【プレスリリース】薬価の毎年改定に反対する共同声明/Joint Statement Opposing Adoption of Annual Repricing

【プレスリリース】薬価の毎年改定に反対する共同声明/Joint Statement Opposing Adoption of Annual Repricing



Joint Statement Opposing Adoption of Annual Repricing

Valid Through December 2017 / 2017年1 月まで有効

On behalf of the U.S. and European business communities, and their respective biopharmaceutical and medical technologies industries, the American Chamber of Commerce in Japan (ACCJ), the Advanced Medical Technology Association (AdvaMed), the American Medical Devices and Diagnostics Manufacturers’ Association (AMDD), the Biotechnology Innovation Organization (BIO), the European Business Council (EBC) Medical Equipment Committee, the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the Pharmaceutical Research and Manufacturers of America (PhRMA) issue the following Joint Statement.

According to numerous media reports, on November 25th Prime Minister Abe tasked the Council for Economic and Fiscal Policy (CEFP) to discuss and finalize policies to fundamentally reform Japan’s drug pricing system. Prime Minister Abe asked the CEFP to complete this enormously complicated reform by the end of December –roughly within one month’s time. Included within this mandate from Prime Minister Abe is a proposal to move from the current system of biennial repricing to a system of annual repricing. Repricing is an issue that impacts the entire healthcare sector, both domestic and foreign. The current system of biennial repricing has served Japan and the Japanese people well by ensuring the predictability of reimbursement, controlling healthcare expenditures, rewarding innovation and, most importantly, improving access for Japanese patients to the most innovative treatments available globally through the elimination of the drug and device lags. Adopting annual repricing threatens to undo all of these achievements. As such, our associations strongly urge Prime Minister Abe, the CEFP and the Japanese Government to reject the adoption of annual repricing. Rather we propose that the Japanese Government establish an inclusive process involving all stakeholders – government, healthcare professionals, academia, industry and patients – to thoroughly discuss and align on a comprehensive set of reforms that best addresses the challenges of ensuring the sustainability of Japan’s healthcare system while properly rewarding innovation. Our associations thank Japan for its careful consideration of this proposal.

The Abe Administration has taken important steps to strengthen the Japanese economy and return it to a period of sustained economic growth, with a significant focus on the role of healthcare industries. We note that in his economic growth strategy, Prime Minister Abe specifically focuses on innovative pharmaceuticals and advanced medical technology as key engines of productivity and growth.

In addition, we applaud the Abe Administration for its vision in establishing the Japan Agency for Medical Research and Development (AMED) to lead coordination of integrated medical R&D from basic research to practical application. We fully agree that the pharmaceutical and medical technologies industries can play an important part in Japan’s future growth and prosperity while contributing to the health and welfare of the Japanese people.

In light of the importance of our industries to the successful attainment of the Prime Minister’s economic goals and in delivering innovative treatments, any change of the schedule for repricing from the current biennial system – which has functioned well for over two decades – to an annual repricing schedule would inhibit investment, and impede innovation. Adopting annual repricing, coming on top of a number of burdensome measures in the 2016 reimbursement revisions, including, among other measures, implementation of the new ‘huge seller repricing’ rule and the increase in the generic adoption target from 70 percent to 80 percent, would add another significant burden on manufacturers’ ability to invest in innovation in Japan. This in turn would damage public health in Japan by reversing the impressive progress that has been made in reducing the drug and device lags, a significant achievement as Japanese patients now have early access to the newest and most innovative medical technologies being developed around the world. A shortening of the repricing schedule to once a year would also make it less likely that the Prime Minister’s economic growth goals will be achieved.

Annual repricing would have a significant negative impact on the entire healthcare sector, including distributors and healthcare facilities, and would have a negative effect on the efforts of physicians to provide the newest and best life-saving and lifeenhancing care to patients, increasing their healthy lifespans. At a time when Prime Minister Abe is working hard to promote a vibrant Japanese healthcare industry and encourage new entrants into the sector, this policy would have the opposite effect.

An annual repricing cycle would hamper the predictability of reimbursement prices for both new and existing medical technologies. This could raise the cost of participating in the Japanese market and make investment riskier, which would be at odds with the Prime Minister’s efforts to attract more investment in research and development and in manufacturing.

Our associations appreciate the importance and challenges of ensuring the fiscal sustainability of Japan’s universal healthcare system, particularly given Japan’s rapidly aging population. That is why we have repeatedly and consistently called on MHLW and the Japanese Government to establish a meaningful partnership with industry and other stakeholders to examine and discuss ways to strengthen the financing of Japan’s healthcare system drawing on the lessons to be learned from global best practices. We believe an inclusive approach, which would benefit from the knowledge and expertise of all stakeholders, rather than a limited spectrum of views, will best serve Japan in the long-run.

