The previous chapters of this report have examined evidence on the
safety, efficacy and ethical considerations of using mitochondrial donation to
reduce the chance of a mother passing on mutated mitochondrial DNA
(mtDNA) to a child, potentially leading to mitochondrial disease.
The issue that remains to be examined is what legislative amendments would
need to be made if mitochondrial donation was to go ahead. The most evident
place to start, is to look to the example set in the United Kingdom (UK).
UK path to regulation
As outlined in previous chapters, in 2015 the UK Parliament passed regulations
to legalise mitochondrial donation for women with a high chance of passing on mitochondrial
disease to their children. The change to law authorised the regulation of
mitochondrial donation to be undertaken by the Human Fertilisation and Embryology
Authority (HFEA), as the UK's independent regulator of fertility treatment and
research using human embryos.
Some research has suggested that having an agency dedicated to fertility and
embryology has assisted the UK to make advances in this field.
The new UK regulations require that a licence from the HFEA for
mitochondrial donation is needed for the clinic administering the treatment, as
well as for individual women seeking treatment.
As of 30 April 2018, the HFEA Statutory Approvals Committee
has considered six applications from individual women to access mitochondrial
donation treatment. Minutes for three applications have been published: two
were approved and the third was rejected pending more information showing that
alternative options available to the patient were not suitable.
As shown by the above HFEA approvals process, access to the treatment is
highly restricted and it is not anticipated that access requirements will be
relaxed in the foreseeable future.
As a first stage prior to clinical use, the HFEA reconvened its expert
advisory panel to advise on whether science suggested mitochondrial donation
was sufficiently safe to be offered in treatment. It was ultimately decided
that the science was safe enough for carefully limited application. Secondly,
the HFEA established a regulatory regime to oversee how and when those licences
would be issued.
The HFEA established a detailed Code of
Practice for the use of mitochondrial donation and its Statutory Approvals Committee
was authorised to approve access to treatment on a case-by-case basis as 'a
clinical risk reduction treatment for carefully selected patients'.
The HFEA Code of Practice covers issues such as:
the consent process;
the information required to be provided to the participants;
selection criteria for gamete (egg and sperm) providers;
the requirement for a clinic to hold a licence authorising it to
offer mitochondrial donation at a designated site;
the requirement for HFEA to approve individual patients' access
to mitochondrial donation and for those patients to be at high risk of
transmitting mutations that will lead to serious mitochondrial disease;
the requirement that only named embryologists are permitted to
undertake the procedure;
the expertise available in the clinic including mitochondrial
disease specialists, reproductive specialists, embryologists, clinical
geneticists, genetic counsellors and molecular geneticists;
the requirement for a documented process for long-term medical
follow-up of children born following mitochondrial donation, provided patients
have consented to that follow-up, and
the requirement to report to the HFEA if the clinic becomes aware
of any adverse outcomes following treatment involving mitochondrial donation.
The UK regulations allow for mitochondrial donation to be undertaken for
a couple at serious risk of passing on severe mitochondrial disease. While no
specific definitions have been outlined in the regulations, the determination
of what is considered 'serious risk' of 'severe mitochondrial disease' is
ultimately determined by the licensing panel at the HFEA. In practice, the Australian
Mitochondrial Disease Foundation (AMDF) submitted that 'severe' is generally
considered to be a condition which would have an early onset in a child's life
and significantly impact their day-to-day functioning and quality of life. It
may, but would not necessarily, be life-limiting.
To support an application for a licence for an individual to undergo
mitochondrial donation, a clinic must provide patient-specific information,
the patient's medical history;
the patient's mutant mtDNA load;
the patient's family medical history of the mtDNA mutation or
scientific literature relevant to the mtDNA mutation or disease,
any additional information which the clinician may consider is
relevant to the application.
The Murdoch Children's Research Institute submitted that in creating
a flexible regulatory regime overseen by an expert
government body 'the UK Parliament recognized that developing detailed
legislation to regulate all aspects of the mitochondrial donation process was
impractical and they devolved much of this responsibility to the HFEA to
determine exactly when and how mitochondrial donation would be delivered in the
The majority of submitters and witnesses to this inquiry recommended a
cautiously staged introduction of mitochondrial donation in Australian clinical
practice, based on the findings of the HFEA in the UK that mitochondrial
donation is sufficiently safe to be introduced into clinical practice in
specific circumstances. The AMDF submitted:
The rigour and depth of the reviews and process undertaken in
the UK should provide the Senators with the confidence that mitochondrial
donation could be introduced into the Australian context. Whilst some of the
regulations adopted in the UK may need to be adapted to align with Australia's
specific expectations or current laws regarding IVF [or ART], they provide a
strong basis from which to work towards offering Australian parents the
capacity to access these techniques.
