Publications for Healthcare and Life Sciences Law Committee
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
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
Cybersecurity and the life sciences sector: the NIS2 Directive
The European Union’s Revised Network and Information Security Directive, Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148, otherwise known as the NIS2 Directive, forms part of a package of measures to improve the cybersecurity of critical organisations.
Released on Dec 3, 2025
Traditional food and food innovation in South America: the regulatory challenges related to identity and globalisation
This article analyses the regulatory challenges faced by Bolivia and Uruguay in regard to balancing the need to preserve traditional foods alongside the need to incorporate food innovation. Based on the concept of novel foods, the article examines how international regulations can both protect and limit access to culturally rooted products within global markets. The opportunities to harmonise food-related identities, sustainability and regulatory developments in South America within this context are also explored.
Released on Dec 3, 2025
Regulatory compliance and trends in life sciences in Paraguay
The life sciences sector in Paraguay, which includes pharmaceuticals, cosmetics, medical devices and other regulated industries, is subject to an increasingly demanding regulatory environment. Competent authorities are strengthening control mechanisms, positioning them as strategic tools to ensure regulatory compliance. In this context, private sector regulatory teams play a key role in managing complaints, anticipating risks and aligning operations with the legal requirements, while integrating robust compliance practices and internal policies. This article assesses the relevant regulatory trends, reporting mechanisms and the evolution of the in-house regulatory team as a strategic actor within the life sciences environment.
Released on Dec 3, 2025
Medical and therapeutic cannabis in Uruguay
Uruguay has strengthened its position as a regional leader in the regulation, research and therapeutic use of cannabis. Through the National Programme for Access to Medicinal and Therapeutic Cannabis, the Ministry of Public Health (MSP) promotes an integrated health approach, professional training and scientific research. Recent initiatives include educational programmes for healthcare professionals, the creation of the Cannabis Research Fund, and the establishment of the Institute for Regulation and Control of Cannabis (IRCCA) Honorary National Council. These actions reflect Uruguay’s commitment to evidence-based policy, innovation and safe patient access to cannabinoid-based treatments within a regulated public health framework.
Released on Dec 3, 2025
Digital therapeutics and AI-driven health apps: regulatory and IP considerations from a Colombian legal perspective
This article examines Colombia’s framework for digital therapeutics and artificial intelligence (AI) driven health apps, linking medical record obligations and data protection requirements to Software as a Medical Device (SaMD) workflows. It outlines the legal status of medical records, the interoperable electronic medical records (HCEI), and safeguards for automated processing, including consent and algorithm auditability. The regulatory section maps current INVIMA registrations and notes the absence of autonomous AI approvals, highlighting reliance on FDA/EU authorisations for homologation. The IP analysis addresses patentability limits for software, protection of computer implemented inventions, and complementary tools such as copyright, industrial designs, trademarks, and trade dress.
Released on Dec 3, 2025
Contractualising ESG: tools for strategic compliance in the life sciences sector
As environmental, social and governance (ESG) compliance becomes a legal imperative in the life sciences industry, contractual clauses are emerging as critical tools for implementing due diligence, mitigating supply chain risks, and meeting regulatory and investor expectations. This article examines the legal function and enforceability of ESG clauses under German law, particularly in light of the German Act on Corporate Due Diligence Obligations in Supply Chains (Lieferkettensorgfaltspflichtengesetz or LkSG) and the EU Corporate Sustainability Due Diligence Directive (CSDDD). It provides practical guidance on clause design, enforceability challenges and the strategic advantages of ESG-driven contract governance.
Released on Dec 3, 2025
Due diligence in life sciences M&A: navigating risk in complex transactions
Due diligence is a vital process within an M&A project that enables buyers to thoroughly assess a target company or group before finalising a deal. In the life sciences sector, this process is particularly complex due to the highly regulated environment and the nature of the products involved. A well-executed due diligence exercise helps identify potential liabilities, evaluate risks, confirm expectations and ensure the transaction is commercially viable.
Released on Dec 3, 2025
Trade secrets and IP protection in biotech collaborations and licensing deals
This article examines how intellectual property (IP) rights, particularly trade secrets and patents, are leveraged in biotech collaborations and licensing agreements, with a focus on the UK legal landscape. It outlines the types of assets commonly licensed, contrasts the benefits and limitations of trade secret protection versus patenting, and provides practical advice for structuring deals to safeguard innovation. The discussion is framed within the UK legal context, with implications for international participants engaging in cross-border biotech ventures.
Released on Dec 3, 2025
Decentralised clinical trials: key considerations for data management and monitoring
Decentralised clinical trials (DCTs) represent a transformative approach to clinical research, offering enhanced accessibility and efficiency while presenting novel regulatory and operational challenges. This article examines key considerations for data management and monitoring in DCTs, focusing on the distribution of responsibilities, technical prerequisites, data quality and General Data Protection Regulation (GDPR) compliance. Particular attention is given to monitoring strategies that account for reduced physical interaction between investigators and participants. The Swedish experience illustrates how national infrastructure and regulatory frameworks shape DCT implementation, highlighting opportunities for strengthening competitiveness in clinical research and jurisdiction-specific challenges, including restrictions on remote access to medical records.
Released on Dec 3, 2025