European Research Area Archives - European Industrial Pharmacists Group (EIPG)

Home  /  European Council’s conclusions on the European Innovation Agenda and research infrastructures  /  European Research Area

Webinar: ICH Q12 Product Lifecycle Management – open road or dead end?


Next EIPG webinar is to be held on Tuesday 18th April 2023 at 17.00 CEST (16.00 BST) in conjunction with PIER and University College Cork. Graham Cook, former Pfizer’s Quality Intelligence and Compliance Information team leader and chair of Read more

Draft ICH M13A guideline on bioequivalence open for consultation


By Giuliana Miglierini The draft ICH M13A harmonised guideline “Bioequivalence for immediate-release solid oral dosage forms” was endorsed by the International Council for Harmonisation on 20 December 2022 and is now open for consultation. Comments can be forwarded until 26 Read more

The Windsor Framework


On 27 February 2023, UK Prime Minister Rishi Sunak and the European Commission President Ursula von der Leyen announced that agreement had been reached on changes to the operation of the Protocol on Ireland/Northern Ireland. The Protocol has been in Read more

•••

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

January 6, 2023 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

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 Pact for Research and Innovation in Europe

September 17, 2021 , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The roadmap to support the implementation of the new vision of the European Research Area (ERA) made a concrete step forward on 16 July 2021, with the adoption by the European Commission of the proposal for a Council Recommendation on “A Pact for Research and Innovation in Europe”. The chosen form of a Recommendation supports the final adoption of the Pact in the form of a single non-binding initiative.
The Commission’s proposal was drafted taking into consideration the results from the public consultation ran between 15 April and 13 May 2021, the views generated within the ERA Forum for Transition (set up as an informal Commission expert group), and the out-comings of workshops involving selected stakeholders.
“The pandemic has shown us the importance of uniting research and innovation efforts that swiftly bring results to the market. It has shown us the importance of investment in jointly agreed strategic priorities between Member states and the EU. The Pact for Research and Innovation we propose today, will facilitate better collaboration, and join our efforts to tackle research and innovation objectives that matter the most for Europe. And it will allow all of us to learn from each other”, said Margrethe Vestager, EU Commission’s Executive Vice-President for a Europe Fit for the Digital Age.
According to Mariya Gabriel, Commissioner for Innovation, Research, Culture, Education and Youth, “The objective of the Pact is to foster the future dialogue process with key actors putting a clear emphasis on sharing best practices and facilitating the collaboration of Member States to invest in and coordinate on common research and innovation objectives”.

The main features of the document
The goal of the Commission is to update the approach used to manage the European Research Area to the most recent models of R&I and financing of scientific research. The new model for ERA was already described in the “Communication on A New ERA for Research and Innovation” (COM(2020) 628 final) adopted on 30 September 2020.
Integration of national policies instead of a simple collaboration is one of the main points to achieve sharing of key principles and values and to guide joint actions in priority areas. These values and principles are now better detailed in the new Pact for Research and Innovation (R&I), which shall represent the basis for national authorities to reform their internal R&I frameworks in the direction of an improved harmonisation between different member states.
Coordination of efforts at the central and national level should benefit from a Union-level coordination and support mechanism, a common ERA policy agenda of jointly agreed ERA actions to be implemented, a dedicated ERA policy online platform for reporting, and a ERA score- board to monitor progress towards common objectives. Regular bilateral and multilateral policy dialogues between member states and the Commission is expected to favour the sharing of best practices and mutual learning exercises.

The inspiring values
Three different dimensions characterise the declination of the principles and values called to inspire future R&I activities. The “upholding values” include ethics and integrity of research and innovation, freedom of scientific research, gender equality and equal opportunities.
“Working better” values target the free circulation of researchers, excellence and value creation as a tool to support European excellence in science generation, together with early sharing of scientific knowledge through open science practices, attractive and merit-based careers, enhanced framework conditions for mobility and exchanges between academia and industry, and open access to research infrastructures, technology infrastructures and their services. The common goal of all these actions refers to the achievement of the highest quality of R&I activities, to be supported by new models of selection and funding; re-use of previous results should be also pursued during research management activities.
The “working together” dimension is based on the key principles of coordination, coherence, and commitment. Member states are called to coordinate their R&I policies and programmes in areas of common interest and to direct research and innovation investments and reforms to- wards achieving the ERA and speed up the green and digital transition. Global outreach should base on collaboration with partners from third countries and regions, while inclusiveness should support the exploitation of ERA’s full potential to compete at the global level. Furthermore, societal responsibility should aim to increase public trust in science and innovation.

Synergies of action
The Pact for R&I is expected to act in synergy with many other pieces of European legislation to achieve its goals. Challenge-based ERA actions should support the increased integration of the Commission and member states, including their regions, cities, and municipalities. The operative tools may be represented for example by collaborative projects to be run as a part of Horizon Europe Missions, European partnerships including EIT Knowledge and Innovation Communities (EIT KICs), joint programming initiatives or multilateral alliance. Inspiration can be obtained also from existing coordination initiatives, such as the Strategic Energy Technology Plan (SET Plan) or the ERAvsCorona initiative.
Integration with the EU Skills Agenda is also important to ensure the alignment of R&I with higher education, and synergies are expected between ERA and the European Higher Education Area (EHEA). Not less important are possible synergies with the EU’s Industrial Strategy, for example in the field of technology infrastructures, industrial Alliances, and common industrial technology roadmaps. A more active citizen and societal engagement in R&I is another target of the Pact.
At the financial level, the EU Commission looks at improved synergies between EU’s, national and regional funding programmes, with attention to favour the excellence-based integration of research-performing organisations from countries with lower R&I performance into EU’s scientific networks and innovation ecosystems.
The proposal adopted by the Commission provides insights on the expected level of investments in R&D: the total expenditure on research and development should reach the 3% target of EU GDP by 2030, with a total public effort on R&D up to 1.25% of EU GDP. The share of national public R&D expenditure committed to joint programmes, research infrastructures and European Partnerships should also reach 5% of national public R&D funding by the same year.
Voluntary targets for investments
A possible weak point in the vision of the Commission for the future of ERA may be represented by the voluntary adhesion member states are called to with respect to the expected level of expenditure on R&I activities. According to Science Business, the 3% target was achieved in 2019 only by Germany, Sweden, and Austria, while the EU average (2.2%) is below that of US, Japan, and Korea.
Critics to the current EU’s “boom and bust” approach to basic research funding came by the outgoing president of the European Research Council (ERC), Jean-Pierre Bourguignon, during a meeting of EU science ministers in Slovenia in July (see Science Business).
According to Bourguignon, basic R&D should be not necessarily targeted towards topics which represents the priority of action of the EU Commission, such as the green and digital agenda. Sufficient funding for bottom-up research should be always available in order to support curiosity-driven research.