Committee publications
India’s clinical trials landscape: regulatory reforms and emerging global trends
India’s clinical trial ecosystem is undergoing a subtle but significant transformation, driven by targeted regulatory reforms and strategic government initiatives. This article highlights the regulatory developments that have shaped the Indian clinical trials industry, as well as the contemporary trends in the global landscape that are shaping regulatory reforms in India.
Released on May 11, 2026
AI based medical devices
On 12 July 2024, the European Union published Regulation (EU) 2024/1689 in the Official Journal of the European Union establishing harmonised rules for artificial intelligence (AI Act). It entered into force on 1 August 2024. This article examines the regulatory framework governing artificial intelli-gence (AI) in medical devices under the AI Act, focusing on its interaction with the Medical Devices Regulation (MDR). It addresses the question of how AI-based medical devices are classified, regulat-ed, and implemented within the EU and Germany. In addition, the article refers to the EU Commis-sion's proposals for a fundamental readjustment of the interaction between the AI Act and the regula-tion of medical devices.
Released on May 11, 2026
Food tradition and innovation in South America: regulatory challenges between identity and globalisation
This article analyses the regulatory challenges faced by Bolivia, Paraguay and Uruguay in balancing the preservation of traditional foods with the incorporation of food innovation. Based on the concept of Novel Foods, it examines how international regulations can both protect and limit the access of culturally rooted products to global markets. The study highlights opportunities to harmonise identity, sustainability, and regulatory development in South America.
Released on May 11, 2026
AI and mental health services
The use of artificial intelligence (AI) in mental health services raises significant legal and ethical challenges, particularly concerning eating disorders and vulnerable populations. AI applications, including chatbots and social media filtering, carry risks of promoting harmful products such as GLP-1 medications and drugs of addiction to mentally unwell individuals. Under Australian law, AI-based mental health tools are regulated by the Therapeutic Goods Act 1989, the TGA Regulations, and the Australian Consumer Law. Key concerns include transparency, bias, data protection, and the need for evidence-based clinical governance. The TGA's July 2025 report calls for urgent review and stronger regulation of digital mental health tools, emphasising the responsibility of health service providers to assess risks and ensure patient safe.
Released on May 11, 2026
Closing uncertainty in China life sciences transactions: the impact of regulation
This article explores how China’s regulatory framework is affecting cross-border life sciences transactions. It focuses on foreign investment review, data transfer rules, and human genetic resources regulation, and how they interact in practice. The article highlights their impact on deal timelines, closing conditions, and transaction structures, and discusses practical approaches to managing these challenges.
Released on May 11, 2026
Registration of Software as a Medical Device (SaMD) in a context of regulatory harmonisation
The development of software with a medical purpose has driven the need for specific regulatory frameworks to ensure its safety and performance. This article analyses the treatment of Software as a Medical Device (SaMD) in Uruguay, Paraguay, and Bolivia, considering the convergence between national regulations, regional harmonization processes, and international standards. Regulatory approaches, registration pathways, and the main technical challenges associated with medical software are examined. Likewise, common trends in validation, risk management, and cybersecurity are identified.
Released on May 11, 2026
Paraguay’s Animal Welfare law: a step forward in the legal recognition of sentient beings
Law No 7513/2025 marks a significant milestone in Paraguay’s legal landscape by formally recognising animals as sentient beings and establishing comprehensive mechanisms for their protection. The law introduces criminal and administrative penalties for acts of abuse and cruelty, creates the National Registry of Animal Abusers (RAGAN), and extends protections to domestic, wild, and captive animals. While the legislation reflects a shift toward acknowledging animal welfare as a societal and legal priority, challenges remain in enforcement and in reconciling traditional practices with modern legal standards. This article examines the legal, institutional, and sociocultural dimensions of Paraguay’s animal welfare reform, highlighting its potential to align national law with international trends in animal protection.
Released on May 11, 2026
Japan's 2025–2026 reforms of health data, AI and clinical research: an integrated legal development
Between December 2025 and April 2026, Japan progressed a coordinated set of reforms relevant to health data: amendments to the Personal Information Protection Act, the Comprehensive Reform Act for Healthcare Service Delivery, and the Digital Administration Act. These proceed under the Basic Policy on Data Utilisation Systems (Cabinet Decision of 13 June 2025), which set the direction with reference to the European Union's European Health Data Space Regulation among other comparators. In parallel, developments under the AI Promotion Act, the SaMD framework, the FY2026 reimbursement revision, and the GCP Ordinance revision on Single IRB utilisation are shaping the data systems for AI development and use. The article summarises each track, the distinction between primary and secondary use that runs through them, and the related AI regulatory developments.
Released on May 11, 2026
Digitalising health in Mexico: a starting point with monumental challenges
A milestone in the history of Mexican health policy was marked on 15 January 2026 with the publication of the decree reforming, adding, and repealing various provisions of the General Health Law (LGS) regarding digital health. This reform, driven by the federal Executive branch, seeks to modernise and integrate the health sector by formally incorporating ‘Digital Health’ as a specific chapter of the law. While this legislative advancement is born of good intentions to expand coverage, improve efficiency, and guarantee effective access to quality services for all people, operational reality reveals that the path toward a true digital transformation faces obstacles of enormous magnitude.
