MIL-OSI Europe: Answer to a written question – DANA in Spain and the risk of medicine and vaccine shortages – E-002481/2024(ASW)

Source: European Parliament

The European Medicines Agency (EMA), together with the Member States, continuously monitors and investigates signals of potential supply disruptions escalated to EU level by national competent authorities to prevent their occurrence and mitigate their effects as far as possible.

The potential impact of the situation in Spain on the supply of medicinal products is closely monitored. Thus far, no critical shortage requiring EU coordination actions has been identified in this context.

In the context of the flood emergency and upon request from the Spanish authorities, the EU Copernicus satellite mapping system[1] was activated on 29 October 2024, and the EU Civil Protection Mechanism[2], on 8 November 2024.

As a result, 83 maps were produced, and several Member States offered in-kind assistance, in the form of heavy vehicles and pumps. The Commission deployed two liaison officers to help coordinate the assistance. The EU’s strategic reserve, rescEU,[3] was not mobilised as the requests were fulfilled by the offers of Member States.

A virtual warehouse for data on vaccine needs and stocks has not been set up yet, apart from the existing IT tool CECIS 2.0, in the area of civil protection.

As part of the implementation of EMA’s extended mandate[4], the European Shortages Monitoring Platform, launched in November 2024, will be used to report shortages and monitor supply, demand, and stock levels of medicinal products for preparedness activities, and during a public health emergency or major event.

As part of the pharmaceutical reform[5], the Commission has proposed to further expand the platform to cover structural shortages and security of supply of critical medicines.

  • [1] https://emergency.copernicus.eu/mapping/#zoom=2&lat=13.56036&lon=33.82273&layers=0BT00
  • [2] https://civil-protection-humanitarian-aid.ec.europa.eu/what/civil-protection/eu-civil-protection-mechanism_en
  • [3] https://civil-protection-humanitarian-aid.ec.europa.eu/what/civil-protection/resceu_en
  • [4] http://data.europa.eu/eli/reg/2022/123/oj
  • [5] https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en

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