Committee publications
Cross-border intellectual property litigation: a Latin American look with a focus on life sciences and patent enforcement
This article aims to give some advice on how to design a cross-border litigation strategy in Latin America with a focus on the life sciences industry and patent enforcement. Considering such frame, our analysis will encompass the scenario in Brazil and Mexico (the two biggest economies of the region) and Mercosur, giving hints on Latam specific issues concerning the interplay between patent protection and health regulations as well as prosecution strategies.
Released on May 12, 2026
FDA’s Departure from conventional policymaking procedures: policy by journal articles
When the new administration took office in January 2025, it introduced a nontraditional form of policymaking at the United States Food and Drug Administration: drug approval reforms announced in restricted-access journal articles. The policy changes outlined in these articles range from introducing a new regulatory approach for individualised therapies to changing the number of clinical investigations generally required for drug approval from two to one. Such policymaking via a journal article lacks many procedural safeguards. This article explores why policymaking in this manner is potentially inconsistent with US administrative law principles under the Administrative Procedure Act and with FDA’s own statutory and regulatory regime, as set forth in the Food and Drug Administration Modernization Act of 1997. We conclude that regulated industry and the public must pursue creative strategies for communicating their needs to the Agency or urge FDA to comply with its procedural obligations. Doing so will ensure that FDA’s policies better account for the interests of industry and the people the Agency serves.
Released on May 12, 2026
Left to our devices: connected care and its legal challenges
The quiet revolution in healthcare is no longer happening in the operating theatre; it is happening on our wrists, in our pockets, and in the cloud. Wearables, home monitoring kits, and AI-driven dashboards promise continuous, connected care, but they also drag hospitals and manufacturers into a thicket of regulatory, liability, and data-governance questions that traditional health law was not designed to answer.
Released on May 12, 2026
All change in the EU: impact of the new EU legislation on combination products in the UK and Switzerland
The European Union’s pharmaceutical reforms will significantly reform medicines regulation, but changes for combination products are more limited, codifying definitions and providing a framework for coordination; applicants must still comply with both the medicines and devices rules. The United Kingdom and Switzerland often align with EU rules but retain separate frameworks; greater divergence may add complexity. The UK remains broadly aligned post-Brexit, but increased divergence may create challenges for reliance pathways and coordination. Switzerland’s authorisation system remains distinct, but alignment on devices means EU device approaches may influence Swissmedic. Overall, impacts are initially procedural, though future EMA developments could drive further divergence.
Released on May 12, 2026
The Bolar exemption in European pharmaceutical law and its further development in the EU pharmaceutical package
This paper examines the evolving scope of the Bolar exemption within EU pharmaceutical law against the backdrop of the proposed Pharmaceutical Package. It highlights the current fragmentation in Member State interpretations, contrasting functional and restrictive approaches, and underscores the resulting legal uncertainty for cross-border market entry strategies. Focusing on Article 85 of the proposed directive, the analysis explores the significant expansion of permitted preparatory acts, including pricing, reimbursement, and public procurement procedures. While the reform advances harmonisation and facilitates earlier market access, it raises new questions regarding the limits of commercial use and the personal scope of application, leaving critical issues unresolved.
Released on May 12, 2026
The role of artificial intelligence in drug discovery and development
The application of artificial intelligence (AI) to pharmaceutical research represents one of the most significant transformations the sector has experienced in recent decades, with the global AI-in-pharma market projected to grow at a 40–43 per cent Compound Annual Growth Rate (CAGR) through 2030. This rapid expansion also brings significant regulatory and governance challenges, particularly with respect to the regulatory acceptability of data generated through AI based methods and the requirements governing the appropriate use of personal data for algorithm training. These issues are prompting authorities worldwide to develop principles and frameworks aimed at ensuring the trustworthy, transparent, and responsible integration of AI into medicinal product development.
Released on May 12, 2026
The Bolar exemption between harmonisation and persistent grey areas: the EU pharma package reform and the Italian perspective
This article examines the current baseline of the Bolar exemption under Article 10(6) of Directive 2001/83/EC, how it has been transposed into Italian law and its distinctive features. It also considers the substantive changes introduced by Article 85 of the new Directive under the EU Pharma Package, the unresolved ambiguities those changes generate, and finally the impact of the reform on the Italian interpretation of the Bolar exemption and on preliminary injunction proceedings before Italian courts.
