EUROPEAN COMMISSION Brussels, 23.2.2021 SWD(2021) 35 final COMMISSION STAFF WORKING DOCUMENT



IMPACT ASSESSMENT REPORT Accompanying the document Proposal for a

DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the participation of the Union in the European Partnership on Metrology jointly undertaken by several Member States

{COM(2021) 89 final} - {SEC(2021) 91 final} - {SWD(2021) 36 final}



Table of contents Part 1 - Common for all candidate institutionalised European Partnerships5 1.Background and context to European Partnerships in Horizon Europe and focus of the impact assessment– What is decided5 1.1.Focus and objectives of the impact assessment5 1.2.The political and legal context6 1.3.Why should the EU act9 2.The Candidate European Partnerships – What needs to be decided10 2.1.Portfolio of candidates for Institutionalised European Partnerships10 2.2.Assessing the necessity of a European Partnership and possible options for implementation11 2.3.Overview of the methodology adopted for the impact assessment15 2.4.Horizontal perspective on candidate Institutionalised European Partnerships20 Part 2 - The Candidate European Partnership on Metrology24 1.Introduction: Political and legal context24 1.1Emerging challenges in the field25 1.2EU relative positioning in the field26 1.3EU policy context beyond 202129 2.Problem definition31 2.1.What are the problems?32 2.2.What are the problem drivers?36

2.3.How will the problem(s) evolve?40 3.Why should the EU act?41 3.1.Subsidiarity: Necessity of EU action41 3.2.Subsidiarity: Added value of EU action42 4.Objectives: What is to be achieved?43 4.1.General objectives of the initiative43 4.2.Specific objectives of the initiative44 4.3.Intervention logic and identification of targeted impacts for the initiative46 4.4.What is needed to achieve these objectives – Key functionalities48 5.What are the available policy options?50 5.1.What is the baseline from which options are assessed?50 5.2Description of the policy options51 6.How do the different policy options compare to achieve the expected impacts?53 6.1.Effectiveness53 6.2.Efficiency57 6.3.Coherence59 6.4.Tabular comparison of options and identification of preferred option62 7.The preferred option - How will actual impacts be monitored and evaluated?65 7.1.The preferred option65 7.2.Objectives and corresponding monitoring indicators66

Glossary Term or acronym Meaning or definition AI Artificial Intelligence BIPM International Bureau of Weights and Measures CEN European Committee for Standardisation CENELEC European Committee for Electrotechnical Standardisation CIPM International Committee for Weights and Measures DI Designated Institute EIT-KICs Knowledge & Innovation Communities of the European Institute of Innovation & Technology EMN European Metrology Network EMPIR European Metrology Programme for Innovation and Research EMRP European Metrology Research Programme ERA European Research Area EURAMET European Association for National Metrology Institutes FP Framework Programme FP7 Seventh Framework Programme ICT Information and Communication Technologies IEC International Electrotechnical Commission IoT Internet of Things ISO International Organization for Standardization JRP Joint Research Project MFF Multiannual Financial Framework MoU Memorandum of Understanding NIM Chinese National Institute of Metrology NIST National Institute of Standards and Technology, United States NMI National Metrology Institute PPP cPPP Public-Private Partnership Contractual Public-Private Partnership PTB Physikalisch Technische Bundesanstalt, Germany R&D Research & Development R&I Research & Innovation SDGs Sustainable Development Goals SI Units International System of Units SMEs Small and Medium size Enterprises SRIA Strategic Research and Innovation Agenda TFEU Treaty on the Functioning of the European Union UNIDO United Nations Industrial Development Organization



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 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 foundations) 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 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. - 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 foundations 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 open 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. 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 open 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. Type Legal form Implementation Co-Programmed Contractual arrangement / MoU Division of labour, whereby Union contribution is implemented through Framework rogramme 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. 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, foundations 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, foundations 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

