Publications for Healthcare and Life Sciences Law Committee
The right to be forgotten in Portugal: health and insurance law considerations
The right to be forgotten plays a crucial role in both insurance law and health law, particularly when addressing sensitive health-related information. This article discusses how health data intersects with insurance law, and the recent developments in Portugal in relation to the right to be forgotten for people who have overcome or mitigated situations of aggravated risk of health or disability.
Released on Feb 11, 2025
The legal framework for partnerships for productive development: PDPs and PDILs
This article analyses recent regulatory changes in Brazil’s health economic-industrial complex, including the transition from Decree 9,245/2017 to Decree 11,715/2023 and the impact of Ordinances 4,472/2024 and 4,473/2024. While these changes aim to enhance oversight, foster innovation and stimulate local production, they have also introduced regulatory uncertainty.
Released on Feb 11, 2025
Conflicts of interest in the relationship between medical professionals and the pharmaceutical industry
This article explores the regulatory gaps in Brazil concerning the relationship between medical professionals and the pharmaceutical industry, focusing on ethical and conflict of interest concerns. It analyses national and state-level measures, including the Minas Gerais ‘Sunshine Act’ and CFM Resolution No 2,386/2024 – discussing their implications, challenges and alignment with global transparency initiatives to safeguard patient care and uphold healthcare integrity.
Released on Feb 11, 2025
Brazil: access and reimbursement of medicines in the public market
This article intends to briefly describe: how the Brazilian legislative framework regulates the incorporation of new pharmaceutical products into the Brazilian public healthcare system (Sistema Único de Saúde or SUS), commonly known as ‘reimbursement’ in other international jurisdictions; which public authorities are involved; what the ‘judicialisation’ phenomenon is; and the importance of strategic legal support throughout the process of incorporation.
Released on Feb 11, 2025
Shortages of critical medicines and pharmaceuticals: legal and regulatory responses
This article addresses Argentina’s main legal framework applicable to shortages of critical medicines and pharmaceutical products, which mandates pharmaceutical companies to notify the National Administration of Drugs, Food and Medical Devices (ANMAT) of any possible discontinuation of medicines, to take preventive measures and instruct recalls and/or corrective actions.
Released on Feb 11, 2025
Gene therapies and orphan drugs: navigating regulatory approval and reimbursement challenges
This article outlines the intricate regulatory framework governing gene therapy and orphan drugs in Argentina. It discusses the key aspects to consider when navigating regulatory approval and facing reimbursement challenges for these products, highlighting the dynamic evolution of healthcare regulations regarding rare diseases.
Released on Feb 11, 2025
AI and the future of healthcare in Peru: exploring legal pathways and ethical dilemmas
Artificial intelligence (AI) is revolutionising healthcare in Peru – enhancing diagnostics, treatment efficiency and patient outcomes. However, the full potential of AI can only be realised by addressing significant challenges, including limited infrastructure, unequal access and insufficient training. Legal frameworks must prioritise data privacy, while ethical considerations ensure equitable access and informed consent. Building public trust through transparency and inclusive policymaking is essential. By overcoming these obstacles, Peru can leverage AI to bridge disparities and deliver improved care across all regions.
Released on Feb 11, 2025
Regulation and access to orphan drugs in Peru: challenges and opportunities
Peru has made meaningful progress in improving access to orphan drugs through regulatory advancements like Laws No. 29698 and No. 31738, which prioritise comprehensive care and streamlined processes for rare disease patients. Initiatives such as expedited treatment and simplified drug registration highlight the country’s commitment to innovation and equity in healthcare. While challenges like high costs and limited diagnostic capacity remain, these advancements provide a solid foundation for progress. By addressing existing barriers and fostering collaboration, Peru has the opportunity to transform its healthcare system and significantly enhance the quality of life for those affected by rare diseases.
