BELGIUM – The European Commission has proposed updated rules on blood, tissue and cells to provide greater protection to donors and recipients and to increase access to innovative transfusion and transplant therapies.

The EU executive aims to extend 20-year-old rules to include babies born from medically assisted reproduction and donors, including the 15 million who give blood, as well as over 34,000 stem cell donors and more than 39,000 egg donors every year.

Screening should protect the 165,000 children born per year from donated eggs, sperm or embryos against genetic disorders.

The updated rules would seek to protect donors from exploitation and risks to their own health and require improved follow-up and reporting of adverse effects of donating.

They would also extend monitoring to other substances of human origin, such as breast milk and fecal microbiota that can be transplanted into a patient to improve their digestive systems.

Among the main improvements, the EU executive wants to increase the protection of patients and extend the scope of the legislation to cover new types of substances of human origin.

The proposal, to cover substances of human origin except organs, would seek to harmonize rules across the 27-nation European Union to ease cross-border exchanges, improving patient access to therapeutics and allowing more innovation.

Every year, 15 million people in Europe donate their blood while there are 4.6 million patients who receive blood transfusions.

The revision of the legal framework is based on a thorough evaluation conducted in the last few years in which the Commission, in close contact with the relevant stakeholders, has identified a number of improvements to the current rules.

Likewise, every year there are also 165,000 babies born with medically assisted reproduction in Europe, roughly 36,000 stem cell transplants for blood cancers, 2,000 require skin transplants for burns and other injuries, and 14,500 cornea transplants.

All these medical activities are possible thanks to donations or transplants of substances of human origin (SoHO) such as blood, plasma, skin, embryo, sperm, microbiota, or corneas.

And since these medical activities include some risks, they need to be regulated and organized through a system of rules ensuring safety for donors and recipients alike.

Unlike the United States, the EU remains committed to voluntary and unpaid donation, which it sees as protecting donors from exploitation.

The revision of the legal framework is based on a thorough evaluation conducted in the last few years in which the Commission, in close contact with the relevant stakeholders, has identified a number of improvements to the current rules.

The new rules, which the European Parliament and EU governments will need to approve, will serve as an EU-wide guide, but individual EU countries will be free to have more stringent rules.

Addressing supply vulnerabilities

Vulnerability in the supply chains of substances of human origin was another area the Commission seeks to address in the revision.

This particularly affects plasma for manufacturing plasma-derived medicinal products (PDMPs) as the EU is heavily dependent on the raw material coming from the US.

Currently, the EU imports up to a third of the blood plasma it requires, mostly from the United States.

The proposal seeks to ensure the bloc is more self-sufficient, with access to life-saving treatments even during a crisis.

But according to the Commission, the proposal can mainly aim to provide member states with some tools to strengthen their collection and supply situation.

According to an EU official, the regulation alone cannot fix the issue as it also depends on the demand and manufacturing sides, which are both outside the framework.

“We are disappointed that the important role of the private sector in the collection of plasma has not been recognized in the current draft,” said Maarten Van Baelen, executive director for Europe of the Plasma Protein Therapeutics Association (PPTA).

He added that neither the private nor the public sector alone can address the issue of the growing clinical need for plasma in the EU.

For the Commission, the proposal includes indirect broader measures that can also increase the trust of the population and allow for broader and more donations.

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