Committee publications
Decoding unique anti-corruption challenges in the life sciences sector
The life sciences sector is subject to rigorous regulatory scrutiny in regard to several aspects. This article delves into the unique anti-corruption risks faced by the sector, driven by industry-specific challenges and global regulatory actions. It examines the tailored risk prevention strategies employed by life sciences companies, the shift from reactive to proactive compliance measures and the vital role of industry guidelines in supplementing anti-corruption statutes. Key risk areas, such as gifts and entertainment, travel, health donations, sponsorships, public education, patient assistance programmes, market access and collaborations, are analysed to provide a comprehensive understanding of the anti-corruption landscape. This article underscores the importance of robust compliance programmes in maintaining transparency, accountability and the overall integrity of the life sciences sector.
Released on Jun 2, 2025
The rise of digital twins in healthcare: some legal insights
During the past few years, the use of digital twins has developed in regard to healthcare research and development and delivery, enabling the replication of organs, results prediction, the identification of potential failures and the improvement of processes without posing a physical risk to the patient. However, this technological advancement poses several pertinent legal challenges (eg, in regard to data protection, intellectual property rights and regulatory compliance, among others), which we explore in this article.
Released on Jun 2, 2025
Detection and prevention of corruption in the life sciences sector: the most common corruption schemes and mitigation measures at a glance
This article aims to provide guidance to companies operating in the life sciences sector in recognising and preventing corruption in regard to their business activities. It provides an overview of the most common bribery schemes, as well as mitigation measures. Some notable case law and studies conducted by international organisations (eg, the World Health Organization, European Commission and Transparency International, etc) are also discussed.
Released on Jun 2, 2025
Regulation and access to advanced therapies: recent developments and future perspectives
Advanced therapies are reshaping biomedicine, offering innovative solutions for severe conditions, such as genetic disorders, chronic diseases and cancer, which often lack effective alternative treatments. Due to their inherent complexity, these therapies require a tailored and harmonised regulatory framework to ensure that the relevant development and evaluation processes are conducted effectively across Europe. The recently enacted Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application represents a significant advancement, providing guidance on substances of human origin, including cells and tissues, which are crucial to the creation of advanced therapy medicinal products.
Released on Jun 2, 2025
Continued acceleration in the use and regulation of AI in the UK life sciences industry
The rapid advancement of artificial intelligence (AI) is transforming the life sciences industry. From drug discovery to diagnosis and personalised medicine, AI is now a crucial tool for pharmaceutical, biotechnology and healthcare businesses. Recognising this significant potential, the UK government has recently announced a comprehensive action plan for the development and implementation of AI solutions across the public and private sectors, including life sciences. As the UK positions itself as a leader in AI innovation, regulatory frameworks are also evolving at pace and seek to address the associated challenges regarding cybersecurity, transparency and patient safety.
Released on Jun 2, 2025
The rise of teleconsultation companies in France: is a stabilised legal and ethical framework likely in 2025?
In 2025, France’s teleconsultation sector is robust, supported by comprehensive regulations. Initially regulated in 2018, commercial companies involved in the provision of teleconsultation services faced ambiguity until the 2023 Social Security Financing Bill mandated that companies secure accreditation and meet digital compliance obligations. A 2024 decree detailed the relevant accreditation processes and the 2025 European Health Data Space Regulation will impose EU-wide data standards. These measures ensure teleconsultation platforms operate ethically, with secure interoperable systems, enhancing patient care and cross-border data exchange. France’s proactive regulatory approach balances innovation with patient protection, ensuring a secure and reliable framework for teleconsultation services.
Released on Jun 2, 2025
Telemedicine and the advanced practice of medicine: an Irish regulatory perspective
This article explores the evolving landscape of telemedicine and advanced medical practices from an Irish regulatory perspective. It delves into the digital health solutions that are becoming integral to healthcare systems, highlighting the Irish government’s commitment to digitalising healthcare services and examining the European Health Data Space Regulation, which aims to harmonise health data management across the EU, enhancing patient rights and fostering a collaborative environment for research and innovation. Additionally, it discusses the convergence of medical devices, medicinal products and software, emphasising the importance of regulatory compliance pursuant to the EU Medical Devices Regulation and the Health Technology Assessment Regulation.
Released on Jun 2, 2025
Japan’s efforts to address drug supply issues: regulatory reforms and industry collaboration
Japan is grappling with drug supply issues due to factors like manufacturing disruptions, a limited number of suppliers, regulatory challenges and sudden demand spikes. The Covid-19 pandemic has further exposed vulnerabilities in the drug supply chain. To address these issues, the authorities have taken a number of steps, such as conducting surveys, requesting reports, proposing legal revisions and publishing case studies. These measures aim to ensure a stable drug supply chain, improve access to alternatives, expedite approval processes and foster a competitive pharmaceutical industry. Japan seeks to create a robust pharmaceutical market capable of meeting the population’s needs, amid global challenges.
