Safety / Projects

Second Programme of Community action in the Field of Health 2008-2013
Stichting Health Action International [HAI_FY2011]
Health Action International (HAI) Europe is a non-profit, independent, European network of consumer groups, public interest NGOs, healthcare providers, academics and individuals.HAI Europe’s mission...
Health Action International (HAI) Europe is a non-profit, independent, European network of consumer groups, public interest NGOs, healthcare providers, academics and individuals.HAI Europe’s mission and goals follow the overarching global work programme set every 5 years.HAI Europe devises plans and strategies for medicines’ policy issues in Europe and acts as a regional centre.

HAI Europe’s mission is:
-to increase access to essential medicines = medicines for priority health needs are available, accessible and affordable for all;
-to improve the rational use of medicines = citizens receive medication appropriate to their clinical needs, in tailored doses, for an adequate period of time,at the lowest cost to them and their community.
HAI works to achieve these goals through research excellence and evidence-based advocacy.
Vision: Poverty and social injustice represent the greatest barriers to sustainable health and development. HAI works for just and equitable societies where people can participate in decisions affecting their health and well being, including the allocation of resources.
Start date: 01/01/2011 - End date: 01/01/2012

Call: Promote Health (Hp-2010)
Topic: Safety
Second Programme of Community action in the Field of Health 2008-2013
Health Action International [HAI_FY2012]
Health Action International (HAI) Europe is a non-profit, independent, European network of consumer groups, public interest NGOs, healthcare providers, academics and individuals. HAI`s mission and goa...
Health Action International (HAI) Europe is a non-profit, independent, European network of consumer groups, public interest NGOs, healthcare providers, academics and individuals. HAI`s mission and goals follow the overarching global work programme set every five years. HAI Europe devises plans and strategies to inform medicines` policy in Europe and acts as a regional coordinating centre.

HAI`s mission is:
- To increase access to Essential Medicines: Ensuring that medicines meeting priority healthcare needs are available, accessible and affordable to all;

- To improve the Rational Use of Medicines: Ensuring that all licensed medicines meet real medical needs, have therapeutic advantages, are acceptably safe, offer value for money and are appropriately prescribed, in tailored doses, for an adequate time at the lowest cost to citizens and their community;

- To promote the participation of citizens in medicines policy: Encouraging and supporting the participation of patients and consumers in decisions that will affect their health and well-being, whilst advocating for the highest levels of transparency, independence and accountability in all aspects of medicines policy.

HAI Europe monitors and encourages EU policy-making around these three thematic priorities. HAI Europe works by implementing innovative methodologies that generate key data, develop and publish key publications and commentary as well as promote knowledge exchange on the impact of medicines policy on public health. The paucity of coherent medicines policies in Europe has driven HAI`s unique focus over the last 30 years and continues to be at the centre of HAI`s research, advocacy, capacity building and expertise, and as a result, has established HAI`s reputation as an authority on pharmaceutical policy issues.

Vision: Poverty and social injustice represent the greatest barriers to sustainable health and development and HAI works for a just and equitable society where people can participate in decisions affecting their health and well being, including the allocation of resources.

Start date: 01/01/2012 - End date: 01/01/2013

Call: Promote Health (Hp-2010)
Topic: Safety
Second Programme of Community action in the Field of Health 2008-2013
HAI_FY2013 [HAI_FY2013]
Health Action International (HAI) Europe is a non-profit, independent, European network of consumer groups, public interest NGOs, healthcare providers, academics and individuals. HAI`s mission and goa...
Health Action International (HAI) Europe is a non-profit, independent, European network of consumer groups, public interest NGOs, healthcare providers, academics and individuals. HAI`s mission and goals follow an overarching global work programme set every five years. HAI Europe devises plans and strategies to inform medicines` policy in Europe and acts as a regional coordinating centre.

HAI`s mission is:

- To increase access to essential medicines: Ensuring that medicines meeting priority healthcare needs are available, accessible and affordable to all;

- To improve the rational use of medicines: Ensuring that all licensed medicines meet real medical needs, have therapeutic advantages, are acceptably safe, offer value for money and are appropriately prescribed, in tailored doses, for an adequate time at the lowest cost to citizens and their community;

- To promote the participation of citizens in medicines policy: Encouraging and supporting the participation of patients and consumers in decisions that will affect their health and well-being, whilst advocating for the highest levels of transparency, independence and accountability in all aspects of medicines policy.

