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EuropaBio Annual Report 2026 highlights Biotech Act and EU’s biotech agenda

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EuropaBio Annual Report 2026 highlights Biotech Act and EU’s biotech agenda

The 2025–2026 period marked a year of intense legislative activity for EuropaBio, the European association representing the biotechnology industry, with a strong focus on the development of the EU Biotech Act. The organisation has recently published its Annual Report 2026, providing an overview of its advocacy efforts and the main policy developments shaping the European biotech landscape.

Over the past year, EuropaBio has continued to expand its membership, which now includes more than 100 direct members, among them over 30 national, regional and sectoral associations representing more than 6,000 innovative SMEs across Europe. New members also include representatives from European contract research organisations (CROs) and consumer food companies, reflecting the growing role of biotechnology across multiple industrial sectors.

Biotech Act takes centre stage

Part I of the proposed EU Biotech Act, published in December 2025, focuses on health biotechnology and introduces measures covering clinical trials, incentives for breakthrough biotech innovation and a new framework for collaborative research and development across Europe. Part II extends the scope to industrial biotechnology, microorganisms and food and non-food applications, while proposing an expanded role for the European Food Safety Authority (EFSA).

Alongside the Biotech Act, European institutions reached a political agreement in March 2026 on the revision of the EU pharmaceutical legislation. Meanwhile, negotiations continue on the Critical Medicines Act, aimed at strengthening pharmaceutical supply chains and improving the availability of critical medicines throughout the European Union. EuropaBio’s Healthcare Biotechnology Council contributed technical expertise to the development of both legislative initiatives. On the regulatory front, the seventh bilateral meeting between EMA and EuropaBio took place in January 2026, while EuropaBio Director General Claire Skentelbery participated in the EMA CEO Round Table in April.

Industrial biotechnology and European collaboration

EuropaBio’s Industrial Biotechnology Council has been actively involved in discussions on Part II of the Biotech Act, the Food and Feed Safety Omnibus package and the upcoming EU Bioeconomy Strategy, with particular attention to genetically modified microorganisms and the need for a regulatory framework better suited to microbial technologies. These topics were also at the centre of the European Forum for Industrial Biotechnology (EFIB), held in June 2026.

The organisation’s Council of National Associations welcomed seven new members, bringing the total to 32 associations from across Europe. The report also highlights the third and fourth editions of the Biotech & Biomanufacturing Policy Summit, held in October 2025 and July 2026 respectively. During the latest edition, EuropaBio presented a preview of the updated EuropaBio–WifOR study assessing the economic impact of the biotechnology sector in the European Union. EuropaBio is also involved in several EU-funded initiatives, including PRIMED, APROVALS and BIOLEAD, supporting regional bio-based value chains, alternative proteins and Europe’s leadership in biomanufacturing.

On the communications side, the association coordinated a joint initiative bringing together more than 40 European, national and regional organisations to advocate for a dedicated Biotech Act II focused on biomanufacturing. Additional awareness campaigns were carried out in connection with World Cancer Day, Rare Disease Day and European Biotech Week. Looking ahead, EuropaBio identifies the implementation of the revised pharmaceutical legislation, the continuation of negotiations on the Critical Medicines Act and the Biotech Act, as well as growing attention to biosecurity and biodefence, among its main priorities. The latter will also be supported by the organisation’s newly established national Biosecurity Task Force.

More than €830 million awarded through ERC Advanced Grants 2025

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More than €830 million awarded through ERC Advanced Grants 2025

The European Research Council (ERC) has announced the results of the 2025 Advanced Grants competition, allocating a total of €838 million to support frontier research projects led by established scientists across Europe. Funded under the Horizon Europe programme, the grants are designed to enable ambitious, high-risk, high-gain research that could lead to major scientific breakthroughs in a wide range of disciplines.

A total of 319 projects have been selected for funding from more than 3,000 proposals submitted, corresponding to a success rate of 9.6%. Each grant will support a five-year research programme, covering fields that range from medicine and neuroscience to engineering, physical sciences, social sciences and the humanities.

