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Pharmacy Order 2010

Volume 717: debated on Monday 1 February 2010

Motion to Approve

Moved By

That the draft order laid before the House on 11 November 2009 be approved.

Relevant Document: First Report from the Joint Committee on Statutory Instruments.

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.

My Lords, I thank the Minister for introducing the order, which, as she indicated, ushers in a new era in the regulation of pharmacists in Great Britain. The creation of the General Pharmaceutical Council as the regulator for the pharmacy profession reflects the pattern that we now almost take for granted across the healthcare professions as a whole—namely, that there should be a clear separation of professional regulation and professional leadership and representation. The Royal Pharmaceutical Society of Great Britain has consulted its members in detail on these changes, and the proposals reflected in the order have been approved formally by them. As the Minister said, the provisions should serve to enhance public confidence. I believe that one can say that without casting any reflection on the diligence and conscientiousness shown by the Royal Pharmaceutical Society during its long history.

In the main, the proposals arising out of the Government’s White Paper Trust, Assurance and Safety have met with acceptance from the pharmacy profession. However, one issue that was the subject of considerable debate—the noble Baroness touched on this—was who should be allowed to use the protected title “pharmacist” once the new regulatory arrangements are in place. The main purpose of having a restricted title is to afford protection to the public. It is a reasonable rule of thumb that that purpose is best achieved by restricting eligibility to the use of a professional title to as narrow a group as possible.

However, the doubts that surfaced during and after the consultation were focused on the status of those with a pharmacy qualification who were not dispensing pharmacists. In this category are industrial and academic pharmacists, pharmacist legal advisers, pharmacists in the Civil Service and many pharmacists who are non-practising. At the moment, this group comprises in aggregate about a third of the membership of the Royal Pharmaceutical Society. It is currently quite easy to move from the practising to the non-practising register and it is generally accepted that a retired pharmacist can continue to call himself a pharmacist in the same way as a retired doctor can still call himself a doctor.

All that will change with this order. My understanding—it would be helpful if the Minister could confirm this—is that the definition of “practises” in Article 3(2) is drawn widely enough to be able to include those pharmacists who have no direct interface with the public, such as those working in academia or industry. However, use of the title “pharmacist” will now be exclusively restricted to those whose name is on the practising register. Anyone who wishes to be included on the new register will be subject not only to a statutory requirement to participate in continuing professional development but also to paying the not insubstantial registration fee.

For those with pharmacy qualifications who are in professional roles that do not involve dispensing to the public or who are non-practising, the requirement to register with the council may appear excessive. Many argue that there is in practice no risk to the public and no ambiguity in a current member of the Royal Pharmaceutical Society who works as a university lecturer calling himself a pharmacist even though he may not be totally up to speed in the area of dispensing. It is therefore questionable whether corralling all categories of the pharmacy profession within the ring-fence of the General Pharmaceutical Council register is proportionate to the different risks that each of them poses and whether, therefore, unnecessary burdens are being created.

The council has apparently recommended that those current pharmacists who decide not to register with the council could call themselves retired or former pharmacists, but many see this as somewhat absurd if not demeaning for those—many of them very eminent people—who continue to apply their professional knowledge and expertise exactly as they have done in the past. It would also be inappropriate because it would fail to differentiate these working pharmacists from members of the profession who had retired or who had been struck off.

I would be grateful if the Minister could explain why the Government have insisted on taking what appears to be a very hard line on this issue, bearing in mind the points that I have made on proportionality and differential risks to the public. I should also be grateful for an explanation of Articles 34 and 35, which provide for temporary entry into the register or a temporary annotation on someone’s registration in the event of a national emergency. If the only register kept by the General Pharmaceutical Council is to be a register of practising pharmacists—in other words, if the current non-practising register is to be done away with—how will the council have access to a list of relevant people whose names can be temporarily added to the practising register? If, as we are meant to suppose, the council is to maintain a list of such individuals, what will they be entitled to call themselves? What is their legal status? Will it be legal to call oneself a non-practising pharmacist, if one is included on this list, as opposed to the official register?

I question whether the provisions in Articles 34 and 35 drive a coach and horses through the strict rules which would normally apply to those wishing to call themselves a pharmacist. In a national emergency, people would suddenly be able to call themselves pharmacists, even though their qualifications may be out of date—the very thing which we are being told is anathema. At best, there seems to be an inconsistency of approach. If the risk of including these people on the national register in times of emergency is seen to be acceptable, notwithstanding their lack of full qualifications, why is it also not seen as an acceptable risk for someone with a pharmacy degree, or a number of medals or awards, or practising in academia or industry, to call themselves a pharmacist, even though they are not on the council register?

I have a couple of further questions. Article 51 deals with impairment of fitness to practise. I may be jumping at shadows, but Article 51(4) looks odd to me. It says that a person’s fitness to practise may be regarded as impaired because of matters arising outside Great Britain and at any time. I would have expected it to say “because of matters arising either inside or outside Great Britain”, on the premise that what is not explicitly mentioned on the face of a statute or order can sometimes be taken as being legally excluded or of doubtful legal weight. It would be helpful to have the Minister’s comments. I should also be grateful to know what the definition is of “the British Islands” in Article 51(1) and whether it should be taken to include Northern Ireland and the Republic of Ireland. I had thought that Northern Ireland was not involved in this order.

