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Boehringer Ingelheim

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health, focusing on innovative therapies in areas of high unmet medical need.

Lobbying Activity

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

13 Jan 2026 · EU Cardiovascular Health Plan, CMA & Biotech Act

Meeting with Christine Singer (Member of the European Parliament)

4 Dec 2025 · Tiergesundheit

Meeting with Christine Schneider (Member of the European Parliament)

2 Dec 2025 · Competitiveness

Meeting with Daniel Caspary (Member of the European Parliament) and Kommissariat der deutschen Bischöfe - Katholisches Büro in Berlin -

2 Dec 2025 · Austausch

Meeting with Andreas Glück (Member of the European Parliament)

5 Nov 2025 · Health

Meeting with Lukas Mandl (Member of the European Parliament)

5 Nov 2025 · Most Favored Nation Executive Order, Critical Medicines Act, EU Pharma Legislation

Meeting with Marta Temido (Member of the European Parliament)

5 Nov 2025 · Papel do Parlamento Europeu nas areas da saúde

Meeting with Angelika Winzig (Member of the European Parliament, Rapporteur for opinion) and PHARMIG - Verband der pharmazeutischen Industrie Österreichs

5 Nov 2025 · Meeting with representatives of Boehringer Ingelheim & Pharmig

Meeting with Sophia Kircher (Member of the European Parliament) and PHARMIG - Verband der pharmazeutischen Industrie Österreichs

4 Nov 2025 · Chemicals Omnibus, EU-US relations

Meeting with Stefan Köhler (Member of the European Parliament)

4 Nov 2025 · Politischer Austausch zum Thema Tierseuchen

Meeting with Maria Walsh (Member of the European Parliament)

4 Nov 2025 · Animal disease

Boehringer Ingelheim Urges Holistic EU Strategy for Heart Health

17 Sept 2025
Topic — New EU initiative to improve cardiovascular health and boost medical innovation.
Message — Include kidney and liver diseases as key risk factors in heart health policies. Promote systematic heart health checks including kidney and liver values. Incentivize secure data sharing via the EHDS to coordinate care across specialties.123
Why — Integrating these conditions into heart health policies expands the market for their specialized therapies.4
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Meeting with Michael McGrath (Commissioner) and

15 Sept 2025 · Competitiveness, data protection, and consumer protection

Meeting with Stéphane Séjourné (Executive Vice-President) and

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

Response to Critical Medicines Act

6 Jul 2025

Boehringer Ingelheim is a leading research-driven biopharmaceutical company dedicated to improving human and animal health. As one of the industrys top global investors in R&D, we focus on creating innovative therapies that address areas of significant unmet medical need, enhancing and extending lives globally. With more than 140 years of heritage, a strong footprint in Europe, and our global HQ in the EU, we welcome the ECs initiative to strengthen manufacturing capabilities and improve the availability of critical medicines within the EU. To achieve the objectives of the CMA, it is crucial to ensure alignment with other ongoing initiatives e.g. the EU Pharma Package, Biotech Act, and the Life Science Strategy etc. The CMA must be harmonized with existing/forthcoming legislation while promoting risk-based measures that enhance competitiveness and supply security, avoiding duplication, unintended consequences and administrative burden. While supporting the EFPIA response, we provide the following additional comments: - Medicinal Products of Common Interest o The definitions of critical medicines, MPCIs, and the methodology for evaluating vulnerabilities require further clarification. - Collaborative/Joint Procurement o Issues of unavailability often stem from the structural setup of national systems. Collaborative procurement should not be viewed as a universal solution but rather as a last resort and in good faith as a joint solution when national mechanisms have proven insufficient. o Collaborative procurement should be limited to countries facing shortages/unavailability and must not be used as an additional cost-containment measure, as utilizing collaborative procurement solely for cost containment could negatively impact both public health and the EUs competitiveness in a global context. o Joint procurement may help address supply and access issues in exceptional cases but its use as a general method for purchasing medicines could have unintended consequences, including exacerbating shortages. - Strategic Projects o The processes for permits and expedited proceedings require further clarification, and legal standards across the EU for such projects should be harmonized to avoid fragmented implementation. o Timelines and durations for incentives and obligations need clarification, as their current scope and duration remain uncertain. o Existing supply chain measures for critical medicines appear to be excluded from financial or regulatory support, potentially disadvantaging companies already investing in the production of critical medicines within the EU. - Contingency Stock Obligations o Contingency stock requirements should be harmonized and proportionate, as poorly implemented obligations could undermine access to medicines. If misapplied, these measures risk amplifying the very problems they aim to resolve by disrupting supply planning and predictability. - Public Procurement to Incentivize Supply Chain Resilience o Current procurement practices in the EU, such as prioritizing the lowest price without considering factors such as supply reliability, can weaken supply chain resilience and lead to shortages. Boehringer supports stronger emphasis in public tenders on the prioritization of the MEAT criteria - International Cooperation o Open and diversified global supply chains are vital to the biopharmaceutical sector. We therefore support enhanced collaboration with international partners to strengthen supply chain resilience and encourage the European Commission to conclude strategic partnerships and build upon existing cooperation frameworks Boehringer Ingelheim is committed to working with all EU stakeholders to ensure the CMA achieves its objectives while strengthening Europes leadership in healthcare innovation. As a company dedicated to human and animal health, we ask the EU to ensure the CMA follows a One Health approach, preventing unintended adverse effects on the availability of veterinary medicinal products
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Boehringer Ingelheim urges EU to prioritize biotech IP and research

