Mitochondrial Donation - a Submission to the Department of Health's
                            Consultation of Draft Regulations on behalf of Affinity

 

                                                       Response Form

Name: Dr John R. Ling

Organisation represented (if appropriate): Affinity – Gospel Churches in Partnership.

Affinity is a partnership of more than 1,200 churches and Christian agencies.  It represents one of the largest groups of evangelical Christians in the UK and Ireland.  Our website is www.affinity.org.uk

The views expressed in this submission have been compiled and approved by the Social Issues Team, a specialist grouping within Affinity with expertise in a wide range of bioethical, legal, social and theological matters.

Address: Affinity, The Old Bank House, 17 Malpas Road, Newport, NP20 5PA.

Question 1: Regulation 2 defines the removal or insertion of nuclear DNA involved in mitochondrial donation. Do you agree with this definition?

Your Comments:

While we remain resolutely opposed to the ethics and practice of mitochondrial donation (MD) (see our Comments on Question 9), this definition seems adequate.
 

Question 2: Regulations 4 (eggs) and 7 (embryos) only allow mitochondrial donation where all the nuclear DNA is transferred from an egg or embryo to another egg or embryo from which all the nuclear DNA has been removed. Do you agree with this description and restriction?

Your Comments:

While we remain resolutely opposed to the ethics and practice of MD (see our Comments on Question 9), these Regulations seem understandable.
 

Question 3: Regulations 5 (eggs) and 7 (embryos) require that, in order to agree that mitochondrial donation can go ahead, the HFEA must decide if there is both a particular risk that the egg or embryo of the patient has a mitochondrial abnormality and a significant risk that a person with the particular mitochondrial abnormality will have or develop a serious physical or mental disability, a serious illness or other serious medical condition. Do you agree that the HFEA should have this role?

Your Comments:

Though far from persuaded of the scientific necessity, medical advisability or the bioethical legitimacy of MD, we recognise that if such a procedure were to be permitted, it must be rigorously regulated and scrupulously monitored.  Whether the HFEA is equal to the task is another matter.  Its history, in terms of administrative competence, clinical compliance and bioethical resolve, has long been questionable.  The HFEA has always been a libertarian organization – for example, has it ever rejected a research or licence proposal?
 

Question 4: Do you agree with the principle that centres should not be permitted to undertake mitochondrial donation without first obtaining authorisation to do so from the HFEA?

Your Comments:

If MD were to be permitted, then its monitoring and administration must be preceded by stringent authorisation – centres alone cannot be allowed to self-regulate.  Perhaps the HFEA is the best currently-available body to oversee this process.
 

Question 5: Do you agree that people donating eggs and embryos for the purposes of mitochondrial donation should not have the same status as those donating eggs and embryos for use in fertility treatment but rather regarded more like organ or tissue donors?

Your Comments:

This is a complex and thorny issue.  While we are always more than our genes, we are never less. Affinity is concerned about the inference here that the donation of just a little genetic material, namely, 37 mitochondrial genes, is of minor significance.  A limited regard at this stage will set a dangerous precedent for the future.  At what numerical point does genetic donation become of major significance?
 

Question 6: Regulation 10 provides that the HFEA should tell a person aged 16, on request, if they were born following mitochondrial donation. Do you agree with this?

Your Comments:

In principle, we should not withhold genetic information.  In other words, all of us should be able to discover who we are biologically.  Anonymous genetic donation, as opposed to tissue or blood donation, is never a good idea.  Secrecy surrounding our origins may appear to be protective, but it has, at least, the potential to create personal and family conflicts.
 

Question 7: Regulation 10 also provides that the information that the HFEA should provide in response to such a request should not identify the mitochondrial donor and be limited to screening tests carried out on the donor and about her family medical history, and any other non-identifying information that the donor has provided with the intention that it is made available in these circumstances. Do you agree with this approach?

Your Comments:

If MD were to become legal, this is the sort of social, legal and medical baggage that it would inevitably engender.  Regulations that impose restrictions on freedom of information are usually bad and in the future may be impossible, legally and bureaucratically, to maintain.
 

Question 8: Regulation 13 provides that the HFEA should tell a mitochondrial donor, on request, when a child has been born from their donation, how many and their sex. Do you agree with this approach?

Your Comments:

Why would a donor wish to know such information?  Would it be simple self interest, or might it lead to searching for the donated child(ren)?  This is reminiscent of the bioethical, legal and social minefield that surrounds the practice of surrogacy.
 

Question 9: Do you have comments on any other aspect of the draft regulations?