The order makes provision for the council to regulate premises, as well as people, and the noble Baroness mentioned this. What premises are we talking about here, other than retail and manufacturing pharmacies? Does the definition include hospital and prison pharmacies, and if not, why not? It would be helpful if the Minister could say precisely in what sense premises will be regulated, because, as we know from the Health Act which we debated last year, PCTs will also have authority to regulate pharmacists’ premises. Where will the dividing line of responsibility fall? I appreciate that there are currently no statutory standards for registered pharmacy premises within existing legislation, and it is clear that the council has a direct interest in promoting safe and effective practice in pharmacies. However, we do not want PCTs doubling up on this kind of oversight and effectively second-guessing the council by applying a different set of standards. What safeguards will there be to prevent this happening?

I should like to turn finally to Articles 10 and 11 of the order, which deal with the power of entry to premises and the powers of an inspector. In any legislation in which provision is made for these kinds of power, I always think that we should take a particularly close look at the wording to make sure that the powers are framed in a way that preserves an appropriate balance of rights between those who are charged with protecting the interests of the public and those whose privacy is being invaded.

In this case we find wording that appears somewhat vague and, therefore, potentially unsatisfactory. Article 10(1) says that an inspector may, subject to producing the relevant documentation, enter,

“any registered pharmacy or other premises at any reasonable hour”.

“Other premises”, one takes it, could refer to any office or commercial building, but could also include a pharmacist’s private dwelling. Paragraph (2) deals with private dwellings by saying that they may be entered,

“only if 24 hours notice … has been given to the occupier”.

There is nothing about obtaining the consent of the occupier first. I am concerned by such an unfettered power being vested in a body such as the inspectorate.

Paragraph (3) then appears to qualify the preceding provision by creating a series of exceptions under which a justice of the peace may order entry to a registered pharmacy or other premises; for example, if the case is urgent, the occupier is absent or there is a need for an element of surprise or secrecy. Again, one takes it that other premises may include a private dwelling-house. Provided that a justice of the peace can be satisfied on one or more of the four conditions, it would seem that he can issue a warrant authorising entry to someone’s private dwelling-house, by force if need be. At that point, an inspector is empowered under Article 11 to search the premises and inspect and remove anything he likes. He does not have to account for what he does; he does not have to issue a receipt for what he takes; he is not liable to make good any damage caused by forcible entry, provided reasonable force is used; and he does not, it would appear, have to confine the timing of his entry to reasonable hours.

I confess to being troubled by this series of provisions. I ask the Minister whether I have read the regulations correctly. Is she satisfied that these powers are appropriate and proportionate? If so, can she point to equivalent powers conferred on other regulatory bodies, particularly in relation to private dwelling-houses? Under Section 62(4) of the Health and Social Care Act 2008, premises used wholly or mainly as a private dwelling are explicitly excluded from the scope of the power of entry conferred on the Care Quality Commission. What is the justification for giving the General Pharmaceutical Council’s inspectorate these more far-reaching powers?

Amendment to the Motion

Moved by

To move, as an amendment to the above Motion, at end to insert “but this House regrets that the draft Order gives power to inspectors appointed under article 8 to enter and search any premises, including any dwelling house, without first obtaining the consent of the occupier of the premises or obtaining from a judge or magistrate a warrant authorising the entry and search.”

My Lords, the purpose of this order has already been explained by the Minister. It is to establish a new regulatory body—a new council—to regulate the conduct of pharmaceutical retail businesses, and to set standards for the practice of pharmacy at registered premises. It is a feature of the order that the council must establish an inspectorate, the function of which will be to enforce the regulatory rules made by the council. I believe all of this to be quite unexceptionable and I do not question the desirability of the order as explained by its accompanying Explanatory Memorandum and the noble Baroness.

However, I do question the need for this order to give the members of the council’s inspectorate the right to enter and search private premises without the consent of the occupiers or owners of the premises, and without obtaining any warrant. This point was touched on by the noble Earl. The right to enter and search is not confined, as the noble Baroness’s introduction might have led one to suppose, to a registered pharmacy. It extends to other premises, as the noble Earl mentioned. It is made expressly clear in the same article that it extends to private dwellings. I suggest that to be both unjustifiable and unnecessary, and that is the basis on which I am moving the regret Motion.

In moving the regret Motion, there are only three points that I want to make, although I will have to expand on them. First, such an unfettered right to enter private premises without consent and without a warrant is, and ought to be regarded as, contrary to principle. The second point is that there is no need for such an unfettered power to be given to the inspectors. The third point is that the giving of such powers to regulatory authorities is a growing tendency in statutory instruments. I have had the privilege of being a member of the House’s Select Committee on the Merits of Statutory Instruments since November. In that short time, three or four statutory instruments have provided powers to enter and search without consent or a warrant. The noble Lord, Lord Selsdon, has done much more research on this issue and has unearthed hundreds of instruments granting such powers. The proliferation of these powers is increasing, is unacceptable and ought to be checked.

Before I expand on those points, I draw your Lordships’ attention to the content of the order in a little more detail in relation to the right of inspectors to enter premises without consent or a warrant. The order provides for that power. It makes criminal any obstruction of the exercise of entry. It goes on, oddly, to provide for circumstances in which the inspectors can apply to a magistrate for a warrant or court order to enter. The magistrate may grant the warrant if they are satisfied that there is a proper reason for the application and provided that the case falls within one of four specified situations. The first is that entry has been refused, or is likely to be refused, by the owner or occupier; the second is that making a request for admission or giving notice to the owner or occupier of the desire to enter would destroy the object of the entry; the third is that the premises are unoccupied or the occupier is temporarily absent; and the fourth is that there is some need for urgency. Those four situations cover every conceivable eventuality in which the need to enter premises and discharge the regulatory function might be desired by an inspector.

