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Dawn Primarolo: It is Government policy that all decisions on what services/treatments to commission and fund are the responsibility of primary care trusts (PCTs). Most PCTs will have their own policy on the commissioning and funding of complementary and alternative medicine (including homoeopathy). Safety, clinical and cost-effectiveness, along with the availability of suitably qualified/regulated practitioners are all taken into account when decisions are being made on the provision of a treatment.
An important source of information that the MHRA uses to monitor the safety of medicines and vaccines is through the receipt of spontaneous reports of suspected adverse reactions via the Yellow Card Scheme (YCS), by health care professionals and patients. This enables new or changing safety issues to be promptly detected.
The number of people in the United Kingdom whose death or hospitalisation was suspected to be associated with influenza vaccination and reported to the MHRA via the YCS is provided by year since 2003 in the following tables. It is not possible to further break these data down by individual trust.
|Number of suspected adverse drug reaction (ADR) reports associated with influenza virus with a fatal outcome, received for the time period 1 January 2003 to 31 May 2008 broken down by year|
|Year of receipt||Number of reports|
|(1) Data for 2008 include ADR data from 1 January 2008 to 31 May 2008|
|Number of suspected ADR reports associated with influenza virus where the reporter has stated the ADR to be serious for the following reason: Involved or prolonged patient hospitalisation, for the time period 1 January 2003 to 31 May 2008 broken down by year|
|Year of receipt||Number of reports|
|(1) Data for 2008 include ADR data from 1 January 2008 to 31 May 2008.|
It is important to note that the reporting of a suspected adverse reaction does not necessarily mean that it has been caused by the vaccinebecause the reports are based on suspicions, no causal link may be established. While some reported suspected adverse reactions may represent true reactions to a vaccine, others may represent illnesses unrelated to vaccination that occur naturally in the population of vaccine recipients or concomitant medicines, and their timing in relation to vaccination may be purely coincidental.
Given that approximately eight million people who are elderly or at high risk of severe cardiac and respiratory illness are likely to be vaccinated with influenza vaccine over the winter season each year, it is inevitable that some patients may die or be hospitalised shortly after vaccination. These events may be reported via the YCS even if the temporal association with vaccination was coincidental.
Sandra Gidley: To ask the Secretary of State for Health what influenza vaccines his Department has purchased; from which producers they were purchased; what quantities of each have been purchased; and if he will make a statement. 
The vaccine was purchased for use in the Poultry Workers Seasonal Flu Programme. Vaccine for the routine seasonal flu programme offering the vaccine to those aged 65 years and over and those in risk groups is purchased by general practitioners rather than the Department.
Mr. Philip Hammond: To ask the Secretary of State for Health (1) what arrangements the Medicines and Healthcare products Regulatory Agency has in place to consider commercial interests when responding to freedom of information requests; 
(2) what plans executive agencies of his Department have to review regulation of (a) unlicensed medicines, (b) off-label medicines and (c) medicinal products specifically manufactured to meet the special needs of a patient; 
Dawn Primarolo: The Medicines and Healthcare products Regulatory Agency (MHRA), in conjunction with the Veterinary Medicines Directorate and representative trade associations, has developed guidance on the disclosure of information under the Freedom of Information Act 2000. When considering the release of information which would or would be likely to prejudice commercial interests, the MHRA will obtain the views of the person or company concerned before making a final decision to disclose or withhold the requested information.
The MHRA is leading a review of the regulatory arrangements in the United Kingdom which allow an authorised health care professional to commission an unlicensed medicinal product to meet the special needs of an individual patient. The MHRA issued a discussion document in February 2008 and interested parties have been invited to submit views by 30 June. There are no plans to review off-label use of medicines.
The Medicines (Advertising) Regulations 1994, as amended, prohibit the advertising of medicines which do not have a marketing authorisation, traditional herbal registration or homoeopathic registration in force. Additionally, the advertising of an unlicensed medicine for human use is prohibited under the Medicines for Human Use (Marketing Authorisation Etc) Regulations 1994 as amended and Schedules 2 and 4 of The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005.
Anne Milton: To ask the Secretary of State for Health pursuant to the answer of 30 April 2008, Official Report, column 451W, on the NHS: vaccination, if he will increase uptake data collection for all treatments recommended for use in the NHS by the Joint Committee on Vaccination and Immunisation; and if he will make a statement. 
Dawn Primarolo: There are no plans currently to extend uptake data collection for immunisations outside the national routine immunisation programme. Data for other treatments are not collected in the format requested. Information on "prescriptions dispensed in the community in England has been placed in the Library and is also available at:
Mr. Ivan Lewis: The Department has not commissioned any research specifically to inform the public engagement process on the future of care and support services, other than research with the public to determine appropriate naming and branding of all materials for use during the engagement process. The Department has commissioned some modelling work from the personal social services research unit which was used to identify the size of the funding gap as laid out in the launch document for the public engagement, and will inform the Green Paper more widely.
