Latest projects

3rd Health Programme (2014-2020)
facilitatinG the Authorisation of Preparation Process for blood and tissues and cells [GAPP]
GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to a...
GAPP Joint Action (facilitatinG the Authorisation of Preparation Process for blood and tissues and cells) is a 36 months JA aiming at facilitating the development of a common and optimal approach to assess and authorise preparation processes in blood and tissues establishments (BEs and TEs). Particular attention will be devoted to innovative processes that might come up taking advantage of the work developed in previous EU funded projects/actions. This Joint Action will clearly contribute to the implementation of Union legislation in the fields of human tissues and cells, blood, providing tools and training to increase harmonisation of those MS activities that regulate the areas of blood transfusion, transplantation of tissues and cells and assisted reproduction, in strong abidance with art 4.5 of Annex I of Regulation 282/2014. These are fields of healthcare that involve a considerable amount of movement of donated substances of human origin between MS and also movement of citizens between MS for treatment, particularly in the field of assisted reproduction. The aim of the action is to prepare a “Good Practice Guidelines to authorisation and preparation process in blood, tissues and cells” and its three technical annexes respectively on i) authorisation changes in donation, procurement and collection, processing, preservation, storage and distribution (divided in three part blood, tissues and cells, and reproductive tissues and cells); ii) assessing the quality and safety of donor testing, microbial inactivation and sterilisation steps as part of PPA; iii) assessing clinical data as part of PPA. In addition to this it will be built a model and a tool to facilitate sharing of information among European Union Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorise preparation processes of tissues, cells, reproductive cells and blood products.
Start date: 01/05/2018 - End date: 30/04/2021

Call: Joint Actions 2016
Topic: 4. Facilitate access to better and safer healthcare for Union citizens
3rd Health Programme (2014-2020)
High-quality blood stem cells products available for all patients in need, and to protect the rights and welfare of volunteer stem cell donors [SAVDON]
Annually more than 20,000 volunteer unrelated blood stem cell donations are undertaken. Living donors donate their cells for patients in need of a transplant. The EU plays an important role in the pro...
Annually more than 20,000 volunteer unrelated blood stem cell donations are undertaken. Living donors donate their cells for patients in need of a transplant. The EU plays an important role in the provision of these products. In 2016 the EU countries provided 6,817 blood stem donations internationally and 3,194 donations were provided nationally.

WMDA plays a key role in the international exchange of blood stem cell products by providing a search tool for healthcare professionals and by setting standards for international exchange. In order to harmonise international exchange and speed up the logistics of the search process WMDA is applying for a Framework Partnership Agreement with the EU.

Volunteers have the right to receive accurate information about their risks to donate their blood stem cells. Since 2002 donor safety has become a highly visible issue. In that time WMDA has started up a reporting system for adverse events and reactions. It is important to reassure potential donors that there are systems in place to protect them from adverse outcomes and that there is a continuous learning system which is informed by global reporting. The next step is to collaborate with regulatory authorities in order to improve dissemination.
In the area of import from third countries it is important to harmonise and to collaborate between EU Member States. At the moment 14% of the adult volunteer donations and 30% of the cord blood products are imported from third countries. To avoid delay for patients waiting on their transplant information needs to be available that can be shared between Competent Authorities and healthcare professionals facilitating searches.
The current ICT infrastructure to support the search process and request for a donation is delaying adequate treatment for patients. Innovation of the ICT infrastructure will help physicians to find a donor with a few clicks in the database.
This proposal describes how WMDA and EU can collaborate from 2018-2021.
Start date: 11/04/2018 - End date: 10/04/2022

Call: Operating grants 2018-2021
Topic: 3rd Health Programme (2014-2020)
3rd Health Programme (2014-2020)
RD REGISTRY DATA WAREHOUSE [REGISTRY WAREHOUSE]
Patient registries and databases are key instruments to support clinical research in the field of rare diseases, to improve patient care and aide healthcare planning. The effort needed to gather regis...
Patient registries and databases are key instruments to support clinical research in the field of rare diseases, to improve patient care and aide healthcare planning. The effort needed to gather registry data is enormous and yet worthwhile since they are the basis for the observation of the natural course of a disease, for planning and for doing feasibility checks of clinical trials. A widely unknown number of RD registries existed, still exist or are in the process of being set up. So far, data exchange is a problem, not foreseen in most registries and cross-border interoperability is not provided. The small number of patients affected by rare diseases make registries even more important than in the normal population or in common diseases as they enable cross-border gathering of data to achieve sufficient sample size for any purpose in clinical research and or public health issues.
Patient and care team members of ERN-LUNG have deducted that the excellent pre-existing registries within ERN-LUNG could give a strong basis for a NEW Registry Warehouse enabling full data exchange and cross-border interoperability. This Rare Disease (RD) REGISTRY DATA WAREHOUSE will be a combination of existing registries, new registries or new registry elements that are brought together with full interoperability. To develop this RD REGISTRY DATA WAREHOUSE we build upon our experience with registries established and coordinated by the applicants (starting with CF, PCD and non-CF BE), existing software solutions (Open Source registry framework OSSE) developed and/or used for RD registries by the applicants and leadership in defining minimum data sets and compliance to data quality standards such as EUCERD Recommendations on RD registries, a project led by the coordinator.
This RD REGISTRY DATA WAREHOUSE will not only improve data management and research in rare lung diseases, but will serve as a blueprint to connect patient registries and databases linked to other rare diseases.

