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Bayer AG

Bayer AG is a global life science company with core businesses in healthcare and agriculture.

Lobbying Activity

Meeting with Norbert Lins (Member of the European Parliament)

2 Dec 2025 · Triolog NGTs

Meeting with Olivér Várhelyi (Commissioner) and

1 Dec 2025 · Digital and AI as an enabler in healthcare

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.

Meeting with Susana Solís Pérez (Member of the European Parliament)

30 Oct 2025 · Bayer's activities in the iberian peninsula and europe

Meeting with Dorota Denning (Cabinet of Commissioner Valdis Dombrovskis) and European farmers and

28 Oct 2025 · Roundtable on Simplification for Agricultural Innovation

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

28 Oct 2025 · Roundtable on Simplification for Pharmaceutical Innovation

Meeting with Liesbet Sommen (Member of the European Parliament) and Novartis International AG and

23 Oct 2025 · Pharmaceutical legislation + Critical Medicines Act

Meeting with Hildegard Bentele (Member of the European Parliament)

17 Oct 2025 · Biotech Act

Meeting with Jan Hendrik Dopheide (Cabinet of Commissioner Maroš Šefčovič)

15 Oct 2025 · EU-UK relations

Bayer urges EU to speed up pesticide approvals and protect conventional chemicals

14 Oct 2025
Topic — EU consultation on simplifying food and feed safety regulations and plant protection product authorizations.
Message — Bayer requests the EU reform hazard-based cut-off criteria that automatically ban substances, modernize endocrine disruptor assessments, and streamline authorization processes for both conventional and biological pesticides. They want emergency authorizations extended beyond 120 days and converted to standard approvals when repeatedly needed.1234
Why — This would protect Bayer's existing chemical products from withdrawal and reduce approval costs and delays.567
Impact — Environmental and consumer groups lose stronger protections against endocrine disruptors and hazardous chemicals.8
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Bayer urges AI research exemption and data simplification

14 Oct 2025
Topic — Digital Omnibus revising EU rules on AI, data protection, and cybersecurity.
Message — Bayer requests clarification that AI used across the medicine lifecycle qualifies under the Article 2(6) research exemption. They want harmonized data protection rules aligned with GDPR and a one-stop-shop for cyber incident reporting. They seek EU-managed AI cloud infrastructure and increased funding for public-private partnerships in health and agriculture.1234
Why — This would reduce compliance burden and allow faster AI deployment in drug development.56
Impact — Consumer and patient groups lose stronger AI safety oversight and transparency protections.
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Meeting with Alexandra Hild (Cabinet of Commissioner Ekaterina Zaharieva), Andreas Schwarz (Cabinet of Commissioner Ekaterina Zaharieva) and

9 Oct 2025 · Startup and Scaleup Strategy; Scaleup Europe Fund

Meeting with Rainer Becker (Director Health and Food Safety)

9 Oct 2025 · Bilateral meeting in the margins of the Copenhagen Life Science Summit

Meeting with Irene Sacristan Sanchez (Head of Unit Health and Food Safety) and Euroseeds and

9 Oct 2025 · Exchange of views on the state of play of the interinstitutional negotiations on the Commission proposal for a Regulation on plants obtained by certain new genomic techniques (NGT proposal)

Meeting with Martin Seychell (Deputy Director-General Directorate-General for International Partnerships)

9 Oct 2025 · Bayer strategic approach for the African market

Meeting with Esther Herranz García (Member of the European Parliament)

8 Oct 2025 · NGTs

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

8 Oct 2025 · Medicine market

Meeting with Veronika Vrecionová (Member of the European Parliament, Committee chair)

8 Oct 2025 · Gene editing and innovation in agriculture

Meeting with Valérie Hayer (Member of the European Parliament)

8 Oct 2025 · NGTs

Meeting with Norbert Lins (Member of the European Parliament)

8 Oct 2025 · NGTs

Meeting with Andreas Glück (Member of the European Parliament)

7 Oct 2025 · NGTs

Meeting with Hildegard Bentele (Member of the European Parliament)

7 Oct 2025 · Biotech and Water

Meeting with Pietro Fiocchi (Member of the European Parliament, Shadow rapporteur)

7 Oct 2025 · NGT

Meeting with Oliver Schenk (Member of the European Parliament)

7 Oct 2025 · Pharmaceutical Industry in the EU

Meeting with Jan-Christoph Oetjen (Member of the European Parliament)

7 Oct 2025 · Exchange on agriculture sector and new innovations

Bayer demands innovation stress test to accelerate EU approvals

3 Oct 2025
Topic — EU framework to remove barriers for innovative companies and attract investors.
Message — Bayer requests an Innovation Stress Test to ensure regulations enable rather than constrain R&D. They want EU-level regulatory sandboxes, faster permitting processes, and streamlined financing access. The company seeks targeted support for innovation hubs and sector-specific investment incentives.123
Why — This would reduce regulatory burdens and speed market entry where approvals are significantly faster globally.45
Impact — Consumer and environmental groups lose stronger oversight of agricultural and pharmaceutical products.67
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Meeting with Olga Solomon (Head of Unit Health and Food Safety) and European Federation of Pharmaceutical Industries and Associations and

3 Oct 2025 · The discussion focused on simplifying Annex II to foster innovation while aligning with ICH guidelines, with ideas for legacy products to gradually transition.

Bayer urges EU to align nature credits with carbon farming framework

26 Sept 2025
Topic — EU roadmap for establishing a voluntary nature credit certification system.
Message — Bayer requests integration of nature credits into existing frameworks like the Carbon Removal Certification Framework and the planned agricultural sustainability compass. They advocate for outcome-based certification covering multiple nature outcomes including endangered species, habitats, and ecosystem services, with flexibility through different credit types and quality tiers.123
Why — This would create business opportunities for their carbon and regenerative agricultural services division.45
Impact — Environmental groups lose if nature credits allow offsetting rather than requiring direct biodiversity improvements.6
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Meeting with Elisabeth Werner (Director-General Agriculture and Rural Development)

12 Sept 2025 · Exchange of views on the ongoing simplification efforts, legislative proposals related to the company’s activities, innovation and resilience

Meeting with Flavio Facioni (Cabinet of Commissioner Olivér Várhelyi)

11 Sept 2025 · Simplification and competitiveness in the agri-food sector

Bayer urges outcome-based farm policy to boost climate resilience

2 Sept 2025
Topic — EU regulation establishing framework for climate preparedness, resilience and risk management.
Message — Bayer requests transition to an outcome-based agricultural policy framework that is inclusive of all tools and practices. They seek simplification of existing regulations to improve access to plant breeding innovation, pesticides, and digital agriculture. They emphasize the need for open trade to ensure resilient agricultural supply chains.1234
Why — This would give farmers access to all crop protection tools and maintain market competitiveness.56
Impact — Environmental groups lose stricter controls on pesticide hazards and GM crops.78
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Meeting with Henna Virkkunen (Executive Vice-President) and

29 Aug 2025 · Competitiveness of European pharma industry

Bayer urges EU to prioritize menopause in gender equality strategy

11 Aug 2025
Topic — EU consultation on its next five-year Gender Equality Strategy 2026-2030.
Message — Bayer calls for menopause to be embedded as a core pillar in the strategy, with investments in research, education, and awareness campaigns. The company seeks harmonized policies ensuring equitable access to both hormonal and innovative non-hormonal therapies across Member States. They recommend workplace inclusion measures and expanded data collection on menopause's socioeconomic impacts.1234
Why — This would expand the market for Bayer's menopause therapies across Europe.567
Impact — National health budgets face increased costs from expanded treatment coverage and research.89
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Meeting with Maroš Šefčovič (Commissioner) and

11 Jul 2025 · Implementation dialogue on customs legislation - Rules of origin

Meeting with Chiara Galiffa (Cabinet of Commissioner Maroš Šefčovič)

11 Jul 2025 · EU-US relations

Bayer urges bioeconomy targets and regulatory reform for agricultural innovation

20 Jun 2025
Topic — EU strategy for circular, regenerative and competitive bioeconomy across sectors.
Message — Bayer requests outcome-based sustainability criteria for biomass, compliance targets for biobased resources across sectors, and regulatory reform enabling access to plant breeding innovation, pesticides, and digital tools. They advocate transitioning from hazard-based to risk-based pesticide regulation and excluding certain genomic techniques from GMO restrictions.12345
Why — This would reduce regulatory burden on their agricultural products and expand markets for seeds and pesticides.678
Impact — Environmental and health advocates lose stronger hazard-based protections against pesticide risks and GMO safeguards.9
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Meeting with Daniel Freund (Member of the European Parliament) and Currenta GmbH & Co. OHG

13 Jun 2025 · Austausch

Meeting with Astrid Dentler (Cabinet of Commissioner Wopke Hoekstra), Miguel Jose Garcia Jones (Cabinet of Commissioner Wopke Hoekstra)

