New Croatian legislation on tissue banking

Human tissues and cells are increasingly used in transplantation, and have also a very promising potential as starting material for tissue engineering and cell therapy. Due to their biological origin, tissues and cells also carry the risks of disease transmission, which need to be reduced as far as possible. Safety and quality standards for tissues and cells have to be concurrent with EU standards in all member states. EU standards in this area have been regulated by the Directive 2004/23/EC, which determines safety and quality standards for human tissues and cells. Two other directives support its implementation regulating technical requirements regarding different process phases of handling tissues and cells. Directive 2006/17/EC regulate technical requirements for donation, procurement and testing of human tissues and cells, whereas technical requirements concerning coding, processing, preservation, storage and distribution of human tissues and cells are regulated by Directive 2006/86/EC. Legal implementations of these directives throughout the European Union take places at different dynamic levels. Countries like Spain, Ireland, Denmark and Bulgaria have successfully completed this process. However, some countries have not met this challenge yet (e.g., Italy, The Netherlands, Latvia, Belgium, Luxembourg, Austria, Slovenia and Sweden), and others are only half-way through (e.g. Slovakia, Rumania, Portugal, Norway, Great Britain, et aI.). Some Member States indicated problems in the implementation of the Directive due to the limited number of experts in the field. In Croatia, the field of tissue and cell transplants is regulated by the Act of Conditions for Removal and Transplantation of Human Body Parts for Therapeutic Purposes (Official Gazette 177/04) and other decrees, which help regulating quality and safety for human tissues and cells, defining authorization systems for tissue and cell banks as well as supervising their work and determining the compliance regarding quality and safety for procurement, testing, processing and distribution of human tissues and cells for therapeutic purposes according to the required standards; Ordinance on Storing Personal Data of Donors and Recipients of Human Body Parts (OG 141/05), Ordinance on Cooperation with Related Foreign and International Organisations for the Purpose of Exchanging Organs and Human Tissues for Transplantation (OG 141/05), Ordinance on Measures to Ensure Safety and Quality of Human Body Parts for Medical Use COG 143/05), Ordinance on Distribution Principles of Unrelated Allogeneic Hematopoietic Cells and the Register of Potential Bone Marrow Donors COG 151/05), Ordinance on Distribution Criteria of Human Body Parts and Compilation of a National Waiting List (OG 152/05), Ordinance on the Method of Storage and Transportation of Human Body Parts Intended for Transplantation COG 152/05), Ordinance on Keeping Medical Documentation on Performed Removals and Transplants of Human Body Parts COG 152/05), Ordinance on Notification Procedures of the Death of Eligible Human Body Part Donors for Therapeutic Purposes (OG 152/05), Ordinance on the Work of Tissue Banks with and Supervision over Health Care Institutes or Divisions of Health Care Institutes COG 1/06), Ordinance on Method, Procedure and Medical Criteria for Death Determination of Body Part Donors for Transplants COG 3/06), and Ordinance on the Work of Coordinators in the Procedure of Removal and Transplantation of Human Body Parts for Therapeutic Purposes COG 51/06). The Croatian legislation is greatly consistent with the legislation of the European Union regarding this field. In the above mentioned law and decrees, Croatia has a legal foundation for regulating this field in compliance with EU standards.