Released on Jun 2, 2025
Regulatory trends in drug pricing and market access in Brazil: strategies for compliance and advocacy
This article aims to contribute to the market access debate by discussing two potential strategies for enhancing compliance and advocacy in the context of drug pricing in Brazil, based on an overview of the regulatory framework. We explore two potential strategies: administrative requests for extraordinary price reviews before the Chamber for Drug Market Regulation (CMED) and a solution related to the ongoing debate surrounding regulatory improvements in the country. This scenario presents opportunities for advocacy and government relations efforts by companies and industry associations within the Brazilian pharmaceutical sector.
Released on Jun 2, 2025
The progress in telemedicine regulation and the emergence of the advanced practice of medicine in Brazil after the Covid-19 pandemic
The Covid-19 pandemic accelerated the adoption of telemedicine in Brazil, leading to the enactment of Law No. 14,510/2022, which established a permanent legal framework for remote healthcare services. This article explores the progress of telemedicine regulation in the country and its role in enabling the provision of advanced health practices, such as artificial intelligence and personalised medicine. It also highlights the contributions of regulatory bodies in adapting to this digital shift and argues that telehealth regulation should be seen as the starting point for a new cycle of innovation involving the Brazilian healthcare system.
Released on Jun 2, 2025
Artificial intelligence in healthcare: legal and regulatory challenges in Brazil
The use of artificial intelligence (AI) in healthcare has grown exponentially, as a reflection of the accelerated pace of technological innovation that characterises this field. This fast pace of development, of which generative AI is an example, brings both benefits and risks, which translate into challenges for Brazil in regard to the process of regulating this field.
Released on Jun 2, 2025
Regulatory trends in drug pricing and market access in Argentina
This article analyses the current regulatory trends in Argentina concerning drug pricing and market access. Based on the complex structure of the Argentine healthcare system, the strategies employed by pharmaceutical companies and healthcare payers, the existing legal frameworks and the role of institutions, such as CONETEC and CATPROS, are discussed. The article also highlights the recent initiative to create a new national health technology assessment agency (ANEFiTS), which could redefine the rules governing access, coverage and pricing in the country.
Released on Jun 2, 2025
The impact of the NIS2 Directive: will hospital CEOs have to become cybersecurity experts?
This article explores the new legal environment in the European Union arising from the revised Network and Information Security Directive (NIS2), which is applicable to the management boards of health sector services providers, notably hospitals and clinics. This EU Directive establishes a new set of obligations, which makes board members directly and personally responsible for the level of cybersecurity compliance by the entities that they manage and administer, as well as making them responsible for the cybersecurity failures the entities may suffer. This article emphasises the importance of management boards designing and adopting strict cybersecurity policies and internal control systems to ensure compliance with the EU Directive and to avoid any liabilities.
Released on Jun 2, 2025
Strategies for managing scarcity and shortages in the supply of drugs, medical devices and other essential goods: insights from the Ecuadorian context
The scarcity and shortage of drugs, medical devices and other essential health-related goods in Ecuador reflects a structural crisis that undermines the healthcare system’s ability to meet public needs. This article explores the complex causes behind these shortages, including flaws in public procurement processes, institutional fragmentation and governance challenges, while analysing their social and economic impacts. It proposes short, medium and long-term strategies and emphasises the need for responsible public debt management and stronger health governance to guarantee sustained and equitable access to critical medical resources.
Released on Jun 2, 2025
Counterfeit pharmaceuticals: innovative strategies for combatting global health threats
Counterfeit pharmaceuticals pose a significant global health threat, endangering millions of lives and undermining public trust in healthcare systems. This article explores the innovative strategies being employed worldwide to combat this issue, such as track-and-trace systems, smart packaging, artificial intelligence (AI)-driven detection and international collaboration. Emphasis is placed on the importance of advanced technologies like blockchain and radio-frequency identification (RFID), which enhance the traceability and authenticity of drugs. Additionally, stronger legal frameworks, public awareness campaigns and efforts to regulate online pharmacies are essential to tackling this problem. By combining these innovations, stakeholders can work towards a more secure pharmaceutical supply chain and improved public health protection.
Released on Jun 2, 2025
Strategies to secure supply chains: effective contractual approaches to overcome scarcity challenges in the supply of drugs, medical devices and other essential goods
Effective supply chain strategies are imperative in mitigating scarcity challenges in the healthcare industry. This article emphasises the importance of robust contractual approaches to ensure a sta-ble and resilient supply chain. Solutions range from the diversification of suppliers to clear quality standards and proactive price clauses. By implementing these contractual safeguards, companies can navigate supply chain complexities, address shortages and foster sustainable partnerships in an evolving healthcare industry. The key lies in crafting agreements that promote flexibility, risk management and performance incentives to enhance overall supply chain resilience.
