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Committee publications

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Significant recent changes to the UK economic migration regime

The UK Home Office has recently implemented policies to reduce legal migration, including work-based immigration. This article outlines the context, details and potential implications of such significant changes to the UK economic migration regime.

Released on May 2, 2024

The impact of the EU’s AI Act on the medical device sector

The EU has created the world’s first government regulation of artificial intelligence (the AI Act) which has significant implications for the medical device industry. The AI Act categorises medical devices as a high-risk group and requires providers to comply with strict standards in terms of risk management, data quality, transparency, human oversight and robustness. In addition to the requirements of the Medical Device Regulation (MDR), medical device manufacturers will have to comply with additional regulations in future.

Released on Apr 30, 2024

Market dynamics and legal implications: analysing product liability in Africa’s medical device sectors

The medical device industry is experiencing rapid growth globally, particularly in Nigeria and across Africa. This expansion presents substantial market opportunities. However, the corresponding increase in product liability lawsuits poses considerable legal and financial risks to international pharmaceutical companies and medical device manufacturers operating in Nigeria and Africa as a whole. This article discusses relevant legislation in Nigeria and proposes practical strategies for medical device manufacturers to minimise the likelihood of product liability claims, suggesting defences to navigate adeptly through product liability suits.

Released on Apr 30, 2024

Trade secrets: a strategic element in the life sciences and biotechnology industries

Trade secrets can play a crucial role in protecting a company’s competitive edge. Unlike patents, which require public disclosure of the invention, trade secrets must remain confidential. This makes them particularly well-suited for protecting intangible assets in many situations. Maintaining secrecy creates an information asymmetry, giving the trade secrets’ holder a significant advantage over competitors. The following considerations aim to assist professionals in strategically choosing trade secrets as a form of intellectual property protection and in adopting appropriate measures for their upkeep.

Released on Apr 30, 2024

DTx: where do EU regulations stand in this emerging, rapidly-growing market?

Digital Therapeutics (DTx) are a new kind of medical device (some even say of medicine), designed to complement, lighten or even replace the need for medication. They are generally said to be evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease.Considered one of the most innovative areas within digital health, DTx target a wide range of conditions, including chronic diseases, diabetes, and mental illness. Their market is booming, with US$17.7bn in revenues forecast for 2027, and nearly a thousand clinical trials underway globally.

Released on Apr 30, 2024

Patient access to new digital therapies: challenges and opportunities of digital therapeutics in the EU

Digital therapeutics, in the form of software designed to treat disorders and diseases, are spreading at varying rates across countries worldwide. Applications include the treatment of conditions such as anxiety and depression, insomnia, obesity and diabetes. There are many benefits of these new technologies in terms of treatment efficacy, adherence and cost savings for national healthcare systems. However, their widespread use is often hampered by the lack of specific rules and procedures for market access, clinical and technological evaluation, approval and reimbursement by national health systems or private insurers. This article addresses these issues with particular reference to the European Union and Italian context.

Released on Apr 30, 2024

Recent landscape on foreign direct investment in Medtech/Pharma in Saudi Arabia

The healthcare and life sciences sector is one of the most significant sectors in Saudi Arabia and is a key focus of Saudi Vision 2030. Through the various Vision 2030 programmes, Saudi Arabia seeks to introduce new strategies to fulfil public health needs through insurance-based financing and increasing private sector participation.

Released on Apr 29, 2024

Navigating scarcity: solutions for medicine shortages in the EU, Central and Eastern Europe

Medicine shortages pose significant challenges within the European Union (EU) due to various factors, including manufacturing issues, regulatory hurdles, and pandemic-induced disruptions. The Covid-19 crisis worsened shortages, leading the EU to propose comprehensive measures. These measures authorise the European Medicines Agency (EMA) to monitor and coordinate supply-related issues. The EU has also introduced initiatives such as the action plan to mitigate medicine shortages or the Critical Medicines Alliance to address shortages collaboratively. Nationally, countries such as the Czech Republic and Slovakia are implementing regulations to manage shortages, although critics question their efficacy. This article delves into strategies and challenges in mitigating medicine shortages in the EU.

Released on Apr 29, 2024

Artificial intelligence and health: current challenges for the law

Artificial Intelligence (AI) has transformed medical care, with the potential to transform patient care and quality of life. It has had a major impact in the field of medical research and diagnosis; has eliminated time-consuming data monitoring methods and has improved the interpretation of large amounts of data derived from different sources to facilitate diagnosis and enhance the ability to execute early treatment initiatives, therefore preventing disease. The era of AI envisages new roles for healthcare providers, legal practitioners and academics as well public policy designers. This article analyses some of the ethical and legal issues in the healthcare sector.

