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Table three
West Hospitals Trust Suffolk NHS

1997-98

196

1998-99

192

1999-2000

197

2000-01

226

2001-02

254

2002-03

282

2003-04

360

2004-05

414

2005-06

410

Notes:
Diagnosis codes F10 mental and behavioural disorders due to use of alcohol; K70 alcoholic liver disease; T51 toxic effect of alcohol. These figures represent a count of all finished in-year admission episodes where the method of admission was coded as emergency: via accident and emergency services, including the casualty department of the provider; or emergency: other means, including patients who arrive via the accident and emergency department of another provider.
Finished in-year admissions
A finished in-year admission is the first period of in-patient care under one consultant within one healthcare provider, excluding admissions beginning before 1 April at the start of the datayear. Please note that admissions do not represent the number of in-patients, as a person may have more than one admission within the year
PCT and SHA data quality
PCT and SHA data was added to historic data-years in the hospital episode statistics (HES) database using 2002-03 boundaries, as a one-off exercise in 2004. The quality of the data on PCT of treatment and SHA of treatment is poor in 1996-97, 1997-98 and 1998-99, with over a third of all finished episodes having missing values in these years. Data quality of PCT of general practitioner practice and SHA of GP practice in 1997-98 and 1998-99 is also poor, with a high proportion missing values where practices changed or ceased to exist. There is less change in completeness of the residence-based fields over time, where the majority of unknown values are due to missing postcodes on birth episodes. Users of time series analysis including these years need to be aware of these issues in their interpretation of the data.
All diagnoses count of episodes
These figures represent a count of all finished in-year admission episodes where the diagnosis was mentioned in any of the 14 (seven prior to 2002-03) diagnosis fields in a HES record.
Data Quality
HES are compiled from data sent by over 300 national health service trusts and 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.
Ungrossed data
Figures have not been adjusted for shortfalls in data (i.e. the data are ungrossed).

Biosimilar Medicines

Dr. Iddon: To ask the Secretary of State for Health (1) what steps she is taking to ensure that medical professionals are incentivised to report under the yellow card scheme adverse drug reactions following the use of a biomedicine or a biosimilar medicine; [117202]

To ask the Secretary of State for Health (2) what discussions she has had with the European Medicines Agency on the development of guidelines for the approval of biosimilar medicines for marketing; [117203]

(3) when she expects the European Medicines Agency to finalise guidelines for biosimilar medicines; [117204]

(4) when she expects publication of Volume 9a of the Rules Governing Medicinal Products in the EU; [117205]

(5) what assessment her Department has made of whether biosimilar medicines should undergo separate clinical trials from the biomedicines to which they are related by chemical structure and production method; [117206]

(6) what discussions she has had with the Medicine and Health Regulatory Authority on assessment applications for marketing authorisations of biosimilar medicines; [117218]

(7) whether she (a) has met and (b) plans to meet the Medicine and Health Regulatory Authority to discuss protocols to ensure patients are not put at risk from adverse drug reactions as a result of interchanging similar biological medicines; [117219]

(8) what work has been undertaken to ensure that suitable definitions and protocols are in place to ensure that similar biomedicines are safe for use by patients and are as efficacious and of as high quality as the originally marketed products; [117220]

(9) what protocols are in place to ensure that patients are informed that their biomedicine is to be substituted by a biosimilar medicine; [117221]

(10) what percentage of adverse drug reactions in the last period for which figures are available were attributed to biosimilar medicines; [117222]

(11) what steps she is taking to raise awareness amongst patients of the risks and benefits associated with biosimilar medicines; [117223]

(12) whether her Department has endorsed the EU Committee for medicinal products for human use guidelines on similar biological medicinal products; [117224]


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(13) what steps manufacturers of biosimilar medicines are required to put in place under pharmacovigilance protocols at the time of submitting the product for marketing authorisation by the Medicine and Healthcare Products Regulatory Authority; [110548]

(14) what steps her Department takes to ensure that pharmacovigilance requirements are met for biosimilar medicines that have been granted marketing authorisation by the Medicine and Health Regulatory Authority; [110555]

(15) how the Medicines and Regulatory Agency distinguishes between generic and biosimilar medicines in its assessment procedures; [110556]

(16) what steps she has taken to ensure that all biosimilar medicines that have been granted a marketing authorisation by the Medicine and Health Regulatory Authority have a sufficiently robust pharmacovigilance mechanism and that all instances of adverse drug reaction are reported under the yellow card scheme; [110557]

(17) what assessment she has made of the potential effect on health of the use of biosimilar medicines. [117321]

Caroline Flint: Biomedicines are medicines that are made from, or contain, biological active substances, unlike conventional medicines, which contain chemical active substances.

