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Pharmacists and Pharmacy Technicians Order 2007

Volume 688: debated on Wednesday 24 January 2007

rose to move, That the Grand Committee do report to the House that it has considered the Pharmacists and Pharmacy Technicians Order 2007.

The noble Baroness said: I am glad to introduce this order, which provides for a complete overhaul of the legislation regulating pharmacists and extends statutory regulation to pharmacy technicians for the first time. This is an order about patient safety and public protection. It fits within the Government’s programme to modernise the way that health professions are regulated. In a number of important respects, it follows the model used for dentists, nurses, opticians and other health professionals. Our work is making regulation more responsive to patients’ needs and better at protecting them.

The order will improve the way in which the Royal Pharmaceutical Society of Great Britain protects patients by: making clearer the society’s responsibilities in protecting the public and its accountability in doing so; reforming the society’s registration process, bringing pharmacy technicians in England and Wales into statutory regulation for the first time; updating provisions for education and training, and introducing statutory requirements for continuing professional development; supporting an emphasis on fitness-to-practise issues; reforming the society’s statutory committee structure; and making the necessary transitional arrangements from the current system.

Pharmacists play a vital part in the provision of healthcare services. They have long been involved in supplying medicines and advising people on their use. However, the practice of pharmacy is entering a new era—one where direct clinical care of patients will become core business. For example, no longer is the prescribing of medicines just the domain of doctors, dentists and nurses. Since 2003, there have been pharmacists who have acted as supplementary prescribers as part of agreed clinical management plans, and some pharmacists are now completing additional training to become independent prescribers of a full range of medicines. That will become commonplace. For the first time, the new community pharmacy arrangements across Great Britain all contain clinical services.

The demand for clinical services from pharmacists continues to grow. In England, we will be introducing pharmacists with a special interest who, when suitably accredited, will specialise in a particular clinical area, just like GPs with a special interest. Pharmacists will also continue to play a huge part in educating, advising and supporting other healthcare professionals, including doctors and non-medical prescribers, on the prescription, supply and administration of medicines. Pharmacy technicians are also starting to provide more direct clinical care of patients. This trend is likely to continue as health reforms progress, with more flexible use of staff properly trained to undertake roles safely to increase access to medicines and care.

There is clearly great scope for pharmacists to do harm if they do not perform properly. That is why pharmacy was the earliest healthcare profession to be statutorily regulated. The latest legislation to do this was the Pharmacy Act 1954. That has served the profession well but is now out of date and limited in its scope compared with that of other health profession regulators. We wish to ensure that those who use the services of pharmacists and pharmacy technicians benefit from the same safeguards as those recently introduced for doctors, nurses, allied health professions, opticians and dentists.

The main provisions to bring pharmacist regulation in line with other professions are the requirement to undergo continuing professional development so that registrants keep their knowledge, skills and aptitudes up to date as long as they continue practising, and a wider range of powers and sanctions relating to investigating and dealing with allegations of impaired fitness to practise. These include impairment through ill health as well as performance and conduct, and impairment related to criminal convictions. New sanctions include the ability to suspend registrants when necessary to protect the public while their fitness to practise is being investigated and adjudicated, and the ability to restrict the practice of those unfit practitioners to areas in which they are safe to practise by attaching conditions to their registration; new powers enabling the society to disclose fitness-to-practise information where that is in the public interest, and to require others to disclose information to it about fitness-to-practise matters; a new duty to co-operate with other public authorities and bodies with an interest in pharmacy matters; and new powers to require practising registrants to be covered by an adequate and appropriate indemnity arrangement, although the implementation of this provision will be delayed while we consider further, in conjunction with the other regulatory bodies, the implications of a court judgment about indemnity arrangements that was handed down over the summer.

This order also contains some provisions specific to the world of pharmacy. The Government want to take this opportunity to extend statutory regulation to pharmacy technicians, in recognition of how their role has developed. They now play a major part in dispensing medicines and other areas of pharmacy practice which used to be the preserve of pharmacists. For example, in some hospitals pharmacy technicians will take a medication history of newly admitted patients. It is entirely right that those who use the service they provide should be protected by safeguards appropriate to their level of skill, knowledge and responsibility.

