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Joint Action on Shortages - Coordination and Harmonisation of the Existing Systems Against Shortages of Medicines - European Network

Acronym: CHESSMEN

General Information

Identification Code: 904406651937-31
Website: [object Object]
Entity Form: Joint Action composed of national authorities
Registration Category: Non-governmental organisations, platforms and networks and similar
Registration Date: 11/15/2023
EP Accredited Number: 0

Mission & Interests

Goals: Shortages of medicines are a longstanding concern in the EU, and the COVID 19 pandemic has placed significant pressure on the medicines supply chain. The EC deemed strategically important to elaborate a Work Programme focused on “Support action to mitigate shortages of medicines and improve the security of supply including of COVID-19 therapeutics”. To this regard, the EC has also considered the need for a harmonised approach, supporting inter-sector discussion fora aimed at strengthening the dialogue between stakeholders throughout the EU. The Joint Action supports Member States, while supporting the existing networks and initiatives already active in the field, enhancing MSs cooperation in: - identifying the root causes of observed shortages of medicines; - monitoring and reporting medicine shortages, including a common dataset proposal; - reducing the impact of shortages on patients; and - reducing the likelihood of medicines shortages via preventive strategies.
Interests Represented: Does not represent commercial interests
Interests:
  • Business and industry
  • Communication
  • Competition
  • Consumers
  • Institutional affairs
  • Public health
Levels of Interest:
  • sub-national
  • european
  • national

Activities

Main EU Legislative Proposals: The relevance of the short supply of medicines as an issue for many EU MSs was already considered as grounds for setting up this Joint Action: moreover, the absence of a harmonised, science-based approach to the measures against shortages is one of the most significant results of the recent, above-mentioned EC document "Future Proofing Pharmaceutical Legislation – Study on Medicines Shortages". In recognition of the problem and of the need for concerted action at the European level, the European Commission requested an analysis of the state of the art of medicines shortages in the EU and of their root causes, as well as an assessment of the current regulatory framework, to devise potential legislative and non-legislative solutions. The document highlights that "comprehensive comparative analysis is severely hampered by a lack of high-quality, standardised information about shortage monitoring at national level". Initiatives targeting the supply of clinically important medicines: - Development of critical medicines lists, aimed at applying extraordinary measures for supply/export/procurement - Obtain medicines in short supply from other MSs, with derogation to labelling/packaging. - Trade restriction (limited to a list of medicines) - Coordination of the production of important active substances (aimed at increasing the transparency of the supply chain) - Exceptional manufacturing activities (e.g. by the National Military Manufacturing site) Ad hoc task-forces/working groups dealing with shortages: - Ad hoc stakeholders working group for managing specific issues - National Emergency Supply Agency, Centre for Pandemic Vaccines and Therapeutics - Medicine Shortages and Defects Notification Centre. - National Commission of Pharmacy and Therapeutics, providing clinical guidance in managing shortages. - Set up of structured interactions with the EU network (e.g. via SPOC network) on specific cases (e.g. human immunoglobulins) - Working groups (with all relevant stakeholders), Ad hoc Advisory Council (with all relevant stakeholders), defining measures and evaluating the "supply-relevant and supply-critical active substances" to be included in a public list. Data gathering and information to patients: - Set-up of online database/app (allowing signals to patients, on-demand) with information on current/forthcoming medicines shortages and publication of the list of shortages/ mitigation measures. - Obligation for pharmacies to notify non-fulfilled orders to distributors: the data contributes to the evaluation of a "national alert level". For example, the CISMED project (Pharmacy-based Medicines Shortages Notification System) - Developing or amending pharmacy dispensing used in pharmacies to enable them to provide specific alerts to physicians/pharmacists in case of temporary unavailability/ shortages of a medicine. Regulatory intervention on use and pricing of medicines: - Procedures for strengthening national perspective on drug use and supporting the national regions in their responsibility for healthcare. - Possible price re-evaluation of critical medicines under short supply - Possibility of granting incentives to the manufacturing and marketing of critical medicines or medicines with low volumes and shortage history.
Communication Activities: The WP on Dissemination will be led by Infarmed, the Portuguese Authority for authorising and regulating human medicines. CHESSMEN dissemination is foreseen to be done through the website (www.ja-chessmen.eu), following the dissemination plan, where also targeted groups will be identified. It will serve as a Hub for all the information related to its rationale, the consortium, aim and objectives of the project and its final outcomes. All public documents, newsletters and updates will be made available on the public part of the website. It will include the links to partners’ and relevant patient organisations and bodies, including DG Sante and HaDEA. All action beneficiaries will contribute to the implementation of the dissemination strategy, through their own communication and dissemination channels, national and European congresses, in which CHESSMEN deliverables can be disclosed among the participants. Dissemination channels include: CHESSMEN project website, beneficiaries’ websites, collaborating organizations websites, social media channels, scientific publications, press-releases. The detailed dissemination strategy, target groups, means and tools will be included in the Exploitation and Communication Plan. Target groups: • Pharmaceutical industry associations • Wholesalers’ associations • Pharmacy associations • Parallel trade associations • Professional associations • Patients’ groups • Consumers • Learned societies • Academia • Relevant technical and scientific bodies
Inter-institutional or Unofficial Groupings: N/A

