Brussels, 26 September 2013
Public Health: Commission refers Poland to Court for failure to comply with EU legislation on quality and safety of human tissues and cells
Today, the Commission decided to take Poland to the European Court of Justice for non-compliance with EU rules on the quality and safety of human tissues and cells.
Human tissues and cells, such as bone marrow, tendons, oocytes, and cornea are used in healthcare to treat people for a wide variety of illnesses and injuries. The transplantation of tissues and cells carries potential risks for disease transmission and this is why it is important to comply with EU legislation aimed at ensuring their quality and safety from donation to transplantation. This is the purpose of Directive 2004/23/CE and its implementing Directives.
Poland's transposition of rules of the relevant Directives is incomplete.
Poland does not apply the Directive's rules on quality and safety to three categories of tissues and cells covered by the EU legislation: reproductive cells, embryonic tissues and foetal tissues. Although the use or non-use of tissues and cells for transplantation are determined under national legislation, Poland has not notified any prohibition or restriction to these categories.
On the 25 January 2013, the Commission sent a reasoned opinion asking Poland to complete the transposition of the relevant Directives.
Poland so far, despite repeated calls by the Commission to complete this transposition, has failed to do so.
On the September infringement package decisions, see MEMO/13/820
On the general infringement procedure, see MEMO/12/12
For more information on infringement procedures:
For further information on the EU policy on the quality and safety of human tissues and cells: http://ec.europa.eu/health/blood_tissues_organs/tissues/index_en.htm