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Statutory Instruments

2024 No. 456

NATIONAL HEALTH SERVICE, ENGLAND

The National Health Service (Charges for Drugs and Appliances) (Amendment) Regulations 2024

Made

2nd April 2024

Laid before Parliament

3rd April 2024

Coming into force

1st May 2024

The Secretary of State makes these Regulations in exercise of the powers conferred by sections 172, 174, 178, 182 and 272(7) and (8) of the National Health Service Act 2006(1).

Citation, commencement, interpretation, extent and application

1.—(1) These Regulations may be cited as the National Health Service (Charges for Drugs and Appliances) (Amendment) Regulations 2024 and come into force on 1st May 2024.

(2) In these Regulations, “the Charges Regulations” means the National Health Service (Charges for Drugs and Appliances) Regulations 2015(2).

(3) These Regulations extend to England and Wales, and apply only to England(3).

Amendments to the Charges Regulations

2.  The Charges Regulations are amended in accordance with regulations 3 to 11.

Amendment to regulation 2

3.  In regulation 2 (interpretation), in paragraph (1), at the appropriate place in the alphabetical order, insert—

prescription only medicine” has the same meaning as in regulation 5(3) of the Human Medicines Regulations 2012 (classification of medicinal products);.

Amendments relating to charges for drugs and appliances

4.—(1) In each of the following provisions, for “£9.65”, substitute “£9.90”

(a)regulation 3(1)(a), (b) and (c), (2)(a), (b) and (c) and (7) (supply of drugs and appliances by chemists);

(b)regulation 4(1)(a), (b) and (c) and (4) (supply of drugs and appliances by doctors);

(c)regulation 5(1)(a), (b) and (c) (out of hours supply of drugs and appliances by providers of out of hours services);

(d)regulation 6(1)(a), (d) and (e) (supply of drugs and appliances by NHS trusts and NHS foundation trusts);

(e)regulation 7(1)(a), (b) and (c) and (5) (supply of drugs and appliances at walk-in centres);

(f)regulation 8(1) (supply of drugs under Patient Group Directions); and

(g)regulation 9(1)(a), (d) and (e) and (8) (supply of drugs and appliances by other providers of NHS services).

(2) In each of the following provisions, for “£19.30”, substitute “£19.80”

(a)regulation 3(1)(a) and (2)(a) (supply of drugs and appliances by chemists);

(b)regulation 4(1)(a) (supply of drugs and appliances by doctors);

(c)regulation 5(1)(a) (out of hours supply of drugs and appliances by providers of out of hours services);

(d)regulation 6(1)(a) and (c) (supply of drugs and appliances by NHS trusts and NHS foundation trusts);

(e)regulation 7(1)(a) (supply of drugs and appliances at walk-in centres); and

(f)regulation 9(1)(a) and (b) (supply of drugs and appliances by other providers of NHS services).

(3) In column (2) of the table in Schedule 1 (charges for fabric supports and wigs)—

(a)for “£31.70” substitute “£32.50”;

(b)for “£47.80” substitute “£49.05”;

(c)for “£78.15” substitute “£80.15”;

(d)for “£207.00” substitute “£212.35”; and

(e)for “£302.70” substitute “£310.55”.

Amendment to regulation 8

5.  In regulation 8 (supply of drugs under Patient Group Directions), omit paragraph (2).

Amendment to regulation 9

6.  In regulation 9 (supply of drugs and appliances by other providers of NHS services), after paragraph (2), insert—

(2A) Paragraph (2) does not apply if the person paying the charge is paying it in respect of a medicine, other than a prescription only medicine, supplied as part of an additional pharmaceutical service(4)..

Amendment to regulation 15

7.  In regulation 15 (certificates of exemption: application and issue), after paragraph (5), add—

(6) The Secretary of State, on being satisfied that an exemption certificate has been issued in error or because of fraud, may revoke that certificate..

Amendments to regulation 16

8.  In regulation 16 (pre-payment certificates: application and grant)—

(a)in paragraph (1)—

(i)after “A person”, insert “(“a patient”)”, and

(ii)for “(referred to in this regulation as”, substitute “for themselves, or someone acting on their behalf, (either of them potentially being, for the purposes of this regulation,”;

(b)in paragraph (3)—

(i)in sub-paragraph (a), for “£31.25” substitute “£32.05”,

(ii)in sub-paragraph (b), for “£111.60” substitute “£114.50”, and

(iii)in sub-paragraph (c), for “£11.16” substitute “£11.45”;

(c)in paragraph (4), for “applicant”, at the first place it occurs, substitute “patient”; and

(d)in paragraph (5)—

(i)for “an applicant”, substitute “a patient”,

(ii)at the end of sub-paragraph (a), insert “and”, and

(iii)omit sub-paragraph (c), and the “and” before it.

