Congressional scrutiny of the U.S. relationship with China marched forward this week as Representatives Rosa DeLauro (D-CT), Bill Pascrell (D-NJ), and Brian Fitzpatrick (R-PA) reintroduced a new and expanded version of the National Critical Capabilities Defense Act (NCCDA)—legislation to create a national security review process for “outbound” transactions by U.S. companies investing overseas.

The bill adds both breadth and specificity to legislation introduced last June.  While our colleagues have detailed the major provisions of the previous version, the new NCCDA differs in several important respects.

First, the bill expands the list of U.S. industries deemed “critical sectors” subject to the notification and review process to include “active pharmaceutical ingredients” and “automobile manufacturing,” and gives the executive branch authority to expand the list further.  The new bill, however, does not add any additional definitions for these terms, nor does it further define the critical sectors that appeared in the 2022 version, including semiconductor manufacturing and advanced packaging, large capacity batteries, critical minerals and materials, artificial intelligence, and quantum information science and technology.

Second, the bill creates a judicial review procedure for actions taken by the executive branch under the NCCDA, allowing aggrieved parties to bring suit directly in the U.S. Court of Appeals for the District of Columbia Circuit.

Finally, the legislation would increase the President’s role over outbound investment reviews by making the White House itself the lead on the new outbound investment review committee—the Committee for National Critical Capabilities.  Previous versions had placed the U.S. Trade Representative in the lead role.

Last year’s NCCDA drew broad stakeholder opposition and did not progress.  The fate of this year’s version is uncertain, but it is clear that the bill is part of a larger story on how the Congress and the Administration are grappling with economic and national security concerns related to China.  We expect a plethora of additional related bills and administration actions, including the anticipated Biden Administration executive order on outbound investment reviews and Senate Majority Leader Chuck Schumer’s (D-NY) announcement that comprehensive, bipartisan legislation addressing the U.S. relationship with China is forthcoming this year. 

Various national competition authorities (“NCAs”) are continuing to consider sustainability arguments in competition cases. However, NCAs are increasingly diverging in their approach as to whether, and to what extent, they are willing to allow sustainability considerations in the competition law framework. This blogpost highlights a few recent developments in jurisdictions on both sides of the Atlantic.

Belgian approval of an initiative in the banana sector

On 30 March 2023, the Belgian Competition Authority (“BCA”) approved a sustainability initiative concerning living wages in the banana industry. This marks the first initiative based on sustainability grounds  approved by the Belgian NCA.

The IDH Sustainable Trade Initiative, a social enterprise working with various entities towards facilitating sustainable trade in global supply chains, and five Belgian supermarkets proposed a collaboration scheme aimed at closing the gap between actual wages and living wages in the banana sector. The collaboration will consist of meetings and discussions where the companies’ internal conduct will be assessed and further developed with the aim to better support living wages for workers in the participants’ banana supply chains.

The collaboration will involve the exchange of certain data and information which the BCA did not consider anticompetitive. The participants have committed to not set mandatory or recommended minimum prices and to not communicate any changes in costs relating to their supply chains. IDH will supervise the collaboration and any data shared will be verified by an independent third party.

Similar initiatives concerning the banana sector  have been proposed in Germany, the Netherlands and the UK. The German NCA has already approved the proposed initiative. Neither the Belgian nor the German NCA considered the initiatives in question to infringe competition law. There is, however, a fine line between such agreements falling in or outside the scope of competition law, and potentially amounting to an infringement. For example, clauses which lead to non-negligible price increases for end-consumers could raise questions and potentially be considered to have anticompetitive effect. It can therefore be expected that that NCAs will periodically monitor the implementation of such initiatives.

Continue Reading Sustainability Agreements: Potential Divergence between Authorities

On April 17, 2023, the Italian Supervisory Authority (“Garante”) published its decision against a company operating digital marketing services finding several GDPR violations, including the use of so-called “dark-patterns” to obtain users’ consent.  The Garante imposed a fine of 300.000 EUR. 

We provide below a brief overview of the Garante’s key findings.

Background

The sanctioned company operated marketing campaigns on behalf of its clients, via text messages, emails and automated calls.  The company’s database of contacts was formed by data collected directly through its online portals (offering news, sweepstakes and trivia), as well as data purchased from data brokers.

