European Research Council 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 Pact for Research and Innovation in Europe

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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.