To ask the Secretary of State for Health whether she has submitted a request to the National Institute for Health and Clinical Excellence to undertake a comparison of the different types of insulin in its future work programme. (129918)

[holding answer 26 March 2007]: I refer the hon. Member to the reply given on 21 March 2007, Official Report, column 1013W.

To ask the Secretary of State for Health pursuant to the answer of 2 February 2007, Official Report, column 546W, on insulin, (1) what adverse effects are associated with the use of (a) animal insulins, (b) synthetic human insulins and (c) analogue insulins; what the incidence is of each effect; and if she will make a statement; (130721)

Detailed information regarding the adverse effects known or suspected to be associated with a medicine is provided in the summary of product characteristics (the product information for prescribers) and the patient information leaflet.

Generally the side effects observed are broadly similar for all types of insulins with the most commonly observed side effects being hypoglycaemia, visual disturbance and injection site reactions. Tables which summarise the current knowledge of frequencies of adverse reactions with different insulins have been placed in the Library. These provide a breakdown of the types of adverse effects and their frequencies, where known. The tables contain the information relating to animal, human and analogue insulins and are separated by the classification of the medicine into the following four groups: rapid; intermediate; long and biphasic action. It is important to note that a report of an adverse reaction does not necessarily mean that the drug caused it and a number of the adverse reactions reported by patients treated with insulin may be due to the underlying diabetes.

There is less information available on the frequency of side effects for some of the older products. Guidelines for the investigation of the safety and efficacy of new medicinal products have developed over the years and the evidence base available for older products tends to be much less than that available for newer products such as the insulin analogues.

The following aspects of the product are evaluated in detail as the evidential basis for the assessment of safety and efficacy of the analogue insulins:

Manufacturing data, including biological purity, stability and viral removal processes;

Laboratory testing of the product activity such as its binding to the relevant tissues;

Testing on animals for safety and activity;

Clinical trials in healthy volunteers and/or patient volunteers to;

Establish the mechanism of action;

Study distribution of the product within human body;

Evaluate safety in sufficient numbers of volunteers to reflect safety issues that would be usually expected in clinical practice; and

Evaluate efficacy in sufficient number of volunteers to demonstrate that the product in question would be clinically useful as intended.

If it is considered that benefit versus risk profile of the product is positive, on the basis of aforementioned evaluation, a recommendation to license the product would normally be made.

A summary of the available data on safety and effectiveness submitted in support of the licence applications for many of the insulin analogues is made publicly available in the form of a European Public Assessment Report available on the website of the European Medicines Agency (www.emea.europa.eu).

Assessing the cost-effectiveness of a treatment is the responsibility of the National Institute for Health and Clinical Excellence (NICE). The Appraisal Committee of NICE are asked to take account of the overall resources available to the national health service. Decisions on the cost-effectives of a treatment must include judgments on the implications for other patient groups.