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Alpha-1-antitrypsin
Dr. Kumar: To ask the Secretary of State for Health if he will make a statement on the (a) creation and (b) use of alpha-1-antitrypsin; and what Government research has been conducted into the effect of humans using the compounds. [20918]
Ms Blears: There are two sources of alpha-1-antitrypsin (AAT) that have been used for therapeutic purposes. Partially purified AAT may be manufactured from pooled human plasma. Recently, AAT has been synthesised with the use of recombinant technology.
Clinical trials have been undertaken in North America and Europe to evaluate the safety and efficacy of therapy with partially purified human AAT given by intravenous infusion in patients with emphysema.
More recently clinical trials of partially purified human or recombinant AAT administered by aerosol therapy to the lungs have been undertaken.
Details of these trials may be found on the websites www.aventisbehring.com/aventisbehring/newsandevents/ alphaclintrial. asp. and www.ppl-therapeutics.com/ Welcome/Products/Product1/bodyproduct1.html.
There have been several trials in national health service hospitals on various aspects of the use of AAT. Details of projects, completed and ongoing, can be found on the National Research Register, which is available on the internet at http://www.doh.gov.uk/research/nrr.htm.
Medical Staff (Assaults)
Dr. Evan Harris: To ask the Secretary of State for Health how many assaults there have been on
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(a) ambulance staff/paramedics and (b) clinical staff in accident and emergency departments in hospitals in each year since 1997. [20832]
Mr. Denis Murphy: To ask the Secretary of State for Health how many (a) health service staff working in accident and emergency departments and (b) ambulance staff have suffered (i) verbal and (ii) physical abuse while carrying out their duties in each of the last five years. [21467]
Ms Blears: Information on the levels of verbal and physical abuse by individual staff group is not collected centrally, but may be held at a local level by national health service employers. Data on violent incidents involving all staff in the NHS were not collected centrally for 1996–97 or 1997–98.
The Department conducted a survey of NHS trusts in England in 1998–99. The survey found that, on average, seven violent incidents were recorded each month per 1,000 staff. This is equivalent to approximately 65,000 violent incidents against NHS trust staff each year. Details of the survey can be found in Health Service Circular 1999/229: "Managing Violence, Accidents and Sickness Absence in the NHS", a copy of which is in the Library.
Figures for recorded violent incidents in 2000–01 are currently being analysed by the Department.
Pharmacy Staff
Mr. Todd: To ask the Secretary of State for Health what recent representations he has received concerning the availability of (a) trained pharmacists and (b) other staff within pharmacy. [21080]
Ms Blears: The Department has received a number of representations from organisations with an interest in pharmacy.
We recognise that, in spite of increasing training places and introducing recruitment and retention initiatives, there have been problems in recruiting pharmacists particularly over the last year. This is a result of the switch from a three to a four-year undergraduate pharmacy course in 1997 and growing demand for pharmacists, particularly in primary care. Skill mix initiatives have increased the demand for other staff within pharmacy leading to shortages in some areas.
The increases in pharmacy student intakes—27 per cent. more new students started training in 2000 than in 1993—point to a significant medium term-growth in the pharmacy workforce despite the change to a four-year undergraduate course. Workforce modelling undertaken by the Department suggests that there will be a 12 per cent. increase in the pharmacy workforce across the national health service and private sector between 1998 and 2003.
Food Supplements
Dr. Fox: To ask the Secretary of State for Health what assessment he has made of the prospect of securing an extension to the deadline proposed in the forthcoming European Directive on Food Supplements for the submission of detailed safety dossiers to the Scientific Committee for Foods in relation to safe nutrients which are available in the United Kingdom but which are not provided for in the proposed Directive. [21695]
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Ms Blears: The Food Standards Agency, which is responsible for negotiating this Directive on behalf of the Government, has been unable to secure an extension of this deadline.
Dr. Fox: To ask the Secretary of State for Health what position his Department has taken in relation to amendments to European medicines directives that would require food supplements to be considered to be medicines; and if he will make a statement. [21696]
Ms Blears: The European Commission sent their proposals to amend the European medicines legislation to the European Parliament and to the Council of Ministers on 26 November 2001, formally launching the legislative process. The Medicines Control Agency (MCA) will be leading for the United Kingdom Government in the forthcoming negotiations on the European Commission's proposals. The MCA is currently considering the implications of the European Commission's proposals, and is consulting other Government Departments with an interest in the proposal to amend Article 2.2 of the Human Medicines Code. The MCA will also be undertaking a wide-ranging public consultation on the proposals in the new year.