However, prior to examining whether the UK regulatory regime provides
good examples for any Australian regulation, a definitional barrier remains, in
that Australian anti-cloning legislation as it is currently drafted prohibits
this technique. This issue is discussed below.
Australian legislative prohibitions on germline modification
The main legislative barrier to mitochondrial donation is the blanket
prohibition on any form of germline genetic modification contained in the Prohibition
of Human Cloning for Reproduction Act 2002 (Cloning Act).
There are three relevant provisions within the Cloning Act: section 13
prohibits the creation of a human embryo outside the body of a woman which
contains genetic material from more than 2 persons and section 20 prohibits
placing such an embryo into a woman. Section 15 prohibits the alteration of the
genome of a human cell where that alteration is inheritable.
However, as discussed in chapter four, evidence to the committee is that
many submitters and witnesses do not consider mitochondrial donation as a
traditional germline (inheritable) genetic modification. While there was some
distinction between how different witnesses characterised it, most agreed that
mitochondrial donation was a new form of genomic modification and should be
treated as such. Associate Professor Catherine Mills, a philosopher and
bioethicist at Monash University, told the committee that because current
legislative prohibitions were 'formulated prior to the possibility of
mitochondrial donation, it's now time for it to be reconsidered.'
This approach accords with the UK regulations allowing for mitochondrial
donation, which classified the treatment as germline modification, but not
The Human Genetics Society of Australasia submitted that 'ethical
reviews in the UK and USA have also recognised that...mitochondrial donation is
distinct from germline genetic modification and should not be prevented based
on false equivalency arguments.'
Bioethicist Dr Ainsley Newson characterised mitochondrial donation as a
novel class of 'conditionally inheritable genomic modifications' and advised:
The conditional inheritance of mitochondrial donation makes
it conceptually distinct from other inheritable (or germ-line) genetic
modifications. This means its automatic prohibition on this ground is not
A simple approach to eliminating the legislative restrictions was
suggested by the National Health and Medical Research Council (NHMRC) as
...so that mtDNA was not included when determining how many people
had contributed genetic material to an embryo (PHCR [Cloning] Act section 13,
section 20). However, it would require careful drafting to ensure that this did
not inadvertently allow other activities that may be unacceptable to the
Academics from Monash University put forward a similar suggestion, that:
The most straightforward legal route would be to treat
mitochondrial DNA as separate from the human genome. This approach parallels
the UK process and resonates with existing legislation of embryos and cloning,
as well as current legal definitions of genetic material and the genome, which
are highly opaque.
However, the submission goes on to state that key definitional issues
must be resolved before legislation can be developed around mitochondrial
whether this technology constitutes genetic modification / gene
technology according to current definitions;
whether it can be considered either germline or somatic
modification, and whether this distinction remains useful; and
how mitochondrial and nuclear DNA should be defined and
Dr Newson submitted that mitochondrial donation is a good example of how
'black letter law' can be an imperfect instrument for regulating emerging
reproductive technologies and that regulatory instruments such as the genetic
privacy regulations under the Privacy Act (Cth) have more flexibility
for change than primary legislation.
The Human Genetics Society of Australasia concurred with this view, and
We would strongly advocate for a flexible and adaptive system
of governance, to help avoid the problems that have come from the existing
regulatory regime; in particular there being no further reviews required to the
cloning/embryo laws. This and similar areas of reproductive science are
fast-moving; and regulation needs to be similarly flexible and adaptive.
As outlined in chapter four, the committee recognises the majority of
the evidence presented that mitochondrial donation is not considered a form of
germline genetic modification as envisioned by Australian laws which prohibit
cloning and other similar forms of genetic modification.
However, the committee remains of the belief that it does not have the
required expertise to make such a determination, and notes a formal
determination must be taken by an appropriate body with the relevant expertise.