I return to the three points. First, on the point of principle, there was a debate not long ago on a Private Member’s Bill, the Second Reading of which was sought by the noble Lord, Lord Selsdon. In the course of that debate, the old trite saying was mentioned that a man’s home is his castle—and so it ought to be. The reason why it ought to be his castle and for the origin of that familiar and somewhat trite expression is that it ought to be the place where the homeowner is entitled to repel, to keep out, those whom he does not want to enter his house, and to allow to enter his house those whom he wishes. That is a feature of home ownership and of the respect for a home to which every person is entitled. That is recognised in Article 8 of the European Convention on Human Rights. There are occasions, of course, when imminent emergency or danger to life or limb may require an entry to be made into private premises, including a home, without a warrant, in order to save life or if some serious criminal activity is feared.

Short of that, none of which can apply to the enforcement of this order, it ought to be accepted as a golden principle that it is not open to the Executive, officials appointed by the Executive, or officials appointed by any other person or body acting under statutory powers, to enter private premises—particularly private dwellings—without either the consent of the occupier or the authority of a court order. So much for the principle. I do not know whether the Minister would dispute the validity of the principle—I hope she would not—but if there is to be any derogation from it, that can take place only on the basis of clear need.

Where is the need in connection with enforcing the regulations and rules relating to pharmacies? The order provides for the right to enter premises under a warrant in the circumstances of: refusal or the likelihood of refusal; urgency; nobody being there, and in case giving notice would destroy the object of entry. In all those circumstances, the order provides for a warrant to be applied for. Of course, if the case can be made out then a magistrate will grant the warrant—and warrants can be applied for very quickly. The inclusion of urgency in the situations where that can happen demonstrates that to be so. The need to give these draconian powers to inspectors to enter without a warrant, notwithstanding no consent, is, I respectfully suggest, quite unnecessary and ought not to have been included.

So much for the absence of any need; the proliferation of these powers in statutory instruments is a matter of fact. On the occasions when those powers have been found in statutory instruments that have come before the Merits Committee in the short time that I have been a member of it, the answer has always been: “Well, these powers have been there and we have enjoyed them for a long time. There it is—what’s the matter with them?”. That is not a demonstration of need; it is not really an excuse.

When the pharmacy order came before the Merits Committee, the committee inquired of the department why this power to enter without consent and without a warrant had been included. The answer that the department provided was of some surprise at the question being asked. The power had been there, it said, in similar terms ever since the Medicines Act 1968. I looked at that Act, and there it was: the power to enter without consent and without a warrant, followed by all the comprehensive circumstances that I have already outlined in which a warrant could be applied for. What, then, was the need in 1968? No answer; these powers had simply always been there and have found their way not simply into this statutory instrument but into others.

The lack, as it seemed to me, of a proper answer from the department was followed by a communication from an official of the Royal Pharmaceutical Society, who asked if he could come to see me and talk about the order. I think that he was concerned at the delay that my regret Motion was causing to the implementation of the order. I arranged to meet him at that royal society’s premises—just on the other side of the river—and put the questions to him. What was the need for this power to enter without a warrant and without consent? I also asked him how often the inspectors were refused admission and how often it was necessary to apply for a warrant. Had the society ever brought a prosecution against some pharmacist for refusing entry that had been requested? He did not know, but said that he would inquire of the chief inspector and come back to me.

Last Wednesday, the official sent me a very helpful and illuminating response from the chief inspector. She said that she had looked into the matter and that, over the past 10 years, there had not been a single occasion when a warrant had been applied for or when admission had been refused on request. There had therefore been no prosecutions brought. The chief inspector went on to say that the powers that had previously been enjoyed under the Medicines Act and those that were proposed to be continued under this order were necessary. However, I suggest that the evidence was against her. How could the absence of a need ever to exercise the power to apply for a warrant show that that power would not by itself be sufficient to discharge the purposes of the inspectors? Consent or a warrant would, I suggest, plainly be sufficient on the evidence of the past 10 years, to which I have referred.

The question is whether a power to enter without consent or without a warrant is permissible and acceptable. Perhaps the proper treatment of this question should be to require the inspector to ask for consent. On the evidence, he would expect to get it. However, if on the very odd occasion he did not get it or did not think that he should warn the pharmacist by asking for consent, he should apply for a warrant and there would be no difficulty about him gaining entry. The requirement of a warrant in the case of disagreement would introduce an acceptable form of control over the power to enter.

A lot is heard about the importance of the rule of law. The rule of law should mean that invasive intrusions into individuals’ homes ought not to be tolerated unless franked by a court order. That is what courts and judges are for. The proposition that obtaining a warrant is merely an optional extra is, I suggest, not satisfactory. On those grounds, I invite the House to agree that regret should be expressed at the inclusion in this order of unnecessary, illogical and unjustifiable powers of entry without consent and without a warrant. I beg to move.

My Lords, I thank the noble Baroness, Lady Thornton, for introducing this substantial and long-awaited order. It has taken some time to come to us but I am very glad that it has done so. I am pleased because there is widespread consent regarding the main thrust of the order. The introduction of a new regulator, the General Pharmaceutical Council, is welcomed by pharmacists and by the Royal Pharmaceutical Society. It is now, I think, accepted—certainly throughout the medical profession—that the regulator and the professional body should not be one and the same, and the ability of one body to carry out those two functions is now somewhat called into question. This regulation builds on Trust, Assurance and Safety, the report which arose not least from the evidence that came to light during the Harold Shipman case about the abuse of drugs, the failure of the system to pick up the abuse of drugs and the way in which a doctor was able to abuse pharmaceuticals in order to commit a crime.

