EU Law and Regulatory

On 18 July 2024, Ursula von der Leyen, the current President of the European Commission (“Commission”), was reconfirmed by the European Parliament for a second term. Ahead of her reconfirmation, President von der Leyen delivered a speech before the European Parliament, accompanied by a 30-page program (the “Guidelines”) that lays down the next five-year policy agenda she proposes for the Commission. This blog outlines the key points to look out for in the “mission letters” she is expected to issue to her Commissioners-designate later this week.

A European “Christmas Tree”

The Guidelines were designed to secure a majority in the European Parliament ahead of the crucial 18 July vote. They affirm that the “priorities set out draw on […] consultations and on the common ideas discussed with the democratic forces in the European Parliament” (a reference to the cordon sanitaire – the agreed common exclusion of far-right parties from political discussions).

However, whilst the Commission has the monopoly on the right of initiative in EU law-making, the European Council (the strategic body that comprises the EU heads of state and government) defines the general political direction and priorities of the European Union. Hence, the European Council is the ultimate agenda-setter. At their 27 June 2024 meeting, the European Council agreed on a draft 2024-2029 Strategic Agenda (“Strategic Agenda”). This sets in stone the European Council’s policy priorities and invites the Commission to put these “into action during the next institutional cycle”. Thus, the Strategic Agenda acted as the basis upon which Von der Leyen prepared her Guidelines.

Other workstreams also influenced the drafting of the Guidelines. Enrico Letta’s report on the future of the EU Single Market advocated for the Commission to propose the establishment of the European Savings and Investments Union. Mario Draghi’s report on competitiveness (published on September 9, 2024) also fed into the Guidelines. Finally, the Guidelines seek to establish a sense of continuity, allowing von der Leyen’s second mandate to build on her first, notably with regards to the Green Deal: “we have achieved a lot together in the last five years, […] we must and will stay the course on all of our goals, including those set out in the European Green Deal”.Continue Reading What do European Commission President von der Leyen’s Political Guidelines Mean for the 2024-2029 Mandate?

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog post, we describe the specific new requirements for the processing of health and social data using cloud-computing. We will also discuss whether the new rules may impact medical research and other projects that utilize cloud-computing for processing health data.

1. Scope and Background of Sec. 393 SGB V

The new Section 393 SGB V (Social Security Code – Book V) has been enacted with the recent “Digital Act” (see our earlier blog on the Digital Act). The title of Section 393 SGB V is “Cloud-Use in the Healthcare System“. Hence, it aims to impose specific requirements for healthcare service providers, statutory health insurances and their contract data processors when they process health data and social data using cloud-computing services. According to the German legislator, the provision aims at enabling the secure use of cloud services as a “modern, generally widespread technology in the healthcare sector and to create minimum technical standards for the use of IT systems based on cloud-computing”.

The new requirements apply to data processing using cloud-computing irrespective of whether the cloud-computing is offered by an external vendor or utilizes a tool that the healthcare providers or health insurance has developed on their own.

The term “cloud-computing service” is defined in the law as “a digital service that enables on-demand management and comprehensive remote access to a scalable and elastic pool of shared computing resources, even if these resources are distributed across multiple locations” (Section 384 Sentence 1 No. 5 SGB V). This reflects the corresponding definition of cloud-computing in Article 6 (30) of the NIS2-Directive (EU) 2022/2555 on cybersecurity measures. Services that fall under this definition include, inter alia, Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS).Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

The European Commission’s draft guidelines on exclusionary abusive conduct by dominant firms under Article 102 TFEU (the “Draft Guidelines”) were published on 1 August 2024. They show a marked change from the 2009 Article 82 [now Article 102] Enforcement Priorities Guidance (the “Priorities Guidance”): economic concept has largely been replaced with the Commission’s interpretation of the European Courts’ caselaw.

The consultation on the Draft Guidelines is open until 31 October 2024. Practical suggestions rooted in and developing the caselaw appear more likely to influence the Commission’s final version of the Draft Guidelines than statements of economics.