If this view is confirmed, then appropriate amendments should be made to Australian
law to keep it up-to-date with science and to allow for, and only allow for,
Australian approach to introduction
As outlined earlier in this chapter, the UK process is similar to an
Australian clinical trial process,
which is overseen by the NHMRC,
or the regulation of medical therapies with restricted access such as the Life
Saving Drugs Program, where a clinician must submit medical evidence on a
patient's health condition which is evaluated by a panel of experts prior to
any approval to access the medication.
The NHMRC submitted that there are two paths by which mitochondrial
donation could be introduced into Australia. The first would be to follow the
process undertaken in the UK, by allowing a small number of centres in
Australia to conduct research, validation and training activities, which
include the creation and destruction of human embryos, prior to any clinical
use. A second option, allowing immediate clinical use but prohibiting the
creation of embryos for research, training and validation, would mean that
children 'born following the first use of mitochondrial donation in Australia
would bear the increased risk associated with establishing expertise in the new
The NHMRC recommended that if mitochondrial donation is to be allowed in
Australia, it should first be conducted within a research context—or clinical
trial—to increase the evidence base for the safety and efficacy of this
An Australian introduction was generally seen by submitters as a
two-pronged approach of allowing almost immediate access to the treatment for a
limited number of women (potentially as a clinical trial) as soon as a clinic
demonstrated the required expertise in administering the treatment, and at the
same time allowing for additional research to be undertaken.
Any clinical use of mitochondrial donation would of course require legislative
amendments as described above.
The committee considers that a limited clinical trial should be
considered before full introduction of mitochondrial donation and that additional
research could be simultaneously conducted. The committee notes that medical
trials would require a change of legislation before they could proceed.
Australian regulatory regime
Most submitters and witnesses in favour of mitochondrial donation put
forward the UK system as a good basis for a regulatory system in Australia, with
The Genetic Support Network of Victoria stressed the importance of
well-planned implementation managed by experts:
Implementation is very important. It will require responsible
and very clear messaging that will be based on a very clear decision. We need a
clear and effective regulatory environment to support mitochondrial donation
and we need to allow our clinical experts to do the job.
AMDF submitted that '[t]he UK regulatory process reflects significant
work and effort over many years in its development and, whilst some tweaking
may need to occur, Australia already has a framework in existence that could be
adapted to address and regulate mitochondrial donation'.
A common recommendation was to use the current Australian system for
regulating both human embryo research and Assisted Reproductive Technology
(ART) clinics. This would entail the Embryo Research Licensing Committee (Licensing
Committee) of the NHMRC to be responsible for the licensing of centres and individuals
seeking treatment, and the Reproductive Technology Accreditation Committee (RTAC)
of the Fertility Society of Australia (Fertility Society)
to have a role in providing advice on the clinical capacity of ART clinics to
provide this service, as well as an ongoing compliance monitoring role of
clinics in collaboration with the Licensing Committee.
The Licensing Committee of the NHMRC was seen to be the most suitable
body to regulate licences, as it is has been responsible for the oversight of
research involving the use of human embryos for 15 years, and is well placed to
regulate research of mitochondrial donation on a case-by-case basis. The
Murdoch Children's Research Institute submitted that there may be greater
public confidence in the regulation of mitochondrial donation if the licences
were granted by a body that is independent of the ART industry, such as the
NHMRC, but suggested that '[i]f this was unsuitable then it may require an
independent body to be set up, perhaps with input from the Australian Academy
of Health and Medical Sciences.'
The Australian Academy of Science further recommended the NHMRC 'oversee
a publicly available database containing information about licences issued and
outcomes, as well as regularly report to the Parliament of Australia'.
A submission from a coalition of professors with expertise in
mitochondrial disease noted that the current NHMRC Licensing Committee did not
include a member with substantive clinical or scientific expertise in
mitochondrial disorders and suggested 'a person with that expertise may be
needed to supplement the committee's existing skills in embryology, ART
technologies, ethics and community representation'.
The RTAC of the Fertility Society submitted they would be able to
include the regulation of mitochondrial donation in their current regulatory
RTAC is the accrediting body for ART in
Australia, and would therefore take on clinic accreditation of this technique.
If further legislative oversight was deemed necessary, the NHMRC embryo
research licensing committee could require ART clinics to seek accreditation.
