Response to Cartagena Law Measures by D.Clinic: A Commitment to Patient Safety and Compliance
D.Clinic, located in the heart of Shibuya, Tokyo, and managed by the esteemed Dr. Yoshihisa Abo, has faced measures issued under the Cartagena Law concerning the gene therapy it has been providing. The Cartagena Law, which regulates the use of genetically engineered organisms to ensure biodiversity preservation, was invoked following updates from Japan's Ministry of Health, Labour and Welfare (MHLW) regarding the non-replicative lentiviral vectors the clinic was utilizing.
The issue arose as the clinic operated under the belief that the vectors were exempt from regulation based on their understanding from earlier legal interpretations. The clinic’s interpretation was supported by the vectors’ lack of replication capability and their absence from official regulatory lists in the past. D.Clinic has always prioritized patient safety and sought verification of legal compliance before implementing any treatment protocols, including gene therapies.
The history surrounding these developments stretches back to 2009 when D.Clinic commenced its treatments, choosing methods deemed legal after discussions with health authorities. The decision to import foreign medical supplies was guided by advice instructing on legal frameworks, ensuring that patient care was both innovative and compliant with existing laws.
However, in January 2025, during a training session organized by the MHLW, it was made clear that the lentiviral vectors in question now fell under Cartagena Law regulations. This was a pivotal moment for D.Clinic, prompting immediate inquiries to the MHLW about the potential for continuing treatments or receiving any grace periods; sadly, those inquiries were met with hints of regulatory breaches.
The clinic received a formal notification on June 2, 2025, regarding a compliance report under the Cartagena Law. Subsequently, the clinic took prompt action by halting treatment information on its website and drafting a comprehensive report detailing the situation, preventive measures, and ongoing compliance initiatives, submitted to the MHLW on June 12, 2025.
Realizing the seriousness of this situation, D.Clinic is now taking rapid steps to comply with authorities and remedy any misunderstandings. Current measures include applying for the necessary permits under the Cartagena Law and cementing patient safety protocols. The clinic is committed to restoring treatments as swiftly as possible for patients in need, particularly those suffering from intractable cancers like gastric cancer and pancreatic cancer.
Dr. Abo extends his sincerest apologies to patients and stakeholders, assuring them that D.Clinic has no direct concerns regarding the spread of genetically modified organisms nor any reported adverse impacts to the environment or human health. The clinic aims to uphold transparency about its progress and actions taken.
Immediate and ongoing actions include:
Founded with the vision of delivering responsible and frontline health care, D.Clinic has gained recognition both domestically and abroad for its commitment to solving medical mysteries, particularly in the realm of hard-to-treat cancers. Its dedication contrasts sharply with other practices that may seem exploitative or lack transparency.
D.Clinic remains steadfast in its mission, emphasizing its resolve to deliver crucial treatments as soon as possible, assuring patients of its continued commitment to ethical and effective care.
Clinic Information
Name: D.Clinic
Director: Dr. Yoshihisa Abo
Address: 3-7-10 Jingumae, Shibuya, Tokyo 150-0001
Website: D.Clinic Website
The issue arose as the clinic operated under the belief that the vectors were exempt from regulation based on their understanding from earlier legal interpretations. The clinic’s interpretation was supported by the vectors’ lack of replication capability and their absence from official regulatory lists in the past. D.Clinic has always prioritized patient safety and sought verification of legal compliance before implementing any treatment protocols, including gene therapies.
The history surrounding these developments stretches back to 2009 when D.Clinic commenced its treatments, choosing methods deemed legal after discussions with health authorities. The decision to import foreign medical supplies was guided by advice instructing on legal frameworks, ensuring that patient care was both innovative and compliant with existing laws.
However, in January 2025, during a training session organized by the MHLW, it was made clear that the lentiviral vectors in question now fell under Cartagena Law regulations. This was a pivotal moment for D.Clinic, prompting immediate inquiries to the MHLW about the potential for continuing treatments or receiving any grace periods; sadly, those inquiries were met with hints of regulatory breaches.
The clinic received a formal notification on June 2, 2025, regarding a compliance report under the Cartagena Law. Subsequently, the clinic took prompt action by halting treatment information on its website and drafting a comprehensive report detailing the situation, preventive measures, and ongoing compliance initiatives, submitted to the MHLW on June 12, 2025.
Realizing the seriousness of this situation, D.Clinic is now taking rapid steps to comply with authorities and remedy any misunderstandings. Current measures include applying for the necessary permits under the Cartagena Law and cementing patient safety protocols. The clinic is committed to restoring treatments as swiftly as possible for patients in need, particularly those suffering from intractable cancers like gastric cancer and pancreatic cancer.
Dr. Abo extends his sincerest apologies to patients and stakeholders, assuring them that D.Clinic has no direct concerns regarding the spread of genetically modified organisms nor any reported adverse impacts to the environment or human health. The clinic aims to uphold transparency about its progress and actions taken.
Immediate and ongoing actions include:
- - Completing response actions for the compliance report promptly.
- - Following through with formal applications for Cartagena Law permits.
- - Providing individual explanations to patients alongside transparency updates on the clinic's website.
- - Strengthening internal protocols to prevent future occurrences.
- - Continuing research and clinical development based on the success records related to complex cancer treatments.
Founded with the vision of delivering responsible and frontline health care, D.Clinic has gained recognition both domestically and abroad for its commitment to solving medical mysteries, particularly in the realm of hard-to-treat cancers. Its dedication contrasts sharply with other practices that may seem exploitative or lack transparency.
D.Clinic remains steadfast in its mission, emphasizing its resolve to deliver crucial treatments as soon as possible, assuring patients of its continued commitment to ethical and effective care.
Clinic Information
Name: D.Clinic
Director: Dr. Yoshihisa Abo
Address: 3-7-10 Jingumae, Shibuya, Tokyo 150-0001
Website: D.Clinic Website
Topics Health）
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