The National Health Service (Pharmaceutical Services, Charges and Prescribing) (Amendment) Regulations 2018

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations amend the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the PLPS Regulations”), which govern the arrangements in England under Part 7 of the National Health Service Act 2006 (“the 2006 Act”) for the provision of pharmaceutical services and local pharmaceutical services. These Regulations also amend the National Health Service (Charges for Drugs and Appliances) Regulations 2015 (“the Charges Regulations”), which provide for the making and recovery of charges for drugs and appliances supplied in England, most often on prescription, under the 2006 Act. These Regulations also amend the National Health Service (General Medical Services Contracts) Regulations 2015 (“the GMS Contracts Regulations”) and the National Health Service (Personal Medical Services Agreements) Regulations 2015 (“the PMS Agreements Regulations”), which make provision in respect of the services provided in England under a general medical services contract and a personal medical services agreement made pursuant to Part 4 of the 2006 Act.

Part 1 contains general provisions. Part 2 contains the amendments to the PLPS Regulations – and principally these amendments relate to electronic prescribing. Prior to these Regulations, an NHS patient wishing to have an electronic prescription dispensed by a provider of pharmaceutical or local pharmaceutical services needed have a nominated dispensing contractor who was recorded as such in the Electronic Prescription Service (EPS). However, new arrangements known as EPS phase 4 will allow for the NHS patient to have a prescription dispensed by a dispensing contractor who is not the patient’s nominated dispensing contractor but to whom the patient presents an EPS token which has the appropriate barcode – as well as allowing for dispensing by a nominated dispensing contractor (regulations 2(2) and (4) to (6), 7(2) and (5)(a), 8(2) and (5)(a), 9(2) and 10(2) and (5)(a)). Not all dispensing contractors will have the facility to dispense against such a token, and these Regulations also ensure that dispensing contractors are not under an obligation to dispense if they do not have the necessary access to the EPS (regulations 7(4), 8(4), 9(5) and 10(4)). All patients who are claiming exemption from prescription charges, apart from those who are exempt by reason of their age, are obliged to make a declaration to the dispensing contractor that they are exempt, and amendments are made to dispensing contractors’ terms of service both in relation to the recording of these declarations and for allowing real time exemption checks of electronic database records managed by the NHS Business Services Authority to be considered by the dispensing contractor as satisfactory evidence of exemption entitlement (regulations 7(3), 8(3), 9(3) and (4), and 10(3)). Forms recording patient declarations, where these have to be completed, have to be sent on by the dispensing contractor to the NHS Business Services Authority (regulations 7(5)(b), 8(5)(b), 9(4) and 10(5)(b)).

Some other amendments are also made to the PLPS Regulations. Provision is made so that prescriptions written by paramedic independent prescribers will be dispensed as part of pharmaceutical and local pharmaceutical services (regulation 2(3)). Providers of such services who are known as NHS chemists are subject to an enforcement scheme that provides for the service of breach and remedial notices by the NHS Commissioning Board (now known as NHS England), and amendments are made to provide for the rescission of such notices (regulations 4 and 5). Also, if NHS England are minded to serve a breach notice relating to an NHS chemist not being open for business at its notified hours without good cause, they are now required to make a reasonable effort to communicate with the NHS chemist to find out what the cause was (regulation 3). A number of decisions by NHS England under the PLPS Regulations are appealable to the NHS Litigation Authority, and there is a simplification of the arrangements under which certain third parties may attend oral hearings, removing a requirement that they need to indicate, when they make their written representations, that they also wish to make oral representations (regulation 6).

Under the Charges Regulations, entitlement to some exemptions from paying prescription charges is based on the patient both having a valid exemption certificate (recording for example a relevant medical exemption) and duly declaring the exemption. The obligations on NHS chemists and doctors in general practice to levy prescription charges are amended so that, if the prescription is an electronic prescription, the obligation not to levy a charge is predicated on the record of that declaration being duly entered into the EPS. In the case of a paper prescription, it is predicated on the paper declaration by or on behalf of the patient. In the case of an electronic prescription, the patient or someone acting on their behalf is nevertheless required to produce a separate declaration of entitlement, unless the dispensing contractor has been able to undertake a check known as a real time exemption check of electronic database records managed by the NHS Business Services Authority, which has confirmed the entitlement to an exemption declared by the patient (regulations 11(2) and (3) and 12 to 14).

Provision is also made in the Charges Regulations so that prescriptions charges can be levied in respect of prescriptions written by paramedic independent prescribers (regulation 11(4) and (5)), and to provide for a statutory gateway to enable information on or derived from both electronic and paper prescriptions to be used for the purposes of paying providers of NHS services (such as NHS chemists and doctors in general practice) and for matters relating to prescription charge enforcement. That statutory gateway also ensures that a duty of confidentiality is owed by the persons using the data for the specified purposes, whether or not they would otherwise owe such a duty (regulation 15).

The terms of service in the GMS Contracts Regulations and the PMS Agreements Regulations in respect of electronic prescribing are also amended to take account of the new EPS phase 4 arrangements, described above, under which patients will be able to have an electronic prescription dispensed by a dispensing contractor who is not the patient’s nominated dispensing contractor. Prior to these Regulations, prescribers prescribing under a general medical services contract or a personal medical services agreement (most commonly doctors in general practice) had the option of issuing either a paper prescription or an electronic prescription. If the prescriber’s practice is participating in EPS phase 4, the prescriber will be under an obligation to issue an electronic rather than a paper prescription, subject to various exceptions. If the NHS patient has a nominated dispensing contractor, he or she will be asked if they wish to use that dispensing contractor, and if they do, the prescriber will not issue an EPS token (making the prescribing process potentially paperless) (regulation 16(2), (3), (5) and (6), 17, 18, 20(2), (3), (5) and (6), 21 and 22). In some instances, prescription items are requested on behalf rather than by patients, and arrangements for nominating dispensing contractors in the PLPS, GMS Contracts and PMS Agreements Regulations are aligned so the same categories of authorised representatives can act on behalf of patients under all these sets of Regulations (regulation 16(4), 19, 20(4) and 23).

An impact assessment has not been prepared for this instrument. It does not create or impose significant costs on business, charities or voluntary bodies. There is also no significant impact on the public sector.