2021 LS&HC Horizons - Flipbook - Page 50
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Hogan Lovells
Asia-Pacific
Life sciences in Japan
We expect continued investment in Japan
by companies seeking to take advantage of
the world’s third-largest market, enhanced
drug development, and potentially more
flexible approaches to drug approval (such as
multi-regional clinical trials) and the
regulatory process.
however, it is becoming much less clear to
what extent the regulator will wait in respect of
relevant patents (e.g., until all avenues of appeal
are exhausted), especially given the Japanese
government’s promotion of generic drugs in the
light of the increasing cost of medicine and the
aging population.
A new system of annual drug price cuts
(previously biennial) will start from 1 April
2021, applying to all medicines with more than
a 5 percent difference between the government
reimbursement price and the wholesaler price
to health care providers such as hospitals and
retail pharmacies (average deviation in 2020:
8 percent). This will likely affect 70 percent of
all National Health Insurance listed drugs,
with an estimated reduction of JPY430 billion
(c. US$4.1 billion) in FY-21.
COVID-19 has heightened public interest and
awareness of the biopharma industry, including
in respect of regulatory approvals, clinical trials,
access to therapies, supply chains, storage and
logistics. We may see efforts to educate citizens
and to enhance access to new and innovative
vaccines, including developments in respect
of their evaluation and adoption, quality
and regulatory standards, and management
of adverse events, as well as their potential
manufacture in Japan in the light of possible
export restrictions elsewhere in the world.
The “patent linkage” system may continue to
evolve. Historically, while a patent was valid and
in force, the regulator would typically refrain
from granting a marketing authorization in
respect of a generic product falling within the
scope of relevant patents, including while a
decision of invalidity by the Japan Patent Office
was being appealed to the IP High Court; now,
Frederick Ch’en
Office Managing Partner, Tokyo
frederick.chen@hoganlovells.com
