Five years have passed since the adoption of the law that allows private health facilities, together with the public ones, to transfer human cells, including stem cells, but this does not yet happen. The law adopted in 2014 is not implemented as there are no mechanisms for authorizing, monitoring and examining the process. Last week, the Government approved a decision by which the Transplant Agency was empowered to coordinate and monitor the assisted human reproduction activities. This envisions the creation of human tissue and cell banks, including of stem and reproductive cells. The decision hasn’t been yet published in the Official Gazette.
Asked by IPN to comment, Transplant Agency director Igor Codreanu said several years ago the legislation was modified and the transfer of hematopoietic cells from the umbilical cord is now also regulated. However, amendments to a number of legal acts were to be approved to ensure the implementation of the legislation.
Igor Codreanu noted that a number of actions were taken meanwhile. Dozens of persons working in the transplantation and organ and tissue donation sectors were trained as part of a twinning project to the value of €1.2 million. During the related activities, shortcomings were identified in the management of other components, such as reproductive medicine and in vitro fertilization. The law exists, but there is no clear monitoring not of the clinical process, but of the tendencies, impediments and number of transfers. On the recommendation of experts, this monitoring was made the task of the Transplant Agency.
After the decision was that recently approved by the Government is published in the Official Gazette, the Transplant Agency will present the necessary documents concerning the authorization of tissue and cell banks and of legal entities that will carry out tissue and cell transfer, transportation, delivery and storage activities for examination and approval.
Igor Codreanu said a number of stages should be regulated so as to ensure a safe process. The person who wants to keep stem cells should have guarantees that all the conditions are respected. The new powers will enable the Transplant Agency to monitor the messages sent by representative of cell banks in the discussions with potential beneficiaries. The persons who use such services should be sure that they are informed correctly.
When all the necessary normative documents are adopted, a clear procedure should be set so that a private individual or the representative of a foreign bank know how to get the necessary authorization.