Start date: 01/04/2018 - End date: 31/03/2021

Call: Rare diseases - support for New Registries
Topic: 4.2 Support Member States, patient organisations and stakeholders by coordinated action at Union level in order to effectively help patients affected by rare diseases. This includes...
Topic: 4.2 Support Member States, patient organisations and stakeholders by coordinated action at Union level in order to effectively help patients affected by rare diseases. This includes the creation of reference networks (in compliance with point 4.1), Union wide information databases and registries for rare diseases based on common criteria.
3rd Health Programme (2014-2020)
A Plan for Action: Ensuring Equitable, Affordable and Responsibly Used Medicines in the European Union [HAI_FPA2018]
Stichting (Foundation) Health Action International's European multi-annual programme 2018-2021 builds on previous work supported by CHAFEA and aims to provide a response to persistent shortfalls in Eu...
Stichting (Foundation) Health Action International's European multi-annual programme 2018-2021 builds on previous work supported by CHAFEA and aims to provide a response to persistent shortfalls in European medicines policy. HAI’s work plan is aligned with the objectives of the Third Health Programme and with HAI’s organisational goals: (1) Access to Affordable Medicines, (2) Medicines Safety, Added Therapeutic Value and Responsible Use, (3) Democratisation of Medicines Policy.

In particular, HAI will campaign to broaden public and policy support to alternative models of biomedical innovation that contribute to medicines affordability and ensure public return on public investment. We will also provide advice and support initiatives that enhance generic competition and empower governments in medicines price negotiations. As a member of the HTA Network Stakeholders Pool for the mandate 2016-2020, HAI will contribute to the work of Stakeholders Pool and issue recommendations to ensure that collaborative efforts strengthen the quality and robustness HTA systems in Europe with the ultimate goal to enhance the sustainability of healthcare systems and medical innovation. Following concerns about the little (or non-existing) added therapeutic value of many new medicines, HAI will seek policy and regulatory support for more robust frameworks for medicines. We will support initiatives for more proactive and robust pharmacovigilance systems to further protect patients’ safety. As a member of the European Medicines Agency (EMA) Patients’ and Consumers’ Working Party (PCWP), HAI will bring independent consumers’ voice to EMA’s policies and initiatives. We will follow closely developments on public access to clinical data in the EU and issue recommendations for enhanced transparency. In addition, we will implement initiatives for enhanced rational use of medicines for example by capacitating healthcare professionals to better assess information on medicines.
Start date: 09/03/2018 - End date: 08/03/2022
Call: Operating grants 2018-2021
Topic: 3rd Health Programme (2014-2020)
3rd Health Programme (2014-2020)
SFP Coalition's multiannual work plan 2018-2021 [SFP FPA 2018-2021]
The Smoke Free Partnership (SFP) is the only Coalition of national, pan-European and international NGOs working exclusively on EU policy analysis and advocacy linked to the implementation of the WHO F...
The Smoke Free Partnership (SFP) is the only Coalition of national, pan-European and international NGOs working exclusively on EU policy analysis and advocacy linked to the implementation of the WHO Framework Convention on Tobacco Control (FCTC). Since its creation in 2005, SFP has led many successful campaigns to advance important EU smoking prevention policy areas, most notably European smoke-free policies and the Tobacco Products Directive, but also the EU Tobacco Tax Directive and policies against illicit tobacco trade. SFP has been recognised for its tobacco control work by the World Health Organisation with the World No Tobacco Day Award in 2011. SFP was also a recipient of the American Cancer Society’s 2015 Luther L. Terry Award for outstanding global achievement and exemplary leadership in Tobacco Control.
This application demonstrates how our strategic objectives directly respond to the first three specific priority areas of the 2017 Call for Proposals for Operating Grants. In particular, SFP and its Coalition Partners will assist the EU institutions and national governments with information and evidence-based intelligence and advice for the development of smoking prevention policies and the promotion of healthy lifestyles to prevent cancer and chronic diseases at EU and national level with a special focus on young people, reducing health inequalities, and promoting health in all policies. SFP will contributing to civil dialogue processes to increase public authorities’ commitment in this area by spearheading successful campaigns and building advocacy capacity among civil society organisations. This application also describes how we will contribute to the objectives of the European Solidarity Corps.
Based on our previous track record of producing results, this application also demonstrates how SFP and its Coalition partners will continue to contribute to the overarching and specific objectives of the Third Health Programme (2014-2020).
Start date: 09/03/2018 - End date: 08/03/2022

Call: Operating grants 2018-2021
Topic: 3rd Health Programme (2014-2020)