Like the Priorities Guidance before it, the Draft Guidelines cover exclusionary conduct that the Commission views as concerning – conduct that benefits the dominant firm by excluding competitors from the market – and not exploitative conduct which benefits the dominant firm by exploiting its market power such as excessive pricing or the use of unfair trading conditions. Though in a departure from the Priorities Guidance, the Draft Guidelines do note overlaps between exclusionary and exploitative analysis: “the principles relevant to the assessment of dominance (section 2) and the justifications based on objective necessity and efficiencies (section 5) are also relevant for the assessment of other forms of abusive conduct, such as exploitative abuses” (paragraph 11 of the Draft Guidelines) and “the same conduct by a dominant undertaking may have both exclusionary and exploitative effects” (footnote 17 of the Draft Guidelines).

The Draft Guidelines also now cover collective dominance and not only single dominance, of which more below.

The Draft Guidelines are important because they signal not only how the Commission intends to apply Article 102 to dominant companies – arguably it is already doing so – but also how the Commission interprets the European Courts’ caselaw since the Priorities Guidance was adopted, and how the Commission wishes to influence the development of the caselaw in the future. In the period since the publication of the Priorities Guidance in 2009, the concepts set out in the Priorities Guidance have had mixed success in front of the European Courts. Some examples:

  • The Court of Justice in the Telia Sonera preliminary ruling said that there can be a margin squeeze even absent an obligation to deal (paragraph. 59), in implicit contradiction of the Priorities Guidance;
  • The General Court in Qualcomm, overturning the Commission’s decision, seemingly extends the relevance of the as efficient competitor test beyond the area of pricing abuses in the Priorities Guidance to exclusivity arrangements;
  • The Court of Justice in the Unilever Italia preliminary ruling and the Intel appeal affirming the use of the as efficient competitor test; and
  • The Court of Justice in the Post Danmark II preliminary ruling noting that less efficient competitors can sometimes constrain dominant companies (paragraph. 60).

Continue Reading From Concept to Precedent: The 2024 Draft Guidelines on Article 102

On July 18, 2024, the President of the European Commission, Ursula von der Leyen, was reconfirmed by the European Parliament for a second five-year term. As part of the process, she delivered a speech before the Parliament, complemented by a 30-page program, which outlines the Commission’s political guidelines and

Continue Reading The Future of EU Defence Policy and a Renewed Focus on Technology Security

On July 30, 2024, the European Commission announced the launch of a consultation on trustworthy general-purpose artificial intelligence (“GPAI”) models and an invitation to stakeholders to express their interest in participating in the drawing up of the first GPAI Code of Practice (the “Code”) under the newly passed EU AI Act (see our previous blog here). Once finalized, GPAI model providers will be able to voluntarily rely on the Code to demonstrate their compliance with certain obligations in the AI Act.

Consultation

The consultation provides stakeholders with the opportunity to have their say on topics that will be covered by the Code. It will also inform the AI Office’s development of the template summary of training material that GPAI model providers will be required to publish under Article 53(1)(d) of the AI Act.

The consultation covers three topics:

  1. Transparency and copyright: This relates to the documentation and policies that providers of GPAI models should have in place to comply with EU copyright law. Part D relates to the content and level of granularity expected from the template summary of training material referenced above.
  2. GPAI models with systemic risk: This relates to how the systemic risks associated with certain GPAI models should be classified, identified and assessed, mitigated, and internally governed (through policies and procedures).
  3. Reviewing and monitoring the GPAI Code of Practice: This relates to how the AI Office will encourage and facilitate the review and adaptation of the Code after its initial implementation.

Interested parties can submit their responses to the consultation via an online form by September 18, 2024. They also have the option to share additional information with the AI Office by filling out the template document featured at the end of the questionnaire.Continue Reading European Commission Launches Consultation and Call for Expression of Interest on GPAI Code of Practice

On 29 June 2024, the Net-Zero Industry Act (“NZIA”) entered into force.  The primary aim of the NZIA is to ensure that the EU has access to secure and sustainable net-zero technologies by scaling up their manufacturing capacity within the EU.

