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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
[F1a GnRH analogue]

[F2(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]

[F3(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]

F4. . .F4. . .F4. . .
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
[F5Oseltamivir (Tamiflu)]

[F5(1) [F6A 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, [F7or who is aged under 65 years and is at risk of developing medical complications from influenza,] where—

(a)the Department of Health [F8and 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.]

[F9(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 [F10are part of an antiviral distribution service provided by [F11NHS England], [F12the United Kingdom Health Security Agency] or a Local Authority.]]

[F5Treatment of influenza]

[F5(2) [F13A 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 [F8and 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.]

[F14(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 [F10are part of an antiviral distribution service provided by [F11NHS England], [F12the United Kingdom Health Security Agency] or a Local Authority.]]

[F5Prophylaxis of influenza]
[F5Zanamivir (Relenza)]

[F15(1)] [F16A 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, [F17or who is aged under 65 years and is at risk of developing medical complications from influenza,] where—

(a)the Department of Health [F8and 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

[F18(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.]

[F5Treatment of influenza ]

[F19(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 [F10are part of an antiviral distribution service provided by [F11NHS England], [F20the United Kingdom Health Security Agency] or a Local Authority.]]

[F21Prophylaxis or treatment of influenza.]

The following drugs for the treatment of erectile dysfunction—

[F26(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 M1 or the Health and Personal Social Services (Northern Ireland) Order 1972 M2for 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

[F27(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]

[F28(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[F29;

Treatment of erectile dysfunction

(2) Any patient]

[F30Treatment 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—

F31...

Textual Amendments

[F32“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

F31...

Textual Amendments

“EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 M3 as adjusted by the Protocol signed at Brussels on 17th March 1993 M4 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 M5; and

Marginal Citations

M3Cm. 2073 and O.J. No. L1, 3.1.1994, p.3.

M4Cm. 2183 and O.J. No. L1, 3.1.1994, p.572.

M5O.J. No. L160, 28.6.1996, p.1.

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

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

Textual Amendments

[F34“gonadotrophin-releasing hormone (“GnRH”) analogue” means a medicinal product that consists of or contains buserelin, gonadorelin, goserelin, leuprorelin acetate, nafarelin or triptorelin;]

Textual Amendments

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

Textual Amendments

[F36“residential care establishment” means a place where persons reside on a long term basis in order to receive continuing care.]

Textual Amendments