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TABLE OF CONTENTS CHAPTER I GENERAL PROVISIONS CHAPTER II TECHNICAL SERVICES CHAPTER III INSTITUTIONS AND STAFF CHAPTER IV SUPERVISION AND ADMINISTRATION CHAPTER V PENALTY PROVISIONS CHAPTER VI SUPPLEMENTARY PROVISIONS CHAPTER I GENERAL PROVISIONS Article 1. The present Regulation is formulated for the purpose of strengthening the administration of the family planning technical services, controlling the quantity of the population, improving the quality of the population and safeguarding citizens' right to reproductive health. Article 2. The present Regulation shall apply to all technical service institutions of family planning and their functionaries within the territory of the People's Republic of China. Article 3. The family planning technical services shall be administered with the principles of state guidance and individual voluntarism. Citizens shall enjoy the right to informed choice regarding methods of contraception. The State shall safeguard citizens' right to obtain appropriate family planning technical services. The State shall provide free contraceptive and birth-control technical services to the couples at a childbearing age in rural areas, and the expenses incurred shall be borne by the local government. The central government shall grant proper subsidies to poor regions in the western part of the country. Article 4. The family planning administrative department of the State Council shall be responsible for administrating the family planning technical services throughout the country; the health and other related administrative departments of the State Council shall, within their own functions, support the family planning administrative department for doing well the family planning technical services. Article 5. The technical service network of family planning shall be composed of the family planning technical service institutions and other medical and health organizations offering family planning technical services, and shall be incorporated into the local health plans. The State shall, relying on scientific and technical progress, improve the technical service quality of family planning and encourage the research, development, introduction and promotion of new technologies, drugs and devices of family planning. CHAPTER II TECHNICAL SERVICES Article 6. The family planning technical services include technical instructions, consultations and clinical medical services relating to family planning. Article 7. Family planning technical instructions and consultations shall include the following contents: (1) Publicity, education and consultation relating to the science popularization of reproductive health; (2) Offering contraceptive devices and related instructions, consultations and follow-up visits; and (3) Offering relevant consultations and follow-up visits to those who have already been performed contraceptive or birth control operations and reversal of vasoligation or tubal ligation Article 8. The technical service institutions of family planning at or above the county level may, within the authorized scope, carry out the following clinical medical services relating to family planning: (1) medical examinations on contraception and birth control; (2) diagnosis and treatment of complications caused by contraceptive or birth control operations or side effects caused by contraceptive devices; (3) performance of contraceptive, birth control operations and reversal of vasoligation or tubal ligation; and (4) implementation of other reproductive health programs relating to childbirth, birth control and sterility. The detailed services shall be jointly prescribed by the family planning administrative department and the health administrative department of the State Council. Article 9. Couples who, due to birth of babies with diseases or disabilities, request birth of additional children shall apply for a medical appraisal to the family planning administrative departments at the county level and upon their permission through preliminary examinations, apply for a further medical appraisal by medical experts organized by the family planning administrative departments of the people's government at the level of city divided into districts. Those who hold objections to medical appraisals may apply for the reappraisal to the family planning administrative departments of the people's government of provinces, autonomous regions and municipalities directly under the Central Government. The medical appraisals organized by the family planning administrative departments of the people's government of provinces, autonomous regions and municipalities directly under the Central Government are final. The specific measures shall be formulated by the family planning administrative department of the State Council in collaboration with the health administrative department of the State Council. Article 10. The family planning technical services, contraceptives and contraceptive devices provided to citizens shall be safe and effective and comply with quality and technical standards set forth by the State. Article 11. The family planning administrative department of the State Council shall regularly formulate and issue catalogue for family planning technologies and contraceptive devices and instruct the popularization and application of those family planning technologies and contraceptive devices that have been placed into the catalogue. Article 12. The development of scientific and technical projects and international cooperation in the field of family planning shall secure examination and approval from the family planning administrative department of the State Council and be subject to the supervision and control of the family planning administrative departments of