2.2.2.1.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. 2.2.2.2.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. 2.2.2.3.Option 3 – Institutionalised European Partnership This type of Partnership is the most complex and high-effort arrangement, and requires meeting additional requirements. Institutionalised European Partnerships 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. ·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). 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. 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 EU scientific capacities to deal with emerging threats and future challenges in a reinforced European Research Area; b)Securing sustainability-driven leadership of EU value chains and EU open strategic autonomy in key technologies and industries; and c)Enhancing the uptake of innovative solutions addressing climate, environmental, health and other global societal challenges in line with Union strategic priorities, including to reach 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 interdisciplinary research and innovation across the Union; b)Accelerate the transitions in areas and sectors of strategic importance for EU priorities, in particular to reach a decrease of 35% in greenhouse gas emissions by 2030, and deliver on the digital transition; c)Enhance the innovation capabilities and performance of European research and innovation value chains, including SMEs; d)Enhance the potential for deployment, uptake and diffusion of innovative solutions; 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 have to respond to 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 modernisation of the air traffic management infrastructure through an Integrated Air Traffic Management initiative should ensure safety and sustainability of air transport, 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 Metrology 1.Introduction: Political and legal context Metrology is the scientific study of measurement. It establishes a common definition of units (weight, time, distance, scale, etc.). This matters as a public good for lots of important areas, such as defence and security but even more safety of products, health, energy, climate change, and environment. When citizens purchase, use or benefit from new products and services, metrology offers an important safeguard for fair and accurate trade, optimisation of production, and implementation of regulations and standards affecting the above public goods. It is also a key ingredient to support new emerging technologies (e.g. quantum). As such, it is a key enabler of economic and societal activity and a public good. Research in metrology can be divided into three (overlapping) activities. The first is the definition of units of measurement. The second is the application of these units in measurement in practice. The third is traceability, which links measurements made in practice back to the defined standard of measurement. The national metrology institutes (NMIs) and their designated institutes (DIs) ensure that these activities are coherent and compliant with scientifically and internationally recognised methods and definitions. A detailed description of the functioning of the NMIs is set out in Annex 6, section 2.2. European research and innovation initiatives in metrology focus on two activities: -scientific or fundamental metrology, which concerns generating new knowledge (e.g. through the establishment of common definition of units of measurement); and -applied or technical metrology, which deals with the application of measurement to industrial and wider societal processes via a “metrology value chain” ranging from researchers, standard setters, industries to end-user – be it a consumer, be it a regulator. There are also links to legal metrology, which covers the regulation of and statutory requirements for calibrating measuring instruments, Quality of research in metrology and the bodies conducting research with the necessary capabilities have wide-ranging impacts on the economy and society, including industry, climate, energy, environment and health. It is also key to innovation in many fields by enabling the demonstration and validation of new concepts and technologies. In addition, it is critical in ensuring global recognition of standards in measurement. Due to its significance for national security, metrology competence in Europe remains at Member States’ level. This document focuses on assessing the most effective, efficient and coherent way of implementing a research initiative on metrology under Horizon Europe. 1.1Emerging challenges in the field The study “100 Radical Innovation Breakthroughs for the future” from 2019 lays out several groups of technologies with a direct need for metrology research and development, such as robotics, computing, biomedicine, and new advanced materials. Overall, emerging technologies in digital (big data, Artificial Intelligence (AI), robotics, industry 4.0), additive manufacturing (3D printing), quantum technologies, biotechnologies, new materials and low carbon technologies are expected to contribute to future innovation. Emerging technologies place new and challenging demands on the metrology system, such as more accurate measurements and entirely new forms and methods in metrology to support the innovation process. An example of such a field is the new demands of applications within Internet of Things (IoT). Another example concerns quantum technologies; the overall quantum computing market is expected to grow from EUR 86 million in 2019 to EUR 262 million in 2024 .