12 Jun 2025 · Discussion on sustainable competitiveness.

Bayer urges EU Biotech Act to simplify agricultural regulations

11 Jun 2025
Topic — The Commission is seeking feedback on creating an enabling environment for biotechnology innovation.
Message — Bayer requests that agricultural biotechnology be included in the new Act's scope. They advocate for simplified approval processes and stronger intellectual property protections for research.12
Why — Faster market access and stronger patent protections would safeguard Bayer's high-cost research investments.34
Impact — Groups advocating for the precautionary principle lose regular safety reviews for bio-engineered products.5
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Meeting with Stéphane Séjourné (Executive Vice-President) and

11 Jun 2025 · An exchange on Europe’s pharmaceutical & life sciences sectors

Meeting with Michael Hager (Cabinet of Commissioner Valdis Dombrovskis)

10 Jun 2025 · Simplification

Bayer urges AI research exemption for pharmaceutical development

5 Jun 2025
Topic — European strategy for AI adoption in science and research council establishment.
Message — Bayer requests exemption of AI systems used solely for medicines R&D from EU AI Act requirements. They advocate for clearer guidelines on the R&D exemption and simplification of overlapping regulatory frameworks across GDPR, Data Act, and AI Act. The company seeks harmonized regulations across jurisdictions and regulatory oversight centralized within EMA.123
Why — This would reduce compliance burdens and allow faster AI experimentation in drug development.45
Impact — European patients lose access as systems launch overseas due to complex EU requirements.6
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Bayer calls for simplified AI regulation to accelerate drug discovery

4 Jun 2025
Topic — EU strategy for AI adoption across strategic sectors including healthcare.
Message — Bayer requests simplified AI regulation with clear guidance on responsible healthcare AI use. They want expanded regulatory sandboxes for biopharma testing and continued public-private collaboration funding. The company emphasizes flexible technology standards focused on outcomes rather than rigid requirements.123
Why — This would reduce regulatory complexity and accelerate their AI-driven drug development.45
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Meeting with Angelika Niebler (Member of the European Parliament)

3 Jun 2025 · EU’s General Pharmaceutical Legislation

Meeting with Cynthia Ní Mhurchú (Member of the European Parliament)

3 Jun 2025 · Menopause Matters: Investing in Women's Health for the Future

Meeting with Svenja Hahn (Member of the European Parliament)

20 May 2025 · Introductory Meeting

Meeting with Veronika Vrecionová (Member of the European Parliament, Committee chair)

15 May 2025 · NGTs

Meeting with Antonella Rossetti (Cabinet of Commissioner Christophe Hansen), Taru Haapaniemi (Cabinet of Commissioner Christophe Hansen)

14 May 2025 · Opportunities for simplification to strengthen competitiveness of European farming; The future of plant biotechnology as a basis for strengthening bioeconomy in Europe; Digital tools and use of AI in farming systems

Meeting with Silvia Bartolini (Cabinet of Executive Vice-President Henna Virkkunen)

29 Apr 2025 · AI

Bayer calls for regulatory simplification and a Life Sciences Office

16 Apr 2025
Topic — The consultation aims to boost EU life sciences competitiveness and reduce global dependencies.
Message — Bayer proposes establishing a dedicated EU Life Sciences Office to coordinate policy and ensure legislative coherence. They advocate for a Biotech Act that acts as a simplification catalyst for approvals and strengthens intellectual property protections.123
Why — These changes would accelerate market entry for innovations and protect high-risk research investments.45
Impact — Environmental groups may lose stringent hazard-based protections against chemical and biotechnology risks.67
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Meeting with Oihane Agirregoitia Martínez (Member of the European Parliament)

8 Apr 2025 · Biotecnología y la competitividad industrial

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 Felix Fernandez-Shaw (Director Directorate-General for International Partnerships) and

1 Apr 2025 · Plenary Feedback round on previously held GGIA Working Group sessions of 9 different thematical groups regarding Latin America and the Caribbean (LAC).

Meeting with Alexander Bernhuber (Member of the European Parliament)

1 Apr 2025 · Pflanzenschutzmittel

Meeting with Pietro Fiocchi (Member of the European Parliament)

26 Mar 2025 · Strategia farmaceutica europea

Meeting with Oliver Schenk (Member of the European Parliament)

26 Mar 2025 · Pharmaceutical Industry in the EU

Meeting with Elsi Katainen (Member of the European Parliament)

26 Mar 2025 · Topical issues in the pharmaceutical sector

Meeting with Marta Temido (Member of the European Parliament)

26 Mar 2025 · Sector farmaceutico, e politíca industrial no contexto europeu

Meeting with Alice Teodorescu Måwe (Member of the European Parliament)

26 Mar 2025 · Pharmaceuticals

Meeting with Dimitris Tsiodras (Member of the European Parliament)

26 Mar 2025 · EU health and research policies

Meeting with Sunčana Glavak (Member of the European Parliament)

26 Mar 2025 · European industrial policy

Meeting with Susana Solís Pérez (Member of the European Parliament)

26 Mar 2025 · European industrial regulation

Meeting with Veronika Cifrová Ostrihoňová (Member of the European Parliament)

26 Mar 2025 · Women's health and medicine shortages in the EU

Meeting with Elena Sancho Murillo (Member of the European Parliament)

26 Mar 2025 · Relevant issues to the AGRI Committee

Meeting with Morten Løkkegaard (Member of the European Parliament, Shadow rapporteur)

26 Mar 2025 · Biotechnology & Simplification

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

26 Mar 2025 · Bioteknologia ja teollisuuden kilpailukyky

Meeting with Stefan Berger (Member of the European Parliament)

25 Mar 2025 · Biotechnology

Meeting with Irene Sacristan Sanchez (Head of Unit Health and Food Safety) and Euroseeds and

25 Mar 2025 · Policy developments relevant to European seed sector (proposal on plants obtained by certain new genomic techniques, NGTs)

Meeting with Maria Walsh (Member of the European Parliament)

25 Mar 2025 · Agricultural policy

Bayer seeks regulatory relief for medical devices in drug trials

20 Mar 2025
Topic — Evaluation of EU regulations on medical devices and in vitro diagnostics.
Message — Bayer requests exemptions from distributor verification requirements for medical devices co-packaged with medicines, clarification that repackaging such devices doesn't trigger manufacturer obligations, and allowance for in-house diagnostic testing outside the EU for clinical trials. They seek to remove notification requirements when using leftover samples in performance studies already approved through CTIS.123
Why — This would reduce handling costs and delays in the supply chain for combination products.45
Impact — Patient safety oversight loses additional verification checkpoints in the distribution chain.6
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Meeting with Vita Jukne (Cabinet of Commissioner Jessika Roswall)

20 Mar 2025 · Chemicals legislation

Meeting with Olivér Várhelyi (Commissioner) and

19 Mar 2025 · EU health policy

Meeting with Sabine Weyand (Director-General Trade)

19 Mar 2025 · Global trade developments, state of play and next steps.

Bayer Seeks Stronger Plant Variety Rights and Farm Seed Restrictions

14 Mar 2025
Topic — Evaluation of EU regulation on intellectual property rights for plant varieties.
Message — Bayer requests stronger protections for essentially-derived varieties aligned with UPOV guidance, rebalancing of farm-saved seed compensation where usage reaches 50% of planted areas, and expansion of distinctness criteria to include disease resistance and nutritional traits developed through new genomic techniques.123
Why — This would protect their breeding investments and enable royalties from NGT innovations currently unprotectable.45
Impact — Farmers lose affordable seed reuse rights as compensation costs could rise significantly.6
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Meeting with Ana Vasconcelos (Member of the European Parliament)

13 Mar 2025 · NGTs

Meeting with Asger Christensen (Member of the European Parliament)

12 Mar 2025 · NGT

Meeting with Cecile Billaux (Head of Unit Directorate-General for International Partnerships)

28 Feb 2025 · Overview of Bayer’s international and EU initiatives and presentation of DG INTPA activity on health in the international dimension

Bayer Urges Thorough Impact Assessment Before Critical Medicines Act

27 Feb 2025
Topic — EU legislation to address supply chain vulnerabilities and shortages of critical medicines.
Message — Bayer requests a thorough impact assessment before publication and streamlined administrative requirements. They want the Act to avoid duplication between national and EU systems. Any incentives for EU manufacturing should consider existing regulations and prioritize existing facilities with competitive advantages.1234
Why — This would reduce administrative costs and protect existing European manufacturing investments.56
Impact — Generic medicine suppliers face stricter requirements while innovative medicines experience fewer disruptions.7
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Meeting with Olivér Várhelyi (Commissioner) and