The provisions relating to the regulation of pharmacy technicians relate only to England and Wales. This is because of the separate powers of the Scottish Parliament to enact its own legislation in respect of devolved healthcare professions, which are those which were not subject to statutory regulation at the time of the Scotland Act 1998. However, we have agreed in principle with the Minister for Health in Scotland that we will introduce an amending order later this year, which will need to be approved by both the United Kingdom and the Scottish Parliaments, which will extend the scope of this current order to encompass Scottish pharmacy technicians. In order to make sure that the regulation of this profession happens consistently across Great Britain, we do not propose to commence the provisions of this order which relate to the regulation of pharmacy technicians until the amendments to its scope are in place.

Another provision peculiar to these professions is the introduction of a division of the regulator’s registers to distinguish between the vast majority of registrants who are in practice and the very few who do not actively practise, such as those who have retired or are on a career break, or who, although they have qualified as pharmacists, are working in fields where they do not practise as a pharmacist or pharmacy technician. For these people it will not be practical or relevant to keep up with continuing professional development or to be covered by indemnity insurance arrangements. I am satisfied that the definition contained in the order of what is meant by “practising” is broad enough to ensure that anyone whose work may have either a direct or an indirect impact on those using pharmacy services will be required to meet the requirements for practising registrants. This includes those working in academic research, management, journalism and industry who give advice on pharmacy matters and hold themselves out to be pharmacists or pharmacy technicians. The order contains provisions in the form of offences and the provision of guidance which will support this.

Members will appreciate that a piece of legislation of this size and scope has been in production for some time. It has been suggested that issues like the consideration of this order to amend the Pharmacy Act would be better held back until after the release of the findings of the Chief Medical Officer’s review of medical regulation and the parallel review of non-medical regulation in the light of the fifth report of the Shipman inquiry. However, the contents of this order are essentially an overhaul of the regulation of pharmacists and the administration of the Royal Pharmaceutical Society of Great Britain, which are long overdue. The extension of statutory regulation of pharmacy technicians is also in the public interest. The subjects covered by this order are issues that need addressing, irrespective of the findings of these two reviews, and they in no way pre-empt either their recommendations or the Government’s response to them.

This order has been well researched, and has found broad favour and support from those who are most affected by it. It has been subject to a full publication and public consultation as required by the Health Act 1999, under which the order is made. A copy of the report on the consultation is available on the Department of Health website. I beg to move.

Moved, That the Grand Committee do report to the House that it has considered the Pharmacists and Pharmacy Technicians Order 2007. 5th Report from the Statutory Instruments Committee.—(Baroness Royall of Blaisdon.)

The Committee will be grateful to the Minister for introducing this order so succinctly and clearly. It is an order which we broadly welcome. As she said, it serves to bring up to date the rules governing the regulation of pharmacists in Great Britain and, for the first time, to put in place arrangements to regulate pharmacy technicians in England and Wales under the supervision of the Royal Pharmaceutical Society.

The order has been the subject of extensive consultation within the pharmacy profession and outside it. As regards the principal provisions in it, we are satisfied that it reflects the society’s policy—which we very definitely share—to strengthen and clarify its powers to protect and promote the health and safety of the general public. In so doing, the order completely replaces the Pharmacy Act 1954.

I am pleased that there has been no question of diluting the role or function of the Royal Pharmaceutical Society as the body responsible for regulating the profession. We have said many times how strongly we support the concept of professional self-regulation, and in the case of pharmacists we see self-regulation, as set out here, encompassing the complete spectrum of regulatory activity, from registration to the setting of standards, and from education, training and continuing professional development to disciplinary procedures. The order is entirely consistent with the provisions contained within the society’s Royal Charter, and builds usefully upon them.

