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SANOFI

Sanofi is a global biopharmaceutical company focusing on disease prevention and innovative medical treatments.

Lobbying Activity

Meeting with Valérie Hayer (Member of the European Parliament) and Amazon Europe Core SARL and

28 Jan 2026 · Politique commerciale de l'UE

Meeting with Vita Jukne (Cabinet of Commissioner Jessika Roswall)

28 Jan 2026 · Implication of REACH revision and the upcoming Per- and Polyfluoroalkyl Substances (PFAS)

Meeting with Romana Jerković (Member of the European Parliament, Rapporteur)

9 Dec 2025 · Cardiovascular Health

Meeting with Stéphane Séjourné (Executive Vice-President) and

5 Dec 2025 · Industrie pharmaceutique, innovation et souveraineté sanitaire européenne.

Meeting with Dorota Denning (Cabinet of Commissioner Valdis Dombrovskis) and European Federation of Pharmaceutical Industries and Associations and Bayer AG

28 Oct 2025 · Roundtable on Simplification for Pharmaceutical Innovation

Sanofi urges flu vaccine inclusion in EU heart plan

15 Sept 2025
Topic — The consultation addresses a new EU strategy to improve cardiovascular health outcomes.
Message — Sanofi wants influenza vaccination integrated into routine cardiovascular care pathways. They advocate for equitable access to high-dose vaccines for older populations.12
Why — This would drive demand for Sanofi's proprietary high-dose influenza vaccine products.3
Impact — Manufacturers of standard influenza vaccines could see reduced demand for their products.4
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Meeting with Cecile Billaux (Head of Unit Directorate-General for International Partnerships)

10 Sept 2025 · Overview of Sanofi’s actions in global health and on local manufacturing in Africa

Meeting with Stéphane Séjourné (Executive Vice-President) and

5 Sept 2025 · - Compétitivité des entreprises - Marché intérieur - Protection de la souveraineté et du pouvoir d’achat - Relation US/EU

Meeting with Rainer Becker (Director Health and Food Safety) and AstraZeneca PLC

4 Sept 2025 · Exchange of views on multinational clinical trials in the context of the upcoming Biotech Act

Meeting with Lucilla Sioli (Director Communications Networks, Content and Technology) and

4 Sept 2025 · Virtual Human Twins

Meeting with Florika Fink-Hooijer (Director-General Health Emergency Preparedness and Response Authority)

29 Jul 2025 · Health security and innovation across Europe, SANOFI’s relevant activities

Meeting with Marco Marsella (Director Health and Food Safety)

15 Jul 2025 · The Digital Human. This flagship program leverages AI-driven avatars and advanced health data solutions.

Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

8 Jul 2025 · Challenges of Sanofi in Europe and opportunities to enhance investment and innovation in the pharmaceutical sector

Meeting with Stéphane Séjourné (Executive Vice-President) and

26 Jun 2025 · Compétitivité; relations USE-UE, CSRD/CS3D, Simplification

Sanofi urges EU to centralize biotech approvals and funding

11 Jun 2025
Topic — The European Commission is developing a framework to accelerate biotechnology innovation and market entry.
Message — Sanofi requests a single EU approval system for clinical trials and a simplified regulatory framework. They also propose merging medical regulations and increasing high-risk investment support.123
Why — Standardized processes would allow Sanofi to launch products faster while reducing administrative burdens.45
Impact — National regulatory bodies would see their influence diminished by centralized European oversight.67
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Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs)

5 Jun 2025 · Challenges for the EU pharmaceutical industry

Sanofi calls for EU AI strategy in life sciences

4 Jun 2025
Topic — European Commission strategy to accelerate AI adoption in strategic sectors.
Message — The company requests frameworks for industry-academia collaboration on AI models, regional innovation hubs for health challenges, and regulatory clarity on the AI Act research exemption. They want fast-tracked health data access for research and expanded use of synthetic clinical data.12345
Why — This would reduce regulatory uncertainty and accelerate drug development timelines.678
Impact — Patient privacy advocates lose stronger safeguards on health data reuse for commercial purposes.910
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Meeting with Gabriela Tschirkova (Cabinet of Commissioner Valdis Dombrovskis)

3 Jun 2025 · Simplification

Meeting with Michael Hager (Cabinet of Commissioner Valdis Dombrovskis)

3 Jun 2025 · Competitiveness of the pharmaceutical sector

Meeting with Ann-Sofie Ronnlund (Cabinet of Commissioner Ekaterina Zaharieva)

28 May 2025 · Life sciences

Meeting with Egelyn Braun (Cabinet of Commissioner Michael McGrath)

