OpenLobby.EU
Explore

Terumo Blood and Cell Technologies

Terumo BCT, a global leader in blood component and cellular technologies, is the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction coupled with leading technologies in therapeutic apheresis and cell processing.

Lobbying Activity

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

17 Dec 2024 · Sickle Cell Disease

Meeting with Stine Bosse (Member of the European Parliament)

18 Sept 2024 · Health Policy

Meeting with Vlad Vasile-Voiculescu (Member of the European Parliament) and Manufacture Française des Pneumatiques Michelin and European Kidney Health Alliance

18 Sept 2024 · Introductory Meeting

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

6 Mar 2024 · sickle cell disease

Meeting with Josianne Cutajar (Member of the European Parliament)

4 Mar 2024 · Sickle Cell Disease

Meeting with Sirpa Pietikäinen (Member of the European Parliament)

28 Feb 2024 · Rare diseases, Sickle Cell Disease

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

10 Nov 2022 · Blood, Tissues and Cells Regulation

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

7 Sept 2022

Terumo Blood and Cell Technologies (TBCT) welcomes the opportunity to provide feedback on the Commission’s Proposal for a Regulation on Substances of Human Origin (SoHO). While the Proposal significantly improves the regulatory framework for SoHO products, additional steps outlined in this submission will strengthen the Regulation to ensure greater protection for patients and donors, and safeguard SoHO products quality and supply continuity. TBCT remain committed to working with the European Union and all stakeholders to develop and implement a framework that prioritises patient and donor safety, ensures SoHO supply continuity and enables innovation. I. Include provisions to ensure safe innovation: the Proposal provides a flexible regulatory framework to accommodate new SoHO products and devices on the market, particularly innovations and technologies for collecting and processing SoHO products. This must be accompanied with provisions to ensure and enforce: (i) increased user, recipient and personnel safety; (ii) consistent high quality of SoHO products; and (iii) adequate risk mitigation. II. Focus on pathogen reduction: introducing provisions to enable use of pathogen reduction technologies that reduce or eliminate potential communicable pathogens will ensure: (i) collected SoHO products can be safely and rapidly distributed and deployed across the EU; and (ii) enhance EU pandemic preparedness and response to emerging pathogen threats which are increasingly exacerbated by climate change. III. Harmonize validation and information sharing: the Proposal encourages national authorities to share evidence for the validation of medical devices. Considering the sizeable differences Member States approaches to medical device validation, the Proposal could include provisions to reduce discrepancies and harmonise validation across the EU. This will minimise disruptions to SoHO supply continuity and accelerate authorisation periods. IV. Strengthen national emergency continuity plans: the creation of national emergency SoHO supply continuity plans will reduce EU dependency on imported SoHO products and mitigate the effects of increasing shortages of blood donations which majorly impact medical procedures. Processing technologies that can reduce avoidable risks, ensure SoHO supply continuity and promote usage optimization must be included and prioritized in such emergency plans. V. Ensure stakeholder consultation in developing enabling legislation and policy: the Proposal recognizes the roles of the ECDC and EDQM given their respective expertise in pandemic preparedness, addressing emerging pathogens, and developing guidelines and standards for a number of different health issues. While the EDQM will rightly lead the development of enabling legislation and guidelines, it is critical that all SoHO stakeholders are involved in developing the technical rules and specifications that will be defined for this sector. This will further ensure timely development and implementation of guidelines and enabling legislation. VI. Enhanced provisions to support digitization: the Proposal introduces a digitized EU SoHO platform, allowing for increased compliance, , quality, consistency and safety. However, due consideration must be given within the framework for risk avoidance and mitigation including potential contamination and avoidable risks to users, recipients and personnel handling SoHO products. VII. Amend description of “significant risk” to certain donations: the Proposal introduces a description of "significant risk" to selected SoHO donations. Existing national, EU and international legislative frameworks addressing SoHO safety and medical devices provide comprehensive measures to ensure donor safety and reduce risks to a minimum. While this proposal aims at continuing and further improving the minimal risk approach, such a “significant risk” label could negatively impact the Commission’s ambition of increasing SoHO collections.
Read full response

