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Joint Action on shortages CHESSMEN

CHESSMEN
Source: © CHESSMEN, 2023

Drug shortages are a long-standing and growing problem in the European Union. The constraints caused by drug shortages were very evident during the COVID-19 pandemic, when a significant increase in demand for drugs was observed. This put considerable pressure on the pharmaceutical supply chain and led to shortages of critical medicines, such as those used in intensive care units. The need for greater EU coordination of activities and harmonisation of Member States' approaches to managing shortages has been highlighted in various studies and reports. The monitoring and prevention of drug shortages are key factors in maintaining long-term and timely access for citizens to the relevant therapeutic products.

CHESSMEN (Coordination and Harmonisation of the Existing Systems against Shortages of Medicines - European Network), a Joint Action co-funded by the EU and officially launched on 16 January 2023, aims to support Member States in their activities to address medicines shortages and targets groups such as EU regulatory authorities, national policy makers, key stakeholders such as industry associations, wholesalers, academic institutes, professional associations, patients' associations and the general public. It complements existing networks and initiatives set up over the last three years, such as the European Medicines Agency (EMA) Single Point of Contact (SPOC) Working Party on Drug Shortages and the EMA/Heads of Medicines Agency (HMA) Task Force on the Availability of Authorised Medicines for Human and Veterinary Use (TF AAM).

The Joint Action benefits from the active participation of a broad consortium of 27 organisations (associated and affiliated) representing 21 EU Member States and one EEA country. By sharing information on quality data, the Joint Action aims to improve coordination and cooperation between Member States and strengthen the capacity to reduce shortages of medicines.

The main objective of the Joint Action is, in the short term, to establish a strong dialogue between different Member States, experts and other relevant bodies and, in the long term, to establish a common basis for working together to prevent or mitigate the effects of drug shortages. To achieve this objective, CHESSMEN aims to strengthen the coordination structure and optimise the use of available resources and existing practices in all Member States by identifying the root causes of medicines shortages, promoting best practices in monitoring, reporting and managing medicines shortages, and defining a proposal for a common data set for reporting and managing medicines shortages. In addition, the CHESSMEN Joint Action aims to develop strategies to prevent shortages by capitalising on and building on existing knowledge, for example by developing model initiatives and practices based on studies carried out by the European Commission and on good practices already in place in EU Member States.

The Joint Action is divided into four horizontal work packages and four technical work packages, led by entities from different countries, to support the implementation of the objectives and establish a harmonised process to reduce drug shortages.

  • Work Package 1 - Coordination, management and evaluation
  • Work Package 2 - Communication, Dissemination and Exploitation
  • Work Package 3 - Evaluation
  • Work Package 4 - Sustainability
  • Work Package 5 - Identification of root causes of identified drug shortages
  • Work Package 6 - Identification of best practices to address drug shortages
  • Work Package 7 - Digital information exchange for monitoring and reporting on drug shortages
  • Work Package 8 - Reducing the likelihood of drug shortages through prevention and mitigation strategies

BfArM is leading Work Package 7, which focuses on the development of a European IT concept model for the monitoring and management of drug shortages, taking into account existing tools and good practices developed at European Member State level, in order to achieve an efficient integration of Member States' existing systems and information sources through an integrative approach.

For more information and the latest news on the CHESSMEN Joint Action, please visit ja-chessmen.eu.

Co-funded by the European Union
Source: © European Union, 1995-2023