As the Minister well knows, much thought has recently been devoted, under the Donaldson and Foster reviews, to the whole area of professional regulation in medicine and allied professions. We do not yet know the outcome of those reviews. However, I should be grateful if the Minister could reassure me that, whatever the outcome in relation to other professional disciplines, she does not envisage substantial changes being necessary to the content of this order. Nothing, of course, can remain set in stone for ever, but I hope that after the very thorough work done by the society, its members and, indeed, the department, there will be no question of having to go back again to square one.

Perhaps the most obvious way in which the new rules represent an improvement over the old ones is in respect of fitness-to-practise procedures. As we have seen with doctors, dentists and other professions, it is right for the relevant regulatory body to have at its disposal a menu of options—in this instance, not only the power to strike a pharmacist off the register but also powers to suspend a pharmacist or to place conditions on his registration, as the Minister has indicated. Without such powers the public could be at risk, so we welcome these new provisions.

However, in its response to the consultation, the society raised one concern which I notice was not accepted by the Government. Article 49(3) provides that, where an allegation is referred to a fitness to practise committee, the society must inform departmental Ministers, the local PCT and the person’s employer. The worry here is that if the allegation is false—and perhaps maliciously so—a huge amount of damage could be done to the reputation and standing of the individual and of his employing organisation by the fact of the matter becoming public knowledge before it is resolved. To guard against that contingency, the society suggested that notification in certain well-defined types of case need not be mandatory but could instead be discretionary, subject to clear rules. Why was this proposal not accepted?

The second conspicuous area of change in the society’s powers relates to education and training. These changes are, equally, very welcome. Up to now, there has been some uncertainty about the society’s powers in relation to education. The order not only clarifies the position but also provides for the education committee to have a wider role in such areas as revalidation and recertification. This is all part of the general drive to promote professionalism in all its varying aspects and that, surely, has to be the way forward for a profession on which the NHS, patients and the public are increasingly becoming reliant. In that connection, it is welcome to see in Article 12(5) that knowledge and use of English is included as one of the factors which may be considered as part of the overall professional qualification.

Similarly, I was pleased to see in Article 48(2) that a pharmacist’s or technician’s “attitudes and behaviour” are to be regarded as integral to the judgment of professional misconduct. The clear implication is that attitudes and behaviour are important elements of what it means to be professionally qualified, and that is surely right.

I have two further questions. As the Minister made clear, the registration and regulation of pharmacy technicians under the order applies to England and Wales. That is because in Scotland the regulation of professions recognised after 1998 is a devolved matter. We often hear that diversity in healthcare arrangements north and south of the border is one of the glories of devolution. I am pleased that the Minister accepts that there is an issue to be addressed here. With dentists and the professions allied to dentistry, it was possible to achieve what was effectively a UK-wide regulation by means of an agreement between the Westminster and Scottish Parliaments. I am pleased that the Minister and her counterparts in Edinburgh are looking to achieve a similar uniformity of regulation for pharmacy technicians. That is very welcome.

Concern was also expressed by the society that under Article 5(1), the Privy Council has a power to alter the size and composition of the council, subject to specified limitations. The society’s charter provides for the Privy Council to do so only if it receives an application to do so from the society in pursuance of a special general resolution. Can the Minister confirm that the order should not be read as meaning that the Privy Council has a power to vary the council’s composition in the absence of any such request from the society?

The order has been long awaited by the pharmaceutical profession. We wish it well.

I, too, thank the Minister for introducing the order. As we have heard, it will update, strengthen and clarify the society’s powers to protect, promote and maintain the health and safety of the public. We agree with that and we support the order.

I, too, welcome the order, which will bring pharmacists into line with other healthcare professionals. Pharmacists play an ever-increasing role in the provision of primary care. The order will recognise that fact and improve the system to ensure fitness to practice and statutorily to regulate pharmacy technicians. That will provide more protection for the public who often experience difficulty in obtaining an appointment to see their GP and are turning to their pharmacist for healthcare advice. Other professional groups, including my own of dentistry, have undertaken fitness-to-practise reforms, and it is right that the pharmacists do the same. It is important that all professional groups keep up to date and maintain a programme of continuing professional development.

