Ministry of Health's Efforts to Ban Screening; Risk of Birth Defects in Newborns

The Ministry of Health of the Islamic Republic has halted the issuance of permits for the production and import of first-trimester screening kits. Experts have described this action as 'strange and shocking,' stating that it will increase the risk of newborns being born with abnormalities and genetic diseases. The Department of Laboratory Equipment and Products of the Ministry of Health recently announced: 'From now on, laboratories are only allowed to use closed analyzer devices for screening for Down syndrome in the first trimester of pregnancy, and the import of open system first-trimester screening kits, including the ELISA method for Down syndrome screening, will no longer be possible.' Following this directive, a board member of the Iranian Medical Genetics Association stated: 'This unprofessional decision will lead to further restrictions for society in conducting fetal screenings, resulting in an increased risk of newborns being born with abnormalities and genetic diseases.' According to domestic media, Mohammad Amin Tabatabai Far added: 'Over the past decades, fetal screening, especially for Down syndrome, has been conducted based on societal needs, but according to Article 53 of the Population Youth Law, screening has been restricted, and under this article, screening can only be performed at the request of parents or a specialist doctor. Now, the Ministry of Health has gone beyond this law and, by halting the issuance of permits for the production and import of first-trimester screening kits, has made it impossible for even parents or specialist doctors to request screening, as the kits must be available to laboratories for screening to take place. If the kits are not available, whether produced domestically or imported, screening will no longer have any meaning.' He continued: 'This decision is very unreasonable and will limit even the access of informed individuals in society to screening. Moreover, halting the issuance of permits for the production and import of first-trimester screening kits will lead to these kits being supplied illegally and at exorbitant prices, which will not only impose costs on the people but also raise questions about the standards and quality of these kits.' The Ministry of Health had previously issued a directive in Ordibehesht 1401 to remove 'fetal abnormality' screening from electronic systems. According to this directive, insurance companies were prohibited from covering the costs of stages and tests for detecting fetal defects. Some doctors criticized this directive, stating: 'With this ban, in addition to increasing the risk of giving birth to disabled infants, screening tests will also become an underground and luxury service exclusive to wealthy families.' Members of the Islamic Consultative Assembly approved the 'Family Support and Population Youth Law' in the summer of 1400 in response to the Supreme Leader's call for increasing the country's population. Meanwhile, the Deputy for the Prevention of Disabilities at the Iranian Welfare Organization had previously stated that since 1392, through fetal screening tests, the birth of 8,400 disabled children had been prevented.