EU Law and Regulatory

Germany’s hospital system is reported to be of high quality but is also very expensive by international standards. Hospitals and healthcare payers such as health insurances are exposed to increasing economic constraints. One particular point of criticism is, for example, the current system of Diagnosis Related Group (DRG)-based fees.

Patient treatments are compensated based on the DRGs which effectively leads to a lump-sum payment system per diagnosis (with certain exemptions). This system has pros and cons. As a downside, it is reported to create incentives for over-treatments to generate DRG-based fees per patient.

At the same time, many hospitals in Germany are at risk of closure and insolvency due to financial challenges. The German federal states have thus asked the federal government for financial support to finance the restructuring of the hospital system and prevent hospitals from bankruptcy.

German federal and state governments have been discussing an intended hospital reform for months. Provided that no additional money flows into the healthcare system, the principle for this reform is “outpatient care before inpatient care”. The financial volume incentive shall therefore be minimised and a concentration on larger hospitals and medical institutions shall optimise or at least improve the current structures and quality of medical care in Germany. This shall also be accompanied by a reduction of the general number of hospitals in Germany.

On 10 July 2023, the key objectives of the envisaged hospital reform plans (Eckpunktepapier: Krankenhausreform) have been agreed on: (1) Ensuring security of supply (in particular public responsibility for ensuring the provision of healthcare, so-called “Daseinsvorsorge”), (2) securing and increasing the quality of treatment, and (3) reducing bureaucracy. Particularly, this is to be reflected in the following key measures:Continue Reading Germany plans significant hospital reform with broad impact on life sciences companies

In a new strategy published on July 11, the European Commission has identified Web 4.0 and virtual worlds—often also referred to as the metaverse—as having the potential to transform the ways in which EU citizens live, work and interact.  The EU’s strategy consists of ten action points addressing four themes drawn from the Digital Decade policy programme and the Commission’s Connectivity package: (1) People and Skills; (2) Business; (3) Government (i.e., public services and projects); and (4) Governance.

The European Commission’s strategy indicates that it is unlikely to propose new regulation in the short to medium-term: indeed, European Competition Commissioner Margarethe Vestager has recently warned against jumping to regulation of virtual worlds as the “first sort of safety pad.” Instead, the Commission views its framework of current and upcoming digital technology-related legislation (including the GDPR, the Digital Services Act, the Digital Markets Act and the proposed Markets in Crypto-Assets Regulation) to be applicable to Web 4.0 and virtual worlds in a “robust” and “future-oriented” manner. 

What Are Virtual Worlds and Web 4.0?

The Commission defines virtual worlds as being “persistent, immersive environments, based on technologies including 3D and extended reality (XR), which make it possible to blend physical and digital worlds in realtime, for a variety of purposes.”  It considers Web 4.0 to be the “fourth generation of the World Wide Web,” which will feature “advanced artificial and ambient intelligence, the internet of things, trusted blockchain transactions, virtual worlds and XR capabilities.”  These will enable digital and real objects to integrate and communicate with each other to “seamlessly blen[d] the physical and digital worlds.”  According to Internal Market Commissioner Thierry Breton, the EU will “connect virtual world developers with industry users, invest in the uptake and scale-up of new technologies, and give people the tools and the skills to safely and confidently use virtual worlds.”  The EU is keen to ensure that it establishes itself as a leader in Web 4.0 and virtual worlds, and that the emerging metaverse reflects EU values, principles, and fundamental rights. The strategy is the latest in a series of metaverse-related EU initiatives and announcements.Continue Reading European Commission Publishes New Strategy on Virtual Worlds

Two speeches by the EU Commission President, Ursula Von de Leyen in March and April 2023, set out the EU’s policy towards China. In late April, the UK Foreign Secretary set out the UK’s emerging strategy and on the same day earlier this month, a UK Government Committee released a report which heavily criticized the UK’s dealings with China and the German Government released its long-awaited (and much-redrafted) China Strategy. 

This blog looks at similarities between the three approaches and what conclusions we might draw about the implications.

EU China Strategy

The EU first labelled China a systemic rival in 2019.  Since then, the European Commission has promoted the idea of “de-risking” the bloc’s most sensitive economic sectors to limit their dependence on China.

In a powerful speech in March 2023 Commission President Ursula Von der Leyen set out the need for the EU to develop its China Strategy.  The new strategy was needed because of what she described as the hardening of China’s overall strategic posture, matched by human rights abuses at home and an increasingly assertive stance in Asia. She was careful to note that the EU’s position on China would depend on how China interacts with ‘Putin’s war’ and how China meets international human rights obligations.  President Von der Leyen labelled as deliberate Chinese policies of disinformation and economic and trade coercion, saying they were used to target ‘countries to ensure they comply and conform’.

