mobility 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

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 account in the definition of the new FP10 (2028-2034) that will follow the current programme Horizon Europe (FP9). Among these are a broader participation, further simplification and reduction of the administrative burden, reinforcement of the dissemination, exploitation and deployment of results, support for the participation of women and enhancement of synergies with other initiatives at EU, national and regional level.

With a overall budget of € 75.6 billion, the main goal of H2020 was to support EU’s economic growth and excellence in science, industrial leadership and societal challenges. We summarise the main features of the report.

Key numbers of Horizon 2020
Calls under H2020 collected more than a million individual applications from 177 countries. Funded projects were more than 35,000, involving more than 40,000 organisations. The true impact of the programme cannot yet be fully appreciated, as 41% of projects were still active at the time of the final evaluation and are expected to yield further results.

Many new technologies in various domains of science were developed thanks to H2020 funding, i.e. mRNA vaccines, photonics and micro- and nanoelectronics, and novel hydrogen-fuelled transports. Sustainable development benefited from investments equal to 64.4% of H2020’s budget.

Activities run under FP8 led to almost 4,000 applications for protection of intellectual property (¾ patents and 12% trademarks). Peer-reviewed publications were over 276,000. Horizon 2020 had a significant effect in boosting employment (+20%) and increasing the turnover and total assets for participating companies (+30%). The mobility of approx. 50,000 researchers across countries and sectors was also supported. The programme allowed to improve the access to newly created or upgraded research infrastructures for more than 24,000 researchers and organisations.

According to the final report, some additional € 159 billion would have been needed to fund all the high-quality proposals submitted. Despite this, the long term impact of the programme is estimated to contribute an average annual increase of €15.9 billion to EU GDP (€429 billion for the period 2014-2040), and a net gain in employment levels of around 220,000 employees at its peak.

Co-investment led to a wide development of public-private partnerships and joint undertakings, with private partners contributing resources (in cash or in kind) two-three times the volume of EU funding. The development of the venture capital ecosystems and networks was also improved.

Key scientific and societal achievements
Medical sciences, quantum mechanics, chemical engineering and composite materials were among the main scientific domains targeted by actions run under Horizon 2020, together with climate change, health and food security and other societal challenges.

The relevance of scientific publications is acknowledged by the citation frequency, that according to the report is twice the global average. A significant number of papers (4%) are among the most cited worldwide, while more than 25% covered emerging and rapidly evolving R&I sectors. The great majority of publications (82%) were published as open access papers, thus greatly supporting the circulation of knowledge.

Emerging health crises were among the main research priorities related to improvement of public health, together with rare diseases and personalised medicine. Ebola and Zika epidemics were the first targeted emergencies, but the real test case was the Covid-19 pandemic: the final report indicates H2020 and the previous FP7 are recognised as the third most frequently acknowledged funding sources for Covid-19 related research in the world.

As for climate change, this field of research received 32% of H2020 funding to support, among others, the development of alternative and low-emission fuels. Other relevant lines of R&I included the development of a smart European electricity grid, automation, energy storage integration and the adoption of renewable energy sources.

As for the ongoing digital transformation, H2020 supported for example the development of safe and user-friendly robotics. Over 20% of the overall budget was dedicated to research in social sciences and humanities disciplines.

Elements to be improved
Horizon 2020 allowed to greatly expand the European network of research infrastructures. According to the final evaluation, access to these facilities may be further improved by enabling greater synergies between EU, national and regional programmes for research infrastructure. Despite H2020 saw improvements in the presence of women in evaluation panels (42%), the fixed target of 50% share of women in scientific advisory panels and as researchers in projects was not yet achieved (43% and 23% respectively).

As for financial aspects, the interim evaluation identified a notable gap in venture and growth capital in the EU to scale up innovations. The issue was addressed through the launch, in the last three years of H2020, of a pilot to run the European Innovation Council (EIC), which according to the report showed positive preliminary results both on the turnover and staffing levels of its beneficiaries, and in tackling the critical funding gap in high-risk areas where limited alternatives are available at national and regional levels.

Preparing for the next FP10
With Horizon Europe framework programme coming to an end in 2027, the final report on results achieved by H2020 represents a first basis to reason on new research targets and financial support to be part of the new FP10 2028-2034 (you can find comments here and here).

While some members of the European Parliament already called for a FP10 budget of at least € 200 billion (see here more), several academic and scientific organisations published their proposals to be considered in the drafting of the new programme.

The European University Association (EUA), Science Europe and the European Association of Research and Technology Organisations (EARTO) sent a joint open letter to EU Commissioner Iliana Ivanova, asking for a doubling of the FP10 budget to €200 billion. A higher budget stability and protection of funding from being shifted to non-R&I purposes are among other requests, together with rebalancing support across various stages of R&I (i.e. bottom-up basic research, applied research, development, and innovation). Sufficient national investments in R&I are also deemed important.

The European universities of science and technology represented by Cesaer also published a note to advance their suggestions, in line with the EU Commission’s goals of a more elaborate EU industrial policy, and the move towards EU-30+. Key elements should include the leadership in deep tech, clean-tech and biotech based on the full knowledge value chain, the use of open and competitive calls to select researchers and innovators and award funding across all parts of FP10, a stable financial environment with at least €200 billion investments and enacting the 3% GDP target to R&I agreed by the EU Council in 2002. An annual review mechanism of current performance and a ring-fence to protect the budget allocated to R&I are among the suggested actions.

Guiding principles proposed by EU-LIFE (the Alliance of research institutes advocating for excellent research in Europe) also address investments in the European Research Council, the bridging role of the European Innovation Council, the need to avoid additional pillars and fragmentation, and the development of a coherent impact approach by reducing the size of consortia and monitoring the impact of initiatives in Pillar 2.

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 fora 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.