Horizon Europe Archives - European Industrial Pharmacists Group (EIPG)

A new member within EIPG


The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

UK will participate to European research programmes

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by Giuliana Miglierini

The divergent road opened as a consequence of the Brexit, in January 2021, between the European Union (EU) and the United Kingdom (UK) is now converging again as for the possibility for UK researchers to participate to Horizon Europe (HE) and Copernicus scientific programmes. The agreement in principle reached on 7 September 2023 by the European Commission and the UK Government was facilitated by the previous Windsor Framework Agreement. It shall now be ratified by the Council of the European Union, and then adopted by the Specialised Committee on Participation in Union Programmes.

The EU and UK are key strategic partners and allies, and today’s agreement proves that point. We will continue to be at the forefront of global science and research.”, said the Presi-dent of the European Commission, Ursula von der Leyen.

The possible association of the UK to Horizon Europe animated a vigorous debate in the past couple of years among the scientific international community, as well as that of other third countries such as Switzerland (those association is still pending, see below).

The current agreements in place between the UK and the EU are not comprehensive of the participation of UK’s students to the Erasmus+ programme, participation that was cancelled by the UK government in 2020.

The financial terms of the agreement

The new association of UK to both HE and Copernicus programmes will become operative star-ting 1 January 2024, superseding the previous transitional agreement that allowed UK researchers to apply and be evaluated as other potential beneficiaries under HE calls. It will become possible for UK researcher to access HE’s 2024 Funding Programme and Work Programme (including the coordination of consortia), and to participate in the European Research Council and Marie Skłodowska-Curie Actions.

According to the European Commission, the estimated annual contribution of the UK to Horizon Europe and the Copernicus component of the Space programme should be on average €2.6 billion, in line with the terms agreed in the Trade and Cooperation Agreement. The EU Commission will issue twice a year a call for funds to the UK corresponding to the due contribution. The overall EU budget for Horizon Europe is €95.5 billion, plus contributions due by the various associated countries.

The agreement is also comprehensive of a correction mechanism referred to Horizon Europe, aimed to compensate the contribution of the UK, should its receipts in grants be higher than its contribution for grants. Under the terms of the Trade and Cooperation Agreement, an automatic correction to the UK’s contribution would occur if it reached a threshold of 8% over two successive years. A balance mechanism has also been put in place to compensate for the UK receiving significantly fewer grants than its contribution. In this instance, the level of UK participation may be improved, or (should it overpays by more than 12%), the issue may be object to scrutiny by the joint Specialised Committee on Participation in Union Programmes to agree upon the measures needed to balance the situation.

A temporary and automatic mechanism has been also agreed to address any risk of critical underperformance by the UK should the imbalance exceed 16%, based on the consideration the country did not fully participate in HE in the past two years.

The main fields of collaboration

UK’s participation to European research programmes will focus on area of mutual interest, i.e. emerging technologies, climate change and health. The participation to strategic parts of Horizon Europe – including those related to strategic assets, interests, autonomy or security – is subject to the previous assessment of UK participants on equal terms with other associated countries (Art. 22(5) of the Horizon Europe Regulation). The participation to other parts of HE will occur on equal terms with researchers and organisations from EU Member States.

Copernicus is part of the European space programme. The association will allow the UK to access a state-of-the art capacity to monitor the Earth and its services. Among the main goals of the programme is the understanding and acting on environmental and climate change related challenges. The UK will also have access to EU Space Surveillance and Tracking services.

The reactions

The announcement of the agreement on the association of the UK to European research pro-grammes found very positive reactions among the different parties interested in solving the issue.

Joining the Horizon Europe programme is a huge win for the scientific research community, who have been pushing for resolution over the past few years. UK innovation and research de-pends on international collaborations which are crucial for driving advancements in all areas of science, including the discovery and early development of new medicines and vaccines”, said Janet Valentine, ABPI Executive Director, Innovation and Research Policy. “The UK accession to Horizon enables the two sides to reinvigorate their longstanding partnership in R&D, and directly contributes to UK growth and competitiveness in the life sciences sector by making the UK an attractive destination for talented researchers.”

This decision represents a long-awaited signal for renewed international collaboration on fundamental frontier research in Europe. It will strengthen the research of all involved, both in the EU and in the UK. At the ERC, we look forward to welcoming back researchers based in the UK, after the trying last few years. They have been sorely missed, and will now be able to participate again as from our 2024 grant competitions”, said the President of the ERC, Maria Leptin.

The academic world represented by Cesaer highlighted the reintegration of UK into Horizon Eu-rope and Copernicus reaffirms the commitment of both the EU and the UK to advancing global scientific excellence. The association of the European universities of science and technology also supports further progress in building a wider international scientific community, with particular reference to Switzerland.

Today, Europe’s universities celebrate the end of a long road that began in 2016 and look for-ward to rebuilding and further developing close partnershipssaid Josep M. Garrell, President of the European Universities Association.

We are extremely grateful for the efforts of everyone in the European research community who has worked tirelessly to help secure this agreement”, added Jamie Arrowsmith, Director of Universities UK International.

Switzerland is still waiting for the association

Despite Switzerland being a very important country for research in life sciences, and location of many of the major pharmaceutical industries, the country is still waiting to restart the negotiations with the EU for its association to the European research programmes. The exclusion of Switzerland from any form of collaboration was the result, in 2021, of the political divergence with the EU on many issues.

We feel alone in the middle of Europe,” Yves Flückiger, rector of the University of Geneva, told Business|Europe.

According to the article by David Matthews, the incumbent Swiss federal elections in October 2023 and the European elections of 2024 may slow down the negotiations on the new political relationship. The association of Switzerland to EU’s research programmes might then not occur before 2025. Some explanatory talks would be already ongoing, adds the article. Sympathy for researchers in Switzerland was expressed by the ERC President, Maria Leptin. “They are not alone in the sense they are loved by all the rest of us,” she said. “There is very high-level research being done in Switzerland, same as in the UK. We all want to be one group that competes at the same level and is evaluated by the same high-level panels.