The application of metrology also ensures accurate measurements in health diagnostics and delivery. Many medical innovations must be demonstrated to be effective and safe before they can be adopted by healthcare systems. The recent pandemics due to the COVID-19 virus will for instance require laboratory testing for which metrology will be crucial to ensure public trust into future tests. Medical equipment is another important priority for research in metrology at international level. The BOHEMIA foresight study sets out a number of positive scenarios for Europe. The study highlights the role of “Cheap, Renewable Energy” and points to the importance of energy efficiency measures and the development of renewables-friendly regulatory frameworks. Efficient energy efficient measures will need to be supported by metrology, which can also contribute to ensuring regulatory frameworks are fit for purpose. Stakeholders opinions Almost all stakeholders interviewed across the value-chain reported that metrology underpins research and innovation in almost all sectors of the economy and most technology domains as well as key policy fields in climate, environment and health and safety. These same stakeholders also reported on the need for the continual development of metrology capabilities to provide accurate measurement data in new technologies and fields and to ensure capabilities in existing metrology domain remain relevant to continually evolving needs. Stakeholders that were interviewed identified a range of challenges across many sectors that require the development of new methods of measurement, and the validation and certification of new technologies. Challenges identified by the stakeholders interviewed included, for example, references to metrology to ensure accurate measurement of chemical and biological materials and processes, soft-matter, digital technologies, quantum and new materials. Stakeholders interviewed from across different stakeholder groups also identified challenges associated with the uptake of new technologies innovation (e.g. quantum technologies or 5G) and integration of innovation within existing complex systems (e.g. integration of renewables into the energy system) via a require coordinated standardisation to ensure pan-European uptake. 1.2EU relative positioning in the field The challenges ahead are numerous but Europe is well positioned to tackle them. Dedicated support under the Sixth and Seventh Framework Programmes, as well as Horizon 2020, has enabled Europe to establish a position as a world leader in metrology research. When support was discontinued under the Fifth Framework Programme, it led in the past to a loss of capacity for new forms of measurement, loss of momentum in metrology research for emerging technologies and, consequently, a hindering of competitiveness. The present situation as a world leader can first be illustrated by the number of publications, average of relative impact factors (ARIF), citations (ARC) and highly-cited papers (HCP) as shown in Table 1. Source: Technopolis report, forthcoming, 2020 Second, more than half of the international metrology committees are being chaired/vice-chaired by persons from European institutes . Third, Europe outweighs other regions in the world when it comes to available calibration and measurement capabilities offered by European institutes: 11335 approved capabilities (covering physical infrastructure and skilled metrologists) exist in Europe compared to 6453 in the Asia-Pacific region and 4631 in the Inter-American metrology region. However, Europe’s leading position in metrology is increasingly facing major challenges from other global regions in terms of scale and focus of investment as well as long-term financial commitment to metrology objectives. In the US, the National Institute of Standards and Technology (NIST), the national metrology institute, had an overall annual budget of USD 724.5 million in 2018 and 2019. Noteworthy actions include a dedicated programme for exploratory measurement sciences (“lab programme”) with an annual budget in excess of USD 60 million and a research programme for fundamental measurements, including quantum science that has an annual budget of more than USD 160 million. Notably, while some scale back of the overall NIST mandate has occurred in 2020, the metrology-related programmes are maintained at the same level of funding as previous years, highlighting the strategic investment of the US in fundamental research and emerging technologies for metrology. According to the latest information available, the National Institute of Metrology (NIM) in China had an operational budget of EUR 180 million in 2018. In addition, China implemented a targeted research programme for metrology between 2016-2019 of about EUR 65 million and funded 160 collaborative research projects across China. An overview of how metrology is supported through the European Framework Programme for research and innovation is provided in the box below, allowing to identify how best to move forward in practice given the challenges ahead and EU positioning in the field. Box 4 – Support for the field in the previous Framework Programmes – key strengths & weaknesses identified What was/is being done with EU research and innovation funding until now