Key Findings

Dark patterns.  The Garante found that, during the subscription process, the user was asked for specific consent relating to marketing purposes and sharing of data with third parties for marketing.  If the user did not select either of the checkboxes, a banner would pop-up, indicating the lack of consent, and displaying a prominent consent button.  The site also displayed a “continue without accepting” option, but this was placed at the bottom of the webpage – outside of the pop-up banner – in simple text form and smaller font size, which made it less visible than the “consent” button.  The Garante, referring to the EDPB’s guidelines (see our blogpost here), held that the use of such interfaces and graphic elements constituted “dark patterns” with the aim of pushing individuals towards providing consent.

Double opt-in.  The Garante noted that consent was not adequately documented.  While the company argued that it required a “double opt-in”, the evidence showed that a confirmation request was not consistently sent out to users.  The Garante recalled that double opt-in is not a mandatory requirement in Italy, but constitutes nonetheless an appropriate method to document consent.

Continue Reading Italian Garante Fines Digital Marketing Company Over Use of Dark Patterns

Late last week, the Committee on Oversight and Accountability published the House of Representative’s “Authorization and Oversight Plans.” The massive 241-page report is required by the House rules, and the Oversight Committee’s report collects the individual oversight plans that each standing committee of the House is required to create at the start of a new Congress. The report is the most comprehensive collection of the committees’ plans for investigations in the coming Congress.

This year’s report reflects a significant shift in priorities, reflecting the change in control of the House to the Republicans. For example, the Oversight Plan speaks to expected oversight of the Administration’s alleged “collusion” with “Big Tech,” the “politicization” of the federal government, China’s interactions with the American economy and national security, and the federal government’s response to the COVID-19 pandemic and ongoing prevention efforts. A repeated priority throughout the plans is seeking out and minimizing instances of “waste, fraud, and abuse” in government programs, which includes scrutinizing the recipients and use of government funds.

The plans of the four most active oversight committees—Oversight and Accountability, Judiciary, Energy and Commerce, and Financial Services—stand out in particular for their focus on the private sector and the way companies interact with the federal government. Other committees, including the Foreign Affairs Committee, have outlined ambitious oversight agendas as well. Of note, the Foreign Affairs Committee has added a Subcommittee on Oversight and Accountability “to undertake more complex oversight and investigative activities,” including on issues related to China, the conflict in Ukraine, the United States’ withdrawal from Afghanistan, and the origins of the pandemic. The Oversight Plan does not include the oversight objectives of the newly created House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party, which we explored in a separate alert.

The following summarizes key portions of the Oversight Plan with implications for the private sector and other individuals and entities that routinely interface with government:

Continue Reading Newly Published “Oversight Plan” Outlines the House’s Investigative Priorities

2022 and 2023 may be remembered as pivotal years for efforts against so-called “greenwashing.”  In this article, we look at some recent developments in the regulation of “green claims” in the UK, the US, and the EU that corporates should be aware of.  We provide a broad summary and comparison snapshot of the UK, US and EU regimes to help companies navigate these rules.  Now is a critical time for companies to get up to speed: authorities in all three jurisdictions are focusing more and more intently on this issue; company reputations will increasingly rise and fall with the strength of their green claims, and national regulators are set to get new powers (including the power to levy significant fines) to tackle companies found in breach.

I.  Summary of recent developments: What’s new in greenwashing?

In January 2022, the UK’s Competition & Markets Authority (“CMA”) launched a sector‑by‑sector review of misleading environmental claims.  The CMA started with the fashion sector, and called out a number of high‑profile, fast‑fashion companies for their practices.  Twelve months later, the CMA announced that it was expanding the investigation to greenwashing around “household essentials”, including food, drink, toiletries and cleaning products.  The CMA’s review is the first concerted application of the CMA’s new Green Claims Code, published in September 2021, which gives guidance for any business (wherever based) making environmental claims in the UK.

Meanwhile, in December 2022, the US Federal Trade Commission’s (“FTC”) launched a review of the “Guides for the Use of Environmental Claims” (“Green Guides”), which was last updated in 2012.  The initial comment period closed on April 24, 2023.  The FTC plans to update the Green Guides to reflect developments in consumers’ perception of environmental marketing claims.  As a part of its ongoing review, the FTC also announced a workshop to examine recyclable claims.  The workshop is scheduled for May 23, 2023 and the public can submit comments on the subject of recyclable claims through June 13, 2023.  For more detail on the review, please see our dedicated blog post, here.