Head Office

Address: Via del Tritone, 181
City: Roma
Country: ITALY
Phone: [object Object]

EU Office

Address: Av. do Brasil 53, Parque de Saúde de Lisboa, Edificio 21
City: Lisboa
Country: PORTUGAL
Phone: [object Object]

Financial Data

New Organisation: true
Current Year: [object Object]
Complementary Information: Joint action CHESSMEN is co-funded by the European Commision EU4Health Programme and by public funding, by National Competent Authorities.

Membership Information

Members10 Percent: 0
Members25 Percent: 0
Members50 Percent: 15
Members75 Percent: 0
Members: 15
Members F T E: 7.5

Structure

Structure Type: Structure
Is Member Of: Information available at https://www.ja-chessmen.eu/beneficiaries Coordinator AIFA - Agenzia Italiana del Farmaco (Italy) Main Beneficiaries AIFA - Agenzia Italiana del Farmaco (Italy) AEMPS - Agencia Española De Medicamentos Y Productos Sanitarios (Spain) ANSM - The Agence Nationale de Sécurité du Médicament et des Produits de Santé (France) ATNA - The Austrian Ministry of Social Affairs, Health, Care and Consumer Protection (Austria) BFARM - Bundesinstitut Für Arzneimittel Und Medizinprodukte (Germany) DKMA - The Danish Medicines Agency (Denmark) DPM - The Division of Pharmacy and Medicines within the Luxembourg Health Directorate (Luxembourg) ESSC - Health Emergency Situation Centre of The Ministry of Health of Lithuania (Lithuania) FAMHP- Federal Agency for Medicines and Health Products (Belgium) FIMEA - Finnish Medicines Agency (Finland) HALMED - Agencija za Lijekove I Medicinske Proizvode (Croatia) HPRA - The Health Products Regulatory Authority (Ireland) INFARMED - The Autoridade Nacional do Medicamento e Produtos de Saúde I.P. (Portugal) JAZMP - Javna Agencija Republike Slovenije Za Zdravila in Medicinske Pripomočke / Agency for Medicinal Products and Medical Devices of The Republic Of Slovenia (Slovenia) LÄKEMEDELSVERKET - The Swedish Medicinal Products Agency (Sweden) MINISTRY VWS - The Department of Pharmaceutical Affairs and Medical Technology of The Dutch Ministry of Health, Welfare and Sport (Netherlands) MS/MOH - Ministerul Sănătății România (Romania) NoMA - Statens Legemiddelverk (Norway) OGYEI - Országos Gyógyszerészeti És Élelmezés-egészségügyi Intézet (Hungary) PHS - The Pharmaceutical Services of Cyprus (Cyprus) SAM - Estonian State Agency of Medicines (Estonia) SUKL - Státní Ústav Pro Kontrolu Léčiv (Czech Republic) Affiliated Entities AGES/BASG - Osterreichische Agentur fur Gesundheit und Ernahrungssicherheit Gmbh (Austria) GÖG - Gesundheit Österreich Gmbh (Austria) ISS - CNS/CNT - Istituto Superiore Di Sanità (Italy) Centro Nazionale Sangue (CNS) Centro Nazionale Trapianti (CNT) NAMMDR - Agentia Nationala a Medicamentului Si a Dispozitivelor Medicale din Romania (Romania) PEI - Paul Ehrlich Institut (Germany)