Last year, the UK enacted new legislation in the form of the Genetic Technology (Precision Breeding) Act
2023 to pursue a post-Brexit deregulatory agenda with respect
to “precision breeding”. New genomic techniques (NGTs)
encompassed by precision breeding can produce targeted genetic
changes that could have occurred through traditional breeding and
natural processes. This differs from previous techniques as it does
not involve the insertion of DNA from separate species and is
therefore generally considered safer.
Despite taking legislative action, there are concerns that the
UK’s deregulatory ambitions are not being lived up to due to
the lack of capacity and funding of regulators, such as the Food
Standards Agency (FSA), causing a bottleneck in bringing products
to market. There have not yet been any gene-edited foods placed on
the market since the legislation was enacted.
The deregulatory agenda
Prior to its enactment, and while the UK was an EU member state,
NGTs were stringently regulated under the EU’s genetically
modified organisms (GMO) legislation. Post-Brexit, the UK (or at
least England) has sought to develop its own regulatory approach to
regulate precision bred organisms (PBOs)
“proportionately to risk“, meaning that plants
(and animals) produced through precision breeding techniques are no
longer regulated as GMOs. This is a similar approach to other
countries such as Japan, which has already concluded that PBOs
should not be regulated as GMOs. The UK’s new regulatory
approach only applies to England as this is an area of devolved
competence. The rest of the UK continues to remain aligned to the
present EU GMO approach.
England’s more relaxed regulatory approach seeks to enable
plants, animals and food and feed products containing or consisting
of PBOs to more easily make their way to market (which would
include being placed on the market in Scotland and Wales under the
mutual recognition principle).
What are precision bred organisms?
Under the Genetic Technology Act, an organism is considered to
be “precision bred” if:
- Any feature of its genome results from the application of
modern biotechnology. - Every feature of its genome that results from the application
of modern biotechnology is stable. - Every feature of its genome could have resulted from
traditional processes, whether or not in conjunction with selection
techniques, or natural transformation. - Its genome does not contain any feature that is a result of any
artificial modification technique (other than modern
biotechnology).
In the case of plants, “traditional
processes” includes sexual fertilisation, spontaneous
mutation, in vitro fertilisation, polyploidy induction,
embryo rescue, grafting, induced mutagenesis, or somatic
hybridisation or cell fusion of plant cells of organisms which are
capable of exchanging genetic material by any of the previously
mentioned processes. Transgenic GMOs are excluded and continue to
be regulated under the GMO regulations.
The purpose of the legislation
The purpose of the new legislation is to allow gene editing
without the need for specific complex approvals under the current
GMO regime – at least in England. This will be replaced by a
lighter-touch regime that is based on notification; that said, it
will still be necessary to apply for a “marketing
notice”. The full details of the proposed application process
are not currently available as it will be created through secondary
legislation.
The FSA ran a consultation on proposals for the new
framework for the regulation of food or feed produced from PBOs
(including both plant and animal PBOs). It published its response on 5 March 2024. The response
outlines that the secondary legislation is currently being drafted
and will be laid before Parliament in the summer, along with
technical guidance, with the aim of implementing the new process by
the end of 2024 or early 2025. The response outlines how the
framework will look and provides an interesting insight into how
this may contrast to the EU position.
Although it is intended that the regulatory framework will apply
to both plant and animal PBOs, it is anticipated that applications
for regulatory approval of plant PBOs will open before applications
relating to animal PBOs.
Two-tiered approach
In the recent response to its consultation, the FSA has
confirmed that its proposal revolves around introducing a two-tiered regulatory approach for
pre-market authorisation, meaning that those PBOs similar to
traditionally bred organisms would benefit from a simpler route to
market.
Tier 1 would be for those PBOs where the safety risks are
understood and are not of concern, which would be determined by
using a triage criteria set by FSA. Once determined, businesses
would need to notify the FSA that its food or feed falls within the
criteria for Tier 1. The FSA would then acknowledge receipt of the
notification and place the PBO on the public register.
The Tier 2 regulatory route would be for those PBOs where the
safety risks require further scrutiny, meaning the authorisation
process would be more rigorous. This route would require an
application to the FSA and completion of an FSA safety
assessment.
Triage questions to determine whether a PBO would be Tier 1 or
Tier 2 include inquiries around novelty, composition (including
allergenicity) and other safety concerns.
UK-EU framework similarities
The FSA’s proposed regulatory framework is similar to the
proposed EU framework in that they both seek to develop a simpler
and more proportionate market authorisation system for NGT
plants/PBOs via a two-tiered approach. The UK approach goes further
than the EU’s proposal as it also covers animal PBOs.
The two regimes may also diverge in relation to the definitions
applied to plants to determine which tier they fall into. The scope
of plants falling within the UK’s Tier 1 may well end up being
broader than those falling within the EU’s NGT 1 tier. In
practice, this could mean that an NGT plant/PBO is considered to be
similar to a traditionally bred organism in the UK and is subject
to a simpler authorisation route in the UK. However, because of the
proposed narrower definition in the EU, the same plant could be
classed as an NGT 2 plant in the EU and, therefore, be subject to a
stricter marketing authorisation process in the EU.