It is also a very welcome move because, as those of us who have had the joy of sitting through the passage of various Bills in the House know, the role of pharmacists is changing. It is changing almost out of recognition compared with, say, 10 or 20 years ago, when the role of the pharmacist was to execute the orders of a doctor. Nowadays, pharmacists take a much wider role in healthcare, and they take a far greater responsibility in the advice that they give about pharmaceuticals and about the maintenance of people’s health, particularly those with long-term conditions. Given the high degree of training which pharmacists have, it is right that their increasing role within healthcare should be recognised.

As the noble Baroness will know, one of my colleagues in another place, Sandra Gidley, is a registered pharmacist and one of my colleagues here, my noble friend Lord Kirkwood of Kirkhope, was a pharmacist. I do not know whether he is allowed to call himself a pharmacist any more—he is probably a retired pharmacist, as I suspect that that is going quite a long way back. Both of them have said that, although there are some questions about it, this is an important order, in that it gives the new regulator power to foresee the changes that will evolve over the next five to 10 years in the role of pharmacists. They will have a much bigger, more direct role in interaction about healthcare with individuals.

I want to raise a few specific points with the noble Baroness, and then I shall return to the point raised by the noble Lord, Lord Scott. One issue that has arisen is that pharmacy now takes place in a number of different settings. It takes place in GP centres, in hospitals, in private hospitals, in retail premises and in industry, as the noble Baroness said. The practice of pharmacy in those different settings comes with a different set of issues.

One point raised by my honourable friend in another place is the role of the regulator and its powers in relation to the employers of pharmacists. They seem to be very limited. The demands of an employer on a pharmacist—let us say, in a retail setting—can be very different from those in a hospital. The number of people around a pharmacist—peers capable of exercising professional checks, balances and judgment—is very different in a retail setting from in a hospital.

Another point is the dimension about devolved legislatures, and the extent to which the regulations will apply. I understood the point made by the noble Baroness about the Pharmaceutical Society of Northern Ireland. I say to the noble Earl, Lord Howe, that I think, from my days studying for geography A-level, that British islands include the Channel Islands and the Isle of Man. They constitute the British Isles. Great Britain and Northern Ireland includes Northern Ireland. Therefore Northern Ireland is not a British isle. I hope that I am proved right on that one.

I make the point that, in Scotland, the law is different. Although the professional standards set out may be ones which the profession in Scotland wants to take on board, the way in which they are applied needs to be the subject of a lot of consultation. In addition, there must be recognition that pharmacists, like many other medical professionals, move around within the EU. In the drawing up of the order, has there been consultation about standards in other member states of the EU, particularly on the issue of a person's fitness to practise. Will there be a form of common assessment? My understanding is that, at the moment, there is no way to prevent a person moving to another EU country when they have had their fitness to practise rejected here and setting up as a pharmacist.

One other point concerns the race equality statements. As noble Lords will have seen from the regulatory impact assessment, a disproportionately high number of pharmacists come from Asian communities. A point made by my honourable friend in another place, Sandra Gidley, is that there is a sense among those pharmacists that a disproportionately high number of them are being referred to bodies questioning their fitness to practise. Is that the case, and is that an issue that the department will monitor?

On the issue of costs, the order represents an increased level of regulation which I presume will have to be paid for by levying additional fees on practising pharmacists. I do not know whether these costs have been estimated, but other regulators have found that the more they have engaged in adjudication of fitness to practise, the greater the costs incurred.

The noble and learned Lord, Lord Scott, has raised an important and interesting issue. I, too, am left wondering why there is not an automatic need to go to a justice of the peace in order to obtain a warrant. I have read the detailed response from the Royal Pharmaceutical Society, which answered a number of the questions quite rightly raised by the noble and learned Lord. I understand from the briefing that there are good reasons why private premises should be entered. The Royal Pharmaceutical Society inspectorate has cited cases where its officers entered private premises because, for example, they had received information indicating that medicines were being stored in and services provided from a resident’s home; or there were serious cases where dwellings or garages were being used as places in which to tamper with medicines, where unlicensed medicines had been inappropriately stored or where medicines were being supplied from the house. So it is conceivable—although perhaps not in the past 10 years—that there have been good reasons why the inspectorate would wish to enter a private dwelling. Quite why it feels the need to do so without a warrant is open to question.

I should say to the noble and learned Lord, Lord Scott, that it is just possible that the existing regime whereby professional colleagues have the power to enter one’s home to check on one’s professional standards could have been a powerful deterrent to people not to break the law. I have often spoken to members of other parts of the medical profession and they have talked about how the potential that they might end up in front of the GMC and some of their peers is a very powerful deterrent on them not to contravene the ethics of their profession. In some cases they have said that it is a much more powerful deterrent than the law. The noble and learned Lord, Lord Scott, is right to raise the issue but there is a side to it that perhaps he and I should explore further with the Royal Pharmaceutical Society.

