Tag Archives: EU regulation

Substances of Human Origin (or SoHO): the New EU Regulation

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PURPOSE OF THE NEW REGULATION. On June 13, 2024, the European Parliament and the Council adopted a new regulation on the substances of human origin (so-called SoHO), repealing Directives 2002/98/EC and 2004/23/EC. The new regulation:

  • was necessary because previous directives only partially managed to harmonize member states’ legislation on cells, tissues and blood; also, a new definition of SoHO was needed;
  • introduces mechanisms to grant continuity and resilience of SoHO supplies and to facilitate EU cross border exchanges and access to SoHO;
  • enhances safety of donors and recipients (included the offspring born from medical assisted procreation).

WHAT IS A ‘SOHO’? A SoHO is now defined as “any substance collected from the human body, whether or not it contains cells and whether or not those cells are alive, including SoHO preparations resulting from the processing of the above-mentioned substance”. The definition has been expanded to include breast milk and gut microbiota, as well as blood preparations different from those used for transfusions. Any future SoHO will be automatically included in the regulation. The regulation also defines SoHO preparation as a SoHO subjected to processing, with a specific clinical indication, intended for human application on a recipient or for distribution.

WHO DEALS WITH SOHO? The regulation also defines which will be the main actors in the organizational chain from SoHO donation to application. Specifically:

  • A SoHO entity is a legal entity established in the EU that carries out SoHO-related activities (e.g. collection, processing, control, storage, release, distribution, import, export, application on human beings,  clinical studies and outcomes recording on SoHO preparations)
  • A SoHO establishment is a SoHo entity that carries out one of the following SoHO-related activities: A) both processing and storage; B) release; C) import; D) export;
  • Competent authorities for SoHO are appointed by each member state and 1) maintain SoHO entities’ registry, 2) deal with authorization process for SoHO establishments and SoHO preparations 3) carry out inspections and evaluate plans for monitoring clinical outcomes.

WHEN?  The regulation will be enforceable by mid-2027.

TAKEAWAYS. Apparently, it is science-friendly as the definition of SoHO will be broader and more flexible than before. Also, in view of its structure, there is hope that it will succeed in ensuring more uniformity and granting an enhanced minimum level of safety across EU.

GDPR Cross-Border Complaints: a New Regulation Proposal Attempts to Harmonize the Procedural Rules Among the Member States

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On July 4, 2023, the European Commission has issued a proposal for a new EU regulation laying down additional procedural rules aimed at ensuring a better and uniform enforcement of the GDPR among the Member States, especially with regard to the handling of cross-border complaints (“Proposal”).

The Proposal has been inspired by the findings of the reports issued by the European Commission and the European Data Protection Board concerning the status of the application of the GDPR among the Member States. Such reports stressed the need to make the handling of cross-border complaints more efficient and levelled across the EU, since the proceedings followed by local data protection authorities (“LDPA”) have been found to be differently designed and may thus lead to different application of the GDPR provisions.

The main features of the Proposal may be summarized as follows:

  • Submission and handling of cross-border complaints: The Proposal aims at removing the existing differences among the procedural rules applied by different LDPAs, namely with regard to how complaints on cross-boarder issues should be filed and which contents they should have. In such respect, a template for the filing of cross-border complaints – including a standard pre-determined set of information to be provided – has been drafted. The Proposal further specifies procedural rules for the rejection of complaints in cross-border cases and clarifies the roles and rights of the lead LDPA and of any other concerned LDPAs. A system of amicable settlement of complaints is also encouraged.
  • Procedural rights of parties under investigation: The Proposal further aims at harmonizing and strengthening the rights of defence in the course of cross-border investigations and proceedings. Specifically, the Proposal recognizes an extended right of the parties to be heard at key stages of the proceedings and imposes the creation of an administrative file and the parties’ rights of access to it.
  • Tools for cooperation between LDPAs: New tools have been designed to ease the building of consensus between the involved LDPAs on the main features of cross-border proceedings since their preliminary phase, in order to limit the recourse to the (time consuming) dispute resolution mechanism provided by section 65 GDPR only in few exceptional cases. LDPAs that are called to handle a cross-border complaint are required to provide other involved LDPAs with a “summary of key issues”, wherethe main findings of facts and legal grounds underlying each complaint are set out. Concerned LDPAs will be able to provide their views on such summary and to raise “relevant and reasoned objections”, in which case a specific fast-track procedure is designed in order to ensure that disagreements among LDPAs are settled at the beginning of the process.
  • Acceleration of cross-border proceedings: Lastly, the Proposal, by imposing strict deadlines, aims to prevent undue delays within the proceedings.

At the moment it is still unclear whether the Proposal will be officially adopted and become a binding regulation. Certainly, it has been welcomed by the European Data Protection Board and by the European Data Protection Supervisor and may be a good opportunity to level the difference among Member States and make the proceedings more efficient.