The Department has evaluated a variety of research. In November 2006, HM Treasury announced that they would undertake an internal review of the funding of services for the over-85s, including the Kings Fund report Securing Good Care for Older People, and research carried out by the Joseph Rowntree Foundation into the funding of social care. The results of this review have fed into the engagement process on the future of care and support services, as have publications by other major stakeholder organisations on this subject.
Mr. Kidney: To ask the Secretary of State for Health what steps his Department plans to take to develop care and support services pending the outcome of its consultation on the future of such services. 
Mr. Ivan Lewis: The cross-sector concordat Putting People First published in December 2007 establishes the collaboration between central and local government, the sectors professional leadership, providers and the regulator. It sets out the shared aims and values which will guide the transformation of adult social care, and recognises that the sector will work across agendas with users and carers to transform peoples experience of local support and services. Copies of the concordat are available in the Library and are also available at:
The transformation of adult social care is supported by the social care reform grant, a new, ring-fenced grant of £520 million over three years to support councils to redesign and reshape their adult social care services, with the majority having most of the core components of a personalised system in place. The expectation is that by 2010-11, councils will have made significant steps towards greater personalisation.
Further information, conditions and advice on the social care reform grant are available in Local Authority Circular (DH) (2008)1: Transforming Social Care which is available on the Departments website at:
To ask the Secretary of State for Health what discussions he has had with (a) care providers in the (i) private, (ii) voluntary and (iii) independent healthcare sectors and (b) representatives of (A)
insurers and (B) the Association of British Insurers as part of his Department's consultation on the future of care and support services. 
Mr. Ivan Lewis: Ministers and officials within the Department have formal and informal meetings with stakeholders on a regular basis. In addition, care providers from different sectors are represented on the Department's national stakeholder forum.
In specific relation to the care, support, independence project, we have set up a stakeholder panel with membership from care providers and insurers, including the Association of British Insurers. This Panel met on 6 April 2008 and further meetings are planned. In addition, representatives from these provider and insurance sectors are being asked to attend regional stakeholder events, scheduled between June and November this year, to discuss the key issues.
Mr. Kidney: To ask the Secretary of State for Health (1) what steps he is taking to involve (a) patients with longer-term conditions and (b) (i) adult and (ii) young carers in his Department's consultation on the future of care and support services; 
Mr. Ivan Lewis: A new care and support system will affect every adult in the country. The purpose of the debate launched by my right. hon. Friend the Prime Minister on 12 May 2008 is to ensure everyone can have their say via the following methods:
at our website www.careandsupport.direct.gov.uk;
writing to the Care and Support Team, Room 543, Richmond House, 79 Whitehall, London SW1A 2NS;
the document The case for changeWhy England needs a new care and support system is also available in an easy read format for people with learning disabilities and in an easy access format for people who have had a stroke. Copies of the document are available in the Library;
a series of public events where the key issues will be discussed in detail. These include a stakeholder event in every Government region and a number of citizen events. The stakeholder events will include user and patient groups that represent patients with long-term conditions including both adults and young carers;
at the end of the six month engagement period there will be a final event bringing stakeholders and citizens together to provide a further opportunity for discussion; and additional research will also be undertaken to ensure groups of people whose views may not be readily heard via the routes outlined above, have the opportunity to give their views.
Mr. Ivan Lewis:
Hon. Members were alerted to the launch of the public engagement on the reform of the care and support system via a written ministerial statement made by my right hon. Friend the Secretary of State on 12 May 2008, Official Report, columns 48-50WS. A copy of the document, The Case for ChangeWhy England Needs a New Care and Support System,
which was published on 12 May 2008 to mark the beginning of this engagement process, is available in the Library.
Mr. Kidney: To ask the Secretary of State for Health if he will treat Derek Wanless's reports on care and support services commissioned by the King's Fund as submissions to his Department's consultation on the future of such services. 
Mr. Ivan Lewis: In the pre-Budget report 2006, HM Treasury announced that the Government would be undertaking an internal review of care for the over-85s, looking in particular at Derek Wanless's report for the King's Fund, Securing Good Care for Older People. The outcome of that review, which was extended to cover the over-65s, is feeding into the development of the Green Paper on reform of the care and support system.
Mr. Amess: To ask the Secretary of State for Health what recent research he has (a) commissioned and (b) evaluated on whether pregnant women who take Vitamin A reduce the risk of having a baby with a cleft lip or palate; and if he will make a statement. 
The Great Ormond Street Hospital and University College London Biomedical Research Centre formed as part of the implementation of the Government's research strategy Best Research for Best Health will however undertake research on the factors that are important in normal and abnormal palate development. Copies of the strategy are available in the Library.
The MRC is additionally supporting a basic research study in animals focused on neural patterning that aims to investigate how excess or insufficient amounts of vitamin A during pregnancy can affect craniofacial development. The MRC has also supported a number of studies exploring genetic factors relating to the development of cleft lip and palate.
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