EU Law and Regulatory

Our webinar series on the European Commission’s draft guidelines on Article 102 is now available on demand here. The series, hosted by Kevin Coates, a former European Commission head of unit and an antitrust partner in Covington’s Brussels office, is in three parts. 

In the first webinar, Massimiliano…

Continue Reading European Commission’s draft guidelines on Article 102 – webinar series

On 18 November 2024, the International Energy Agency (“IEA”) published a detailed 163-page Report titled “Recycling of Critical Minerals: Strategies to Scale Up Recycling and Urban Mining” (the “Report”). The Report emphasizes the importance of recycling in securing the supply of essential minerals – such as copper, lithium…

Continue Reading Regulatory Insights from the IEA’s New Report on Recycling Critical Raw Materials

The European Medicines Agency (EMA) has announced that it will expand its activities under its clinical data publication policy (CDP Policy, also known as Policy 0070) to cover all clinical data submitted under new marketing authorization applications (MAAs) for medicinal products as well as any applications for line extensions or new indications, or where the MAA results in a negative opinion or is otherwise withdrawn.  These expanded activities are due to apply for MAAs submitted from April 2025 onwards.

The EMA originally implemented its CDP Policy in October 2016.  The policy provides a proactive obligation on the EMA to publish clinical data submitted to the agency under any MAA submitted via the EU centralized procedure.  However, the EMA has faced challenges during implementation of the policy due to operational constraints.  The CDP Policy therefore currently only applies to the following centralized procedures:

  • applications for COVID-19 medicines; and
  • initial MAAs for new active substances that receive a positive or negative opinion from the Committee for Medicinal Products for Human Use (CHMP), or which are withdrawn.

The latest announcement from the EMA means that line extensions and applications for major clinical Type II variations (such as the extension of indications) will similarly be subject to the CDP Policy from April 2025.  However, biosimilar, hybrid and generic MAAs are still excluded from the scope of the CDP Policy.  These types of applications usually include limited clinical data, and the EMA had observed that these data sets were infrequently accessed by the public when previously made available under the CDP Policy.

What clinical data is subject to the CDP Policy?

The CDP Policy applies to the following categories of data submitted with a centralized procedure MAA:

  • the clinical overview, which provides a critical analysis of the clinical data in the submission package, including the conclusions and implications of the clinical data;
  • the clinical summary, which provides a detailed factual summarization of all the clinical information submitted;
  • the study reports for the individual clinical studies; and
  • three appendices to the clinical study reports, namely the study protocol, the sample case report form used to record information on an individual patient, and documentation of the statistical methods used to analyze the data.

Continue Reading EMA Clinical Data Publication Policy to Cover All New Marketing Authorization Applications, Line Extensions and Major Clinical Type II Variations Starting Q2 2025

EU justice
European Union Law Scales of Justice

In a precedent decision, on 13 November 2024, the EU General Court annulled significant parts of a Commission Regulation, which sought to restrict or place under scrutiny the addition of certain botanicals containing hydroxyanthracene derivatives (“HADs”) to foods.  The Court held that the Commission had exceeded its powers by seeking to regulate botanical “preparations.”  Moreover, the Commission, in relying on the scientific opinion of the European Food Safety Authority (“EFSA”), had failed to demonstrate that the relevant substances would be ingested in amounts greatly exceeding those consumed from a normal diet or otherwise represented a potential risk to consumers. 

1. Background

Regulation (EC) 1925/2006 governs the addition of vitamins and minerals and of certain other substances to food (the “Fortification Regulation”).  Article 8 permits the Commission on its own initiative, or on the basis of information provided by Member States, to prohibit, restrict or place under scrutiny “substances” and “ingredients containing a substance”, which are “added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.”

In 2016, the Commission, relying on Article 8, requested EFSA to provide a scientific opinion on the safety of HADs and preparations containing HADs.  In November 2017, EFSA adopted its scientific opinion “Safety of hydroxyanthracene derivatives for use in foods” (“the EFSA Opinion”) in which it concluded as follows:Continue Reading EU Court Overturns EU-wide Botanical Food Ban

On November 4, 2024, the European Commission (“Commission”) adopted the implementing regulation on transparency reporting under the Digital Services Act (“DSA”). The implementing regulation is intended to harmonise the format and reporting time periods of the transparency reports required by the DSA.

Transparency reporting is required under Articles 15, 24 and 42 of the DSA. Obligations vary depending on whether the reporting entity is a provider of an intermediary service, hosting service, online platform, very large online platform (“VLOP”) or very large online search engine (“VLOSE”) (collectively, “Providers”).

The implementing regulation requires Providers to use the templates set out in Annex 1 of that regulation when complying with their DSA transparency reporting obligations. Providers must complete and publish this information in accordance with the instructions set out in Annex 2.

