Committee publications
Strategic litigation and gender apartheid in Iran and Afghanistan: remarks from the IBA Human Rights Law Committee Panel (Mexico City, 2024)
At the 2024 IBA Annual Conference in Mexico City, I joined a panel on strategic litigation hosted by the IBA Human Rights Law Committee to speak about gender apartheid in Iran and Afghanistan. I was born in Iran and have been living in Canada for over 20 years. I have personally experienced the consequences of this system of repression. Each time I returned, I was detained for ‘improper’ hijab – an accusation rooted not in morality, but in a deliberate political strategy to control and intimidate. These experiences are not exceptional; they are the norm for many women under regimes that institutionalise gender-based oppression.
Released on Dec 18, 2025
IBA European Regional Forum Northern Region Retreat in Vilnius: a gathering of insight, energy and connection
In October, members of the Forum’s Northern Region convened in the heart of Vilnius, Lithuania, for a regional retreat that blended rich professional content with the warmth of reconnecting in person. Set against the backdrop of Vilnius’ vibrant Old Town and hosted with immense care by Lithuanian colleagues – Ruta Karpiciute from ELLEX Valiunas and Dziuginta Balciune from WIDEN – the retreat offered participants both inspiration and space to reflect on shared goals for the year ahead.
Released on Dec 11, 2025
The IBA Annual Conference 2025: my experience as a European Regional Forum scholar
A report of the IBA Annual Conference 2025 from the European Regional Forum.
Released on Dec 11, 2025
Deepfakes – can the AI Act protect Europe?
At the IBA Annual Conference in Toronto, experts in AI policy, synthetic media and digital forensics examined a straightforward but uncomfortable question: ‘Deepfakes – can the AI Act protect Europe?’ The short answer is: not yet, and not on its own.
Released on Dec 11, 2025
Rebuilding Ukraine – opportunities for lawyers and their clients
A thought-provoking session titled ‘Rebuilding Ukraine – opportunities for lawyers and their clients’ took place at the recent IBA Annual Conference in Toronto. Lasting over an hour, the session explored how the international legal community can play a pivotal role in shaping Ukraine’s legal system and supporting its sustainable post-war recovery.
Released on Dec 11, 2025
How to score in football’s World Cup host countries
An engaging and dynamic panel took place at this year’s Annual Conference, titled ‘How to score in football’s World Cup host countries’. The session was organised jointly by all six IBA regional for: African, Arab, Asia Pacific, European, Latin American, and North American. This produced a rare and enriching collaboration among the Association’s global divisions.
Released on Dec 11, 2025
Unlocking housing supply: regulatory and public land strategies in Spain
Over the past few years, residential asset prices in Spain have experienced a sustained upward trajectory, reaching historically unprecedented levels. This inflationary trend is primarily driven by a structural imbalance between a severely constrained housing supply and a steadily growing demand.
Released on Dec 8, 2025
The legal landscape for the use of AI in drug discovery in Indonesia, Thailand and Vietnam
Artificial intelligence (AI) is reshaping the global pharmaceutical industry through its expanding role in drug discovery. From identifying novel compounds to enhancing clinical trial processes, its influence is increasingly evident in Southeast Asian countries, where the intellectual property (IP) regime faces new challenges posed by AI-generated pharmaceutical inventions. For legal practitioners, providing sound counsel in this evolving field requires a deep understanding of the IP framework and the uncertainties that surround it in Southeast Asia.
Released on Dec 8, 2025
Ten things law firms should be doing about AI now
In September 2024 the AI & Tech Subcommittee of the IBA Law Firm Management Committee published its first ‘10 things law firms should be doing about AI now’. With the development of AI within the legal industry moving quickly, we have updated the memo. The objective remains the same: provide an overview of developments and practical steps for law firm leaders with a view to AI.
Released on Dec 5, 2025
China's regulation of artificial intelligence – progress and challenges
Artificial intelligence (AI) is developing rapidly in China, with the number of patents and the size of the market both ranking highly among countries. However, this rapid development has posed new challenges to the legal framework, ethical norms and social governance, prompting China to continuously adjust and improve the relevant regulatory system.
