Royal Decree-Law 9/2017 of 26 May transposing EU directives in financial, commercial, and health sectors and on worker displacement

OFFICIAL STATE BULLETIN No. 126 Saturday, 27 May 2017 Sec. I. Page 42820

I. GENERAL PROVISIONS HEAD OF STATE 5855 Royal Decree-Law 9/2017, of 26 May, transposing European Union directives in the financial, commercial, and health sectors, and on the posting of workers.

STATEMENT OF MOTIVES I Timely transposition of European Union directives currently constitutes one of the priority objectives established by the European Council. The European Commission submits periodic reports to the Competitiveness Council, which are given high political value as they serve to measure the effectiveness and credibility of Member States in implementing the internal market.

Compliance with this objective is even more prioritized today given the scenario designed by the Treaty of Lisbon, which amends the Treaty on European Union and the Treaty establishing the European Community, regarding failures to transpose directives on time. In such cases, the Commission may request the Court of Justice of the European Union to impose significant financial penalties in an accelerated manner (Article 260.3 of the Treaty on the Functioning of the European Union – TFEU).

Spain has consistently complied with the timely transposition objectives committed to since their inception.

However, throughout 2016, due to the prolongation of the caretaker government situation, the legislative work required by the transposition of these directives into the internal legal order could not be carried out in strict compliance with Article 21.5 of Law 50/1997, of 27 November, on the Government.

The non-compliance with these obligations has negative consequences for our country, compromising its political credibility and potentially leading to the imposition of monetary fines, based on Article 260.3 of the TFEU. Therefore, all necessary resources must be employed to avoid such an unfavorable scenario.

Given the gravity of the consequences of continuing to accumulate delays in incorporating such directives into the Spanish legal order, it is necessary to resort to the approval of a Royal Decree-Law to proceed with their transposition. This will allow closing the infringement proceedings opened and thereby avoid the imposition of economic sanctions on Spain.

Regarding the use of the Royal Decree-Law as a transposition instrument, it should be noted that the Constitutional Court, in Judgment 23/1993, of 21 January, states that the Royal Decree-Law is a constitutionally lawful instrument to address problematic economic situations, and in its Judgment 1/2012, of 13 January, it validates the concurrence of the enabling budget of the extraordinary and urgent need of Article 86.1 of the Constitution when there is "patent delay in transposition" and the existence of "infringement proceedings against the Kingdom of Spain." In the subsequent sections of this Statement of Motives, the reasons justifying the extraordinary and urgent need to transpose the various directives in each of the cases covered by this Royal Decree-Law will be specified.

II Title I, which encompasses Articles One and Two, contains the normative modifications that transpose directives related to the financial system.

Article One of the Royal Decree-Law modifies Law 41/1999, of 12 November, on payment and settlement systems for securities, with a double objective: on the one hand, to modify the definition of firmness and irrevocability of transfer orders so that their determination by the systems conforms to the operating protocols of the pan-European settlement platform for securities operations TARGET2-Securities, to which the Spanish central securities depository will join in September 2017. On the other hand, the wording of Article 14.1 is modified to adapt the Spanish legal order to what is provided in Article 87 of Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories. Consequently, the effects on guarantees established in favor of managers or participants in a payment or securities settlement and clearing system are regulated in insolvency proceedings. It must be taken into account, in this regard, that the aforementioned Article 87 incorporates the regulation of these effects on guarantees by modifying Article 9 of Directive 98/26/EC of the European Parliament and of the Council of 19 May 1998 on settlement finality in payment and securities settlement systems. Therefore, it is necessary to modify Law 41/1999, of 12 November, cited above, to adequately fulfill our obligations regarding the application of European law.

Regarding the first of the proposed modifications, the definition that the operating protocols of the TARGET2-Securities settlement platform makes of the firmness and irrevocability of the orders it receives differs from that established in our Law 41/1999, of 12 November, applicable to the Spanish central securities depository.

The Spanish central securities depository (Iberclear) must join TARGET2-Securities in September 2017; therefore, it is necessary to urgently make these adjustments in the wording of the Spanish rule to guarantee full legal certainty of the operations carried out on this platform during the transition to the new model and that they comply with the provisions of Directive 98/26/EC. In this way, compliance is given to what is provided in Article 39, paragraphs 2 and 3 of Regulation (EU) 909/2014 of the European Parliament and of the Council on improving securities settlement in the European Union and on central securities depositories and amending Directives 98/26/EC and 2014/65/EU and Regulation (EU) No 236/2012.

Thus, in 2012, Iberclear assumed a series of commitments with the Eurosystem by signing the TARGET2-Securities Framework Agreement, the pan-European securities settlement platform promoted by the Eurosystem as a private initiative. As agreed, Iberclear must migrate in the last migration window, on 18 September 2017. These responsibilities that Iberclear assumed with the signing of the Framework Agreement start from the assumption that Spanish regulation supports the migration and its rules are consistent with both European regulations and the functioning of the platform.

