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Astellas Pharma Europe Limited

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At Astellas, we are relentless in our pursuit of scientific progress and in identifying unmet medical needs by monitoring the changes in healthcare from multiple perspectives.

Lobbying Activity

Response to Gender Equality Strategy 2026-2030

11 Aug 2025

Astellas is committed to turning innovative science into VALUE for our societies, and women suffering from menopause symptoms is a priority. Menopause, though a natural stage of life, is a health transition and transformative life cycle stage for all women it is a life stage that profoundly shapes the health, well-being, and opportunities of millions of women, which requires adequate cross-area policy actions. Studies demonstrate how menopause symptoms impair womens work through absenteeism, presenteeism (working while feeling unwell), and reduced overall productivity. This results in reduced working hours, underemployment, unemployment, compromised career progression, withdrawal from the workplace, and financial insecurity for women. This also results in substantial effects on employers and economies at scale. Women experiencing the menopause transition represent an important fraction of the workforce globally. According to the European Menopause and Andropause Society (EMAS) worldwide, there are 657 million women aged 4559, and around half contribute to the labor force during their menopausal years. Scaled up, menopausal symptoms therefore have a significant impact on national economies, through reduced productivity and the loss of women from the workforce. Article 8 of TFEU states that the Union shall aim to eliminate inequalities and promote equality between genders. Thus, it is time to encourage adequate policy reforms that ensure access to health, care, treatments, reduce workplace discrimination, and support women and MSs economies. It is crucial to address the significant gaps in practices and policies across healthcare settings, workplaces, and society to create more supportive environments for women during the menopause transition. It is essential to drive this effort, and policy changes are necessary to ensure women are supported during this critical life stage. The Global Menopause Policy Platform (GMPP - an initiative sponsored by Astellas), composed of cross-country clinical experts and advocates representing 9 nationalities, identified the following priorities: 1. Workplace policies: The EU can play a role in encouraging and incentivizing the integration of menopause into employee support structures & HR programs. This includes encouraging employers to adopt policies that recognize the symptoms of menopause and foster inclusive, supportive work environments; and encourage and afford women to seek the care they need. 2. Funding research: The EU can make a difference by allocating funding for research on menopause and its economic impacts. This research would help guide national health policies and provide crucial data on how menopause affects womens health, productivity, and the economy at large. 3. Medical education: The EU can play an important role in calling for the inclusion of menopause in medical curricula and educational policies across MSs, so healthcare professionals are better educated about menopause, its symptoms, and the latest available treatment options. This will improve care at both primary and specialized levels. 4. Improving access to care: Given the impact of menopause on women, productivity, and the economy. The EU and governments should ensure dedicated Womens Health Strategies are in place and integrate menopause care into national health strategies and public health planning. This includes diagnosis, counselling, and treatment options to relieve menopause and related symptoms. 5. Public awareness campaigns: The EU should support and implement public health campaigns to provide evidence-based information and reduce stigma around menopause, thereby encouraging women to seek support proactively without stigmatization. We remain at your disposal for further cooperation - we are keen to connect your team with GMPP network to further discuss societal and medical needs and how to reduce gender inequalities.
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Meeting with Stéphane Séjourné (Executive Vice-President) and

19 May 2025 · Compétitivité, Simplification

Meeting with Pascal Arimont (Member of the European Parliament) and RPP Group

25 Mar 2025 · Addressing the Needs of Individuals with Geographic Atrophy (GA) and Vision Impairment – Breakfast discussion

Meeting with Stéphane Séjourné (Executive Vice-President) and

21 Mar 2025 · - Marché intérieur - Compétitivité - Sécurité économique - Simplification - Relation USA / Europe

Meeting with Pascal Arimont (Member of the European Parliament) and RPP Group

25 Feb 2025 · Geographic Atrophy

Meeting with Pascal Arimont (Member of the European Parliament)

16 Jan 2025 · Geographic Atrophy

Meeting with Pascal Arimont (Member of the European Parliament)

11 Dec 2024 · Geographic Atrophy

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

4 Dec 2024 · Plan de Acción Europeo en Trasplantes

Meeting with Pascal Arimont (Member of the European Parliament)