13 May 2025 · Exchange of views on competitiveness, simplification and collective redress

Response to Evaluation of the European Centre for Disease Prevention and Control

9 May 2025

Sanofi welcomes the opportunity to contribute to the ECDC mandate review. Effective collaboration between public health agencies and vaccine manufacturers is critical to protect Europe against health threats. Here are our proposals: Structured Dialogue and Information Sharing with Industry Partners: Currently, there is no structured communication between ECDC and vaccines manufacturers (or representative bodies) regarding vaccine horizon scanning, evidence generation to inform evaluation of public health interventions or supply forecasting. In contrast, such industry engagement is the working model of the EMA and HERA for planning, evaluation, and crisis preparedness. Vaccine manufacturers have technical knowledge on infectious pathogens, vaccines composition and performance, supply and AEs. Dialogue with manufacturers would enable timely sharing of technical knowledge, supply insights and emerging evidence supporting the ECDC to fulfil its mandate. Recommendations: Establish regular, transparent communication with vaccine manufacturers and joint frameworks for horizon scanning, evidence sharing and supply coordination. Structured engagement rules can prevent conflicts of interest (or the appearance of same) and are used by numerous scientific agencies (e.g. ACIP, WHO). Improvement of Scientific Standards, Transparency and Accountability in Systematic Reviews (SRs): Since 2020, the ECDC has increased the number, scope and importance of SRs. Increasingly they are used as important references for national decision-making and immunization policy by multiple countries. It is in public interest that SRs consistently meet the highest standards; however, the requisite processes and procedures have not been instituted to ensure SRs are conducted in a transparent, fair and consistent manner adhering to good administration principles. Without a well-established, documented and publicly visible process (e.g. GRADE), there can be no guarantee that SRs have followed high scientific standards worthy of the imprimatur of the ECDC. As a networked agency with limited resources, the ECDC relies on partners to conduct SRs. This reliance can result in a lack of transparency on who is involved in authorship and peer review e.g. the VESRA consortium (including a public health institute, two academic institutions, and a private consulting firm) has a service contract to conduct recent SRs. Despite their involvement in writing and review management, not all authors from these organizations are listed as contributors in the Enhanced Flu Vaccines SR 2024. This may compromise the perceived independence and rigor of the SRs. Responsibility for Peer Review is diffused among a volunteer network from NITAGs. No national authority, organization or named individual has explicit responsibility to provide input. Such unclear processes can result in conclusions that contradict established scientific standards e.g.in the above 2024 SR, the certainty of evidence provided by non-randomized observational studies was graded as equal to double blind RCTs that had been reviewed by regulators and accepted as a basis for licensure. Such an approach contrasts with that of the EMA, which evaluates industry-sponsored research for vaccines registration. The SR conclusions can conflict with EMAs licensure data, confusing policymakers and the lay public. Recommendations: 1. Protocols, peer review, and quality control processes should be transparent and well-documented. Protocols should be posted for comment before initiation of the SR; 2.Provide opportunities for vaccine manufacturers to present/submit an updated view on relevant or forthcoming data; 3.Ensure active peer review by accountable reviewers; 4.Transparency on risk of bias tools (e.g. GRADE) used, aligning evidence grading with regulatory standards; 5.Post SR for comment and right of reply for affected parties (e.g. if they believe data has been misrepresented).
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Sanofi urges EU to double biopharma funding for competitiveness

17 Apr 2025
Topic — The European Commission is developing a new multidisciplinary strategy for European life sciences.
Message — Sanofi proposes a coordinated EU strategy including competitiveness checks and doubling biopharma research funding. They also request stronger intellectual property protections and streamlined rules for using artificial intelligence.123
Why — These measures would provide greater investment certainty and lower costs for pharmaceutical innovation.45
Impact — Public health budgets could face higher costs from extended intellectual property protections.6
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Meeting with Maurice Whelan (Head of Unit Joint Research Centre), Tobias Wiesenthal (Head of Unit Joint Research Centre) and

4 Apr 2025 · Scientific roundtable discussion between the European Commission’s Joint Research Centre and the pharmaceutical industry on the topic of leveraging health data and data sciences for innovation

Meeting with Michael Hager (Cabinet of Commissioner Valdis Dombrovskis), Nicolo Brignoli (Cabinet of Commissioner Valdis Dombrovskis)

2 Apr 2025 · Competitiveness

Meeting with Lucie Šestáková (Cabinet of Commissioner Jozef Síkela), Natividad Lorenzo (Cabinet of Commissioner Jozef Síkela) and

28 Mar 2025 · Global Gateway

Meeting with Felice Zaccheo (Head of Unit Directorate-General for International Partnerships)

19 Mar 2025 · To discuss Sanofi’s involvement in LAC and opportunities for actionable cooperations under the GGIA to contribute to health self-sufficiency in LAC.

Meeting with Olivier Girard (Head of Unit Health Emergency Preparedness and Response Authority)

12 Mar 2025 · Discussion on Joint procurement to improve availability of antibiotics and avoid shortages

Meeting with Kristoffer Storm (Member of the European Parliament)

11 Mar 2025 · Pharmaceutical Industry

Meeting with Maurice Whelan (Head of Unit Joint Research Centre), Tobias Wiesenthal (Head of Unit Joint Research Centre) and

27 Jan 2025 · Exploit interest in a scientific roundtable between the European Commission’s Joint Research Centre and the pharmaceutical industry on the topic of leveraging health data and data sciences for innovation

Meeting with András Tivadar Kulja (Member of the European Parliament)

5 Dec 2024 · European health policy

Meeting with Eszter Lakos (Member of the European Parliament)

11 Nov 2024 · Pharmaceutical sector

Meeting with Oliver Schenk (Member of the European Parliament) and Novartis International AG and

4 Nov 2024 · Pharmastandort Deutschland

Meeting with Billy Kelleher (Member of the European Parliament)

1 Oct 2024 · Pharma strategy

Meeting with Josep Borrell Fontelles (High Representative) and Banco Santander, S.A. and

30 Sept 2024 · The objective of the lunch is to gather the views of key representatives from the EU private sector regarding the present situation in Mexico and prospects under the new administration, notably from an economic perspective, in an open dialogue.

