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Mr. Steen: To ask the Secretary of State for Health if he will take steps to give Synthetic Insulin Tolerance Syndrome drug protection under orphan drug status; and if he will take steps to ensure there are adequate available supplies of animal insulin from British animals. 
Ms Rosie Winterton: The decision on granting orphan designation rests with the European Commission, based on advice received from the Committee for Orphan Medicinal Products of the European Medicines Agency. The procedures established for sponsors to apply for orphan designation, and the criteria upon which a decision on orphan designation is based, are described in the European Parliament and the Council Regulation (EC) 141/2000 and the Commission Regulation (EC) 847/2000.
Mr. Steen: To ask the Secretary of State for Health (1) if he will request the Committee on the Safety of Medicine to review its data on the application of insulin treatment for diabetic patients; and if he will list licensed manufacturers of human insulin; 
(2) if he will list the ingredients in human insulin used to treat the symptoms of diabetes; and what steps are taken to ensure that diabetic patients injecting human insulin are advised of the likely side effects; 
(3) how many reports were made to the Committee on the Safety of Medicines (CSM) about adverse drug reactions for the application of human insulin to diabetic sufferers in each of the last three years; how many human insulin drugs have been issued with a licence by the CSM; and if he will instruct the CSM to obtain all trial data on the effects of human insulins on diabetics. 
Ms Rosie Winterton: All new United Kingdom drug applications, including insulins, are evaluated by the committee on safety of medicines (CSM), which advises the Licensing Authority as to whether a marketing authorisation should be granted. The European applications are evaluated by the committee for medicinal products for human use (CHMP) on behalf of the European Medicines Agency (EMEA). The applicant will include, in their submission, results of clinical trials conducted in the proposed indication for which the licence is sought. Therefore the data, including clinical trial data, on the effects of human insulins on diabetics is considered with each application. The CSM has kept the safety of human insulin under close review and considered the available data on a number of occasions.
Reports of "suspected" adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and CSM through the spontaneous reporting scheme, the yellow card scheme. Approximately 20,000 reports of ADRs are reported to the MHRA/CSM through this scheme each year.
|Total number of reports received|
It is important to note that a report of an adverse reaction 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 underlying disease. Additionally, the use of medicines may vary between different age groups. Use of medicines in the elderly, for example, is higher than in other age groups and elderly patients are more likely to be using combinations of medicines. The number of reports received via the yellow card scheme does not directly equate to the number of people who suffer adverse reactions to drugs for a number of reasons as this scheme is associated with an unknown level of under-reporting.
The ingredient in human insulin used to treat the symptoms of diabetes is insulin. Other ingredients are to formulate the product and are: glycerol, phenol, metacresol, zinc chloride, sodium chloride, disodium phosphate dehydrate, sodium hydroxide, hydrochloric acid and water for injection.
There are 213 individual marketing authorisations for human and/or recombinant insulins in the UK, of which 18 were authorised by the UK's MHRA. All other licences are European authorisations and were authorised by the European Commission, following assessment by the EMEA. The 18 licences authorised by the Medicines Control Agency/MHRA are all manufactured by Novo Nordisk in France.
Miss McIntosh: To ask the Secretary of State for Health if he will make a statement on the use of locum doctors under the new out-of-hours arrangements for general practitioners in North Yorkshire. 
Miss Melanie Johnson: North and East Yorkshire and Northern Lincolnshire Strategic Health Authority estimates that around 20 per cent. of the out of hours general practitioner services provided by North Yorkshire emergency doctors is currently provided by locum doctors.
Dr. Murrison: To ask the Secretary of State for Health what assessment he has made of whether small businesses will be the subject of vexatious litigation arising from the proposal to challenge discrimination against people with mental health difficulties, referred to in the Choosing Health White Paper; and what discussions he has had with other Government Departments in making this assessment. 
Ms Rosie Winterton: No assessment has been made of the risk of vexatious litigation arising from those wishing to challenge discrimination against people with mental health difficulties. The policies set out in "Choosing Health" were developed after wide ranging consultation and we will be working with key stakeholders in their planning and implementation.
Ms Rosie Winterton: The information requested is not centrally available. In accordance with our policy of shifting the balance of power, supported by other national policy documents such as the national service framework for mental health, primary care trusts in conjunction with their strategic health authorities and other local stakeholders are responsible for assessing local health needs, and planning the allocation of their resources accordingly.
Ms Rosie Winterton:
The requested information is not yet available. Progress on the number of graduate primary care mental health workers employed in the
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national health service will be available when the Durham adult mental health service mapping is finalised in May 2005.
Miss Melanie Johnson: Expert advice from the committee on medical aspects of food policy is that goats' milk, like cows' milk, is low in iron, vitamins A and D and is also low in folic acid compared to human and cows' milk. Goats' milk is often perceived as being less allergenic than cows' milk, or else providing additional nourishment, although these claims have not been substantiated. Infant formulas and follow-on formulas based on goats' milk have not been approved for use in Europe and are not recommended by the Department.
It is for these reasons that goats' milk isexcluded from the Welfare Food Scheme. Where a child has a diagnosed intolerance to cows' milk, a doctor may prescribe a suitable alternative. Prescriptions are, of course, free for children and those in receipt of income support.
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