REVIEW OF THE HUMAN FERTILISATION & EMBRYOLOGY ACT:

A PUBLIC CONSULTATION.

DEPARTMENT OF HEALTH 2005

This pro forma repeats all of the questions and proposals in the above titled consultation document. The boxes below will expand as you type. When completed it should be e-mailed to review-hfe-act@dh.gsi.gov.uk

The closing date for responses is Friday 25 November.
Personal details
Title: Dr
Names: Michael Jarmulowicz
Organisation: (if relevant) Joint Ethico-Medical Committee of the Catholic Union of Great Britain and the Guild of Catholic Doctors
Address: Brampton House
Hospital of St John & St Elizabeth
60 Grove End Road
London
Postcode: NW8 9NH
E-mail address: enquiries@catholicdoctors.org.uk
   

Not all questions have been answered. Where no answer has been given that question and associated response box have been deleted from this document

 

Questions and proposals for consultation

The model and scope of regulation

1. The Government believes that both the development and use of human reproductive technologies, and their regulation in response to public concerns, should continue to be subject to legislation. (Paragraph 2.7).
We agree. The area of human reproductive technology should continue to be subject to control by legislation.

 

2. On balance, the Government believes that the current model of regulation, whereby Parliament sets the prohibitions and parameters within which an independent statutory authority licenses activities, has worked well and should continue. (Paragraph 2.14).
The current model has not worked well. Appointments to the licensing body have been selective, in that those with any objection to the legislation have not been appointed. The licensing body is therefore not representative of the population in general, and the resultant decisions of the licensing bodies have reflected the views of those appointed. For example, the result of the first consultation by the HFEA on the use of cloned human embryos was overwhelmingly opposed to the proposals. In response the HFEA created the spurious concept of therapeutic cloning – which in reality has nothing to do with therapy – and so allow cloning experimentation, and persuaded the government to approve appropriate legislation.

 

3. However, the Government also accepts that legislation should be more explicit and provide Parliament with greater powers to debate and amend the law. In particular, the Government accepts the need to clarify the extent of any policy-making role of the regulator. (Paragraph 2.15).
The reality is that recent government legislation has been far from explicit – eg the Mental Capacity Bill avoided defining ‘best interests’; The Human Tissue Act is vague in many areas and has left specific details to be decided by the Human Tissue Authority. Such details, including matters of principle, should be properly debated and decided by Parliament and not left to an appointed body. When the HFE Bill was initially debated, the government reassured the public that this was not going to be the start of a slippery slope, but the decisions of the HFEA have been a slow progressive descent down the slippery slope.

 

4. The Government believes that legislation should make clear that all human embryos outside the body are within the scope of regulation and subject to the control of the statutory licensing authority regardless of the manner of their creation. (Paragraph 2.20).
Agreed. However, the actions of the government clearly flouted the original intentions of Parliament. During the passage of the HFE Bill Members of Parliament voted to ban all forms of cloning. It was unfortunate that the definition of an embryo in the HFEA overlooked that cloning could be done using an unfertilised ovum. This resulted in the scientific community, with government support, using this legal loophole, to allow human cloning for experimental purposes.

 

6. The Government proposes that eggs undergoing processes intended to result in the creation of embryos – whether fertilisation or other non-fertilisation processes – should continue to be subject to regulation. (Paragraph 2.27).
Agreed. No processes or activities that might result in the creation of a human embryo should be exempt from legislation.

 

7. The Government believes that the potential use of artificial gametes raises safety issues and that some uses may also raise ethical concerns. Therefore the Government proposes that the use of artificial gametes in assisted reproduction treatment should not be permitted but that the HFE Act should contain a regulation-making power giving Parliament more flexibility to allow the use of artificial gametes in future should it wish to do so. (Paragraph 2.31).
Use of artificial gametes should be banned, and there should be no clause to allow future flexibility. Parliament always has the right to amend legislation, and if it does so then debates the issues. But discussion of the issues need to be based on scientific reality and solid evidence as to why specific legislation is needed. Any debate now about the potential use of artificial gametes will have to be based on hypothetical scenarios. The proposal for a ‘regulation-making power’ is an attempt to push through a liberalising clause, with subsequent enactment by statutory instrument which will not be subject to the same parliamentary scrutiny as primary legislation.

 

8. The Government seeks views on the extent to which regulation should apply to the use of a couple’s "fresh" gametes. Should this be limited to technical and safety issues only or should treatment involving a couple’s fresh gametes be subject to the full requirements of the HFE Act where these are relevant? (Paragraph 2.37).
Manipulation of all gametes should be subject to legislative control.

