Co-Chair
Cécile
Théard-Jallu

Co-Chair
Anne Walsh

Healthcare and Life Sciences Law Committee

The Healthcare and Life Sciences Law Committee is rooted in legal issues arising within healthcare sectors throughout the world as well as affiliated interest areas within the life sciences arena. In this regard, it is concerned with those fields of science that involve the scientific study of living organisms, with a special focus on all aspects of healthcare law.

About the Committee

The Healthcare and Life Sciences Law Committee is rooted in legal issues arising within healthcare sectors throughout the world as well as affiliated interest areas within the life sciences arena. In this regard, it is concerned with those fields of science that involve the scientific study of living organisms, with a special focus on all aspects of healthcare law, including such areas as medicine law, intellectual property, biotech, bioethics, regulatory issues and scientific developments, on a worldwide basis.

The Healthcare and Life Sciences Law Committee is a fast-growing committee with a dynamic and diverse membership across the globe.

The challenges the industry is facing today, a growing competitiveness and regulatory changes demand that we work together to deepen and develop this area of practice with a prominent place in our environment. This is essential to provide our clients with services rendered by highly trained quality professionals.

In this regard, the committee provides a forum of discussion among health and life Science lawyers, and aims to provide regular updates of important changes in this ground. This allows transversality of knowledge and experience, making use of the benefits of globalization and allowing that the developments and accomplishments obtained by those who exercise their profession in countries where life Science practice is more advanced are seized by those who have just started their journey in this area.

This exchange of knowledge and experiences will be at its height in the conferences and seminars organised by our committee within the IBA, or in the events in which our committee participates. The exchange enriches those who participate and directly collaborates with development and professionalisation of the practice area at the global level.

Forthcoming conferences and webinars View All Conferences

Publications

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

Projects

IBA Healthcare and Life Science Law Committee telemedicine survey

The Healthcare and Life Sciences Law Committee has produced a new comparative legal guide covering the highly relevant topic of telemedicine across 54 countries. This guide is intended to offer practitioners and industry users easy access to the relevant applicable rules. Each jurisdiction answers the most frequently raised questions in relation to telemedicine.