Memorandum 55
Supplementary evidence from the Department
of Health
Further information following the oral evidence
session on 24 October 2007.
Annex A—A note on the definition of "registered
medical practitioner" in the context of the Abortion Act
1967 and what would be required to expand the definition to include
nurses.
Annex B—A note on the numbers taking part
in the pilot schemes involving the provision of early medical
abortion services in non-traditional settings.
Annex C—A note on the legal advice given
to the Department on allowing women to take the second medication
in a medical abortion at home.
Annex D—A note on research commissioned
by the Department into foetal pain.
Annex E—Annual statistics on abortions
as a percentage of all conceptions since 1990.
Annex F—A note on the objectives of the
pilot studies referred to above.
October 2007
Annex A
REGISTERED MEDICAL
PRACTITIONER
I agreed to let the Committee have a note on
the need for a registered medical practitioner to complete the
certification required in relation to each termination of pregnancy.
In order for a pregnancy to be lawfully terminated
it must be carried out in accordance with the Abortion Act 1967.
This requires that the pregnancy is terminated by a registered
medical practitioner and that two registered medical practitioners
are of the opinion, formed in good faith, that one or more of
the grounds set out in section 1(1)(a) to (d) of the Act applies
in relation to the particular pregnancy, (unless it is considered
to be immediately necessary to save a woman's life or to prevent
grave permanent injury to her health, in which case the only opinion
which is needed is that of the registered medical practitioner
who is performing the termination (section 1(4))).
The term "registered medical practitioner"
is not defined in the Abortion Act. It is however defined in Schedule
1 to the Interpretation Act 1978 to mean:
"A fully registered person within the meaning
of the Medical Act 1983".
Section 2 of the Abortion Act enables the Minister
of Health in respect of England and Wales and the Secretary of
State in respect of Scotland, to make regulations requiring any
opinion that is required by the Act "to be certified by the
practitioners or practitioner concerned in such form and at such
time as may be prescribed by the regulations".
The Abortion Regulations 1991 (S.I 1991/499)
were made under section 2. Regulation 3 of the Regulations requires
that any opinion required by the Act is certified either in the
forms set out in Schedule 1 to the Regulations, or in a certificate
giving the details set out in the relevant sub-paragraph of regulation
3.
Both types of certificate—one in relation
to terminations to be performed under section 1(1)(a) to (d),
the other in relation to terminations under section 1(4), require
the signature of the registered medical practitioner or practitioners
concerned.
The Department considers that the Regulations
could not be amended to enable a nurse to provide certification
in relation to the practitioner's opinion, because this could
not be regarded as having been "certified by the practitioner
or practitioners concerned".
Section 48 of the Medical Act 1983 states that
any certificate required by any enactment, from a medical practitioner
(or from certain specified types of medical practitioner eg surgeon)
shall not be valid unless the person signing it is fully registered.
In order to expand the definition of "registered
medical practitioner" in the Abortion Act, so that it covers
nurses, it would be necessary to amend that Act, the Medical Act
or the Interpretation Act 1978.
Annex B
NUMBERS TAKING
PART IN
THE PILOT
SCHEMES INVOLVING
THE PROVISION
OF EARLY
MEDICAL ABORTION
SERVICES IN
NON-TRADITIONAL
SETTINGS
The annual rate at St Mary's Hospital over the
past three years has been around 550 per year.
The annual rate at Gerrards Cross Hospital over
the past three years has been around 200 per year.
This amounts to a total of around 750 early
medical terminations per year over three years which totals around
2,250 over the three year period.
The full evaluation report of the pilots is
expected on the 31 January 2008.
The Department of Health will publish the findings
from the evaluation when they are available.
Annex C
TREATMENT FOR
THE TERMINATION
OF PREGNANCY
AND CLASS
OF PLACE
I agreed to let the Committee have a note on
the power of the Secretary of State to approve "a home"
as a class of place where the second stage of a medical termination
of pregnancy may be carried out.
Section 1(3) and (3A) of the Abortion Act 1967
"the Act" provides as follows:
"(3) Except as provided by subsection
(4) of this section, any treatment for the termination of pregnancy
must be carried out in a hospital vested in the Secretary of State
for the purposes of his functions under the National Health Service
Act 2006 or the National Health Service (Scotland) Act 1978 or
in a hospital vested in a Primary Care Trust or a National Health
Service trust or an NHS foundation trust or in a place approved
for the purposes of this section by the Secretary of State.
(3A) The power under subsection (3) of this
section to approve a place includes power, in relation to treatment
consisting primarily in the use of such medicines as may be specified
in the approval and carried out in such manner as may be so specified,
to approve a class of places."
The current method of medical abortion consists
of two stages: first, a mifepristone (also known as RU486) tablet
taken orally (which blocks a hormone needed to make a fertilised
egg cling to the womb lining) followed 48 hours later by a prostaglandin
pessary taken vaginally (which triggers contractions and bleeding,
and causes the fetus to be expelled).