local people's governments at or above county level. Article 13. Advertisements involving any family planning technology shall be examined and approved by the family planning administrative department of the people's governments at the level of provinces, autonomous regions or municipalities directly under the Central Government. Article 14. Institutions offering family planning technical services shall, when performing contraceptive and birth control operations, special examinations and special treatments, obtain permission from the patients and shall ensure the safety of the patients. Article 15. No organization or individual may carry out the fetus gender identification not required by medical needs or selective abortion. CHAPTER III INSTITUTIONS AND STAFF Article 16. The institutions offering family planning technical services include the technical service institutions of family planning and the medical and health institutions offering family planning technical services. Article 17. An institution offering family planning technical services shall comply with the standards on the establishment of such institutions provided for by the family planning administrative department of the State Council. Article 18. The establishment of technical service institutions of family planning shall be approved by the family planning administrative department at or above the level of city divided into districts and be given a License for the Technical Service Institutions of Family Planning, on which the items of family planning technical services approved shall be specified. Article 19. A medical and health institution offering the family planning technical services shall obtain approval from the local health administrative department of the people's government at or above the county level, which shall specify on the Practicing License of Medical Institutions the approved technical services of family planning and circular a notice to the family planning administrative department at the same level. Article 20. Townships where medical institutions are already operational shall not create new technical service institutions of family planning; however, those medical institutions shall set up special sections (offices) devoted to the family planning technical services; in townships where both medical institutions and technical service institutions of family planning are in operation, both institutions shall perform their family planning technical services respectively. A township where no medical institution is in service needs to set up technical service institutions of family planning, and its examination and approval shall be carried out in strict compliance with the provisions of Article 18 in this Regulation. Article 21. A technical service institution of family planning offering prenatal diagnosis shall obtain permission from the family planning administrative department of the people's government of a province, autonomous region or municipality directly under the Central Government and secure approval from the health administrative department at the same level and report to the family planning administrative department of the State Council for archival filing. A technical service institution of family planning that uses auxiliary technologies to treat infertility shall obtain approval from the health administrative department of the people' government at or above the provincial level and report to the family planning administrative department at the same level. The specific measures for the administration of the infertility treatment with auxiliary technologies shall be enacted by the health administrative department of the State Council in collaboration with the family planning administrative department of the State Council. The technical instructions for the infertility treatment with auxiliary technologies shall be formulated by the health administrative department of the State Council after soliciting opinions from the family planning administrative department of the State Council. Article 22. The practicing licenses of technical service institutions of family planning shall be verified once every three years by the original approval-granting organ. No practicing license of the technical service institutions of family planning may be bought, sold, lent, leased, altered or forged. Any technical service institution of family planning that lost its practicing license shall apply for re-issuance to the original license-issuing organ within 30 days computed from the day when the practicing license is found to be lost. Article 23. A institution offering family planning technical service shall practice according to the approved business scope and services and abide by relevant laws, administrative regulations and medical technical standards and the systems of rescuing and transferring patients provided for by the health administrative department of the State Council. Article 24. The family planning administrative departments of the people's governments at or above the country level shall carry out regular inspections to the family planning technical services within their jurisdictions. Article 25. The State shall institute a mechanism for controlling the distribution of contraceptive devices. Specific measures shall be formulated by the drug supervisory and regulatory department of the State Council in collaboration with the family planning administrative department of the State Council and other departments in-charge. Article 26. The personnel engaged in the family planning technical services who perform clinical services relating to family planning in accordance with this Regulation shall, according to the Law on Practicing Physicians and relevant rules about nurses, obtain licenses for practicing