26 Feb 2025 · Healthcare, biotech and agri-food policies

Meeting with Maroš Šefčovič (Commissioner) and

15 Feb 2025 · Introductory meeting / trade policy with a focus on EU-US

Meeting with Gabriela Tschirkova (Cabinet of Commissioner Valdis Dombrovskis)

14 Feb 2025 · Simplification - agricolture, pharma, sustainability reporting, Taxonomy

Meeting with Wopke Hoekstra (Commissioner) and

14 Feb 2025 · Clean Industrial Deal

Meeting with Antonella Rossetti (Cabinet of Commissioner Christophe Hansen), Maxi Espeter (Cabinet of Commissioner Christophe Hansen)

13 Feb 2025 · Mutual introduction exchange on key policy priorities in the agricultural sector

Meeting with Flavio Facioni (Cabinet of Commissioner Olivér Várhelyi), Laszlo Andrejko (Cabinet of Commissioner Olivér Várhelyi)

5 Feb 2025 · EU health policy

Meeting with Gabriele Bischoff (Member of the European Parliament, Shadow rapporteur) and DHL Group and

24 Jan 2025 · Austausch mit dem Wirtschaftsforum der SPD e.V. zur Revision Eurobetriebsräte

Meeting with Peter Liese (Member of the European Parliament) and Pharma Deutschland e.V

12 Dec 2024 · Austausch

Meeting with Bernd Lange (Member of the European Parliament, Committee chair)

4 Dec 2024 · General Exchange of View

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

3 Dec 2024 · New EU Pharmaceutical Legislation

Meeting with Michael Hager (Cabinet of Commissioner Valdis Dombrovskis)

2 Dec 2024 · Simplification

Meeting with Andreas Glück (Member of the European Parliament) and Carl Zeiss AG

21 Nov 2024 · Environmental Policy

Meeting with Stefan Köhler (Member of the European Parliament) and BASF SE and AnimalhealthEurope

23 Oct 2024 · Politischer Austausch

Meeting with Michalis Hadjipantela (Member of the European Parliament) and TotalEnergies SE

22 Oct 2024 · Introductory Meeting

Meeting with Wouter Beke (Member of the European Parliament)

18 Oct 2024 · Sustainable competitiveness

Meeting with Katri Kulmuni (Member of the European Parliament) and Chemical Industry Federation of Finland (Kemianteollisuus ry) and Orion Corporation

16 Oct 2024 · Ajankohtaiset EU-lakihankkeet

Meeting with Martin Häusling (Member of the European Parliament)

16 Oct 2024 · Gespräch mit Vertreter*innen von Bayer zu Innovation, Nachhaltigkeit und Wirtschaftskraft

Response to Commission Roadmap to phase out animal testing

15 Oct 2024

The European Commissions roadmap to phase out animal testing in chemical safety assessments will outline milestones and specific actions to phase out animal testing in such assessments. This phase-out will impact the current safety testing paradigm for products developed by Bayer, including medicinal and crop protection chemicals. In principle, Bayer supports the roadmap to reduce reliance on animal testing in the chemicals industry and has also contributed to this topic together with our industry partners (please see positions of Cefic, EFPIA, and CropLife Europe). With this in mind, we would like to point out that safety and efficacy remain our primary concerns for every new product. Animal studies still play an important role in ensuring that the benefits of our products outweigh the risks to humans, animals, and the environment. More than 90 percent of the animal studies we conduct are legally required. But even when they are not, and rather justified by scientific reasons, we make sure that all our studies are ethically and scientifically justified. We take our responsibilities seriously towards the laboratory animals that are involved in developing them. Examples of the scientific value of current animal models can be found on our website (e.g., https://www.bayer.com/en/animal-studies/animal-studies-for-pharmaceuticals; https://www.bayer.com/en/animal-studies/animal-studies-for-crop-protection-products; https://www.bayer.com/en/animal-studies/animal-studies-our-responsibility). The 3Rs Reduce, Refine, Replace guide our research and development. The number of animals used in our studies has decreased significantly in the past years. In 2023, our scientists and our cooperation partners worldwide used laboratory animals as part of their research. 79.6 percent of all laboratory animals at Bayer are mice and rats. Fish make up 10.2 percent and birds 6.0 percent. Livestock animals make up 0.6 percent and based on specific regulatory studies 2.0 percent are frogs. For the latest facts and figures, please see: https://www.bayer.com/en/animal-studies/animal-studies-facts-and-figures. When animal testing is unavoidable, we carefully design our experiments. All studies are performed with the highest concern for the health and comfort of the animals in our care. An expert is always appointed to deal with animal welfare matters. In Germany, it is the Animal Welfare Officer who takes on this important responsibility. In recent years, alternative methods to replace and supplement animal studies have greatly improved. However, it is not yet possible in most cases to develop and test new medicinal or crop protection products for treatment of both humans and animals without any animal studies. It is the opinion of Bayer that chemical safety assessments should be based on the best available scientific methods. Today, these still include laboratory animal models. Replacement of in vivo models with alternative technologies should be dependent on two key milestones: 1) the emergence of relevant and reliable non-animal technologies and; 2) the timely acceptance of these methods by the relevant authorities and by society, as the basis for chemical safety decisions. While Bayer supports the replacement of animal tests where possible, they should be permitted as long as animal tests remain the best available scientific method for a specific safety assessment. This approach moves their position in the safety testing toolkit from a default method to an exceptional approach, when specifically justified.
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Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

15 Oct 2024 · EU health policy

Meeting with Peter Van Kemseke (Cabinet of President Ursula von der Leyen)

10 Oct 2024 · EB Summit

Meeting with Daniel Buda (Member of the European Parliament)

3 Oct 2024 · The strategic dialogue on the future of agriculture and the future vision on agriculture

Meeting with Dan-Ştefan Motreanu (Member of the European Parliament)

3 Oct 2024 · The strategic dialogue on the future of agriculture and the future vision on agriculture

Meeting with Jens Geier (Member of the European Parliament)

18 Sept 2024 · General Exchange on the new legislative term

Meeting with Stefan Köhler (Member of the European Parliament) and The European Association for the Promotion of Cogeneration and Wageningen University

18 Sept 2024 · Politischer Austausch

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

10 Sept 2024 · European Healthcare

Meeting with Norbert Lins (Member of the European Parliament)

24 Jul 2024 · Exchange on relevant topics for the new legislative period

Meeting with Alexander Bernhuber (Member of the European Parliament)

22 Jul 2024 · Outlook on priorities in COM AGRI and COM ENVI

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

2 Jul 2024 · sustainable agriculture/pesticides/NGTs

Meeting with Anna Cavazzini (Member of the European Parliament)

7 May 2024 · Nachhaltige Landwirtschaft

Meeting with Damian Boeselager (Member of the European Parliament)

6 May 2024 · EU Elections Event

Meeting with Alexandra Geese (Member of the European Parliament) and Covestro AG and LANXESS AG

9 Apr 2024 · European Elections

Meeting with Terry Reintke (Member of the European Parliament)

18 Mar 2024 · Green Deal, Industrial Policies

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and European Confederation of Pharmaceutical Entrepreneurs

7 Mar 2024 · Directive on Medicinal products for human use

Meeting with Dolors Montserrat (Member of the European Parliament)

6 Mar 2024 · Revision of the pharmaceutical legislation

Meeting with Sunčana Glavak (Member of the European Parliament)

29 Feb 2024 · Pharma package

Meeting with Mauri Pekkarinen (Member of the European Parliament)

28 Feb 2024 · Discussion on health care related issues

Meeting with Andreas Glück (Member of the European Parliament)

28 Feb 2024 · Pharma-Paket

Meeting with Jan-Christoph Oetjen (Member of the European Parliament)

28 Feb 2024 · Competitiveness of European Industry

Meeting with Anna Cavazzini (Member of the European Parliament, Committee chair) and Apple Inc. and

23 Feb 2024 · Aktuelle Themen in der Europapolitik und Sachsen

Meeting with Wopke Hoekstra (Commissioner)

17 Feb 2024 · Latest developments on EU climate policy

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion)

16 Feb 2024 · Pharmaceutical Package

Meeting with Peter Liese (Member of the European Parliament)

23 Jan 2024 · Austausch

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion)

17 Jan 2024 · Pharmaceutical Package (Regulation)

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 Izaskun Bilbao Barandica (Member of the European Parliament)

21 Nov 2023 · Acuerdo Mercosur

Meeting with Gabriel Mato (Member of the European Parliament)

21 Nov 2023 · Meeting about Mercosur

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

21 Nov 2023 · Medicines

Meeting with Asger Christensen (Member of the European Parliament, Shadow rapporteur for opinion)

16 Nov 2023 · Agriculture

Meeting with Martin Hojsík (Member of the European Parliament, Rapporteur) and European Environmental Bureau and

15 Nov 2023 · Soil Health Law

Meeting with Beatrice Covassi (Member of the European Parliament, Shadow rapporteur) and European Environmental Bureau and

