Integration in national policies and sustainability

Objectives
This WP will set up a plan to describe the potential of GAPP results for integration in policies (at national, regional or local levels) and to ensure the sustainability of the JA activities at national or on the local or regional level. As a final result a common proposal for supporting a sustainable implementation in single countries will be agreed upon. Through the development of plans and tools for implementation in the MS of the outcome from this JA.
The work will focus on implementation and thereby sustainability at two levels.
• At the CA level for regional/ national policies and eventually homogenous within Europe
• At the professional level for acceptance and thereby integration into good practice at national/ European
level.

Description of work, lead partner and role of applicants
WP4 will set up a model for CA ´s in the MS to incorporate the results of the JA into policies at national/local level. Along with such policies WP4 will provide additional input to the work of WP2 (dissemination) and evaluate the acceptance (at the CA and the professional level) of the results in this JA. Consensus about the criteria in the process for authorisation when introducing new methods in Blood, Tissues and Cells including ART, will eventually create recommendations of good practice among the professionals and acceptance of future regulations.

At the CA level:
In particular the deliverables from WP5 will provide the basis for recommendations, depending on the various institutional organisations in the different MS.
Also the deliverables from WP5 with guidance on what to authorize, how to apply for authorization, definition of significant changes of processes as well as suitable teams for authorization will be important parts to integrate at the level of CA in the different MS.
Likewise the guidance on assessment of validations from the work of WP6 and the impact of clinical data from WP8, will have to be implemented at the CA level and included in the customized tool-box for the different MS.
Most likely it will be necessary to define a minimal requirement at the CA level and maybe rate the suggested recommendations from basic/acceptable to a desired level. We have to take into account that some MS already have working processes for authorization and licencing of new methods (at least in some areas in this sector) whereas others do not. Thus, the plan for implementation will be created as a ladder where the CA can introduce the recommendations/ requirements stepwise which will facilitate adjustments also at the CA level.

At the professional level:
An important part in implementation and sustainability of requirements and recommendations is to obtain consensus at the professional level. The results of the JA should be accepted by the professionals, preferably through their organisations (EBA, ESHRE, EATB, EEBA JAICE etc). These organisations are included as collaborating partners in WP6. WP8, with focus on clinical data as part of the authorization will have the output from other projects as a basis (VISTART, EuroGTP and ECCTR) where professional organisations have participated. WP4 suggest that the deliverables from WP6 and WP8 should be presented at the European meetings held by these associations, also described in the dissemination plan by WP2.
In this WP, the National Tissue Council (within the Swedish Association of Local Authorities and Regions) will be collaborating partners. The Tissue Council have working groups for Blood, ART, HPC and one for each regenerative tissue and one of their tasks is to provide guidance to tissue establishments. Thus, their role as collaborative partners will be to provide expertise and evaluate the recommendations and added value of the results from the JA and provide recommendations to the tissue establishments at the national level.

Expected Deliverables
D 4.1 -Report on the integration at one national level – a pilot in SE (month 26)
D 4.2 -Recommendations for integration in national/regional /local policies (month 29)
MD.6 – Report on the integration in national policies and sustainability (month 36)

WP4 Leader: The Health and Social Care Inspectorate (IVO), Sweden