My Lords, I beg to move that the Bill be now further considered on Report.

Moved accordingly, and, on Question, Motion agreed to.

Clause 17 [Accountable officers and their responsibilities as to controlled drugs]:

moved Amendment No. 23:

Page 15, line 20, leave out from first "The" to "appearing" in line 21 and insert "descriptions of bodies, or bodies, that may be so prescribed are descriptions of bodies, or bodies,"

My Lords, government Amendments Nos. 26 and 27 have been tabled to meet concerns raised in Grand Committee about the authorised persons who can enter and inspect an individual's home in relation to securing the safe, appropriate and effective management of controlled drugs. Government Amendment No. 26 limits when an authorised person for the purposes of Clause 20 can enter relevant premises which are or form part of a private dwelling. It ensures that an authorised person may enter such premises only if accompanied by a constable or in such other circumstances as may be prescribed by regulations. Government Amendment No. 27 is purely consequential.

Amendment No. 26 contains a power to prescribe circumstances in regulations where an authorised person would not need to be accompanied by a constable. This is quite simply to ensure that if, for example, a medical practitioner's surgery is separate from their private dwelling but needs to be accessed through the private dwelling—through a shared hallway, for example—it would be possible not to require the presence of a constable.

It would also be appropriate to use the power to exclude care homes from the requirement. Whilst they can properly be classed as a private dwelling, because they are already inspected by the Commission for Social Care Inspection it would seem illogical to require the presence of a constable in these specific circumstances.

Amendments Nos. 23, 24, 25, 28 and 29 are merely minor drafting and technical in nature. I beg to move.

My Lords, I welcome these amendments and I thank the Minister for having considered the matter.

On Question, amendment agreed to.

Clause 18 [Co-operation between health bodies and other organisations]:

moved Amendments Nos. 24 and 25:

Page 17, line 15, leave out from first "The" to "which" in line 17 and insert "descriptions of bodies, or bodies, that may be so prescribed are—

(a) descriptions of bodies, or bodies,"

Page 17, line 19, leave out "Bodies" and insert "Descriptions of bodies, or bodies,"

On Question, amendments agreed to.

Clause 20 [Controlled drugs: power to enter and inspect]:

moved Amendments Nos. 26 to 29:

Page 19, line 9, at end insert—

"( ) The power conferred by subsection (1)(a) may be exercised by an authorised person to enter relevant premises which are or form part of a private dwelling only if he is accompanied by a constable.

But this subsection does not apply in such circumstances as may be prescribed by regulations made by the relevant authority."

Page 19, line 27, leave out "subsection (1)" and insert "this section"

Page 19, line 30, after "The" insert "descriptions of"

Page 19, line 30, after "are" insert "descriptions of"

On Question, amendments agreed to.

Clause 26 [Requirements about supervision]:

moved Amendment No. 30:

Page 22, line 16, leave out "may" and insert "shall"

My Lords, we had some extremely useful and constructive debates in Grand Committee on the issue of pharmacy supervision, and I return to the subject only briefly because there are perhaps two or three points on which we did not reach as definitive a conclusion as we might ideally have wished. Against that background, I hope the Minister will have guessed that Amendment No. 30, being a rather hackneyed format, is designed purely as a probe.

One of the profession's main worries—I mention, in particular, the Pharmacists' Defence Association—is the extent to which it is reasonable to allow the pharmacist to be absent from the pharmacy whilst still ensuring that patient safety is not compromised. The Minister made some helpful comments in Grand Committee on remote supervision and the use of technology in improving patients' access to medicines. I am sure he is right that, as time goes on, we shall see the development of this technology which, in places such as Australia, where distances are very large, probably has an important part to play in ensuring that patients' needs are looked after. However, in Britain, the arguments for embracing this kind of technology are less strong because pharmacies, as a rule, are no more than a short car or bus ride away from a patient. Many members of the profession feel that the use of technology should not be encouraged as a substitute for pharmacists being physically present in a pharmacy because technology, however good it is, merely introduces new challenges for the maintenance of patient safety. Pharmacists cited a case in California where 4,700 people received incorrect medication when a dispensing robot went wrong.

At a broader level, we need to be clear how we justify the absence of the pharmacist from the pharmacy and in what circumstances. Clearly, as we debated before, there are frequently good reasons why a pharmacist in the course of his professional duties has to be allowed to leave the chemist's shop. But the watchword here, as the Minister himself emphasised, must always be patient safety. The Pharmacists' Defence Association has advised me of a suggestion by the department of fixing a predetermined percentage of the working day as the maximum period for which the pharmacist will be allowed to be absent from the premises.

Personally, I am very doubtful about whether a hard-and-fast percentage is the right approach, because having chosen a figure it is always possible to argue for a figure that is higher or lower in different circumstances. A fixed percentage such as 20 per cent is bound to be arbitrary. But we surely need to ask a more fundamental question: whether and to what extent supervision can ever properly take place when the pharmacist is not physically present.

Let us leave aside remote supervision through the use of technology, which I have already covered. If a pharmacist is absent from the pharmacy, to what extent is it safe for him to rely on support staff to follow the rules laid down in standard operating procedures? The PDA tells me that it regularly encounters incidents of support staff acting outside their competences and putting patient safety at risk. That is surely worrying. So in creating flexibility for pharmacists to be absent, which on one level I understand the need for very well, we ought to keep in mind that there is an inevitable trade-off for that flexibility in the form of a potential risk to patient safety. None of us wants to see that compromised. If an arbitrary percentage of "absent time" were proposed, it would need to be closely justified by reference to the patient safety principle.

The regulations will deal with the finer details, but I should be most grateful to hear from the Minister a little more of how the Government propose to square this circle. I beg to move.

My Lords, Clause 26(1) inserts new subsection (7A) into Section 10 of the Medicines Act 1968. It enables us to make clear what a pharmacist has to do to satisfy the supervision requirements in respect of the preparation and assembly of medicines. Through this power we can specify which activities pharmacists must undertake themselves and when aspects of the preparation and assembly of a medicine can be delegated to other trained and competent pharmacy staff working under the supervision of the pharmacist. This power also enables us to prescribe conditions that must be met where a pharmacist supervises these activities remotely. However, the power does not relate to our proposals to enable the responsible pharmacist to delegate certain aspects of supervision for suitably trained and registered health professionals such as pharmacy technicians, which can already be achieved using order-making powers in the Medicines Act.

I accept the spirit in which the noble Earl moved his amendment—to find out a little more about what we are up to in this area, if I may put it that way. Certainly, the exercise of the pharmacist's responsibilities is not wholly dependent on his or her physical presence in the pharmacy at all times. I reassure the noble Earl that we recognise the need for parameters to be set on the pharmacist's absence, but they should not, as now, constrain the pharmacist from using his extensive clinical training to offer services away from the pharmacy and working with other health professionals in the community.

