European Commission v Republic of Poland.

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2015:379
• Court: Court of Justice (European Union)
• Date: 11 June 2015
• Docket Number: C-29/14
• Procedure Type: Recurso por incumplimiento – fundado
• Celex Number: 62014CJ0029

JUDGMENT OF THE COURT (Third Chamber)

11 June 2015 ( *1 )

‛Failure of a Member State to fulfil obligations — Public health — Directive 2004/23/EC — Directive 2006/17/EC — Directive 2006/86/EC — Exclusion of reproductive cells, foetal tissues and embryonic tissues from the scope of national legislation transposing those directives’

In Case C‑29/14,

ACTION under Article 258 TFEU for failure to fulfil obligations, brought on 21 January 2014,

European Commission, represented by C. Gheorghiu and M. Owsiany-Hornung, acting as Agents, with an address for service in Luxembourg,

applicant,

v

Republic of Poland, represented by B. Majczyna, acting as Agent,

defendant,

THE COURT (Third Chamber),

composed of M. Ilešič, President of the Chamber, A. Ó Caoimh, C. Toader, E. Jarašiūnas and C.G. Fernlund (Rapporteur), Judges,

Advocate General: M. Wathelet,

Registrar: A. Calot Escobar,

having regard to the written procedure,

having decided, after hearing the Advocate General, to proceed to judgment without an Opinion,

gives the following

Judgment

1 By its action, the European Commission requests the Court to 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 (OJ 2004 L 102, p. 48), 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 (OJ 2006 L 38, p. 40) 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 (OJ 2006 L 294, p. 32) by excluding reproductive cells and foetal and embryonic tissue from the scope of the provisions of national law transposing those directives.

Legal context

EU law

Directive 2004/23

2 Recitals 1, 2 and 4 in the preamble to Directive 2004/23 are worded as follows: ‘(1) The transplantation of human tissues and cells is a strongly expanding field of medicine offering great opportunities for the treatment of as yet incurable diseases. The quality and safety of these substances should be ensured, particularly in order to prevent the transmission of diseases. (2) The availability of human tissues and cells used for therapeutic purposes is dependent on Community citizens who are prepared to donate them. In order to safeguard public health and to prevent the transmission of infectious diseases by these tissues and cells, all safety measures need to be taken during their donation, procurement, testing, processing, preservation, storage, distribution and use. … (4) There is an urgent need for a unified framework in order to ensure high standards of quality and safety with respect to the procurement, testing, processing, storage and distribution of tissues and cells across the Community and to facilitate exchanges thereof for patients receiving this type of therapy each year. It is essential, therefore, that Community provisions ensure that human tissues and cells, whatever their intended use, are of comparable quality and safety. The establishment of such standards, therefore, will help to reassure the public that human tissues and cells that are procured in another Member State, nonetheless carry the same guarantees as those in their own country.’

3 According to recital 7 in the preamble to that directive, the latter should ‘apply to … reproductive cells (eggs, sperm), foetal tissues and cells and adult and embryonic stem cells’.

4 Article 31 of Directive 2004/23, entitled ‘Transposition’, provides: ‘1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive not later than 7 April 2006. They shall forthwith inform the Commission thereof. When Member States adopt these measures they shall contain a reference to this Directive or shall be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be laid down by the Member States. … 3. Member States shall communicate to the Commission the texts of the provisions of national law that they have already adopted or which they adopt in the field governed by this Directive.’

Directive 2006/17

5 Article 3 of Directive 2006/17 provides: ‘The competent authority or authorities shall ensure that donors comply with the selection criteria set out in: … (b) Annex III for donors of reproductive cells.’

6 Article 4 of that directive, entitled ‘Laboratory tests required for donors’, provides in paragraph 2: ‘The competent authority or authorities shall ensure that: (a) donors of reproductive cells undergo the biological tests set out in points 1, 2 and 3 of Annex III; (b) the tests referred to in point (a) above are carried out in compliance with the general requirements set out in point 4 of Annex III.’

7 Under Article 7 of that directive, entitled ‘Transposition’: ‘1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 November 2006, at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.’

8 Annex III to Directive 2006/17 lays down the selection criteria and laboratory tests required for donors of reproductive cells as referred to in Article 3(b) and Article 4(2) of that directive.

Directive 2006/86

9 Article 10 of Directive 2006/86, entitled ‘European coding system’, provides: ‘1. A single European identifying code shall be allocated to all donated material at the tissue establishment, to ensure proper identification of the donor and the traceability of all donated material and to provide information on the main characteristics and properties of tissues and cells. The code shall incorporate at least the information set out in Annex VII. 2. Paragraph 1 shall not apply to partner donation of reproductive cells.’

10 Article 11 of that directive, entitled ‘Transposition’, provides: ‘1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 2007, at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with Article 10 of this Directive, by 1 September 2008. When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made. 2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.’

Polish law

11 The directives at issue were transposed into the Polish internal legal order principally by the Law relating to the removal, storage and transplantation of cells, tissues and organs (ustawa o pobieraniu, przechowywaniu i przeszczepianiu komórek, tkanek i narządów) of 1 July 2005 (Dz. U. 2005, No 169, position 1411), as subsequently amended (‘the principal transposing act’).

12 Article 1(2)(1) of the principal transposing act provides that it does not apply to ‘the removal and transplantation of reproductive cells, gonads, foetal tissues, embryonic tissues and reproductive organs and the elements thereof’.

13 The Republic of Poland also adopted, on the basis of the principal transposing act, a series of implementing acts, including several orders of the Minister for Health, designed also to transpose into Polish law the majority of the provisions of the directives at issue (‘the implementing acts’). Those implementing acts also do not apply to the removal and transplantation of the cells and tissues referred to in paragraph 12 of the present judgment.

Pre-litigation procedure

14 After establishing that the principal transposing act applied neither to reproductive cells nor to foetal and embryonic tissues (‘the tissues and cells at issue’), the Commission, by letters of 14 February 2008 and 23 February 2009, requested the Republic of Poland to provide clarification as to what the Commission considered to be an incomplete transposition, in the internal legal order, of the directives at issue and as to the progress in regard to the full transposition of those directives.

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