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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

Environmental sustainability: the EIPG perspective


Piero Iamartino Although the impact of medicines on the environment has been highlighted since the 70s of the last century with the emergence of the first reports of pollution in surface waters, it is only since the beginning of the Read more

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Lessons learnt to transition from Horizon 2020 to the new FP10

February 19, 2024 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The European Commission published the ex post evaluation of Horizon 2020 (H2020), the FP8 framework programme for research and innovation (R&I) run in years 2014-2020.

The report identifies several areas of possible improvement, which may be taken into account in the definition of the new FP10 (2028-2034) that will follow the current programme Horizon Europe (FP9). Among these are a broader participation, further simplification and reduction of the administrative burden, reinforcement of the dissemination, exploitation and deployment of results, support for the participation of women and enhancement of synergies with other initiatives at EU, national and regional level.

With a overall budget of € 75.6 billion, the main goal of H2020 was to support EU’s economic growth and excellence in science, industrial leadership and societal challenges. We summarise the main features of the report.

Key numbers of Horizon 2020
Calls under H2020 collected more than a million individual applications from 177 countries. Funded projects were more than 35,000, involving more than 40,000 organisations. The true impact of the programme cannot yet be fully appreciated, as 41% of projects were still active at the time of the final evaluation and are expected to yield further results.

Many new technologies in various domains of science were developed thanks to H2020 funding, i.e. mRNA vaccines, photonics and micro- and nanoelectronics, and novel hydrogen-fuelled transports. Sustainable development benefited from investments equal to 64.4% of H2020’s budget.

Activities run under FP8 led to almost 4,000 applications for protection of intellectual property (¾ patents and 12% trademarks). Peer-reviewed publications were over 276,000. Horizon 2020 had a significant effect in boosting employment (+20%) and increasing the turnover and total assets for participating companies (+30%). The mobility of approx. 50,000 researchers across countries and sectors was also supported. The programme allowed to improve the access to newly created or upgraded research infrastructures for more than 24,000 researchers and organisations.

According to the final report, some additional € 159 billion would have been needed to fund all the high-quality proposals submitted. Despite this, the long term impact of the programme is estimated to contribute an average annual increase of €15.9 billion to EU GDP (€429 billion for the period 2014-2040), and a net gain in employment levels of around 220,000 employees at its peak.

Co-investment led to a wide development of public-private partnerships and joint undertakings, with private partners contributing resources (in cash or in kind) two-three times the volume of EU funding. The development of the venture capital ecosystems and networks was also improved.

Key scientific and societal achievements
Medical sciences, quantum mechanics, chemical engineering and composite materials were among the main scientific domains targeted by actions run under Horizon 2020, together with climate change, health and food security and other societal challenges.

The relevance of scientific publications is acknowledged by the citation frequency, that according to the report is twice the global average. A significant number of papers (4%) are among the most cited worldwide, while more than 25% covered emerging and rapidly evolving R&I sectors. The great majority of publications (82%) were published as open access papers, thus greatly supporting the circulation of knowledge.

Emerging health crises were among the main research priorities related to improvement of public health, together with rare diseases and personalised medicine. Ebola and Zika epidemics were the first targeted emergencies, but the real test case was the Covid-19 pandemic: the final report indicates H2020 and the previous FP7 are recognised as the third most frequently acknowledged funding sources for Covid-19 related research in the world.

As for climate change, this field of research received 32% of H2020 funding to support, among others, the development of alternative and low-emission fuels. Other relevant lines of R&I included the development of a smart European electricity grid, automation, energy storage integration and the adoption of renewable energy sources.

As for the ongoing digital transformation, H2020 supported for example the development of safe and user-friendly robotics. Over 20% of the overall budget was dedicated to research in social sciences and humanities disciplines.

Elements to be improved
Horizon 2020 allowed to greatly expand the European network of research infrastructures. According to the final evaluation, access to these facilities may be further improved by enabling greater synergies between EU, national and regional programmes for research infrastructure. Despite H2020 saw improvements in the presence of women in evaluation panels (42%), the fixed target of 50% share of women in scientific advisory panels and as researchers in projects was not yet achieved (43% and 23% respectively).

As for financial aspects, the interim evaluation identified a notable gap in venture and growth capital in the EU to scale up innovations. The issue was addressed through the launch, in the last three years of H2020, of a pilot to run the European Innovation Council (EIC), which according to the report showed positive preliminary results both on the turnover and staffing levels of its beneficiaries, and in tackling the critical funding gap in high-risk areas where limited alternatives are available at national and regional levels.

Preparing for the next FP10
With Horizon Europe framework programme coming to an end in 2027, the final report on results achieved by H2020 represents a first basis to reason on new research targets and financial support to be part of the new FP10 2028-2034 (you can find comments here and here).

While some members of the European Parliament already called for a FP10 budget of at least € 200 billion (see here more), several academic and scientific organisations published their proposals to be considered in the drafting of the new programme.

The European University Association (EUA), Science Europe and the European Association of Research and Technology Organisations (EARTO) sent a joint open letter to EU Commissioner Iliana Ivanova, asking for a doubling of the FP10 budget to €200 billion. A higher budget stability and protection of funding from being shifted to non-R&I purposes are among other requests, together with rebalancing support across various stages of R&I (i.e. bottom-up basic research, applied research, development, and innovation). Sufficient national investments in R&I are also deemed important.

The European universities of science and technology represented by Cesaer also published a note to advance their suggestions, in line with the EU Commission’s goals of a more elaborate EU industrial policy, and the move towards EU-30+. Key elements should include the leadership in deep tech, clean-tech and biotech based on the full knowledge value chain, the use of open and competitive calls to select researchers and innovators and award funding across all parts of FP10, a stable financial environment with at least €200 billion investments and enacting the 3% GDP target to R&I agreed by the EU Council in 2002. An annual review mechanism of current performance and a ring-fence to protect the budget allocated to R&I are among the suggested actions.

Guiding principles proposed by EU-LIFE (the Alliance of research institutes advocating for excellent research in Europe) also address investments in the European Research Council, the bridging role of the European Innovation Council, the need to avoid additional pillars and fragmentation, and the development of a coherent impact approach by reducing the size of consortia and monitoring the impact of initiatives in Pillar 2.


The new European Innovation Agenda

July 29, 2022 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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

July 1, 2022 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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.