The debate on the “Do No Significant Harm” principle in R&D

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by Giulianna Miglierini

The “Do No Significant Harm” (DNSH) principle is a widely diffused approach aimed to guarantee the respect of ethical limits while dealing with many kinds of activities. It is the case, for example, of the use of big data to conduct behavioural studies, or of health research aimed to be of help to society without hurting anyone. Available frameworks regulating the ethical approach to research usually focus on the protection of participants against unwanted, potentially harmful effects resulting from the study. Examples of such frameworks are the 1964 Declaration of Helsinki and the 1979 Belmont Re-port, which do not mention the protection of other people and of the environment.

The DNSH and the European Green Deal

The introduction of the Do Not Significant Harm principle within the Taxonomy regulation (EU 2020/825) represents the first example of its extensive application aimed to prevent unintended damages to the environment. According to the regulation, beneficiaries of financial support from EU institutions are expected to assess the possible negative climate and environmental impacts of their projects, and to avoid any activity that may negatively impact the sustainability objectives of the European Green Deal.

These include six main areas of attention, i.e. mitigation of and adaptation to climate change, sustainable use and protection of water and marine resources, control and prevention of pollution, the transition to a circular economy, and the protection and restoration of biodiversity and ecosystems.

The inclusion of the DNSH principle in the Taxonomy regulations means that the above-mentioned objectives would apply to any EU funded activity, including framework research programmes such as Horizon Europe.

Many critics arose from this move of the Commission, as it may greatly affect the effective capacity of researchers to plan and realise their activities. As a part of the debate, MEP member Christian Ehler presented in July 2021 a written question to the Commission aimed to clarify how the DNSH aspects of a project would be evaluated and scored during the assessment of the proposals, and the impact they may have on the final outcome of such assessment.

The written answer provided by EU Commissioner Mariya Gabriel stated that “the application of the ‘Do No Significant Harm’ principle in Horizon Europe is voluntary at project level”, and that its inclusion in the project description will have no impact on the assessment of the proposal. According to the Commission, no declaration of projects compliance with the principle is re-quested, and no undue increase of the administrative burden for applicants is present. Instead, the reference made to the DNSH principle would only aim to raise awareness about the environmental risks linked to research activities and encourage the identification and mitigation of potential measures.

A second written question presented in August 2022 asked the Commission to provide further details, i.e. how many applications under Horizon Europe included the DNSH principle in the project description, the percentage of 2021/2022 budget covered by DNSH and the number of evaluations in which the DNSH principle was used in the assessment of the application.

The written answer by Commissioner Gabriel indicated references to the DNSH principle in proposals vary according to its relevance to the specific thematic area and technology readiness levels. Only 2.6% of proposals referred to parts of the programme that make no explicit reference to DNSH considered the principle; this percentage reached 29.6% for applications referred to parts of the programme making explicit reference to it (data 12 August 2022). Commissioner Gabriel also said almost half of the budget of the work programme for 2021-2022 made explicit reference to the DNSH principle, and that all EU actions and policies have to be consistent with the objectives of the Paris Agreement and the Green Deal oath ‘do no harm’.

The ongoing debate

No matter to say, the position of the European Commission to extend the implementation of the DNSH principle across all research activities activated a reach debate within the R&I community. The initial objections by MEPs were based, according to Mr. Ehler, on the possible absence of “democratically legitimised criteria” (read more on Science|Business).

According to a viewpoint article published in Science|Business, the DNSH approach chosen by the Commission would be not the right way to address the issue of environmental sustainability. “Rather, research and innovation policy should be reconfigured to allow researchers to ‘stay with’ the harms they (might) do”, wrote the authors. The alternative to DNSH sees greater attention towards a better understanding of what really constitutes a “harm”. According to the authors, a definition of “significant harm” should be agreed upon between humans, non-humans, and ecosystems experiencing harm, thus avoiding any technocratically and unilaterally handed down definition. They also discuss the appropriateness of the concept of ‘situatedness’ in order to reach a suitable definition of significant harm.

Key to this vision should be the “understanding that there is no universal, objective viewpoint from which one might determine which research is beneficial or harmful, for whom, and to what degree”. To this instance, elements to be considered in the assessment include the time needed for the harm to manifest, its geographical location or the involvement of marginalised actors. Furthermore, the approach adopted by the EU Commission would not be suited to solve the ambiguities. A possible solution would be represented by the “creation of spaces where ambiguous harms can be appropriately engaged”.

The associations representing the academic and scientific world also took a position against the extension of the DNSH principle to all projects under European R&I framework programmes.

The European University Association (EUA), CESAER (representing universities of Science and Technology) and Science Europe (on behalf of major public organisations funding or performing research in the EU) jointly published a statement to ask support to the Parliament as for the approval of amendment 165, focused on feasibility, appropriateness and proportionality of all programmes and activities, in accordance with the relevant sector-specific rules. The associations also underline that the implementation of the DNSH principle should not be counterproductive and weaken the contribution of the R&I community to sustainability and green objectives.

According to EUA, clear guidelines are missing on how the principle should be implemented in practical terms. Furthermore, the broad application of the DNSH principle might especially undermine the possibility to undertake fundamental research activities. As for now, the principle applies only to European Innovation Council projects, and missions and clusters of Pillar II of particular relevance for their environmental outcomes and impacts.

In a position paper of October 2022, CAESAR asked, among others, for an “ethics by design” approach, based on a ethical checklist to be included in the design phase of projects. Briefings with the proposal evaluator and project reviewer should also be improved in order to clarify when the DNSH principle has to be taken into account.

According to Science Europe, the implementation of the principle should not add an additional administrative burden to researchers and increase the complexity of project proposals and evaluations. The association also asks for the broader application of the DNSH principle to be preceded by a thorough assessment of its current implementation in Horizon Europe.