HAI Europe monitors and encourages EU policy-making around these three thematic priorities. HAI Europe works by implementing innovative methodologies that generate key data, develop and publish key publications and commentary as well as promote knowledge exchange on the impact of medicines policy on public health. The paucity of coherent medicines policies in Europe has driven HAI`s unique focus over the last 30 years and continues to be at the centre of HAI`s research, advocacy, capacity building and expertise, and as a result, has established HAI`s reputation as an authority on pharmaceutical policy issues.

HAI`s vision is:

Poverty and social injustice represent the greatest barriers to sustainable health and development and HAI works for a just and equitable society where people can participate in decisions affecting their health and well being, including the allocation of resources.

Start date: 01/01/2013 - End date: 01/01/2014

Call: Promote Health (Hp-2012)
Topic: Safety
3rd Health Programme (2014-2020)
Good Practices for demonstrating safety and quality through recipient follow-up [Euro-GTP II]
The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective impleme...
The main objective of this project is to set up the good practices applied to tissues and cells (T&C) preparation processes and patient follow-up procedures, to ensure their safe and effective implementation.
The outputs of this project will provide tools for assessing and verifying the quality, promote safety and assure efficacy of therapies with human tissues, Hematopoietic Stem Cells (HSC) and Assisted Reproductive Technologies (ART), addressing mainly to the implementation of novel T&C preparation processes and clinical indications, but also to the need of retrospective studies where weaknesses or insufficient safety data currently exist.
Recommendations will be forwarded to Tissue Establishments (TE) and Organizations Responsible for Human Application (ORHA), as the main actors in the process of validation and designing T&C preparation processes and patient follow-up according to a clinical indication.
This project aim to define the threshold of novelty, including definition of the factors that should be considered to determine the scope and depth of the clinical follow-up studies needed. The scope and extent of the recommended studies will be determined on the basis of a risk based approach performed taking into account factors such as the novelty of the product/preparation process/clinical indication, and its technical complexity.
A T&C Database of products, preparation procedures, clinical applications and their current status of authorisation and implementation will be established, working as a starting point for determining the ‘novelty’ of processes/therapies by TEs and ORHAs, and allowing the use of established processes/therapies by any centre that strictly follows the same procedure/clinical procedure/indication.
This project also aims to define a “GTP’s management model” that could provide impetus for future standards harmonisation and promotion, and allow the establishment of European accreditation and training programs for TE.
Start date: 01/04/2016 - End date: 31/03/2019

Call: Call for Proposals for Projects 2015
Topic: Safety
3rd Health Programme (2014-2020)
Promoting Implementation of Recommendations on Policy, Information and Data for Rare Diseases [RD-ACTION]
Rare diseases (RD) have been identified as one of the paradigmatic fields in which actions conducted at the European level constitute the adequate response to their specific problems: poor recognition...
Rare diseases (RD) have been identified as one of the paradigmatic fields in which actions conducted at the European level constitute the adequate response to their specific problems: poor recognition leading to diagnostic delay and inappropriate management including adapted social services, poor health outcomes, social burden, limited knowledge on natural history and pathophysiology leading to an insufficient development of new therapies. The low prevalence and the specificity of RD make that a global, multi-stakeholder approach, intended to gather specific expertise and to build shared strategies is necessary to address these issues.
The general objectives of RD-Action are to:
▪ Support the further development and sustainability of the Orphanet database, the biggest global repository of information on RD
▪ Contribute to solutions to ensure an appropriate codification of RD in health information systems
▪ Continue implementation of the priorities identified in Council Recommendation 2009/C151/02 and the Commission Communication (COM 2008 679) on RD, with a view to ensuring the sustainability of the recommended priority actions and to support the work of the Commission Expert Group on Rare Diseases (CEGRD).
This JA will expand and consolidate the achievements of the former JAs on RD supported by the European Commission: the Orphanet JA and the EUCERD JA. More precisely, this proposal has the ambition to help member states to implement the recommended measures adopted or to be adopted by the CEGRD and to produce the data necessary for countries to do so. Interactions between the production of data at the Orphanet database level and the implementation of policy priorities including codification will be strengthened during this JA.RD-Action large geographical coverage is key to success as it will promote the transfer of European recommendations into national policies and the collection of information and concerns from MS to the CEGRD, thus to the European Commission.

Start date: 01/06/2015 - End date: 31/07/2018

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: Safety