Work Package 1
Coordination, management and evaluation
WP 1, led by AIFA, is responsible for the management and coordination of the project, horizontally and vertically, ensuring that it is implemented as planned, and managed following the EU rules and procedures.
Work Package 2
Communication, dissemination and exploitation
WP 2, led by INFARMED, I.P., is responsible for the identification of the target groups, both internal and external, the respective dissemination and communication strategy, as well as the development of the project visual identity and for setting up the intermediate and final meetings.
Work Package 3
WP3, led by FAMHP, is responsible for the evaluation of the Joint Action, namely the evaluation of the effectiveness of the project.
Work Package 4
WP 4, led by HPRA, is responsible for ensuing the sustainability of the identified policy measures, including good practices, in line with the overall objectives of the JA.
The WP 4 is in close collaboration with the other WPs to support the technical WPs in order to assure the timely development of the deliverables, to analyze the transferability between Member States and networks.
Work Package 5
Identifying the root causes of observed shortages of medicines
WP 5, led by AEMPS, is responsible for the identification and analysis of the root causes of shortages of medicines, based on the review of publicly available reports and grey literature, together with the knowledge and hands-on experience of the members of National Competent Authorities and the Consortium.
- Build a comprehensive list of key definitions and terminology related to shortages of medicines.
- Conduct a literature review on existing reports and publications that include information related to root causes of medicine shortages at EU level.
- Data analysis taking into account all the parameters involved, identifying the body responsible for the implementation of mitigation strategies.
Work Package 6
Identification of best practices to address medicines shortages
WP 6, led by JAZMP, is responsible for the identification of established knowledge, procedures and practices in order to support the process of monitoring, reporting, and managing medicine shortages.
- Collection of the existing documents in the EU, EMA/HMA and national contexts related to shortages of medicines to support harmonized approach to the topics of the JA and facilitate all the next steps in all technical work packages.
- Identification and mapping of the best practices in monitoring, reporting, and managing medicine shortages.
- Based on the outcomes of mapping activity, development of comprehensive protocol for monitoring, reporting and managing medicine shortages to support harmonisation of the approaches within Member States.
- Contribute to the work of TWG1 of the TF AAM on the development of EU list of critical medicines, and based on the outcomes prepare the recommendations for development of National lists of critical medicines. (new objective).
- Performing pilot on demand forecasting at national level for selected medicines.
- Development of training material on the WP6 outputs and workshop for the NCAs.
Work Package 7
Digital Information Exchange for Monitoring and reporting medicine shortages
WP 7, led by BFARM, is to develop a European IT concept model to monitor and manage medicines shortages, taking into consideration the already existing tools/good practices developed at EU MS level, in order to achieve an efficient merging of the available systems and information sources of MS, with an inclusive approach.
- The main objective of the development of the European IT Concept Model is to take into account existing tools and best practices in the Member States.
- The aim is to bring together the best available knowledge in a coherent way, focusing on essential minimum requirements for data and interoperability of systems.
- The easy and direct availability of information on supply shortages would provide significant added value to all actors in the distribution chain, from production to therapeutic use.
- The approach to be developed aims to involve as broadly as possible those involved in the whole distribution process.
- Such a system is complex, but should be tiered so that each user receives the information they need in their area of activity (demand-driven access to information).
Work Package 8
Reducing the likelihood of medicines shortages via preventive and mitigation strategies
WP 8, led by FIMEA, will work on selecting recommendations/policies for best preventive and mitigation measures adopted in the Member States and elaborating proposals of common EU implementation measures adaptable to the national context.
- To support Member States in the prevention and mitigation of likelihood of medicines shortages.
- To minimize the effects of shortages on patient-care.
- Selecting for best practices of preventive and mitigation measures in use or in development in EU-countries in collaboration with the participating countries and from the information collected in WP 6.
- Producing good practice guidance for stakeholder dialogue platforms for supply chain stakeholders, patients and healthcare providers as part of the prevention and mitigation plan, especially for the pre-crisis situations.
- Selecting recommendations/policies for best preventive and mitigation measures adopted in the Member States and elaborating proposals of common EU implementation measures adaptable to the national context.