Select Committee on Science and Technology Written Evidence

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


  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


  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


  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.


  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


  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


Conceptions—all ages
YearTotal (1,000s) Percentage ending In abortion

Annex F


  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,

    —  comfort,

    —  privacy,

    —  confidentiality,

    —  pain management,

    —  counselling facilities,

    —  post-abortion contraception advice, and

    —  after care/follow-up.

  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,

    —  likely waiting times,

    —  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

      —  emergency equipment

    —    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.

    —    On-call arrangements.

    —    Emergency protocols.

    —    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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