INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE [ INSERM ]

101 Rue de Tolbiac 75654 PARIS - France

Involved in the following projects during the 3rd programme

3rd Health Programme (2014-2020)
Codification for Rare Diseases [RDCODE]
The objective of this project is to support Member States in improving gathering information on rare diseases by implementation of Orphacodes (rare diseases specific codification system). The implemen...
The objective of this project is to support Member States in improving gathering information on rare diseases by implementation of Orphacodes (rare diseases specific codification system). The implementation process will be guided by the "Standard procedure and guide for the coding with Orphacodes" and the "Specification and implementation manual of the Master file" both developed in the frame of the current RD-ACTION Joint Action. The aim of the Orphacode project is to promote the use of the Orphanet nomenclature for implementation into routine coding systems. This enables a standardised and consistent level of information to be shared at European level. Starting with countries that have no systematic implementation of the Orpha codification yet, but that are actively committed already in doing so, this project will provide a sufficient real-world implementation experience to be captured by other countries in the future. Outcomes are: 1. Development of comprehensive rules of use and meta-data documentation for Orphacodes use in clinical health information and other applications that has been developed and rigorously tested in health care systems from EC countries of varying sizes, health information systems, and languages 2. An electronic repository will be created to house this information at the Orphanet website, linking to Orphadata, to include: guidance for use of Orphacodes; teaching and training documents used in health care systems; tools for export of Orphacodes to federated data exploitation at the EC level. 3. Through collaboration of RDCODE partners and invited collaboration with key stakeholders at workshops, effective implementation will be achieved at implementing countries as well as momentum will be developed in other jurisdictions to implement Orphacodes in widespread use to accurately measure the impact of rare diseases in the EC.
Start date: 01/01/2019 - End date: 31/12/2021

Call: Call for Proposals for Projects 2018
Topic: Orphacodes Project
3rd Health Programme (2014-2020)
BRidging Information and Data Generation for Evidence-based Health Policy and Research [BRIDGE Health]
BRIDGE Health (BRidging Information and Data Generation for Evidence-based Health Policy and Research) aims to create European health information (EU-HI) and data generation networks covering major EU...
BRIDGE Health (BRidging Information and Data Generation for Evidence-based Health Policy and Research) aims to create European health information (EU-HI) and data generation networks covering major EU health policy areas. The network uses comprehensive experience and assures a knowledge transfer from past health and research frameworks.

The aim is to work towards a comprehensive, integrated and sustainable EU-HI supporting evidence-based health policy and research for the EU and Member States by providing blueprints and/or concepts of building blocks for a future EU-HI research infrastructure consortium (ERIC-HI).

The project bridges key EU projects in domains of population and health system monitoring and indicator development, health examination surveys, environment and health, population injury and disease registries, clinical and administrative health data collection systems and methods of health system monitoring and evaluation.

The project aims to:
1) enhance the transferability of health information and data for policy and improve the utility and use of data and indicators for stakeholders in policy making, public health surveillance and health care;
2) reduce health information inequality within the EU and within MS;
3) develop a blueprint for a sustainable and integrated EU Health information system by developing common methods for a) standardising the collection and exchange of health information within and between domains, between MS, including e-health platforms; b) ensuring data quality, including procedures for internal and external validation of health indicators; c) undertaking priority setting exercises for health information, d) addressing ethical and legal issues associated with the collection and use of health data within MS and the EU.

Coordination, dialogue and interaction with DG-SANCO, the Expert Group on Health Information, Eurostat, DG Research and other DGs ensure the sustainability of the work and bridges to a future ERIC-HI.
Start date: 01/05/2015 - End date: 31/10/2017
Call: Call for Proposals for Projects 2014
Topic: Health monitoring and reporting system
3rd Health Programme (2014-2020)
VASCERN Registries [VASCERN Registries]
This project proposal concerns the registry needs of VASCERN, the ERN on rare multystemic vascular diseases, which was launched in March 2017 and which is a 5 years project co-funded by the 3rd Health...
This project proposal concerns the registry needs of VASCERN, the ERN on rare multystemic vascular diseases, which was launched in March 2017 and which is a 5 years project co-funded by the 3rd Health Programme under a Framework Partnership Agreement.

