§ Mr. SandersTo ask the Secretary of State for Health pursuant to the answer of 23 June 2004,Official Report, column 1434W, on insulin, if he will place in the Library details of contacts between his Department and companies that supply insulin. [184405]
§ Ms Rosie WintertonThe information requested cannot be provided without incurring disproportionate cost, or without breaching commercial confidentiality (exemption 13 of the open government code applies).
My noble Friend, the Parliamentary Under-Secretary of State (The Lord Warner), who has responsibility for pharmaceutical industry matters will write to the hon. Member with an overview of the current situation regarding the supply of insulin shortly. A copy of this letter will be placed in the Library.
§ Mr. AmessTo ask the Secretary of State for Health pursuant to his answer of 28 June 2004,Official Report, column 106W, whether the licensing process compared mortality rates, the development of diabetic complications and the quality of life of those using animal and synthetic insulin; and if he will make a statement. [184700]
§ Ms Rosie WintertonAll authorised insulins, whether human (synthetic) insulin or animal insulin, have been demonstrated to be efficacious in people with diabetes mellitus. As part of the licensing approval process for 907W any medicinal product, including insulins, the applicant has to provide evidence that the product meets appropriate standards of quality, safety and efficacy. These standards are set out in European Guidance documents, including, for example, "Notes for Guidance on Clinical Investigation of Medicinal Products in the Treatment of Diabetes Mellitus" (CPMP/EWP/1080/00). This will include clinical trial data of appropriate duration in patients with diabetes as set out in the guidance document. The primary purpose of the confirmatory studies involving the assessed insulin is to demonstrate a favourable effect on blood glucose control (this is considered clinically relevant in terms of risk reduction of diabetic complications).
Data on mortality rates, development of diabetic complications and quality of life are not necessarily required for the licensing process. Additionally, there are no requirements for comparative studies between animal and synthetic insulins as part of the licensing process. Therefore, the licensing process has not compared mortality rates, development of diabetic complications or the quality of life of patients using animal and synthetic insulins. After licensing, all drugs, including insulins, are continually monitored for safety. The decision to use one or other of the insulins rests with the physician in consultation with the patient.
The committee on safety of medicines and its subcommittee 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 blood glucose control or 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 a safety problem specific to human insulin.