It is important that the pharmacy is seen as the responsible pharmacist's main place of work, where he will spend most of his working time to exercise fully his responsibility for the safe and effective running of the pharmacy. However, like the noble Earl, I am not wildly enthused about fixing a minimum percentage of time; that would be arbitrary and would not deal with the range of circumstances that may exist. We intend to set out in the regulations the circumstances and conditions supporting the pharmacist's absence from the pharmacy—for example, for arrangements to be in place for pharmacy staff to contact the responsible pharmacist when he is away from the pharmacy, or another available pharmacist, to provide advice.

I assure the noble Earl and the House that we shall consult extensively on the development of the regulations in due course. In the mean time, we outlined in an information paper published in January how they might develop. If the noble Earl has not seen the paper, I can send it to him and to other noble Lords. We shall proceed with great care and caution in this area and will do so in full consultation with the pharmacists' interests. We believe that this issue needs to be thrashed out in the consultation on the regulations, and I hope that the noble Earl will be more reassured by what I have said.

My Lords, I thank the Minister for his considered answer. I took heart from what he said, because it seemed to convey the balance and common sense that I had hoped to hear from him. I welcome his commitment to full consultation on this issue; I am sure that the profession will expect and welcome that. With goodwill on both sides, I believe that the issue can be satisfactorily resolved to meet the concerns that I outlined. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 30 [The responsible pharmacist]:

moved Amendment No. 31:

Page 25, line 36, leave out from "time" to end of line 38.

My Lords, this amendment returns to similar ground to that covered by the noble Earl's amendment. I, too, came away from our deliberations in Grand Committee uneasy about the proposals to change the regime of one pharmacist having to be present at all times in one pharmacy. The noble Earl argued the case on the grounds of patient safety, which is entirely valid, but I want to come at it from a slightly different point of view: quality of service and advice.

In Grand Committee I set out the case—quite well, I think—for maintaining what is perhaps one of the most valuable parts of the health service in the high street: the availability of a qualified pharmacist to advise and give information about medicines and treatment, often where there are very few other sources of information. We talked a lot about how pharmacists are often extremely important in using their skills to analyse how someone's medication is working. That quite often happens when someone comes in for a repeat prescription, when it may be more evident than at the time when a GP made an order for a prescription that something is not right. That is a very valuable service.

The Minister cited two examples of why the Government's proposal is preferable. He mentioned vending machines in Australia, as we have heard, and temporary pharmacies at rock festivals. I do not find either of those examples particularly compelling. I am not being flippant, but I genuinely think that there is much to be lost if the existing guarantee that a responsible pharmacist will be in a pharmacy is removed. That, frankly, is not made up for by the examples he gave.

I tabled this amendment to offer the Minister another opportunity to set out examples of what he believes would and, crucially, would not be permitted under the new regime if the Bill went ahead as it is. I need to be convinced a bit more. I am not one to stand in the way of technological progress, but I believe we are light years away from technology sensitive enough to deal with some of the conditions people will have, and I do not believe detection will be possible at long distance, at least not of the quality that is possible face to face. I hope the Minister will be able to give us some more reassurance. I beg to move.

My Lords, the noble Baroness, Lady Barker, has made some powerful points, and I agreed with much of what she said.

I want to come at this issue from a slightly different angle. In Grand Committee the Minister gave some welcome reassurances on the general principle of one pharmacist/one pharmacy, which I and other noble Lords believe is right. However, the trick the Bill needs to pull off is both to safeguard that general principle while not closing the door to evolution in how pharmacies are run. We are living through a time of considerable change for pharmacies, and it would be unwise to set in stone provisions that do not allow for a certain amount of flexibility within the confines of one pharmacist/one pharmacy.

I cite one example. A major pharmacy group is working on a hub-and-spoke idea for dispensing prescriptions. The prescriptions arrive at a central pharmacy, either electronically or from an outlying pharmacy where the patient is. That central pharmacy then dispenses under the supervision of a pharmacist. It then sends the medicines to the outlying pharmacy to be handed to the patient by the pharmacist in that shop; in other words, there is no loss of supervision at any stage of the process. But I suggest that it is the pharmacist at the centre who is really acting as the responsible pharmacist within the terms of the Bill.

The point of that idea is to free up time for providing services in the "spoke" pharmacies. The pharmacist at the centre plays a superintending role over the other pharmacies in the cluster, but each of those has a pharmacist in them. That is a variation on the theme of one pharmacist per pharmacy. While I hope no one would take issue with the arrangement from a patient safety perspective, the lines are rather blurred, strictly speaking, as to who the responsible pharmacist in that example actually is. Again, we are dependent on the regulations to see how and in what circumstances the Government are prepared to relax the one pharmacist per pharmacy rule.

The Minister will need to take care not to go faster than the profession wishes to go, but at the same time to leave room for sensible variations within a framework of maintaining patient safety. That is not by any means an easy balance to strike, but I do not believe it is impossible.

My Lords, I recognise the lingering doubts expressed in Committee that have prompted a return to this amendment. I reiterate the firm statement I made in Committee: the general rule should be one responsible pharmacist/one pharmacy. That is our position. However, the noble Earl, Lord Howe, has shown how circumstances can change. People can come up with new ways of operating that are consistent with patient safety but provide better service to them. None of us wants to get in the way of those changes where they can be made to operate. The noble Earl's point about not going faster than the profession wants to go is sensible, and one with which we find it difficult to disagree.

The Government are quite clear on this matter. We think it is important to allow the pharmacist in charge to meet fully his or her statutory responsibility for the safe and effective running of the pharmacy. I do not think that there is any disagreement between us on that. As I have stated before, we expect the vast majority of pharmacies to each have a responsible pharmacist. I also welcome this opportunity to make clear once more that any exception to this general rule will need to meet specified conditions and circumstances set out in regulations for it to be considered on its merits and our intention is that these regulations are tightly drawn. The overall intention of the regulations will be to ensure that the responsible pharmacist fully exercises his or her duty to maintain patient safety in each of the pharmacies for which they are responsible, including supervision of dispensing activities.

We cannot be sure that a requirement to make an exception to the general rule of one responsible pharmacist, one pharmacy will not arise in the future. I am sorry that the noble Baroness did not like my examples. I recognise that there will not be a Glastonbury festival this year, so perhaps the rock festival example may not be one on which I wish to place a lot of weight. However, I come back to my vending machine, even if it is an Australian vending machine. It is quite possible that vending machines will be used in this country in this way. Already, as I said, we can accept that for a pharmacist to be responsible solely for pharmacy premises where a vending machine is located would not necessarily be a sensible way of using a pharmacist's extensive clinical training. If the noble Baroness's amendment were accepted, a vending machine would literally have to have a pharmacist standing by it all the time. That does not seem to us a sensible way to proceed, particularly when people of all shades of opinion recognise that much more use can be made of pharmacists' skills in areas other than the preparation, sale and supply of medicines, important though that is as their core business. Other services were included in the pharmacists' contract negotiations, such as health promotion campaigns, signposting and advice on stopping smoking. Those services are not governed by the Medicines Act. We believe that pharmacists can provide those services and pharmacists believe that they can provide those services for the benefit of patients. That is why it is important to future proof this legislation so that when new ways of working, technological or otherwise, come along, we do not put unnecessary legislative barriers in their way, but use the regulations provided for in the Bill to ensure that patient safety is safeguarded.

