Pharmacy Order 2010

This is my reward. The Pharmacy Order 2010 will establish the General Pharmaceutical Council (GPhC), the new regulator for pharmacists, pharmacy technicians and registered pharmacy premises in Great Britain. It will complete the separation of professional regulation from professional leadership in pharmacy signalled by the powers taken in the Health and Social Care Act 2008. Measures included in the Health and Social Care Act 2008 enable the transfer of all the regulatory functions of the RPSGB and the Pharmaceutical Society of Northern Ireland (PSNI) to the new body, the GPhC. I have tried to minimise the number of initials, but their use seems inevitable. Northern Ireland Ministers have taken the decision not to transfer the PSNI’s functions at this stage, but they have the power to do so in the future should they so wish. My remarks are fairly long because this is a detailed order. I hope that noble Lords will bear with me because it is important that we look at the order. I know that this is the third time that it has been scheduled, so it is important that we get through it this time. Any Section 60 order to make these changes would be subject to consultation and the affirmative resolution procedure, with debate in the Northern Ireland Assembly. The Pharmacy Order will enhance public confidence in the ability of the pharmacy regulator to protect the public, deal with poor professional standards and allow the leaders of the pharmacy professions to advocate for the professions. The order has been laid in the Scottish Parliament, as the regulation of pharmacy technicians is a devolved issue. It was debated in the other place on 13 January and the passage of the order was agreed. I draw noble Lords’ attention to two small typographical errors in the order, for which I apologise. Legal advice from both the Department of Health and the Scottish Government is that the order can be amended prior to it being made and my officials will therefore arrange for a corrected version to be presented in Privy Council. The second paragraph of the preamble to the order should have referred to Her Majesty, with the advice of Her Privy Council, as the person making the instrument as opposed to the Secretary of State and Scottish Minister. Similarly, the references to paragraph (1)(g) in Article 11(2) and (3) should in fact be references to paragraph (1)(f). I also draw the attention of noble Lords to three further small amendments to this order which are now required as a result of the Lisbon treaty entering into force on 1 December. References in Articles 21(4)(b), 22(2)(b) and 66(2) to "the Treaties" are now required to be replaced by references to "the EU Treaties". The order continues the process of implementing the Government’s programme to improve patient safety through the reform and modernisation of the regulation of the healthcare professions, as set out in the White Paper, Trust, Assurance and Safety. The order brings pharmacy into line with the arrangements for other healthcare professions that have separate bodies for regulation and representation for the profession. Both roles are necessary, but cannot be performed in the same organisation without creating a conflict of interest between the needs of public safety and professional leadership. As the order is a substantial document, I will go through the provisions. Part 1 contains preliminary matters, including commencement provisions and interpretation. Part 2 makes provision for the establishment of the council and its statutory committees, in addition to setting out the key functions and core purpose of a professional regulator, which is to safeguard patients and the public, in particular those using the services of registrants and those services provided by registered pharmacies. Part 3 sets out the powers the council will have with regard to registered pharmacists. For the first time, there will be a power to set standards for registered pharmacists. It also makes provision for the inspection of pharmacy premises and sets out the powers of the inspectors appointed by the General Pharmaceutical Council. The regulation of registered pharmacy premises sets the pharmacy regulator apart from other professional health and social care regulators. We have chosen to maintain the regulation of professionals and registered pharmacy premises within the same organisation so that a holistic approach can be taken towards the delivery of pharmaceutical services. I have heard concerns about the potential for duplication of regulation of inspection and assure the House that provision has been made in the order for the sharing of information with other regulators to help avoid such duplication of activity. Parts 4 and 5 set out the criteria for an individual pharmacist’s or pharmacy technician’s entry to the register and the educational requirements of both professions. It also sets out the standards expected of those who are registered and the requirement that they continue to demonstrate how they meet those standards through continuing professional development. In addition, it describes the arrangements for entry to the register for those coming from the European Union and elsewhere overseas. There are also provisions for temporary registrations to be used in the event of an emergency. Fitness-to-practise procedures are set out alongside appeals procedures in Parts 6 and 7. Schedule 1 provides more detail on the constitution of the council and governance arrangements. Schedules 2 and 3 deal with matters relating to visiting practitioners. Amendments, repeals, revocations, transitional provisions and savings are dealt with in Schedules 4, 5 and 6. I draw your Lordships’ attention to Schedule 4 in particular, which amends the Medicines Act 1968. As the Act is a UK-wide instrument, the amendments ensure that the current position in relation to registered pharmacies in Northern Ireland remains untouched. A great deal of attention has been paid to ensure the smooth transfer of the regulatory functions from the Royal Pharmaceutical Society of Great Britain to the new GPhC in the Schedule 5 transitional arrangements. That should mean that no current student is disadvantaged by the transfer and fitness-to-practise cases already in train can be completed. TUPE for affected staff is covered here. I assure noble Lords that a communications programme is in place to keep staff well informed. Staff transferring to the GPhC will be eligible to join the NHS pension scheme and, subject to individual choices, able to transfer contributions from their existing pension provider to the NHS scheme. I am aware that the Royal Pharmaceutical Society of Great Britain, while not wishing to impede the Pharmacy Order, is concerned that it might adversely affect its closed staff pension scheme, at least for some of its members. I assure the society that my Department takes the matter most seriously and is working to ensure that the transfer of staff from the RPSGB scheme to that of the GPhC does not worsen the funding position of the closed scheme. The separation of professional leadership and regulation in pharmacy received widespread support during the consultation on the draft order. However, it would be remiss of me not to reflect the discussions on the issue of restricted titles and the proposal not to have a non-practising register. The RPSGB has traditionally held a non-practising register for those pharmacists no longer working in the profession but who wish to maintain their contact. These people will now be able to join the professional leadership body and continue their allegiance with pharmacy. Given this option for those who have retired or who are no longer practising, we propose that the regulator should concern itself only with registering and regulating active professionals. The current restricted titles of pharmacist and pharmacy technician are bound by membership of the RPSGB. In the future they will be restricted to registrants of the GPhC. The loss of these titles has been keenly felt by a small but vocal minority of mainly retired pharmacists. Clearly they are eligible to call themselves retired or former pharmacists but must not mislead the public on the currency of their advice or expertise. Others have suggested that academic or industrial pharmacists do not need to register because the systems they work in are already regulated. The nub of their argument is that they do not wish to be regulated but wish to continue to call themselves pharmacists. They argue that only those providing direct services to patients need regulation. This would mean pharmacists in supervisory or strategic roles, education and industry would not be covered by the requirement to register and therefore not subject to requirements for continuing professional development. That is the nub of the issue. We believe that there is an individual obligation above and beyond that of any additional systems regulation—be that in industry, education or the NHS—that defines a healthcare professional as opposed to any other member of the workforce. Those people must ensure that the patient’s interests and public safety are paramount. This applies to those teaching the next generation of professionals and to those developing, licensing and marketing new medicines. For these reasons, the order requires that such professionals must register with the GPhC if they want to use the restricted titles. I commend the order to the House.