These levels of controls would see that Mitochondrial transfer was conducted in
the most stringent manner to ensure optimal outcomes for the families at risk
and society in general.
The majority of submitters were supportive of replicating the double-licensing
system used in the UK, where both the clinic and the patient must have a
licence prior to the use of mitochondrial donation. Professor Christodoulou
outlined how this could work in practice:
Firstly, one wants to be confident that the organisation
that's going to be offering the IVF technology has the skill set and expertise
to be able to do that. That would require expert panels to review the
scientific and clinical credentials of whatever the organisation was...
And then the second aspect of the licensing—and this is very
much following the UK model—is that one needs to be really careful about
identifying for which families this technology will truly be of benefit. That
would require the evaluation by an expert panel—which I would suggest should
include both paediatric and adult mitochondrial specialists, IVF specialists,
geneticists and, importantly, community representation as well—to identify on a
case-by-case basis those individuals who would truly benefit by having
mitochondrial donation versus others who might be better potentially directed
towards traditional prenatal testing or preimplantation genetic diagnosis or
where none of these technologies may be relevant.
There were a number of additional regulatory issues that were
recommended by submitters and witnesses as important components to a regulatory
regime that protected the safety and well-being of parents using mitochondrial
donation, children born of this technique and potential donors. These are
Restrict purpose to mitochondrial
The clinical purpose of mitochondrial donation was discussed by multiple
submitters and witnesses. Beyond preventing mitochondrial disease, mitochondrial
donation has been tested as a treatment for certain infertility issues,
and recent medical research has indicated that mtDNA mutations are implicated
in many further health problems, such as diabetes, autism and some inheritable
Mitochondrial donation may well prove, at some unknown point in the future, to
be a viable prevention treatment for health conditions beyond mitochondrial
However, there was a universal view that while mitochondrial donation
was still in its early years and is somewhat experimental, the unknown risks may
be acceptable to take for reducing the generational transmission of severe
mitochondrial disease to children, but was not considered appropriate to take
for other diseases or as an ART enhancement at this point in time.
Professor David Thorburn of the Murdoch Children's Research Institute
recommended that limiting mitochondrial donation to preventing mitochondrial
disease should be done in primary legislation.
However, Professor Thorburn further noted that while mitochondrial donation
should be 'ring-fenced' to the purpose of mitochondrial disease, there is still
a degree of flexibility required in the assessment of how to implement that in
I think it's impossible to put all the detail into the
legislation. It's going to be quite complicated and it will be necessary to
hand off—there's not exactly an equivalent of the Human Fertilisation and Embryology
Authority in Australia, but it needs to be, to a degree, handed off to an
expert independent committee to narrow down the details of how that can proceed
in practice but be restricted to using it for mitochondrial DNA donation to
prevent severe mitochondrial disease.
Dr Newson also argued for some flexibility on the grounds that women
most likely to pass on the more serious forms of mitochondrial disease are
often too sick to be able to use mitochondrial donation.
Associate Professor Catherine Mills agreed that it would be prudent to
start with limiting access to those women most in need of this technology as 'women
whose children would most clearly suffer from serious mitochondrial disease in
the circumstance of not using the technology' and noted that the risks of this
technology 'would still probably have lesser health impacts than the risks of
Further to this, the UK restricts mitochondrial donation to couples for
whom pre-implantation genetic diagnosis (PGD) or other methods would be
inappropriate or unlikely to succeed. As stated earlier in this chapter, a
person seeking a licence in the UK must demonstrate that other methods for
having children are not an option.
Professor Thorburn supported this position and told the committee that
'[p]re-treatment assessment must take into account a range of factors and I
also believe this should be overseen by a body independent of the ART industry,
which could presumably be the same body overseeing licensing of centres, with
input from experts in multiple disciplines'.
In practice, many submitters and witnesses pointed to the UK regulation
regime as a good way to restrict access to mitochondrial donation through the
dual licensing system.
Multiple donation techniques
As outlined in chapter three, evidence suggests a preferred method of mitochondrial
donation does not appear to have yet been identified. Consideration needs to be
given to the way any possible regulation is framed to permit the safest and
most up-to-date scientific techniques to be used in Australia.
