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Social care. Written evidence 15 October 2009.

Type

House of Commons papers; Select Committee written evidence; Parliamentary committees

Committee

Health Committee

Date

15 October 2009

Reference

HC 1021 2008-09

House

House of Commons

Patient safety. Memoranda in the form of evidence laid before the Health Select Committee.

Type

House of Commons papers; Select Committee written evidence; Parliamentary committees

Committee

Health Committee

Notes

Report published as HC 151 2008-09

Date

30 October 2008

Reference

HC 1137 2007-08

House

House of Commons

National Institute for Health and Clinical Excellence (NICE). Memoranda in the form of evidence laid before the Health Select Committee.

Type

House of Commons papers; Select Committee written evidence; Parliamentary committees

Committee

Health Committee

Notes

Report printed as HC 27 2007-08

Subjects

Assessments; Companies; Cost effectiveness; Finance; Licensing; Drugs; NHS; Medical treatments; Patients; Prescription drugs; Public expenditure; Primary care trusts; Prices; National Institute for Health and Care Excellence; Standards; Technology; British Medical Association; Pfizer; Alzheimer's Society; National Osteoporosis Society; Multiple Sclerosis Society; Clinical trials; Royal College of Nursing; Bioindustry Association; British Psychological Society; Cancer Research UK; Diabetes UK; Hepatitis C Trust; British Association for Counselling and Psychotherapy; Help the Aged; Motor Neurone Disease Association; Royal College of Midwives; Amgen Roche; Association of British Healthcare Industries; AstraZeneca; Arthritis and Musculoskeletal Alliance; Breakthrough Breast Cancer; Cancerbackup; Continence Foundation; Cystic Fibrosis Trust; JEC; Medical Technology Group; National Infertility Awareness Campaign; National Childbirth Trust; Myalgic Encephalomyelitis Association; National Rheumatoid Arthritis Society; Royal College of Paediatrics and Child Health; Roche; Sanofi-Aventis; Wyeth; Academy of Medical Sciences; Roy Castle Lung Cancer Foundation; Specialised Healthcare Alliance; Medtronic; American Pharmaceutical Group; Archimedes Pharma; Beat; Bayer Schering Pharma; British Society for Rheumatology; Bristol Myers Squibb Pharmaceuticals; Deltex Medical; Eli Lilly; European Medicines Group; Ethical Medicines Industry Group; FEmISA; Improving Surgical Outcomes Group; Institute for Innovation and Valuation in Health Care; Kidney Cancer UK; Kinetic Concepts; Leukaemia Care; Merck; Myeloma UK; Pelvic Pain Support Network; Rarer Cancers Forum; Royal College of Physicians of Edinburgh; Sirtex Medical; Servier Laboratories; 25% ME Group; Meads, Catherine; Bouder, Frederic; Barkham, Michael; Lofstedt, Ragnar; Simkin, Sandra; Austin, Daphne; Jones, Doris; Hooper, Malcolm; Chalmers, Iain; Hyde, Chris; Lee, Gay; Evans, Imogen; Marshall, Tom; Lee, Michael; Telford, Peter; Walsh, John; Syrett, Keith; Thornton, Hazel; Thomson, David; Woodward, Rose

Date

26 April 2007

Reference

HC 503 2006-07

House

House of Commons

Warner, Lord

Whether any combined measles, mumps and rubella vaccine manufactured by either GlaxoSmithKline or Aventis or any of their predecessor companies, and used in the United Kingdom, has contained the mercury-based thimerosal. [HL 1973].

Asked by

Countess of Mar (Crossbench)

Type

Written questions

Status

Answered

Date

29 March 2004

Reference

HL 1973; 659 c140WA

House

House of Lords

Dept for Environment Food and Rural Affairs

To ask the Secretary of State for Environment, Food and Rural Affairs, on what basis the herbicide regime for use on GM maize was chosen for the farm-scale trials; what role Aventis (now Bayer) had in its choice; what international research was conducted to establish whether this was a commercially...

