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Takeda Pharmaceuticals International AG

Takeda

Takeda is a global biopharmaceutical company focused on R&D for innovative medicines.

Lobbying Activity

Meeting with Ulla Schwager (Head of Unit Competition) and Johnson Johnson and

3 Dec 2025 · Exchange of views on developments in the pharmaceutical industry and aspects of competition law and policy enforcement in this industry sector

Meeting with Olivér Várhelyi (Commissioner) and

2 Oct 2025 · All pressing portfolio topics

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

25 Jun 2025 · the EU biopharmaceutical landscape

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

25 Jun 2025 · to follow

Takeda urges strong IP protections and rare disease action

17 Apr 2025
Topic — The EU is developing a strategy to improve competitiveness in life sciences innovation.
Message — Takeda recommends preserving predictable incentives and simplifying approval processes for new medicines. They propose maintaining current orphan designation thresholds and adopting a Rare Disease Action Plan. The company also advocates for long-term funding and enhanced health data sharing.123
Why — These measures would protect Takeda's high-risk investments and reduce their regulatory burdens.45
Impact — Generic drug manufacturers may face delayed market entry if current IP protections remain.67
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Takeda advocates for tailored rules on critical medicine supply

27 Feb 2025
Topic — This initiative addresses supply chain vulnerabilities and dependencies for critical European medicines.
Message — The organization requests a risk-based approach that avoids duplicating existing regulations. They oppose national stockpiling for plasma-derived products and urge focus on increasing plasma collection.123
Why — Tailored regulatory measures would prevent disruptions to complex manufacturing and lower inventory costs.4
Impact — Patients in some regions lose access if national stockpiling causes medicine shortages elsewhere.5
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Meeting with Niels Flemming Hansen (Member of the European Parliament)

11 Dec 2024 · Priorites for the mandate

Meeting with Christian Ehler (Member of the European Parliament)

10 Dec 2024 · Industrial Policy

Meeting with Stine Bosse (Member of the European Parliament, Committee chair) and DIGITALEUROPE and

10 Dec 2024 · European health policy

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

29 Oct 2024

An effective system for engagement and dialogue is essential for attracting R&D in the region and improving the EU's competitiveness. The development of this framework should be seen as an opportunity to enhance, not reduce, the EUs competitiveness. Takeda believes that addressing our concerns in the IA and upcoming guidance documents will significantly enhance the usefulness of the process and enable systematic, consolidated EU input into development plans. We ask our response also be considered in the development of JSC process guidelines. 1. Infrequency of request periods: Takedas main concern relates to the infrequency of request periods. The draft IA proposes, at least two request periods per year. To be most useful, the frequency of the JSC request periods should match that of the EMA which accepts scientific advice applications on a monthly basis, with clearly outlined timelines (see attached). The stated purpose of the JSC is for the HTA CG to support the HTD on their development plans for a given health technology (HTA Regulation, Article 16) and to improve the generation of scientific evidence. The proposed application schedule is inflexible and is misaligned to the dynamic medicine development process setting only two JSC application periods will not work and will limit the EUs ability to achieve this aim. We propose that monthly requests periods are introduced which would enable the HTDs to receive timely input into their development plans, as is current practice with the EMA. Furthermore, a calendar for JSC request periods and advice timeline should be published, in line with the EMA scientific advice calendar (see attached). This will improve efficiency in ensuring HTA advice is received in a timely manner during the dynamic development process. We note matched HTA-EMA advice availability was a recommendation in the EUnetHTA White Paper Future Model of Cooperation. With only 2 annual request periods, JSC slots are unlikely to match R&D milestones and may results in HTDs proceeding with development plans without EU input. This goes against one of the principle aims of the new EU HTA system, of attracting further R&D in the region. 2. Enabling individual expert input: Takeda supports the inclusion of individual experts in JSCs to ensure high quality and relevant input and welcome the provisions on confidentiality agreements. To further protect confidentiality, all participants should have individually signed confidentiality agreements and be bound to professional secrecy. If members of associations are involved in JSCs, the materials should be shared only with individuals under confidentiality agreements. This is critical as the briefing package contains commercially sensitive information. We would like to reiterate the importance of allowing sufficient time for identifying individual experts in upcoming JSC guidelines. This will enable the proper consultation of the stakeholder network on general issues and in the identification of individual experts. 3. Requests for additional evidence: According to the draft IA, assessors may request additional evidence at any point in the development of the outcome document. Additional questions and requests are most helpful before and during the advice meeting, however it is not customary to provide extensive evidence following a scientific consultation meeting. While we welcome the opportunity to provide clarifying evidence post-meeting, extensive requests for additional information should be limited without the opportunity for another meeting. 4. Capacity: The JSC subgroup must ensure that all HTDs that request JSCs receive it, and that all products subject to a JCA are eligible. Granting JSCs to first in class products will give an unacceptable competitive advantage. Thus, transparency, equitability and fairness in the JSC selection criteria is essential. To ensure sufficient capacity, Takeda supports a fee for service model for the provision of JSCs.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

