TOKYO -- The Japan Society of Obstetrics and Gynecology's ethics panel on Feb. 12 approved a draft plan to allow more medical institutions to carry out noninvasive prenatal testing (NIPT) to screen fetuses for potentially serious health issues, according to society officials.
The panel essentially approved the easing of its guidelines on requirements for facilities that are authorized to conduct NIPT, in which the mother's blood is sampled to detect irregularities in her fetus's chromosomes -- structures in cells containing genes that control the design and functions of the human body. The rule changes would allow doctors at smaller clinics and independent practitioners to conduct the tests.
The society plans to review the draft revisions at a meeting of its directors in March before sounding out related academic societies. However, it is not clear if those bodies will approve expansion of NIPT because their members include strong critics of the plan.
NIPT was introduced to Japan in 2013 through clinical studies at limited facilities. The testing method, however, has faced criticism that it leads to "selection of life," as more than 90 percent of pregnant women chose abortion when the screening finds abnormalities. The proposed revisions to the guidelines would be the first change since their introduction.
Initially, the revisions were discussed at a committee of 16 people including representatives of the obstetrics and gynecology society and other academic societies, members of patient groups and scholars in ethics. The panel failed to reach a consensus after three meetings from August last year, resulting in the obstetrics and gynecology organization compiling its own draft revisions.
The draft would allow the test to be carried out by "collaborating facilities" on top of major medical institutions with full-time OB-GYNs and pediatricians as well as a genetic outpatient ward. Collaborating facilities would be required to fulfill substantially fewer qualifications. But they would have to be capable of handling child deliveries and have an OB-GYN who has received counseling training on the new testing technique.
Pregnant mothers who test positive for fetal irregularities would be required to visit major facilities for genetic counseling by specialists. Testing of the mother's amniotic fluid to confirm the NIPT results would be carried out at the collaborating facilities in principle, as would any abortions.
NIPT, which requires careful handling, was introduced under a cooperative program by five relevant organizations including the obstetrics and gynecology society, the Japanese Association of Medical Sciences and the Japan Society of Human Genetics. But some members of the human genetic society and other bodies are criticizing the plan to expand NIPT. They say that allowing only OB-GYNs to conduct counseling of the mothers constitutes a conflict of interest because those physicians would be able to make more money by expanding NIPT. Others say that the society is making the draft revisions to accommodate a predetermined move to increase the number of facilities that can conduct NIPT.
Meanwhile, the number of noninvasive prenatal tests conducted at unauthorized facilities is thought to have been rising rapidly in recent years.
(Japanese original by Norikazu Chiba, Science & Environment News Department)