15 Nov 2023 · Public Hearing - Soil Monitoring Law

Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion)

14 Nov 2023 · Pharmaceutical Package (Regulation)

Meeting with Andreas Glück (Member of the European Parliament)

13 Nov 2023 · Neue Züchtungsmethoden

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

10 Nov 2023 · Directive on Medicinal products for human use

Response to Evaluation and revision of the general pharmaceutical legislation

7 Nov 2023

Bayer is grateful for the opportunity to engage in the dialogue concerning the pharmaceutical legislation reform. Alongside our primary recommendations below, additional details can be found in the annex. Bayer has a 160-year legacy of European innovation and proudly maintains 11 Pharma R&D and production facilities throughout Europe. We share the goals of improving the availability and accessibility of medicines whilst fostering a competitive innovation landscape in Europe. Nevertheless, we hold serious reservations about certain provisions in the legislation that may expedite the erosion of the EU's innovative industry. This could discourage crucial investment in medicine R&D, jeopardise employment opportunities, stifle economic growth, and ultimately hinder patients' access to cutting-edge treatments. Reducing Regulatory Data Protection and Orphan Market Exclusivity, along with imposing inhibitory conditions for innovators, will exacerbate existing negative trends. This encompasses a 25% decline in European R&D investment and a reduction in Europe's global clinical trial share from 25% to 19%. These proposals run counter to the call by EU Heads of State in March 2023 to strengthen, rather than diminish, incentives for innovation to restore Europe's competitiveness and meet patient needs. To incentivise research addressing European patients' needs, it is crucial to define unmet medical need in a patient-centred, inclusive way. This approach will encourage advances in prevention, treatment, and care, ensuring no patient is left behind. We are deeply concerned that weakening the OME regime will impede this progress, undermining the European orphan drug ecosystem and future investments in rare disease research. In the case of paediatric medicines, the absence of a clear obligation framework in their development will hinder, rather than support, new advancements in paediatric medicines in Europe. Expanding the Bolar exemption beyond marketing approval poses a threat to the enforcement of valid IP rights, further jeopardising EU competitiveness. Timely generic competition already exists. This expansion undermines the integrity of the IP system relied upon by innovators for their substantial investment in researching and developing novel therapies in Europe for European patients. While Bayer places a strong emphasis on environmental sustainability and supports the appropriate deployment of ERAs, the option to refuse or restrict marketing authorisation solely on environmental grounds jeopardises the established authorisation system and could potentially delay or prevent patient access to life-saving medicines. Policy solutions for shortages should be proportionate to the risk, enhance cooperation, and leverage digital technologies. Developing prevention plans for all medicines without a risk-based approach would strain resources for both industry and regulators. Recognising the transformative potential of self-care through the reclassification of medicines from prescription to non-prescription status is imperative. To incentivise these switches, extending the data protection period from +1 to +3 years and the recognition of a broader range of generated evidence such as behavioural studies and RWE is crucial to benefit citizens, and for the sustainable use of healthcare resources. Regarding the prescription criteria for antimicrobials, we urge a case-by-case assessment. The newly proposed categorisation, including antifungals and antivirals, limits access to self-care for patients in the EU while not addressing AMR concerns, a consideration typically evaluated during the determination of the legal status of medicinal products. Bayer's vision is Health for all, Hunger for none. Building upon our European legacy, we remain committed to collaborating with all stakeholders in crafting solutions that bridge the innovation competitiveness gap with other regions. We wish to underscore our alignment with EFPIA and AESGP in this endeavour.
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Response to Evaluation and revision of the general pharmaceutical legislation

7 Nov 2023

Bayer is grateful for the opportunity to engage in the dialogue concerning the pharmaceutical legislation reform. Alongside our primary recommendations below, additional details can be found in the annex. Bayer has a 160-year legacy of European innovation and proudly maintains 11 Pharma R&D and production facilities throughout Europe. We share the goals of improving the availability and accessibility of medicines whilst fostering a competitive innovation landscape in Europe. Nevertheless, we hold serious reservations about certain provisions in the legislation that may expedite the erosion of the EU's innovative industry. This could discourage crucial investment in medicine R&D, jeopardise employment opportunities, stifle economic growth, and ultimately hinder patients' access to cutting-edge treatments. Reducing Regulatory Data Protection and Orphan Market Exclusivity, along with imposing inhibitory conditions for innovators, will exacerbate existing negative trends. This encompasses a 25% decline in European R&D investment and a reduction in Europe's global clinical trial share from 25% to 19%. These proposals run counter to the call by EU Heads of State in March 2023 to strengthen, rather than diminish, incentives for innovation to restore Europe's competitiveness and meet patient needs. To incentivise research addressing European patients' needs, it is crucial to define unmet medical need in a patient-centred, inclusive way. This approach will encourage advances in prevention, treatment, and care, ensuring no patient is left behind. We are deeply concerned that weakening the OME regime will impede this progress, undermining the European orphan drug ecosystem and future investments in rare disease research. In the case of paediatric medicines, the absence of a clear obligation framework in their development will hinder, rather than support, new advancements in paediatric medicines in Europe. Expanding the Bolar exemption beyond marketing approval poses a threat to the enforcement of valid IP rights, further jeopardising EU competitiveness. Timely generic competition already exists. This expansion undermines the integrity of the IP system relied upon by innovators for their substantial investment in researching and developing novel therapies in Europe for European patients. While Bayer places a strong emphasis on environmental sustainability and supports the appropriate deployment of ERAs, the option to refuse or restrict marketing authorisation solely on environmental grounds jeopardises the established authorisation system and could potentially delay or prevent patient access to life-saving medicines. Policy solutions for shortages should be proportionate to the risk, enhance cooperation, and leverage digital technologies. Developing prevention plans for all medicines without a risk-based approach would strain resources for both industry and regulators. Recognising the transformative potential of self-care through the reclassification of medicines from prescription to non-prescription status is imperative. To incentivise these switches, extending the data protection period from +1 to +3 years and the recognition of a broader range of generated evidence such as behavioural studies and RWE is crucial to benefit citizens, and for the sustainable use of healthcare resources. Regarding the prescription criteria for antimicrobials, we urge a case-by-case assessment. The newly proposed categorisation, including antifungals and antivirals, limits access to self-care for patients in the EU while not addressing AMR concerns, a consideration typically evaluated during the determination of the legal status of medicinal products. Bayer's vision is Health for all, Hunger for none. Building upon our European legacy, we remain committed to collaborating with all stakeholders in crafting solutions that bridge the innovation competitiveness gap with other regions. We wish to underscore our alignment with EFPIA and AESGP in this endeavour.
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Meeting with Jan Huitema (Member of the European Parliament, Shadow rapporteur)

7 Nov 2023 · New Genomic Techniques

Meeting with José Manuel Fernandes (Member of the European Parliament, Shadow rapporteur for opinion)

7 Nov 2023 · Soil monitoring law

Meeting with Nils Torvalds (Member of the European Parliament, Rapporteur)

7 Nov 2023 · UWWTD

Bayer Urges Pragmatic Soil Health Standards for Farmers

1 Nov 2023
Topic — EU proposal for monitoring, restoring, and sustainably managing healthy soils by 2050.
Message — Bayer wants a flexible, outcome-based approach rather than mandatory lists of soil management practices. They advocate for a gradual scoring system instead of the current strict pass-fail health assessment. They also request the inclusion of a specific agricultural productive land category.123
Why — This would ensure Bayer's agricultural products and innovations face fewer regulatory barriers.45
Impact — Environmental advocates could see soil protections weakened by the removal of strict health indicators.6
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Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and Acumen Public Affairs

31 Oct 2023 · Pharmaceutical Package (Regulation)

Meeting with Jan Huitema (Member of the European Parliament, Shadow rapporteur) and Friends of the Earth Europe and CropLife Europe

24 Oct 2023 · New Genomic Techniques

Meeting with Henna Virkkunen (Member of the European Parliament, Rapporteur for opinion) and Lääketeollisuus ry

13 Oct 2023 · Medicinal products for human use

Meeting with Tiemo Wölken (Member of the European Parliament, Rapporteur)

11 Oct 2023 · Pharmarevision (staff level)

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

10 Oct 2023 · Medicines

Meeting with Martin Hojsík (Member of the European Parliament, Rapporteur)

5 Oct 2023 · Soil, NGTs

Meeting with Clara Aguilera (Member of the European Parliament, Rapporteur for opinion)

28 Sept 2023 · Sustainable Use of Pesticides Regulation

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

4 Sept 2023 · Chemicals Strategy for Sustainability

Meeting with Suvi Leinonen (Cabinet of Commissioner Jutta Urpilainen)

26 May 2023 · Food security. Sustainable food system transformation.

Meeting with Miapetra Kumpula-Natri (Member of the European Parliament)

