‘Designer babies’ patent – experts respond

A patent on a method which allows prospective parents to pick and choose their children’s traits prior to undergoing fertility treatment has alarmed many ethicists and genetics researchers.

The patent, granted to the direct-to-consumer genetics company 23andMe last week, lays claim to a broad genetic analysis tool for allowing parents to select for specific traits in their offspring, such as lack of specific genetic diseases or eye colour.

The method allows sperm and eggs to be selected that are most likely to produce traits chosen by the parents, such as eye colour or athleticism, and also allows screening out of sperm and eggs likely to lead to genetic disease. The patent is discussed in a commentary article published today in the journal Genetics in Medicine.

“It is clear that selecting children in ways such as those patented by 23andMe is hugely ethically controversial,” writes Prof Sigrid Sterckx of Ghent University with his colleagues.

“The use of preimplantation genetic diagnosis to avoid implantation of embryos bearing serious genetic abnormalities is by now becoming commonplace, but a computerized process for selecting gamete donors to achieve a baby with a “phenotype of interest” that the prospective parent “desires in his/her hypothetical offspring,” as 23andMe puts it, seems to have much broader implications, for this process also entails the selection of traits that are not disease related.”

The authors of the commentary article suggest that public trust is central to the continuing success of human genetics research, and urge all those engaged in human genetics research to be as transparent as possible about research goals and patenting activity.

23andMe has just published a post on the company’s blog, defending the patent.

The SMC collected the following expert commentary. Feel free to use these quotes in your reporting.

Dr Colin Gavaghan, Director, NZ Law Foundation Centre for Emerging Technologies, Faculty of Law, University of Otago, comments:

“In my book  Defending the Genetic Supermarket, I argued that prospective parents should, on the whole, be allowed to make these sorts of choices if they want; or at least, we should be able to offer them a pretty good reason if we are to ban them from doing so. That’s a controversial position, and a lot of people of course disagree.

“But whatever we think about the rights and wrongs of this technology, I’m not sure that the patent process is the best way to regulate it. If we think there are serious moral objections to these sorts of choices, then let them be worked through via the democratic process. At the moment, the HART Act in New Zealand – and the regulatory system it put in place – limits the sorts of choices parents can make. Social sex selection, for example, is illegal, whether by screening embryos or gametes or any other means. Personally, I’m not convinced that such a ban is needed, but I do think this was a better way to go about things; a transparent decision made by democratically accountable MPs, rather than entrusting such decisions to a committee whose primary responsibility lies with technical adjudication of intellectual property claims.”

Prof Martin Kennedy, Genetics Researcher, University of Otago, Christchurch, comments:

“My initial reaction to this is fairly negative, and I agree with all the sentiments expressed in the commentary. I’d add that if 23andme are serious about developing or implementing this kind of thing, they will have a long way to go to make it both workable and legal, never mind the many questions around morality. So I think an additional question beyond those raised in the commentary is “where could they legally carry out such testing?”. In any country with a carefully regulated IVF environment (like NZ) I doubt this would be acceptable; but perhaps they are anticipating a commercial operation based in a jurisdiction that does not have tight controls on such things? Such a cavalier approach would, I am quite sure, seriously stretch the limited credibility of 23andme.

“The patent presumably protects a potential future market that 23andme is considering exploiting, but the morality, ethics, science, and legality of the hypothetical approach are all questionable at best.

“I’d also emphasize that most things in life result from the contribution of many genes in interaction with environmental factors, and the science for predicting risk of complex traits is in its infancy; for example, we cannot accurately predict individual risks for common diseases from genes alone. So I think the science to make this kind of approach feasible for common traits is not yet mature, although for rare single gene diseases, and single gene traits screening will be quite accurate.

“Finally, perhaps the fact that this patent has been awarded will stimulate our legal and ethical experts, and the New Zealand public, to carefully consider whether this proposed technology has a place in NZ society or not. My personal view is it is starting down the slippery slope that ends at GATTACA, and I for one would not want a private company leading us towards that particular future (much as I love that movie)!”

Our colleagues at the Australian SMC also collected the following expert commentary.