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

14 Dec 2020

Terumo BCT welcomes the European Commission’s Inception Impact Assessment (IIA) on the revision of the blood, tissues and cells (BTC) legislation. Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies. As rightly pointed out in the IIA, the BCT legislation lags behind innovation. By way of example, the use of technologies that automate blood component and cell preparation is increasingly widespread. Preparing blood components from whole blood donations is a manufacturing exercise that is very demanding. In this context, automated processing reduces variability related to human interventions, leading to better standardisation of final products, improved documentation and increased traceability. Automation also reduces the handling time which minimises the potential occupational exposure to contaminated substances. When it comes to cell manufacturing, the use of closed systems significantly reduces open events and hands-on tasks. As a result, the cell culture environment remains intact during the cell culture process. We therefore believe that the safety and quality of BTC are two crucial aspects that can and must benefit from the advancements in science and technology such as automation and cell therapy technologies. We support the recognition of the benefits of setting quality and safety standards for BTC at EU level to address cross-border threats to public health. Directive 2002/98/EC prescribes that “appropriate use of scientific progress in the detection and inactivation and elimination of transfusion transmissible pathogenic agents” be made. Technologies that contribute to blood safety such as pathogen reduction technologies can be effective in protecting against a broad spectrum of emerging tested and untested pathogens. Since the adoption of the Blood Directive, these technologies have been implemented to varying degrees across the EU, resulting in varying degrees of safety but also varying processes for validating the safety and efficacy of blood components which should be tackled in any future EU framework. The common thread in all policy options that will be assessed during the Impact Assessment is the joint consideration of BTC and the potential future legislative scenarios. As rightly pointed out in the IIA, there is some uncertainty related to legal borderlines for innovative BTC. The resulting complexity may be exacerbated by merging the basic acts into a single legal framework for blood, tissues, cells and potentially novel substances of human origin which have their specifics and own establishments. Turning to the specific policy options, we recognise the value of involving experts in the definition and updating of technical requirements to ensure they keep pace with scientific and technological developments. We believe that policy option 2 would help achieve this objective while ensuring an appropriate level of harmonisation across the EU. The degree of harmonisation achieved by the BTC legislation has been limited, hence hampering to some extent innovation in the field. The obligation for establishments to take into account technical rules and specifications that will be defined and updated by authoritative bodies would address this shortcoming recognised in the Commission’s evaluation report. However, although the ECDC plays a key role in ensuring the safety of substances of human origin in the EU, the legitimacy of the Council of Europe which is not an EU agency and whose membership goes beyond the EU Member States should be questioned. In addition, we consider it critical to involve the BTC stakeholders listed in the IIA, in the development of the technical rules and specifications to ensure these are suitable and specific to all types of substances that would be considered in the future legislative framework. Terumo BCT kindly invites the Commission to consider the above aspects as part of the upcoming Impact Assessment.
Read full response

Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

Terumo BCT welcomes the European Commission’s strategy to ensure timely patient access to affordable medicines. Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies. We are the only company with the unique combination of apheresis collections, manual and automated whole blood processing, and pathogen reduction technologies. The Roadmap rightly states the need to modernise the way the EU ensures access to medicines for its population in a post COVID-19 context. While technological and scientific developments are continuously changing the design of therapies, we believe it is essential to consider medical devices as part of the solution to medicine shortages in the EU. Medical devices offer alternative treatment options for certain conditions. Promoting the use of viable alternatives should help mitigate medicine shortages, enable better access to medicines for those conditions where there is no viable therapeutic alternative and provide doctors with the clinical freedom to prescribe the best possible treatment of their choice. By way of example, Therapeutic Plasma Exchange (TPE) is a procedure used to treat a variety of medical conditions including Guillain-Barré Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Myasthenia Gravis as well as autoimmune diseases. Although professional societies and international guidelines have demonstrated that TPE and immunoglobulin are therapeutically equivalent for the treatment of these rare neurological conditions, the former is usually chosen over the latter despite growing demand and supply challenges. A similar rationale applies to the treatment of Sickle Cell Disease through Red Blood Cell Exchange (RBCX) for which the technology is available, but access remains challenging. We feel that these considerations and challenges are appropriate for discussion during the review of the legislation on medicines for rare diseases and children. Advances in technology now allow patients to receive their treatment in an outpatient setting. In the UK, a centre has been established at the University of Southampton Hospital NHS Foundation Trust that delivers TPE on this day-case model where patients do not have to stay in hospital. Evidence shows that it is a safe, effective treatment for patients and has resulted in saved neuroscience ICU bed days that are now available to treat other critically ill neurology and neurosurgery patients. Medicine shortages have a direct impact on the sustainability of the healthcare systems. At a time when ensuring the resilience and sustainability of the healthcare systems has become a priority across the EU, we strongly believe that medical devices and the above-mentioned day-case model should be part of an EU solution to ensure appropriate patient access to treatment. We further welcome the pursuit of the objective of enabling innovation including for unmet medical needs and the recognition that important scientific and technological advances are transforming the landscape and becoming increasingly integrated as part of overarching therapies. The role of medical devices in the manufacturing and delivery of new therapies such as cell and gene therapies should be considered in the development of the Pharmaceutical Strategy. Chimeric antigen receptor (CAR) T-cell medicines are a case in point as medical devices are crucial for the collection, expansion and delivery of cells. New cell harvesting and processing technologies allowing to unblock the potential of tissues and cells for cancer treatment and diagnosis have been made available in the last decade. Access to those technologies is fundamental for reaching the Pharmaceutical Strategy’s goal of ensuring timely access to medicines. In light of the above, Terumo BCT supports the development of an EU framework in synergy with relevant EU policies including the medical devices legislation
Read full response

