Following the Government’s proposed legislative reforms in the regulation of assisted reproduction and embryology in December 2006 (as set out in the White Paper, Review of the Human Fertilisation and Embryology Act), the Human Tissues and Embryos (Draft) Bill (the “Draft Bill”) was published on 17 May 2007.
It is proposed that the Draft Bill will update certain parts of the Human Fertilisation and Embryology Act 1990 (the “1990 Act”) and, by doing so, fill various gaps in what is seen as a rather outdated regulatory regime, particularly in light of recent technological advances and shifts in the public’s perception of the ethical issues at stake. The Government’s stated aims for the Draft Bill are:
- to ensure that legitimate medical and scientific applications of human reproductive technologies can flourish;
- to promote public confidence in the development and use of human reproductive technologies through efficient regulatory controls applicable to them; and
- to secure that regulatory controls accord with better regulation principles and encourage best regulatory practice.
The Draft Bill proposes that the current regulators, the Human Fertilisation and Embryology Authority (“HFEA”) and the Human Tissue Authority (“HTA”) shall be replaced by a single regulatory body, the Regulatory Authority for Tissue and Embryos (“RATE”). RATE will be the single Competent Authority for the EU Tissue and Cells Directive (EU 2004/23/EC) and will take sole responsibility for the “regulation and inspection of all functions relating to the whole range of human tissues – blood, organs, tissues, cells gametes and embryos”. It is proposed that RATE will also take responsibility from the Medicines and Healthcare Products Regulatory Agency (MHRA) for the regulation of the donation, procurement and supply of blood and blood products.
The Draft Bill proposes amending the 1990 Act to ensure that regulation will apply to all live human embryos (however created) and all live human gametes.
Whilst the White Paper had proposed banning the creation of human-animal hybrids and chimeras subject to a power allowing for possible exceptions, the HFEA delayed making a decision in relation to cytoplasmic hybrids (‘cybrids’, created by replacing the nucleus of an animal egg with a human nucleus). Following an inquiry by the House of Commons Science and Technology Committee into the White Paper’s proposals on hybrid and chimeras (as reported in the Life Sciences Update, June 2007), the Draft Bill now provides that the creation under licence of cybrids, human transgenic embryos (human embryos altered by the introduction of animal DNA) and human-animal chimeras (human embryos altered by the introduction of one or more animal cells) will be permitted for research purposes, subject to a 14 day development time limit and with the absolute prohibition on implantation into a womb. So-called "true" human-animal hybrids, created by fusing human and animal gametes, will remain prohibited.
The Draft Bill proposes strictly defined criteria for the authorisation embryo testing, such as testing to establish whether an embryo contains an abnormal number of chromosomes likely to result in miscarriage. The current ban on sex selection except where there are medical reasons to do so is maintained by the Draft Bill.
The Draft Bill proposes that the statutory storage period for embryos be extended from 5 years to 10 years and, where one of the couple involved withdraws their consent, there should be a cooling off period of up to 1 year before destruction of the embryo.
The 1990 Act currently provides that the need of a child for a father must be taken into account as condition for the provision of fertility treatment. The Draft Bill proposes that this be removed but that the consideration of the welfare of the child is retained.
The full text of the Draft Bill, together with explanatory notes is available at: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsLegislation/DH_074718
The Draft Bill has now been subjected to pre-legislative review by a Parliamentary Joint Committee during which further evidence from numerous stakeholders was taken and consideration was given to possible recommendations regarding the provisions of the Draft Bill. On 1 August 2007, the Committee published its report on the Draft Bill which included a number of severe criticisms.
In particular, the Committee came to the conclusion that the establishment of RATE was not desirable. The committee reasoned that the HFEA and HTA currently each dealt with clearly distinct area and the oversight provided by the HFEA and HTA respectively would be better than that which could be provided by RATE alone. Accordingly, the Committee strongly urged the Government to abandon this part of the Draft Bill.
With regard to the Draft Bill’s proposals for the creation and use of inter-species embryos for research, the Committee felt that this should be put to a free vote in the Houses of Parliament, and, if such research was supported in the vote, then it should be for the regulatory body to have the authority to decide which type of research is permitted on a case by case basis. The Committee also concluded that the Draft Bill’s proposals to remove the ‘need for a father’ consideration from fertility treatment conditions should be put to a free vote but recommended that it be retained in an amended form capable of being interpreted as the 'need for a second parent'.
The Committee has also recommended relaxing the restrictions on the use of embryo selection technology so as permit its use to produce so-called ‘saviour siblings’ where there is a ‘serious’ risk to the life of a sibling which could be treated by umbilical cord blood stem cells, rather than only in cases where a condition is ‘life-threatening’.
Finally, the Committee have recommended that children born from donated sperm or eggs have this information recorded on their birth certificate so as to afford them the right to know of their biological origins and have proper access to donor registers that would allow them to identity their genetic parents.
A full copy of the Committee’s report can be found at http://www.publications.parliament.uk/pa/jt/jtembryos.htm