Pharmaceutical manufacturers are allowed to copy branded medicines once all patent and data protection periods have expired. Copies of branded conventional medicines are known as generics and copies of biomedicines are known as biosimilar medicines. Because of the biological nature of biomedicines and biosimilar medicines, there may be subtle differences between the branded reference product and each copy product. This means that there are additional factors to be considered when copies of biomedicines are made and when they are assessed by the regulator for a marketing authorisation.

Under current regulations a company applying for a marketing authorisation for a biosimilar medicine must provide comprehensive data to demonstrate the quality of its product, and include data to show that its product is comparable to the reference product. It must also submit safety and efficacy data, although the extent of such data will depend on the product and its similarity to the reference product. Much of the clinical data to support an application for a marketing authorisation for a biosimilar product will derive from separate clinical trials conducted using this product.

In contrast, manufacturers of copies of conventional medicines (generics) are required only to demonstrate bio-equivalence with the relevant reference product, which broadly means that they only need to demonstrate that if the same dose of the generic and reference product is given, the same effect can be expected.

Applicants for marketing authorisations for all medicines (including biosimilar medicines) must provide a description of their pharmacovigilance system (this is a description of how they intend to monitor the safety of the medicine in use). The requirements of a pharmacovigilance system are laid down in legislation. The Medicines and Healthcare products Regulatory Agency (MHRA) carries out inspections to ensure the pharmacovigilance system is suitable and the company is fulfilling its obligations. Companies wanting to market a new product must also
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provide a risk management plan which describes the current knowledge of the product, outlines a plan to fill any gaps in knowledge and any measures needed to minimise any risk from the product.

Because biosimilar medicines are not identical copies of reference products, the subtle differences may make a difference to their effect when taken by patients. These differences may not become fully apparent until greater experience in the use of the medicines has been established. It is preferable, therefore, that when such products are prescribed they should be clearly identified and prescribed by brand name to ensure that patients receive the exact product prescribed and that their safety in use can be properly monitored.

Information on how to use a medicine and the possible side effects associated with its use is provided to patients in the patient information leaflet (PIL) which accompanies the medicine. When new information arises that impacts on the balance of risk and benefit of any medicine this is evaluated and, where appropriate, the PIL is amended, and if necessary health professionals are advised.

Health professionals and patients are encouraged to report suspected adverse reactions to any medicine to the MHRA via the voluntary yellow card scheme, which collects and monitors such reports, evaluates them and takes any action necessary to ensure patient safety. The MHRA is committed to increasing overall reporting of adverse reactions and an Expert Advisory Group of the Commission on Human Medicines is advising on this issue.

The rules governing the content of an application for a biosimilar medicine and the assessment undertaken by the regulator are laid down in legislation and guidelines. Specifically, the data requirements to support an application for a biosimilar medicine are outlined in Section 4 of Part II of Annex 1 of Directive 2003/63/EC. Volume 9a of the Rules Governing Medicinal Products in the European Union, which provides guidance on applying the legislation, was published by the Commission on 25 January 2007. The MHRA has participated in all the groups that have discussed these provisions and has endorsed the European legislation that sets out the rules for assessing applications for biosimilar medicines and the various guidelines including the Guidelines on Similar Biological Medicinal Products drawn up by the EU Committee for Medicinal Products for Human Use.

To date only two biosimilar products (growth hormones) have been authorised for use in the United Kingdom. They were both authorised through the European centralised procedure overseen by the European Medicines Agency. They are intended to be prescribed by physicians adequately experienced in diagnosis and management of patients with growth deficiency. The Government are not aware any of any reports of suspected adverse reactions associated with the use of these two products.

