Co-Chair
Cecile
Theard-Jallu

Co-Chair
Anne Walsh

Healthcare and Life Sciences Law Committee

The Healthcare and Life Sciences Law Committee addresses legal issues in the healthcare and life sciences sectors, such as medicine, intellectual property, biotech, bioethics, regulatory matters, and scientific developments. With a dynamic, diverse, and growing membership, the Committee fosters collaboration to tackle industry challenges, such as increased competition and regulatory changes.

We provide a platform for discussion, sharing knowledge, and updating members on key developments. Through conferences, seminars, and global events, the Committee promotes professional growth, enabling members to benefit from advanced practices in well-established jurisdictions while supporting those new to this field.

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 Sciences Law Committee annual global surveys

Each year the Healthcare and Life Sciences Law Committee has produced a new comparative legal guide covering a highly relevant topic in over 50 countries. This guide is intended to offer practitioners and industry users easy access to the relevant applicable rules. In 2023, the Committee addressed questions related to telemedicine. In 2024, the Committee summarised the requirements for promoting pharmaceutical and medical devices in these countries.


Join us on LinkedIn

If you are a member of the Healthcare and Life Sciences Law Committee, for additional networking opportunities, programs, interviews with fellow members and tips all exclusive to members, join our LinkedIn page at: https://www.linkedin.com/groups/9166617/.