Committee publications
Inspirational legal women: a conversation with Akila Agrawal
An insightful discussion with Akila Agrawal
Released on Jun 3, 2025
Getting to Know the ERF – Lilli Parbo
Get to know the European Regional Forum’s Council Member for Finland, Lilli Parbo.
Released on Jun 3, 2025
Navigating 2024: the Italian venture capital biotech market and the crucial role of intellectual property assets as a deal maker or deal breaker
This article aims to provide a preliminary outline of the major venture capital (VC) trends in the life sciences sector targeting Italian biotech companies, mainly operating in certain specific sub-segments, as a result of it being ascertained that the Italian life sciences market ranked as one of the most funded industries by VC in 2024. The article focuses on the importance of intellectual property (IP) assets in VC life science deals, through a discussion of how IP generally qualify as a ‘deal maker’ or ‘deal breaker’, capable of having a significative impacts on all the phases of VC deals: (1) related to the due diligence process and regardless of whether the biotech is the IP owner or uses such IP in the context of a licence agreement; (2) taking into account specific peculiarities of the Italian legal framework, such as the reform of the so-called abolition of the professor’s privilege; and (iii) with a focus on the contractual structure of VC deals, by pointing out some of the most common closing conditions and the market standards in terms of the release of IP representations and warranties.
Released on Jun 2, 2025
The regulation of cultivated meat in Singapore and the US: lessons for Mexico
Despite its potential, cultivated meat remains a novel and scarcely adopted technology. Its unfamiliar production methods raise valid questions about regulation and food safety. Since cultivated meat is derived from animals, yet produced through biotechnology, it falls outside traditional regulatory frameworks for either conventional meat or genetically modified organisms. This article explores how Singapore and the United States, the first two countries to approve the release of cultivated meat for the consumer market, have addressed these challenges and discusses the lessons Mexico can draw from their experience in the developing its own regulatory framework for cultivated meat.
Released on Jun 2, 2025
The innovation pipeline in Mexico’s food, biotech and pharmaceutical sectors
Mexico’s life sciences sector is shifting from rigid regulatory frameworks towards systems that foster innovation, while maintaining safety standards. Driven by trade agreements, regional cooperation and digital transformation, these changes create investment opportunities and market expansion, across food, biotech and pharmaceutical industries. This article examines how some key sectors benefit from modernisation and harmonised regulatory efforts and how Mexico is emerging as an active participant in shaping life sciences regulation throughout Latin America, rather than merely adopting external standards.
Released on Jun 2, 2025
Telemedicine in Germany: legal framework, challenges and perspectives
Telemedicine has become more important in Germany since the Covid-19 pandemic. Such services include video consultations, teleconsultations and remote monitoring. Although telemedicine is generally permitted, it is subject to strict legal requirements, particularly in the context of statutory health insurance. Professional regulations, advertising law and data protection regulations set clear obligations in this context. Cross-border treatment, liability and reimbursement are also important legal aspects. The current laws, such as the Digital Healthcare Act and EU regulations, support digital healthcare services. However, clearer framework conditions are still required to ensure legally compliant and efficient implementation of such services, particularly with regard to artificial intelligence (AI)-driven tools, which offer new opportunities, but also raise legal uncertainties.
Released on Jun 2, 2025
Telemedicine in Argentina and the advanced practice of medicine
This article outlines the regulatory framework governing telemedicine in Argentina, examining the categories of teleservices permitted and the requirements that healthcare professionals, institutions and telemedicine service providers must comply with. It also discusses the main legal framework applicable to the advanced practice of medicine, characterised by the application of new technologies in the healthcare sector.
Released on Jun 2, 2025
Counterfeit pharmaceuticals: innovative strategies for combatting global health threats in the UK
The United Kingdom’s pharmaceutical industry faces substantial challenges from counterfeit pharmaceuticals, exacerbated by the rise of online pharmacies and drug shortages. This article explores innovative strategies to combat these threats, focusing on authentication technologies, public awareness campaigns and international collaboration. The UK has a robust regulatory framework, but there have been limited technological advancements as yet. However, initiatives like the Medicines and Healthcare products Regulatory Agency’s use of AI in partnership with eBay and public campaigns, such as #FakeMeds and the Yellow Card scheme, highlight the ongoing efforts in this regard. The article underscores the need for continued innovation and global cooperation to effectively address the evolving counterfeit pharmaceuticals landscape.
Released on Jun 2, 2025
Trends in life sciences mergers and acquisitions, investment and strategic collaborations
This article highlights two trends in life sciences mergers and acquisitions (M&A) transactions. First, it highlights the increasing relevance of cybersecurity legislation in M&A transactions in regulated sectors, particularly in the healthcare, pharmaceutical and medical device sectors, with a focus on Belgium’s implementation of 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, otherwise known as the NIS2 Directive. Secondly, this article focuses on the increasing use of artificial intelligence (AI) in the Swiss healthcare sector, especially in regard to pharmaceuticals and diagnostics. AI-related risks are significant in M&A transactions. Although Switzerland doesn’t have a specific AI law, existing regulations apply, and Swiss companies may be affected by the extraterritorial reach of the European Union’s AI Act. Legislative changes are expected, and companies must ensure compliance with the relevant rules to remain attractive to investors.
