal uptake, possibility to systemic approach (portfolios of projects, scaling up of results, synergies with other funds. Additionality: Activities/investments of partners/ national funding Priority-setting process and directionality Priority setting: Strategic Plan and annual work programmes, covering max. 4 years. Limitations: Fully taking into account existing or to be developed SRIA/ roadmap Priority setting: Strategic R&I agenda/ roadmap agreed between partners & EC, covering usually 7 years, incl. allocation of Union contribution Input to FP annual work programme drafted by partners, finalised by EC (comitology) Objectives & commitments set in contractual arrangement Priority setting: Strategic R&I agenda/ roadmap agreed between partners & EC, covering usually 7 years, incl. allocation of Union contribution Annual work programme drafted by partners, approved by EC Objectives & commitments set in Grant Agreement Priority setting: Strategic R&I agenda/ roadmap agreed between partners & EC, covering usually 7 years, incl. allocation of Union contribution Annual work programme drafted by partners, approved by EC Objectives & commitments set in legal act Priority setting: Strategic R&I agenda/ roadmap agreed between partners & EC, covering usually 7 years, incl. allocation of Union contribution Annual work programme drafted by partners, approved by EC (veto-right in governance) Objectives & commitments set in legal act Coherence: internal (Horizon Europe) & external (other Union programmes, national programmes, industrial strategies) Internal: Coherence between different parts of the FP Annual Work programme can be ensured by EC External: Limited for other Union programmes, no synergies with national/regional programmes & activities Internal: Coherence among partnerships & with parts of the FP Annual Work programme can be ensured by partners & EC External: Limited synergies with other Union programmes & industrial strategies. If MS participate, with national/ regional programmes & activities Internal: Coherence among partnerships & with parts of the FP Annual Work programme can be ensured by partners & EC External: Synergies with national/ regional programmes & activities Internal: Coherence among partnerships & with parts of the FP Annual Work programme can be ensured by partners & EC External: Synergies with national/ regional programmes & activities Internal: Coherence among partnerships & with parts of the FP Annual Work programme can be ensured by partners & EC External: Synergies with other Union programmes and industrial strategies If MS participate, with national/ regional programmes & activities 2.2.3.Option 1 - Co-programmed European Partnership This form of European Partnership is based upon a Memorandum of Understanding or a Contractual Arrangement signed by the Commission and the private and/or public partners. Private partners are represented by industry associations, which also support the daily management of the partnership. This type of partnership would allow for a large degree of flexibility for the activities, partners and priorities to continuously evolve. The commitments of partners are political efforts described in the contractual arrangement and the contributions from partners are provided in-kind more than financially. The priorities for the calls, proposed by the Partnership’s members for integration in the Horizon Europe’s Work Programmes, are subject to further input from Member States (comitology) and Commission services. The Union contribution is implemented within the executive agency managing Horizon Europe calls for research and innovation projects proposals. The full array of Horizon Europe instruments can be used, ranging from research and innovation (RIA) types of actions to coordination and support actions (CSA) and including grants, prizes, and procurement. 2.2.4.Option 2 – Co-funded European Partnership The Co-funded European Partnership is based on a Grant Agreement between the Commission and a consortium of partners, resulting from a specific call in the Horizon Europe Work Programme. This form of implementation only allows to address public partners at its core. Typically these provide co-funding to a common programme of activities established and/or implemented by entities managing and/or funding national R&I programmes. The recipients of the EU co-funding implement the initiative under their responsibility, with national funding/resources pooled to implement the programme with co-funding from the Union. The expectation is that these entities would cover most if not all EU Member States. Calls and evaluations would be organised centrally, beneficiaries in selected projects would be funded at national level, following national funding rules. 2.2.5.Option 3 – Institutionalised European Partnership This type of Partnership is the most complex and high-effort arrangement, and requires meeting additional requirements. Institutionalised European Partnership are based on a Council Regulation (Article 187 TFEU or a Decision by the European Parliament and Council (Article 185 TFEU) and are implemented by dedicated structures created for that purpose. These regulatory needs limit the flexibility for a change in the core objectives, partners, and/or commitments as these would require amending legislation. The basic rationale for this type of partnership is the need for a strong integration of R&I agendas in the private and/or public sectors in the EU in order to address a strategic challenge. It is therefore necessary to demonstrate that other forms of implementation would not achieve the objectives or would not generate the necessary expected impacts, and that a long-term perspective and high degree of integration is needed. For both Article 187 and 185 initiatives, contributions from partners can be in the form of financial and in-kind contributions. Eligibility for participation and funding follows by default the rules of Horizon Europe, unless a derogation is introduced in the basic act. Option 3a - Institutionalised Partnerships based on Article 185 TFEU Article 185 of the TFEU allows the Union to participate in programmes jointly undertaken by Member States and limits therefore the scope to public partners which are Member States and Associated Third Countries. This type of Institutionalised Partnership aims therefore at reaching the greatest possible impact through the integration of national and EU funding, aligning national strategies in order to optimise the use of public resources and overcome fragmentation of the public research effort. It brings together R&I governance bodies of most if not all EU Member States (legal requirement: at least 40% of Member States) as well as Associated Third Countries that designate a legal entity (Dedicated Implementation Structure) of their choice for the implementation. By default, participation of non-associated Third Countries is not foreseen. Such participation is possible only if it is foreseen in the basic act and subject to conclusion of an international agreement. Option 3b - Institutionalised Partnerships based on Article 187 TFEU Article 187 of the TFEU allows the Union to set up joint undertakings or any other structure necessary for the efficient execution of EU research, technological development and demonstration programmes. This type of Institutionalised Partnership brings together a stable set of public and private partners with a strong commitment to taking a more integrated approach and requires the set-up of a dedicated legal entity (Union body, Joint Undertaking (JU)) that carries full responsibility for the management of the Partnership and implementation of the calls. Different configurations are possible: ·Partnerships focused on creating strategic industrial partnerships where, most often, the partner organisations are represented by one or more industry associations, or in some cases individual private partners; ·Partnerships coordinating national ministries, public funding agencies, and governmental research organisations in the Member States and Associated Countries; ·Or a combination of the two: the so-called tripartite model. Participation of non-associated Third Countries is only possible if foreseen in the basic act and subject to conclusion of an international agreement. 