Meeting with Andreas Glück (Member of the European Parliament)

16 Sept 2024 · Health

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

24 Jul 2024 · Choroby oddechowe w UE

Sanofi warns EU clinical assessment rules risk patient access

2 Apr 2024
Topic — Implementing rules for joint clinical assessments of new medicines at EU level.
Message — Sanofi requests greater developer involvement in scoping and mandatory meetings to clarify expectations. They advocate extending the dossier submission timeline to 135 days. For vaccines, rules must explicitly involve National Immunisation Technical Advisory Groups.123
Why — This would allow the company to shape the assessment scope and reduce submission errors.45
Impact — Patients risk losing fast access to treatments if the current unworkable rules are adopted.6
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Meeting with Thierry Breton (Commissioner)

19 Mar 2024 · industrial competitiveness of pharma sector

Meeting with Olivier Guersent (Director-General Competition)

5 Mar 2024 · Discussion on IPCEI

Meeting with Angelika Winzig (Member of the European Parliament)

4 Mar 2024 · Pharma Package

Meeting with Dolors Montserrat (Member of the European Parliament)

1 Mar 2024 · Future of pharmaceutical sector in Europe

Response to Review of the Health Emergency Preparedness and Response Authority (HERA)

16 Feb 2024

The establishment of HERA in 2021 brought attention to the crucial need for European R&D across various company types. Since then, HERA strived to fill a critical gap in pandemic preparedness and response by setting up a durable consortium, with the capacity to rapidly characterize emerging pathogens to adapt MCMs and improve access to samples and data worldwide. To secure Europes health resilience in an increasingly unstable global ecosystem, the Commission needs to further bolster HERAs role, with a higher flexibility and resources, to strengthen Europes health security. Several areas that need special attention are the following: a. Strengthening HERAs role as a key actor to enable health security and open strategic autonomy of Europe. Securing resilience of Europe in crisis response and preparedness would mean: i) strengthening HERAs role and ability to prepare for future health emergencies; ii) deepen understanding of climate change as driver of more pathogen crises, iii) enabling continuous access to qualitative epidemiological scenario-planning and live vaccination coverage rate information to manufacturers of MCMs, iv) expanding HERAs scope beyond health emergencies with co-financing of areas of high risks, v) further develop and leverage funding instruments for projects of significant importance for health sovereignty and for technology platforms for future innovations, including for late-stage development. b. Providing HERA appropriate resources to have the capability to allocate funds annually and demonstrate budget flexibility. Having its own resources and possessing the ability to leverage additional funding from diverse European channels drawing from BARDAs experience are crucial for addressing unforeseen crises. Emphasis should be placed on extended multi-annual funding cycles rather than shorter ones. c. Accelerating EU sustainable innovation capacity by boosting investments in R&D and advanced manufacturing. Proposing risk-sharing strategies to tackle market failures, especially in high-risk areas, is crucial. A stronger differentiation between crisis response and preparedness modes in the R&D partnership answer is essential: in crisis mode, HERA is not adequately competitive for product race development licensure that will request BARDA-like 1/1 contracts. HERA should invest in flexible and agile manufacturing capacity to keep the ability to rapidly scale-up. Joint procurement should be reserved for use only in cases of unforeseen cross border health threats. Sustainable, strategic procurement principles including criteria beyond price should be applied to public health more broadly to ensure sustainable, competitive supply. d. Deepening cooperation with stakeholders by actively involving industry (individual companies on top of trade associations in scenario mapping, threat prioritization, and late-stage development to boost drugs and vaccines development and ensure coordination between EU regulators to simplify the regulatory pathway for innovative medicines addressing health threats. Any measure potentially affecting industry operations should be subject to pre-consultation and continued dialogue for lessons learned and adjustments. e. Fostering EU / international coherence: Ensuring there is no duplication between HERA, Member States, EU Commission and EU bodies (EMA, ECDC) and that existing infrastructures are leveraged. HERA shall demonstrate EU leadership in pandemic preparedness and response. Furthermore, HERA should take a prominent role in fostering an effective and cohesive international approach including with BARDA, CEPI, Skarda. To effectively fulfil its mission and enhance Europe's health security, HERA faces the challenge of acquiring an optimal blend of flexibility, resources, autonomy and expertise for seamless implementation and success. In this regard, Sanofi remains fully committed to continuing collaboration with HERA.
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Meeting with Stella Kyriakides (Commissioner) and

17 Jan 2024 · Meeting with Mr Roy Papatheodorou, SANOFI Executive Vice President and General Counsel

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and European Federation of Pharmaceutical Industries and Associations and

12 Dec 2023 · Directive on Medicinal products for human use

Meeting with Dolors Montserrat (Member of the European Parliament)

17 Nov 2023 · Pharmaceutical Manufacturing in Europe

Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur)

10 Nov 2023 · Visite d'usine

Sanofi warns EU pharmaceutical reforms threaten European life sciences competitiveness

8 Nov 2023
Topic — EU revision of pharmaceutical legislation to improve access, innovation, and supply security.
Message — Sanofi requests longer orphan market exclusivity with a 15-year cap instead of 13 years, removal of the high unmet medical need definition, and rejection of six-month advance notification for supply disruptions. They support risk-based shortage prevention plans and streamlined regulatory approval processes.1234
Why — This would extend patent protection for their rare disease drugs and reduce administrative burdens.56
Impact — Patients lose faster access to affordable medicines through extended monopoly periods for treatments.7
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Sanofi warns pharmaceutical reforms threaten European innovation and competitiveness

8 Nov 2023
Topic — EU revision of pharmaceutical legislation to improve medicine access, foster innovation, and strengthen supply security.
Message — Sanofi opposes reducing regulatory data protection from 8 to 6 years and linking it to supply obligations. They seek stronger incentives including extending baseline protection to compete globally. They advocate a broader definition of unmet medical need focused on patient outcomes rather than just mortality reduction.1234
Why — This would maintain their competitive position against US markets offering 12-year protection for biologics.56
Impact — Patients lose faster access as companies delay launches in smaller markets without supply obligations.7
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Meeting with Catherine Amalric (Member of the European Parliament, Shadow rapporteur)