Professor John Carroll from the Monash Biomedicine Discovery
Institute noted that pronuclear transfer is the preferred method being
investigated by the UK clinic licensed to undertake mitochondrial donation 'which
gives me more confidence in being able to understand any technical details
about making that as good as it possibly can be'. That being said, Professor
Carroll recommended that both pronuclear transfer and maternal spindle transfer
should be allowed for under any Australian regulatory regime, to 'give us the
best flexibility and adaptability as we move forward through the process of
learning how successful the technique is and how we can adapt it and improve it
as will always happen in new techniques like this'.
Professor Carolyn Sue, Director of the Mitochondrial Disease
Research Centre at the Kolling Institute of Medical Research, agreed and noted
that if both techniques for mitochondrial donation were available, patients
with an ethical objection to the destruction of embryos would be able to access
Professor Justin St John, Head of the Mitochondrial Genetics
Group at the Hudson Institute of Medical Research, presented evidence to the
committee on new techniques for mitochondrial donation which uses eggs at an
earlier development stage that currently used in maternal spindle transfer. This
was discussed in detail in chapter three. Professor St John recommended that
changes to law should be inclusive, to allow for scientific changes.
Clinical capacity and numbers
The regulation of ART clinics offering mitochondrial donation in the UK
is done by the HFEA. Professor Thorburn supported any Australian regulation to
follow the approach of the HFEA, which imposes 'a requirement for appropriate
levels of skill being demonstrated by named practitioners within a named
clinic, and relevant key performance indicators being met, parameters that will
be assessed by the HFEA'.
Professor Thorburn recognised that regulation in Australia would be more
complex than the UK method, as the clinical application of new ART techniques
would need to be accredited by the RTAC of the Fertility Society.
Most people and organisations in favour of mitochondrial donation
recommended that clinic numbers be limited in the initial stage, to allow for
one or two centres of excellence to be established. The Human Genetics Society
of Australasia also submitted this would 'aggregate relevant clinical
experience, provide training, patient follow-up and clinical audit so as to
support the greatest possible benefits to patients and healthy outcomes for
Professor Sue told the committee that the capacity exists within
Australian clinics to provide this treatment:
When I speak to IVF centres, there is an appetite for this
technology transferral. There's no real concern about not being able to do it.
It's more about changing the legislation to make it legal and also determining
the demand for this procedure. I think the capability is there, the appetite is
there, but the legislation doesn't allow us to do it at this stage.
Dr Petra Wale from the Fertility Society noted that mitochondrial
donation would not be 'a routine offering on an IVF platform' and that limiting
the numbers of clinics providing this treatment would create centres of
Professor Sue also discussed the number of clinics which should be
initially licensed, and noted that while the UK had licensed only one clinic at
this stage, the geographical spread of Australia meant that a 'tyranny of
distance' could create equity and fairness issues for patients should only a
single clinic be licensed in Australia.
AMDF pointed to the UK model for follow-up, where clinics offering
mitochondrial donation must have a documented process for monitoring children
born following mitochondrial donation, including medical follow-up, with mandatory
reporting of any adverse events, such as birth defects, genetic abnormality or
another adverse outcome such as a miscarriage.
The Australian Academy of Science further recommended that haplotype
information should also be collected.
Dr Nadine Richings, Vice Chair of Scientists in Reproductive Technology
recommended rigorous follow-up similar to the procedures followed with the
introduction of the ART process intracytoplasmic sperm injection, ICSI. Dr
Richings informed the committee that:
If mitochondrial donation was permitted Australia, SIRT would
support and recommended rigorous evaluations of laboratory outcomes and also
follow-ups of any children born through these procedures. The Australia and New
Zealand Assisted Reproduction Database, ANZARD, could report this information.
The purpose of ANZARD is to collect, monitor and monitor the perinatal outcomes
of assisted reproduction and to assess the effectiveness of ART treatments. It
would be an appropriate organisation or scheme to review this information.
Chapter three discussed the ongoing scientific debates around the need
for haplogroup matching. This chapter highlighted that while there was still
disagreement in the scientific community regarding the potential level of risk
involved in 'mixing' haplogroups, there was consensus that any risk was far
lower than the known risks of passing on mitochondrial disease.
Professor Thorburn submitted he is concerned that requiring haplogroup
matching would reduce the pool of possible donor eggs and that:
Until there is more experience with mitochondrial donation,
it seems reasonable to recommend haplogroup matching if practicable but to
enable couples to choose to use an unmatched haplogroup donor.
