Committee publications
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
Advertising and labelling of medicinal products on social media
This article examines the regulatory landscape surrounding the advertising and promotion of prescription-only medicines on social media, with a particular focus on Ireland and on GLP-1s. It explores digital promotion and regulatory frameworks, highlighting the role of the key Irish stakeholders in monitoring and enforcing advertising compliance. It discusses recent trends in the online promotion of GLP-1s, content creators and recent steps taken by the European Medicines Agency (EMA) in this space. It also considers the implications of recent enforcement actions and the importance of robust internal policies (including for employees) to ensure compliance in the digital age.
Released on Dec 3, 2025
Poland to amend reimbursement laws again, this time for the better?
The article analyses Poland’s draft law amending the reimbursement act, aimed at reversing some of the reforms adopted in 2023. Key proposals include a new reimbursement category bridging outpatient and inpatient use, streamlined applications for prioritised products, and clarified health technology assessment (HTA) and negotiation mechanisms. The draft refines pricing through more flexible price increases and rolling post-exclusivity reductions. It narrows reimbursement secrecy, rebalances obligations concerning continuity of supply obligations, and enhances digital reporting and data access. According to the Polish government, all this is supposed to improve access to innovative medicinal products, as well as predictability and transparency of reimbursement.
Released on Dec 3, 2025
Decentralised and remote clinical trials: evolving legal framework
The rapid shift toward decentralised and remote clinical trials, accelerated by the Covid-19 pandemic, is transforming trial design and oversight. This article maps the evolving legal framework, addressing Good Clinical Practice recognition, varying European Union and United States approaches, and emerging guidance under Accelerating Clinical Trials in the EU (ACT EU) and European Medicines Agency (EMA) recommendations. It analyses core operational risks: patient safety, eConsent integrity, data protection and cross-border data transfers, cybersecurity, telemedicine compliance, investigational product delivery, and device/software classification. It seems that decentralised models can expand access and reduce costs of clinical trials, provided risk-based safeguards are embedded and national rules are aligned with international standards.
Released on Dec 3, 2025
Argentina – advertising and labelling of medical products on social media
This article analyses the Argentine legal framework applicable to the advertising and labelling of medicines and medical devices, particularly in the context of social media and digital platforms. It also explores the main compliance challenges, enforcement trends and recommendations for companies seeking to promote health-related products online.
Released on Dec 3, 2025
Medical cannabis: regulatory divergence and product liability
Regulations on medicinal cannabis in Argentina have evolved significantly over the past eight years; however, market development remains limited. This article examines the key factors influencing the current regulatory landscape, with a particular focus on medicinal use and product liability, which is essential to ensuring the safe and responsible use of cannabis.
Released on Dec 3, 2025
Artificial intelligence in drug discovery: the legal status of AI-generated inventions
The rapid development of artificial intelligence (AI) in recent years has the potential to significantly lower the entry barriers for drug development. However, as AI systems become increasingly more sophisticated, our legal frameworks must grapple with the possibility of inventions made by or using AI being patented. In the recent Thaler case, two inventions created autonomously by AI were denied patent protection. The Supreme Court in 2023 ruled that a natural person must be marked as the ‘inventor’ on a patent application, but whether the use of AI to help develop an invention precludes patentability remains a live legal issue.
Released on Dec 3, 2025
Artificial intelligence in drug discovery: legal status of AI-generated inventions
This article explores the impact of artificial intelligence (AI) on drug discovery and the legal issues surrounding AI-generated inventions. It analyses the progression of AI-driven tools, their integration into the pharmaceutical industry, and the intellectual property challenges that arise as AI systems become increasingly independent. This article highlights the need to reassess existing legal frameworks to keep pace with the evolving autonomy of AI in the drug development process.
Released on Dec 3, 2025
Voluntary assisted dying and end-of-life decision-making: a global perspective and lessons to be learnt
There are a number of ethical issues associated with end-of-life decision-making, including suicide and the rights of healthcare professionals and organisations to conscientiously object on religious grounds. The legal position on active euthanasia and passive advance care directives, being decisions concerning the withdrawal of life-sustaining treatment, varies significantly across jurisdictions. While some countries, such as Canada and Australia, have progressive frameworks permitting VAD and ACDs, others, including Singapore, India and the United Kingdom, maintain more restrictive approaches. Recent legislative developments, particularly in Australia and Canada, highlight the importance of having clear safeguards in place, capacity assessments and respect for individual autonomy during end-of-life care.
Released on Dec 3, 2025
Why ESG matters in due diligence and healthcare and life science legal transactions
Environmental, social and governance (ESG) considerations are increasingly significant in healthcare and life sciences due diligence and legal transactions. Australian and international funders now impose ESG requirements, with recent legislative changes mandating sustainability reporting for large entities. Regulatory bodies such as the Australian Securities and Investment Commission (ASIC) and the Australian Competition and Consumer Commission (ACCC) are prioritising enforcement against ‘greenwashing’, as demonstrated by landmark cases against Mercer and Vanguard for misleading ESG claims. Accurate environmental claims, robust due diligence and clear contractual obligations are essential to manage ESG risks. Businesses must ensure ongoing compliance, transparency, and staff training to avoid legal and reputational consequences in this evolving regulatory landscape.
