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BRUCE Fiona

Fiona Bruce is MP for Congleton.

Back in March, I wrote a piece for ConservativeHome examining the ethical implications of mitochondrial replacement techniques. Today I address the growing public safety concerns surrounding the Government’s proposals.

The handling of GM food technology in the 1990s has become a text book example of how not to deal with consumer concerns about the application of science. It demonstrated how adopting a cavalier attitude toward public fears can seriously backfire. I am concerned that the Government is in danger of again adopting a too cavalier attitude towards public safety and ethical concerns regarding new technologies, this time pronuclear and maternal spindle transfer (PNT and MST), aimed at constructing human embryos without human mitochondrial disease.

The Government initially moved very carefully in relation to public safety, requesting two reports from the Human Fertilisation and Embryology Authority (HFEA) in 2011 and 2013 to assess the safety of PNT and MST. On both occasions the HFEA reported back that while they were not aware of any evidence that the procedures were unsafe, it would be important to conduct a series of preclinical experiments – some of which they described as critical – to back this up.

In a context where the HFEA has said that there is preclinical research which must first be undertaken, some of it critical, the appropriate way forward surely would be to wait before making any decision about the procedures until all the experiments have been conducted and the findings published and placed in the public domain – ? That approach would be completely transparent and the public would know that research is being conducted in an unhurried and proper way.

What has happened in this case of proposed mitochondrial transfer techniques has been quite different. Just three months after the publication of the HFEA’s second Report – before much of its recommended research had started let alone been concluded and published – the Chief Medical Officer announced that the Government was going to proceed to publish draft legislation for consultation; in other words, to ask Parliament to approve regulations permitting these techniques before they had been proven safe.

Rushing ahead of the publication of the preclinical results is surely not a helpful approach to adopt when dealing with a public concerned about consumer protection, particularly in a matter of literally life itself. The difficulties arising from this strategy were further compounded by the intervention of Sir John Tooke, President of the Academy of Medical Sciences who stated: ‘Introducing regulations now will ensure that there is no avoidable delay in these treatments reaching affected families once there is sufficient evidence of safety and efficacy.’ In other words Parliament should sign off legislation before the preclinical safety research is concluded!

Those of us who viewed with great concern the decision to act before the conclusion of the preclinical work hoped that the draft legislation would not actually be published for consultation until after the preclinical work was concluded. In February this year, however, before the conclusion of that research, the draft legislation was published for consultation. To make matters worse the latest and third safety Report from the HFEA, which came out very recently after the conclusion of a public consultation on the draft legislation, clearly repeats that there is still important preclinical work to be conducted, some of it critical – and some of it new!

Among other things the Report says:

“Further experiments need to be carried out before introducing either” (MST or PNT) “into clinical practice to provide further reassurance about efficiency and safety…”

and

“there is a potential concern, however, for subsequent generations”

and again

“There are still experiments that need to be completed before clinical treatment should be offered. The panel considers that some of these experiments are critical.”

That draft legislation should have been produced and consulted upon when there are still critical preclinical safety experiments yet to be recommended let alone conducted, and the results written up and published, is both shocking and concerning.

Whilst it is too late to change the fact that a decision to proceed was announced and draft legislation published and consulted on before the conclusion of the preclinical research, crucially there is an opportunity to adopt a more prudent approach to Parliament’s consideration of the proposed legislation.

To this end I recently tabled a very simple but important amendment to the Consumer Rights Bill requiring that Parliament should not be asked to vote on legislation allowing PNT and MST until after publication in peer reviewed journal articles of the findings of all the preclinical research which the HFEA has recommended in response to the Government’s questions about the safety of the proposed procedures. During the debate on that bill last week I was able to speak briefly to address this concern in the House of Commons.

The importance of the approach set out in my amendment was actually underlined only last week also, very powerfully by an intervention from Britain’s premier fertility expert, Lord Robert Winston. The Independent on Sunday reported that Lord Winston ‘…warns against the introduction of mitochondrial transfer – which produces embryos with genetic material from three “parents” – because he fears not enough has been done to assess the risks to children born as a result.

In the interview Lord Winston said:

“The idea of replacing [defective] mitochondria with mitochondria that don’t have the defect is a wholly good thing to do,”

and on safety:

“The problem is that I don’t believe there has been enough work done to make sure mitochondrial replacement is truly safe. There probably needs to be a great deal more research in as many animal models as possible before it’s done.”’

In light of Lord Winston’s comments, we should insist not only that all the HFEA tests are concluded and written up in peer reviewed journal articles before legislation is presented to Parliament, but that the number of critical tests should be extended.

The Government needs to slow down, consult other experts outside the HFEA about the extent of the preclinical research, and not bring any legislation to Parliament unless or until all the necessary preclinical work has been concluded and published in peer reviewed journals which are accessible to Parliamentarians and members of the public. It also needs to have greater regard for many of our constituents’ ethical concerns regarding these procedures, but consideration of these will have to wait for another occasion.

No mother wants to conceive a child with mitochondrial disease but neither do they wish to conceive a child with genetic abnormalities because we have rushed into introducing scientific techniques which should have been tested more robustly.

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