King & Spalding (JD Supra European Union)

Um die in der von der UN verabschiedeten Agenda 2030 und dem Pariser Klimaschutzabkommen festgelegten Ziele, insbesondere den Übergang zu einer CO2-armen, nachhaltigeren, ressourceneffizienten Kreislaufwirtschaft mit dem Ziel einer nachhaltigen Entwicklung, umzusetzen, wurden diverse Gesetzesvorhaben auf europäischer Ebene ins Leben gerufen. Zur Sicherung der langfristigen Wettbewerbsfähigkeit...

Spätestens seit die Verordnung (EU) 2019/2088 („Offenlegungsverordnung“ oder „SFDR“) am 10. März 2021 in ihren ersten Teilen in Kraft getreten ist, sind sogenannte „Artikel 8-Fonds“ und „Artikel 9-Fonds“ in aller Munde. Die gesamte Fondsbranche, inklusive ihrer Verbände, versucht, im Zusammenspiel mit den europäischen und nationalen Aufsichtsbehörden, die gesetzlichen Vorgaben praxisgerecht und...

Allegations of genocide, forced labour, or widespread abuse of minorities in various countries fill the airspace daily; governments are increasingly paying heed to business practices abroad. In the EU and its member States, new national and Union measures are being discussed; human rights concerns are the subject of disputes under bilateral and regional trade agreements, and there is a push for a

EU Regulation on Artificial Intelligence - On April 21, 2021 the European Commission published its Proposal for a Regulation on Artificial Intelligence, the first ever legal framework on AI. With its Proposal the European Commission addresses the risks of AI systems and positions Europe to play a leading role in setting standard for the regulation of AI globally.

The Sustainable Finance Disclosure Regulation (SFDR) - The SFDR is part of a package of measures introduced to implement the EU action plan on sustainable finance which aims to push more capital towards sustainable activities. The SFDR introduces various mandatory disclosure-related requirements for financial market participants and financial advisors at entity, service and product level

On January 29, 2021, Canada and the European Union (the “EU”) took additional steps to establish the EU-Canada Comprehensive Economic and Trade Agreement (the “CETA”)[i] by adopting four decisions required to implement its new dispute resolution system. Pending ratification, the CETA will transform investment protection for Canadian companies and nationals investing in the EU, as well as EU...

On 19 November 2020, the European Court of Justice (“ECJ”) ruled on the French ban of cannabidiol (“CBD”) extracted from whole hemp plants in a case relating to the marketing and distribution of hemp oil containing CBD (case C 663/18)[i]. The legality of the ban and of other national restrictions on CBD and CBD products depend on whether such restrictions are adequate and proportionate to the...

On 23 September 2020, in a landmark case, Medac v Commission, the trial-level General Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan drug status of Trecondi (Treosulfan). The EU Commission had concluded that Medac did not demonstrate “significant benefit” of Trecondi over medicinal products containing...

The European Commission (Commission) has released a Staff Working Document concerning its joint evaluation of the Orphan Regulation and the Paediatric Regulation (collectively, the Regulations) (Joint Evaluation) and an executive summary thereof... The Joint Evaluation assessed the strengths and weaknesses of the Regulations, both separately and in combination with each other; explained past...

GDPR, the key piece of European privacy law, sets out strict controls on the transfer of personal data from the EU to non-EU jurisdictions and makes it unlawful to transfer personal data from the EU to a non-EU based business. A transfer of personal data also includes access to personal data stored in the EU from a non-EU country. Some jurisdictions have been excepted from the rule, as the EU...

In March, most European Union (‘EU’) countries ordered some form of lockdown and adopted many national measures to address or prevent issues raised by COVID-19. The health crisis pushed national authorities to focus on their respective populations and needs, but measures were also adopted at the European level. The European health regulators, i.e., the European Commission (‘EU Commission’),...

The unprecedented global spread of coronavirus, or COVID-19, has taken a major toll on governments and businesses in both trying to protect people and contain the outbreak. The human impact has also seen, tragically, thousands of people die so far.

The European Commission ("Commission") presented the results of the stakeholders’ consultation on its "Note on Handling of Duplicate Marketing Authorisation Applications" ("Note on Duplicates") during the Pharmaceutical Committee meeting of November 2019. The Commission envisions erecting new barriers to limit the abilities of innovator manufacturers to launch duplicate (generic or biologic)...

Manufacturers of food products need to meet the requirements of food laws and expectations of consumers, who are seeking more information about the healthfulness of food products. Many manufacturers are responding by providing additional health-related information, e.g., nutrition scores that look like traffic lights, called “traffic light labels.” But recent developments demonstrate that such...

In a statement before the G7 Summit, which was held on August 24-26, 2019, French President Emmanuel Macron vowed to block the recently negotiated trade deal between the European Union (“EU”) and Mercosur, the South American trade bloc formed by Argentina, Brazil, Paraguay, and Uruguay, unless Brazilian President Jair Bolsonaro takes action to deal with the fires now affecting substantial areas...