European Council’s conclusions on the European Innovation Agenda and research infrastructures

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by Giuliana Miglierini

The European socio-economic framework is undergoing a profound transformative moment, as a result of the new vision impressed by the von der Leyen Commission, with its goals in the field of the Digital and Green transitions. The subsequent crisis caused by the Covid pandemic and the following war at the boundaries of the European Union deeply impacted the already fragile economy, asking for new measures to sustain its competitiveness and ability to innovate.

A major goal of the Commission’s Agenda is to reposition the EU as a global leader in innovation. The European Council endorsed this vision at the beginning of December 2022, by adopting the Conclusions on the New European Innovation Agenda.

The recent crises have shown the need for the EU to support an open strategic autonomy in order to curb the dependencies and vulnerabilities that affect our industry. We have to strengthen the EU’s own capacity in strategic areas. This will not be possible without ambitious investments in innovation”, said Vladimír Balaš, Czech Minister for Education, Youth and Sport, commenting the document.

The European Council also adopted its new Conclusions on research infrastructures (RIs), which complement and complete the framework to support innovation and set the basis for the full development of the European Research Area (ERA).

According to the European Commission, almost two thirds of the EU’s growth is driven by innovation. Despite this, the EU still positions behind other countries as for Gross domestic product expenditure on R&D activities (2.18%, vs 4.52% of South Korea, 3.28% of Japan and 2.82% of the US. Only China slightly follows at 2.14%). The same trend applies also to business enterprise investments in R&D (EU 1.45%, vs 3.63% of South Korea, 2.6% Japan, 2.05% of the US, and 1.66% of China).

The new Innovation Agenda

The Conclusions on the New European Innovation Agenda are the result of a work started in November 2021, when the Council’s Recommendation on a Pact for Research and Innovation (R&I) in Europe highlighted the importance of synergies with sectorial policies and industrial policy, as well as the coordination of R&I policies and programmes to support the development of breakthrough and incremental innovations across the Union. The New European Innovation Agenda was announced by the Commission in July 2022 and is intended to fully exploit the potential of deep tech innovations. In September 2022, the Czech Presidency of the Council started the drafting of the conclusions, and the final text adopted by the Competitiveness Council (Research) at its meeting of 2 December 2022.

All types of innovation play a critical role in driving EU’s competitiveness, states the document, with a particular emphasis on research-driven innovation, deemed able of shaping and creating new markets. Incremental and breakthrough innovation are both essential to maximise the societal and economic value of the resulting outcomes. Investing in higher education and R&I is thus essential to achieve these goals, and to position the EU as a global R&I leader. Social sciences and humanities should also be part of the comprehensive approach to innovation described by the Conclusions.

The diversification of supplies and the mitigation measures to tackle strategic dependencies on external suppliers are critical issues to be faced to compete in the complex global geopolitical scenario. An open approach to international R&I cooperation is still the goal of the European institutions, requiring shared fundamental values and principles with other countries and a balanced and reciprocal approach.

At the regulatory level, flexibility, fit-for-purpose, forward-looking and innovation-friendly remain the preferred keywords to characterise the new framework. The development of breakthrough, deep-tech and disruptive innovations should be supported by standardisation and accreditation, and regulatory adaptation and experimentation.

The Council also supports the role of private R&I investments and strategic use of intellectual assets as a fundamental part of the undergoing transition, as well as further policy reforms at Union, national and regional levels to better encourage the full development and implementation of new technologies, including testing and demonstration facilities.

The European Innovation Council (EIC) Fund has been confirmed as the tool to support investments in innovation. Among others, the Conclusions ask the Commission to implement the EIC’s Scale Up 100 action and to facilitate access to capital for innovative start-ups and SMEs through the InvestEU Programme.

Conclusions on Research Infrastructures

The second document approved in December 2022 updates the vision of the European RI ecosystem, with a particular focus on the system of integrated research infrastructures. Access to RIs is deemed fundamental to support innovation by private, large and medium-small companies. It can take different forms, i.e. proprietary access to RIs, contractual research, joint R&I, training and industrial, supply of top-class products and services to RIs. Research infrastructures are also important to sustain regional development and support the availability of a wide range of skills and relating jobs.

A central part of document is represented by the call to proceed with the implementation of the ERA Policy Agenda for the period 2022–2024 and, in particular, ERA Action 8 (“Strengthen sustainability, accessibility and resilience of RIs in the ERA”). To this instance, a major activity should aim to involve RIs in producing, collecting, processing, storing and providing quality certified scientific data in accordance with the FAIR (Findable, Accessible, Interoperable and Reusable) principles. This action is considered essential to facilitate the sharing and use of data across a broad range of disciplines as well as at the international level.

To improve the RIs’ framework, the invitation of the Council is for the European Strategy Forum on Research Infrastructures (ESFRI) to run a comparative study aimed to identify best practices and elaborate recommendations to national and regional RI stakeholders by the end of 2023. A common approach for the staff of the RIs, especially in the case of a European Research Infrastructure Consortium (ERIC), is also envisaged.

Research infrastructures can’t operate without the support of Technology Infrastructures (TIs); a mapping exercises of the last ones is considered essential in order to proceed with the implementation of the TI concept within the ERA Policy Agenda. Members states and the Commission should also work to better identify the role of RIs in the implementation of Horizon Europe (i.e. European Partnerships and Missions, industrial technology roadmaps, etc.). RIs may also contribute to designing new services based on their different missions and should be supported by long-term investments by member states with the support of the Commission. To this instance, the analysis of possible types of financial support throughout RIs’ life cycle, with identification of good practices and synergies of various funding resources, should be accomplished by ESFRI.

The Council also invited the Commission to present an initiative on a revised European Charter for Access to Research Infrastructures by the end of 2023. A better coordination between ESFRI and the European Open Science Cloud (EOSC) Steering Board would also be needed.


The new European Innovation Agenda

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by Giuliana Miglierini

A new piece of legislation adds to the framework supporting the new paradigms set forth by the European Commission: the European Innovation Agenda (EIA) aims to position the EU as a global leading player in innovation, especially in the field of deep techs. These are usually referred to as a combination of physical, biological and digital emerging technologies targeted to develop new, transformative solutions in all areas of economy and society.

