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.
EMIH’s 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.
Five Key proposals:
1. Integrate microbiome innovation in the Biotech Act: Explicitly include microbiome science and product development in the European Biotech Act—following the example set by France in its June 2022 Strategic Plan for Health—which recognised the microbiome as a strategic pillar.
2. Establish a Horizon Scanning Programme (task a dedicated body—such as EMIH): Identification of microbiome products expected to reach the market within 5–10 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 full submission is available here.
