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Bristol-Myers Squibb Company

BMS

Bristol-Myers Squibb is a global biopharmaceutical company that discovers, develops and delivers medicines for serious diseases.

Lobbying Activity

Meeting with Andi Cristea (Member of the European Parliament) and American Chamber of Commerce to the European Union and

25 Nov 2025 · Recent developments in EU-US trade policy

Meeting with Michele Picaro (Member of the European Parliament)

20 Nov 2025 · Meeting

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

18 Nov 2025 · Biotechnology acts

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

18 Nov 2025 · to follow

Meeting with Hildegard Bentele (Member of the European Parliament) and American Chamber of Commerce to the European Union and

8 Oct 2025 · Biotech

Meeting with Victor Negrescu (Member of the European Parliament) and American Chamber of Commerce to the European Union and

8 Oct 2025 · AmCham EU Healthcare Committee Meeting

Meeting with Giulia Del Brenna (Head of Unit Internal Market, Industry, Entrepreneurship and SMEs)

30 Sept 2025 · Issues and concerns related to the EU’s competitiveness in this sector, in particular regarding European legislation, U.S. tariffs on pharmaceuticals, and intellectual property.

Meeting with Rainer Becker (Director Health and Food Safety)

17 Sept 2025 · Exchange on clinical trials in the context of the upcoming proposal for an EU Biotech Act

Meeting with Aurelijus Veryga (Member of the European Parliament)

10 Sept 2025 · The Critical Medicines Act: Opportunities Ahead

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

10 Sept 2025 · Critical Medicines Act and procurement

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

30 Jul 2025 · Critical Medicines Act

Meeting with Viktória Ferenc (Member of the European Parliament)

2 Jul 2025 · Introduction, exchange of views on pharmaceutical legislation

Meeting with Kris Van Dijck (Member of the European Parliament)

30 Apr 2025 · pharma industry in the EU

Bristol Myers Squibb urges stronger IP and innovation rewards

17 Apr 2025
Topic — A consultation on a new strategy to boost European life sciences competitiveness.
Message — BMS calls for stronger intellectual property rights and an ecosystem that rewards innovative products. They argue for increasing healthcare budgets to allow for faster deployment of new treatments.123
Why — Enhanced intellectual property protections would safeguard their investments and ensure faster reimbursement for medicines.45
Impact — Public health payers face higher costs from increased healthcare budgets and delayed generic competition.67
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Meeting with Andreas Glück (Member of the European Parliament)

22 Jan 2025 · Health

Meeting with Tomislav Sokol (Member of the European Parliament)

22 Jan 2025 · Health Policy

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

21 Jan 2025 · Biotech sector in the EU

Meeting with Aurelijus Veryga (Member of the European Parliament)

21 Jan 2025 · The Future of Clinical Trials and the EU Life Sciences Strategy

Response to Health technology assessment – Joint scientific consultations on medicinal products for human use