Breakthrough R&D and large capital investment are the identified tools to support their development. “We need to boost our innovation ecosystems to develop human-centered technologies. This new Innovation Agenda builds on the significant work done already on innovation in the last years and will help us accelerate our digital and green transition. The Agenda is rooted in the digital, physical and biological spheres and will enable us tackle better burning concerns, such as breaking the dependence from fossil fuels or securing our food supply in a sustainable way.”, said Margrethe Vestager, Executive Vice-President for a Europe fit for the Digital Age.

The five areas of intervention

The European Innovation Agenda is divided in five different flagship areas, for a total of 25 actions.

Startups and scale-up companies will be the central focus of the Agenda and the target of investments by both private capital and institutional investors. Simplified listing rules are planned to support their scaling. The debt-equity bias reduction allowance on corporate income tax would also benefit of a later stage venture capital financing, with expansion of the European scale-up action for the risk capital mechanism under InvestEU. An innovation gender and diversity index and the EIT Women2Invest Programme are other planned actions in the area.

Relevant investments are envisaged to attract and train at least 1 million talents in the field of deep tech and to support women entrepreneurship. Among the planned activities are an innovation intern scheme for startups and scale-ups, and an EU talent pool to help young innovative companies to attract extra-EU specialists. A Women entrepreneurship and leadership scheme and the establishment of a best practice exchange on startup employees’ stock options are also planned. Other initiatives shall support the promotion of an entrepreneurial and innovation culture; these actions will include support to education and innovation practice communities, Erasmus+ alliances for innovation, and a Digital Europe call to train future experts.

Under the regulatory perspective, regulatory sandboxes and experimentation spaces coupled to public procurement are expected to facilitate the development of new ideas. Among the possible experimental approaches mentioned by the EIA there are open innovation test beds in renewable hydrogen, living labs and innovation procurement. This last sector may see the establishment of an Innovation Procurement Specialist Advisory Service.

Guidance will be provided to policy makers on regulatory sandboxes. State aid rules shall also be revised to better support the construction of testing and experimentation facilities, namely in the field of AI innovation.

Interconnections of the different players and the creation of a network of European Innovation Ecosystems will be pursued through “regional innovation valleys”. Interregional innovation projects should benefit of a total budget of €10 billion, that shall also be used to support member states’ efforts towards the integrated use of cohesion policy and Horizon Europe instruments. Among the planned actions is the doubling of the number of Hydrogen valleys in the EU, the creation of a Innospace (a one stop shop for innovation) and the establishment of the EIC ScaleUp 100 index, reflecting the hundred deep tech startups with the potential to scale up as global leaders or potential unicorn.

Finally, the transparency of the overall process will be pursued using clearer terminology, indicators and data sets to improve the policy framework, and a better policy support to member states. This shall allow for a better comparability of data sets and the use of shared definitions to inform and coordinate policies at all levels, through the European Innovation Council Forum.

The new European Innovation Agenda will complement existing tools to support R&D and innovation, such as Horizon Europe’s actions targeted to startups, scaleups and small and medium-sized enterprises (SMEs), the funding by the European Innovation Council (EIC) (we wrote about this here) and the new Knowledge and Innovation Communities (KICs) created by the European Institute of Innovation and Technology (EIT).

Comments from the stakeholders

For more than a year we have consulted the stakeholders, such as innovation ecosystem leaders, startups, unicorns, women founders, women working in the capital venture, universities, and businesses. Together, we will make Europe the global powerhouse for deep-tech innovations and startups”, said Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth.

Among contributors to the debate was EuropaBio, that published its response to the Commission’s proposal.

The requests of the association representing the biotechnology industry to remove regulatory barriers through the establishment of regulatory sandboxes has been recognised in the EIA, as well as the need to invest in scientific and industrial excellence and bridge the innovation gap between member states. Other key issues highlighted by EuropaBio included the need to review the GMO legislation to overcome the process-based approach that often results in unequal regulatory treatment for similar products with equivalent risk profiles, together with improved policies for rewarding innovation and the need to build digital literacy skills.

The Irish Pharmaceutical Healthcare Association also commented the Commission’s proposal. According to the post signed by Bernard Mallee, IPHA’s Director of Communications and Advocacy, despite the effort of the Commission to boost innovation and fill the gap with US and China in the development of breakthrough treatments, mixed results may be expected. Incentives in areas of unmet medical need and the fight against antimicrobial resistance are identified as key issues. The suggested solution is a better underlying commercial model targeted to invest in the development of new antibiotics, and the importance of health data in driving medical research and managing healthcare systems. Improved iterative scientific dialogue and dynamic regulatory assessment based on real-world data and innovative trial designs are other point of concern for IPHA. Harmonisation of the EU Special Protection Certificate framework was also suggested, while the coordination of compulsory licensing in emergency situations in Europe was judged at risk of de-incentivise innovation. IPHA also supports the High-Level Forum on Better Access to Health Innovation initiative launched by EFPIA.

Positive comments to the new European Innovation Agenda also came from the European Startup Network (representative of 38 national startups associations) and the European Regions Research and Innovation Network (ERRIN) (see more on ScienceBusiness).

The revision of the pharmaceutical legislation is also central to the agenda of the Czech EU Presidency for the second half of 2022. Again, the goal is to close the gap with the competitor countries and speed up the approval of new treatments. According to Euractiv, it takes on average 150 days longer to get an innovative medicine approved in Europe than in the US. Just 22% of innovative medicines are being developed in the EU, vs 48% of the US (data EFPIA).


EIC: challenges for the governance and opportunities for innovation

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by Giuliana Miglierini

The European Innovation Council (EIC) was launched in March 2021 by the EU Commission to support the growth of highly innovative startup companies. Since then, the programme experienced some difficulties to become fully operative, as delays occurred with companies requesting grant-only or grant-first support and with the decision-making procedures for companies requesting blended finance or equity-only investments.

