Asia

October 12, 2024, marks the 10-year anniversary of entry into force of the Nagoya Protocol on Access to Genetic Resources and Fair Benefit-Sharing from their Utilization (“ABS”). This additional treaty to the Convention on Biological Diversity (“CBD”) has now been ratified by 142 countries. Over the past decade, Nagoya Protocol has resulted in the mushrooming of more than one-hundred thirty (130+) national ABS laws around the globe. All this time the Covington life sciences team has stood by its pharmaceutical, food and biotech clients to navigate this ever-more challenging Harlequin’s costume that is the global ABS legal regime. 

In this Client Alert we share lessons learned from our 10+ years of experience on ABS in the life sciences sector.[1] As an anniversary edition, this document is a long read. For ease of navigation, we have structured it as a Q&A. 

We first recall the basics of ABS. Then we cover key questions from clients such as e.g. compliance best practices and enforcement trends. Finally, we look to challenges in the near-future, focusing on emerging ABS regimes such as the global mechanism on benefit-sharing from Digital Sequence Information (“DSI”), the genetic resource disclosure requirement when filing patents under a new World Intellectual Property Organization (“WIPO”) treaty, the new “pathogen” ABS provisions of the World Health Organization (“WHO”) Pandemic Treaty, the High Seas Treaty on marine genetic resources, and last but not least, the new corporate due diligence obligations under the EU’s Corporate Sustainability Due Diligence Directive (“CS3D”).

If you have any questions or would like a meeting concerning the material discussed in this Client Alert, please contact our partner Bart Van Vooren at bvanvooren@cov.com.

The ABC of ABS

1. What is the purpose of the Nagoya Protocol?

The Convention on Biological Diversity of 1992 recognizes the sovereignty of countries over biological resources within their jurisdiction. The CBD has three main objectives: (1) the conservation of biodiversity, (2) its sustainable use, and (3) “the fair and equitable sharing of benefits from the arising from the utilization of genetic resources.” Although there are 196 Parties to the CBD, by 2014 very few countries had implemented rules on ABS. The Nagoya Protocol was therefore negotiated as a supplemental treaty to achieve the third objective of the CBD. It does so by empowering countries to impose prior authorization (Access) and payment requirements (Benefit-Sharing) on companies that commercialize products or processes that utilize biological materials. This supposedly creates a financial resources and incentive for countries to protect biodiversity.Continue Reading The Nagoya Protocol at Its 10th Anniversary: Lessons Learned and New Challenges from ‘Access and Benefit-Sharing’

With the rapid evolution of artificial intelligence (AI) technology, the regulatory frameworks for AI in the Asia–Pacific (APAC) region continue to develop quickly. Policymakers and regulators have been prompted to consider either reviewing existing regulatory frameworks to ensure their effectiveness in addressing emerging risks brought by AI, or proposing new, AI-specific rules or regulations. Overall, there appears to be a trend across the region to promote AI uses and developments, with most jurisdictions focusing on high-level and principle-based guidance. While a few jurisdictions are considering regulations specific to AI, they are still at an early stage. Further, privacy regulators and some industry regulators, such as financial regulators, are starting to play a role in AI governance.

This blog post provides an overview of various approaches in regulating AI and managing AI-related risks in the APAC region.  

  • AI-Specific Laws and Regulations

Several jurisdictions in the region are moving toward AI-specific regulations, including the People’s Republic of China (hereinafter referred to as China), South Korea, and Taiwan.

  • China has been most active in shaping regulations specific to generative AI technologies since 2023. It has taken a multifaceted approach that combines AI-specific regulations, national standards and technical guidance to govern generative AI services and the regulatory focus has been on services that are provided to the public in China. The Interim Administrative Measures for Generative Artificial Intelligence Services represent a milestone as the first comprehensive regulation specifically addressing generative AI services (a summary of this regulation can be found in our previous post here). Several non-binding technical documents and national standards have been issued or are being drafted to further implement this regulation. Prior to the regulation that specifically addresses generative AI services, China had issued regulations for deep synthesis and algorithmic recommendations. Further, China promulgated rules on conducting an ethical review of scientific activities involving generative AI.
  • Beyond a few provisions on narrow aspects scattered in other regimes, South Korea does not presently have a comprehensive AI-specific regulatory framework. Proposed in early 2023, the draft Act on Fostering the AI Industry and Securing Trustworthy AI remains currently pending before the National Assembly. If enacted, it would set out the first comprehensive legislative framework governing the usage of AI in South Korea, generally reflecting an approach that would permit AI usage and developments subject to subsequent safeguards if and as needed. In parallel, the Personal Information Protection Commission (PIPC) has been advocating for a flexible approach to AI based on self-regulation, with support from the PIPC. Furthermore, the Korean Fair Trade Commission (KFTC) will soon start a detailed study to identify potential AI-induced risks in terms of consumer protection as well as unfair or anti-competitive practices, which might result in KFTC-supervised self-regulation of certain AI aspects through industry codes of conduct supplemented by a set of guidelines on AI, or even proposed legislation or amendments to existing consumer protection or antitrust rules. 
  • Similarly, Taiwan is drafting a basic law governing AI, i.e., the Basic Law for Development of Artificial Intelligence, which will set out fundamental principles for AI development and for the government to promote the development of AI technologies. However, it is still uncertain whether and when Taiwan will pass this draft law.
  • Non-binding AI Principles and Guidelines