Dedicated R&I activities related to metrology including collaborative projects have been particularly supported through the EMRP and EMPIR initiatives under the Seventh Framework Programme and Horizon 2020. Both initiatives were evaluated by external experts in October 2017. The first partnership in metrology (the European Metrology Research Programme – EMRP) was established under Article 185 TFEU (formerly Article 169) in 2009, with a budget of EUR 400 million and focussing on delivering a joint European Research Area for metrology. This involved funding of joint research projects and researchers’ mobility. The partnership combined the efforts of 19 Member States and four associated countries. Building on the lessons from EMRP and on an ex-ante impact assessment in 2013, the European Metrology Programme for Innovation and Research – EMPIR – was launched in 2014 under Horizon 2020. With the aim of focussing more on major societal challenges, it broadened the scope and ambition of the metrology partnership to address innovation in addition to research. Participation widened compared to EMRP, with 23 Member States and five associated countries engaging. EMPIR allowed building a significant capacity as regards physical infrastructure and skilled metrologists, whereby the more advanced metrology institutes transferred knowledge and shared expertise, thus allowing less advanced institutes to participate as partners in projects. However, the interim evaluation concluded there is still a significant capacity gap between metrology institutes today. Details on the way the partnership functions are available in Annex 6. What has or is being achieved so far In October 2017, the Commission published the final evaluation of the EMRP programme and an interim evaluation of the EMPIR programme . EMRP brought together any relevant players for metrology research from all participating countries: national metrology institutes (NMI), their designated institutes (DI) and linked laboratories. These players were all capable to participate in EMRP funded projects. In addition, the EMRP confirmed that, by marshalling resources, the programme was enhancing the inter-disciplinarity of metrology research, which had traditionally been organised around specific disciplines, such as length, time, and mass. Thus, EMRP allowed for research projects directly contributing to meeting societal challenges in relation to, for example, health, environment and energy. EMRP enabled European metrology institutes, industrial organisations and academia to collaborate on joint research projects within specified fields: industry, energy, environment, health, new technologies and SI units. Annual EMRP research calls between 2009 and 2013 enabled the funding of 119 projects . These 119 projects were led by 957 transnational research infrastructures. They involved participation by 916 organisations in addition to national metrology institutes, of which 50% were from universities and research and technology organisations and 41% were from industry. There are also 140 non-European participants in these projects . The final evaluation of EMRP in 2017 confirmed the success of having built capacities for undertaking metrology research in each of the participating countries. As a consequence, the evaluations concluded that there is no longer a need to fund the mobility of researchers between participating countries in the future under a future European partnership but this could be left to national budgets. A second finding of the final evaluation of EMRP was to highlight the need for including quality infrastructures but also independent academia, universities and industries to address emerging trends for metrology research much more effectively. Compared to EMRP, a new process was accordingly put in place under the EMPIR to engage more universities and industry from outside the national institutes: a 30% target was set for EU funding to beneficiaries outside the core national metrology institute partners. A target of EUR 400 million was also set for increased turnover stemming from applications and products developed by industries in the EMPIR funded collaborative projects. As a conclusion, the EMRP and EMPIR partnerships have enabled Europe to establish a leading global position in measurement, traceability and standard setting. In terms of scientific publications in metrology, during the years 2010-2018, five out of the top ten most prolific organisations were European. What are the key areas for improvement & unmet challenges? The evaluation of 2017 recommended a new partnership at European level based on three recommendations: First, the strategic component should be strengthened. The national metrology institutes should engage with other stakeholder communities to develop “metrology value chains” that could support the Single Market. The evaluation did not advocate a centralised European structure to implement the recommendation. It favoured a bottom-up approach to metrology activities based on agreed European-level objectives. For these reasons, the evaluation recommended that pan-European “centres of excellence” in the form of networks (“European Metrology Networks”- EMN) should feature in a potential successor partnership in order to deepen the capacity of metrology to respond to major societal challenges. Secondly, the role of external stakeholders, such as universities and industry should no longer be limited to participation in projects selected after calls. Instead, they should in future be more involved in programme development as well as have more opportunities to participate in projects compared to the 30% participation rate foreseen for external participants under EMPIR. The third recommendation was for programme implementation to proactively address metrology applications in emerging scientific areas and focus more on tackling societal challenges. 1.3EU policy context beyond 2021

