§ Mr. AmessTo ask the Secretary of State for Health (1) what estimate he has made of the number of patients who are suited to treatment with animal insulin rather than synthetic insulin; [137592]
(2) how many people with diabetes require (a) animal insulin and (b) synthetic insulin; [137597]
(3) what representations his Department has received from patients about the suitability of synthetic insulin. [137600]
§ Ms Rosie WintertonData on the number of people using these insulins are not collected. However, the table shows the number of prescription items that were dispensed in the community in England, and their cost, in the 12 months ended June 2003.
Decisions on the most suitable type of insulin should be made by people with diabetes in consultation with their healthcare providers. The Department has received no representations about the suitability of synthetic insulin.
Number of prescription items and net ingredient cost of Insulins that were dispensed in the community in England for the 12 months ending June 2003 Number of prescription items (thousand) Net ingredient cost (£000) Highly purified animal insulin 128.1 4,217.2 Human sequence (GM Insulin) 3,522.0 150,528.8 All Insulins 3,650.0 154,746.0 Notes
1. The data is from the Prescription Cost Analysis (PCA) system which covers all prescription items that are dispensed in the community in England. This does not include drugs dispensed in hospitals or private prescriptions.
2. Insulins are those defined in the British National Formulary (BNF) paragraph 6.1.1, "Insulins". Insulin drugs have been grouped into highly purified animal and human sequence (GM) insulin in line with the British National Formulary (BNF).
3. Doctors write prescriptions on a prescription form. Each single item written on the form is counted as a prescription item. The net ingredient cost refers to the cost (which the dispenser is reimbursed) of the drug before discounts and does not include any dispensing costs or fees.
596W
§ Mr. AmessTo ask the Secretary of State for Health (1) what evidence he has received on adverse reactions to synthetic insulin among diabetics which were not experienced when animal insulin was used; and if he will make a statement; [137593]
(2) what plans he has to issue guidance to the medical profession about adverse reactions to synthetic insulin; [137595]
(3) what studies he has (a) commissioned and (b) received on the suitability of synthetic insulin for treatment of diabetes; [137598]
(4) what steps his Department takes to avail itself of research from a wide range of sources into the safety and suitability of synthetic insulin. [137599]
§ Ms Rosie WintertonThe Committee on Safety of Medicines (CSM) and its Sub-Committee on Pharmacovigilance (SCOP) have kept the safety of synthetic (human) insulins under close review and have considered the available data on a number of occasions. Most recently in 2002, the SCOP considered the findings of an independent review of controlled clinical trial data by the Cochrane Collaboration. The conclusions of the Cochrane review were that there is no difference in the incidence of adverse events between patients on synthetic insulin compared with patients on animal insulins. The SCOP confirmed its previous advice that there is no clear evidence of safety problem specific to human insulin. However, the issue will be reviewed again should further information become available.
The Medicines and Healthcare products Regulatory Agency (MHRA) receives reports of suspected adverse drug reactions (ADRs) via the Yellow Card scheme. The most commonly reported suspected ADRs with both synthetic (human) and animal insulins are disorders of metabolism and nutrition such as hypoglycaemia and hypoglycaemia unawareness, followed by skin and subcutaneous tissue disorder such as injection site reaction. However the reporting of a reaction does not necessarily mean that the drug caused the problem.
A higher number of suspected ADR reports have been received in association with synthetic insulin through the Yellow Card Scheme, however this may reflect the fact that 80 per cent. of patients with Type 1 Insulin Dependent Diabetes Mellitus are estimated to be receiving synthetic insulin in the United Kingdom.
Full guidance on prescribing and use of synthetic insulins, including possible side effects, is provided in the product information for prescribes and patients. This includes warnings about the risk of hypoglycaemia unawareness particularly upon transfer from animal insulins to synthetic insulins. Key prescribing information is also included in the British National Formulary, which is sent by the Department to doctors and pharmacists.
Both human and animal derived insulins are currently available and the MHRA is not aware of any specific plans for the discontinuation of production of animal derived insulins. However, decisions as to the most suitable type of insulin for particular patients are clinical matters and must be made by individual doctors.
597W
§ Mr. AmessTo ask the Secretary of State for Health if he will meet representatives of the Insulin Dependent Diabetes Trust to discuss the continued(a) choice between and (b) availability of (i) synthetic and (ii) animal insulin. [137594]
§ Ms Rosie WintertonI am not aware of any problems with either the choice between or availability of the various types of insulin. I should, however, be interested to have details of the Insulin Dependent Diabetes Trust's concerns and would be happy for them to write to me in the first instance.
§ Mr. AmessTo ask the Secretary of State for Health what steps he will take to ensure competition in(a) the manufacture of insulin and (b) the manufacture of different types of insulin for treatment of diabetes; and if he will make a statement. [137596]
§ Ms Rosie WintertonThe Department, working closely with other bodies such as the NHS Purchasing and Supply Agency and pharmaceutical companies, has arrangements in place to ensure security of supply of medicines.
In addition the Pharmaceutical Price Regulation Scheme aims to:
secure the provision of safe and effective medicines for the NHS at reasonable prices;promote a strong and profitable pharmaceutical industry capable of such sustained research and development expenditure as should lead to the future availability of new and improved medicines;encourage the efficient and competitive development and supply of medicines to pharmaceutical markets in this and other countries.Finally, the patent system provides considerable incentives for companies to compete in the development of new and innovative medicines.