2.3.Overview of the methodology adopted for the impact assessment The methodology for each impact assessment is based on the Commission Better Regulation Guidelines to evaluate and compare options with regards to their efficiency, effectiveness and coherence. This also integrates key selection criteria for European Partnerships. Box 2 Summary of European Partnerships selection criteria ·Effectiveness in achieving the related objectives and impacts of the Programme; ·Coherence and synergies of the European Partnership within the EU R&I landscape; ·Transparency & openness as regards the identification of priorities and objectives and the involvement of partners & stakeholders from the entire value chain, backgrounds & disciplines; ·Ex-ante demonstration of additionality and directionality; ·Ex-ante demonstration of the partners’ long-term commitment. 2.3.1.Overview of the methodologies employed

In terms of methods and evidence used, the impact assessments draw on an external study covering all candidate Institutionalised European Partnerships in parallel to ensure a high level of coherence and comparability of analysis, in addition to an horizontal analysis. For all initiatives, the understanding of the overall context of the candidate institutionalised European Partnerships relied on desk research, including among others the lessons learned from previous partnerships. This was complemented by the analysis of a range of quantitative and qualitative evidence, including evaluations of past and ongoing initiatives; foresight studies; statistical analyses of Framework Programmes application and participation data, and Community Innovation Survey data; analyses of science, technology and innovation indicators; reviews of academic literature; sectoral competitiveness studies and expert hearings. The analyses included a portfolio analysis, a stakeholder and social network analysis in order to profile the actors involved as well as their co-operation patterns, and an assessment of the partnerships’ outputs (bibliometrics and patent analysis). A cost modelling exercise was performed in order to feed into the efficiency assessments of the partnership options, as described below. Public consultations (both open and targeted) supported the comparative assessment of the policy options. For each initiative, up to 50 relevant stakeholders were interviewed by the external contractor (policymakers, business including SMEs and business associations, research institutes and universities, and civil organisations, among others). In addition, the analysis was informed by the results of the Open Public Consultation run between September and November 2019, the consultation of Member States through the Strategic Programme Committee and the online feedback received on the Inception Impact Assessments of the set of initiatives. A more detailed description of the methodology and evidence base that were mobilised, completed by thematic specific methodologies, is provided in Annexes 4 and 6. 2.3.2.Method for identifying the preferred option The first step of the assessments consisted in scoping the problems that the initiatives are expected to solve given the overall economic, technological, scientific and social context, including the lessons to be learned from past and ongoing partnerships on what worked well and less well. This supported the identification of the objectives of the initiative in the medium and long-term with the underlying intervention logic – showing how to get there. Given the focus of the impact assessment on comparing different forms of implementation, the Better Regulation framework has then been adapted to introduce “key functionalities needed” - making the transition between the definition of the objectives and what would be crucial to achieve them in terms of implementation. The identification of “key functionalities needed” for each initiative as an additional step in the impact assessment is based on the distinguishing factors between the different options (see Section 2.2.1). In practical terms, each option is assessed on the basis of the degree to which it would allow for the key needed functionalities to be covered, as regards e.g. the type and composition of actors that can be involved (‘openness’), the range of activities that can be performed (including additionality and level of integration), the level of directionality and integration of R&I strategies; the possibilities offered for coherence and synergies with other components of Horizon Europe, including other Partnerships (internal coherence), and the coherence with the wider policy environments, including with the relevant regulatory and standardisation framework (external coherence). This approach guides the identification of discarded options while allowing at the same time a structured comparison of the options not only as regards their effectiveness, efficiency and coherence, but also against a set of other key selection criteria for European Partnerships (openness, transparency, directionality) . In line with the Better Regulation Framework, the assessment of the effectiveness, efficiency and coherence of each option is made compared to the baseline. Therefore, for each of these aspects the performance of using traditional calls under Horizon Europe is first estimated and scored 0 to serve as a reference point. This includes the discontinuation costs/benefits of existing implementation structures when relevant. The policy options are then scored compared to the baseline with a + and – system with a two-point scale, to show a slightly or highly additional/lower performance compared to the baseline. A scoring of 0 of a policy option means that it would deliver as much as the baseline option. On the basis of the evidence collected, the intervention logic of each initiative and the key functionalities needed, the impact assessments first evaluate the effectiveness of the various policy options to deliver on their objectives. To be in line with the Horizon Europe impact framework, the fulfilment of the specific objectives of the initiative is translated into ‘expected impacts’ - how success would look like -, differentiating between scientific, economic/ technological, and societal (including environmental) impacts. Each impact assessment considers to which extent the different policy options provides the ‘key functionalities needed’ to achieve the intended objectives. The effectiveness assessment does not use a compound score but shows how the options would deliver on the different types of expected impacts. This is done to increase transparency and accuracy in the assessment of options . A similar approach is followed to evaluate the coherence of options with the overarching objectives of the EU’s R&I policy, and distinguishes between internal and external coherence. Specifically, internal coherence covers the consistency of the activities that could be implemented with the rest of Horizon Europe, including European Partnerships (any type). External coherence refers to the potential for synergies and/or complementarities (including risks of