Released on Feb 11, 2025
Shortages of critical medicines and pharmaceuticals in Brazil
Anvisa (the Brazilian health regulatory agency) ensures public health protection through the regulation of drugs and medical devices. According to Brazilian regulation, marketing authorisation (MA) holders are obliged to report interruptions in drug supply to prevent shortages. During the pandemic, these regulations were crucial in managing the supply chain and ensuring the availability of essential medical products.
Released on Feb 11, 2025
Corporate responsibility in private healthcare and ESG challenges in a shifting political landscape
This article explores the evolving role of corporate social responsibility (CSR) and environmental, social and governance (ESG) practices in the private healthcare sector, particularly in the context of shifting political landscapes. It examines how private healthcare providers must navigate regulatory uncertainties and the growing demand for sustainable practices. The piece discusses the European Union’s leadership in ESG regulations and contrasts it with the potential deregulation under United States political shifts. It emphasises the importance of leadership in adapting to these changes, balancing innovation with social responsibility to ensure long-term sustainability and positive health outcomes in a competitive market.
Released on Feb 11, 2025
Experimental regulation in private healthcare systems: the strategic role of sandboxes
The evolution of socio-economic relations demands ongoing adjustments in government actions, reshaping administrative law toward governance models that prioritise flexibility. Regulatory tools such as the regulatory sandbox reconcile legal certainty with disruptive innovation. In Brazil's healthcare sector, the expansion of pre-paid cards or discount cards exposes regulatory challenges in a fragmented framework. To address this issue, the National Agency for Supplementary Health (ANS) implemented a regulatory sandbox aligned with global practices, fostering innovation, competitiveness and access. This supervised environment exemplifies a paradigm shift, balancing state intervention with economic freedom and positioning Brazil as a leader in innovative and efficient governance.
Released on Feb 11, 2025
Mexico’s response to critical medicine shortages: legal framework and compulsory licensing in the global context
This paper examines Mexico’s efforts to address medicine shortages, balancing intellectual property rights with public health needs. By analysing recent reforms, particularly compulsory licensing, and the role of COFEPRIS, we highlight the challenges and opportunities for emerging economies. The study also considers the impact of TRIPS-plus provisions and emerging technologies on Mexico’s pharmaceutical sector.
Released on Feb 11, 2025
AI in healthcare: legal and ethical considerations in this new frontier
The article explores the transformative potential of artificial intelligence (AI) in healthcare, highlighting its benefits in drug development, diagnosis and patient care. It underscores the necessity for robust regulatory frameworks to address safety, privacy and bias concerns. Various international and national regulatory approaches are discussed, including the EU’s AI Act and the US FDA’s guidelines. Ethical issues such as bias, transparency, and professional accountability are examined. The article advocates for international collaboration and scenario-based assessments to ensure AI’s safe and ethical deployment in healthcare.
Released on Feb 11, 2025
Defective medical devices: the ‘defence of regulatory compliance’ under Swiss law – does it need to be reassessed?
Against the background of the stricter regulation of medical devices under the revised Swiss Medical Devices Ordinance (MedDO) and the EU Medical Devices Regulation (MDR), the question has arisen as to whether the defence of regulatory compliance, or at least the weighting of this argument of the manufacturer in product liability proceedings, needs reassessment. The author of this article argues in favour of such a stronger weighting if the product in question is an MDR medical device or another therapeutic product.
Released on Feb 11, 2025
The interplay between intellectual property and healthcare innovation: the role of trade secrets, compulsory licensing, and patent law
Innovation in healthcare is primarily fuelled by intellectual property. The significance of intellectual property rights extends beyond merely establishing the ownership of inventions; they are also crucial for transforming these inventions into economic assets. By enabling inventors to market their innovations without worrying about imminent competition or imitation, these rights are intended to incentivise creativity and innovation.
Released on Feb 11, 2025
Gene therapies and orphan drugs: regulatory regime and reimbursement challenges
Argentina has established comprehensive regulations governing the use of gene therapies and orphan drugs for patients with rare diseases, as defined by Law No 26,689. This legal framework provides a foundation for tackling the unique needs of individuals with rare diseases. Despite these efforts, orphan drugs remain expensive, and reimbursement challenges persist, often requiring legal action. This article summarises the regulatory framework for these treatments and addresses the obstacles that still lie ahead.
