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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,

"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,

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.

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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 Lord Scott of Foscote

Lord Scott of Foscote: 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.

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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.

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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.

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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?

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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.

Baroness Barker: 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

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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

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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?

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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

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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.

Lord Mayhew of Twysden: 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.

Lord Selsdon: 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.

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