The tone of President Von der Leyen’s speech was set against the EU’s assessment that a newly assertive China was moving from an era of ‘reform and opening’ to one of ‘security and control’ whose purpose was ‘a systemic change of the international order [to place] China at its centre’.  In her speech, The Commission President noted that ‘all companies in China…are…obliged … to assist state intelligence-gathering operations and to keep it secret’. President Von der Leyen concluded that Chinese focus on military, tech and economic security would increasingly trump the appeal of free markets and open trade.

However, President Von de Leyen made clear that the EU did not seek to ‘cut economic, societal, political or scientific ties’, but rather to ‘rebalance the relationship on the basis of transparency, predictability and reciprocity.’ Using language reminiscent of President Macron’s call for the EU to seek greater ‘strategic autonomy’, President Von der Leyen argued that the new relationship would require the EU’s economy and industry to be more competitive and resilient in the cyber and maritime, space and digital, defence, innovation, health, digital and clean-tech sectors. President Von der Leyen pointed to the Net-Zero Industry and the Critical Raw Materials Acts as examples of the EU’s determination to respond to Chinese domination of these critical sectors.Continue Reading China and Europe: De-Risking the Relationship

On July 10, 2023, the European Commission adopted its adequacy decision on the EU-U.S. Data Privacy Framework (“DPF”). The decision, which took effect on the day of its adoption, concludes that the United States ensures an adequate level of protection for personal data transferred from the EEA to companies certified to the DPF. This blog post summarizes the key findings of the decision, what organizations wishing to certify to the DPF need to do and the process for certifying, as well as the impact on other transfer mechanisms such as the standard contractual clauses (“SCCs”), and on transfers from the UK and Switzerland.

Background

The Commission’s adoption of the adequacy decision follows three key recent developments:

  1. the endorsement of the draft decision by a committee of EU Member State representatives;
  2. the designation by the U.S. Department of Justice of the European Union and Iceland, Liechtenstein, and Norway (which together with the EU form the EEA) as “qualifying states,” for the purposes of President Biden’s Executive Order 14086 on Enhancing Safeguards for U.S. Signals Intelligence Activities (“EO 14086”). This designation enables EU data subjects to submit complaints concerning alleged violations of U.S. law governing signals intelligence activities to the redress mechanism set forth in the Executive Order and implementing regulations (see our previous blog post here); and
  3. updates to the U.S. Intelligence Community’s policies and procedures to implement the safeguards established under EO 14086, announced by the U.S. Office of Director of National Intelligence on July 3, 2023.

The final adequacy decision, which largely corresponds to the Commission’s draft decision (see our prior blog post here), concludes “the United States … ensures a level of protection for personal data transferred from the Union to certified organisations in the United States under the EU-U.S. Data Privacy Framework that is essentially equivalent to the one guaranteed by [the GDPR]” (para. 201).

Key Findings of the Decision

In reaching the final decision, the Commission confirms a few key points:Continue Reading European Commission Adopts Adequacy Decision on the EU-U.S. Data Privacy Framework

On 10 July 2023, the European Commission (the “Commission”) adopted the Implementing Regulation (“IR”) for the European Union (“EU”) Foreign Subsidies Regulation (“FSR”). The FSR, which starts to apply today, 12 July 2023, creates a new instrument designed to prevent foreign subsidies from distorting the EU internal market (see our blog). The objective is to level the playing field within EU markets between companies subject to scrutiny under the EU State aid rules and companies receiving subsidies from non-EU Member States.

To attain this objective, the FSR empowers the Commission to assess foreign subsidies either on its own motion or after the notification of concentrations or public procurement tenders in the EU where certain thresholds are exceeded. Foreign subsidies are financial contributions (i.e. any value transfer) granted by non-EU countries, or entities whose action can be attributed to a non-EU country (i.e. foreign financial contributions or “FFC”) that confer a benefit that is not available on the market, specifically to one or to several companies or industries. Where foreign subsidies are problematic, this assessment may lead to remedies and even to the prohibition of the concentration or of the award of a public contract. Although the FSR starts to apply on 12 July 2023, allowing the Commission to investigate foreign subsidies on its own motion, the notification obligations only kick in on 12 October 2023. That means that notification may be requested for transactions signed after 12 July but not closed by 12 October and for public procurement procedures initiated after 12 July.

The purpose of the IR is to set out the rules applicable to proceedings conducted by the Commission under the FSR, including the submission of notifications.

Key things you need to know about the IR and the notification obligations:

  • The IR enacts the forms that notifying parties will have to complete and submit to the Commission in the context of concentrations and public procurement tenders.
  • The Commission must review foreign subsidies within statutory time limits that start to run as soon as the notification is complete and that may be suspended to obtain further information.
  • Detailed information must be submitted for FFCs that are considered to fall into the most distortive categories of foreign subsidies, whereas aggregate information must be provided for most other FFCs.
  • Information must be provided for FFCs provided to all group entities of the party or parties involved.
  • Companies that are likely to be involved in large concentrations or public procurements would be well advised to prepare sufficiently well in advance to avoid delays in their clearance timeline.

