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Fresenius SE & Co.KGaA

FSE

Fresenius SE & Co.

Lobbying Activity

Meeting with Veronica Manfredi (Director Environment)

12 Nov 2025 · Meeting with Fresenius on the recast Urban Wastewater Treatment Directive (UWWTD)

Meeting with Veronica Manfredi (Director Environment)

12 Nov 2025 · Meeting with Fresenius on the recast Urban Wastewater Treatment Directive

Meeting with Estelle Goeger (Cabinet of Executive Vice-President Stéphane Séjourné) and Bundesverband der Deutschen Industrie e.V. and

4 Nov 2025 · Overview of the Commission's Single Market Strategy.

Response to General revision of the General Block Exemption Regulation

6 Oct 2025

As a globally operating healthcare group with a strong European footprint, Fresenius is closely engaged in ensuring the reliable supply of essential medicines in Europe and internationally. Fresenius Kabi, as part of the Fresenius Group, manufactures essential generic medicines for critically and chronically ill patients and operates an extensive production network across 10 EU Member States, employing more than 15,000 people. Given our role in the European and global supply of critical medicines, the regulatory framework for State aid is highly relevant to our operations. We therefore welcome the opportunity to provide feedback to the European Commission on the revision of the General Block Exemption Regulation (GBER) and its implications for the production of critical medicines in the EU. The European Commission has recently published a proposal for a Critical Medicines Act (CMA) as well as guidance on the application of State aid rules to critical medicines. From Fresenius Kabis perspective, this guidance does not sufficiently address the specific challenges faced by manufacturers of off-patent medicines under the current State aid framework. Instead, it merely outlines how existing aid instruments could be applied for CMA purposes. As a result, the State aid framework still falls short of creating a simpler and unified system that enables Member States to provide targeted support for the (improved or increased) manufacturing of critical medicines within the European Union. We believe that introducing a new exemption category under the General Block Exemption Regulation (GBER) for aid granted to producers of critical medicines would be instrumental in achieving the CMAs objectives of addressing supply chain vulnerabilities and supporting the security of supply and availability of critical medicines. The GBER should evolve to reflect new EU policy priorities. The Commissions proposal clearly recognizes pharmaceuticals as a strategic sector and the security of supply and availability of critical medicines as a strategic EU objective. The GBER already includes exemptions for other key EU objectives, such as the green transition: In 2023, the GBER was amended, alongside the Temporary Framework, to simplify and accelerate aid for sectors aligned with the Green Deal Industrial Plan. These changes facilitated state aid support for sectors vital to the EUs green and digital transitions. A targeted GBER amendment for critical medicines would similarly facilitate, simplify, and speed up the granting of aid in a sector essential to public health and strategic autonomy. The market for critical medicines is characterized by persistent structural failures that hinder sufficient investment in production capacity and supply resilience. Over the past decades, substantial parts of the critical medicines value chainparticularly for generic medicineshave been relocated outside the European Union. Investment location decisions in our sector are primarily driven by cost considerations, and companies do not internalize the significant externalities associated with supply security. Off-patent medicine manufacturers face ongoing pricing pressure due to lowest-price-focused pricing and reimbursement as well as public procurement policies. Additionally, high environmental standards and administrative burdens in Europe further squeeze already thin margins. Considering that labor, production, and regulatory costs for medicines are much lower outside Europe, the EU is likely to continue losing molecules, especially for critical medicines that are essential for achieving open strategic autonomy. An amendment of the GBER is necessary to achieve the aims of the CMA, as current state aid frameworks are not suitable to support the production of off-patent medicines, which account for 9 out of 10 critical medicines. Most tools require first-of-a-kind innovation, but innovative product
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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)

3 Jul 2025 · Exchange of views on the upcoming Biotech Act

Meeting with Pietro Fiocchi (Member of the European Parliament)

26 Jun 2025 · Tematiche ambientali

Meeting with Jan Ceyssens (Cabinet of Commissioner Jessika Roswall)