2 Oct 2023 · Reform of the EU pharmaceutical legislation

Meeting with Salvatore De Meo (Member of the European Parliament)

25 Sept 2023 · Various

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and European Federation of Pharmaceutical Industries and Associations and

7 Sept 2023 · Revision of the Pharmaceutical Legislation (staff level)

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Novartis International AG and

18 Jul 2023 · Directive on Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur) and European Federation of Pharmaceutical Industries and Associations and BioMarin UK Limited

7 Jun 2023 · Revision of Pharmaceutical Legislation (staff level)

Meeting with Karsten Lucke (Member of the European Parliament)

6 Jun 2023 · Health Security Strategy

Meeting with Nicola Beer (Member of the European Parliament, Rapporteur)

6 Jun 2023 · Critical Raw Materials Act

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur)

31 May 2023 · Directive on Medicinal products for human use

Meeting with Patrizia Toia (Member of the European Parliament)

3 May 2023 · Pharmaceutical strategy

Meeting with Sara Cerdas (Member of the European Parliament)

3 Apr 2023 · Reunião Sanofi Portugal

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

27 Mar 2023 · Pharmaceutical legislation and transparency regarding the Advanced Purchase Agreements on vaccines (APA)

Meeting with Nathalie Colin-Oesterlé (Member of the European Parliament) and Vaccines Europe

15 Feb 2023 · Pharmaceutical review

Meeting with Frédérique Ries (Member of the European Parliament) and Servier

13 Dec 2022 · Maintenir l'innovation pharmaceutique en Europe et l'accès des patients aux médicaments

Meeting with Andreas Glück (Member of the European Parliament, Committee chair)

7 Dec 2022 · EU Vaccine Strategy

Meeting with Eszter Batta (Cabinet of Commissioner Thierry Breton)

14 Oct 2022 · Pharmaceutical investments, implementation of the Pharma Strategy

Meeting with Karolina Herbout-Borczak (Cabinet of Commissioner Stella Kyriakides) and ABDA - Bundesvereinigung Deutscher Apothekerverbände e.V.

7 Sept 2022 · Meeting with the German Pharmaceutical Association and Sanofi to discuss the pharmaceutical reform

Meeting with Karsten Lucke (Member of the European Parliament)

27 Jun 2022 · Initiativen für die Pandemievorsorge / Vorbereitung Jahrestagung House of Pharma & Healthcare

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

14 Jun 2022 · R&D, production and manufacturing of essential medicines

Meeting with Dimitri Lorenzani (Cabinet of Vice-President Maroš Šefčovič)

10 Jun 2022 · Discussion on stragegic foresight

Meeting with Karin Karlsbro (Member of the European Parliament) and AstraZeneca PLC and

17 May 2022 · Pharmaceuticals

Meeting with Andreas Glück (Member of the European Parliament, Committee chair)

11 May 2022 · MDR & IVDR

Meeting with Maurits-Jan Prinz (Cabinet of Commissioner Thierry Breton)

3 Feb 2022 · Initiatives in the health industrial ecosystem

Meeting with Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis), Elina Melngaile (Cabinet of Executive Vice-President Valdis Dombrovskis), Kevin Keary (Cabinet of Executive Vice-President Valdis Dombrovskis) and

26 Oct 2021 · Pharmaceutical sector – trade related issues

Sanofi Calls for Centralized AI Authorization and Healthcare Exemptions

22 Jul 2021
Topic — EU regulation establishing harmonized rules for artificial intelligence systems and applications.
Message — Sanofi requests a centralized authorization process for AI regulation with mutual recognition between authorities. They want existing healthcare surveillance mechanisms to be used for AI monitoring instead of creating duplicate reporting requirements. The company seeks to exclude traditional statistical methods and clinical evidence generation from the AI definition.123
Why — This would reduce compliance burdens and avoid duplicating existing pharmaceutical safety reporting systems.45
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Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

Sanofi urges streamlined drug approvals and digital product information

27 Apr 2021
Topic — Revision of EU pharmaceutical legislation to improve access, innovation, and supply security.
Message — Sanofi requests replacing paper leaflets with electronic product information, adopting common EU packaging for essential medicines, and implementing risk-based vaccine batch testing instead of systematic retesting. They also seek full integration of ICH Q12 guidelines and streamlined GMO assessment processes.12345
Why — This would reduce regulatory burden, speed up product availability, and cut wastage costs.678
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Meeting with Eszter Batta (Cabinet of Commissioner Thierry Breton)

