ASGCT Submits Comments to WHO Advisory Committee

ASGCT submitted comments on August 16 to the World Health Organization’s (WHO) Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. The goal of the Advisory Committee is to develop recommendations to guide governments, institutions, and researchers on scientific, ethical, social, and legal challenges related to both germline and somatic cell human genome editing.

ASGCT's response to the Advisory Committee’s call for public input focused on four key points:

1. ASGCT’s position is that germline gene editing combined with implantation of gene-edited embryos to achieve pregnancy, are technologies that are not ready for use in humans and pose very serious problems for which there is no scientific or general societal consensus.
2. ASGCT expressed respectful concern about the Committee’s recommendation to develop a global registry of all research and development relevant to its mandate, because registering somatic cell research may duplicate national regulatory requirements and add administrative burdens that could delay progress in the development of gene and cell therapies. ASGCT’s position is that somatic cell gene therapies should be subject to existing regulatory frameworks to ensure safety and efficacy. For these reasons, the Society requested the Committee only consider requiring the use of a registry for gene editing research on germline cells and embryos.
3. The WHO Committee has asked that anyone with knowledge of research and development relevant to its mandate to engage with the committee immediately. ASGCT fully supports the development and use of effective and accessible mechanisms for reporting clinical germline gene editing. We do not, however, find this reporting necessary for research based on somatic cells.
4. ASGCT also urged the WHO to obtain feedback from all relevant and diverse stakeholders for a broad dialogue on the committee’s remit. In particular ASGCT requested expanded representation of expert biomedical researchers in gene editing, as well as a relevant patient or caregiver, on the Advisory Committee.

The WHO committee, created in response to the November 2018 revelation of clinical use of germline gene editing, will continue its work in the year ahead. ASGCT has requested representation of a Society delegate on the working group to develop the architecture of the registry. It is our hope that the committee can support the boundless promise of the responsible use of gene editing therapies, while preventing use of the technology outside of current ethical and scientific norms. Achieving that goal will require a fine balance, and ASGCT stands ready to assist the committee.

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