With respect to the second modification, it is about completing the adaptation of our legal order to Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories. The deadline given to Member States to adopt and publish the necessary measures to comply with these modifications was 17 August 2014. If the measures contained in this Royal Decree-Law are not adopted immediately, the Kingdom of Spain as a Member State of the European Union could incur non-compliance with the obligations imposed on it. For these purposes, the European Commission initiated the formal infringement procedure on 30 September 2016, by notification of a Letter of Formal Notice 2016/2112 and, recently, on 28 April 2017, it notified a Reasoned Opinion, in accordance with Article 258 of the Treaty on the Functioning of the European Union.

Article Two of the Royal Decree-Law modifies Article 234.2 of the consolidated text of the Securities Market Law, approved by Royal Legislative Decree 4/2015, of 23 October, to establish the suspension of the exercise of voting rights of the shares of issuers when acquisitions of significant shareholdings have not been communicated. With this modification, the incorporation into our legal order of Directive 2013/50/EU of 22 October 2013 amending Directives 2004/109/EC of the European Parliament and of the Council on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market; Directive 2003/71/EC of the European Parliament and of the Council on the prospectus to be published when securities are offered to the public or admitted to trading; and Directive 2007/14/EC of the Commission laying down implementing provisions for certain provisions of Directive 2004/109/EC, whose transposition deadline expired on 26 November 2015, is completed.

The completion, more than a year ago, of the transposition deadline for Directive 2013/50/EU of the European Parliament and of the Council of 22 October 2013, combined with the need for the competent supervisor to be equipped with the necessary instruments for the adequate application of the provisions contained in the Directive, justifies the extraordinary and urgent need to complete its transposition. For these purposes, the European Commission is processing a formal infringement procedure on which it has already issued Reasoned Opinion 2016/0063, of 17 November 2016.

III Title II, which comprises Articles Three and Four, contains the modifications derived from the transposition of Directive 2014/104/EU of the European Parliament and of the Council of 26 November 2014 on certain rules governing actions for damages under national law for infringements of the competition law of Member States and of the European Union.

The European Union promulgated this directive with the purpose of establishing effective procedural mechanisms that make it possible to claim damages caused as a result of infringements of competition law, since, in the absence of such procedural channels, experience has shown that compliance with substantive regulations suffers, even in spite of the existence of specific sanctioning law.

It establishes rules intended to eliminate obstacles that prevent the proper functioning of actionable claims, which guarantee the promotion of real competition in the internal market and equivalent protection throughout the Union for all who have suffered the damage resulting from the infringement of competition.

The directive also includes rules regulating issues of various nature, such as those dealing with procedural matters and others dealing with damages actions for their proper compensation, and finally the consideration of technological factors.

To this end, Article Three modifies Law 15/2007, of 3 July, on the Defence of Competition, introducing a new Title VI relating to the compensation of damages caused by restrictive competition practices. In service of the objectives required by Directive 2014/104/EU, the provisions of the same are introduced into the Spanish legal order, highlighting among others the liability of those who infringe competition law to indemnify the damages and losses caused by such infringement; it is also declared the right to full compensation for damages caused by these actions; or the joint liability of those who have carried out the infringement jointly is provided, although this general rule is nuanced in accordance with the rules of the directive.

The Royal Decree-Law establishes a limitation period of 5 years for the exercise of damages actions, and regulates the quantification of damages and losses regarding the burden of proof – which lies with the claimant – introducing certain nuances, such as a rebuttable presumption of causation of damage in infringements qualified as cartels, or the possibility for judges to estimate a certain amount of damages if the existence thereof is proven but it is practically impossible or excessively difficult to quantify them precisely.

Finally, the proof and quantification of the overcharge are regulated, as well as certain peculiarities of damages actions exercised by plaintiffs located at different levels of the supply chain. All of the above with the clear objective of guaranteeing that the damages suffered by subjects (whether companies or consumers) as a result of such anti-competitive practices are effectively compensated.

By incorporating this new Title VI into Law 15/2007, of 3 July, on the Defence of Competition, it is also intended to extend the new regulations to claims for damages caused by infringements of Articles 1 and 2 of said law that do not affect trade between Member States of the Union and that, therefore, do not fall within the scope of application of Articles 101 and 102 of the Treaty on the Functioning of the European Union, but not to acts of unfair competition that, by distorting free competition, affect the public interest since they have a specific regime in Law 3/1991, of 10 January, on Unfair Competition.

Finally, a series of definitions included in Article 2 of Directive 2014/104/EU of the European Parliament and of the Council of 26 November 2014 are incorporated into the Spanish legal order in the fourth additional provision of Law 15/2007, of 3 July, in order to allow a better understanding of the remaining provisions of the cited law. This incorporation includes legal institutions currently non-existent in the Spanish legal order, such as, for example, settlement requests defined in the aforementioned additional provision, referred to the procedure provided in the European Commission Communication on the development of settlement procedures with a view to adopting decisions pursuant to Articles 7 and 23 of Council Regulation (EC) No 1/2003 in cartel cases (2008/C 167/01, OJEU of 2 July 2008) and similar regulations in other Member States of the Union. The inclusion of such definitions also facilitates the filing before Spanish courts of damages actions derived from sanctioning resolutions of the European Commission or other national competition authorities.