overlaps/gaps) of the initiative with its external environment, including with other programmes under the MFF 2021-27, but also the framework conditions at European, national or regional level (incl. regulatory aspects, standardisation). To compare the expected costs and benefits of each option (efficiency), the thematic impact assessments broadly follow a cost-effectiveness approach to establish to which extent the intended objectives can be achieved for a given cost. A preliminary step in this process is to obtain a measure of the expected costs of the policy options, to be used in the thematic assessments. As the options correspond to different implementation modes, relevant cost categories generally include the costs of setting-up and running an initiative. For instance, set-up costs includes items such as the preparation of a European Partnership proposal and the preparation of an implementation structure. The running costs include the annual work programme preparation costs. Where a Partnership already exists, discontinuation costs and cost-savings are also taken into account . The table below provides an overview of the cost categories used in the impact assessment and a qualitative scoring of their intensity when compared to the baseline option (traditional calls). Providing a monetised value for these average static costs would have been misleading, because of the different features and needs of each candidate initiative. The table shows the overall administrative, operational and coordination costs of the various options. These costs are then put into context in the impact assessments to reflect the expected co-financing rates and the total budget available for each of the policy options, assuming a common Union contribution (cost-efficiency): ·The costs related to the baseline scenario (traditional calls under Horizon Europe) are pre-dominantly the costs of implementing the respective Union contribution via calls and project, managed by the executive agencies (around 4%, efficiency of 96% for the overall investment). ·For a Co-Programmed partnership the costs of preparation and implementation increase only marginally compared to the baseline (<1%), but lead to an additional R&I investment of at least the same amount than the Union contribution (efficiency of 98% for the overall investment). ·For a Co-Funded partnership the additional R&I investment by Member States accounts for 2,3 times the Union contribution . The additional costs compared to the baseline of preparing and implementing the partnership, including the management of the Union contribution implemented by the national programmes, can be estimated at 6% of the Union contribution (efficiency of 98% related to the overall investment). ·For an Article 185 initiative the additional R&I investment by Member States is equal to the Union contribution . The additional costs compared to the baseline of preparing and implementing the partnership, including the management of the Union contribution implemented by the dedicated implementation structure, can be estimated at 7% of the Union contribution (efficiency of 96% related to the overall investment). ·For an Article 187 initiative the additional R&I investment by partners is equal to the Union contribution . The additional costs compared to the baseline of preparing and implementing the partnership, including the management of the Union contribution implemented by the dedicated implementation structure, can be estimated at 9% of the Union contribution (efficiency of 94% related to the overall investment). Figure 4 - Intensity of additional costs compared with Horizon Europe Calls (for Partners, stakeholders, public and EU) Cost items Baseline: traditional calls Option 1: Co-programmed Option 2

Co-funded Option 3a -Art. 185 Option 3b -Art. 187 Preparation and set-up costs Preparation of a partnership proposal (partners and EC) 0 ↑↑ Set-up of a dedicated implementation structure 0 Existing: ↑

New: ↑↑ Existing: ↑↑

New: ↑↑↑ Preparation of the SRIA / roadmap 0 ↑↑ Ex-ante Impact Assessment for partnership 0 ↑↑↑ Preparation of EC proposal and negotiation 0 ↑↑↑ Running costs (Annual cycle of implementation) Annual Work Programme preparation 0 ↑ Call and project implementation 0 0

In case of MS contributions: ↑ ↑ ↑ ↑ Cost to applicants Comparable, unless there are strong arguments of major differences in oversubscription Partners costs not covered by the above 0 ↑ 0 ↑ ↑ Additional EC costs (e.g. supervision) 0 ↑ ↑ ↑ ↑↑ Winding down costs EC 0 ↑↑↑ Partners 0 ↑ 0 ↑ ↑ Notes: 0: no additional costs, as compared with the baseline; ↑: minor additional costs, as compared with the baseline; ↑↑: medium additional costs, as compared with the baseline; ↑↑↑: higher costs, as compared with the baseline. The cost categories estimated for the common model are then used to develop a scorecard analysis and further refine the assessment of options for each of the 12 candidate Institutionalised Partnerships. Specifically, the scores related to the set-up and implementation costs are used in the thematic impact assessments to consider the scale of the expected benefits and thereby allow a simple “value for money” analysis (cost-effectiveness) . In carrying out the scoring of options, the results of fieldwork, desk research and stakeholder consultation undertaken and taken into account. For the identification of the preferred option, the scorecard analysis builds a hierarchy of the options by individual criterion and overall in order to identify a single preferred policy option or in case of an inconclusive comparison of options, a number of ‘retained’ options or hybrid. This exercise supports the systematic appraisal of alternative options across multiple types of monetary, non-monetary and qualitative dimensions. It also allows for easy visualisation of the pros and cons of each option. Each option is attributed a score of the adjudged performance against each criterion with the three broad appraisal dimensions of effectiveness, efficiency and coherence.

As a last step, the alignment of the preferred option with key criteria for the selection of European Partnerships is described, reflecting the outcomes of the ‘necessity test’. The monitoring and evaluation arrangements are concluding the assessment, with an identification of the key indicators to track progress towards the objectives over time. 2.4.Horizontal perspective on candidate Institutionalised European Partnerships 2.4.1.Overall impact orientation, coherence and efficiency needs The consolidated intervention logic for the set of candidate Institutionalised European Partnerships in the Figure below builds upon the objectives as reported in the individual impact assessments. Figure 5 – Overall intervention logic of the European Partnerships under Horizon Europe When analysed as a package the 12 candidate Institutionalised European Partnerships are expected to support the achievement of the European policy priorities targeted by Horizon Europe by pursuing the following joint general objectives: a)Strengthening and integrating EU scientific and technological capacities to support knowledge creation and diffusion notably in view to better respond to global challenges and emerging threats and contribute to a reinforced European Research Area; b)Securing sustainability-driven global leadership of EU value chains and EU strategic autonomy in key technologies and industries; and c)Accelerate the uptake of innovative solutions addressing climate, environmental, health and other global societal challenges contributing to Union strategic priorities, in particular to reach the Sustainable Development Goals and climate neutrality in the Union in 2050.

