vLex European Union

Shortly after updating the related draft Questions and Answers document, the European Commission has published two new documents concerning the Clinical Trials Regulation (EU) 536/2014. The first document is an informed consent and patient recruitment procedure template. The second document is an updated clinical trial Application Form. (See Article)

The Situation: Spain currently has a system that allows the filing of collective actions but it has not been employed frequently to date, and most consumer-related issues are still litigated on an individual basis. Developments: If adopted, the proposed EU Directive on representative actions for the protection of the collective interests of consumers would necessitate certain changes in the Spanish legislation. (See Article)

The EU has, on 6 November 2019, published in the Official Journal a delegated regulation (the “Delegated Regulation”) supplementing the EU Securitisation Regulation (the “Securitisation Regulation”) with regard to regulatory technical standards (“RTS”) on the homogeneity of the underlying exposures in securitisation. The Delegated Regulation will enter into force 20 days after publication. Please see full Publication below for more information. (See Article)

The Financial Stability Board has published the 2019 list of global systemically important banks. Alongside the 2019 G-SIB list, the Basel Committee on Banking Supervision has published further information relating to its 2019 assessment of G-SIBs, including... (See Article)

The EU General Data Protection Regulation (GDPR) regulates the use of personal data collected from European data subjects, including activities of non-European companies that target or process European data subject personal data. Compliance with the regulation’s requirements can be challenging for many organizations and its potential fines daunting. This installment of The eData Guide to GDPR examines two methods for compliance. (See Article)

The budget planning of the European Union (EU) has been a central topic of the organization’s internal discussions in recent months. After concluding talks on the budget and expenditures for 2020, EU policymakers are now continuing negotiations regarding the Multiannual Financial Framework (MFF) for 2021-2027... (See Article)

The Eurozone Single Resolution Board has published a series of three opinions setting out its own internal rules for the circumstances in which it may restrict the rights of data subjects under Regulation (EU) 2018/1725, data protection legislation that is commonly understood as the public sector equivalent of the General Data Protection Regulation... (See Article)

The European Banking Authority has published a consultation paper on its draft Implementing Technical Standards for supervisory reporting and public disclosure of minimum requirements for own funds and eligible liabilities (or “MREL”) and total loss-absorbing capacity (or “TLAC”). Responses to the consultation should be submitted by February 22, 2020. The EBA expects to submit the final draft ITS to the European Commission in June 2020. (See Article)

Diplomatic relations between the European Union (EU) and Turkey are once again being tested as the EU imposes sanctions on Turkey over a natural gas and oil drilling dispute in the Eastern Mediterranean Sea. Turkey has been exploring oil and gas fields near the coast of Cyprus, testing the sovereign territory claims of Cyprus in the waters surrounding the island, also known as the Exclusive Economic Zone (EEZ). Estimations suggest that the waters south of Cyprus’ coast harbor up to 227 billion cubic meters of natural gas. This could amount to revenues of more than €40 billion.... (See Article)

Money laundering and terrorist financing have gained increased attention by the media and legislators in Europe in recent years. The EU is making an effort to prevent and combat money laundering and associated risks through the revision of EU law. Meanwhile, Brexit has become a risk to the policing of money laundering in Europe and the UK. Post-Brexit, the UK must ensure that legal frameworks policing money laundering are firm and law enforcement is guaranteed. This Risk Report places focus on recent developments in EU laws on money laundering and terrorist financing and examines how Brexit will influence money laundering risks in the UK... Please see full Publication below for more information. (See Article)

The European Banking Authority has launched a consultation on its proposed draft Implementing Technical Standards on specific supervisory reporting requirements for market risk. “Market risk” relates to the risk of losses that banks face to their on- and off-balance sheet positions from adverse movements in market prices... (See Article)

On November 25, 2019, the European Union (EU) Observatory for Nanomaterials (EUON) announced the publication of a study published in Frontiers in Pharmacology entitled “Unpredictable Nanoparticle Retention in Commonly Used Plastic Syringes Introduces Dosage Uncertainties That May Compromise the Accuracy of Nanomedicine and Nanotoxicology Studies.” (See Article)

On 27 July 2017, the chief executive of the Financial Conduct Authority, Andrew Bailey, announced that the London Interbank Offered Rate (LIBOR) may not continue to be available after 2021. Since this announcement, a number of national working groups have been set up, and consultations carried out, to develop and select alternative risk-free rates (RFRs) to replace LIBOR. (See Article)

EURid, the Registry operating the .EU Top Level Domain (TLD) for Europe, launched the .e? TLD (".EU" in Greek) on 14 November 2019.  EURid had already launched the Cyrillic equivalent . (See Article)

As part of our periodic updates, here is an overview of recent developments of relevance to participants in the real estate finance market across certain key jurisdictions in Europe. (See Article)

The European Chemicals Agency (ECHA) announced on December 3, 2019, that it has developed a new Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification. According to ECHA, it aligns ECHA’s guidance with the amended annexes of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation that will apply to nanomaterials and enter into force on January 1, 2020. (See Article)

