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Statutory Instruments

2004 No. 629

NATIONAL HEALTH SERVICE, ENGLAND

National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004

Made

8th March 2004

Laid before Parliament

11th March 2004

Coming into force

1st April 2004

M1 The Secretary of State for Health in exercise of the powers conferred upon him by sections 28U and 126(4) of the National Health Service Act 1977 and of all other powers enabling him in that behalf, hereby makes the following Regulations:

Citation, commencement and application

1. —(1) These regulations may be cited as the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 and shall come into force on 1st April 2004.

(2) These Regulations apply to England only.

[F1 Drugs, medicines and other substances that may not be ordered

2. —(1) The following drugs, medicines and other substances may not be ordered for patients in the provision of medical services under a general medical services contract—

(a) a drug, medicine or other substance which is listed in Schedule 1;

(b) any gluten-free food; or

(c) any very low gluten food.

(2) But—

(a) paragraph (1)(b) does not apply to gluten-free bread or a gluten-free food mix;

(b) paragraph (1)(c) does not apply to very low gluten bread or a very low gluten food mix.

(3) For the purposes of this regulation—

(a) a food is gluten-free if the food, as sold to the final consumer—

(i) contains no more than 20mg/ kg of gluten, and

(ii) where it contains oats has been specially produced, prepared and or processed in a way to avoid contamination by wheat, rye, barley or their crossbred varieties;

(b) a food is very low gluten if the food, as sold to the final consumer, contains no more than 100mg/ kg of gluten and consists of, or contains, one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been specially processed to reduce the gluten content, and where it contains oats—

(i) it has been specially produced, prepared or processed in a way to avoid contamination by wheat, rye, barley or their crossbred varieties, and

(ii) the gluten content of the oats does not exceed 20mg/kg.

(4) In this regulation—

“food mix” means a mixture of two or more ingredients which is to be—

(a)

combined with any one or more additional ingredients; and

(b)

baked or otherwise cooked;

“gluten” means a protein fraction from wheat, rye, barley, oats or their crossbred varieties and derivatives, which is insoluble in water and 0.5 M sodium chloride solution. F1]

Drugs, medicines and other substances that may be ordered only in certain circumstances

3. A drug, medicine or other substance specified in an entry in column 1 of Schedule 2 may not be ordered for a patient in the provision of medical services under a general medical services contract unless—

(a) that patient is a person of a description mentioned in column 2 of that entry; and

(b) that drug, medicine or other substance is prescribed for that patient only for the purpose specified in column 3 of that entry.

Signed by authority of the Secretary of State

John Hutton

Minister of State,

Department of Health

Regulation 2

SCHEDULE 1 DRUGS, MEDICINES AND OTHER SUBSTANCES NOT TO BE ORDERED UNDER A GENERAL MEDICAL SERVICES CONTRACT

Regulation 3

SCHEDULE 2 DRUGS, MEDICINES AND OTHER SUBSTANCES THAT MAY BE ORDERED ONLY IN CERTAIN CIRCUMSTANCES

Column 1 Column 2 Column 3
Drugs Patient Purpose
Clobazam Any patient Treatment of epilepsy
[F3 a GnRH analogue F3]

[F4 (1) Any patient who is aged 18 or over

(2) Any patient who is aged under 18 to whom the practitioner is providing treatment under the contract which does not include treatment for the purpose of puberty suppression in respect of gender dysphoria, gender incongruence or a combination of both

(3) Any patient who is aged under 18, and who—

(a) before 26th June 2024, started a course of treatment with a GnRH analogue for the purpose of puberty suppression in respect of gender dysphoria, gender incongruence or a combination of both, and in this context, a person is treated as having started a course of treatment with a GnRH analogue if, on or after 3rd December 2023, that person was issued with a NHS or private prescription for a GnRH analogue, whether or not the prescription has been dispensed or the prescribed GnRH analogue has been taken by that person before 26th June 2024; or

(b) is being treated with a GnRH analogue as part of a National Institute for Health and Care Research clinical trial related to treatment with a GnRH analogue for the purpose of puberty suppression in respect of gender dysphoria, gender incongruence or a combination of both F4]

[F5 (1) Treatment for any purpose

(2) Treatment for any purpose other than treatment for the purpose of puberty suppression in respect of gender dysphoria, gender incongruence or a combination of both