28 Oct 2024

BMS welcomes the opportunity to comment on the JSC Implementing Act. JSCs play a key role in establishing a dialogue between HTDs and HTA bodies on variations in clinical practice and how these will be handled methodologically. Discussions on the relevance of comparators for the EU process, the evidence that supports the use of these comparators and statistical/methodological considerations are intrinsically linked. The questions asked and the answers provided should be framed in a way that drives answers to these fundamental issues which will ensure we elevate the overall quality of joint clinical assessments in Europe. In line with those objectives, our points of concerns and recommendations are the following: (A) Limited, slot-based system of JSC request periods. The proposed slot-based planning and frequency of requests is too limited in time and does not reflect the industry reality in a global drug development environment. At least 4 request periods per year for medicinal products would be preferrable (Art. 2(2)). The Commission and HTA bodies should ensure sufficient resource capacities to make JSCs operational in practice, with no delay on the regulatory SA process. The concept of granted requests should be clarified, in conjunction with the criteria of Art. 17(3) of the HTA Regulation, to ensure proper consideration and justifications for non-granted requests. We recommend clear methodology on granting or refusing requests, with the main criteria being the complexity of the potential JCA (e.g. multiplicity of PICOs, requirement of advanced statistical methods for comparative efficacy, complex endpoints), to maximize the value of the JSC. (B) Timelines and confidentiality. Very low clarity is given to the confidential treatment of the information submitted by the HTD (Art. 6) and to the deadlines/timetables for submission of the briefing package (Art. 4(1)). The text should include rules preventing the dissemination of information outside the JSC subgroup, avoiding the dissemination of business-sensitive information, including the outcome document. It should also set minimum timeframes for the submission of the briefing package and amended briefing package. (C) Purpose of the JSC meeting and scope of questions for discussion. The JSC meeting with the HTD is crucial for quality. However, no clarity is given to the scope of questions/issues for discussion. It should be explicitly specified that the list of questions for discussion shall be drawn up taking into account the questions sent in by the HTD in the briefing package, and that the list of issues prepared by the JSC subgroup is an indicative scope of the topics for discussion (Art. 9(1)). The JSC meeting will also cover other elements from the briefing package and the questions provided by the HTD (Art. 12). (D) Coherence and continuum of information among various HTA and regulatory processes. The EU HTA work, as well as the EU/national regulatory procedures for medicinal products, should be run in a coherent manner ensuring a continuum of information so that the JSC dialogue informs the generation of evidence that supports JCAs. Provisions organising the cooperation between the HTA secretariat and the EMA (e.g. Art. 7(5) Art. 8) should aim to promote coherence across JCAs, JSCs and EMA procedures (Recital 11). The outcome document shall be the result of a coherent advice, recognizing the complexity of the treatment landscape, rather than a compilation of all country specificities (in the spirit of Art. 16 of the HTA Regulation as well as Art. 8 for JCAs).
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Meeting with Vlad Vasile-Voiculescu (Member of the European Parliament)

13 Sept 2024 · Introductory Meeting

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

11 Sept 2024 · European Health policy

Meeting with Christian Ehler (Member of the European Parliament)

19 Jul 2024 · European industrial policy

Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

25 Jun 2024

Bristol Myers Squibb (BMS) acknowledges the draft implementing act on managing conflicts of interest (CoI) in the Health Technology Assessment (HTA) joint work. We ask the Commission to revise its approach to allow the involvement of the best available expertise, ensuring transparency in documenting experts declared interests, thereby fostering an inclusive and high-quality system. BMS is committed to managing CoI and adheres to stringent rules in the context of the European Medicines Agency (EMA) and Member States authorities. However, we find the proposed CoI framework for the joint HTA work too rigid given the potential shortage of EU/international experts with relevant disease knowledge. Insufficient expert participation may compromise the quality and legitimacy of the joint HTA outcomes. It is important to note that experts are consulted for their insights and do not have voting rights. The responsibility to weigh the input provided by different experts rests with the assessors, co-assessors, and JCA subgroup. We therefore advocate for a more flexible and inclusive CoI management approach. Art. 25 of the HTA Regulation (2021/2282) states that the Commission shall adopt general procedural rules ensuring that the members of the Coordination Group, patients, clinical experts and other experts take part in the joint work in an independent and transparent manner, free from CoI. Art. 5(7) requires the Commission to lay down rules for the implementation of the CoI policy, in particular rules for the assessment of CoI () and the action to be taken where a conflict or potential conflict arises. However, the exclusion table in Annex II of the proposed implementing act risks undermining the quality of the new system by potentially excluding the best clinical and patient experts. The limited pool of experts in the context of increased activities requires a more nuanced approach with different types and degrees of CoI (direct, indirect, potential). The difficulty to find, train and retain experts in Europe is a serious obstacle, especially for rare diseases and highly innovative treatments with complex technologies or specific populations (e.g., precision oncology), in certain fields (e.g., gene therapy, AI, Biostatistics) and pathologies (e.g., multiple myeloma, lupus and beta-thalassemia). Annex II fails to reflect this reality and would result in frequent de facto unilateral exclusion of experts, which in our view goes beyond the spirit of Articles 25 & 5 of the HTA Regulation. Should a reference be made to such a table, we believe it would be appropriate to do so in a guidance document inspired by current EMA practices, built on the model of a more nuanced classification system for CoI. It would also allow for more periodic reviews to ensure the adequacy of the CoI criteria with the evolutions of the healthcare landscape. While we appreciate the provisions in Art. 7(3) & 8(5) of the draft implementing act that permit the participation of patients and experts by transparently disclosing their interests, we believe this should be the norm, not the exception. Furthermore, the individuals level of expertise should be a key consideration to ensure that those with the most relevant expertise are not uncritically substituted with less experienced individuals. Instead of default exclusions, a more flexible and balanced system should allow participation with full disclosure of interests and consideration of their magnitude and potential implications. This would enable more informed deliberations (reference in the attachment) and the gathering of high-quality pan-European experience. Not all CoI necessarily lead to bias when properly managed and framed to preserve impartiality of the final outcomes. Different grades of CoI and different degrees of participation/restriction measures exist in the Member States and other mature HTA systems, and should inspire the EU approach.
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Bristol-Myers Squibb Urges More Involvement in EU Clinical Scoping

