LS&HC Horizons 2022 - Flipbook - Page 3
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
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Welcome
The Covid-19 pandemic remains a dominant
theme in our forward looking view for
companies in the life sciences and health care
industry, as the past year has continued to
create challenges and a seemingly endless
stream of lockdowns and viral surges. While
uncertainties abound, we remain hopeful that
the innovations necessitated by our collective
pivot to pandemic life will become a part
of our new normal.
The worldwide vaccine rollout enabled the gradual easing
of Covid-19 mandates, but with a watchful eye on the
evolution of new variants. The pandemic continued to
drive the development and adoption of new technologies
and innovations resulting in massive investments into AI,
virtual health solutions, telehealth products, and related
cybersecurity measures. It also spurred increased scrutiny
by regulatory authorities over supply chain reliability, and
we expect to see continued activity in this area with the
enactment of new diligence obligations, return to in person
inspections, and overall manufacturing accountability.
Precision medicines continue to provide opportunities
within evolving regulatory frameworks that are as complex
as their innovative technologies. Moreover, advanced
analytics are enabling the incorporation of data collected
outside of a traditional clinical setting and regulators are
taking note. The need for rapid response and working with
regulators to expedite development and review processes
will continue to be crucial for the life sciences and health
care industry for many years to come.
In the transactional space, we also see increasing
complexity, as partners develop innovative terms and
payment structures to account for long development
timelines and allocation of manufacturing risk for bespoke
therapies. While investors may continue to take a cautious
approach towards IPOs, indications point to a robust M&A
and partnering market in 2022 as many large companies
have amassed significant amounts of cash. We believe that
innovators having strong data and sound fundamentals
will continue to attract investments. We also continue to
advise clients on innovative alliances between government,
industry, and academia. Conversely, we also see an
increase in arbitration, particularly involving cross-border
contractual disputes.
In addition to the seismic shifts stemming from coronavirus,
life sciences and health care companies are affected by
specific issues in each geographic region. In the United
States, data collection continues to attract the interest
of state regulatory bodies in addition to meeting federal
requirements. This is similarly true elsewhere in the
Americas, where we see cybersecurity and privacy concerns
raised in the context of new digital health offerings in
Mexico. The UK is developing new legislation in areas such
as medical device regulation, balancing increased flexibility
post-Brexit with aligning closely with EU and other major
international regulatory systems. In the EU, our life
sciences and health care clients are also navigating changing
legislation with the introduction of new regulations on
clinical trials and medical devices, and proposals for new
legislation on artificial intelligence. Companies are also
watching the coming implementation of the Unitary Patent
Court and its impact on existing systems in Member States.
These themes also carry over to Asia-Pacific markets, from
regulators watchful of PPE in Australia to recent patent
reforms having significant regulatory impacts elsewhere in
the region. We have been advising clients doing business
in China on new regulations on the use of human genetic
resources and the implementation of amendments to the
patent law, with significant implications for patent linkage
and future marketing authorizations. Patent linkage also
continues to be an important topic in Japan, along with the
evolution of suitable pricing models for access to innovative
therapies. Last but not least, the challenges faced as life
sciences companies interact with local third parties in
India is also emblematic of these within- versus crossborder tensions.
These are just some of the current and evolving trends that
are shaping the future of the industry, which we discuss in
the following pages. 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 at the ready to provide
you with creative strategies for your most promising
opportunities and integrated solutions that protect and
support your business when issues arise. We hope that
you find our view of the horizon thought-provoking.
We look forward to working together, and hopefully
seeing each other again soon.
Global Co-Heads, Life Sciences
and Health Care Industry Sector
Steve Abrams
Partner, Philadelphia
Lynn Mehler
Partner, Washington, D.C.
Jane Summerfield
Partner, London
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