(3) Treatment for the purpose of puberty suppression in respect gender dysphoria, gender incongruence or a combination of both F5]

F6 . . . F6 . . . F6 . . .
Locabiotal Aerosol Any patient Treatment of infections and inflammation of the oropharynx
Niferex Elixir 30ml Paediatric Dropper Bottle Infants born prematurely Prophylaxis and treatment of iron deficiency
Nizoral Cream Any patient Treatment of seborrhoeic dermatitis and pityriasis versicolor
[F7 Oseltamivir (Tamiflu) F7]

[F7 (1) [F8 A patient who is aged 1 year or over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, [F9 or who is aged under 65 years and is at risk of developing medical complications from influenza, F9] where—

(a) the Department of Health [F10 and Social Care F10] has notified general medical practitioners that the influenza virus is circulating in the community; F8]

(b) the patient has an influenza-like illness; and

(c) the patient can start therapy within 48 hours of the onset of symptoms. F7]

[F11 (1A) Any patient suffering from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Secretary of State or [F12 are part of an antiviral distribution service provided by [F13 NHS England F13] , [F14 the United Kingdom Health Security Agency F14] or a Local Authority. F12,F11]]

[F7 Treatment of influenza F7]

[F7 (2) [F15 A patient who is aged 1 year or over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, where—

(a) the Department of Health [F10 and Social Care F10] has notified general medical practitioners that the influenza virus is circulating in the community; F15]

(b) the patient has been exposed to an influenza-like illness through being in close contact with someone with whom he lives who is or has been suffering from an influenza-like illness;

(c) the patient is not effectively protected by vaccination against influenza because—

(i) he has not been vaccinated because vaccination is contraindicated;

(ii) he has not been vaccinated since the previous influenza season;

(iii) he has been vaccinated but it has yet to take effect; or

(iv) he has been vaccinated but the vaccine is not well matched to the strain of influenza circulating in the locality in which the patient resides or is or has been present;

(d) the patient lives in a residential care establishment and another resident or member of staff of the establishment has an influenza-like illness; and

(e) the patient can start prophylaxis within 48 hours of exposure to an influenza-like illness. F7]

[F16 (2A) Any patient at risk from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Secretary of State or [F12 are part of an antiviral distribution service provided by [F13 NHS England F13] , [F14 the United Kingdom Health Security Agency F14] or a Local Authority. F12,F16]]

[F7 Prophylaxis of influenza F7]
[F7 Zanamivir (Relenza) F7]

[F17 (1) F17][F18 A patient who is aged 5 years or over and who is at clinical risk or a patient who is pregnant or aged 65 years or over, [F19 or who is aged under 65 years and is at risk of developing medical complications from influenza, F19] where—

(a) the Department of Health [F10 and Social Care F10] has notified general medical practitioners that the influenza virus is circulating in the community; F18]

(b) the patient has an influenza-like illness; and

[F20 (c) in the case of a patient—

(i) who has attained the age of 5 years but not the age of 13 years, that patient can start therapy within 36 hours of the onset of symptoms; and

(ii) who is aged 13 years or over, that patient can start therapy within 48 hours of the onset of symptoms. F20]

[F7 Treatment of influenza F7]

[F21 (2) Any patient at risk of or suffering from influenza during an outbreak of pandemic influenza (influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza), where the drug is ordered under arrangements for the distribution of the drug free of charge which are approved by the Secretary of State or [F12 are part of an antiviral distribution service provided by [F13 NHS England F13] , [F22 the United Kingdom Health Security Agency F22] or a Local Authority. F12,F21]]

[F23 Prophylaxis or treatment of influenza. F23]

The following drugs for the treatment of erectile dysfunction—

  • F25 Alprostadil [F24 Avanafil F24] ...

  • F26,F25 ... ...

  • F26,F25 ... ...

  • F26,F25 ... ...

  • F25 Tadalafil ...

  • F26,F25 ... ...

  • F25 Vardenafil [F27 Viagra F27] ...