Asked by

Michael Meacher (Labour)

Answering body

Department for Environment, Food and Rural Affairs

Type

Written questions

Status

Answered

Tabled on

3 December 2003

For answer on

9 December 2003

Answered on

9 December 2003

Mr. Meacher: To ask the Secretary of State for Environment, Food and Rural Affairs (1) on what basis the herbicide regime for use on GM maize was chosen for the farm-scale trials; what role Aventis (now Bayer) had in its choice; what international research was conducted to establish whether this was a commercially realistic regime to control weeds; and what research she has conducted on whether farmers in other countries use more aggressive herbicide mixes; [142304] (2) what arrangements were made to ensure that farmers growing the GM trial crops managed them in a commercially realistic manner; and whether they were (a) required and (b) allowed to respray if the crop was under threat from excess weeds and was unlikely to produce an optimum yield. [142305] Mr. Morley: [holding answer 8 December 2003]: The herbicide regime used by farmers growing GM maize in the farm-scale trials was proposed by the product manufacturer, AgrEvo (now Bayer Crop Science). The way farmers could then use the product was further specified under the terms of the draft product label in line with the experimental approval. The draft product label gave farmers the freedom to apply more than one application of the herbicide if they required, providing it was within the specified crop growth stage limits. The experimental approval assumed use of the herbicide under UK conditions. No research was conducted on the method of use of this or any other herbicides in other countries as this was not considered necessary. The Scientific Steering Committee overseeing the farm-scale evaluations (FSEs) were content from the outset that the proposals for the use of the pesticide provided by the manufacturers and specified in the draft product label were capable of delivering cost-effective weed control under UK conditions. A full audit of herbicide use was conducted as part of the FSEs and published as part of the results (Champion et al. 2003). This paper also gives details of the number of GM maize fields that received more than one application of herbicide. In the published results it was concluded that cost-effective weed control had been achieved. This conclusion was endorsed by the steering committee and was further validated by the publishing journal through their peer-review process.

Date

9 December 2003

Reference

415 c379W; 142304;142305

House

House of Commons

Dept for Environment Food and Rural Affairs

To ask the Secretary of State for Environment, Food and Rural Affairs, what opinions the Advisory Committee on Releases to the Environment has received from the Advisory Committee on Feedingstuffs (ACAF) on the dossier of evidence presented by Aventis in support of its application for marketing consent for the T25...

Asked by

Joan Ruddock (Labour)

