APPENDIX 41
Supplementary memorandum from the Human
Fertilisation and Embryology Authority
POSSIBLE CHANGES
TO THE
HFE ACT 1990
The following are the main areas of the 1990
Act which need to be considered as part of a wider review. This
is based on the HFEA's initial assessment.
DEFINITIONS/REMIT
Section 1(1a) and 4, Definition of "embryo"
and "gametes"
An amended definition of "embryo"
and "gametes" might clarify that the remit of the Act
also extends to embryos that have been created by other means
than "fertilisation" (CNR, parthenogenesis), and to
artificially created gametes.
Schedule 2 (3(1)), Regulation of CNR
If amended, could include provision for the
specific regulation of CNR and research on embryos created by
parthenogenesis.
Section 2(1), Definition of "treatment services"
A tighter definition of "treatment services"
might clarify that the use of IVF for reasons unrelated to fertility
issues can be within the remit of the Authority (for example PGD/HLA).
IMPLICATIONS OF
THE EU TISSUE
DIRECTIVE
Section 4, GIFT and IUI
Extending remit to GIFT (using patients' own
gametes) and IUI would bring these treatments into line with others
and would enable Authority to regulate issues of multiple births,
counselling, consent procedures and so on. Also seems to be required
by EU Tissue Directive, which covers the donation, procurement,
testing, processing, preservation, storage and distribution of
all mature gametes.
Section 4, Commercial provision of gametes
Bringing the commercial provision of gametes,
including internet providers within the scope of the Act would
enable the Authority to regulate this currently unregulated area
(for example enforcing 6 month quarantine period).
Internet sperm providers are probably within
the reach of the EU tissue directive.
FAMILY LAW
CONTEXT
Sections 13(5) and 25(2), Welfare of the child
assessment
Need to review whether requirement of "child's
need for a father" is in line with Civil Partnerships Bill
(CPB), European Convention of Human Rights (ECHR) and the Adoption
and Children Act 2002 (ACA 2002).
Section 28
Need to review whether "treatment together
provisions" which apply only to heterosexual couples are
in line with the CPB, ECHR and ACA 2002. This might require a
new definition of "parent".
Section 28(5B)(c) and Section 1 of HFE, (Deceased
Fathers) Act 2003
Where sperm is stored prior to cancer treatments
and provisions have been made for using the sperm after the man's
death, it is not always clear how the "treatment together"
requirement can be fulfilled (in order to record an unmarried
man as the father of a posthumous child).
Section 30, Parental orders
Need to review whether allowing parental orders
in surrogacy agreements only for married couples is in line with
the CPB, ECHR and the ACA 2002.
Schedule 3, Consent to storage of gametes
Gillick-competent cancer patients can consent
to the storage of gametes for later use. There might be a case
for extending this option to non-Gillick competent children, by
allowing parents to consent on behalf of their children. There
might also be a case for reviewing the situation for temporarily
incapacitated adults (but not those in a persistent coma).
CONFIDENTIALITY
Section 33(1), (2), (3), Disclosure of information
Enabling Authority to more easily share information
(for example with GMC or MRC) would better reflect current law
and opinion on appropriate extent of confidentiality of patient
information and would also allow linking the HFEA register with
other medical databases, such as the cancer register. Current
restrictions also make it harder for the HFEA to recruit staff
or employ consultants.
Section 33(2)(b), Information given to the Authority
in confidence
Needs to be reviewed in light of the Data Protection
Act 1998 (DPA), and the Freedom of Information Act (FOI).
Section 33 (6c), Disclosure only to a named individual
Abolition would enable clinics, for example,
to make welfare of the child inquiries to the GP practice, rather
than an individual GP. It might also facilitate access by researchers
to confidential information.
THE ROLE
AND FUNCTION
OF THE
AUTHORITY
Section 8, Statutory functions of the Authority
Need to assess whether there is a case for clearer
set of objectives for the Authority against which it could assess
its own functions and be externally accountable. This might include
a commitment to protecting the interests of patients by ensuring
that licensed centres adopt suitable practices or to ensuring
that research on embryos is carried out in an appropriate ethical
and regulatory framework.
Sections 25 and 26, Code of Practice
Modernising the format of the Code of Practice
(making it a "live", flexible and constantly updateable
document) might necessitate changes to the requirement that every
amendment needs prior approval from the Secretary of State. This
would be based on a duty to consult on proposed rules or changes
to rules.
Section 41, Sanctions
A wider range of options for addressing non-compliance
with licence conditions (ie a system of fines) would give the
Authority more teeth in addressing situations which might require
a firm response, but where suspension or revocation of the licences
could not be justified.
Schedule 2 (1) and (2), Time-limited licences
only
To enable non-time limited treatment and storage
licences to be issued subject to regular inspection of clinics
(no less than every two years) might simplify the licensing regime
without compromising the effective regulation of clinics.
Schedule 2 (3), Licensing clinical trials and
training
The ability to issue clinical trials licences
might give greater control over the introduction of new techniques
and technologies into clinical practice. Training licences would
allow proper regulation of training which currently can only be
undertaken under a research licence.
Additional regulation making powers
The currently limited regulation making powers
of the Act mean that a change in policy (for example the abolition
of donor anonymity) cannot be enforced through regulation, but
only through changing every individual licence of every clinic
dealing with donor sperm.
Statutory storage periods
There might be a case for including statutory
storage periods in the Code of Practice, rather than in a number
of regulations.
June 2004
| 