11 Jun 2025
Topic — The consultation seeks measures to accelerate biotechnology transition from laboratories to the market.
Message — The organization requests a robust and harmonized intellectual property framework to attract investment. They advocate for simplified clinical trial approvals and tools to de-risk manufacturing investments.123
Why — Stronger intellectual property rights and manufacturing support would protect their significant research investments.4
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Meeting with Andrea Wechsler (Member of the European Parliament)

10 Jun 2025 · EU Research Policy

Response to Quantum Strategy of the EU

3 Jun 2025

Boehringer Ingelheim is a leading biopharmaceutical company committed to advancing human and animal health. As one of the industrys top R&D investors, we focus on developing innovative therapies that address areas of high unmet medical need to improve and extend lives worldwide. With our heritage and strong footprint in Europe for over 140 years, we welcome the European Commissions initiative to develop an EU Quantum Strategy. Quantum technologies are emerging as key drivers of future industrial competitiveness and technological sovereignty in Europe. In the pharmaceutical sector, quantum computing holds particular promise to transform drug discovery, biological modelling, and materials science. Boehringer Ingelheim has made considerable investments in this space building internal expertise and funding research collaborations to help mature the technology. We welcome the EUs recognition, as reflected in the European Declaration on Quantum Technologies and the Draghi report, that a coordinated and ambitious approach is needed to fully leverage Europes potential and address key structural challenges. We believe the EU Quantum Strategy can support Europes competitiveness if it goes beyond hardware and infrastructure to also enable applied innovation and commercial deployment. We make the following recommendations for the strategy: 1. Incentivise the development of algorithms and applications. The current strategy proposal focuses primarily on hardware production and supporting infrastructure. However, much of the industrial interest and long-term value in quantum computing stems from the development of algorithms capable of replacing or significantly outperforming classical workflows. These applications are essential to unlocking the true potential of quantum technologies. 2. Continue to support and strengthen academic quantum research excellence. The EU has historically nurtured a strong academic foundation in quantum science by funding ambitious research projects. However, retaining talent particularly during the transition from junior to senior roles remains a challenge. Fiscal incentives for quantum startups and companies hiring quantum talent can help address this gap. Expertise and training should be concentrated around established leaders in the field to attract and develop top talent. 3. Ease the regulatory burden on immigration to attract quantum talent. Quantum experts are globally scarce. Startups, research institutions and universities must be able to recruit talent efficiently from around the world. Streamlining immigration procedures and reducing administrative barriers will be key to maintaining a competitive edge. 4. Foster a strong quantum startup ecosystem. Create a favourable tax and funding environment that allows promising ideas to grow into successful products. Ensure that EU funding instruments include clear milestones to drive innovation at pace. Build mechanisms for startups to engage early with industry stakeholders and receive meaningful feedback to guide their development. 5. Concentrate funding strategically to maintain global competitiveness. Global competitors, particularly the US and China, are funnelling substantial resources into a select few hardware providers. For the EU to remain competitive, it will also need to make bold strategic choices and focus funding in a similarly targeted way. Quantum computing will be critical in shaping the future of innovation across sectors including health. Europe has a strong academic base and active public funding, but it must now close the gap in talent retention, industrial scaling, and private investment. Boehringer Ingelheim supports a forward-looking EU Quantum Strategy that not only strengthens infrastructure and sovereignty, but also drives real-world applications and ecosystem development. We stand ready to contribute as a partner in this shared European effort.
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Meeting with Maria Walsh (Member of the European Parliament)

