Table 1.

Summaries and comparisons of different aspects of regulations^* about cord blood banking in six selected countries

Germany	Spain	Switzerland	Hungary	Poland	Italy
Banks must be accredited by local authorities for respective Federal State and the central authority. Since cord blood is treated as a pharmaceutical product, requirements toward banks are more strict than in other countries – similar to pharmaceutical manufacturing. Every hospital where cord blood is collected, needs to be separately accredited by authorities, and needs to have a contract with the accredited bank. Hospital personnel need to be regularly trained on how to collect cord blood. Samples can be collected only for accredited banks.	Banks who offer cord blood banking services need to be authorized with each collection center (hospital) according to the Royal Decree-Law. It establishes quality and safety standards for the donation, obtaining, evaluation, processing, preservation, storage and distribution of human cells. In addition, each cord blood bank has to be authorized by each health ministry of each region in the country. Samples stored in Spain have to be available for unrelated too. Most banks are offering storage abroad.	Every entity which deals with cells and tissues, needs to fulfil the requirements of the Transplantation Act. Requirements for banks differ on the basis of purpose of banking (autologous vs allogeneic). It is allowed for accredited entities to send collected samples cross-border after obtaining permission.	Cord blood banking is fully regulated by local law. Banks need to follow the same rules as other entities involved in transplantations of cells and organs. Samples can be send abroad under certain conditions, and that can be done by an entity which is licensed by local authorities.	Activity of banks are regulated by the Transplantation Law. Banks need to be accredited, inspected and follow regular audits. Only banks accredited by Polish authorities can offer services. The bank is responsible for collection sites, it is obliged to have a contract between bank, hospital and collecting person. Regular trainings and reporting are mandatory. Exporting collecting samples is possible for accredited banks.	Family banking is possible only in situations when there is a patient with set diagnosis that collected cord blood can be used for him. If there is no such case, it is allowed to organize individual collection in the hospital using a collection kit provided by one of the companies and then send it to a bank abroad. Permission needs to be organized by parents.

^*Once banks are offering additional cryopreservation of other perinatal tissues such as umbilical cord, placenta, and amniotic membranes, other regulations may apply.