General Pharmaceutical Council

Introduction

Since coming into post I have been aware of the critical parliamentary processes which affect our establishment in 2010. Now I am delighted to report that the Pharmacy Order 2010 has been approved by the Privy Council and we are due to come into existence as an independent legal entity – the General Pharmaceutical Council – by mid-March 2010.

This will be a very important moment, not least because it will mean we are no longer 'designate'! It means the Council and Chief Executive appointments will be able to be ratified by the Appointments Commission and the GPhC will be able to make formal decisions as an independent body.

More importantly still, it means we have been able to move onto the next stage of the establishment process – the consultation on the draft legislative rules. So, in this issue, I am delighted to be able to announce the beginning of an 11-week consultation on the legislative rules that the GPhC will use when it takes up responsibility for the regulation of pharmacy later this year. The shorter consultation has been agreed in order to make best use of likely parliamentary time.

As always, my main interest is in encouraging you to take part in and respond to the consultation. Further details of how to do this are set out below.

This bulletin also provides an update on where we are in regard to the opening date and transfer of regulation. Essentially a 'go live' operational date will be set once the parliamentary timetable for 2010 is clear. As Duncan Rudkin, Chief Executive designate, said in our January bulletin, we are working hard to finalise all the details of the planning so that we can confirm the opening date with confidence, but, because of the impending general election and the need for parliamentary approval to the rules, regret we can't do that yet.

Meanwhile, the work of the Council designate goes on in preparation for the transfer of regulatory responsibilities from the RPSGB. This includes the analysis of the results of the consultation on standards recently concluded by the Council for Healthcare Regulatory Excellence and arrangements for further GPhC consultation on revisions to the proposed standards, about which we will have full details in March. Thank you for your input to our work so far, and I hope to hear from you and your colleagues on the rules consultation.

Bob Nicholls CBE
GPhC Chair designate

Consultation on draft rules

The GPhC designate is seeking views on its draft legislative rules to ensure they are clear, comprehensive and fair.

Five sets of rules – which set out the detail of key processes – are being made available for consultation from 16 February to 4 May 2010.

The GPhC has been given the responsibility, in the Pharmacy Order 2010, to make rules in a number of areas and the five included in this consultation are:

• Fees
• Registration
• Appeals
• Statutory Committees and their Advisers
• Fitness to Practise.

The legislative rules set out clearly how GPhC regulation will operate and are designed to work alongside the GPhC's regulatory standards. These first five sets are those which need to be in place to enable the GPhC to open.

GPhC Chair designate Bob Nicholls said: "I am pleased to publish our consultation on the first five sets of draft legislative rules which will enable the effective working of the GPhC as a statutory regulator.

"We encourage people to take the time to understand the key changes, and what they mean for the public and professionals, and to respond to this consultation."

The draft rules build on those of the current regulator, the Royal Pharmaceutical Society of Great Britain (RPSGB). Where necessary, changes have been made in order to ensure that the rules are in line with the new statutory framework in the Pharmacy Order 2010.

The framework has a number of key elements:

• The Pharmacy Order 2010 sets out the role, purpose, duties and powers of the GPhC
• The rules, which are secondary legislation, add the procedural detail which makes the Order work in practice
• The standards make clear to registrants what the standards are to which they should work
• Procedures set out important administrative detail in some areas where rules are not legally appropriate.

The draft rules contain some important changes to key areas, which the GPhC designate wishes to highlight. For example:

• The process for renewal of entries in the register for pharmacists, pharmacy technicians and owners of pharmacy premises
• The structure of fees for new registrants and the cessation of fees for non-practising and overseas pharmacists. Those who wish to join the GPhC register will need to do so as practising registrants and pay the appropriate fees
• The structures for the three statutory committees – Appeals, Investigating and Fitness to Practise
• The criteria that the Fitness to Practise Committee must consider when deciding whether an individual is fit to practise and changes to disclosure requirements
• Changes to case management meetings and provisions around witnesses.

Full details are contained in the rules document and key changes are highlighted in the accompanying consultation document. To view the rules consultation documents, and send your comments, on our website www.pharmacyregulation.org.

Following the consultation, the rules will be subject to parliamentary and Privy Council processes, prior to the opening date and transfer of regulation to the GPhC.

A separate consultation on the 2011 registration renewal fees – which outlines how much pharmacists, pharmacy technicians and owners of premises may be required to pay – will take place later in 2010.

A further two sets of rules – covering continuing professional development and superintendents, pharmacy owners and premises – will be made available for consultation in due course. These are not likely to come into force until after the transfer of regulation to the GPhC.

Establishment news

This month has brought about two major milestones in the parliamentary process, both essential components in the establishment process.

The House of Lords passed the Pharmacy Order 2010 on 2 February following a lively debate. This cleared the path for the Pharmacy Order 2010 to be approved at the Privy Council session on 10 February. As a result, the GPhC designate is due to become an independent legal entity by mid-March 2010.

Legal status allows the following to take place:

• The Appointments Commission can ratify the appointments of the Chair, Council members and Chief Executive – so they are no longer 'designate'.
• The GPhC becomes an independent legal entity.
• The GPhC can set standards and make legislative rules.
• The GPhC can appoint and pay staff and it can pay its Council members.
• The transitional provisions in the Pharmacy Order 2010 can take effect. These are designed to ensure that a smooth transition is effected to ensure ongoing regulation.

The opening date, for the transfer of regulation, will be set once the parliamentary timetable for 2010 is clear.

New standards consultation

The GPhC Council designate has agreed to consult further on its regulatory standards during 2010.

At its meeting on 10 February 2010, the Council designate heard that over 200 responses had been received by the Council for Healthcare Regulatory Excellence after the closure of the first consultation on the draft standards on 12 January 2010.

The Council designate will consider the report of the responses to the consultation at its 10 March meeting and, in the light of these, will recommend any initial changes to the draft standards and set out details of the further consultation which will be necessary.

The new consultation will be developed and carried out by the GPhC to ensure key stakeholders, registrants and others with an interest in the standards can see the way their initial responses have been considered as well as feeding in further comments.

Council designate update

The GPhC Council designate met on 9-10 February to consider the draft legislative rules and the arrangements for consultation. In addition, the Council designate considered papers on establishment project planning, stakeholder engagement and several governance items. The next Council designate meeting is on 9-10 March 2010.