[F28 (1) The following patients with erectile dysfunction– F28]

(a) M2,M3 a man with erectile dysfunction who on 14th September 1998 was receiving a course of treatment under the Act, the National Health Service (Scotland ) Act 1978 or the Health and Personal Social Services (Northern Ireland) Order 1972 for this condition with any of the following drugs—

  • Alprostadil (Caverject), (MUSE), (Viridal)

  • Apomorphine Hydrochloride (Uprima)

  • Moxisylyte Hydrochloride (Erecnos)

  • Sildenafil (Viagra)

  • Tadalafil (Cialis)

  • Thymoxamine

  • Hydrochloride (Erecnos); or

[F29 (b) a man who is a national of an EEA State who—

(i) immediately before IP completion day was entitled to treatment by virtue of Article 7(2) of Council Regulation 1612/68 as extended by the EEA Agreement or was entitled to treatment by virtue of any other enforceable EU right;

(ii) has erectile dysfunction and was on 14th September 1998 receiving a course of treatment under a national health insurance system of an EEA State for that condition with any of the drugs listed in sub-paragraph (a); and

(iii) immediately before IP completion day was receiving a course of treatment as part of the health service for the condition mentioned in paragraph (ii) of this sub-paragraph with any of the drugs listed in sub-paragraph (a); or F29]

[F30 (c) a man who is not a national of an EEA State but who is the member of the family of such a national and who—

(i) immediately before IP completion day had an enforceable EU right to be treated no less favourably than the national in the provision of medical treatment;

(ii) has erectile dysfunction and was on 14th September 1998 receiving a course of treatment for that condition with any of the drugs listed in sub-paragraph (a); and

(iii) immediately before IP completion day was receiving a course of treatment as part of the health service for the condition mentioned in paragraph (ii) of this sub-paragraph with any of the drugs listed in sub-paragraph (a); or F30]

(d) a man who is suffering from any of the following—

  • diabetes

  • multiple sclerosis

  • parkinson’s disease

  • poliomyelitis

  • prostate cancer

  • severe pelvic injury

  • single gene neurological disease

  • spina bifida

  • spinal cord injury; or

(e) a man who is receiving treatment for renal failure by dialysis; or

(f) a man who has had the following surgery—

  • prostatectomy

  • radical pelvic surgery

  • renal failure treated by transplant [F31 ;

Treatment of erectile dysfunction

(2) Any patient F31]

[F32 Treatment of a condition, other than erectile dysfunction, in respect of which the drug ordered is considered an appropriate treatment F32]

In this Schedule—

F33 ...

[F34 “at clinical risk” means in relation to a patient, a patient who—

(a) has chronic respiratory disease;

(b) has asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission;

(c) has chronic heart disease;

(d) has chronic renal failure;

(e) has chronic liver disease;

(f) has chronic neurological disease;

(g) has diabetes; or

(h) is immunosuppressed; F34]

F33 ...

M4,M5,M6 “ EEA Agreement ” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993 and as amended so far as is relevant to these Regulations, by Decision of the EEA Joint Committee No 7/94 of 21st March 1994 ; and

“ EEA State ” means a State which is a contracting party to the EEA Agreement or Switzerland.

[F35 “general medical practitioner” has the meaning given in regulation 3 of the National Health Service (General Medical Services Contracts) Regulations 2015 ; F35]

[F36 “gonadotrophin-releasing hormone (“GnRH”) analogue” means a medicinal product that consists of or contains buserelin, gonadorelin, goserelin, leuprorelin acetate, nafarelin or triptorelin; F36]

[F37 “patient” has the meaning given in regulation 3 of the National Health Service (General Medical Services Contracts) Regulations 2015 ; F37]

[F38 “residential care establishment” means a place where persons reside on a long term basis in order to receive continuing care. F38]

Status: There are currently no known outstanding effects for the National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004.
National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) Regulations 2004 (2004/629)
Version from: 26 June 2024