Released on Dec 4, 2025
The legal landscape for the provision of home respiratory care in Portugal
This article analyses the legal framework on the provision of home respiratory care in Portugal. It addresses the evolution of the applicable legal framework, the benefits of competition among providers and national coverage, with references to the contracting model for these services and its advantages.
Released on Dec 4, 2025
AI and digital health in Brazil: balancing innovation and regulation
Brazil’s digital health offering is rapidly evolving. The Brazilian National Digital Health Strategy 2020–2028 (Estratégia de Saúde Digital or ESD) and the National Health Data Network (Rede Nacional de Dados em Saúde or RNDS) lay down the foundations for interoperability, while the Brazilian Artificial Intelligence (AI) Plan 2024–2028 (Plano Brasileiro de Inteligência Artificial or PBIA) steers the health-focused AI initiatives. Despite having no AI-specific statute and the ongoing debate over Bill No. 2,338/2023, the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária or ANVISA) regulates AI-enabled software as a medical device (SaMD) according to the applicable risk-based rules, including Resolutions 657/2022, 751/2022 and 830/2023. Privacy governance, led by the National Data Protection Authority (Agência Nacional de Proteção de Dados or ANPD) pursuant to the General Personal Data Protection Law (Lei Geral de Proteção de Dados Pessoais or LGPD), shapes dataset access and model transparency. This article maps the relevant obligations, interoperability challenges and priorities for the creation of a safety- and innovation-balanced regulatory framework in Brazil.
Released on Dec 4, 2025
Beyond borders 2025: the top five considerations on the road to success in cross-border life sciences M&A
The pharmaceutical industry is entering a defining era of transformation. As the complexity of therapeutics increases, from antibody–drug conjugates to trispecific T-cell engagers, so does the need for sophisticated dealmaking strategies. At the same time, factors such as geopolitical uncertainty, artificial intelligence (AI)-driven innovation and the impending patent cliff are pushing life sciences companies to rethink where and how they invest. This article explores five key considerations that are shaping success in cross-border life sciences M&A, with examples from recent transactions that illustrate these shifting trends.
Released on Dec 4, 2025
Whistleblower protections in Brazil’s healthcare sector: legal frameworks and global comparisons
In the life sciences and healthcare industries, compliance is critical to safeguarding public health and corporate integrity. As global enforcement intensifies, Brazil has taken steps to strengthen its whistleblower protection framework, notably through the enactment of Decree No. 10,153/2019. This Decree aims to encourage the reporting of misconduct within the federal public administration, including healthcare-related fraud, by protecting the identity of whistleblowers.
Released on Dec 4, 2025
Due diligence challenges encountered during M&A transactions in the health insurance sector
This article analyses the due diligence challenges encountered during merger and acquisition transactions within Brazil’s health insurance industry, characterised by increasing consolidation and strict regulation by the National Regulatory Agency for Private Health Insurance and Plans (Agência Nacional de Saúde Suplementar or ANS) and the Administrative Council for Economic Defense (Conselho Administrativo de Defesa Econômica or CADE). It considers the legal, prudential, actuarial and antitrust dimensions of due diligence, highlighting its role as an instrument of governance, risk mitigation and solvency preservation. Based on recent cases and market practices, it is essential to conduct a thorough review of all the relevant aspects of a potential transaction to ensure that financial sustainability, transparency and regulatory value is achieved in M&A transactions.
Released on Dec 4, 2025
Simplified healthcare plans: international evidence and a regulatory agenda for Brazil
Simplified healthcare plans represent a strategic business opportunity within Brazil’s private healthcare market. By offering essential outpatient coverage at lower premiums, these plans appeal to an underserved segment of patients who fall between the Brazilian public healthcare system and traditional private healthcare plans. International models show that simplified designs can expand the consumer base, stabilise claims ratios and stimulate innovation in product structure and cost management. In Brazil, the model’s potential lies in balancing affordability with profitability through modular offerings and the integration of digital technology.
