EU Law and Regulatory

On 23 May 2024, the EU’s Critical Raw Materials Act (“CRMA”) entered into force.  The Regulation’s adoption within just one year after it was first proposed in March 2023 signals the EU’s political commitment to strengthen Europe’s strategic autonomy on the supply of Strategic Raw Materials (“SRMs”) and the broader category of “Critical Raw Materials” (“CRMs”).   

Here are the key takeaways for companies:

  • The CRMA sets non-binding capacity targets within the EU for the extraction, processing, refining, and recycling of SRMs that are key to achieve the green and digital transition.
  • To reach such targets, the CRMA empowers the European Commission (“the Commission”) to recognize projects that extract, process, refine or recycle SRMs, including projects outside the EU, as Strategic Projects (“SPs”) so that they may benefit from easier access to financing, expedited permitting process, and matchmaking with off-takers.  The Commission is expected to recognize the first SPs by the end of 2024.
  • The Commission must monitor disruption risks and propose mitigation measures, if needed, to ensure a secure supply of CRMs.  To enable the Commission to do this effectively, companies may be subject to new specific obligations, such as participating in surveys, carrying out risk assessments of SRMs supply chains, mitigating possible vulnerabilities, reporting on the implementation and the financing of their SPs, labelling some products, and recycling a minimum content of permanent magnets.  
  • The Commission will also create and operate a Joint Purchasing Mechanism to aggregate the demand of interested EU off-takers consuming SRMs and seek offers from suppliers to match that aggregated demand.

Critical and Strategic Raw Materials and Capacity Targets

SRMs are indispensable raw materials for strategic sectors that facilitate transition to a greener, digital economy.  They are characterized by high forecasted demand growth and significant challenges in scaling up production in Europe to meet such demand.  Annex I to the CRMA lists 17 SRMs, including copper, gallium, lithium, manganese, and titanium metal.Continue Reading The EU Critical Raw Materials Act enters into force

In line with its previous decision-making practice (see our previous sustainability blog posts here and here), on 8 May 2024, the German Federal Cartel Office (“FCO”) declared the implementation of a new European industry standard for reusable pot plant trays compatible with competition law.

Since 2021, companies and associations from the European Green Sector

Although the final text of the EU AI Act should enter into force in the next few months, many of its obligations will only start to apply two or more years after that (for further details, see our earlier blog here). To address this gap, the Commission is encouraging industry to take early, voluntary

On January 17, 2024, the European Data Protection Board (“EDPB”) published its report on the 2023 Coordinated Enforcement Framework (“CEF”), which examines the current landscape and obstacles faced by data protection officers (“DPOs”) across the EU.  In particular, the report provides a snapshot of the findings of each supervisory authority (“SA”) on the role of

In early March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS).  For now, we only have a work-in-progress draft version of the text, but a number of interesting points can already be highlighted.  This article focusses on the obligations of data holders; for an overview of the EHDS generally, see our first post in this series.

We expect the final text of the EHDS to be adopted by the European Parliament in April 2024 and by the EU Member States shortly thereafter.

1: Health data holder

The term “health data holder” includes, among others, any natural or legal person developing products or services intended for health, developing or manufacturing wellness applications, or performing research in relation to healthcare, who:

  • in relation to personal electronic health data: in its capacity of a data controller has the right or obligation to process the health data, including for research and innovation purposes; or
  • in relation to non-personal electronic health data: has the ability to make the data available through control of the technical design of a product and related services.  These terms appear to be taken from the Data Act, but they are not defined under the EHDS.

In practice, this means that, for example, hospitals, as data controllers, are data holders of their electronic health records.  Similarly, pharmaceutical companies are data holders of clinical trial data and biobanks.  Medical device companies may be data holders of non-personal data generated by their devices, if they have access to that data and an ability to produce it.  However, medical device companies would not qualify as a data holder where they merely process personal electronic health data on behalf of a hospital.

Individual researchers and micro enterprises are not data holders, unless EU Member States decide differently for their territory.

2: Data sets covered by EHDS

The EHDS sets out a long list of covered electronic health data that should be made available for secondary use under the EHDS.  It includes, among others:

  • electronic health records;
  • human genetic data;
  • biobanks;
  • data from wellness applications;
  • clinical trial data – though according to the recitals, this only applies when the trial has ended;
  • medical device data;
  • data from registries; and
  • data from research cohorts and surveys, after the first publication of the results – a qualifier that does not seem to apply for clinical trial data.

Continue Reading EHDS Series – 2: The European Health Data Space from the Health Data Holder’s Perspective

In early March, the EU released its first-ever European Defence Industrial Strategy (EDIS), accompanied by a proposed regulation establishing the European Defence Industry Programme (EDIP). The aim is to boost defence capabilities in Europe through greater and more efficient spending. In particular, the strategy seeks to reverse recent trends, whereby 78% of defence acquisitions by EU countries since Russia’s full-scale aggression against Ukraine were made with non-EU producers, with U.S. firms accounting for 63%. It also addresses recent concerns by the defence industry over ESG constraints on obtaining private financing.