Released on Jun 2, 2025
The hospital exemption pathway for non-industrially manufactured advanced therapy medicinal products: a fragmented landscape in the face of EU legislative reform
The regulation of advanced therapy medicinal products (ATMPs) under the hospital exemption (HE) scheme in the European Union remains highly fragmented, with national approaches varying significantly. Spain’s model, for instance, closely aligns ATMPs subject to the HE scheme with authorised products. The revision of pharmaceutical legislation aims to standardise the relevant requirements, enhance traceability and clarify the related compliance obligations. However, concerns persist in relation to ambiguous definitions and regulatory gaps. The European Parliament’s amendments have left key issues unresolved. As negotiations continue at the level of the Council of the European Union and trilogues approach, striking a balance between fostering innovation and ensuring regulatory coherence remains a pressing challenge for EU policymakers.
Released on Jun 2, 2025
Three-dimensional printing of medical devices
3D printing can be used to create customised medical devices using patient-specific data. This article addresses the regulatory status of this transformative technique and its development in Argentina. Although there are no regulations specific to 3D printing used in the manufacturing of medical devices, the National Administration of Drugs, Food and Medical Devices has published a guide outlining the key technical considerations for products developed through additive manufacturing, a broad category that includes 3D printing within its scope.
Released on Jun 2, 2025
Sales in law: why great lawyers are already great at sales
Many lawyers feel uncomfortable with the word ‘sales’. The idea of pitching, persuading or promoting can feel unnatural. And it’s no wonder – multiple studies show that salespeople are widely perceived as untrustworthy, and lawyers aren’t rated much higher. The encouraging part, though, is that great lawyers already apply the core principles of good sales. The real shift is in mindset: moving from ‘selling’ to consultative relationship-building – something most great lawyers are already doing when supporting their clients.
Released on May 29, 2025
How to deepen client relationships for lifelong retention
Building long-lasting client relationships is essential for any successful legal practice. While acquiring new clients is important, the true value lies in nurturing relationships over time, creating stability and scalability crucial for long-term success. This guide will help you effectively build and maintain these vital client connections, even with a busy schedule.
Released on May 29, 2025
Constituting tribunals in investment arbitration
The IA Subcommittee has worked with four of the major arbitral institutions administering investment arbitrations to obtain that data and related statistics
Released on May 29, 2025
Getting to Know the ERF – Alessandro Barzaghi
Get to know the European Regional Forum’s Council Member for Italy, Alessandro Barzaghi.
Released on May 28, 2025
Perspectives on the reform proposed to the Brazilian Civil Code for corporate law
In 2025, the Brazilian Congress initiated formal discussions on a bill to substantially amend the Brazilian Civil Code. Among the various topics under consideration are significant changes to Brazilian corporate law. This article provides an overview of the proposed modifications, with a particular focus on their potential impact on foreign companies seeking to invest in Brazil.
Released on May 23, 2025
Material adverse change clauses in M&A: the risks of USMCA renegotiation and tariff uncertainty
This article examines the enforceability of Material Adverse Change (MAC) clauses in scenarios involving tariffs or sudden treaty changes, analysing how courts in the United States and Mexico might assess such enforceability claims under their respective legal systems.
Released on May 23, 2025
Indonesia legal insights: merger filing procedures and requirements in Indonesia in accordance with competition law
Monopolistic practices and/or unfair business competition are subject to heavy scrutiny by the Indonesian Government, especially in the context of transactions involving Mergers and Acquisitions (‘M&A’) where there is a risk that the combined company could result in monopolistic business practice taking place. The Indonesian government has imposed a requirement for companies conducting merger, consolidation or acquisition transactions to file reports of these activities through merger filing to the Business Competition Supervisory Commission (Komisi Pengawas Persaingan Usaha or ‘KPPU’) for approval. This article aims to outline the applicable criteria that require certain transactions to be subject to merger filing, as well as the relevant procedures to be abided by when conducting merger filing.
Released on May 23, 2025
The use of irrevocable PoAs in Ukraine: practical considerations
Ukrainian law permits the use of irrevocable powers of attorney (PoAs). These are governed by the Civil Code of Ukraine as well as the Law of Ukraine On Joint Stock Companies and the Law of Ukraine On Limited Liability Companies and Additional Liability Companies, as applicable. While irrevocable PoAs are allowed in the context of both limited liability companies (LLCs) and joint stock companies, this article focuses on their use in LLC structures, as these represent the most common corporate vehicle for such arrangements in practice.
Released on May 22, 2025
Thirteenth Annual Global Report
The 13th Annual Global Report from the GEI
Released on May 21, 2025
Inspirational legal women: a conversation with Imbi Jürgen
An insightful discussion with Imbi Jürgen
Released on May 20, 2025
The latest updates to the Guest Investor Residency Programme
This article outlines the Hungary’s Guest Investor Programme, known as the Hungarian Golden Visa Programme, and explains that latest updates.
Released on May 19, 2025
Why your due diligence checklist may not work in Mexico
This article delves into the risks that arise heading into closing, which commonly create a no-deal situation. It will walk readers through the most important aspects to have in mind and share practical strategies to build a due diligence checklist that actually works in Mexico – keeping the reader informed, compliant and on track to close on time.
Released on May 19, 2025