Christian Ehler Archives - European Industrial Pharmacists Group (EIPG)

Lessons learnt to transition from Horizon 2020 to the new FP10


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 Read more

Approvals and flops in drug development in 2023


by Giuliana Miglierini Approvals and flops in drug development in 2023 The European Medicines Agency published its annual highlights, showing 77 medicines were recommended for marketing authorisation, and just 3 received a negative opinion (withdrawals were 19). In 2023 some highly expected Read more

Webinar: Oral Colon Drug Delivery - Design Strategies


EIPG webinar Next EIPG webinar is to be held on Wednesday 21st of February 2024 at 17.00 CET (16.00 GMT) in conjunction with PIER and University College Cork. Anastasia Foppoli, will discuss on the various approaches and the general aspects Read more

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

, , , , , , , , , , , , , , , , , , , , , , , , , , ,

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.


EIC: challenges for the governance and opportunities for innovation

, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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.