Next, with respect to the provisions of the directive to facilitate proof in proceedings for damages resulting from the violation of competition rules, the main objective of the modification introduced by Article Four of this Royal Decree-Law in Law 1/2000, of 7 January, on Civil Procedure, is the achievement of better protection of the rights of litigants in this field. To this end, said Article Seven introduces a regulation on access to sources of proof in Law 1/2000, of 7 January, through a new Section 1.ª bis ("On access to sources of proof in proceedings for damages claims for infringement of competition rules") within Chapter V ("On proof: general provisions") of Title I ("On provisions common to declaratory proceedings") of Book II ("On declaratory proceedings"), in which, among other aspects, the requirements to request from the court a measure of access to sources of proof, an exemplary list of possible measures, as well as their execution and the consequences of obstruction to their practice, always modulated by the principle of proportionality, are determined.

With all this, the notion of source of proof is given legal status, through which it refers to any element capable of serving as a basis for subsequent evidentiary practice at the appropriate procedural moment. Through the new regulation, it is allowed for litigants in the field of Competition Law to have knowledge of the elements that will serve them to try to form judicial conviction according to the ordinary rules in the matter of proposing and practicing proof; however, and precisely for this reason, access to sources of proof does not exempt the litigant from the burden of proposing in due time and form the practice of the pertinent evidentiary means.

The Royal Decree-Law also refers specifically to access to sources of proof that are in the possession of public administrations and entities of public law, providing, for the latter case, the impossibility of access to documentation or material of a reserved or secret nature.

With the objective of ensuring the effective realization of access, and against cases of obstruction of such access, the rule collects a series of consequences on the effects of the proof in the process in question, leaving aside the criminal liability in which anyone acting thus might incur.

The passage of the deadline for incorporation into the Spanish legal order of Directive 2014/104/EU, which ended on 27 December 2016, justifies the use of the Royal Decree-Law as a transposition instrument, as the circumstance of extraordinary and urgent need required by Article 86 of the Constitution concurs. Indeed, it is urgent to carry out the necessary adaptation of our Law and put an end to the delay in fulfilling this obligation, considering the negative consequences that such delay entails both for citizens, for whose benefit the effectiveness of actions for compensation for damages and losses derived from infringements of competition law should be guaranteed, and for the State, due to the risk of being sanctioned by the European Union institutions through an infringement procedure that has been initiated ex officio by the European Commission in January 2017.

IV Title III, composed of Article Five, contains the modifications that incorporate European Union directives into the internal order in the health sector.

Royal Decree-Law 9/2014, of 4 July, establishing quality and safety standards for the donation, procurement, evaluation, processing, preservation, storage and distribution of human cells and tissues and approving coordination and functioning rules for their use in humans, consolidated the incorporation into the internal legal order 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; of 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 and procurement of human tissues and cells; as well as 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 coding, processing, preservation, storage and distribution of human tissues and cells.

Subsequent to the approval of Royal Decree-Law 9/2014, of 4 July, two Community directives have been approved that have introduced new requirements in the matter of human cells and tissues, motivating the need to modify said Royal Decree-Law in order to adapt its provisions to these requirements. These are, on the one hand, Commission Directive (EU) 2015/565 of 8 April 2015 amending Directive 2006/86/EC as regards certain technical requirements for the coding of human cells and tissues; and, on the other hand, Commission Directive 2015/566 of 8 April 2015 implementing Directive 2004/23/EC as regards the procedures for verifying the equivalence of quality and safety standards of imported cells and tissues.

In this way, the traceability of human cells and tissues is strengthened from the donor to the recipient and vice versa. To this end, and as a guarantee of such traceability, certain technical requirements for the coding of human cells and tissues are established.

Specifically, the application of the unique European code is guaranteed, which provides information on the donation and on the product, attributing to each of these concepts a specific identification sequence that will comply with the format and structure established in the rule itself.

For those tissues and cells that are excluded or exempt from the application of the unique European code, rules are established that guarantee their adequate traceability throughout the entire chain, from donation and procurement to application in humans.

And in situations other than distribution where tissues and cells are put into circulation, such as transfer to another operator for subsequent processing, with or without return, the identification sequence of the donation must be applied, at minimum, in the attached documentation.

Tissue establishments, including importing tissue establishments, must correctly apply the requirements of the unique European code, with the National Transplant Organization and the autonomous communities being responsible for ensuring such application. In this way, all authorized tissue establishments must have a unique number and appear in the EU Tissue Establishments Compendium.

Furthermore, with the new regulation introduced in Royal Decree-Law 9/2014, of 4 July, it is required that imports of cells and tissues be carried out only by tissue establishments authorized for this purpose, called importing tissue establishments, except in those cases where the direct importation of specific cells and tissues can be authorized, such as, for example, to authorize the importation of hematopoietic stem cells originating...