26 Mar 2021 · Health in the industry policy update

Response to European Health Emergency Response Authority

24 Feb 2021

The Covid-19 pandemic has demonstrated the need for governments, institutions, and companies to react rapidly and effectively to major, unforeseen disruptions. Thus, strengthening the European capacities to address cross borders health threats and deliver integrated responses is of utmost importance. As such, Sanofi strongly welcomes the European Commission’s ambition to create a Health Emergency and Response Authority (HERA) to work on biomedical research, preparation, and response. As a global actor, Sanofi has the medicines portfolio, the manufacturing and supply chain capacity and the track record of public-private partnerships to keep playing a key role in the preparedness and response to pandemics. As such, we emphasize the need to implement new models of long-term end-to-end collaboration between public and private sectors at the EU level. HERA should be solution-oriented, providing a single-entry point for stakeholders and enabling long term and flexible financial commitments to activities with uncertain commercial success, in the context of health emergency preparedness. To fully deliver against its proposal, HERA needs to be a structure capable of boosting cooperation, reactivity, and connectivity. This requires a clear definition role and responsibilities complementing the existing European and global bodies, including EMA, ECDC, EU Commission, CEPI, WHO, and a clear structured dialogue with the industry, from project definition to commercialization. HERA should fill the gap in two critical areas: boost competitive R&D and support building flexible manufacturing capacities for medical countermeasures in Europe. Firstly, the ability to award contracts to private companies guaranteeing quality and scientific excellence is crucial to HERA in addressing the gaps in competitive R&D. Secondly, Sanofi supports the establishment of flexible manufacturing models, designed up front to be readily adapted to changes. The approach proposed in the HERA Incubator to create ‘ever-warm’ flexible multi-technology production capacities for vaccines and medicines should be a core asset of the future HERA. Additionally, we believe that the “hub and spoke” model as a layout of flexible facility should be considered to leverage existing manufacturing networks. Moreover, when it comes to R&D, HERA’s “Health Emergency” scope needs to be qualified. This is important as along these lines short to mid-term threats like AMR/AFR (or non-identified immediate threats) would be managed through different European PPP mechanisms, e.g. IMI. Sanofi believes that HERA’s success relies on its capacity to adopt an agile and pragmatic approach to its activities, like BARDA in the US. The EU and Member States should create a structured and transparent approach for the selection of priorities, and to facilitate sustainable and scalable funding commitments. A well-defined governance for collaboration with the industry, and with other EU and global agencies is needed as well as a supportive policy, legal and regulatory environment. In this context, we support policy option 3 “Full end-to-end Authority & streamlining of EU level initiatives on medical countermeasures for serious cross-border threats to health” as the latter combines key principles capable of making tangible outcomes. As global crisis requires global responses, we would like to further highlight the role HERA can play beyond European borders by expanding beyond its role of regional agency to be a global actor in crisis response and preparedness. HERA should be interconnected with Global Emergency Pandemic & Response processes, e.g. CEPI, WT, BMGF and the US BARDA. This would avoid fragmentation, duplication, and competition. For example, the European PHEIC could be synchronized with the WHO PHEIC through the ECDC. HERA will pave the way to achieve a higher level of open strategic autonomy for the development and deployment of the most adapted countermeasures in Europe.
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Response to Proposal for a Regulation on a Union framework addressing public health emergencies (EMA)

2 Feb 2021

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 therefore welcomes the European Commission’s proposal to reinforce the role of the European Medicines Agencies in crisis preparedness and efforts towards an integrated reporting system that should measure actual shortages that have a patient impact in Europe. Firstly, we would like to express our concern regarding the definition of “major event” (art.2), as we believe it is too broad. It is difficult to assess which events can be considered major events and, in this sense, we ask for a more precise definition of the concept. Secondly, concerning monitoring of shortages, the EMA should identify countries where the same medicinal equivalence is marketed, and contact concerned marketing authorization holders (MAHs) to increase their manufacturing capacity to supply the countries concerned by a shortage. In addition to specifying the procedures for establishing the list of critical medicines as outlined in art.9(1a), Sanofi welcomes a procedure to revise and update such a list, including deleting medicines that are no longer considered critical in the context of a major event or of a health emergency (art.6). Moreover, we ask for clarification on whether the web portal will be public (art.6(4)). To facilitate the reliable exchange of medicinal products information in a robust and consistent manner, we would like to suggest that regarding art.9(3f) and (3e) “details of available alternative medicinal products” should be provided in cooperation with local health authorities as they may have more complete information than a single MAH. We would like to further clarify if, in the framework of a critical medicine activity, a SPOC will be identified at the Agency for any reporting, including the activities specifically mentioned as necessitating reporting to the Medicines Steering Group. It should be reinforced that the request for member states to provide estimated data on volume of demand should concern the INN and not an individual brand (art.11(1a)). We urge that this information be made available to manufacturers (under confidential terms) as this type of data is critical to manage stocks and establish solid production forecasts and therefore an essential element in ensuring adequate supply for the whole EU area. We would also welcome greater clarity and transparency on how the EMA/local HAs are using and analysing the information provided by MAHs. As the decision for submitting a MAA or a modification of an existing one should stay within the remit of the MAH, we recommend a revision of the employed term “opinion” (art.16) regarding the ETF and the CHMP. Moreover, the regulation lacks a differentiation between CHMP and the Emergency Task Force when it comes to providing scientific advice. Regarding the Medical Devices Steering Group, there is a need to clarify if the EMA will have the ultimate responsibility for conformity assessment of high-risk medical device and will be staffed for it. Regarding the EHDS infrastructure, Sanofi would like to note that Pharmaceutical companies should also be able to access data for R&D and post-marketing surveillance purposes. Additionally, we believe the definition, timelines and standards for reporting shortages across the EU and across medicinal products requires further harmonisation, beyond a situation of major event or a public health emergency. Ultimately, we highlight the necessity for the EMA to put the appropriate confidentiality measures in place to avoid the risks related to cyberattacks. The COVID 19 pandemic shows the EC's critical role to ensure implementation of regulatory flexibility to facilitate supply and prevent unilateral actions at national level that may increase shortages.
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Response to Proposal for a Regulation on serious cross-border threats to health