25 May 2023 · Meeting on EU medicine legislation

Meeting with Irène Tolleret (Member of the European Parliament) and BASF SE and CropLife Europe

10 May 2023 · Pesticides

Bayer warns EU pharmaceutical taxonomy criteria are unrealistic and discourage investment

3 May 2023
Topic — EU Taxonomy criteria for environmentally sustainable pharmaceutical manufacturing activities.
Message — Bayer requests removing requirements to assess biodegradation of transformation products and metabolites, as the pharmaceutical industry lacks necessary data. They argue companies meeting other important environmental criteria would be classified as non-green due to missing this single data requirement. They propose criteria should allow APIs that are biodegradable to qualify as green without requiring comparison to competing products.123
Why — This would allow pharmaceutical companies to achieve taxonomy alignment and maintain investor confidence.45
Impact — Environmental groups lose stricter standards requiring comprehensive pollution data for pharmaceutical products.6
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Bayer warns EU pharma taxonomy criteria are unrealistic and disincentivize innovation

2 May 2023
Topic — EU classification system for environmentally sustainable pharmaceutical manufacturing investments.
Message — Bayer requests removal of transformation products and metabolites criteria, arguing the industry lacks necessary data. They want criteria that recognize biodegradable APIs as green without additional requirements. They propose delaying reporting alignment until 2025 to match other sustainability directives.123
Why — This would allow Bayer's biodegradable products to qualify as green without costly testing.45
Impact — Environmental groups lose stronger protections against pharmaceutical pollution in waterways.
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Bayer urges holistic approach to chemical classification revision

30 Mar 2023
Topic — EU revision of chemical classification, labelling and packaging rules under CLP Regulation.
Message — Bayer requests that weight of evidence determinations allow consideration of all relevant information beyond simple value comparisons. They want grouping based on comprehensive data examination, not just structural similarity. They oppose direct transposition of decisions from other regulations into harmonised classifications.123
Why — This would reduce false positive classifications and lower their regulatory burden.45
Impact — Environmental and health advocates lose stricter automatic protections against hazardous chemicals.6
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Meeting with Lukas Visek (Cabinet of Executive Vice-President Frans Timmermans)

21 Mar 2023 · Sustainable use of pesticides and new genomic techniques

Bayer urges flat baseline and flexible permanence for EU carbon farming

17 Mar 2023
Topic — EU regulation on certifying carbon removals from ecosystems and industrial solutions.
Message — Bayer requests a flat standardised baseline for arable mineral soils, flexible longevity options through monitoring extensions and portfolio-wide mechanisms, and inclusion of social and economic co-benefits alongside environmental ones. They emphasize carbon removals should supplement emissions reductions, not replace them.1234
Why — This would reduce transaction costs and reward their existing carbon farming initiatives.56
Impact — Climate integrity suffers if removals offset emissions that should be reduced instead.78
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Meeting with Axel Voss (Member of the European Parliament, Shadow rapporteur) and BUSINESSEUROPE and

8 Mar 2023 · Corporate Sustainability Due Diligence

Meeting with Franc Bogovič (Member of the European Parliament, Shadow rapporteur for opinion) and Pesticide Action Network Europe

2 Mar 2023 · Meeting on SUR regulation proposal

Meeting with Christine Schneider (Member of the European Parliament)

28 Feb 2023 · CSS

Meeting with Martin Hojsík (Member of the European Parliament, Shadow rapporteur)

28 Feb 2023 · hazard classes under the EU Classification, Labelling and Packaging and pesticides

Meeting with Clara Aguilera (Member of the European Parliament, Rapporteur for opinion)

23 Feb 2023 · Draft Regulation SUR

Meeting with Adriana Maldonado López (Member of the European Parliament)

14 Feb 2023 · Reglamento del Espacio Europeo de Datos Sanitario

Meeting with Karen Melchior (Member of the European Parliament)

8 Feb 2023 · Request for early availability of guidance and recognizable standards in CSDDD

Meeting with Jens Gieseke (Member of the European Parliament)

7 Dec 2022 · Austausch zur Europapolitik

Meeting with István Ujhelyi (Member of the European Parliament)

7 Dec 2022 · Europe's Beating Cancer Plan

Meeting with Susana Solís Pérez (Member of the European Parliament, Shadow rapporteur)

30 Nov 2022 · EHDS

Meeting with Petar Vitanov (Member of the European Parliament, Shadow rapporteur)

30 Nov 2022 · EHDS

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

30 Nov 2022 · European Health Data Space - EHDS

Meeting with Wolfgang Burtscher (Director-General Agriculture and Rural Development)

28 Nov 2022 · General agriculture of the future

Meeting with Lukas Visek (Cabinet of Executive Vice-President Frans Timmermans)

27 Oct 2022 · Sustainable food systems

Meeting with Maciej Golubiewski (Cabinet of Commissioner Janusz Wojciechowski)

27 Oct 2022 · HoCs meeting with Senior VP Bayer AG

Bayer urges flexibility in new EU chemical hazard classification rules

18 Oct 2022
Topic — New hazard classes for endocrine disruptors and persistent/mobile substances under CLP Regulation.
Message — Bayer requests alignment with existing EU definitions for endocrine disruptors and flexibility to use Weight of Evidence approaches for persistent and mobile substance classifications. They seek allowances for evidence showing adverse effects are not relevant to humans or populations.123
Why — This would allow them to avoid classifying chemicals where adverse effects lack human or environmental relevance.45
Impact — Environmental and health advocates lose stronger protections against endocrine-disrupting and persistent chemicals.6
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Meeting with Alexander Bernhuber (Member of the European Parliament, Shadow rapporteur)

18 Oct 2022 · Sustainable use of Pesticides

Meeting with Franc Bogovič (Member of the European Parliament) and CropLife Europe

18 Oct 2022 · Meeting on agriculture related legislation

Meeting with Martin Häusling (Member of the European Parliament)

12 Oct 2022 · Austausch zum Umbau der Landwirtschaft und regionalen Perspektiven

Meeting with Jorge Pinto Antunes (Cabinet of Commissioner Janusz Wojciechowski) and Euroseeds and

11 Oct 2022 · To discuss the contribution of innovative plant breeding to food security and sustainability to achieve the green deal objectives

Meeting with Joanna Stawowy (Cabinet of Commissioner Janusz Wojciechowski), Jorge Pinto Antunes (Cabinet of Commissioner Janusz Wojciechowski) and

11 Oct 2022 · To discuss the contribution of innovative plant breeding to food security and sustainability to achieve the green deal objectives

Bayer urges impact-based pesticide rules over volume cuts

19 Sept 2022
Topic — EU regulation revising sustainable use of pesticides and integrated pest management.
Message — Bayer requests the EU shift from volume-based reduction targets to impact-based indicators measuring environmental effects. They advocate maintaining IPM as the cornerstone while promoting digital and precision farming technologies. The company seeks faster approval processes for biopesticides and exemptions allowing chemical pesticides as integrated tools, not last resort.123
Why — This would allow continued sales of high-volume pesticides while shifting regulatory focus from quantity to methodology.45
Impact — Environmental and health advocates lose clearer volume-based reduction commitments and stronger pesticide restrictions in sensitive areas.67
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Meeting with Jutta Urpilainen (Commissioner)

26 Aug 2022 · Factory visit as part of mission; SDGs

Meeting with Stefan Berger (Member of the European Parliament)

19 Aug 2022 · Pflanzenschutz

Bayer urges harmonized data access rules across EU health space

28 Jul 2022
Topic — New EU regulation on sharing and reusing electronic health data for research and care.
Message — Bayer requests harmonized implementation across Member States with common data standards and clear timelines. They want protection for commercially confidential clinical trial data and trade secrets. They seek unified interpretation of key terms like 'anonymisation' and 'scientific research' to enable cross-border research.1234
Why — This would enable efficient global research operations and protect proprietary clinical trial information.56
Impact — Public health authorities lose some immediate access to commercial clinical trial data.7
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Meeting with Peter Liese (Member of the European Parliament, Rapporteur) and American Chamber of Commerce to the European Union

6 Jul 2022 · ETS

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

28 Jun 2022 · Medicines

Meeting with Axel Voss (Member of the European Parliament, Shadow rapporteur) and Verband der Chemischen Industrie e.V.