Rather than make no provision we believe that it is necessary to allow us the opportunity to consider such circumstances as and when they arise. To return to the vending machine example, if the noble Baroness's amendment were accepted we would limit the pharmacist's capability to do other things and the opportunities for improving the public's access to certain medicines.

I hope that I have made it clear that these regulations will safeguard public safety in looking at any exception to the general rule, while allowing us to take account of future changes so that we do not hamstring existing and future developments in the provision of pharmaceutical services and ways of improving the public's access to medicines. It is important to be clear that there is no long list of exceptions to this rule. Almost by definition this provision allows us to make exceptions. If we had a long list of these exceptions, I would provide them. However, we do not have such a list. That does not seem to me to alter the case that we have some known exceptions, which makes it sensible to make this future-proofing provision in legislation. With those assurances, I hope that the noble Baroness will feel able to withdraw her amendment.

My Lords, I thank the Minister for taking the time to go through the arguments once again. I hope he will accept that I am not in any way against the use of technologies that will enable pharmacists to be more efficient or to take on other roles, but my central point remains that only a pharmacist can be a pharmacist. Other people can carry out other activities, such as giving smoking cessation advice or advice on diet, but pharmacists have absolutely fundamental and central skills, and much of what they do is built on that basic trust. At a time when medicines are becoming much more complex and much more personalised, it seems to me to be potentially harmful to remove the personal relationship between pharmacists and their customers, which has been central both to quality of service and patient safety. I have listened to what the Minister said, and I do not intend to push this to a vote. I will look at the regulations with very great care indeed. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

moved Amendment No. 32:

Page 26, line 12, leave out "qualifications and"

My Lords, in Grand Committee, the Minister explained that it is the Government's intention to consult all interested parties on the content of the regulations that will set out the requirements that a pharmacist must meet in order to take on the responsibilities associated with being in charge of a pharmacy. That was a welcome assurance.

The point I raised then, and which I raise again today through the amendment, relates to the mention in proposed new Section 72A(7)(a) of the qualifications that a pharmacist must have if he is to be a responsible pharmacist. We all understand that pharmacists must be properly qualified. If you wish to practise as a pharmacist in this country, you must be a member of the statutory regulatory body for the profession, which is the Royal Pharmaceutical Society of Great Britain. You are thereby registered with the society and are entitled to use the registered title of pharmacist. Those requirements and entitlements are recognised throughout the European Union, and each member state has its own equivalent and comparable arrangements.

However, in proposed new Section 72A there is a power for Ministers to lay down additional requirements for anyone seeking to become the responsible pharmacist. The Minister explained that in subsection (7)(a) the Government wished to ensure, quite rightly, that the training and experience of such a pharmacist are fit for purpose. The question mark that I raise over the inclusion of the word "qualifications" is that it appears to confer a power on Ministers to stipulate a professional qualification over and above that of being a member of the Royal Pharmaceutical Society of Great Britain. If the Government were to make such a stipulation, the implications would be far-reaching. Is there any intention at present to propose that? If so, the profession certainly needs to know about it. If there is not, I wonder whether there is a need to include the word "qualifications", because clearly no person may be appointed to be a responsible pharmacist unless he or she is already a qualified pharmacist with all that carries with it.

The profession has voiced its concern to me that the qualification necessary to run a retail pharmacy business in this country should be no more nor less than it is elsewhere in Europe. I have sympathy with that view. It would be helpful to hear a little more from the Minister, not about the issue of experience, which is less contentious in this context, but about the specific issue of professional qualifications. I beg to move.

My Lords, being able to specify in regulations the qualifications and experience that a responsible pharmacist must have is an important safeguard. However, I can reassure the noble Earl that when we refer to qualifications we are not thinking in terms of any significant extra formal or academic qualification over and above registration as a pharmacist. As we outlined in the information paper that we published in January 2006, this might mean, for example, that to become a responsible pharmacist, someone has to have been qualified as a registered pharmacist for a number of years and, in the case of a community pharmacy, have experience of working in a registered pharmacy in that setting.

Of course, the UK must, as a matter of European law, recognise the qualifications of pharmacists qualified in other European Community member states. Nothing in this regulation-making power is intended to be inconsistent with that. Indeed, any regulations made under this power which were inconsistent with that would be susceptible to legal challenge.

However, one option that we might wish to pursue, subject to proper consultation with the profession and its interests, might be that the pharmaceutical societies could include on the register of pharmacists an annotation against the names of those pharmacists who have the necessary length of qualification and the appropriate experience in a community pharmacy to take on the role of responsible pharmacist. That would make the position easier and more transparent for pharmacists and pharmacy owners alike. In legal terms, such an annotation could be viewed as a qualification. Therefore, retaining power to make provision about both the qualifications and the experience that a person must have if he is to be a responsible pharmacist would be needed to introduce such an approach through regulations.

We have also made clear our intention—which I repeat today—to consult all interested parties on the development of these regulations. For example, the timing of their introduction, to allow the professional regulatory bodies, pharmacy owners and others to put in place arrangements to enable pharmacists wishing to take on this important role to meet the requirements, is essential. We clearly recognise the need for the pharmacist workforce to be able to meet any such conditions that are set, while maintaining the public's ready access to pharmaceutical services. So, we are well-seized of the need to take the profession with us in this area and we will ensure that it is fully involved in regulations made under this provision.

I hope that I have explained why we feel that the words "qualifications and experience" are appropriate to use in the legislation. We will carefully consider all these issues with interested parties through widespread discussion and consultation in determining what conditions might be set to ensure that a responsible pharmacist is able to meet his or her statutory duties fully and effectively—and to maintain public safety, which is the point behind the legislation. That is the be-all and end-all of what we are trying to do. I hope that that has provided some explanation and reassurance to the noble Earl.

My Lords, I am glad that I tabled the amendment, because that was a helpful reply which contained not only some welcome reassurance, but some valuable clarification of the Government's intentions, which, I am sure, the profession will duly note with appreciation. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 35 [Applications for provision of pharmaceutical services]:

moved Amendment No. 33:

Page 30, line 39, after "applications" insert "(other than proposals based on price or discount)"

My Lords, Clause 35 sets out new provisions governing applications submitted to PCTs for the provision of pharmaceutical services. In Grand Committee, I raised serious concerns about this clause and, I am sorry to say, despite the Minister's comments then and his subsequent letter to me, for which I thank him, those concerns substantially remain.

The Minister has explained that the provisions in new subsection (2B) are intended to cover what one might term a "tie break", where two or more pharmacy applications are considered side by side and are regarded as equally meritorious in the context of the necessary and desirable test. In those circumstances, new subsection (2B) would allow a PCT to take into account a number of other factors, among which would be the availability and price of over-the-counter medicines and other products in each of the pharmacies competing for the approval. My chief worry—it is widely shared in the pharmacy profession—is that this additional criterion carries with it an inherent unfairness, an inherent ambiguity and considerable difficulties for effective monitoring and enforcement.