2 Feb 2021

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. Industry is a key partner in this effort and Sanofi urges rapid progress towards new public-private approaches from early detection to manufacturing at scale to address today’s gaps and tomorrow’s capacities. Sanofi supports a solid legal framework to enable preparedness and response measures in an efficient and rapid manner. As an EU-headquartered company active in vaccines and pharmaceuticals R&D and manufacturing, we see an important need for a more inclusive and collaborative approach towards industry. We consider three areas of particular relevance: Firstly, there is a need to improve how epidemiological and demand data is shared with industry during a health emergency. The COVID 19 pandemic showed the need for sharing modelling data about the likely progression of the pandemic in each country, as well as patient need and hospital capacity data in Member States. This is critical for manufacturers to manage stocks and establish solid production forecasts and therefore an essential element in ensuring adequate supply. This will contribute to get the right drug to the right hospital in the right country at the right time and having a clear picture of needs in any future waves of a communicable disease outbreak. We regret that the proposal does not foresee any mechanism to share with industry epidemiological data, modelling and response scenarios. This could be done, for example, via the digital platform for surveillance (art. 14). Secondly, the Early Warning and Response System should also reach out to industry as early signals will be relevant for enabling industry to anticipate appropriate R&D and manufacturing activities. Sanofi welcomes the strengthened role for the European Commission to decide the existence of an emergency situation (Article 23) but this should nevertheless be done in coordination with global actors such as the WHO. The Regulation should also be clear in defining under which circumstances measures such as joint procurement of medical countermeasures (Article 12), as well as stockpiling, can be triggered. The joint procurement instrument and stockpiling should remain reserved only for serious cross border threats to health such as pandemics and have a clearly defined scope, be feasible and sustainable. Imposition of very short notice and non-viable conditions in the implementation of joint procurement measures are counter-productive. Learnings need to be integrated from past joint procurements implemented within the framework of current Decision No 1082/2013/EU on serious cross-border threats to health. Joint procurement is not a solution for more sustainable supply of vaccines and biologics in Europe in general and will fail to address the underlying causes of shortages of vaccines and biologics (such as complex life cycle, management, growing and often unpredictable global demand etc). Finally, we strongly recommend that consultation with industry be integrated into the process of the Union health crises and preparedness plan and national preparedness and response planning. This will contribute to better planning for manufacturing and R&D capacity. Dialogue between EU authorities and stakeholders, including industry, was critical during the first wave of the COVID 19 pandemic and the future infrastructure and processes for preparedness need to build on that. We urge that the EU-wide and national plans contribute to avoiding unilateral stockpiling requirements that put at risk supply of critical medicines. The future European Health Emergency Preparedness and Response Authority should facilitate the implementation of dialogue and create the conditions for stronger EU pandemic preparedness.
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Response to Proposal for a Regulation establishing a European Centre for Disease Prevention and Control (ECDC)

2 Feb 2021

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. 3 of the Regulation to include preparedness and response activities in the ECDC’s mandate. We would like to highlight three key issues. Firstly, clear rules to govern interactions between industry and ECDC should be included in the proposal to improve dialogue and enable collaboration where appropriate and in full respect of the ECDC’s independence. Dialogue with the ECDC could be regulated under similar rules as those developed by WHO under the FENSA framework or similar to the US CDC’s approach. Considering that the vaccines and pharmaceutical industry play an important role in health emergencies, we regret this aspect is not sufficiently addressed in the proposal. Secondly, while Sanofi is pleased to see that development scenarios for response will be included in the ECDC legal framework (Article 5.4(g)), we consider it of high value if this type of data can be made available for use by other stakeholders, including industry. One of the lessons learned from the Covid-19 pandemic was the need for the ECDC to develop COVID-19 epidemiological scenario planning at EU level, which would have benefited industry as well in its investment and response planning. In the absence of such scenario plans, vaccine manufacturers developed their own epidemiological models and scenarios, based on their own (more limited) assumptions, to inform industrial decisions, with major risk due to lack of shared European vision. Lack of collaboration also creates inefficiencies, for example in the conduct of phase IV studies. Extensive phase IV studies are already required by the European Medicines Agency (EMA) and implemented in vaccine manufacturers’ RMPs, using member states’ capabilities and resources and for which EMA relies on industry. Not involving the industry in the coordination of independent post-marketing vaccine effectiveness and safety monitoring studies (Article 5a.4) driven by ECDC will create significant duplicative efforts and waste of resources Sanofi therefore calls for vaccine manufacturers to be involved in the establishment of the new vaccines monitoring platform and framework for these studies. To ensure the necessary level of independence, clarification how manufacturers are informed about and engaged with the findings is needed but also how those findings will be used by regulatory bodies and other organizations. Sanofi also calls for the collaboration between ECDC and NITAGs to provide support to member states in their systematic reviews. We would like to see greater uptake of reports by relevant national bodies, as well as leverage these where they can contribute to horizon-scanning of future immunization options. Finally, a review of ECDC decision-making process and modalities of its relation with the member states should be addressed by relevant modifications of Article 18 to guarantee that ECDC can take decisions independently, via its management team, according to endorsed strategic roadmap and extended mission. The role of the Advisory Forum should be fully consistent with Chapter 18.3 of the ECDC Regulation to “support the director in ensuring the scientific excellence and independence of activities and opinions of the Centre” and shall not overlap with the role of the ECDC management team or that of the Management Board. We support updated Article 4 of the proposal on “Obligations of the Member States” which are more comprehensive and should help ECDC in pursuing its mission. Cross-border health threats, like the current pandemic, can only be tackled by a greater coordination role for the ECDC and collaboration with all relevant partners, public and private.
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Sanofi urges industry access to EU health data infrastructure

2 Feb 2021
Topic — EU regulation on data sharing, digital health services, and AI use in healthcare.
Message — Sanofi requests that industry be included as a key partner in the EHDS user group alongside public bodies. They want the private sector invited to contribute and access EHDS data for legitimate purposes under appropriate governance. They emphasize that EU-wide regulation should be the default position with limited national restrictions.123
Why — This would enable pharmaceutical companies to access real-world data for drug development and regulatory submissions.45
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Meeting with Ursula von der Leyen (President) and Johnson Johnson and

31 Jan 2021 · Meeting with CEOs of the pharmaceutical companies with which the Commission has signed Advance Purchase Agreements

Response to Revision of the Communication on important projects of common European interest

