Case C‑29/14

European Commission

v

Republic of Poland

‛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’

Summary — Judgment of the Court (Third Chamber), 11 June 2015

Actions for failure to fulfil obligations — Proof of failure — Burden of proof on Commission — Presumptions — Unlawful — Failure to fulfil the obligation to inform placed on the Member States by the directive — Consequences (Art. 4(3) TEU; Art. 258 TFEU) Actions for failure to fulfil obligations — Examination of the merits by the Court — Situation to be taken into consideration — Situation on expiry of the period laid down in the reasoned opinion — Transposing measures in force before that time-limit but not relied on during the pre-litigation procedure — Account taken (Art. 4(3) TEU; Art. 258 TFEU; European Parliament and Council Directive 2004/23; Commission Directives 2006/17 and 2006/86) Acts of the institutions — Directives — Implementation by Member States — Need for clear and precise transposition — Transposition of a directive without legislative action — Conditions — Existence of general principles of law which guarantee that the directive will be fully applied — Not permissible in the case of an express requirement that reference be made to a directive (Art. 288, third para., TFEU; European Parliament and Council Directive 2004/23, Art. 31; Commission Directives 2006/17, Art. 7 and 2006/86, Art. 11) Public health — Human tissues and cells — Standards of quality and security — Directive 2004/23 — Technical requirements — Directives 2006/17 and 2006/86 — Exclusion of reproductive cells and foetal and embryonic tissue from the scope of the provisions of national law transposing those directives — Failure to fulfil obligations (European Parliament and Council Directive 2004/23, Art. 31; Commission Directives 2006/17, Arts 3(b), 4(2) and (7) and Annex III, and 2006/86, Art. 11)

See the text of the decision. (see paras 32, 33) See the text of the decision. (see paras 34, 35) See the text of the decision. (see paras 37, 38, 46-49) A Member State fails to fulfil its obligations under Article 31 of Directive 2004/23 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, under Articles 3(b), 4(2) and 7 of, and Annex III to, Commission Directive 2006/17 implementing Directive 2004/23 as regards certain technical requirements for the donation, procurement and testing of human tissues and cells, and under Article 11 of Directive 2006/86 implementing Directive 2004/23 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, by excluding reproductive cells and foetal and embryonic tissue from the scope of the provisions of national law transposing those directives. (see para. 51, operative part)

Case C‑29/14

European Commission

v

Republic of Poland

‛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’

Summary — Judgment of the Court (Third Chamber), 11 June 2015

Actions for failure to fulfil obligations — Proof of failure — Burden of proof on Commission — Presumptions — Unlawful — Failure to fulfil the obligation to inform placed on the Member States by the directive — Consequences (Art. 4(3) TEU; Art. 258 TFEU) Actions for failure to fulfil obligations — Examination of the merits by the Court — Situation to be taken into consideration — Situation on expiry of the period laid down in the reasoned opinion — Transposing measures in force before that time-limit but not relied on during the pre-litigation procedure — Account taken (Art. 4(3) TEU; Art. 258 TFEU; European Parliament and Council Directive 2004/23; Commission Directives 2006/17 and 2006/86) Acts of the institutions — Directives — Implementation by Member States — Need for clear and precise transposition — Transposition of a directive without legislative action — Conditions — Existence of general principles of law which guarantee that the directive will be fully applied — Not permissible in the case of an express requirement that reference be made to a directive (Art. 288, third para., TFEU; European Parliament and Council Directive 2004/23, Art. 31; Commission Directives 2006/17, Art. 7 and 2006/86, Art. 11) Public health — Human tissues and cells — Standards of quality and security — Directive 2004/23 — Technical requirements — Directives 2006/17 and 2006/86 — Exclusion of reproductive cells and foetal and embryonic tissue from the scope of the provisions of national law transposing those directives — Failure to fulfil obligations (European Parliament and Council Directive 2004/23, Art. 31; Commission Directives 2006/17, Arts 3(b), 4(2) and (7) and Annex III, and 2006/86, Art. 11)