The Minister was at pains to assure me that the price of OTC medicines was not the main driver of this clause but, rather, one of a number of variable factors that PCTs should consider when choosing between otherwise equal applications. I suggest to him that, in practice, that is not how the process is likely to work. The price of medicines is easy to set and easy to quantify. By contrast, what is referred to as the range of improvements to services will be difficult to define and harder to quantify.

It is true that applicants are to be encouraged to think of innovative ways of providing new services. The trouble is that the more innovative the bids, the more difficult they will be to judge. Larger companies are therefore likely to find that promising a selection of cheaper medicines is much simpler than spending time thinking up new services. Price is therefore likely to become the dominant defining factor in a tie-break and, because of that, pharmacies will be induced into a downward spiral of price reductions that will affect their profits.

If this is not price-fixing, it comes extremely close to it. If retail prices are deliberately manipulated downwards by the NHS, patients will ultimately pay for that. Reductions in profits from OTC sales will have to be recouped somehow or other. They will be recouped either by increasing the prices of non-OTC lines or lines not forming part of the range of improvements, or by reducing other services to patients. Pharmacists have always provided professional services to patients but, ultimately, pharmacy companies are businesses and not charities. Advice and testing, which to the patient may appear to be free, in reality all cost money. That is why the inclusion of the price of medicines in this clause looks set to be self-defeating—in two ways. It will be self-defeating in the bidding process because large price cuts will tend to trump innovative thinking, and it will be self-defeating later because, if those price cuts become a reality, corners will be cut in other areas that are bound to prove unwelcome.

However, before we get even this far, we need to remind ourselves of something rather fundamental. The sale of OTC medicines by pharmacies is, and always has been, completely outside the scope of the NHS contract. The governing regulations do not refer to OTC medicines or to their price. The sale of these medicines and the price at which they are sold are matters that have always been determined by the marketplace. It is a private transaction in which the NHS bears none of the risks. For the NHS to attempt to manipulate a market in which it has no locus is, in my view, objectionable and wrong in principle.

Aside from the principle, the practical difficulties for the NHS in its monitoring role will be considerable. I wonder whether the Department of Health fully appreciates the extent to which the pricing of OTC medicines varies, particularly for seasonal products. Supplies can vary from week to week, depending on factors such as the weather, promotions or factory constraints. Once a product is out of stock, it can be some time before it comes back into stock, as most products are produced in batches rather than in continuous production. Ranging and pricing decisions within pharmacies are complex and change continually.

Against that background, how does one monitor whether a pharmacy is adhering to the terms of its original bid? How is performance to be measured? PCTs will struggle to keep up with what is happening. If they do not keep up, one has to ask the point of such a regulation. Indeed, to make any fist of monitoring pricing agreements, PCTs will have to contact pharmacies at least monthly for the relevant information. At the moment, the monitoring of pharmacies by PCTs relies on annual visits, so the regulatory burden on both parties looks set to increase quite a lot. Alternatively, we may have a situation in which lower prices are offered only at the time of the annual PCT visit. Pharmacies know when a visit is to be undertaken because PCTs have to give notice.

I wonder how much of that has been thought through. The detail of how monitoring and enforcement might work is distinctly lacking. When one tries to think it through, it is hard to know how it could be accomplished fairly. If unfairness is perceived, one thing is certain: those who have lost out in the bidding process will challenge PCTs, very probably through the courts.

No such difficulties arise when only the provision of services determines the outcome of a tie-break. Pharmacies are not in the least frightened of having to bid on the basis of enhanced services. Not only is that a more reasonable basis for a decision, because it relates to the pharmacy contract, but it is also much easier to monitor. Either a service is being provided to the agreed standard or it is not. The Minister has argued that smaller providers will not be significantly disadvantaged by the provision, but I beg to differ. The smaller providers will find it hard to compete on price. Yes, they may have access to wholesale buying groups, but those are not the same as vertically integrated supplier chains, where costs can be more easily stripped out. Yet we all know that usually it is the smaller suppliers who have the kind of local knowledge that may serve to identify the right range of pharmacy services for a local area and they could well end up doing a better job than some of the bigger providers.

I have not been convinced by the rather generalised reasoning deployed by the Minister up to now. I do not feel that he has addressed the concerns that I outlined in Grand Committee or just now. No one argues against the need for a better way to resolve tie-breaks than at the moment and I do not believe anyone seriously argues that a focus on enhanced services is not a reasonable way to proceed. I urge the Minister to rethink the wisdom of allowing medicines' prices to enter the equation. In my view, that is not the right way to go. I beg to move.

My Lords, we support the amendment of the noble Earl, Lord Howe, for all the reasons that he has set out. If this provision goes ahead, I too feel that, inevitably, there will be a slant in favour of the big providers and away from the small, community-based pharmacies or sole traders. They simply cannot compete on the basis of the price on the general sales list. We all know how supermarkets, even those without a pharmacy, have moved into the pharmacy business because they can already sell general sales list products. They therefore get the bulk discounts.

The noble Earl, Lord Howe, has come up with an elegant solution to the problem which he and I identified in Grand Committee. I hope that the Minister will be sympathetic to it.

My Lords, before I deploy my argument, I have a terrible feeling that I may not convince the noble Earl. However, I will attempt to go through this in a bit more detail, in the hope that I can persuade him that we are behaving reasonably.

When determining chemist applications to provide NHS pharmaceutical services, legislation means that primary care trusts cannot take into account any additional services that the chemist might offer. The Government committed to changing this as part of their balanced package of measures responding to the Office of Fair Trading's report into retail pharmacies. That is how we came into this issue.

Until recently, NHS pharmaceutical services, as defined under the National Health Service Act 1977, primarily comprised the supply of drugs, medicines and listed appliances. It is important to hang on to the fact that we are changing the range of services which can be taken into account in the kind of situations under discussion. However, with the introduction of the new contractual framework for NHS community pharmacies in April 2005, pharmacists are required to provide other essential services, such as promoting healthy lifestyles and support for self-care, linked to the dispensing of medicines. It is an additional range, but, inevitably, some of that continues to be linked to the dispensing of medicines. These new changes aim to improve choice and convenience for patients and help reduce reliance on NHS services.

Sales of over-the-counter medicines and other related healthcare products have been estimated to account for 10 per cent of a typical pharmacy's turnover, compared with 80 per cent derived from NHS prescription business. Important though over-the-counter medicines are, they are a relatively small proportion of the turnover of the business in this context. Although I accept that the range of medicines available over the counter is being significantly extended—so one would possibly expect that balance to change—it is still a relatively small proportion of the total income of a typical pharmacy's turnover. Such sales are, of course, private transactions and, as such, do not come under the requirements for pharmaceutical services under the NHS Act. Nevertheless, as services, they are closely related to other services we are interested in, particularly the requirement on pharmacies to support patient self-care as an essential NHS service.

I fully accept that over-the-counter medicines are an important part of helping patients to take more responsibility for self-care. I am not dismissing their role, but putting it into context: they are a relatively small proportion of the total turnover.

We therefore consulted further on this complex issue last summer, on the proposal to enable primary care trusts to consider, in their assessment of chemist applications, what improvements they could bring to the provision of, or access to, over-the-counter medicines and other healthcare products. Expanding consideration in this way would, for the first time, capture this aspect of a chemist's activity within the primary care trust's overall assessment of chemist applications.

