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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,

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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.

Lord Marlesford: 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

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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

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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.

9.15 pm

Lord Elton: 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-

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.

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Baroness Thornton: 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

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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.

Lord Elton: 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.

Baroness Thornton: 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

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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

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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.

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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.

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