Continue Reading Overview of AI Regulatory Landscape in APAC

On September 28, 2023, the Cyberspace Administration of China (“CAC”) issued draft Provisions on Standardizing and Promoting Cross-Border Data Flows (Draft for Comment) (规范和促进数据跨境流动规定（征求意见稿）) (draft “Provisions”) (Chinese version available here) for a public consultation, which will conclude on October 15, 2023. 

The draft Provisions propose…

Continue Reading China Proposes Significant Changes to Cross-Border Transfer Rules

Following our recent overview of key topics to watch in the National Defense Authorization Act (“NDAA”) for Fiscal Year (“FY”) 2024, available here, we continue our coverage with a “deep dive” into NDAA provisions related to the People’s Republic of China (“China” or “PRC”) in each of the House and Senate bills.  DoD’s focus on strengthening U.S. deterrence and competitive positioning vis-à-vis China features prominently in the 2022 National Defense Strategy (“NDS”) and in recent national security discourse.  This focus is shared by the Select Committee on Strategic Competition Between the United States and the Chinese Communist Party (“Select Committee”), led by Chairman Mike Gallagher (R-WI) and Ranking Member Raja Krishnamoorthi (D-IL). 

It is no surprise, then, that House and Senate versions of the NDAA include hundreds of provisions—leveraging all elements of national power—intended to address what the NDS brands as China’s “pacing” challenge, including many grounded in Select Committee policy recommendations.  Because the NDAA is viewed as “must-pass” legislation, it has served in past years as a vehicle through which other bills not directly related to DoD are enacted in law.  In one respect, this year is no different—the Senate version of the NDAA incorporates both the Department of State and Intelligence 2024 Authorization bills, each of which includes provisions related to China. 

To get a flavor of the approach to China in this year’s NDAA, look no further than the “Ending China’s Developing Nation Status Act” in Section 1399L of the Senate bill, which would require U.S. opposition to granting China “developing nation” status in treaties under negotiation and by international organizations of which the U.S. and China are members, such as the World Trade Organization.  Classification as a “developing nation” affords China access to preferential loans and other economic benefits intended to increase trading opportunities, notwithstanding its current status as an upper-middle income country (as determined by the World Bank), and the world’s second largest economy, trailing only the U.S.  Not to be outdone, Section 155 of the House bill contains a provision mandating expedited deployment of advanced radars to track high-altitude balloons and other potential threats to the U.S., in direct response to the incident earlier this year in which a Chinese balloon flew across the U.S. before being shot down by the Air Force.

Given these provisions, and many more (some we discuss below), this year’s NDAA strikes us as different.  It incorporates many more China-related provisions and many of these would impose greater obligations on government contractors to limit their interactions with the PRC and entities affiliated with the PRC Government.  Whether the laundry list of China-related provisions in the current NDAA survive, and in what form, will be determined by the conference process currently underway.  But these provisions have the potential to impose significant near-term burdens on contractors—requiring them to assess their obligations and make adjustments to ensure compliance.  Indeed, these provisions may be far more disruptive than requirements imposed by prior year NDAA China provisions that contractors have navigated by reassessing supply chains and increasing due diligence.  All government contractors and suppliers to government contractors with any connection to China would be well advised to monitor how the NDAA conference approaches resolution of this legislation over the coming months.Continue Reading Not to Be Outpaced: NDAA Presents Measures Addressing China

Earlier this month the Biden Administration released its long-anticipated Executive Order on Addressing United States Investments in Certain National Security Technologies and Products in Countries of Concern (“EO”), which imposes (1) prohibitions on certain outbound investments in the semiconductors and microelectronics, quantum information technologies, and artificial intelligence sectors, and (2)…

Continue Reading Covington Alert: U.S. Launches Outbound Investment Screening Targeting China with Further Developments Forthcoming

Introduction

In early 2023, two final judgments in three related intellectual property matters were made public by the Supreme People’s Court of China (the “SPC”).[1] These judgments represent a significant development in the protection and enforcement of intellectual property rights (“IPRs”) in China, with particular implications for foreign-invested enterprises. This article provides a brief review of these high-profile cases and offers recommendations for foreign companies navigating the commercial landscape in China.

