Organs: Rules specify legal liabilities for malpractice

More than a decade after China unveiled its national regulation on human organ transplantation, the first major revision to the rules was released on Thursday, with the focus on promoting awareness about organ donation and standardizing the management of organ donation, procurement, distribution and transplantation procedures.

Premier Li Qiang signed a decree of the State Council to unveil the rules on human organ donation and transplantation, which will take effect on May 1, 2024.

The rules have been refined from the ones on human organ transplantation issued in 2007 to meet the demands of changing situations and ensure the healthy development of the cause.

"In recent years, new circumstances have arisen in the field, such as a shortage of organs to meet clinical demand despite a rapid increase in organ donation," the Ministry of Justice and the National Health Commission said in a statement.

The revised rules highlight the publicity of organ donation to further advance its development and optimize the conditions and procedures for organ donation following the Civil Code. They improve the regulation of the system of obtaining and distributing organs for transplantation and the application of relevant technologies in organ transplantation.

The rules also specify the qualification requirements of medical institutions and practitioners for carrying out organ transplantations. They further improve related provisions on legal liabilities and strengthen the punishment of malpractice in the field.

The annual number of organ donations in China has been rising in recent years. Currently, the nation ranks second in the world in terms of the number of organ donations, according to China Organ Transplant Development Foundation.

Guo Yanhong, an official with the National Health Commission, said during an event in June that China recorded nearly 1,600 posthumous organ donations in the last three months, up 13 percent year-on-year.

However, the number of organ donors per million population stood at 3.98 last year, lagging behind some countries, and the number of patients in need of donated organs is rising, officials said.

Shen Weixing, a law professor at Tsinghua University, said the revised rules not only include "donation" in its title, but also expand related contents. "The new rules stress mobilizing different government departments and the whole society to engage in awareness drives, creating a positive regulatory environment for increasing organ donations," he said.

Taking lessons from past practices, the rules raise more detailed and comprehensive requirements for organ management, including designating at least two organ coordinators to supervise the procurement of organs from bodies on-site and establishing green channels for transporting organs.

The rules also require provincial-level or high-level health authorities to formulate their own regulations and conduct regular inspection of hospitals involved in transplantation procedures.

Zheng Shusen, a senior organ transplantation surgeon at the First Affiliated Hospital of Zhejiang University in Hangzhou, Zhejiang province, and an academician of the Chinese Academy of Engineering, said that China began providing a green channel for organ transfers in 2016, cutting the average time of transporting organs by at least one hour.

"The new rules raise specific requirements for medical institutions involved in procuring organs, and formulate standards for procuring technologies, which will play an important role in ensuring quality of donated organs and protecting health and rights of receivers," he said in a signed article released this month.

Medical facilities that fail the regular evaluations will have their certifications revoked, according to the rules. The implementation of the rules is expected to strengthen management of organ transplantation institutions.

The rules propose tougher penalties for malpractices, such as faking donation and transplantation data, overriding the national system that automatically distributes donor organs and failing to enforce results of the system.

Huang Jiefu, director of the National Human Organ Donation and Transplant Committee, said during a recent interview with the newspaper Guangxi Daily that more than 150,000 organs have been donated posthumously by 49,000 people.