xmlns:atom="http://www.w3.org/2005/Atom"

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 application

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.

Drugs, medicines and other substances that may not be ordered

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.

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 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.

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

Regulation 3

SCHEDULE 2DRUGS ON MEDICINES TO BE ORDERED ONLY IN CERTAIN CIRCUMSTANCES

Column 1Column 2Column 3
DrugsPatientCondition

In this Schedule—

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(6) as adjusted by the Protocol signed at Brussels on 17th March 1993(7) 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(8);

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

ClobazamAny patientTreatment of epilepsy
Cyanocobalamin TabletsA patient who is a vegan or who has a proven vitamin B12 deficiency of dietary originTreatment or prevention of vitamin B12 deficiency
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

The following drugs for the treatment of erectile dysfunction—

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

Apomorphine Hydrochloride (Uprima)

Moxisylyte Hydrochloride (Erecnos)

Sildenafil (Viagra)

Tadalafil (Cialis)

Thymoxamine Hydrochloride (Erecnos)

Vardenafil (Levitra)

(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

(b)man who is a national of an EEA State who is entitled to treatment by virtue of Article 7(2) of Council Regulation 1612/68(5) as extended by the EEA Agreement or by virtue of any other enforceable Community right who 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 this condition with any of the drugs listed in sub-paragraph (a); or

(c)a man who is not a national of an EEA State but who is the member of the family of such a national who has an enforceable Community right to be treated no less favourably than the national in the provision of medical treatment and has erectile dysfunction and was being treated for that condition on 14th September 1998 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

Treatment of erectile dysfunction

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(9).

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)

O.J. No. L257, 19.10.68, p.22.

(6)

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

(7)

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

(8)

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

(9)

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