24 Apr 2025 · Mental Health

Boehringer Ingelheim urges EU to restore pharmaceutical innovation leadership

15 Apr 2025
Topic — A new strategy to boost European competitiveness and innovation in life sciences.
Message — The company calls for an EU Life Sciences Coordinator and a simplification package to reduce regulatory complexity. They also seek strengthened intellectual property rights and more harmonized, faster clinical trial approvals.1234
Why — Predictable market conditions and regulatory simplification would lower costs and attract more investment.56
Impact — Environmental protections could be weakened to avoid restricting chemicals used in medicine production.7
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Meeting with Stéphane Séjourné (Executive Vice-President) and

10 Apr 2025 · Impact of US tariffs

Meeting with Kerstin Jorna (Director-General Internal Market, Industry, Entrepreneurship and SMEs) and

10 Apr 2025 · Impact of US tariffs

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

5 Mar 2025 · Health

Meeting with Jutta Paulus (Member of the European Parliament)

12 Dec 2024 · Pharma- und gesundheitspolitische Prioritäten

Meeting with Maria Noichl (Member of the European Parliament, Shadow rapporteur)

10 Dec 2024 · Grenzüberschreitende Tiergesundheit

Meeting with Oliver Schenk (Member of the European Parliament)

10 Dec 2024 · The Pharmaceutical Industry in the EU

Meeting with Norbert Lins (Member of the European Parliament)

12 Nov 2024 · Vorbeugung von grenzüberschreitenden Tierseuchen

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

8 Nov 2024 · Futuro Industria farmaceútica

Meeting with Laura Ballarín Cereza (Member of the European Parliament)

6 Nov 2024 · Priorities for the new mandate

Meeting with Eric Sargiacomo (Member of the European Parliament)

6 Nov 2024 · Vaccination animale

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

6 Nov 2024 · Pharma / medicines

Meeting with Lukas Mandl (Member of the European Parliament)

5 Nov 2024 · Security of supply, European Industrial Location

Meeting with Niels Flemming Hansen (Member of the European Parliament)

5 Nov 2024 · Priorities for the mandate

Meeting with Valérie Hayer (Member of the European Parliament)

5 Nov 2024 · animal health

Meeting with Andreas Glück (Member of the European Parliament) and Novartis International AG

4 Nov 2024 · Health

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

4 Nov 2024 · Pharmastandort Deutschland

Meeting with Lukas Sieper (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations and

16 Jul 2024 · Introductory meeting at networking event

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

7 Nov 2023 · Medicinal products for human use

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

24 Oct 2023 · discussion on the General Pharmaceutical Package revision

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

18 Jul 2023 · Directive on Medicinal products for human use

Meeting with Christine Schneider (Member of the European Parliament)

19 Apr 2023 · Pharmapaket

Boehringer Ingelheim calls for EU mental health innovation strategy

15 Feb 2023
Topic — EU initiative addressing mental health through promotion, prevention, and resilient policy frameworks.
Message — BI requests a stable regulatory framework to boost research and public-private partnerships. They urge payers to recognize indirect costs and patient experiences when valuing innovation.12
Why — Wider recognition of innovation value would facilitate higher reimbursement rates for their medications.3
Impact — National health budgets may face pressure if they must compensate for indirect social costs.4
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Meeting with Karsten Lucke (Member of the European Parliament)

13 Feb 2023 · Werksbesuch / Forschung und Entwicklung

Meeting with Günther Sidl (Member of the European Parliament) and Wirtschaftskammer Österreich and PHARMIG - Verband der pharmazeutischen Industrie Österreichs

20 Oct 2022 · General Exchange of Views

Meeting with Karsten Lucke (Member of the European Parliament)

28 Sept 2022 · Forschung und Entwicklung

Meeting with Sara Cerdas (Member of the European Parliament)

28 Sept 2022 · Parcerias público-privadas em R&D farmacêutico

Meeting with Maria da Graça Carvalho (Member of the European Parliament)

26 Sept 2022 · Id prevenç]ao doenças cr[onicas

Meeting with Johannes Hahn (Commissioner) and

28 Jul 2022 · Current economic and geopolitical challenges. European strategic autonomy. Consequences of Covid-19 for European health policy.