Released on Dec 4, 2025
Due diligence challenges in life sciences M&A: the need to focus on regulatory compliance, product liability and data integrity
Merger and acquisition (M&A) transactions in France’s healthcare and life sciences sectors, such as acquiring medical device manufacturers or stakes in clinical groups (La société d'exercice libéral à responsabilité limitée or SELARLs), draw investor interest, but require intense legal and regulatory scrutiny, amid overlapping national and European frameworks. A multidimensional approach to due diligence integrates these three pillars in order to guarantee secure, value-sustaining deals are reached.
Released on Dec 4, 2025
Digital therapeutics and AI-driven health apps: sanitary regulatory and IP considerations in Argentina
This article examines the legal status of digital therapeutics and artificial intelligence (AI)-driven health applications within the Argentine regulatory framework, focusing on their potential classification as a medical device or software as a medical device (SaMD) from a local law perspective, the data protection obligations that the processing of health-related information triggers and the intellectual property considerations applicable to software and AI-based health technologies.
Released on Dec 4, 2025
Xenotransplantation and the law: Mexico as a case study on regulatory barriers
This article analyses xenotransplantation from a global perspective, highlighting the relevant technological drivers, ethical debates, regulatory frameworks and clinical milestones. Additionally, this article uses Mexico’s legal framework as a practical case study, showing how existing health laws can inadvertently create barriers to interspecies organ transplantation (animal to human), even though the laws themselves do not explicitly prohibit it.
Released on Dec 4, 2025
Regulatory evolution of medicinal cannabis and the new legal framework for hemp in cosmetic and food applications in Peru
Peru’s regulatory landscape for cannabis and hemp is evolving rapidly. The country has made considerable progress in the development of marketing authorisation categories and compounding, facilitating access to medicinal cannabis. The recent enactment of Law No. 32195 introduces a legal framework for industrial hemp, paving the way for its use in cosmetics and food. This article explores the positive regulatory developments and the anticipated impact of the upcoming regulation, highlighting Peru’s alignment with international standards and its potential for industrial innovation.
Released on Dec 4, 2025
Regulatory challenges to the treatment of rare and orphan diseases
This article analyses the regulatory challenges faced in regard to the treatment of rare and orphan diseases in Peru, highlighting recent legal advances, such as the enactment of Law No. 29698, its regulatory framework and Law No. 32319. Key issues involving the new accelerated procedure for the sanitary registration of products for the treatment of rare diseases are examined, as well as challenges related to financing, research and data management. The implementation of certain mechanisms, such as the reliance model adopted by the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos, Insumos y drogas or DIGEMID), is emphasised as a strategic step towards improving patient access to high-cost treatments and strengthening regulatory efficiency.
Released on Dec 4, 2025
Environmental sustainability and ESG compliance in the life sciences industry
Sustainability laws affect businesses across the life sciences sector, from medical devices, pharmaceuticals and cosmetics to food and chemicals. In this article, we outline five key areas of regulation affecting the industry and provide some practical tips for companies to adopt as they prepare for compliance.
Released on Dec 4, 2025
Medical cannabis in Paraguay: regulatory framework and development opportunities
The use of cannabis for medicinal purposes in Paraguay is regulated by a specific legal framework that seeks to ensure both the promotion of scientific research and access to treatment for patients in need. Law No. 6007/2017 establishes the national programme for medical and scientific study and research on the medicinal use of the cannabis plant and its derivatives (Que crea El Programa Nacional para el Estudio y la Investigación Médica y Científica del uso Medicinal de la Planta de CANNABIS y sus Derivados or PROINCUMEC), which is subject to administration by the National Health Surveillance Directorate (Dirección Nacional de Vigilancia Sanitaria or DINAVISA) and the supervision of the National Anti-Drug Secretariat (Secretaría Nacional Antidrogas or SENAD).
