(a) data used for ordering the drug or appliance (which may be in the form of a prescription form), if the data, in the form in which it is used for ordering the drug or appliance, is also used for the purposes of claiming a payment by way of—

(i) reimbursement for the cost of the supply of the drug or appliance, or

(ii) remuneration for the service provided in the course of which the drug or appliance was supplied;

(b) data derived from the data used for ordering the drug or appliance (which may have been in the form of a prescription form), which is to be or has been provided to a health service body by a provider of NHS services for the purposes of claiming a payment by way of—

(i) reimbursement for the cost of the supply of the drug or appliance, or

(ii) remuneration for the service provided in the course of which the drug or appliance was supplied; and

(3) The processing of data which relates to a patient and which is or is part of data described in paragraph (2) 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

where the processing is by or on behalf of a relevant body or a provider of NHS services (including by another body on behalf of the relevant body or the provider of NHS services) and is for the purposes of performing, or facilitating the performance of, the functions listed in paragraph (4).

(4) Those functions are—

(a) reimbursement for the cost of the supply of that drug or appliance (taking account, as appropriate, of any charge payable under these Regulations);

(b) remuneration for providing the service in the course of which that drug or appliance was supplied (taking account, as appropriate, of any charge payable under these Regulations);

(d) providing advice, assistance and support to patients or their representatives in respect of whether a charge is payable under these Regulations;

(e) recovery of unpaid charges payable under these Regulations, and the making and recovery of penalty charges;

(f) repayment or partial repayment of amounts paid as a charge under these Regulations where no amount or only part of the amount was payable; and

(g) management functions of a relevant body relating to ensuring that the functions mentioned in sub-paragraphs (a) to (f) are performed effectively, efficiently and economically.

(5) A person who—

(a) is employed or engaged by a relevant body or provider of NHS services, or by a body processing data on their behalf as mentioned in paragraph (3); and

(b) in the course of being so employed or engaged is required, for the purposes mentioned in paragraph (3), to undertake the processing of data described in paragraph (2),

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, if the processing is for the purposes mentioned in paragraph (3), that person is able, lawfully, to process that data by virtue of this regulation.

(6) Words and expressions used in both—

(a) paragraphs (3) and (5); 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) to, the Data Protection Act 2018,

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

Transitional provision

Consequential amendments

Revocations

Exemption from charges: supply of a smaller quantity of product in accordance with a SSP

13A

(1) No charge is payable under regulation 3(1) or (2) or 4(1) in respect of the supply of a drug or appliance in accordance with a SSP if, as a consequence of the supply being in accordance with a SSP instead of being in accordance with a prescription form or an associated batch issue, the patient receives a smaller quantity of the drug or fewer appliances than the quantity originally ordered.

(2) If, as a consequence of the supply of a drug or appliance being in accordance with a SSP instead of being in accordance with a prescription form or an associated batch issue—

(a) more than one charge would (but for this sub-paragraph) become payable under regulation 3(1) or (2) or 4(1) in respect of what is supplied in accordance with the SSP instead of only one charge being payable, then only one charge is payable in respect of what is supplied in accordance with that SSP; or

(b) a charge would (but for this sub-paragraph) become payable under regulation 3(1) or (2) or 4(1) in respect of what is supplied in accordance with the SSP instead of no charge being payable, then no charge is payable in respect of what is supplied in accordance with that SSP.

Exemption for prescriptions provided or issued in Northern Ireland

Certificates of exemption: application and issue

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

Repayment of charges

Transitional provision

Consequential amendments

Revocations

Declarations, signatures and evidence of entitlement or of payment during a pandemic etc.

10A

(1) Where, by virtue of these Regulations, a person is required to make, provide, complete or sign any declaration, or provide any evidence (including by way of completing a form or providing a certificate), but as a consequence of a disease being, or in anticipation of a disease being imminently—

(a) pandemic; and

(b) a serious risk or potentially a serious risk to human health,

the Secretary of State has made an announcement to the effect that, in order to assist in the management of the serious risk or potentially serious risk to human health, for the period specified in the announcement, that requirement is to be waived or modified in the manner specified in the announcement, that requirement is waived or is as modified in the specified manner for the specified period.

(2) Modifications under paragraph (1) may include modifications imposing requirements on a person other than the person who, but for the announcement, would be required to make, provide, complete or sign any declaration, or provide any evidence.

(3) An announcement under paragraph (1) may be withdrawn or amended at any time.