In terms of specific objectives, they jointly aim to: a)Enhance the critical mass and scientific capabilities in cross-sectoral and interdisciplinary research and innovation across the Union; b)Accelerate the social, ecological and economic transitions in areas and sectors of strategic importance for Union priorities, in particular to reduce greenhouse gas emissions by 2030 according to the targets set in line with the European Green Deal, and deliver on the green and digital transition; c)Enhance the innovation capabilities and performance of existing and new European research and innovation value chains, in particular SMEs; d)Accelerate the deployment, uptake and diffusion of innovative solutions in reinforced European R&I ecosystems, including through wide and early engagement and co-creation with end-users, citizen and regulatory and standardisation bodies; e)Deliver environmental and productivity improvements in new products and services thanks to a harnessing of EU capabilities and resources. In terms of their operations, taking an horizontal perspective on all initiatives allows for the identification of further possible collective efficiency and coherence gains for more impact: ·Coherence for impact: The extent and speed by which the expected results and impacts will be reached, will depend on the scale of the R&I efforts triggered, the profile of the partners involved, the strength of their commitments, and the scope of the R&I activities funded. To be fully effective it comes out clearly that future partnerships need to operate over their whole life cycle in full coherence with their environment, including potential end users, regulators and standardisation bodies. This relates also to the alignment with relevant EU, national or regional policies and synergies with R&I programmes. This needs to be factored in as of the design stage to ensure a wide take-up and/or deployment of the solutions developed, including their interoperability. ·Collaboration for impact: Effectiveness could also be improved collectively through enhanced cross-disciplinary and cross-sectoral collaboration and an improved integration of value chains and ecosystems. An adequate governance structure appears in particular necessary to ensure cross-fertilisation between all European Partnerships. This applies not only to initiatives where similar R&I topics are covered and/or the same stakeholders involved or targeted, but also to the interconnections needed between the ‘thematic’ and the ‘vertical’ Partnerships, as these are expected to develop methodologies and technologies for application in EU priority areas. Already at very early stages of preparing new initiatives, Strategic Research and Innovation Agendas and roadmaps need to be aligned, particularly for partnerships that develop enabling technologies that are needed in other Partnerships. The goal should be to achieve greater impacts jointly in light of common challenges. ·Efficiency for impact: Potential efficiency gains could also be achieved by joining up the operational functions of Joint Undertakings that do not have a strong context dependency and providing them through a common back-office . A number of operational activities of the Joint Undertakings are of a technical or administrative nature (e.g. financial management of contracts), or procured from external service providers (e.g. IT, communication activities, recruitment services, auditing) by each Joint Undertaking separately. If better streamlined this could create a win-win situation for all partners leading to better harmonization, economies of scales, and less complexity in supervision and support by the Commission services. 2.4.2.Analysis of coherence of the overall portfolio of candidate initiatives at the thematic level Looking at the coherence of the set of initiatives at the thematic level, the “digital centric” initiatives have a strong focus on supporting the digital competitiveness of the EU ecosystem. Their activities are expected to improve alignment and coordination with Member States and industry for the development of world-competitive EU strategic digital technology value chains and associated expertise. Addressing the Key Digital Technologies, the 5G and 6G connectivity needs as part of a Smart Networks and Services initiative and the underlying supercomputing capacities through a European High Performance Computing initiative present potential for synergies that can be addressed through cooperative actions (e.g. joint calls, coordinated support activities, etc.). They may as well profit from and contribute to Partnerships envisaged for Photonics, AI, data, robotics, Global competitive space system and Made in Europe, together with the EIT Digital. Synergies between these initiatives and several programmes (Digital Europe and Connecting Europe as well as cohesion programmes) are needed in areas where EU industry has to develop leadership and competitiveness in the global digital economy. They are expected to impact critical value chains including on sectors where digital is a strong enabler of transformation (health, industrial manufacturing, mobility/transport, etc.). The transport sector face systemic changes linked to decarbonisation and digitalisation. Large scale R&I actions are needed to prepare the transition of these complex sectors to provide clean, safer, digital and economically viable services for citizens and businesses. Past decades have shown that developing and implementing change is difficult in transport due to its systemic nature, many stakeholders involved, long planning cycles and large investments needed. A systemic change of the air traffic network through an Integrated Air Traffic Management initiative should ensure safety and sustainability of aviation, while a Clean Aviation initiative should focus on the competitiveness of tomorrow’s clean aircrafts made in Europe. The initiative for Transforming Europe’s rail system would comprehensively address the rail sector to make it a cornerstone in tomorrow’s clean and efficient door-to-door transport services, affordable for every citizen as well as the most climate-friendly mode of transport for freight. Connected and Automated Mobility is the future of road transport, but Europe is threatened to fall behind other global regions with strong players and large harmonised markets. The initiative Safe and Automated Road Transport would bring stakeholders together, creating joint momentum in digitalising road transport and developing new user-based services. Stronger links and joint actions will be established between initiatives to enable common progress wherever possible. The Clean Hydrogen initiative would be fundamental to that regard. Synergies would also be sought with partnerships driving the digital technological developments. To deliver a deep decarbonisation of highly emitting industrial sectors such as the steel, transport and chemical industries would require the production, distribution and storage of hydrogen at scale. The candidate hydrogen initiative would have a central positioning in terms of providing solutions to the challenges for sustainable mobility and energy, but also is expected to operate in synergies with other industry related initiatives. The initiative would interact in particular with initiatives on the zero emission road and water transport, transforming Europe’s railway system, clean aviation, batteries, circular industry, clean steel and built environment partnerships. There are many opportunities for collaboration for the delivery and end-use of hydrogen. However, the Clean Hydrogen initiative would be the only partnership focused on addressing hydrogen production technologies. Metrology, the science of measurement, is an enabler across all domains of R&I. It supports the monitoring of the Emissions Trading System, smart grids and pollution, but also contributes to meeting demands for measurement techniques from emerging digital technologies and applications. More generally, emerging technologies across a wide range of fields from biotechnologies, new materials, health diagnostics or low carbon technologies are giving rise to demands requiring a world-leading EU metrology system. The initiative for a Circular Bio-based Europe is intended to solve a shortage of industry investments in the development of bio-based products whose markets do not have yet certain long-term prospects. The Innovative Health Initiative and EU-Africa Global Health address the lack of investments in the development of solutions to specific health challenges. The initiative on Innovative SMEs supports innovation-driven SMEs in participating in international, collaborative R&I projects with other innovative firms and research-intensive partners. As a horizontal initiative it is expected to help innovative SMEs to grow and to be successfully embedded in global value chains by developing methodologies and technologies for potential application in the other partnership areas or further development by the instruments of the European Innovation Council. The description of the interconnections between all initiatives for each Horizon Europe cluster is provided in the policy context of each impact assessment and further assessed in the coherence assessment for each option. Part 2 - The Candidate European Partnership on EU-Africa Global Health 1.INTRODUCTION: POLITICAL AND LEGAL CONTEXT The death toll from infectious diseases is spread disproportionally around the world, with low- and middle- income countries being most affected, particularly sub-Saharan Africa. , Infectious diseases, such as lower respiratory infections, HIV/AIDS, diarrhoeal diseases, malaria and tuberculosis, remain the main cause of death, disability, and ill-health in sub-Saharan Africa.