Here are the key takeaways:

  • The NZIA focuses on 19 Net-Zero Technologies (“NZTs”), including renewable fuels of non-biological origin (“RFNBOs”), solar, wind, nuclear, batteries, and carbon capture and carbon storage technologies.  The Regulation sets non-binding benchmarks for 40% local production of such technologies by 2030 and 15% global market share by 2040.  
  • To reach those benchmarks, Net-Zero Technologies Manufacturing Projects (“NZT Manufacturing Projects”) will benefit from streamlined permitting procedures.  Further, NZT Manufacturing Projects that are deemed “strategic” will benefit from expedited permitting timelines.
  • The NZIA introduces a target of achieving an annual injection capacity of at least 50 million tons of CO2 by 2030.  Oil and gas producers identified by Member States must contribute to this target, according to a proportion to be defined by the Commission for each individual producer.  Member States must adopt penalties for non-compliance.
  • National public procurement procedures for NZT Manufacturing Projects must include requirements for achieving a minimum level of environmental sustainability, to be set out in future implementing regulations.  In addition, for any given NZT Manufacturing Project, the contracting authorities and entities must consider the project’s so-called “resilience contribution”, which relates to supply chain diversification.  When the majority (or a near majority) of a specific net-zero technology (or any of its main components) originates from a third country, the contracting authority or entity must impose specific public procurement conditions to reduce dependency on that country.
  • Auctions to deploy renewable energy sources and schemes that incentivize households, companies, and consumers to purchase NZT final products must also be designed to favor bidders that contribute to increasing the sustainability and resilience of the supply of NZTs within the EU.
  • Member States may establish regulatory sandboxes, i.e., schemes enabling companies to test technologies in a controlled real-world environment under monitoring by a competent authority.

Continue Reading The EU Net-Zero Industry Act enters into force

On 18 July 2024, the current President of the European Commission (“Commission”), Ursula von der Leyen, was reconfirmed by the European Parliament for a second 5-year term. As part of her reconfirmation, President von der Leyen delivered a speech before the European Parliament, complemented by a 30-page program, which lays down the Commission’s political program for the next five years.

A key pillar of the program – “A new plan for Europe’s sustainable prosperity and competitiveness” – has the objective of combining competitiveness and prosperity with the achievement of the European Green Deal goals.

Specifically on competition policy, according to President von der Leyen, a new approach is needed to achieve this objective. This blog post projects where competition policy is likely headed in the 2024-2029 period by commenting on the most relevant paragraphs of the program.

Von der Leyen: “I believe we need a new approach to competition policy, better geared to our common goals and more supportive of companies scaling up in global markets – while always ensuring a level playing field. This should be reflected in the way we assess mergers so that innovation and resilience are fully taken into account. We will ensure competition policy keeps pace with evolving global markets and prevents market concentration from raising prices or lowering the quality of goods or services for consumers. We will look at all of our policies through a security lens.”

  • This statement reaffirms the classic principles underlying competition law, i.e., the focus on ensuring a level playing field, preventing market concentration, and ultimately avoiding a negative impact on prices/quality of goods or services.
  • However, the President’s comments recognize the impact of global dynamics and the need for EU companies to be able to respond to global pressures. In the context of Siemens/Alstom and Lufthansa/ITA, there is growing pressure from EU Member States to allow European champions and this program could signal an openness to that effect.
  • The President also calls for an increased focus on innovation and resilience in the substantive assessment of mergers. This could mean (i) that the Commission will expand its assessment of the impact of ESG (Environmental, Social, and Governance) standards and security, (ii) that the Commission would be open to a greater role of wider efficiency justifications/public interest considerations in merger control and competition law assessments, and/or (iii) that the impact on the overall economic competitiveness of the EU, and the aim of geopolitical de-risking for critical supply chains and technologies, may play an increasingly important role in the assessment of mergers.

