Company: SNY
Filing Date: 2025-02-13
Form Type: 20-F
Source: 0001121404-25-000010
Chunk: 108

Company: Sanofi
Filing Date: 2025-02-13
Form: 20-F
Chunk 108
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3, the EC adopted a proposal for a new directive and a new regulation, which represent the largest pharmaceutical reform in the EU in over 20 years.The revision aims to achieve greater equity of access and use of medicines across the EU. The package is still under tripartite discussions between the EC, the Parliament and the Council of Member States, and adoption is unlikely until 2028. The new legislation contains a few components with direct impact on access. The most concerning draft proposals relate to modulated regulatory data protection and orphan market exclusivity periods; greater transparency in R&D costs; faster availability of generics and biosimilars; and more stringent obligations for the supply of medicines. The industry is deeply concerned by the potential detrimental impact of the package on innovation, competitiveness and patient access across Europe because of weakened intellectual property protection. Harmonization of EU health technology assessment (HTA) is also intended to address patient access inequalities in Europe, with official implementation in January 2025. To achieve this, a joint EU HTA process is being implemented in phases, starting with oncology medicines and advanced therapy medicinal products (ATMPs) from 2025, before expanding to orphan drugs in 2028 and other products in 2030. It will introduce EU-level joint scientific consultations (JSCs) and joint clinical assessments (JCAs) that will serve as the basis for national value assessments and price negotiations. 25 JCAs are planned to be conducted by the EU HTA Coordination Group (HTACG) in 2025. While preparations gathered pace in 2024, there are short-term risks and uncertainties related to the new JCA framework, especially as regards methodologies (i.e. comparators and endpoints), potential delayed assessments, and the disruption caused to national HTA processes in adopting EU HTA without additional resources. In addition, the new EU HTA regulation will trigger increased workload and higher evidence requirements at launch, requiring Sanofi and other manufacturers to adapt their operating models. As countries and companies transition to the new processes, EU-wide coordination on HTA is anticipated to gain momentum, albeit slower than initially expected. Another priority of the EC is to secure the uninterrupted supply of medicines in Europe. In 2024 it launched the Critical Medicines Alliance, paving the way for a possible Critical Medicines Act in the future. To mitigate drug shortages, the EC is pursuing several actions including reshoring of generics production, compulsory stockpiling, and joint procurement of the most critical medicines. China China is pursuing reforms towards "