International participation and new research opportunities

The successful researchers represent more than 30 nationalities, highlighting the international character of the ERC programme. Beyond supporting cutting-edge science, the funded projects are also expected to have a significant economic impact, creating more than 3,000 new jobs within the research teams that will carry out the projects over the next five years.

Among the awardees are 13 researchers currently based outside Europe, including nine from the United States, two from Australia and two from Canada. Seven of these scientists benefited from the additional relocation support available under the “Choose Europe for Science” initiative, which aims to attract leading international researchers to European research institutions.

Looking ahead to the 2026 call

While the 2025 competition has now concluded, preparations for the next funding round are already underway. The ERC Advanced Grants 2026 call has closed for applications, with the submission deadline set on 27 August 2026. Successful applicants will continue the ERC’s mission of advancing excellent, investigator-driven research capable of addressing some of the most complex scientific challenges and generating discoveries with long-term societal impact.

Latest EFPIA’s data on the social and economic value of pharmaceutical innovation

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Latest EFPIA’s data on the social and economic value of pharmaceutical innovation

Investment in innovative medicines should be regarded not merely as a healthcare expenditure but as a driver of substantial social and economic value. This is the key finding of EFPIA’s latest comprehensive study on the value of pharmaceutical innovation, published in June 2026. According to the report, Europe invested €11.67 billion in innovative medicines between 2014 and 2024. Over the same period, these investments generated an overall impact of more than €66 billion, with returns reaching up to six times the original investment.

Health and economic benefits

Beyond improving patient outcomes, the study highlights the broad societal benefits associated with newly approved medicines. Across 29 European countries, their use is linked to 1.83 million fewer years of life lost before the age of 85 and 20.9 million fewer hospital days. The economic impact is equally significant. Innovative medicines are estimated to have generated €38 billion in workforce productivity, €19 billion in unpaid contributions – reflecting the value of informal care and other unpaid activities – and €9 billion in hospital cost savings. Among the therapeutic areas analysed, oncology delivered the highest return, with every euro invested in cancer medicines generating €6.80 in value. Medicines for diabetes and metabolic diseases also showed particularly strong returns.

EFPIA’s recommendations

Based on these findings, EFPIA calls on policymakers to recognise pharmaceutical innovation as an investment rather than a cost to healthcare systems. The report also stresses the importance of ensuring timely and equitable access to innovative medicines across Europe by streamlining approval, reimbursement and uptake pathways. In addition, EFPIA urges coordinated policy action to strengthen Europe’s life sciences ecosystem and enhance the region’s long-term competitiveness and innovation capacity.

UWWTD Directive: European Parliament calls for a new impact assessment

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UWWTD Directive: European Parliament calls for a new impact assessment

On 18 June, the European Parliament adopted a resolution calling for a new impact assessment and a temporary suspension (“stop the clock”) of the Extended Producer Responsibility (EPR) obligations established under the Urban Wastewater Treatment Directive (UWWTD). The resolution was approved with 294 votes in favour, 245 against and 28 abstentions.

The issue, which has been widely debated and is currently the subject of ongoing legal proceedings, now moves to the European Commission. The Commission will have to decide whether to accept Parliament’s request for a new impact assessment and a temporary suspension of the EPR obligations.

The Parliament’s resolution

The resolution reaffirms Parliament’s support for the environmental objectives of the directive, stressing that quaternary treatment for the removal of micropollutants is essential to protect public health, safeguard ecosystems and address emerging threats such as antimicrobial resistance. However, Members of the European Parliament argue that the costs of advanced wastewater treatment should not fall on taxpayers or consumers but should instead be borne, in a fair and proportionate manner, by the sectors contributing to water pollution.

According to the resolution, the EPR scheme remains the most effective mechanism for implementing the “polluter pays” principle. The key element of Parliament’s vote is the request for the European Commission to produce, by the end of 2026, a new impact assessment identifying the substances present in urban wastewater, verifying the costs of quaternary treatment and the allocation of responsibilities among the sectors concerned, while also assessing the potential impact on the availability, affordability and accessibility of medicines. Pending completion of this assessment, MEPs have called for a temporary suspension of the EPR provisions, the quaternary treatment requirements and the related financial obligations.

