A challenging economic and geopolitical climate has not deterred life sciences businesses across the globe from producing innovative and ground-breaking medicines and technologies. This report highlights key legal and regulatory developments in the UK and the EU – and the related liability risks. Our experts also shine a spotlight on a number of priority topics for life sciences businesses, and their insurers, to consider as they plan for operational resilience in the months ahead.
Notwithstanding an unprecedented period of uncertainty arising from Brexit and the COVID-19 pandemic – the impacts of which continue to be felt across all industry segments - life sciences businesses are emerging as resilient and forward thinking, working tirelessly to produce devices, treatments and therapies that will support global health in the years ahead whilst accounting for environmental, social and governance (ESG) priorities.
Advancements in medical technologies and the application of artificial intelligence have resulted in ground-breaking products and processes; new treatments and therapies have revolutionised the sector. Alongside this, the relationship between the life sciences industry and global businesses’ ESG commitments continues to flourish.
Confidence in the capabilities of the industry is reflected in global investment and funding programmes. For example, the UK Government announced on 28 March 2023 that there will be £277 million in private and government investment that will help fund and advance manufacturing projects in medical diagnostics and human medicines.
In the EU, Horizon Europe, the EU’s primary funding programme for research and innovation, which has a budget of €95.5 billion, continues to encourage research and collaboration whilst supporting breakthrough innovations through its European Innovation Council.
As technology continues to drive innovation in life sciences at pace, law makers in the UK and EU are each carving out their own legislative paths. This requires a proactive approach to ensure that the legal and regulatory frameworks that govern life sciences products are fit for the risks and challenges arising in the modern world, as well as introducing, and managing, increasing ESG-related obligations.
The report examines the risks related to these key trends, including the relevant regulatory and legislative developments to watch.
Building upon the extraordinary accelerated development and use of digital technologies during the COVID-19 pandemic, digital transformation remains a priority for pharmaceutical, medical device and biotech companies who are joining forces with technology businesses to produce advanced digital health products and services, ranging from smart health applications and devices to digital therapeutics that can manage chronic health conditions.
We look at key regulatory and legislative developments in this area, including the future medical devices regulatory framework in the UK and the extension of the transitional periods for the EU Medical Device Regulation and EU In-Vitro Diagnostic Regulation.
Key liability risks
As the laws and regulations governing digital technologies in the UK and EU continue to evolve and seek to keep pace with the speed at which the technologies are developing, legal claims in relation to product liability, AI and data privacy are increasingly key liability risks for life sciences companies and their insurers.
We discuss key regulatory and legislative developments in this area, including the impact of the Data Protection and Digital Information (No.2) Bill.
Treatment and therapies
Pioneering treatments and therapies continue to be a priority for life sciences companies. The development and use of personalised medicine has gathered pace in recent years, and 2023 is expected to present further opportunity for patients to receive medicines and treatments that are personalised to them.
Here, we focus on the development of pioneering treatment and therapies, including cellular treatments and psychedelics, whilst also providing background on the reform of UK clinical trials regulation.
Environmental, social and governance (ESG)
Innovation and ESG concepts are inextricably linked. From the development of the COVID-19 vaccine to the rapid development of novel MedTech products, breakthroughs within the life sciences industry continue to contribute significantly towards creating a safer and healthier society.
In this report, we consider key ESG-related risks for life sciences companies, including Polyfluoroalkyl substances (PFAS), the impact of diversity, equity and inclusion (DEI) on medical devices, and the European Commission's proposals for a Directive 2022/0051 on Corporate Sustainability Due Diligence.
Trends and future risks
In our forecast reports, we offer insight into legal and regulatory change as well as hot topics to watch, providing practical commentary based on our sector knowledge to corporates and insurers.Find out more