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CSL Behring

CSL Behring is a global biotherapeutics leader specializing in plasma-derived and recombinant protein therapies.

Lobbying Activity

Meeting with Seán Kelly (Member of the European Parliament, Delegation chair)

20 Nov 2025 · Discussing opportunities for co=operation and investment between Australian and European pharmaceutical firms

Meeting with Marion Walsmann (Member of the European Parliament, Rapporteur for opinion)

3 Sept 2025 · CMA

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

17 Jul 2025 · Critical Medicines Act

Meeting with Andreas Glück (Member of the European Parliament, Shadow rapporteur for opinion) and AstraZeneca PLC

15 Jul 2025 · CMA

Meeting with András Tivadar Kulja (Member of the European Parliament, Shadow rapporteur for opinion)

3 Jul 2025 · Critical medicines act

Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

25 Jun 2025 · Roundtable Critical Medicines Act

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

5 Jun 2025 · to follow

Meeting with Patricia Reilly (Cabinet of President Ursula von der Leyen)

5 Jun 2025 · Current policy challenges and opportunities

Meeting with Oliver Schenk (Member of the European Parliament, Rapporteur for opinion)

19 May 2025 · Critical Medicines Act

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

14 May 2025 · Health policy

Meeting with Andreas Glück (Member of the European Parliament, Shadow rapporteur for opinion)

12 May 2025 · Critical Medicines

Response to Communication on the EU Stockpiling Strategy

9 May 2025

CSL Behring, a member of the Critical Medicines Alliance, welcomes the opportunity to provide feedback on the EU stockpiling strategy. We are a leading global biotechnology company specializing in the manufacturing of plasma-derived therapies (PDMPs) and other medicines for the treatment of rare and serious diseases in areas like hematology or immunology. More than 300,000 patients in the EU rely on PDMPs, which, in certain cases, represent their only available treatment option. The inclusion of most PDMPs in the EMA List of Critical Medicines underscores the essential nature of these therapies. With growing patient needs, ensuring a reliable and uninterrupted supply of PDMPs is more important than ever. We welcome the European Commissions efforts under the Critical Medicines Act (CMA) to ensure that contingency stocks requirements in one Member State do not have a negative impact on the security of supply in other Member States. We understand the distinction of the EU stockpiling strategy, which refers to stockpiling by a (public) health institution to anticipate and manage specific risks. Considering that the measures proposed under the EU stockpiling strategy, the strategy on medical countermeasures and the CMA are complementary, CSL would like to restate its recommendations for a comprehensive, balanced, proportionate, flexible, predictable, coordinated and effective approach towards stockpiling of medicines. An additional legislative piece in this interplay is the pharma package regulation, which enables the Commission to adopt implementing acts to improve the security of supply, including EU-wide contingency stocks. In recent years, Member States have increasingly introduced national stockpiling requirements for critical medicines, including PDMPs. However, coordinated action at the EU level has yet to materialize. Disproportionate and uncoordinated national stockpiling measuresoften implemented without corresponding market demandrisk creating unintended negative consequences for both patients and manufacturers. Moreover, excessive stockpiling obligations are undermining the economic viability of these essential products and eroding the competitiveness of EU countries in this field. In a recital of the CMA, the European Commission has announced forthcoming Commission guidelines on Member States requirements for contingency company stocks. Action to address this is welcome, however purely non-binding guidance might have limited impact. We therefore call for mandatory or strongly coordinated approaches to establish common principles for contingency stock requirements, through the CMA and other EU initiatives. In that regard, we recommend the following measures to establish an agile and flexible regulatory framework and a coordinated approach: Maximum thresholds for national stockpiling should be duly endorsed by national authorities. Requirements must be deemed necessary, duly justified, and proportionate to their intended purpose. Stockpiling requirements should be calculated based on past and future demand information, such as individually awarded tenders or contracted sales, rather than total historical sales. Volumes and duration of obligations should be determined in consultation with marketing authorization holders and healthcare professionals. Obligations for critical medicines should be time-limited and subject to regular reassessment. Obligations must be proportional to a suppliers actual supply commitments. Union-level contingency stocks shall supersede national requirements. The European Commission should play a monitoring role and implement certain guardrails against overly extensive requirements. To support the effective implementation of coordinated contingency stock measures, the European Commission should support and enhance flexibility and agility in distribution of critical medicines. Labelling and packaging flexibilities for critical medicines may be a favorable measure.
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Meeting with Oliver Schenk (Member of the European Parliament)

