A volunteer lays flowers in front of a monument in honour of organ donors during a commemorative event held at a human organ donor memorial park in Kunming, southwest China's Yunnan Province, April 3, 2019. Photo: Xinhua

China's National Health Commission (NHC) has issued a draft for a revision to the Human Organ Transplantation Regulation to solicit public opinions, which includes rules on procurement, fair allocation of organs, legal age for donation and related charges as well as strengthened punishment on trafficking and illegal transplant.

The current regulation was promulgated in 2007 and the revision is a long-awaited legal move to address problems and to fulfill the needs in the practice of organ donation and transplantation, observers said. 

The draft, published on NHC's website on Wednesday, states "the nation encourages people to donate organs when they pass away" and appointed the Red Cross Society of China to carry out related registration and commemoration work. 

Liu Changqiu, a health law expert and research fellow at the Shanghai Academy of Social Sciences, noted that the revision contains the lessons learned from practice into a legal charter for future reference and points the way forward for the China's organ donation and transplantation program. 

The long-awaited revision addresses problems that have emerged since the country's reform in the area from 2010 and specifies sections where the current regulation is ambiguous, Liu told the Global Times on Thursday. 

The draft gives specific regulations on how donor organs are to be acquired and allocated to recipients, stipulating that live organs can only be donated to relatives of the donor. Juveniles are barred from being a live donor.  

Liu explained that the restriction on juveniles making live donations is in line with the amendment of the Criminal Law in 2011, which wrote organ trafficking into its charters as a crime. 

Underage individuals may not fully understand or recognize the risks and costs of organ donation, and the legislation will protect their rights, Liu said, noting this is also common practice internationally.

But Cai Yu, a law professor at the Yunnan University of Finance and Economics, suggested that age restriction should not be a one-size-fits-all policy. Underage donation should be allowed after passing ethics review, a review of the donor's decision-making capabilities and obtaining parental agreement. 

Cai suggested there should be flexibility allowed in the system. For example, donations between relatives should be allowed to bypass the system, such as a parent to a child or the reverse.

Use of organs in violation of a person's wishes is prohibited. Unless a deceased person has explicitly stated they do not wish to be a donor, the person's spouse, adult children and parents can agree to the procedure on his or her behalf, according to the draft. 

To tackle the dark zone of organ trafficking, the draft regulation specifies that the NHC must regularly review and certify hospitals that carry out transplant surgeries. 

It also contains specific rules on the process of procurement, transportation and transplantation, as well as links that incur fees for the receiver to rule out possibility of extra charges and organ trafficking. 

Organs will be allocated through the China Organ Transplant Response System and surgeons are not allowed to change the system or use organs not allocated via the system or from unclear sources. 

The draft will strengthen punishment for violations and stipulates specific fines and penalties. Taking an organ without an individual's consent and taking live organs of a person under 18 constitutes a crime. Individuals and institutions involved in organ trafficking and illegal transplants will face a fine of eight to 10 times the illegal gain, as well as other punishments including suspension of the license to practice transplants.  

Zhao Hongtao, the secretary general of China Organ Transplantation Development Foundation, told the Global Times that the draft will remain open for comment for a month, and adjustments will be made accordingly. Work started on the draft in 2016 and health authorities, medical institutions, associations and experts have been consulted.  

Liu noted that Western countries have long been criticizing and attacking China's organ donation and transplantation practices and using them as a vehicle to smear China's human rights situation, which will not change with a single legal revision.  

"The revision reflects our spirit of the rule of law and objectively, our transparency in conducting the work will leave the West with no weapon to attack us," Liu said.   

In 2010, China started a pilot reform of deceased organ donation, and 34 donations were made that year. As of 2019, 27,262 donations had been made and another 2,228 donations were made in 2020. 

Data shows that China has roughly 300,000 patients waiting for an organ transplant each year.