physicians, practicing assistant physicians, rural physicians or nurses and practice in institutions set up pursuant to this Regulation. A practicing physician or practicing assistant physician working in the technical service institution of family planning shall, in accordance with the provisions in the Law on Practicing Physicians, apply for registration to the local health administrative department of the people's government at or above the county level. The specific measures shall be jointly enacted by the family planning administrative department of the State Council and the health administrative department of the State Council. No private medical institution may perform birth control operations. Article 27. Anyone of the family planning technical services shall engage in the family planning technical services in accordance with the approved business scope, services and kinds of operations, and shall abide by relevant laws, regulations, rules, technical instructions, codes on professional ethics and management systems relating to their professions. CHAPTER IV SUPERVISION AND ADMINISTRATION Article 28. The family planning administrative department of the State Council shall be responsible for supervising and administering the family planning technical services nationwide. Local family planning administrative departments at or above the county level shall be responsible for supervising and administering the family planning technical services within their respective jurisdictions. Health administrative departments at or above the county level shall, in accordance with this Regulation, be responsible for supervising and administering medical and health organizations offering family planning technical services. Article 29. The State shall establish a statistical system for the family planning technical services and an appraisal and reporting system for accidents in the family planning technical services, operational complications of family planning and side effects from the contraceptive devices. The measures for appraising and administering operational complications of family planning shall be formulated by the family planning administrative department of the State Council in collaboration with the health administrative department of the State Council. A technical service institution of family planning which has operational accidents of family planning, discovers operational complications or side effects in connection with the use of contraceptive devices shall, within the time limit prescribed by the family planning administrative department of the State Council, report to both the family planning and health administrative departments of its local people's government; for major accidents, serious complications and serious or newly recorded side effects in connection with an operation or use of contraceptive devices, the said institution shall, simultaneously and level by level, report to the superior family planning and health administrative departments up to the family planning and the health administrative departments of the State Council. Article 30. The family planning administrative department of the State Council shall, in collaboration with the health administrative department of the State Council, collect and analyze the foresaid accidents, complications and side effects and circulate them to relevant departments. The family planning administrative department of the State Council, shall, in accordance with relevant regulations, publish the said major accidents, serious complications or side effects in connection with an operation or use of contraceptive devices in a timely manner, and may authorize the family planning administrative departments of provinces, autonomous regions or municipalities directly under the Central Government to timely publish and circulate the foresaid accidents, complications and side effects occurring within their own jurisdictions. CHAPTER V PENALTY PROVISIONS Article 31. Any institution or individual other than the technical service institutions of family planning and the medical and health institutions that violates this Regulation and engages in the family planning technical services without approval shall be ordered to get right and given a warning by the family planning administrative department of the people' government at or above the county level, and its illegal proceeds, relevant drugs and medical appliances shall be confiscated. Those with an illegal proceeds of more than 5,000 yuan shall be fined 2 up to 5 times of their illegal proceeds; those without illegal proceeds or whose illegal proceeds are less than 5,000 yuan shall be imposed with a fine of 5,000 up to 20,000 yuan; those who have caused serious consequences and therefore constitute crimes shall be subject to criminal liabilities. Article 32. Any technical service institution of family planning that violates this Regulation and engages in prenatal diagnosis and uses accessorial reproductive techniques to treat infertility without approval shall be ordered to get right and given a warning by the health administrative department of the people' government at or above the county level, and its illegal proceeds, relevant drugs and medical appliances shall be confiscated. Those with an illegal proceeds of more than 5,000 yuan shall be fined 2 up to 5 times of their illegal proceeds; those without illegal proceeds or whose illegal proceeds are less than 5,000 yuan shall be imposed with a fine of 5,000 up to 20,000 yuan; where the circumstances are serious, its practicing license of family planning technical services shall be revoked by the original license-issuing organ. Article 33. Any institution or individual, which violates this Regulation and fails to verify its practicing licensing certificate of family