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BIO Statement on Unsubstantiated Reports of Heritable Human Genome Editing Experiments in China

November 28, 2018

BIO Statement on Unsubstantiated Reports of Heritable
Human Genome Editing Experiments in China 

 

Washington, DC (November 28, 2018) – The Biotechnology Innovation Organization (BIO) issued the following statement regarding unsubstantiated reports this week of experiments involving heritable human genome editing in China:

“While we still are waiting for the full facts of this story to come to light and be independently verified, we found the human genome editing activity by an individual scientist out of China, as described in press reports, to be deeply troubling if true. Any human germline experimentation of this kind would be irresponsible.  BIO and its member companies view the science of genome editing as having not advanced sufficiently for clinical applications involving potentially heritable human genetic changes to be appropriate, and such activity is prohibited in the United States. It is vital that extensive discussions and engagement continue to take place among all major stakeholders, including members of the scientific, patient, caregiver, policy, legal, ethical, and faith communities, to determine whether, and under which conditions, germline genome editing should take place for human clinical application.

“Accordingly, BIO member companies involved in human genome editing are focused on using gene editing technologies for clinical applications on somatic (non-heritable) cellular therapies designed to treat patients currently suffering from devastating genetic diseases.  We support the robust U.S. regulatory framework that oversees clinical use of genome editing in non-heritable cells, which is similar to that of other advanced biotherapeutic technologies such as gene therapy. BIO also has an established working group of member companies involved in genome editing, which is leading our efforts to develop appropriate policies for this evolving technology and to engage in dialogue with relevant stakeholders on its benefits and responsible application.

“BIO strongly condemns any actions in violation of laws and regulations. BIO and scientific leaders across the globe stand united in calling upon policymakers and the scientific community around the world to set, follow, and enforce guidelines and policies for the responsible application of human genome editing technology in their respective countries.”

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