Dr. Fox: To ask the Secretary of State for Health what plans he has to meet (a) Consumers of Health Choice, (b) the National Association of Health Stores and (c) the Health Food Manufacturers Association to discuss the implications of the proposed EU Food Supplements Directive for United Kingdom (i) consumers, (ii) retailers and (iii) manufacturers. [21682]
Ms Blears: None. Officials from the Food Standards Agency, which is responsible for negotiating this Directive on the Government's behalf, are in regular contact with all interested parties to discuss progress on and interpretation and implications of the proposed Directive.
Dr. Fox: To ask the Secretary of State for Health (1) what plans he has to ask the European Commission to indicate the way in which it intends to interpret Article 5 of the proposed European Directive on Food Supplements; [21722]
- (2) what assessment he has made of the extent to which the forthcoming EU Food Supplements Directive would (a) permit and (b) require the setting of maximum permitted levels for vitamins and minerals at or close to the upper safe level for such nutrients; [21693]
(3) what assessment he has made of the meaning and practical implications of the requirement in Article 5 of the proposed European Directive on Food Supplements to take account of specified factors. [21721]
Ms Blears: Article 5 of the Directive, which lists a number of matters which need to be considered when setting maximum limits, would permit but not require maximum limits to be set at levels close to the upper safe level. Upper safe levels are listed as the first consideration, but it is not clear to what extent other factors, like measures of supposed need, will influence the Commission's proposals. We currently have no plans to press for clarification of this point. The Food Standards Agency, which is responsible for negotiating this Directive on the Government's behalf, has sought clarification without success, and is now concentrating on
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pressing the Commission to base its proposals on thorough scientific risk assessments, and arguing this case with other member states.
Dr. Fox: To ask the Secretary of State for Health what assessment he has made of the impact of the proposed EU Food Supplements Directive on the United Kingdom specialist food supplement (a) market and (b) consumers; and if he will make a statement. [21686]
Ms Blears: The Food Standards Agency, which is responsible for negotiating this Directive on the Government's behalf, has consulted widely on its likely impact. There would be labelling costs falling on manufacturers of all food supplements, but these would be substantially offset by a two-year transitional period. For the specialist food supplement sector and consumers of these products any additional impact would depend on future developments on lists of permitted nutrients and maximum limits.
Dr. Fox: To ask the Secretary of State for Health if he will make a statement on the timetable for the publication of the proposed (a) draft and (b) final versions of the forthcoming report from the Ad Hoc Expert Group on Vitamins and Minerals; what the scope is of that report; and what steps he is planning to take to promote its findings to (i) the European Commission, (ii) the European Union's Scientific Committee for Food and (iii) other member states of the European Union. [21694]
Ms Blears: The risk assessments for vitamins and minerals being undertaken by the Expert Group on Vitamins and Minerals will be issued for public consultation in early 2002, with a view to publishing the final report in the spring. There is cross-membership between the Expert Group and the Scientific Committee on Food which has already received all papers prepared for consideration by the Expert Group. The European Commission, EU member states and the Scientific Committee on Food will be sent copies of the report at both stages. The final report will inform the United Kingdom position in respect of the EU Directive on Food Supplements.
Dr. Fox: To ask the Secretary of State for Health how many (a) nutrients and (b) nutrient sources would be permitted under the forthcoming European Directive on Food Supplements; what steps he is taking to identify safe nutrients which are available on the United Kingdom market but are not on the lists in the Directive; and how he plans to ensure that United Kingdom (i) manufacturers, (ii) retailers and (iii) consumers may use these nutrients once the Directive is implemented. [21691]
Ms Blears: The Directive lists nutrients and nutrient sources permitted for use in food supplements; the lists currently include 28 nutrients and 112 nutrient sources. We are aware that many nutrients used in the United Kingdom are not on the lists and plan to allow additional substances to be used by all parties during the optional seven year transitional period which was written into the Directive at our request. We have no plans to prepare a list of these substances; manufacturers and retailers are understood to be compiling such lists and co-operating over submission of dossiers supporting addition of these substances to the 'permitted' lists. These substances would then be available for use throughout the European Union.
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Dr. Fox: To ask the Secretary of State for Health what his policy is on protecting the existing United Kingdom market in safe higher potency vitamins and minerals in negotiations on the interpretation of Article 5 of the forthcoming proposed European Directive on Food Supplements. [22368]
Ms Blears [holding answer 11 December 2001]: We oppose any unnecessary restrictions on the range of products available to consumers. We are therefore pressing the European Commission to propose maximum limits for vitamins and minerals in food supplements which are close to the upper safe levels.
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