My Lords, I am perfectly prepared to accept, as the noble Baroness, Lady Barker, has said, that there may well be circumstances where it is proper for an inspector appointed under this order to gain entry to and inspect premises, but the central question to the amendment is whether the power should be exercised without the consent of the occupier—the registered pharmacist, let us say—and without the benefit of a court order. I support the noble and learned Lord, Lord Scott, because he is absolutely right to base his case on the fact that entry without consent and without the benefit of a court order is contrary to principle. I should like the Minister to tell us whether the Government accept that it is contrary to principle. There are many circumstances in which it is legitimate to go against a principle, but they depend essentially on exceptional circumstances of which probably the most important is necessity, as the noble and learned Lord said. So what necessity is perceived by the Government in drawing this power as widely as it is drawn?

I suggest that this is a glaring departure from principle and one that is not justified by any perceived necessity. Why is it glaring? It is glaring because the council can make any order that it likes, consistent with the powers which the statute gives it. Article 9 states:

“The Council must make provision in rules relating to … the circumstances in which inspectors may conduct special inspections of, and other visits to, registered pharmacies”.

If one looks a little further, one can see that, within its overall purposes, the council has carte blanche to make any rule it likes. Once it has done so, all the panoply of powers which this order confers on inspectors becomes available. So it is a glaringly wide departure from principle and one for which it is very difficult to see any justification when one approaches it, as I do, without knowledge of the Government’s case. So I hope the Minister will say, first, whether the Government accept that it is contrary to principle to have a power of entry without consent and without a court order, bearing in mind that the court order provisions here are permissive and not obligatory, and secondly, whether she perceives any necessity for a breach of that principle.

My Lords, as I have tabled the Powers of Entry Bill, it is inevitable that I should say something on this matter, but I will be brief. First, I thank the Minister for her interest in the pharmaceutical industry and remind her, although she needs no reminding, that at the moment, with our manufacturing industries fading away, pharmaceuticals represent possibly the best in the country, with £7 billion of investment in research every year and a surplus of £6 billion. Within that, it is a fairly responsible industry.

The problem that we have had over a period of time has been the failure of Government to know their own powers. Will the Minister let me know what her own departmental powers of entry are? By my calculation, she has a total of 75 powers and will have another one added today. Thirty-eight—or half—of those powers are under Acts of Parliament and the other half of them are under regulation. Are they really necessary? In particular, is it appropriate that one should have the right to visit or enter someone’s property or premises without permission and without a court order?

It is a little worrying that we have a Government who have no knowledge of the 1,208 powers of entry they have under regulation and under Acts of Parliament. Over the past five years I have asked questions of every ministry as to what their powers of entry are. I would appreciate it if the Minister felt able, at an appropriate time in a few weeks or so, to write me a letter answering the question about the powers of entry of the Department of Health.

That is only a minor issue. The real concern is that, if neither Government nor people know what their powers of entry are, we have a breakdown of democracy. It is a relatively easy matter to put right. What I have suggested is that there should be simply a schedule of all those Bills and Acts of Parliament that give powers of entry and how they should be implemented. The simple principle is that one should not be able to enter a person’s property or premises without permission and a court order.

One of the difficulties is that powers of entry originally had a relatively small clause. In most Bills now, the number of pages entitled to implementation of powers of entry are possibly three times as many as the content of the Bill. The health Bill which we discussed earlier was relatively short, but the regulations and matters that went with it were enormous. I should be grateful if the Minister could confirm what her powers of entry are—as the Department of Health—and, of course, I naturally support the proposal of the noble and learned Lord, Lord Scott.

My Lords, it is clear that the House owes a great debt to the noble and learned Lord, Lord Scott, for raising this matter. It is a very important subject, which I predict will grow in importance. It is to the credit of the House of Lords that, very largely due to the initiative and hard work of my noble friend Lord Selsdon over a number of years, it is taking seriously this important issue.

It is particularly useful to draw to the attention of the authorities of the House the role in this of the Merits of Statutory Instruments Committee. Years ago, I was on the old Statutory Instruments Committee, and very boring it was, because all we had the power to do was to look at powers; in other words, the vires. All we had to say was whether the statutory instrument in question had vires as drafted under the legislation or whether they were Henry VIII clauses. Now, the committee looks at the merits of statutory instruments, which is a big advance. I suggest that, from now on, that committee should always consider whether there are powers of entry in a statutory instrument, whether they are appropriate and necessary, and whether they contain proper safeguards against powers which are disproportionate, particularly powers of entry without warrant. The golden principle to which the noble and learned Lord referred, of the right, particularly of the householder or a landholder, to keep people off their property without due cause for entry, must be revived—it dates right back to Magna Carta.

I am disappointed that we should need to discuss this matter tonight, because we had heard that the Government were seized of its importance at the Second Reading of my noble friend’s Bill; indeed, I remember the Prime Minister himself expressing interest in powers of entry last year. Well, his influence may be fading. It is extraordinary that, with the decision that there should be a co-ordinated approach, we have so unjoined-up an example of government as this. I ask the Minister to say directly and honestly—of course, she will be honest—whether the Department of Health consulted the Home Office before drafting the clauses in question, because, apart from anything else, they seem to be extraordinarily badly drafted. As the noble and learned Lord pointed out, they contain perfectly satisfactory conditions for powers to be used with a warrant, but they are then all overridden by loose and sloppy wording which appears to allow entry without a warrant. That is wholly unacceptable.

If we were to pass the amendment—and I shall certainly support the noble and learned Lord in the Lobby if he chooses to take the opinion of the House—it would not affect either the implementation of the order or the speed with which it is done; it would merely put down a marker very publicly, as I hope to some extent this debate will do.

