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In brief

The EU has approved the new Regulation on Substances of Human Origin (SoHO) aimed at improving the safety and quality of blood, tissues and cells used in health care and facilitating the circulation of these substances within the EU.


Key takeaways

The new regulation broadens the scope of SoHO to human breast milk and intestinal microbiota and covers a variety of activities, ranging from registration and testing of donors, collection and processing to human application and clinical outcome monitoring of substances of human origin.

In addition, the regulation establishes an EU-level coordination board for SoHOs, introduces common EU procedures for the authorization and assessment of SoHO preparations, requires member states to designate a national authority and other competent authorities to authorize preparations and ensure independent and transparent oversight of related activities, sets out additional authorization and inspection requirements for establishments working with SoHOs, and establishes the new EU SoHO IT platform.

The regulation also provides for an early warning system to deal with serious incidents and reactions, which may create a risk to recipients or donors, and requires member states to implement a system to ensure a sufficient and adequate supply of SoHO, including through the development of national contingency plans to deal with possible critical issues.

According to that regulation, SoHO donations should, in principle, be voluntary and unpaid, and donors should not receive financial incentives. Living donors may receive compensation or reimbursement, as appropriate, in line with national legislation.

The regulation will become applicable once it is published in the Official Journal of the European Union.

Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

Author

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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