4 Nov 2024 · Geographic Atrophy and EU Activity

Meeting with Pascal Arimont (Member of the European Parliament)

9 Sept 2024 · Growing burden of geographic

Response to Health technology assessment – Cooperation with the European Medicines Agency

24 Jul 2024

Astellas welcomes the opportunity to comment on the Implementing Regulation on Information Exchange of the Coordination Group with the EMA and wishes to submit the following comments: General considerations: The period before submitting a Marketing Authorization Application is vital for developers competing to launch their innovations first in Europe. Most information covered by this Implementing Regulation comes from health technology developers (HTD), who should handle its dissemination to authorities and stakeholders. This data supports the EMAs planning and resource management. Given its competitive nature, such as target filing dates, it must be rigorously protected and disclosed only when necessary and relevant. Additionally, it should not appear in the Annual Work Plan of the Coordination Group in a way that could identify source data. Regarding Article 2: The EMA is required to share information by April 30th of the preceding year, but this information might not always be available at that time. We suggest a phased approach, releasing relevant information as it becomes available and limiting the sharing to what is essential for each specific submission. Regarding Article 7: Control over who receives information from the EMA is also critical. While this Implementing Regulation governs the information shared by the EMA through its IT system, with the secretariat of the Coordination Group (HTA secretariat), we would like to see the same level of technical and legal protection to apply when the HTA Secretariat shares the information received by the EMA with the Coordination Group and its subgroups. Regarding Article 8: The information the EMA is expected to share under this Implementing Regulation with the HTA Secretariat should always be communicated to the HTD. Furthermore, as the data originator, the HTD must be appropriately involved in the confidentiality assessment of any of its information that might be shared, ensuring this is done within adequate timelines. If the EMA is uncertain about the level of confidentiality, it must consult the HTD before sharing any information with the HTA Secretariat. For their part, the HTA Secretariat must assign at least an equivalent level of confidentiality to this information. This includes enforcing professional secrecy obligations for all employees and contractors who receive such information. Regarding Article 9: The proposed penalties for breaches of confidentiality do not provide an adequate deterrent against unauthorized disclosures. We strongly advocate for the implementation of stricter sanctions for individuals who violate confidentiality provisions that cover not only representatives of the Coordination Group, its subgroups or individual experts, but also all employees and contractors who may also receive such information. In addition, whenever the Commission becomes aware that a representative of the Members of the Coordination Group, its subgroups or individual experts failed to respect the obligations of professional secrecy, and a clarification of the situation is requested, the HTD should also be informed immediately. With these recommended changes, Astellas is confident that this Implementing Regulation will accomplish an effective and timely exchange of information between the Coordination Group with the facilitation of the HTA secretariat, with the EMA on the JCA and JSC.
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Response to Health technology assessment – Procedural rules for the assessment and management of conflicts of interest in joint wo