Released on Dec 4, 2025
Digital accessibility in favour of disabled people in France: years of legislative efforts now enhanced by the transposition of Directive (EU) 2019/882 (EAA)
Digital accessibility in favour of disabled persons remains a major challenge despite 20 years of legislative efforts. In France, the 2005 Disability Act imposes obligations on the public and assimilated sector as well as certain large private companies, while Directive (EU) 2019/882, applicable since 28 June 2025 and now transposed into French law, establishes a separate regime for private actors, targeting in particular e-commerce, payment terminals and transport services. This article sheds light on the relationship between the two sets of regulation and asks: is the EAA an additional constraint or is this combination of rules a strategic lever?
Released on Dec 4, 2025
Pharmaceutical advertising in Brazil: regulatory framework, social media and associated debates
The growing influence of social media marketing has reshaped how pharmaceutical products are promoted, challenging existing regulatory models. This article examines Brazil’s legal and regulatory framework for pharmaceutical advertising, highlighting how digital platforms and influencer culture circumvent traditional rules and increase the risks of misinformation and self-medication. It explores tensions between consumer rights, freedom of expression and public health protection by analysing Brazilian law, ANVISA’s Resolution No 96/2008 and recent judicial developments such as the ADI 7,788 case. Comparative perspectives from the United States and the European Union help contextualise Brazil’s precautionary approach to regulating pharmaceutical communication in the digital era.
Released on Dec 4, 2025
Managing drug stocks: current issues in France and challenges at European level
Drug shortages are becoming increasingly frequent, due to multiple factors. At French and European levels, regulations have been strengthened and impose more obligations on pharmaceutical companies. While patient protection and treatment availability are indisputable priorities, the obligations imposed on manufacturers must remain proportionate and compatible with economic, logistical and technical realities. Indeed, the response cannot be limited to a constant tightening of obligations (and penalties) weighing on pharmaceutical companies. A more global and concerted approach is needed, particularly at European level, to reconcile the imperatives of health safety and the economic realities of the pharmaceutical sector.
Released on Dec 4, 2025
Brazilian regulatory expectations for connected medical devices
This article examines the cybersecurity and data protection requirements for connected medical devices in Brazil, integrating the Brazilian Health Regulatory Agency’s (Agência Nacional de Vigilância Sanitári or ANVISA) device safety guidance (including Guide No. 38/2020) with the General Data Protection Law’s (Lei Geral de Proteção de Dados Pessoais or LGPD) obligations when dealing with sensitive health data. The article concludes with a set of practical measures to align clinical safety, regulatory compliance and resilience during Internet of Medical Things (IoMT) and software as a medical device (SaMD) deployments.
Released on Dec 4, 2025
Natural disasters and the fragility of the right to health in Mexico
In recent weeks, heavy rains and floods affecting states in south Mexico have once again exposed the fragility of Mexico’s public health system. In the most marginalised rural communities, access to medical services is often interrupted or disappears entirely, revealing the persistent inequality that continues to characterise the country. This article reflects on the relationship between environmental vulnerability, poverty and health, and underscores the urgent need for public policies that integrate health resilience and social justice.
Released on Dec 3, 2025
Japan’s evolving AI and digital health regulations: legal developments and outlook
This article provides an overview of Japan’s evolving regulatory landscape for artificial intelligence (AI) and digital health. It highlights key developments pursuant to the Pharmaceuticals and Medical Devices Act, including initiatives such as the Digital Transformation Action Strategies in Healthcare (DASH) for software as a medical device (SaMD), as well as emerging trends in AI-driven drug discovery. The discussion also outlines Japan’s broader AI governance framework, including the AI Business Operator Guidelines and the newly enacted AI Promotion Act.
Released on Dec 3, 2025
Digital therapeutics and AI-driven health apps: regulatory and intellectual property considerations
Determining a product’s classification is arguably one of the most important steps involving its initial assessment. Whether a product is considered a medical device, an in vitro diagnostic device (IVD) or a consumer product will dictate the specific product safety and compliance legislation that applies.
Released on Dec 3, 2025