Appropriately in Wimbledon week, the noble Earl talked about tie-breaks. I emphasise that this new provision will come into play only where a primary care trust is assessing two or more applications together. They must all pass the "necessary or desirable" test, but it would not be necessary or desirable to grant them all. This will occur in a competitive situation when applications take place at the same time.

This amendment would enable primary care trusts to consider only the range of over-the-counter medicines and other healthcare products each applicant sells and the advice it gives. As I understand the noble Earl, his point was that it would remove the ability of primary care trusts to consider price or discounts. I stress that our proposal is not simply about cheaper or cut-price medicines and that primary care trusts' considerations in these matters will not be solely financial, for the reasons I have given. While price can obviously be a factor, it is not, nor will it be, the primary determining factor. Our proposal goes much wider. It centres on improvements in access to a wide range of health-related products, including medicines, and the support and advice available to the patient to go with that supply. The primary care trust will take account of that wider range of considerations in deciding between rival applications.

Our proposal is not about comparing the discounts that companies can gain from wholesalers but about trying to get the best range of services available to patients in a particular set of circumstances. With consultees' indication that discounts would also be open to smaller pharmacies through access to larger wholesale-buying groups, it is about patients' access to over-the-counter medicines and healthcare products—and access also means affordability. We cannot get away from the fact that the price of a product has some impact on its affordability and its accessibility to patients. Primary care trusts therefore need to be able to take into account prices of products when assessing applications. I again emphasise that a wide range of considerations will be made, not just the price of over-the-counter medicines, and that that consideration will happen in the limited set of circumstances when rival applications are being determined at the same time.

I do not accept the noble Earl's essential point that the price of over-the-counter medicines will be a dominating factor. He is implying that that will skew the decisions. Price is just one factor, not necessarily the main one, in determining which application a PCT will accept. It is worth putting on the record that the National Assembly for Wales, while it did not accept the recommendations in the Office of Fair Trading report and has not introduced the regulatory reforms now in place in England, has decided to implement this proposal for NHS pharmaceutical services. The clause therefore contains an equivalent provision for Wales.

I am still slightly unclear whether the noble Earl is on the side of a free and open market, in which case the PCT's ability to take price into account is surely important, or whether he is concerned about patients, in which case price remains important but should not be the only factor. I say that price is one factor among many others. We think that our clause strikes the balance between price, which is good for patients, and wider support services, which are also good for patients. It is a balanced judgment, and we think our proposal is balanced. I hope that I have given some comfort to the noble Earl and the noble Baroness, Lady Barker.

My Lords, I am grateful to the Minister for his reply. I appreciate his efforts to set out the Government's thinking in this area. I am disappointed that he is not persuaded by my argument.

The noble Lord is right that, in many cases, over-the-counter medicines form a relatively small element of a typical pharmacy's turnover, but they can make a critical difference to the viability of a business. That is the concern of many pharmacies. He is right that accessibility is important, as, indeed, is affordability, but OTC medicines are commonly thought of as a distress purchase. They are not, in general, price sensitive.

I do not feel that the Minister dealt properly with one or two of the points that I tried to make; notably, that it is improperly intrusive for the NHS to seek to manipulate prices of goods in a private market, outside its own jurisdiction. I am not sure how this process will be made sufficiently fair and transparent to avoid lengthy and costly challenges. Equally, I do not think that the Minister convinced me on the difficulty of monitoring retail prices against the terms of a winning bid. I see huge scope for problems in trying to do that fairly. Nor did I feel that he dealt satisfactory with the weak position of the smaller supplier relative to the much stronger commercial muscle enjoyed by supermarket chains. So I am still not convinced and I am still concerned.

However, I do not think that much purpose would be served by dividing the House on such an issue. If the Government are firm in their view, perhaps they will agree after a suitable period to review how the clause is implemented in practice. I shall not suggest to the Minister what that interval should be—he might think a couple of years. At that stage, consultation with interested parties would show whether there are problems of the kind that I have envisaged. Will the Minister agree to look at this idea before Third Reading and write to me about it?

My Lords, I am willing to do that. It always makes a lot of sense to test how new changes have worked in practice. The noble Earl's idea is a good one, and I am happy to consider it and write to him and other noble Lords.

My Lords, I am grateful to the Minister for that assurance. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 38 [General ophthalmic services contracts]:

moved Amendment No. 33A:

Page 35, line 35, at end insert—

"(6) Before making regulations under sections 28WA to 28WE, the Secretary of State shall consult such persons or organisations as appear to him to be representative of persons providing ophthalmic services."

My Lords, in Grand Committee we had a series of short but very useful debates on the ophthalmic clauses in the Bill, following on from the equally useful debates conducted in another place. It is extremely helpful and reassuring to have had explicit statements from the Government about the importance of eye health, particularly for vulnerable groups such as children and older people. It is important to have on the record the Minister's commitment that the NHS sight test fee will remain centrally funded and negotiated, that it will not be constrained by local budgets and that patients will continue to have access to the provider of their choice. All this matters very much. There were worries that some contractors might be excluded from the GOS through no fault of their own. Those worries have been successfully dispelled by the Minister's assurance that contractors that meet national criteria will continue to be entitled to a GOS contract.

All this is very positive. The simple point I want to raise through the amendment is that the GOS review presents a major opportunity to improve eye care and eye health for the whole population. I very much hope that the Government will use this opportunity to listen to and work with the profession.

Wisely, the Government have listened to the profession about why the current eyecare system has been a national success, and, as a result, the GOS system is to continue. To build on that success and to improve services even further, it is vital for the Government and the profession to work side-by-side to examine the issues constructively and in detail. The GOS review must be thorough and open. I hope that the Minister can reassure me that openness and thoroughness will indeed characterise the forthcoming review. I beg to move.

My Lords, I do not think that there is any issue between me and the noble Earl. We are committed to consultation on the regulations and I am happy to make the commitment that there will be full consultation on regulations on general ophthalmic services contracts with representatives of providers of ophthalmic services. We do not think it necessary for that to be in the Bill. That has not been previous practice and such a requirement is not in primary legislation for current general ophthalmic services, nor for medicine, dentistry or pharmacy. We see no reason why it should be necessary in this case. However, I emphasise that we will have full consultation with the profession on the regulations before they are made.

It is important also to make the point that we intend to consult other bodies on certain contractual issues. For example, in relation to exclusion from holding a contract, we would consult with the Counter Fraud and Security Management Service, as one reason for exclusion is likely to be a history of fraud. So there will be a wider range of people whom we want to consult. However, that does not diminish in any way our firm commitment, which I am happy to repeat, that we will have full consultation on the regulations. We think it unnecessary to provide for that in the Bill. I hope that that gives the noble Earl the reassurance for which he was looking.