米国と欧州の経済界、および製薬・医療技術業界を代表し、在日米国商工会議所( ACCJ ) 、先進医療技術工業会(AdvaMed)、米国医療機器・IVD 工業会(AMDD)、バイオテクノロジーイノベーション協会(BIO)、欧州ビジネス協会 (EBC)医療機器委員会、欧州製薬団体連合会(EFPIA)、そして米国研究製薬工業協会(PhRMA)は、以下の共同声明を発表 する。



総理が掲げる経済目標の達成における私たちの業界の重要性、そして、革新的な治療を提供するという使命を考慮するのであれば、これまで20年以上にわたってうまく機能してきた現行制度による1年おきの薬価改定に何らかの変更を加えて毎年改定に移 行させるという決断は、投資を抑制し、イノベーションを妨げることになりかねない。2016年度の診療報酬改定には、「特例再算定」という新たなルールの導入や後発医薬品の比率を70%から80%にまで押し上げるという目標など、多くの困難な課題が含まれるが、その上さらに薬価の毎年改定が実現すれば、製薬業界にとっては日本においてイノベーションに投資する能力にさらに制限が課されることとなる。そして結果的には、ドラッグラグやデバイスラグを短縮することで達成された重要な進展を逆行させ、日本の患者の皆様が世界中で開発された最先端の医療技術に素早くアクセスできるようになったという現状を退行させ、日本の公衆衛生を損なうことにもなりかねない。さらに、1年おきという薬価改定期間の短縮は、総理が掲げる経済成長の目標の達成可能性も低下させる恐れがある。

毎年改定は、卸売業者や医療施設などを含む医療業界全般にわたって重大な否定的影響を及ぼすものであり、救命と生活の質向上のために最新かつ最良の医療を患者に提供し、その健康寿命を延ばすべく努力している医師たちにも悪影響を与えかねない。 安倍総理が日本の医療業界の活性化を促進し、この分野への新規参入を促すため尽力している中にあって、この政策は逆の効果 を生むであろう。

毎年改定というサイクルは、現存の医療技術についても、これから生まれる技術に関しても、償還価格の予見性を阻害する恐れがある。これにより、日本市場への参入コストも投資リスクも上昇するとみられるが、これは研究開発や製造に対してより多 くの投資を呼び込もうと考える総理の狙いと逆行する動きと言えるだろう。

私たちは、国民皆保険制度を維持することが、急激な高齢化に直面した日本においては特に、どれほどの重要性と困難を有しているかを理解している。だからこそ、厚生労働省を含む日本政府に働きかけ、グローバル・ベストプラクティスから学びつつ、 日本の医療システムにおける財政を強化するための方策を議論するために、業界とその他関係者との意義あるパートナーシップ を構築すべきであると繰り返し、そして、一貫して提言してきた。限定された視点に立つのではなく、すべての関係者の知識と 経験を取り込んだ、より包括的なアプローチこそが、長期的には日本の利益になると確信している。


The American Chamber of Commerce in Japan (ACCJ)

The American Chamber of Commerce in Japan (ACCJ) was established in 1948 by representatives of 40 American companies and has grown into one of the most influential business organizations in Japan. Consisting mainly of executives from American companies, currently the ACCJ has members representing 1,000 companies with offices in Tokyo, Nagoya, and Osaka. Working closely with the governments of the United States and Japan, business organizations, and others, the ACCJ promotes activities that help achieve its mission of further developing commerce between the United States and Japan, promoting the interests of U.S. companies and members, and improving the international business environment in Japan. The ACCJ’s more than 60 committees represent a variety of industries and make policy recommendations through advocacy tools such as viewpoints, public comments and white papers. The ACCJ holds approximately 500 events and seminars a year, many of which focus on government policy and economic trends. The ACCJ is also committed to promoting charitable events and CSR activities.


在日米国商工会議所(ACCJ)は、米国企業40 社により1948 年に設立された日本で最大の外国経済団体です。米国企業の日本における経営者を中心に、現在は約1,000社を代表する会員で構成され、東京、名古屋、大阪に事務所を置いています。日米両国政府や経済団体等との協力関係のもと、「日米の経済関係の更なる進展、米国企業および会員活動の支援、そして、日本における国際的なビジネス環境の強化」というミッションの実現に向けた活動を展開しています。また、60以上の業界・分野別委員会を中心に活動を行い、意見書やパブリック・コメント、白書等を通じた政策提言や、政策や経済の動向等について年間500 以上のイベントやセミナーを開催するとともに、各種チャリティー等の企業の社会的責任(CSR)活動にも積極的に取り組んでいます。


The European Business Council (EBC)

The European Business Council (EBC) is the trade policy arm of 16 European national chambers of commerce and business associations in Japan. It is also registered with the Ministry of Trade, Economy and Industry as the European (EU) Chamber of Commerce in Japan. Established in 1972, the EBC works to improve the trade and investment environment for European companies in Japan. The EBC currently represents more than 2,500 local European companies and individuals who are members of their national chambers of commerce. Some 250 of these companies participate directly in the EBC’s 26 sector-based committees.

