Genome Editing, Bioethics, Policy and Politics in the UK and in the US

I believe that we as bioethicists have a responsibility to try and bring to the surface the underlying forces that that shape the ethical boundaries of a particular debate in a country versus another. Political, social and economic factors shape ethics and policy making as they shape science and technology in different ways in different countries.
09/22/2015 04:48 pm ET Updated Sep 19, 2016

Scientists at the Francis Crick Institute in London have approached the Human Fertilisation and Embryology Authority - the UK Regulatory Body governing research on embryos, human embryonic stem cells and assisted reproduction - to request a license to apply CRISPR/Cas9 technology to human embryos.

The case is reminiscent of a debate going on in the UK almost ten years ago, when in 2006 scientists at King's College London and at the university of Newcastle applied to the HFEA for license to research on cybrids. At that time, very few people knew what cybrids were, and the most common reactions as elicited by the media were of 'disgust' and fear of human-animal monstruos creatures such as the mythical half-man half-bull Minotaur.

In reality, both in 2006 and now, scientists apply to the HFEA for a license to work on embryos in vitro for up to 14 days with the aim to derive human emrbyonic stem cells lines for disease-modelling. No human-animal monsters were being created then, nor designer babies are created now. What we are witnessing is the creation of different, although analogous, dystopic imaginaries originated by the applications of technologies to human embryos.

Shortly after the cybrids case, Shinya Yamanaka and his induced pluripotent stem cells came about and nobody has heard anything anymore on cybrids. The scientsts who had applied to HFEA moved on to work on the new iPS technologies for disease modelling in vitro.

It may be the case that something very similar is happening now, namely that we may be focusing too much on the wrong applications of the CRISPR technology to the human embryos, and overlooking other applications which could revolutionise biotechnology in the next few years.

CRISPR/Cas9 is technology that has been used in the laboratories all over the world for years (for an explanation see here), and for the most part, not on embryos or human embryonic stem cells. Here are only some examples of possible applications of the technologies that are currently being overlooked:

1. Creation of humanised animal models for organ transplant. Organ transplant is a huge problem worldwide and CRISPR-Cas9 could provide a way out of the shortage by inserting human genes into pigs or other animals from which organs could be harvested which would avoid the problem of graft-vs-host disease. The cross-species experiments raise ethical issues of course, such as: is there a threshold above which animals with human genes raise issues of 'personhood'?

2. Genedrive effect and dual use of research: one of the applications of CRISPR-Cas9 in Drosophila Melanogaster (the fly used as animal model in laboratories all over the world) has created mutants which are genetically 'dominant', i.e. whose effect also pass down to future generations of flies that, if released into the environment, could wipe out wild-type flies. While it has been argued that this could be used to eradicate a population of disease- (e.g. malaria) carrying mosquitos, it is also plausible to speculate that it could also be used for the opposite purposes, in a perfect instance of a dual-use dilemma (research that can be used for good and for bad purposes).

3. Engineered crops: CRISPR/Cas9 has far-reaching applications in crops. While these are not new (engineered transgenic crops have existed for years), the efficiency and cheapness of the technology, combined with the fact that some of the mutations may have a dominant effect through the Genedrive effect already mentioned, pose questions for the preservation of biodiversity.

The narrow focus of the current debate on the applications on human embryos overclouds also other important political and social considerations.

US scientists have been calling for a moratorium on applications of CRISPR/Cas9 to human embryos since March 2015. But what are the motivations behind the call for a moratorium? For one, the recent patenting dispute in the US for the applications of CRISPR, has to a large extent escaped the media radar, and unjustifiably so, as plausibly intellectual property issues represent a powerful mover in the US debate.

The NIH has reiterated the ban on applications of CRISPR/Cas9 to human embryos. A meeting of the National Academy of Sciences to discuss human genome editing applications is planned for early December in DC.

Meanwhile, the UK is taking advantage of the US stalemate, with the move by group leader Katya Niakan to request a license to apply CRISPR to human embryos, the UK positions itself as "pioneer" within the realm of "responsible research and innovation" which has been the catch phrase of scientists and European research in the last few years.

Niakan's application to the HFEA needs to be read a clear statement that no new regulations are needed in the UK, but the HFEA Embryology Act, dating back to 1990, which permits research in vitro (i.e.m non-clinical) on embryos up to 14 days, is sufficient for all intents and purposes also for CRISPR/Cas9.

Indeed, as put by UK scientist Robin Lovell Badge (also at the Francis Crick Institute, and who has written against the need for a moratorium), if Niakan's research group were given a license, it would mark "the first approval by a national regulator."

Riding the wave of the recent Parliamentary approval of human embryonic mitochondrial DNA replacement techniques, the UK now wishes to continued to be portrayed as a pioneer and model for responsible research and innovation for other countries. It is therefore plausible to speculate that a HFEA license will be granted to Niakan's research group, although probably it will be narrow in scope and in duration.

Meanwhile, in the US, where bioethics is so intimately linked to politics that it becomes polarised along the Republican/sanctity of embryo/ban on research, and Democrats/prochoice/pro research, the fate of CRISPR/Cas9 research will probably depend on who will take a seat in the White House in November 2016.

Economic considerations play a role too in shaping the debate.

Funders in the UK, such as the Wellcome Trust and the Medical Research Council, are also unsurprisingly backing such responsible research and innovation, as a recent joint statement leads us to think. They must also like that the very first request to the HFEA comes from Francis Crick Institute (sponsored by the above funders among others), as it will plausibly attract scientists from all around the world to work in the UK, including from the US, especially if the NAS will confirm in December the ban on applications of CRISPR to human embryos. The Francis Crick Institute is a brand new research institute in the heart of London which, from early 2016, will host more than 1250 scientists working in the clinical applications of molecular biology cancer, cardiovascular and neurodegenerative diseases.

These are only some of the considerations that are overshadowed by a narrow focus on the applications of CRISPR/Cas9 to the human embryos, with the accompanying creation of eugenics imaginaries that the media portray.

I believe that we as bioethicists have a responsibility to try and bring to the surface the underlying forces that that shape the ethical boundaries of a particular debate in a country versus another. Political, social and economic factors shape ethics and policy making as they shape science and technology in different ways in different countries.

Not only, but as bioethicists, and in general as citizens interested in the public good, we also have a duty to redistribute the scarce resources of ethical concern and public attention away from the embryo and towards the animal and environmental applications of CRISPR/Cas9 technology. In this sense, a look at our not very far past and at the cybrids case could be illuminating.