The current Sars-CoV-2, also called COVID-19, pandemic is a clear reminder, that due to increased global connectivity through world trade and tourism, infectious diseases spread rapidly around the globe causing huge human and also economic suffering in many countries, including Europe. Therefore research into health technologies to detect, treat and prevent infectious diseases will not only protect people’s right to health worldwide, but might also contribute to halt the spread of emerging epidemics. Medical and technological research and innovation are needed to accelerate the production of key interventions such as precise diagnostics tests, therapeutic treatments and preventive vaccines to alleviate the burden of infectious diseases and ensure a healthy and productive life, especially in the most vulnerable and affected region such as sub-Saharan Africa. The successful development and deployment of such interventions needs to take into account the environmental and social context, including the capacities of the health systems, of countries in which these diseases are prevalent. In addition, the development of health technologies, especially at the late stage of clinical development, is an expensive process with high costs and a long timeframe, hence it requires large scale and especially coordinated funding. This document focuses on assessing the most effective, efficient and coherent way of implementing an initiative under Horizon Europe, which would focus on joint research and innovation activities to accelerate the development of suitable, effective, safe, accessible and affordable health technologies to fight infectious diseases affecting sub-Saharan Africa. The assessment will help to decide on which of the following different policy options should be pursued in order to legally establish and financially support this partnership: ·Option 0: Traditional Framework Programme calls ·Option 1: Co-funded partnership, based on a grant agreement ·Option 2: Co-programmed partnership, based on a memorandum of understanding; ·Option 3a: Institutionalised partnership, based on a decision of European Parliament and Council under Article 185 TFEU; ·Option 3b: Institutionalised partnership, based on a Council regulation under Article 187 TFEU. 1.1.Emerging challenges in the field The World is undergoing rapid population growth with more than 9.7 billion people by 2050, whereby Africa is accounting for more than half of the projected global population growth. Climate and environmental changes such as hotter summers, warmer winters or increased annual rainfalls, potentially introduce diseases to new areas, and increase the disease burden of many tropical and neglected diseases. Antimicrobials agents or antibiotics are crucial in the treatment of many infectious diseases, but the spread of drug-resistance, or antimicrobial resistance (AMR), could undermine the progress made to date. Although, due to lack of monitoring, the precise levels of AMR in the African region are not recorded, available data suggest that the African region follows the global trend of rising AMR prevalence, with significant resistance, found for numerous treatments against tuberculosis, malaria, HIV/AIDS, cholera, and dysentery. Apart from increasing the level of mortality and morbidity in the region, drug-resistance puts a financial burden on health systems as it increases the costs of treatment. In addition to the burden posed by well-recognised diseases such as HIV, malaria and tuberculosis, as well as neglected tropical diseases, the world is seeing an increasing number of outbreaks of emerging infectious diseases, which may be further exacerbated by climate change. Emerging infectious diseases can be caused by newly identified infectious pathogens which cause public health problems either locally or internationally such as Ebola or the new corona viruses. Pathogens may also re-emerge with new characteristics, such as multidrug-resistance, or in different places, to cause new epidemics. Outbreaks of emerging infectious diseases have the potential to cause enormous social and economic damage globally and particularly in already heavily constrained health systems in Africa. , , Outbreaks can also discourage use of healthcare, indirectly leading to greater morbidity, mortality and financial costs. Moreover, previously unknown or new strains of virus can emerge due to close contact with animals, spread by modern transportation or crowded urban environments, causing epidemics, such as the current COVID-19 pandemic. This is a global health crisis unlike any in the last 75 years history, killing people, spreading human suffering, and upending people’s lives. Previously other recent known outbreaks have been: SARS in 2002–2003, H1N1 in 2009 or MERS in 2014, Zika in 2016 and Ebola in 2014 and 2016. Preparedness and response research, that can provide an evidence base to increase individual and community resilience, facilitate operational readiness, improve decision-making during emergency response, and speed the recovery of public health and healthcare systems and communities, remain the preferred path to contain epidemics and pandemics, and early public health interventions are the second and essential line of attack.

A further important challenge is the rise of chronic non-communicable diseases (NCDs), such as cardiovascular disease, diabetes and cancer also in Africa. Along with the unresolved epidemic of infectious diseases, this presents Africa with an unwelcome double burden of disease. Diabetes patients are over three times more likely to become infected with tuberculosis, while COVID-19 infection is more severe in patients with high blood pressure, heart disease, lung disease, cancer or diabetes. The resulting increased levels of comorbidity are likely to create new challenges for the development and use of effective treatment strategies, in particular in sub-Saharan Africa, overstretching the already strained health systems. Encouragingly, over the past decade, there have been significant scientific and technological advances in the development of health technologies, such as those in the areas of DNA sequencing and genome editing that are opening up new avenues, to prevent, diagnose and treat infectious diseases. In addition, since the Ebola crisis in West Africa, the industry seems to be gaining interest in global health projects targeting priority R&D gaps. Some of them have created integrated global health R&D units. Moreover, large philanthropic foundations have found the challenges of global health as too big to tackle on their own, and therefore are more willing than before to join forces and collaborate with public organisations to fund research & innovation in the field of infectious diseases. Noteworthy is furthermore the digitalisation of Africa and the increasing use of mobile technologies. Digital technology has the potential to