Boehringer Ingelheim urges F-gas phase-down delay for medicines

29 Jun 2022
Topic — Review of EU rules on climate-warming fluorinated gases used in medical inhalers.
Message — BI calls to maintain the reference value for medical F-gases and postpone the phase-down until 2030. They warn that current timelines are unrealistic for the necessary clinical testing of alternatives.12
Why — This delay would protect its domestic manufacturing operations and ensure continued global market supply.3
Impact — Environmental groups and climate targets lose as high-GWP gases persist in the atmosphere.4
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Meeting with Susana Solís Pérez (Member of the European Parliament)

31 May 2022 · Estrategia Famaceutica

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

4 Apr 2022

Family-owned since it was established in 1885, Boehringer Ingelheim pursues a long-term vision and stands for continuous investment in medical innovation to improve the health and quality of life of humans and animals. We welcome the opportunity to input into this consultation and urge the EU Commission (EC) to consider the below industry view put forward by EFPIA. Bringing new therapies to patients is a long, complex and risky process that requires long-term and continuous investments. Patents are critical to that purpose and to the EU’s innovation and industrial ambitions. SPCs, by restoring some of the effective patent term lost when developing the drug and applying for marketing authorization, are of fundamental importance to ensure sustainable investments into the R&D of new medicines. The 2020 evaluation of the SPC Regulation has confirmed the effectiveness of SPCs as incentives for pharmaceutical innovation while highlighting a few shortcomings, associated with the fragmentation of the system. Any changes should not risk jeopardizing a well-functioning SPC system and we call on the EC to avoid that risk and rather make adjustments to overcome the fragmentation of the system. We strongly support the creation of a centralized system for SPC protection (option C1). The creation of a unitary SPC title is the logical next step to achieve a simpler and more effective system for SPCs based on European patents with unitary effect (“Unitary patents”). Without a unitary SPC title, the pharmaceutical industry will be unable to benefit from unitary patents. As "classical” European patents will also continue to be granted, if only for Member States which are not part of the UP system, a dual system should be established to achieve the desired harmonization and transparency, combining a unitary SPC system for “Unitary patents” and a single grant mechanism for national SPCs based on “classical” European patents. A single grant mechanism simplifies the administrative process, limiting duplication of work for applicants and national offices (NPOs), thereby allowing better use of resources and expertise. It allows any company holding a MA, centralized or not, to obtain national SPCs by filing a single SPC application through this mechanism. It improves consistency across NPOs’ practices as well as facilitates the transparency and availability of EU-wide SPC information through a common register. The system delivering unitary SPCs and SPCs based on “classical” European patents should rely on a single centralized granting body to achieve the necessary harmonization. The body entrusted with granting SPCs should have expertise with patents, regulatory and administrative procedures but also with the specific need of SPCs in our industrial sector. We recommend the creation of a virtual granting authority composed of SPC experts from NPOs. A single body for both pathways ensures a cost-efficient system. It is critical that decisions made by the virtual granting authority are challengeable before an instance which has the required SPC expertise. It must be possible for this body to refer points of law under the SPC Regulation to the CJEU to ensure a consistent interpretation. Targeted amendments of the SPC Regulations (option C2) are unnecessary and unlikely to address the stated policy objectives. Many questions have been answered by the CJEU and it is unlikely that the substantive law could be clarified satisfactorily or comprehensively in an amended version. Any new provision or wording would inevitably raise new questions for interpretation by the CJEU, lead to further uncertainties for all parties and thus jeopardize the SPC system. Interpretative guidelines (option B) for the examination of SPC applications could provide illustrative guidance on how to apply the SPC Regulation in light of the CJEU case law and thereby facilitate decisions by the new centralized body (Option C1). We stand ready to further discuss with the EC.
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Meeting with Margaritis Schinas (Vice-President) and