Future metrology research and innovation funded under Horizon Europe should be framed within and contribute to the future EU priorities. As an enabler across sectors and across disciplines, metrology solutions touch on all six priorities pursued by the Von der Leyen Commission, as Table 2 illustrates. Table 2: Role of metrology in the context of the priorities of the Von Der Leyen Commission Priority Illustrations of Role of Metrology European Green Deal Provision of metrics for achieving climate neutrality Economy that Works for People Innovative and more accurate measurement tools are integral to a successful plan to fight cancer Europe Fit for Digital Age Central to standard-setting for 5G networks and digital services Protecting our European Way of Life Essential to provide confidence in a fully-functioning Schengen Area to reinforce the European approach to customs risk management Stronger Europe in the World Underpins Europe’s role as a standard setter in leading a strong, open and fair trade agenda and a functioning Emissions Trading System New Push for European Democracy Ensuring standard to protect Europe against covert external interference In a specific European context, metrology ensures that measurements made are traceable to internationally agreed definitions and measurement standards. This is the basis of national and international metrology systems that create the accurate, reliable and trustworthy measurements that underpin a wide range of economic activities and public services, covering the entire internal market within an economy that works for people. This concerns safety of products a consumer wants to buy as well as financial services; metrology enables each financial trade to be accurately time-stamped to provide traceable evidence of transactions and ensure compliance with European financial regulations. Achieving climate neutrality by 2050 will require clear measurement capabilities in remote sensing (such as Earth observation), environment and energy. More specifically, the policy areas of the Commission priority the European Green Deal are all directly related to metrology challenges. Accurate and traceable measurement capabilities enable robust environmental monitoring of the state of the climate. They also support the effective design and enforcement of environmental regulations by providing trustworthy data for the climate variables that support the Paris Agreement on Climate Change and for environmental parameters such as air and water quality. As regards energy, measurement science will for instance be essential to support the implementation of the transition to renewable fuels. In a low carbon future, understanding the magnitude, timescale and impact of climate change will be central. This requires accurate and reliable monitoring of all climate variables over the long timescales needed to detect and understand climate trends. Furthermore, metrology should underpin fit for purpose environmental regulation, such as on water or air pollution, including monitoring and enforcement. Beyond energy and environment, policy areas of the Green Deal such as sustainable industry, sustainable mobility, and biodiversity will all need a modern and capable metrology system. To foster a Europe Fit for the Digital Age, accurate state-of-the-art measurement capabilities in NMIs and DIs will enable modern digital services such as 5G but also all emerging digital technologies, such as quantum or artificial intelligence. As metrology is an enabler of all scientific and technological fields, improvements in metrology capabilities can accelerate scientific advancement and industrial developments to help address challenges related for example to health, environment, climate change, social protection and cultural heritage. Any future European metrology initiative for joint research and innovation would therefore need to create and exploit linkages with several other initiatives, within and beyond Horizon Europe. In Horizon Europe, metrology is part of the research and innovation activities funded under the Pillar II Cluster Digital, Industry and Space as the robust accurate measurements provided by metrology make a critical contribution across manufacturing sectors, particularly to high-precision manufacturing of high-value-added products such as aerospace, high-performance ICT and space equipment and pharmaceuticals. However, the use of robust accurate measurements is much wider than this and therefore the candidate European Metrology Partnership is relevant to a wide range of other European Partnerships and policies. For instance, better metrology systems and measurement capabilities will make a direct contribution to the rolling out of 5G applications and to the installation and operation of smart electrical grids and therefore serve the objectives of the Partnership for Smart Networks and Services and the Partnership for Clean Energy Transition. Metrology is also important to ensuring accurate measurements in health diagnostics and delivery and therefore synergies can be explored with partnerships related to the use of health technologies in health, i.e. the Innovative Health Initiative and the Partnership for Large-scale innovation and transformation of health systems in a digital and ageing society. More generally, complementarities will need to be built with envisaged European Partnerships under Horizon Europe as regards: ·digital intensive industries, such as Made in Europe as regards discrete manufacturing; ·Processes4Planet (previously called Climate Neutral and Circular Industries) as regards monitoring of CO2 emissions and air pollution in general; ·Key Digital Technologies; Artificial Intelligence, data and robotics; ·Towards zero-emission road transport (2Zero); Safe and Automated Road Transport as regards connected driving and Clean Aviation. ·Synergies could also be explored with the Innovative Health Initiative and the Partnership for Large-scale innovation and transformation of health systems in a digital and ageing society. Beyond Horizon Europe, complementarities are also needed with other European programmes to support the deployment of metrology solutions such as with the Connecting Europe Facility, the Digital Europe Programme, or the LIFE environmental programme. Finally, any future metrology initiative for joint research and innovation should fully take into account the regulatory and standardisation framework and work in close collaboration with the public authorities in charge. 2.Problem definition

