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”.
Reactions to the proposed ban of PFAS
by Giuliana Miglierini
A proposal to ban around 10,000 per- and polyfluoroalkyl substances (PFAS) was submitted in January 2023 to the European Chemicals Agency (ECHA) by authorities of Germany, Denmark, the Netherlands, Norway, and Sweden. The proposal was published on ECHA website on 7 February 2023.
The focus is the so-called “forever chemicals”, i.e. very high persistence PFAS typically characterised by bioaccumulation (also in plants), great mobility and a long range transport potential, and potential endocrine activity.
“This landmark proposal by the five authorities supports the ambitions of the EU’s Chemicals Strategy and the Zero Pollution action plan. While the evaluation of such a broad proposal with thousands of substances, and many uses, will be challenging, we are ready.”, said Peter van der Zandt, ECHA’s Director for Risk Assessment.
The proposal was open to public consultation on 22 March 2023, giving rise to the collection of 5,600 comments. Opinions will be issued by ECHA’s scientific committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC), to be then forwarded to the EU Commission for final decision.
The current role of PFAS
PFAS are characterised by the presence of alkyl groups in which many or all the hydrogen atoms have been replaced with fluorine. The main carbon chain of these substances may have different lengths, from small molecules to long chain PFAS and polymers, and may carry a very wide variety of other functional groups. The strength of the carbon-fluorine bond is the root cause of PFAS persistence, leading to these substances remaining in the environment for decades to centuries.
Per- and polyfluoroalkyl substances are currently used in many different industrial sectors, thanks to their useful technical properties. Among others, PFAS can be used to repel water, oil and dirt from surfaces, and is characterised by a high durability under extreme conditions of temperature, pressure, radiation, and chemicals. PFAS also present electrical and thermal insulation properties.
The main features of the restriction proposal
According to the authorities that submitted the proposal, around 4.4 million tons of PFAS would end up in the environment over the next 30 years in the case of no action. Ban would refer to manufacture, placing on the market and use as such, as constituent in other substances or in mixture as well as in articles.
Two options for restriction have been considered, a full ban or specific derogations for certain industries, based on the analyses of alternatives, efforts put in place for switching to them, and socio-economic considerations. The ban would be effective above a set concentration limit; a transition period of 18 months should occur between final adoption and entry into force. Use-specific, time-limited derogation might refer, for example, to a 5-year period in the case of food contact materials for industrial food and feed production (as alternatives are already under development, but are not yet available to entry into force), or to a 12 years for implantable medical devices (for which identification, development and certification of alternatives is still needed).
During the public consultation phase, comments were received from more than 4,400 organisations, companies and individuals, to be reviewed by both the RAC and SEAC committees and the five proposing countries. Sweden, Germany and Japan are the countries that contributed the higher number of comments, well in advance of Belgium, China, Italy and the US. Companies provided more than the half of the comments (58,7%), followed by individuals (27,3%), and industrial or trade associations (9,8%). The full list of entities participating to the consultation is available at the consultation webpage.
EFPIA response to ECHA’s consultation
The European Federation of Pharmaceutical Industries and Associations (EFPIA) contributed to the consultation with a detailed document. Another joint ISPE-EFPIA document particularly addressed the use of fluoropolymers and fluoroelastomers in medicinal product manufacturing facilities.
“While we support the need to restrict certain PFAS, we need to find the right approach to ensure the continued manufacturing and availability of medicines in Europe. A total ban would see medicines’ manufacturing in the EU grind to a halt in under three years. It would also jeopardise the production of all pharmaceutical substances in Europe and would conflict with the EU’s strategy of reducing dependency on nations outside of the EEA in the event of shortages or pandemics.”, said EFPIA’s director general, Nathalie Moll.
EFPIA’s consultation documents highlights the many different uses of PFAS in the pharmaceutical industry, ranging from active pharmaceutical ingredients (API) falling within the definition of PFAS used in the proposal, to building blocks and raw materials used within chemical synthesis of PFAS and non-PFAS medicines. Other reagents and equipment might also fall within the scope of the ban, as well as packaging materials or combination products such as pre-filled syringes. The ban would also affect the manufacturing process, where PFAS materials are used in a wide variety of applications.
It might thus result in the disappearance from the market of a large number of important medicines, warns EFPIA, due to the unavailability of replacement materials, and the time required to obtain regulatory re-approval of alternatives. The supply chain of pharmaceuticals would be also impacted at many stages, thus possibly exacerbating shortages.
In its analysis, EFPIA highlights how some PFAS are considered of low concern by the OECD, and in particular “those used in actual medicines have no or low identified risk through medicines risk benefit or environmental risk assessments”.
A patient access impact analysis was also jointly developed by the involved industrial associations (AESGP, EFCG, EFPIA, Medicines for Europe and Vaccines Europe), showing that the current proposal would lead to at least 47,677 global marketing authorisations being affected by the ban. More than 600 medicines from the WHO Essential Medicines List would be at risk; restrictions would greatly impact also the European Member State’s “Critical Medicines lists”.
EFPIA submitted also a socio-economic assessment of the proposal, according to which a broad restriction of PFAS used in the production of human medicines would have disproportionate negative impacts on the European economy and society. “Without additional derogations, the entire pharmaceutical industry would no longer be able to manufacture active pharmaceutical ingredients (APIs) (whether classified as PFAS or non-PFAS APIs) or associated medicinal products in the EEA”, writes EFPIA, resulting in APIs production to necessarily move out of the European Economic Area.
The position of the medical device sector
MedTech Europe also published a position paper on the PFAS restriction proposal and called for “a realistic transition pathway to non-PFAS alternatives that are both reliable and feasible for medical technologies (including their manufacturing and supply chain) to avoid shortages of medical technologies for patients and practitioners”.
The position paper presents many PFAS use cases in the field of medical devices, together with the criticalities posed by the proposed transition. In particular, broad derogations should be considered to allow sufficient time to first “identify all PFAS uses in medical technologies and to subsequently move to alternatives where these are proven to be technically viable, available besides in conformity with the sector-specific MD and IVD Regulations so as fit for the intended purpose”. In this case too, the need to manage complex supply chains would require a realistic timeline in order to address dependencies, and long development timelines and steps to ensure compliance with the sectorial legislation.