Released on Apr 29, 2024

Product liability and medical devices in Brazil

This article provides an overview of product liability in Brazil and the application of consumer law standards to suppliers of medical devices with respect to consumers as end users.

Released on Apr 29, 2024

Balancing public health and IP rights: compulsory licensing and evergreening practices

This article explores the complex interplay between compulsory licensing and patent evergreening within the pharmaceutical sector. It examines the implications of these two tools on innovation, public health, and market competition across various jurisdictions. While a compulsory licence is supposed to safeguard public interest at large by allowing a third party to use a patented invention for the public good, evergreening allows organisations to extend their patent protection beyond the original 20-year term by making incremental changes to their original innovation. Consequently, when employed judiciously, these approaches can help maintain a healthy balance between a country’s public welfare and its financial ecosystem. This article therefore looks at some interesting perspectives on the outlook of different countries on these provisions.

Released on Apr 29, 2024

Artificial intelligence and life sciences: a perspective from Singapore

This article examines the evolving intersection of artificial intelligence (AI) and the life sciences sector in Singapore, focusing on the relevant regulatory frameworks and developments. The article further describes the public consultation approach that Singapore has taken in relation to addressing ethical, legal and social concerns for human biomedical research.

Released on Apr 29, 2024

The protection of health data in Brazil

The Brazilian Data Protection Law (Law No 13,709/2018 or 'LGPD') is the most comprehensive data protection law enacted in Brazil and it applies to: (1) data processing activities in Brazil; (2) processing of data collected in Brazil or concerning individuals located in Brazil; and (3) data processing activities with the purpose to offer goods/services to individuals in Brazil.

Released on Apr 29, 2024

Product liability and implanted medical devices in Brazil

The import, manufacturing and sale of medical devices in Brazil require prior registration with the Brazilian Health and Surveillance Agency (Agência Nacional de Vigilância Sanitária or 'ANVISA') with evidence of the product's safety, effectiveness and quality.

Released on Apr 29, 2024

The synergy between artificial intelligence and life sciences: a revolutionary interplay

Throughout history, technological developments have played a fundamental role in revolutionising the provision of healthcare. Corroborating this premise, artificial intelligence (AI) is currently leading the Fourth Industrial Revolution, opening an unprecedented era of advances in healthcare technology through the introduction of technological tools into the life sciences. Seeking to enlighten the synergy between this disruptive technology and the life sciences, this article explores the major developments arising from the integration of AI into the various branches of the life sciences, as well as the main challenges and ethical considerations that accompany these developments.

Released on Apr 29, 2024

Exploring the promise and challenges of AI in healthcare: a discussion with ChatGPT on disease prediction, diagnosis and ethical considerations

In this discussion, we explore the intersection of artificial intelligence (AI) and healthcare, focusing on the potential of AI models to predict diseases with appropriate inputs and the ethical, practical and regulatory considerations involved. We examine the idea of hyperspecialised AI models aiding in diagnosis and the challenges of ensuring accuracy, addressing bias, and maintaining privacy and data security. The interview also touched on treating AI models as software as a medical device (SaMD) and the implications of using AI, such as ChatGPT, for diagnosing diseases based on user-provided symptoms.

Released on Apr 29, 2024

The intersection of Big Data and healthcare: advancements and challenges in Hungary

One of the biggest challenges facing social healthcare systems is the implementation of prevention programmes versus treatment. Health promotion and disease prevention is not only the individual’s responsibility but the result of coordinated organisational actions. In future health development, digital solutions, harmonisation of databases and value-based healthcare could be the key aspects of addressing the challenges.

Released on Apr 29, 2024

Interoperability in healthcare in Brazil: trends and challenges

The debate over the integration of systems and information has been in the spotlight of the healthcare sector in Brazil. Collaborative and integrated management in the delivery of healthcare services is a key strategy driving the sector towards digital transformation. This article presents the current and future trends, as well as the hurdles for the implementation of full interoperability in healthcare in Brazil, from a legal and practical point of view.

Released on Apr 29, 2024

Artificial intelligence and life sciences

AI development, notably generative AI, has experienced a significant increase, with life sciences and healthcare as a key investment area. Despite its potential benefits in diagnosis and treatment, AI presents risks such as biases, accessibility issues and cybersecurity threats. Additionally, there are concerns about social risks.