This could add a layer of complexity, cost and administrative
burden on businesses wanting to place products on both the UK and
EU markets. In this case, businesses will need to ensure that the
right route for authorisation is taken to ensure products are not
prohibited from being placed on the relevant market.
Product labelling
Another key difference between the FSA’s proposed approach
compared to the EU’s proposed approach, in particular the
European Parliament’s position, is that there are no plans to
introduce mandatory labelling for those products produced by
precision breeding.
The FSA’s Advisory Committee on Novel Foods and Processes
previously stated that there is no scientific evidence
that PBOs are “intrinsically more hazardous than
traditionally bred organisms’“. This has informed the
UK government’s
position, which is that there is no justification for labelling
requirements to indicate where foods have been produced as a result
of precision breeding techniques.
However, the FSA’s latest consultation response highlighted
that respondents were concerned with the absence of mandatory
labelling. The FSA reiterated that the issue of labelling is the
responsibility of the government but it would pass on these
concerns to the government. At time of writing, mandatory labelling
requirements are not included in the FSA’s proposal.
Other regulatory considerations
Although the purpose of the new legislation in the UK is to
allow gene editing without the need for specific complex approvals
under the current GMO regime, businesses should note that those
products may still be subject to other regulatory regimes, such as
being approved as a novel food.
However, the “regulated products regime”, which
includes novel foods, is currently undergoing a
review by the FSA. Two proposals to reform the regime have been
put forward:
- To remove renewal requirements for various food products,
including food or feed containing, consisting of or produced from
GMOs. - To remove the process of laying legislation after ministerial
authorisation of a regulated product, which currently slows down
the approval process. Instead the authorisation would be added to
an official register, following a ministerial decision, which the
FSA said will speed up the process.
A consultation on these new proposals was
launched on 3 April and the FSA noted that it hopes to introduce
these legislative changes ahead of the general election. The
consultation closes on 5 June 2024.
This recent development highlights the regulator’s desire to
modernise and expedite authorisation procedures. The FSA has stated
that failing to take urgent action will result in an inability to
cope with the increasing caseload, further underscoring the
pressing need for progress in this space.
Patent rights
Unlike the European Parliament’s proposed NGT plant patent ban, the UK Genetic
Technology Act does not address the intellectual property position
with respect to PBOs. As such, it seems that the usual European
Patent Office (EPO) approach will continue to apply.
This means that plants and animals can be patented where they
are not “exclusively obtained by means of an essentially
biological process” and if the invention is not confined
to a particular plant or animal variety. Therefore, plants or
animals that are produced by a technical process, such as gene
editing that modifies the genetic characteristics of the plant or
animal are, in theory, patentable.
However, this position could be impacted by the European
Parliament’s proposed EU patent ban if the NGT plant patent ban
was enacted and the EPO was to act in response to it. However, this
would be a politically controversial and practically
difficult move for the EPO to make.
At this stage, it seems that gene-edited plants and animals
falling within the scope of the Genetic Technology Act could be
patentable (subject to the usual patentability requirements). This
is be good news for players seeking to make investment into
developing agri-tech inventions – the ability to secure
robust patent protection may well incentivise investment.
Osborne Clarke comment
Although the UK managed to enact the Genetic Technology
(Precision Breeding) Act 2023 in a timely manner, its progress in
making it practically easier to bring innovative food and feed
products to market has been slow.
Specifically, out of the 450 regulated product applications,
including novel foods and genetically modified products, submitted
since January 2021, only 63 have received regulatory approval,
primarily due to resource constraints within the FSA.
However, the FSA’s recent activity illustrates its
commitment to translating the deregulation benefits of the Genetic
Technology Act into practice. The drafting of legislation for the
new regulatory framework for PBOs in England is now underway. As is
the FSA’s consultation on the reformed regulated products
regimes.
However, the potential impact an upcoming UK general election
could have on progress in this area also needs to be considered.
The Labour party has pledged to establish a new Regulatory Innovation
Office to provide strategic direction for regulators and to set
benchmarked targets aligned with international standards. While
this announcement primarily focused on the life sciences sector, it
does highlight the potential for the FSA to be held accountable,
which could impact the authorisation of PBOs. But how quickly could
any promised changes be implemented?
The suspected divergence between the EU and UK regulatory
frameworks on gene-editing means that businesses operating in both
regions will need to navigate different sets of rules and
requirements. They will need to understand and comply with the
specific regulations in each jurisdiction to ensure market access
and compliance with safety and labelling requirements.
Businesses should also begin to have conversations around the
proposed two-tier system and how this may affect the timeline for
getting products to market. This could include considering whether
there are any early-stage decisions that can be made to potentially
reduce the risk profile of a PBO, and, as such, also reduce the
associated regulatory burdens.
With the regulation of GMOs being a devolved issue in the UK,
businesses should also be aware that the UK nations themselves
could
diverge on these issues. This could have a cooling effect on
the marketing of PBOs in the UK due to potentially increased costs
and administrative burdens.
Businesses operating in this space should continue to monitor
the evolving regulatory landscapes in the UK and the EU.
This is the second Insight in our series on the deregulation
of gene editing in plants. The first part of the series looked at
the regulatory changes proposed in the
EU.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
#Developing #Approach #Deregulating #Gene #Editing #Plants #Patent