New regulation 16A of the Charges Regulations

9.  After regulation 16 (pre-payment certificates: application and grant), insert—

Sharing of data relating to applications for pre-payment certificates

16A.(1) As regards any application made for a pre-payment certificate mentioned in regulation 16(1) (either by the patient or someone making an application on their behalf), paragraph (2) applies to the data (which may be electronic data) arising from—

(a)the completion of the application form (by whosoever completes it);

(b)the processing of the application form for the purposes of assessing whether or not a patient meets the entitlement criteria for the pre-payment certificate;

(c)the issuing of a pre-payment certificate to a patient where it is appropriate to do so; and

(d)the management of these processes to ensure that they are performed effectively, efficiently and economically.

(2) Where paragraph (3) applies, the processing of data which is or is part of data described in paragraph (1) is—

(a)necessary for the performance of a task carried out in the public interest;

(b)the exercise of a function conferred on a person by an enactment (whether or not it would be so but for this sub-paragraph); and

(c)if the data is personal data concerning health, necessary for the management of health care systems or services.

(3) This paragraph applies where the processing is for the purposes of performing, or facilitating the performance of, the functions mentioned in paragraph (1).

(4) A person who is required, for the purposes of performing, or facilitating the performance of, the functions mentioned in paragraph (1), to undertake the processing of data which is or is part of data described in that paragraph, owes a duty of confidentiality in respect of that data (whether or not that person would do so but for this paragraph), but that duty is such that the person is able for those purposes, lawfully, to process that data by virtue of this regulation.

(5) Words and expressions used in both—

(a)paragraphs (2) to (4); and

(b)Parts 1 and 2 (preliminary and general processing) of, and paragraph 2(2)(f) of Schedule 1 (special categories of personal data and criminal convictions etc data – health or social care purposes) to, the Data Protection Act 2018(5),

bear the meanings they bear in those provisions of the Data Protection Act 2018..

Amendment to regulation 17

10.  In regulation 17 (pre-payment certificates: repayment), in paragraph (6), omit “the pre-payment certificate (where granted) and”.

Amendment to regulation 17A

11.  In regulation 17A(4) (HRT only pre-payment certificates), in sub-paragraph (a), for “£19.30” substitute “£19.80”.

Transitional provision relating to the Charges Regulations

12.  Where, on or after 1st May 2024, an appliance specified in Schedule 1 to the Charges Regulations (charges for fabric supports and wigs) is supplied pursuant to an order given before that date, the Charges Regulations are to have effect in relation to that supply as if these Regulations had not come into force.

Signed by authority of the Secretary of State for Health and Social Care

Andrea Leadsom

Parliamentary Under Secretary of State

Department of Health and Social Care

2nd April 2024

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the National Health Service (Charges for Drugs and Appliances) Regulations 2015 (“the Charges Regulations”).

The Charges Regulations include the charges that are payable for the supply of NHS drugs and appliances in England.

Regulation 3 inserts a definition for “prescription only medicine” into the Charges Regulations.

Regulation 4 amends regulations 3 to 9 of the Charges Regulations to increase the single prescription charge applied for the supply of drugs, appliances and elastic hosiery from £9.65 to £9.90 (if the hosiery charge is for a pair, the charge is double that amount). This is an increase of 2.59%. There are also increases to the charges for fabric supports and wigs of 2.58% on average.

Regulations 5 and 6 amend regulations 8 and 9 of the Charges Regulations to remove signature requirements in some cases in which a charge is paid.

Regulation 7 amends regulation 15 of the Charges Regulations to introduce the ability to revoke exemption certificates issued in error or because of fraud.

Regulation 8 amends regulation 16 of the Charges Regulations to increase the cost of 3 and 12-month pre-payment certificates, and monthly instalments for 12-month pre-payment certificates, by approximately 2.58%. Regulation 8 also allows third parties to make applications for pre-payment certificates on a patient’s behalf, and removes reference to the requirement for pre-payment certificates to be returned.

Regulation 9 inserts a new regulation 16A to include a statutory information gateway in respect of pre-payment certificates, to support the claiming and provision of such certificates and the management of those processes.

Regulation 10 removes the requirement for pre-payment certificates to be returned with refund applications.

Regulation 11 amends regulation 17A of the Charges Regulations to increase the cost of the HRT only pre-payment certificate from £19.30 to £19.80, an increase of 2.59%.

Regulation 12 makes transitional provision in relation to fabric supports and wigs supplied pursuant to NHS prescriptions written before 1st May 2024.

A full impact assessment has not been produced for this instrument as no, or no significant, impact on the private or voluntary sectors is foreseen, and only a limited impact on the public sector, below the threshold for producing a full impact assessment.

(1)

2006 c. 41. See section 275(1) of the National Health Service Act 2006 for the definitions of “prescribed” and “regulations” that are relevant to the powers being exercised.

(3)

By virtue of section 271(1) of the National Health Service Act 2006, the functions of the Secretary of State being exercised in the making of these Regulations are exercisable only in relation to England.

(4)

See section 127(4) of the National Health Service Act 2006 for the definition of “additional pharmaceutical services”.