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Background
In the 2007 White Paper Trust, Assurance and Safety: The Regulation of Health Professionals in the 21st Century, the Government signalled its intention to 'work with the pharmacy profession to establish a General Pharmaceutical Council responsible for the regulation of pharmacists and pharmacy technicians, and the registration of pharmacy premises'.
In May 2007, the report of the Working Party on Professional Regulation and Leadership in Pharmacy, led by Lord Carter of Coles:
The Health and Social Care Act 2008 enabled the GPhC to be created, by amending existing primary legislation. It completed its parliamentary process in July 2008.
The Act also enabled all the regulatory functions of the Royal Pharmaceutical Society of Great Britain (and of the Pharmaceutical Society of Northern Ireland, subject to a decision by Northern Ireland Ministers) to be transferred to the GPhC.
The consultation process
A draft section 60 Order, the draft Pharmacy Order 2010, set out the role, functions and powers of the GPhC in December 2008. This is one of a suite of section 60 Orders designed to implement reform and harmonise the approach to professional regulation across different healthcare professions.
The draft Order followed the recommendations on the establishment of regulatory bodies set out in Trust, Assurance and Safety. These recommendations were that:
- councils should generally be smaller – just 10 to 15 members – with at least equal numbers of lay and professional members
- organisations should have faster, more transparent procedures
- organisations should develop meaningful accountability to the public and to service users.
The draft Order went through three months of consultation, which ended in March 2009. There were five consultation events across England, Scotland and Wales, and pharmacy professionals and stakeholder organisations were encouraged to contribute via the Department of Health website.
The consultation outcome
There was a good level of response to the consultation, and broad support for the overall approach to establishing the GPhC. The full consultation report is available to download.
The Department of Health and the Scottish Government published their response to the draft Order in June 2009.
In particular, respondents supported the key underpinning principles of:
- the overriding interest being the safety and quality of care that patients receive
- a proportionate, risk-based approach to the regulation of both pharmacy professionals and pharmacy premises that the proposed legislative framework for the GPhC seeks to facilitate
- including broad provisions in the draft Pharmacy Order 2009 to allow the new regulator flexibility to adapt quickly to developments in pharmacy practice in the future and to reflect these through its standard setting and other functions.
There were three issues that caused particular debate in the responses to consultation:
1) Restricted titles and a single register for practising registrants
The title 'pharmacist' is already restricted under the Medicines Act 1968 to those who are on the register of the RPSGB. The consultation on the draft Pharmacy Order 2010 proposed that the title remains restricted to those who are on the register of the GPhC and have therefore met all the registration requirements necessary to satisfy the regulator that they are fully qualified, competent and fit to practise.
The principal concerns of respondents who opposed the proposals were that only those who fall within the draft Pharmacy Order 2010 definition of 'practising' will be able to register with the GPhC and have access to use of the protected title. Some respondents expressed a wish to continue to call themselves pharmacists whether or not they are in a practising role or on the GPhC register. It has also been suggested that only those pharmacists in direct, patient-facing roles require regulation. This would leave those involved, for example, in the development of medicines, teaching, supervision and leadership of pharmacy, with no statutory requirement to demonstrate that they remain up to date and fit to practise.
In line with the key focus for the GPhC on public protection and patient safety, the Government decided to implement the proposals in the draft Pharmacy Order 2010 to continue to restrict the title 'pharmacist' to those who are on the register for the GPhC and have therefore met the requirements necessary to satisfy the regulator that they are fully qualified, competent and fit to practise.
There will be no restriction on an individual who has left the register referring to themselves as a former or retired pharmacist.
2) Standards for pharmacy premises
There was broad support from respondents across Great Britain for the proposed powers for the GPhC in relation to pharmacy premises. However, the consultation responses have raised important issues, including the need to avoid unnecessary duplication of activity with other monitoring and inspection organisations. The Government has agreed to reflect this thinking throughout the work to develop an initial set of regulatory standards for the GPhC.
3) Development of standards and rules
It is clear from a number of 'unsure' responses to the consultation proposals that some respondents were looking for the more detailed provision that will come later. Preparatory work to develop an initial set of standards and rules for the GPhC is under way. This work will include opportunities to engage and involve a wide range of stakeholders, including patients and the public, in developing the more detailed thinking that will underpin the broad standard-setting powers and other key functions of the GPhC.
Next steps
The Pharmacy Orderhas been through the Parliamentary process and was passed in February 2010.
A three-month consultation on the standards has been undertaken. Consultations on the legislative rules and other statutory instruments that the GPhC requires is currently underway. Now that the GPhC is legal it will carry out further engagement with stakeholders on the standards and rules.
The creation of the GPhC marks the beginning of a reform programme for the pharmacy profession. Future reforms are likely to include the introduction of revalidation for pharmacy professionals and the independent adjudication of fitness-to-practise cases.