16 Jun 2022 · Corporate Sustainability Due Diligence

Bayer urges broader biodiversity focus beyond pollinators

8 Jun 2022
Topic — EU revision of pollinator protection strategy to reverse insect decline by 2030.
Message — Bayer requests the initiative expand beyond pollinators to all beneficial organisms and biodiversity. They want farmers supported in managing ecosystem services and disservices, with clear targets and public financing for habitat creation. They emphasize maintaining farm productivity through continued access to pesticides and innovation.1234
Why — This would preserve their pesticide market while shifting conservation costs to public funding.567
Impact — Environmental groups lose focused pollinator protection as emphasis shifts to broader biodiversity goals.89
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Meeting with Franc Bogovič (Member of the European Parliament)

30 May 2022 · Meeting with Bayer Crop Science on new genomic techniques

Meeting with Cristian-Silviu Buşoi (Member of the European Parliament)

11 May 2022 · health and life-science innovation, challenges of healthcare in Europe

Bayer urges EU carbon removal framework with market integration

29 Apr 2022
Topic — EU regulation certifying carbon removals from ecosystems and industrial solutions.
Message — Bayer requests a regulatory framework linked to existing emissions trading systems, result-based finance for farmers, and harmonized monitoring standards. They want certified carbon removals to be tradable in LULUCF, ESR, and eventually EU ETS markets. The framework should build on voluntary carbon markets and avoid prescribing specific farming practices.123
Why — This would create market demand for their carbon farming programs across Europe.45
Impact — Environmental groups lose stronger safeguards against avoided loss crediting and baseline manipulation.6
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Meeting with Kathleen Van Brempt (Member of the European Parliament)

27 Apr 2022 · The Green Deal and food security

Response to Unitary Supplementary Protection Certificates (SPC) – creation and granting procedure

5 Apr 2022

Bayer is committed to continuously working with the EU Institutions, Member States and all other stakeholders towards creating a healthier future, improved food systems and a more competitive Europe. Therefore, we welcome the opportunity to share feedback in the call for evidence of the European Commission’s impact assessment regarding a unitary SPC and/or single SPC granting mechanism. We believe that the route to the effective harmonization of SPCs is through the introduction of a unitary SPC having the same geographical scope as the unitary patent. A harmonized term and scope of the unitary SPC as well as a uniform application of the legal framework by a single granting body and a single appeal court would lead to most efficiency, transparency, and legal certainty. Unitary SPCs could be granted in a single granting mechanism by a centralized office, or a virtual body composed of SPC experts from national patent offices. Such a centralized body would be able to rely on the existing expertise at national level. As the unitary patent system is to enter into force soon, a unitary SPC should also be established rapidly to avoid any uncertainty for users. Without a unitary SPC, unitary patents will not be available for medicinal and plant protection products. This could lead to a potential decrease of sustainable investments into research and development of life-saving medicines for patients and essential products ensuring farmers’ livelihoods. Unitary SPCs should consequently be available in both areas. National SPCs based on national patents should remain in place. Introducing both a unitary SPC and a single granting procedure for national SPCs would be a comprehensive approach to improve the efficiency of the system. However, we believe that priority should be given to introduction of the unitary SPC. An additional centralized procedure for national SPCs should not slow down the creation of such a unitary certificate. Bayer therefore supports the introduction of a unitary SPC being granted in a single granting mechanism. Such a mechanism could harmonize the system, thereby addressing the shortcomings associated with its fragmentation.
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Meeting with Martin Häusling (Member of the European Parliament)

25 Mar 2022 · Austausch bzgl. Bayer-Aktivitäten mit Russland infolge des Ukrainekriegs

Bayer urges result-based approach for EU Soil Health Law

11 Mar 2022
Topic — New EU regulation on protecting, sustainably managing and restoring EU soils.
Message — Bayer requests the law be result-based, setting soil health goals but leaving farming practices to farmers. They want harmonized EU soil indicators while avoiding regulatory overlap with existing directives. The company seeks flexible, risk-based approaches that enable access to necessary tools and avoid hurdles for innovation.123
Why — This would preserve farmer autonomy and avoid additional testing requirements for pesticides.45
Impact — Environmental groups lose prescriptive farming practices that could directly protect soil health.6
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Meeting with Frans Timmermans (Executive Vice-President) and Nestlé S.A. and

3 Dec 2021 · Discussion on investments into carbon removals with business representatives

Bayer urges private sector carbon farming incentives in LULUCF revision

3 Nov 2021
Topic — EU regulation on greenhouse gas removals from land use, forestry and agriculture.
Message — Bayer requests tools and incentives for farmers to achieve carbon removal targets through a project-based mechanism where farmers can independently register climate mitigation projects and generate tradable credits. They want carbon storage in soils and permanent vegetation explicitly recognized in the regulation, and synchronization with the Common Agricultural Policy to enable cross-eligible activities.123
Why — This creates new revenue streams for Bayer's carbon farming programs and digital tools.45
Impact — Climate advocates lose stricter emission reduction requirements in favor of offsetting flexibility.6
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Meeting with Axel Voss (Member of the European Parliament, Shadow rapporteur)

12 Oct 2021 · Corporate Sustainability Due Diligence

Meeting with Roberto Viola (Director-General Communications Networks, Content and Technology)

12 Oct 2021 · Health data & health data space

Bayer urges EU carbon farming incentives and harmonized certification

6 Oct 2021
Topic — EU consultation on carbon removal certification and carbon farming initiative.
Message — Bayer requests that the Commission stimulate Member State removal action, mobilize private sector involvement, and develop harmonized certification rules. They advocate for flexible trading of carbon removals across EU sectors and creating a carbon bank to purchase credits. The company emphasizes the need for cost-effective certification and capacity building for farmers.1234
Why — This would create new revenue streams from carbon credits for Bayer's farming customers.56
Impact — Environmental groups lose if flexible offsetting dilutes actual emission reduction efforts.7
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Response to Amendment of protective measures against pests of plants

24 Aug 2021

We thank you for the opportunity to comment to the Draft Commission Implementing Regulation, ref. Ares(2021)4803196 – 27/07/2021 amending Implementing Regulation 2019/2072 as regards the listing of pests, prohibitions and requirements for the introduction into, and movement within, the Union of plants, plant products and other objects. Please find our comments as Bayer Crop Science attached.
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Response to Requirements for Artificial Intelligence

29 Jul 2021

Mastering the new opportunities and challenges of innovation in life sciences is key for societies in the 21st century. One important element is a supportive policy and regulatory framework that fosters scientific advancement while at the same time ensuring trust and a high safety standard for human health and the environment. Bayer stands at the forefront of the “Bio-Revolution” with Artificial Intelligence (AI) being a crucial technical enabler for drug development, applications in Cell- and Gene-Therapy, New-Breeding-Techniques or Data-Driven-Farming. The way AI is regulated is a decisive factor for EU’s future competitiveness in the international field. Bayer shares the EU Commission’s ambition of making Europe a world-leading destination for the development and deployment of trustworthy AI. In order to maintain Europe’s competitiveness, the Act should not impose unproportionate duties on European AI providers. To create an even playing field for European AI providers with the rest of the world, the Act itself must be competitive to non-European AI legislation. As an active member of the EU Commission’s AI High-Level Expert Group 2018-20, Bayer has been working on human centered policy proposals for the regulation of AI that ground on a risk-based approach combined with a sector-specific regulation. We therefore highly welcome that the EU Commission has put the risk-based approach at the center of the regulation and are convinced that looking at the risk of applications is key to strike the balance between necessary regulation and innovative freedom. Below, we present our initial assessment of the proposal: Definition We welcome that the definition of AI in the proposal builds on the work of the OECD with its technology-neutral character allowing for the fast developments of AI technologies. However, parts of the proposed definition focus on outdated aspects of AI, such as logic- and knowledge-based approaches and optimized searched methods (Annex 1 (b) and (c), respectively). Rather, the definition of AI should focus and include current and future aspects of AI to avoid overly broad application. Regulatory Environment We understand that AI is a cross-cutting technique that falls under various existing legislation but are concerned that an overly complex regulatory environment is created. Especially for AI systems that are in scope of sector specific legislation (e.g. medical devices) three regulatory dimensions would apply: the proposed AI Act, the Medical Devices Regulation and the General Data Protection Regulation (GDPR) with overlapping requirements, such as for technical documentation. Furthermore, the proposal does not solve the tension between GDPR principles, such as data minimization, purpose limitation or storage limitation, and the full deployment of the potential of AI. Clear guidance from data protection authorities is required on the processing of personal data in the context of AI. Validation – Human domain – Risk approach High quality data is essential for the successful uptake of safe AI in Europe. To ensure the consistency between training data and production data, the validation mechanisms could extend to include ground-truth evidence to reproduce the underlying data generating process. Further, the inclusion of human domain experts in certain cases would also be beneficial to detect incongruences between AI output and rational conclusions. Governance structure & penalties The successful development and deployment of AI in Europe will also depend on the governance requirements for the underlying data. Bayer asks for more clarity on the governance structure and to whom, for instance, serious incidents must be reported.
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Bayer urges broader farm data collection beyond organic practices

