APPENDIX 18
Memorandum from the Scottish Council on
Human Bioethics
EXECUTIVE SUMMARY
The Scottish Council on Human Bioethics considers
that the HFEA should become more accountable to Parliament. An
appropriate parliamentary committee, such as the Science and Technology
Committee of the House of Commons, should be able to closely monitor
any regulatory decisions of the HFEA and intervene if it feels
that a particular issue requires wider discussion and consideration.
The SCHB is also concerned that the 18 members
of the HFEA are often selectively appointed to only represent
certain views and that they have too much power to act, without
consultation with Parliament, in the important area of human reproductive
technologies.
The Science and Technology Committee announced
the following terms of reference for its inquiry into Human Reproductive
Technologies and the Law. These were drawn up after analysing
a report of the online consultation produced by the Hansard Society:
1. To consider (a) the balance between legislation,
regulation and reproductive freedom; (b) the role of Parliament
in the area of human reproductive technologies; and (c) the foundation,
adequacy and appropriateness of the ethical framework for legislation
on reproductive technologies.
(a) the balance between legislation, regulation
and reproductive freedom
1.1 The SCHB agrees that reproductive decisions
should not be left exclusively to the persons concerned since
this would leave reproductive technologies open to exploitation.
For example, some persons in certain circumstances may act for
their own immediate interests rather than examine the wider ethical
issues such as those pertaining to the child being considered
and society as a whole. No person or couple exists in isolation.
In other words, there is clearly a need for regulation and/or
legislation.
1.2 Concerning the balance between legislation
prepared by Parliament and regulations which may be established
by regulatory authorities or ministers, the SCHB concurs that
the former should be preferred, where possible. This is because
the drafting of legislation enables all sections of society to
take part in the discussions through the parliamentary process.
1.3 Where regulations and/or legislation
are being considered they should, in so far as possible, anticipate
future biologically possibilities, even though it may be difficult
to determine these developments.
1.4 In order to address the problem of possible
new developments, legal provisions should state only what is specifically
acceptable, thereby prohibiting all other procedures. This will
then avoid an enumeration of prohibitions which may, with time,
become obsolete, unclear and vague.
For example, new UK legislation with respect
to reproductive cloning eventually enacted a provision indicating
what was acceptable by stating that "A person who places
in a woman a human embryo which has been created otherwise than
by fertilisation is guilty of an offence" (Section 1 of the
Human Reproductive Cloning Act 2001).This was done in order to
address misunderstandings resulting from only having prohibitions
in existing legislation which did not specifically apply to human
cloning.
1.5 The SCHB is also of the opinion that
a committee, such as the past Warnock committee, would be best
suited in assessing the relevant ethical framework and the drafting
of preliminary recommendations. But its composition must reflect
the diversity of views within society.
(b) the role of Parliament in the area of human
reproductive technologies
1.6 The SCHB considers that the UK Parliament
should ensure that it drafts all-encompassing legislation when
preparing laws in the area of human reproduction. This would minimise
the issues that would have to be regulated ad hoc by other
bodies which may be less representative of society.
1.7 In addition, the SCHB is of the view
that it would be impractical for the UK Parliament itself to act
as a regulatory body. Thus there is a need for a body such as
the HFEA to be appointed which has the appropriate expertise to
consider the issues that arise.
However, this body clearly needs to be accountable
to Parliament and an appropriate parliamentary committee should
be able to closely monitor any regulatory decisions.
The SCHB is also concerned that the present
HFEA may have too much power to act, without consultation with
Parliament, in the important area of human reproductive technologies.
1.8 The SCHB notes that the question relating
to whether or not the area of human reproductive technologies
becomes a devolved matter for the Scottish Parliament and the
Northern Ireland Legislative Assembly should be considered.
(c) the foundation, adequacy and appropriateness
of the ethical framework for legislation on reproductive technologies
1.9 The SCHB is concerned that the current
ethical framework underlying UK legislation is often little more
than situation and utilitarian ethics. Instead, an acknowledgement
of human identity and personhood with, as a consequence, the protection
of human dignity should be the underlying basis on which to draft
new legislation.
1.10 In this respect, the SCHB recognises
a need to determine whether or not animal-human hybrid embryos
could be acknowledged as having a human identity and personhood
and whether or not they should be addressed under "human"
legislation. The Council notes that public debate is urgently
required in this regard.
1.11 Moreover, the SCHB emphasises that
legislation on reproductive technologies should be evidence-based.
For example, it is currently often assumed that the early embryo
does not have the same status as an adult human person without
any scientific evidence being presented. The Council notes that
it would be inappropriate not to address the debate relating to
the moral status of the embryo in any new enquiry. This is because
the debate is crucial to the manner in which many consider the
different biomedical procedures. In other words, it is not sufficient
to dogmatically maintain that a conclusive and final decision
has already been taken concerning this issue. It is because human
personhood and dignity are not decided through majority votes
that a considerable debate remains concerning the status of the
early embryo!
2. To consider the provisions of the Human
Fertilisation and Embryology Act 1990 in the context of other
national and international legislation and regulation of medical
practice and research. To include related legislation such as
the EU human tissue directive, and law covering human rights,
surrogacy, adoption and abortion. To include relevant declarations
and statements by international bodies. To compare the safety
and welfare provisions of the Human Fertilisation and Embryology
Act 1990 with those that cover other areas of medical practice.
2.1 The SCHB notes that UK legislation concerning
embryo research is generally a lot more liberal than elsewhere
in the world and that it would be highly desirable for UK legislation
to encompass relevant international declarations and conventions.
