The World Health Organization (WHO) has released findings from its two-year independent global consultation on how human genome editing tools such as CRISPR should be used in an ethical and non-harmful way to benefit human health, without holding back scientific progress.
The 18-member consultation group was established after it was revealed in 2018 that Chinese scientist, He Jiankui, had used CRISPR techniques to edit two human embryos. Later dismissed from his position at the Southern University of Science and Technology in Shenzhen, the incident made it clear to international health authorities that more guidance was needed on how to regulate this new technology.
Two separate reports have been produced from the WHO advisory committee, the first—entitled ‘Human genome editing: a framework for governance’—advises on how to govern use of such technology using a number of different possible scenarios that governments or regulators may have to deal with.
Breaking the topic down into five areas: nonheritable genome editing after birth and prenatally, heritable genome editing, human epigenetic editing and genetic enhancement, the report describes possible scenarios for each area and appropriate ways to deal with them. For example, a hypothetical clinical trial of non-heritable human genome editing to treat sickle cell disease proposed to take place in West Africa and a proposal to use non-heritable or epigenetic genome editing to enhance athletic performance.
“Human genome editing has great potential to improve human health and medicine… However, there are important areas of ongoing uncertainty as to potential benefits and risks, and gaps in scientific understanding in such key domains as off-target effects and long-term risks,” write the authors of the report.
“Somatic, germline and heritable human genome editing raise important and outstanding ethical and social issues. Challenges associated with somatic human genome editing include, for example, rogue clinics, medical travel, as well as the reporting of illegal, unregistered, unethical or unsafe research and other activities including the offer of unproven so-called therapeutic interventions. Heritable human genome editing also gives rise to great concerns as the edit might be passed to subsequent generations.”
The second report, entitled ‘Human genome editing: recommendations’, outlines nine suggested actions and pathways governments and regulators should take going forward.
Two of these include making the WHO a leader in international efforts to regulate use of this technology and for it to act as an international independent advisor for governments seeking guidance on how to set up regulations within their own countries.
After the Chinese gene-editing scandal in 2018, there were several calls for the setting up of a registry of trials carrying out human genome editing. The WHO committee publicly supported this in a statement made in 2019, as well as agreeing with calls for a moratorium on germline editing at the current time. This earlier suggestion was upheld in the newly published recommendations and it is suggested that the WHO should manage this registry in consultation with national and internal ethics committees and set up an expert panel to oversee and manage the registry.
To try and avoid unethical or unsafe research in this area, the WHO committee suggests that both non-heritable and heritable human genome editing research should only take place in countries with well-established medical regulators that have the ability to oversee such research. They also want to establish a safe, confidential and accessible way for reporting of illegal or problematic research going on in this area.
A key issue raised by the committee was accessibility of therapeutics being developed using this technology. For example, several companies are currently working on gene-editing based therapeutics for sickle-cell anemia. This condition disproportionately affects people in Africa, but there are concerns that high future pricing may mean that very few people that need the therapy will be able to access it, if trials prove successful. The WHO committee suggests that patent holders of such technology should be encouraged to develop reasonable deals with countries that may have a high need for the therapies, but minimal resources, to try and ensure equitable access to the technology.
There is no doubt that human genome editing is a complex area and one that many non-experts are ill informed about. Because of this, the consultation group highlighted education, engagement and empowerment as an area that needed more focus. They recommend continuing ongoing international working groups and discussions about this topic, as well as the creation of reports and other educational material on this area. They also charge the WHO with creating a set of officially endorsed ethical principles to be used by its own staff working in this area and other collaborators.
The final recommendation by the committee is more of a look to the future. With such a fast-moving technology that is continually changing and being upgraded it is important for any regulations to be regularly checked and updated. They suggest that a similar consultation and updated report and recommendations should be published in less than 3 years’ time.
“These new reports from WHO’s Expert Advisory Committee represent a leap forward for this area of rapidly emerging science,” said WHO’s Chief Scientist, Soumya Swaminathan. “As global research delves deeper into the human genome, we must minimize risks and leverage ways that science can drive better health for everyone, everywhere.”
The WHO will now work to implement the suggestions raised in the report such as progressing the setting up of a specialized clinical trials registry and providing a mechanism for people working in research and industry to report concerns about ongoing or future research in this area.
