Impact of new European regulations on banking of ocular and other tissues used in ophthalmology

Abstract

In order to guarantee the safety and quality of human tissues and cells (HTCs) for human applications in the European Community (EC) member states, the European Parliament and the Council and the European Commission adopted three new European Directives in the 2004 and 2006. The main aim of the directives was to establish a unified regulatory framework in all the EC member states to ensure high standards of quality and safety with respect to the procurement EC and to facilitate the exchange of HTCs and products derived from them for patients receiving this type of therapy. The basic principles of the new directives aim to protect the recipients of HTCs from potentially transmittable diseases and other risks arising from poor-quality material or processing and, by protecting recipients, to safeguard the wider public health. The EC provisions shall ensure that HTCs, whatever their intended use or source, are of comparable quality and safety in all of the member states. The procurement, testing and processing of ocular tissues, such as cornea, sclera and limbal stem cells, are included in the HTCs regulated by the directives. The directives will have a great impact on both the existing and new ocular tissue establishments, as much effort, massive workload and additional financial sources will be required for their implementation into ocular tissue banking practices. On the other hand, their implementation is expected to substantially increase the quality and safety of the ocular tissue grafts procured and processed by tissue establishments, as well as the biovigilance pertained to ocular tissue transplantation.