22 May 2025 · Discussions on Urban Wastewater Treatment Directive (UWWTD)

Response to EU Strategy on medical countermeasures

9 May 2025

Fresenius Group welcomes the opportunity to provide feedback on the European Commissions Strategy to support medical countermeasures (MCMs) against public health threats. The Commissions commitment to strengthening Europes resilience through coordinated preparedness mechanisms is appreciated. Better anticipation, planning, and solidarity among Member States are critical to enhancing Europes security of supply. The off-patent pharmaceutical sector emphasizes the importance of a resilient, competitive, and agile environment for the development, manufacturing, and supply of MCMs. Given the essential role of off-patent medicines in public health preparedness, it is essential to strengthen a sustainable, autonomys market for European manufacturers. We urge the Strategy to acknowledge and include the following considerations: 1) Importance of Off-Patent Medicines: Off-patent medicines, including antibiotics and injectable anesthetics, are crucial for public health preparedness. These medicines are often subject to regulated pricing and tender-based markets. These tendering processes cannot be driven by the price only; they must include the European source of the medicine in a sustainable ratio to receive a sustainable market, which ensures the supply of medicines for patients. 2) Stockpiling and Supply Security: Ensure national stockpiling mandates are consistent with the internal market and notified under relevant EU procedures. Focus stockpiling efforts on medicines with verified supply vulnerabilities to prevent widespread disruptions. Develop an EU-wide impact assessment framework to evaluate the consequences of national stockpiling measures on regional supply. 3) Procurement: Prioritize supply security in tender design by incorporating mandatory MEAT (Most Economically Advantageous Tender) criteria and dividing tenders among multiple suppliers. We advocate for a European premium price that covers higher production costs, because of manufacturing quality, environmental, and working standards. Ensure joint procurement tools focus on small volume medicines with actual market constraints and introduce regulatory flexibilities. Avoid overlaps with ongoing national procurement processes and honor existing commercial obligations. 4) Regulatory Processes: Simplify and shorten approval and variation processes, ensuring submission predictability. Move towards broader adoption of multi-country packs and labeling harmonization. Transition to electronic product information (ePI) to ensure real-time updates and support the digital transition in healthcare. It also must be considered that regulatory processes are less cost-intensive outside of the EU. 5) Financial Allocation: Foresee dedicated budget supporting off-patent innovation and investments in manufacturing and supply chain resilience under the current and forthcoming Multiannual Financial Framework. Promotion of EU-based manufacturing is a solution to mitigate the risk associated with global supply chain disruption, which leads to the risk of not reacting to crises in time. 6) Alignment with existing and forthcoming initiatives: Ensure legal clarity and consistency by aligning this strategy with existing and upcoming legislative and non-legislative inistiatives.
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Meeting with Angelika Niebler (Member of the European Parliament)

7 May 2025 · EU Health Care Policies

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

29 Apr 2025 · Biotech Act, medicines shortages

Meeting with Stine Bosse (Member of the European Parliament)

27 Mar 2025 · European health policy

Meeting with Eero Heinäluoma (Member of the European Parliament, Shadow rapporteur) and EuropaBio

27 Mar 2025 · Biotech and Biomanufacturing

Response to Evaluation of the Public Procurement Directives

6 Mar 2025

Fresenius Group welcomes the opportunity to contribute to this call for evidence, as the revision of the Public Procurement Directive 2014/24/EU (PPD) provides a framework for the public procurement of medicines (PPM). We are operating in a highly regulated pricing framework, which does not allow for the adjustment of prices to increasing costs (e.g. energy, transport inflation). Moreover, single-winner, price-only tenders exacerbate market consolidation, particularly for EU Critical Medicines (9/10 generics). The Public Procurement Directive should make the application of MEAT award criteria mandatory in PPM tender design to boost competition in the off-patent sector. Currently, up to 84% of awarded pharmaceutical contracts are based solely on price, according to the Commission study on best practices in PPM. Tendering processes can not be driven by price only: it must include the European source of the medicine in a sustainable ratio. Mandatory parts of MEAT criteria should be supply chain resilience, sustainability, and reliability. Investing in manufacturing in Europe strengthens the supply reliability of critical medicines in Europe. Also, we are creating skilled and high value jobs in the European economy. There is a positive impact on environmental aspects as strict environmental production rules and a reduced carbon footprint associated with long-distance transportation. These efforts must be rewarded in tendering processes and must result in an EU premium price. Although environmental criteria are not yet widely used, some countries, such as Denmark and France have experience and could be used as a best practice. To ensure supply security and prevent the consolidation of manufacturing and supply chains, the PPD should mandate the awarding of contracts to multiple suppliers in the case of PPM. In most countries, contracts are typically granted to a single winner, a practice that renders supply security highly vulnerable to potential disruptions experienced by the sole manufacturer. Furthermore, this approach disincentivizes other suppliers to staying active in the market and step in to address potential medicine shortages. To ensure a smooth roll-out, the exemptions to this rule should be foreseen, taking into account suppliers' ability to deliver, as there may be cases where only one active supplier is present. To maximise participation in PPM tenders and secure viable bids from the off-patent industry, it is crucial to enhance demand predictability and foreseeability in tender design. This requires a lead time of at least six months from contract signature to the first supply date, along with accurate volume estimates and a binding purchase obligation. Disproportionate penalties should be scrutinized and excluded from the bidding process. In addition, the PPD should allow for inflation price adjustment to balance price with supply security. Finally, termination reasons and notice periods should be properly regulated to prevent speculative behavior by either party, which could subsequently disrupt the supply chain or continuity of treatment. While Article 69 of the PPD requires authorities to investigate abnormally low bids, the enforcement and execution of this provision is vague and subject to national implementation. To strengthen fair competition, the provision on investigation should be reinforced, the PPD should establish indicative criteria, on the basis of which contracting authorities assess the price/performance ratio of potential abnormally low bids, including prior tendering experience.
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Meeting with Oliver Schenk (Member of the European Parliament)

24 Jan 2025 · Wettbewerbsfähigkeit der europäischen Pharma-Industrie

Meeting with Oliver Schenk (Member of the European Parliament)

17 Sept 2024 · UWWTD

Meeting with Michael Hager (Cabinet of Executive Vice-President Valdis Dombrovskis)

5 Mar 2024 · Strengthen Europe's critical sectors

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

22 Feb 2024 · 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

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

Meeting with Tiemo Wölken (Member of the European Parliament)

4 Apr 2023 · EU-Health Policy with a focus on AMR (staff level)

Meeting with Sara Cerdas (Member of the European Parliament)

7 Nov 2022 · Legislação farmacêutica

Meeting with Esther De Lange (Member of the European Parliament)

23 Aug 2022 · Pharmaceutical Strategy - APA