In recent years, the European Union has undertaken significant reforms to enhance the safety and quality of substances of human origin (SoHO), which encompass blood, tissues, cells, and other human-derived materials used in medical treatments. These reforms aim to modernize the regulatory framework, ensuring it remains robust and adaptable to scientific advancements.
Background
The existing directives on blood, tissues, and cells were established in response to concerns over the transmission of communicable diseases in the late 20th century. While these directives have been instrumental in safeguarding public health, evaluations revealed gaps due to rapid scientific developments and varying oversight systems among member states. These discrepancies have sometimes hindered the cross-border exchange of SoHO and obstructed innovation in the sector.
The Council has adopted new rules aimed at improving the safety and quality of blood, tissues and cells used in healthcare and facilitating cross-border circulation of these substances in the EU. https://health.ec.europa.eu/blood-tissues-cells-and-organs/overview/new-eu-rules-substances-human-origin_en
The regulation on substances of human origin (SoHO) will ensure better protection for donors and recipients, as well as for children born following medically assisted reproduction. The new rules aim to strengthen the existing legal framework while also increasing flexibility in order to keep up with scientific and technical developments.
The new regulation aims to better protect donors, recipients, and children born from medically assisted reproduction. It introduces the term “substances of human origin” to include not only blood, tissues, and cells but also human breast milk and intestinal microbiota, among others. The regulation emphasizes increased harmonization to facilitate cross-border exchanges and access to therapies, including through the creation of an EU SoHO coordination and advisory body.
The regulation also underscores the importance of voluntary and unpaid donation, rapid alert systems for serious incidents, and the development of national emergency plans to address potential shortages. The regulation also provides for strengthened oversight systems, with national competent authorities supervising activities related to SoHO in an independent and transparent manner.
Under the new regulation, member states may choose to apply stricter measures to protect their citizens.
Key Developments:
– setting up an EU-level SoHO coordination board supporting member states in the implementation of the regulation
– introducing common EU-wide procedures for the authorisation and assessment of SoHO preparations
– requiring member states to designate a SoHO national authority and other competent authorities to – authorise SoHO preparations and ensure independent and transparent oversight of SoHO-related activities
– setting out additional authorisation and inspection requirements for establishments that both process and store, release, import or export substances of human origin
– establishing a new common IT platform, the EU SoHO platform, to register and exchange information on related activities.
Implementation Timeline
The new regulation was published on 17 July 2024. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202401938. Most of its provisions will come into effect from 7 August 2027, with certain rules being implemented in 2028. This phased approach allows member states and relevant organizations adequate time to adapt to the new requirements.
Conclusion
The EU’s regulatory changes represent an effort to modernize the oversight of substances of human origin. By broadening the scope of regulated substances, enhancing donor and recipient protections, and promoting harmonization across member states, the EU aims to ensure that its healthcare systems can safely and effectively utilize these vital materials in the face of evolving scientific and medical landscapes.
