European Union

Written by Laurence.Amand-Eeckhout.

CONTEXT

Health biotechnologies are increasingly important for public health, innovation, and the European Union’s competitiveness in global research and healthcare markets. They encompass, for example, gene therapies for rare diseases, cell therapies to treat cancer, immunotherapies, bio-artificial skin for burn treatment, and mRNA vaccines. Biotechnology is among the fastest-growing economic sectors in the EU, yet the EU continues to lag behind the United States and China in translating biotech innovation into commercially viable products and large-scale manufacturing. Structural challenges remain, particularly in clinical development, regulatory processes, and manufacturing capacity.
On 16 December 2025, the European Commission proposed a package of measures intended to improve the health of EU citizens, and ensure the long-term resilience and competitiveness of the EU health sector. The package includes a proposal for a ‘European biotech act’ setting out an EU-level framework to strengthen the competitiveness of the health biotechnology and biomanufacturing sector in the EU, by simplifying regulatory processes, promoting innovation, boosting EU-based biomanufacturing with new incentives and support tools, and facilitating access to finance, while maintaining high safety, ethics and sustainability standards.
Following this health-focused initiative, the Commission is expected to propose a second European Biotech Act later in 2026, centred on industrial biotechnologies and biomanufacturing, to ensure a competitive internal market for all biotechnology areas.

LEGISLATIVE PROPOSAL

2025/0406(COD) – Proposal for a regulation of the European Parliament and of the Council on establishing a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health and amending Regulations (EC) No 178/2002, (EC) No 1394/2007, (EU) No 536/2014, (EU) 2019/6, (EU) 2024/795 and (EU) 2024/1938 (European Biotech Act) – COM(2025) 1022, 16 December 2025.

NEXT STEPS IN THE EUROPEAN PARLIAMENT

For the latest developments in this legislative procedure, see the Legislative Train Schedule:2025/0406(COD)

Read the complete briefing on ‘European biotech act‘ in the Think Tank pages of the European Parliament.

Le Dr Gul Qaisrani, médecin dans une clinique privée, a été le premier à détecter l'épidémie de VIH fin 2024 après avoir constaté une augmentation du nombre d'enfants venant à sa clinique et testés positifs au virus du sida.

Press briefing ahead of the upcoming Foreign Affairs Council will take place on 17 April 2026 at 14.30.

European Council President António Costa held a press conference in Doha, Qatar, following his visit to the Gulf region.

Statement by the High Representative on behalf of the EU on the alignment of certain third countries with Council Decision (CFSP) 2026/696 concerning restrictive measures in respect of actions undermining or threatening the territorial integrity, sovereignty and independence of Ukraine.

Statement by the High Representative on behalf of the EU on the alignment of certain third countries with Council Decision (CFSP) 2026/646 concerning restrictive measures in view of Russia’s destabilising activities.

Statement by the High Representative on behalf of the European Union on the alignment of certain third countries with Council Decision (CFSP) 2026/588 of 16 March 2026 concerning restrictive measures against cyber-attacks threatening the Union or its Member States.

EU heads of state or government will gather in in Lefkosia and Agia Napa (Cyprus), to discuss about geopolitics and the MFF.

EU co-legislators reached a provisional agreement on new rules to address global steel overcapacity and strengthen protection of the EU steel market.

President Costa to visit United Arab Emirates, Saudi Arabia and Qatar.

Eurogroup President Kyriakos Pierrakakis will represent the Eurogroup at the Spring Meetings of the IMF and World Bank Group in Washington, DC.

Weekly schedule of President António Costa, 13 - 19 April 2026.

The Council adopted implementing decisions making the financial assistance under the SAFE regulation available to Czechia and France.

The EU issued a statement on the ceasefire agreed by the United States and Iran.