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Vitamins and Herbs
Mr. Mitchell: To ask the Secretary of State for Health what plans the Medicines Control Agency has to review the guidance in Medicines Act Leaflet Number 8; and what is the status of that leaflet. [61618]
Ms Jowell: The Medicines Control Agency will review its Guidance Leaflet (Medicines Act Leaflet 8: "A Guide to What is a Medicinal Product") to reflect any changes to medicines legislation which are approved by Parliament following the conclusion of its present consultation exercise on proposals to place the classification process for "borderline products" on a statutory basis. The leaflet is for guidance only.
Mr. Mitchell: To ask the Secretary of State for Health if a manufacturer of a blend of herbs and vitamins which is assessed by the Medicines Control Agency as medicinal by presentation is given the opportunity to review the presentation of that product prior to enforcement action being taken. [61639]
Ms Jowell: When notifying a manufacturer that it has determined a product is a medicine because it is presented for treating or preventing disease, the Medicines Control Agency requires compliance with the law by withdrawal of the product. The manufacturer may subsequently be able to comply with the law by placing the product on the market in a way which does not present it as treating or preventing disease.
Mr. Mitchell:
To ask the Secretary of State for Health what plans officials in (a) his Department and (b) the
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Medicines Control Agency have to meet manufacturers of vitamin and herb blends to discuss the licensing of their products as medicines in the United Kingdom. [61669]
Ms Jowell:
Officials of the Medicines Control Agency (MCA), an executive agency of the Department, regularly meet the associations representing manufacturers of these products. When necessary, officials of the MCA also meet individual manufacturers to discuss the licensing of their products.
Mr. Mitchell:
To ask the Secretary of State for Health by what criteria the Medicines Control Agency assesses whether a blend of herbs and vitamins is medicinal by (a) function and (b) presentation; and if a manufacturer whose products are so assessed is given a written statement of the reasons for that decision. [61638]
Ms Jowell:
The Medicines Control Agency (MCA) assesses products against the definition of a medicinal product in European Commission and United Kingdom law. It also has regard to legal precedent and its own published guidance (Leaflet MAL 8: "A Guide to What is a Medicinal Product"). Broadly, the assessment of a product's functionality focuses on the pharmacological effect of its ingredient(s) on human physiology, while the assessment of a product's presentation considers a whole range of factors, including any claims made for the product in promotional material or on its labelling and packaging (whether explicit or implied), its name, the form, and the consumers targeted. The MCA also considers the opinion of the product's purpose an averagely well informed consumer would gain from its ingredient(s) and presentation. It is normal practice for the MCA to explain to the manufacturer the grounds for a classification decision.
Mr. Mitchell:
To ask the Secretary of State for Health if the Medicines Control Agency consults independent scientific experts when considering whether a herb and vitamin blend is medicinal by function; and if the manufacturer of such a product is able to have access to expert advice obtained by the agency. [61637]
Ms Jowell:
The Medicines Control Agency (MCA) generally relies on the objective and expert advice of its own medical and pharmaceutical assessors. However, there are occasions when taking advice from external experts is appropriate. The MCA informs manufacturers of the impact of expert advice when classifying their products.
Mr. Llew Smith:
To ask the Secretary of State for Health what requests he has made to the manufacturers of MR and MMR vaccines for data on the possible side-effects of their products. [61612]
Ms Jowell:
Since 1988 the Medicines Control Agency (MCA) has requested information from the manufacturers of measles, mumps and rubella vaccine about aseptic meningitis and idiopathic thrombocytopenic purpura.
Manufacturers have an ongoing obligation to provide to the MCA all serious suspected adverse reactions within 15 days of receipt, and to provide periodic safety update reports at specified intervals.
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In addition, manufacturers may be requested at any time to provide further information necessary for the evaluation of the risks and benefits of a medicine.
Dr. Brand:
To ask the Secretary of State for Health how many medical negligence cases have been settled out of court in each of the last three years; and how many of the medical practitioners who have accepted medical negligence through an out of court settlement have been referred to the General Medical Council. [61799]
Mr. Milburn:
The information requested is not collected centrally.
Mr. Cotter:
To ask the Secretary of State for Health how many people have been diagnosed with cardiac disease or illness in each of the last five years; and how many of those people have died as a result of that disease or illness. [61945]
Mr. Hutton:
The number of people diagnosed with cardiac disease or illness is not available. The Health Survey for England 1994 showed that, overall, 23.7 per cent. of men reported suffering from a cardiovascular disorder, as did 25.7 per cent. of women. However, this could include a wide range of conditions such as raised blood pressure, heart murmurs or irregular rhythms, angina, strokes and heart attacks.
| Specialty | Ordinary admissions | Day cases | Total |
|---|---|---|---|
| Cardiothoracic surgery | 63,224 | 3,066 | 66,290 |
| Cardiology | 121,212 | 27,757 | 148,969 |
| Totals | 184,436 | 30,823 | 215,259 |
| Year | EASR(22) | Deaths |
|---|---|---|
| 1990 | 207.4 | 138,154 |
| 1991 | 206.0 | 139,961 |
| 1992 | 197.9 | 136,118 |
| 1993 | 195.5 | 136,160 |
| 1994 | 179.3 | 125,962 |
| 1995 | 173.6 | 123,886 |
| 1996 | 167.3 | 120,792 |
| 1997 | 157.7 | 114,849 |
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| Year | EASR(22) | Deaths |
|---|---|---|
| 1990 | 292.9 | 200,728 |
| 1991 | 292.3 | 204,244 |
| 1992 | 279.9 | 198,244 |
| 1993 | 270.1 | 193,423 |
| 1994 | 250.3 | 180,837 |
| 1995 | 244.2 | 179,594 |
| 1996 | 237.6 | 176,884 |
| 1997 | 225.0 | 168,995 |
| Year | EASR (22) | Deaths |
|---|---|---|
| 1990 | 351.7 | 242,205 |
| 1991 | 348.8 | 244,778 |
| 1992 | 334.4 | 237,982 |
| 1993 | 334.0 | 240,609 |
| 1994 | 310.5 | 225,561 |
| 1995 | 305.1 | 225,511 |
| 1996 | 297.7 | 222,695 |
| 1997 | 283.7 | 214,104 |
(22) European Age Standardised Rate per 100,000 population (EASR) is the most meaningful illustration. However it helps to know what this represents in actual bodies so we have included numbers of deaths
Waiting Lists
Mr. Brady: To ask the Secretary of State for Health if he will issue guidelines to all health authorities requiring that patients should not be removed from waiting lists at the time that they are booked for an operation. [61843]
Mr. Milburn [holding answer 1 December 1998]: Waiting lists should include both patients who have been given a date for admission and those waiting to be notified of one. This is set out clearly in NHS Waiting Times Guidelines for Good Administrative Practice, issued to health authorities and trusts in January 1996. Copies are available in the Library.
Elderly Patients (Emergency Readmissions)
Mr. Burstow: To ask the Secretary of State for Health if he will publish the first and second quarter figures for 1998-99 for the number of patients aged 75 years and over who were readmitted to hospital as an emergency within 28 days of discharge. [61872]
Mr. Milburn [holding answer 1 December 1998]: The number of patients aged 75 and over who were readmitted as an emergency within 28 days of discharge in the first two quarters of 1998-99 is shown in the table. The table also shows this figure as a percentage of people over 75 who have been discharged from hospital in the previous 90 days.
| Number of readmissions | As a % of discharges | |
|---|---|---|
| Q1 | 29,506 | 8.6 |
| Q2 | 29,076 | 8.1 |
Source:
NHS Executive Quarterly Monitoring Activity data 1998-99.
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