News & Insights

China Issues New Draft Regulation on Human Genetic Resources

Global Life Sciences: China Update

China’s State Council published a draft Regulation on Administration of Human Genetic Resources on October 30, 2012 soliciting public comments by November 29, 2012. The draft is intended to replace the current Interim Measures for the Administration of Human Genetic Resources (1998) (“Interim Measures”) issued by the P.R.C. Ministry of Sciences and Technology (“MOST”). The new draft tightens regulations relating to the collection, storage, import and export, and R&D of Chinese human genetic resources.

By redefining human genetic resources as “resources and materials, such as human organs, tissues, cells, nucleic acid and nucleic acid products which contain human genome, genes or gene products, as well as any information derived from such resources and materials,” this draft encompasses any material containing information derived from physical human genetic materials. Also, as a sign of the government’s increasing awareness of cross-border electronic data transmission in R&D activities involving Chinese human genetic resources, the draft specifically emphasizes that any form of cross-border movement of Chinese human genetic resources cannot be done without prior approval from the government.

A new system to regulate the collection and storage of human genetic resources is also created by the draft; an institution conducting this type of work must be a legal “person” established in China and licensed by the government. If the draft is finalized as is, these licensed institutions will be the only entities that legally can collect, store and provide human genetic resources in China.

With regard to Sino-foreign R&D activities involving Chinese human genetic resources, the draft imposes an additional set of new requirements. First, foreign companies must collaborate with legal persons established in China. Second, while Sino-foreign R&D projects will continue to be subject to prior approvals, several new restrictions proposed in the draft will authorize the government to decline approvals, for reasons including: (1) the genetic materials are derived from illegal sources; (2) the project may endanger national or public security or damage the nation’s interests; or (3) the project may “cause discrimination.”

The current Interim Measures are particularly protective of Chinese partners in Sino-foreign collaboration projects, requiring the ownership of Chinese human genetic resources to be vested in the Chinese partner and mandating joint ownership of any intellectual property (“IP”) rights arising from the collaboration. The draft removes such protective requirements but encourages Chinese partners to actively pursue IP protections for the collaborations.

Multinational pharmaceutical companies that are conducting R&D activities involving Chinese human genetic resources should carefully review this draft and consider providing comments either individually or as part of a group.

Sidley China Life Sciences Practice

Sidley has a powerful, fully integrated life sciences practice serving multi-national pharmaceutical, biotechnology, medical device and food companies in every aspect of their business operations in China. Sidley’s Foreign Direct Investment, general Commercial, Corporate, M&A/Joint Venture, Antitrust, FCPA, Licensing, IP, provincial government work, as well our Regulatory practice permits us to serve virtually every legal need of our life sciences clients in China.

Sidley is the first international law firm to establish a stand-alone, comprehensive food and drug regulatory practice in China. As an integral part of our Global Life Sciences practice, we bring our knowledge of industry practices in the U.S. and EU to each project in China and help develop global Standard Operation Procedures (SOPs) and benchmark best practices.

For further information on the China Life Sciences Practice, please contact:

Chen Yang

Zhengyu Tang

Yuet Ming Tham

Sidley Global Life Sciences Practice

On three continents, Sidley’s Global Life Sciences Practice team offers coordinated cross-border and national advice on Food, Drug and Medical Device Regulatory, Life Sciences Enforcement, Litigation and Compliance, Healthcare Regulatory, Products Liability, Intellectual Property, Corporate and Technology Transactions, Securities and Corporate Finance, International Trade and Arbitration, FCPA/Anti-Corruption, Antitrust/Competition, Environmental/Nanotechnology.

Globally rated as one of the top life sciences practices, our team includes former senior government officials, medical doctors and leaders in various life sciences fields.

For further information on the Global Life Sciences Practice, please contact:

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