LS&HC Horizons 2023 - Flipbook - Page 53
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | APAC
53
Life Sciences in Japan
Japan is emerging into the “with corona” world
with heightened public interest and awareness
of the biopharma industry. Domestic efforts
in tackling the pandemic (including new
vaccines now being developed by Japanese
pharma companies) appear to be encouraging
greater alignment of Japan with international
standards for clinical trials, with the relevant
regulator potentially accepting the benefits
of harmonizing the Japanese rules and
regulations more closely with those of
other countries.
We anticipate that companies will still
prioritize and invest in Japan, while monitoring
closely how the world’s third-largest market
refines the regulatory process to strike an
appropriate balance between encouraging
innovation and managing associated costs.
Advocacy for the maintenance of suitable
pricing (premium) for innovative drugs has
continued; if successful, this may lead to
improved commercial predictability and thus
some restoration of the Japanese market’s
attractiveness. There is increased desire to
eliminate “drug lag” and provide practical
support for developing bioventures.
Dr. Frederick Ch'en
Office Managing Partner, Tokyo
We expect increased focus on data privacy/
protection, cybersecurity, digital health
(especially wearable tech and personalized
data-driven care), automation and artificial
intelligence; there may also be a gradual
emphasis on issues relating to access to
medicines as well as unmet medical needs.
Originator versus generics patent cases are
expected to endure. The “patent linkage”
system may evolve such that the extent to
which the regulator typically refrains from
granting a marketing authorization for
a generic product falling within the scope
of relevant patents may become clearer.
A number of biologics and biosimilar patent
cases remain the focus of dispute resolution
in Japan, somewhat mirroring cases elsewhere,
and we expect these to increase. As in previous
years, we recommend analyzing and assessing
the practical impact of Japan-specific
developments in due course.
Band One for Life
Sciences in Japan and
Asia-Pacific in Chambers
Asia-Pacific, 2023
