EU Health Crisis Package Includes Supply Chain Revamps, Central Procurement & Regulatory Flexibility
The European Commission says that all the legislation for the creation of the European Health Union is now in place, following the publication of regulations on the supply and availability of medical countermeasures, centrally coordinated procurement mechanisms, and “ever-ready” manufacturing capacity for use in health emergencies.
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EU legislation just approved by legislators will require the European Commission to provide information on prices, manufacturers, delivery time frames and joint procurement processes for vaccines and medicines used in tackling future health crises such as pandemics.
As part of its expanded mandate, the EU regulator is identifying those medicines whose supply will need to be closely monitored during health crisis situations. The lists will draw on various information sources, including real-world evidence databases.
The World Health Organization has published a “step-by-step guide” for countries wishing to increase their capacity for monitoring pathogens with pandemic and epidemic potential. The EU and the UK have cleared an updated version of Moderna’s COVID-19 vaccine Spikevax targeting the XBB.1.5 variant, while the EU has followed the US in approving Gilead’s Veklury as the first treatment for COVID-19 patients with mild-to-severe liver damage.