accelerate and transform health research and product development, as well as the delivery of healthcare itself. For instance, it can be used to improve the collection, analysis and sharing of high-quality research data. It can also change the way services are delivered in hard-to-reach areas, for instance, using digital diagnostics or drones. , 1.2.EU relative positioning in the field Europe has been traditionally strong in tropical diseases research and during the last two decades the EU has provided support to research and innovation on infectious diseases through the different EU Framework Programmes FP6 (2002-2006), FP7 (2007-2013) and Horizon 2020 (2014-2020). This funding has covered all the phases of the research and innovation pathway from pre-clinical discovery to clinical trials for diagnostics, vaccines, therapeutics, as well as microbicides and vector control. , , The strength of European research has not been so much in the quantity of investment, but rather in the way funding is addressing the needs of the research community and the impacts on shaping the environment for research. There has been a strong focus on collaboration between researchers from different countries, sectors and disciplines. This has helped to build wide networks of scientists who can cover the entire innovation cycle, from basic research to implementation in order to support crucial discoveries, as well as drive economic growth and job creation. In 2018, the EU was the third largest public funder of neglected infectious diseases with USD 113 million. This funding also includes the EU funding to the European and Developing Countries Clinical Trials Partnership (EDCTP). Table 1: Public R&D funders 2018 on poverty related & neglected infectious diseases The European and Developing Countries Clinical Trials Partnership, was launched in 2003 to accelerate the development of medical interventions to prevent, control and treat HIV/AIDS, malaria and tuberculosis contributing to reduce the economic burden caused by these diseases in sub-Saharan Africa. Under the second EDCTP programme this scope was extended in 2014 to include the neglected infectious diseases. Currently it is a partnership of 16 African and 14 European member countries, assembled around the EDCTP Association (established under Dutch law), and the European Union. The EU financial contribution to the second EDCTP programme (2014-2020), up to EUR 683 million, comes from the H2020 framework programme, based on the decision of the European Parliament and the Council under Article 185 of the Treaty. The new partnership, the EU-Africa Global Health Partnership under Horizon Europe, builds on the first and second EDCTP programmes and aims to advance the clinical development of suitable, effective, safe, accessible and affordable health technologies (e.g. diagnostics, treatments and vaccines) to help reduce the burden of infectious diseases in sub-Saharan Africa and strengthen capacities to improve the R&I response to (re-)emerging infectious diseases. EDCTP has delivered, since 2003, more than 800 scientific peer-reviewed publications, built ethical review panels, regulatory capacity and networks of scientists for exchange high-quality clinical research, generating data with a significant impact on global and national health policy and practice. Moreover, since 2014, EDCTP has integrated the global health Participating States Initiated Activities in the EDCTP work annual plans, providing alignment of the European countries research efforts in this area. During 2014-2019, EDCTP2 has awarded EUR 605 million in grant funding, supporting 83 clinical trials and other clinical research activities conducted by European-Africa consortia, 130 fellowships in career development of researchers from sub-Saharan Africa, and 57 grants to strengthen the enabling environment for conducting clinical trials and clinical research in Africa. As result, nearly 7,500 people in Africa have participated in training and workshops on study protocol, specimen collection, research administration, good clinical practice and epidemics preparedness, etc. EDCTP-funded studies have made vital contributions to the development of HIV antiretroviral drug formulations tailored to children; EDCTP has also supported the evaluation of the Xpert MTB/RIF diagnostic technology for the detection of drug-resistant tuberculosis bacteria, now recommended by the WHO and implemented globally. EDCTP studies have generated key evidence on malaria treatments for pregnant women, who are particularly susceptible to malaria, among other examples. Thus, EDCTP is already a well-branded global health initiative that has made vital contributions to the development of treatments against diseases like AIDS, tuberculosis, malaria and neglected infectious diseases. It has strengthened capacity in sub-Saharan Africa and fostered strong research collaboration between the EU and Africa. The global spreading of COVID-19, in a pandemic of unprecedented global scale, could not be avoided despite existing knowledge about other coronaviruses of earlier epidemics. This means that the GHP candidate becomes even more relevant to addressing explicitly the research preparedness and response in case of emerging epidemics and in its role of coordinating research and innovation support with other funders. Therefore, the proposed EU-Africa Global Health partnership will explicitly address strengthening capacities to improve the R&I response to (re-)emerging infectious diseases. The scope of the new partnership should also be extended to better cover the threat of antimicrobial resistance (AMR) and emerging infectious diseases with the potential to cause pandemics. This widened scope would also be reflected in the goal of the GHP, also called EDCTP3. The name ‘EU-Africa Global Health Partnership’ was proposed to give an indication of ambition. However, dialogue with Member States and African countries revealed that they would in a first stage prefer to focus on sub-Saharan Africa, as that is where the main burden of infectious diseases lies. In the evaluation of all the EU partnerships of Horizon 2020 based on Article 185 carried out in 2017, the Commission has underscored that ‘the topics addressed by […] EDCTP2 are to a large extent not tackled with other Horizon 2020 actions’. Moreover, the thematic EDCTP2 independent Interim Evaluation panel highlighted the invaluable and unique contribution of the programme to sub-Saharan Africa and that that EDCTP had ‘made important inroads in strengthening cooperation and partnership between European and sub-Saharan African countries and developing clinical trial capacity and scientific career development in Africa’. It also noted that, because of the long timescales associated with new healthcare product development and implementation, achieving EDCTP’s ambitious goals will require long-term commitment and investment.