26 Jun 2024

Involvement of the most knowledgeable patients and clinical experts in joint HTA work is pivotal for high-quality outputs which are relevant to the EU health system. This requires a pragmatic approach to CoI management which is transparent, flexible and aligned across EU institutions. The current Implementing Act (IA) falls far short of this as it is too restrictive and risks creating silos with negative consequences on the development of innovation. Close collaboration with stakeholders is critical for the development of medicines suitable for EU healthcare systems. The current IA text jeopardizes EU input into R&D as it creates a dichotomous system whereby experts are required to choose to either participate in research or participate in EU HTA. Instead, the IA can achieve the required objectivity of HTA outputs, while ensuring most qualified experts are available to assessors, by requiring transparency and managing of CoI. Takeda supports EFPIA and EUCOPEs position that COI should be declared and managed on a case-by-case basis, without strict exclusion lists. The algorithm in Annex II is deeply flawed, risks excluding the most competent experts and will lead to unintended consequences. Annex II should be removed as it is not appropriate for legislation and is better suited to a guideline that can be updated. A transition period should be introduced until the first legislation review in 2028, during which time, COIs should be declared but no exclusions should take place. This would allow the new system to learn from experience, prevent unnecessary exclusions and develop final CoI rules that are fit-for-purpose. We call for a harmonized approach to COI management by leveraging existing guidelines from EMA to ensure appropriate and timely implementation of HTA Regulation. We note EMA and mature HTA agencies (i.e. GER) take a different COI approach to decision makers (assessors, voting members) versus experts without decision power; the latter focused on transparent disclosure but not exclusion. The same approach should be applied to EU HTA. Our specific concerns are: 1. Limiting involvement of experts: Clinical and patient input in advisory boards is paramount in developing trials that address EU needs, utilise patient-relevant endpoints and are patient-friendly to ensure quality data collection without imposing an unnecessary burden. The CoI proposed rules would restrict advisory participation and risk creating a less patient-centric approach to healthcare. Aside from employment or current consultancy, all other interests should be declared and mitigated transparently, allowing patient and clinical experts without decision-making ability to participate. 2. Investigators should not be excluded to avoid the elimination of the most knowledgeable, and likely only experts with experience of using the technology. The IA risks adversely penalizing clinicians involved in research and it counterproductive to fostering a research friendly environment in the EU. 3. In rare diseases, the pool of available experts is even smaller, and there is a genuine risk of eliminating all experts if an overly restrictive approach is pursued. Specific exemptions for experts in small populations, must be introduced, not only through derogation as outlined in article 7. 4. Lead of an association: We welcome the shift from strict sponsorship thresholds but are concerned the role-based approach may eliminate relevant patient experts in small organisations and call for a case-by-case basis application. 5. Reimbursement of expenses: The proposed threshold is arbitrary, too low, and is not equitable across Member States. If unchanged, fewer clinicians will attend conferences, stifling education and knowledge sharing. To foster high quality assessments, we urge these changes be made so that the IA may enable necessary flexibility when seeking input from the most relevant patient and clinical expert regardless of their COI as far as COI is declared.
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Takeda Warns Proposed EU Health Assessment Rules Are Unworkable

2 Apr 2024
Topic — Commission implementing rules for joint clinical assessments of new medicinal products.
Message — Takeda demands mandatory involvement in the scoping process and significantly longer submission deadlines. They believe current timelines underestimate the resources required for high-quality dossiers.123
Why — Longer timeframes would help companies successfully manage complex data requirements for launches.45
Impact — Patients and health systems may receive low-quality assessments that hinder access.6
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Meeting with Alexander Bernhuber (Member of the European Parliament)

7 Mar 2024 · Pharma Package

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

24 Jan 2024 · Directive on Medicinal products for human use

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

Takeda Urges EU to Protect Predictable Pharmaceutical Innovation Incentives

24 Oct 2023
Topic — The European Commission is revising legislation to ensure affordable medicines and innovation.
Message — Takeda argues against using a strict legal definition of medical need to determine incentives. They reject requirements to launch products in every member state within a fixed timeline.12
Why — This would allow the company to maintain its current, predictable market protection periods.3
Impact — Environmental protection efforts suffer if risks cannot block medicine approvals by regulators.4
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Takeda urges predictable drug incentives and flexible market rules

