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Purpose:The current paper focuses on the ethical approaches to data protection and confidentiality (DP&C) and the quality and safety (Q&S) requirements in the European Union (EU) blood, tissues and cells (BTC) legislation, namely: Directive 2002/98/EC, Directive 2004/23/EC, Directive 2005/61/EC, Directive 2005/62/EC, Directive 2006/86/EC, Commission Directive (EU) 2015/565, SWD( 2019) 376 final and the external evaluation SANTE/2017/B4/010. Background: In the EU, the ethical requirements for the BTC legal framework focus also on the quality, eligibility, safety, and protection standards. In addition, the SWD(2019) 376 final on the evaluation of the EU BTC legislation released in October 2019 draws attention to the challenges of technology, consent and donation, testing procedures and management of the BTC services. Content: The paper highlights the EU BTC setting standards by examining the particular provisions for the: hemovigilance, eligibility of donors, blood and blood components (BBC), consent, decisions required at the Member States (MS) level, healthcare standards, measures for the blood establishments (BE) and tissue establishments (TE) and particular issues concerning the donation of tissues and/or cells (T&C). Conclusions: Nevertheless, the intended function of the analysis is to focus on the EU BTC legislation and to enable research responsive to the latest initiatives launched by the European Blood Alliance (EBA) and Nuffield Council on Bioethics (NCB) in the field of the definitions and ethical processes.
The present paper aims at monitoring the meanings of the "human values" and the "ethical behavior" in the European Union (EU) official documentation. In a time of complex researches in the field of the participatory governance, the EU legal database of EUR-Lex provides various conceptions, meanings and uses of both terms.
Problem statement: Advancing a Health-Care Cross-Regional Model (HCRM) is aimed at revisiting the programmes and services facing migration and enriching the benefits of the European Union (EU) policies. The HCRM frames of the mixed public-private fixings are handled to recover the system's shortcuts in the field of health-care policies and the input factors of migration.Research Questions: Does a Health-Care Cross-Regional Model (HCRM) provide a feasible and adaptable solution to EU programs surpassing the input factors of migration? What are the effective public health measures centring on the social assistance and offering most opportunities for the migrant population?Purpose of the Study: The study ventures the lack of public acknowledgement and of crossregional scrutiny from the health-care field enabling concurrent engagements to the European and national headsets.Research Methods: Research methods were used as follows: 1) a CRQ (cross-regional questionnaire) assigned to 73 respondents; 2) an interpretative research for the social phenomena of migration; 3) a concept mapping for the HCRM's determinants. Findings: 1) High level of engagement of the HCRM model maximizes the EU's sectorial earnings 2) Interconnecting "win-win" approach to the EU policy offering most opportunities for the migrants 3) CPQ is aimed at showing an overall success of the implemented migrant support measures in terms of the social services outcomes Conclusions: It has been established that a Healthcare Cross-Regional Model (HCRM) will produce a feasible and approximate solution to the migration issues involving social and cultural conveniences and granting national policy-makers to enlist feasible opportunities.
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