25 Jun 2024

Astellas summary statement on the draft Implementing regulation regarding the initiative Health Technology Assessment procedural rules for assessing and managing conflicts of interest The new EU HTA Regulation will increase the demand for clinicians, patients and other relevant external experts. Astellas believes it is crucial to balance managing conflicts of interest while effectively utilizing their input. Experts who participate in the joint work of the Coordination Group and its subgroups require a flexible and equitable approach with complete transparency about any potential conflicts of interest. Transparent collaboration should be prioritized over strict exclusion, with necessary interactions disclosed and carefully considered. Indirect interactions with developers should not disqualify experts from providing their expertise and experience to the joint work. In light of these considerations, we recommend the following changes to the implementing act and its annexes: We believe that for rare diseases, limitations and exclusions should not be enforced. Securing expert advice for rare diseases presents unique challenges. Clinician expertise in these areas is often difficult to engage. Patients often require extensive training. Given these complexities, conventional rules may be inappropriate and may exclude essential insights from patients, clinicians and other relevant experts. If indirect interests are transparently declared, they should not result in an exclusion, but in a full and open inclusion of expert input. Besides rare diseases, these principles are also critical for other areas with significant unmet medical needs. We recommend considering varying levels of conflicting interests to match clinicians' diverse profiles. Flexibility in the current regulation will ensure their knowledge is available for joint work. Annex II's stringent limitations may deter investigators and principal investigators, due to lack of conflict resolution alternatives. This could exclude valuable clinical insights, as the rules do not distinguish between research roles. A nuanced approach is needed to ensure clinicians' expertise is utilized and not sidelined by a one-size-fits-all policy. Ensure that the involvement of experts is determined by expertise needs and the level of potential conflict, not merely by the completion of a clearance period. The three-year clearance rule in Annex II for interactions with health technology developers could severely restrict expert involvement in joint work, potentially excluding crucial expertise. This is particularly concerning in fields like oncology and rare diseases, where experienced clinicians and patients are vital yet scarce. Assessments should prioritize expertise and manage conflicts rather than strictly adhering to a clearance period. Differentiate between direct and indirect interests to maintain necessary adaptability, in line with the EMA policy1. While direct interests such as employment or advisory roles must be reported and may prompt specific actions, indirect interests (e.g., investigator or principal investigator) should be reported but not automatically trigger restrictive measures. In the case of rare diseases, restrictions should only apply if there is a direct link with the health technology under discussion or its competitors, such as employment or consultancy roles. Finally, we recommend that external experts can challenge exclusion or limitations of the participation decisions, so to ensure fair and justified participation in the joint work. We trust that, with these changes, the implementing act and annexes will truly reflect the provision of the EU HTA Regulation and ensure equitable and fair participation in the joint work process of relevant experts. 1.European Medicines Agency policy on the handling of competing interests of scientific committees members and experts, 15 December 2022 EMA/136875/2022
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Response to Health technology assessment - Joint clinical assessments of medicinal products

2 Apr 2024

After careful review of the draft Implementing Regulation on the Joint Clinical Assessment (JCA), Astellas have significant concerns regarding its provisions in two major categories, specifically: the timelines for (finalizing) the scoping process and dossier preparation, and the lack of meaningful involvement of the health technology developer throughout the entire process. The timelines designated for developing and finalizing the scope and those allocated for preparing the JCA dossier are imbalanced and impractical. This poses a risk to achieving the Regulation's primary objectives of enhancing access to innovative health technologies for EU patients, optimizing resource utilization, improving the quality of Health Technology Assessment (HTA) across the EU, minimizing duplication of efforts and ensuring the long-term sustainability of the EU HTA collaboration. The current proposal allows up to 140 days for finalizing the JCA scope in standard European Medicines Agency procedures. However, this assumes a 3-month first clock stop which may not always be the case. Astellas own experience indicates that the first clock stop could be as short as 30 days, leaving the health technology developer with only 56 days to finalize the JCA dossier after the completion of the scoping process. These timelines are even more challenging for accelerated procedures and Type II variations. To ensure the development of a high-quality dossier, the scoping process should be shortened to a maximum of 90 days for standard European Medicines Agency procedures and 60 days for accelerated ones/Type II variations. More efficient scoping timelines can be achieved by building upon the extensive experience in scoping processes that exists among EU Member States National HTAs and by ensuring meaningful involvement of the health technology developer throughout the JCA process. Astellas believes a fair and balanced involvement of the health technology developer is essential for ensuring the high quality of the JCA dossier and the smooth conduct of the assessment itself. This collaboration should be reflected in the health technology developers mandatory participation in meetings with the JCA subgroup and in particular the assessor and co-assessor, at different stages of the process: 1. a scoping meeting, following submission to the European Medicines Agency of a Marketing Authorization Application (Art. 2) 2. participation in the assessment scope consolidation meeting, alongside other stakeholders (Art. 10) 3. an assessment scope explanation meeting (Art. 11). These changes align with best practice examples already implemented in several EU Member States that begin preparing for their National HTA processes well before the submission of an Application for Marketing Authorisation to the European Medicines Agency. Meaningful involvement of the health technology developers should also be reflected by allowing them to provide the HTA secretariat with all relevant information that would support and facilitate the development of the assessment scope, not limited to the summary of the product characteristics and the clinical overview section in the European Medicines Agency file (Art. 2), but also expected comparators and outcomes relevant for the therapeutic area and patient population for the product under assessment. Astellas emphasizes that the preparation of a high-quality JCA dossier entails extensive and complex analyses, which necessitates sufficient time and substantial effort for completion. It is crucial that the procedural timelines set by the European Medicines Agency are not affected or compromised by impractical JCA timelines but are instead reflected in shorter scoping timelines and meaningful health technology developers involvement in the entire JCA process. Therefore, the above suggested procedural changes will strengthen the spirit of the Regulation and ensure high-quality deliverables that will benefit patients in the EU.
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Meeting with Laura Ballarín Cereza (Member of the European Parliament, Shadow rapporteur for opinion) and American Chamber of Commerce to the European Union and