There is a real danger of antagonising the public with this plethora of powers of entry without a warrant. How can it be that, if the police need warrants in almost all cases, the same should not apply to the great number of other inspectorates, which is growing every year? It is absurd that they should not need them. We recognise that there are circumstances when everyday powers are needed; there is general consent about that. The trading standards people have to be able to visit premises as and when they wish. They do not need a warrant and there is no objection because the visits are an essential aspect of their role.

Another issue that has come up in recent years is the need for more direct powers in respect of the protection of children, but in my view the right approach to that is for a case to be made to a magistrate when someone is thought to be at risk. A continuing power would be given for the appropriate people to visit those premises as and when. In itself that would be a safeguard because of the failure of social workers to do their job properly by entering premises to check on some wretched child who is being neglected or abused. It would be much harder to justify with the melange of excuses we always hear after a case has been exposed because the first question would be: “Did you or did you not apply to a magistrate for proper rights of entry to check on that particular case?”. In that area, it would be a huge plus to require there to be a magistrate’s warrant.

It is a good thing that we have discussed this issue and I hope very much that the Government will agree to accept the amendment. I hope that it will not be implied that we are wasting parliamentary time in discussing this little matter. The noble and learned Lord has made the case very clear, and he has taken trouble to consult, that there is no conceivable need for this power to exist, especially since the order itself lays down clear conditions under which a warrant could be obtained. It is the overriding provision that has been slipped in which is unacceptable. Perhaps the Minister will tell us that it was all a mistake, that they never consulted with anybody, and that they do not have good legal people in her department.

My Lords, having sat on the Bench on which the noble Baroness is now sitting, I know that it is infused with a reflex which all government Ministers have to amendment of this sort, which is to resist them. In some way they clip a feather on the end of the wing of government. I hope she will resist the reflex, or at least when she is not in her place tomorrow, she will read the sage and powerful words of the noble and learned Lord, Lord Scott of Foscote. To me he has made an unanswerable case against this regulation, but he merely wishes to express regret rather than opposition, which I would have gone further and done. I will not repeat any of those arguments, but would ask her to take them on board.

I shall be exceedingly brief because I sympathise with all the noble Lords now on the Front Benches in the Chamber. They have been in their places for much longer than me and I do not think that they have had their supper yet, and therefore perhaps will not be as alert as one might otherwise expect. I merely want to pick up on the point made by my noble and learned friend Lord Mayhew, and that is the point of principle. We should remind ourselves from time to time what Parliament is for. It was set up to protect the citizen from the Crown, and as the Crown has proliferated, it has the function of protecting the citizen from the overmighty subject. The corporate subject is now overmighty in many cases. In this case, the corporate subject—the inspectorate—has been given powers that are not commensurate with what are needed. That has been quite clearly stated and convincingly, conclusively stated by all my noble friends on the Back Benches.

If the Government accept that it is a matter of principle that before anybody can intrude on a person’s premises they should have the authority of law, we should have been reassured by what the noble Lord, Lord Brett, the Minister’s colleague, said a fortnight ago last Friday when replying to the debate on the Bill proposed by my noble friend Lord Selsdon. On the concern that everybody had and which he shared about the control of powers of entry, he said:


and this was intended to be reassuring—

“as noble Lords are aware, each individual power of entry is subject to parliamentary scrutiny. Any proposed new power of entry contained in a Bill or draft statutory instrument must complete the relevant parliamentary process”.—[Official Report, 15/1/10; col. 733.]

That is exactly what we are doing now, and we are going to let it through. We are not reassured by that but deeply unhappy, and I am even more unhappy with the vast phalanxes of inspectors of different organisations with similar and similarly uncontrolled powers that appear to exist. I hope that in the next Parliament this is a wrong that will be redressed.

My Lords, I start by recognising the distinguished work and record of the Royal Pharmaceutical Society of Great Britain, which I omitted to mention in my opening remarks. I should like to rectify that and say how grateful we are for the wonderful work that it has done over a very long period. I intend first to deal with the issue of the rights of entry, which have been raised by several noble Lords. I also read with interest the note that the royal society sent to the noble and learned Lord, Lord Scott. I also note that in the process of preparing for this I failed to find anything in the Merits Committee’s report on this issue to suggest that this was a key issue of concern for it in its examination of the order.

I know from the words of the noble and learned Lord, Lord Mayhew, and the noble Lords, Lord Selsdon, Lord Marlesford and Lord Elton, that this is a broader issue that needs to be discussed across the piece. Therefore, it is unlikely that I shall be able to satisfy them tonight. However, I note that this is a campaign to which we will return. The noble and learned Lord, Lord Scott, has explained to me in writing and in person his broader concerns about this matter, for which I am grateful.

Why does the inspectorate need the power to enter an individual’s private dwelling without obtaining a warrant? I shall read through my brief to get this into the record. It may not satisfy noble Lords, but I need to say these things and will then seek to answer some of the specific points raised.

These powers are needed because of the different business models which may operate from registered pharmacy premises. Examples include an application to register the bedroom of a private flat as an internet pharmacy or registered pharmacies that operate from the ground floor of private dwellings with the upper floors or outside storage areas designated as living space. Inspectors have to ensure compliance with standards for storage of medicines that may be in those areas designated as private dwelling space. Access to storage areas may also cross into private dwellings via hallways, stairs and so on. The noble Baroness, Lady Barker, outlined the issues well in her remarks.