The Cases: A Brief Overview

Golden-Elephant Sincerity (“GES”), a foreign-invested chemical company, holds proprietary rights to trade secrets and two patents concerning the production of melamine.[2] In April 2014, it was revealed that Shandong Hualu-Hengsheng Chemical Co., Ltd. (“SHH”) was involved in developing a melamine production line that was strikingly similar to GES’s own design. Mingda Yin, GES’s former chief engineer, was implicated in the unauthorized transfer of confidential information to SHH, raising serious legal and ethical concerns.

Subsequent investigations revealed that Mingda Yin may have provided GES’s confidential information to two additional companies responsible for the design and/or engineering of SHH’s production line, Ningbo Fareast Chemical Group Co., Ltd. and Ningbo AT&M Environmental & Chemical Engineering Design Co., Ltd.

GES, along with other plaintiffs, filed a series of civil lawsuits against the alleged infringers for patent infringement and misappropriation of trade secrets.[3] While the lower courts’ judgments were not entirely favorable to GES, the cases were then appealed to the SPC, and the SPC overruled the judgments of the lower courts and granted enhanced remedies in support of all of the plaintiffs’ requests.Continue Reading Landmark Judgments in Chinese Intellectual Property Law: Implications and Strategic Considerations for Foreign-Invested Enterprises

On April 11, 2023, the Cyberspace Administration of China (“CAC”) released draft Administrative Measures for Generative Artificial Intelligence Services (《生成式人工智能服务管理办法（征求意见稿）》) (“draft Measures”) (official Chinese version available here) for public consultation.  The deadline for submitting comments is May 10, 2023.

The draft Measures would regulate generative Artificial Intelligence (“AI”) services that are “provided to the public in mainland China.”  These requirements cover a wide range of issues that are frequently debated in relation to the governance of generative AI globally, such as data protection, non-discrimination, bias and the quality of training data.  The draft Measures also highlight issues arising from the use of generative AI that are of particular concern to the Chinese government, such as content moderation, the completion of a security assessment for new technologies, and algorithmic transparency.  The draft Measures thus reflect the Chinese government’s objective to craft its own governance model for new technologies such as generative AI.

Further, and notwithstanding the requirements introduced by the draft Measures (as described in greater detail below), the text states that the government encourages the (indigenous) development of (and international cooperation in relation to) generative AI technology, and encourages companies to adopt “secure and trustworthy software, tools, computing and data resources” to that end. 

Notably, the draft Measures do not make a distinction between generative AI services offered to individual consumers or enterprise customers, although certain requirements appear to be more directed to consumer-facing services than enterprise services.Continue Reading China Proposes Draft Measures to Regulate Generative AI

On March 28, 2023, the United States and Japan entered into a bilateral agreement, titled the Agreement Between the Government of the United States of America and the Government of Japan on Strengthening Critical Minerals Supply Chains (“U.S.-Japan Critical Minerals Agreement” or “Agreement”). 

Context and Significance of the U.S.-Japan…

Continue Reading Threading the Needle with the Narrow U.S.-Japan Critical Minerals Agreement to Expand the Availability for EV Credits of the Inflation Reduction Act

The House of Representatives formally established the new “Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party,” with a bipartisan vote of 365-65. The Select Committee, to be chaired by Rep. Mike Gallagher (R-WI), a former military intelligence officer who also serves on the…

Continue Reading Preparing for Investigations by the New House Select Committee on China

In 2022, the European Union announced the creation of Digital Partnerships with three Asian countries: Japan, South Korea and Singapore. This is in line with the EU’s Digital Compass strategy which seeks to make the European Union the most connected continent by 2030. The European Commission is expanding its connections between Europe and the rest of the world to address the digital divide and further develop a sustainable digital economy with trusted partners.

Below we set out the key points from the Digital Partnerships that the European Commission has announced with Japan, South Korea and Singapore, respectively.