23 Jan 2024 · Pharmaceutical Package (Regulation)

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

12 Dec 2023 · Directive on Medicinal products for human use

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

18 Jul 2023 · Directive on Medicinal products for human use

Response to Cancer Screening Recommendation

18 Feb 2022

Astellas is a member of the Let's Talk Prostate Cancer (LTPC) Expert Group. This LTPC campaign is organised and funded by Astellas Pharma Europe Ltd. www.letstalkprostatecancer.com We welcome this opportunity to give Astellas feedback on cancer screening, which is one of the main ask the LTPC campaign is making to policymakers: "We support the call for a cancer dashboard at the European level, supported by the European Health Data Space, to include prostate cancer in national cancer plans, to showcase associated mortality and incidence across countries, and to raise awareness of socio-economic, ethnic, national and regional inequalities. It is important to explicitly draw the attention of policymakers and the general public to the increasing prostate cancer mortality rate. To tackle the stigma associated with prostate cancer, a culture of openness about the side effects of treatment, as well as the importance of early screening, supported by MRI scanning, should be promoted at both EU and national level by governments, health authorities and patient organisations. In the upcoming review of the 2003 Council Recommendation on Cancer Screening, it is crucial that prostate cancer is included as a priority area, to ensure screening is supported through EU-wide guidelines and operational quality assurances. With currently only 48% of men being aware of prostate cancer risks and prostate specific antigen testing (Europa Uomo (2019). Europa Uomo highlights lack of PCa awareness at EAU - https://www.europa-uomo.org/news/europa-uomo-highlights-lack-of-pca-awareness-at-eau/ ), we call for campaigns and education programmes at all levels, supported by policymakers, to educate individuals about their risk, prevention methods and treatment options."
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Response to Evaluation and revision of the general pharmaceutical legislation

26 Apr 2021

We welcome the European Commission call to improve current access to innovative medicines across the European Union. Following the EFPIA report on the root causes of unavailability and delays of innovative medicines we acknowledge causes are multifactorial and as a pharmaceutical company, we play a role in this. We are ready to start renewed discussions with all authorities and parties involved in this intricate system that reimburses innovative medicines to all patients in the EU. We believe the COVID-19 pandemic has shown indeed that a timely access to safe, high quality and affordable medicines at all times is essential for a solid and innovative pharmaceutical industry that can rapidly address any shortage risks or new manufacturing requirements. However, ensuring the efficacy, quality and safety of medicines is, and will always be with or without a pandemic, the sine qua non condition for bringing new medicines to patients. We believe the European Union should focus on building on the successful record that attracted many non-European companies such as Astellas to invest in the EU. The competitiveness of our industry in the EU needs to be enhanced through an independent strategy that includes a regulatory environment attracting innovation and investment, and a political agenda promoting global harmonized standards and regulatory convergence including the uptake of digital health technologies. Projects such as Accumulus (www.accumulus.org) are already addressing this need by improving the data-sharing ecosystem using the latest cloud technology. While we acknowledge the issue in the EU of delayed access to innovative medicines in particular for high unmet needs, we would encourage the European Commission to look at access to generic medicines and biosimilars in parallel rather than mixing the two as cause and effect on patients of accessing these two different types of medicines are very different. The COVID-19 pandemic has put the pharmaceutical supply chain under stress, but it is important to understand the specificities of each industrial actor and the existing framework such as the European Medicines Verification System that already controls the quality and availability of medicines efficiently in the different EU Member States. We welcome the initiative to simplify regulatory procedures as a way to improve patient access to innovative medicines but we also encourage each national health authority to improve their own procedures to adjust and effectively decrease patient waiting times. We see the uptake of digital technologies as key to reach this objective at all EU levels. We do not believe that rewards for placing innovative medicines on all markets simultaneously will be able to incentivize companies to innovate, especially for high unmet need, unless this is enabled by a national decision to reimburse this type of medicines. In the EU, a marketing authorization is a regulatory authorization and not an access to patient’s authorization. The responsibility to improve access to medicines does not rest exclusively on the shoulders of the pharmaceutical industry, it also involves policy makers at the EU, national and regional level, among others. Thus, we encourage the European Commission to further align and coordinate with Member States to improve sustainable access to innovative medicines for EU patients. It is critical that national authorities are closely involved in these discussions together with all responsible actors, including operators, in one dialogue framed in a High-Level Forum as EFPIA is proposing. Astellas stands ready to help the European Commission understand the breadth of innovation on the horizon to ensure the EU has adequate regulatory systems, including for combination products. Fianlly, we believe in the EU’s potential to have a leading role in hosting and nurturing cutting-edge health innovation while controlling its environmental impact.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

