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Deposited Paper DEP2013-1754

Ensuring best practice in the notification of product discontinuations. Best practice guidelines. 10 p.

Deposited by

Department of Health

Type

Deposited papers

Date

4 November 2013

Reference

DEP2013-1754

House

House of Lords

Synthon BV

My honourable friend the Minister of State, Department of Health (Simon Burns) has made the following Written Ministerial Statement. In 2001 and 2002, the Medicines Control Agency (a forerunner to the Medicines and Healthcare products Regulatory Agency) refused to accept certain marketing authorisation applications from Synthon. Synthon challenged the decision...

Member

Earl Howe (Conservative)

Department

Department of Health

Type

Written statements

Date

13 October 2010

Reference

721 c32-4WS

House

House of Lords

Synathon BV v. Licensing Authority of the Department of Health

In 2001 and 2002, the Medicines Control Agency (a forerunner to the Medicines and Healthcare products Regulatory Agency) refused to accept certain marketing authorisation applications from Synthon. Synthon challenged the decision by way of judicial review. In 2008 the European Court of Justice issued a judgment in relation to C-452/06...

Member

Simon Burns (Conservative)

Department

Department of Health

Type

Written statements

Date

13 October 2010

Reference

516 c24WS

House

House of Commons

NHS Finance

To ask the Secretary of State for Health what the level of NHS income from charges was in 2004–05; and how much was accounted for by income from (a) fees and charges from health authorities, (b) fees and charges from district health authorities, (c) road traffic accident income, (d) fees...

Asked by

Lord Lansley (Conservative)

Answering body

Department of Health

Type

Written questions

Status

Answered

Tabled on

6 December 2005

For answer on

8 December 2005

Answered on

9 January 2006

National health service income figures from fees and charges are shown in the table. The table includes fees and charges to bodies outside the NHS, charges to private and overseas patients and charges to NHS patients.The only charges to NHS patients are those for dental and prescription charges.

Breakdown of NHS income from charges by charge type 2004–05
Charges	£ million
(a) Strategic health authority—fees and charges	33.7
(b) District health authorities	—
(c) Road traffic accident income	110.3
(d) NHS trusts—fees and charges	669.4
(e) NHS Logistics fees	1.0
(f) Dental charges	451.8
(g) Prescription charges	424.6
(h) Nursing home inspection fees	—
(i) Subsidised dried milk	—
(j) Medicines Control Agency—licences and inspections	—
(k) Youth treatment service income	—
(l) NHS Pensions Agency fees	0.6
(m) Medical Devices Agency fees	—
(n) Human Fertilisation and Embryology Authority—licence fees		4.1
(o) English National Board for Nursing—registration fees	—
(p) Other	316.1
Total	2,011.6
(a) Health authorities became strategic health authorities in 2002–03. Figures include fees and charges for primary care trusts. (e) Previously the NHS Supplies Authority. (h) From April 2002, the National Care Standards Commission regulated nursing homes. Health authorities no longer collect the fee income. (i) Not collected after 2002–03 (following a review with the NAO to eliminate non-material items). (p) Information relating to charges for private patients and overseas visitors has been provided for NHS trusts and primary care trusts. Source: Information on fees and charges has been provided from the audited accounts of the relevant NHS bodies.
⁽³¹⁾ Organisations no longer exist.

Date

9 January 2006

Reference

36431; 441 c145-6W

House

House of Commons

Dept of Health

To ask the Secretary of State for Health, what the level of NHS income from charges was in each year since 1990-91, broken down by income from (a) fees and charges from health authorities, (b) fees and charges from district health authorities, (c) road traffic accident income, (d) fees and...

Asked by

Lord Lansley (Conservative)