EU-Japan Digital Partnership

During the EU-Japan Summit organised on May 12, 2022, the European Union and Japan concluded the EU-Japan Digital Partnership, the first digital cooperation initiative to advance economic growth and provide a safe and inclusive space to solve digital issues. This effort furthers the “Data Free Flow with Trust” agenda, aimed at facilitating safe and secure cross-border data flows.

The EU-Japan Partnership will also focus on the following areas:

  • 5G/6G technologies;
  • Ethical considerations for Artificial Intelligence (“AI”);
  • Global supply chains in the semiconductor industry;
  • Green data infrastructures and data innovation;
  • Development of digital skills for private and public sectors; and
  • Facilitation of digital trade and application of global interoperable standards.

As part of the common vision, the Digital Partnership identified a number of key action items, as follows:

  • Collaborating on the development of innovative technologies through research;
  • Implementing concrete pilot projects in cutting-edge areas such as AI and digital identity;
  • Establishing mechanisms for international collaboration and common approaches to digital transformation; and
  • Developing common principles and rules through regulatory cooperation on key technology enablers for digital trade.

All the above will reflect the highest standards of data protection and follow the objectives set out by the EU-Japan mutual adequacy arrangement. The implementation of the EU-Japan Digital Partnership will start in 2023 and the countries will review their targets and progress on an annual basis.

EU-South Korea Digital Partnership

On November 28, 2022, the European Union and the Republic of Korea launched a new Digital Partnership to boost the cooperation between the two countries in the digital field. This collaboration will mainly focus on:

  • Semiconductors;
  • Next generation mobile networks;
  • Quantum technology;
  • High Performing Computing (“HPC”);
  • Cybersecurity;
  • AI;
  • Digital platforms and standardization; and
  • Data and digital skills.

The key action items from the EU-Korea Digital Partnership include:

  • Engaging in collaborative research activities, facilitating access to, and participation in, international standardisation relating to emerging technologies in the digital sector.
  • The sharing of information on: (i) cybersecurity threats and other aspects of cybersecurity, (ii) data-related laws and systems, which build on the existing adequacy decision that the European Commission granted to Korea (and ensuring data free flow of data between Korea and the EU) and working towards identifying commonalities between their existing regulatory approaches, (iii) views on a 6G roadmap and future 6G spectrum needs, (iv) the laws and systems aimed at the development and global use of trustworthy and human-centric AI (e.g., definitions, use cases, high risk AI applications, and response measures) and coordinating positions on AI governance, (v) platform policies, and (vi) approaches to protectionist measures in the digital space.
  • The Digital Partnership will also establish a Korea-EU forum for semiconductor researchers to (i) discuss and share information on the latest technologies and trends, (ii) identify gaps and potential disruptions to the global supply chain, and (iii) explore potential opportunities for international standardisation of trusted chips and chip security.

EU-Singapore Digital Partnership

The European Union and Singapore announced on December 15, 2022 a new partnership that will focus on the digital sector and its issues. The EU-Singapore Digital Partnership will be formally signed and launched in 2023 and aims at reinforcing existing relationships between the European Union and Singapore in the digital realm to achieve sustainable economic growth. The range of digital issues the collaboration will focus on are:

  • Trade facilitation;
  • Trusted data flows and data innovation;
  • Digital trust and standards;
  • Digital skills for workers;
  • Digital transformation of businesses and public services; and
  • Emerging technologies (e.g. 5G/6G, AI and digital identities).

In contrast to the other partnerships, the EU-Singapore Digital Partnership is the first one to agree on the development and application of Digital Trade Principles (“Principles”). These Principles are designed to provide a common framework for digital strategies, which will in turn be used contribute to the ongoing OECD discussions on establishing rules regarding electronic commerce.

What are the next steps?

In announcing these Digital Partnerships, EU Commissioner, Thierry Breton mentioned that these Digital Partnerships are likely to:

  • impact recent EU proposals, such as the EU Chips Act or AI Act; and
  • help achieve interoperability between the EU and Asia, as the EU Commission and ASEAN countries continue to cooperate in the digital space.

As mentioned above, all three Digital Partnerships will be formally launched in 2023. We expect that the Digital Partnerships will be used as a strategic pathfinder for closer region-to-region digital connectivity and to develop enhanced cooperation with other ASEAN countries such as Thailand, Malaysia, among others.

If you would like to learn more about these Digital Partnerships, or how Covington could help you participate in related policy initiatives, please do not hesitate to contact us.Continue Reading EU Digital Partnerships with Asia: A New Path Towards Enhanced Digital Collaboration and Opportunities