The Templates

Annex 1 contains two templates: (1) a “Quantitative Template” consisting of eight sections and (2) a “Qualitative Template” consisting of one section (collectively, the “Templates”):

  • The Quantitative Template is to be used to provide quantitative machine-readable information on content moderation. Each of the eight sections sets out tables where Providers can input standardised information on issues such as Member State orders to act against illegal content, notices submitted under the DSA, own-initiative content moderation, and handling of complaints through their internal complaint mechanisms.
  • The Qualitative Template is to be used to provide qualitative information on content moderation. It requires Providers to input free text descriptions under a range of indicators such as “Summary of the content moderation engaged in at the providers’ own initiative” or “Safeguards applied to the use of automated means.”

Continue Reading European Commission Adopts Implementing Regulation on DSA Transparency Reporting Obligations

On October 3, 2024, the European Commission published a report evaluating the effectiveness of existing EU consumer protection laws in protecting consumers in the digital space.  More specifically, the report assesses the effectiveness of the following three consumer protection laws: (i) the Unfair Commercial Practices Directive (“UCPD”); (ii) the Consumer…

Continue Reading EU Commission Publishes Report Assessing EU Consumer Laws and Paves Way for New and Stronger EU Consumer Law for the Digital Space

What are the key take-aways of the mission letter to Teresa Ribera Rodríguez, EVP-designate responsible for EU competition policy?

On 17 September 2024, European Commission (“Commission”) President Ursula von der Leyen (“President”), announced her proposed College of Commissioners (“College”) for her second 5-year term. The Commissioners-designate still need to be confirmed by the European Parliament (“EP”).

Of particularly interest from a competition policy perspective is the President’s mission letter (“Mission Letter”) to Teresa Ribera Rodríguez, the designated Executive Vice-President (“EVP-designate”) for a “Clean, Just and Competitive Transition”. The Mission Letter sets out the priorities and action plans of the European Commission for the next 5 years.

In this blogpost, we introduce EVP-designate Ribera and the tasks which the President has set for her, specifically on competition policy. 

About EVP-designate Ribera

Like many of her colleague Commissioners, past and present, EVP-designate Riberahas held several national ministerial posts: she has been serving as Spain’s Minister for Ecological Transition and Demographic Challenge since 2018 and has had two consecutive terms as Vice-President of the Spanish Government since 2020. She has also been serving as a member of the Spanish Parliament since 2019.

A lawyer by training, EVP-designate Riberahas also held high-level private and public posts focusing on sustainable development and climate change. She served as Spain’s State Secretary for Climate Change (2008-2011) and as director of the Institute for Sustainable Development and International Relations (2014-2018) – likely suitable experience given indications in her Mission Letter that these topics will only gain in relevance, both for the Commission and its competition portfolio.Continue Reading New Commissioner, New Mission, New Policy for Competition?

Now that the EU Artificial Intelligence Act (“AI Act”) has entered into force, the EU institutions are turning their attention to the proposal for a directive on adapting non-contractual civil liability rules to artificial intelligence (the so-called “AI Liability Directive”).  Although the EU Parliament and the Council informally agreed on the text of the proposal in December 2023 (see our previous blog posts here and here), the text of the proposal is expected to change based on a complementary impact assessment published by the European Parliamentary Research Service on September 19.

Brief Overview of the AI Liability Directive

The AI Liability Directive was proposed to establish harmonised rules in fault-based claims (e.g., negligence).  These were to cover the disclosure of evidence on high-risk artificial intelligence (“AI”) systems and the burden of proof including, in certain circumstances, a rebuttable presumption of causation between the fault of the defendant (i.e., the provider or deployer of an AI system) and the output produced by the AI system or the failure of the AI system to produce an output.

Potential Changes to the AI Liability Directive

In July, news reports leaked a slightly amended version of the European Commission’s AI Liability Directive proposal to align the wording with the adopted AI Act (Council document ST 12523 2024 INIT).  The amendments reflect the difference in numbering between the proposed AI Act and the enacted version.

Over the summer, the EU Parliamentary Research Service carried out a complementary impact assessment to evaluate whether the AI Liability Directive should remain on the EU’s list of priorities.  In particular, the new assessment was to determine whether the AI Liability Directive is still needed in light of the proposal for a new Product Liability Directive (see our blog post here).Continue Reading The EU Considers Changing the EU AI Liability Directive into a Software Liability Regulation

On September 12, 2024, the European Commission announced that it will launch a public consultation on additional standard contractual clauses for international transfers of personal data to non-EU controllers and processors that are subject to the EU GDPR extra-territorially (“Additional SCCs”), something that has been promised by the European Commission…

Continue Reading EU Commission Announces New SCCs for International Transfers to Non-EU Controllers and Processors Subject to the GDPR