8 Oct 2021 · Pharma policies

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

Boehringer Ingelheim welcomes the opportunity to input into this consultation. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective and stands for continuous investment in medical innovation to improve the health of humans and animals. As a research-driven biopharmaceutical company, our patient-centric research focus lies on areas of high unmet medical need. Sustainable development and careful use of resources is part of our DNA. The Commission’s evaluation is an opportunity to build on learnings from the COVID-19 pandemic and to foster pro-innovation policy frameworks that incentivize investments into R&D and new scientific advances. Faced with global competition, the EU should further build a world-class regulatory system and digital infrastructure to lead the innovation race and ensure that patients get rapid access to innovative therapies. We would like to make the following proposals and refer to EFPIA’s positions for further details: To enable the regulatory framework to respond quickly to patient needs, we propose to: - Reinforce expertise-driven assessment and enable a more agile centralized authorization framework by removing unnecessary interfaces between the Commission, EMA and Committees; - Enhance the expedited pathways framework supporting innovation; - Expand the role of EMA in the assessment of drug-device/diagnostic combination products; - Allow replacement of the paper patient information leaflets with electronic versions. Moreover, it is crucial to identify and remove barriers that could block future innovative R&D approaches in Europe, e.g. by ensuring the acceptance of real-world evidence in medicines evaluation pre- and post-authorization. The revision of the Variations Regulation 1234/2008 is required to simplify and modernize the EU post-approval framework. We also believe that enhanced security and transparency of supply chains using the data stored in European and national repositories can provide additional intelligence in monitoring drug shortages. We urge the Commission to maintain the currently balanced incentives framework in Europe. Incentives are essential to stimulate long-term, costly, high-risk investments and to drive scientific progress and medical innovation for the benefit of patients and health systems. A strong and reliable incentives framework strengthens the EU’s competitiveness, creates growth and jobs and ensures that the EU remains a powerhouse of biopharmaceutical innovation. For areas where there is a lack of a viable market (e.g. antimicrobials) and where the current framework has not yet covered all needs (e.g. OMP/Paediatrics), we suggest that novel incentives adapted to the specific challenges of particular disease areas will be considered. To attract investment to Europe, it is important that incentives are predictable and do not change at a late stage in the drug development process due to other factors. Since access to medicines is dependent on mostly national and health system related factors as well as market dynamics, which cannot be foreseen at the time of R&D investments, linking incentives to access could jeopardize the objectives of incentivizing and improving access to innovation in the EU. Access barriers to innovation cannot be solved through a revision of EU legislation, but should be addressed through careful analyses of access delays and availability issues of specific products in specific countries. A strengthened framework for EU HTA collaboration, including the development and mandatory use of joint clinical assessment reports, would go a long way towards improving access to innovative therapies. Boehringer Ingelheim is committed to work with the Commission and stakeholders on these topics and to contribute to building a strong and future-oriented EU life sciences ecosystem for the benefit of patients.
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Meeting with Thierry Breton (Commissioner) and

16 Feb 2021 · Pact for Skills roundtable with the representatives of the health sector

Meeting with Nicolas Schmit (Commissioner) and

16 Feb 2021 · Pact for Skills roundtable with the representatives of the health sector.

Response to Revision of the EU legislation on medicines for children and rare diseases

