The EU and the US are expected to extend the mutual recognition for manufacturing standards to plasma and vaccines, as well as to keep monitoring the worrying protectionist developments in China on medical devices.
The revision of the EU's blood directive offers the chance to overhaul outdated restrictions that prevent those in same-sex relationships from becoming blood and plasma donors.
As an Alpha-1 Antitrypsin Deficiency (AATD) patient, Frank Willersinn is dependent on a treatment with a plasma-derived medicine (PDMP) to make sure his body does not deteriorate.
The debate over compensating plasma donations remains one of the more sensitive issues in the revision of the EU's blood, tissues and cells legislation.
The US is facing its worst blood and plasma shortage in more than a decade due to a combination of the COVID pandemic and bad weather conditions, which stakeholders have warned could have ripple effects across the pond.
It’s not all about Brexit on the other side of the Channel as England is bracing to face up to another harsh challenge in the coming months: building an entire plasma supply chain from the scratch.
Ensuring sufficient plasma collection in Europe remains a thorny issue but the forthcoming revision of the EU framework for pharmaceuticals offers the potential to turn the tide.
Communication about the importance of plasma donations can be improved by focusing on a clear definition in the EU legislation, ensuring that more awareness is raised about the role it plays in producing life-saving medical products, a centre-right EU lawmaker told EURACTIV.
The ongoing revision of the European legislation on blood, tissues, and cells offers an opportunity to tackle the highly problematic dependency on plasma collected in the US for manufacturing plasma-derived medicinal products (PDMPs), according to an EU health official.
Even though the efficiency of plasma therapies against COVID-19 are not yet demonstrated, increasing Europe's blood collection capacity will contribute to address chronic shortages, the European Commission has said.
The use of COVID-19 convalescent plasma (CCP) as a therapeutic option, despite its ups and downs, has shown the European Union's renewed interest in plasma-derived medicinal products (PDMPs).