The Basel Committee on Banking Supervision has opened two consultations on revisions to the Basel III Pillar 3 disclosure requirements, one related to market risk disclosures and one on sovereign exposures disclosures. Responses to both consultations should be submitted by February 14, 2020. No indication is given as to when the sovereign exposure disclosure requirements might be introduced. The Basel Committee intends to publish the revisions of the market risk disclosure requirements in time for implementation of the revisions by member jurisdictions by no later than January 1, 2022. (See Article)

We keep discussing about new technologies with our TMT Bites. From big data to blockchain, from IoT to artificial intelligence. All these technologies and developments raise a number of challenges, including the “jurisdiction creep”, i.e. the possibility to “attract” in a jurisdiction data protection, security requirements or other regulations that are applicable in foreign countries, without being fully aware of all the rules to take into account. This is a persistent issue (for instance this was one of the main concerns raised by the WP29 back in 2014 when addressing IoT technologies). Certain technologies may inevitably be “cross border” (for instance, when data are processed in other juri (See Article)

Following its consultation earlier this year, the European Securities and Markets Authority has published final reports and the final technical advice on third-country CCP tiering, comparable compliance and fees under draft revisions to the European Market Infrastructure Regulation, known as EMIR 2.2. EMIR 2.2 will change the requirements for the supervision of both EU and third-country CCPs, and includes the controversial formal EU "location policy" for CCPs. The technical advice will assist the Commission in preparing the final delegated legislation that will supplement the EMIR 2.2. (See Article)

Recently, representatives of EU member states agreed on a mutual position regarding the Commission's Proposal for a Directive on representative actions for the protection of the collective interests of consumers, and repealing Directive 2009/22/EC. (See Article)

We present you with a selection of key regulatory developments in the EU. (See Article)

On 1 January 2019, International Financial Reporting Standards 16 came into effect, which introduced a change in reporting requirements for operating leases (such as leaseback leases). But has this had the negative effect on the prevalence of sale and leaseback transactions that the real estate market initially predicted? Victoria Landsbert investigates… (See Article)

A source has been added El derecho de la Unión Europea y la vivienda. Análisis de experiencias nacionales e internacionales by Juli Ponce Solé (Editorial Instituto Nacional de Administración Pública (INAP), 2019)

Dangers of Cooperation or Coordination on Purchasing - Two recent cases demonstrate the competition law risks which can arise when competitors cooperate or coordinate in relation to purchasing. Competition law compliance programmes must deal with this issue and ensure that the boundary between acceptable and unacceptable behaviour is understood. (See Article)

The European Commission’s Joint Research Center (JRC) recently published a white paper entitled Anticipation of regulatory needs for nanotechnology-enabled health products. The white paper notes that at this time, “no specific regulatory framework exists for nanotechnology-enabled health products but the current regulatory practice requires additional guidance in order to fully cover the particularities of such products.” (See Article)

What is it? The EU has finalised and issued a new framework for the prudential regulation of investment firms. It will set new classification for investment firms that will in turn determine which of the new capital requirements apply to them. The framework will also set governance and remuneration requirements. As a broad overview: ..Class 1 firms will remain subject to the current CRD IV/CRR framework (as amended by CRD V/CRR II); ..Class 2 firms will become subject to the new requirements in full (including prudential requirements, remuneration and governance rules); ..Class 3 firms will be put under a less stringent ‘lighter’ regime within the new framework (eg no need to c (See Article)

The European Central Bank has published a report by the working group on euro risk-free rates on the financial accounting implications of the transition from EONIA to €STR and the introduction of €STR-based fallbacks for EURIBOR. EONIA will be phased out in favor of the Euro short-term rate (or “€STR”), which began to be published on October 2, 2019. EONIA will cease to be published entirely on January 3, 2022 and in the meantime the methodology for calculating EONIA has been redefined as €STR plus a fixed spread... (See Article)

The whistleblowing rules in Europe are about to change dramatically. The new Directive on the protection of persons who report breaches of Union law, also referred to as the “Whistleblowing Directive,” will require Member States to create rules that mandate organizations with more than 50 workers to set up whistleblowing hotlines and accept reports about violations of the EU law. (See Article)

November, in addition to marking a month for observing key events in Europe’s past that have contributed to the European project, is also a month when policymakers look to finalize next year’s priorities. Despite the far from ideal delay to December 1 for the incoming EU Commission of President Ursula von der Leyen (VDL) and the now newly vetted Commissioners taking up their posts, some policy “commitments” have been made as part of the vetting process. These build off VDL’s “priority” guidelines that were further refined in various “mission letters” sent to all Commission Vice-Presidents- and Commissioner-designates, effectively setting the 2019-2024 cycle’s priorities but also committing the incoming policymakers to deliver on-going legislative procedures, including those linked to the EU’s (agreed) budget and future legislative proposals and reviews of existing legislation. (See Article)

Ursula von der Leyen’s Commission has been confirmed by the European Parliament. President von der Leyen has entrusted Margrethe Vestager with promoting Europe’s digital economy while continuing for a rare second-term as Competition Commissioner. Concerns remain over whether Commissioner Vestager can avoid  conflicts of interest between her two portfolios. (See Article)