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Welsh Statutory Instruments

2004 No. 1022 (W.119)

NATIONAL HEALTH SERVICE, WALES

The National Health Service (General Medical Services Contracts) (Prescription of Drugs Etc.) (Wales) Regulations 2004

Made

30th March 2004

Coming into force

1st April 2004

The National Assembly for Wales, in exercise of the powers conferred upon it by sections 28U and 126(4) of the National Health Service Act 1977(1)hereby makes the following Regulations:—

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.) (Wales) Regulations 2004 and shall come into force on 1st April 2004.

(2) These Regulations apply to Wales only.

Commencement Information

I1Reg. 1 in force at 1.4.2004, see reg. 1(1)

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

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

Commencement Information

I2Reg. 2 in force at 1.4.2004, see reg. 1(1)

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 patients 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.

Commencement Information

I3Reg. 3 in force at 1.4.2004, see reg. 1(1)

Signed on behalf of he National Assembly for Wales under section 66(1) of the Government of Wales Act 1998(2)

D. Elis-Thomas

The Presiding Officer of the National Assembly

30th March 2004

Regulation 2

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

Commencement Information

I4Sch. 1 in force at 1.4.2004, see reg. 1(1)

Regulation 3

SCHEDULE 2E+WDRUGS [F1OR] MEDICINES TO BE ORDERED ONLY IN CERTAIN CIRCUMSTANCES

Textual Amendments

Commencement Information

I5Sch. 2 in force at 1.4.2004, see reg. 1(1)

Column 1Column 2Column 3
DrugsPatientCondition

In this Schedule—

F2...

[F3“at-risk” means in relation to a patient, a patient who—

(a)

has chronic respiratory disease (including asthma and chronic obstructive pulmonary disease);

(b)

has significant cardiovascular disease, excluding a patient who has hypertension only;

(c)

has chronic renal disease;

(d)

is immunocompromised;

(e)

has diabetes mellitus;

(f)

has chronic liver disease; or

(g)

has chronic neurological disease;]

F2...

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(5) as adjusted by the Protocol signed at Brussels on 17th March 1993(6) 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(7);

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

[F4general medical practitioner” means a medical practitioner whose name is included in the General Practitioner Register, kept by the General Medical Council under section 2 of the Medical Act 1983;]

[F4GnRH analogue” means gonadotrophin-releasing hormone, a medicinal product that consists of or contains buserelin, gonadorelin, goserelin, leuprorelin acetate, nafarelin or triptorelin;]

[F5“Pandemic influenza” means influenza caused by a new virus subtype that has an increased and sustained transmission during a global outbreak of influenza;]

[F6“patient” has the same meaning as in the [F7National Health Services (General Medical Service Contracts) (Wales) Regulations 2023];]

[F6“residential care establishment” means a place where persons reside on a long-term basis in order to receive continuing care.]

ClobazamAny patientTreatment of epilepsy
F8. . .F8. . .F8. . .
[F9GnRH analogue]

[F10(1) Any patient who is aged 18 or over.

(2) Any patient who is aged under 18 to whom the general medical 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 19 July 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 3 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 19 July 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.]

[F11(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 of gender dysphoria, gender incongruence or a combination of both.]

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
[F12Oseltamivir (Tamiflu)

[F13(1) A patient F14... who is at clinical risk or a patient who is pregnant or aged 65 years or over, or who is aged under 65 years and is at risk of developing medical complications for influenza, where—

(a)the Welsh Ministers have 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.

(2) A patient F14... who is at clinical risk or a patient who is pregnant or aged 65 years or over, or who is aged under 65 years and is at risk of developing medical complications for influenza, where—

(a)it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or is present or was present at the time that the virus was circulating;

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

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

(3) 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 Welsh Minsters.

Treatment of influenza

(4)  A patient F14... who is at clinical risk or a patient who is pregnant or aged 65 years or over, where—

(a)the Welsh Ministers have 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.

(5) A patient F14... who is at clinical risk or a patient who is pregnant or aged 65 years or over, where—

(a)it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or is present or was present at the time that the virus was circulating;

(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.

(6) 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 Welsh Ministers.

Prophylaxis of infinfluenza]]

The following drugs for the treatment of erectile dysfunction—

Alprostadil F15...

[F16Avanafil]

F17... F18...

F17... F19...

Sildenafil F20...

Tadalafil F21...

F17... F19...

Vardenafil F22...

[F23(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(3) or the Health and Personal Social Services (Northern Ireland) Order 1972(4) for this condition with any of the following drugs—

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

  • Apomorphine Hydrochloride (Uprima)

  • Moxisylyte Hydrochloride Assembly (Erecnos)

  • Sildenafil (Viagra)

  • Tadalafil (Cialis)

  • Thymoxamine Hydrochloride (Erecnos); or

[F24(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]

[F25(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

[F26(g)a man who has been diagnosed as suffering severe distress resulting from erectile dysfunction where the assessment has been made by a specialist service or GP under arrangements made with a Local Health Board to provide such assessments][F27;

Treatment of erectile dysfunction

(2) Any patient]

[F28Treatment of a condition other than erectile dysfunction, in respect of which the drug ordered is in receipt of a UK or EU marketing authorisation for the treatment of that condition]
[F12Zanamivir (Relenza)

[F29(1)  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, or who is aged under 65 years and is at risk of developing medical complications from influenza, where—

(a)the Welsh Ministers have notified general medical practitioners that the influenza virus is circulating in the community;

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

(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;

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

(2) 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, or who is aged under 65 years and is at risk of developing medical complications from influenza where—

(a)it has been determined in accordance with a community based virological surveillance scheme that influenza A or influenza B is circulating in the locality in which the patient resides or was present at the time that the virus was circulating;

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

(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;

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

Treatment of influenza

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 Welsh Ministers.

Prophylaxis or treatment of influenza]]

Textual Amendments

Explanatory Note

(This note is not part of the Regulations)

These 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(8).

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.

(1)

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) (“the 2003 Act”).

(5)

Cm. 2073 and O.J. No. L1, 3.1.1944, p.3.

(6)

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

(7)

O.J. No. L160, 28.6. 1996, p.1.

(8)

Section 28Q was inserted into the Act by section 175(1) of the 2003 Act.