Released on May 11, 2026
The evolution of the protection of pharmaceutical patents in Argentina: from historical exclusion to case-by-case patentability examination
The protection of pharmaceutical inventions in Argentina has evolved from a historical exclusion of patentability, established by Patent Law No 111 (1864), toward a system aligned with international standards following the incorporation of the TRIPS Agreement and the enactment of Law No 24,481. At the administrative level, pharmaceutical patentability policy was strongly shaped by guidelines adopted in 2012 through Joint Resolution Nos 118/2012, 546/2012, and 107/2012, which introduced restrictive criteria regarding patentable subject matter in this industrial sector. These guidelines were recently repealed in 2026, restoring a case-by-case examination of patentability.
Released on May 11, 2026
Biotechnological cannabinoids and regulatory classification challenges in Argentina
In recent years, Argentina has developed a comprehensive regulatory framework for medicinal cannabis aimed at promoting scientific research, ensuring patient access and fostering the development of a domestic production and commercialisation chain. This framework has been built primarily around the cannabis plant and its derivatives, reflecting a regulatory approach centered on plant-based production. At the same time, advances in biotechnology are transforming the way active pharmaceutical ingredients (APIs) are developed and manufactured worldwide. Cannabinoids, traditionally obtained from Cannabis sativa, may also be produced through biotechnological processes, raising questions about the continued adequacy of legal frameworks that rely on the botanical origin of such substances.
Released on May 11, 2026
Insolvency and Restructuring International - April 2026
Released on May 8, 2026
Message from the ERF Co-Chairs
With 2026 well underway, the Co-Chairs would like to share the energy, ideas and purpose that underlined our recent IBA European Regional Forum Officers’ and Council Members’ Retreat in Turin and set out the drivers of our work in the year ahead.
Released on May 8, 2026
Voices from the field – Lucas Passos
This series asks the Anti-Corruption Committee’s officers the most significant anti-corruption risks and challenges that are currently affecting their region. This edition is with Lucas Passos, the Committee’s Secretary, who discusses the anti-corruption landscape in Latin America and the Caribbean, including challenges surrounding politically exposed persons and the adoption of AI driven analytics into their systems at the World Bank Group.
Released on May 5, 2026
Voices from the field - Daniel Addo Asiedu
This series asks the Anti-Corruption Committee’s officers the most significant anti-corruption risks and challenges that are currently affecting their region. This first edition starts with Daniel Addo Asiedu, the Committee’s Regional Representative for Africa, who discusses Ghana’s uneven handling of cases of politically exposed persons and the country’s shift towards an anti-corruption landscape defined by digitised public financial management.
Released on May 5, 2026
Getting to know the ERF – Jasmina Suljović
Get to know our members of the European Regional Forum, with the 2026 series starting with Jasmina Suljović. She describes her experience of being European as finding strength in togetherness and highlights how she hopes to learn from others within the ERF for the year ahead
Released on May 5, 2026
Key US employment law issues of concern to Chinese employers in 2026: a strategic update
US employment law risk has expanded well beyond traditional human resources compliance. For employers operating in the US employment issues increasingly intersect with immigration enforcement, data governance, workplace management strategy and regulatory investigations. These risks are amplified by a fragmented legal system in which federal, state and local rules overlap, and where enforcement agencies and private litigants play an increasingly active role. This article provides a focused overview of five US employment law areas which are currently of the greatest concern to employers: immigration enforcement, DEI programmes, cybersecurity and employee data protection, challenges in implementing return-to-work policies and whistleblower claims. The article highlights enforcement trends, litigation risk and governance considerations most relevant to multinational and China-based employers.
Released on May 4, 2026
Managing multinational employment law compliance in the era of constant change: disability rights reform in North Macedonia’s labour market
This article analyses a new proposed Law on Professional Rehabilitation and Support of Employment of Persons with Disabilities to be adopted in North Macedonia, placing it within the broader challenges of multinational employment law compliance. It explores the law’s objectives, mechanisms, and alignment with EU and international standards, while considering implications for multinational employers navigating diverse regulatory frameworks.
Released on May 4, 2026
Union consultation goes digital amid renewed debate over traditional principles of union recognition
Recent Italian case law decisions spanned from considering the impact of increasingly digital workplaces on trade union rights to re-examining traditional union representation and recognition principles. In two 2026 decisions the Court of Cassation clarified that digital consultation methods may satisfy statutory obligations, provided that substantive participation is preserved. Together, these rulings reflect a consistent judicial approach: procedural forms may evolve, but the core functions of representation and collective negotiation must remain intact. Running in parallel, the Constitutional Court’s October 2025 ruling on Article 19 of the Workers’ Statute reshaped the criteria for workplace union recognition by rejecting exclusive dependence on company‑level bargaining participation as the sole gateway to RSA status and grounding representation rights in objective measures of union national representativeness.