Answering body

Department of Health

Type

Written questions

Status

Answered

Tabled on

15 March 2005

For answer on

6 April 2005

Answered on

6 April 2005

Mr. Lansley: To ask the Secretary of State for Health what the level of NHS income from charges was in each year since 1990-91, broken down by income from (a) fees and charges from health authorities, (b) fees and charges from district health authorities, (c) road traffic accident income, (d) fees and charges from NHS trusts, (e) NHS Supplies Authority fees, (f) dental charges, (g) prescription charges, (h) nursing home inspection fees, (i) subsidised dried milk, (j) Medicines Control Agency: licences and inspections, (k) youth treatment service income, (l) NHS Pensions Agency fees, (m) Medical Devices Agency fees, (n) Human Fertilisation and Embryology Authority: licences fees, (o) English National Board for Nursing registration fees and (p) other charges. [222805] Mr. Hutton: National health service income figures from fees and charges are shown in the table. The table includes fees and charges to bodies outside the NHS, charges to private and overseas patients and charges to NHS patients. The only charges to NHS patients are those for dental and prescription charges. The proportion of charges to NHS patients compared with the total fees and charges income has fallen from 54.4 per cent. in 1997-98 to 45.9 per cent. in 2003-04. Breakdown of NHS income from charges by charge type 1990-91 to 2003-04 _________________________________________________________________________________________________. £ million Charges 1990-91 1991-92 1992-93 1993-94 1994-95 1995-96 1996-97 (a) Health authority --fees -- -- -- -- -- -- 6.3 and charges1, 2 (b) District health -- -- -- -- -- 2.3 -- authorities3,4 (c) Road traffic accident -- -- -- -- -- -- -- income5 (d) NHS trusts--fees and -- 5.0 29.8 55.5 110.3 123.4 152.4 charges6 (e) NHS supplies authority -- -- -- -- -- 50.1 44.1 fees7 (f) Dental charges8 -- -- -- 367.0 383.3 381.2 383.0 (g) Prescription charges8 -- -- -- 265.3 287.2 298.7 295.7 (h) Nursing home inspection -- -- -- -- -- 4.6 5.0 fees9,14 (i) Subsidised dried milk -- -- -- 1.0 1.3 1.6 2.2 (j) Medicines Control -- -- -- 24.1 25.6 22.4 26.8 Agency--licences and inspections (k) Youth treatment service -- -- -- 4.1 3.5 3.7 3.5 income (1) NHS Pensions Agency -- -- -- -- -- -- -- fees10 (m) Medical Devices Agency -- -- -- -- 1.2 1.5 2.5 Fees11 (n) Human Fertilisation and -- -- -- 0.8 0.9 1.0 1.5 Embryology Authority: licence fees (o) English National Board -- -- -- -- -- -- -- for Nursing (ENB): registration fees12,13 (p) Other15 116.2 140.8 157.3 182.0 197.1 211.7 238.2 Total 116.2 145.8 187.1 899.8 1,010.4 1,102.2 1,161.2 _________________________________________________________________________________________________. Breakdown of NHS income from charges by charge type 1990-91 to 2003-04 _________________________________________________________________________________________________. £ million Charges 1997-98 1998-99 1999-2000 2000-01 2001-02 2002-03 2003-04 (a) Health authority --fees 67.7 90.1 92.0 113.8 65.8 44.8 29.4 and charges1, 2 (b) District health -- -- -- -- -- -- -- authorities3,4 (c) Road traffic accident -- -- 30.0 75.8 98.3 105.0 117.6 income5 (d) NHS trusts--fees and 169.6 216.7 224.2 266.0 268.2 386.1 531.7 charges6 (e) NHS supplies authority 39.1 36.1 20.3 0.4 0.2 0.2 0.8 fees7 (f) Dental charges8 388.4 419.6 431.2 453.1 472.1 486.7 483.6 (g) Prescription charges8 320.9 341.3 366.7 386.9 413.1 425.4 428.3 (h) Nursing home inspection 4.8 8.8 9.5 9.8 6.2 -- -- fees9,14 (i) Subsidised dried milk 2.5 2.6 2.4 2.3 3.0 2.9 -- (j) Medicines Control 28.1 26.6 29.4 34.1 36.7 41.3 -- Agency--licences and inspections (k) Youth treatment service 4.5 4.7 4.6 0.1 -- -- -- income (1) NHS Pensions Agency 2.3 6.2 2.2 1.8 1.6 0.9 0.1 fees10 (m) Medical Devices Agency 0.2 0.2 0.2 0.3 0.4 0.4 -- Fees11 (n) Human Fertilisation and 1.3 1.4 1.6 1.2 1.6 2.5 3.5 Embryology Authority: licence fees (o) English National Board -- 1.6 1.6 1.6 -- -- -- for Nursing (ENB): registration fees12,13 (p) Other15 275.0 296.6 315.3 320.3 347.2 372.8 391.1 Total 1,304.4 1,452.5 1,531.3 1,667.5 1,714.4 1,869.0 1,986.0 _________________________________________________________________________________________________. 1 Figures from 2000-01 include charges for primary care trusts (PCTs). 2 Health authorities were established on 1 April 1996 and strategic health authorities on 1 October 2002. 3 Figures were not collected prior to 1995-96. 4 District health authorities ceased to exist after 1 April 1996. 5 Figures were not collected prior to 1999-2000. 6 Figures from 2001-02 includes charges from PCTs. 7 From 2000-01 NHS Supplies Authority split into NHS Purchasing and Supplies Agency and NHS Logistics. All fees for forward years score against the NHS Logistics. 8 Dental and prescription charge income prior to 2001-02 drawn from cash data in appropriation accounts. 2001-02 and subsequent years' data drawn from resource data in Summarised Accounts. 9 Figures not collected on a consistent basis prior to 1996-97. 10 No income generated prior to 1997-98. 11 The Agency was established in September 1994. 12 Figures prior to 1998-99 are not available. 13 In 2001-02 the Department has directed that no ETR fees should be charged and that ETR fees held in reserve should be utilised to fund the ENB's on-going students record function for the final year of its operation. 14 From April 2002, the National Care Standards Commission (NCSC) regulated nursing homes; health authorities no longer collect the fee income. 15 "Other" contains mainly charges for private patients and overseas visitors but also special health authority fees and charges. Notes: 1. Information on fees and charges in (a) to (o) has been provided from the audited accounts of NHS bodies and specified NDPBs. 2. Information in (p) has been provided for NHS trusts, PCTs and special health authorities. 3. Information has not been provided for other non-departmental public bodies as accounts for the period are not readily available. 4. The presentation of fees and charges in accounts is not necessarily consistent between years and therefore direct comparisons may not be relevant. 5. The NHS and a number of listed bodies have been subject to reorganisations over the period under question, therefore figures may only be available for limited years.