An impact assessment study on the EU funding on poverty related and neglected infectious diseases concluded that to ensure that innovations can be adopted, more health systems and implementation research is needed; as well as to include the low and middle income countries at different stages of the health research and innovation pathway. Overall, there is a need for more ‘pull’ policy incentives to help bridge research and impacts, as well as to increase awareness of EU funding efforts for better coordination with other funders. A SWOT analysis (strengths, weaknesses, opportunities, threats) of the first two EDCTP programmes carried out by EDCTP, drawing on the independent Evaluations and impact assessments, as well as the insights of Scientific Advisory Committee members and other key stakeholders, suggested that EDCTP has established itself as an important contributor to health research in sub-Saharan Africa, with a distinct niche in the funding landscape – particularly through its progressive commitment to later-stage trials and to under-served groups with unmet medical needs. The analysis further showed that the partnership’s integration of capacity-building activities into EDCTP projects, as well as its dedicated capacity-building funding, through the regional networks and fellowship programme in sub-Saharan Africa, was a notable feature of the partnership’s work (details in Annex 6). 1.3.EU policy context beyond 2021 The European Commission is committed to the United Nations 2030 Agenda for Sustainable Development, with a set of Sustainable Development Goals directly related to global health: (SDG3), calling to ‘ensure healthy lives and promote well-being for all at all ages’ and SDG1 ‘to end poverty in all its forms everywhere’. Supporting global health is also related to SDG 9 ‘Build resilient infrastructure, promote inclusive and sustainable industrialization and foster innovation’ and SDG17 ‘Strengthen the means of implementation and revitalize the global partnership for sustainable development”. The Commission reflection paper Towards a Sustainable Europe by 2030, adopted in January 2019, outlines three scenarios on how best to progress on the SDGs: 1) an overarching EU SDGs strategy to guide all actions by the EU and Member States; 2) continued mainstreaming of the SDGs in all relevant EU policies by the Commission, but not enforcing Member States’ action; and 3) putting enhanced focus on external action while consolidating current sustainability ambition at EU level. It emphasizes the continuous need to face persisting or novel challenges in science, society and policy for achieving a sustainable Europe by 2030. In this context health research and related innovation actions play a significant role in improving productivity, health care systems and the functioning of its industries. The proposed initiative is fully in line with the recent Communication on the Global EU response to COVID-19 that asks for ‘Stepping up the preparation with EU Member States and third countries of the Global Health Partnership’ and the Commission’s comprehensive Africa Strategy ‘Towards a comprehensive Strategy with Africa’ adopted in March 2020. It is also in line with the ‘EU-Africa Alliance for Sustainable Investments and Jobs’ of September 2018, where the EU is committed to increase access to quality education, skills, research, innovation, health and social rights, and to reinforce Africa as a partner in trade, in foreign investment and in development, and to tackle together the green and digital transformations, as well as promoting sustainable investments and jobs. In December 2019, when the new Commission took office, it presented its new priorities for the upcoming years, including the ‘A European Green Deal’, ‘A people-centred economy’ and ‘A Digital Europe’, which are particularly relevant for health research and innovation. In her letter to the Commissioner for Innovation, Research, Culture, Education and Youth, Mariya Gabriel, the President of the European Commission, Ursula von der Leyen requests the maximisation ‘of the potential of the EC exchange programmes to foster international cooperation in education, research and innovation’. Moreover, to the Commissioner for International Partnerships, Jutta Urpilainen, she asks to ‘make the most of the political, economic and investment opportunities that Africa offers, with its growing economies, populations and digital innovations, and to work on a new comprehensive strategy for Africa creating a partnership of equals and mutual interest’. Under Horizon Europe, the GHP/EDCTP3 would be part of R&I activities funded under Pillar II Cluster 1 Health, which is one of the six Horizon Europe clusters. Pillar II addresses global challenges and industrial competitiveness. Cluster Health is supporting the Sustainable Development Goals, notably SDG 3 ‘Ensure healthy lives and promote well-being for all at all ages’. The potential inter-connections between partnership initiatives in the Health cluster of Horizon Europe and other EU policies and priorities are presented in Figure 6. Figure 6: Potential inter-connections between the Health cluster of Horizon Europe and EU policies and priorities. 2.PROBLEM DEFINITION Taken into consideration the scale of the challenges ahead for addressing infectious diseases threats globally and the current scientific, technological and economic positioning of Europe, as well as the overarching EU policy context, a set of problems have been identified where EU research and innovation in the field of Global Health would have a specific role to play. This has been summarised in a problem tree presented in Figure 7 portraying the identified problems, their drivers and potential consequences if the problems are not addressed. The lack of robust health technologies and the insufficient clinical research capacity for tackling infectious diseases in sub-Saharan Africa are due largely to a number of problem drivers: insufficient knowledge of the pathogens causing the diseases; fragmentation of public and private research efforts to tackle infectious diseases affecting sub-Saharan Africa, insufficient number of trained scientists in sub-Saharan Africa and the insufficient capacity of national health systems in sub-Saharan Africa to detect, diagnose and monitor (re) emerging infectious diseases As well as impacts on population, these factors undermine economic development in the region and increase the risk of global dissemination of novel pathogens. In order to address these problems and their drivers, it is important to establish a partnership structure that is most suitable for the needed actions. Let us first look at the problems and their drivers in more detail in order to understand what kind of partnership is needed. Figure 7: Problem tree behind an initiative for European R&I on EU-Africa Global Health 2.1.What are the problems? The main problem the partnership aims to address is the lack of suitable diagnostics, treatments and vaccines, the so-called health technologies, to address infectious diseases, such as HIV, malaria, tuberculosis but also leishmaniosis that are prevalent in Africa, especially in sub-Saharan Africa. One of the lessons learnt, also now with the COVID-19 pandemic, is that with the increased connectivity of different regions in the world, through world trade and tourism, infectious diseases in one part of the world do not stay there but can rapidly affect other regions. Therefore, developing these health technologies in sub-Saharan Africa is the starting point to contain infectious diseases in this region and protect the health of the citizens in the concerned countries and globally, including in Europe.