欧州ビジネス協会 (EBC)

欧州ビジネス協会(EBC)は欧州16 ヶ国の在日商工会 議所・ビジネス協会にとっての通商政策部門であり、 1972 年に設立されて以来、在日欧州企業にとっての通 商・投資環境の改善を目指し、活動を続けている。EBC の会員は法人と個人を合わせ現在約2,500 を数えるが、 会員はすべて各国の商工会議所に所属し、日本で活動し ている。会員企業の役員約250 人が、EBC の26 の産業 別委員会に直接参加をし、多岐にわたる産業セクターに おいて日本の商環境の改善を目的に努力をつづけてい る。EBC は、在日欧州(連合)商工会議所として経済産 業省に登録されている。


The Advanced Medical Technology Association (AdvaMed)

The Advanced Medical Technology Association (AdvaMed) is the world’s largest medical technology association. Based in Washington, D.C., AdvaMed represents international manufacturers of medical devices, diagnostic products and medical information systems.


先進医療技術工業会(AdvaMed)は、世界最大の医療技 術事業者団体です。ワシントンDC に拠点を置き、最先 端医療機器、体外診断薬、医療情報システムなどを製造 する国際的なメーカーが加盟しています。


The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD)

The American Medical Devices and Diagnostics Manufacturers’ Association (AMDD) was established on April 1, 2009 to represent the Japanese operations of 63 U.S.-based companies that provide medical devices, including heart pacemakers, ICDs, catheters such as PCI and stent grafts, orthopedics such as artificial joints, and artificial ocular lenses, imaging diagnostic equipment, in vitro diagnostics and other advanced medical technologies to patients and healthcare providers in Japan. The Association’s member companies account for approximately 21,000 jobs in Japan. Of the medical devices approved within Japan between January 2005 and December 2011, 58% were products of AMDD member companies. For more information about the AMDD, please visit:

米国医療機器・IVD 工業会(AMDD)

米国医療機器・IVD 工業会(AMDD)は2009年4月1日に設立された、米国に本社を置く医療機器、体外診断用医薬品(IVD)などの先進医療技術を提供している日本法人63 社によって構成される業界団体です。AMDDの会員企業は、心臓ペースメーカーやICD、人工心臓弁、PCI などのカテーテル、ステントグラフト、人工関節などの整形外科材料、眼内レンズ、大型画像診断機器、遺伝子診断、IVD およびシステム機器などを始めとしたさまざまな先進医療技術を提供しており、日本においては会員企業全体で約21,000 人の雇用を創出しています。また2005年1月から2011年12月までの間に国内で承認された新医療機器の58%は、AMDD 会員企業の製品です。
詳しくは Website: http://www.amdd.jpをご覧ください。


European Federation of Pharmaceutical Industries and Associations (EFPIA)

EFPIA Japan represents 24 R&D-based pharmaceutical companies, and is the voice of the European innovative pharmaceutical industry in Japan. Through the early introduction of innovative medicines and vaccines we aim to contribute to the health of patients in Japan.


EFPIA Japan は日本で事業展開している欧州の革新的製薬企業を代表する団体であり、研究開発志向型の製薬企業24 社が加盟しています。革新的な医薬品・ワクチンの早期導入を通じて、日本の医療と患者さんに貢献することをめざしています。


Pharmaceutical Research and Manufacturers of America (PhRMA)

PhRMA Japan represents the U.S. research-based pharmaceutical companies. Its mission is to promote the health of patients and contribute to the healthier lives of all people.

米国研究製薬工業協会 (PhRMA)



Biotechnology Innovation Organization (Bio)

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.


バイオテクノロジー産業機構(BIO)は、米国など30以上 の国々にあるバイオテクノロジー関連の企業や研究機関、米国各州のバイオテクノロジーセンターとその関連組織1,100以上が参加する団体です。BIOに加盟している組織は、医療、農業、産業、環境などの分野で革新的なバイオテクノロジーの研究と開発に携わっています。またBIO は、バイオテクノロジー業界最大のイベントであるBIO International Convention を年に1回開催しているほか、有力な投資家を集めたパートナリングカンファレンスを世界各地で開催しています。