Finally, the EU has proposed two Directives to modernize and harmonize the rules on green claims across the bloc (together, the “EU Green Claims Proposals”).  Currently, EU law does not specifically regulate environmental claims.  Instead, environmental claims are subject only to general consumer protection and advertising rules (set out in Directive 2005/29 on Unfair Business-to-Consumer Practices and Directive 2006/114 on Comparative Advertising).  Admittedly, the EU has published guidance on interpreting and applying the general rules in the context of green claims (see the guidance here, and see our previous blog post discussing the guidance here).  However, in practice, EU Member States approach interpretation and enforcement in a variety of different ways.  On March 3, 2022, the European Commission published a Proposal for a Directive Empowering Consumers for the Green Transition, also known as the “Greenwashing Directive.”  The Greenwashing Directive amends the EU’s existing consumer protection rules, and bans a number of general green claims, such as “climate neutral” or “eco-friendly.”  It also imposes some rules on the use of non-environmental sustainability claims or “social impact” claims, such as “locally produced” or “fair labour.”  One year later, on March 22, 2023, the European Commission presented a Proposal for a Directive on Green Claims (“Green Claims Directive”), which we discussed here.  The Green Claims Directive proposes a new and strict framework, applicable to all companies operating in the EU/EEA, to harmonize the rules on the substantiation of voluntary green claims. 

Below, we outline the key aspects of the different legislative frameworks.

Continue Reading The Green Claims Global Drive: Developments in the UK, US and EU

Following the COVID-19 pandemic and the relatively slow approval of vaccines in the EU versus other key jurisdictions, as part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023, the European Commission has proposed to introduce temporary emergency marketing authorizations (“TEMAs”) for use when there is a “public health emergency.”  The TEMA will be an “agile, fast and streamlined” process to allow products to be developed and made available as soon as possible in emergency situations.  However, it remains to be seen whether in practice the TEMA process will provide a faster procedure than existing routes for early and expedited approval of medicinal products, such as conditional marketing authorizations (“CMAs”) or Member State procedures for temporary approval.

Reason to Introduce the TEMA

The EU took a coordinated approach to approval and procurement of vaccines during the COVID-19 pandemic.  In the EU, COVID-19 vaccines were approved using the CMA procedure combined with a rolling expedited review.  According to the European Medicines Agency (“EMA”), CMAs were the “the most appropriate tool to grant access to COVID-19 vaccines to all EU citizens at the same time and to underpin mass vaccination campaigns.”  Vaccines approved with a CMA included Comirnaty, Nuvaxovid and Spikevax (amongst others).

However, the approval of COVID-19 vaccines in the EU was slower than in other jurisdictions.  For example, the UK MHRA granted Comirnaty a temporary authorization on December 2, 2020.  The US FDA gave the vaccine an Emergency Use Authorization on December 11, 2020.  Whereas, the Commission did not grant a CMA for the vaccine until December 21, 2020.

Continue Reading EU Pharma Legislation Review Series: Temporary Emergency Marketing Authorizations

As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“theProposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages.  In particular, there are new obligations for Marketing Authorization Holders (“MAH”) and competent authorities are given more power to better monitor and control the availability of medicines on the market.

As we have discussed previously, these measures aim to tackle the broader problem of security and robustness of pharmaceutical supply chains, which became especially prominent during the COVID-19 pandemic.  In this blog, we briefly explore some of the changes introduced by the Proposal.

Preventing Supply Disruptions and Shortages

Critical Medicinal Products

The Proposal expands the monitoring of “critical medicinal products” beyond emergency situations.  Now, medicinal products “for which insufficient supply results in serious harm or risk of serious harm to patients” will be included in the “Union list of critical medicinal products” (“Union list”), and the Commission will have the power to implement measures such as stockpiling of active pharmaceutical ingredients or finished dosage forms.  

Continue Reading EU Pharma Legislation Review Series: Supply Security and Shortages Control

On April 25, 2023, four federal agencies — the Department of Justice (“DOJ”), Federal Trade Commission (“FTC”), Consumer Financial Protection Bureau (“CFPB”), and Equal Employment Opportunity Commission (“EEOC”) — released a joint statement on the agencies’ efforts to address discrimination and bias in automated systems. 

The statement applies to “automated systems,” which are broadly defined “to mean software and algorithmic processes” beyond AI.  Although the statement notes the significant benefits that can flow from the use of automated systems, it also cautions against unlawful discrimination that may result from that use. 