29 Mar 2024
Topic — New rules for the joint clinical assessment of medicinal products across Europe.
Message — BMS requests that drug developers propose assessment scopes and be involved throughout scoping. They also call for longer deadlines to submit high-quality evidence dossiers.12
Why — The company would gain better predictability and resource efficiency during assessments.34
Impact — Public transparency is reduced by stricter protections for commercially sensitive data.5
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Meeting with Deirdre Clune (Member of the European Parliament)

21 Feb 2024 · Pharmaceutical Package

Meeting with Ondřej Knotek (Member of the European Parliament)

20 Feb 2024 · Pharmaceutical package

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and Affordable Medicines Europe

5 Jan 2024 · Directive on Medicinal products for human use

Meeting with Javier Zarzalejos (Member of the European Parliament, Shadow rapporteur)

4 Dec 2023 · Meeting with Bristol Myers Squibb to discuss the Supplementary protection certificates (SPCs) package

Meeting with Tomislav Sokol (Member of the European Parliament, Shadow rapporteur) and Novo Nordisk A/S

15 Nov 2023 · Pharmaceutical legislation

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

8 Nov 2023 · Reform of the EU pharmaceutical legislation

Meeting with Javier Zarzalejos (Member of the European Parliament, Shadow rapporteur)

6 Nov 2023 · Meeting with Bristol Myers Squibb to discuss the Supplementary protection certificates (SPCs) package

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

10 Oct 2023 · Directive on Medicinal products for human use

Meeting with Tom Vandenkendelaere (Member of the European Parliament)

5 Oct 2023 · pharmaceutical review

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

4 Oct 2023 · SPC Package (staff level)

Meeting with Pernille Weiss-Ehler (Member of the European Parliament, Rapporteur) and American Chamber of Commerce to the European Union and

11 Jul 2023 · Directive on Medicinal products for human use

Meeting with Billy Kelleher (Member of the European Parliament)

28 Jun 2023 · Pharmaceutical Strategy

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

7 Apr 2023 · National Action Plan for Cancer and EU opportunities

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

15 Nov 2022 · European Health Data Space - EHDS

Meeting with Tom Vandenkendelaere (Member of the European Parliament)