Answering body

Department for Environment, Food and Rural Affairs

Type

Written questions

Status

Answered

Tabled on

16 July 2001

For answer on

6 November 2002

Answered on

6 November 2002

Joan Ruddock: To ask the Secretary of State for Environment, Food and Rural Affairs what opinions the Advisory Committee on Releases to the Environment has received from the Advisory Committee on Feedingstuffs (ACAF) on the dossier of evidence presented by Aventis in support of its application for marketing consent for T25 GM maize, with particular reference to their opinion on the chicken feeding study; and if she will place a copy of ACAF's opinion in respect of (a) the whole dossier and (b) the chicken feeding study in the Library. [4932] Mr. Meacher: [holding answer 19 July 2002]: At the request of the department, The Advisory Committee on Releases to the Environment (ACRE) has, since November 2000, been considering the criticisms of the safety of Aventis' (formerly AgrEvo and now Bayer Cropscience) GM maize, T25, which has been raised at the hearing into the addition of CHARDON LL (a variety of T25) to the national list of seeds. ACRE subsequently requested advice from ACAF on the animal feed aspects of the criticisms. AgrEvo applied in 1995 through the French authorities for approval under EU directive 90/220 to place its GM T25 maize on the European market for cultivation and use as animal feed. In June 1995 France circulated the dossier to the other member states with the recommendation that T25 maize be given approval. After due consideration European Union member states approved the marketing of T25 maize in 1998. As part of this process ACRE considered the French opinion and dossier supporting the application and gave its advice to the government in June 1996. This was prior to the formation of ACAF. The chicken feeding study was not part of the original dossier submitted in 1996 and so was not considered by ACRE. A summary of the study was circulated by the French in 1997 as supplementary information on the nutritional qualities of the maize. The French authorities were of the view that the study did not add any significant new information to the dossier. Officials in MAFF considered the study, but as it was a nutritional rather than a safety study, it was not sent to ACRE. In reconsidering aspects of the T25 maize dossier ACRE has asked ACAF to look at the available data and advise on the substance of the criticisms raised at the CHARDONLL hearing in relation to animal feed and in particular the mortality rate in the chicken study. The growth rates in the two groups were broadly equivalent, but of the 140 fed T25 maize grain, 10 chicks (7 per cent.) died, whereas only 5 of the 140 (3.5 per cent.) died in the control group. In this type of experiment up to 8 per cent. would be expected to die. So the mortality rate is within the expected range. The question raised in the CHARDONLL is whether this is of concern and worthy of further investigation. A copy of the letter of 5 September 2001 from ACAF to ACRE setting out the committee's views on the whole dossier and the chicken feeding study has been placed in the Library. A copy is also on the public register held by my Department in Ashdown House In summary, ACAF is satisfied that, on the basis of the information presented by AgroEvo, there is nothing to indicate that T25 maize grain or its products pose any more risk to animals or humans than non-GM maize varieties if used in animal feed. I have asked ACAF for their reasons for this conclusion. However, ACAF advised ACRE that the data in the dossier are not sufficient to conclude at this stage, that T25 silage (rather than grain) is substantially equivalent to other maize varieties. Although it is unlikely that T25 maize silage is unsafe to feed to animals, its equivalence should be confirmed. The UK regulatory authority has subsequently written to Aventis to request further data on the composition of T25 silage. ACRE has given preliminary advice that nothing has been raised that warrants taking immediate action under the directive to withdraw T25 maize from the market. ACRE will shortly be issuing its advice on concerns raised during the CHARDON LL hearing, including criticisms of the chicken feeding study. This advice will also include ACRE's response to points raised at its T25 maize open hearing held in February 2002. At their hearing the Committee, in conjunction with ACAF, invited a number of witnesses and experts including Dr. Kestin and Dr. Knowles. Guided by the evidence taken at this meeting, any subsequent comments on the evidence from the public and the background information that is already available, ACRE will advise Ministers further on the validity of the T25 risk assessment.

Date

6 November 2002

Reference

4932; 392 c356-8W;392 c375-7W

House

House of Commons

Dept of Trade and Industry

To ask the Secretary of State for Trade and Industry, what representations she has received on the impact of the judgment of the European Court of Justice in Aventis Pharma Deutschland GmbH V Kohpharma GmbH.

Asked by

Nigel Waterson (Conservative)

Answering body

Department of Trade and Industry

Type

Written questions

Status

Answered

Date

24 October 2002

Reference

76306; 391 c425W;391 c423W

House

House of Commons

Dept for Environment Food and Rural Affairs

To ask the Secretary of State for Environment, Food and Rural Affairs, what further information has been obtained from the European Commission following the suspension of the public hearings on Aventi's T25 genetically modified maize; what evidence and clarification has been obtained from the French competent authorities; if she will...

Asked by

Alan Simpson (Labour)

