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NHS Cord Blood Bank

Dr. Richard Taylor: To ask the Secretary of State for Health (1) for what reasons the NHS cord blood bank is to be relocated to Bristol; [215589]

(2) what the estimated cost of the proposed relocation of the NHS cord blood bank to Bristol will be. [215590]

Dawn Primarolo: The processing, storage and testing of cord blood will move to the new blood centre at Filton, which will also house other stem cell activities.

NHS Blood and Transplant will continue to collect cord blood donations in the four hospitals where this currently takes place, with collection also due to begin at St George’s Hospital in Tooting later this year.

The rationale for moving processing, storage and testing of cord blood to Filton rests on considerations of:

safety and quality assurance

capacity, capability and training/career opportunities for staff. The benefits of co-locating the NHS cord blood bank at Filton include the fact that staff processing cord blood will have the opportunity to develop their skills and expertise with bone marrow and peripheral blood testing; and

consolidation of services to retain a good geographic spread across the country, while enabling the service to be more productive and ensuring the necessary flexibility to meet clinical and safety requirements now and in the future.

The development of new facilities for storage of cord blood units at Edgware or Colindale is not an option due to lack of space and additional cost.

The initial estimate of the cost of moving the processing, testing and storage of cord blood from Edgware to the new Filton Blood Centre is £80,000.

NHS: Drugs

Jeff Ennis: To ask the Secretary of State for Health what estimate he has made of the (a) number of patients who experienced serious side effects as a direct consequence of taking prescribed medicines in the last period for which figures are available and (b) cost to the NHS of dealing with this problem. [213992]

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Dawn Primarolo: Reports of suspected adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the spontaneous reporting scheme; the Yellow Card Scheme (YCS).

The YCS collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines.

During the last financial year (1 April 2007 to 31 March 2008), the MHRA received 19,227 serious suspected ADR reports associated with all medicines. It is not possible to provide numbers of ADR reports received specifically for prescribed medicines as this information is not collected on yellow cards.

It is important to note that the number of reports received via the YCS does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons, as the YCS is associated with an unknown level of under-reporting.

It is also important to note that the submission of a suspected ADR report does not necessarily mean that it was caused by the drug. Many factors have to be taken into account in assessing causal relationships including temporal association, the possible contribution of concomitant medication and the patient’s underlying disease.

An assessment has been made by the National Patient Safety Agency (NPSA) of the cost to the national health service of avoidable harm related to taking prescribed medicines. This is outlined in their fourth Patient Safety Observatory report “Safety in doses: medication safety incidents in the NHS”, which estimated the figure at £770 million each year in England.

Copies of this publication have been placed in the Library and are also available on the NPSA’s website at:

www.npsa.nhs.uk/patientsafety/alerts-and-directives/directives-guidance/safety-in-doses/

Nuffield Orthopaedic Centre

Mr. Vaizey: To ask the Secretary of State for Health what the date was of each meeting his officials have had with the South Central Strategic Health Authority on the future of the Nuffield Orthopaedic Centre in the last 12 months; what the purpose of those meetings was; and what was discussed at each. [216317]

Mr. Ivan Lewis: The following meetings have taken place between departmental officials and South Central strategic health authority (SHA) on the future of the Nuffield Orthopaedic Centre in the last 12 months:

On 11 June 2008, departmental officials met with senior executives of South Central SHA to review the SHA’s financial and service plans and projected performance for the South Central area. This included reference to the expected performance of the Nuffield Orthopaedic Centre in 2008-09.

On 19 June 2008, departmental officials met the chief executive and deputy chief executive of South Central SHA specifically for them to explain its approach to the strategic review of future options for the Nuffield Orthopaedic Centre. The SHA agreed to keep the Department informed of developments as the review progressed and potential options emerged.

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Nutrition

Mr. Jenkins: To ask the Secretary of State for Health what estimate he has made of the proportion of the population which consumes less than five portions of fruit and vegetables a day. [215763]

Dawn Primarolo: “The Health Survey for England 2006” shows 70 per cent. of adults and 79 per cent. of children aged five to 15 consuming less than five portions of fruit and vegetables per day. Copies of this publication have already been placed in the Library.

