HONG KONG – In an era when data are more valuable than gold, China has rolled out new regulations to strengthen control of its human genetics data. Any foreign biotech companies or institutes intending to use Chinese data must engage a Chinese partner in the research project, amongst other new requirements.

The new regulations will come into effect July 1. Human genetic resources are defined as human genome, human organs, tissues, cells, blood, and related gene materials and information, which Xu Nanping, China's vice minister of science and technology, said are of strategic value.

"The new regulation aims to strengthen the management of human genetic resources and encourage a proper use of them," said Xu in a press conference.

Home to 1.3 billion people, China takes up nearly one-fifth of the world's population. Its huge population represents a genetics goldmine, and the government wants to make sure that its players will have a part to play in scientific research that uses that goldmine.

First thing to note is that foreign parties must involve Chinese partners – namely scientific institutions, universities, medical institutions or enterprises – in order to use China's human genetic resources for scientific research. Foreign parties include individuals and institutions that are established or controlled by foreign organizations.

Foreign parties cannot collect or preserve China's human genetic resources within China or transfer them abroad. They must also fully engage their Chinese partners and give them open access to and a copy of all records and data.

To get a project off the ground, both Chinese and foreign parties must seek approval from China's Ministry of Science and Technology, the main authority regulating human genetic resources.

Such approval is not necessary when the human genetic resources are used in multinational clinical trials to get marketing approval for relevant drugs or medical devices in China, and when such data will not be transferred abroad.

To transfer Chinese human genetic resources abroad, the parties must seek approval from the Ministry of Science and Technology and projects will have to pass an ethical review.

The second major change is in the ownership of intellectual property rights. If the Sino-foreign joint research yields results by using China's human genetic resources, both Chinese and foreign parties will jointly file for the patent application and share the rights.

Alternatively, both sides can sign an agreement to establish the rights of use, assignment and distribution of benefits if they do not seek to have their work patented. They also cannot transfer the results to a third party without mutual agreement.

"The new regulations make it clear who is subject to the rule, who the intellectual property rights belong to, and in what circumstances the applicants will only need to go through the simpler procedures," Daisy He, associate at law firm CMS Beijing, told BioWorld.

"There were regulations of human genetic resources before, but it wasn't clear. A lot of foreign companies were not aware that they violated the law," she added.

Violators will be fined

Last October, the Ministry of Science and Technology said five companies and one research hospital breached the law by transferring Chinese human genetic data to other parties in China or outside the country without an approval from the ministry's human genetic resources office.

Those to be named include British pharma giant Astrazeneca plc, which transferred the data to two Chinese firms, Amoy Diagnostics Co. Ltd. and Kunhao Ruicheng Pharmaceutical Research and Development (Beijing) Co. Ltd., without permission.

Chinese genomics giant Beijing Genomics Institute and Shanghai's Huashan Hospital, on the other hand, published Chinese genetic data that were part of one of their studies in international journals without approval.

Chinese regulators also punished leading contract research organization Wuxi Apptec Co. Ltd. for trying to transfer human genetic data out of the country by marking it as dog genetic data.

According to the new regulations, those that violate the law will have to stop their activities and be fined up to ¥10 million (US$1.45 million). Regulators will also confiscate their human genetic data and gains. In more serious cases, the lawbreakers will be banned from collecting, preserving, using or exporting human genetic data for up to five years, or even permanently.

China's new move has raised the question as to whether it will make it harder for international collaborations and biotech advancement, as now whenever Chinese data are involved, part of the project must be carried out in China with a Chinese partner. That can be difficult for foreign companies and researchers.

But He defended the new rule: "China is just protecting its own data and it hasn't shut the door for Sino-foreign collaborations. Foreign companies just need to follow the rules and make sure they don't step over the red line."

The new rules on genetic data follow the ones on the use of biomedical technologies that are considered high risk. In February, China made the stipulation that clinical research and application of new biomedical technologies, such as gene editing, stem cell technology, cloning and assisted reproduction, must obtain government approval. (See BioWorld, March 4, 2019.)

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