Date

6 April 2005

Reference

432 c1554-8W;432 c1550-4W; 222805

House

House of Commons

Deposited Paper Dep 04/1392

Letter dated 01.07.2004 from Lord Warner to Chris Grayling MP regarding the correspondence and submissions sent to and received by the Medicines Control Agency relating to the regulation of Kava-kava. Incl. material disclosed. DH. 2004.

Deposited by

Department of Health

Type

Deposited papers

Date

8 July 2004

Reference

Dep 04/1392

House

House of Lords; House of Commons

Dept of Health

To ask the Secretary of State for Health, how many prosecutions against sellers of unlicensed medicines via the internet (a) have been undertaken, (b) have been successful and (c) are in preparation by (i) the Medicines Control Agency for each year between 1997 and 2003 and (ii) the Medicines and...

Asked by

Paul Burstow (Liberal Democrat)

Answering body

Department of Health

Type

Written questions

Status

Answered

Date

10 May 2004

Reference

421 c166W; 167809

House

House of Commons

Dept of Health

To ask the Secretary of State for Health, how many investigations have been carried out into the sale of unlicensed medicines via the internet by (a) the Medicines Control Agency for each year between 1997 and 2003 and (b) the Medicines and Healthcare Regulatory Agency in the last year. -...

Asked by

Paul Burstow (Liberal Democrat)

Answering body

Department of Health

Type

Written questions

Status

Answered

Date

10 May 2004

Reference

421 c166W; 167808

House

House of Commons

Warner, Lord

How many staff were employed on 1 April 1997 by (a) the Medical Devices Agency; and (b) the Medicines Control Agency. [HL 4773]. - Inc figures.

Asked by

Earl Attlee (Conservative)

Type

Written questions

Status

Answered

Date

23 October 2003

Reference

653 c195WA; HL 4773

House

House of Lords

Dept of Health

To ask the Secretary of State for Health, how many reports the Medicines Control Agency has received of suicides attributed to Efexor in each of the last five years; and how many yellow card reports the Medicines Control Agency has received about Efexor in each of the last five years....

Asked by

Paul Flynn (Labour)

Answering body

Department of Health

Type

Written questions

Status

Answered

Tabled on

13 October 2003

For answer on

20 October 2003

Answered on

20 October 2003

Paul Flynn: To ask the Secretary of State for Health how many reports the Medicines Control Agency has received of suicides attributed to Efexor in each of the last five years; and how many yellow card reports the Medicines Control Agency has received about Efexor in each of the last five years. [132315] Miss Melanie Johnson: The number of adverse drug reactions received by the Medicines and Healthcare Products Regulatory Agency (MHRA) under the yellow card scheme in respect of venlafaxine (Efexor) over the last five years is shown in the table, together with the number of reports of completed suicide. _________________________________________________________________________________________________. Number of UK reports for venlafaxine Number of reports of completed suicide for (Efexor) venlafaxine (Efexor) 1998 589 2 1999 444 3 2000 349 3 2001 303 1 2002 316 1 _________________________________________________________________________________________________. 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, including an unknown level of under-reporting. It is important to note that the reporting of a reaction does not necessarily mean it was caused by the drug and may relate to other factors, such as the patients underlying illness or other medicines taken concurrently. As with all medicines, the MHRA and the Committee on Safety of Medicines are keeping the safety of venlafaxine under continuous review. The summary of product characteristics for venlafaxine advises prescribers about the risk of suicide that is inherent in patients with depressive illness.

