Inside EU Health: Spanish proposal on access; biosimilars; illicit tobacco trade; anaphylaxis; preparedness; radioisotopes; insulin
Spain pushes EU to use its purchasing power on innovative medicines; better deal for biosimilars; auditors on illicit tobacco trade; anaphylaxis preparedness; crisis procurement handbook; EU backs next-generation mRNA nasal sprays; strategy on radioisotopes; EU approves €400m aid for insulin supply
Spain pushes EU to use its purchasing power on innovative medicines
Spain wants the EU to use its collective demand for innovative medicines to strengthen negotiating leverage and attract biotech investment and manufacturing.
Catherine Feore
MEPs seek to boost biosimilars in pharma protection deal
EU Legal Affairs Committee support compromise offering drugmakers longer protection in return for European investment, while clearing the way for faster biosimilar competition.
MEP Tiemo Wölken (S&D, Germany) told Vital Signs that the compromise was “a balanced deal that benefits both innovative industry and biosimilar manufacturers.”
Catherine Feore
Auditors call for a more ‘robust’ EU response to illicit tobacco trade
The EU is failing to keep pace with increasingly sophisticated criminal networks behind the illicit tobacco trade, according to the European Court of Auditors (ECA), which has called for a more robust and coordinated response from the European Commission and member states.
Catherine Feore
New European alliance calls for urgent action on anaphylaxis preparedness
A new European alliance was launched (9 September) at the European Parliament to tackle major gaps in how people and professionals can be better prepared to treat anaphylaxis and anaphylactic shock, a potentially fatal allergic reaction in which a swift response can make the difference.
Catherine Feore
EU completes fourth JCA, assessing SMA gene therapy
“We are just getting started,” said Maya Matthews, Deputy Director and Head of Unit for Health Technology Assessment, on LinkedIn as the EU published its fourth Joint Clinical Assessment (JCA).
The assessment covers a gene therapy designed to address the underlying genetic cause of 5q spinal muscular atrophy, Itvisma, made be Novartis.
The developer initially sought an indication covering patients aged six months and older. However, on 26 February 2026, it informed the European Commission that the proposed population had changed to patients aged two years and older.
The Commission published the assessment on 10 September alongside an updated list of JCAs, with numerous further assessments now in the pipeline.
Directorate-General for Health and Food Safety
EU backs next-generation mRNA nasal sprays against respiratory viruses
The European Commission and European Investment Bank are investing €30 million in biotech company Ethris to develop next-generation mRNA therapeutics and vaccines against respiratory viruses, including those with pandemic potential.
“COVID showed us the cost of being caught off guard. We must stay one step ahead,” said Hadja Lahbib, Commissioner for Equality, Preparedness and Crisis Management.
The treatments would be administered by inhalation or nasal spray, targeting viruses at their point of entry and potentially reducing transmission.
The investment comes through HERA Invest, which supports small and mid-sized companies developing medical countermeasures.
EU publishes crisis procurement handbook drawing on COVID-19 lessons
The European Commission has published a new EU Crisis Procurement Handbook, providing a step-by-step guide for securing vaccines, treatments, diagnostics and other medical countermeasures during health emergencies.
Catherine Feore
Commission unveils strategy to secure the EU’s supply of medical radioisotopes
The European Commission has unveiled a new strategy to strengthen the EU's long-term supply of medical radioisotopes through the European Radioisotope Valley Initiative (ERVI). These materials are vital for diagnosing diseases and treating cancer, with demand expected to rise significantly.
The strategy seeks to build on Europe’s leading position in radioisotope production while reducing dependencies on foreign suppliers, particularly Russia. Currently, the EU relies on imports for certain stable isotopes and lacks domestic production of metallic High-Assay Low-Enriched Uranium (HALEU).
Germany receives EU approval for €400m to keep Sanofi insulin production in Europe
The European Commission has approved €400 million in German state aid for Sanofi to maintain and strengthen insulin production at its Frankfurt-Höchst site. The funding will support a new insulin factory, due for completion by the end of 2032, while Sanofi must produce at least 1.1 tonnes of insulin annually and maintain a one-tonne stockpile of insulin active ingredients until 2042 to ensure the supply to Germany and EEA markets.
The Commission says that without the support, Sanofi would close its German insulin production, leaving Germany with no insulin production site and just one remaining site in the EEA.
Commission Executive Vice-President Teresa Ribera called the decision “an important step towards ensuring the security of supply of critical medicines in the EU,” while saying the support would remain “targeted and proportionate.”