Response to Protecting citizens against health threats

23 Apr 2018

Any strategy intended to improve the prevention and control of infectious diseases must address climate change as a major challenge to the control of infectious and vector-borne diseases, as recognized by the WHO This is so because bioclimatic factors, current and future, are crucial factors influencing both vectors and pathogens. Many of the major killers are highly climate sensitive as regards temperature and rainfall, as a result of which climate change threatens to slow, halt or reverse the progress that the global public health community has made against many of these diseases. The physiological factors that regulate survivorship, reproduction, and transmission of parasite and pathogen distribution are also closely associated with climate. As a result, climate change is expected to promote more intense and prolonged outbreaks of vector-borne disease and alter the geographic boundaries of transmission. Under Resolution of 24 September 2008 on the mid-term review of the Environment and Health Action Plan, the European Parliament called on “Member States and the Commission to respond adequately to the new threats posed by climate change, such as the increased presence of emerging viruses and undetected pathogens, and therefore to implement new and existing pathogen reduction technologies that reduce known and undetected viruses and other pathogens transmitted by blood”. This was echoed by the Commission it its ‘Commission Staff Working Document on Adaptation to climate change impacts on human, animal and plant health’. Zika showcases how bioclimatic factors influence the transmission of a disease: with rising temperatures, the mosquitoes that carry the Zika virus seem to flourish in the heat. In fact, the warmer it gets, the more efficiently the mosquito is able to transmit the illness. Taking into account that several emerging pathogens are likely transmissible by blood transfusion, climate change will affect the safety and supply of blood globally through its impact on vector-borne disease. Globally, climate change is likely to compound existing problems of blood safety and supply in already endemic areas and cause future shortages in fresh blood products through its impact on transmission of vector-borne disease. The increasing challenge posed by climate change calls for preparedness plans for control of outbreaks of blood-borne pathogens that cover the continuity of blood supply, by preserving the number of eligible donors. As the European Commission recently highlighted in the ‘Summary of the Blood, Tissues and Cells Stakeholder Event (20th September 2017)’ “a lack of emergency preparedness plans for EU crisis situations was seen as problematic, posing a risk to ensuring continued supply of blood, tissues and cells” and “emergency preparedness to ensure supply in crisis situations was identified as an area where co-ordination of regulatory oversight in the European setting should be considered”. This coordination certainly needs to consider the different political areas related to climate change and infectious diseases. In this regard, medical therapeutic countermeasures, play a key role. For example, pathogen reduction technologies offer a new approach to increase blood safety by actively/directly targeting possible, also emerging pathogens or donor leukocytes. Medical therapeutic countermeasures, EU best-practice example: Belgium Belgium adopted pathogen-reduction technologies nationwide. Articles 8 and 10 of Royal Decree (RD) of 28 June 2009 mandated the reduction of pathogens in platelet concentrates: platelet concentrates now undergo a pathogen reduction process according to a validated method. The RD also as basis for the Opinion of the Belgian Superior Health Council n ° 8700 on 'The clinical efficacy of pathogen reduction in view of the Implementation for Platelet Concentrates' (2011)
Read full response