In this regard, the SCHB is of the opinion that
possible new legislation in the UK relating to Human Fertilisation
and Embryology should be amended so that it becomes compliant
with the following provisions of international declarations, legislation
and regulation:
UNITED NATIONS
EDUCATIONAL, SCIENTIFIC
AND CULTURAL
ORGANIZATION:
— The draft Universal Declaration on
Bioethics (currently being prepared by UNESCO).
— The Universal Declaration on the
Human Genome and Human Rights.[101]
— The International Declaration on
Human Genetic Data.[102]
Council of Europe
— Convention on Human Rights and Biomedicine
(European Treaty Series—No 164):[103]
Article 18 (2) (Research on embryos in vitro) which states that:
"The creation of human embryos for research
purposes is prohibited."
— Additional Protocol on the Prohibition
of Cloning Human Beings (European Treaty Series— No 168):[104]
Article 1 which states that:
(1) "Any intervention seeking to create
a human being genetically identical to another human being, whether
living or dead, is prohibited."
(2) "For the purpose of this article,
the term human being "genetically identical" to another
human being means a human being sharing with another the same
nuclear gene set."
European Union
— Directive 2004/23/EC of the European
Parliament and of the Council of 31 March 2004 on setting standards
of quality and safety for the donation, procurement, testing,
processing, preservation, storage and distribution of human tissues
and cells
2.2 Finally, the SCHB concurs that the precautionary
principal should be applied concerning the status of the human
embryo. In other words, until explicit scientific proof of the
contrary can be provided, a human embryo, as soon as it is created,
should be considered as having the same moral status as an adult
human person.
2.3 For the same precautionary reasons,
the SCHB supports the definition of an embryo given in German
legislation which indicates that any totipotent cell, extracted
from an embryo which may divide and develop into an individual
human being once the necessary further conditions are provided,[105]
is also an embryo.
2.4 The Council notes in this regard that
the process of human development is a continuous one in which
any demarcation would be arbitrary and merely conventional as
exemplified by the different upper time limits for abortions and
embryological destructive research across Europe. Within the development
process it is indeed impossible to indicate a non-arbitrary point
of transition from human non-person to human person.
3. To consider the challenges to the Human
Fertilisation and Embryology Act 1990 from (a) the development
of new technologies for research and treatment, and their ethical
and societal implications and (b) recent changes in ethical and
societal attitudes.
To include new areas of research, treatments
and interventions, such as cloning, cell nuclear transfer, transplants
of ovarian and testicular tissue, embryo splitting, selection
of genetic characteristics (including sex selection), stem cell
therapy and the use of immature gametes.
3.1 The SCHB considers that the Human Fertilisation
and Embryology Act 1990 is no longer capable of addressing new
developments in embryology. This is reflected by the possibility
for research to be permitted by omission and the ever-increasing
number of court cases being initiated to provide additional clarifications
to the Act.
3.2 New developments, which presently exist
in a legal vacuum, should be regulated in any new legislation:
See Annex A (HFEA and new human sperm, eggs and embryos) and B
(HFEA and new human-animal hybrid entities).
3.3 Moreover, in a similar manner to Article
4 of the UN Optional Protocol to the Convention on the Rights
of the Child on the sale of children, child prostitution and child
pornography, the SCHB agrees that UK legislators should consider
the possibility of drafting bioethical extra-territorial provisions
making it an offence for UK nationals and habitual residents going
abroad to undertake procedures which are prohibited in the UK.
4. To consider the composition, expertise
and approach of the Human Fertilisation and Embryology Authority,
its code of practice, licensing arrangements and the provision
of information to patients, the profession and the public
4.1 The SCHB is of the opinion that the
current HFEA does not adequately regulate new developments and
seems to excessively support scientific research, without adequate
weight being given to other views and considerations.
In this respect, the SCHB notes that the absence
of any minority reports often indicates a unanimous decision.
This suggests that the composition of the HFEA does not adequately
reflect the wide spectrum of views within society. Indeed, many
believe that the 18 members of the HFEA are selectively appointed
to only represent certain views.
4.2 Therefore, the SCHB proposes that the
HFEA, or future equivalent body, should include individuals representing
very different viewpoints, thereby better reflecting society.
If this is not done, a false and misleading impression of unanimity
will be presented with the HFEA only making decisions "for"
society without being representative of society.
4.3 New solutions should be considered to
enable the general public to become better informed and more engaged
in decision-making relating to what should be acceptable. In other
words, a body, such as the HFEA, should undertake sufficient and
appropriate consultations of the general public.
Moreover, the Houses of Lords and Commons, as
the bodies representing the UK members of society, should be more
involved in the decisions of the HFEA.
4.4 Concerning the dual role of the HFEA
relating to its licensing and regulatory powers, the SCHB is of
the opinion that the licensing of interventions and procedures
should remain the responsibility of the HFEA but that the regulation
of any new biological or reproductive possibilities should take
place in collaboration between the experts of the HFEA and the
democratic representatives of Parliament.
May 2004
101 http://portal.unesco.org/en/ev.php@URL_ID=13177&URL_DO=DO_TOPIC&URL_SECTION=201.html. Back
102
http://portal.unesco.org/shs/en/file_download.php/6016a4bea4c293a23e913de638045ea9Declaration_en.pdf Back
103
Signed by 31 of the 45 Council of Europe Members States, http://conventions.coe.int/Treaty/en/Treaties/Word/164.doc Back
104
Signed by 29 of the 45 Council of Europe Members States, http://conventions.coe.int/Treaty/en/Treaties/Word/168.doc Back
105
Section 8 of the German Embryo Protection Act of 13 December
1990. Back
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