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questionnaire. Responses made via email or post were
also accepted while the consultation was open. A total
of 1,836 responses were received, the majority of which
were received via the consultation website. Respondents
include stakeholder organizations, individuals with personal
experience of mitochondrial disease, as well as a large
number of members of the public.
Each of these strands tapped into different groups, using
different strategies. An enormous amount of time and
energy was invested by HFEA staff in providing information
to support the events, much of which can still be consulted
on the HFEA website. It is noticeable that media coverage
of the mitochondria replacement story throughout
this period was unusually well-informed: the HFEA
website encourages interested parties to use any text or
illustration they like, to inform their own work, and several
journalists incorporated graphic as well as textual material.
The public consultation also benefited from the fact that,
fortuitously, the Nuffield Council on Bioethics conducted
a six-month inquiry into the ethical issues raised by
“new techniques that aim to prevent the transmission of
maternally-inherited mitochondrial DNA disorders” during
the same period, concluding that “if these novel techniques
are adequately proven to be acceptably safe and effective
as treatments, it would be ethical for families to use
them” 7 .
Taken together, the expert and public consultations
provided a solid platform on which to build the HFEA’s
advice to ministers. After more than three years of
engagement with scientists, ethicists and the broader
public on mitochondria replacement, the HFEA reported
to the Secretary of State for Health as follows:
“It is not the task of the HFEA to advise the
Government as to whether it should permit mitochondria
replacement in treatment. That decision would require a
change in the law and is, quite properly, one which only
Parliament can take. If the Government does wish to
take steps to change the law, it must draft Regulations as
provided by the Human Fertilisation and Embryology Act
1990 (as amended).”
“Our advice to Government is that there is general
support for permitting mitochondria replacement in the
UK, so long as it is safe enough to offer in a treatment
setting and is done within a regulatory framework. Despite
the strong ethical concerns that some respondents to the
consultation expressed, the overall view is that ethical
concerns are outweighed by the arguments in favour of
permitting mitochondria replacement.” 8
I think this is a quite remarkable outcome for such a
contentious piece of clinical innovation. I believe that
the painstaking way in which the various consultations
were conducted was in large measure responsible for
the unexpectedly consensual and positive outcome.
In February 2014, the Department of Health opened
a consultation on draft regulations for the use of
mitochondria replacement techniques, which would
eventually make such treatments lawful.
On 22 July 2014, the department published its response
to the consultation on draft regulations, in which it
expressed its satisfaction with the extensive process of
the consultation overall, and announced its decision to go
ahead with putting the regulations before Parliament:
“This consultation on proposed regulations has been
the culmination of detailed consideration over a four year
period, where the Government has aimed to ensure that
full account is taken of all the available evidence on the
science, ethics and safety of the techniques and that all
voices are heard.”
“The Government has decided to proceed with putting
regulations before Parliament, subject to giving further
consideration to the Expert Panel’s recommendations,
refining the draft regulations to take account of changes
identified during the consultation, and discussion with
the HFEA about an appropriate approval process. The
Government will consider the timing of the regulations in
the light of these actions. The regulations will be subject
to full scrutiny by the public and Parliament through the
affirmative procedure.” 9
Risk and uncertainty again
When I began writing this chapter, the regulations which
would govern mitochondria replacement treatment were
expected to be put before Parliament by the end of 2014.
Given the success of the consultation process that had
preceded the drafting of regulations, it was assumed at the
HFEA that the necessary changes to the statute would
have become law by the end of 2014. But that, it turned
out, was not the end of the story.
On 1 September 2014 a debate took place in the House
of Commons Chamber on mitochondrial replacement
techniques and public safety, scheduled by the Backbench
Business Committee. The motion was moved by the
Conservative MP Fiona Bruce, and ran as follows:
“That this House takes note of the Human Fertilisation
and Embryology Authority’s most recent scientific review
into the safety and efficacy of mitochondrial replacement
techniques which highlights concerns for subsequent
generations of children born through maternal spindle
transfer and pronuclear transfer; welcomes the recent
comments of scientists that, prior to the introduction of
such techniques, more research ought to be undertaken and
a full assessment conducted of the potential risk to children
born as a result; and calls upon the Government, in light
of these public safety concerns, to delay bringing forward
regulations on mitochondrial replacement.” (my emphasis)
There was, I confess, some dismay amongst those
who had so carefully seen the matter through to this
point, at the prospect of further delay being introduced.
What was disappointing was that after all the careful
consultation and explanation, there was the old issue of
risk and uncertainty once again, raising its ugly head. Those
supporting the motion made it clear that the issue was a
real reluctance to introduce regulations before there was
scientific evidence to show that mitochondria replacement
techniques were safe and risk-free. This was the very thing