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WHAT IS A JOINT ACTION?

Joint Actions are a funding instrument under the third EU Health Programme 2014-2020. They are designed and financed by Member State authorities and the EU to address specific priorities under the EU Health Programme. Joint Actions have a clear EU added value – they are expected to contribute to solving problems at the European level, and to have a greater impact that single national activities, especially at policy making level. They are co-financed either by competent authorities that are responsible for health in the Member States (e.g. Health Ministries) or in the third countries participating in the Programme, or by public sector bodies and non-governmental bodies mandated by those competent authorities. Joint Actions involve on average 24 beneficiaries, depending on the scope of the action, must be related to the existing EU policies in the field of public health and in other policy fields and must not duplicate actions that can be taken at Member State level.

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ABOUT GAPP

GAPP Joint Action is aiming at facilitating the development of a common and optimal approach to assess and authorize preparation processes in blood and tissues establishments (BEs and TEs), adapting requirements as prescribed by Article 29 of Directive 2002/98/EC and Article 28 of Directive 2004/23/EC .

Since the directives for these fields were adopted, significant technical developments have taken place and the complexity of preparation processes has greatly increased. Increasing complexity of processing can bring significant quality and functionality improvements for patients, and/or more efficient use of donations, but it can also bring increased risk, particularly as the level of complexity brings the final product towards the borderline with medicinal products.

GAPP will ensure that any possible advantage or outcome is taken into account from two ongoing Public Health Programme projects focused on tissues and cells (EuroGTP and ECCTR) incorporating a need for clinical follow-up data as part of a comprehensive process authorization.

GAPP durable output is that a knowledge sharing platform on PPAs will be developed and fed in order to facilitate sharing of information among European Union, Competent Authorities and a number of CA inspectors will be trained specifically to assess and authorize preparation processes of tissues, cells, reproductive cells and blood products.

 GAPP objectives are:

1) increasing consistency and efficacy of competent authority regulatory activities through harmonization of EU-level tools for authorization procedures for preparation processes at blood and tissues establishments

2) developing a concept model for a European knowledge-sharing platform that can support CAs in the assessment and evaluation of novel preparation processes of products

3) developing an international network of experts that can support CAs in the assessment and evaluation of preparation processes of products, trained by the Joint Action

WHAT IS THE EUROPEAN COMMISSION’S ROLE?

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.

It implements the EU Consumer Programme and the Better Training for Safer Food initiative as well as the EU Health Programme, which co-funds the GAPP Joint Action. The Consumers, Health and Food Executive Agency (CHAFEA), as referred to-date, provided a professional service in performing the tasks and activities entrusted to it by the European Commission (EC) working closely with the EC Directorate-General Health and Food Safety (DG SANTE) that has the policy leadership on the EU health related policies aiming to protect and improve public health.

Press here for further information on EC, DG SANTE and HaDEA.

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© 2018 GAPP JOINT ACTION | WP2: Dissemnination & Communication