Taking into consideration the challenges the sector is facing and the current scientific, technological and economic position of Europe in the field as well as EU priorities, a set of problems and problem drivers were identified. Figure 6 shows a problem tree portraying problems, their drivers and consequences. The first problem focusses on lessons learnt out of FP7 and Horizon 2020 to increase impact of research and innovation in metrology. The second and third problem address challenges from outside which metrology researchers are facing much more in future. 2.1.What are the problems? 2.1.1.Problem 1: Lack of impact of metrology research programmes at EU level The lack of impact at programme level was identified as a general problem with Article 185 initiatives in the horizontal evaluation of partnerships under Horizon 2020. In the case of metrology, this has arisen because of the bottom-up approach of the partnerships to date. Metrology in Europe is implemented by NMIs. Dedicated support under the Sixth and Seventh Framework Programmes as well as Horizon 2020 has made significant progress in terms of coordination and integration of the activities of these national institutes. To date, integration at European level has been focussed on pooling of national resources only at individual project level through organisation of calls. While this bottom-up approach has demonstrated the openness of national institutes to integrate their activities, it lacks the directionality required for metrology to impact effectively on policy-making processes. In this regard, the interim evaluation of the EMPIR Programme highlighted the need to strengthen the strategic component (namely the contents of work programmes) to support policy in relation to the Single Market and to respond to major societal challenges. There are certainly examples of individual metrology projects that demonstrate the potential for metrology to achieve policy impact. However, they are limited to individual projects. ·The HUMEA project has focussed on knowledge transfer and reduction of duplication of metrology capacity in ten countries in the specific field of calibration for relative humidity. This is relevant for a range of industries and applications, and in particular for measuring atmospheric gases, which has a direct link to climate change variables. However, as an individual project launched from such a bottom-up call, its capacity to influence policy processes is limited. It does, at the same time, illustrate how a future metrology initiative could, through a more top-down strategic approach targeting policy challenges, impact on the Green Deal adopted at European level in December 2019 by contributing to meeting the new targets and new priorities set. ·The Bio-Stand project has addressed measurement for in-vitro diagnostics. As a stand-alone project, it has only limited policy impact. However, a top-down strategic approach reflected in a work programme would enable rapid programmed actions by metrology institutes at European level and so make it efficient to deploy capacity for testing and analysis. Moreover, a more programmatic approach would speed up the European response to urgent issues such as the COVID-19 pandemic. ·In the area of 5G networks, where it is estimated that subscriptions will grow from EUR 6 million in 2019 to EUR 319 million in 2024, individual projects have been funded by EMPIR. However, these isolated efforts are insufficient to meet the need for strategic capacity building in order to deploy 5G networks efficiently across the EU. 5G compatible devices will require EU wide standardised measurement procedures for the assessment of specific absorption rate of human exposure to radio frequency fields from hand-held and body-mounted wireless communication devices. In summary, there is a problem of lack of policy impact because the bottom-up focus of the partnerships to date has hindered the development of a portfolio approach to project selection in response to top-down identification of programming priorities. Stakeholder opinion The vast majority of the participants in the public consultation (86%) representing academia, company/business organisation, EU citizens and public authorities believes that the new initiative in metrology needs or fully needs to have a higher impact of research programmes. By breaking down the responses to the sub-groups of stakeholders, representatives of company/business organisation agreed with that statement at 98% while the lowest percentage (78%) was observed among the participants who responded as EU citizens. The majority of the participants in the public consultation (69%) consider that the new initiative in metrology is needed or fully needed to be more responsive towards EU policy objectives. Only 11% considered that it is not needed or not needed at all. No significant differences were observed between the different groups of respondents. 2.1.2.Problem 2: Increased global competition in metrology As the graphic below illustrates, under-investment in metrology in Europe compared to the rest of the world is a long-standing problem.