 

Welfare of the child

13. The Government seeks views on whether taking account of the welfare of the child who may be born as a result of treatment and any other child who may be affected should remain an HFE Act obligation on persons providing treatment services. (Paragraph 3.19).
The aim of fertility treatment is to bring into being a new unique human individual. When indulging in sexual activity couples should accept the responsibilities consequent to begetting children. In assisted reproduction the staff are closely involved in the process of creation of new life and cannot completely abdicate all responsibility for the process. The fact that naturally couples may irresponsibly have children, does not remove the responsibility of clinicians closely involved in assisted reproduction from any welfare considerations, even though it is recognised that such evaluation, by its very nature, will be imperfect and incomplete.

Consideration of the welfare of the child must remain an obligation of assisted reproduction techniques

 

14. The Government seeks views on whether, if a welfare of the child requirement remains in the HFE Act, compliance with it should be a matter for "good medical practice" and the clinician’s judgement, rather than be subject to HFEA guidance and regulation. (Paragraph 3.23).
Reducing the burden of consideration of welfare of the child to ‘clinician’s judgement’ or ‘good medical practice’ will in effect remove any possibility of accountability or censure. There will be no effective criteria on which to question that ‘judgement’?

 

16. If a legal obligation to consider the welfare of the child is retained, should it be reformulated to refer to a risk of serious harm? For example, should it specify that treatment should not be provided where the clinician believes there is risk of

significant harm? (Paragraph 3.26).
The welfare of the child is paramount. It will be a sad day if legislation involving the creation of an infinitely valuable human being has as its standard of acceptability the absence of ‘risk of serious or significant harm’. Attempts to reduce the assessment of the future welfare of the child are a sad indication of how society is refusing to accept responsibility for its actions.

 

17. Do you think that the requirement to take account of "the need of the child for a father", as part of considering the welfare of the child, should be removed from the Act? Alternatively, do you think that it should be replaced with "the need of the child for a father and a mother"? (Paragraph 3.32).
Studies have repeatedly shown that children flourish best in the traditional family structure with a father and a mother. There would be no harm is amending the clause to include both the father and mother, as suggested in the question, albeit that it is not possible, currently, to bring a child to birth without a mother.

 

 

Reproductive choices: screening and selection

31. The Government invites views on whether legislation should set out the general criteria under which embryo screening and selection can be undertaken. If so, what should those general criteria be? (Paragraph 5.19).
We are opposed in principle to embryo screening and selection. The HFEA decisions over the last few years have slowly relaxed the criteria for screening, and shown that we are progressing down a slippery slope. There is a current HFEA consultation on whether to allow screening for genes that are in essence only risk factors for future disease in adulthood (such as breast cancer), some of which are treatable. There is no logical reason why if screening is allowed in such cases, why couples should be refused screening for traits that may have positive advantages for the individual, and then we will be very much on the road to ‘designer babies’.

 

33. Should the particular uses of embryo screening and selection remain a matter for decision and licensing by a statutory regulator in accordance with the general criteria set by Parliament? (Paragraph 5.21).
As stated in answer to an earlier question, the licensing authority membership is dominated by people closely involved in the process, and it would be anticipated that they would support use of all technological advances. Therefore, the particular use of screening should be defined in law and not left to the licensing authority, who we do not believe can make decisions which truly reflect society as a whole, rather they will side with the small and biased reproductive industry.

 

35. What are your views on the regulation of PGD with tissue typing? Should the legislation set out criteria under which this should be allowed? If so what should they be? Beyond that should particular uses need to be approved by the regulator – or should patients with their clinicians be free to make their own decisions? (Paragraph 5.23).
As we have said in repeated submissions to various bodies, children are NOT commodities that should be created for the benefit of others, ie being a tissue donor for a sibling.

 

37. The Government seeks views on sex selection for non-medical reasons. In particular, should this be banned? Or should people be allowed to use sex selection techniques for family balancing purposes as the Science and Technology Committee suggest? If so, how many children of one gender should a couple already have before being allowed to use sex selection techniques to try for a child of the other gender? (Paragraph 5.32).
Sex selection should be banned, especially for non-medical reasons. If sex selection were to be allowed, there is no logically defendable position of what a ‘balanced’ family should be? And control of this process would rapidly be unenforcible.