19 Apr 2022 · General introduction

Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

Bristol Myers Squibb (BMS) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. New medical technologies, from innovative oncology and immunotherapies to mRNA and CRISPR gene editing offer unprecedented opportunities to improve the lives of Europeans. Powerful new data sciences and technologies, from artificial intelligence to cloud data-sharing services, are transforming the way we develop and assess new medicines. The European Commission’s recently announced “Evaluation and revision of the general pharmaceutical legislation” will be based on a historical evaluation of the strengths and weaknesses of the existing legislation. While the words “future-proofing” can be found in the roadmap, the Commission’s work plan would benefit from a robust prospective analysis identifying and understanding the future of medical and data technologies, especially as it relates to innovation and competitiveness within the biopharmaceutical industry, if it really wants to build a model fit for the future. Europe’s regulatory framework must continue to keep pace with science and technology evolution, and address fragmentation in order to remain world-class in the face of ever-changing global regulatory models. We have seen some forward looking flexibility in the COVID crisis response, through use of rapid and flexible pathways in the regulatory process, and global coordination and learnings from other regions and EMA’s own 25 years of experience. Europe has thus an unprecedented opportunity to design a future-proof, agile regulatory model, adapted to fast pace science and technology, including solid expedited pathways and flexibility, that would build on linking enhanced iterative regulatory dialogue with rapid data submission upon ongoing evidence generation and enabled by contemporary information technology capabilities. This model would allow more rapid approval of medicines and faster access for patients to new treatments. Drug development is at its very core a collaborative process. Much of our innovation at BMS comes from within, transitioning ideas from discovery to development to regulatory to commercial application. These ideas are often the results of our partnerships with either academics or ‘biotechs’. We welcome opportunities to co-create good science across a broad set of partners in the scientific community. Today we have more than 100 active partnerships and collaborations with academic research centers, laboratories, clinicians, clinical trials organizations, and pharmaceutical and biotech firms around the world. The COVID-19 pandemic has demonstrated that the European biopharmaceutical collaboration model is not as resilient as it should be. It needs to foster smaller European biotechs and academic partnerships as catalysts for new ideas. A legislative requirement for companies to supply all 27 EU markets may not be sustainable for smaller biopharmaceutical companies and therefore jeopardize this synergy around innovation and undermine the European biopharmaceutical ecosystem. There is a clear opportunity for the Commission to strengthen this ecosystem particularly by supporting and enhancing smaller innovation centers, currently at high risk of disappearing. The Commission’s Inception Impact Assessment states that “the long-term positive economic effects to the global pharmaceuticals market are likely to counterbalance the initial one-off negative economic impact created by additional obligations to operators”. Global markets and investment decisions will be the ultimate arbiter of the validity of such statements.
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Response to Revision of the EU legislation on medicines for children and rare diseases