Average fruit and vegetable consumption was 3.9 portions per day(ppd) among adults and 3.3 ppd among children.

Obesity: Children

Mr. Hoyle: To ask the Secretary of State for Health what recent research his Department has (a) commissioned and (b) evaluated on levels of (i) childhood obesity and (ii) children's levels of exercise; and what benchmarking his Department has done of the results of such research against equivalent figures for other European countries. [214173]

Dawn Primarolo: The Information Centre for health and social care is commissioned by the Department to collect and evaluate data on the National Child Measurement programme (NCMP) and the Health Survey for England (HSE).

The NCMP provides the most comprehensive data on obesity among children aged 4 to 5 and 10 to 11 years. The most recent available data can be found in “National Child Measurement Programme: 2006-07 school year, headline results”, which was published on 21 February 2008. Copies of this publication have already been placed in the Library.

The HSE collects data on levels of obesity and physical activity in children aged 2 to 15. The most recent available data can be found in “Health Survey for England 2006: Volume 2 Obesity and other risk factors in children”, which was published on 31 January 2008. Copies of this publication have already been placed in the Library.

“Healthy Weight, Healthy Lives: a Cross Government Strategy for England”, published on 23 January 2008 (copies of the Strategy have already been placed in the Library), committed the Government to establishing the National Obesity Observatory. In June 2008 it published “National Child Measurement Programme: Detailed Analysis of the 2006-07 National Dataset”, which highlights the usefulness of the NCMP for advancing our understanding of underweight, overweight and obese children. Copies of this publication have been placed in the Library.

The Department has not benchmarked these figures on levels of obesity and physical activity in children against equivalent figures for other European countries. The Government Office of Science's Foresight project “Tackling Obesities: Future Choices” is a world-leading analysis of the causes and consequences of obesity, which includes an evidence review “International Comparisons of Obesity Trends, Determinants and Responses”, which compares levels of child obesity in
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England with figures for other European countries. Copies of this publication have been placed in the library.

The Health Behaviour in School-Aged Children: World Health Organization Collaborative Cross-National Study's latest report “Inequalities in Young People's Health”, presents a comparison of levels of physical activity by young people aged 11, 13, and 15 years in 41 countries and regions across Europe and North America, including England. It was published on 17 June 2008. The relevant section of this publication has been placed in the Library.

Andrew Rosindell: To ask the Secretary of State for Health what data his Department collect on levels of obesity on a regional basis; and what estimate he has made of obesity levels among children in London in each of the last five years. [214182]

Dawn Primarolo: The information requested is not available in the exact format requested.

Information on the percentage of adults aged 16 and over, and children aged 2 to 15 in England who are obese, broken down by Government office region and strategic health authority (SHA), are collected in the Health Survey for England.

The most recent available data for adults can be found in Table 5.3, page 99, “Health Survey for England 2006: Volume 1 Cardiovascular disease and risk factors in adults”, which was published on 31 January 2008. Copies of this publication are available in the Library.

The most recent available data for children can be found in Tables 2.3 and 2.11, pages 36 and 43, “Health Survey for England 2006: Volume 2 Obesity and other risk factors in children”, which was published on 31 January 2008. Copies of this publication have been placed in the Library.

Information on the trends in obesity among children in the London Government office region for 1995-97, 1998-2000, 2001-2003, and 2004-06 can be found in Table 2.11, page 43, “Health Survey for England 2006: Volume 2 Obesity and other risk factors in children”.

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Obesity: Peterborough

Mr. Stewart Jackson: To ask the Secretary of State for Health how many people were classified as clinically obese in Peterborough Primary Care Trust area and its predecessor bodies in each year since 1997; and if he will make a statement. [214799]

Dawn Primarolo: The information on the number of people classified as clinically obese in Peterborough Primary Care Trust, and its predecessors in each year since 1997, is not held centrally.

