From AI to CRISPR: How Should Emerging Reproductive Technologies Be Regulated?

The question of regulating cutting-edge reproductive technologies has been brought back to the forefront of debate (if it was ever absent) most obviously by the prospect of genome editing using CRISPR in human reproduction, but also more recently by the incorporation of algorithmic methods and artificial intelligence (AI) that promise improvements in fertility practices.

The Progress Educational Trust (PET) event 'From AI to CRISPR: How Should Emerging Reproductive Technologies Be Regulated?' brought together a wide range of experts in the field to discuss the regulation of such technologies, from 'femtech' to time-lapse imaging of developing embryos in fertility clinics, and – of course – genome editing.

Sarah Norcross, director of PET and chair of the event, set the scene with a headline from the previous week, about a chain of IVF clinics across India using AI for embryo selection. Reminding the audience that the majority of respondents to the recent PET/Ipsos report supported the use of human genome editing to prevent children from developing serious conditions, she said that questions about the regulation of new fertility-related technologies are not a matter of crystal ball gazing but of more pressing importance.

First to speak was Dr Helen O'Neill, chief executive and founder of Hertility Health. Dr O'Neill said that technology is essential when it comes to implementing healthcare measures, but that investment in femtech is still on the back foot. We have finance apps to manage our finances, but what do we have for health?

Dr O'Neill argued that if we address essential regulatory questions – such as how best to regulate digital diagnostic tools, who regulates research, and who is responsible for guidelines – then the regulatory process can be calibrated for scale.

Next up was Dr Alison Campbell, chief scientific officer and director of embryology at CARE Fertility. She described how CARE has spent ten years developing a digital, time-lapse embryo imaging approach using in-house data from more than 25,000 IVF cycles, producing its own statistical algorithms to help assess and select embryos, and further developing a machine learning model to predict aspects of embryo development.

Dr Campbell argued that was inevitable that embryo selection would transition from traditional morphology to time-lapse image capture to AI. There are many potential benefits to be had, but Dr Campbell cautioned that we must be rigorous and tread carefully.

Having explored how recent technological developments have been used to develop fertility practices, Dr Andy Greenfield, honorary research fellow at the University of Oxford's Nuffield Department of Women's and Reproductive Health, considered regulation more broadly.

Dr Greenfield said that regulation can contribute to building public trust, by ensuring that technology conforms to standards and providing redress if something goes wrong, but it can also hinder innovation. The task, as Dr Greenfield saw it, was to produce regulation that is proportionate to both risks and benefits and that is well-timed. Good regulation should embrace ethics and public engagement, take into account commercial considerations needed to attract investment, and foster a culture of openness and growth.

Dr Greenfield said it was also important to consider alternative forms of regulation and explore the use of regulatory 'sandboxes', learning from how fintech explored innovative products and services without incurring normal regulatory consequences. If the law were ever changed to permit the use of genome editing in reproduction, then rather than extending the opportunity to use this technology to all clinics at once, there could be a process of carefully exploring prototypes and testing new approaches.

Such an outcome-based approach can allows a regulator to learn how to deal with new technologies and policies, which can develop over time. But it would also require amending legislation to give greater discretion to the regulator, so that it can work more flexibly with the sector that it regulates.

Next, Alex Denoon, partner at the law firm Bristows, pointed out that many of these emerging technologies are already covered by existing regulatory frameworks. For example, the medical devices framework would cover an AI system to assist with selection of an embryo, or the use of software to control conception. Indeed, many AI medical devices are already approved and widely used. The medicines framework would apply to a product administered to a mother or in utero.

Under these frameworks, the safety and utility of the products must be proven, based on clinical trials and subject to mandatory post-market surveillance. However, there is some flexibility. The UK's medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), can grant compassionate use exemptions and temporary approval for otherwise unauthorised products. Therefore, Denoon said, robust frameworks already exist for regulating technologies used in reproductive healthcare. There is no strong justification for additional regulation, which could add uncertainty and delay progress.

Denoon also addressed question of who regulates. If it was one day permitted to edit the genomes of embryos in vitro, would the UK's fertility regulator – the Human Fertilisation and Embryology Authority (HFEA) – have the institutional competence to deal with related matters of quality, safety, and efficacy? For Denoon, the MHRA – which responded with such agility to the demands of the COVID pandemic – would be equipped to address such issues, reserving a more limited role for the HFEA.

Dr Greenfield responded by arguing that there may well be a general expectation that it was the place of the HFEA to regulate in this area, and that different regulators would need to work together.

The audience questions that followed addressed issues including data protection, building an international consensus, and whether current regulatory frameworks and bodies are fit for purpose. One attendee asked how the pioneering work of Dr Patrick Steptoe and Professor Sir Robert Edwards would be viewed, if it were being attempted under present-day regulations.

Another attendee asked whether adding extra layers to the regulation of fertility-related technologies implied, wrongly, that fertility should be treated differently from other areas of health and medicine. Dr O'Neill agreed with the gist of this question, but Dr Greenfield argued that aspects of fertility deserved to be regarded as distinct from other areas of medicine.

The event illustrated the challenges of how best to think about novel technologies that relate to reproduction. Perhaps there needs to be as much innovation in our solutions as there is in the technologies themselves – or not, as the case may be.

PET is grateful to the British Fertility Society and Merck for supporting this event.

The next free-to-attend online event from PET, taking place on Wednesday 2 November 2022, will be '30 Years of ICSI: An Injection of Hope for Male Infertility'.

Find out more and register here.