According to the Commission, this situation is a result of the restructuring of the EIC Fund to better reflect Horizon Europe legislation and the outcomes of the pilot phase. Negotiations are also ongoing with an external fund manager of the EIC Fund and are expected to close by the end of June. Internal discussions in the European Commission and IT problems are among the possible causes of the delays, reported Politico. A situation that is highly impacting on the selected companies, that are hampered from proceeding with the timely development of their business.

The difficult governance of the EIC prompted the European Parliament to start an investigation, led by Horizon Europe’s rapporteur Christian Ehler, to better clarify the issues undermining the EIC functioning (see more on ScienceBusiness). Mr. Ehler asked the stakeholders to provide inputs by 14 June; the final outcomes of the investigation will be summarised in a non-legislative report on the implementation of the EIC.

The idea behind the report is to get the debate about the future of the EIC out in the open and provide the Parliament’s perspective on it. As co-legislator we have a duty to ensure the Commission implements the legislation we approved,” said Christian Ehler.

The EIC Accelerator

Available investments for startups and SMEs under the EIC Accelerator programme total €2.5 million for grants and €0.5 to €15 million equity investments through the EIC Fund. Higher investments are possible to support the development of technologies of strategic European interest.

A fast assessment procedure was introduced in 2021 to submit new projects at any time. A tailored business coaching support is available to successful candidates to draft the full applications, which are then evaluated at regular cut-off dates approximately every three months. The Commission announced it is finalising its decision-making procedure for the grant and equity components to companies selected for blended finance during the 2021 cut-offs. This is expected to allow the signature of contracts for the grant component of blended finance in a couple of days after the closure of the decision-making procedure, followed by the payment of a pre-financing of the grant one week later. A due diligence is needed to support the investment decision by the EIC Fund for the equity component, that will thus occur few weeks or months later.

The current status of the EIC Accelerator

According to the European Commission, 65 companies were selected for funding under the EIC Accelerator programme for the June 2021 cut-off, following the evaluation of their full application. Of these, 29 companies requested grant-only or grant-first support and 31 requested blended finance, including a grant component and equity investment. Contracts for six grant-only or grant-first companies were still to be signed as of 13 May 2022. The grant component is expected to close by early June 2022, while for the equity investment component and equity-only closure of the investment agreement is expected after June.

Some other 99 companies were selected for support in the October 2021 cut-off. Only one contract of the overall 34 companies that requested grant-only or grant-first support has been signed. Signature of the grant component for companies that selected blended finance is planned in July 2022, followed by the equity component and equity-only projects from the summer up to the end of the year.

The third cut-off round of March 2022 saw the selection of some other 74 companies, over a total of more than 1000 applications. Selected companies will each receive grants and/or equity investments up to €17.5 million. The next cut-offs for full applications is 15 June and 7 October.

Deep-tech training needed

A report published in April 2022 by the EIC Pilot Expert Group suggests the creation of two new deep-tech training programmes to better support the development of human entrepreneurial talent while fostering technological solutions. “We argue that EIC can’t succeed without including in its mandate the objective of proactively realising the entrepreneurial talent of Europe’s brilliant scientists”, write the members of the Expert Group in the foreword of the document.

The EIC Trailblazer Programme and the Pioneer Programme are the tools identified to reach this challenging goal. Both of the programmes should be implemented in a phased manner using pilot projects to allow for experimentation and learning, according to the recommendations set forth in the report. A main expected outcome is the creation of a new generation of deep-tech entrepreneurs, the EIC Innovators, able to better evaluate how their technologies are fitting into the world for commercialisation and impact.

The EIC Trailblazer Programme is targeted to support talented PhD candidates and postdocs that are part of projects funded by the EIC Pathfinder and EIC Transition. These EIC Trailblazer Fellows may receive a deep tech training programme, aimed to work as an internal accelerator and an elite programme targeting proto-entrepreneurs. A special prize and/or grant may also be considered to recognise scientific and entrepreneurial talents.

The Pioneer programme would allow for deep-tech add-on modules sponsored by the EIC to complement existing programmes delivered at the local level, in member states and potentially EU associated countries. Beneficiaries would include talented scientists that one day may apply for EIC funding, the “proto-EIC Innovators”.

Comments from research-intensive universities

The Guild of European research-intensive universities published a statement to contribute to MEP Christian Ehler’s initiative of a report on the implementation of the EIC. A better recognition of the role of universities’ Technology transfer offices (TTOs) as key actors in enabling researchers to develop their results for commercial and societal purposes is the key message of the Guild. To this instance, duplication of activities of the TTOs in terms of project management and support services should be avoided. Concerns are also highlighted with reference to the standard Intellectual Property (IP) provisions in the EIC Pathfinder and Transition schemes, as they might negatively affect the functioning of already well-performing TTOs without strengthening the capacities of weaker TTOs.

A positive experience is also acknowledged as for the EIC Transition scheme, that supports universities and their spin-offs with appropriate financial support for proof-of-concept projects. The Guild asks for the extension of this funding scheme to support an higher number of innovative projects.

An example of funded project

Swedish company Bico (formerly Cellink) is an example of EIC-funded project which saw a very rapid growth of its business, achieving $ 1 billion in market valuation in the first five years of activity. Founded in 2016, the company is now leader in the bioink sector and is developing new bio-printing technologies to be used for 3D printing of organs and tissues, so to overcome the lack of donors, reduce shortages and improve drug development.

Bioprinting is only one of the technologies included in Bico’s portfolio; gene therapy, gene editing, CRISPR, diagnostics are also investigated. The company built up from the first universal bioink created by Professor Paul Gatenholm (Chalmers University), a special biomaterial that enables human cells to grow outside the body and perform all the vital functions.


The Made in Europe partnership for manufacturing

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by Giuliana Miglierini

The availability of a robust framework to support a sustainable European manufacturing system is undoubtedly a priority in the challenging times we are experiencing. In the pharmaceutical sector, the reshoring of productions of both active ingredients and finished medicinal products is already a key point of the new EU Pharmaceutical Strategy and of the consequent ongoing revision of the legislation governing the sector.

