China toughens organ transplant rules

China has published rules governing human organ transplants in its latest effort to clean up a business that has been criticised as being profit-driven, with little regard for medical ethics.

The rules issued by China’s State Council, or Cabinet, include a ban on the sale of human organs for profit and on donations by people under 18, according to the text of the regulations published by the Communist Party newspaper People’s Daily.

The rules also make it illegal to harvest human organs without permission and standardise transplant procedures at the limited number of hospitals licensed to perform such procedures.

The rules, which take effect on May 1, do not apply to the transplants of human tissue such as cells, cornea and marrow, according to the paper.

Little information about China’s lucrative transplant business is publicly available. Human rights groups have said many organs – including those transplanted into wealthy foreigners – come from executed prisoners who may not have given their permission.

The official Xinhua News Agency said most organs used in transplants came from Chinese citizens who had voluntarily donated. But a senior health official had said in November that most organs harvested from bodies were from executed prisoners, with their prior consent, according to a China Daily newspaper report.

Chinese legislators have been pushing for years for a law to regulate and promote voluntary organ donations. The rules are needed, they say, to prevent unqualified doctors and profit-hungry hospitals from abusing patients.

Health officials say China faces a severe shortage of human organs, estimating that out of 1.5 million people who need transplants in China each year, only about 10,000 operations are carried out.

Voluntary donations remain far below demand in China, partly due to cultural biases against organ removal before burial.