30 Jun 2021
Topic — EU proposal to expand farm data network to include environmental and social practices.
Message — Bayer requests data collection cover all farming tools and systems, not just organic methods. They want inclusion of conventional, digital, chemical, biological and mechanical practices. The company argues the current focus on Farm to Fork targets is too narrow for effective sustainability policy.12
Why — This would legitimize conventional and chemical farming methods alongside organic practices in sustainability policy.34
Impact — Environmental advocates lose emphasis on reducing pesticide and fertilizer use through targeted Farm to Fork metrics.5
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Meeting with Andrea Beltramello (Cabinet of Executive Vice-President Valdis Dombrovskis), Caroline Boeshertz (Cabinet of Executive Vice-President Valdis Dombrovskis) and

28 May 2021 · Sustainable corporate governance and due diligence

Bayer calls for agile EU regulation to boost pharmaceutical innovation

27 Apr 2021
Topic — The consultation aims to revise EU pharmaceutical law to ensure affordability and promote research innovation.
Message — Bayer proposes institutionalizing pandemic-era agility by streamlining EMA committees and granting them direct approval powers. They also advocate for expanding centralized procedures to clinical trials and harmonizing data protection rules.123
Why — This would speed up market entry and foster an environment where genetic research can flourish.4
Impact — National regulators may lose funding if fees are distributed solely based on quality and resource needs.5
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Meeting with Lukas Visek (Cabinet of Executive Vice-President Frans Timmermans)

9 Mar 2021 · Carbon farming

Meeting with Thierry Breton (Commissioner) and

8 Feb 2021 · Task Force on vaccine production

Response to A European Health Data Space

3 Feb 2021

Bayer welcomes the European Commission’s agenda to create a European Health Data Space (EHDS) that will promote access to health data, foster the European digital health market, and enable the use of AI in health. Bayer actively participates in several data sharing projects, because we believe in the value of electronic health records (EHR) and patient-generated health data (PGHD) to promote scientific advances. Combined with data analytics, anonymized, systematic and longitudinal collection of EHR and PGHD it enables examination and development of effective therapies for chronic diseases. An EHDS can greatly contribute to a better understanding of health conditions and their progression, treatment pathways and outcomes, risk and prevention of aggravation and to the development of innovative therapies. Many practical issues still need to be solved to enable Europe’s research community to deliver on the promise of Big Data in healthcare. Firstly, there is an urgent need for a common understanding of the General Data Protection Regulation by data controllers, their advisors and authorities. To make the most of the potential of digital health, the European Commission should support the viability of pan-European data repositories assuring the economic sustainability of indication-specific repositories and facilitating access to health data for research and innovation on an on-going basis. The secondary use of EHR and PGHD is then crucial to advance research. To ensure the technical interoperability of European digital health data sets, Bayer asks for a regulatory framework that applies the FAIR data principles, to guarantee findability, accessibility, interoperability and re-use of digital assets. Harmonization of specifications is also key to strengthen the quality of Real-World Data (RWD) to better inform regulatory and health technology assessment (HTA) decision making. Digital health solutions, such as telehealth, digital health records and digital therapeutics, have the potential to improve access to healthcare, while also improving its quality and efficiency. Bayer fully supports a genuine single market in digital health. For this market to take shape, certain technical, educational, and regulatory frameworks need to be defined and harmonized. Investments in infrastructures and in health care professionals, as well as public education to prepare health systems for the uptake of novel solutions is necessary. The current convergence of big data availability, faster data transmission and large-scale computing power creates tremendous opportunity for the application of artificial intelligence (AI) and machine learning in the healthcare system. We support the European Commission’s objective to enable AI in health products and services and welcome the aim to develop guidance for product development standards and regulatory product clearance pathways. In addition, it is important to design an EHDS that will allow exchange and integration of data sets beyond the EU. An exclusively European data space will limit its impact and foreclose opportunities to collaborate with data intensive advanced economies. Bayer believes that Europe should implement a framework that enables the development of digital health solutions and the emergence of EU champions in the digital space. Now is the time to unleash the potential of the digital transformation to deliver on the promise of improving the availability, access and sustainability of health care in Europe.
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Meeting with Estela Pineiro-Kruik (Cabinet of Executive Vice-President Frans Timmermans), Lukas Visek (Cabinet of Executive Vice-President Frans Timmermans)

25 Jan 2021 · Preparation of a panel discussion at the Davos summit

Bayer calls for science-based pesticide targets and innovation focus

3 Aug 2020
Topic — A review of EU rules to reduce pesticide risks and promote sustainable agriculture.
Message — Bayer argues that pesticide reduction targets must be realistic, science-based, and preceded by comprehensive impact assessments. They advocate for an enabling framework to bring innovations like digital tools and genomic editing to market faster.12
Why — Focusing on innovation and impact assessments helps Bayer protect market access and lower compliance burdens.34
Impact — Environmental groups lose if the demand for more data slows the phase-out of pesticides.5
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Response to Legislative framework for the governance of common European data spaces

31 Jul 2020

Bayer welcomes the European Commission agenda to make Europe fit for the digital age and its proposal to create a Common European Data Space in the fields of health and agriculture. Bayer participates in many data sharing activities because we believe in the value of data to promote scientific advances. In the field of healthcare, a Common European Data Space can greatly contribute to a better understanding of health conditions and to the development of tailored therapies. A unified European approach in the field would better position Europe in the worldwide data economy and foster innovation. Bayer considers very important to further strengthen links between networks of leading educational institutes and the private sector to secure mutual learning and knowledge transfer. Furthermore, European Common Data Spaces can help to enable focus. It is then important to design a system able to allow exchange and integration of data beyond the EU. An exclusively European data space will limit its impact and foreclose opportunities to collaborate with data intensive advanced economies. Access and processing of health data are crucial to optimizing pharmaceutical innovation and the development of precision medicines. The General Data Protection Regulation (GDPR) is a first step towards a harmonized EU Data Protection approach, however, two years after its effective date, many practical issues still persist and there is an urgent need for a shared understanding of the GDPR by data controllers, their advisors and authorities. One major concern is the lack of an industry specific approach that causes major hurdles in life-science industries, such as in performing EU-wide clinical trials. If new legal enablers are to be considered to foster the data-driven economy, these should take an industry specific approach and not a one size fits all. Any new regulatory action relevant from a data privacy point of view needs to be consistent with existing legal frameworks namely the GDPR and the ePrivacy Regulation. The diversity of inconsistent legislative frameworks represents an economic burden and limits the compliant collection and use of data. Harmonization and interoperability of patients’ health data from clinical trials, disease registries and electronic health records (EHRs) throughout Europe can greatly contribute to a better understanding of health conditions and improve quality of care. Harmonization of requirements is also key to strengthen the quality of Real World Data (RWD) to better inform regulatory and health technology assessment (HTA) decision making. Although there are several initiatives from regulatory authorities to provide guidance on the use and submission of RWD, it is still missing clear support on how to meet the data requirements. Therefore, Bayer asks for the application of the FAIR data principles to guarantee findability, accessibility, interoperability and re-use of digital assets. Investments are also needed to build the technical infrastructures of the Common Data Spaces, as well as the development of digital skills and competencies. Bayer believes that Europe should aim for the right balance between protecting patients’ privacy and the urgent need of a framework that enables the development of digital health solutions as well as the emergence of EU champions in the digital space. The time is now to unleash the potential of the digital transformation to help with the economic recovery and build Europe’s digital sovereignty.
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Meeting with Catherine Geslain-Laneelle (Cabinet of Commissioner Janusz Wojciechowski), Jorge Pinto Antunes (Cabinet of Commissioner Janusz Wojciechowski)

23 Jul 2020 · Bayer to share their perspectives on the Green Deal and the measures already launched at the end of May.

Bayer urges EU to prioritize innovation and protect intellectual property

6 Jul 2020
Topic — The EU is developing a strategy to ensure affordable medicine supplies.
Message — Bayer calls for a strong intellectual property framework and modernized pricing systems. They suggest using digital transformation and regulatory flexibility to improve medicine accessibility.123
Why — This would ensure higher returns on investment for their innovative therapies.45
Impact — National health budgets may face higher costs due to flexible pricing.6
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Meeting with Dermot Ryan (Cabinet of Commissioner Phil Hogan)

24 Jun 2020 · Green deal

Response to EU rules on industrial emissions - revision

21 Apr 2020

Bayer would like to express its full support of the Commission Zero Pollution ambition and objective to protect Europe natural capital and people health. By initiating a European Green Deal, Europe has taken a decisive step to address the most pressing challenges of our generation. Our feedback on the Industrial Emissions Directive roadmap can be found in the attached document.
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Meeting with Thierry Breton (Commissioner) and Compagnie de SAINT-GOBAIN and