Papillomavirus

Mark Simmonds: To ask the Secretary of State for Health what specifications were included in the tendering process for the vaccine against human papillomavirus. [215083]

Dawn Primarolo: The specification set out in the procurement documents for the human papillomavirus vaccine (HPV) identified the following categories of requirements:

Requirements described as ‘mandatory’ are compulsory requirements. Offerors must confirm in their offer that they are able to fully meet all mandatory requirements in order for such offer to be a fully compliant offer. Offers which do not meet all mandatory requirements may be rejected by the agency⁽¹⁾;

Requirements described as ‘non-mandatory’ are desirable, but not compulsory requirements. The offeror’s ability to meet the non-mandatory requirements will form part of the evaluation of the offer, but non-compliance with the non-mandatory requirements will not, of itself, render that offer non-compliant; and

Requirements described as 'information' are requests for information or documentation. The quality and/or content of such information or documentation will form part of the evaluation of the offer. The required information must be included in an offer in order for that offer to be a fully complaint offer.

The detailed requirements were:

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		Requirement
1.1.0—Product
1.1.1	HPV supplied as a suspension for injection in a pre-filled syringe.	Mandatory requirement
1.1.2	The vaccine must be licensed for use in the United Kingdom to protect against HPV strains 16 and 18.	Mandatory requirement
1.1.3	The vaccine must be indicated for the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to HPV types 16 and 18.	Mandatory requirement
1.1.4	The vaccine must be licensed for administration to girls aged 12 and older via a maximum of three doses.	Mandatory requirement
1.1.5	In addition to the protection against HPV strains 16 and 18 the Authority(2) will consider other aspects of product efficacy, to include	Non-mandatory requirement
	additional licensed indications;
	cross protection against HPV strains other than those types covered in the licensed indications from pre and post licensing clinical trials;
	duration of protection for all licensed indications; and
	management of storage temperature excursions as supported by accelerated stability studies.
1.1.6	Offerors are required to provide supporting information as part of their submission.	Information requirement
1.1.7	Offerors are requested to provide information in relation to variations to the dosage schedules for their vaccine.	Information requirement
1.2.0—Presentation
1.2.1	The vaccine must be supplied as a pre-filled syringe with needle for administration.	Mandatory requirement
1.2.2	The Authority has a preference for a single syringe pack presentation to reduce the potential for wastage during the Immunisation Programme.	Non-mandatory requirement
1.2.3	Offerors must provide details of the pack sizes available.	Information requirement
1.3.0—Shelf life
1.3.1	The licensed shelf life of the vaccine shall be at least three years	Mandatory requirement
1.3.2	Shelf life of the product supplied should be equal to the maximum shelf life less the time used for release and shipment of the product to the Authority(2) and shall be no less than two years.	Mandatory requirement
1.3.3.	Offerors must provide details of the anticipated shelf life of the vaccine to be supplied to the Authority(2). This must be supported by information on the production and final product release timelines, including the maximum time required for external quality assessment by the OMCL(3) if the expiry date of a vaccine batch is determined before this production stage in the vaccine Marketing Authorisation.	Information requirement
1.4.0—Temperature indicators
1.4.1	The Authority(2) has a preference for the inclusion in the vaccine packaging of a temperature indicator which would indicate if the vaccine had been exposed to a temperature above or below the storage requirements specified in the Marketing Authorisation.	Non-mandatory requirement
	The purpose of this request is to reduce wastage where there has been a transient increase or reduction in temperature in storage and the supply as measured by the surrounding air temperature and the product temperature may have remained within the approved temperature range.
1.4.2	This response should include, but is not limited to, information on the availability of such temperature indicators and the feasibility of providing these with the vaccine doses supplied during the life of this Agreement.	Information requirement
1.5.0—Cold chain delivery requirements
1.5.1	Offerors are requested to provide details of the method of distribution and temperature control systems that will be employed, including the records that will be provided to the Authority(2).	Information requirement
1.6.0—Batch numbering system
1.6.1	Offerors are requested to provide details of the structure of their batch numbering system for the vaccine. This information is being requested to allow the Authority(2) to incorporate an error checking system for the recording of batch numbering into the Child Health Monitoring computer systems.	Information requirement
