Research and Innovation Archives - European Industrial Pharmacists Group (EIPG)

EMA’s pilot scheme for academic and non-profit development of ATMPs


by Giuliana Miglierini Advanced therapy medicinal products (ATMPs) are often developed by academic and non-profit organisations, because of their high level expertise in the biotechnological techniques that underpin many new therapeutic approaches. On the other hand, these organisations often lack Read more

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

European Council’s recommendations on R&I

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by Giuliana Miglierini

The end of 2023 saw some steps forward to better support the European framework on Research and Innovation (R&I). The Council of Europe approved on 8 December 2023 its conclusions on the impact of research and innovation (R&I) in policymaking. The Council also reached a political agreement on a recommendation of a framework supporting researchers and research careers in the EU. R&I is strategically important as one of the main tools to make Europe more attractive to young talents and to create a open and sustainable European labour market for researchers, innovators and entrepreneurs. We summarise the main features of the Council’s decisions.

How to support the European R&I

The Council conclusions were proposed by the Spanish Presidency (Ministry of Science, Innovation and Universities), and they represent one of its main priorities in the area of research and innovation.

Three mutually complementary dimensions have been identified as fundamental to the success of European R&I. Science plays an important role to reinforce the political process of decision making, which in turn is key to improve life conditions of EU citizens and strengthen democracy. To this instance, the inclusion of scientific evidence and knowledge in the regulatory process and a better coherence of policy initiatives in different areas are deemed important by the Council. According to the conclusions, such an inclusion should help to improve the response capacity of the EU and member states against both structural and cyclical or circumstantial challenges. The document also recalls the ‘Science for Policy’ concept and the EU’s long-standing tradition of relying on science and evidence-based knowledge in all disciplines to support decision-making.

The availability of strong R&I ecosystems in all member states is deemed fundamental to sustain EU’s competitiveness and should be supported among others by the implementation of open-science policies and new technologies and innovation, including social innovation.

The best available scientific evidence should also always be included in impact assessments, so to improve citizens’ trust in public action, as well as the added value of the legislation. To this instance, a rigorous methodological framework would be needed, even though uncertainties are still possible. Transparent and responsible communication would support a better dissemination of scientific outcomes at all levels. The Council also recommended the mapping of the existing practices of knowledge valorisation in policymaking and the national institutional scientific advisory systems and mechanisms. The Commission should also extend the use of the Technical Support Instrument and the Policy Support Facility to support public policymakers and strengthen public structures for scientific advice.

Local and regional innovation ecosystems and ERA’s R&I

R&I may also represent a boost to enhance cooperation and territorial cohesion, reduce R&I fragmentation and disparities between and within member states and to sustain the creation of regional and local innovation ecosystems. Their design should aim to build synergies between cohesion policy and R&I funds. To this regard, according to the Council the R&I framework programme (i.e. Horizon Europe) should continue to drive research excellence in all member states.

Regional centres of excellence may represent a particularly interesting tool to support the regional dimension, with a special attention to the less innovative ecosystems. This goal is part of the New European Innovation Agenda (NEIA), as well as the Regional Innovation Valleys and the pilot project of the Partnerships for Regional Innovation. Cross-border cooperation (especially between less and more innovative member states and regions) may also be key to support better economic, social, and territorial cohesion and reinforce R&I efficiency.

The third dimension is referred to the policy impact of the Recovery and Resilience Facility (RRF) on the design of R&I policies in the European Research Area (ERA) after the pandemic crisis. This last occurrence had a positive effect in enabling many actions at the national level, allowing for targeted investments and reforms. The new ERA should be based on trust, shared responsibilities, and societal engagement and diversity.

Many sectoral and R&I policies experienced a joint approach to their improvement, including the additionality of the Facility with other EU funds. The Council invited the Commission to run a separate study that complements the mid-term evaluation of the RRF, expected by February 2024. The exercise should consider the differences between the RRF and other EU funds.

The reform of research careers

The political agreement reached by the Council on the proposal of a European framework to attract and retain research, innovation and entrepreneurial talents in Europe updates the R1- R4 profiles for researchers, introduced in 2011. It also introduces the European Charter for Re-searchers (ECR), a revision of the 2005 ECR and the Code of Conduct for the Recruitment of Researchers.

The revised definition of researcher and the related research activities are expected to widen career options, thus making European R&I framework more attractive for both internal and foreign talents.

According to the proposal, the term “researcher” would identify professionals engaged in the conception or creation of new knowledge, active in basic or applied research, experimental development, operating research equipment, or project management within any sector of the economy or society (i.e.academia, business, governmental laboratories and the public administration, and the non-profit sector). Careers in research management are also included in the definition.

Four different profiles have been identified to describe the career steps of researchers. First Stage Researcher (R1) are doing research under supervision up to the point of a PhD or equivalent level of competence and experience. Recognised Researcher (R2) hold a PhD or equivalent level of competence and experience but are not yet fully independent in their ability to develop their own research, attract funding, or lead a research group. R1 and R2 refer to researchers at the beginning of their career in science. R3 and R4 refer to senior researchers. Established Re-searcher (R3) holds a PhD or equivalent level of competence and possesses sufficient experience to independently develop and run their own research. Leading Researcher (R4) are recognised as leading their research field by their peers.

The Council recommends that these profiles are referenced to by members states in all vacancies specifically addressed to researchers. Member states are also called to promote equal esteem and reward of the different paths of research careers, regardless of the sector of employment or activity. Appropriate measuring should support comparison of careers across member states, sectors, and institutions, so enabling their full interoperability. The Council recommendation also aims to reduce the precarity of research labour by promoting adequate social protection measures. Inter-sectoral mobility is also encouraged, as well as better equality in research careers, as a tool to respond to the request of highly skilled talents. The Council expects that all organisations employing or providing funding for researchers would provide endorsement of the new “European Charter for Researchers”.


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.