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.
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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.

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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.
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Disease of the cornea (the transparent layer covering the front of the eye) is the second cause of blindness worldwide. The cornea is the most transplanted tissue with over 100,000 corneas transplanted annually. In Europe an estimated 30,000 corneal transplants are performed each year.
Currently there is no harmonisation of information across the European Union on the numbers or origins of the scarce corneas tissue available for transplant, the optimum procedure for transplant and the visual outcome and quality of life of corneal transplant patients.
The ESCRS in 2006 with the support of the Executive Agency for Health and Consumers pioneered an online Quality Registry of the outcomes of cataract and refractive surgeries (EUREQUO). ESCRS continues to support this Registry and has currently a database of over 2,000,000 surgeries.
ESCRS proposes to extend this platform to create a registry of corneal transplantation surgeries in Europe. The European Cornea and Cell Transplantation Network (ECCTR) will link three existing registries and recruit additional centres of excellence and eye banks to contribute data on availability of corneal tissue, methods of transplantation, and visual outcomes of surgery.
The focus of our consortium is on bringing added value and making a positive impact on one of the priority actions set out in the annual Work Programme for 2015; contributing to the fourth overall objective:” To build a common assessment methodology to allow academics, health professionals and authorities to assess and verify safety, quality and efficacy of (new) transplantation therapies and/or other types of clinical applications of human tissues and cells (e.g. assisted reproductive technologies).”
After the completion of this action the ECCTR will have all the data necessary to develop European Guidelines for Corneal Transplant Surgery to better utilise scarce cornea tissue ensure European self-sufficiency and reduce patient waiting lists.
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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.

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