1.Lack of health technologies or interventions for tackling infectious diseases in sub-Saharan Africa Although important strides have been made in combating infectious diseases, much still needs to be done at scientific level. For instance, although the development of antiretroviral therapy in the fight against HIV has been a major game changer, there still is no effective vaccine to prevent HIV infection. Likewise, whilst there are numerous treatments against tuberculosis, the increasing threat of (multi-)drug-resistant forms of the disease increase the urgency for the development of new vaccines with greater efficacy and broader application, as well as for continued development of new (combination) treatments. For other diseases, such as Dengue – a mosquito-borne viral infection affecting around 390 million people annually –, there is no effective treatment. Moreover, the progress made in combatting infectious diseases is being increasingly challenged by the rising levels of drug resistance or antimicrobial resistance. For instance, whilst chloroquine has long been used as a malaria treatment, there now is widespread resistance against it in most areas of the world. Intensified research efforts aiming at introduction of new modern health technologies in sub-Saharan Africa would have a major effect on the infectious disease burden in this region. 2.Insufficient clinical research capacity for tackling infectious diseases in sub-Saharan Africa associated with insufficient knowledge exchange and research collaboration with EU Even where suitable health technologies are available, there often is a challenge in getting them to where they are most needed and ensuring that they are used to optimal effect. Most sub-Saharan African countries are faced with weak, under-resourced health systems. As a result, health technologies that have proven efficacious in trial environments may show reduced effectiveness in real-world settings, when they are not used correctly, or if they are used only intermittently as a result of insufficient availability. While development aid and local capacity development activities have led to some progress in the delivery of existing health technologies such as diagnostics, vaccines and therapeutics to the region, much remains to be achieved to ensure that new health technologies are available and accessible to the people in need, calling also for implementation research. In many disease-endemic countries in Africa, there is insufficient capacity for conducting health research and clinical trials. This concerns the equipment and tools needed to support trials (e.g. laboratory equipment, computers), as well as the human resources (e.g. health care workers, technicians, researchers) and the broader enabling research environment (e.g. ethical review boards, and national medicines regulatory authorities). There is also an insufficient capacity to harness and package available local, regional and global evidence to inform health policies and practice. In line with this challenge is the growing importance of implementation research to achieve the Sustainable Development Goals. As discussed, research and product development to combat infectious diseases require a multi-stakeholder approach and a common research agenda that brings together different forms of expertise. Crucially, this also demands strong involvement from funders and stakeholders, including researchers from disease-endemic countries, as these are best placed to understand the specific needs of the populations and how research is expected to serve. This includes increasing attention for principles of fair research, needed to ensure that African researchers can play a full and equitable role in research collaborations. 2.2.What are the key problem drivers? The key causes of the problems from the R&I perspective, are the following: 1.Insufficient knowledge of the pathogens causing infectious diseases that have high capacity to evade immune responses and develop resistance to treatment. The most prevalent pathogens that are predominantly affecting low- and middle-income countries, such as HIV, the causative agent of tuberculosis Mycobacterium tuberculosis and the malaria parasite Plasmodium, have shown tremendous resilience against control measures against them. One of the main reasons is the insufficient knowledge about host-pathogen interaction and about the mechanism on how they cause disease and escape human immune system. This has made the search for new vaccines and treatment a slow process, emphasizing the need to conduct clinical trials in many different target populations and settings. Clinical trials are essential to know how pathogens react to medical interventions and to determining the efficacy and safety of such interventions. While valuable safety and efficacy data can be drawn from studies in high-income countries, often studies need to be conducted within sub-Saharan Africa itself. This may be because the infections are found only in this region, or particular strains of pathogen are found mainly in sub-Saharan Africa. In addition, responses to drugs or vaccines may be different in various populations, because of genetic differences or environmental factors. For example, particular genetic variations found in Africa affect responses to some antiretroviral drugs, while responses to rotavirus vaccine are generally lower in sub-Saharan Africa than in high-income countries. Importantly, for later-stage and post registration trials and implementation studies, the nature of local health systems is a crucial factor, central to study design. Given their high degree of local relevance, these studies generally deliver the evidence most useful to national policymakers. A collaborative approach is required to develop and evaluate vaccines, drugs and other tools needed to control these diseases. Partnerships across a wide range of actors are needed to chaperone new interventions through complex evaluations in disease-endemic settings, regulatory pathways, and implementation into health systems. Collaboration between public and private funders, together with research institutes, product development partnerships and national health authorities, is therefore key to further progress. 2.Fragmentation of public and private research efforts to tackle infectious diseases affecting sub-Saharan Africa.

There are few economic incentives for companies to invest in interventions for diseases that predominantly affect low-resource settings. Development of vaccines and drugs is both costly and high risk, and the lack of financial resources in countries in sub-Saharan Africa inevitably makes them an unattractive market for commercial organisations. The low commercial potential for achieving enough return on investment has led the industry to show, until recently, limited interest to invest in R&I for infectious diseases, especially those that are prevalent in LMICs. For devices such as diagnostics, a further challenge is the need for products that are affordable, reliable, easy to use, and robust enough for challenging environmental settings. This demanding set of criteria deters investment when the potential to achieve a reasonable return on investment is highly uncertain. As a result, the product development pipeline for infectious diseases is poorly stocked, and the progress has been slow. For instance, in 2019, there were only 129 active clinical studies/trials on poverty related neglected diseases, compared to 3,499 oncology studies/trials. The 2018 Access to Medicines Index showed that in the pipelines of the 20 largest pharmaceutical companies, out of 1,314 R&D projects, only 298 targeted priority gaps products for infectious diseases. Most of the support to R&I in this area in sub-Saharan Africa has been provided through public sources. Europe has a long history of supporting medical research in sub-Saharan Africa, often being based on informal contacts between researchers and institutions, and bilateral arrangements that reflect long-standing geopolitical legacies. While excellent research has been carried out, clinical evaluation of medical interventions requires systematic investment in infrastructure, generally across several countries, which can be challenging to achieve through bilateral or project-based initiatives. Tackling infectious diseases affecting sub-Saharan Africa with modern technology tools requires the involvement of a large set of actors. These range from academic researchers to international development agencies, philanthropies and pharmaceutical companies. As each of these actors have their own priorities and focus areas, one of the main challenges is uniting such diverse actors around a common strategic agenda and roadmaps, in order to use resources effectively and efficiently. Although Member States have shown willingness to align and coordinate their national programmes for R&D infectious diseases around a common strategic research agenda, these efforts are hindered by national political priorities for international cooperation and development, which often follow political international agreements with different criteria than the research and innovation agenda efforts. Individual funders, both public and private, including industry, and scientists often address a scientific problem in infectious diseases with a single hypothesis or theory. In case of complex diseases and circumstances, it would be advantageous to combine the knowledge and hypothesis of several groups and get a comprehensive understanding of the disease process. Infectious diseases that represent the most sophisticated mechanisms of evasion and escape from our defences, require a collaborative approach to tackle them, and partnerships with a wide range of actors have the best chances of finding the vaccines and drugs against these diseases. Communication between public and private funders together with scientists and scientists is one of the keys of finding comprehensive solutions. 3.Insufficient number of trained scientists on infectious diseases clinical research in sub-Saharan Africa (medical doctors, researchers) Sub-Saharan Africa is faced with a lack of adequate research infrastructure and established researchers capable of initiating and maintaining competitive research outputs. Despite the many gains over the last few years, sub-Saharan Africa is still faced with a dearth of recognised researchers capable of maintaining competitive research outputs. Many researchers are working in isolation and engaging in activities that may have short-term economic advantages but are often not relevant to clinical research. Partnership-centered networks are needed to train scientists and build clinical research capacity so that more African scientists become experts of clinical research. Clinical studies are governed by stringent international regulations, covering areas such as the conduct of trials, ethical approvals and the quality of laboratory analyses. Studies therefore require sufficient infrastructure and an appropriately trained workforce in order to carry out studies generating data cons