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The revision of the EU's blood directive offers the chance to overhaul outdated restrictions that prevent those in same-sex relationships from becoming blood and plasma donors.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.
Every year more people across the EU are diagnosed with life-threatening conditions which can only be treated with plasma-derived medicines.
The revision of the European Union Blood, Tissues and Cells (BTC) Legislation brings an opportunity to strengthen its legal framework to encourage new approaches that will increase the collection of plasma across Europe.
In the coming decade, it is expected that more European patients will need access to plasma-derived medicines.
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.
The European Commission is currently revising the EU Blood, Tissue and Cells legislation, to take into account the most recent technological, scientific, epidemiological and societal developments.
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.
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The unique aspects of human plasma need to be framed more precisely in the EU Blood Directive. The revision of the European Union Blood, Tissues and Cells Legislation brings an opportunity to strengthen this legal framework to encourage new approaches that …
This paper offers a health economic model to estimate the value of treatment with immunoglobulin replacement therapy (IgGRT) for CVID patients.
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).
Plasma-derived medicinal products (PDMPs), derived from human plasma from healthy donors, are essential for around 300,000 European patients who rely on these therapies to treat a variety of rare, chronic, and potentially life-threatening conditions, which are often genetic in origin. …
Remarks on establishing a reliable supply of therapies, the urgent need to increase plasma collection across the EU, and the impact of the COVID-19 on the plasma donation system (as of October 2020), presented at the Global Plasma Summit.
