On 14 July 2022, the European Commission published a proposal for a Regulation on “substances of human origin” (“SoHO”) intended for human application.  The proposed Regulation is intended to replace the existing and largely outdated Directives on SoHO, respectively on Blood and on Tissues and Cells.  These sets of rules govern the sourcing and use of starting materials for innovative therapies, such as blood, tissues and cells.  Pharmaceutical companies active in the manufacturing of advanced therapy medicinal products (“ATMPs”) are therefore well advised to closely monitor the developments surrounding the proposed Regulation.

The revised legal framework will uphold certain key principles from the existing rules, such as the general principle of voluntary and unpaid donation (although limited compensations for losses related to donor participation are permitted).  EU Member States will also retain full competences on ethical decisions regarding the provision of SoHO-based treatments in their respective healthcare systems.  However, the initiative also proposes a number of important changes to the existing legal framework on SoHO:

  • Harmonized application of rules across the EU: With the proposed Regulation, the European Commission intends to “improve harmonisation, ensuring a uniform level of protection across the EU and simplifying cross-border exchange and access of SoHO therapies”.  To this aim, the Commission will set up a “SoHO Coordination Board”, chaired by the Commission, which will act as an advisory body to support Member States in the uniform implementation of the Regulation (e.g., the SCB is tasked to develop common good practices for inspection and vigilance on SoHO).  With the choice of the legislative instrument, a Regulation, the Commission aims at reducing disparities in the implementation of rules by Member States.  At present, the roll-out of innovative therapies, such as ATMP, throughout EU Member States is hampered by disparities in the implementation of the applicable rules on SoHO.  By harmonizing the rules governing, the sourcing and the use of SoHO, the proposed Regulation is expected to significantly decrease the administrative burden on pharmaceutical companies.  The Commission’s initiative is therefore also a welcome and long overdue instrument to increase access to SoHO-based therapies for patients.
  • Extended scope of application: The proposal extends the scope of the Regulation to any SoHO that are to be applied to humans.  This means, in essence, that the Regulation will also cover substances such as breast milk, intestinal microbiota, and blood preparations that are not used for transfusion.  As an exception, Organs will continue to be regulated separately under Directive 2010/53/EU.  The proposed Regulation aims to provide a legal framework for all the activities to be performed on those substances, from donor recruitment to human application.
  • EU-wide technical standards for the protection of donors, recipients and offspring: SoHO have to be prepared and treated according to specific technical standards to ensure their quality and safety.  Under the proposed Regulation, such standards will be set out either by the European Commission through Implementing Acts or, in their absence, by the European Directorate for the Quality of Medicines & HealthCare (“EDQM”) and the European Centre for Disease Prevention and Control (“ECDC”).  The standards adopted by these expert bodies, which are already widely applied in the sector, will therefore become the main means to meet the EU standards of quality and safety for SoHO.
  • Enhanced self-sufficiency of SoHO supplies: The EU has historically been reliant on other countries for the supply of certain SoHO, such as the United States for plasma used to manufacture plasma-derived medicine.  To counterweight this trend, the proposal lays down provisions meant to ensure EU self-sufficiency and guarantee continuity of supply in case of unforeseen events.  EU Member States will therefore be expected to set up national SoHO emergency plans and alerts for SoHOs that are critically important for patients, in order to anticipate on EU supply interruptions and take timely action to mitigate those risks.
  • New “EU SoHO Platform”: This proposed platform will be developed, hosted, and centrally managed by the European Commission and will be accessible to competent authorities, SoHO entities and establishments (including healthcare providers), patients, donors (and offspring), expert bodies and the Commission.  The platform will allow for the collection and publication of data on donations, clinical use and possible adverse reactions. 

The proposal put forward by the European Commission will now be discussed in parallel by the Council and the European Parliament.  If adopted, the Regulation would come into force after a transition period (set at either 2 or 3 years). If you have any questions on this proposal, please contact Bart Van Vooren.

Tags: Advanced Therapy Medicinal Products, ATMP, EU Legislation, European Commission, life sciences, Medicinal Products, Pharmaceutical Companies
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Photo of Bart Van Vooren Bart Van Vooren

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart…

Bart Van Vooren, partner leads a dynamic practice at the intersection of EU regulatory law, global health, and biodiversity law. In these fields, he advises innovative pharmaceutical, food, cosmetic and technology companies on complex EU and global regulatory, compliance and policy assignments.

Bart holds a Ph.D. in EU and International Law and was a professor of EU law until 2013. During that time, he wrote the first-ever handbook with Cambridge University Press on “EU External Relations Law” (2014). He then transitioned to private practice, and frequently acted for the Belgian government before the EU Court of Justice (e.g. C-16/16P Belgium vs Commission). Bart joined Covington in 2016, leading some of our most consequential EU litigation proceedings (e.g. C-311/18 “Schrems II”) over the years.  Having handled nearly 50 cases before the EU Court, he’s uniquely qualified to support our corporate clients in our most high-stakes disputes. Recent examples include T-189/21 Aloe Vera of Europe v Commission (which we won, so the Commission decided to appeal); as well as T-201/21 Covington & Burling and Van Vooren v Commission (which we also won, and hence is also on appeal).

As a pioneer in biodiversity law, over the past 15 years Bart has built a unique, global practice on Access and Benefit-Sharing (ABS) laws under the Convention on Biological Diversity, the Nagoya Protocol, the Plant Treaty, the High Seas Treaty and the WHO Pandemic Agreement. ABS compliance is critical when sourcing biological materials for life sciences R&D and I work with many of the world’s innovative life sciences companies on the whole range of e.g. transactional, contractual, compliance, IP, (EU) regulatory and litigation work relating to ABS. As biodiversity has increasingly become identified as a major commercial and financial risk to companies, so has the practice expanded to e.g. biodiversity credit markets, biodiversity insurance, biodiversity claims and advertising, and so on. Since April 2025, Bart has been appointed as the industry representative to the Steering Committee of the UN Biodiversity Fund that seeks funding from the private sector for biodiversity conservation and restoration.

Bart also pioneered our global health practice. He has advised pharmaceutical clients on seasonal and pandemic influenza since 2016. Since then, this practice area expanded to cover all matters relating to infectious diseases, and as of 2020, emergency preparedness and response (eg. WHO prequalification, International Coordination Group negotiations, Emergency Use Listing, International Health Regulations Rev 2024). He has been the pharmaceutical industry’s lead lawyer advising on the WHO Pandemic Treaty negotiations, adopted on 14 May 2025. Currently, he continues to advise on the work of the Intergovernmental Working Group (“IGWG”) teasing out the technical details of the “Pathogen Access and Benefit-Sharing System” intended to create legally binding obligations on companies to commit vaccines, therapeutics and diagnostics in case of a new global health emergency.

In Chambers rankings, clients have kindly described Bart as “very knowledgeable, action-focused and service-focused lawyer”, adding that he “really tries to find a way of working through challenges”, am “customer-oriented” and provide “sound advice and reasonable options for our business with pros and cons.”

Finally, Bart has an active pro bono practice assisting NGOs defending the human rights of persons with a disability through strategic litigation before the EU Court.

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