JD Supra European Union › King & Spalding

• JD Supra European Union

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Court (“GC”) of the European Union (“EU”) annulled the decision of the European Commission (“EU Commission”) that had withdrawn the orphan drug status of Trecondi (Treosulfan).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...

• JD Supra European Union

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;...

• JD Supra European Union

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...

• JD Supra European Union

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’),...

• JD Supra European Union

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.

• JD Supra European Union

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...

• JD Supra European Union

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...

• JD Supra European Union

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...

• JD Supra European Union

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.

• JD Supra European Union

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...

• JD Supra European Union

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

• JD Supra European Union

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

• JD Supra European Union

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...

• JD Supra European Union

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

• JD Supra European Union

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...

• JD Supra European Union

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...

• JD Supra European Union

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

• JD Supra European Union

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.

• JD Supra European Union

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...

• JD Supra European Union

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...

• JD Supra European Union

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

• JD Supra European Union

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 (

• JD Supra European Union

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...

• JD Supra European Union

On July 6, 2018, the European Union and Japan successfully concluded talks on mutual recognition of data protection regimes. The EU has reached unilateral adequacy decisions with other countries, but this is the first time that a reciprocal agreement has been reached between the EU and a third country (i.e., a non-EU Member State) and will allow unhindered data transfers between the EU and Japan,

• JD Supra European Union

On July 12, 2018, the American Civil Liberties Union filed a Freedom of Information Act request seeking the release of a report by the Privacy and Civil Liberties Oversight Board (“PCLOB”) on the handling of personal information as a part of U.S. intelligence activities. The ACLU’s FOIA request follows the EU Parliament’s call on July 5, 2018 to suspend the EU-U.S. Privacy Shield based in part on

• JD Supra European Union

On May 25, 2018, at the effective date of the General Data Protection Regulation (“GDPR”), the European Data Protection Board (“EDPB”) adopted its “Guidelines 2/2018 on derogations of Article 49 under Regulation 2016/679” (“Derogation Guidelines”). Therein, the EDPB clarified that the “legal defense” derogation in Article 49(1)(e) also applies, among other things, to criminal, administrative, and

• JD Supra European Union

Gas is a key source of energy supply to Europe and plays a fundamental role in Europe’s energy supply mix. Europe is a net importer of gas, which enters in one of two ways: either as natural gas transported via pipeline or as liquefied natural gas (LNG) which is regasified in an LNG import (or regasification) terminal. This report provides an overview of the large-scale LNG import...

• JD Supra European Union

The European Data Protection Board (“EDPB”), established under the General Data Protection Regulation (“GDPR”), said in a statement that the use of so-called “cookie walls” should be prohibited under the proposed EU e-Privacy Regulation.

• JD Supra European Union

On April 23, 2018, the European Commission issued a proposal for an EU Directive on the protection of persons reporting on breaches of EU law (the “Directive”). The Directive is designed to shield persons who report breaches of EU law that they have observed in their work-related activities. Safe reporting channels will have to be set up for a wide range of EU law breaches in various industries...

• JD Supra European Union

On April 20, 2018, the European Banking Authority released two new consultation papers dealing with the criteria for “simple, transparent and standardised” (STS) securitisations, one for asset backed commercial paper (ABCP-CP) and the other for all other STS securitisations (Non-ABCP-CP). The two consultation papers elaborate on some of the provisions contained in the European Union regulation...