Life Sciences Horizons Brochure 2025 - Flipbook - Page 2
2025 Horizons Life Sciences and Health Care
Welcome
1
In 2025, Life Sciences and Health Care
(LS&HC) companies face rapidly evolving
regulatory paradigms that create
transactional risks and require daily
monitoring. After more than 70 national
elections in 2024, the dust hasn’t fully
settled, not least in the U.S., where
President Trump has taken office for the
second time. Indeed, political shifts across
the world – coupled with geopolitical
uncertainty – set the tone for changes
to come.
supply chain issues; a rethinking of purchasing and supply
strategics due to shortage of raw materials and price
increases; and industry cooperations forming a new
approach to procurement.
As staff cuts hit governmental agencies, LS&HC
stakeholders are intensely focused on the policy
implications for global financial markets, investment
strategies, and M&A opportunities. Among numerous
effects, the second Trump administration and “MAHA”
influences will shape AI policy, GLP compounding rules,
U.S. inspections and enforcement capabilities, drug
shortage regulations, ongoing laboratory developed test
(LDT) litigation, and reimbursement policies for innovative
diagnostics and preemptive health platforms. 2024 also
saw Loper Bright replace the former agency friendly
Chevron standard in U.S. courts, meaning life science
companies now have a new tool in their arsenal for
challenging governmental decisions.
Meanwhile, AI-enabled technologies are continuing to
demonstrate enormous potential to create a healthier
world, fueling advances in areas as varied as drug
development, software-as-a-service, and analysis of
medical images. Aiming to keep pace with these rapid
technological developments, regulations including the
EU’s AI Act, and guidance stemming from FDA’s inaugural
Digital Health Advisory Committee meeting in November,
present unique challenges for AI developers in the health
sector, including the possibility of duplicative regulations
or even conflicting regulatory obligations.
In Latin America, the U.S., Europe, the Middle East, and
Southeast Asia, we are seeing governments taking
aggressive stances on corruption. The life sciences industry
in particular faces increasing scrutiny over bribery and
corruption practices. Recent developments in False Claims
Act litigation, support for patient organizations, and the
integration of AI within legal and compliance departments
are vital components in addressing bribery and corruption
risks. In Europe in particular, key enforcement actions
targeted anti-competitive practices in 2024, including
pay-for-delay agreements, market disparagement, and
patent abuse.
All around the globe, a shift away from fossil fuels and
toward sustainable greenhouse gas emissions – the “energy
transition” – makes compliance with environmental,
social, and governance (ESG) policies more important than
ever. Recent geopolitical and economic headwinds are
driving an increased focus on strengthening and
transforming supply chains, including political pressure to
reconfigure supply chains to ensure strategically important
industries (“near shoring”). We are also seeing increased
scrutiny of fair supply chains and compliance with
corporate responsibility standards; a need to digitally
transform to better anticipate, mitigate and document
In the EU, the Corporate Sustainability Due Diligence
Directive (CSDDD) and Corporate Sustainability Reporting
Directive (CSRD) have placed greater focus on ESG
regulatory enforcement activity. In the U.S., the Drug
Supply Chain Security Act (DSCSA) is beginning to be
enforced, creating an electronic interoperable system that
will identify and trace prescription drug distribution. In
addition, new EU directives impose strict requirements on
use of genetically modified organisms (GMOs), aiming to
mitigate environmental and public health risks, including
the need for detailed environmental risk assessments and
authorizations.
In the UK, the MHRA has taken a relatively light touch and
"pro-innovation" approach so far, as set out in its AI
regulatory strategy. In the EU, the Product Liability
Directive has taken effect, and focuses on addressing the
challenges posed by digital products and other emerging
technologies. Policymakers continue to face a steep
learning curve, and industry perspectives are vital to
advance appropriate regulations that both foster
innovation while protecting patients and users from the
negative impacts that can come with the promise of AI.
AI developers continue to struggle within the existing
legacy coverage and reimbursement pathways. At the same
time, the issues around patient data are growing in
complexity as regulators, patients, and clinicians become
better equipped to understand the challenges and risks of
utilizing patient data.
In the dealmaking space, Chinese biopharma companies
are increasingly turning to licensing and collaboration
deals for external financing due to a challenging
fundraising environment. In Japan, we expect more
strategic transactional activity (i.e., licensing and M&A)
in 2025, as private equity interests grow despite the
escalating risks of cross-border transactions, including
geopolitical disruptions, fluctuating valuations, and
regulatory uncertainties. The U.S. is also seeing increased
life sciences deal activity risks associated with antitrust
regulatory uncertainty. Proactive M&A strategy is crucial,
as regulatory hurdles, financial missteps, and operational
disruptions can derail deals.
The Hogan Lovells global Life Sciences and Health Care
team – comprised of more than 500 lawyers around the
world who support more than 1,000 clients in the industry
– stands ready to provide you with creative strategies to
help achieve your most promising opportunities, and
integrated solutions to protect and support your business.
We hope that you find our view of the horizon thoughtprovoking. We look forward to working together with
you as we accelerate faster and further into the future.
Global Co-Heads, Life Sciences
and Health Care Sector
Steve Abrams
Partner
Philadelphia
Lynn Mehler
Partner
Washington, D.C.
Jane Summerfield
Partner
London