Answering body

Department for Environment, Food and Rural Affairs

Type

Written questions

Status

Answered

Tabled on

6 February 2002

For answer on

5 March 2002

Answered on

5 March 2002

Mr. Alan Simpson: To ask the Secretary of State for Environment, Food and Rural Affairs what further information has been obtained from the European Commission following the suspension of the public hearings on Aventis T25 genetically modified maize; what evidence and clarification has been obtained from the French competent authorities; if she will (a) make this information publicly available and (b) place it in the Library; and when the hearings will be reconvened. [34938] Mr. Meacher: The European Commission has not responded substantively to letters from DEFRA Ministers and officials on the French maize variety testing system. However, the Commission has proposed amendments to Directive 72/180/EEC determining the minimum characteristics and conditions for examining the distinctness, uniformity and stability (DUS) of maize and some other species. These amendments, which bring the Directive into line with current best scientific practice, came into force on 14 February 2002 for implementation in member states no later than 31 March 2002. The French testing authorities carried out a further year of official tests on the genetically modified maize variety Chardon LL in 2001 and provided a test report to the UK authorities in November 2001 based on the required two years of official DUS tests. The French authorities have confirmed that the tests were conducted according to the new Directive requirements. A copy of the French DUS report on Chardon LL will be placed in the Library. Ministers have agreed in principle that if all of the legal and technical requirements have been met, the Chardon hearing may resume in spring 2002. The parties to the hearing will be informed when a decision has been taken.

Date

5 March 2002

Reference

34938; 381 c210W

House

House of Commons

Dept for Environment Food and Rural Affairs

To ask the Secretary of State for Health, if he will hold an open public investigation into the health implications of the currently approved trials of Aventis T25 maize.

Asked by

Alan Simpson (Labour)

Answering body

Department for Environment, Food and Rural Affairs

Type

Written questions

Status

Answered

Tabled on

17 July 2001

For answer on

29 October 2001

Answered on

29 October 2001

Mr. Alan Simpson: To ask the Secretary of State for Health if he will hold an open public investigation into the health implications of the currently approved trials of Aventis T25 maize. [5652] Mr. Meacher: I have been asked to reply. I am confident that the current approved trials of Aventis T25 maize do not pose a risk to health and in any case none of the GM crop in the trials will enter the food or feed chain. The implications of health of Aventis genetically modified maize known as T25 were assessed during the passage of the marketing dossier through the European GMO regulatory regime. T25 maize was granted regulatory approval under Directive 90/220 for unrestricted cultivation throughout the European Union in 1998 through the French authorities. The dossier, including the assessment of risks to health, is on the public register held by my Department and is available for scrutiny. However concerns about the safety of T25 maize for animal feed have been raised and need to be addressed. These concerns have been presented in public as part of the DEFRA public hearing into the seed listing of the variety of T25 known as ChardonLL. This hearing is currently suspended pending further information from the European Commission and the French competent authorities. However, the Government have referred all the written evidence presented to the hearing relating to the safety of T25 to the Advisory Committee on Releases to the Environment for advice. ACRE has sought further advice on the animal feed issues from the Advisory Committee on Animal Feed. ACRE expects to finalise its advice to Government before the end of the year. As part of this re-evaluation we intend to hold an additional open debate involving both Aventis and its critics, where ACRE can question the strength of the scientific evidence from both sides. The safety of T25 maize for use in food is regulated by the European novel food regulations and is a matter for the Food Standards Agency.

Date

29 October 2001

Reference

5652; 373 c552-3W

House

House of Commons

Dept for Environment Food and Rural Affairs

To ask the Secretary of State for Environment, Food and Rural Affairs, if she will list the meetings she has had with (a) Aventis and (b) the Crop Protection Association to discuss access to information on experimental approvals for glufosinate ammonium. - No such meetings have been held. (Holding answer...

Asked by

Colin Breed (Liberal Democrat)

Answering body

Department for Environment, Food and Rural Affairs

Type

Written questions

Status

Answered

Date

20 July 2001

Reference

3755; 372 c629W

House

House of Commons

Dept of Health

To ask the Secretary of State for Health, when the Advisory Committee for Novel Foods discussed the Aventis study entitled the Effect of Glufosinate-Resistant Corn on the Growth of Male Broiler Chickens; and if he will place the minutes of this meeting in the Library.

Asked by

Alan Simpson (Labour)

Answering body

Department of Health

Type

Written questions

Status

Answered

Date

20 July 2001

Reference

5654; 372 c732W

House

House of Commons

Prime Minister

To ask the Prime Minister, how many representations he has received calling for suspension of the marketing consent for the Aventis genetically modified maize, known as T25.