My Lords, once again, I thank the Minister. That does give me a great deal of reassurance. I thank him for what he has said and I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 49 [Code of practice relating to delegated functions]:

moved Amendment No. 34:

Page 44, line 4, after "to" insert—

"(a) "

My Lords, the amendments in this group all relate to the disclosure of information obtained through the use of the powers set out in this part. Clause 49 gives the Secretary of State and the National Assembly for Wales the power to produce a code of practice that will clearly detail the rights and responsibilities of those exercising the power and those subject to it, to ensure that the powers are used appropriately.

Amendments Nos. 34 and 35 will ensure that we can make provision in the code of practice about the procedures that authorised officers disclosing information under Clause 50 must follow, specifically where requests are made to disclose information that identifies individuals.

It is intended that most disclosures will be made with the consent of the relevant individual. Where that is not the case, the authorised officer will be obliged under the code to consider whether the information can be disclosed in an anonymised form. It is expected that the majority of disclosures under the powers will be made in such a way that individuals cannot be identified.

Clause 50 outlines the circumstances in which information obtained using the powers set out in this part can be disclosed by, or on behalf of, the appropriate national authority. Information obtained by the use of the powers must not be disclosed unless it is required for the specific conditions set out in the Bill, or the patient has given their consent. Amendment No. 36 to subsection (3) is intended to ensure that disclosure can also be made in accordance with an order of a tribunal as well as a court as currently drafted.

Amendment No. 37 to subsection (5) further restricts the onward use or further disclosure of information disclosed under Clause 50(3), so that information disclosed under Clause 50(3) must not be used or further disclosed by any other person except under the conditions in this subsection. If information is incorrectly disclosed, the person could be committing a criminal offence as outlined in Clause 53. Under the provision, the restriction on the use or further disclosure of the information applies only to the person to whom the information is disclosed. Clause 51 requires that certain information obtained from personal records be classified as protected information for the purposes of disclosure for proceedings. This is required if the identity of the individual can be ascertained from the information itself, or if the discloser has reasonable cause to believe that this information, taken with other information obtained and disclosed in accordance with these clauses, could reveal an individual's identity.

Amendment No. 38 replaces the previous clause and seeks to ensure that the provision on protected information applies to civil and relevant disciplinary proceedings and is not limited to criminal proceedings. Under Section 51(2), the discloser of protected information must take all reasonable steps to ensure that all protected information is disclosed only to someone to whom it is necessary to disclose it in conjunction with the proceedings. Under the code of practice, an obligation will be imposed on the discloser to mark the information as protected. Protected information cannot be disclosed in evidence unless the proceedings are wholly in private or the court or tribunal, in which the proceedings may be partly or wholly in public, has given its permission. The court or tribunal may agree to this if it is satisfied that it is in the interests of justice that the information is disclosed. In considering such an application, the court or tribunal must also consider whether, in the interests of the individual concerned, the hearing ought to be wholly or partly in private. The court can grant permission on such terms as it thinks fit. The protected information need not be disclosed in its original form; for example, the court may agree that sensitive details requiring protection should be blocked out—known as redact—or that documents can be summarised.

Clause 53 provides offences relating to the disclosure or use of information obtained by the use of these powers. Amendment No. 39 is a consequential amendment designed to ensure that the correct subsection of the amended Clause 51 retains the offence previously drafted. I am grateful to the noble Earl, Lord Howe, for his amendment which was tabled in Grand Committee and which was aimed at tightening the safeguards around the disclosure of personal information so that information is not disclosed to any person to whom it is not necessary to disclose it. That amendment gave us pause for thought, and this package of amendments aims to respond as robustly as possible to this important issue. I beg to move.

My Lords, I thank the Minister for these amendments and for his helpful reassurances, which pick up a number of points and concerns about patient confidentiality that we debated in Grand Committee.

On Question, amendment agreed to.

moved Amendment No. 35:

Page 44, line 6, at end insert—

"(b) procedures to be followed in relation to the disclosure (in accordance with sections 50 and (Protection of personal information disclosed for purposes of proceedings)) of information obtained by or on behalf of a Special Health Authority in the exercise of such functions."

On Question, amendment agreed to.

Clause 50 [Disclosure of information]:

moved Amendments Nos. 36 and 37:

Page 45, line 5, at end insert "or tribunal"

Page 45, line 19, leave out from "disclosed" to end of line 24 and insert "except—

(a) for a purpose connected with the functions, investigation or proceedings for the purposes of which it was so disclosed, or

(b) in accordance with an enactment or order of a court or tribunal."

On Question, amendments agreed to.

Clause 51 [Special protection for personal records]:

moved Amendment No. 38:

Leave out Clause 51 and insert the following new Clause—

"PROTECTION OF PERSONAL INFORMATION DISCLOSED FOR PURPOSES OF PROCEEDINGS

(1) Information obtained from personal records produced in compliance with a notice under section 46 is "protected information" for the purposes of this section if—

(a) a person ("the discloser"), in accordance with section 50(3), discloses the information for the purposes of any proceedings, and

(b) either—

(i) the identity of the individual in question can be ascertained from the information itself, or

(ii) the discloser has reasonable cause to believe that it will be possible for a person who obtains the information as a direct or indirect consequence of the disclosure to ascertain the individual's identity from that information taken with other information obtained by virtue of section 46 or 47 and disclosed by or on behalf of the appropriate national authority.

(2) The discloser must take all reasonable steps to ensure that, once disclosed by him in accordance with section 50(3), the protected information is not further disclosed to any person who is not someone to whom it is necessary to disclose the information for any purpose connected with the proceedings mentioned in subsection (1)(a).

(3) In subsection (2) the reference to further disclosure of the information does not include any such disclosure—

(a) by way of evidence in any proceedings, or

(b) in accordance with an enactment or order of a court or tribunal.

(4) The appropriate national authority must make provision, whether in a code of practice issued under section 49 or otherwise, for requiring any person disclosing protected information in accordance with section 50(3) to ensure, by the use of a distinguishing mark or in some other way, that the information is clearly identified as protected information for the purposes of this section.

(5) Information that appears to be protected information must not be disclosed by way of evidence in any proceedings unless—

(a) the whole of the proceedings are held in private, or

(b) in any other case, the information is disclosed in accordance with permission given by the court or tribunal on an application under subsection (6).

(6) If, on an application by a party to—

(a) proceedings before a court, or

(b) proceedings of any description before a tribunal that sits, or may sit, in public during the whole or part of proceedings of that description, the court or tribunal is satisfied that it is in the interests of justice for any information that appears to be protected information to be disclosed by way of evidence in the proceedings, it may give permission for the information to be so disclosed, on such terms as it thinks fit.

(7) When determining such an application, the court or tribunal must consider whether, in the interests of protecting the identity of the individual to whom the information relates, the whole or part of the proceedings should be held in private.

(8) If the court or tribunal is satisfied that the whole or part of the proceedings should be held in private, it must give such directions, or take such other steps, as appear to it to be appropriate.

(9) In this section "proceedings" means—

(a) criminal or civil proceedings, or

(b) relevant disciplinary proceedings (as defined by section 50(4))."

On Question, amendment agreed to.

Clause 53 [Offences relating to disclosure or use of information]:

moved Amendment No. 39:

Page 46, line 36, leave out "51(3)" and insert "(Protection of personal information disclosed for purposes of proceedings)(2)"

On Question, amendment agreed to.