21 Dec 2020

IPCEIs can be powerful game-changers to advance the European Union’s strategic priorities and economic and societal values. Sanofi welcomes the opportunity to comment on the planned revision of the "Communication on important projects of common European interest" to integrate emerging economic and societal challenges. This is an important step towards answering the call by the European Council on the Commission to help Member States develop new IPCEIs (European Council Conclusions 1-2 October 2020). The revised Communication should include “strategic autonomy”, declared a key objective of the EU by the European Council, within the scope of what is of “common European interest”. In light of the changing global context and impact of the COVID-19 pandemic, Europe needs well-resourced capacities and infrastructure to rapidly respond to emergencies and protect global supply chains, especially in the health area . In this respect, we refer to statements by President Emmanuel Macron and Chancellor Angela Merkel of 18 May 2020: “We strive for a strategically positioned European healthcare industry which will, in full respect of the Member States’ responsibility for their social security and healthcare systems, upgrade the European dimension of healthcare and reduce EU dependency”. More recently, the Council Conclusions of 18 Dec 2020 on ‘COVID 19 Lessons Learnt’ highlight the need to identify and address strategic dependencies in the industrial ecosystem for health. In addition, it is critical to adapt EU competition policy to support the EU’s green and digital agenda. A transition to clean and efficient manufacturing, integrating cutting-edge technology can be a powerful driver of competitiveness. However, high EU production costs can impact the competitiveness of industrial actors operating in the EU. Therefore, we believe public-private efforts are needed now to strengthen Europe's health industry ecosystem to: 1. Fund research, development and manufacturing capabilities on priorities for public health, especially for projects that are insufficiently attractive for economic actors under current conditions, e.g. for critical medicines in the off-patent sector, and to build reserve and flexible manufacturing capacity to ensure health emergency preparedness 2. Build Europe’s manufacturing capacity while investing into green and digital technology 3. Advance Europe at the forefront of innovation in bioproduction (e.g. cell/gene therapies, mRNA etc.), generating high-skill employment, given the substantial investments we see in these fields in other parts of the world Other aspects are critically important to assess eligibility of large-scale projects: 1. Analysis of full innovation and production value chain to identify existing gaps and enable inclusion of a broad set of non-industrial and industrial partners, including SMEs as they form an integral part of the pharmaceutical R&D and manufacturing ecosystem, including in digital technology and AI. 2. A case-by-case approach to and analysis of the specific ecosystem to ensure flexibility and pragmatism in the assessment of a proposed IPCEI. This analysis should consider investments into the given sector in other parts of the world. 3. The level of complexity and risks inherent in R&D investments requiring substantial industrial effort including for investments considered essential for strengthening Europe’s resilience and strategic autonomy, with both CAPEX and OPEX included in the range of eligible expenditures. 4. Include process innovation, e.g. to substantially increase efficiency of resources and environmental protection or integrating digital and AI technology. The review should help to further optimise the processes and governance of IPCEIs to ensure these instruments can generate growth and technological innovation especially where no single member state can build the critical level of capacity development needed in strategic sectors for the rest of the EU.
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Response to Revision of the EU legislation on medicines for children and rare diseases

21 Dec 2020

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. We also welcome its intention to define unmet needs and would suggest that a multi-stakeholder working group, including industry, be established to start a dialogue on the matter. We are deeply concerned about potential changes to the prevalence threshold. According to data from the Orphanet database, more than 80% of rare disease patients are affected by less than 150 rare diseases with a prevalence of 1-5 in 10,000. Reducing the threshold could curtail medicines development for conditions which are no longer regarded as rare. In addition, the potential value of introducing an incidence criterion for specific rare diseases is unclear. Replacing the prevalence criterion with an incidence criterion would penalize medicines developed for diseases with higher mortality today. We would welcome a clarification on the rationale for it. Market exclusivity remains an important incentive for developers and we are concerned about the proposition that its duration be determined by the ‘type of development’ of a product (i.e. innovative, repurposed, second or multiple indications). New indications often constitute follow-on innovation that is critical to achieve meaningful patient outcome and is essential to address unmet needs. Without incentives for new indications, companies are unlikely to take the necessary steps to develop and file for marketing authorizations. Regarding the Pediatric Regulation, we share the view that its success has been more nuanced. Since 2006, the number of centrally-authorized new pediatric medicines and indications has more than doubled but access has not followed. We agree with the analysis that incentives in the Pediatric Regulation are insufficient to stimulate research and development. We are supportive of additional incentives, such as transferable vouchers. Many development challenges could be addressed without revising the Pediatric Regulation. This is the case for unintended delays in early-phase clinical trials, related to the Pediatric Investigation Plan process. We would welcome an acceleration of the implementation of the recommendations resulting from the EMA-EC action plan on pediatrics. We are deeply concerned about the proposition that incentives such as the 6-month SPC extension, market exclusivity or any novel reward would be pre-conditioned on the placing on the market of an orphan or pediatric medicinal product in most or all EU Member States (MS). Many of the hurdles that prevent companies from launching in most or all EU MS come from decisions that are beyond their control (e.g. low prioritization of orphan and pediatric diseases, budgetary decisions, HTA processes). We support the EC’s endeavor to better understand the root causes of access delays across the EU. Most importantly, the framework supporting the development and commercialization of orphan and pediatric medicines is in dire need of a well-functioning European health data space. Repurposing research data would go a long way. It would require addressing some of the challenges associated with the GDPR. Despite progress made through the European Reference Networks, the development of orphan and pediatric medicines is still challenged by fragmented datasets across the EU. Once OMP and pediatric medicines have received marketing authorization, access is often delayed because of heterogenous evidentiary requirements and assessment processes across MS. In addition, more efforts need to be made to build consensus on how real-world data can inform decisions made by regulators, HTA bodies, payers and clinicians across the EU.
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Meeting with Kurt Vandenberghe (Cabinet of President Ursula von der Leyen)

