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19 Jul 2005 : Column 1671W—continued

Emergency Contraception

Mr. Amess: To ask the Secretary of State for Health if she will list the (a) organisations and (b) individuals consulted by Oxford Primary Care Trust before they expanded a pilot scheme offering free morning-after pills to teenagers to cover 24 pharmacies in the region; and if she will make a statement. [12778]

Caroline Flint: This information is not held centrally.

Mr. Amess: To ask the Secretary of State for Health (1) why it is necessary for a pharmacist with a conscientious objection to prescribing emergency contraception over the counter without prescription to refer a patient to another pharmacist who does not have such a conscientious objection; and if she will make a statement; [12788]

(2) if she will introduce legislation to allow a pharmacist with a conscientious objection to prescribing emergency contraception over the counter without prescription to rely on the rights created by section 4 of the Abortion Act 1967; and if she will make a statement. [12789]

Caroline Flint: Emergency hormonal contraception (EHC) is not a method of abortion. In 2002, there was a High Court ruling that the supply and use of EHC is lawful and that the prevention of implantation, which is brought about by emergency contraception products, does not amount to procuring a miscarriage under the 1861 Offences Against the Person Act. The conscience clause set out in section 4 of the Abortion Act is therefore not relevant to the supply of EHC.
 
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The Royal Pharmaceutical Society of Great Britain's code of ethics and standards states that

Mr. Amess: To ask the Secretary of State for Health how many prescriptions of the morning-after pill there were in the last 10 years for which figures are available; and if she will break down prescription by age. [10571]

Caroline Flint: Hormonal emergency contraception, the morning-after pill, may be prescribed by general practitioners or by family planning clinics. The numbers of prescriptions in the last 10 years may be found in the statistical bulletin, NHS Contraceptive Services, England, 2003–04", which is available in the Library and also on the Department's website at www.dh.gov.uk/assetRoot/04/09/00/22/04090022.pdf.

Table 10 in the bulletin shows GP prescriptions and table five those in family planning clinics. Hormonal emergency contraception is also available at pharmacies but statistical information about pharmacy provision is not available.

An age breakdown is not available for GP prescriptions. The age breakdown of women prescribed hormonal emergency contraception by family planning clinics is shown in table six of the bulletin.

Mr. Amess: To ask the Secretary of State for Health (1) what research has been commissioned by her Department into the safety of post coital contraception with respect to girls aged (a) 12 to 14 and (b) 14 to 16 years; and if she will make a statement; [10611]

(2) what clinical trials involving girls between the ages of 11 and 15 years have been conducted with respect to levonorgestrel; [10612]

(3) if levonorgestrel is licensed for use by girls between the ages of 11 and 15. [10613]

Caroline Flint: As with all marketed medicines, the safety of post coital contraception is continuously monitored by the Medicines and Healthcare products Regulatory Agency (MHRA).

Post coital contraception is currently available as a levonorgestrel, containing emergency hormonal contraceptive (Levonelle/Levonelle-2) and as the post-coital insertion of a copper-containing intra-uterine device (IUD).

No safety concerns were identified in two World Health Organisation (WHO) sponsored clinical trials of emergency hormonal contraception that included girls aged 16 and under. In addition, extensive worldwide use of levonorgestrel in over 9 million women, including those under 16 years, have not identified any serious safety concerns or provided evidence that the safety of levonorgestrel is any different in the under 16s. There are also no safety concerns about the use of IUDs in women age under 16. However, these are very rarely used in young women with no children.

Clinical trials for new drugs are not routinely conducted on young people under 16 unless they are specifically indicated for use in children. The judgment on the balance of risks and benefits in women under 16
 
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is the responsibility of the prescribing physician. Health care professionals are encouraged to discuss the potential side effects with everyone who seeks treatment. In addition, prescribers are expected to satisfy themselves that all women understand the risks and benefits of using post coital contraception and that it is in their best interests to receive the treatment.

In the event of any important new safety information emerging, the MHRA will take action to ensure that this is accurately reflected in the product information and communicated to health professionals and women using these products.

No clinical trials of levonorgestrel use specific to women under 16 have been conducted in the United Kingdom. The marketing authorisation that was granted in 1999 for the prescription-only product was supported by evidence from two large randomised controlled trials, one conducted by the WHO 1 , and one using published data from uncontrolled studies. Most women in the clinical trials were aged between 16 and 48, but a few girls aged 14 and 15 were included. No data were available for girls between ages 11 and 14 years. Age analysis of efficacy and safety in randomised studies did not identify any population that responded differently to treatment. Since then another WHO-sponsored study has evaluated 4,136 women aged between 14 and 52 years (mean age 27 years) who attended family planning clinics requesting emergency contraception 2 . In excess of 2,700 women were given levonorgestrel, and of these, 439 were teenage girls (with 85 aged 16 and under). No safety concerns were identified in the study.

Levonorgestrel is available as Levonelle-2G,, a prescription-only medicine licensed for emergency contraception that is available only under medical supervision. The licence does not specify a lower age limit for women but health care professionals are expected to satisfy themselves, in accordance with guidelines, that treatment is in the patient's best interests and that she understands the advice she is receiving.

Levonorgestrel is also available as LevonelleG, which is for sale in pharmacies and is not recommended for use by young women under 16 years of age without medical supervision. Comprehensive guidance and training on best practice for the supply of Levonelle in pharmacies has been issued to all pharmacists. This includes what questions should be asked of women, which women should be referred to a doctor for advice and ensuring that they are satisfied that the client is aged 16 or over.

Food Labelling

Mr. Laurence Robertson: To ask the Secretary of State for Health what discussions she has had with supermarkets about the effective labelling of food to help consumers understand where the items are produced; and if she will make a statement. [13190]

Caroline Flint: I have had no discussion with supermarkets on the labelling of the geographical origin of foods. However, the Food Standards Agency (FSA) has issued good practice guidance on country of origin
 
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labelling, following a consultation with all stakeholders, including the food retail sector. The FSA is currently undertaking a survey to assess the extent to which this guidance is being followed. The outcome of this survey will inform a review of this guidance, and this review will involve further discussions with the food retail sector.

Norman Baker: To ask the Secretary of State for Health what controls are in place on the (a) labelling and (b) sale of imported food derived from cloned animals. [12646]

Caroline Flint [holding answer 18 July 2005]: There are no European Union controls which apply specifically to the labelling or import of food derived from cloned animals. The authorisation of cloned animals for food production would fall within the scope of the EU novel foods regulation which would also provide controls for the labelling of such food products.

No such application has been received within the EU to date.


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