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Mr. Hollobone: To ask the Secretary of State for Health pursuant to the answer of 23 November 2005, Official Report, columns 2108-09W, on diabetes, what criteria she used in making the decision not to refer all insulin products used in the UK to the National Institute for Health and Clinical Excellence. 
Andy Burnham [holding answer 3 May 2006]: The National Institute for Health and Clinical Excellence's clinical guidelines on the management of both type one and type two diabetes conclude that the majority of studies indicate that both human and animal insulins are equally effective and report no significant differences in hypoglycaemic episodes and glycaemic control between the insulin of human and animal chemical structures.
I understand that the choice of insulin is influenced by other factors such as delivery systems and cultural preferences, and so the decision to use one or other of the insulin types rests entirely with the physician, in consultation with the patient.
Mr. Kevan Jones: To ask the Secretary of State for Health (1) what assessment she has made of the performance of Alliance Medical Ltd. in providing diagnostic scans in the NHS; and if she will make a statement; 
(2) what aspects of performance her Department examines when carrying out (a) weekly, (b) monthly and (c) annual assessments of the performance of Alliance Medical Ltd. in providing diagnostic scans in the NHS. 
Andy Burnham: Alliance Medical Ltd.'s contract performance is reviewed by a combination of the weekly and monthly activity reports. The aspects of performance that are assessed include the volume of scans, number of patients contacted and booked, report dispatch times, patient satisfaction, referrer satisfaction, cancellations and quality of radiological reporting. These are collected on a monthly basis. Weekly data are also collected on the number of scans performed at each site visited.
In addition, the clinical aspects of the service have been assessed through joint Departmental and Royal College of Radiologists clinical audits. Each audit compared performance of the Alliance Medical Ltd. service with that of the NHS. The second audit was published on 11 May 2006 and on the Royal College of Radiologists' website at: www.rcr.ac.uk/docs/radiology/pdf/MR_CG_Audit_April2006.pdf.
Mr. Amess: To ask the Secretary of State for Health (1) what research has been (a) funded and (b) carried out by her Department on the use of embryonic stem cells to develop human teeth; and if she will make a statement; 
Andy Burnham: The Department is not funding research into stem cells for creating replacement teeth. The Government believe that stem cell research offers enormous potential to deliver new treatments, including the improved reconstructive dental surgery for those who have suffered severe injury or cancer.
To date, the published scientific evidence has not established which types of stem cells will be the most useful for human therapies. Therefore, following the UK stem cell initiative report in 2005, the Government have announced up to £100 million for all forms of stem cell research in 2006 to 2008.
Dr. Richard Taylor: To ask the Secretary of State for Health when the Foster Review of non-medical health regulation is expected to be published; and how much time she expects to make available for consultation about its recommendations. 
Andy Burnham: We will publish our decisions on the review of non-medical professional regulation and on the chief medical officer's review of medical revalidation and related subjects in due course. We will identify any matters requiring consultation and announce the duration of such consultation.
Mrs. Maria Miller: To ask the Secretary of State for Health what assessment her Department has made of the ability of (a) GP practices and (b) primary care trusts to fund (i) the purchase of new buildings and(ii) the rental of premises under the new GP contract; and if she will make a statement. 
Ms Rosie Winterton: General practitioner practices should seek the agreement of their primary care trust (PCT) on plans to move to new practice premises. Irrespective of the new general medical services contract, general practitioner practices have always had the ability to lease rented premises or borrow capital to fund new-build premises. In turn, primary care trusts and their predecessor bodies have the ability to consider funding agreed associated revenue costs from their resource allocations.
Dr. Richard Taylor: To ask the Secretary of Statefor Health what the cost was to public funds of the (a) General Osteopathic Council, (b) General Chiropractic Council and (c) Health Professions Council in (i) 2004-05 and (ii) 2005-06. 
Andy Burnham: No money was paid to these organisations, which are self-funded through registrants' subscriptions, with the exception of £1,465.40 paid to the General Chiropractic Council in 2005-06 for the cost of room hire and catering.
The Medicines and Healthcare products Regulatory Authority in the United Kingdom and the European Medicines Agency (EMEA) for the European Union (EU) consider the safety and efficacy of treatments. The National Institute for Health and Clinical Excellence (NICE) considers the clinical and cost effectiveness of certain licensed treatments for use in the national health service.
In February 2006, Roche applied to the EMEA to extend its licence indication for Herceptin to include adjuvant treatment of early breast cancer. At the end of April, the EMEA's committee for medicinal products for human use recommended that Herceptin be approved for this indication. The next stage in the regulatory process is for the European Commission to evaluate this recommendation with a view to issuing marketing authorisation in the EU. A decision is expected in a few weeks.
Herceptin for early stage breast cancer has already been referred to NICE. The appraisal is proceeding, through the new fast track process for single technology appraisals, in parallel with the licensing process. NICE has indicated that guidance could be available in July, subject to licensing.
Mr. Paterson: To ask the Secretary of State for Health what advice she has received from the national cancer director on the merits of prescribing Herceptin to treat early stage breast cancer. 
Ms Rosie Winterton: The views of the national cancer director are taken into account when submissions and briefings are put to Ministers on cancer-related issues although these are not always specifically identified. In addition, the national cancer director may take the opportunity to provide Ministers with advice or views on specific issues during the course of meetings. A detailed record of these discussions will not always be taken.