The order is 73 pages long. Could the Minister remind me whether registered pharmacy technicians will be able to be an alternative to pharmacists in pharmaceutical outlets, including chemist shops and GP surgeries, where it is extremely convenient to be able to collect medicines, especially in rural areas, where there is not always a chemist in the vicinity?

Finally, when the osteopaths and chiropractic practitioners became registered they were hit with unexpectedly high registration fees and extra costs for indemnity. Has the Minister any idea—and the information may be well hidden in the 73 pages—what the cost of registration and indemnity might be for a pharmacist and pharmacy technician under these new regulations? I also stress the importance of the points made by my noble friend Lord McColl on attitudes, behaviour and language. I am sure that the Minister will have time to respond to those concerns at this stage.

I am very grateful for the broad and strong support from noble Lords opposite on this order, which is technical but extremely important.

The noble Lord, Lord McColl, asked whether changes would be made following the two reviews that are currently taking place. We must wait for the White Paper, which will be published a little later this year. We do not want to pre-empt any decisions relating to that. Some changes may be made to strengthen best regulatory practice across all regulators, but pharmacists would certainly not be singled out, as it were.

In relation to disclosure of information when an investigation is taking place, I well understand the concern expressed by the noble Lord, Lord McColl. It is important for patient protection that those who employ or contract with pharmacists or pharmacy technicians are alerted as soon as possible when the society is investigating an allegation. In rare cases, this will be the first warning received of a serious problem that would put patients at risk if a pharmacist or pharmacy technician continued to work. Before referring complaints to the statutory committees, the registrar of the society weeds out cases in which statutory action would not be appropriate. So there would be time. It would not be a knee-jerk reaction; a procedure would be followed before people on the outside were alerted to the complaints.

I appreciate that pharmacists or pharmacy technicians and those who represent them may find the requirement for disclosure that an allegation has been made unsettling. However, this is a tried and tested approach used by other regulators and we consider that it represents an appropriate balance between a registrant’s privacy and the need to protect members of the public, which of course is the purpose of professional regulation.

I thank the Minister very much for allowing me to intervene. Do I take it that someone would be suspended only over something relevant to the safety of the patient, not for some other misconduct? Would it be related only to whether the technician was a danger to his patient?

I will write to the noble Lord with clarification, but in any case when a complaint was so serious that it was being investigated by a committee there would be some potential danger to the public involved. Therefore, I imagine that for wider interested persons to be informed there would be some danger to the public, but I shall clarify that point in writing to the noble Lord.

I shall respond to the other questions. With regard to the costs of registration and indemnity, there are no hidden figures in these pages. However, increases in registration charges can be made only after consultation with the registrant, so I would not have thought there would be any great hikes in charges. I am sure the registrants themselves would oppose such a measure. We are taking time to explore the whole issue of indemnity insurance, but many pharmacists already pay for indemnity costs, so I imagine there would be no huge change there.

On the use of English, we are glad to see that it is important in relation to attitudes and behaviours in misconduct cases. It is good and proper that the use of English is considered in all those cases. With regard to the change in the size and composition of the council, it should not be read as the Privy Council. The noble Lord, Lord McColl, asked if the Privy Council could vary the composition of the society of the council without a request. I understand that, yes, that would be possible, but there are no plans to do so. It is simply potentially possible.

I do not know if I have left any questions unanswered. Members may wish to remind me now; if not, I will gladly respond in writing.

May I remind the Minister of the question of whether a pharmacy technician and a pharmacist have equal standing in the running of a chemist shop?

I beg the noble Lord’s pardon. Pharmacy technicians can work in community pharmacies. We think that would be of benefit, especially to rural communities, as the noble Lord indicated, but they would have to be under the supervision of a registered pharmacist.

Having answered those questions, I am delighted that we are all in broad agreement on this order, and I commend it to your Lordships.

On Question, Motion agreed to.

If that completes the business of the Grand Committee today, the Committee stands adjourned.

The Committee adjourned at 6.58 pm.