Today, the European Commission decided to refer Poland to the Court of Justice of the EU for not transposing certain provisions of EU legislation laying down the quality and safety standards for human blood (Directives 2002/98/EC, 2004/33/EC and 2005/61/EC). These Directives lay down a number of provisions aimed at ensuring the safety of blood, including rules for the minimum age of donors, conditions for importing blood from third counties, and reporting obligations of blood establishments.
To date, Poland has not informed the European Commission about the adoption of national legislation comprehensively transposing the relevant EU Directives. Poland had to bring into force the laws, regulations and administrative provisions necessary to comply with the Directives 2002/98/EC and 2004/33/EC by 8 February 2005, and the Directive 2005/61/EC by 31 August 2006, as well as to communicate to the Commission the relevant texts of the provisions of national law transposing these Directives. Instead, the draft new law on the donation of blood and blood treatment remains the subject of legislative procedures at governmental level.
The European Commission, therefore, considers that Poland has failed to fulfil certain obligations under Directives 2002/98/EC, 2004/33/EC and 2005/61/EC on quality and safety standards for human blood and blood components, namely:
- On the eligibility of donors: Polish rules concerning admissibility of minors are less protective than the EU rules (in particular, donors below the age of 17 are permitted).
- On imports of blood and blood components from third countries: Polish legislation does not transpose EU legislation requiring equivalent traceability and testing standards to those applicable to blood and blood components collected in the EU.
- The required content of the annual activity reports of blood establishments is not fully reflected in the Polish legislation.
On the December 2015 infringement package decisions, please refer to the fullMEMO/15/6223.
On the general infringement procedure, see MEMO/12/12.
On infringement procedures, see here.