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Japan: Doctors Punished for Unauthorized Cord Blood Treatments

(Oct. 5, 2017) On September 22, 2017, two doctors in Japan were punished with a fine of one million yen (about US$9,000), based on the Act on the Safety of Regenerative Medicine, for having transplanted the umbilical cord blood of one person to another without prior submission of a treatment plan to the Ministry of Health, Labour and Welfare (MHLW).  (Applications Without Prior Reports, Summary Prosecution of Doctors, MAINICHI OSAKA (Sept. 22, 2017) (in Japanese); Act on the Safety of Regenerative Medicine, Act No. 85 of 2013, E- GOV (in Japanese).)

Background

Because cord blood contains blood-forming stem cells, it can be used for transplantation as an alternative to bone marrow. (Cord Blood Q&A, National Cord Blood Program website (2015).)   In 1994, the first cord blood transplantation in Japan was done, and in 1995 Japan’s first cord blood bank was established.  (On Bone Marrow and the Cord Blood Bank, Japanese Red Cross Society website (in Japanese).)

In 1999, the Japanese Red Cross started to manage information on stored cord blood and made it publicly searchable. (Japan Cord Blood Bank Network Will Close Business at the End of March 2014, Japanese Red Cross Society website (Mar. 24, 2014) (in Japanese).)  It was financially assisted by the MHLW.  (Warning on Storage of Cord Blood Outside the Public System, JAPAN ASSOCIATION OF OBSTETRICIANS AND GYNECOLOGISTS NEWSLETTER (Nov. 2002) (in Japanese).)  In September 2012, the Act on Promotion of Proper Provision of Blood-Forming Stem Cells for Transplantation (Blood-Forming Stem Cells Provision Act) was enacted; it became effective on January 1, 2014.  (Act No. 90 of 2012, E-GOV (in Japanese).)  Under the Act, the Japanese Red Cross was designated a Blood-Forming Stem Cells Provision Support Institution.  (Japan Cord Blood Bank Network Will Close Business at the End of March 2014, supra.)

Under the Blood-Forming Stem Cells Provision Act, a business that provides cord blood to medical institutions must obtain approval to do so from the MHLW. (Blood-Forming Stem Cells Provision Act, art. 30.)  Currently, there are six approved cord blood banks in Japan.  However, the Act does not regulate businesses that store cord blood for the babies’ possible future medical treatment (for private use).  (To Women Who Will Be Mothers by Giving Birth (Information Relating to Cord Blood), MHLW website (last visited Sept. 30, 2017) (in Japanese).)

Criminal Case

The doctors who were fined had administered cord blood for cosmetic therapy and for cancer treatments.  The effectiveness and safety of such therapies have not been proven.  (Six Arrested in Connection with Unauthorized Cord Blood Treatments, JAPAN TIMES (Aug. 27, 2017).)  The cord blood used for such therapy or treatments was from a bankrupt cord blood bank that stored cord blood for private use.  (Report on Investigation of Actual Business of Private Cord Blood Banks, MHLW Health Department website (Sept. 12, 2017) (in Japanese).)

Previously, on May 8, 2017, the MHLW had ordered a clinic that had transplanted the cord blood of one person to another to suspend business based on the Act on the Safety of Regenerative Medicine.  (Press Release, Emergency Order Based on the Act on the Safety of Regenerative Medicine, MHLW website (May 9, 2017) (in Japanese).)  On June 28, 2017, 11 additional clinics received the same order.  (Press Release, Emergency Order Based on the Act on the Safety of Regenerative Medicine, MHLW (June 29, 2017) (in Japanese).)

On August 27, 2017, six people, including dealers and doctors, were arrested on suspicion of violation of the Act.  (Six Arrested in Connection with Unauthorized Cord Blood Treatments, supra.)  On September 15, 2017, two dealers were re-arrested for fraud on suspicion of having deceived owners by telling them that they would transfer the cord blood to medical research institutions for medical research purposes.  In addition, charges against doctors of seven other clinics were also investigated and referred to the public prosecutor’s office.  (Dealers Arrested Again, Suspected of Embezzlement of Seized Blood and of Fraud, by Ehime Prefecture Police, JIJI (Sept. 15, 2017) (in Japanese).)  The two doctors who were fined were in this group; the other cases are still pending.  (Id.)

Possible New Regulation

The Japan Medical Association issued a statement in August 2017 recommending that a new regulation be adopted on banks for private uses of cord blood. (Statement on Illegal Treatments Using Cord Blood, Japan Medical Association (Aug. 30, 2017) (in Japanese).) The MHLW created a webpage to provide information on cord blood banks to the general public. The MHLW also requested that private cord blood banks notify the MHLW of their existence. (To Women to Be Mothers by Giving Birth, supra.)  The MHLW tasked a committee of experts to deliberate countermeasures against problems of unregulated cord banks. ([Illustrated Guide] Results of Survey of Private Cord Blood Banks (Sept. 2017), JIJI (in Japanese).)