Displaying information

Status of this instrument

in force Provision is in force
in force* In force only for specified purposes (see footnote)
not in force Not in force in England (may be in force in other geographies, see footnotes)
defined term Defined term
dfn Defined term (alternative style)
footnote commentary transitional and savings in force status related provisions geo extent insert/omit source count in force adj
F1 Reg. 2 substituted (4.12.2018) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2018 (S.I. 2018/1134) , regs. 1 , 2(2) substituted
F2 Words in Sch. 1 omitted (4.12.2018) by virtue of The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2018 (S.I. 2018/1134) , regs. 1 , 2(3) omitted
F3 Words in Sch. 2 inserted (26.6.2024) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2024 (S.I. 2024/728) , regs. 1(2) , 2(2)(a) inserted
F4 Words in Sch. 2 inserted (26.6.2024) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2024 (S.I. 2024/728) , regs. 1(2) , 2(2)(b) inserted
F5 Words in Sch. 2 inserted (26.6.2024) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2024 (S.I. 2024/728) , regs. 1(2) , 2(2)(c) inserted
F6 Words in Sch. 2 omitted (1.4.2013) by virtue of The National Health Service (Primary Medical Services) (Miscellaneous Amendments and Transitional Provisions) Regulations 2013 (S.I. 2013/363) , regs. 1(1) , 54(2)(a) omitted
F7 Words in Sch. 2 inserted (3.1.2005) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2004 (S.I. 2004/3215) , regs. 1(1) , 2(a) inserted
F8 Words in Sch. 2 substituted (1.11.2010) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2010 (S.I. 2010/2389) , regs. 1(1) , 2(2)(a) substituted
F9 Words in Sch. 2 inserted (20.4.2011) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2011 (S.I. 2011/680) , regs. 1(1) , 2(2) inserted
F10 Words in Sch. 2 inserted (11.4.2018) by The Secretaries of State for Health and Social Care and for Housing, Communities and Local Government and Transfer of Functions (Commonhold Land) Order 2018 (S.I. 2018/378) , art. 1(2) , Sch. para. 20(f) (with art. 14 ) this amendment (text inserted) should be read in conjunction with other related provisions, see the commentary. inserted
F11 Words in Sch. 2 inserted (21.8.2009) by The National Health Service (Prescribing and Charging Amendments Relating to Pandemic Influenza) Regulations 2009 (S.I. 2009/2230) , regs. 1(1) , 5(a)(i) inserted
F12 Words in Sch. 2 substituted (1.4.2013) by The National Health Service (Primary Medical Services) (Miscellaneous Amendments and Transitional Provisions) Regulations 2013 (S.I. 2013/363) , regs. 1(1) , 54(2)(b)(c) substituted
F13 Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071) , reg. 1(1) , Sch. para. 1 substituted
F14 Words in Sch. 2 substituted (1.10.2021) by The Public Health England (Dissolution) (Consequential Amendments) Regulations 2021 (S.I. 2021/974) , regs. 1(1) , 3(2)(a) substituted
F15 Words in Sch. 2 substituted (1.11.2010) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2010 (S.I. 2010/2389) , regs. 1(1) , 2(2)(b) substituted
F16 Words in Sch. 2 inserted (21.8.2009) by The National Health Service (Prescribing and Charging Amendments Relating to Pandemic Influenza) Regulations 2009 (S.I. 2009/2230) , regs. 1(1) , 5(a)(ii) inserted
F17 Sch. 2: entry renumbered (21.8.2009) by The National Health Service (Prescribing and Charging Amendments Relating to Pandemic Influenza) Regulations 2009 (S.I. 2009/2230) , regs. 1(1) , 5(b)(i) renumbered
F18 Words in Sch. 2 substituted (1.11.2010) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2010 (S.I. 2010/2389) , regs. 1(1) , 2(3)(a) substituted
F19 Words in Sch. 2 inserted (20.4.2011) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2011 (S.I. 2011/680) , regs. 1(1) , 2(3) inserted
F20 Words in Sch. 2 substituted (1.11.2010) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2010 (S.I. 2010/2389) , regs. 1(1) , 2(3)(b) substituted
F21 Words in Sch. 2 added (21.8.2009) by The National Health Service (Prescribing and Charging Amendments Relating to Pandemic Influenza) Regulations 2009 (S.I. 2009/2230) , regs. 1(1) , 5(b)(i) added
F22 Words in Sch. 2 substituted (1.10.2021) by The Public Health England (Dissolution) (Consequential Amendments) Regulations 2021 (S.I. 2021/974) , regs. 1(1) , 3(2)(b) substituted