A broader action addressed to the entire European industrial system was launched in 2019 within the framework programme Horizon Europe (HE) 2021-2027: the Made in Europe manufacturing partnership aims to become the main driver for sustainable manufacturing in Europe. The partnership was modelled with the contribution of the European Commission, member states and the European Factories of the Future Research Association (EFFRA); the latter is also the leading entity in charge of coordinating the initiative, which include all actors taking part to the manufacturing ecosystem (i.e. academia, industry, non-governmental organisations and the public sector).

The main goals of the Made in Europe partnership

The two themes of ecological and digital transitions central to the policies of the von der Leyen Commission are the main source of inspiration for the Made in Europe partnership. The availability of a European manufacturing environment able to compete on global scenarios thanks to its technological leadership is the main objective of the initiative. Many challenges need to be faced to reach it, especially in the field of the integration of technologies based on artificial intelligence to fully exploit the potential of industrial data, the reshaping of a circular economy and a high flexibility in response to emerging trends and issues.

The Made in Europe partnership represents a common platform for national and regional manufacturing technology initiatives, including the required disciplines and technologies. The principles governing its actions are described in a guidance document available at the EFFRA website; a Strategic Research and Innovation Agenda (SRIA) is also available.

According to the guidance document, manufactured goods represented in 2018 83% of EU exports, and accounted for a annual trade surplus of 286 billion euro. Despite this very high surplus, the document warns it may be not sufficient to cover deficits arising from the purchase of non-manufactured goods and services. Also considering these factors, the balance moved from a surplus of € 22 billion in 2017 to a deficit of € 25 billion in 2018. This situation may now dramatically evolve further, due to the high increase of costs of energy and raw materials experienced in the last month, as a consequence of the war occurring at the Eastern boundaries of the EU. A situation that might make harder for the EU to also face the competition of Asiatic economies.

The guidance document identifies twelve challenges to be faced by the European manufacturing industry, starting from the need to strongly reduce to the minimal level its environmental impact. To this instance, optimisation of resource efficiency and the carbon intensity of the entire supply chains are among the main factors to be addressed, leading to the opportunity for European-made environmental-friendly but high-priced products. This switch also supports the development of circular models for the economy, and the use of next-generation sustainable materials and products, requiring to manage profound changes if the manufacturing systems and related supply chains. Recycling and re-manufacturing may play in the future an important role in redefining products’ life cycle. The resilience and agility of the European manufacturing industry shall be also tackled, in order to limit the impact of sudden crisis, as occurred with the Covid-19 pandemic or now with the Ukraine war. This goal calls for the availability of flexible and reconfigurable production lines within a country or region, suggests the document. The pharmaceutical sector already experienced criticalities during the Covid-19 arising from the dependence from extra-EU supplies; the same applies to all European industrial sectors, and according to the Made in Europe partnership it should be faced through achieving manufacturing sovereignty and technological leadership in key areas and critical value chains. A very challenging objective, that requires a coordinated European effort on manufacturing.

As for competition from other economies, the document warns that big public-private manufacturing partnerships are being launched also in Asia and America (i.e. Made in China). Environmental and social aspects should be jointly considered in the location/relocation of manufacturing companies, to account for the environmental sustainability of the businesses coupled to the requirements arising from a EU’s population mainly living in urban areas.

The challenges of digitalisation

Many of the above-mentioned targets identified by the Made in Europe partnership may benefit from the potential offered by the implementation of digital technologies to accelerate innovation and industrial transformation, thus leading to the improvement of the overall efficiency of manufacturing. Data are becoming a central driver for the creation of value, but companies are called to better understand the data economy also from a non-technological point of view. Cybersecurity should be also carefully addressed, as digitalisation is reflected by a higher vulnerability to cyber attacks.

Digitalisation also impacts on the availability of new business models, such as “manufacturing-as-a-service” and “collaborative product-service engineering”. Automated systems governed by artificial intelligence are now widely available in many industrial plants, and attention should be paid to modes of interactions between collaborative robots and human operators. Nevertheless, the availability of trained and skilled human staff is considered as a major barrier and threat by the Made in Europe partnership, particularly for SMEs.

The planned actions

Six different calls for actions in the field of green and digital transitions were launched by the Made in Europe manufacturing partnership within the Horizon Europe work programme 2021-2022. The total available budget is around € 1 billion. Topics of interest included AI enhanced robotic systems for smart manufacturing, zero-defect manufacturing towards zero-waste, laser-based technologies for green manufacturing, manufacturing technologies for bio-based materials, advanced digital technologies for manufacturing, and data-driven distributed industrial environments.

The Made in Europe partnership was also involved in calls about reconfigurable production process chains, products with complex functional surfaces, excellence in distributed control and modular manufacturing, intelligent work piece handling in a full production line, ICT Innovation for manufacturing sustainability in SMEs, and digital tools to support the engineering of a circular economy.

A consultation on possible topics to be included in the HE work programme 2023-2024 is still open to comments and can be accessed by the dedicated webpage at the EFFRA website. A summary document is also available presenting potential recommendations and discussion topics received up to now. New possible lines of actions may address the availability of “excellent, responsive and smart factories & supply chains” , how to achieve a circular products and climate- neutral manufacturing, new use models referred to new integrated business, product-service and production approaches, and models for a human-centered and human-driven manufacturing innovation.


Horizon Europe Association – Statement on behalf of the European Health Stakeholder Group

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As representatives of the European Union’s health community, we are united in our call for the United Kingdom’s association to Horizon Europe to be formalised as soon as possible.

Horizon Europe aims to tackle the major global challenges of our time but achieving this aim will be impossible without international collaboration. The COVID-19 pandemic has clearly highlighted the critical value of global partnerships to advance scientific discovery and innovation, especially where speed is of the utmost importance. The depth and strength of successful international collaborations resulting from the relationships built up over many years with the UK is long established.