Schedule 4 [The Appointments Commission: supplementary]:

moved Amendment No. 40:

Page 75, line 34, after "may" insert—

"(a) prescribe conditions which must be satisfied in relation to persons before they are appointed as health and social care commissioners;

(b) make provision as to the circumstances in which persons are disqualified for being health and social care commissioners;

(c) "

My Lords, Government amendments Nos. 40 and 41 are minor amendments to allow those appointed to the Health and Social Care Appointments Committee to be treated in the same way as the non-executive members of the appointments commission. Schedule 4 provides for regulations prescribing the conditions and disqualifications that apply to the non-executive members of the commission. These regulations may also make provision for the terms on which non-executive members are appointed. Similar provision has also been made for regulations to make provision for the terms on which the health and social care commissioners are appointed. However, the power to make regulations prescribing conditions and disqualifications has not been replicated.

At least one, and up to four, of the health and social care commissioners must also be appointed as a non-executive member. Under the terms of the Bill as currently drafted, therefore, it would be possible to prescribe the conditions and disqualifications that applied to those commissioners who were non-executives but not to the remaining commissioners. These amendments therefore allow conditions and disqualifications to be applied to all the health and social care commissioners. Government Amendments Nos. 42, 43, 47 and 48 are purely drafting technical amendments. I beg to move.

On Question, amendment agreed to.

moved Amendments Nos. 41 and 42:

Page 75, line 36, leave out "regulations may in particular make" and insert "provision that may be made in relation to the health and social care commissioners under sub-paragraph (5)(c) includes, in particular, "

Page 77, line 15, leave out "NHS bodies other than Special Health Authorities" and insert "Strategic Health Authorities, Primary Care Trusts or NHS trusts"

On Question, amendments agreed to.

Clause 71 [Interpretation]:

moved Amendment No. 43:

Page 55, leave out line 18.

On Question, amendment agreed to.

moved Amendment No. 44:

After Clause 73, insert the following new clause—

"PRESCRIPTIONS: LABELLING SHOWING ACTUAL COST

(1) The National Health Service (Charges for Drugs and Appliances) Regulations 2000 (S.I. 2000/620) are amended as follows.

(2) After regulation 11 insert—

"11A PRESCRIPTIONS: LABELLING SHOWING ACTUAL COST

(1) The packaging of any drugs or appliances supplied in accordance with regulations 3 to 6A shall carry a label showing the full retail cost of those drugs or appliances.

(2) Paragraph (1) applies irrespective of whether—

(a) there is an exemption from charging under regulation 7 or 7A, or

(b) a valid exemption certificate under regulation 8 is in force.""

My Lords, first, I should like to apologise to the Minister and the House for not moving this amendment and my next amendment in Grand Committee. It was due to a long-standing family commitment. For many years, I have thought that it is important for patients to realise what good value they are getting when they get a prescription over the counter. This amendment is wonderfully simple and will cost absolutely nothing. All the pharmacist will have to do is press an extra button on the computer, which will give the complete value of the medicine being dispensed.

I also believe strongly that if the true value was on the face of a prescribed medicine, it would encourage people to finish their drugs. I am sure that the Minister is aware that an enormous number of drugs simply do not get finished. That often means that a patient will have to return to the doctor, say, two or three months later to have a repeat prescription. It is also important for patients to realise the incredible value for money they are getting. I have had quite a postbag on this amendment. Indeed, in some countries, when people are discharged from hospital they are given a bill which says how much it technically would have cost—that is, the cost of the theatre and their stay in hospital, and the anaesthetist's and surgeon's charges. I do not suggest that we should do that as it would be fairly bureaucratic and would indeed cost money. The joy and ease of this amendment is that it would cost nothing and would be simple to put into operation. I beg to move.

My Lords, the noble Lord, Lord Palmer, has made an extremely powerful case with which I find myself immediately in sympathy. It is one of life's truths that what we do not have to pay for we do not value. We have all benefited during our lives from the National Health Service. I am quite sure that we have all appreciated the treatment that we have received. But the noble Lord is right: we would appreciate it all the more if only we were made aware of the cost of the treatment for which the taxpayer was picking up the bill.

Many people would be shocked if they knew what their medicines cost. Some drugs, as the noble Lord mentioned, are expensive in most people's terms. However, some drugs cost less than the prescription charge. It would undoubtedly benefit us all if patients of the NHS were to be more cost conscious. Like the noble Lord, I strongly suspect that there would be far less wastage and far greater rates of compliance. I am told that 50 per cent of prescribed medicines are never taken, which is a huge rate of wastage. I should be most interested to hear what the Minister has to say in response to the noble Lord's very cogent arguments.

My Lords, I have added my name to this amendment because, like my noble friend Lord Palmer, I believe that waste and over-prescribing in the NHS are a tragedy that diverts funds from urgently needed medical care. I refer in particular to those medicines which have a short shelf life, or which are dangerous if taken for more than, say, 10, 14 or 21 days. An example of those would be steroid formulations. The latter are normally dispensed in excessively large tubes or other containers so that up to 90 per cent goes to waste. If over a reasonable period of time enough patients were made aware of this, surely pressure could be brought to bear on the manufacturers to dispense their products in more realistically sized containers.

My Lords, I certainly agree with the noble Lord, Lord Palmer, that patients should be as well informed as possible about the NHS services they receive to enable them to make informed decisions about their treatment. Making them aware of the cost of their prescription medicines would probably contribute to that and might reduce waste if patients are less inclined to order repeat prescriptions that are not required. However, while I am sympathetic to some of the underlying arguments behind the new clause, I have to say to the noble Lord that life is not quite as simple as he suggests and that there would be a number of practical problems, which mean that I am unable to support it.

First, changes to primary legislation are not required in order to effect the change the noble Lord intends here. The amendment would enshrine a regulatory change in primary legislation with no flexibility to amend the regulation by secondary legislation if that were required in the future. That is of particular concern because the effect of this measure on patients is as yet unknown. It may, for example, discourage some from taking their medication—a particular risk among elderly patients, I should think. Further, we may find that providing information on the label may not be the most appropriate way to identify the cost to a patient.

Secondly, the scope of this amendment means that it would affect many more areas of the NHS than just prescriptions dispensed by a pharmacy or a dispensing doctor in primary care. It would affect, for example, prescriptions dispensed by appliance contractors and out-of-hours service providers, prescriptions dispensed to hospital outpatients, treatments from walk-in centres, as well as those resulting from patient group directions. So it would range widely over a varied set of circumstances relating to patients. This would add to the complexity and cost of implementing such an arrangement.

I have to say to the noble Lord that this is not a cost-free option. All dispensing contractors and suppliers of medicines would need to have mechanisms in place to establish a price and to label their medicines appropriately. In most cases this would mean upgrading their computer software to print prices on dispensing labels, and computer pricing databases would need to be kept up to date. It is also expected, especially to begin with, that patients would ask about the price indicated on the label. Given that, I think that I have said enough to suggest that simply pressing a button would not be the way one could introduce this measure. I have further arguments along these lines but I will not delight the noble Lord with them. However, I am happy to give him a fuller set of arguments.

