Action grants on substances of human origin (SoHo) - Increase resilience, ensure continuity of supply and access to safe and high quality therapies, in particular in times of crisis

Topic description

Objective:

Background and policy context
The COVID-19 pandemic has significantly tested the resilience of blood and transplant systems and has strongly reduced supply, availability, use and access to these therapies.
There is a need to improve resilience, ensure the continuity of supply, increase access, safety and quality of therapies, in particular in times of infectious disease outbreaks.
The action supports the policy priority to respond to the COVID-19 pandemic and implements the EU4Health Programme’s general objective of improving the availability, accessibility and affordability of medicinal products and medical devices, and crisis-relevant products in the Union, and of supporting innovation regarding such products (Article 3, point (c)) through the specific objectives defined in Article 4, point (c) of Regulation (EU) 2021/522.

Objectives pursued
This action aims to enable the medical/professional organisations and Member State authorities in SoHO subsectors to develop and exchange good practices for professionals and authorities to optimise supply and increase access to quality and safe use of critical therapies based on substances of human origin donated by fellow citizens.

Description of the activities to be funded under this topic
Proposed measures and actions can be targeted at local/hospital level, regional/national level and supra-national/Union level. The measures and actions developed can be implemented by professionals, in collaboration with their national authorities as appropriate, across the Union.
The work will aim to identify, share, assess and refine measures and actions taken and planned to mitigate the impact of the COVID-19 pandemic on safety, quality and accessibility of these therapies.
The specific sub-sectors that will be supported include in particular:
- blood and blood components (red blood cells, plasma);
- organs (e.g. kidneys, liver, heart);
- haematopoietic stem cells (bone marrow, cord blood);
- gametes and embryos (for reproductive medicine);
- tissues (corneas, heart valves).

Expected results and impact
The expected results of this action are the following:
- development and dissemination of good practices and guidance by medical/professional associations and Member States authorities in the SoHO subsectors to strengthen and make more resilient transplant, transfusion and medically assisted reproduction systems, in particular during crises;
- contribution to a more sustainable supply and increased access to essential SoHO therapies with mitigating actions to avoid disruptions (by comparison with the annual volumes monitored routinely for several SoHO subsectors).
These activities will enable professional associations and Member States authorities in the sector to ensure a more resilient supply system for sustainable access to safe SoHO. Ultimately, this action will contribute to strengthening the safety and the protection of patients receiving SoHO therapies.

Specific mandatory deliverables and/or milestones
- Identification of good practices and guidance for clinics and healthcare systems where existing.
- Development of good practices and guidance for clinics and healthcare systems.
- Dissemination/exchange of good practices between medical/professional association across the Union and Member States authorities.

Specific action-level indicators for reporting purposes
The applicants will include the following specific action-level indicators and related reporting activities in their proposals:
- number of events / meetings / exchanges organised;
- number of participants in the events (by country / sector);
- satisfaction rate of participants;
- number of best practices developed;
- number of clinics/healthcare systems with improved preparedness and response planning;
- number of transplant procedures, and other applications of Substances of Human Origin (in particular volatility in times of crisis);
- (outreach) number of stakeholders endorsing finalised good practices by: individuals / entities, Member States authorities, stakeholder associations per country/field.
The applicants are required to include in their proposals additional specific action-level indicators which will be agreed with the HaDEA during the grant agreement preparation.