22.3.2014

EN

Official Journal of the European Union

C 85/17

(Case C-29/14)

2014/C 85/32

Language of the case: Polish

Parties

Applicant: European Commission (represented by: C. Gheorghiu and M. Owsiany-Hornung, Agents)

Defendant: Republic of Poland

Form of order sought

The Commission claims that the Court should:

—declare that the Republic of Poland has failed to fulfil its obligations under Article 31 of Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, (1) under Articles 3(b), 4(2) and 7 of, and Annex III to, Commission Directive 2006/17/EC of 8 February 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, (2) and under Article 11 of Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (3) by exempting reproductive cells and embryonic and foetal tissue from the scope of the provisions of national law designed to transpose those directives;

—order the Republic of Poland to pay the costs of the proceedings.

Pleas in law and main arguments

Poland’s transposition of Directives 2004/23, 2006/17 and 2006/86 into the Polish legal system is incomplete because the scope of the Law of 1 July 2005 on the procurement, storage and transplantation of cells, tissue and organs, by which those directives were transposed into the Polish legal system, and of the implementing measures adopted on the basis of that Law does not encompass reproductive cells and embryonic and foetal tissue.

As a result, Polish legislation contains no provisions for the transposition of Directives 2004/23 and 2006/86 in so far as those directives relate to reproductive cells and embryonic and foetal tissue.

There has also been a failure to transpose the provisions of Directive 2006/17 concerning reproductive cells, that is to say, Articles 3(b) and 4(2) of, and Annex III to, that directive.

In the procedure prior to the judicial proceedings, while the Republic of Poland confirmed that there were no corresponding provisions in national law, it stressed the following: ‘In the context of reproductive cells and embryonic and foetal tissue, the provisions of the directives are to a large degree applied in daily clinical practice — they have been transposed at an expert level …’

The Commission takes the view that it was necessary for the provisions in question to be transposed in full by way of legally binding measures.

(1) OJ 2004 L 102, p. 48.

(2) OJ 2006 L 38, p. 40.

(3) OJ 2006 L 294, p. 32.