24 Oct 2023
Topic — The European Commission is evaluating and revising the general pharmaceutical legal framework.
Message — Takeda seeks a predictable incentive system and opposes binding definitions of medical needs. They reject making rewards dependent on launching products across all member states.12
Why — A predictable framework allows the company to secure long-term investments in innovative treatments.3
Impact — Environmental advocates lose if ecological risks are excluded from drug marketing authorization decisions.4
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Meeting with Günther Sidl (Member of the European Parliament)

13 Jul 2023 · General Exchange of Views

Meeting with Margrete Auken (Member of the European Parliament, Shadow rapporteur)

7 Jun 2023 · Pharma legislation

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

7 Jun 2023 · Directive on Medicinal products for human use

Meeting with Salvatore De Meo (Member of the European Parliament)

1 Jun 2023 · SoHO

Meeting with Salvatore De Meo (Member of the European Parliament)

7 Mar 2023 · SoHO

Meeting with Kateřina Konečná (Member of the European Parliament, Shadow rapporteur)

21 Feb 2023 · SOHO regulation

Meeting with Elina Melngaile (Cabinet of Executive Vice-President Valdis Dombrovskis) and Plasma Protein Therapeutics Association Europe, international Association without lucrative purpose

20 Jan 2023 · EU-US Mutual Recognition Agreement on Pharmaceutical Good Manufacturing Practices

Response to Revision of the Union legislation on blood, tissues and cells

8 Sept 2022

As a patient-focused, values-based, R&D-driven global biopharmaceutical company, Takeda welcomes the proposal for a new Regulation on Substances of Human Origin (SoHO) and the Commission's efforts to help ensure legislation can respond to new scientific and technical developments while meeting the needs of European patients and safeguarding donor health and safety. Takeda has a long legacy in rare diseases and is a global leader in plasma-derived therapies (PDTs). We collect plasma in three EU countries and run four PDT manufacturing sites in the EU as part of an interdependent global network. We believe the proposal takes important steps to address the growing need of over 300,000 Europeans who rely on these lifesaving medicines, and Europe’s reliance on the US for 40% of the plasma needed to manufacture PDTs. However, EU legislators can do more to help ensure broad and reliable patient access to these therapies. As a PPTA member, we endorse their consultation response and emphasize the following: Our industry supports measures and standards based on scientific evidence that help ensure donor health and safety. For example, PPTA members implement voluntary industry standards that provide common definitions to assess and monitor Donor Adverse Events in plasma collection facilities. We therefore welcome proposals requiring SoHO entities to collect donor recruitment and collection data in a centralized EU SoHO Platform. However, we are concerned that the Regulation states that “donations of plasma imply a significant risk.” A recent PPTA study of over two million plasma donations has shown that adverse events related to plasma donations are very rare (around 16 events per 10,000 donations) and 90% are mild in nature. These results are confirmed by many scientific studies. Overall, the adverse events rate in plasma donors is comparable to that of whole blood donors. We support measures proposed to help Member States collect more plasma, such as differentiation of plasma for fractionation from blood components for transfusion, based on new definitions. These lay the ground to support the increased availability of plasma in Europe, including through different donor deferral criteria for plasma donors. We welcome clarification that a “fixed-rate allowance” is compatible with the ‘Voluntary Unpaid Donations’ principle. But we recommend retaining the Directive 2004/23 definition stating “donors may receive compensation… making good the expenses and inconveniences related to the donation”, as the inconvenience related to donations of different SoHO can be significant. To address the EU’s reliance on US plasma, the Regulation should inform Member States of the importance of developing proactive plans, in addition to emergency plans, to support the collection of critical SoHO like plasma for fractionation. For example, the Commission recognizes that plasmapheresis is the most efficient method to collect plasma, but not all EU countries have dedicated plasmapheresis programs. Takeda looks forward to collaborative dialogue with the SoHO Coordination Board and ECDC and EDQM and to supporting development of technical guidelines with our longstanding expertise in plasmapheresis and plasma for fractionation. This is critical to ensure guidelines consider the substantial differences, compared with transfusable components, around donor deferrals, mandatory testing, manufacturing, and storage. Guidelines should also strive for international regulatory convergence. Takeda believes that partnership between policymakers, regulators, patient organizations, clinicians and industry is critical to finding and implementing sustainable solutions. Given our industry collects almost half of the plasma required for Europe today from only four EU countries, we can be a key part of the solution alongside the public sector. We look forward to collaborating with all stakeholders to ensure that the final Regulation delivers for patients and donors.
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Takeda urges EU to modernize pharma rules through data innovation