Continue Reading The EU Foreign Subsidies Regulation starts to apply – what you need to know about the notification obligations

On April 27, 2023, US National Security Advisor Jake Sullivan delivered a lecture at the Brookings Institution on American economic policy in which he promoted a ‘new Washington consensus’. His speech resonated loudly within EU member states and its institutions. What he said fits very well in the current debate in Brussels on economic and trade policy – a debate which divides policy makers even inside the European Commission in Brussels.

The need for a ‘new’ consensus

Jake Sullivan’s presentation, indeed, reinforces the views of those in Europe who feel there is a need for some distance from globalization, free trade and an economic system based solely on liberalism, competition rules and the law of the market. This system was often presented as ‘the Washington consensus’; this term was first coined by a British economist in 1989 to describe a world of free markets, with the United States as guarantor and relying mainly on the World Bank and the IMF. This ‘consensus’ developed in Washington during the Clinton administration and extended to the other side of the Atlantic – until the turn of the new century.

But now, times have changed: the US is no longer hegemonic; the world has fractured; western values are openly challenged by China and others in the ‘global south’ – and the Trump administration renounced major multinational treaties like TTIP and the TPP. Sullivan describes superbly the reasons why a ‘new’ consensus is needed: ‘a financial crisis that shook the middle class, a pandemic which exposed the fragility of our supply chains, a changing climate that threatens lives and livelihoods, the invasion of Ukraine by Russia which underscores the risks of overdependence’ – and, on top of that, a China which continues to subsidize the growth of its industry and ‘becoming a leader in critical technologies which will define the future’.

This diagnosis, and what Sullivan suggests, match perfectly the thinking by those in Europe who promote an EU ‘industrial policy’ – a novelty for the European Union. Clearly, liberalism and free trade retain strong supporters in European countries and in the EU Commission. Recently the EU ratified an agreement with Chile, concluded a treaty with New Zealand, and persists in completing the ratification of agreements with the Mercosur and Mexico. But even the Commission has to admit that the time of TTIP and other comprehensive trade agreements has passed and that those who want to relax state aid rules and encourage subsidies to the industry are dominating the scene.Continue Reading Europe and the ‘new Washington consensus’

On 23 June 2023, the Council of the European Union (the “Council”) adopted a new package of economic sanctions against Russia. In addition to new asset-freezing designations, this eleventh package of sanctions includes new trade, transport and financial restrictive measures.

In recent weeks the UK has implemented various amendments to its existing sanctions regimes targeting Russia and Belarus, including the expansion of the UK’s Belarus-related sanctions regime to include certain restrictions previously introduced with respect to Russia and restrictions on the provision by UK persons of certain legal services.  The UK has also amended a number of General Licenses applicable to these two sanctions regimes and introduced new General Licenses, and updated aspects of its sanctions-related guidance, as detailed below.

Summary of New EU Russia Sanctions

Asset-freezing Designations

Council Implementing Regulation (EU) 2023/1216 designates additional individuals and entities to the EU asset-freezing list. The new designations include Russian government and military officials as well as Russian IT companies and the two Russian banks, MRB Bank and CMR Bank, which operate in the non-government controlled Ukrainian territories of Donetsk, Luhansk, Kherson and Zaporizhzhia.

Council Regulation (EU) 2023/1215 broadens the listing criteria upon which specific designations can be made under EU sanctions against Russia, to include, inter alia, the significant frustration of EU sanctions as a basis for designation. The regulation also introduces new derogations, including a derogation for the winding down of a Russian joint venture co-owned with the designated individual Alexey Alexandrovits Mordashov as well as a derogation allowing the disposal of certain types of securities held with specified listed entities.Continue Reading EU and UK Adopt New Sanctions Against Russia

Late yesterday, the EU institutions reached political agreement on the European Data Act (see the European Commission’s press release here and the Council’s press release here).  The proposal for a Data Act was first tabled by the European Commission in February 2022 as a key piece of the European Strategy for Data (see our

On 31 May 2023, at the close of the fourth meeting of the US-EU Trade & Tech Council (“TTC”), Margrethe Vestager – the European Union’s Executive Vice President, responsible for competition and digital strategy – announced that the EU and US are working together to develop a voluntary AI Code of Conduct in advance of

On 11 May 2023, members of the European Parliament’s internal market (IMCO) and civil liberties (LIBE) committees agreed their final text on the EU’s proposed AI Act. After MEPs formalize their position through a plenary vote (expected this summer), the AI Act will enter the last stage of the legislative process: “trilogue” negotiations with the