TOPIC : Scaling up the univocal Identification of Medicinal Products
|Publication date:||27 October 2017|
|Types of action:||IA Innovation action|
|DeadlineModel: Planned opening date:||single-stage 16 October 2018||Deadline:||24 April 2019 17:00:00|
|Time Zone : (Brussels time)|
Topic DescriptionSpecific Challenge:
Across the European Union, medicinal products display differences in names, variations in strength or their package size. The unavailability of a specific product may also necessitate substitution in many instances, if a patient is to be timely served in a pharmacy. Moreover, due to differences in marketing authorisation procedures, not every medicinal product is available in each Member State, and it is not unusual that the same product may have different names across Member States or the same name may identify a different product in another Member State. As substitution is regularly necessary to dispense a foreign ePrescription (eDispensation), a univocal identification of medicinal products would enable and enhance the dispensation of a foreign ePrescription and would provide benefits to patient health, patient safety, pharmacovigilance and would also allow better data analysis of clinical records. Most national ePrescription and medicines databases are not currently supporting relevant identification attributes and codes. As the EU-wide implementation of ISO IDMP (identification of medicinal products) standards is currently under way by the European Medicines Agency (EMA) and the EU Regulatory Network to comply with the EU Pharmacovigilance legislation, this action aims at enabling and fostering the use of a common EU medicinal Product repository (ISO IDMP compliant) to fulfil the ePrescription/eDispensation in a cross-border setting use case. This will provide a univocal identification of medicinal products across Europe and potentially beyond.Scope:
This innovation action is expected to support two goals: (i) the cross-border mobility of European patients by offering safer eDispensations across borders, (ii) the implementation of the IDMP standards in Member States drug databases (including a possible linkage to the EU SPOR - Substance, Product, Organisation and Referential master data database) allowing the identification of locally available medicinal products which are equivalent to the one identified in a foreign prescription.
This requires creating an EU ePrescription/eDispensing approach to use the future EU SPOR database. A common approach and operating model needs to be developed, including common processes for validation of contents, error mitigation, linkage of the EU SPOR database with the ePrescription/eDispensing systems, updates and mappings to other systems for at least 5 Member States' organisations. Harmonisation guidelines of prescribing and dispensation practices in a cross-border setting could be a further focus.
The proposal should demonstrate its ability to:
- Define the additional quality criteria, processes, actors, risk minimisation measures and safety nets to be applied to the data coming from the EU SPOR database to ensure that the data can be safely used by the ePrescription/eDispensing systems and any harm to patient is avoided;
- Define and implement APIs or use the ones that will be provided by the SPOR system) for data retrieval/view;
- Ensure the quality of data, usability of data for national agencies, determine and support the implementation and validation of adaptations needed at national or regional levels;
- Support integration with existing cross-border ePrescription services, such as implemented under the Connecting Europe Facility;
- Improved pharmacovigilance, inclusion of pharmacovigilance modules capable of reporting adverse drug reactions to relevant regulators using the format defined by the ISO ICSR (Individual Case Safety Report) standard into clinical software systems, validation and diffusion;
- Establish a Working Group of European medicinal products database producers to support the implementation of the IDMP standard;
- Raise awareness and ensure coordination of pre-competitive activities, cooperation with EMA and the EU Regulatory Network (e.g. national competent authorities), and other relevant stakeholders (producers of ePrescribing, clinical record systems);
- Raise awareness and explore benefits for both regulatory and clinical contexts, use cases for public health, big data;
- Disseminate to clinical actors (prescribers, physicians, nurses) the ISO IDMP data base contents, usage, value generation and relevance for integrated care;
- Contribute to EU-US Trans-Atlantic cooperation and trans-border medicinal products data access and exchange (semantic interoperability);
- Ensure compliance with relevant EU legislation, in particular REGULATION (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data;
- Contribute, where relevant, to the sustainability and diffusion of European eHealth services, such as implemented under the CEF.