Leaving the decision to about whether to use haplogroup matching, after
counselling, to the prospective parents was endorsed by the Australian Academy
of Sciences, Murdoch Children's Research Institute and Victorian Genetic
Clinical Services and Professors David Thorburn, John Christodoulou, Carolyn Sue,
John Carroll, Mike Ryan and Aleksandra Filipovska.
Embryo sex selection
Many submitters and witnesses discussed the proposal in the United
States that mitochondrial donation would be limited to only use male embryos,
so that any negative germline modifications would not be passed on to subsequent
generations. The Australian Academy of Science submitted that this was
considered by the HFEA for mitochondrial donation in the UK, but was ultimately
rejected due to concerns this would require another intervention, in this case
PGD, in an embryo that had already been subject to heavy manipulation, and
would also halve the number of suitable embryos and reduce the chance of
achieving a pregnancy.
The NHMRC ethical guidelines for ART allows for sex selection of embryos
to reduce the risk of transmission of a genetic condition, disease or
abnormality, but not for family balancing or other reasons.
Whether or not the selection of male embryos to reduce the chance of passing on
inheritable changes brought about by mitochondrial donation would be considered
under these guidelines as an acceptable option, would have to be explored by
the NHMRC. The choice for undertaking sex selection would then lie with the
Professor Sue noted that this would also require careful pre-treatment
counselling from a qualified geneticist:
[F]or patients who are dealing with a choice of having a male
child with a maternity-transmitted disorder that may be something of importance
and something that you or I are not able to inflict or control from any
individual's choice. If the procedure is such that mitochondrial donation does
or does not enable the choice of a male child, that is something I would have
to guide the patient on: 'These are the risks. If you have the mitochondrial
donation the risk is low. However, if they are a female they have a likelihood
of passing it on if there is still some carryover'...That's something that a
reproductive options clinic would offer and something that we would intend to
do and evaluate after the procedure would be legalised.
The need for pre-treatment counselling was raised by multiple
submitters, to ensure that couples considering using mitochondrial donation
were fully informed of the known and unknown risks, the efficacy of the
treatment, as well as other options for having genetically or non-genetically
The AMDF submitted that the UK model offers a good basis for pre-treatment
counselling and closely aligns with Australian pre-treatment counselling for ART
procedures. AMDF further submitted that:
In terms of counselling, it seems appropriate that advice
should be provided to prospective parents about the alternative options
available to them in terms of their reproductive options and about the
scientific concepts involved, such as pronuclear transfer, maternal spindle
transfer, and potential haplogroup matching. In addition, in line with current
medical practice regarding IVF, the risks and benefits of the procedures should
Professor Thorburn also stressed the range of information that should be
provided to parents in order to facilitate informed consent.
Parents need to know what the
full range of options is, including adoption, egg donation, prenatal diagnosis,
preimplantation genetic diagnosis and mitochondrial donation. Some of those
options either will not be suitable for the families or will not be acceptable
to the families, but it's important that they be provided with all the
information about potential safety and efficacy.
The committee concurs with the views of the majority of submitters and
witnesses, that the UK model of regulation provides a sound basis for adaptation
to the Australian ART clinical context. The evidence shows that Australian
clinics have the capacity to refine the skills necessary to undertake
mitochondrial donation. Evidence also shows that the Australian research and
clinical practice frameworks are sound and robust enough to be adapted to
ensure that mitochondrial donation is regulated and appropriately monitored.
The committee notes that evidence presented to this inquiry on the areas
of oversight for an appropriate regulatory regime will be useful to
establishing an appropriate Australian system for mitochondrial donation.
The committee stresses the importance of detailed pre-treatment
counselling for anyone who seeks mitochondrial donation as a treatment, to
ensure they are fully aware of the risks, efficacy and other options that may
be available to them.
Accessing overseas clinics
Professor Sue explained to the committee that her mitochondrial disease
clinic has been in discussions with the fertility clinic in the UK which holds
the licence to provide mitochondrial donation:
Through our planned Reproductive Options Clinic, Australian
women with MD will be provided with a pathway by which they can undergo
mitochondrial donation under safe and regulated conditions at the Mitochondrial
Donation Centre in Newcastle, UK. However, this avenue, while helpful for some
women, will be prohibitively expensive for others.
