EUCOPE’s first reflections on the adoption of amended report regulating substances of human origin (SoHO)

On 18 July, European lawmakers within the Health and Environment (ENVI) committee voted to adopt the amended report on Substances of Human Origin (SoHo). The report aims to improve the safety and quality standards for both donors and recipients of blood, plasma, skin, embryo, sperm, and corneas, with the recent inclusion of breast milk and microbiota in the scope of the revision.

EUCOPE sees this revision as an opportunity to build on the rules and requirements established over two decades ago and is now in need of updating. The revision of the SoHO regulation introduces a number of much-needed changes for improving the sustainability of the SoHO ecosystem and fostering further harmonisation.

EUCOPE appreciates the committee’s efforts to ensure future quality and safety standards as well as a reliable supply of critical substances of human origin, including plasma, while promoting the EU’s autonomy and reducing dependence on imports from third countries. EUCOPE also welcomes the committee’s amendments to help ensure transparent, inclusive and evidence-based processes involving all relevant stakeholders to keep the legislation up-to-date.

EUCOPE’s Recommendations

The ‘EU SoHO Platform’ has the potential to improve the transparency of national reporting and supervisory activities and facilitate timely data and report submission while helping Member States to share best practices. However, EUCOPE believes that further measures in the EU SoHO Regulation are needed to build a future-oriented framework. They include:

1. Encourage the sustainability of plasma collection

The SoHO regulation should help reduce the EU’s reliance on the US for 40% of the plasma it needs to make life-saving plasma-derived medicinal products (PDMPs) for EU patients. It is critical that Member States have the tools to increase plasma donations in the EU to support patient access to PDMPs and EU strategic autonomy. EUCOPE believes that compensation of SoHO donors for the expenses and inconveniences related to the donation is an important tool to support a sustainable supply of critical SoHO, including plasma. The regulation should recognise the diversity of compensation methods in different EU Member States and ensure that established plasma donation models are maintained. In Austria, Czech Republic, Germany, and Hungary, plasma donors receive a fixed monetary allowance as compensation, with private centres collecting 44% of total plasma in the EU. EUCOPE believes that a broad and open definition of SoHO donor compensation, which aligns with the Voluntary Unpaid Donation (VUD) principles, will give Member States the flexibility to ensure the supply of critical SoHO across the EU while maintaining the highest safety standards.

2. Introduce the Blood Patient Management (BPM) concept into the Regulation

The concept of blood patient management (BPM), defined as a set of evidence-based practices to optimise medical and surgical patient outcomes through the preservation of the patient’s own blood, is recognised by EUCOPE as contributing to the sufficiency of SoHOs. Despite the World Health Organisation (WHO) urging for the implementation of PBM in 2021 and calling on all Member States to act quickly to adopt a national PBM policy, the concept has not been adopted in the revised text. The scientific and medical community has outlined the value of PBM implementation in times of crisis in the context of the COVID-19 pandemic. EUCOPE believes that PBM should be acknowledged in the regulation and its definition included in the text.

3. Ensure a significant role for the European Medicines Agency (EMA) when discussing borderlines/therapies

While EUCOPE acknowledges the important role played by the SoHO Coordination Board (SCB) in coordinating activities related to substances of human origin, EUCOPE believes that the European Medicines Agency (EMA) should have a major role when discussing borderline therapies, to uphold high standards and ensure pharmaceutical framework integrity. As discussions on the SoHO Regulation continue, and extend to the Pharmaceutical Package, it is important to ensure a robust role for the EMA in the decision-making process when considering the regulatory status of a particular substance, product, or activity under this regulation.

Next Steps

The Plenary voting in the European Parliament is scheduled for 11 September 2023. Following this, the trialogue will commence under the leadership of the Spanish EU Presidency.

EUCOPE remains committed to engaging with the wider community regarding the revision of the SoHO regulation.

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For more information about EUCOPE’s work on the SoHO Regulation, please contact Stefania Alessi (alessi@eucope.org)