It is expected that Members of the Consortium should include a wide range of relevant stakeholders and experts including inter alia Pharmacists, National Competent Authorities, IT Integrators, producers of ePrescribing, clinical record systems. It should demonstrate its ability to deliver large scale implementation and coordination of European projects. Participation of Industry is encouraged in the most appropriate phases of the project.
The work should also provide an assessment of impacts based on benefits and costs to be anticipated. This should include not only regulatory impact, but also impact on setting global standards and best practice, and impact on clinical data quality and interoperability along with the spill-over effects on pharmaceutical companies, data base producers and competitive advantage of European companies.
Synergies with actions and activities supported by different programmes and policy initiatives of the Commission should be encouraged and resources from previous European projects should be considered.
The Commission considers that proposals requesting a contribution from the EU of between EUR 5 and 8 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.Expected Impact:
The proposal should provide appropriate indicators to measure its progress and specific impact in the following areas:
- Design and implementation of an IT solution based on the EU SPOR database to support ePrescribing/eDispensing in a cross-border setting is designed and implemented, open for integration with existing cross-border ePrescription and electronic health record services, such as under CEF or H2020
- Better address adverse events/effects and safety issues by enhanced development of standard vocabulary for the related reporting;
- Better health data access across Europe for patients and healthcare providers;
- Improved quality of care resulting in enhanced patient safety;
- Improved efficiency gains in term of timeliness of intervention;
- Extended healthcare continuum across borders;
- Collection and re-use of a data set that is sufficiently large to detect (statistically) significant findings;
- Provision of medicinal products information for under-resourced stakeholders.
Topic conditions and documents
1. Eligible countries: described in Annex A of the Work Programme.
A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon 2020 projects. See the information in the Online Manual.
In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding to support its participation in projects supported under this topic
Proposal page limits and layout: please refer to Part B of the proposal template in the submission system below.
- Evaluation criteria, scoring and thresholds are described in Annex H of the Work Programme.
- Submission and evaluation processes are described in the Online Manual.
4. Indicative time for evaluation and grant agreements:
Information on the outcome of evaluation (single-stage call): maximum 5 months from the deadline for submission.
Signature of grant agreements: maximum 8 months from the deadline for submission.
5. Proposal templates, evaluation forms and model grant agreements (MGA):
6. Additional provisions:
Members of consortium are required to conclude a consortium agreement, in principle prior to the signature of the grant agreement.
7. Open access must be granted to all scientific publications resulting from Horizon 2020 actions.
Where relevant, proposals should also provide information on how the participants will manage the research data generated and/or collected during the project, such as details on what types of data the project will generate, whether and how this data will be exploited or made accessible for verification and re-use, and how it will be curated and preserved.
Open access to research data
The Open Research Data Pilot has been extended to cover all Horizon 2020 topics for which the submission is opened on 26 July 2016 or later. Projects funded under this topic will therefore by default provide open access to the research data they generate, except if they decide to opt-out under the conditions described in Annex L of the Work Programme. Projects can opt-out at any stage, that is both before and after the grant signature.
Note that the evaluation phase proposals will not be evaluated more favourably because they plan to open or share their data, and will not be penalised for opting out.
Open research data sharing applies to the data needed to validate the results presented in scientific publications. Additionally, projects can choose to make other data available open access and need to describe their approach in a Data Management Plan.
Projects need to create a Data Management Plan (DMP), except if they opt-out of making their research data open access. A first version of the DMP must be provided as an early deliverable within six months of the project and should be updated during the project as appropriate. The Commission already provides guidance documents, including a template for DMPs. See the Online Manual.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The legal requirements for projects participating in this pilot are in the article 29.3 of the Model Grant Agreement.
8. Additional documents:
1. Introduction WP 2018-20
5. Introduction to Leadership in enabling and industrial technologies (LEITs) WP 2018-20
5i. Information and communication technologies (ICT) WP 2018-20
8. Health, demographic change and well-being WP 2018-20
16. Science with and for society WP 2018-20
18. Dissemination, Exploitation and Evaluation WP 2018-20
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