Explanatory note

These Regulations amend the Human Medicines Regulations 2012 (“the 2012 Regulations”), which govern the arrangements throughout the United Kingdom for the licensing, manufacture, marketing, wholesale dealing and the sale and supply of medicines for human use. They also amend the Medicines Act 1968 (“the 1968 Act”).

Section 10 of the 1968 Act, amongst other matters, allows for certain activities relating to dispensing of medicines to be done without the need for a manufacturer’s licence – most significantly, the assembly and preparation of medicines at hospitals and registered pharmacies, where this is undertaken by or under the supervision of a pharmacist. “Registered pharmacies” are the pharmacy premises of retail pharmacy businesses, and section 10(1)(b)(i) of the 1968 Act has until now prevented such pharmacies assembling medicines on behalf of other registered pharmacies – unless both pharmacies were part of the same retail pharmacy business. Going forward, any registered pharmacy will be able to rely on the section 10 exemption to outsource final assembly, or part-assembly, of medicines to any other registered pharmacy. This has been achieved in part by the removal of the restriction in section 10 (regulation 2(2)).

If final assembly or part-assembly had previously been outsourced, the supply of medicines between different businesses would have been considered wholesale dealing. However, rather than updating the definitions of “wholesale dealing” and “retail sale” in section 131 of the 1968 Act, these definitions have been removed (regulation 2(3)). As a consequence, by virtue of section 132(1) of the 1968 Act, the definitions of these terms in the 2012 Regulations will apply for the purposes of the 1968 Act. The relevant 2012 Regulations definitions have separately been updated to take account of the new outsourcing arrangements (regulations 5(3) and 6).

Regulation 3 of the 2012 Regulations allows, in terms and amongst other matters, for the preparation and assembly of medicines by doctors at the end of the medicines supply chain to be done without the need for a manufacturer’s licence. Going forward, this exemption is amended to allow GP practices that provide NHS pharmaceutical services (“NHS dispensing practices”) to outsource assembly, or part-assembly, to registered pharmacies (regulation 4). Alongside this, there are related inclusions of new definitions (regulation 5(2)).

The outsourcing permitted by these amendments to section 10 of the 1968 Act and to regulation 3 of the 2012 Regulations provide the legal platform that enables the operation of what is known as “hub and spoke” dispensing. Hub and spoke dispensing is where one entity (a “spoke”) takes in an order for the sale or supply of a medicine and arranges for another entity (a “hub”) to assemble or part-assemble the medicine that has been ordered. At that stage, to come within the new framework, the hub must then supply the medicine back to the spoke for the spoke to supply it to or for the use of the patient.

The new regulation 222A of the 2012 Regulations (inserted by regulation 9) establishes that the exchanges of medicines between the hub and the spoke are deemed to be a retail sale – and this is in addition to the actual retail sale or supply that takes place when the spoke supplies a medicine to or for the use of the patient. The hub has to be a registered pharmacy in order to benefit from the new arrangements and the spoke has to be either a registered pharmacy or an NHS dispensing practice. General conditions are set for these arrangements, which include displaying a notice to draw the attention of patients of the spoke to the hub and spoke arrangements. In the case of any pharmacies or dispensing doctors that dispense via an internet service, this notice has to be included in the pharmacy’s or the practice’s internet presence.

The new regulation 222B of the 2012 Regulations (also inserted by regulation 9) provides for a new statutory information gateway for hub and spoke dispensing in order to support the transfer of personal information between the spoke and the hub that is necessary for the purposes of fulfilling the orders and of discharging any related professional obligations. If the statutory conditions that relate to hub and spoke arrangements, or to the confidentiality obligations in respect of processing personal data, are breached, the new information gateway deeming compliance with the relevant data protection legislation would no longer be available to the business.

Ordinarily, during the dispensing process at the end of the medicines supply chain, details of the name and address of the dispenser of a medicine are included in the dispensing label that is affixed to the medicine prior to final supply. These Regulations provide that it is the spoke’s name and address that must be on the dispensing label – and the final decisions relating to the particulars to be included, for example the directions for use for the medicine, are to be taken by the spoke. The date of supply on the dispensing label, however, is to be the date of supply from the hub to the spoke, not the date of the final supply from the spoke to the patient (regulations 11 and 12).

Regulations 220, 221 and 274 of the 2012 Regulations are amended respectively to change references to the sale or supply of products “at” or “on” premises to sale or supply “at or from” premises. These amendments bring the 2012 Regulations into line with the 1968 Act in clarifying that transactions may take place from pharmacy premises, the transaction being completed elsewhere (regulations 7, 8 and 10).

An impact assessment has been produced for this instrument and is available from the Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU. A copy of it is also published alongside this instrument on www.legislation.gov.uk.