Released on May 12, 2026
Preventive health and longevity: the role of reimbursement law in shaping clinical priorities in the United States
This article explores how reimbursement law shapes preventive health in the United States. While prevention is widely promoted in policy and clinical guidance, access to services depends on how they are covered and paid for. Legal frameworks, including coverage mandates and medical necessity standards, determine which preventive services are affordable and widely used. Payment models often favour procedures and short-term outcomes over long-term prevention. New technologies and efforts to address social determinants of health highlight ongoing gaps in coverage. Ultimately, reimbursement systems do more than pay for care – they influence what prevention looks like in everyday clinical practice and who is able to access it.
Released on May 12, 2026
Overview of Japanese data exclusivity system and patent linkage system
This article provides an overview of Japan’s reexamination system and patent linkage system, both of which protect the interests of brand-name drug companies. The reexamination system effectively functions as a form of data exclusivity by preventing generic entry during a specified period. The Japanese patent linkage system, operated through MHLW notifications without a statutory basis, coordinates generic drug approvals with patent rights. The article also examines recent reforms introduced at the end of 2025, including the formal inclusion of biosimilars, the clarification of patent information submission requirements, and the introduction of an expert advisor system. The practical implications of these reforms and future developments are also discussed.
Released on May 12, 2026
Clinical trials: current trends and perspectives at a global level – Argentina
This article examines current global trends and perspectives in clinical trials, with a particular focus on the increasing international harmonization of regulatory standards governing Good Clinical Practice (GCP). It also analyses a major recent regulatory update in Argentina concerning GCP for clinical pharmacology trials, which strengthens ethical safeguards and modernises the applicable framework.
Released on May 12, 2026
Data Protection and Bolar in Peru in light of the EU Pharma Package
This article examines Peru’s pharmaceutical data protection and Bolar exemption regimes in light of the European Union Pharma Package’s latest compromise texts. It argues that Peru maintains a comparatively narrow regime. In Peru, data protection is limited to new chemical entities, is not fully realised in practice, and excludes biologics, while the Bolar exemption is largely confined to activities necessary for marketing authorisation. By contrast, the EU Pharma Package adopts a broader and more differentiated model that links regulatory incentives and patent-related exceptions to public health objectives, therapeutic value and effective post-patent market entry for generics. The article concludes that Peru could benefit from a more functional and policy-oriented regulatory approach.
Released on May 11, 2026
Rethinking patentability in the age of AI and biotechnology: a Peruvian perspective
This article addresses how Peruvian patent law may respond to the growing convergence of artificial intelligence and biotechnology. It suggests that, rather than requiring an entirely new legal regime, this technological shift calls for a more careful and rigorous application of existing patentability standards under the current framework. In that context, it examines questions of human inventorship, inventive step, sufficiency of disclosure, and compliance with rules governing biodiversity and traditional knowledge. Overall, the article proposes that Peru already has the legal tools to address these challenges, provided patent examination is carried out with greater technical rigor and a more exacting approach to the limits and requirements established by law.
Released on May 11, 2026
Preventive health and longevity: regulatory enablers beyond traditional healthcare compliance
The shift toward preventive health and longevity is reshaping healthcare infrastructure, moving from reactive care to continuous, resource-intensive systems. In Mexico, while health law remains the foundation, it is insufficient to ensure operational viability. This article argues that the scalability and continuity of preventive health systems depend on three additional regulatory pillars: environmental compliance, water governance and risk management frameworks. Drawing on an international perspective, it shows that these elements are not ancillary obligations but structural enablers of infrastructure resilience, investment viability and uninterrupted operation in emerging market.
Released on May 11, 2026
Regulating artificial intelligence in healthcare in Brazil: role of the Professional Council of Medicine and challenges of a fragmented framework
This article examines CFM Resolution No 2,454/2026, which regulates the use of artificial intelligence (AI) in medical practice in Brazil. Issued by the Federal Council of Medicine (CFM), the Resolution adopts a ‘human-in-the-loop’ approach, establishing that AI must serve exclusively as a decision-support tool, with physicians retaining ultimate clinical authority. The article analyses the CFM's regulatory competence under Law No 3,268/1957, its interaction with existing frameworks, including ANVISA's medical device regulations and the Brazilian General Data Protection Law, and the structural tensions arising from Brazil's fragmented AI governance landscape. It further considers the pending Brazilian AI Bill (PL No 2,338/2023) as a pathway toward greater regulatory coherence. The authors conclude that, while the Resolution formalises well-established medical ethics principles, comprehensive coordination among regulatory authorities remains essential.