Exemption from charges for prisoners and persons detained in other secure accommodation

Exemption from charges for detainees

Exemption from charges: risks to public health

Exemption from charges: supply of a smaller quantity of product in accordance with a SSP

Exemption for prescriptions provided or issued in Northern Ireland

Certificates of exemption: application and issue

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

Repayment of charges

Transitional provision

Consequential amendments

Revocations

Coronavirus and influenza vaccinations and immunisations

13B

(1) No charge is payable under these Regulations in respect of the supply or administration to an eligible person of a medicinal product used for vaccination or immunisation against coronavirus or influenza virus.

(2) In this regulation—

“coronavirus” has the meaning given in section 1(1) of the Coronavirus Act 2020; and

“eligible person” means a person who is of a class or description that means they would be entitled to be supplied with the medicinal product, or have it administered to them, in accordance with—a national patient group direction under regulation 233 of the Human Medicines Regulations 2012 (exemption for supply etc under a PGD by a person conducting a retail pharmacy business), signed on behalf of NHS England in accordance with paragraph (5)(a) of that regulation; ora national protocol under regulation 247A of the Human Medicines Regulations 2012 (protocols relating to coronavirus and influenza vaccinations and immunisations) approved by the Secretary of State,

whether or not the medicinal product is supplied or administered to that person in accordance with such a patient group direction or protocol.

Exemption for prescriptions provided or issued in Northern Ireland

Certificates of exemption: application and issue

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

Repayment of charges

Transitional provision

Consequential amendments

Revocations

15A

(1) As regards any application made for an exemption certificate mentioned in regulation 15(1)(a) (either by the applicant or by a health care professional making an application on the applicant’s 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 an applicant meets the entitlement criteria for the exemption certificate;

(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

(3) This paragraph applies where the processing—

(a) is by or on behalf of a relevant body or a provider of NHS services, including by another body on behalf of the relevant body or the provider of NHS services; and

(b) is for the purposes of performing, or facilitating the performance of, the functions mentioned in paragraph (1).

(4) A person who—

(a) is employed or engaged by a relevant body or provider of NHS services, or by a body processing data on their behalf as mentioned in paragraph (3)(a); and

(b) in the course of being so employed or engaged 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,

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

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

Repayment of charges

Transitional provision

Consequential amendments

Revocations

Exemption from charges: supplies in accordance with a SSP

HRT only pre-payment certificates

17A

(1) The Secretary of State may make arrangements for the grant of pre-payment certificates solely in respect of prescription items that are used for hormone replacement therapy (HRT) treatment, in particular by—

(a) publishing in the Drug Tariff a list of the drugs and appliances (“listed HRT prescription items”) in respect of which no charge is payable by a person on whom exemption from charging in respect of the listed HRT prescription items is conferred by the granting of such a certificate (referred to in these Regulations as a “HRT only PPC”); and

(b) specifying how applications for the grant of HRT only PPCs are to be made.

(2) Any such arrangements must provide that a patient may apply for a HRT only PPC whether or not the listed HRT prescription items are prescribed for them for use for HRT treatment or for some other purpose.

(3) The list mentioned in paragraph (1)(a) is only to include those of the prescription items used for HRT treatment that the Secretary of State wishes to include in the arrangements mentioned in paragraph (1), not all the prescription items that may be used for HRT treatment.

(4) In order to benefit from any arrangements as mentioned in paragraph (1), a patient or someone acting on their behalf (an “applicant”) may apply for a HRT only PPC, but if an applicant does so, the applicant must—

(a) pay to the Secretary of State the sum payable for the HRT only PPC, which is £19.80 (and an application is not valid if that amount has not been received by the Secretary of State); and

(b) provide the Secretary of State with the information required to determine that application by—

(i) duly completing and submitting an application for a HRT only PPC on a form approved by the Secretary of State and provided for that purpose, or

(ii) providing the Secretary of State with that information in a manner that is otherwise acceptable to the Secretary of State.

(5) A HRT only PPC is valid for a period of 12 months and an application for a HRT only PPC must include the date from which the patient wishes it to be valid.

(6) A HRT only PPC is valid from the date included in the application pursuant to paragraph (5), where the applicant has specified a date that is—

(a) before the application is made and that date is no more than one month prior to the date on which the application is made (so if the application is made on 1st May, the start date may be no earlier than 1st April);

(b) the date on which the application is made; or

(c) after the application is made and that date is no more than one month after the date on which the application is made (so if the application is made on 1st April, the start date may be no later than 1st May),

but otherwise, the HRT only PPC is valid from the date on which the application is received.

