The Pharmacy (Premises Standards, Information Obligations, etc.) Order 2016

EXPLANATORY NOTE

(This note is not part of the Order)

This Order, principally, makes provision relating to the setting of standards for the safe and effective practice of pharmacy at registered pharmacies, and relating to the enforcement of those standards. Pharmacies have to be registered in the United Kingdom if a retail pharmacy business is carried on at those premises. In Great Britain they are registered by the General Pharmaceutical Council (GPhC) and in Northern Ireland by the Pharmaceutical Society of Northern Ireland (PSNI).

Part 1 contains general provisions, including powers to make commencement and transitional provisions orders and the procedural requirements relating to them.

The powers of the GPhC to set standards (“premises standards”) in connection with the carrying on of retail pharmacy businesses by the persons carrying on those businesses (“pharmacy owners”) are amended so that its premises standards are no longer to be set in rules. In addition, the illustrative list of the content of its premises standards is revised, and now indicates that the standards may relate to matters such as the working environment at registered pharmacies and associated premises, and the patient and public experience at registered premises (articles 6, 7, 19(1) to (4), 20 and 22). The GPhC is now also required to consult the Welsh Ministers, the Scottish Ministers and the Secretary of State for Health on all their statutory standards before setting them (article 18). The PSNI is given new powers to set premises standards, worded in essentially the same terms as the equivalent powers of the GPhC (article 13), and some obsolete provisions relating to premises requirements for Northern Ireland are removed (article 8).

Enforcement of premises standards in Great Britain may be by improvement notices served by the GPhC, but unlike breaches of other improvement notices, breaches of improvement notices served in relation to breaches of premises standards are not to lead to criminal sanctions. Instead, the Registrar of the GPhC is given powers to refer non-compliance to the GPhC’s Fitness to Practise Committee (FTPC) (article 23).

The sanctions regime that the FTPC and the PSNI’s Statutory Committee (SC) operate in relation to pharmacy owners is altered in a number of respects. Firstly, the procedure in section 80 of the Medicines Act 1968 (which enables the FTPC and the SC to remove entries from the premises part of the GPhC’s register or from the PSNI premises register – or to disqualify a pharmacy owner) now applies in relation to breaches of PSNI premises standards as well as to breaches of GPhC premises standards. Secondly, the section 80 procedures are changed so that they apply not just to pharmacy owners that are bodies corporate, but also to pharmacy owners that are partnerships or individual pharmacists. Thirdly, provision is made so that sanctions may only be applied in relation to breaches of premises standards where the FTPC or SC is satisfied that the pharmacy owner is unfit to carry on the relevant business safely and effectively (articles 9, 10, 16 and 26).

If the FTPC or SC does decide to impose sanctions at a final hearing after a finding of impairment is made against a pharmacy owner, those sanctions do not take effect until an appeal is determined or the time for bringing an appeal is passed. Powers are therefore given to the committees to enable them to suspend premises entries in the relevant registers after a finding of impairment, until the matter of an appeal is resolved, where this is in the public interest and subject to safeguards by way of rights of appeal (article 11).

The FTPC is also given powers under the Pharmacy Order 2010, and the SC is given powers under the Pharmacy (Northern Ireland) Order 1976, to suspend some or all of a pharmacy owner’s premises entries in the relevant register where an investigation of the pharmacy owner has commenced but has not reached the stage of a final hearing. These powers are given by way of modification of the powers that the FTPC and SC already have to suspend the entries of individual pharmacists in the relevant registers while an investigation of whether their fitness to practise is impaired is ongoing, where it is in the public interest to do so, with essentially the same safeguards by way of rights of appeal (articles (14, 15 and 25).

The GPhC and the PSNI are given powers to make rules or regulations to provide that, where premises entries in the relevant registers have been suspended under these new interim suspension arrangements, they can treat those entries as still in the relevant register for certain purposes (article 5). The PSNI’s usual procedures for making subordinate legislation are applied to regulations made under Part 4 of the Medicines Act 1968 (article 12).

This Order also deals with some matters relating to the gathering and publication of information by the GPhC.

Firstly, article 7 of the Pharmacy Order 2010, which deals with premises standards, also contains rule making provisions that deal with information gathering from pharmacy owners by the GPhC, and these provisions are modified in a number of respects. For example: rule making under that article becomes optional rather than obligatory; the GPhC is permitted to require pharmacy owners to provide information about cautions as well as criminal convictions, and to require pharmacy owners to provide specified types of additional information about superintendent pharmacists of bodies corporate; and the GPhC is given greater flexibility in terms of what it may set in rules about the process and timing of gathering information. The improvement notice system in the Pharmacy Order 2010 is also changed so that it can be used to deal with failures by pharmacy owners to meet their obligations under the article 7 rules relating to information gathering (articles 19(5) to (8) and 22).

Secondly, it is made clear that GPhC can publish reports of the inspections and other visits that its inspectors make, and that these reports may include an account of the outcomes of such inspections and visits (article 21).

Thirdly, corrections are made to article 29 of the Pharmacy Order 2010, which erroneously provided for the Registrar General to notify the Registrar of the GPhC of deaths of registered pharmacists and registered pharmacy technicians in Great Britain. The requisite notification should in fact be made in England or Wales by a registrar of births and deaths and in Scotland by a district registrar (articles 17 and 24).

An impact assessment relating to this instrument has been prepared and copies can be obtained from the Department of Health, Wellington House, 133-155 Waterloo Road, London SE1 8UG. It is also available alongside this instrument on www.legislation.gov.uk.