F23 Words in Sch. 2 inserted (21.8.2009) by The National Health Service (Prescribing and Charging Amendments Relating to Pandemic Influenza) Regulations 2009 (S.I. 2009/2230) , regs. 1(1) , 5(b)(ii) inserted
F24 Word in Sch. 2 inserted (1.8.2014) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2014 (S.I. 2014/1625) , regs. 1(2) , 2(b)(i) inserted
F25 Words in Sch. 2 omitted (1.10.2013) by virtue of The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) (Amendment) Regulations 2013 (S.I. 2013/2194) , regs. 1(2) , 2(a) omitted
F26 Words in Sch. 2 omitted (1.8.2014) by virtue of The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2014 (S.I. 2014/1625) , regs. 1(2) , 2(a) omitted
F27 Word in Sch. 2 inserted (1.8.2014) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2014 (S.I. 2014/1625) , regs. 1(2) , 2(b)(ii) inserted
F28 Words in Sch. 2 inserted (1.10.2013) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) (Amendment) Regulations 2013 (S.I. 2013/2194) , regs. 1(2) , 2(b)(i) inserted
F29 Words in Sch. 2 substituted (31.12.2020) by The National Health Service (Cross-Border Healthcare and Miscellaneous Amendments etc.) (EU Exit) Regulations 2019 (S.I. 2019/777) , regs. 1(1) , 9(2)(a) (as substituted by S.I. 2020/1348 , regs. 1 , 8 ); 2020 c. 1 , Sch. 5 para. 1(1) substituted
F30 Words in Sch. 2 substituted (31.12.2020) by The National Health Service (Cross-Border Healthcare and Miscellaneous Amendments etc.) (EU Exit) Regulations 2019 (S.I. 2019/777) , regs. 1(1) , 9(2)(b) (as substituted by S.I. 2020/1348 , regs. 1 , 8 ); 2020 c. 1 , Sch. 5 para. 1(1) substituted
F31 Words in Sch. 2 inserted (1.10.2013) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) (Amendment) Regulations 2013 (S.I. 2013/2194) , regs. 1(2) , 2(b)(ii) inserted
F32 Words in Sch. 2 inserted (1.10.2013) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc) (Amendment) Regulations 2013 (S.I. 2013/2194) , regs. 1(2) , 2(c) inserted
F33 Words in Sch. 2 omitted (1.11.2010) by virtue of The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2010 (S.I. 2010/2389) , regs. 1(1) , 2(4)(a) omitted
F33 Words in Sch. 2 omitted (1.11.2010) by virtue of The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2010 (S.I. 2010/2389) , regs. 1(1) , 2(4)(a) omitted
F34 Words in Sch. 2 inserted (1.11.2010) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2010 (S.I. 2010/2389) , regs. 1(1) , 2(4)(b) inserted
F35 Words in Sch. 2 substituted (7.12.2015) by The National Health Service (General Medical Services Contracts) Regulations 2015 (S.I. 2015/1862) , reg. 1(2) , Sch. 4 para. 1(a) (with reg. 2 ) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F36 Words in Sch. 2 inserted (26.6.2024) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2024 (S.I. 2024/728) , regs. 1(2) , 2(3) inserted
F37 Words in Sch. 2 substituted (7.12.2015) by The National Health Service (General Medical Services Contracts) Regulations 2015 (S.I. 2015/1862) , reg. 1(2) , Sch. 4 para. 1(b) (with reg. 2 ) this amendment (text substituted) should be read in conjunction with other related provisions, see the commentary. substituted
F38 Words in Sch. 2 inserted (3.1.2005) by The National Health Service (General Medical Services Contracts) (Prescription of Drugs etc.) (Amendment) Regulations 2004 (S.I. 2004/3215) , regs. 1(1) , 2(d) inserted
M1 1977 c. 49 ; section 28U was inserted by section 175(1) of the Health and Social Care ( Community Health and Standards Act 2003 (c. 43) .
M2 1978 c. 29 .
M3 S.I. 1972/1265 (NI 14).
M4 Cm. 2073 and O.J. No. L1, 3.1.1994, p.3.
M5 Cm. 2183 and O.J. No. L1, 3.1.1994, p.572.
M6 O.J. No. L160, 28.6.1996, p.1.
Defined Term Section/Article ID Scope of Application
at clinical risk para SCHEDULE 2 def_36be6f440a
EEA Agreement para SCHEDULE 2 def_feb96b87a8
EEA State para SCHEDULE 2 def_b636dbf759
food mix reg. 2. def_384fb12ca1
general medical practitioner para SCHEDULE 2 def_5331c1d3b8
gluten reg. 2. def_0e805d28f7
GnRH para SCHEDULE 2 def_c39147db65
patient para SCHEDULE 2 def_a785f222a8
residential care establishment para SCHEDULE 2 def_27289b48ae

Status of changes to instrument text

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