However, Professor Sue also outlined that other countries such as Mexico
and Vietnam are offering this technology as 'medical tourism', without adequate
regulations or academic oversight. Professor Sue argues that allowing
mitochondrial donation in Australia will 'provide Australians with the
opportunity to undergo procedures that are quality controlled, approved and
A number of other submissions also raised this as a significant concern and
that Australian mitochondrial disease support groups have already been
contacted by a clinic in Vietnam offering these services to Australians.
Whether Australian legislative prohibitions on mitochondrial donation
would make such actions an offence for an Australian couple has not yet been
To address the issue of Australians accessing treatment overseas,
submitters recommended consideration of modifying Australian law to allow for
this. Dr Newson further recommended there should be post-birth arrangement in
place in Australia for any couples who successfully sought treatment overseas.
The committee understands that although the UK clinic offering
mitochondrial donation is not yet accepting Australian patients, this may occur
before this treatment is available in Australia. The committee also notes that
mitochondrial donation may become available in less well-regulated countries. Any
consideration of changes to legislation should take these issues into account.
Many submitters pointed out that Victoria, New South Wales, South
Australia and Western Australia have state-based legislation around
reproductive technology, which would also have to be amended to allow for
For example, under state reproductive health laws, all Australian
jurisdictions require the genetic origins of the resulting child be certain. In
some states, this would
constrain the implantation of more than one embryo where mitochondrial donation
has been used, and may also preclude anonymous mtDNA donation.
In other states, such as NSW, Commonwealth anti-cloning laws have been
replicated and would require amendment to allow for mitochondrial donation to
be undertaken in that jurisdiction.
State-based laws do provide some regulatory opportunities, in that some
states have regulatory bodies which could incorporate a role in overseeing
mitochondrial donation, such as the Victorian Assisted Reproductive Treatment
Authority. The Murdoch Children's Research Institute, however, argued that a
national approach to regulation would be preferred.
The committee understands that reproductive technology is regulated at
both a Commonwealth and state level. In some cases, states have replicated
Commonwealth anti-cloning laws. In order for mitochondrial donation to be used
in clinical practice, this will require some amendment to the state or
territory laws of the jurisdiction where the initial clinic(s) are established.
This will best be addressed by the relevant Health Ministers working
collaboratively, potentially through a Council of Australian Governments
Given the ethical considerations of mitochondrial donation, many
submitters and witnesses acknowledged that public consultation should occur
prior to changes in the legislation and any rollout of the clinical use of
mitochondrial donation. Professor Christodoulou noted that this is an area
where the views of the whole community should be taken into account, not just
those with a specific interest in this treatment.
AMDF noted that this inquiry itself was part of the process to review
the science and the ethics and gauge public opinion.
I believe that most Australians provided with the relevant
information would support the use of mitochondrial donation to prevent the
devastating outcomes of mitochondrial disease.
Many submitters stressed the importance of accurate information being
provided to the public during any consultation, and avoiding emotive and
incorrect terms such as 'three-parent babies'.
Associate Professor Mills also stressed the importance of maintaining
'transparency and accuracy in discussions about the therapeutic efficacy of
mitochondrial donation'. Associate Professor Mills told the committee:
Mitochondrial diseases can be caused by mutations in nuclear
DNA that control mitochondria as well as mitochondrial DNA. This technology
only addresses mitochondrial disease that arises from mitochondrial DNA, which
is inherited maternally. Given this, it's important in discussions of
mitochondrial donation that its capacity to cure or treat mitochondrial disease
is not overstated. It's not a cure for existing people but a means of
preventing the birth of some people who are likely to be born with
mitochondrial disease—or, to put the point more positively, enabling the birth
of people without such diseases.
Dr Newson discussed a citizens' jury she recently conducted into
community attitudes on mitochondrial donation. Dr Newson submitted that '[i]f
citizens are provided with good quality evidence and have the opportunity to
reason and think on the question at hand, they will be able to come to a
well-informed and soundly reasoned decision that reflects their values'. Dr
Newson outlined the process where participants 'hear balanced evidence, [from
expert witnesses] have the opportunity to ask the experts questions, deliberate
(with and without a neutral facilitator present) and come to a decision – the
"verdict", which can include dissenting opinions'. The jury ran over
one and a half days and comprised 14 members from a range of ages and cultures,
who had no experience of mitochondrial disease.