Released on Dec 3, 2025
Blurred lines: law, science, and the regulation of dual-use biological research
Covid-19 showed the world how catastrophic biological threats can be. Dual-use research of concern (DURC) – research that could benefit society but also be misused as bioweapons – has always existed in life sciences. With artificial intelligence (AI) now accelerating research capabilities, global biosecurity frameworks urgently need strengthening. This article traces DURC’s evolution from voluntary scientific self-regulation to today’s complex legal landscape; examines how major jurisdictions regulate biosecurity differently; and proposes an adaptive framework that balances scientific innovation with national security through enforceable verification mechanisms, proportionality principles and international cooperation.
Released on Dec 3, 2025
AI in drug discovery: a regulatory tightrope walk
Artificial intelligence (AI) is revolutionising drug discovery, offering unprecedented speed and precision. However, its opaque decision-making, data bias risks and continuous learning capabilities challenge traditional regulatory frameworks. This article explores the need for explainability, data integrity and adaptive oversight, advocating for risk-based, globally harmonised approaches to ensure safety, accountability and innovation in AI-driven pharmaceutical development.
Released on Dec 3, 2025
A new era of climate accountability: unpacking the implications of new international advisory opinions for corporations
This article summarises highlights from the ‘Climate change: implications of the International Court of Justice and Inter-American Court of Human Rights advisory opinions for corporations’ webinar which took place on 9 October 2025. The webinar was presented by the IBA Oil & Gas Law Committee, supported by the IBA Business Human Rights Committee, the IBA Power Law Committee, the IBA Energy, Environment, Natural Resources and Infrastructure Law Section (SEERIL), the IBA Asia Pacific Regional Forum, the IBA African Regional Forum and the IBA’s Legal Policy & Research Unit.
Released on Dec 1, 2025
Interview with Ambassador David MacNaughton on diplomacy, dealmaking and the rule of law
At the Corporate and M&A Law Committee reception and dinner at the Art Gallery of Ontario, Ambassador David MacNaughton was interviewed by Committee Co-Chairs Nicola Charlston and Bertrand Cardi. He offered pragmatic reflections on diplomacy and negotiation in an era of heightened geopolitical complexity.
Released on Dec 1, 2025
Locking up the deal – perspectives and practices from around the world
This 2025 Toronto session explored the mechanisms and strategies used by global deal practitioners to provide greater deal certainty in regard to M&A transactions. The panel, chaired by Sarah Young and Rabindra Jhunjhunwala, featured perspectives from legal advisers, in-house counsel and an investment banker, with the panel hailing from the United States, Canada, Japan and India.
Released on Dec 1, 2025
The role of shareholders in M&A transactions
This 2025 Toronto session explored the different ways of dealing with shareholders when executing M&A transactions. In particular, the panel, which was moderated by Gabriella Covino and Harry Coghill, noted that significant M&A transactions generally require engagement with one or both sets of shareholders.
Released on Dec 1, 2025
M&A café – roundtables
The M&A café roundtables session, organised by Dovilè Burgiene and Lorenzo Olgiati, featured five specialised discussion sessions involving participants, with each session led by experienced moderators. The roundtables covered hot due diligence issues; government intervention trends; the impact of AI on M&A transactions; directors’ liability issues; and private equity transaction trends, respectively.
Released on Dec 1, 2025
Distressed M&A: geopolitical upheaval, distressed M&A markets and strategies for success
This panel at the IBA Annual Conference Toronto 2025 examined the impact of global economic uncertainty on distressed M&A activity, addressing market trends, deal structures and jurisdictional differences. The panelists discussed strategies for managing pre-insolvency and insolvency transactions in their relevant jurisdictions and from different angles, with particular attention paid to due diligence challenges, stakeholder coordination and liability management.
Released on Dec 1, 2025
Canadian pension funds – the evolving Canadian model
This panel session at the IBA Annual Conference Toronto 2025 was on the subject of ‘Canadian pension funds – the evolving Canadian model’ and featured an impressive line-up of participants from four of the ‘Maple 8’ pension funds.
Released on Dec 1, 2025
Running auctions or strategic review processes – legal tips and advice
This 2025 Toronto conference session offered valuable insights into the design and execution of auction and strategic review processes during M&A transactions.
Released on Dec 1, 2025
Welcome to the wild west: activism in Canada and elsewhere
This 2025 Toronto session provided a lively discussion among the panelists involving a live activism scenario, covering relevant legal considerations to keep in mind, potential defensive measures, components of a strong activism response framework and adviser team, as well as shareholder engagement strategies, among other subjects.
Released on Dec 1, 2025
Data centres: the good, the bad and the ugly
This discussion at the IBA Annual Conference Toronto 2025 looked at the explosive growth of global data generation, examining how rising AI workloads, hyperscaler expansion and power scarcity are reshaping the fundamentals of site selection, permitting, energy strategy and infrastructure planning.
Released on Dec 1, 2025
Navigating franchise investments: legal strategies for private equity in franchise transactions
This joint committee panel at the IBA Annual Conference Toronto 2025 involved a thoughtful discussion among the panelists covering the relevant legal considerations to keep in mind when dealing with private equity (PE) investments in franchise transactions, which was of interest to practitioners involved in private equity practice, as well as advertising and franchise specialists.
Released on Dec 1, 2025