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European Microbiome Innovation for Health

EMIH

The European Microbiome Innovation for Health (EMIH) aims to ensure the recognition of microbiota-based medical innovation as a revolutionary and promising sector for patients and economies across the European Union by policymakers and by key healthcare stakeholders.

Lobbying Activity

Meeting with Olivér Várhelyi (Commissioner)

16 Oct 2025 · State of play of microbiome related matters

Response to Biotech Act

11 Jun 2025

The European Microbiome Innovation for Health (EMIH) highly welcomes the initiative of the European Commission to propose a European Biotech Act. This emerging sector needs a proper regulatory framework to ensure patients safety and timely access to innovative biotechnologies, to complete the future pharmaceutical legislation and implementing acts of the Regulation on Substances of Human Origins (SoHO). EMIH calls the European Commission to initiate a constructive and regular dialogue with all stakeholders involved in the biotech sector, to ensure their needs are well considered in this Regulation, including patient organizations, academia and industrial representatives. As an independent, non-profit organisation gathering key stakeholders from public and private sectors from the microbiome ecosystem, EMIH can provide concrete expertise to the European Commission. Members include companies specialised in biotechnology, research institutes, hospitals and patient associations representing the whole microbiome ecosystem. It is currently a growing organisation in Europe gathering different key stakeholders from industry (Starts ups included), academies and investors from the microbiome sector EMIHs ambition is to promote patients safety and timely access to microbiome innovation within the European Health Union. Its members are committed to developing advances in microbiota-based therapeutics, diagnostics and medical bioproduction based on the highest quality standards while supporting the drafting of health policies to the greatest benefit of patients and industry. KEY PROPOSALS 1. Integrate microbiome innovation in the Biotech Act Explicitly include microbiome science and product development in the European Biotech Actfollowing the example set by France in its June 2022 Strategic Plan for Healthwhich recognised the microbiome as a strategic pillar. 2. Establish a Horizon Scanning Programme (task a dedicated bodysuch as EMIH) - Identification of microbiome products expected to reach the market within 510 years. This foresight will support proactive regulatory planning and policy design. 3. Strengthen dialogue between innovators and policymakers Create formal mechanisms for emerging microbiome companies to engage with European policymakers and regulators to ensure policy is grounded in operational realities. 4. Create financial incentives for industry stakeholders launching first in Europe and prioritise microbiome innovation within future health research programmes; THE EUROPEAN BIOTECH ACT NEEDS TO INCLUDE MICROBIOME INNOVATION The microbiome is an emerging field in life sciences, with tremendous potential to transform patient care across multiple therapeutic areas. Europe is uniquely positioned to lead in this field, with world-class academic research and several advanced clinical-stage companies developing microbiome-based innovations across diagnostics (IVDs), medicines and medical devices. Globally, countries like the United-States and South Korea have recognised the strategic importance of microbiome innovation and implemented targeted incentives (500M$ for Korea in 2021; around 1b$ for the US) to structure and grow their ecosystems. This has resulted in significant acceleration of both scientific discovery and translational development. To ensure Europe remains competitive and patient access is not delayed, it is essential that the European Biotech Act explicitly addresses the needs of microbiome-based health products. These innovations require: Science-based, fit-for-purpose regulatory pathways; Alignment across regulatory, research, and industrial policies to avoid fragmentation; Stronger collaboration frameworks to support cross-sector dialogue and innovation.
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Meeting with Rainer Becker (Director Health and Food Safety)

17 Feb 2025 · To explore collaboration opportunities to improve patient health outcomes via microbiome innovation and to share perspectives on this topic in view of the EU Biotech Act