The Committee has asked for the Department's
view as to the legality of the Secretary of State approving "the
home" as an approved place for the taking of prostaglandin.
Three legal questions arise:
1. If a pregnancy is terminated by the
self-administration of a pessary in the home, is it "terminated
by a registered medical practitioner" within section 1(1)
of the Act?
2. Is self-administration a form of
treatment covered by the Act?
3. Can a patient's home be approved
under section 1(3) of the Act?
Turning to each question in turn:
1. Termination by a registered medical practitioner
The House of Lords in Department of Health
and Social Security v Royal College of Nursing ("the
RCN case") considered the role of nurses in the provision
of treatment for a medical abortion. The Department considers
that there is no difference in principle between a nurse administering
a drug or instructing a patient on how to administer a drug. The
requirement of supervision set out in the case, can equally be
exercised where the patient self-administers at home, as where
it is administered by a nurse.
2. Is self-administration "treatment"
covered by the Act?
The Act does not include a definition of the
word "treatment". In the absence of relevant judicial
or other guidance on the matter, the expression "any treatment
for the termination of pregnancy" must be given its ordinary
and natural meaning. The Department of Health considers that the
expression covers any treatment given with a view to terminating
the pregnancy but does not necessarily cover those bodily processes
of the patient which follow in consequence of those acts—such
as the expulsion of the fetus. The Department considers that both
active parts of an early medical abortion must be carried out
in accordance with section 1(3).
The Department considers that it makes no difference
whether the drug is administered by a nurse or doctor or where
the patient self-administers.
3. Can a patient's home be approved under
section 1(3)
In the Department's view "a home"
can be approved as a class of place under section 1(3A). Section
1(3A) is broadly worded.
CALCULATION OF
24 WEEK PERIOD
I would also like to take this opportunity to
clarify the meaning of "the pregnancy has not exceeded its
twenty-fourth week". In yesterday's evidence session two
different figures were cited. A pregnancy has exceeded it 24th
week on the day that the 25th week commences—that is when
it is over 168 days. [The accepted view is that the period commences
with the first day of the woman's last period.]
Annex D
RESEARCH COMMISSIONED
BY THE
DEPARTMENT INTO
FETAL PAIN
Following the publication of the MRC report
in 2001 it was recognised that the recommendations from the report
were very clearly within the MRC's research remit and that they
would take this work forward.
The Department of Health provides funding to
NHS organisations to meet the service support costs associated
with MRC funded research.
Since the 2001 study the MRC has not received
many applications in this area; one reason for this may be that
such research, particularly involving humans, is very difficult
to undertake.
The MRC has funded, and continues to fund, studies
on embryonic and fetal development which may help inform discussions
on abortion time limits.
Examples of MRC-funded Research in this area
include:
— Mammalian neurogenesis—Dr
V Episkopou at the MRC Clinical Sciences Centre in London. Ongoing;
£1.9 million expenditure to date (to 2005-06). This research
aims to increase understanding of the molecular events that underlie
early embryonic patterning and central nervous system development.
— Molecular embryology—Dr
D P Norris at the MRC Mammalian Genetics Unit in Harwell. Ongoing;
£300,000 expenditure to date (to 2005-06). This work is focussed
on understanding how left-right (L-R) symmetry is broken in the
early embryo.
— Generation of neuronal diversity
in the developing telencephalon—Dr N Kessaris at University
College London. Ongoing; awarded £325,000. This research
aims to increase understanding of how the brain forms during normal
embryonic development.
— Two grants to the University
College London Paediatric Pain Research Centre, although this
is work primarily on infant pain, not fetal pain.
— Infant Pain Mechanisms—short
and long term effects, Professor M Fitzgerald £1.1 million
— Cortical pain responses in human
infants—towards a rational analgesic strategy, Professor
M Fitzgerald, £0.8 million.
Annex E
ANNUAL STATISTICS
ON ABORTIONS
AS A
PERCENTAGE OF
ALL CONCEPTIONS
(ENGLAND AND
WALES) SINCE
1990
Conceptions—all ages
| Year | Total (1,000s)
| Percentage ending In abortion |
| 1990 | 871.5 | 19.9
|
| 1991 | 853.6 | 19.3
|
| 1992 | 828.0 | 19.3
|
| 1993 | 819.0 | 19.2
|
| 1994 | 801.6 | 19.5
|
| 1995 | 790.3 | 19.7
|
| 1996 | 816.9 | 20.8
|
| 1997 | 800.4 | 21.3
|
| 1998 | 797.0 | 22.3
|
| 1999 | 774.0 | 22.6
|
| 2000 | 767.0 | 22.7
|
| 2001 | 763.7 | 23.2
|
| 2002 | 787.0 | 22.5
|
| 2003 | 806.8 | 22.5
|
| 2004 | 826.8 | 22.4
|
| 2005 | 837.4 | 22.3
|
Annex F
OBJECTIVES OF
THE EVALUATION
The main purpose of the pilot sites is to evaluate the two
sites in order to formulate a protocol for the provision of a
safe, early medical abortion service in a non-traditional setting.
