再生医療の自由診療にも「検証」を 学会の新方針、利益追求と区別
"Certification" needed even for new medical treatments in regenerative medicine, a new policy from academics to differentiate those that are profit-seeking
野口憲太
NOGUCHI, Kenta
2025年3月28日 11時00分
2025-03-28T11:00
国内で年間約8万人の患者に行われている「再生医療」の自由診療をめぐり、日本再生医療学会が、科学的検証に乗り出す方針を明らかにした。有効性などの評価を目的とした自由診療を「検証型診療」と独自に認定し、推進するという。ただ、認定の手続きや検証の方法などは未定で、具体的な制度設計のゆくえが注目される。
Every year about 80,000 patients undergo "generative medicine" treatments in Japan. The Japanese Generative Medicine Society has brought to light the policy that puts forward the use of scientific certification. The goal of creating a stand-alone "Medical Treatment Certification" is to evaluate treatments in terms of efficacy, among others. However, since the details of the approval process and the method of certification are still unclear, the specifics of the regulation are now getting attention.
十分なエビデンス(科学的根拠)もないまま、患者の期待を利用する診療は許すべきではない――。日本再生医療学会は3月19日、横浜市で会見を開き、学会の方針を発表した。自由診療のなかに学会として「検証型診療」という区分をつくり、診療を通じた知見から科学的根拠を得ることを目的にするという。
Without enough (scientifically based) evidence, treatments that take advantage of patients should not be allowed. On the 19th of March, the Japanese Society for Regenerative Medicine held a meeting in Yokohama City, and presented the policy. As an academic society, they've created a "Medical Treatment Certification" for classifying new medical treatments. Its goal is to obtain scientific basis from the findings accumulated through the treatments.
一方で、根拠よりも利益追求を優先する自由診療を「無検証診療」と名付け、「検証型」と明確に区別する。将来的には、「検証型」を通じて適切だと評価された治療の費用を、民間保険でカバーしてもらうといった新しい仕組みについても議論していく考えだという。
They've added a "Certification Type" and labeled new medical treatments that prioritize profit-seeking over evidence-based as "Uncertified Medical Treatment" to clearly differentiate them from those that have already obtained certification. Through this policy, expenses to pay for medical treatment would later be covered by the public health insurance agency in a new scheme that is currently undergoing deliberation.
日本では、患者のためになると医師が判断して、全額自費の自由診療でならば、国に承認されていない薬なども使うことができる。患者の選択肢を広げる側面がある一方、安全性や有効性が確認されていない医療が金銭的利益のために利用される場合もあるとの批判もある。
In Japan, physicians make decisions for the sake of the patients, and the entire treatment cost may include the use of medicines, among others, that are not approved by Japan. Other than the view that patients should have more available choices, there's also criticism in the use of medical treatment that hasn't yet been approved for their safety and efficacy, among others, for the sake of making a profit.
厚生労働省によると、2023年度に計約8万人の患者が、再生医療の自由診療を受けている。
According to the Ministry of Health, Labor and Welfare, in 2023 a total of about 80,000 patients have undergone new medical treatments in regenerative medicine.
国際的には、未確立な医療の提供は「少数の患者に限られるべき」だとの考え方もあるため、こうした状況には、海外から厳しい目も向けられている。世界の研究者らでつくる国際幹細胞学会(ISSCR)は今年2月、厚労相宛ての要望書を提出し、再生医療に関する規制を強化するよう求めた。
Internationally, offering unestablished medical treatments is "limited to only a minority of patients." Even so, they would receive intense scrutiny overseas. The International Society for Stem Cell Research (ISSCR), which is comprised of teams of researchers all over the world, has submitted a proposal to the Ministry of Labor in February of this year, seeking to enforce regulations concerning generative medicine.
このままでは再生医療の業界全体の信頼性が損なわれかねず、日本再生医療学会は今回の方針を打ち出した。
The Japanese Society of Generative Medicine has submitted the policy so that people would not lose confidence in generative medicine.
課題は制度設計
Issues in the regulation
## MORE
However, the details of the regulation have not yet been set.
With regard to how the "Certification Type" is to be added, Chairman OKANO, Hideyuki of the academic society has said, "Discussions are underway."
While he's seen that controlling the effects of the spread of "uncertified" new medical treatment is also limited, "I haven't yet considered the penalty to be imposed on those that are not certified. We need to create a scheme where the evaluation of clinics is improved upon receiving certification for good medical treatment practices."
To verify the safety and efficacy of the medicine, among others, there exists a correct way of using clinical trials to obtain national approval. While the process will take time and money, once approved, the basic rules will become relevant to the public health insurance agency, as evidence-based medical treatments spread and reach the patients.
In generative medicine where living cells are involved, it becomes difficult to produce outcomes that have the same quality in great numbers. This raises even further the level of difficulty required to develop new medical treatments. The society has explained "the need to examine" the use of new medical treatments as a way to make sure that those that are safe and efficacious do reach the patients.
According to the academic society, the purpose of the "Certification Type" is to not only gain national approval through the collection of usable private data, but also to find promising outcomes from the medical techniques. Hence, they've also been called in English, "explorative therapy."
Another issue is how to link together the process of gaining national approval and the medical treatment that has been evaluated to be promising based on its "Certification Type."
Knowledgeable on issues pertaining to generative medicine, Mr. IKKA, Tsunakuni (Director of Bioethics) says, "While we tip our hats to the thinking that somehow new medical treatments should be done even if there are issues, we don't yet know whether a "Medical Treatment Certification" is even a suitable method to solve the problem. While the specifics of the regulation remain unclear, what is most important is to note that generative medicine used in new medical treatments still do not have enough evidence that certifies them up to the necessary standard so that they could be called 'medical treatment.' This reiterates what the academic society has said."
UPDATED: 2025-03-31T08:59
## REFERENCE
1) GOOGLE SEARCH ENGINE; TRANSLATE;