Blockchain continues to take on an increasingly important role in the mainstream of the global trade community. Recent developments indicate that stakeholders around the world, including governmental and non-governmental bodies, are increasingly looking for ways to integrate the technology into various international trade applications.

The UK is due to leave the European Union on March 29, 2019 (“Brexit”). Within the EEA, “passport rights” permit financial services institutions and funds authorised in any EEA Member State to conduct business cross border (whether by establishing a branch or on a purely cross border services basis) into any other EEA Member State, which currently includes the UK. Similarly, while still within...

On Tuesday, January 29, 2019, British Prime Minister Theresa May won approval from Parliament to negotiate a revised agreement for the exit of the United Kingdom (“UK”) from the European Union (“EU”). Prime Minister May intends to reopen discussions with the EU over the “backstop” provision to which the UK and the EU sides agreed as part of their November 2018 draft agreement for the UK’s orderly

In a move which has drawn fire from industry and civil-liberties groups, the European Union (“EU”) is moving forward with a bill to enable law enforcement authorities to access digital evidence held by private companies in other member states or outside the EU. On December 7, 2018, the bloc’s governing body, the European Council, voted to open negotiations with the European Parliament on the form

On November 21, 2018, the data protection authority of the German state of Baden-Württemberg (“LfDI”) imposed a fine of EUR 20,000 on a German social media company for failing to encrypt user passwords, the first fine issued under the General Data Protection Regulation (“GDPR”) in Germany. In considering the amount of the fine to be imposed on the company, the LfDI explicitly rewarded the...

On November 16, 2018, the European Data Protection Board (“EDPB”), the General Data Protection Regulation (“GDPR”) successor of the Art. 29 Data Protection Working Group, released its long-awaited Guidelines 3/2018 on the territorial scope of the GDPR (Article 3) (“Guidelines”) for public consultation. While not final, the Guidelines already address several pressing issues regarding the GDPR’s (e

The European Data Protection Authorities, assembled in the European Data Protection Board (“EDPB” or “Board”), met at their third plenary meeting held on the 26th of September. At its meeting, the Board agreed on common criteria for Data Protection Impact Assessments (“DPIA”), adopted new draft guidelines on the territorial scope of the EU’s General Data Protection Regulation (“GDPR”), and...

On October 19, 2018, senior officials from the United States government, the European Commission (the “Commission”), and European data protection authorities met in Brussels for the second annual review of the EU-U.S. Privacy Shield framework (the “Shield”). Over two days, the officials discussed such important matters as the oversight and enforcement of the Shield and the collection of personal...

In a ruling handed down on October 2, 2018, the Court of Justice of the European Union (“CJEU”) held that law enforcement agencies are entitled to access certain categories of “non-serious” personal data held by mobile phone companies and other communications providers. Notably, the court found that the right to access this type of personal data—which includes first and last names and addresses—d

A voluntary, self-regulatory European Code of Practice on Disinformation (the “Code”) was published on September 26, 2018. Under this Code, technology, media and advertising companies commit to implementing new measures to counter “fake news” (i.e. various types of false information including fabricated, manipulated and misleading content) and other forms of disinformation.

On September 5, 2018, the European Commission (“EC”) published its draft decision on whether Japan’s 2003 Act on the Protection of Personal Information (“APPI”) provides protection equivalent to the protection of personal data guaranteed by the General Data Protection Regulation (“GDPR”). The EC found that the APPI ensures an adequate level of protection for personal data transferred to...

On April 11, 2018, the European Commission presented its Proposal for a Regulation of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain (COM(2018) 179, the “Proposal”). The Proposal would amend Regulation (EC) No 178/2002, which lays down the general principles and requirements of food law, and would introduce new...

On June 9, 2018, the new Directive (EU) 2016/943 of the European Parliament and of the Council of 8 June 2016 on the protection of undisclosed know-how and business information (trade secrets) against their unlawful acquisition, use, and disclosure (the “Directive”) went into effect. The Directive harmonizes the legislation of the EU Member States against the unlawful acquisition, disclosure, and

On July 31, 2018, the Irish Supreme Court made the unprecedented decision to grant Facebook leave to appeal the Irish High Court’s referral of certain matters in an ongoing data privacy case to the European Court of Justice (“ECJ”). The Irish High Court had referred questions relating to the validity of certain data transfer channels, known as controller to processor standard contractual clauses (

On August 2, 2018, the European Insurance and Occupational Pensions Authority (“EIOPA”) published a report summarizing its findings regarding the limited market for stand-alone cyber insurance coverage in Europe, the factors that have restricted the growth of such coverage, and measures that can be taken to further develop the market. The EIOPA—an EU regulatory body overseeing the insurance...