The General Pharmaceutical Council (GPhC) is the body responsible for the independent regulation of the pharmacists, pharmacy technicians and pharmacy premises within England, Scotland and Wales. It was created in September 2010 when the functions of the body then responsible for regulation and professional representation, the Royal Pharmaceutical Society of Great Britain, were split. At that time, the Royal Pharmaceutical Society of Great Britain began trading as the Royal Pharmaceutical Society and adopted only the representative functions of the pharmacy profession, whilst the GPhC assumed the regulatory functions.
Statutory The Health and Social Care Act 2008 and the subsequent Pharmacy Order 2010 allowed for regulatory functions of the RPSGB to be transferred to the new pharmacy regulator, the GPhC. The GPhC is therefore responsible for the update and maintenance of the registers of pharmacists, pharmacy technicians, pharmacy premises and pharmacy training premises. These registers can be accessed electronically by any member of the public online at the GPhC's website.
In addition the GPhC states that the Health and Social Care Act 2008 has sufficient provisions to allow for the transfer of regulatory powers from the Pharmaceutical Society of Northern Ireland to the GPhC in the future, subject to approval of Northern Ireland Ministers.
The principal functions of the GPhC, as stated within Pharmacy Order 2010 are: to establish and maintain a register of pharmacists, pharmacy technicians and premises at which a retail pharmacy business is; to set and promote standards for the safe and effective practice of pharmacy at registered pharmacies; to set standards to which registrants must demonstrate that their fitness to practise is not impaired; to promote the safe and effective practice of pharmacy by registrants; to set standards and requirements in respect of the education, training, acquisition of experience and continuing professional development that it is necessary for pharmacists and pharmacy technicians to achieve to be entered in the Register or to receive an annotation in the Register and to maintain competence; and to ensure the continued fitness to practise of registrants.
Furthermore, under statute, the GPhC must have the following committees; Investigating Committee (considers allegations that a registrant's fitness to practise is impaired, and can refer to the Fitness to Practise Committee for a full inquiry); Fitness to Practise Committee (makes decisions in cases where a registrant's fitness to practise may be impaired, for reasons concerning their conduct, professional performance or health); and Appeals Committee (considers appeals of decisions relating to applications for registration and registration status).
The Pharmacy Order 2010 requires not only that the GPhC sets acceptable standards of continuing professional development (CPD), but that it ensures that all registrants meet those required standards, and that there are processes in place for various remedial measures, including removal of a registrant from the register if they either fail to meet these standards, or make a false statement in relation to their CPD.
Governance The GPhC is governed by a fourteen-member GPhC Council, with equal numbers of lay and registrant members, which is operationally independent from the government, the professionals it regulates and any other interest groups. The GPhC states that to reinforce this independence, all members of the GPhC Council, including the chair, are appointed by the Privy Council, rather than elected.
The first chair of the GPhC Council was Bob Nicholls CBE, a lay member with extensive experience in the National Health Service, who has previously been a lay member of the General Medical Council, among other regulatory appointments. Bob Nicholls was replaced in 2014 by Nigel Clarke, a lay member with experience of the General Osteopathic Council and chairing the Future Professional Body for Pharmacy and then the Transitional Committee, which created the prospectus for the reformed Royal Pharmaceutical Society In February 2022, Gisela Abbam was appointed as chair, replacing Nigel Clarke
Interests of Members of the Governing Council Nigel Clarke was the GPhC Chairman from 2014–2022. He was previously a partner of GJW, the firm Boots used for its public affairs and lobbying, between 1993 and 1998 and onwards. He was part of Prime Minister David Cameron's business trade delegation to India in 2013, the year before his appointment to the healthcare regulator in 2014. Clarke was also the business partner of Digby Emson, a former Boots superintendent, who was the chairman of the GPhC's audit and risk committee (circa 2017-2020) and also a council member (2014-2020).
The chairman of the GPhC's audit and risk committee, Digby Emson was (from 2008 onwards, and ongoing as at July 2022) the chairman of Buttercups, an organisation that sells training courses for pre-registration pharmacists, and training courses and apprenticeships for pharmacy technicians and pharmacy support staff. The GPhC's regulatory duties include setting standards for and accrediting the education and training of pharmacists and pharmacy technicians. The GPhC also sets requirements for the education and training of pharmacy support staff. As such, there was an apparent conflict of interests in holding this role.
Regulation of pharmacy premises The GPhC is responsible for regulating pharmacy premises across Great Britain. It carries out inspections of pharmacy premises.
The GPhC has a legal objective, under Article 6 of The Pharmacy Order 2010, to promote and maintain proper standards in relation to the carrying on of retail pharmacy businesses at registered pharmacies.