6 Jan 2021

As a global biopharmaceutical company focused on transforming the lives of patients through science, Bristol-Myers Squibb (BMS) strongly believes in a legislative framework conducive to medical innovation addressing unmet needs (UMN) and available to all patients who need it. However, we believe that the Commission’s options laid out in the inception impact assessment are unlikely to achieve the desired objectives. With therapies approved for 107 conditions since its adoption, 20-50% of which have been attributed to the legislation depending on estimates, the OMP Regulation is an undeniable success. BMS agrees that more needs to be done in therapeutic areas where no treatment exists, but UMN as a concept should not be restricted to diseases with no treatment option. In many therapeutic areas where new medicines have been authorized in the past years (including oncology), patients face poor outcomes and are waiting for medical progress. Strong incentives therefore need to be upheld even in those areas with approved therapies. Secondly, pharmaceutical innovation builds on the advancement of science and progresses in building blocks. More targeted incentives are unlikely to generate innovation where the basic science may be lacking and the Commission should instead consider what can be done from the public sector perspective, collaboratively with stakeholders. The above also applies to the Paediatric Regulation, which has had a substantial impact on medicines development as recognized by the Commission’s 10-year report. As a first step, the EMA-European Commission “Joint action plan” should be fully implemented, including identification of UMNs. The Commission concludes that “overcompensation” of OMPs needs addressing, yet the Technopolis report has shown such cases to be marginal, with 50% of products having an annual turnover of €10 million or less and only 15% a turnover of over €100 million. The report also suggests that the “artificial splitting of common diseases into rare subsets” are rare scenarios and subject to strict conditions. In addition, a market exclusivity (ME) period may be granted for each new condition for which a product is developed and approved, which is justified as such periods are independent, not cumulative and compensate specific requirements for separate development programs. Lastly, the Commission’s 2016 notice to applicants on articles 3, 5 and 7 of the OMP Regulation has reinforced evidence requirements to maintain the significant benefit assessment and obtain or maintain ME. The sharp decrease in the number of new orphan designations and increase in withdrawals of ODs from 2016 onwards demonstrates the system’s rigor. Medical innovation serves no purpose if patients cannot access it, and BMS shares the Commission’s concern with delays and unavailability of medicines in the EU. However, conditionality of incentives will not resolve this issue, as its causes are multifold and rooted in complex and country-specific operating environments. Strong differences in spending levels, administrative processes, differences in evidentiary requirements, misalignment in perceptions of price and value, and external reference pricing are among the complex access hurdles faced by manufacturers. Improvements to the current system are possible without jeopardizing the EU’s innovation ecosystem and BMS welcomes the Commission’s focus on modernizing the legislation and increasing efficiency. Novel rewards such as priority review, vouchers and increased scientific interactions (like the FDA’s breakthrough designation with its rolling review) attached to a regulatory “expedited pathway” are interesting avenues to stimulate innovation. Evolving EMA guidelines to enable greater acceptance of real-world evidence, and greater flexibility in requirements at the time of market access would also contribute to attracting investment in rare diseases. BMS is ready to discuss such concepts with the Commission.
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

Bristol Myers Squibb (BMS) welcomes the opportunity to provide input in this public consultation for the revision of the Blood, Tissues & Cells Legislation. In this contribution we will focus on the Blood directive specifically. For our response to the Tissues & Cells Legislation, we refer to the contributions of EFPIA, ARM and EUCOPE. BMS has cooperated with a large and diverse group of stakeholders in the blood transfusion space, including experts from the fields of haematology and blood management, nursing, patient advocacy, health economics and hospital management, to develop the Blood and Beyond initiative. The aim of the initiative is to raise awareness of the impact of blood transfusion on patients, support networks, healthcare systems and society at large; with the overarching goal to help advance policies and practices that improve patient outcomes by optimizing blood management and supporting innovation across Europe. The recent report published by the Blood and Beyond initiative provides recommendations that can contribute to the overall objectives of the revision of the Blood directive (attached). We welcome the revision of the Blood Directive as an important step to adjust the legislation to ensure sustainability of blood supplies, a need that is exacerbated by the COVID-19 pandemic. Sustainability of blood supplies We support the importance of defining a robust, forward-looking framework that addresses gaps and divergencies between countries to support a sustainable blood supply and use. - The revision of the Directive is an opportunity to embed best practices in managing the existing blood supply, including patient blood management principles (endorsed by the WHO) as an approach to optimize the care of patients who might need a blood transfusion while decreasing the amount of blood needed. This approach is not only valuable in the surgical setting, but also in medical care for chronic diseases (including cancer), especially as around 2/3 of red blood cell transfusions are used in medical care of these chronic diseases. - The revised directive should define measures to ensure the effective implementation of such best practices, like patient blood management, across Europe, as this will support optimization of clinical practice of transfusion as per WHO guidance. Additionally, this will support patient safety while conserving the blood supply. - EU monitoring of blood use needs to be based on accurate, comparable data collection systems. In order to provide evidence to support improvements in transfusion practices, anticipate blood shortages and optimize blood use, such monitoring should encompass types of uses, indications, observance of patient blood management guidelines and WHO/EDQM guidance in the field. - Future legislation should ensure a holistic and patient-centered approach to blood management in Europe. Changes to EU-wide quality oversight provisions should allow to address currently observed variations across countries, as reported in the evaluation. Implications of COVID-19 The COVID-19 pandemic has exacerbated existing challenges with regards to red blood cell supply and red blood cell transfusion services. The blood supply systems in Europe, that were already under pressure, became even more strained because of the effects of social distancing measures on blood donations. Some patients with chronic diseases requiring regular blood transfusions experienced disruptions in their transfusion care. Rethinking blood use in Europe to optimize blood management in chronic diseases is an urgent need and that should be taken into consideration in the revised legislation. (Blood and Beyond is a multi-stakeholder initiative developed and funded by Celgene, now part of Bristol Myers Squibb, involving experts from the fields of hematology and blood management, nursing, patient advocacy, health economics and hospital management.)
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Response to Europe’s Beating Cancer Plan