Released on Feb 10, 2025
The intricate interplay between intellectual property and competition law as exemplified by the Xalatan case
The relationship between intellectual property and competition law becomes particularly challenging when exclusive rights are used to hinder market competition, as testified in several Italian cases and particularly in the landmark Xalatan case. The Italian Competition Authority, confirmed by the top administrative court, ruled that Pfizer’s patent strategy abusively delayed market entry from generic competitors beyond natural patent expiration by exploiting loopholes in patent regulation. Notably, this recently resulted in the top civil court to award damages to the national health service (Servizio Sanitario Nazionale or SSN) in related private damages litigation. This set of decisions, which represent landmark rulings, highlight the increasing demand to balance the protection of IP-exclusive rights with maintaining fair and competitive markets.
Released on Feb 10, 2025
Decentralised clinical trials (DCTs): steps forward in the European and Italian regulatory frameworks
The lack of clear rules for the decentralisation of clinical trials and related activities is one of the main obstacles to the widespread use of decentralised clinical trials (DCTs). The Covid-19 pandemic revealed the shortcomings of European regulatory systems, but it has also shown the enormous potential of implementing decentralised solutions for the validity and success of trials, as well as for rationalising the use of available resources. European and national authorities – including Italy – are moving towards defining a regulatory framework for DCTs that supports operators, innovation and research in the health sector.
Released on Feb 10, 2025
Increased liability due to the new EU Product Liability Directive: what does this mean for the medical and pharmaceutical industry?
The introduction of the new EU Product Liability Directive aims at leading product laws to the digital age, including stricter liability for distributing digital and AI-based products. This has significant legal implications for both consumers and manufacturers, which must be taken into account in the contractual documents along the supply chain. Now more than ever, manufacturers and providers of digital healthcare products should regularly assess potential liability risks and have their contracts checked.
Released on Feb 10, 2025
Secondary use of health data: a few hints on the EU legal landscape and how to anticipate this use in R&D contracts?
The European Union legal landscape has evolved these past years to foster the sharing of health data and support the EU’s sovereign digital single market. One important objective is to develop health data secondary use for research, development, innovation and public health policies. R&D partners will have to implement a number of principles to anticipate and organise this secondary use in their contracts.
Released on Feb 10, 2025
The use of biosimilars and regulatory challenges worldwide
The growing demand for highly complex and effective drugs, combined with the search for more affordable therapeutic options, has driven the development of biosimilar drugs. These products have similar characteristics to biological reference drugs and have been gaining ground as a viable alternative in terms of both cost and efficiency. However, their production and marketing face significant regulatory challenges in Brazil and around the world. This article explores the current scenario of biosimilars, highlighting the main regulatory challenges and trends, focusing on the Brazilian context and international practices, with special interest for the legal public and the pharmaceutical industry.
Released on Feb 10, 2025
Neurorights: Is the creation of new human rights effective in protecting human dignity from the misuse of neurotechnology?
The advance of neurotechnologies, driven by neuroscience, biomedical engineering and artificial intelligence, has brought significant benefits for health, education and security, as well as ethical and legal challenges. These advances raise questions about privacy, misuse of neural data and individual autonomy, indicating the need to regulate so-called ‘neurorights’, seeking to balance the benefits of innovation with the protection of fundamental human rights. This article addresses the challenges arising with the advance of neurotechnologies, and raises the debate on whether regulating neurorights as internationally recognised human rights would be the most efficient way to protect human dignity against possible misuse of neurotechnologies.
Released on Feb 10, 2025
Health is wealth
The article discusses the current scene as regards mergers and acquisitions (M&A) and private equity (PE) and venture capital (VC) transactions in the healthcare sector, with an emphasis on India. It further discusses the key considerations to be taken note of in light of current law, and future trends/developments in the law.