5 Jan 2021

Family-owned since it was established in 1885, Boehringer Ingelheim (BI) pursues a long-term vision and stands for continuous investment in medical innovation to improve the health and quality of life of humans and animals. Building on a strong heritage in treating communicable and non-communicable diseases, our patient centric research focus remains on diseases where the medical need for innovation is high for all humans, including rare diseases (RD) patients. We consider paediatric development as an integral part of the overall drug development process and are committed to driving research and development of therapies for RD. In doing so, we apply a holistic approach to patient support that addresses patients’ medical needs and barriers to access. BI calls on the Commission (EC) to foster pro-innovation policies in the EU that continue to attract investments into pharmaceutical R&D. We support the aim of the EU Paediatric and Orphan Regulations and believe that children and RD patients have greatly benefited from the progress achieved through the legislation. We are committed to further contribute to the important task to provide better medicines for children and RD patients and welcome the opportunity to share our views on the IIA. We urge the EC to take into consideration the below points, reflecting the aligned industry view put forward by the European Federation of Pharmaceutical Industries and Associations. There is a need for new incentives, dedicated research funding and accelerated regulatory pathways to stimulate R&D in areas of unmet need. We believe that any process to identify unmet needs must be built on a multi-stakeholder discussion –including patients and caregivers– and spill over to and be recognized by downstream decision-makers, i.e. HTA bodies and payers. Reducing rewards for fulfilling the paediatric investigation plans obligations or reducing incentives to focus only on ultra-RD where no treatment exists or on first in class innovation will not redirect R&D into areas of needs. Instead, it risks leaving out significant numbers of pathologies and patients and undermining Europe’s attractiveness as a region for innovation. Reducing prevalence thresholds or using a cumulative prevalence criterion fails to recognize the importance of follow-on innovation to achieve meaningful patient outcome. Making rewards and incentives conditional on launch obligations fails to understand the economics behind biopharmaceutical research and the complexities of launching medicines across the EU. Developing medicines for children and RD patients only provides a very marginal economic case, which is why these areas are not attractive to generic and biosimilar developers. We encourage the EC to urgently identify the multifactorial root causes of access differences to find targeted solutions through collaboration with other stakeholders including national healthcare systems (e.g. HTA and P&R bodies). There needs to be a recognition that wealthier EU Member States (MS) should not benefit from the lower prices that ought to be available, in the interests of patient access, to lower-income MS. We welcome the EC’s intention to keep pace with scientific and technological developments and ensure that procedures remain efficient. Regulatory authorities should be entrusted to ensure that the system works and keeps up with global regulatory and scientific developments. Key scientific and procedural developments can be consolidated in guidance, e.g. on issues such as biomarker-defined conditions or class waivers for paediatric development. We believe that necessary improvements should be implemented by pragmatic measures and optimized interpretation of the Regulations, rather than by re-opening them. Therefore, we call on the EC to also consider the options identified in the IIA as ‘baseline’ options. We stand ready to work with the EC to ensure future development and delivery of innovative medicines for all patients in Europe.
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Response to Commission Implementing Decision on standard contractual clauses for the transfer of personal data to third countries

10 Dec 2020

Dear ladies and gentlemen, Boehringer Ingelheim welcomes the opportunity to provide feedback regarding the European Commission’s consultation regarding a draft implementing decision on Standard Contractual Clauses for the transfer of personal data to third countries pursuant to Regulation (EU) 2016/679 of the European Parliament and of the Council as set forth in the atteched document. Kind regards on behalf of Boehringer Ingelheim Global Data Protection Office
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

25 Jun 2020

Family-owned since it was established in 1885, Boehringer Ingelheim pursues a long-term vision and stands for continuous investment in medical innovation to improve the health and quality of life of humans and animals. Building on a strong heritage in treating communicable and non-communicable diseases, our patient-centric research focus remains on diseases where the medical need for innovation is high. In animal health, BI stands for advanced prevention. Given our strong footprint in Europe, we welcome the EU Commission’s objective to develop a Pharmaceutical Strategy, which ensures that the European pharmaceutical industry remains “an innovator and world leader” and that patients get access to the treatments they need. In our view, the strategy should focus on building a thriving European life sciences ecosystem, which efficiently enables and supports innovative healthcare solutions and thus allows Europe’s citizens to benefit from medical innovation. It should also pursue a “One Health” approach to prevent future global health crises. To deliver on its own objectives, Boehringer Ingelheim calls on the Commission to develop a more ambitious strategic framework, which fosters a pro-innovation policy environment that continues to attract also foreign investments into R&D to secure future growth and competitiveness - particularly important to support economic recovery. The Strategy should focus on three key objectives: 1. Guarantee a stable Intellectual Property (IP) framework and avoid erosion of patent rights. IP is essential to stimulate long-term, high-risk investments and to drive scientific progress and medical innovation for patients. Strong and reliable IP and patent frameworks strengthen the EU’s competitiveness, create growth and jobs, attract the world’s smartest brains and ensure that the EU remains a powerhouse of biopharmaceutical innovation. The Strategy should build on the EU’s successful IP legislation and must not put it at risk. 2. Design the world’s most efficient, state-of-the-art regulatory system and digital infrastructure. The EU should not only be a leader in driving R&D but also in translating new scientific developments and technologies into actual treatments for patients. The Pharmaceutical Strategy should help boost the development and use of digital technologies, including the EU Health Data Space, and support enhanced and broader evidence generation through increased acceptance of Real World Evidence and related new platforms. 3. Ensure supply and access to innovative treatments. Boehringer Ingelheim welcomes the Commission’s intention to strengthen strategic value chains and framework conditions for European production. We operate in a global supply network and are convinced that global supply chains remain essential for the high-quality development and reliable delivery of innovative biopharmaceuticals. Protectionist measures or short-term interventions may lead to unintended effects in the market and must be avoided. Our own production network encompasses the entire value chain from raw materials to finished pharmaceutical products, and our company retained the ability to deliver its treatments to patients during the COVID-19 crisis. Healthcare systems face challenges due to ageing populations, the burden of chronic diseases and increased budget pressures, potentially aggravated by the COVID-19 crisis. The Pharmaceutical Strategy and related initiatives represent an opportunity to strengthen healthcare systems by striking a balance between the need for sustainable healthcare spending whilst incentivizing sustained investments into future innovation. We also call on all EU institutions to ensure the rapid implementation of a strengthened framework for EU collaboration on HTA, including the development and use of joint clinical assessment reports to optimize resources and value-based reimbursement to maximize the availability of innovative therapies for patients.
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Response to Animal disease notification, reporting, surveillance, eradication and disease-free status

