(Nov. 27, 2009) On November 13, 2009, China's Ministry of Health issued the Technology Management Norms for Umbilical Cord Blood Hematopoietic Stem Cell [UCBHSC] Therapy. The stated purpose of the Norms is to standardize clinical use of such therapy while ensuring medical quality and safety. These Norms are the basis on which technical reviews of medical institutions that apply for permission to engage in clinical use of UCBHSC therapy technology are to be conducted, and they constitute the minimum requirements for development of UCBHSC therapy technology by the medical institutions and their doctors. The Norms are also applicable to UCBHSC transplant technology.
The Norms are divided into three main sections, covering the basic requirements for the medical institutions, for their personnel, and for technology management. Medical institutions that develop UCBHSC therapy technology must be suited to the functions and duties involved and have lawful UCBHSC sources. The eligible institutions are level-three (i.e., at the national, provincial, or city level) general hospitals, hospitals for blood diseases, or children's hospitals authorized to engage in internal medicine or children's medicine involving blood diseases. They should have, or have access to, certain other facilities as well, such as laboratories and pathology units.
Personnel requirements include basic standards (e.g., on the requisite number of qualified physicians and ratio of nurses to beds), the qualifications for UCBHSC therapy physicians and nurses, and requirements for other relevant health professional and technical personnel.
As for technology management, the Norms call for strict compliance with relevant specifications for technical operations and with diagnostic guidelines. They also call for decision-making and treatment based on the patient's condition, the treatment options, and other factors, and for scientific, strict adherence to a regime of UCBHSC therapy technology indications. Illnesses for which the technology is appropriate include hereditary and congenital diseases and certain malignant and non-malignant acquired diseases. Contraindications for its use are serious mental illness; serious heart, liver, kidney, or lung malfunctioning; and uncontrollable, serious infections. (Circular of the General Office of the Ministry of Health on Printing and Issuing the Technology Management Norms for Umbilical Cord Blood Hematopoietic Stem Cell Therapy (for Trial Implementation) [with hyperlink to the text of the Norms] [in Chinese], Ministry of Health of the People's Republic of China website, Nov. 20, 2009, available at http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohyzs/s3585/200911