Under the current version of the directive, which entered into force on 1 January 2025, manufacturers of pharmaceuticals and cosmetics are required to cover 80% of the costs associated with removing micropollutants, with full implementation scheduled for 2045.

Industry reactions

Medicines for Europe described the vote as “a significant milestone for patients’ access to medicines,” noting that the Parliament’s resolution reflects concerns also raised during the recent EU Health Council meeting. The association once again urged the European Commission to urgently suspend the EPR scheme and launch an independent review of the implementation framework, including its methodology and underlying economic assumptions. According to Adrian van den Hoven, Director General of Medicines for Europe, the vote sends a clear message: Europe cannot jeopardise access to essential medicines for millions of patients on the basis of a flawed methodology.

EFPIA, representing the innovative pharmaceutical industry, also welcomed the European Parliament’s resolution. In a statement, the federation recalled that it has long argued that certain provisions of the directive are inconsistent with the principles of proportionality, non-discrimination and the “polluter pays” principle underpinning EU legislation. According to EFPIA, assigning the costs of quaternary treatment exclusively to the pharmaceutical and cosmetics sectors fails to reflect the contribution of all sources of micropollutants and could negatively affect pharmaceutical supply chains as well as Europe’s manufacturing and innovation capacity

Universal vaccines: AI opens a new frontier in disease prevention

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Universal vaccines: AI opens a new frontier in disease prevention

A single vaccine capable of providing broad-spectrum protection against multiple viruses and their variants may sound like science fiction. Yet this is precisely the goal of a new technology developed by researchers at the University of Cambridge, aimed at preventing future pandemics before they emerge. The study findings have been published in the Journal of Infection. «We’ve converted vaccine development from being reactive to being future proof – commented Professor Jonathan Heeney – Our vaccines will continue to provide protection against viruses even as they mutate into new strains».

Designing a universal super-antigen with AI

Unlike current vaccines, which target a specific viral strain or variant through a single antigen, the Cambridge team sought to develop a “universal” vaccine capable of protecting against all potential variants of coronaviruses. To achieve this, the researchers analysed genomic sequence data from the Sarbecovirus subgenus collected through global surveillance programmes. Using machine learning algorithms, they designed a super-antigen incorporating antigenic features shared across the entire group of viruses under investigation—including viruses that have not yet emerged. The technology has already been evaluated in a Phase I clinical trial involving approximately 40 healthy adult volunteers aged between 18 and 50 years. The study was conducted at the NIHR Southampton Clinical Research Facility and the NIHR Cambridge Clinical Research Facility.

Previous preclinical studies in animal models had already demonstrated that the vaccine is capable of eliciting a strong immune response against a broad range of coronaviruses. The next stage of development will be a larger Phase II clinical trial designed to assess its immunogenicity in a broader and more diverse population. According to the researchers, the super-antigen is compatible with most existing vaccine delivery platforms. For the first-in-human trial, it was administered as a DNA vaccine using a needle-free microfluidic jet delivery system, a technology that could facilitate the rapid vaccination of large populations.

From phase I trials to pandemic preparedness

The Cambridge researchers—who also founded the university spin-out company DIOSynVax—state that this is the first vaccine active component designed entirely through computer simulations to be tested in humans. In the future, the same approach could also be extended to other viral families, including Ebola viruses.

«Viruses like Influenza, Coronaviruses and the Ebola group are evolving continuously and by the time vaccines are rolled out, they may be poorly matched – the current ‘reactive’ vaccine system struggles to keep pace – said Professor Saul Faust from the University of Southampton, the trial’s chief investigator – This new class of universal vaccines are future-proofed. They not only protect against many variants simultaneously, but potentially against related viruses that haven’t yet emerged and spilt over to humans. If we can develop and clinically advance this new class of vaccines before a virus outbreak begins, millions of lives could be saved, lockdowns avoided and the economy preserved».