In our VASCERN registries' project, we will:
• Use the JRC / ERDRI for storing metadata / EU Common dataset and start transforming the registries into FAIR registries
• Adapt the plan to the structure of VASCERN which is unique because of many diseases with no relations between them (no common point between PPL and HTAD except that these diseases are vascular diseases): therefore there is a need for different registries:

1) common data registry: minimum EU dataset. Already available will be the core of each registry of each of our 5 Rare Disease Working Groups (RDWG).
2) Diseases specific registries: one per RDWG (meaning 5). These rare diseases specific registries can be based on the more complete and evaluated registry (HTAD, MSA and HHT) or can be the creation of a new registry (VASCA and PPL)
Start date: 01/05/2020 - End date: 30/04/2023

Call: Call for Proposals for Projects 2019
Topic: Rare disease registries for the European Reference Networks (Heading 2.1 of the AWP 2019)
3rd Health Programme (2014-2020)
Efficient response to highly dangerous and emerging pathogens at EU level [EMERGE]
The human population is confronted with emerging and re-emerging infectious pathogens that can cause serious cross-border outbreaks. A recent example is the Ebola outbreak requiring strong diagnostic,...
The human population is confronted with emerging and re-emerging infectious pathogens that can cause serious cross-border outbreaks. A recent example is the Ebola outbreak requiring strong diagnostic, clinical, and public health measures in Europe and abroad in order to get this incident under control. The JA EMERGE is in compliance with the European policy (Decision No 1082/2013/EU) where the need for an efficient, rapid and coordinated response to high threat pathogens is defined. The JA EMERGE comprises a European network with more then 40 diagnostic laboratories focused on risk group 3 bacteria and risk groups 3 and 4 viruses. It will act in a so-called inter-epidemic mode (IEM) which can be activated and switched into an outbreak response mode (ORM) on request by the Health Security Committee in order to direct all activities to the outbreak management. A number of other laboratory networks, institutions and agencies are contributing to the management of cross-border infectious outbreaks. EMERGE will provide a platform for establishment and consolidation of a common, coordinated and effective response to infectious disease outbreaks at EU level and abroad (WP4). State of the art and new diagnostic methods for high threat pathogens, including in-house and commercial kits, will be evaluated for their applicability and recommended in outbreak situations when suitable (WP5). External quality assurance exercises will ensure best approaches for laboratory responsiveness in outbreak situations (WP6). These activities must be supported by an appropriate training to share best practices of diagnostics and bio-risk management (WP7). In conclusion, the general objective will be to ensure efficient response to serious emergent and re-emergent cross-border events by reinforcing the existing EU network of BSL 3 and BSL 4 laboratories which are already active in the field of identification of dangerous bacterial and viral human pathogens.
Start date: 01/06/2015 - End date: 31/03/2019

Call: Grants for actions co-financed with Member State authorities 2014 (Joint Actions)
Topic: Pathogens Joint Action
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: Rare Disease Joint Action
3rd Health Programme (2014-2020)
Orphanet Network [ONW]
Rare diseases (RD) have been considered a challenge for Europe, for they have been identified as one of the paradigmatic fields in which actions conducted at the European level constitute the adequate...
Rare diseases (RD) have been considered a challenge for Europe, for they 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. Amongst the key actions the European Commission (EC) has contributed to develop so far in order to address key priorities in the field of RD there is Orphanet, a European Knowledge base dedicated to RD and orphan drugs, accessible from the portal www.orpha.net, and providing re-usable data through the platform www.orphadata.org. Orphanet has also be recognised, by the EC , as having a de facto monopoly in its field. The objectives of the project are:
1. To provide the RD community with interoperability tools, in particular around an inventory of RD, to allow for semantic interoperability between countries and between domains (health, research)
2. To provide high-quality information on RD, in particular through an encyclopedia in several languages,
3. To provide a directory of expert services in order to help patients, physicians and stakeholders finding the expertise on a particular disease in Europe and beyond, and to produce data needed to support policy actions.
4. To further develop and sustain Orphanet as the reference knowledge base on RD, by establishing and consolidating collaboration within the Orphanet pan-European network and with European Reference Networks (ERNs) for the production, improvement and dissemination of knowledge on rare diseases. It will allow for the creation of a consistent expertise ecosystem for rare diseases in Europe.
The overall outcome is the consolidation of Orphanet as the reference source of information on RD for European citizens.

Start date: 01/06/2018 - End date: 30/06/2021

Call: Direct Grants
Topic: Orphanet (de facto monopoly in line with Article 190 (1) (c) of Delegated Regulation (EU) No 1268/2012)
3rd Health Programme (2014-2020)
European Joint Action on Vaccination [EU-JAV]
Vaccination is a valuable investment in health with highly positive return for the sustained development of populations. It is a preventive tool involving much less cost than the cost of targeted dise...
Vaccination is a valuable investment in health with highly positive return for the sustained development of populations. It is a preventive tool involving much less cost than the cost of targeted diseases and their consequences. Vaccination is a truly complex cross sectoral issue, as pertaining to basic immunology discovery, benefit/safety evaluation and epidemiological surveillance, to public health policies and health system planning, to forecasting and financing, to health professionals’ education and health literacy, to cultural identities and social norms. By involving a wide variety of stakeholders, the EU-JAV project aims at building concrete tools to improve vaccination coverage in EU and therefore improve population health. EU-JAV will also capitalise on the numerous existing initiatives and projects, to challenge and strengthen the European cooperation of Member states on vaccination while contributing to sustainably integrate EU-JAV achievements in health policies of European countries. The JA Vaccination proposes to address several important issues, common to many countries such as establishing a sustained cooperation of relevant Member State authorities, defining basic principles for vaccine demand forecasting, developing a concept and prototype for a data warehouse for EU-wide sharing of vaccine supply and demand data among dedicated stakeholders, defining common stages and criteria for priority-setting of vaccine research and development, developing a concept and prototype for a vaccine R&D priority setting framework, defining structural, technical and legal specifications as regards data requirements for electronic vaccine registries/databases/immunisation information systems and providing a framework to cooperate on confidence from research to best practices and implementation. To achieve this ambitious concrete actions, the project gathers 20 partners from 20 different countries as well as international organisations and relevant stakeholders.
Start date: 01/08/2018 - End date: 31/03/2022

