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Business & Regulation Standards & Regulation

Cutting Out the Middleman

With China’s capacity for cell and gene therapy (CGT) research expanding at a rapid rate, the country is keen to expand access as much as possible. A draft proposal from the Chinese health minister aims to allow elite hospitals to sell CGTs without the seal of approval typically required from regulators. 1400 Chinese hospitals that provide specialist care and conduct medical research will have the chance to apply for a licence enabling them to sell CGTs to patients after proving their competence in processing these therapies and conducting clinical trials. Hospitals and companies who fail to obtain the licence would still need to receive approval from the China Food and Drug Administration.

The proposed legislation represents a u-turn from previous thinking in China. After the death of a student in 2016, the country took heavy measures to ensure that unapproved CGT products could not be sold. The student, who suffered from a rare form of cancer, paid over $30,000 for an immunotherapy, which ultimately resulted in their death. Prior to this, the sale of CGTs went unregulated, giving many hospitals across the country the opportunity to sell them despite ongoing safety and efficiency testing. The restriction imposed by the government sought to protect patients from adverse, and even fatal, outcomes but as also led to a decrease in the number of patients participating in clinical trials.

The new draft policy has been met with mixed reviews. While some within the Chinese scientific community support the proposal, citing its potential to put patients in control of their own health and bolster the clinical trial process, others are wary about the inadvertent sale of dangerous therapies. Time will tell if the proposal comes to pass.

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  1. Nature News, “Chinese hospitals set to sell experimental cell therapies”. Available at: go.nature.com/2ZQx1mp . Last accessed May 7, 2019.

About the Author

Maryam Mahdi

Assistant Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

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