In the context of the revision of the European blood and tissues and cells legislation, the PPTA is calling on policymakers and regulators throughout Europe to strengthen the legal framework to benefit plasma donations for plasma-derived medicines and encourage new approaches that increase the collection of plasma across the EU.
The foundation of safe plasma therapies is a regular healthy plasma donor population, stressed the group.
Plasma collections declined nearly 20% last year compared to 2019 due to the COVID-19 pandemic and appear to still be down this year, according to that association.
Given that the complex manufacturing of plasma-derived therapies can take 7-12 months, it said that any decline in plasma donations could impact patients’ ability to access their lifesaving therapies, ultimately jeopardizing their health.
“Around 300,000 patients across Europe rely on plasma-derived medicinal products (PDMPs), which can only be made out of human plasma,” said Maarten Van Baelen, executive director, PPTA Europe.
“However, the EU still relies for 30% of its plasma on the US. 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,” he continued.
As the EU legal framework around the collection of plasma is now undergoing a revision, this creates an opportunity to rethink how plasma is currently collected in Europe, said the PPTA lead.
In its own EU Pharma strategy, the EU already identified the need to reduce “dependency from third countries” of starting materials for essential medicines.
Public-private collection model
“Today only four countries in the EU - Austria, Czech Republic, Germany and Hungary - have a combined public-private collection model and contribute more than 55% of all plasma collected in the EU.
“In these four countries, four times more plasma per resident is collected, compared to the other countries, which only have a non-for-profit model.
“The other EU countries designate the responsibility to collect plasma to a single non-profit/public entity. However, for the last 20 years, the EU’s public sector has shown little growth in plasma collection, compared to the private sector which has delivered most of the EU’s increased plasma donation required to meet the growing clinical need for PDMPs,” Van Baelen told BioPharma-Reporter.
In terms of the new approaches that might increase the collection of plasma across the EU, he said the EU Blood Directive, related European legislation, and national public health regulations need to explicitly recognize the unique nature of plasma that is used for manufacturing of plasma-derived medicinal products, as it is fundamentally different from whole blood and other labile blood components.
Europe’s reliance on plasma from the US needs to be addressed by encouraging the creation of a stronger European plasma donation ecosystem, argued Van Baelen.
A renewed EU Blood Directive, he outlined, should:
- Clarify the difference between plasma used for transfusion and plasma used to manufacture plasma-derived medicinal products. This is the foundation of policies that will encourage increased availability of plasma.
- Support EU member states as they put in place dedicated programs for direct plasma collection (plasmapheresis); and outreach actions that inform communities of the critical importance of plasma-derived medicinal products and the need for plasma donations.
- Encourage plasma donations by clarifying that a fixed-rate allowance to compensate donors – for expenses and inconveniences related to donation – is in line with the principle of Voluntary Unpaid Donation, similar to EU Tissues & Cells Directive 2004/23/EC, art. 12.1.
- Promote the coexistence of public blood and plasma collection centers, together with private plasma collection centers.
Over the past 10 years, the use of immunoglobulins – among the most commonly used PDMPs – has almost doubled, reports the PPTA.
And a June 2021 report commissioned by Takeda found that, in the coming decade, more European patients will need access to plasma-derived therapies, which are used to treat a wide range of (rare) diseases from bleeding disorders and inhibitor deficiencies to primary and secondary immunodeficiencies.