General Practitioners: Pay

Mr. Lansley: To ask the Secretary of State for Health what plans she has to instruct NHS employers to negotiate a cap on general practitioners' earnings under the General Medical Services contract. [118153]


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Andy Burnham: At present we have no such plans. At the request of the British Medical Association's general practitioners committee (GPC), the independent Doctors and Dentists Review Body will be making a recommendation on an inflation increase for general practitioners for 2007-08.

Haemophilia

Jenny Willott: To ask the Secretary of State for Health (1) how many and what proportion of documents relating to the infection of haemophiliacs with contaminated blood products which have been returned to the Department of Health by Blackett, Heart and Pratt Solicitors have (a) undergone independent legal examination and (b) been passed to the Haemophilia Society; [119897]

(2) how many documents relating to the infection of haemophiliacs with contaminated blood products have been returned to the Department by Blackett, Heart and Pratt solicitors; and if she will make a statement. [119898]

Caroline Flint: In May 2006, Blackett Hart and Pratt solicitors returned 623 documents to departmental solicitors. All the documents were reviewed by independent counsel, before they were sent to officials in the Department. The vast majority of these documents (604 in total) were released in line with the Freedom of Information (FOI) Act 2000. The documents were sent to a number of individuals at their request and to the Haemophilia Society.

Some documents were withheld under FOI. However, officials are further reviewing these papers with a view to releasing them if possible.

Health Authorities: Eastern Region

Alistair Burt: To ask the Secretary of State for Health what recent meetings she has had with the strategic health authority for the Eastern Region. [119385]

Andy Burnham: The Secretary of State has not met recently with NHS East of England. I met with Keith Pearson, chair of NHS East of England, and Pearse Butler, chief executive of NHS East of England, on 17 October. I also met with Neil McKay, the new chief executive, on 7 December. Regular meetings also take place at official level.

Health Professions: Disciplinary Proceedings

Norman Lamb: To ask the Secretary of State for Health how many (a) doctors, (b) dentists, (c) nurses and (d) other clinical staff are suspended from work in the NHS; and what the longest period is for which an individual has been suspended in each case. [121472]

Ms Rosie Winterton [holding answer 19 February 2007]: National clinical assessment service (NCAS) figures show that 115 doctors (66 general practitioners and 49 hospital doctors) and seven dentists are currently on suspension in the national health service in England.

The information includes doctors and dentists from foundation trusts even though they are not under the
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management of the Department, as this does give Parliament a total picture for England.

NCAS is not responsible for monitoring suspensions of other healthcare professionals and cannot therefore provide information about nurses or other clinical staff.

Figures for other clinical staff are not held centrally.

Information regarding the duration of the longest suspension is not available as this could identify the postholder.

Health Visitors

Mr. Walker: To ask the Secretary of State for Health how many whole-time equivalent health visitors were employed by the NHS in each year since 1996; and if she will make a statement. [120930]

Ms Rosie Winterton [holding answer 19 February 2007]: The table shows the number of full-time equivalent health visitors since 1996. There has been an increase in the headcount number of health visitors since 1997 of 408 (3 per cent.) and there has been significant growth in the overall number of nurses working in primary and community care settings in 2004-05 of 3,389 (3.3 per cent.) and since 1997 of 28,504 (36.9 per cent.).

Full-time equivalent number of health visitors 1996 to 2005
Full-time equivalent

1996

10,132

1997

10,025

1998

10,068

1999

10,161

2000

10,046

2001

10,186

2002

9,912

2003

9,999

2004

10,137

2005

9,809

Source:
Non medical workforce census

Homeopathy

Dr. Vis: To ask the Secretary of State for Health (1) if she will write to primary care trusts to remind them that access to homeopathy in the NHS should continue to be an option for all patients; [118038]

(2) what the Government's policy is on the future provision of complementary medicine through NHS homeopathic hospitals. [118362]

Caroline Flint: The Government consider that decision making on individual clinical interventions, whether conventional, or complementary/alternative treatments, has to be a matter for local national health service providers and practitioners as they are best placed to know their community's needs. In making such decisions, they have to take into account evidence for the safety, clinical and cost-effectiveness of any treatments, the availability of suitably qualified practitioners, and the needs of the individual patient. Clinical responsibility rests with the NHS professional who makes the decision to refer and who must therefore be able to justify any
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treatment they recommend. If they are unconvinced about the suitability of a particular treatment, they cannot be made to refer.


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