The statement starts by summarizing the existing legal authorities that apply to automated systems and each agency’s guidance and statements related to AI.  Helpfully, the statement serves to aggregate links to key AI-related guidance documents from each agency, providing a one-stop-shop for important AI-related publications for all four entities.  For example, the statement summarizes the EEOC’s remit in enforcing federal laws that make it unlawful to discriminate against an applicant or employee and the EEOC’s enforcement activities related to AI, and includes a link to a technical assistance document.  Similarly, the report outlines the FTC’s reports and guidance on AI, and includes multiple links to FTC AI-related documents.

After providing an overview of each agency’s position and links to key documents, the statement then summarizes the following sources of potential discrimination and bias, which could indicate the regulatory and enforcement priorities of these agencies.

  • Data and Datasets:  The statement notes that outcomes generated by automated systems can be skewed by unrepresentative or imbalanced data sets.  The statement says that flawed data sets, along with correlation between data and protected classes, can lead to discriminatory outcomes.
  • Model Opacity and Access:  The statement observes that some automated systems are “black boxes,” meaning that the internal workings of automated systems are not always transparent to people, and thus difficult to oversee.
  • Design and Use:  The statement also notes that flawed assumptions about users may play a role in unfair or biased outcomes.

We will continue to monitor these and related developments across our blogs.

Continue Reading <em>DOJ, FTC, CFPB, and EEOC Statement on Discrimination and AI</em>

Those in the business of fast‑moving consumer goods (“FMCGs”) are likely aware of the plethora of environmental and product stewardship regulations applicable to the FMCG sector.  These laws are set to increase and expand in application.  What FMCG companies also need to get to grips with are a range of broader (and also fast‑moving!) environmental, social and governance (“ESG”) developments and consequent risks and opportunities.  Companies need to understand how the new world of ESG impacts their supply chains, key ingredients and components, consumer choice and confidence, competitive advantage, market accessibility, and marketing. 

Designed as a ‘primer’ for FMCG companies, in this piece, we cover a range of key trends in the emerging UK and EU ESG legal landscape as relevant for the FMCG sector, from farmers to Food Business Operators (“FBOs”) and from manufacturers to retailers.  We also discuss some key legal and reputational risks; as well as pointers to help companies decipher and prepare for the ESG storm.

We focus on the UK and the EU (first movers on many ESG issues), but the landscape in other jurisdictions (including, for example, the US) is also evolving and becoming more complex.

Key ESG Issues for FMCGs

We think there are four categories of key ESG developments for FMCGs to watch: (I) corporate reporting and disclosure regimes; (II) green/sustainability claims and labelling; (III) supply chain obligations; and (IV) product packaging and presentation.

Many emerging ESG frameworks cut across sectors.  This may be efficient for regulators, but can make identifying sector-specific risks and opportunities more challenging.  We have sought to do that below.

Continue Reading Green Groceries: Key ESG Issues for the FMCG Industry (including FBOs)

The relationship between the UK and the Republic of Ireland (ROI) came into sharp focus recently, as US President Joe Biden visited ROI.  Biden’s visit coincided with the 25th anniversary of the Belfast (Good Friday) Agreement 1998 (GFA) which brought an end to 30 years of Troubles in Northern Ireland (NI).  The UK government will have welcomed the fact that President Biden described the Windsor Framework (WF) as one of two pillars (along with the GFA) which are key to future peace and prosperity in NI.  The WF is also fundamental to the recent improvement of the tripartite UK-EU-ROI relationship.

The Northern Ireland Protocol (NIP) was part of the UK’s withdrawal from the EU and sought to square the circle of respecting the GFA, whilst maintaining NI’s place in the UK Single Market. But the Unionist community in NI felt the NIP left NI being treated differently from the rest of the UK – a feeling which led to the 2022 suspension of the Stormont Assembly. The negotiation of the WF demonstrated a new and welcome willingness of the UK and the EU to negotiate mutually acceptable solutions to some of the problems created by Brexit (even if the WF has not (so far) achieved one of its objectives of re‑starting power-sharing at Stormont).

What has Changed under the WF?

The WF addresses a number of the difficulties with the NIP — including arrangements for medicines, cross‑border transport of plants and pets, and the power of the NI Government to raise objections to EU legislation that applies in NI (the “Stormont Brake”).  The WF also creates a “Green Lane” (for agri‑foods being traded only into NI) and a “Red Lane” (for agri‑food products ‘at risk’ of leaving the UK’s Single Market and being traded into the EU’s Single Market).  Green Lane goods will be required to carry  new labelling stating ‘not for sale in the EU’ and, in comparison with the checks on such goods required under the NIP, Green Lane goods will be subject to reduced customs checks and procedures.

Continue Reading The Implications of the Windsor Framework