European Commission v Republic of Poland.
Date: 2015-06-11
32. In that regard, it should be noted that the Republic of Poland referred to those transposition measures for the first time at the stage of the defence, a fact which cannot be reconciled with the duty of sincere cooperation imposed on Member States under Article 4(3) TEU (see, to that effect, judgment in Commission  v Spain , C‑151/12, EU:C:2013:690, paragraph 49).
33. The Court has already held that, while, in proceedings under Article 258 TFEU for failure to fulfil obligations, it is incumbent on the Commission to place before the Court the information needed to enable the Court to establish that an obligation has not been fulfilled, it is also incumbent on the Member States, pursuant to Article 4(3) TEU, to facilitate the achievement of the Commission’s tasks. Moreover, the information concerning the transposition of a directive which the Member States are obliged to provide to the Commission must be clear and precise, and it must unequivocally indicate the legislative, regulatory and administrative measures by which the Member State considers that it has fulfilled the various obligations imposed on it by the directive. In the absence of such information, the Commission is not in a position to determine whether the Member State has genuinely and fully implemented the directive. The failure of a Member State to fulfil that obligation, whether by providing no information at all or by providing insufficiently clear and precise information, may of itself justify recourse to the procedure under Article 258 TFEU in order to establish that failure to fulfil the obligation (see, to that effect, judgment in Commission  v Italy , C‑456/03, EU:C:2005:388, paragraphs 26 and 27).
34. In the present case, however, it should be noted that, although the transposition measures invoked by the Republic of Poland at the stage of the defence were not mentioned by it during the pre-litigation procedure, the present action concerns, not a failure to fulfil the obligation to provide information, but a failure to fulfil the obligation to transpose the directives at issue into Polish national law, with respect to the tissues and cells at issue. It follows that the mere fact that the Republic of Poland failed to inform the Commission, during the pre-litigation procedure, that, in its opinion, those directives had already been fully transposed into the national law in force cannot suffice to establish the alleged failure to fulfil obligations (see, to that effect, judgment in Commission  v Poland , C‑478/13, EU:C:2014:2253, paragraph 33 and the case-law cited).
35. As a consequence, in so far as the measures invoked by the Republic of Poland in its defence were in force when the period laid down by the reasoned opinion expired, the Court must take them into account when determining whether that obligation has not been fulfilled (judgment in Commission  v Poland , C‑478/13, EU:C:2014:2253, paragraph 34 and the case-law cited).
37. In that regard, it follows from settled case-law that the provisions of a directive must be implemented with unquestionable binding force, and with the specificity, precision and clarity necessary to satisfy the requirements of legal certainty (see, inter alia, judgment in Commission  v Greece , C‑81/07, EU:C:2008:172, paragraph 19 and the case-law cited). That principle of legal certainty requires appropriate publicity for the national measures adopted pursuant to EU rules in such a way as to enable the persons concerned by such measures to ascertain the scope of their rights and obligations in the particular area governed by EU law (judgment in Commission  v Belgium , C‑415/01, EU:C:2003:118, paragraph 21).
38. It is none the less the case that, according to the actual wording of the third paragraph of Article 288 TFEU, Member States may choose the form and methods for implementing directives which best ensure the result which they seek to achieve. It is also apparent from that provision that the transposition of a directive into national law does not necessarily require legislative action in each Member State. Thus, it is not always necessary formally to enact the requirements of a directive in a specific express legal provision, since the general legal context may be sufficient for implementation of a directive, depending on its content. In particular, the existence of general principles of constitutional or administrative law may render superfluous transposition by specific legislative or regulatory measures, provided, however, that those principles actually ensure the full application of the directive by the national administrative authorities and that, where the relevant provision of the directive seeks to create rights for individuals, the legal situation arising from those principles is sufficiently precise and clear and that the persons concerned are placed in a position to know the full extent of their rights and obligations and, where appropriate, to be able to invoke them before the national courts (see, inter alia, judgment in Commission  v France , C‑296/01, EU:C:2003:626, paragraph 55 and the case-law cited).
40. First of all, the Court has already held that it is necessary in every case to determine the nature of the provisions of a directive to which infringement proceedings relate, in order to assess the extent of the obligation as to transposition which is imposed on the Member States (judgment in Commission  v Luxembourg , C‑32/05, EU:C:2006:749, paragraph 36).
49. Finally, it was in any event necessary for the Republic of Poland to adopt specific transposition measures given that Article 31 of Directive 2004/23, Article 7 of Directive 2006/17 and Article 11 of Directive 2006/86 expressly require Member States to ensure that their measures transposing those directives include a reference to them or that such reference is made when they are officially published (see, to that effect, judgment in Commission  v Spain , C‑360/95, EU:C:1997:624, paragraph 13).