Sanofi

Please find attached Sanofi response to the European Commission Public Consultation on Public Procurement Rules Revision About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth.

Sanofi Response to the European Commission’s Public Consultation Review of the Technical Criteria of the European Taxonomy (Climate and Environment Delegated Acts) Sanofi welcomes the European Commission’s decision to remove pharmaceutical activities 1.1 Manufacture of active substances and 1.2 Manufacture of medicinal products from the scope of the Pollution objective.

Filed in French · English published by the European Commission

Sanofi has been compliant with the European Taxonomy since 2021. The entry into force of the objective on pollution since the 2023 financial year and the application of the criteria of activity 1.2 Manufacture of medicinal products reveal major obstacles.

Filed in French · English published by the European Commission

Sanofi acknowledges the objectives of the proposed draft Regulation and welcomes the attempt to improve todays pharmaceutical framework. While we appreciate the streamlining and digitisation of regulatory procedures, we are concerned that other proposed provisions will pose a major threat to Europes competitiveness in life sciences and its ability to deliver new medicines faster.

Sanofi welcomes the objectives of the proposed draft Directive to improve todays system. We appreciate the streamlining and digitisation of regulatory procedures but are concerned that other proposals will pose a major threat to Europes competitiveness in life sciences and its ability to deliver new medicines faster.

Sanofi welcomes the European Commission’s (EC) assessment that the general pharmaceutical legislation should be fully adapted to cover new scientific and technological developments. We have identified six areas where procedures could be simplified and/or streamlined to reduce timelines, regulatory burden, and improve patient access. 1.

Sanofi supports the Commission's aim to ensure that Europeans benefit from technologies developed and functioning according to EU values, fundamental rights and principles, and welcomes the idea that AI should be a force for good in society. We use AI to accelerate discovery and development across R&D programs and improve the efficiency of processes across the organization.

Sanofi is one of the world's leading healthcare companies and the largest EU-headquartered pharmaceutical company, with deep and long-standing roots across the European research, clinical development and manufacturing.

Sanofis response to the European Commissions Call for Evidence on EU Biotech Act Sanofi welcomes the European Commission's initiative to develop a European Biotech Act. We believe this represents a critical opportunity to strengthen Europe's position in the global biotech landscape while addressing key challenges facing the sector.

Sanofi welcomes the Commission's Biotech Act II initiative and submits one core message: biopharmaceuticals must be included within the scope of Biotech Act II as a strategic industrial capability. Biomanufacturing is a horizontal industrial capability shared across all end uses. Excluding biopharmaceuticals would leave out the segment where Europe retains its strongest industrial footprint.

Sanofi is a global biopharmaceutical company focused on human health and a global leader in pharmaceutical research and development. Our ability to generate, access and use health and health-related data for research is critical to develop and launch new vaccines and treatments, address unmet medical needs, and optimize supply chain processes.

Sanofi welcomes the EU Safe Hearts Plan as a timely and much-needed strategic response to Europe's leading public health challenge. We are pleased to contribute to the call for evidence shaping this initiative. Cardiovascular diseases remain the foremost cause of death and disability across the EU.

The OMP Regulation has been a significant success. It has contributed to bringing around 180 medicines on the EU market and has benefitted more than 6 million patients across the EU. Sanofi welcomes the European Commission’s (EC) efforts to explore the creation of additional incentives to stimulate innovation and the development of orphan and pediatric medicines in areas of unmet needs.

Sanofi welcomes the EHDS and its potential to drive health innovation in Europe while urging implementation clarity, protections, and lead times needed for genuine research value. The following is our feedback on the draft HealthData@EU implementing regulation: Connected Entities (Articles 2(b) & 5) Publish implementation timelines well in advance given varying digital maturity of entities.

The Covid-19 pandemic has shown the important role that the ECDC should play in risk assessments, analysis of epidemiological information and recommendations for actions to prevent and control communicable diseases. The current ECDC mission must be expanded to help address major cross border health threats like pandemics and we therefore welcome Art.

Industry and Sanofi have doubled their efforts throughout the COVID 19 pandemic to mitigate risks of shortages by increasing production and reallocating stocks where highest needs were identified. However, we have seen supply chain disruptions of critical medicines and medical devices.

Sanofi welcomes the overall ambition of the Health Union. It is essential to fundamentally strengthen Europe’s ability to “work together to detect, prepare and respond collectively” to make healthcare systems more resilient and prepared for health emergencies.