Date

20 October 2003

Reference

411 c456W;411 c459-60W; 132315

House

House of Commons

Medicines Control Agency report and accounts for 2002/03.

Type

House of Commons papers

Notes

Received 06.08.03

Date

15 July 2003

Reference

HC 756 2002/03

House

House of Commons

Written Statement on the publication of the annual report and accounts for the Medicines Control Agency for 2002-03 (HC 756 2002/03)

Written Statement on the publication of the annual report and accounts for the Medicines Control Agency for 2002-03 (HC 756 2002/03). (Copies in the Library).

Member

Stephen Ladyman (Labour)

Department

Department of Health

Type

Written statements

Date

15 July 2003

Reference

409 c26WS

House

House of Commons

Warner, Lord

Lords statement on when they will publish the Medicines Control Agency annual report and accounts for 2002-03. [HL 4036]. - Laid before Parliament today, HC 756, copies in the Library.

Asked by

Baroness Nicol (Labour)

Type

Written questions

Status

Answered

Date

15 July 2003

Reference

HL 4036; 651 c114WA

House

House of Lords

Dept of Health

To ask the Secretary of State for Health, pursuant to his Answer of 7th March 2003, 400 c1273-4W, on staff numbers, what the total pay costs incurred by the (a) Medical Devices Agency, (b) Meat Hygiene Service and (c) Medicines Control Agency were in each year since 1997. - Including...

Asked by

Archie Norman (Conservative)

Answering body

Department of Health

Type

Written questions

Status

Answered

Date

18 June 2003

Reference

113378; 407 c282W

House

House of Commons

Dept of Health

To ask the Secretary of State for Health, what recent discussions he has had with the Medicines Control Agency about the drug seroxat.

Asked by

John Bercow (Conservative)

Answering body

Department of Health

Type

Written questions

Status

Answered

Date

3 June 2003

Reference

114100; 406 c86-7W

House

House of Commons

Dept of Health

To ask the Secretary of State for Health, how many reports the Medicines Control Agency has received of suicides attributed to Seroxat in each of the last three years; how many yellow card reports the Medicines Control Agency has received about Seroxat in each of the last three years; what...

Asked by

Paul Flynn (Labour)

Answering body

Department of Health

Type

Written questions

Status

Answered

Date

3 June 2003

Reference

406 c75-6W;406 c75-7W; 114707;114708;114709;114823

House

House of Commons

Dept of Health

To ask the Secretary of State for Health, what research his Department has undertaken on the implementation of MLX 291 by the Medicines Control Agency and its effect on (a) morbidity and (b) mortality in patient groups; and if he will make a statement; what assessment he has made of...

Asked by

Nick Harvey (Liberal Democrat)

Answering body

Department of Health

Type

Written questions

Status

Answered

Tabled on

11 April 2003

For answer on

30 April 2003

Answered on

30 April 2003

Nick Harvey: To ask the Secretary of State for Health (1) what research his Department has undertaken on the implementation of MLX 291 by the Medicines Control Agency and its effect on (a) morbidity and (b) mortality in patient groups; and if he will make a statement; [109529] (2) what assessment he has made of the possibility of MLX 291 causing medicines to be decanted into unsuitable containers, with particular reference to those more easily accessible to children; and if he will make a statement; [109531] (3) what representations he has received on MLX 291; and if he will make a statement. [109530] Mr. Lammy: Consultation letter MLX 291 contained proposals to introduce new regulations relating to paracetamol, aspirin and iron supplements in order to take account of the British Standard on Child Resistant Packaging for non reclosable packaging for pharmaceuticals--BS 8404. It also proposed that medicines containing more than 24mg of elemental iron per unit does as well as liquid paracetamol preparations will also, for the first time, i.e. current requirements applying to reclosable containers of solid dosage and paracetamol. The proposals contained in MLX 291 were based on advice from the Committee on Safety of Medicines (CSM) which considered published data from Hospital Episode Statistics (HES) for England and Wales and from Hospital Accident Surveillance System (HASS) data, from the Department of Trade and Industry's (DTIs) consumer safety unit. The aim of the amended legislation is to reduce or prevent toxicity from accidental drug overdose in children, which results in nearly 150 hospital admissions per week. The existing requirements for child resistant packaging in the Medicines (Child Safety) Regulations 1975 (as amended) already contain a provision to allow patients to receive these medicines in a container which is not child resistant, if they wish to do so and make a specific request to a pharmacist or doctor to that effect. The proposed new regulations include an extended adult test on accessibility for those up to 75 years rather than 60 years of age under the old standard. There is currently no proposal to remove the existing provision to dispose these medicines in non child resistant containers given the many and various ways in which elderly patients now receive their medication, including home delivery from the pharmacy. The public consultation on the proposals started on 26 November and closed on 18 February 2003. A large number of responses have been received and the Medicines Commission will be consulted shortly. Once this process is complete, in accordance with the terms of the Code of Practice on Access to Government Information, the Agency intends to make copies of replies received publicly available.