Released on Apr 29, 2024

Trade secrets and the recently launched Unified Patent Court (UPC)

How does this brand new pan-national patent court address the conflicting interests of streamlining patent infringement cases without jeopardising the rights of the defendant to conceal its trade secret from been disclosed to its competitors? First orders seem to be very pragmatic and still very much linked to the nationality of the judges in charge of the case.

Released on Apr 29, 2024

Securing innovation: tackling widespread counterfeiting and intellectual property piracy in Pakistan

Pakistan, like many countries, is confronting a significant issue in the form of increasing counterfeiting and intellectual property (IP) infringement, which poses a risk to innovation and economic development. This complicated problem not only poses the danger of impeding the growth of a strong innovation environment but also presents substantial threats to economic stability, public health and consumer safety.

Released on Apr 29, 2024

Financing of advanced new therapies, and regulatory status of gene therapies and orphan drugs

The advanced therapy products have required health authorities to act proactively to conceive appropriate regulatory solutions to make them available to patients. In this article, we present an overview of the current Brazilian regulatory scenario concerning advanced therapy products and how the public and private health systems have moved to make access to these products feasible within the Brazilian context.

Released on Apr 29, 2024

Enhanced AI risk management system for importing medical products

Advanced or disruptive technologies are reconfiguring the paradigm, providing innovative techniques that benefit the operations of border control agencies. This article explores the applications and benefits of implementing AI in health controlling authorities' risk assessment for the import of medical products, based on a recent Peruvian experience.

Released on Apr 29, 2024

Regulatory status and reimbursement of gene therapies and orphan drugs in Switzerland: taking CAR-T therapy as an example

This article examines the regulatory and reimbursement landscape for gene therapies and or-phan drugs in Switzerland, with a focus on CAR-T therapy. As Switzerland navigates the inte-gration of these advanced treatments into its healthcare system, we explore the roles of Swissmedic and the Transplantation Act (the 'TA'), challenges in reimbursement, and the inno-vative approaches to pricing and market access. The article underscores the collaborative ef-forts between regulators, healthcare professionals, and the pharmaceutical industry, providing a comprehensive view for stakeholders at the World Life Sciences Conference and beyond.

Released on Apr 29, 2024

Bolar exemption, UPCA and Pharma Package: what to expect? An Italian perspective

When the Bolar exemption was introduced at the EU level in 2004 (though some Member State case law applied it prior to that date), it struck a balance between the need for patent owners to preserve their proprietary rights as long as possible and the desire of businesses to enter the market without undue delay the day after patent expiration (known as 'Day 1').

Released on Apr 29, 2024

Life sciences deals in Brazil in the post-pandemic era

M&A activity in Brazil in the healthcare and life sciences sectors soared during the coronavirus pandemic. However, in the aftermath, dealmaking has been drastically affected. Despite the challenges, the current post-pandemic landscape unveils new opportunities, targeting low-risk, complementary and profitable businesses in search for synergy and efficiency.

Released on Apr 29, 2024

ESG compliance in action in the Brazilian life sciences industry

The article addresses the Brazilian ESG framework and, specifically, rules that should be observed by players active in the life sciences sector. Despite the lack of specific legal ESG criteria for different industry sectors in Brazil, there are some pieces of legislation and initiatives relating to environmental, social and governance aspects that should be observed by life sciences businesses.

Released on Apr 29, 2024

Navigating trade secret protection in R&D collaborations: requirements and challenges

In today's dynamic business environment, research and development (R&D) collaborations are pivotal drivers of innovation, spanning various sectors. Yet, the efficacy of many such collaborations relies heavily on ensuring the protection of confidential information and/or trade secrets. This article delves into the intricate requirements and challenges associated with safeguarding confidential information and/or trade secrets within R&D alliances and partnerships, drawing on established legal frameworks and industry norms.

Released on Apr 29, 2024

E-commerce of medicinal products: global freedom or national restrictions?

The international trade of medical products through e-commerce platforms presents numerous challenges and opportunities. This article explores the complexities and implications of global freedom in the commercialisation of medical products, focusing on regulatory hurdles, ethical concerns, and the balance between accessibility and safety

Released on Apr 29, 2024

Navigating the multigenerational workforce and advocating for gender pay equality in the Thai legal sphere

Managing a multigenerational workforce poses challenges for Thai law firms, where traditional values often clash with modern practices. This article explores these challenges, and advocates for gender pay equality, emphasising the need for inclusive policies and proactive measures to bridge generational and gender gaps in the workplace.

Released on Apr 25, 2024