Article 10(2) of the order provides that an inspector should give 24 hours’ notice of the intended entry into premises that are, or form part of, a private dwelling- house. This is not intended to give an inspector a power to enter such premises without consent or by force. Article 10(3) covers the position when entry has been refused, in which case an inspector must apply for a warrant. The possibility of refusal of entry without a warrant is specifically catered for in Article 10, which provides alternative measures that the inspector will be required to employ in order to exercise their functions. This involves obtaining a warrant.

This country has a very good reputation for preventing the unlawful supply of medicines and preventing counterfeit medicines from entering the supply chain. This is a credit to the work of inspectors like those of the pharmacy regulator and those of the Medicines and Healthcare products Regulatory Agency. The same powers authorise the inspectors of the Veterinary Medicines Directorate, who inspect businesses such as saddlers and merchants who supply riding saddles and tack as well as veterinary medicines. Many of these businesses operate from farms where the shop and stores form part of the private dwelling. In the vast majority of cases, registrants are compliant with requests to enter premises without recourse to the formal powers. However, there are some cases where these powers are needed and must therefore be provided for. This is therefore a transfer of powers, not an addition. In our view, it is not an issue of principle but an issue of transferring powers.

The noble Lord, Lord Selsdon, startled me for a moment, I confess, when he asked me personally what my powers of entry were. Sorry to be flippant, but I was thinking, “Have I got my keys with me for tonight?”. I will have to write to him about the department’s powers of entry specifically, and I undertake to do that.

I say to the noble Lord, Lord Marlesford, that I do not regard this as wasting Parliament’s time; it is an important issue, and I am certainly very happy to discuss it.

The noble and learned Lord, Lord Mayhew, raised the issue of whether the order allows any rule to be made. The answer is no, the rules must be subject to consultation and laid before Parliament and the Scottish Parliament for negative resolution after approval by the Privy Council.

The noble Lord, Lord Marlesford, asked whether the department consulted the Home Office. No, we did not consult the Home Office; we consulted the Ministry of Justice and it was content.

The noble and learned Lord, Lord Scott, was questioning the Medicines Act 1968 provisions of entry and inspection. That Act is also the vehicle that provides the entry and inspection powers of the Medicines and Healthcare products Regulatory Agency, so they protect the medicine supply chain in this country.

The noble and learned Lord also asked about warrants and inspectors’ powers and why the inspectorate cannot obtain a warrant after being refused access rather than having the power to gain access in the first place. Article 10(2) of the order provides that an inspector should give 24 hours’ notice of the intended entry to any premises that are or form part of a private dwelling- house. This is not intended to give an inspector the power to enter such premises without consent or by force. Article 10(3) covers the position where entry has been refused in which the inspector must apply for a warrant, and I think that I have already explained that to the noble and learned Lord.

I think that my remarks so far also cover most of the points that the noble Earl, Lord Howe, raised about powers of entry.

My Lords, the Minister has drawn our attention to the fact that there is a protection of private dwelling-houses, which had not escaped my notice, but all other premises are not protected by those provisions. Those are also a matter of great concern.

I had sort of assumed that that was the case, but I take note of what the noble Lord has said.

The noble Earl, Lord Howe, asked why there are different powers of entry for the Care Quality Commission’s inspectors. These powers stem from existing powers under the Medicines Act 1968 and the Poisons Act 1972, and are about safeguarding medicines and the poison supply chain.

I turn to the detail of the noble Earl’s question. We were asked why the GPhC has chosen to take such a hard line on the restricted title. We consider that the titles “pharmacist” and “pharmacy technician”, rather than “registered pharmacist” and “registered pharmacy technician”, are those that hold the most meaning for patients and the public, a view that was supported by the feedback from the patient and public consultation event. The title “pharmacist” is already restricted, under the Medicines Act 1968, to those who are on the register of the RPSGB, and we are not proposing to change the protected titles. The consultation on the draft Pharmacy Order 2009 proposed that the titles “pharmacist” and “pharmacy technician” remain restricted to those who are on the register of the General Pharmaceutical Council and therefore have met all the registration requirements necessary to satisfy the regulator that they are fully qualified, competent and fit to practise.

The key principle shaping the development of our proposals on protected titles is that the primary focus of the new regulator for pharmacy, the GPhC, should be on public interest and patient safety, and that individuals should not mislead the public as to the currency of their restricted status, skills and knowledge. The same issue of restricting titles to regulated individuals was raised by retired dentists during the passage of the Health and Social Care Act, as noble Lords will recall. Their move to allow retired and former dentists to carry on using the title was rejected, and they were also very upset by this. Allowing pharmacists to lessen the restrictions on their title may reopen the debate for other professions—and I think it probably will; this is one of those issues that will roll on.

Pharmacists currently on the non-practising register can apply to join the practising register either prior to or post the transfer of the regulatory functions to the GPhC, although they may be subject to return-to- practice requirements. In addition, those pharmacists who are currently on the non-practising register can choose to join the professional body for pharmacists if they wish to keep in touch with the profession.

The noble Earl asked what happens to people qualified as pharmacists but not in a dispensing role, in particular in industry or academia. There are two issues here. First, all domains where pharmacists practise, whether it is the NHS, the independent health sector, academia or industry, have both system and professional regulation. The regulation of products or services does not mean that individual healthcare professions do not have professional responsibilities. Secondly, there are clearly roles in industry where there is a personal choice whether the individual registers as a pharmacist or not. The draft Pharmacy Order 2009 set out the Government’s view of what is required for registration. After that, the individual must decide whether they want to continue to use the restricted title “pharmacist”, and if they do, they must register.

