US blood shortage crisis leaves EU patients vulnerable

As it stands, the whole world is dependent on plasma collected in the US, meaning 5% of the world population is responsible for roughly 60% of the plasma global supply chain. [SHUTTERSTOCK]

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.

According to a statement from the American Red Cross – which provides some 40% of the nation’s blood – there has been a 10% overall blood donation decline since March 2020, and a 62% drop in college and high school blood drives during the pandemic.

Faced with what it has dubbed a “national blood crisis,” the association estimates that the US has less than a one-day supply of critical blood types.

As such, it has had to limit blood product distributions to hospitals, with up to one-quarter of hospital blood needs not being met.

The significant drop in donations was put down to a combination of the pandemic, as well as weather conditions and staffing limitations leading to ongoing cancellations of planned blood drives.

“The effects of the COVID-19 pandemic on plasma donation continue into this year, as the average number of donations per centre across the US in the first few months of 2021 were down approximately 11% compared to last year, further deepening the nearly 20% decline in donations in 2020 compared to 2019,” the Plasma Protein Therapeutics Association (PPTA) explained in a statement.

COVID-19 pandemic casts new light on plasma therapies

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).

While the American Red Cross collects blood and plasma — the straw-coloured, liquid portion of blood — for direct transfusion, other stakeholders have also raised alarm bells about the impact of a potential shortage of supply in other areas.

In particular, there are warnings that a supply problem in the US could see a shortage of plasma for the creation of plasma-derived medicinal products (PDMPs), which are used to treat a variety of rare, chronic, and potentially life-threatening conditions.

This includes immune deficiencies, immune-mediated peripheral neuropathies, hereditary angioedema and haemophilia among other bleeding disorders.

As it stands, the whole world is dependent on plasma collected in the US, meaning 5% of the world population is responsible for roughly 60% of the plasma global supply chain.

This concern was one of the key findings identified by the Commission in the 2019 evaluation of the EU legal frameworks on blood, tissues and cells.

The Commission’s analysis acknowledged an “insufficient supply concerning plasma where the EU is highly dependent on imports from the US.”

“While in the EU, the number of private plasma collection centres increased from 37 in 2005 to 103 in 2016, this is far from sufficient to keep up with the increasing demand for manufacturing of plasma-derived medicines,” the evaluation continues.

Several stakeholders have raised the issue of dependency – pointing at the risk to the continuity of supply if there were a supply interruption from the US –  in their meeting with the Competent Authorities on Substances of Human Origin Expert Group (CASOHO), a permanent committee that assists the European Commission in the implementation of the existing EU legislation.

In August 2019, the US Food and Drug Administration already raised concerns regarding increased demand and shortages of immunoglobulins in the US which, according to the Commission’s evaluation, “might exacerbate the impact of the EU dependence on that region.”

According to the PPTA, 30%, or 3.8 million litres, of the plasma used to manufacture PDMPs for the 300,000 EU patients in need of it comes from the US.

The curious case of the English plasma supply

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.

And this has already started to spill over, the association said, warning in a statement that it was aware of emerging reports that patients increasingly lack “reliable access to lifesaving PDMPs” in the EU.

In the short term, PPTA urged all healthy adults to donate plasma at one of the more than 1,100 donation centres throughout the US and in four European countries.

However, the association also urged authorities to take a longer perspective on the issue, pointing out that this is a problem that is set to worsen in the coming decade as more patients across the EU are diagnosed with life-threatening plasma protein-related disorders.

Maarten Van Baelen, Executive Director of PPTA Europe, said that it is “up to policymakers to remove barriers that limit opportunities for committed and healthy adults to donate their plasma and to address Europe’s reliance on plasma from third countries,” underlining the urgent need to strengthen the “broader European plasma donation ecosystem”.

[Edited by Gerardo Fortuna and Nathalie Weatherald]

New EU's pharma rules: a game-changer for strategic autonomy on plasma?

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.

Subscribe to our newsletters