3 Jul 2019

Regarding Part VI Bovine Viral Diarrhoea, I have concerns with the conditions within Section 2 ‘Maintenance of the Status’. This section relates to the requirements for maintenance of BVD free status and only allows a zone/Member State to be recognised as BVD free if vaccination is prohibited. The general model of BVDV control is based on three key elements: biosecurity to prevent introduction of infection into BVD free herds, elimination of PI animals to reduce virus circulation and surveillance of BVD free herds to enable early detection of reinfection (Lindberg and Alenius, 1999). Vaccination is considered to be an essential biosecurity measure and accordingly, surveillance, the final aspect of eradication, can be implemented using diagnostic procedures which accommodate for the use of vaccines against BVDV e.g. youngstock spot tests. In Europe, there are two main types of systematic control programmes in place, those allowing and those prohibiting vaccination. The first BVD eradication programmes were launched in the 1990s and prohibited vaccination (Hult and Lindberg, 2005). Stakeholders in these countries chose this method because, in their unique situations of remote geography and low cattle density, BVDV-specific antibodies were always indicative of field BVDV infection. All of the more recent BVDV control programmes have allowed vaccination, and in fact in Germany, due to previous negative experiences where vaccination was discontinued, authorities in certain states subsidise and can order BVD vaccination (Bachofen et al., 2013). Furthermore, almost all countries with systematic control programmes that prohibited vaccination have reported severe damage from the reintroduction of BVDV into cattle populations that have become seronegative, and vulnerable, following the removal of PIs and the constant natural immune boosting that these animals provide (Moennig and Becher, 2018). The approach proposed in this legislation is appropriate for the majority of other viral pathogens e.g. IBR, FMD, Aujeszky’s etc. however BVD is highly infectious, has the ability to cross the placenta and create persistently infected animals and can cause severe economic and welfare implications, particularly when re-introduced into a naïve population. The absence of antibodies against BVDV is not a pre-requisite to proving that virus is not circulating within a population. Furthermore, in contrast to IBR, the presence of BVDV antibodies does not represent any risk in terms of the potential for reactivation of latent virus but in fact demonstrates some level of protection against BVDV. On this basis, I ask that the prohibition of vaccination is reconsidered and options are provided for Member States to become ‘BVD free’ while maintaining the opportunity to protect the health and welfare of their susceptible bovine population from the reintroduction of virus with the use of the safe and efficacious vaccines that are available in Europe.
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Meeting with Günther Oettinger (Commissioner)

27 Nov 2018 · MFF

Meeting with Maria Asenius (Cabinet of Vice-President Cecilia Malmström), Miguel Ceballos Baron (Cabinet of Vice-President Cecilia Malmström) and European Federation of Pharmaceutical Industries and Associations

19 Nov 2015 · TTIP