23 Nov 2020 · Alliances

Meeting with Thierry Breton (Commissioner) and

16 Nov 2020 · Pharmaceutical manufacturing in the EU

Meeting with Pascal Canfin (Member of the European Parliament)

26 Oct 2020 · Covid 19

Meeting with Thierry Breton (Commissioner) and

13 Oct 2020 · Pharmaceutical manufacturing in the EU

Sanofi urges EU to boost pharmaceutical manufacturing and innovation

7 Jul 2020
Topic — This consultation explores ways to ensure a stable, affordable medicine supply across Europe.
Message — Sanofi calls for a European Alliance for manufacturing to ensure a cost-effective and scalable medicine supply. They request public-private partnerships to fund R&D and de-risk production for health emergency countermeasures. The company also urges the EU to maintain incentives for orphan drug development.123
Why — Public funding and specialized incentives would reduce Sanofi’s financial risks in drug development.45
Impact — Non-European pharmaceutical hubs may lose their competitive edge as the EU prioritizes strategic independence.67
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Meeting with Thierry Breton (Commissioner)

25 May 2020 · Perspectives on the fight against COVID-19

Meeting with Thierry Breton (Commissioner) and Koninklijke Philips and

6 Apr 2020 · Digitisation of healthcare and innovative e-health solutions.

Sanofi urges EU cancer plan to boost innovation and data

4 Mar 2020
Topic — The EU initiative aims to reduce the cancer burden through cross-border coordination.
Message — Sanofi calls for enhanced data sharing and a unified EU-wide drug assessment platform. They advocate for personalized medicine and using real-world data to improve treatment access.12
Why — Centralized assessments and guaranteed budgets would speed up market access for new treatments.34
Impact — National health ministries may lose control over their drug spending and evaluation criteria.5
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Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis) and Novartis International AG

21 Feb 2018 · HTA; Supplementary Protection Certificates (SPC)

Meeting with Lucie Mattera (Cabinet of Commissioner Pierre Moscovici) and Novartis International AG

25 Jan 2018 · European patent protection

Meeting with Manuel Mateo Goyet (Cabinet of Commissioner Mariya Gabriel)

24 Jan 2018 · Digital Healthcare

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

24 Jan 2018 · HTA; E-Health

Meeting with Bernardus Smulders (Cabinet of First Vice-President Frans Timmermans)

10 Oct 2017 · Life Science in the EU

Response to REACH Regulation - Annex XIV

14 Oct 2016

Sanofi welcome the opportunity to comment. The entry of 4-(1,1,3,3Tetramethylbutyl)phenol, ethoxylated (4-tert-OPnEO ) in Annex XIV would have a huge impact on pharmaceutical industry. It is sanofi ambition to continue to make progress in replacing hazardous substances and to reduce environmental impact. However 4-tert-OPnEO is a critical raw material for viral inactivation of biotech medicinal products. As a compound present in medicinal products for human use, it has not be shown to be hazardous nor toxic for patient. This is supported by clinical studies and pharmacovigilance of medicines in which the compound has been present for years. Substitution by another substance or technology would affect complex validation processes and may require animal testing and clinical trials to prove equivalent efficacy and safety, that are mandatory by Medicinal Health Agencies in EU and outside EU. The current REACH Authorisation process is uncertain and might put patient at health risk and/or lead to product shortage. Sanofi would strongly request for long review periods (>12 years) should OPnEO be included in the Annex XIV and/or calls upon official authorities to find feasible and concrete solutions which will include patient safety, self-sufficiency in health, and excellence of manufacturing and medical research in Europe.
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Meeting with Nils Behrndt (Cabinet of Vice-President Neven Mimica)

18 Apr 2016 · Access to health care including pharmaceuticals in developing countries

Meeting with Clara Martinez Alberola (Cabinet of President Jean-Claude Juncker)

18 Apr 2016 · EPSC, Interinstitutional relations

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

17 Mar 2016 · AMR, HTA

Meeting with Vytenis Andriukaitis (Commissioner) and

2 Jul 2015 · vaccinations

Meeting with Robert Madelin (Director-General Communications Networks, Content and Technology) and American Chamber of Commerce to the European Union and

3 Jun 2015 · New College and Better Regulation

Meeting with Giulia Del Brenna (Cabinet of Commissioner Carlos Moedas)

7 May 2015 · Implementation Council Conclusions on Vaccination

Meeting with Clara Martinez Alberola (Cabinet of President Jean-Claude Juncker)

27 Mar 2015 · How to strengthen a European coherent approach with focus on ERA development, ways to reduce the fragmented approach in Europe for evaluation the value of new medicines for improved access for the patient, and means of creating a more dynamic environment for medicine development in Europe and driving an ambitious agenda allowing the European life sciences sector to remain competetive on a global scale.

Meeting with Juho Romakkaniemi (Cabinet of Vice-President Jyrki Katainen)

19 Mar 2015 · New Commission, Investment plan, TTIP

Meeting with Clara Martinez Alberola (Cabinet of President Jean-Claude Juncker)

19 Feb 2015 · Exchange of views in the perspective to present of Health & Growth and to discuss ERA, medicine development and its access for the patient

Meeting with Rolf Carsten Bermig (Cabinet of Commissioner Elżbieta Bieńkowska)

21 Jan 2015 · A reflection on how Europe can move towards the development of a genuine European Research Area, benefiting from closer cooperation between the private and the academic and public sectors and better exploit the links between fundamental and translational research.