Legislation Italy

Donation:

• A law concerning organ donation exists.
• A distinction is made between the eye and the cornea: the eye is considered as an organ, the cornea as tissue.

• Organ donation is an opt out donation system, although it is standard practice to speak with designated family members of the deceased before making any decision with regard to potential procurement.opt out donation system, although it is standard practice to speak with designated family members of the deceased before making any decision with regard to potential procurement.

Cornea banking:

• Eye Banks need to be accredited/certified by the 'Centro Nazionale Trapianti' (National Transplants Centre) as the competent authority.
• Inspection of eye banks occurs by inspectors nominated by the 'Centro Nazionale Trapianti'. The criteria are set out in the technical document "Linee Guida per il prelievo, la processazione e la distribuzione di tessuti a scopo di trapianto" (Guidelines for the retrieval, processing and distribution of tissues for the purpose of transplant) produced by the Consulta tecnica permanente per i trapianti (Permanent Technical Council for Transplants) and the Centro Nazionale Trapianti.
• A national Eye Bank organization exists: SIBO (Società Italiana Banche degli Occhi = Italian Society of Eye Banks).
• A tissue banking organization does not exist.
• Legal requirements for corneal storage solutions have not yet been defined.