Decision on Sex Testing and Gender Selective Abortion (Comment Draft)

These "Provisions on the prohibition of non-medically necessary fetal sex determination and termination of pregnancy for sex selection (draft for solicitation of opinions)" are hereby released to the public for solicitation of opinions as drafted by this commission together with the Ministry of Public Security, the Administration for Industry and Commerce, and the Food and Drgu Administration, so as to promote balanced gender trends in the birth population and lawfully combat non-medically necessary fetal sex determination and termination of pregnancy for sex selection.

1. Log in to the Chinese Government's legal information network (http://www.chinalaw.gov.CN), and enter at the home page left side's:"System for soliciting comments on draft departmental regulations" andsubmit comments.

2. Log into the National Health and Family Planning Commission website(Website: http://www.nhfpc.gov.CN), go to "comments", then click solicitation of comments for "provisions on the prohibition of non-medically necessary fetal sex determination and termination of pregnancy for sex selection (Draft for solicitation of comments", and submit comments.

3. E-mail: weisheng@chinalaw.gov.cn

4. Mailing address: National Health and Family Planning Commission Legal Affairs Department; 14 ZhiChun Road, Haidian District, Beijing, 100191.

The deadline for comments is October 2, 2014.

National Health and Family Planning Commission

September 1, 2014

Provisions for the Prohibition of Non-medically Mandated Fetal Sex Determination and Elective Termination of Pregnancy for Sex Selection

(Draft for solicitation of comments)

(National Health and Family Planning Commission, Ministry of Public Security, General Administration for Industry and Commerce, State Food and Drug Administration)

Article 1: 为了保持出生人口性别结构平衡，促进人口长期均衡发展，根据《中华人民共和国人口与计划生育法》、《中华人民共和国母婴保健法》、《计划生育技术服务管理条例》和《中华人民共和国母婴保健法实施办法》等法律法规，制定本规定。

Article 2: 非医学需要的胎儿性别鉴定和选择性别人工终止妊娠，是指除经医学诊断胎儿可能为伴性遗传病等需要进行胎儿性别鉴定和选择性别人工终止妊娠以外，所进行的胎儿性别鉴定和选择性别人工终止妊娠。

It is prohibited for any entity or individual to carry out a non-medically mandated fetal sex determination or termination of pregnancy for sex selection.

It is prohibited for any entity or individual to make introductions for or organize a non medically mandated fetal sex determination or termination of pregnancy for sex selection.

Article 3: 禁止非医学需要的胎儿性别鉴定和选择性别人工终止妊娠的工作应当纳入计划生育目标管理责任制。

Article 4: 各级卫生计生、公安、工商行政和食品药品监管部门应当建立查处非医学需要的胎儿性别鉴定和选择性别人工终止妊娠违法行为的协调机制和联合执法机制，共同实施监督管理。 卫生计生、工商行政和食品药品监管部门应当按照各自职责，制定胎儿性别鉴定、人工终止妊娠以及相关药品和医疗器械等管理制度。

Article 5: 县级以上卫生计生行政部门履行以下职责:

(1) Responsible for supervising and organizing, coordinated efforts to uncover non-medically nescessary fetal sex determination and termination of pregnancy for sex selection ;

(2) Responsible for work such as supervising medical health-care establishments' and their professional staff's entrance into practice and use of medical instruments and promoting and training in relevant laws, regulations and practice standards.

(3) Responsible for administrating the use of the population information management system, and guiding medical health-care establishments prompt and accurate entry of newborn births, deaths and other relevant information.

(4) Other matters in laws and regulations involving non-medically necessary fetal sex determination and termination of pregnancy for sex selection .