Call: Joint Actions 2017
Topic: Joint Action on vaccination
3rd Health Programme (2014-2020)
European Joint Action on antimicrobial resistance and associated infections [EU-JAMRAI]
Antimicrobial resistance (AMR) is a serious public health threat that is gaining swift ground. The increase of multi-resistant bacteria associated to the lack of new antibiotics represents a threat to...
Antimicrobial resistance (AMR) is a serious public health threat that is gaining swift ground. The increase of multi-resistant bacteria associated to the lack of new antibiotics represents a threat to global health. Some patients are faced with no therapeutic solutions as some bacteria resist to all antibiotics. Moreover, “old” antibiotics and to some extent more “recent” ones are gradually removed from the market because they are not economically sustainable, albeit being still possibly efficient. The issue of antimicrobial resistance is a real challenge that decision-makers are well aware of and has gained a high priority among public health challenges.
A closely related challenge is the issue of Healthcare Associated Infections that shall not be considered separately. In fact, infection prevention and control strategies should go hand in hand with i) prudent use of antibiotics ii) appropriate tools for monitoring and surveillance and iii) accurate diagnostic tests to decide on the right therapy.
The various national, European and international initiatives that have emerged over the last decade have shown a great commitment to actively tackle these issues.It is essential that all actors in the field of AMR join forces so as to avoid duplication of efforts and ensure greater coherence. Moreover, it is essential that the strategies adopted extend beyond the sole human health domain and bring a global One Health response.
The overall objective of the AMR-HCAI JA is to ensure that policies for control of AMR and HCAI are adopted and implemented across EU MS in a coordinated way, ensuring national specificities are accounted for, in line with the ECDC and WHO guidelines and recommendations, and in conjunction with other European initiatives.This will be made possible by bringing together different networks of policy makers, experts and organizations on AMR and HCAI working in different European and International initiatives and projects relevant for policy decision.
Start date: 01/09/2017 - End date: 28/02/2021

Call: Joint Actions 2016
Topic: Antimicrobial resistance and Health Care Associated Infections
3rd Health Programme (2014-2020)
Joint Action on Rare Cancers [JARC]
This Joint Action on Rare Cancers (JARC) will be aimed at:

1. prioritising rare cancers (RCs) in the agenda of the Europe (EU) and Member States;
2. developing innovative and shared solutions for ...
This Joint Action on Rare Cancers (JARC) will be aimed at:

1. prioritising rare cancers (RCs) in the agenda of the Europe (EU) and Member States;
2. developing innovative and shared solutions for European Reference Networks (ERNs) on RCs, in the areas of quality of care, innovation, education and state of the art definition on prevention, diagnosis and treatment.
The objectives of JARC will be achieved by creating a platform for competent national authorities as well as institutions, scientific and professional societies and patient organisations, to produce consensus-based recommendations, with a special view to the new ERNs, seen as a great opportunity for improvement of RC patient outcomes in the EU.
Following the results of the RARECARE project, all the 12 families of RCs will be considered. Consensus-based recommendations about RCs will be provided to improve: 1) epidemiological surveillance of RCs; 2) quality of healthcare, primarily through the new ERNs; 3) the availability of clinical practice guidelines on RCs; 4) innovation, also by optimizing clinical research regulations as well as practices and semantics regarding patient data and tissues; 5) medical and patient education; 6) health policy measures on RCs at the EU and national level; 7) patient empowerment (which will be pursued across all items dealt with by JARC). All EU stakeholders in the field of RCs and rare diseases will be involved.
JARC will carry forward the aims of the Third Health Programme by improving chances of EU RC patients to have access to appropriate healthcare, primarily through optimal shaping of ERNs. Thus, all this should result in reduced healthcare inequalities, increased innovation in health, increased sustainability of health systems, decreased health migration and reduction of gaps in rare cancers survival across EU countries.

Start date: 01/10/2016 - End date: 30/09/2019

Call: Health Programme Adhoc Call for invited (named) beneficiaries
Topic: Rare cancer