Continue Reading The 2024-2029 Commission Political Guidelines: Where Is Competition Policy Likely Headed?

By Madelaine Harrington & Marty Hansen on July 17, 2024

On 12 July 2024, EU lawmakers published the EU Artificial Intelligence Act (“AI Act”), a first-of-its-kind regulation aiming to harmonise rules on AI models and systems across the EU. The AI Act prohibits certain AI practices, and sets out regulations on

Continue Reading EU Artificial Intelligence Act Published

Last week, on 4 July 2024, the German Parliament (Bundestag) has passed significant changes to the country’s drug pricing and reimbursement laws. Just six months after the German Federal Health Ministry (BMG) presented a first draft bill for a “Medical Research Act” (Medizinforschungsgesetz or MFG), the German Parliament has now accepted a modified version of that bill. The Medical Research Act mainly amends (1) national laws for clinical trials with drugs and medical devices, (2) rules for ATMPs (3) drug pricing and reimbursement laws (AMNOG) and (4) initiates a re-organization of the regulatory agencies and ethics committees.

In this blog, we take a closer look at the much-discussed changes in the German drug pricing and reimbursement area. We will focus on two key elements:

  • The controversial new feature of “confidential reimbursement prices”; and
  • The new link between drug pricing and local clinical trials which offers pricing incentives for companies that can show that a “relevant part”  of the clinical trials for a new medicine were conducted in Germany.

We had noted in an earlier blog that the German rules for pharmaceutical pricing and reimbursement are among the most complicated legal areas in the entire world of life sciences laws. With the now coming new laws, Germany adds some additional complexity to its system.

1. Background

The discussed changes to the German drug pricing and reimbursement laws are part of the German Government’s new National Pharma Strategy that aims to enhance Germany’s attractiveness as a place for pharmaceutical research, development, and manufacturing. The Government presented an underlying strategy paper in December 2023 and the Medical Research Act is the first legislative implementation step of that strategy. For an overview of this new National Pharma Strategy, we invite you to read our previous blog on this topic.

The Medical Research Act was first presented to stakeholders in late January 2024. For a comprehensive overview of this first draft, please see our earlier earlier blog. After an initial consultation, the Government revised the draft and initiated the legislative process at the end of May 2024. Overall, the Government has deployed an unusually fast pace and was successful with its plan to get the bill through Parliament before the summer break.Continue Reading Germany amends drug pricing and reimbursement laws with “Medical Research Act” – Drug pricing becomes intertwined with local clinical research expectations

On 31 May 2024, the European Commission (“Commission”) adopted an amendment to its Regional aid Guidelines (“RAG”), allowing EU Member States to grant higher amounts of aid to investment projects falling into the Strategic Technologies for Europe Platform’s (“STEP”) objectives in disadvantaged areas of the EU. STEP is an EU initiative designed to boost the EU’s industrial competitiveness and reinforce EU sovereignty by supporting critical and emerging strategic technologies and their respective value chains.

Key takeaways

  • In the EU, large businesses can only receive State aid from Member States for their large investment projects (“LIPs”) in production facilities if their projects take place in disadvantaged areas of the EU. The conditions to access such State support and the maximum aid amount are laid down in the RAG.
  • STEP’s objectives are to support the development and the manufacturing of clean tech, digital technologies, and bio-tech.
  • The amendment to the RAG allows Member States to grant large businesses higher amounts of aid for their LIPs where they contribute to the STEP objectives.

Regional aid

Aid to large businesses pursuing LIPs is generally considered unnecessary and highly distortive because these businesses already have access to capital and are a significant presence on the market. Such aid can, in principle, only be authorised by the Commission under strict conditions and if it supports an initial investment in new production facilities, output diversification into new products, or a fundamental change in a production process.Continue Reading The Commission amends regional aid rules to foster support for strategic technology projects