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 As global mistrust deepens, European Union officials are casting
around for ways to reduce the bloc's dependence on American plasma,
the liquid component of blood used in a host of drugs and now widely
applied in COVID-19 experimental therapies.
The coronavirus crisis should push authorities to overhaul Europe's
blood donation system, according to some industry players. The
United States' steadier plasma supplies are partly due to its system
of paying people to donate blood used to develop medicines. In most
European countries, donations are unpaid because of safety and
ethical reasons.
A strategy for "achieving EU sufficiency" on plasma was discussed at
an extraordinary COVID-19 meeting of blood experts organised last
week by the European Commission, the EU executive arm, according to
the meeting's agenda.
A spokesman for the Commission had no immediate comment about the
outcome of the meeting.
The EU is setting aside a large budget to increase its
pharmaceutical independence. It is now funding a project to
manufacture a plasma-derived medicinal product against COVID-19 and
has also set up a database to share results of therapies applied in
European hospitals.
Plasma has long been used to produce critical medicines such as
immunoglobulins and medication that helps control bleeding. The
global market for these products is worth about $20 billion a year
and analysts estimate it will grow.
Around 35% of the plasma for medicines needed by about 300,000
Europeans with chronic diseases comes from the United States,
according to the Plasma Protein Therapeutics Association (PPTA), a
trading body for the biggest manufacturers of plasma-derived
therapies.
"This situation exposes European patients to the risk of sudden
interruptions of plasma supplies from the U.S.", said an official at
the European Directorate for the Quality of Medicines and Healthcare
(EDQM), a body that sets quality and ethical standards for drugs in
Europe.
The PPTA drugmakers body sees a strategy based on unpaid blood
donations as counterproductive. It pointed to Germany, the largest
collector of plasma in Europe, as one of the few countries that
compensate blood donors.
Standard-setters and plasma collectors, however, want Europe to
achieve self-sufficiency by boosting unpaid donations.
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The debate around payments is not new; critics point to concerns that it is
unethical to pay people for parts of their body, and worries that safety
standards could be compromised if companies rely financially on plasma
collections.
COVID-RELATED SHORTAGES?
An official from the European Blood Alliance (EBA), which brings together
non-profit blood collection institutions across Europe, said concerns on
supplies have increased in recent months as Europe and the United States have
vied to acquire essential resources against the virus, including promising
vaccines and personal protective gear. [nL8N2BA4IU].
Europe's worries on plasma have also been exacerbated by COVID-19 lockdowns,
which have kept many donors away from blood collection centres, the EBA official
said.
A Commission official said measures had been taken during the pandemic to
"mitigate the risk" of plasma shortages, including a temporary softening of
regulatory requirements for blood collection centres.
Although no shortages for transfusions were recorded, experts said problems may
arise later in the year for supplies of plasma-derived drugs.
The epidemic has boosted demand for unprocessed plasma, as many medics across
the world transfuse it directly from COVID-19 survivors to infected people,
often with positive results, although its efficacy is still under investigation.
If this so-called convalescent plasma, or a medicine derived from it, prove
definitively effective against the disease, that could further strain Europe's
supplies, the EDQM official said, adding that a strategy for its collection at
industrial scale should be quickly devised.
Convalescent plasma is also being investigated as a possible prophylaxis to
prevent COVID-19 infections as antibodies extracted from it could be transfused
to boost immunity defences of vulnerable people.
Japanese pharmaceutical giant Takeda is co-leading a global corporate alliance
aimed at developing a plasma-based treatment for COVID-19, for which clinical
trials will begin in July [nL1N2CV2G2].
(Reporting by Francesco Guarascio @fraguarascio; Editing by Pravin Char)
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