27 Apr 2021
Topic — The consultation seeks to update EU pharmaceutical laws to ensure affordable innovation.
Message — Takeda advocates for a regulatory system that integrates real-world data and artificial intelligence. They also support a consensus-based definition for unmet medical needs.123
Why — Reducing administrative burdens and simplifying clinical trials would significantly lower compliance costs.45
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Takeda urges broader definitions and flexible incentives for rare diseases

6 Jan 2021
Topic — The EU is reviewing legislation on developing medicines for children and rare diseases.
Message — Takeda recommends redefining unmet needs to include factors like disease severity and quality of life. They urge for flexibility in paediatric study requirements and the integration of real-world evidence. The evaluation should cover the entire value chain from research to patient access.123
Why — Broader definitions and flexible requirements would reduce Takeda's regulatory hurdles and protect its research investments.45
Impact — National health systems could face increased budget pressure if more treatments qualify for high-value incentives.6
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

Takeda is a global, patient-focused, values-based and R&D-driven biopharmaceutical company committed to better health and a brighter future. We welcome the initiative to review EU legislation on Blood, Tissues and Cells (BTC) to ensure it considers new scientific and technical developments and includes the necessary provisions to meet donor and patient needs, while ensuring their safety. We acknowledge the IIA’s focus on options to update the legislation, but note important gaps between the policy options proposed and challenges highlighted in the 2019 Evaluation Report, especially regarding donation of plasma for fractionation to make plasma-derived therapies (PDTs). PDTs are critical, life-saving and life-sustaining medicines for people with rare and complex diseases. They are sometimes the only available treatment. Increased diagnosis rates, improvement in standards of care and broader indications have led to a surge in demand for PDTs, which continues to outpace supply. Significantly more plasma for fractionation must be collected in EU countries to meet growing demand for PDTs in Europe. Continued over-reliance on US plasma puts the sustainable supply of plasma products in the EU at risk. An enhanced role for the EU in supporting increased plasma collection is consistent with the Commission’s objective to “optimize access to, and avoid shortages of BTC therapies”, and its ambitions to “build a stronger European Health Union” and stimulate European competitiveness and strengthen Europe’s industrial base. We ask the Commission to help Member States and stakeholders collect more plasma by addressing legislation, regulatory hurdles and policy barriers that currently impede plasma collection for fractionation. EU and national legal frameworks must differentiate between collection of whole blood and blood components for transfusion, and, plasma collection for fractionation. Many of the restrictive measures applied to plasma for fractionation do not consider how collected blood or plasma will be used and therefore, in some cases, are inappropriately applied, i.e. PDT manufacturing processes already include effective pathogen inactivation and removal processes. This ‘one-size-fit-all’ approach to regulation limits the sourcing of plasma, inhibiting efforts to meet growing patient need. The revision should explore all options to increase plasma donation including updated donor acceptance criteria that reflect state-of-the art pathogen testing, and the co-existence of public and private infrastructure to ensure that industry can contribute to increasing plasma collection in support of public health. EU countries that allow industry to collect plasma, combined with balanced import/export measures, supply their patients more sustainably with PDTs than countries who do not. Providing incentives to plasma donors should be part of this review. Monetary compensation is effective in the four EU countries where this is permitted. Today, these countries collect over 50% of source plasma in Europe. Recognising the benefits of compensating plasma donors for time and inconvenience, as in Article 12 of the EU Tissue and Cells Directive, is critical. Whilst we recognise the need to accommodate regular updates to the legislation, future processes and procedures must be transparent and provide a framework for plasma collectors and fractionators to share their knowledge and expertise alongside experts in transfusion. We welcome robust, transparent and inclusive stakeholder consultation processes for any future framework for updating the legislation. Takeda has a 75+ year pioneering legacy in producing PDTs and is committed to enabling continuity of care for patients relying on our therapies through continued innovation and an acceleration of long-term investment. We look forward to working with policymakers and bringing new data and perspectives to the discussion on plasma donation in Europe to enable a more sustainable plasma landscape.
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Takeda urges EU to prioritize digital health and rare disease data

30 Jun 2020
Topic — Public consultation on a new EU pharmaceutical strategy for affordable and innovative medicines.
Message — Takeda requests the creation of a harmonised European Health Data Space. They advocate for using real world evidence to address rare disease uncertainties. The company also seeks to expand Europe’s plasma collection infrastructure.123
Why — Flexible evidence standards would help Takeda secure faster market access for drugs.4
Impact — Public health systems risk paying high prices for medicines with unproven benefits.56
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Meeting with Manuel Mateo Goyet (Cabinet of Commissioner Mariya Gabriel)

14 Sept 2017 · eHealth