Dr Newson submitted that while the report of the citizen's jury has not
yet been published, she did note that a 11 of 14 jurors answered either 'yes'
or 'yes with conditions' (such as an appropriate licensing regime) to the
question of whether Australia should allow children to be born following
Associate Professor Mills summed up the need for public consultation to
take place in Australia around mitochondrial donation:
Furthermore, while we can learn from the UK process that took
place in the lead-up to legislative reform, that process of public discussion
can't simply replace a similar process in Australia. The issues involved in
mitochondrial donation are sufficiently complex, and the potential regulatory
reform sufficiently far-reaching, that a robust process of public and expert
consultation and debate is required prior to its introduction into clinical
The committee agrees that mitochondrial donation should not be introduced
without allowing for public consultation.
The committee notes that this inquiry plays a part in public
consultation, and considers that from the evidence presented so far,
mitochondrial donation may not be seen as a controversial medical treatment.
The committee further notes that any legislative change will, most
likely, involve a Senate legislation inquiry, which will give further
opportunity for the Australian public to put their views to the parliament on
whether this treatment should be legalised.
The committee agrees that public consultation is necessary before any
full rollout of mitochondrial donation and that parliamentary inquiries alone
will not be sufficient public consultation.
Evidence suggests that mitochondrial donation is a form of genetic
modification that was not envisioned at the time that anti-cloning laws were
enacted in Australia. As such, these laws prevent mitochondrial donation from
being researched and used in clinical practice. Science has moved significantly
faster than legislation.
Therefore, as outlined in chapter four, a foundational question must be
answered before any possible introduction of mitochondrial donation into
Australian clinical practice: does this treatment constitute germline gene
modification in the manner known at the time that such practices were
prohibited under Australian anti-cloning laws, and is it appropriate to modify
laws to incorporate mitochondrial donation?
Defining what kind of gene modification this treatment is, is
fundamental to developing the most appropriate legislative amendments to
legalise mitochondrial donation if that is supported by the community. The
committee does not envision this process as requiring an extensive or lengthy
The committee concurs with the views of many submitters and witnesses,
that, should mitochondrial donation be introduced to Australia, enacting a
regulatory and oversight regime for mitochondrial donation would be most
appropriately done through regulations which empower the NHMRC, supported by
the RTAC of the Fertility Society to manage the oversight and restricted access
to mitochondrial donation as a clinical treatment.
In this way, regulations can be amended and adapted to keep up to date
with changing scientific knowledge, with the review and approval of the Parliament
The committee notes the strong potential of mitochondrial donation to
address the debilitating effects of inheriting mitochondrial disease. The
committee recommends that public consultation be undertaken regarding the
introduction of mitochondrial donation to Australian clinical practice. To
facilitate this consultation, the committee further recommends the Australian
Government prepare a consultation paper, including options for legislative
change that would be required. The Minister for Health should seek advice from
the National Health and Medical Research Council on the most appropriate timing
and format for this consultation.
The committee recommends that the Australian Government task the National
Health and Medical Research Council with advising on the following questions:
Whether mitochondrial donation is distinct from germline genetic
Is there any new information to indicate that research findings
from the United Kingdom, that the science of mitochondrial donation is safe for
introduction into controlled clinical practice, cannot be applied in an
Whether other approaches to inheriting mitochondrial disease
should also be the focus of Australian research.
The committee recommends the findings be used to inform future legislative
The committee notes that the Prohibition of Human Cloning for
Reproduction Act 2002 and the Research Involving Human Embryos Act 2002
would require amendment to insert a power to make regulations allowing for
mitochondrial donation, with an appropriate regulatory regime overseen by the
National Health and Medical Research Council.
The committee recommends the Minster for Health take the findings of this
report to the Council of Australian Governments (COAG) Health Council to
progress the implementation of this report's recommendations with the states
The committee recommends, noting the need for community consultation and
scientific review, the urgency of treatment for current patients and the small
number of patients seeking this treatment, that the Australian Government
initiate dialogue with the relevant authorities in the United Kingdom to
facilitate access for Australian patients to the United Kingdom treatment
facility as an interim measure.
Senator Rachel Siewert
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