Released on Jun 2, 2025
Pharmaceutical regulations in Uruguay and Paraguay: recent regulatory changes, trends and challenges
Pharmaceutical regulations in Uruguay and Paraguay have undergone significant changes aimed at strengthening oversight, streamlining the approval of innovative medicines and adapting to technological advancements. Constant change, international cooperation and the use of reliance mechanisms aim to optimise the management of pharmaceutical products and reduce approval times. Projections point towards greater regulatory harmonisation, which will enhance the sector’s competitiveness and improve access to innovative treatments. These developments contribute to the consolidation of a more dynamic regulatory framework, aligned with international standards, thus boosting system efficiency and ensuring the safe availability of medicines.
Released on Jun 2, 2025
Advances in the regulation of medicine pricing and advertising in Paraguay: the emphasis on transparency and consumer protection
In Paraguay, the regulation of medicine pricing is the responsibility of the National Health Surveillance Directorate (Dirección Nacional de Vigilancia Sanitaria or DINAVISA), which employs methodologies based on international standards to ensure fair and accessible prices. Recent regulatory amendments have introduced a pricing system that references the market values in other countries with similar regulations, aiming to promote fairness and transparency in the marketing of pharmaceutical products. Regarding medicine advertising, the regulatory framework includes restrictions to avoid the dissemination of misleading information and to ensure transparency. Notwithstanding the progress made in terms of regulating this part of the provision of healthcare, the advertising authorisation process is still carried out manually, highlighting the need for digital modernisation.
Released on Jun 2, 2025
Chile’s new data protection law and its effects on health data privacy
Chile’s new Data Privacy Law (Law No. 21,719) marks a relevant shift in the regulation of health data, broadening the legal bases for processing, strengthening individual rights and introducing robust enforcement mechanisms. Effective from December 2026, it creates a dedicated Data Protection Agency and sets forth rules on sensitive and special data categories, including health-related information. While consent remains central, the law allows data processing on broader grounds and, for the first time, mandates privacy impact assessments, breach notifications and a strict sanctions regime. While much of the reform’s impact will depend on the Data Protection Agency’s future actions concerning the implementation of the law, the new law brings Chile closer to global standards, balancing data subjects’ rights with the growing importance of health innovation.
Released on Jun 2, 2025
Hemp as a superfood: new products and an innovative industry facing regulatory challenges
Uruguay is integrating hemp-derived products into its food industry, which requires a clear legal framework to regulate its use that also fosters growth of the industry. The sector faces regulatory uncertainty, especially concerning tetrahydrocannabinol (THC) limits, food safety standards and export restrictions. While global demand for hemp-based superfoods is rising, national legislation remains fragmented. Companies like Goland are expanding their operations, but require harmonised regulations for sustainable development. Key measures include regulatory alignment, certification systems, public–private collaboration and consumer education. Addressing these gaps will position Uruguay as a leader in the hemp-based food market, while ensuring safety and compliance.
Released on Jun 2, 2025
Telemedicine and advanced medical practice in Uruguay
This article explores the regulatory, institutional and operational development of telemedicine in Uruguay, highlighting its evolution since the Covid-19 pandemic. It examines the benefits of this model, particularly in terms of accessibility and equity, and proposes a reform agenda for the advancement towards more sophisticated healthcare practices. Key challenges include interoperability, professional training, ethics, cybersecurity and quality evaluation. Ultimately, the article emphasises the need for a structural public policy that fully integrates telemedicine into the national health system.
Released on Jun 2, 2025
Patient access programmes/patient assistance programmes: legal benefits and challenges for patients
In 2023, the market for patient support programmes (PSPs) was valued at $18.82bn and is predicted to reach $64.36bn by 2031. These figures undoubtedly demonstrate the success of PSP initiatives around the world. However, due to the lack of a clear regulatory framework, PSPs face a variety of legal challenges. This article discusses the key legal aspects of PSPs by analysing the concept, genesis and main requirements in relation to PSPs. Also, the article examines the core challenges faced by the industry and provides practical solutions in order to ensure PSP compliance.
Released on Jun 2, 2025
Governing the future: bridging the gap between artificial intelligence, the law and regulation
This article addresses the necessity for legal frameworks and regulations to evolve in parallel with technological advancements. It focuses on artificial intelligence (AI), particularly its impact on the healthcare sector. The discussion covers the emerging regulatory landscape concerning AI in both the European Union and Turkey, including relevant guidelines and legislative developments. The article emphasises the importance of regulating AI applications in healthcare to ensure legal certainty, ethical compliance and data privacy.
Released on Jun 2, 2025
Gene therapies in Chile or the ‘torment of Tantalus’ between regulation and innovation
Health-related debates often emerge earlier in developed countries, but this does not mean they are irrelevant in developing nations, as diseases do not recognise borders. Thus, in a world driven by intense research and development, gene therapies have taken centre stage for companies, regulatory agencies and researchers alike. In countries, such as Chile, where the regulatory framework remains underdeveloped, discussions on the implementation of specific regulations in this field are critical, otherwise, not only will research be hindered, but public health may also be put at risk.
Released on Jun 2, 2025
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