Released on May 4, 2026
Navigating intermittency: how Canada is developing a reliable, resilient and secure electricity grid
Concerns about growing demand, blackouts, conflicts and even cyberattacks have put the need to focus on building reliability, resilience and security in electricity grids at the forefront of policy. Canada’s continued focus on energy diversification has led to a growing reliance on intermittent energy resources; however, these energy sources are not always reliable. To address these issues, Canada, both federally and provincially, is beginning to explore a variety of solutions, including modernising and better connecting the national grid, as well as enhancing energy storage.
Released on May 4, 2026
Electric power grids – how to achieve reliability, resilience and security with a growing share of intermittent sources. Are smart grids and BESS the solution?
Brazil’s energy sector is undergoing a rapid transformation, driven by the increasing integration of solar and wind power. While these sources offer environmental and strategic benefits, their intermittent nature poses significant challenges for grid stability. As the National Interconnected System struggles with technical and regulatory deficiencies, technological solutions such as smart grids and battery energy storage systems (BESS) become crucial to ensure reliability, flexibility and energy security. Swift regulatory action will be essential for the integration of smart grids and BESS, and, by extension, for the success of Brazil’s energy transition.
Released on May 4, 2026
The energy storage market in Brazil and its value for the development of data centres
The intersection of data centres and battery energy storage systems presents significant opportunities for Brazil and the broader global market. As the demand for data processing and storage continues to grow, fuelled by innovations such as AI, the need for reliable and sustainable energy solutions becomes increasingly critical.
Released on May 4, 2026
Message from Co-Chairs
Welcome to the Arbitration Committee Newsletter, providing the latest updates from the committee: a message from the co-chairs, annual Arbitration Day, latest projects, members' corner and upcoming events.
Released on Apr 30, 2026
India’s new Labour Codes: recognition of trade unions
India’s new labour codes presents by far the biggest change in the country’s employment law legislative history. This article focuses on the concept of recognition of trade unions, as introduced by the law.
Released on Apr 29, 2026
The Nokia case: ‘genuine collective purpose’ and the future of enterprise-based representation
This article examines the Israeli National Labour Court’s ruling in the Nokia case, focusing on the legal definition of a ‘workers organisation’. The decision rejects recognition of an internal, enterprise-based committee, emphasising the requirement of a genuine collective purpose. The Court held that a body upholding individual employment agreements as primary cannot qualify for recognition. The article places this reasoning within broader transformations in labour markets, where hybrid models of representation are emerging. It argues that the ruling highlights an unresolved tension between traditional collective bargaining frameworks and evolving employee preferences for more flexible, individualised forms of collective representation.
Released on Apr 29, 2026
Collective proceedings in Brazil and the emerging procedural blueprints for structural proceedings and corporate civil class actions
As a civil law jurisdiction, Brazil currently has numerous proposed bills before its legislative bodies. In recent years, two pending proposals before the National Congress that could significantly change the landscape of collective proceedings have gained momentum: bill project number 2.925/2023 and bill project number 03/2025. This article summarises the main changes these proposals, as they currently stand, would introduced to the regulatory landscape of collective proceedings in Brazil.
Released on Apr 29, 2026
Canada’s class action landscape: what international counsel need to know
Canada continues to entrench itself as one of the most active and plaintiff‑friendly class action jurisdictions globally. In 2025, more than 200 proposed class actions were filed across the country, confirming both the scale and the sustained momentum of collective litigation north of the border. For international lawyers advising multinational clients, these developments underscore Canada’s growing relevance as a source of litigation risk, particularly in matters involving data, digital business models and emerging technologies. This article explores the country’s landscape, analysing increases in data privacy class actions, the continued increase in environmental litigation and the emergence of AI as a defining feature of the industry.
Released on Apr 29, 2026
Cost recovery risks in Italian class and representative actions
This article examines how Italy’s loser pays rule interacts with class actions and representative actions brought by undercapitalised consumer associations, exposing defendants to significant cost recovery risks even when they prevail based on the merits of the case. The Italian framework is also compared with other jurisdictions that rely on security for costs and calibrated reforms are suggested that aim to reconcile effective collective redress with the fair allocation of litigation expenses.
Released on Apr 29, 2026
Recent developments and pending legislation relating to representative group litigation in Singapore
This article explores the specific frameworks of Class Actions in Singapore. Examining recent cases in cryptocurrency and environmental damage, this article explores how the country is moving forward with proposed legislation that would reform the representative system for retail investors and establish a grant scheme to co-fund meritorious investor actions to address the funding gap.
Released on Apr 29, 2026
Due process in structural litigation: some areas in need of attention in Brazilian Bill 3/2025
The Brazilian Bill 3/2025, or the ‘Structural Litigation Bill’, proposes the creation of a dedicated statutory framework for structural collective litigation, which would introduce a flexible, prospective procedure that is designed to address complex systemic disputes. This article argues that structural litigation, as envisioned by the Bill, presents significant challenges to the rule of law in regard to civil procedure.
Released on Apr 29, 2026