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Over the last few months, the world's focus has understandably
been on the tumult of the novel coronavirus 2019 (COVID-19)
pandemic. However, in the meantime, quiet progress continues to be
made in terms of R&D into innovative pharma sectors - with
Japan's regenerative sector as a prime example.
Japan has been a pioneer of regenerative medicine, after the
country's Diet (national legislature) passed a law in November 2013
classifying stem-cell therapies as a regenerative medicine under
the country's Pharmaceuticals and Medical Devices Law. Not only
that - after setting up "regenerative medicine products" as a new
product category, Japan also introduced a "conditional and
time-limited approval system" that enabled regenerative medicine to
gain approval while their efficacy was still only "presumed". A
year later, the country also approved insurance coverage for
regenerative medicines after they receive conditional and
time-limited approval.
This year, those regulations continue to bear fruit in the form
of several 'firsts' in the regenerative sector. In March 2020,
Japan's Ministry of Health, Labour and Welfare (MHLW) approved the
country's first ophthalmology-focused regenerative treatment: Japan
Tissue Engineering (J-TEC, Japan)'s Nepic (autologous cultured
corneal epidermis, EYE-01M), for the treatment of corneal
epithelial stem cell deficiency. In June, the MHLW approved the
first clinical research programme for the transplantation of
induced pluripotent stem (iPS) cell retinal sheets in patients with
retinitis pigmentosa. Japan has now approved nine regenerative
medicines, including Novartis's gene therapy Zolgensma
(onasemnogene abeparvovec) in March 2020 for the treatment of
spinal muscular atrophy.
All these decisions point to a country that is anxious to
maintain its reputation as a pro-innovation pharma market, even as
major pharmaceutical associations and drugmakers increasingly
protest that the contrary is true. In particular, Japan's
government - with an eye on its soaring healthcare spending - has
implemented increasingly robust drug pricing regulations. In
November 2018, the Pharmaceutical Research and Manufacturers of
America (PhRMA) association warned that Japan's pharmaceutical
sector risks becoming deprioritised by overseas drug makers if the
"wrong type" of policies is implemented. The statement echoed
similar concerns from other major pharma trade associations,
including the European Federation of Pharmaceutical Industries and
Associations (EFPIA) and the Japan Pharmaceutical Manufacturers
Association (JPMA).
While Japan is not expected to take its foot off the
drug-pricing pedal in its bid to reduce healthcare spending, the
country's attractiveness is expected to grow as an investment and
approval destination for pharma multinationals developing
regenerative treatments. The country looks set to further cement
this approach. Last month, a Japan government council held its
first meeting focusing on progress in the country's R&D into
regenerative medicine and cell and gene therapies. The meeting,
which brought together the MHLW, the Ministry of Education and the
Ministry of Economy, Trade and Industry, discussed Japan's 2030
roadmap for R&D of regenerative treatments, with the aim of
setting out concrete proposals from April 2021. The council, which
was set up in July 2020, will help to accelerate the formulation of
Japan's health and medical strategy for FY 2020-24.
Looking ahead, pandemic notwithstanding, Japan's regenerative
sector is expected to continue to create ripple effects - including
attracting overseas interest and knowledge-sharing, as well as
providing further opportunities for international mergers and
acquisitions. So far, Australian biotech firms Mesoblast and
Regeneus have significantly expanded their presence in Japan.
Interest goes both ways: in October 2019, Astellas also agreed to
invest USD12.5 million into two of US firm LabCentral's cell and
gene innovation startups. Overall, case studies such as Japan's
regenerative sector strike a hopeful note that when the COVID-19
pandemic finally leaves centre stage, the right foundations will
have been put in place to drive future growth in the life sciences
sector.
Posted 20 October 2020 by Sophie Cairns, Senior Research Analyst, Life Sciences, IHS Markit
