We have received a press release from the Fondazione Banca degli Occhi del Veneto.
ITALIAN RESEARCH WITH NON-CLINICAL ORGAN, TISSUE AND CELLS HAS BEEN PUT ON HOLD
by Stefano Ferrari, PhD and Diego Ponzin, MD
Fondazione Banca degli Occhi del Veneto, Venice, Italy
December 2021
An unexpected verdict released at the end of November 2021 by the Legal Office of the Ministry of Health stated that in Italy there are not legal bases for the alternative use of organs, tissues and cells, donated for transplantation and revealed unsuitable to the primary purpose. The main assumption was that, according to the current national legislation on transplantation, the donor’s relatives are entitled to testify and release a consent only for the clinical use of organ, tissues and cells.
How can tissue and eye banks, and surgeons, progress, improve their technical skills and offer new therapeutic options to patients? Regenerative medicine can progress if basic and clinical experimental studies are rigorously designed and conducted in the presence of valid starting human-derived material. A source of human samples might be represented by tissue / cell banks, which store human (ocular) tissues or cells for transplantation, as there are cases where they appear not to be suitable, because of donor contraindications or poor biological quality. In these cases, the use of these tissues for medical research provides an additional, ethical donation option.
In the European Union, standards for tissues and cells are regulated by the Directives 2004/23/EC (safety and quality standards), Directive 2006/17/EC (technical requirements for donation, procurement and testing of human tissues and cells), and Directive 2006/86/EC (technical requirements concerning coding, processing, preservation, storage and distribution of human tissues and cells). The European Directives recognise the need for research in the fields of tissue and cell application.
Fondazione Banca degli Occhi del Veneto is a non-profit social welfare organisation, established to respond to the growing need for ocular tissue for transplant. Founded by the Veneto Regional Authority and designated as a Regional Reference Centre for Corneal Transplantation, Fondazione Banca degli Occhi is today one of the leading eye banks in Europe. Its activities are focused towards increasing public awareness about the importance of donation, and procuring and distributing suitable donor ocular tissues for transplantation. A Research Centre, a Stem Cell Factory (GMP facility), and a tertiary Clinical Centre, and a program to make tissues unsuitable for transplantation available for research, have also been established. The program complied with the requirements of voluntary participation, gratuity and anonymity and traceability. In particular, the donor’s relative was informed at the time of donation of the alternatives, should the ocular tissues not be suitable for transplantation. The vast majority of relatives adhered to this proposal.
We believe that guidelines and laws should explicitly allow tissues that are not suitable for transplantation to be used for educational, research and training purposes, if carried out according to strict ethical and legal boundaries. If the central motive for donation is to help patients in need, this should not be seen as a betrayal of the donor’s intents. At the Fondazione Banca degli Occhi del Veneto, a number of research programs, also on rare disease such as aniridia, has been forcibly stopped, while hundreds of invaluable human specimen must be disposed without appeal.