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18 Dec 2007 : Column 1391W—continued

MRSA: Disease Control

Mr. Lancaster: To ask the Secretary of State for Health what guidance his Department provides on personal hygiene measures to be taken by patients prior to attending a pre-operation assessment to help minimise the spread of MRSA. [173882]

Ann Keen: The Department has not produced guidance about measures to be taken by patients before a pre-operation assessment and arrangements will be determined locally by trusts. However, in the course of 2008-09, methicillin resistant Staphylococcus aureus
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(MRSA) screening for all elective admissions will be introduced as part of the pre-operation assessment and this will help reduce MRSA infection rates.

National Blood Service

Mr. Robathan: To ask the Secretary of State for Health what assessment he has made of the adequacy of levels of donations of blood to the National Blood Service; and if he will make a statement. [174145]

Dawn Primarolo: The National Blood Service (NBS) aims to have between 40,000 to 50,000 units of red blood cells in stock. This target allows for a sizable stock for contingency purposes above and beyond normal demand for red blood cells.

As of 14 December 2007, the NBS had 31,853 units of red blood cells in stock. While this is below target levels, the NBS continues to meet demand for blood from hospitals.

The NBS recognises the need to increase blood collection and has put in place a number of initiatives, such as increased marketing activity to current and potential blood donors and the introduction of an appointments system for donors.

However fewer people are giving blood regularly, a trend that the NBS is working to reverse.

NHS Foundation Trusts: Public Appointments

Mr. McCartney: To ask the Secretary of State for Health which individuals have been appointed to the boards of NHS foundation trusts in the North West of England since 2001 to date, broken down by (a) employment background, (b) ethnicity, (c) sex and (d) political affiliation. [174924]

Ann Keen: Monitor, the statutory name of which is the independent regulator of NHS foundation trusts, authorised the first national health service foundation trusts (NHSFTs) on 1 April 2004.

The public register on Monitor's website contains a list of board members for each NHSFT. This is available at:

More detailed information is not collected by Monitor but may be obtained by contacting the chair of each NHSFT in the north-west region. The following NHSFTs are located in the north-west region (as at 1 December 2007):

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NHS: Drugs

Dr. Iddon: To ask the Secretary of State for Health (1) how many biosimilar medicines are licensed for use in the United Kingdom; [173695]

(2) if the Government will take steps to preclude the automatic substitution of brands with similar biological medicines to ensure patients are not put at unnecessary risk from potential adverse drug reactions; [173696]

(3) if he will hold discussions with (a) the Medicines and Healthcare Products Regulatory Agency and (b) the European Medicines Agency to ensure that manufacturers of biosimilar medicines submit full clinical trial data on each indication for their products rather than extrapolated data from the reference product; [173697]

(4) if he will ensure that biosimilar medicine packaging and accompanying patient information leaflets (a) contain details of the formulation and manufacturing process for the biosimilar agent and (b) make reference to the potential risk of not being able to determine which drug resulted in an adverse drug reaction as a result of interchanging similar biological medicines. [173698]

Dawn Primarolo: The relevant European Union (EU) legislation requires that packaging and leaflets include information on the qualitative composition for active substances and excipients and the quantitative composition for active substances, the pharmaceutical form and content of the active drug substance in weight, volume or units of dosage, the name and address of the manufacturer, the name and address of the marketing authorisation holder and, where applicable, the name of his appointed representatives in the member states.

They must also include a description of the relevant adverse reactions which may occur under normal use of the medicinal product and, if necessary, the action to be taken in such a case. The patient should be expressly asked to communicate any adverse reaction which is not mentioned in the package leaflet to his doctor or pharmacist.

Details of the manufacturing processes are commercially confidential and are subject to intellectual property rights and cannot be made publicly available.

The demonstration of the similar nature of two biological medicinal products may not always be required for each indication applied for. European legislation does not exclude extrapolation of evidence based on the biosimilar product. Existing guidance provided by European Medicines Agency (EMEA) allows such extrapolation, when demonstrated in an appropriate clinical situation, as long as it is justified on a scientific basis. Therefore the type and amount of additional data to be provided shall be determined on a case-by-case basis in accordance with relevant scientific guidelines.

