To strengthen new drug development capabilities, Prime Minister: "To create more than 10 companies with a value of over 10 billion yen"

Recently NHK News on-line reported the following:

新薬開発力強化へ 首相“価値100億円以上の企業 10社以上に”

2024年7月30日 19時12分

政府は国内での新薬の開発力を強化するため、国内外の製薬企業などから意見を聞く会合を開き、岸田総理大臣は、新薬開発に関わるスタートアップ企業への投資を増やし、価値が100億円以上の企業を2028年までに10社以上生み出すことを目指す方針を表明しました。

政府は、新型コロナの感染拡大時にワクチンや治療薬開発で海外に後れをとったことなどを踏まえ、新薬の開発力を強化したいとしていて、30日、総理大臣官邸で国内外の大手製薬会社や、研究機関、患者団体など関係者から意見を聞く「創薬エコシステムサミット」と名付けた会合を開催しました。

この中で、岸田総理大臣は「医薬品産業を成長産業と位置づけ、必要な予算を確保し、国内外から優れた人材や資金を集結させることで、日本を世界の人々に貢献できる『創薬の地』としていく」と述べました。

そして、2028年までに新薬開発に関わるスタートアップ企業への民間投資額を2倍に増やし、価値が100億円以上の企業を10社以上生み出すことを目指す方針を表明しました。

政府は、海外の企業とも連携して治験を行える国内拠点の整備や、海外で使われている小児用や難病などの薬が国内で使えない「ドラッグ・ロス」の解消にも取り組むことにしていて、会合では官民の連携に向けて、来年度、新たな協議会を創設する方針も確認しました。

 

日本の創薬の現状は

厚生労働省によりますと、世界の医薬品市場に占める日本発の医薬品の売上高は、年々減少傾向にあり、2014年には1割を切ったほか、新型コロナの感染拡大時にはワクチンや治療薬の開発で海外に遅れをとりました。

また、海外で承認されている薬が国内で使えない「ドラッグ・ロス」も問題となっていて、小児用や難病などの薬86品目で、患者が少ないためにデータが取りにくかったり、採算性が低かったりすることを理由に、国内での治験が行われていないということです。

このため、ことし5月に政府の有識者らによる会議がまとめた新たな戦略では、国による人材育成や研究への支援の強化に加え、治験の環境整備や、規制のあり方の見直しなど、国内外から人材や資金を呼び込むための仕組みを構築する必要性が指摘されました。

今回のサミットはこれを受けて開催されたもので、政府は海外の製薬企業などから国内での事業展開や、投資に当たっての障壁を聞き取るほか、日本で進められている研究の情報を提供するなどして、日本を世界に肩を並べる「創薬の地」とすることを目指すとしています。

Translation

In order to strengthen domestic new drug development capabilities, the government held a meeting to hear opinions from domestic and foreign pharmaceutical companies, and Prime Minister Kishida announced a policy to increase investment in startup companies involved in new drug development and aimed to create by 2028 more than 10 companies with a value of over 10 billion yen.

In light of the fact that Japan fell behind other countries in vaccine and treatment development during the spread of COVID-19, the government wanted to strengthen new drug development capabilities, and on the 30th, a meeting called the "Drug Discovery Ecosystem Summit" was held at the Prime Minister's Office to hear opinions from major domestic and foreign pharmaceutical companies, research institutes, patient groups, and other related parties.

In this meeting, Prime Minister Kishida said, "We will position the pharmaceutical industry as a growth industry, secure the necessary budget, and bring together excellent human resources and funds from both within and outside Japan, making Japan a 'drug discovery center' that can contribute to the people of the world."

Also, the government announced a policy to double private investment in startup companies involved in new drug development by 2028, aiming to create more than 10 companies with a value of over 10 billion yen.

The government also planned to work with overseas companies to develop domestic bases for clinical trials and to eliminate "drug loss," where drugs used overseas for pediatric use or for intractable diseases could not be used in Japan. At the meeting, the government also confirmed its intention to establish a new council next year to promote public-private collaboration.

The current state of new drugs development in Japan

According to the Ministry of Health, Labor and Welfare, sales of pharmaceuticals originating in Japan in the global pharmaceutical market had been declining year by year, falling below 10% in 2014, and at the time of the spread of the new corona infection, Japan lagged behind overseas in the development of vaccines and therapeutic drugs.

In addition, "drug loss," where drugs approved overseas could not be used in Japan, was also a problem, and 86 drugs for pediatric use or intractable diseases were not undergoing clinical trials in Japan because of the difficulty in collecting data due to the small number of patients and low profit.

For this reason, a new strategy compiled by a government panel of experts in May pointed out the need for the government to strengthen support for human resource development and research, as well as to create mechanisms to attract talent and funding from both within and outside of Japan, such as improving the environment for clinical trials and reviewing regulations.

This summit was held in response to the above, and the government aimed to make Japan a " drugs development hub" that would stand shoulder to shoulder with the world by listening to overseas pharmaceutical companies and others about the barriers they faced in expanding their business and investing in Japan, as well as providing them with information on research being conducted in Japan.

              So, sales of pharmaceuticals originating in Japan in the global pharmaceutical market fell below 10% in 2014. In order to strengthen domestic new drug development capabilities, Japan announced a policy to increase investment in new drug development with an aim to create by 2028 more than 10 companies with a value of over 10 billion yen each. All along Japan has been good at providing heath care services.