europeanpharmaceuticalreviewJuly 14, 2021
Tag: WHO , Human Genome Editing , health
The World Health Organization (WHO) has published the first global recommendations to help establish human genome editing as a tool for public health. The guidelines, released in two companion reports, emphasise safety, effectiveness and ethics.
The reports, one the governance framework on human genome editing and the other recommendations from the WHO’s Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing, are the result of over two years of consultation with hundreds of participants representing various stakeholders. Parties involved in the consultation included faith leaders, indigenous people, patients, researchers and scientists.
“Human genome editing has the potential to advance our ability to treat and cure disease, but the full impact will only be realised if we deploy it for the benefit of all people, instead of fuelling more health inequity between and within countries,” stated Dr Tedros Adhanom Ghebreyesus, WHO Director-General.
The potential benefits of human genome editing are vast, ranging from enabling targeted and personalised treatment of diseases such as cancer to preventing genetic disorders. For instance, somatic gene therapies, used to treat disease, have been used to address HIV, sickle-cell disease and transthyretin amyloidosis. However, risks still exist, particularly in with germline and heritable editing, which alter the genome in a way that could be passed down to subsequent generations.
The new reports provide recommendations on the governance and oversight of human genome editing in nine discrete areas:
Leadership by the WHO and its Director-General
International collaboration for effective governance and oversight
Human genome editing registries
International research and medical travel
Illegal, unregistered, unethical or unsafe research and other activities
Intellectual property
Education, engagement and empowerment
Ethical values and principles for use by WHO
Review of the recommendations.
They focus on systems-level improvements that will build capacity in all countries to ensure that human genome editing is used safely, effectively and ethically. The reports also provide a new governance framework that identifies specific tools, institutions and scenarios to illustrate practical challenges in implementing, regulating and overseeing research into the human genome.
“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, Dr Soumya Swaminathan. “As global research delves deeper into the human genome, we must minimise risks and leverage ways that science can drive better health for everyone, everywhere.”
Going forward the WHO said it will convene a small expert committee to consider next steps for the genome editing registry, including how to better monitor clinical trials using human genome editing technologies of concern; convene multi-sector stakeholders to develop an accessible mechanism for confidential reporting of concerns about possibly illegal, unregistered, unethical and unsafe human genome editing research and other activities; and lead regional webinars focusing on regional/local needs to increase education, engagement and empowerment, as well as consider how to build an inclusive global dialogue and create web-based resources for reliable information for the technology.
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