3 Mar 2020

BMS is grounded in the mission of delivering scientific breakthroughs to transform outcomes for cancer patients and has ignited an era of scientific innovation that has changed survival expectations in multiple tumor types through breakthroughs from taxane-based chemotherapy to immuno-oncology (I-O). We are actively engaged to find solutions to reduce the burden of cancer and improve the sustainability of our health systems, collaborating with all stakeholders. BMS strongly welcomes the EU’s commitment to reduce the impact of cancer in Europe. The pace of scientific discovery has yielded incredible advances in survival for cancer patients in the past decade – Europe’s Beating Cancer Plan must support such innovation to the benefit of EU citizens. To deliver on its potential, the Plan must orientate all eyes on the shared goal and progress must be measurable. BMS encourages the Commission to be bold and set ambitious, time-bound, EU-relevant targets and to engage all stakeholders to pool their expertise to achieve these. Knowledge, data and scientific evidence Ensuring access and use of data is a prerequisite for sustainable health systems and improved patient outcomes, but the full value of data and digital health solutions requires an enabling health data ecosystem. We look to the Commission to guide the development of a unified approach to the collection, curation, governance and interoperability of health data and the establishment of a European digital health infrastructure. - Data collection: address the fragmentation of data samples by supporting the development of uniform approaches to data collection based on open standards and interoperable medical records. - Data sharing: adoption of codes of conduct or secondary legislation to provide a framework for secondary use for health-related data. - Valuing data: guidance from the European Commission and relevant agencies on inclusion of patient-generated data and real-world evidence into evaluation methodologies used for regulatory and HTA purposes. BMS stands ready to share insights from its own experience through projects such as IO-Optimise, a partnership with healthcare systems across major countries to generate timely, ongoing and complementary real-world insights on the evolving lung cancers landscape to deliver value to healthcare professionals, patients, academic researchers, payers and regulators. Treatment and Care The EU regulatory framework for pharmaceuticals has been successful in bringing innovation to European patients. Similarly, the Intellectual Property Framework and other incentives have fostered unprecedented innovation in Europe. The Commission’s upcoming Pharmaceutical Strategy should continue to stimulate a dynamic innovation climate. BMS believes all patients should have access to optimal cancer care and we support policies that advance this effort. There are significant differences across Europe in the level of overall healthcare and cancer-specific investment, leading to persistent disparities in access and quality of care and reduced outcomes. The Beating Cancer Plan is an opportunity to address this and should include strategies to focus and optimise existing EU instruments to support Member States in levelling up health system performance (i.e. Joint Actions to promote best practice, EU Structural Funds to enable system improvements e.g. cancer registries, data infrastructure, AI etc). The establishment of a European Cancer Knowledge Centre holds vast potential for the pooling of expertise in research prevention, data and registries, as well in guidelines for cancer screening, diagnosis and care. Such a collective resource on which all Member States can draw would help Europe deliver on the promise to reduce inequalities and improve outcomes across the continent. Specifically, early diagnosis is key and BMS encourages the Commission to consider further guidance for cancer types including lung and skin cancer based on available evidence.
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Meeting with Annika Nowak (Cabinet of Commissioner Vytenis Andriukaitis)

8 Dec 2016 · HTA, HSPA

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

8 Dec 2016 · Innovation and investment