Plasma donor compensation still an ‘open wound’ in EU’s blood directive revision

The debate over compensating plasma donations remains one of the most sensitive issues in the revision of the EU’s blood, tissue, and cells legislation.

While many are familiar with blood donations, there is little awareness of plasma donations in the general public, although they are becoming increasingly important in the EU and worldwide.

Plasma might be required for patients who have lost blood due to a medical emergency, as well as for those with clotting disorders and even newborn babies with jaundice.

But plasma is also a component used in the manufacturing of plasma-derived medicinal products (PDMPs), which treat a variety of rare, chronic, and potentially life-threatening conditions.

That includes diseases of genetic origin, as well as immunodeficiencies, bleeding disorders and neurological illnesses.

It is estimated that 300,000 patients in Europe rely on these life-saving medicines. Part of these medicines is manufactured from plasma collected in the EU – about eight million litres of plasma per year.

However, this is not enough. The rest of the plasma is imported from the US and more than 30% of PDMPs manufactured in Europe use plasma bought from overseas.

In recent years, the demand for plasma has rapidly grown and the global blood plasma derivatives market is projected to see compound annual growth of 9% per year from 2017 to 2023.

With the global increase in the global use and market of PDMPs and the EU’s wish to reduce outsourcing plasma, the demand for plasma donation is growing simultaneously.

Unlike the not-for-profit sector, private providers often offer financial incentives to donors, making use of the discretion offered by the current EU framework.

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.

Uncertainty over the term ‘compensation’

Donation is considered voluntary if the donor receives no payment and donates out of their own free will.

Donors may also receive compensation as long as it is “strictly limited to making good the expenses and inconveniences related to donation,” according to Article 14 of the 2004 EU directive on human tissues and cells donation.

However, the same reference was not included in the EU blood legislation, which is relevant for plasma.

While conditions under which compensation may be granted are left to member states’ discretion, there is no such definition of compensation or incentives in the EU law though.

In 2016, a Commission Staff working document on the implementation of the voluntary unpaid donation (VUD) principle stressed the lack of clarity around the concept of compensation.

This uncertainty around the term has led to inconsistent approaches among member states, reducing the harmonisation in the EU and undermining the single market.

An own-initiative report approved by the European Parliament in 2012 highlighted very different national interpretations of concepts related to compensations, from tax benefits to paid days off work or incentives.

According to the European Plasma Alliance (EPA), which represents about 100 plasma collection centres in the EU, the differences in the way donors are compensated in the EU are “intolerable”.

In Austria, Czechia, Germany, and Hungary, for instance, direct compensations are reported at around €15-30, while in Poland, plasma donors are compensated with eight chocolate bars, a paid full day off work, and a tax reduction – for an equivalent of €46.

US blood shortage crisis leaves EU patients vulnerable

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.

Paid or unpaid, that is the question

The debate over which of the two options – voluntary or paid donation – could better address the lack of plasma supply is still open.

As highlighted by the Commission itself in its evaluation, it is about finding a “balance between protecting the human body from commercialisation and ensuring sufficient supply for patients in need of therapy”.

The Commission document showed that countries using mixed systems of compensated and uncompensated donations – such as Austria, Germany, and the Czech Republic – collect 32-66 litres of plasma per 1,000 population, while countries that only collect plasma from uncompensated donors collect 15.5-21.5 litres.

But some health stakeholders fear that allowing more compensation or payment for plasma donors can attract donors away from the non-profit sector, which remains responsible for supplying whole blood.

“In some member states, the development of commercial plasma collection centres, operating with paid donors, is eroding the voluntary donor base for blood products and jeopardizing the sustainability of the supply of the full range of blood products,” the European Blood Alliance (EBA), an association of non-for-profit European blood establishments, said in a note.

The EBA also expressed concern that the growth of the private sector could increase the commercial exploitation of donors, impacting the safety and quality of plasma.

However, the EU’s medicines agency EMA stated in 2002 that there is no difference in safety between remunerated and non-remunerated plasma, as long as there is proper screening at donation and a validated viral reduction/removal step.

On the other hand, the plasma private sector is advocating in favour of applying the same reference to compensation included in the tissue and cell legislation to the blood framework as well.

“Plasma donors are not paid or remunerated for their donation. They are volunteers,” said a spokesperson for the plasma Plasma Protein Therapeutics Association (PPTA).

“Volunteers can be compensated for their expenses, and plasma donors can also be compensated for their expenses and the inconvenience related to the donation,” they said, adding that this form of compensation “offers efficient, safe, and effective approach to increase plasma donations.”

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.

[Edited by Zoran Radosavljevic]

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