Released on Feb 10, 2025
What we talk when we talk about orphan drugs in Chile: access, research and sanitary registrations
As markets become more sophisticated and focus on fundamental human issues, scientific research in pharmaceuticals gains increasing importance. However, why do orphan drugs attract less attention in these areas? In Chile, issues related to access to these medications, research and sanitary registration of products illustrate the challenges faced by small countries in improving conditions for populations affected by rare diseases.
Released on Feb 10, 2025
The Brazilian Supreme Court’s innovative approach towards patients’ lawsuits claiming access to gene therapies
Based on the guarantees provided by the Federal Constitution, many patients seek access to treatments through court orders, including medicines without marketing authorisation from the Brazilian health regulatory agency (Anvisa) or which are not reimbursed by the public health system (Sistema Único de Saúde or SUS). This phenomenon is called health litigation. However, the Brazilian Supreme Court (STF) recently innovated the approach towards lawsuits aiming for access to a specific gene therapy, Elevidys. The case pending before the STF is a precedent that may influence future strategies of pharmaceutical companies for commercialising high-cost medicines in Brazil, involving coordinated efforts among key regulatory entities.
Released on Feb 10, 2025
Hemp in Brazil: a promising omen coming from the judiciary
In 2022, a Brazilian startup filed a lawsuit seeking the adjudication of its right to cultivate hemp and market its parts in Brazil for medicinal and industrial uses. The Superior Court of Justice (STJ) ruled in November 2024 that hemp with low THC levels cannot be considered proscribed under Brazilian law, allowing its economic exploitation for medicinal and pharmaceutical purposes. This decision mandates ANVISA to establish regulations within six months. The ruling is unprecedented, differentiating hemp from psychoactive cannabis, and emphasising the need for public policies to manage cannabis varieties.
Released on Feb 10, 2025
Early months of the updated framework for novel foods and ingredients: proactive transparency – progress and challenges
The first months of implementing Anvisa’s RDC 839/2023, which updated the regulatory framework for novel foods and ingredients in Brazil, have already brought some practical challenges for the food industry. For example, the Resolution introduced proactive transparency measures by Anvisa, reinforcing and recognising the confidentiality of the dossiers and exclusivity for companies that can demonstrate that the approvals rely on trade secrets. The purpose of this article is to briefly set out some of the progress and challenges experienced so far, providing insights into expectations for 2025.
Released on Feb 10, 2025
Safeguarding innovation: why strong patent protection is crucial for advancements in healthcare
This article examines the critical role of having robust intellectual property rights (IPR), particularly patents, when driving innovation within the healthcare sector. It highlights that strong patent protection incentivises the substantial investments required for research and development (R&D) of new medicines, medical devices and diagnostic tools. While acknowledging concerns about access to affordable healthcare, the article emphasises the importance of respecting patent rights to ensure continued advance in medical science and the development of life-saving treatments. By analysing the relevance of having patent law and the potential consequences of the wrongful use of compulsory licensing, this article advocates for a system that prioritises the protection of intellectual property as a cornerstone in healthcare innovation.
Released on Feb 10, 2025
Voluntary assisted dying laws in Australia
Voluntary assisted dying (VAD) has become legal in all states and territories in Australia except the Northern Territory following many years of debate regarding this issue. The legislation considers eligibility, checks and balances that address concerns over safeguards for patients, and legal rights and obligations of health professionals. Australian case law has held that voluntary assisted dying is not suicide under crimes legislation, however, the procedure under the VAD legislation needs to be closely followed.
Released on Feb 10, 2025
Reproductive health, IVF and surrogacy: legal and ethical issues
Complex legal and ethical issues surround assisted human reproduction, IVF and surrogacy. When does life begin? Should parents be able to select embryos in order to choose sex? Should women have the human right of reproductive freedom? What about the rights of the parents, surrogate and children? This article discusses the law in Australia and some of the leading cases in Australia and overseas.
Released on Feb 10, 2025