China has drafted its first regulation on human organ transplants amid growing calls from national lawmakers for fast legislation to help better regulate the sector and facilitate donations.

Minister of Health Gao Qiang said the regulation uses technical codes and criteria for human organ transplants.

"It mainly aims to strengthen the regulation of organ transplants from the perspective of medical science and services," he told China Daily on the sidelines of the on-going annual session of the National People's Congress (NPC).

The regulation, now open to advice and suggestions from medical experts, will be submitted to the Legislative Affairs Office of the State Council for final approval.

Sources said the regulation would ban human organ sales and introduce, for the first time in China, a set of medical standards on brain death.

Once enacted, the regulation is expected to help introduce more discipline and order to the organ transplant sector.

The ministry's move, however, still falls short of the expectation of national lawmakers who have been pushing for legislation on organ transplants since 1986.

NPC deputy Chen Haixiao, a surgeon with Taizhou Hospital in east China's Zhejiang Province, strongly complained about the lack of legislative progress in regulating human organ transplants.

"I understand it is not easy to formulate a law and it will take time," he told China Daily. "But the legislation on human organ transplants and donations is too slow anyway."

At last year's NPC session, Chen and another 100 deputies put forward three motions urging for legislation on organ donation.

In December last year, the NPC Standing Committee, which handles the legislative work, replied that the time was still not right for starting the legislation.

"We suggest related departments of the State Council actively organize research about legislation on human organ transplants and consider formulating the law when the time is right," it said at the time.

But Chen warned that a legislation process that is too slow may cause more problems especially as the human organ transplant sector is poorly regulated in China. The lack of regulation has led to excessive waste of medical resources as well as poor medical practices in organ transplants, he said.

In China about 20 human organs are used in transplant operations including kidneys and livers.

Statistics indicate that at least 2 million Chinese people need an organ transplant each year but in fact only around to 20,000 are conducted because of a shortage of donated organs.

The huge gap between supply and demand has prompted some people to organize organ sales in China for large profits, Chen said.

Concept of brain death

The NPC deputy went on to say that China's failure to adopt the concept of brain death has greatly hindered the development in organ transplants.

So far 189 member states of the United Nations accept the concept of 'brain death' which is defined as the irreversible loss of brain function.

But China continues with the traditional concept of cardiac death which means a person is considered dead only when their heartbeat and breathing stop. Cardiac death causes the loss of blood in organs of a brain-dead person making them unsuitable donors. 

Chen, however, acknowledged that the Chinese people's ingrained traditional concept of death and their religion does hinder their acceptance of the concept of brain death and the practice of donating organs.

Traditionally, the Chinese people hold that the body of the dead should be kept intact.

Chen predicted that the concept of brain death and cardiac death may co-exist in the country and allow the public to choose either of them as the standard for determining death.

"As organ transplant and donation is both a medical and ethical issue. We need to raise public awareness about it," Chen said, "in that sense, the earlier we start the legislation, the better."

(China Daily March 13, 2006)