10 October 2016
PhD student in the Department of Global Health & Social Medicine, King's College LondonAppeared in BioNews 872
The announcement of the first baby born using mitochondrial spindle transfer (MST), one of the two techniques that allow the replacement of faulty mitochondrial DNA, caught many by surprise (1). Specifically, it surprised members of the scientific and bioethics community in the UK, which last year became the first country in the world to allow the clinical use of mitochondrial replacement techniques (2).
In February 2015, the UK Parliament approved the clinical implementation of mitochondrial replacement techniques, after a very long process that involved the usual suspects of the British scientific, legal and ethical communities – the Wellcome Trust, the Medical Research Council, the HFEA (Human Fertilisation and Embryology Authority) the Nuffield Council, among others. In particular, the HFEA carried out three scientific reviews of the methods to avoid mitochondrial diseases in offspring (3,4,5) to assess their safety and the efficacy, and held a public consultation on the ethics of mitochondrial replacement techniques (6). In addition, the Nuffield Council on Bioethics put together a working group to review the ethical, legal and social aspects of these techniques and subsequently produced a report (7). After this process, the UK Parliament convened to deliberate and vote on this issue, and ultimately opted for the approval of the techniques (2).
At last year's Progress Educational Trust conference (8), Viscount Matt Ridley, science writer and Conservative peer, provided an account of the House of Lords debate on the matter and the process that led to the parliamentary vote. He expressed his satisfaction of how well the whole issue was dealt with and remarked on the primacy of British scientific and ethical oversight bodies. Indeed, the UK has always prided itself on being a country that has a rather liberal approach to the governance of science and technology while maintaining rigorous evaluation of new advances. This view is echoed by British bioethicist John Harris, who has on several occasions remarked how proud we should be of the UK for permitting this research to go forward, but in a safe and responsible manner (9).
This optimism and faith in the British way of regulating science is certainly not new and is embodied by the UK being a country of firsts. It was in the UK that the first IVF baby was born in 1979, the first sheep was successfully cloned in 1996, and the mitochondrial replacement techniques were first approved. It was here, too, that the first 'mito-babies' should have been born. However, something went awry, and the first baby born through MST was in Mexico.
The Mexican mitochondrial case was rightly called a 'fiasco' by bioethicist César Palacios González, for several reasons (see BioNews 871). For instance, there is the risk of facilitating the approval of various proposed amendments to the National Health Law on assisted reproduction that are currently being discussed by the Mexican Government. These amendments, if approved, would result in a more restrictive and very conservative law on assisted reproduction. In addition to this, there is the risk of scientists from other countries where these techniques are banned taking advantage of current regulatory legal voids in Mexico.
Additionally, the Mexican case represented a failure of the Mexican regulatory framework to provide oversight of the clinical implementation of novel practices. This is certainly problematic for consequentialist reasons – namely, that it could cause a backlash against scientific advances and the issuing of more restrictive laws. It is also problematic because it could cause a loss of public trust in scientists and a consequent loss of public acceptance of concrete applications of research, public confidence in policies informed by scientific research, and a loss of consensus on the investment of public resources in science.
However, there are other reasons why the Mexican case can be viewed as a fiasco. In my view, one of the major consequences of this announcement is that countries where the governance of science and the ethical debate on scientific progress are less advanced will be seen as not able to carry out 'proper' and 'rigorous' research. Something similar to this happened last year when a group of Chinese scientists announced that they had used CRISPR/Cas9, a new genome-editing technique, on non-viable human embryos (11). The initial reactions to this announcement were, especially from the United States, outrage and the call for a moratorium on the use of genome-editing techniques on human embryos (12,13). This response resulted in an international debate on the ethical and technical aspects of the use of genome editing on human embryos, and with the withdrawal of the infamous paper that first reported the experiment. Despite the calls for a moratorium and for a 'prudent path forward' (13), less than a year later the HFEA approved an application by a group of British scientists led by Kathy Niakan to carry out experiments on in-vitro human embryos using CRISPR (14).
The Mexican case will likely foster a sense of superiority for Western, highly developed countries like the UK over other countries which, for cultural, social and economic reasons, have different legal and ethical approaches to the governance of science.
It is certainly true that research should be allowed to go forward if a proper regulatory system is in place to oversee it. It is also true that some countries, such as Mexico, might lack these systems and that gaps in the law can be used to push basic and clinical research ahead, prior to required reviews. However, the Mexican and the Chinese cases should not be used as a means to reaffirm the moral and technical supremacy of the West over other countries.