Your Comments:

We responded to the previous public Consultation on Mitochondrial Donation (MD) in December 2012.  We began that submission by affirming four basic facts.  We do so again because the legitimacy of every innovative medical practice and legal authorization must be judged by the most stringent bioethical foundations.  1] Human life begins at fertilization.  2] All human life is precious and therefore deserves to be protected.  3] IVF and PGD procedures always destroy human embryos.  4] Because IVF and PGD are integral to maternal spindle transfer (MST) and pronuclear transfer (PNT), we are opposed to the legalization and use of these two novel procedures.

In our December 2012 submission we also stated that, ‘None of this is to deny compassion towards those who suffer from mitochondrial diseases.  And we understand the desire of some sufferers to have children who are, not only genetically related, but also free from such diseases.  However, while we are neither anti-progress nor anti-science, we maintain that medical research must be conducted within robust bioethical boundaries.  Inevitably, this means that some scientific procedures will be forbidden.  We maintain that MST and PNT should be in this prohibited category.’

We recognize that the MD debate has been hastily moved on from considering questions of its appropriateness to those of its implementation.  Yet nothing in the intervening months has changed our thinking about MD.  The fundamental question to be put before Parliament is this: ‘Do we want to create genetically-modified children?’  These draft regulations, designed to circumvent the current illegality of such a course of action, will be merely the prelude to calls for more and greater changes.  If approved, the crucial precedent will be established.  The proposed 0.1% of donated DNA will inevitably become 1% and then why not 10%?  MD is certainly not a matter of just ‘changing the batteries in a camera’ or ‘adding extra RAM to a computer’ as some of its advocates have misleadingly stated.  Moreover, if modifications to mitochondrial DNA are to be permitted, then why not to nuclear DNA?  Every bioethical issue is subject to such ‘slippery slopes’ and MD is no exception.

Furthermore, we are concerned about the quality of the evidence that has been used to promote MD.  For instance, the analyses and conclusions of the HFEA’s 2012 public dialogue and consultation were deeply flawed – there was no clear-cut support for MD.  And the finding of the Expert Panel that ‘… no evidence that either technique was unsafe’ is as specious as it is grossly inadequate.  In addition, we were told that regulatory approval would be withheld until sufficient research on the safety and efficacy of MD in humans was published.  Where are these promised data?  The adverse outcomes of MD with animals, such as their failed and abnormal development, should prompt all experiments with human subjects to be halted.  Any such unintended harm to the lives of treated children, and their subsequent generations, is too high a price to pay.  And there are other specific issues that have yet to be satisfactorily addressed.  For example, nowhere in the Consultation document is there discussion of mitochondrial heteroplasmy (the persistence of some mitochondria from both the mother’s and the donor’s ova), the effects of any ‘mismatch’ between nuclear and mitochondrial DNA, the impact of non-genetic cytoplasmic components, and the role of epigenetics in the ‘new’ embryo.  These, and other legitimate concerns, demonstrate that these draft regulations are overly premature.  The likely occurrence of unforeseen and harmful consequences means that proceeding with human MD would be foolish.

Yet despite warnings about the safety, effectiveness and ethics of MD from the US Food and Drug Administration and other high-ranking bodies, such as the Council of Europe’s Convention on Human Rights and Biomedicine, plus numerous individual scientists and bioethicists, the UK has relentlessly forged ahead, driven by a powerful minority lobby within its scientific and political communities.  Their expressed hope that by authorizing MD the UK would become a world leader in this controversial, unpredictable, potentially dangerous and bioethically dubious enterprise is a vulgar motive.  An important question to answer is this: Why have some 40 countries, including our near neighbours like France and Germany, already banned these MD procedures?

And one additional, momentous objection remains.  The germline nature of MST and PNT crosses a most serious scientific and bioethical Rubicon, a barrier that many other countries have clearly recognized and refused to traverse.  Crossing it inevitably raises the issue and threat of legalizing future, larger scale, eugenic manipulation.  The spectre of the so-called ‘designer baby’ is fearful.

The fact that these draft regulations on MD take up six pages of byzantine detail should raise additional concerns, if not alarm bells, about the wisdom of seeking to advance these contentious techniques.  The need for such convoluted minutiae heralds a move away from the natural order, an excessive legal tinkering with established mores, and thereby represents an unprecedented threat to what it means to be human.  It is all too reminiscent of the recent farrago that surrounded the demand to create human-admixed embryos.  They too were once proclaimed to be ‘ethical’ and ‘essential’, but have since proved to be both ineffective and unnecessary.

In essence, MD is not a treatment, but rather a method for ensuring that affected individuals are never born.  The deliberate destruction of human embryos is never good medicine.  Nor is any clinical practice that is purposefully risky with uncertain patient outcomes.  Therefore, we conclude that these draft regulations are both reckless and reprehensible.  We strongly urge the Department of Health to recommend a prohibition of MST and PNT techniques.