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Tampere University

TUNI

The mission of the Tampere University is to promote free research and academic and artistic education, to provide higher education based on research specified by legislation on universities.

Lobbying Activity

Meeting with Mehdi Hocine (Head of Unit Internal Market, Industry, Entrepreneurship and SMEs) and Aalborg Universitet

6 Feb 2025 · Discussion on the benefits of research on Fluid Power transmission systems

Meeting with Arto Virtanen (Cabinet of Commissioner Jutta Urpilainen), Renaud Savignat (Cabinet of Commissioner Jutta Urpilainen)

1 Dec 2022 · Cooperation on higher education

Meeting with Renaud Savignat (Cabinet of Commissioner Jutta Urpilainen)

27 Oct 2022 · Research interview re EU knowledge networks in higher education policymaking

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

8 Sept 2022

We welcome the Commission proposal for an EU regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application (2022/0216). Regarding the choice of the legal instruments, the implementation of a single Regulation that will directly apply in all member states and the possibility to use EDQM and ECDC guidelines for more efficient updating of the technical requirements are justified improvements for enhanced harmonization. We would like to comment on the definition of the SoHo entity in relation to their registration requirements (Articles 2, 18, 19, 37). The proposal requires organizations that conduct donor testing (Article 2 c), quality control testing (Article 2 f) and human application (Article 2 l) of SoHos to register as a SoHo entity. Registration as a SoHo entity brings certain obligations and requirements for these organizations. This registration requirement is new compared to the existing legislation. There are currently internationally recognized standards (e.g. ISO-standards) and national/international accreditation programs for the quality assurance of laboratories and test methods that are used for the testing of donors and SoHos. The registration of these organizations as SoHo entities would increase costs and most likely reduce the number of organizations offering these services, while the contribution of this requirement to the safety and quality of SoHos remains unclear. We propose that the aforementioned activities be removed from Article 2 and remain as activities that can be outsourced to third parties by the SoHo entities (Article 41 2 viii) and SoHo establishments (Article 50 3 g). The requirement for clinics and hospitals that use SoHos in clinical applications to register as SoHo entities creates an unnecessary burden for the clinical use of SoHos. We propose that this activity be removed from Article 2. The specific requirements (e.g. Articles 44, 47 and 59) should fall under the responsibility of the SoHo entity or SoHo establishment distributing the SoHos for clinical use. We would encourage to reconsider the responsibilities defined for the physician at a SoHo establishment (Article 51). While it is necessary to have medical expertise in establishing and applying the donor eligibility criteria, there are other situations, e.g. establishing criteria for the allocation of SoHos, investigating suspected adverse occurrences and supervising clinical data collection activities, which could fall under the general responsibilities of the Responsible Person (Article 38). Regea Tissue Center is a clinical tissue bank and a GMP cell manufacturing unit. Regea is a non-profit organization operating under Tampere University.
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

Tampere University Regea Cell and Tissue Center supports the initiative for updating the legislation on blood, tissues and cells. Product classification: An EU level mechanism for product classification should be implemented for products having SOHOs as starting materials. Policy options: We consider Policy option 1 to conflict with the harmonization objective of the European Union, as the option would not define common practices to ensure the quality and safety of BTCs. We regard Policy option 2 as problematic. There is certainly a need for detailed guidelines by European Expert Bodies reflecting the current knowledge of infectious diseases as well as various technical specifications regarding BTCs. However, the purpose of these guidelines is to provide guidance, examples and alternatives both for conducting the activities and for developing the field of BTCs. These guidelines would continue to contribute most if the contents would not be as strictly defined as is required of mandatory legislation. We consider Policy option 3 the most relevant option for the current need of updating and harmonizing safety and quality requirements of BTCs. Since 2004 the field of SOHOs has evolved enormously, also the collective knowledge of the field. There are well established needs for updating and complementing the current legislation. Requirements with a suitable scope and level of detail in the form of Commission directives would best serve both tissue establishments and national authorities. In the future there is a need for a continuous evaluation process, which should be done in collaboration with the European Expert Bodies.
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