Source: Euramet The above figure shows the situation which the current initiative EMPIR was facing at its launch in 2014. The competitive push from other global players, such as US, China and India continues today, puts at risk EU position against its global competitors. In the last decade, US, China and India increased their investments into metrology by 60%, 50% and 52% respectively. Investments into European institutes remained relatively static and did not respond to new and increasingly important research fields. The inadequate level of investment, coupled with fragmentation of metrology capabilities in Europe, has caused it to be distributed too thinly, with a lack of strategic focus. This problem is illustrated, for example, in the area of electricity and magnetism. These are fundamental disciplines in metrology with about 50 different electrical quantities. In 2015, only nine countries had measurement capability for any electricity and magnetism quantity. Only five institutes both receive traceability as well as providing it, while the majority only receives traceability. By contrast, their substantially higher levels of overall investment have allowed our competitors to target metrology funding on strategic priorities via centralised structures that provide for engagement with stakeholders along the metrology value chain. As mentioned earlier, US metrology investment in quantum science is more than USD 160 million annually. In China in 2018, the budget of the national metrology institute increased by EUR 50 million to EUR 180 million to support dedicated investment in infrastructure development. By comparison, PTB, the national metrology institute in Germany and the largest NMI in Europe, has a total operating annual budget of EUR 200 million. This disadvantage arises in part from the fragmented nature of metrology investment across Europe. Metrology systems are funded directly by governments and implemented by dedicated national institutes. Creating, maintaining and further developing metrology capabilities (physical infrastructure and skilled metrologists) and conducting metrology research within NMIs and DIs have high fixed costs which, with fairly static national metrology budgets, limit individual NMIs/DIs abilities to respond effectively to new needs. Moreover, the national agencies responsible for public funding in support of strategic objectives related to innovation and societal challenges are not directly engaged in metrology. Similarly, market operators avail of their services passively because they are mainly involved in the outputs of metrology as end-users and less in the development of new metrology services. While there is involvement of the different players in project definition, implementation and exploitation, the metrology community does not significantly engage with other actors at the level of programme development. This means that there is no formal forum for industry to articulate its expectations at European level as to where research investment in metrology should be prioritised. While efforts in this direction have been made in recent years, such as through contacts with the Factories of the Future Public-Private Partnership under Horizon 2020, this articulation has remained weak. Hence, there is no clear link between the programme development and industrial investment in subsequent stages along the metrology value chain. As result, the capacity of metrology to contribute to the development of high-quality new products and services is sub-optimal. Stakeholder opinion The vast majority of the participants in the public consultation (87%) representing academia, company/business organisation, EU citizens and public authorities agreed or fully agreed that the new initiative in metrology needs to make a significant contribution to enhance the role of the EU in comparison to other global players in metrology research. No significant differences were observed among the different stakeholder groups, with the percentage of those agreeing or fully agreeing ranging from 80% to 90%. 2.1.3.Problem 3: Increasing societal challenges which require trustworthy standards and regulations Europe is facing an increasingly rapid rate of social transition, such as to respond to climate change, environment, energy, health, and safety of products. This imposes new demands on the metrology system to contribute to meeting new societal challenges by providing guarantees to citizens and society as a whole as regards the trustworthiness of standards and regulations. Addressing new challenges and/or improving policy responses to existing challenges place new demands on the metrology system – in terms of increased accuracy of measurements, measurement of new parameters and faster and affordable measurement tools. There are already cases where metrology has responded to the challenge, such as the projects to respond to the new measurement requirements under the Water Framework Directive. It has been estimated that 50 EU regulations and directives affecting energy, environment, climate change and public health depend on metrology research outcomes. The “Low Carbon Economy” scenario developed