The Medicines and Healthcare products Regulatory Agency has not issued a specific guideline to clinicians on substitution. All medicines, including biological medicines, should be prescribed by clinicians in accordance with the approved advice provided in the Summary of Product Characteristics which provides full information about the product, including its side effects and its use.

The Royal Pharmaceutical Society of Great Britain's Professional standards and guidance for the sale and
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supply of medicines provides advice to pharmacists on switching from innovator biological medicines to biosimilar medicines and states that except in an emergency, a specifically named product should not be substituted by any other product without the approval of the patient or carer and the prescriber, and in the case of hospital drugs, the approval of the therapeutics committee, or in line with other similar locally agreed protocols.

To date there are five biosimilar medicinal products approved for use in the EU. This includes two preparations of the recombinant growth hormone, somatropin, namely Omnitrope and Valtropin and three preparations of epoetin alfa; Abseamed, Binocrit, and Epoetin alfa Hexal.

There are several more biosimilar medicinal products currently under assessment.


Dr. Desmond Turner: To ask the Secretary of State for Health what representations he has received on the quality of evidence submitted by the Liverpool Reviews and Implementation Group to the National Institute for Health and Clinical Excellence's review of the economic models for determining cost-effectiveness in technology appraisals. [173120]

Dawn Primarolo: We have received no such representations.

NHS: Speech Therapy

Mr. Kemp: To ask the Secretary of State for Health how many speech therapist hours per week are available within the NHS in the North East region. [173565]

Ann Keen: The information is not available in the format requested. The following table shows the number of qualified speech and language therapy staff in the North East Strategic Health Authority area as at 30 September 2006.

Full-time equivalent



Of which:

North East Strategic Health Authority area


Notes: 1. Full time equivalent figures are rounded to the nearest whole number. 2. One full-time equivalent is based on 37.5 hours per week. Source: The Information Centre for health and social care Non-Medical Workforce Census.

Northern Lincolnshire and Goole Hospitals NHS Trust

Shona McIsaac: To ask the Secretary of State for Health how many finished consultant episodes there were in each specialty at Northern Lincolnshire and Goole NHS Foundation Trust in 2005-06; and if he will make a statement. [172521]

Ann Keen: The information requested has been set out in the following table.

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Count of finished consultant episodes by main speciality for the Northern Lincolnshire and Goole NHS Foundation Trust in 2005-06
Main specialty Goole treatment centre Northern Lincolnshire and Goole Hospitals NHS Trust Total finished consultant episodes

Accident and Emergency






Cardiothoracic Surgery



Clinical Haematology



Clinical Immunology and Allergy



Critical Care Medicine







Ear, Nose and Throat



General Medicine




General Surgery



Geriatric Medicine






Medical Oncology













Oral Surgery












Trauma and Orthopaedics







Not Known







(1) Low numbers. Due to reasons of confidentiality, figures between one and five have been suppressed. Where it was possible to identify numbers from the total due to a single suppressed number in a row or column, an additional smallest number have been suppressed in order to protect patient confidentiality.
1. Northern Lincolnshire and Goole NHS Foundation Trust is made up of the Northern Lincolnshire and Goole Hospitals NHS Trust and the Goole Treatment Centre. The total finished consultant episodes column is the total figure for the whole trust.
2. The specialty in each consultant episode is the specialty the consultant practices under.
3. Data quality. Hospital Episode Statistics (HES) are compiled from data sent by over 300 national health service trusts and primary care trusts (PCTs) in England. The Information Centre for health and social care liaises closely with these organisations to encourage submission of complete and valid data and seeks to minimise inaccuracies and the effect of missing and invalid data via HES processes. While this brings about improvement over time, some shortcomings remain.
4. Finished Consultant Episode (FCE). An FCE is defined as a period of admitted patient care under one consultant within one health care provider. The figures do not represent the number of patients, as a person may have more than one episode of care within the year.
5. Specialty. Care is needed when analysing HES data by specialty, or by groups of specialties (such as Acute). Trusts have different ways of managing specialties and attributing codes so it is better to analyse by specific diagnoses, operations or other recorded information.
6. Ungrossed Data. Figures have not been adjusted for shortfalls in data (i.e. the data are ungrossed).
Hospital Episode Statistics (HES), The Information Centre for Health & Social Care

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