Article 6: 阻挠卫生计生、工商行政、食品药品监管等部门工作人员依法查处非医学需要的胎儿性别鉴定和选择性别人工终止妊娠违法行为的，由县级以上公安部门依据《治安管理处罚法》予以处罚。

Article 7: 县级以上工商行政管理机关对含有胎儿性别鉴定和人工终止妊娠内容的广告实施监管，并依法查处违法行为。

Article 8: 县级以上食品药品监管部门对与胎儿性别鉴定和人工终止妊娠相关的超声诊断仪、染色体检测专用设备等医疗器械、药品的生产、销售和使用实施监管，并依法查处相关违法行为。

Article 9: 医学需要的胎儿性别鉴定，由省、自治区、直辖市卫生计生行政部门指定的医疗保健机构按照国务院卫生计生行政部门的规定实施。

Article 10: 实施医学需要的胎儿性别鉴定，应当由医疗保健机构组织3名以上具有临床经验和医学遗传学知识并具有副主任医师以上的专业技术职务的专家集体审核。 经诊断，确需人工终止妊娠的，由鉴定机构为孕妇出具医学诊断报告，并通报当地县级卫生计生部门。

Article 11: 符合法定生育条件，除下列情形外，不得实施选择性别人工终止妊娠：

(1) Where the fetus has a serious genetic illness;

(2) Where the fetus has severe defects;

(3) Where because of a serious illness, continued gestation might jeopardize the safety of the pregnant woman's life or seriously endanger her health;

(D) Other situations provided in laws or rules.

Article 12: 医疗保健机构应当在工作场所设置禁止非医学需要的胎儿性别鉴定和选择性别人工终止妊娠的醒目标志。 其医务人员应当严格遵守《执业医师法》和超声诊断、染色体检测、人工终止妊娠手术管理等相关制度。

Article 13: 实施人工终止妊娠手术的机构应当在手术前查验、登记受术者身份证明，并及时将施术情况通报当地县级卫生计生部门。

Article 14: 医疗保健机构发生新生儿死亡的，应当及时出具死亡证明，并向当地县级卫生计生行政等部门报告。

Where newborn deaths occur outside of a medical treatment and health-care establishment, the parents shall report it to the local village (township) government and the neighborhood office of the health and family planning organs. The village (township) government and neighborhood office of health and family planning shall review and verify, and report to the local Health and Family Planning Administrative Departments at the county level or above; Where there is a crime involved, it shall be promptly transferred to the public security organs for handling in accordance with law.

Article 15: 终止妊娠药品目录由国家食品药品监管部门会同国家卫生计生部门制定发布。 药品生产、批发企业只能将终止妊娠药品销售给药品批发企业或者获准施行终止妊娠手术的医疗保健机构。 药品生产、批发企业销售终止妊娠药品时，应当严格查验购货方资质，并按规定做好销售记录和药品电子监管码核注核销。 禁止药品零售企业销售终止妊娠药品。

Drugs for the termination of pregnancies may be used only under the guidance and supervision of doctors at a medical treatment and health-care establishment that is allowed to carry out surgical termination of pregnancies.

Institutions performing surgical terminations of pregnancy upon approval shall establish truthful and complete records of drug purchases and a complete record of those using drugs for termination of pregnancies.

Article 16: 国家食品药品监管部门应当对超声诊断仪、染色体检测专用设备等医疗器械实行电子监管码管理。

Producers of medical instruments shall strictly carry out the electronic monitoring code management system, and note in the medical instruments' instruction manuals that use in non-medically necessary fetal sex determination is prohibited.

Sellers of medical instruments selling ultrasound diagnostic aparatuses, specialized equipment for chromosome testing and other such medical instruments shall review and register the usage certifications of purchasers, and establish a truthful and complete record of the purchase; they must not sell ultrasound diagnostic apparatuses, specialized equipment for chromosome testing or other such medical instruments to individuals or units not possessing credentials.