Released on May 11, 2026
Preventive health and longevity: legal perspectives shaping the future of healthcare
This article examines how the preventive health and longevity agenda is reshaping traditional legal concepts within the Uruguayan healthcare system. It argues that prevention, digital health, telemedicine and population ageing are transforming legal notions of the patient, consent, health data, care and autonomy. Uruguay provides a useful case study because it combines near-universal coverage with a solid regulatory framework on patients’ rights, data protection, electronic health records, telemedicine and the rights of older persons. The article concludes that the key challenge lies not in recognising new rights, but in adapting the healthcare system to integrate prevention, technology, autonomy, care and equity.
Released on May 11, 2026
The invisible capital market: how the pharmaceutical industry learned to raise billions without ever calling it finance
Collaboration and licence agreements function as the life sciences sector's primary financing instrument, yet remain entirely invisible to capital markets regulation and statistics. This article traces the three successive transformations by which a contractual document becomes a structured asset, a subscribable instrument, and a self-sustaining financing structure, and demonstrates that the conditions of financeability can only be secured at the time of initial drafting.
Released on May 11, 2026
A cautionary tale: navigating jurisdiction and arbitration in cross‑border life sciences disputes
The globalisation of life sciences research, development and commercialisation has given rise to increasingly complex cross‑border IP disputes, typically combining contractual and enforcement issues across multiple jurisdictions. Managing these disputes effectively depends on a well‑aligned dispute resolution framework. Misalignment between governing law, jurisdiction, arbitral seat and arbitration rules frequently creates avoidable procedural complexity, cost and enforcement risk. Drawing on recent disputes, this article highlights the impact of such inconsistencies and underscores the importance of early, coherent alignment of dispute resolution provisions in life sciences collaborations.
Released on May 11, 2026
Life sciences M&A in uncertain markets with a focus on Brazil: earnouts, CVRS, contingent milestones and IP driven valuation mechanics
Life sciences mergers and acquisitions in Brazil present distinctive valuation challenges arising from regulatory complexity, pricing controls, intellectual property uncertainty, and broader macroeconomic volatility. As the largest pharmaceutical market in Latin America, Brazil remains strategically attractive, yet structurally different from United States and European jurisdictions, requiring deal structures that can accommodate prolonged regulatory timelines and execution risk. This article examines how contingent consideration mechanisms – particularly earnouts, contingent value rights (CVRs), and milestone-based payments – have become central tools for bridging valuation gaps in Brazilian life sciences transactions. It explores how these mechanisms are increasingly aligned with Brazil-specific value drivers, including ANVISA regulatory approvals, CMED pricing ceilings, CONITEC reimbursement decisions, and patent strength before INPI. The analysis further highlights the critical role of intellectual property-driven valuation models, including risk-adjusted NPV approaches that reflect local patent prosecution and enforcement dynamics. Ultimately, the article argues that successful Brazil-related life sciences deals treat uncertainty not as a deterrent but as a variable to be actively structured, priced, and managed through sophisticated contingent consideration frameworks.
Released on May 11, 2026
Preventive health and the wellness market in Brazil: legal and regulatory perspectives
Brazil, one of the world’s most rapidly aging societies, presents a structural tension between a reactive healthcare model and growing demand for preventive health. The global wellness market expansion evidences a paradigmatic reorientation: health is increasingly conceived as a life project. This article argues that the transition toward a preventive paradigm constitutes a constitutional requirement under the 1988 Federal Constitution and an economic imperative. It examines the limitations of the fee-for-service model in supplementary health, ANS regulatory initiatives, and SUS structural challenges. It concludes that Brazilian law must convert prevention into a legally enforceable obligation, democratising active longevity across society.
Released on May 11, 2026
Peru: statistical overview of clinical trials and research centres
Peru has built a regulated framework for clinical research centered on the Peruvian Registry of Clinical Trials (REPEC), administered by the National Institute of Health (INS). As of February 2026, the registry records 263 authorised research centres and 5,088 cumulative authorised clinical trials. This article presents a statistical overview of those centres, examining their operational status, geographic distribution, and therapeutic specialisation. The data reveals a research ecosystem led by oncology, with Lima as its principal hub and identifiable opportunities for growth across regions and therapeutic areas.
Released on May 11, 2026
Clinical trials: the latest trends and developments in Australia and globally
Clinical trial regulation is being reshaped by two forces: the harmonisation of international governance standards and the integration of new technologies into trial design and conduct. This article examines both. It considers the adoption of ICH E6(R3) – the revised Good Clinical Practice guideline – across the European Union, the United Kingdom, Australia and the United States, and addresses recent procedural reforms in those jurisdictions. It then turns to the regulatory acceptance of artificial intelligence, digital twins and decentralised trial methods, before concluding with an assessment of Australia as a clinical trial destination, covering its regulatory pathways, fiscal incentives, and the legal and investment considerations relevant to foreign sponsors.
Released on May 11, 2026
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