in the BOHEMIA study, where energy and environmental aspects are central, highlights further the important role of metrology. In a low carbon future, understanding the magnitude, timescale and impact of climate change will be central. This requires accurate and reliable monitoring of all climate variables over the long timescales needed to detect and understand climate trends. More broadly, as recognised by the United Nations Industrial Development Organization (UNIDO), addressing societal challenges and sustainable development goals in climate change, environment protection, sustainable energy and healthcare relies on metrology capabilities for the robust identification and assessment of risks, and the design and implementation of effective policy, regulation and standards to mitigate them. Accordingly, the link between metrology and regulatory developments needs to be strengthened in order to rapidly provide the measurement infrastructure and systems for the society to comply and use the new frameworks. If not, the consequences for metrology would be detrimental because the metrology would not be fit for purpose. In a landscape where policy needs evolve fast, such as response to pandemics or to climate change, the current gap between the metrology capacity development, and regulation and standards setters will only increase without actions to strengthen the integration of metrology. The rate of social transitions is also highlighted in the Commission’s orientations paper for the Strategic Plan on Horizon Europe, in which metrology is specifically mentioned as a potential area for intervention. In this regard, the 2017 interim evaluation of the EMPIR initiative recommended that a future metrology initiative should have a particular focus on the contribution of metrology to societal challenges. Stakeholder opinion The vast majority of the participants in the public consultation (87%) representing academia, company/business organisation, EU citizens and public authorities considered relevant or very relevant to optimise contributions to future standards and regulations at EU level. No significant differences were observed among the different stakeholder groups, with the percentage of those agreeing or fully agreeing ranging from 84% to 88%. 2.2.What are the problem drivers?

2.2.1.Problem driver 1: Fragmentation and duplication of metrology research programmes at EU level A strategically fragmented metrology research system reduces the effectiveness and efficiency of the Single Market and the Innovation Union. The efficient access to markets depends today on the local access to calibration and certification services, which in turn will be completely defined by the capacity of the metrology system in a certain country. There is no European entry point for specific applications on a European level, although the European association, EURAMET, can function as a gateway. However, EURAMET does not provide metrology services for specific applications directly. EMRP and EMPIR partnerships have made progress in bringing metrology research resources together by focussing on project level research collaboration. Certainly, EMPIR has leveraged more than 50% of the research budget of national programmes and has successfully created integration momentum via the 169 collaborative research projects directly funded under the initiative. However, it has been mostly limited to project collaborations, with the focus of projects still being driven by national priorities. Any European-level metrology capacity created in the initiative is solely bottom-up from a diverse set of projects and thus cannot be self-maintained in the longer term. Under EMPIR, 28 national metrology systems in Europe (23 Member States and 5 associated countries) act under national mandates, addressing gaps in some Member States. The EURAMET members also address some overlaps and duplication of metrology research capacity, but still on a fragmented level through initiatives of the individual Member States. EURAMET has for example registered 1223 bi- or multilateral projects (from 1988 to 2010) for cross-border collaboration, of which 150 are still active today. The current fragmented approach to research at strategic level does not provide the efficiency required to respond to the increasing demands on the metrology system in Europe. This inhibits Europe’s ability to provide the metrology infrastructure required to capitalise optimally on all challenges Europe is facing, such as supporting emerging technologies for the benefit of European competitiveness globally, and to address major societal challenges for the benefit of European citizens. After the 2017 EMPIR mid-term evaluation, a process for streamlining cooperation at the level of devising the work programme of the partnership has already started: six European Metrology Networks (EMNs) have been initiated from a larger list of potential areas identified in which EURAMET members would be able to invest in joint capacities. Additional networks are foreseen to be established in the coming years. Following a written consultation of Member States launched on 18 March 2020, Member States con