China has adopted a broad set of regulations on the collection and use of its ‘human genetic resources’ in an attempt to restrict their exploitation by foreign biotechnology and pharmaceutical companies.

China is becoming increasingly aware that its large population and relatively high number of distinct ethnic groups provide fertile ground for the search for disease genes that could hold the key to profitable diagnostic and therapeutic techniques.

Foreign companies have reportedly been obtaining data from studies carried out in China in collaboration with local researchers without obtaining official approval or ensuring any significant return to Chinese research institutions.

But, under the new regulations, official authorization will be required for any research project that seeks to “sample, collect, merchandize or export” human genetic resources. These are defined as “any materials of and from human beings that contain human genome, genes or gene products, or parts thereof”.

The regulations also specify that, if valuable genetic information emerges from a collaboration between a Chinese research institution and a foreign organization, profits from the resultant patents should be shared in proportion to the contribution of the two bodies concerned. Requests for the approval of individual projects and for the export of genetic material will be examined and issued on a quarterly basis. Collaborative projects already established will also be required to apply for approval.

Those who helped draft the regulations, which will be administered through a new Administration Office of National Human Genetic Resources of China, say they tried to ensure that the regulations are not too rigid or restrictive on collaborative projects.

Boqin Qiang, for example, first vice-president of the Chinese Academy of Medical Sciences and leader of the Beijing Human Genome Research Centre, emphasizes that Chinese scientists are keen to establish such projects with foreign research groups, and that the regulations are not intend to act as a barrier.

The regulations also require that proper informed consent should be obtained from all those who provide samples of genetic material for researchers, or, where appropriate, from their family members. This will bring Chinese research procedures in line with those in Western countries. “Obtaining informed consent in this way is an important part of the process,” says Zhu Chen, director of the Shanghai Human Genome Research Centre, who has also been closely involved in drafting the regulations.

Chen says he strongly supports clauses in the regulations on the equitable sharing of intellectual property rights. “If people in China do some of the work involved in collecting and processing samples, then they should share in the commercial benefits in recognition of their contribution,” he says.

In addition to the genome centres in Beijing and Shanghai (see Nature 394, 109; 1998), China currently has about 30 laboratories involved in human genome research. Work is under way to study the genetic basis in the Chinese population of various diseases, including cancers, leukaemia, schizophrenia and cardiovascular diseases.