Italy: New Umbilical Cord Blood Bank provisions coming soon

31 October 2007

Enrico Baccetti, Paolo Balboni

Bill proposal No. S 267 on the use of umbilical cord blood for the production of hematopoietic stem cells (the “Bill”) may be passed by the Italian Senate and become law by the end of this year. The Bill follows the Regulation of 4 May 2007 entitled Urgent Measures on Cord Stem Cells Matter (the “Regulation”).

Pursuant to the Regulation, only public organisations and specifically accredited private entities are allowed to collect and keep cord blood donated for allogenic use whilst the conservation for the purposes of autologous use is only authorised in two specific circumstances: i) for the benefit of the newborn or a consanguineous child suffering, at the time of cord blood collection, from a pathology for which it is “scientifically grounded and clinically appropriate” to treat by means of cord stem cells; or ii) for dedicated use in families which have a high risk of having offspring affected by a genetically-based disease for which it is “scientifically grounded and clinically appropriate” to treat by means of cord stem cells.

Finally, according to the provisions set out in the Regulation, a specific authorisation from the Ministry of Health is required to import or export umbilical cord stem cells for the purposes of either autologous or allogenic transplants.

As it stands, the Bill does not depart from the provisions set out in the Regulation but adds a number of rules designed to promote the philanthropic donation of cord blood. In particular, Section 3 provides that the Ministry of Health must issue a decree setting out a project for: a) the creation of a national network of banks for the conservation of umbilical cords to be used for transplantation purposes; b) the organisation of annual programmes for the development of related activities; and c) the identification of public and private transfusion centres on the basis of an accreditation system.

Moreover, the Bill provides for setting up by ministerial decree of the “National Registry of cord blood donations” (the “National Registry”) in order to make it simpler to locate donations. The National Registry will coordinate regional and interregional registries. Criteria to allocate the funds to be used for the purchase of the necessary equipment will also be set out in this decree. Furthermore, under Section 7 of the Bill, the Health Ministry must also commence public campaigns to promote the donation of cord blood.

The Bill remains subject to modifications until it is enacted into Italian law.