The ultimate benchmark for success, as recounted by one EU foreign minister, is whether these measures will help deter Russia and other adversaries. Nonetheless, it reflects greater operational focus of the EU on defence and security issues, and what in practice the European Commission and other EU institutions can do to bolster capabilities in a policy area that will remain the primary prerogative of EU Member States.

Plugging Defence Gaps

Since the end of the Cold War, European defence has suffered from perennial underinvestment and lack of policy support for the defence industry. Whereas Europe collectively spent on defence over half of the U.S. totals in the early 1990s, it now spends about one-third compared to the United States—arguably at a time of much greater security threats to Europe compared to America. There are simply not enough soldiers, tanks, planes, ships, missiles, guns, and ammunition in Europe, nor domestic facilities to produce the necessary weapons systems and materiel. Moreover, EU countries have procured defence products at a national level, exacerbating fragmentation within the European market. This fragmentation has led to the creation of national industrial silos and numerous defence systems that often lack interoperability.Continue Reading Mobilizing Greater Defence Capabilities in Europe: the EU’s Defence Industrial Strategy

Earlier this week, Members of the European Parliament (MEPs) cast their votes in favor of the much-anticipated AI Act. With 523 votes in favor, 46 votes against, and 49 abstentions, the vote is a culmination of an effort that began in April 2021, when the EU Commission first published its proposal for the Act.

Here’s

On February 28, the European Data Protection Board (“EDPB”) announced that EU supervisory authorities (“SAs”) will undertake a coordinated enforcement action in 2024 regarding data subjects’ right of access under the GDPR.  For context, the EDPB selects a particular topic each year to serve as the focus for pan-EU coordinated enforcement.

In 2023, regulators focused

This year’s Munich Security Conference reemphasized the need for Europe to invest in greater defense capabilities and foster a regulatory environment that is conducive to building a defense and technological industrial base. In Munich, President Ursula von der Leyen committed to appointing a European Commissioner for Defence, if she is reselected later this year by the European Council and European Parliament. And the EU is also due to publish shortly a new defense industrial strategy, mirroring in part, the first-ever U.S. National Defense Industrial Strategy (NDIS) released earlier this year by the Department of Defense.

The NDIS, in turn, recognizes the need for a strong defense industry in both the U.S. and the EU, as well as other allies and partners across the globe, in order to strengthen supply chain resilience and ensure the production and delivery of critical defense supplies. And global leaders generally see the imperative of working together over the long-term to advance integrated deterrence policies and to strengthen and modernize defense industrial base ecosystems. We will continue tracking these geopolitical trends, which are likely to persist regardless of electoral outcomes in Europe or the United States.

These developments across both sides of the Atlantic follow on a number of significant new funding streams in Europe over the past couple of years, for instance:

  • The 2021 revision of the European Defense Fund Regulation allocated €8 billion for common research and development projects, meant to be spent during the 2021-2027 multi-annual financial framework (MFF).
  • As a direct response to Ukraine’s request for assistance with the supply of 155 mm-caliber artillery rounds, the EU adopted the 2023 Act in Support of Ammunition Production (ASAP), with a €500 million fund to scale up production of ammunition and missiles.
  • Most recently, the EU adopted the 2023 European Defense Industry Reinforcement through Common Procurement Act (EDIRPA), introduced a joint procurement fund of €300 million to facilitate Member States’ collective acquisition of defense products.
  • The European Peace Facility (EPF), an off-budget instrument, with an overall financial ceiling exceeding €12 billion, is primarily destined toward procurement of military material and large-scale financing of weapon supplies to allied third countries (including €6.1 billion for Ukraine).

Continue Reading Insights from the Munich Security Conference: Towards an Expanding U.S.-EU Defense Taxonomy?

On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency, AMA shows significant promise to harmonize the regulatory landscape across the continent in order to improve access to quality, safe and efficacious medical products in Africa. Other key organizations who are working to establish and implement the vision set out for AMA include the African Union (AU), comprising of 55 member states in Africa, the African Union Development Agency (AUDA-NEPAD) and the World Health Organization (WHO). Of importance, AMA is expected to play an important role in facilitating intra-regional trade for pharmaceuticals in the context of the Africa Continental Free Trade Area (AfCFTA).

Background to AMA and medicines regulation in Africa

Africa currently has limited harmonization of medicines regulation between jurisdictions. The functionality and regulatory capacity of national medicines regulatory authorities varies significantly. For example, many national regulators lack the technical expertise to independently assess innovative marketing authorization applications and instead adopt “reliance” procedures, whereby authorization by a foreign stringent regulatory authority or registration as a WHO pre-qualified product may be a condition for approval. Pharmaceutical manufacturers seeking to conduct multinational clinical trials or launch their products across Africa can often face challenges when navigating the divergent requirements for each country (and can face additional delays during each approval process).

Multiple initiatives in the last decade have aimed to increase the harmonization of medicines regulation across Africa with varying degrees of success, such as:Continue Reading EMA announces €10 million of funding to support the establishment of the African Medicines Agency