Article 7 of the Pharmacy Order 2010 requires the GPhC to set standards that are to be met in connection with the carrying on of a retail pharmacy business at or from a registered pharmacy by the pharmacy owner. Article 7 provides examples of the standards the GPhC may set, but does not limit the contents of those standards.
Whilst the GPhC regulates registered pharmacies, it also regulates the pharmacists and pharmacy technicians who work in the environment and conditions therein. It may take action against pharmacists and pharmacy technicians following allegations regarding their fitness to practise. If a person's conduct was attributable wholly or in part to shortcomings in the working environment or conditions at the registered pharmacy, it is not clear to what extent the GPhC would take this into account, or to what extent it would take further action in respect of the premises itself. If the GPhC were to find that the registered premises had not met standards, questions would arise as any shortcomings on the GPhC's part of regulating the environment and conditions at that pharmacy. The GPhC has an ostensible conflict of interests in regulating individuals and premises at the same time. The GPhC may be inclined to set less stringent standards for registered pharmacies, or to find that those standards have been met, or not to inspect the pharmacies regularly or rigorously, to avoid pharmacists or pharmacy technicians being able to argue that their conduct was in whole or in part attributable to poor standards at the pharmacy, or a failure on the part of the GPhC.
Failures in premises regulation A Freedom of Information request submitted by The Pharmacists’ Defence Association in late 2017 found that although the GPhC had issued over 3,500 sanctions against individual registrants (which number had risen to 4,111 by mid 2018), i.e. pharmacists and pharmacy technicians, it had never issued a single sanction for a breach of pharmacy premises standards since its inception in 2010. This was in the context of 995 occasions in the two financial years preceding the FOI request in which the GPhC had identified serious issues at registered pharmacies that it wanted rectifying, where its standards for registered pharmacies had not been met.
The Freedom of Information request also revealed that the GPhC had never:
A further Freedom of Information request submitted by The Pharmacists’ Defence Association in mid-2018 revealed that whilst carrying out routine inspections of pharmacies, the GPhC had issued 667 ‘poor’ ratings between 1 November 2013 and 24 June 2018. A poor rating signified that:
The PDA juxtaposed this finding against the finding from its earlier FOI request that the GPhC had never issued any sanctions for breaches of its premises standards.
The GPhC keeps a "bank of acceptable tolerances" to help it decide what pharmacy inspection rating to give, when it inspects a registered pharmacy. The GPhC refused to disclose the details of the bank of acceptable tolerances, saying that it would prejudice the exercise of its functions.
The GPhC's approach to pharmacy premises regulation changed in 2023 when it announced that it would conduct fewer routine inspections of pharmacies. The GPhC stated that it was doing so "to ensure we support pharmacies during these challenging times to provide safe and effective care to patients". The GPhC has no statutory role in "supporting pharmacies" and would be less likely to detect problems if not conducting inspections; whether or not "challenging times" exist is not, according to the GPhC's statutory role set out in The Pharmacy Order 2010, a matter to which the GPhC should or must have regard. According to the GPhC's statement, the cessation of inspections would improve the provision of safe and effective care - implying that its conduct of inspections would in fact reduce the safe and effective care provided to patients.
Relationships with pharmacy chains As part of its role as a premises regulator, the GPhC appoints strategic relationship managers to chain pharmacies with more than 50 pharmacies. The GPhC has not provided any information about this role in the public domain, such as how it contributes to pharmacy inspection results, or why it treats chain pharmacies differently. It appears that some of the inspection outcome is predetermined as a desktop exercise by the GPhC in conjunction with the head office of the chain pharmacy, before the GPhC visits the pharmacy. This approach would not account for whether the GPhC's requirements were being met in practice at the pharmacy. An internal document from a large pharmacy chain stated: "The GPhC is mindful that community pharmacy multiples are different from independent pharmacies in that their policies and procedures are developed centrally and much of the decision-making cannot be made at local level. Therefore, the GPhC has appointed a designated Strategic relationship manager to all multiples with more than 50 pharmacies. The purpose of this is to achieve improved consistency, with the strategic relationship manager holding three formalised structured meetings with the Superintendent Pharmacist and his/her team each year to review corporate documents and processes. This will facilitate other inspectors’ reviews of individual premises to confirm ongoing compliance with company policies and procedures."
Powers to regulate corporate bodies The GPhC listed its powers to regulate corporate bodies, effected through its committees, thus:
The committee has the power under Section 80 of the Medicines Act 1968 to deal with ‘disqualification allegations’ made against a corporate body that carries on a retail pharmacy business. The committee may direct that: a corporate body should be disqualified for the purposes of Part IV of the Medicines Act 1968 a ‘representative’ of the corporate body should be disqualified as being a representative for the purposes of Part IV of the Medicines Act 1968 the registrar should remove from the register of premises some or all of the premises at which the corporate body carries on retail pharmacy