In a December 2022 blog post, I reflected on the pathway from science advice to implementation of science-based recommendations that arise from commissioned reports from our office. Not all our advice is commissioned – sometimes the science community proactively raises issues with implications for government policy – and sometimes this happens when the issue has not yet made it onto the policy agenda. The best example of this during my time as PMCSA has been on the topic of gene editing and the HSNO Act – which of course has recently jumped very much into the political limelight.
In their detailed 2019 report, the Royal Society Te Apārangi made the case to revisit the legal and regulatory framework for genetic modification in Aotearoa. To support this report and urge the government to add this issue to their policy agenda, I wrote a briefing to the Prime Minister highlighting the policy implications of the Royal Society report.
In response, Minister Parker asked officials to advise him of where “lower regulatory hurdles ought to be considered to enable medical uses that would result in no heritable traits, or laboratory tests where any risks are mitigated by containment” and noted the intention to consider clarifying “conflicting or inconsistent definitions across the regulatory framework.”
The Ministry for the Environment has been working away in the background, and has undertaken preliminary consultation with scientists and stakeholders. The Ministry for the Environment has now released a consultation document, seeking feedback on a suggested approach to relaxing aspects of the way that genetic modification is regulated in Aotearoa. In particular, the Ministry for the Environment is looking at ways to lower the compliance costs for doing research in containment, where risks are mitigated by well-established protocols which have proved very effective in the decades years since they were introduced. This work is in parallel to the recently announced changes to the way that therapeutics that involve GMOs will be regulated under the new Therapeutics Products Bill.
The current consultation is a significant and important first step to modernising the way we manage genetic editing and I’d encourage everyone to have their say before consultation closes on August 25th. The main piece of legislation governing genetic modification in Aotearoa, the HSNO Act, was introduced in 1996 (and related regulations in 1998) and has only been lightly amended since. That’s despite the rapid pace of change in gene technology, particularly the rise of precision gene editing (the ability to make highly specific changes to an organism’s DNA) over the last two decades. From a technology that didn’t exist at the turn of the century to a suite of tools that are increasingly being used in labs, clinical trials, agriculture, and pest and disease management around the world, gene editing has introduced new challenges and opportunities that weren’t envisaged when our regulatory framework was formed.
This has contributed to divergence between the potential risks from the technology in the way genetic modification is legally defined and what those risks are in practice, paradoxically leading to modern gene editing techniques being more stringently regulated than older, less precise ones. This was covered in an excellent article by Jamie Morton last year (paywalled).
A perfect example of the sorts of paradoxes the current system has thrown up is a human gene editing trial that has taken place in Aotearoa. The trial involves a CRISPR-based therapeutic developed by a US company, as a one-off treatment for individuals with hypercholesterolaemia to control their cholesterol. The trial was approved to be carried out in Aotearoa by the by the Gene Technology Advisory Council and MedSafe, but the research that led up to the trial would have been very difficult to carry out here within the confines of the HSNO Act. It’s frustrating for researchers when contained lab experiments have tougher regulatory hurdles than doing the experiment in humans!
Tackling the inconsistencies in how risks are identified and managed, not simply assuming technologies are safer because they have been in use longer, will help Aotearoa to embrace the opportunities presented by gene editing, and proportionately manage the risks.
Let’s hope that this first step is followed by further steps to update the legislation to make it future-proof, built on a risk-based approach rather than a technology-based one, to allow the legislation and regulatory framework to cope with the rapid evolution of technology. It will be important to do this in such a way that constructive and inclusive debate can be had about the different applications of genetic tools on a case-by-case basis, moving us towards a regulatory system that manages risks thoughtfully and proportionately on a case by case basis.
Read more about gene editing and the New Zealand regulatory context on our gene editing topic webpage