この度の新薬データ改ざん問題につきまして、患者様ならびに関係者の皆様に多大なるご迷惑をおかけいたしましたこと、痛恨の極みであり、深くお詫び申し上げます。
Regarding the recent problem of data falsification surrounding our new drug, the inconvenience caused to our patients and to all those concerned is a source of the deepest regret to me, and I offer my most sincere apologies.
長年にわたって不正が隠蔽されていたという事実は、もはや一企業のガバナンスの欠如にとどまらず、業界全体の信頼を根底から揺るがす事態です。社長ご自身の経営責任について、いかにお考えでしょうか。
The fact that this wrongdoing was concealed over many years is no longer merely a question of governance failure at a single company; it is a situation that shakes the trust of the entire industry to its very foundations. What are your thoughts on your own responsibility as a manager?
すべての責任は、私自身の監視の甘さに起因するものと猛省しております。真相を究明せんがため、外部の有識者からなる第三者委員会を立ち上げ、徹底的な調査を行う所存でございます。
I am gravely reflecting on the fact that all of this responsibility traces back to laxness in my own oversight. In order to bring the truth to light, we intend to establish a third-party committee made up of external experts and to carry out a thorough investigation.
第三者委員会への丸投げは、責任逃れにかこつけた時間稼ぎだと言わざるを得ません。国民の命に関わる問題ゆえに、今この場で明確な辞任の意思を示すべきではないでしょうか。
I must say that handing everything over to a third-party committee amounts to nothing more than buying time under the pretext of evading responsibility. Given that this is a matter affecting the lives of citizens, should you not, here and now, clearly state your intention to resign?
辞任すら辞さぬ覚悟でおりますが、まずは事実関係を余すところなく明らかにし、再発防止策を講じることこそが、私に課せられた最後の責務であると認識しております。
I am prepared even for resignation, but I recognize that first clarifying the facts in their entirety, and putting recurrence-prevention measures in place, is the final duty that has been laid upon me.
データ改ざんを最初に指示したのは誰か、また、それを把握しながら看過した役員は何名いたのか、現時点で判明している事実をお示しください。
Please indicate, as far as the facts are known at this point, who first instructed the data falsification, and how many executives were aware of it yet looked the other way.
内部調査によりますと、研究開発本部長が直接の指示者として浮上しております。役員レベルでの認識については、第三者委員会の検証を待つ必要があり、現段階で軽々に名前を挙げることは、かえって調査の公正を損ねかねません。
According to our internal investigation, the head of the R&D division has emerged as the direct instructing party. As for awareness at the executive level, we must wait for verification by the third-party committee; to name specific individuals lightly at this stage could itself undermine the fairness of the inquiry.
被害を受けた可能性のある患者数は、貴社の試算でどの程度に上りますか。また、補償スキームの具体案はおありでしょうか。
By your company's own estimate, how many patients may have been affected? And do you have a concrete compensation scheme in place?
当該医薬品の累計処方件数は約十二万件にのぼります。健康被害との因果関係については、独立した医師団による検証を経て確定する必要がありますが、補償につきましては上限を設けることなく、誠意ある対応を貫く所存でございます。
The cumulative number of prescriptions of the drug in question reaches approximately one hundred and twenty thousand. The causal link with any health damage will need to be established through verification by an independent panel of physicians, but as for compensation, we intend to respond in good faith without imposing any upper limit.
業界自主規制の機能不全を問う声も上がっております。厚生労働省への報告体制について、具体的な改善案はお持ちでしょうか。
There are voices questioning the breakdown of the industry's self-regulation. Do you have any concrete proposal for improving reporting to the Ministry of Health, Labour and Welfare?
これまでの自主規制が形骸化していた現実は、率直に認めざるを得ません。臨床データのリアルタイム提出と外部監査の常設、この二点を骨子とする改革案を、来週中にも当局へ提出いたします。
We have no choice but to admit candidly that self-regulation up to now has become a mere formality. We will submit to the authorities, as early as next week, a reform proposal built around two pillars: real-time submission of clinical data, and the permanent installation of external auditors.
最後に伺います。今回の問題により失われた信頼を、社長ご自身、どのように回復していかれるおつもりですか。
One final question. How do you yourself intend to recover the trust that has been lost through this affair?
信頼は、言葉ではなく、日々の積み重ねでしか取り戻せないものと痛感しております。本日をもって、私の残された時間のすべてを、再発防止と被害者救済に捧げる覚悟でございます。何卒、厳しいご指導を賜りますようお願い申し上げます。
Trust, I am painfully aware, can only be regained not through words but through the accumulation of daily actions. As of today, I am resolved to devote all the time remaining to me to preventing recurrence and to providing redress to those harmed. I most earnestly ask for your strict guidance going forward.