Regarding Assisted Reproductive Technologies, the main outcome should be the existence in all Member States, at the governmental level, of a sustainable structure: Competent Authorities (or delegated bodies, medical Agencies) with a sufficient knowledge about Assisted Reproductive Technologies issues raised both by the European regulation (European Union Tissues and Cells Directive, cross border Directive) and by internal national regulation. DG-SANCO (Directorate General for Health and Consumers of the European Commission) should benefit from best-informed advice and opinion from each Member States for any consultation or political decision to be taken regarding the field.
The recommendations concerning the set-up of a Haematopoietic Stem Cells donor follow-up registry will set the basic framework for establishing registries as a tool for the upgrade/improvement of safety in Haematopoietic Stem Cells donation.
The guidelines for Cord Blood Banks main outcome will be the establishment of EU common good practices in the field, particularly in those areas where there are notable gaps. Overall outcome will be a significant increase in quality and safety practice in the whole Cord Blood Banks domain, and Competent Authorities having tools to assess the compliance of Cord Blood Banks thanks to emitted guidelines.
ARTHIQS having mainly institutional goals, targeted groups will also be policy makers:
- Member States Ministries of Health and National representative will also have tools to organise Assisted Reproductive Technologies and Haematopoietic Stem Cells national fields, to ensure a well-organised authorisation scheme through inspections, and through trained representatives to defend national positions at the EU level.
- Since the guidelines to be generated will be reflecting consensus positions from ARTHIQS partners, the work regarding Assisted Reproductive Technologies and Haematopoietic Stem Cells shall be useful for potential future technical amendments of the current EU legislation for tissues and cells and also in case of a potential revision of this legislation.
ARTHIQS guidance and tools generated will support a direct implementation for the benefit of donors and recipients across the EU, and in a cost-efficient manner for Member States. Importantly, sustainability of ARTHIQS work will be ensured by training for representatives of all 28 Member States in both Assisted Reproductive Technologies and Haematopoietic Stem Cells, and by a careful dissemination strategy relying on ARTHIQS communication leaders, all partners and collaborators and on professionals and scientific societies.
Agence de la biomédecine