Our view, which is supported by the response to the consultation on the draft Pharmacy Order 2009, is that to restrict regulation merely to those with patient-facing roles would leave those involved in the development of medicines, teaching and leadership with no statutory requirement to maintain their levels of knowledge or skills. In some circumstances, this may present a risk to patient safety.

I have dealt with the issue of retired pharmacists. The noble Earl asked why, if the plan is to allow retired pharmacists to register as pharmacists during an emergency, they cannot be allowed to register during normal times. The planning for emergencies, such as an influenza pandemic, includes worst-case scenarios where significant numbers of the population are affected; in particular, front-line healthcare staff. If these scenarios ever became reality, the recently retired would be called upon, as would final-year students. These are extreme measures—not just for pharmacists but other medical professions too—for use in a national emergency, and it is appropriate to plan for that. The body that would have the names of retired pharmacists would indeed be the professional body for pharmacists. As I have said, those who were interested in continuing a link with their profession would be listed there.

The technical question about Great Britain was exactly as the noble Baroness, Lady Barker, outlined. The British Isles are the UK plus the Isle of Man and the Channel Islands. The reason for putting it in these terms is that we would want to be aware of any offences committed in British islands outside Great Britain. Professionals from Northern Ireland, the Isle of Man and Channel Islands are eligible to register with the GPhC with no further requirements than those living in Great Britain.

I think that that has covered most of the points raised. I was asked whether, in Article 51(4), we meant inside or outside and by specifying “outside” we had inadvertently not covered the inside of Great Britain. The extent of the order is covered in Article 2 and specifically states that it covers England, Wales and Scotland. Anything that happens outside is pertinent to fitness-to-practise decisions. We are confident that we have achieved the desired outcome.

The noble Baroness, Lady Barker, raised the role of the employer. The GPhC will have powers to set standards and rules for pharmacy owners and superintendent pharmacists. The standards and rules require a framework for quality and improvement. However, it is for primary care organisations who commission services to assess whether the staffing and skill mix are sufficient to deliver specific contracts. The noble Baroness will be aware that primary care contracting arrangements are different in each of the three countries. Therefore, it would be inappropriate for the regulator to stipulate standards in these areas. The noble Baroness is completely right that the situation with pharmacists is evolving. The demands being put on pharmacists will change and be greater, I suspect, as we move forward.

The noble Baroness raised concerns about fitness-to-practise cases and suggested that those involving ethnic minorities were potentially disproportionate. I will take that back to the department and ask that question, but the GPhC, by virtue of the provisions of the order, will be under a duty to publish in its annual report a description of the arrangements that the council has put in place to ensure that it adheres to good practice in relation to equality and diversity.

The noble Baroness asked about the cost of the GPhC and the setting-up fees. The cost impact assessment that accompanies the order suggests that the base annual costs for regulation being incurred by the RPSGB have been assessed at £12,518,182. The non-recurrent transitional costs of £4,384,559 incurred or planned for 2008-09 and 2009-10 have been included. In addition, the annual running costs of regulation through the GPhC have been assessed at just under £3.5 million. Those costs were included in the calculations under fees to be charged.

The noble Baroness also asked about the common assessment for European professionals. The European legislation means that the regulator will need to recognise EU healthcare professional qualifications. The powers under the order allow the regulator to obtain certificates on the practice of good standards. I hope that that answers all the questions, if not all satisfactorily.

Before the noble Baroness sits down, I may be able to save her some work. Instead of her writing to me, I will write to her tomorrow with the schedule of all the Bills. She can then confirm to me if it is correct, because I do make mistakes.

My Lords, there are three things I want to say in reply in support of my amendment. First, the Minister suggested that if an inspector were to enter premises without a warrant and were turned away, that would not by itself be a criminal offence. I believe her to be wrong about that. The terms of Article 10 are quite clear. Article 10(1) says that:

“An inspector, on producing evidence”,

of who he is,

“may, for the purposes of the exercise of a function conferred on the inspector by article 8 … enter any registered pharmacy or other premises at any reasonable hour”.

That is a right given to him by Article 10(1). Article 12 says that:

“Any person … who intentionally obstructs an inspector exercising functions under article 10 or 11 commits an offence and is liable, on summary conviction, to a fine”.

Nothing there suggests that it is necessary before a criminal offence is committed for the inspector to get a warrant. There it is: a right to enter, without a warrant, obstruction of which is a criminal offence.

That is an outrageous piece of legislation. The fact that it has been in place since 1968 in a primary Act of Parliament does not make it any less outrageous; that makes it worse. It has sat there for years, providing the precedent for repetition in other instruments—I hope not in other primary Acts, but there may be some—and I respectfully suggest that it is time this was recognised and stopped.

I entirely accept the point of the noble Baroness, Lady Barker—also made by the noble Baroness, Lady Thornton—that there will be times when inspectors need to get into premises quickly without the owner or occupier knowing. That may happen. The fact that it has not happened within the past 10 years, as seems to be the case, does not mean that it may not happen in future. If that is the position, the inspector should get a warrant. The owner of the premises does not know: warrants are applied for ex parte, without notice to the owner of the premises. It is no justification for allowing entry without a warrant; a court should control that situation. The regret that this Motion invites the House to express is one that is long overdue. I beg to move.

Motion agreed.