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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

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 M1 and of all other powers enabling him in that behalf, hereby makes the following Regulations:

Marginal Citations

M11977 c. 49; section 28U was inserted by section 175(1) of the Health and Social Care (Community Health and Standards Act 2003 (c. 43).

Citation, commencement and applicationE+W

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.

[F1Drugs, medicines and other substances that may not be orderedE+W

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.]

Textual Amendments

Drugs, medicines and other substances that may be ordered only in certain circumstancesE+W

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 1E+WDRUGS, MEDICINES AND OTHER SUBSTANCES NOT TO BE ORDERED UNDER A GENERAL MEDICAL SERVICES CONTRACT

Textual Amendments

Regulation 3

SCHEDULE 2E+WDRUGS, MEDICINES AND OTHER SUBSTANCES THAT MAY BE ORDERED ONLY IN CERTAIN CIRCUMSTANCES

Column 1Column 2Column 3
DrugsPatientPurpose
ClobazamAny patientTreatment of epilepsy
F3. . .F3. . .F3. . .
Locabiotal AerosolAny patientTreatment of infections and inflammation of the oropharynx
Niferex Elixir 30ml Paediatric Dropper BottleInfants born prematurelyProphylaxis and treatment of iron deficiency
Nizoral CreamAny patientTreatment of seborrhoeic dermatitis and pityriasis versicolor
[F4Oseltamivir (Tamiflu)]

[F4(1) [F5A 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, [F6or who is aged under 65 years and is at risk of developing medical complications from influenza,] where—

(a)the Department of Health [F7and Social Care] has notified general medical practitioners that the influenza virus is circulating in the community;]

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

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

[F8(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 [F9are part of an antiviral distribution service provided by [F10NHS England], [F11the United Kingdom Health Security Agency] or a Local Authority.]]

[F4Treatment of influenza]

[F4(2) [F12A 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 [F7and Social Care] has notified general medical practitioners that the influenza virus is circulating in the community;]

(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.]

[F13(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 [F9are part of an antiviral distribution service provided by [F10NHS England], [F11the United Kingdom Health Security Agency] or a Local Authority.]]

[F4Prophylaxis of influenza]
[F4Zanamivir (Relenza)]

[F14(1)] [F15A 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, [F16or who is aged under 65 years and is at risk of developing medical complications from influenza,] where—

(a)the Department of Health [F7and Social Care] has notified general medical practitioners that the influenza virus is circulating in the community;]

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

[F17(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.]

[F4Treatment of influenza ]

[F18(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 [F9are part of an antiviral distribution service provided by [F10NHS England], [F19the United Kingdom Health Security Agency] or a Local Authority.]]

[F20Prophylaxis or treatment of influenza.]

The following drugs for the treatment of erectile dysfunction—

[F25(1) The following patients with erectile dysfunction–]

(a)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 M2 or the Health and Personal Social Services (Northern Ireland) Order 1972 M3for 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

[F26(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]

[F27(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]

(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[F28;

Treatment of erectile dysfunction

(2) Any patient]

[F29Treatment of a condition, other than erectile dysfunction, in respect of which the drug ordered is considered an appropriate treatment]

Textual Amendments

Marginal Citations

In this Schedule—

F30...

Textual Amendments

[F31“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;]

Textual Amendments

F30...

Textual Amendments

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 M4 as adjusted by the Protocol signed at Brussels on 17th March 1993 M5 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 M6; and

Marginal Citations

M4Cm. 2073 and O.J. No. L1, 3.1.1994, p.3.

M5Cm. 2183 and O.J. No. L1, 3.1.1994, p.572.

M6O.J. No. L160, 28.6.1996, p.1.

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

[F32“general medical practitioner” has the meaning given in regulation 3 of the National Health Service (General Medical Services Contracts) Regulations 2015;]

Textual Amendments

[F33“patient” has the meaning given in regulation 3 of the National Health Service (General Medical Services Contracts) Regulations 2015;]

Textual Amendments

[F34“residential care establishment” means a place where persons reside on a long term basis in order to receive continuing care.]

Textual Amendments

Explanatory Note

(This note is not part of the Regulations)

M7These Regulations make provision as to the drugs, medicines or other substances that may be ordered for patients in the provision of medical services under a general medical services contract within the meaning of section 28Q of the National Health Service Act 1977 .

Regulation 2 and Schedule 1 list the drugs, medicines and other substances that may not be ordered under such a contract.

Regulation 3 and Schedule 2 specify the drugs, medicines and other substances that may be ordered under such a contract only in certain circumstances and sets out those circumstances.