Date

30 April 2003

Reference

404 c428-9W; 109529;109531;109530

House

House of Commons

Dept for Environment Food and Rural Affairs

To ask the Secretary of State for Environment, Food and Rural Affairs, what assessment she has made of the benefits of combining the Medicine Control Agency with the Veterinary Medicine Directorate, with reference to EU Directive 6565.

Asked by

Andrew Murrison (Conservative)

Answering body

Department for Environment, Food and Rural Affairs

Type

Written questions

Status

Answered

Date

28 April 2003

Reference

108906; 404 c39-40W;404 c40W

House

House of Commons

Dept of Health

To ask the Secretary of State for Health, what advice he has received from the Medicines Control Agency about the possible link between the use of the drug Seroxat and suicide; what representations he has received on the withdrawal of the antidepressant Seroxat; how many coroners have written to him...

Asked by

David Stewart (Labour)

Answering body

Department of Health

Type

Written questions

Status

Answered

Tabled on

19 March 2003

For answer on

27 March 2003

Answered on

27 March 2003

Mr. David Stewart: To ask the Secretary of State for Health (1) what advice he has received from the Medicines Control Agency about the possible link between the use of the drug Seroxat and suicide; [104566] (2) what representations he has received on the withdrawal of the antidepressant Seroxat; [104567] (3) how many coroners have written to him expressing concerns about the drug Seroxat; and how many have called for urgent inquiries. [104565] Ms Blears: Since it was authorised in 1990 the safety of paroxetine (Seroxat) has been closely monitored by the Medicines Control Agency (MCA) and the Government's independent expert advisory committee, Committee on Safety of Medicines (CSM). The CSM has considered the question of suicidal behaviour in association with Seroxat on a number of ccasions and carefully assessed any new data. The CSM has advised that there is insufficient evidence to confirm a causal relationship between Selective Serotonin Reuptake Inhibitors (SSRIs) and suicidal behaviour. The CSM has advised that it is general clinical experience that patients taking any antidepressant may develop an increase in suicidal behaviour in the first few weeks of treatment. Product information for prescribes and patients for all SSRIs has been amended to include warnings that suicidal behaviour may increase in the early stages of treatment as with any antidepressant. In September 2000, an article was published in the drug safety bulletin, Current Problems in Pharmacovigilance, which is distributed to all doctors and pharmacists. An expert working group on the safety of SSRIs has been set up by the CSM to review the current available evidence relating to the safety of SSRIs, including paroxetine, particularly in relation to suicidal behaviour and withdrawal reactions. The expert working group will report its findings to CSM in due course. Since 1997, the MCA has received a range of representations, including parliamentary questions, letters from hon. and right hon. Members, patients and health care professionals expressing concerns about the safety of paroxetine (Seroxat), none of which have been from coroners. The MCA and the CSM receive reports of suspected adverse drug reactions to medicinal products via the yellow card scheme. Since marketing authorisation was granted in 1990, the MCA and CSM have received 8,702 such reports for paroxetine (Seroxat). One of these reports has been received from a coroner. In addition the MCA has written to the coroner for Brecon to obtain further details of a recently publicised case.

Date

27 March 2003

Reference

402 c404W; 104566;104567;104565

House

House of Commons

Adjournment debate on Ciproxin trials at Southampton General Hospital

Adjournment debate on Ciproxin trials at Southampton General Hospital.

Lead member

Sandra Gidley

Answering member

David Lammy

Department

Department of Health

Type

Adjournment debates

Date

14 March 2003

Reference

401 c601-8

House

House of Commons

Librarians' tools

Type

House

Session

Year

Department

Member

Primary member

Answering member

Legislative stage

Legislation

Subject

Publisher