7 Apr 2020 · The impact of COVID-19 on the built environment ecosystem

Response to Europe’s Beating Cancer Plan

3 Mar 2020

Bayer welcomes the Cancer Plan roadmap and concurs with its focus on the key stages of the disease. The European institutions can play a decisive role to increase care outcomes with pan-European initiatives and harmonizing deviating standards in prevention, treatment and care. It should be mentioned that approximately 73% of survival gains in cancer have been attribute to new medicines. This number proves how important access to treatments and investments into research are. Thanks to pharmaceutical research, many cancers are chronic diseases now. Cancer research is necessary today and in future to find new treatments with a curative intend. Therefore, the EU should strive to achieve harmonized care outcomes across its member states. Screening & testing: The increasing cancer incidences need to be met by a stronger focus on screening and testing to early identify a cancer and enable patients’ access to the best available treatment right from the diagnosis. Bayer supports an update of the 2003 screening recommendations which should also be supplemented by a new European recommendation on genomic tumor testing. Such recommendation could also be accompanied by a set of principles to integrate precision medicines into EU health systems. With the help of these policies, the Commission can ensure that the Union and its member states do not lag behind in medical progress and integrate rapidly advancing science into health systems. Additionally, the Commission could initiate a Precision Oncology Network within its European Reference Network (ERN) to pool resources and knowledge. Research & innovation: Cancer research has been fundamental to achieving improvements in survival. During the last decade, R&D investment in cancer research by the pharmaceutical industry has grown much quicker than investment by public and non-profit private sources. Cancer research in Europe needs greater attention and funding from public sources in the coming years by the Commission and the member states. The IMI cancer projects provide an excellent framework for collaborative approaches and Bayer will continue to support this initiative. Investments: Advances in cancer care and survival need adequate investments. Total cancer care spending as a share of total health expenditure has been rather low compared to the cancer burden – between 4-7% are devoted to cancer in member states, a relatively stable rate over time. Encouraging member states to allocate larger budgets to fight cancer should be addressed in European Commission reports (i.e. European Semester and State of Health). Digital technologies have the power to fundamentally transform patient care. Access and processing of health data are crucial to optimizing pharmaceutical innovation and the development of precision medicines. In this regard, the secondary use of health data by using and linking different patient health data sets like disease registries or EHRs can contribute to a better understanding of health conditions, disease progression and treatment pathways. Bayer asks the Commission to facilitate the secondary use of health data throughout Europe and create corresponding requirements for the development of data sharing platforms. To this end, further discussion and alignment among Member States and the European Data Protection Board is crucial. Bayer supports a European Joint Clinical Assessment (JCA) with an effective harmonization of clinical data requirements and removal of duplicative assessments to accelerate patient access to medicines. For joint assessments of new treatment paradigms in oncology, sufficiently developed innovative HTA methodologies should be applied to enable the evaluation of smaller data sets, novel clinical endpoints and evidence from novel study designs (basket trial, platform trial, single arm trial). To address evidence gaps that exist at the time of the initial assessment HTA bodies should take Real World Data (RWE) for a re-assessment into account.
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Response to Listing regulated pests, plants, plant products and other objects

10 Sept 2019

We thank you for the opportunity to comment to the Draft Commission Implementing Regulation (Ares(2019)5318433 & /1-14) establishing uniform conditions for the implementation of Regulation (EU) 2016/2031 of the European Parliament and the Council, as regards protective measures against pests of plants. We hereby share our comments as Bayer Crop Science.
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Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

25 Jun 2019 · Innovation in agriculture, new breding techniques

Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis), Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

28 Mar 2019 · MRLs for pesticides

Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

9 Jan 2019 · New breeding techniques

Meeting with Vytenis Andriukaitis (Commissioner) and

21 Nov 2018 · The role of transparency in scientific assessment

Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

6 Nov 2018 · Preparation of Commissioner's intervention at November Bayer's event

Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

25 Sept 2018 · Sustainable farming

Response to Evaluation of the EU Biodiversity Strategy to 2020

2 Jul 2018

To improve Target 3a on agriculture and biodiversity, we suggest to better integrate biodiversity conservation and agricultural / crop production, and to refer to mainstreaming biodiversity into crop management more specifically in the 2020 BD Strategy text, in line with the CBD goals and others of the EU. Currently the text of Target 3a reads more like agriculture has to provide the public good of maintaining and enhancing biodiversity, whereas the public good of food production is not addressed. To achieve a better integration of both sectors it is important to also highlight the benefits of Agri-environmental or Greening measures for crop management, thus working towards a win-win for both is key. In this context research on the benefits of agro-ecosystem services such as soil fertility, soil erosion avoidance, water regulation and pollination for crop production are key. They have been very limited in the EU, despite a strong focus on ecosystem services overall – see EU ecosystem services conference in Antwerp last year with 750 participants. Soil fertility as the most relevant agro-ecosystem service for crop production could this way also be emphasized and efforts to manage soil could also be supportive of preventing land degradation – addressing aspects of the IPBES assessment.
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Meeting with Marika Lautso-Mousnier (Cabinet of Vice-President Jyrki Katainen) and EPPA SA

2 Mar 2018 · Crop protection industry and the Regulation 1107/2009 on the approval of active substances in the field of crop protection

Meeting with Jyrki Katainen (Vice-President) and Novartis International AG and Pfizer Inc.

21 Nov 2017 · Internal Market's industrial property legal framework relating to supplementary protection certificates (SPC) and patent research exemptions; innovation in the pharmaceutical industry

Meeting with Günther Oettinger (Commissioner)

19 Jul 2017 · Industry 4.0

Meeting with Aurore Maillet (Cabinet of Vice-President Karmenu Vella)

11 Jul 2017 · Endocrine disruption, neonicotinoids and sustainable use of pesticides

Meeting with Vytenis Andriukaitis (Commissioner) and

10 Jul 2017 · Plant protection products

Meeting with Robert Schröder (Cabinet of Commissioner Carlos Moedas)

30 May 2017 · innovative agriculture

Meeting with Léon Delvaux (Cabinet of President Jean-Claude Juncker)

25 Apr 2017 · Challenges for the agricultural sector

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

6 Apr 2017 · current political priorities

Meeting with Nathalie Chaze (Cabinet of Commissioner Vytenis Andriukaitis)

29 Mar 2017 · Endocrine disruptors, approval of plant protection products

Meeting with Phil Hogan (Commissioner)

15 Nov 2016 · Attend Reception

Bayer warns chemical restrictions could disrupt life-saving drug production

4 Oct 2016
Topic — This consultation addresses adding substances like 4-tert-OPnEO to the REACH authorization list.
Message — Bayer requests review periods exceeding 12 years to guarantee the supply of medicines. They argue substitution would require new clinical studies and complex regulatory re-validation.12
Why — Bayer avoids high costs and regulatory hurdles by maintaining its current drug manufacturing processes.3
Impact — Environmental interests lose as the phase-out of hazardous chemical emissions is significantly delayed.4
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Meeting with Günther Oettinger (Commissioner)

27 Sept 2016 · e-Health

Meeting with Jyrki Katainen (Vice-President)

27 Sept 2016 · Competitiveness

Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

21 Sept 2016 · Access to Medicines, HTA

Meeting with Carlos Moedas (Commissioner)

18 Apr 2016 · Open innovation & Innovative Medicine Initiative 2 (IMI2)

Meeting with Frans Timmermans (First Vice-President)

3 Dec 2015 · Business Europe CEO day

Meeting with Alexander Italianer (Secretary-General Secretariat-General)

3 Dec 2015 · Business Europe CEO day

Meeting with Jyrki Katainen (Vice-President) and

3 Dec 2015 · Business Europe CEO day

Meeting with Carlos Moedas (Commissioner) and BUSINESSEUROPE and

3 Dec 2015 · Business Europe CEO day

Meeting with Heidi Jern (Cabinet of Vice-President Jyrki Katainen), Juho Romakkaniemi (Cabinet of Vice-President Jyrki Katainen) and BUSINESSEUROPE

27 Aug 2015 · Circular Economy

Meeting with Phil Hogan (Commissioner)

9 Jun 2015 · Agri Issues

Meeting with Robert-Jan Smits (Director-General Research and Innovation)

6 May 2015 · Innovation in Europe

Meeting with Günther Oettinger (Commissioner)

6 May 2015 · Digitalisierung der Industrie

Meeting with Carl-Christian Buhr (Cabinet of Commissioner Phil Hogan)

2 Mar 2015 · Presentation of Bayer's activities in data science ("big data on the fields"), presentation of relevant Horizon 2020 R&D&I support areas

Meeting with Tom Tynan (Cabinet of Commissioner Phil Hogan)

12 Feb 2015 · Core fields of activity of Bayer CropScience, Key regulatory framework, concerns regarding the implementation of the Plant Protection Products Regulation 1107/2009 and the Maximum Residues Level Regulation 396/2005, impact of EU regulations on trade in agricultural products and product availability for farmers, impact of the hazard-based approach and regulatory cut offs for Endocrine Disruptors, Neonicotinoids and bee health

Meeting with Robert Madelin (Director-General Communications Networks, Content and Technology) and BASF SE and

12 Feb 2015 · Digital Single Market, Innovation