Healthy Soch
In the wake of the dramatic announcement in November 2018 of the birth of the world’s first genome edited babies, the World Health Organization (WHO) convened an Expert Advisory Committee on Human Genome Editing. The Committee was formally established in February 2019 and given a clear mandate to examine the scientific, ethical, social and legal challenges associated with human genome editing in both somatic cells and cells of the germline, including early embryos. More specifically, the Committee was tasked by the Director General Dr. Tedros Adhanom Ghebreyesus to advise and make recommendations on appropriate governance mechanisms.
The Committee is comprised of eighteen members coming from all parts of the world, representing a broad range of disciplines, expertise, and experience. Since our first meeting in March 2019 we have embarked on an ambitious program of work. This has resulted in a number of concrete initiatives including the creation of a registry to provide a transparent and structured mechanism for collecting and curating details of planned and ongoing developments in both germline and somatic genome editing research, including clinical trials. This registry, which is now being piloted on a WHO platform, will allow everyone to know what genome editing research is being undertaken and where.
In the midst of the Committee’s ongoing work, Dr. Denis Rebrikov, a Russian molecular biologist, announced plans to pursue heritable human genome editing. Initially, the plan was to genetically modify the CCR5 gene to provide resistance to HIV. This plan was later modified as the focus shifted to the genetic modification of the GJB2 gene to prevent a type of hereditary deafness. In response to these concerning news reports, in August 2019, the WHO Director General issued a statement calling on all nations to support the work of the WHO and to desist from permitting research on heritable human genome editing within their borders:
Human germline genome editing poses unique and unprecedented ethical and technical challenges. I have accepted the interim recommendations of WHO’s Expert Advisory Committee that regulatory authorities in all countries should not allow any further work in this area until its implications have been properly considered.
A few months later, in October 2019, consistent with the position of the WHO and its Expert Advisory Committee, the Ministry of Health of the Russian Federation announced that “any clinical use of editing technologies of the genome of human embryos and germ cells is premature”. The Ministry also endorsed the WHO perspective that it would be irresponsible and unacceptable to use genome edited embryos to initiate human pregnancies. Finally, and most importantly, the Ministry of Health’s press release explicitly stated that the WHO position, “supported by the Russian Federation, should be decisive in the formation of country policies in this area.”
This strong statement by the Ministry of Health of the Russian Federation is a reassuring example of how seriously some countries are taking the rapid developments in the science of genome editing, especially human germline editing, and its ethical ramifications. Consider, for example, the recent publication on prime editing which involves making changes to a single base pair into any other, altering several base pairs at once, or inducing small precise deletions or insertions. This is an exciting technology that may enhance our ability to make precise alterations in DNA sequences in living cells.
The Russian statement in support of the WHO’s ongoing work sets an important example for regulatory authorities committed to assisting with the development of a global framework for the coordination of regulation, legislation and policies governing frontier science. We are not advocating for a single mechanism but a governance framework that can:
- identify relevant issues, a range of specific mechanisms to address them, and be developed incollaboration with the widest possible range of institutions, organizations and peoples.
- Be scalable, sustainable and appropriate for use at the international, regional, national and local levels.
- Work in parts of the world where there is traditionally weaker regulation of scientific and clinicalresearch and practice, and where genome editing may not yet be pursued or invested in with great intensity.
- Provide those with specific governance roles for human genome editing with the tools and guidance they need.
Plans to date are for a governance framework grounded in the following guiding principles:
- Transparency – to be understood as a commitment to share information on what is happening, how and why it is necessary, including the Committee’s own processes and outcomes;
- Inclusivity – to be understood as a commitment to draw on the full contributions of all parts of global society, thereby providing diverse points of view, skill sets and additional methods of program management and measurement;
- Responsible stewardship of science – to be understood as a commitment to follow good practice in scientific and clinical conduct, attempting to maximize potential benefits and minimize potential harm;
- Fairness – to be understood as a commitment to fair dealings in relation to all persons and groups, and equal access to opportunities and potential benefits; and
- Social justice – to be understood in relation to a commitment to celebrate and promote diversity by rejecting patterns of discrimination based on personal or group characteristics including gender, race, ethnicity, sexuality, age, and disability.
Consistent with these principles is a commitment to better understand what effective public and community engagement should look like when developing governance mechanisms for human genome editing. The Expert Advisory Committee is exploring how we can expand the views and perspectives that feed into our work and are organizing consultations on these issues.
Collectively, we have a responsibility to make the best use of emerging technologies to improve the health and well-being of all people everywhere. This can be achieved only through collaborative effort on a global scale; no lone scientist or lone country should seek to impose their standards on the global