planning technical services within the time limit and continues to conduct family planning technical services, shall be ordered to handle the verification formalities afterwards within the time limit by the original license-issuing organ. If any institution refuses to verify, its practicing license of family planning technical services shall be revoked by the original license-issuing organ. Article 34. Any institution or individual that violates this Regulation and buys, sells, lends, leases, alters or forges its license of family planning technical services, shall be ordered to get right and given a warning by the original license-issuing organ, and its illegal proceeds shall be confiscated. Those with an illegal proceeds of more than 3,000 yuan shall be fined 2 up to 5 times of their illegal proceeds; those without illegal proceeds or whose illegal proceeds are less than 3,000 yuan shall be imposed with a fine of 3,000 up to 5,000 yuan; where the circumstances are serious, its practicing license of family planning technical services shall be revoked by the original license-issuing organ. Article 35. Any technical service institution of family planning that violates Paragraph 3 of Article 3 in this Regulation and provides contraceptive and birth control services for couples at a reproductive age in rural areas and charges fees therefrom, shall be ordered to return all collected fees and be given a warning by the family planning administrative department of the people' government at or above the county level, and be fined 2 up to 5 times of collected fees. Where the circumstances are serious, its chief principal, person in-charge and other persons that hold to be directly responsible shall be subject to administrative sanctions such as demotion or dismissal. Article 36. Any technical service institution of family planning that violates this Regulation and expands its family planning technical services without approval shall be ordered to get right and given a warning by the original license-issuing organ, and its illegal proceeds shall be confiscated. Those with an illegal proceeds of more than 5,000 yuan shall be fined 2 up to 5 times of their illegal proceeds; those without illegal proceeds or whose illegal proceeds are less than 5,000 yuan shall be imposed with a fine of 5,000 up to 20,000 yuan; where the circumstances are serious, its practicing license of family planning technical services shall be revoked by the original license-issuing organ. Article 37. Any technical service institution of family planning that violates this Regulation and employs a person without any corresponding physician qualification to engage in clinical medical services regarding the family planning technical services shall be ordered to get right by the family planning administrative department of the people' government at or above the county level according to its functions, and its illegal proceeds shall be confiscated. Those with an illegal proceeds of more than 3,000 yuan shall be fined 1 up to 3 times of their illegal proceeds; those without illegal proceeds or whose illegal proceeds are less than 3,000 yuan shall be imposed with a fine of 3,000 up to 5,000 yuan; where the circumstances are serious, its practicing license of family planning technical services shall be revoked by the original license-issuing organ. Article 38. Any technical service institution of family planning that produces fake certificates and constitute crimes shall be subject to criminal liabilities; those who have not yet constituted crimies shall be ordered to get right and given warnings by the original license-issuing organ, and their illegal proceeds shall be confiscated. Those with an illegal proceeds of more than 5,000 yuan shall be fined 2 up to 5 times of their illegal proceeds; those without illegal proceeds or whose illegal proceeds are less than 5,000 yuan shall be imposed with a fine of 5,000 up to 20,000 yuan; where the circumstances are serious, its practicing license of the family planning technical services shall be revoked by the original license-issuing organ. Article 39. In case any family planning administrative department or any health administrative department violates rules and approves unqualified technical service institutions of family planning or medical and health institutions to conduct clinical medical services in relation to family planning or fails to exercise its supervisory functions, or fails to investigate any illegal act found and therefore results in major accident of the family planning technical services, its chief principal, person in-charge and other persons that hold to be directly responsible shall be subject to administrative sanctions such as demotion or dismissal. If the violation constitutes crimes, the offender shall be subject to criminal liabilities. CHAPTER VI SUPPLEMENTARY PROVISIONS Article 40. Any institution or any professional individual engaging in the family planning technical services that has already been in practice before the implementation of this Regulation shall, in accordance with this Regulation, handle formalities of application, registration, approval and obtain certificates within three months computed from the implementation day of this Regulation. Article 41. Any individual who offers family planning technical services in a rural technical service institution of family planning or a rural medical and health institution, if he is in conformity with this Regulation, may obtain a practicing license upon the confirmation; or if he is in unconformity with this Regulation, shall be dealt with according to relevant rules of the State Council. Article 42. The present Regulation shall come into force as of October 1, 2001. |
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