Fourth Industrial Revolution

How should we regulate genome editing?

Empty sample tubes showing their unique '2DID numbers' wait to be filled at Biobank, the worlds largest blood and urine sample freezer near Manchester, northern England, in this March 18, 2010 file picture. Francis Collins, who helped map the human genome, did not get around to having his own genes analyzed until last summer. And he was surprised by what he learned. Collins has a predisposition for type-2 diabetes, something he had never suspected. The lanky, former director of the National Human Genome Research Institute (NHGRI) discovered this through tests offered by Navigenics, 23andMe and DecodeMe -- companies that charge customers a few hundred dollars for a peek at their genetic makeup. Picture taken March 18, 2010. To match Special Report SCIENCE/GENOME  REUTERS/Phil Noble (BRITAIN - Tags: SOCIETY HEALTH SCI TECH) - RTR2C8WZ

These seven guiding principles could help regulate human genome editing Image: REUTERS/Phil Noble

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President and Chief Executive Officer, Alliance for Aging Research
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Genome editing is now much easier, faster, cheaper and more versatile than ever. One of these editing techniques, known as CRISPR-Cas9, could allow for new editing applications, ranging from viruses and bacteria, to animals, plants and human beings. But as we pursue this technology, how should we regulate it?

An answer to the ethics and governance debate

The National Academy of Sciences (NAS) and the National Academy of Medicine (NAM) made a bold attempt to answer this question in a collaborative report, Human Genome Editing: Science, Ethics, and Governance. NAS and NAM appointed a 22-member, international expert committee to explore the current state of the science and clinical applications; potential risks and benefits to human health; and the standards for addressing what are known as “off-target effects”, which are unintended consequences associated with editing specific genes. The committee also discussed issues of equity and access, and the ethical considerations for how this technology could impact societal attitudes towards disability and disease.

The report established a set of seven governance principles with respect to human genome editing to apply globally across different political or cultural contexts.

The rationale behind these principles is that genome editing research is an international endeavour, and all nations should ensure that any potential clinical applications reflect societal values and be subject to appropriate oversight and regulation. The committee’s hope is that these overarching principles will be reflected in each nation’s scientific community and regulatory processes, and ultimately enhance consistency of regulation across nations.

The seven governance principles at a glance
The principles in application

Using these principles, the report’s authors found that gene editing in basic laboratory research is important to advance understanding of the links between genes and diseases like cancer, Alzheimer’s disease, and the progression of inheritable diseases. However, once researchers start applying gene editing to human cells, such as editing blood cells to treat sickle cell disease, human gene editing should be approached carefully and only to treat and prevent disease and disability. The report concludes that existing regulations in the US and other countries adequately manage responsible development of both basic science and therapies for treatment or prevention of non-inherited disease or disability.

The committee also determined that any use of human gene editing for enhancement purposes – other than treatment or prevention of disease and disability – should not be approved today. Public engagement and discussion on this topic needs to happen, and specific funding should be allotted to support this dialogue.

Germline editing, the deletion of a gene before birth to erase an inherited disease from an embryo and prevent it from being passed on to future generations, is not yet possible. The NAS/NAM recognizes that there are arguments for limited applications to prevent heritable disease should that become feasible. But it is time to think carefully about the implications of its use while the technology is being explored, rather than waiting until the decisions as to whether to proceed or not are imminent.

Germline editing carries potentially longer-term consequences since the changes made – typically applied to sperm or ova, but which could also apply to embryos – alter the genetic destiny of a family. This means that along with the positive effects that could cure a genetic disorder such as Huntington’s disease, potentially unintended effects could accompany the change, and be passed to future generations. Although CRISPR is hailed for its precision, concerns lie with what might happen if it misses its target, which it can. DNA is complex and many genes are intricately linked, so it could well be that modifying one gene has the scientists’ desired outcome but also inadvertently affects the function of other genes and molecules.

The future of human genome editing governance

The NAS/NAM principles approach to regulation of genome editing technologies was smart as a first step. Principles generally serve to motivate people to do the things that seem good and right, but without the constraints and external pressure of specific rules. Introduce specific regulations on the safety and efficacy of gene editing and that starts to infringe on people’s ethical limits, which traditional medical product regulation is not designed to address.

And that is the dilemma we all face. Many of our concerns about gene editing technologies are “out of bounds” for the institutions we rely on to regulate those technologies. For example, public views on genome editing in the context of issues such as research on human embryos vary both among and within countries and reflect both religious and secular influences. The result has been public policies ranging from permissive, to regulated, to prohibitionist. The seven governing principles become difficult to reconcile when setting regulatory guidance in this context.

This is where the World Economic Forum’s Center for the Fourth Industrial Revolution and Global Future Council on Human Enhancement can play a pivotal role. If there is agreement that the debate about genome editing is global, then using the NAS/NAM governance principles as a basis for setting practical regulations will require worldwide coordination. The Center is well-positioned to engage and coordinate regulators from across the globe to leverage these guidelines and drill down on more specific guidance for each technology; convene the public input process that should accompany it; and explore how to incorporate ethical and social concerns into safety and efficacy discussions.

There is real potential in gene editing to combat many chronic diseases and thousands of genetically inherited diseases, which affect hundreds of millions of people worldwide. The NAS/NAM report opened a door that requires us all to look further.

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