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European Network of Tissue Establishments

eNOTE

The association eNOTE, which is devoid of any lucrative intent, has as a non-profit for international purpose of grouping tissue banks (private or public companies or enterprises) ensuring the collection, transportation, conservation, transformation or distribution of tissues of human origin for therapeutic or scientific use.

Lobbying Activity

Response to Revision of the Union legislation on blood, tissues and cells

7 Sept 2022

The European Network Of Tissue Establishments (eNOTE) gathers several European tissue banks, mainly involved in the field of bone grafting for orthopaedic et dental applications. Contrary to the heterogeneous situation that prevails today between Member States with Directive 2004/23, the new regulation 2022/0216 provides a favorable framework for the harmonization of practices, conditions of authorization and circulation of SoHO products within the EU. However, the proposed text presents several notions that are not sufficiently precise and whose interpretation may vary according to the circumstances and involved competent authorities. The understanding of these provisions is difficult and their application will be likely to diverge. The objective of harmonization is therefore unattainable. In particular, Article 25 on the SoHO establishment authorisation system sets out the conditions under which an SoHO entity should be licensed as a SoHO facility based on the size, criticality or complexity of its activities: these criteria are too vague. They should be quantified so as not to be arbitrary. In Article 51 on the physician attached to the SoHo facility, the responsibilities assigned to the physician are too broad and confusing: - In item (c), "the design and supervision of clinical data collection activities" is directly the responsibility of the investigating surgeon. It cannot be assigned to a physician outside the clinical investigation. - In point (d), "other tasks of relevance to the health of donors and recipients" must be specified to avoid arbitrary interpretations depending on the circumstances. Also, the notion of "third party contracted by a SoHO entity" should be defined in Article 3 to avoid confusion with a SoHO entity and precise which tasks could be subcontracted.
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