(7) A HRT only PPC is only valid in respect of a prescription item that is a listed HRT prescription item at the time of the supply of the prescription item, unless—

(a) the prescription item was a listed HRT prescription item before that time but it has since been removed from the list in the Drug Tariff; and

(b) it was a listed HRT prescription item at the time the prescription in pursuance of which the product is supplied was issued (whether the product is supplied in accordance with that prescription or a serious shortage protocol),

in which case, the HRT only PPC is also valid in respect of that product.

(8) As regards any HRT only PPCs that are to be valid during the first month for which any arrangements as mentioned in paragraph (1) are made—

(a) the date to be included by the applicant in the application pursuant to paragraph (5) must be a date no earlier than the date on which the arrangements start; and

(b) if an earlier start date for the HRT only PPC is included but the application is otherwise valid, the HRT only PPC is valid from the date on which the arrangements start.

Repayment of charges

Transitional provision

Consequential amendments

Revocations

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;

(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

(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,

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

Pre-payment certificates: repayment

HRT only pre-payment certificates

Repayment of charges

Transitional provision

Consequential amendments

Revocations

Treatments for tuberculosis

13C

(1) No charge is payable under these Regulations in respect of the supply or administration of any drug for the treatment of—

(a) tuberculosis;

(b) the effects of tuberculosis; or

(2) Paragraph (1) applies if the supply—

(a) is made in accordance with a patient group direction; or

(b) has been ordered on a prescription form, and the prescriber has included in the form the reference “FS”.

Exemption for prescriptions provided or issued in Northern Ireland

Certificates of exemption: application and issue

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

HRT only pre-payment certificates

Repayment of charges

Transitional provision

Consequential amendments

Revocations

Reading this document does not replace reading the official text published on legislation.gov.uk. Contains public sector information licensed under the Open Government Licence v3.0. We assume no responsibility for any inaccuracies arising from the conversion of the original CLML XML to this format.

This text is published under legislation.gov.uk's own terms of reuse, not a Legalize or public-domain licence. legislation.gov.uk
Open Government Licence v3.0 (attribution required)
© Crown and database right. Derived from content available under the Open Government Licence v3.0 from legislation.gov.uk.

The National Health Service (Charges for Drugs and Appliances) Regulations 2015

Sharing of prescription and charging data

18A

Transitional provision

Consequential amendments

Revocations

Exemption from charges: supply of a smaller quantity of product in accordance with a SSP

13A

Exemption for prescriptions provided or issued in Northern Ireland

Certificates of exemption: application and issue

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

Repayment of charges

Sharing of prescription and charging data

Transitional provision

Consequential amendments

Revocations

Declarations, signatures and evidence of entitlement or of payment during a pandemic etc.

10A

Exemption from charges for prisoners and persons detained in other secure accommodation

Exemption from charges for detainees

Exemption from charges: risks to public health

Exemption from charges: supply of a smaller quantity of product in accordance with a SSP

Exemption for prescriptions provided or issued in Northern Ireland

Certificates of exemption: application and issue

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

Repayment of charges

Sharing of prescription and charging data

Transitional provision

Consequential amendments

Revocations

Coronavirus and influenza vaccinations and immunisations

13B

Exemption for prescriptions provided or issued in Northern Ireland

Certificates of exemption: application and issue

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

Repayment of charges

Sharing of prescription and charging data

Transitional provision

Consequential amendments

Revocations

Sharing of data relating to applications for medical and maternity exemption certificates

15A

Pre-payment certificates: application and grant

Pre-payment certificates: repayment

Repayment of charges

Sharing of prescription and charging data

Transitional provision

Consequential amendments

Revocations

Exemption from charges: supplies in accordance with a SSP

HRT only pre-payment certificates

17A

Repayment of charges

Sharing of prescription and charging data

Transitional provision

Consequential amendments

Revocations

Sharing of data relating to applications for pre-payment certificates

16A

Pre-payment certificates: repayment

HRT only pre-payment certificates

Repayment of charges

Sharing of prescription and charging data

Transitional provision

Consequential amendments

Revocations

Treatments for tuberculosis

13C

Exemption for prescriptions provided or issued in Northern Ireland

Certificates of exemption: application and issue

Sharing of data relating to applications for medical and maternity exemption certificates

Pre-payment certificates: application and grant

Sharing of data relating to applications for pre-payment certificates

Pre-payment certificates: repayment

HRT only pre-payment certificates

Repayment of charges

Sharing of prescription and charging data