Associate Professor Luk Rombauts, Adjunct Clinical Associate Professor at Monash University, and Head of Reproductive Medicine, Monash Medical Centre, comments:

“23andMe will develop a genetic service to screen egg or sperm donors for desirable traits. Egg or sperm donors are already screened for transmittable infectious diseases and for a range of genetic disorders, such as cystic fibrosis. Screening more widely for other genetic disorders can make sense, but there is a point where screening becomes futile because many diseases are more likely to be driven by environmental factors rather than by genetic influences.

“As an IVF doctor I worry that some seem to forget that the true value in parenting lies not in designing the perfect child (they may disappoint greatly anyway), but to be there, always, for the needs of the child as it comes.

“It is also unclear who will hold 23andMe accountable for the claims they make. It is a very profitable no-lose proposition for the company. When prospective parents in Australia base their donor choice on currently available information they are very likely to have a healthy donor-conceived child with many of the selected traits anyway, so for 23andMe to claim all these ‘matches’ as their success is drawing a long bow. Furthermore, when things turn sour, the company can easily hide behind their disclaimer that they don’t guarantee a desired outcome, they merely increase the probability of such an outcome. It is obvious that there is a clear need for regulatory oversight to check that the company delivers what it promises.”

Associate Professor Jayne Lucke is a Principal Research Fellow at the Centre for Clinical Research, The University of Queensland. She comments:  

“The patent granted to 23andMe for “a method of gamete selection” is startling because it seems to explicitly cross the line between the accepted practice of preimplantation genetic diagnosis to eliminate a specific disease risk and a much more controversial idea – the selection of socially desirable traits to custom design a baby. By framing the proposal around the method, the patent has been granted without appearing to address the moral and ethical implications, or the question of public opinion about whether the procedure is appropriate. The commentary from Sterckx and colleagues raises a number of questions for public debate surrounding the use of genetic and reproductive technologies. The idea of a “baby farm” manufacturing babies on demand for customers with no emotional or biological connection to the gametes or the resulting child is clearly unacceptable. But where should we draw the line between methods for disease prevention and those seeking to enhance future children with the “right” characteristics, whatever they may be?”

Professor Loane Skene is a Professor of Law at Melbourne Law School, an Adjunct Professor in the Medical Faculty  at the University of Melbourne and former Deputy Chair of the Lockhart Committee on human cloning and embryo research. She comments: 

“Patents are intellectual property rights that reward inventors for inventing something new and useful. The inventors are granted a monopoly right for a limited period to gain a financial reward for their effort and creativity in inventing the product.  It is not the role of patent authorities to canvass community views on potential ethical issues of new inventions. They do not have the resources or expertise to do that.  But, even in jurisdictions where broad public interest factors may be considered in granting a patent, it is not ethically objectionable to allow couples to choose, or even to form, an embryo that does not have a genetic medical condition. That decision is better for the child to be born than taking the chance that the embryo may be affected. Indeed, such choices are allowed under the current law in Australia, as in other countries. To suggest that couples will turn to IVF, with its burdens, uncertainty, costs and potential risks, simply to have a ‘designer baby’ with blue eyes or sporting prowess seems highly unlikely. ”

Dr Leslie Cannold is an author, academic ethicist, columnist, activist, and Australian public intellectual. She comments: 

“Patent law was never intended to manage the moral complexities that arise from 23andMe’s screen and sort method of producing a child with non-disease attributes desired by the parent/s. It is up to society to get our collective heads around what is happening in the lab, and to deploy the political process to regulate it accordingly. Bio-tech companies could start the process of bringing the public into its confidence by customers whose genetic information is being used to develop its new technologies are both informed and consenting to the use of their genetic information for this purpose.

“Neither the moral nor political idea of reproductive freedom was intended to accommodate parental preferences for pink or blue, or a child with a better long-term health profile or more sporting ability. While it is questionable whether science can deliver many of the genetic predispositions promised in the 23andMe patent, what is certain is that the science that forms the foundation of the application was never intended for such frivolous use. Indeed, it’s deployment for such purposes risks undermining public support and funding for scientific endeavour intended to relieve the pain of unwanted infertility and familial transmission of debilitating disease.”

An illustration from 23andMe's patent application for a "designer baby" system. (23andMe)
An illustration from 23andMe’s patent application for a “designer baby” system. (23andMe)