EFPIA reports on the path to decarbonization

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EFPIA reports on the path to decarbonization

Four years after its last update, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a new edition of its climate change report, providing an overview of the actions undertaken by the innovative pharmaceutical industry to meet the European institutions’ call for the decarbonization of business activities. A total of 28 companies participated in the survey, up from 18 in the 2022 edition.

Key findings of the report

The climate survey conducted among EFPIA members in 2025 points to an acceleration in corporate action, with average Scope 1 emissions reduced by 16% and Scope 2 emissions by approximately 64% between 2019 and 2024. The primary driver behind this trend has been identified as the rapid transition to renewable energy sources. Scope 1 emissions are those generated directly by activities under a company’s control, while Scope 2 emissions are indirect emissions associated with energy produced by third parties but purchased and consumed by the company.

More than half of the companies surveyed (60%) also reported a reduction in Scope 3 emissions—those generated across the company’s entire value chain—by an average of 17%. However, EFPIA notes that achieving meaningful reductions in Scope 3 emissions requires strong engagement and collaboration from suppliers. Between 2019 and 2024, companies also recorded an average 43% reduction in emissions intensity, falling from 21 tonnes CO₂e/mEUR to 9 t CO₂e/mEUR.

The report also highlights that most innovative pharmaceutical companies are actively pursuing Net Zero targets, with nearly all respondents (90%) aligning their goals with the Science Based Targets initiative (SBTi) framework. In this context, companies are increasingly focusing on energy efficiency measures, including HVAC optimization, heat recovery systems, heat pumps and ISO 50001 energy management systems.

The EFPIA survey further reveals a more advanced level of maturity regarding product carbon footprint management, supported by the use of lower-carbon raw materials and greater process circularity. Additional positive developments include the transition to hybrid and electric vehicle fleets and the adoption of refrigerants with a lower Global Warming Potential (GWP).

Most EFPIA member companies (90%) carried out climate risk assessments in 2025, representing a 15-percentage-point increase compared with the 2022 survey. In addition, 80% of companies use internationally recognized Environmental, Social and Governance (ESG) frameworks to support climate-related reporting and management processes.

Looking ahead

Looking to the future, the EFPIA report highlights the importance of regulatory harmonization, whereby Product Category Rules (PCRs) should serve as complementary documents alongside Life Cycle Assessment (LCA) standards. In particular, EFPIA supports the adoption of the “PAS 2090:2025, Pharmaceutical Products – Product Category Rules for Environmental Life Cycle Assessments” framework. Published in November 2025, the standard is the result of collaboration between the Pharmaceutical LCA Consortium and other stakeholders across the pharmaceutical value chain.

EFPIA is calling on institutions and regulatory authorities to recognize PAS 2090 as the most robust approach for the pharmaceutical sector. Another key factor in ensuring effective implementation of the proposed framework will be partnerships, with EFPIA urging closer collaboration with suppliers and technology partners to improve data quality and traceability, as well as the adoption of advanced and weighted methodologies for calculating Scope 3 emissions.

EMA’s SME support programme marks 20 years of activity

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EMA’s SME support programme marks 20 years of activity

The European Medicines Agency’s (EMA) support programme for small and medium-sized enterprises (SMEs) has reached its twentieth year of operation. Since 2005, when the dedicated SME Office was established, more than 5,000 companies have had their SME status officially recognised by the Agency, according to EMA’s latest report. Of these, over 3,000 have received direct assistance and support in the development of human or veterinary medicines.

Key figures on SMEs registered with EMA

In 2025, nearly 2,000 SMEs were registered with EMA, with the largest shares located in Germany (12.2%) and France (10.1%). Italian SMEs accounted for 6.3% of the total. Most companies (81%) operate exclusively in the pharmaceutical sector, while others are active in both pharmaceuticals and medical devices (16%) or solely in the medical device field. More than two-thirds (67%) of pharmaceutical SMEs currently have products under development. Academic spin-offs represent 13% of all registered SMEs, while the report also notes that 7.5% of SMEs have been acquired over the past three years.