2.1.0—Delivery schedule
2.1.1	Offerors must be able to deliver 820,000 doses during August and September 2008. The delivery profile for this requirement must comprise of no less than 50,000 doses delivered by 1 August 2008, 200,000 doses delivered by 15 August 2008, 115,000 doses delivered by 22 August, 255,000 doses delivered by the 5 September 2008 and 200,000 doses delivered by 19 September 2008. Offerors should note that no deliveries can be made before 1 July 2008.	Mandatory requirement
	Offerors may vary the requirements laid out in 2.1.1, but only in so far that the Authority receives the quantities required before all of the dates stated in 2.1.1, though not prior to 1 July 2008.
2.1.2	Offerors should include a proposed delivery schedule detailing how they would deliver the consignments necessary to complete the delivery of the first 820,000 doses to the Authority’s(2) nominated distributor. Offerors should note that no deliveries can be made before 1 July 2008.	Information requirement
2.1.3	Offerors must be able to deliver the total number of doses of vaccine as identified in the delivery requirements.	Mandatory requirement
2.1.4	Offerors must be able to deliver the ‘in year’ totals that is 1,620,000 doses delivered in year 1 of the contract, 3,900,000 doses delivered in year 2 of the contract and 2,025,300 doses delivered in year 3 of the contract.	Mandatory requirement
2.1.5	For all deliveries after the first 820,000 doses, in addition to 2.1.1, 2.1.3 and 2.1.4, offerors must ensure the programme stock levels are maintained and therefore the proposed schedule is mandatory in that the Authority must receive the quantities required before all of the dates stated.	Mandatory requirement
2.1.6	Taking account of the mandatory requirements laid out in 2.1.1, 2.1.3, 2.1.4 and 2.1.5, Offerors are encouraged to deliver in accordance with the delivery profile outlined. Offerors should note that the offers will be evaluated on how well the proposed delivery schedule matches (or in the case of the first 820,000 doses, exceed) the requirements.	Non-mandatory requirement
2.1.7	Offerors are required to provide their proposed delivery schedule.	Information requirement
2.2.0—Pallets
2.2.1	The Authority would prefer the Offeror to use Europallets for the delivery to the Authority’s distribution agent and for storage within the distribution agent's warehouse	Non-mandatory requirement
2.2.2	Offerors are required to provide details of their pallet-packing configuration.	Information requirement
2.3.0—Manufacturing contingency plans
2.3.1	Offerors must be able to demonstrate to the Authority that they have an effective contingency plan for the maintenance of vaccine supply to cover manufacturing problems and staff shortages. This should include the use of alternative production facilities and safety stock provisions.	Mandatory requirement
2.3.2	Offerors are requested to provide a summary of the contingency plan. The Authority will use the information provided in this summary document to evaluate the supply risks in the tender evaluation. Offerors should provide a summary document and clearly state the file name/reference.	Information requirement
2.4.0—Production Capacity
2.4.1	Offerors are requested to provide the Authority with the following details which will also be used to assess the supply risks in the tender evaluation:	Information requirement
	The average number of doses in a production batch of vaccine;
	The current and maximum production capacity in terms of finished vaccine dose per week or month;
	The current production demand in doses per month;
	The number of batches submitted for release by the OMCL(s) and the pass rate in the last 12 months; and
	The production cycle time.
2.4.2	Offerors are requested to include any additional information to be taken into consideration in relation to production capacity.	Information requirement
2.5.0—Risk management of storage and distribution
	Offerors must be able to demonstrate to the Authority that they have an effective risk management approach to storage and distribution of the vaccine. Offerors are required to provide a summary of their risk management plans to minimise loss of stock in relation to	Information requirement
	storage arrangements prior to delivery to the Authority; and
	transportation of stock to the Authority’s nominated distributor.
	Offerors should provide a summary document and clearly state the file name / reference summary.
2.6.0—Variant offers
	In addition to their core offer, offerors may wish to provide the Authority with a single variant offer that improves the clinical and/or cost effectiveness of the vaccination programme. The Authority is not considering any options for direct delivery of the product from supplier to the primary care trust or general practitioner under this procurement exercise. Any valid variant offers received will be subject to the same evaluation criteria as the core offer.	Non-mandatory requirement
(1) Any references in the specification to the agency refers to National Health Service Purchasing and Supply Agency. (2) Any reference in the specification to the authority refers to the Department of Health. (3) OMCL refers to the Official Medical Control Laboratory.

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