This protocol will be used to define a "class of place".
1. The evaluation will address the following key outcome
objectives:
— Safety—whether early medical abortions
at the pilot sites are as safe as those undertaken in NHS hospitals.
— Effectiveness—whether early medical
abortions at the pilot sites are as effective as those undertaken
in NHS hospitals in terms of achieving complete abortions without
further surgical or medical intervention.
— Acceptability—One of the key elements
of the evaluation is to establish the level of acceptability among
women visiting the pilot sites for an early medical abortion,
and how it compares with acceptability levels for NHS hospital
settings. In particular to assess the degree of satisfaction with:
— overall service provided,
— physical environment of the non-traditional setting,
— staff conduct/attitude,
— counselling facilities,
— post-abortion contraception advice, and
2. The evaluation will also encompass a facility-based
assessment in order to provide DH with sufficient information
to formulate a protocol to define a "class of place".
We envisage key elements of the facility-based assessment to include:
— Accessibility to services:
— types of services offered—reproductive health
and contraceptive services,
— whether services are available at appropriate
times ie during the times of day and days of week when women can
and want to use them,
— consideration of the population profile (women
of childbearing age, adolescent pregnancy rates) in service availability,
and
— whether location of service is suitable/accessible.
— Physical environment/space (of pilot sites):
— whether the organisation of space is conducive
to providing a high quality service,
— do the waiting, examination, treatment, recovery
and counselling areas provide enough privacy?
— are there sufficient toilets and wash areas?
— availability of other basic infrastructure such
as clean water, reliable power supply, ventilation and storage
space, and
— whether any recreational facilities exist eg Television?
— Supplies and equipment:
— whether the necessary supplies, medications
and equipment is in place to ensure the safety and efficacy of
the abortion service,
— pregnancy tests, exam tables, ob/gyn instruments,
ultrasound scanner, etc,
— mifepristone, prostaglandin, analgesics,
antibiotics etc, and
— Staffing infrastructure, competencies and
training:
— staffing infrastructure—number and type
of staff involved at pilot site, and level to which staff trained
in reproductive health,
— what types of staff are involved in providing
the various aspects of abortion care (within both a clinical and
legal context),
— staff awareness of which healthcare personnel
can provide abortion care,
— determine staff's level of skill in abortion-related
care eg:
— knowledge of methods and clinical skills for evaluating
a pregnant woman an performing an early medical abortion;
— knowledge and practices for providing appropriate
contraceptive counselling for clients after abortion; and
— knowledge and practices of follow-up care including
management of complications.
— assess site's training capacity including current
in-house training activities, and
— determine site administrators' attitude and motivation
to provide training and for whom.
— Staff perceptions and support for improving
services:
— awareness of health issues surrounding abortion,
— awareness of social issues associated with abortion
eg cultural barriers to contraception use and domestic violence,
— understanding of legal and ethical mandate to
provide abortions,
— staff attitudes towards abortion and informed
consent,
— staff perceptions of women who seek abortions,
and
— acceptability of early medical abortions.
— Local stakeholder perceptions and support:
— What was the level of support /opposition to an
abortion service (in a non-traditional setting) among local health
officials, how was this gauged?
In addition to the above elements, the pilot sites will be
assessed in terms of their current protocols/activities for the
following:
— Initial patient assessment -including scanning
process.
— Counselling—degree of privacy, use
of visual aids, provision of information/brochures, procedures
for informed consent, how staff discuss options for dealing with
an unwanted pregnancy.
— Management during abortive phase— heavy
bleeding, nausea.
— Pain management—type of analgesia offered,
dosage and the support needed to help manage the pain—more
support equals less need for strong painkillers.
— Post-procedural treatment.
— Infection prevention practices.
— Arrangements for sensitive disposal of fetal
remains.
— Contraception advice—types of contraceptive
available /offered to patients after abortion, systems for referral
to other contraceptive providers.
— Discharge and facilities for follow-up care—confirmation
that abortion is completed.
— Laboratory support for blood tests—mechanism
for obtaining supplies of anti D at relatively short notice, especially
if lab situated on different site.
— Referral systems for management of clinical
complications—mechanisms for monitoring patients who are
referred.
— Facilities for accepting referred patients.
— Record keeping—whether log books exist
for recording abortion data and if so what type of information
is collected.
— Confidentiality and young person specific
protocol—(under 16's).
— Involvement of significant others—partners,
parents, carers, guardians.
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