In terms of company size, small enterprises account for 35% of the total, micro-enterprises for 38%, and medium-sized companies for 27%. The majority of registered SMEs (77%) focus on human medicines, followed by providers of regulatory and consultancy services (14%). The development pipelines of EMA-registered SMEs are primarily focused on medicinal products (52%), particularly small-molecule medicines, which also represent 52% of projects under development. In addition, nearly one-quarter of the companies are involved in the development of orphan medicines.

Strong contribution to pharmaceutical innovation

The success rate for obtaining marketing authorisations for medicines developed by registered SMEs reached 64% during the 2021–2025 period. In 2025 alone, EMA issued seven positive opinions and one negative opinion, while six applications were withdrawn before the Agency delivered its assessment. The success rate was even higher (80%) for marketing authorisation applications concerning veterinary medicines submitted during the same period.

A significant number of products developed by SMEs and authorised by EMA have addressed unmet medical needs. Around half (46%) of PRIME designations were granted to small and medium-sized enterprises, while recommendations for advanced therapies developed by SMEs accounted for 40% of the total. SMEs have also played an active role in several EMA initiatives designed to foster innovation, including scientific advice and protocol assistance procedures, applications for the qualification of novel methodologies, and participation in briefing meetings with the Innovation Task Force.

Progress in conducting clinical trials in the EU

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Progress in conducting clinical trials in the EU

The first report on the state of clinical trials in Europe, published jointly by the European Commission, the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) in mid-May, provides an overview of active clinical trials in the first quarter of 2026 and compares current performance with the objectives established under the Accelerating Clinical Trials in the EU (ACT EU) initiative. These targets are also aligned with the proposed EU Biotech Act, currently under review by European co-legislators, and form part of broader efforts to position the European Union as a preferred destination for clinical research while ensuring timely patient access to innovative treatments.

Increase in Multinational Clinical Trials

The first quarter of 2026 recorded an increase in the number of multinational clinical trials, with nineteen more trials authorized than the historical average. This brings the EU closer to its goal of achieving 500 additional multinational clinical trials by 2030, a target that would require the activation of at least 100 new multinational studies per year.

March 2026 recorded the highest number of multinational trial authorizations, with 110 studies approved. Patient recruitment performance also showed improvement, with approximately 40% of studies enrolling the required number of participants within 200 days of the authorization application. The target for 2030 is 66%.

Key Findings of the Report

The report identified a total of 668 clinical trial applications, the majority of which (416) were single-country studies. Among these, non-commercial studies predominated (262).

The opposite trend was observed for multinational trials (252), which were mainly commercial studies (229). A total of 538 authorized studies were monitored in the report, showing a more balanced distribution between multinational trials (232) and single-country trials (306).

The data were obtained from the Clinical Trials Information System (CTIS) and relate to studies falling within the scope of Regulation (EU) No. 536/2014 on clinical trials.

During the first quarter of 2026, an average of 208 applications per month for new clinical trials were submitted through CTIS. The average time from submission to authorization for a new early-phase clinical trial was 118 days.

Since its launch, CTIS has received more than 13,000 clinical trial applications. At the time of publication of the report, approximately 6,400 early-phase clinical trials were ongoing in the EU/EEA under the Clinical Trials Regulation framework.

EMA highlights regulatory challenges and opportunities for radiopharmaceuticals

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EMA highlights regulatory challenges and opportunities for radiopharmaceuticals

The European Medicines Agency (EMA) has highlighted the growing importance of radiopharmaceuticals in healthcare, underlining both the opportunities and regulatory challenges associated with this rapidly evolving field. The observations are included in the Agency’s Horizon Scanning report, published in May 2026, which examines emerging trends likely to influence the future of medicines in Europe.

Radiopharmaceuticals are playing an increasingly significant role in both diagnostic imaging and targeted therapies, particularly in oncology. According to the EMA, the unique characteristics of these medicinal products require a dedicated regulatory approach that considers not only pharmaceutical legislation but also safety standards related to exposure to ionising radiation.

The report notes that radiopharmaceuticals include a broad range of products, such as radionuclide precursors, generators and kits used for in-house preparation. Their development, manufacturing, distribution and clinical use involve technical and logistical requirements that differ substantially from those of conventional medicines.