We have all reaped the mutual health benefits of these collaborations. Together, we have significantly advanced health care across Europe, saving and improving citizens’ lives. Clinical trials, particularly on diseases with limited patient populations, have been heavily reliant on EU-UK collaboration, while close research and innovation partnerships continue to accelerate life-changing medical research.

Going forward, we must continue to work together in order to meet the challenges of our swiftly changing world. Our ability to respond to the threat of climate change and outbreaks of new diseases like COVID-19 has been greatly improved by close scientific and clinical partnerships across Europe. Knowledge and discovery do not stop at borders: the shared global challenges we face require joint solutions. Collaboration through the research framework programmes is a springboard to productive partnerships across the world.

As a community, we welcomed the provision in Protocol I of the EU-UK Trade and Cooperation Agreement for the UK to associate to Horizon Europe. The subsequent Q&A document from the European Commission provided us with confirmation that we could apply with UK entities for the first multi-beneficiary calls. Based on these reassurances, EU health research organisations have been working with UK partners on the understanding that they would shortly become full associate members. However, the absence of a clear timeframe for formalising UK association is now causing increasing concern. We notice too with regret that while the specialised committees for other policy areas are already established, the Specialised Committee on Participation in Union Programmes has not yet even had its first meeting.

This continuing uncertainty risks jeopardising current and future research partnerships, and time is fast running out. With the first Horizon Europe grant agreements nearing finalisation and new calls expected imminently, UK association must be formalised. Now is the time to act. Further delays or the spectre of non-association would result in a missed opportunity to tackle the major challenges of our time, diminish our collective research capabilities and weaken Europe’s position in the highly competitive global market.

Many profound and long-lasting EU-UK research partnerships are at stake. These are of high value to Europe as a whole – and to the world at large. We owe it to future generations in the EU and beyond to ensure that the new EU-UK relationship best serves them through research.

We stand with our colleagues in the European Union’s research and innovation community in urging the European Commission to formalise the United Kingdom’s association to Horizon Europe without further delay.

The European Health Stakeholder Group

The joint statement in full can be found in the following versions: EN, FR and IT.


The new vision for the European research landscape

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by Giuliana Miglierini

The new European framework for research and innovation, Horizon Europe (HE, 2021-2027), is now operative. A great deal of work has been accomplished in the recent months in order to define the possibility for third countries to participate to the new projects that will be activated. The List of Participating Countries in Horizon Europe was published by the European Commission at mid-June; it includes eighteen third countries associated to the framework programme, according to the provisions set forth by Regulation 2021/6951.

Eighteen third countries associated to Horizon Europe
The list also includes the United Kingdom, which became a third country after the Brexit, but with the exception of its participation to the EIC Fund (which is part of the EIC Accelerator that provides investment through equity or other repayable form).
The status of associated country makes its legal entities entitled to participate to HE’s projects under equivalent conditions as legal entities from the EU member states, unless specific limitations or conditions are specified in the work programme and/or call/topic text. All the sixteen non-EU countries associated to Horizon 2020 have expressed interest to continue the collaboration with the EU’s researchers. Transitional arrangements are in place to govern their participation to HE while waiting for the definitive closure of the negotiations.
Israel, Iceland and Norway are other components of this list, together with the majority of East European countries, Turkey, Morocco and Tunisia. Among not associated countries, Liechtenstein openly expressed its intention not to become an associated country. Further negotiations can lead to the expansion of the list.
Non-associated countries and international organisations can participate to most Horizon Europe’s calls, unless specific limitations or conditions apply; particularly interesting from this point of view are topics of research specifically directed to improve international cooperation.
Participants from not associated countries are not automatically eligible for funding, thus have to participate to the research activities at their own cost. Some exceptional circumstances allow them to access funding, i.e. in the case of outstanding competence/expertise, or if access to particular research infrastructures, data or geographical environment is needed. Automatic funding is available to a selected list of low- to middle-income countries from Africa, Asia, South America and Oceania.

The case of Switzerland
Switzerland is currently excluded from the pool of associated countries to Horizon Europe.
This is the result of the decision of the Swiss Federal Council occurred at the end of May to stop the seven years-long negotiations with the EU Commission (see more on Science Business).
Significantly, scientific research and the status of associated country within HE was not part of this negotiation, that was focused instead on bilateral agreements for the free movement of persons and mutual recognition of industry standards, agricultural products, air transport and land transport, as reported by Science Business.
The exclusion of Switzerland immediately caused a vivid debate among European scientists, worried for the possible consequences of the inability of their Swiss colleagues to take part to HE’s projects. An Open Letter signed by many different European Science,Technology & Innovation (STI) Councils and Advisory Bodies and other Science organisations (among which Science Europe and Cesaer) urges for the full association of Switzerland with Horizon Europe.
The signatories of this letter would like to underline the importance of continuing the long established and mutually beneficial cooperation between the EU and Switzerland in the domain of research and innovation”, states the letter. Many are the past contributions from the Helvetic country to the success of European research, starting with the hosting of the European Organisation for Nuclear Research (CERN) up to the foundation of the European Space Agency. “Downgrading Switzerland to a third country would severely limit its expertise being brought into Horizon Europe projects tackling today’s and tomorrow’s global challenges. We are convinced that this would lead to a lose-lose situation, putting successful cooperation in strategic areas at risk and ultimately weaken the ERA as a whole”, write the scientific organisations.