Astellas is a global Japanese company that prides itself for turning innovative science into value for patients. Astellas has a strong presence in the European Union, including manufacturing sites and significant clinical trial programmes. Astellas is investing heavily in the development of cell and gene and regenerative medicines and is keen to bring these to Europe in the coming years. Our supply chains run on stock levels that are above average for the industry. As a result we have experienced no major supply shortages for many years, and none during the COVID-19 crisis. Astellas welcomes the EU Commission’s ambition to develop a pharmaceutical strategy that addresses concerns around the affordability of, and patient access to medicines while ensuring that the EU remains an attractive destination for pharmaceutical investment. To meet the needs of patients and ensure the sustainability of our business and the pharmaceutical industry as a whole, we encourage the European Commission to: • Take account of the evidence that issues of affordability of healthcare go beyond the price of medicines and are caused by multiple factors (see EFPIA 'The root cause of unavailability and delay to innovative medicines' June 2020). The industry expects to play its role in tackling the economic challenges caused by the COVID-19 crisis and Astellas remains supportive of efforts to align prices of medicines with value and to find solutions where the value of medicines and clinical benefit is unclear or where affordability is a barrier to timely patient access. However, it is critical that the focus on affordability does not lead to measures that would undermine the sustainability of the industry and the ambition to strengthen the footprint of global pharmaceutical companies in the EU. • Play a co-ordinating role in bringing together all relevant stakeholders from the public and the private sector to tackle delays in patient access to innovative medicines by addressing all of the barriers, including protracted reimbursement processes, data generated to support these processes and slow uptake of innovation. • Accept the global nature of manufacturing and supply chains and address the main causes of supply shortages during the COVID-19 crisis: such as unnecessary stockpiling in Member States and export bans. • Create the right conditions so that patients across the EU have timely access to safe and effective Advanced Therapy Medicinal Products (ATMPs). In line with the submission of the Association of Regenerative Medicines (ARM) this requires: o Robust, transparent, evidence-based and harmonised regulatory procedures o Streamlined regulatory requirements for clinical trials with ATMPs o Co-ordination of ATMP clinical assessments at EU level o Facilitation of cross-border treatment, and o New initiatives to build real-world evidence infrastructure and disease registries at pan-European level • Lead discussions between different stakeholders, particularly between the EMA and other leading regulatory bodies on harmonisation and data gaps for emerging technologies. The pandemic has demonstrated that proactively exchanging knowledge between global regions accelerates the process of finding solutions to global public health concerns. • Link this Strategy to the EMA Regulatory Science to 2025 plan. Astellas is aligned with EFPIA’s proposal to establish a High-Level Multi-Stakeholder Forum which offers a place for all stakeholders in the healthcare system (including industry) to work collectively to find solutions. In the absence of such a forum, we encourage the European Commission to engage in an extensive constructive dialogue on its proposals to ensure that its strategy is fit for purpose. Astellas understands the economic and social crisis that the European Union experiences following the COVID-19 pandemic. As a long-term business operator in Europe, we stand ready to cooperate and play our part in addressing them.
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