[MLIT] Publication of a Proposal to Revise the Operational Guidelines of the Amended Act on Organ Transplantation

On 21 January 2022, the Ministry of Health, Labour and Welfare (MHLW) published a proposal to partially revise the operational guidelines of the Act on Organ Transplantation (hereinafter referred to as “the Act”).

The MHLW initially put these guidelines in place (through the Notification of the Director-General of the Health and Medical Service Bureau of the MHLW, No. 1329 of 1997) to ensure the proper implementation of the Act (Law No. 104 of 1997) and the Enforcement Regulations of the Act (MHLW Ordinance No. 78 of 1997).

In 2009, the Act on the Partial Amendment of the Act on Organ Transplantation (Law No. 83 of 2009) amended the Act by stipulating that organ donation is possible with the family's consent even if the deceased's will is unknown.

Ten years after the amendment, the Organ Transplantation Committee under the Disease Control Sub-council of the Health Sciences Council considered a review of the guidelines to ensure that the wishes of bereaved families to donate the deceased's organs are respected. As a result, the MHLW has proposed the following revisions.

The current guidelines state that if a child suspected of being abused has died, no removal of organs shall be performed. However, to clarify the exclusion criteria for abuse cases in organ donation under the age of 18, the proposal is to state that, unless the notification as per the Child Abuse Prevention Act is given, organs may be removed for as long as the bereaved family gives its written consent. At the same time, it is further proposed to add that, if it is confirmed that the welfare office or child guidance center has not intervened in an abuse case, the removal of organs may be performed under the confirmation of the hospital ethics committee or a similar body.

Persons with intellectual disabilities under 15 years of age may donate their organs similar to those without intellectual disabilities, on condition that those who expressed their wish before death not to donate their organs are excluded, and that the bereaved family issues a written consent.

Incidentally, the background to the proposed revision concerning the former is that the current guidelines, which exclude cases of abuse in organ donation for those under 18 years of age, have led to reluctance in organ donation. In some cases, organ donation is put off due to concerns that suspicions of abuse cannot be completely ruled out. With regard to the latter, some argue that organ donation guidelines should be rectified for those under 15 years of age as there are inconsistencies in the handling of organ donation depending on the presence or absence of an intellectual disability.

The revisions are expected to come into force on 1 April 2022. The proposal is open for public comment until 21 February 2022. For more information, please visit the website below (in Japanese only):
https://public-comment.e-gov.go.jp/servlet/Public?CLASSNAME=PCMMSTDETAIL&id=495210375&Mode=0