In relation to Herceptin, the national cancer director has made the Secretary of State aware of the reasons why oncologists specialising in breast cancer have found the preliminary findings of recent trials so encouraging. For example:
the studies were large trials, involving over 12,000 women, and appeared to have been conducted to a high standard;
the findings in relation to disease free survival from all of the studies were remarkably consistent adding to the robustness of the data;
both the HERA trial (carried out in Europe) and the combined American trial (NSABP B31 and NCCTG N9831) had reported significant benefits in distant recurrence free survival which could be an early surrogate for improved overall survival in breast cancer trials;
in general the absolute benefits of adjuvant therapies are small in the early years but increase over time;
the benefits of Herceptin are additional to those seen with standard adjuvant therapies;
the cardiac side-effects of Herceptin were well recognised and experience suggested that they were manageable and were outweighed by the benefits of Herceptin.
Mr. Paterson: To ask the Secretary of State for Health (1) whether primary care trusts in England may refuse to prescribe Herceptin to patients with early stage breast cancer on the grounds of its cost; 
(2) whether primary care trusts in England have been given written guidance on the circumstances under which it is acceptable to refuse to prescribe Herceptin to patients with early stage breast cancer. 
Ms Rosie Winterton: Primary care trusts (PCTs) do not make prescribing decisions. It is for individual clinicians, in discussion with a patient, to decide whether or not it is suitable to prescribe a specific drug. PCTs may need to be involved to decide whether to support the clinician's decision and supply the drug at NHS expense. PCTs need to take a range of factors into account, including local factors, when considering the funding of drugs and other treatments.
Guidance has not been issued to primary care trusts in England on the circumstances under which it is acceptable to refuse to prescribe Herceptin to patients with early stage breast cancer. However, the national cancer research institute (NCRI) has produced a United Kingdom clinical guideline on the use of Herceptin for early breast cancer. This provides useful information to those considering prescribing Herceptin for this indication in advance of a decision on licensing and the publication of National Institute for Health and Clinical Excellence guidance. The NCRI guidance was brought to the attention of PCTs via Issue 300 of the chief executive's bulletin published on 13 January 2006.
The cost of Herceptin for the treatment of early stage breast cancer is estimated to be in the region of £20,000 per patient per year. The cost per PCT would depend on the number of women diagnosed with HER2+ early stage breast cancer in each PCT for whom Herceptin might be appropriate.
Mr. Paterson: To ask the Secretary of State for Health what European drug prescription agencies have issued guidelines on the prescription of Herceptin to patients with early stage breast cancer. 
Andy Burnham: Herceptin is a centrally authorised product across the European Union (EU). This means that, rather than each country's licensing body assessing the safety and efficacy of this drug, it is assessed by the European Medicines Agency (EMEA)which has representation from each member state's licensing body. The regulatory indication approved by the EMEA applies to all member states.
Herceptin currently has an EU-wide licence for use treating advanced breast cancer and an application is currently being processed by the EMEA to extend this licence to include the adjuvant treatment of early stage breast cancer. At the end of April, the EMEA's committee for medicinal products for human use recommended that Herceptin be approved for this indication. The next stage in the regulatory process is for the European Commission to evaluate this recommendation with a view to issuing marketing authorisation in the EU. A decision is expected in a few weeks.
The Department does not hold up-to-date information about what, if any, guidance bodies elsewhere in Europe may have issued about use of Herceptin for early stage breast cancer prior to a decision on licensing. This information can be obtained only at disproportionate cost.
Andy Burnham: For any new appliance to be prescribed on the national health service by a general practitioner, it must be listed under Part IX of the Drug Tariff. A listing on Part IX is only possible following a successful application from the appliance manufacturer. This involves consideration of its effectiveness compared to other products, its impact on quality of life, suitability for prescribing in primary care, and price. On listing there are agreed arrangements for funding.
If the appliance manufacturer wishes to make an application to place their product on Part IX of the Drug Tariff, they should contact the prescription pricing division of the Business Services Authority.
Anne Main: To ask the Secretary of State for Health (1) what contingency plans have been made by (a) her Department and (b) Wockhardt UK to ensure that supplies of animal insulins are sufficient to enable their continued and widespread use when Novo Nordisk supplies are no longer available; 
(2) what alternative sources of animal insulins are under consideration from outside the UK to supply the needs of UK users in the event of Wockhardt UK experiencing further difficulties of production and supply; and if she will make a statement. 
Andy Burnham: The Department is in regular contact with Wockhardt. The company is currently enhancing its production capacity. It is working towards building contingency stocks for each of its insulin presentations. It is also taking steps to identify a contract manufacturer as a back-up in the event of problems at its current manufacturing site.
The Department is aware of other possible suppliers of animal insulin elsewhere in the world, but it is up to individual companies to decide where they market their products. The Department is not aware of any companies from outside the United Kingdom (UK) who plan to market animal insulin in the UK.
Anne Main: To ask the Secretary of State for Health (1) what proportion of insulin products in use in the UK have been fully assessed for their (a) comparative clinical and cost-effectiveness and (b) long-term safety and efficacy by the National Institute for Health and Clinical Excellence; and if she will make a statement; 
(2) if she will refer all insulin products to the National Institute for Health and Clinical Excellence (NICE) for a comparative clinical and cost-effectiveness and long-term safety and efficacy evaluation with a request that NICE develops standard guidance on the use of insulins; and if she will make a statement. 
Andy Burnham: All licensed insulins have been fully assessed and found to satisfy the regulatory requirements for quality, safety and efficacy. The safety of human insulins in clinical practice is continually monitored by the Medicines and Healthcare products Regulatory Agency and the European Medicines Agency.
Clinical guidelines produced by the National Institute for Health and Clinical Excellence on the management of both type one and type two diabetes conclude that the majority of studies indicate that both human and animal insulins are equally effective and report no significant differences in hypoglycaemic episodes and glycaemic control between the insulin of human and animal chemical structures.
Andy Burnham: The NHS Purchasing and Supply Agency does not currently contract for these two products. The price that national health service trusts in England pay is the published list price less wholesaler discount which would normally be around 11 per cent.
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