 

38. The Government proposes that the prohibition in the HFE Act on genetic modification of embryos for reproductive purposes should continue and be extended to gametes used in treatment. We invite views as to whether the legislation should include a power for Parliament to relax this ban through regulations (rather than primary legislation) if assured of safety and efficacy. (Paragraph 5.38).
We are opposed to all genetic modification of gametes and embryos and so support the proposal in the first sentence of the question. We are opposed to any mechanism whereby this ban could be relaxed by regulation (we assume this refers to statutory instrument). As argued earlier, we believe it is dangerous to allow significant changes in the law by statutory instrument, which does not receive the same parliamentary scrutiny as primary legislation.

 

Research

57. In common with the Science and Technology Committee, the Government believes that there is no case at present for either an extension or a reduction to the 14 day time limit for keeping an embryo. Any change would remain a matter for Parliament. (Paragraph 9.15).
Why is there use of the phrase ‘at present’ in the question? The argument, since the inception of the bill, was that the 14-day limit was imposed because the development of the nervous system (primitive streak) was considered the critical point that marked the beginning of individual development. There can never be any justification for allowing extension of the period for experimentation on the embryo.

 

58. The Government believes that research undertaken on embryos using the cell nuclear replacement technique for the purpose of studying mitochondrial diseases should be permissible in law, subject to licensing. (Paragraph 9.22).
To many non-scientific individuals, it is not obvious that this question and paragraph 9.21 of the consultation document relate to removal of the prohibition of cloning as defined in the original bill (and referred to in Q59). If the government allows Cell Nuclear Replacement into embryos for mitochondrial diseases, then there is no justification for continuing the ban for any other reason. The ban on Cell Nuclear Replacement into embryos should remain.

 

59. Further, the Government invites views on removing the current prohibition on "replacing a nucleus of a cell of an embryo with a nucleus taken from the cell of any person, another embryo or a subsequent development of an embryo" for research purposes, subject to licensing. (Paragraph 9.23).
That this suggestion is being made, indicates that the argument that this legislation was the start of a slippery slope was valid. It is only 15 years since Parliament overwhelmingly opposed all forms of cloning. Bad parliamentary drafting allowed the loophole of cloning using an unfertilised egg, and now, using the reality that this sort of cloning is occurring, it is proposed that the ban on cloning outlawed only a few years ago should be overturned. We recommend the reverse of the proposal above, and would like to see the loophole, which allowed cloning using unfertilised ova, closed. All cloning for research should be banned.

 

60. The Government invites views on whether the law should permit altering the genetic structure of an embryo for research purposes, subject to licensing. (Paragraph 9.28).
There must be a ban for any alteration of the genetic structure of an embryo. The long term outcome, which by definition could be passed on into all future generations, cannot be known and the potential risk of serious effects is too great to be acceptable.

 

61. The Government invites views on whether the law should permit the creation of human-animal hybrid or chimera embryos for research purposes only (subject to the limit of 14 days culture in vitro, after which the embryos would have to be destroyed). (Paragraph 9.35).
There should be a ban on human-animal hybrids. We oppose the use of human embryos on the basis of the human dignity which an embryo has. Creating human-animal hybrids is a further insult to that human dignity. What is the scientific evidence for use of hybrids. The justification for using human embryos was that the same information could not be gained from animal embryos, so why should hybrids not suffer the same problem? A hybrid will not behave in the same was as human.

 

62. The Government invites views on whether the current list of legitimate purposes for licensed research involving embryos remains appropriate. (Paragraph 9.38).
Any relaxation of the current list of legitimate purposes of research is just a continued slide down the slippery slope of allowing all research for any purpose.

 

65. The Government invites comments on the desirability of allowing the creation of embryos for the treatment of serious diseases (as distinct from research into developing treatments for serious diseases which is already allowed). (Paragraph 9.47).
It is assumed, though not explicitly stated, that this refers to the creation of embryos for the creation of stem cells, which would then be implanted into the diseased person. It would be a mistake to give permissive legislation for a technique for which there is no data on its safety of efficacy, particularly in such an area of great sensitivity.

The Regulatory Authority for Tissues and Embryos

66. The Government proposes that RATE, in common with the HFEA and HTA, will be headed by a lay chairperson, and have substantial lay representation among its membership. The membership will also need to have, or have access to, sufficient medical and scientific expertise in relation to the activities that come within its remit. (Paragraph 10.4).
In the same way that government select committees reflect the composition of parties in Parliament, so a body such as RATE should reflect the views of society. It appears that such bodies have in the past only had members appointed who were favourable to the techniques being regulated.

24 November 2005