Article 17: 医疗保健、教学科研机构购置超声诊断仪、染色体检测专用设备等可用于鉴定胎儿性别的医疗器械时，应当提供机构资质原件和复印件，交销售企业核查、登记，并将所购医疗器械的型号、编码、数量等信息报当地县级食品药品监管部门备案，建立相应的管理制度。

Article 18: 对发布非医学需要的胎儿性别鉴定或者非医学需要的选择性别人工终止妊娠广告的，由县级以上工商行政管理机关会同同级卫生计生行政部门按照《中华人民共和国广告法》等相关法律法规进行处罚。

Article 19: 对违反规定利用相关技术为他人实施非医学需要的胎儿性别鉴定或者选择性别人工终止妊娠的机构或者个人，由县级以上卫生计生行政部门依据《人口与计划生育法》第三十六条进行处理；对医疗保健机构的法定代表人、直接负责的主管人员和其他直接责任人员，依法给予处分。

Article 20: 对介绍、组织孕妇实施非医学需要的胎儿性别鉴定或者选择性别人工终止妊娠的，县级以上卫生计生、公安等部门应当责令改正，给予警告；对情节严重的，可处以5000元以上3万元以下的罚款；构成犯罪的，依法追究刑事责任。

Article 21: 医疗保健机构或者人员未取得母婴保健技术许可，出具虚假的医学需要的人工终止妊娠相关医学诊断意见书或者证明，制作虚假手术记录的，由县级以上卫生计生行政部门给予警告，责令停止违法行为，没收违法所得；没有违法所得或者违法所得不足5000元的，处1万元以上2万元以下的罚款；违法所得5000元以上的，处违法所得3倍以上5倍以下的罚款。

Where persons engaged in maternal and infant health-care services submit false medical diagnostic opinions or proofs for non-medically necessary termination of pregnancy or fabricate false surgery records, they are given disciplinary punishments in accordance with law, where the circumstances are serious, the relevant maternal and infant health-care technical practice credentials or medical practice certificates are revoked by the department originally issuing them.

Article 22: 经批准实施人工终止妊娠手术的机构未建立真实完整的终止妊娠药品购进记录，未为终止妊娠药品使用者建立完整档案的，由当地县级卫生计生行政部门责令改正、给予警告；拒不改正的，处以1万元以上2万元以下的罚款。 对医疗、保健机构的法定代表人、直接负责的主管人和其他直接责任人员，依法给予处分。

Article 23: 购置可用于胎儿性别鉴定的设备不备案的，由县级以上食品药品监管部门责令改正、给予警告；拒不改正的，处以5000元以上1万元以下的罚款。

Article 24: 药品生产、批发企业销售终止妊娠药品，未查验购药者的资格证明或未作销售记录的，由县级以上食品药品监管部门责令改正、给予警告；拒不改正的，处5000元以上1万元以下罚款；情节严重的，依法吊销《药品生产许可证》、《药品经营许可证》。

Article 25: 有下列行为之一的，由县级以上食品药品监管部门责令改正、给予警告，没收违法经营的产品和违法所得；违法所得1万元以上的，处违法所得3倍以上5倍以下的罚款；没有违法所得或者违法所得不足1万元的，处1万元以上3万元以下的罚款：

(1) Producers of medical instruments that do not carry out electronic code monitoring management for ultrasound diagnostic apparatuses, specialized equipment for chromosome testing and other medical instruments;

(2) Producers of medical instruments selling ultrasound diagnostic apparatuses, specialized equipment for chromosome testing or other such medical instruments to institutions or individuals lacking credentials to purchase them.

(3) drug manufacturers or wholesalers sell drugs for terminating pregnancy medical and healthcare establishments or individuals not approved to carry out termination of pregnancy

(4) unauthorized production, wholesale, or sale of drugs for terminating pregnancy.

Article 26: 进行非医学需要的胎儿性别鉴定或者选择性别人工终止妊娠的孕妇，由县级卫生计生行政部门责令改正，给予警告。

Article 27: 鼓励举报违反本规定的行为。 举报内容经查证属实的，应当给予举报人相应的奖励。

Article 28: 本规定自 年 月 日起施行。 2002年原国家计生委、原卫生部、原国家药品监管局联合发布的《关于禁止非医学需要的胎儿性别鉴定和选择性别人工终止妊娠的规定》同时废止。