29 Apr 2025 · Pharmaceutical Industry in the EU

CSL Behring urges predictable frameworks to boost European biotech innovation

17 Apr 2025
Topic — This consultation develops a strategy to improve the competitiveness of European life sciences.
Message — CSL Behring calls for predictable frameworks that reward innovation and improve clinical trials. They suggest outcomes-based contracting models and better use of health data. They also recommend targeted revisions to the Clinical Trials Regulation to speed up approvals.123
Why — Simpler rules and tax breaks would reduce compliance costs and market barriers.4
Impact — National health systems lose the power to implement mandatory price-control measures.5
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Meeting with Michalis Hadjipantela (Member of the European Parliament)

8 Apr 2025 · Introductory Meeting - Rare Diseases

Meeting with Elena Nevado Del Campo (Member of the European Parliament)

7 Apr 2025 · Health priorities

Meeting with Aurelijus Veryga (Member of the European Parliament)

26 Mar 2025 · Critical Medicines Act and Availability of Essential Medicines in the EU

Meeting with Stine Bosse (Member of the European Parliament)

10 Mar 2025 · European health policy

CSL Behring calls for mandatory quality criteria in medicine tenders

4 Mar 2025
Topic — The European Commission is evaluating the effectiveness of public procurement rules for various sectors.
Message — The EU should mandate specific tender criteria and weight ranges that reward supply reliability and product innovation. Authorities must move away from single-winner, price-only contracts toward multi-winner models involving clinical staff. Tenders should also adjust pricing for inflation and maintain confidentiality of unit prices.123
Why — The company would avoid price erosion and protect its margins against inflation and low-cost competitors.45
Impact — Public health payers may face higher procurement costs if cheaper single-winner contracts are prohibited.67
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CSL Behring Urges EU to Bolster Plasma Supply Chains

26 Feb 2025
Topic — EU initiative addressing supply vulnerabilities and reducing dependencies for critical medicines.
Message — The organization calls for increased plasma collection within Europe and a network of trusted partner countries. They propose mandatory tender criteria to reward supply reliability and urge a reconsideration of pricing policies. They also advocate for flexible, interconnected stockpiles instead of uncoordinated national requirements.123
Why — Reforming pricing and tender rules would improve the company's profitability and market stability.45
Impact — National health budgets may face higher costs if price containment policies are relaxed.6
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Meeting with Stine Bosse (Member of the European Parliament)

14 Feb 2025 · European health policy

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament) and European Alliance for Cardiovascular Health

18 Nov 2024 · EU health policy

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

CSL Behring warns new pharma rules threaten European innovation

4 Nov 2023
Topic — The EU is revising pharmaceutical legislation to ensure medicine accessibility and innovation.
Message — CSL Behring opposes linking market exclusivity incentives to mandatory product launches in all member states. They advocate for a broader definition of medical needs and urgent policies to increase plasma collection.12
Why — Maintaining current data protection periods would protect their market position and profits.3
Impact — Patients in smaller markets may face delays if launch requirements are scrapped.4
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CSL Behring Urges Faster EU Medicine Variation Rules

26 Sept 2023
Topic — The European Commission is updating the rules for post-authorisation changes to medicines.
Message — CSL Behring supports simplified procedures and removing administrative complexity for biological medicines. They advocate for risk-based principles across all products and a streamlined plasma master file process.123
Why — Updated rules would allow the company to manage product changes more efficiently.45
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Meeting with István Ujhelyi (Member of the European Parliament)

26 Jan 2023 · SOHO

Meeting with Tomislav Sokol (Member of the European Parliament, Rapporteur)

12 Jan 2023 · European Health Data Space - EHDS

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

12 Jan 2023 · discussion on SoHO regulation

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

10 Jan 2023 · SoHO