Committee publications
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
Mergers: practical issues in international M&A deals
Planning and structuring an M&A deal is becoming increasingly challenging, especially when dealing with cross-border transactions involving multiple jurisdictions. This session at the IBA Annual Conference Toronto 2025 focused on how to navigate this shifting landscape and effectively manage antitrust risks within M&A transactions.
Released on Dec 1, 2025
Business combinations of profit-driven companies with purpose-driven companies
This 2025 Toronto session explored how mission-focused and profit-oriented organisations can align their values and strategies during mergers, investments and in regard to governance.
Released on Dec 1, 2025
Foreign direct investment and political considerations in M&A deals: increasing scrutiny in an era of greater protectionism
This 2025 Toronto session was moderated by Audrey Chen and Alastair Mordaunt, with experts from Germany, Canada and the United Kingdom. It discussed the constantly evolving foreign direct investment landscape, noting that outcomes are unpredictable when facing various practical challenges.
Released on Dec 1, 2025
Why take chances? A deep dive into the regulatory, compliance and transactional complexities of acquiring a gambling business
Gambling M&As in North America and Europe today in the .com space often involve activities that are not legal in the sense that they are not specifically licensed or authorised by the relevant jurisdiction in which they operate, raising numerous challenges for lawyers. This panel at the IBA Annual Conference Toronto 2025 explored this subject.
Released on Dec 1, 2025
Treat-ease? Not if GAARs and the PPT can help it
The implementation of general anti-avoidance rules (GAARs) has been an attempt to prevent the use of tax treaties to enable tax evasion, granting a country’s tax authority enough power to disregard a particular corporate structure or transaction, and deny a benefit granted by a double taxation treaty when tax avoidance could exist. Even so, the task of GAARs comes with challenges, as the interpretation of ‘when’ and ‘how’ GAARs should be applied can vary from one country to another. This session at the 2024 IBA Annual Conference in Mexico City discussed the status on the implementation of GAARs in Brazil, Mexico, Switzerland and the Netherlands.
Released on Nov 25, 2025
Structuring business investment into Mexico
This panel at the 2024 IBA Annual Conference in Mexico City addressed the main recent developments in the tax structuring of foreign investments into Mexico. Considering that such foreign investments are predominantly made by United States investors (41.4 per cent of investment over the period 2006–2024), and by Spanish investors (10 per cent of investment over the same period), the panel focused first on the main general tax implications arising in Mexico for foreign investors.
Released on Nov 25, 2025
Mandatory reporting and the preservation of client rights to privacy, access and privilege
Mandatory reporting obligations adopted by different jurisdictions have created tensions between fundamental principles such as solicitor-client privilege, confidentiality and transparency. As countries implement stricter reporting regimes, different parties face challenges balancing compliance with these principles. This panel at the 2024 IBA Annual Conference in Mexico City discussed the approaches and current developments in different countries on these subjects.
Released on Nov 25, 2025
Tax-AI-tion and the digital divide – how does artificial intelligence impact on tax practice?
This panel at the 2024 IBA Annual Conference in Mexico City provided an in-depth exploration of the challenges and opportunities that AI presents to taxation and transfer pricing. Experts from various countries, including Argentina, Brazil, Mexico, South Korea and Spain, addressed how AI impacts value chains, the evolving role of AI in tax administration, and the regulatory frameworks needed to ensure fair practices.
Released on Nov 25, 2025
Employers of record: a global review of immigration, employment and tax issues
This panel discussion at the 2024 IBA Annual Conference in Mexico City examined the complexities associated with the employer of record (EOR) model in global employment contexts. The panel featured legal experts from different regions, who shared their insights on the challenges, limitations and operational strategies associated with EORs.
Released on Nov 25, 2025