The situation with respect to China, the US and Canada
The “open strategic autonomy” is the new paradigm of action the von der Leyen Commission shall apply also in the field of research and innovation. According to Science Business, this approach will represent the basis for the negotiations with countries like China, that might require a higher level of attention with respect to the need of providing adequate protection for the intellectual property developed by European scientists.
Preliminary discussions to solve legal issues that prevented the participation of US universities to EU research projects in the past years are also undergoing. In the meantime, the high level EUUS Trade and Technology Council (TTC) was launched by US president Joe Biden and EU Commission president Ursula von der Leyen during the US-EU Summit in Brussels on June 15, 2021.
The TTC will meet periodically at the political level to coordinate approaches to key global trade, economic, and technology issues and to deepen transatlantic trade and economic relations commitment to strengthen our technological and industrial leadership and expand bilateral trade and investment. It also gives us tools to address threats such as unfair competition and the misuse of new technologies. This is a top priority for the EU, and we warmly welcome the fact that it is now also at the top of the transatlantic trade agenda”, said Valdis Dombrovskis, European Commission Executive Vice-President and EU Trade Commissioner.
The TTC will operate through several working groups, responsible to translate the political decisions into deliverables, coordinate the technical work and report to the political level. Among the first topics for its action is cooperation in the field of technology standards and secure supply chains.
Preliminary negotiations took place also with Canada in the course of the European Union-Canada summit, in June (See more here). Specific points in the field of health mentioned in the final joint statement include the launch of a new Canada-EU dialogue on health under the Strategic Partnership Agreement to improve health cooperation in multilateral contexts, and an enhanced bilateral cooperation under Horizon Europe. This last action should see some exploratory discussions towards a possible association of Canada to the framework programme, particularly with respect to the green and digital transitions and AI and quantum cooperation.

A new Strategy for Science Europe
Science Europe, the organisation representing major national research performing organisations (RPOs) and research funding organisations (RFOs) in Europe, has published its new Strategy 2021-2026 and the related Action Plan.
The central vision of the news Strategy is that “for a European Research Area with optimal conditions, to support robust education, research and innovation systems”. This goal will be pursued by defining the long-term perspectives for European research and selecting the best-practice approaches. Scientific knowledge as a common good, research as a public service, freedom of scientific inquiry, responsibility of all actors in ensuring the highest possible standards of quality, ethics, integrity, inclusivity, and openness in the conduct and management of research are just some of the values that have inspired the Strategy.
Three priorities will guide members organisations, starting from the role RPOs and RFOs can play in shaping future developments of the European research policy. Open science will continue to represent the paradigm of choice in order to ensure sustainability of the R&I system. A possible evolution of the current framework may result in the proposed European Framework Programmes for Research and Innovation. Science Europe will support its members in promoting investment in R&I and in closing the performance divide between different national R&I systems in Europe. Complementarities shall constitute the basis of bilateral and multilateral collaboration between member organisations, as well as of cross-border collaborations at a global level.
The diffusion of a solid, quality-driven research culture is a fundamental requirement for its success. Science Europe plans to play a central role with other European institutions in jointly define and implement the positive culture shift needed to create sustainable research ecosystems. This goal will take advantage of the different approaches and values that are used by researchers from different EU countries, taking also into consideration the global challenges and societal expectations and the degree of self-organisation of the European R&I system. Incentives and rewards are foreseen as a way to improve the sustainable development of research systems, together with a better coherence between policy areas.
According to Science Europe, the European research framework is called to an effort to develop new, long-term solutions for the current challenges that affects society. Interdependencies between curiosity-driven and challenge-oriented approaches should be addressed in order to boost this target, together with the support to Open Science models. A stronger engagement between researchers, policy makers and society, and improved support to trans-disciplinary research are key objectives set forth by Science Europe’s Strategy.

A Strategic Agenda from five industrial associations
From the industrial point of view, the activation of the new Horizon Europe research framework will correspond to the end of the Innovative Medicines Initiative (IMI), that characterised the public-private partnerships for research in the pharmaceutical and life sciences sectors in the past decade.
A new framework is expected to take its place, the proposed Innovative Health Initiative (IHI), which should be activated in the context of Horizon Europe. While the European Commission is still working to define the legislation governing the new partnerships, a Strategic Agenda for Research & Innovation in Healthcare has been released by five European industry associations representing the pharmaceutical, biotech and medical technologies industries (COCIR, EFPIA, MedTech Europe, EuropaBio and Vaccines Europe).The Agenda has been jointly drafted by the prospective IHI Joint Undertaking member industry associations and the European Commission services (based on the results of a public consultation ran in 2019) and it should represent the basis for the final, formal adoption of the new IHI framework after the partnership legislation has been adopted and the partnership is operational. A new tool is planned within Horizon Europe to run the IHI, the institutionalised Public-Private Partnerships, which are expected to help de-risking the pre-competitive public-private collaboration.
The vision illustrated by the document reflects the new models of cross-sectorial integration of technologies, know-how, products, services and workflows in order to build true new peoplecentred healthcare systems. The development of new solutions for the prevention, diagnosis and treatment of diseases should aim to sustain the good health of EU citizens, and decrease the disease burden for patients, care givers and healthcare professionals.
The new European ecosystem for R&I should aim, according to the document, to facilitate translation of scientific knowledge into innovation, so to respond to the strategic unmet public health needs in a cost-effective way.
Five specific objectives to be achieved by 2030 are envisaged by the Strategy, from a better understanding of the determinants of health and priority disease areas to the integration of fragmented health R&I efforts, up to the development of tools, data, platforms, technologies and processes for improved prediction, prevention, interception, diagnosis, treatment and management of diseases. Projects will be also targeted to demonstrate the feasibility of peoplecentred, integrated healthcare solutions. Digitalisation and data exchange will be central activities to achieve this goal, and will also support the development of new and improved methodologies and models for the comprehensive assessment of the added value of integrated healthcare innovations.
Examples of the activities that may be part of the new IHI projects are the discovery, development and testing of new molecules, and the study of their mechanisms of action; the development and testing of new processes and technologies, and new methodologies for the assessment of safety, health outcomes or for health-economic evaluation. Development may be run up to the pre-standardisation activities or pilots/proofs of feasibility scale, including in-silico trials. Contributions to the development of regulatory science are also an expected outcome. The pharmaceutical and medical technology sectors will be engaged in multi-sectorial activities, moving from product- and pathology-centric goals to patient-centric development. Priorities of research shall be set forth by early engagement with public sector stakeholders, through the establishment of a new Innovation Panel.