The need for greater regulatory harmonisation

As scientific knowledge and regulatory frameworks continue to evolve, the EMA stresses the importance of achieving better harmonisation at both European and global levels. Consistent regulatory approaches could facilitate innovation while maintaining high standards of quality, safety and efficacy. The Agency points out that the sector is advancing rapidly, creating new opportunities for personalised medicine but also raising complex regulatory questions. Greater alignment among authorities could help streamline development pathways and support wider patient access to innovative treatments.

Another key theme emerging from the report is the broad range of expertise required throughout the lifecycle of radiopharmaceuticals. From research and development to manufacturing, clinical application and radiation safety, these products involve specialists from multiple disciplines. This complexity makes ongoing collaboration essential. The EMA highlights the value of early and continuous dialogue among stakeholders, including developers, manufacturers, healthcare professionals, researchers and regulatory authorities. Such engagement can help regulators gain a deeper understanding of the scientific, technical and operational challenges specific to the radiopharmaceutical sector.

Supporting future innovation

The report also draws attention to the importance of securing the supply of radiopharmaceuticals. Given their critical role in diagnosis and treatment, any disruption in availability could have a direct impact on patient care. For this reason, the EMA recommends that regulators and policymakers build on the work already carried out by expert groups focused on maintaining supply chains and preventing shortages. Strengthening these efforts will be crucial as demand for radiopharmaceuticals continues to grow across Europe.

Looking ahead, the EMA considers radiopharmaceuticals a strategic area for the future of healthcare and precision medicine. To fully realise their potential, the Agency argues that regulatory systems must continue to evolve, supported by stronger stakeholder collaboration and coordinated actions to address both scientific and supply-related challenges. By fostering harmonisation, encouraging dialogue and safeguarding availability, regulators can help create an environment that supports innovation while ensuring patient safety and access to these increasingly important therapies.

Preliminary agreement on the Critical Medicines Act

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Preliminary agreement on the Critical Medicines Act

On 12 May 2026, the Cyprus presidency of the European Council reached a provisional agreement with the European Parliament on the Critical Medicines Act, a new regulation designed to strengthen the resilience of the European pharmaceutical sector. The initiative is intended to address recurring shortages and improve the long-term availability and security of supply of both critical medicines and medicines considered strategically important for public health across the European Union.

The agreement comes at a time when European healthcare systems continue to face growing pressure linked to supply chain disruptions, geopolitical instability and increasing dependence on non-EU manufacturing for essential pharmaceutical ingredients.

Strengthening supply chains and EU manufacturing

Among the key measures included in the agreement is the diversification of pharmaceutical supply chains, aimed at reducing excessive reliance on a limited number of suppliers or geographic areas. The regulation also promotes joint and collaborative procurement mechanisms between member states, with the objective of improving coordination and ensuring faster access to essential medicines during periods of crisis or shortage.

Another central element of the proposed legislation is the strengthening of manufacturing capacity within the EU, particularly for critical medicines and their active pharmaceutical ingredients (APIs). The goal is to reinforce Europe’s strategic autonomy in the pharmaceutical sector and reduce vulnerabilities linked to external production hubs.

The provisional agreement also introduces new resilience-related requirements for public procurement procedures. Contracting authorities will be required to integrate criteria linked to supply security and continuity when purchasing medicines, encouraging more sustainable and reliable sourcing strategies.

New rules on procurement and contingency stocks

The text also lowers the threshold of member states required to request the European Commission to carry out procurement on their behalf, reducing the minimum number from nine countries to five. This change is expected to facilitate faster and more flexible joint purchasing initiatives among EU members.

In addition, the agreement specifies that contingency stock requirements must remain transparent and comply with the principles of solidarity and proportionality, in order to avoid imbalances between member states and prevent unnecessary pressure on supply systems.

The scope of the regulation has also been expanded to include orphan medicinal products in selected key therapeutic areas, reflecting increasing attention to the availability of treatments for rare diseases.

The provisional agreement will now need to be formally endorsed and adopted by both the Council and the European Parliament before the regulation can enter into force and move towards implementation.

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