Asked by

Alan Simpson (Labour)

Answering body

Prime Minister

Type

Written questions

Status

Answered

Date

19 July 2001

Reference

5651; 372 c319W

House

House of Commons

Dept of Health

To ask the Secretary of State for Health, pursuant to his Answer of 5th April 2000 at 347 c502W, on Aventis T25 maize, what was the voluntary scheme under which the application was made; how the application was (a) processed and (b) determined; who were the animal feed experts who...

Asked by

Joan Ruddock (Labour)

Answering body

Department of Health

Type

Written questions

Status

Answered

Tabled on

12 April 2000

For answer on

2 May 2000

Answered on

2 May 2000

Joan Ruddock: To ask the Secretary of State for Health, pursuant to his answer of 5 April 2000, Official Report, column 502W, on Aventis T25 maize, what was the voluntary scheme under which the application was made; how the application was (a) processed and (b) determined; who were the animal feed experts who advised him on the safety of T25 GM maize for animal feed; and if he will place in the Library a copy of the application, together with copies of the correspondence relating to the animal feed application between himself, his advisers and the company. [119304] Ms Stuart: [holding answer 17 April 2000]: I am advised by the Food Standards Agency that the voluntary scheme related to novel food safety assessment and was operated by the Advisory Committee on Novel Foods and Processes (ACNFP). Although there was no equivalent scheme for novel animal feeds, the dossier of information was also considered by officials with expertise on animal feed matters. However, at this time, in the middle of 1996, the application from France under Council Directive 90/220/EEC for European Community marketing consent began to be considered. I am placing in the Library a copy of the advice from the European Commission's Scientific Committee on Plants. This explains, among other things, the animal feed issues considered prior to the granting of EC marketing consent for this crop. I am also placing in the Library copies of correspondence between the Ministry of Agriculture, Fisheries and Food and the applicant company culminating in the then Parliamentary Secretary's letter which was based on advice from the ACNFP.

Date

2 May 2000

Reference

119304; 349 c49W

House

House of Commons

Dept of Health

(Pursuant to reply on 03.04.2000 at 347 c325W) To ask the Minister of Agriculture, Fisheries and Food, what applications have been made to him for clearance of Aventis T25 maize for use as animal feed; and if he will place in the Library the details of all clearances granted. -...

Asked by

Joan Ruddock (Labour)

Answering body

Department of Health

Type

Written questions

Status

Answered

For answer on

5 April 2000

Answered on

5 April 2000

Joan Ruddock: To ask the Minister of Agriculture, Fisheries and Food what applications have been made to him for clearance of Aventis T25 maize for use as animal feed; and if he will place in the Library the details of all clearances granted. [117276] Ms Stuart: As responsibility for food safety and standards matters has now passed to the Food Standards Agency (FSA) which reports to Parliament through Health Ministers, I have been asked to reply. I am advised by the Food Standards Agency that AgrEvo (now Aventis) submitted an application, to the Ministry of Agriculture, Fisheries and Food, for voluntary approval of food and feed safety clearance of glufosinate ammonium tolerant maize in 1995. In addition, an application to market AgrEvo's T25 maize for cultivation and importation for processing into food and animal feed was received, via the Department of the Environment, under Council Directive 90/220/EEC from the French competent authority in 1996. Details of the food safety clearance are contained in the annual report for 1996 of the Advisory Committee on Novel Foods and Processes. The marketing consent under Directive 90/220/EEC was issued by France in 1998 following publication of the Commission's Decision in the "Official Journal of the European Communities" (L131, 5.5.98). This consent, which authorises the marketing of T25 maize for use in food and animal feed, was agreed by the Member States taking into account the advice of the EC Scientific Committee for Plants. The committee's remit included the consideration of any adverse effects on human health or the environment arising from the placing on the market of this maize. Copies of both documents are available in the Library.

Date

5 April 2000

Reference

117276; 347 c502W

House

House of Commons

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