Lastly, I want to point out that what is meant by the "full retail cost" is not clear. While suppliers publish a list price for a product, that is not necessarily the cost to the NHS of supplying it to the patient. The cost of supplying a product to the patient from a dispensing contractor, for example, would need to take into account any service fee provided to the contractor, along with any discount arrangements and additional expenses that may be claimed. Dispensers would not be in a position to know all these details, so further practical problems would arise in that area.

On balance, I believe that the amendment should be rejected because of its legislative inflexibility, the risk that it may discourage some patients from taking vital medicines, and the very considerable practical problems and costs which it would create. I am sorry to disappoint the noble Lord in that response, but life is just a bit more complicated than he may have thought when he tabled the amendment.

My Lords, I am, naturally, extremely disappointed. After the noble Baroness, Lady Royall, and I had conversed in the Corridor about this, I thought that the amendment would meet with a certain amount of government acceptance. I shall read very carefully exactly what the Minister said. With the greatest possible respect, I think there was rather a lot of civil servant jargon in his reply and it was rather difficult to understand exactly what he was trying to get at.

Before I withdraw the amendment, perhaps I may ask the Minister whether he will be kind enough to spare me 10 minutes in his office before we come to Third Reading because I should like to explore this matter in a little more depth.

My Lords, I shall have to consult my diary. I am always delighted to meet Members of the House on all kinds of issues. I think the noble Lord does me a disservice in saying that I am just trotting out the Civil Service brief. There are some very serious practical problems involved in this and he needs to understand them. I am happy to write to the noble Lord to see whether I can convince him, but this matter is certainly not as straightforward as he thinks in terms of implementation.

My Lords, I apologise most sincerely if I paid a disservice to the Minister because he knows that I hold him in high regard. I look forward very much to receiving perhaps the briefest outline of what he was trying to convince me. In the mean time, I beg leave to withdraw the amendment.

Amendment, by leave withdrawn.

moved Amendment No. 45:

After Clause 75, insert the following new clause—

"TAX RELIEF ON PREMIUMS FOR MEDICAL INSURANCE

(1) Where an individual makes a payment in respect of a premium under a contract of private medical insurance, it shall be deducted from or set off against his income for the year of assessment in which it is made for the purposes of calculating his liability to income tax.

(2) In this section—

(a) a premium, in relation to a contract of insurance, is any amount payable under the contract to the insurer,

(b) a contract is a contract of private medical insurance where—

(i) it either provides indemnity in respect of all or any of the costs of all or any of the treatments, medical services and other matters for the time being specified in regulations made by the Secretary of State, or in addition to providing indemnity of that description provides cash benefits falling within rules for the time being so specified,

(ii) it does not confer any right other than such a right as is mentioned in sub-paragraph (i) above, and

(iii) the premium under the contract is reasonable."

My Lords, I accept that this amendment is perhaps a little more controversial. The madness behind this thinking is that if more people were able to take out private medical insurance, this would in theory reduce the waiting lists in the National Health Service. I know from my own experience, despite the fact that I have mega claims every year—or, at least, I have done in the past—that my private medical insurance is one of the highest expenditures I have in the whole year.

One must not forget that the general public spent nearly £7 billion on private healthcare in 2003, which was literally four times less than it was 10 years ago. I accept that this is controversial and, of course, a Treasury matter—I dare say the Minister will not be able to give me much joy—but, none the less, I thought it was worth airing because I am sure that at the end of the day it would reduce the time that people have to wait for care under the National Health Service. I beg to move.

My Lords, I notice that the Conservative Front Bench did not rise to support this amendment.

I can reassure the noble Lord, Lord Palmer, that the Civil Service did not have to write any speech for me on this issue. This is clearly not the Government's policy. Such a subsidy for private medical insurance would be ineffective, inequitable and inefficient. The Government abolished tax relief on private medical insurance for the over-60s in 1997. The Institute for Fiscal Studies found that the tax relief introduced in the 1990s failed to generate increased demand for private health insurance. Other industry commentators have supported this conclusion. Introducing some form of tax relief or other subsidy for those who use the private sector would definitely conflict with the Government's belief that the best way to use resources and provide healthcare is through a tax-funded health service which is free at the point of use. This is where the Government will continue to focus their healthcare spending.

Furthermore—this is absolutely critical and the noble Lord needs to reflect on it—tax relief for private medical insurance would be inefficient as it would cost £1 billion in tax relief just for those who already have private health insurance. It is a dead weight cost. That is the equivalent of losing 15,000 GPs, 35,000 nurses or eight hospitals. In the unlikely event that it generated extra demand for private health insurance, it would also risk drawing skilled doctors and nurses away from the NHS to the private sector.

I think I have said enough to convince the House that the Government are wildly unenthusiastic about this amendment. I was rather hoping that we could have more sport through noble Lords on the Conservative Front Bench standing up and supporting this way of spending £1 billion.

My Lords, as the Minister mentioned a moment ago, what with Wimbledon fortnight, I am sorry that the Opposition Front Bench has not been more supportive of this amendment, but I understand why. I thank the Minister for his clear thinking on it and I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 79 [Orders and regulations]:

moved Amendment No. 46:

Page 60, line 41, after "section" insert "2,"

My Lords, at first glance, this may seem like a purely technical and perhaps even trivial amendment. It is nothing of the sort. If it is agreed, it has the potential, first, to save the livelihood of a number of licensees who may be struggling financially, perhaps because they are sited in out-of-the-way locations and, secondly, to make all the difference to the comfort and well being of those 45 per cent of pub customers who enjoy a pipe, cigar or cigarette with their pint.

The amendment effectively relates to the question of what constitutes "substantially enclosed", which are places where, if the Bill remains unamended, smoking will no longer be permitted. When this issue was raised in Grand Committee, the Minister argued that the precise definition of "substantially enclosed" would be highly technical and accordingly best left to the negative resolution procedure—in contrast, let it be noted, to all the other proposed regulations in the Bill. However, he then revealed that the revised regulations—revised since last summer—that the Government had in mind for England were not at all complex or technical, but very simple and straightforward. They state that at least 50 per cent of the wall area of any room or other space to be exempted from the smoking ban would have to be open to the wind and rain. That applies to England only. The Welsh, through the medium of the Welsh Assembly, will be allowed to decide on their own formula. They could resolve that only 20 per cent to 25 per cent of the wall area needs to be open, or at the other extreme, that 70 per cent to 75 per cent of the perimeter wall must be exposed to the elements.

We must concern ourselves this evening solely with England. We—by which I include the noble Baroness, Lady Boothroyd, who strongly supports the amendment and would have added her name to it had she been able to be present—submit that it is not necessary to declare that as much as 50 per cent of wall space must be open to the elements in order to protect employees. We should remember that, as it stands, the Bill will bite even where there are no employees. For example, it will hit a small partnership or even a husband and wife team, where both parties enjoy a cigarette equally. The Bill insists that they be protected from one another even if they have no wish to be so protected.

The Government will no doubt argue that having 50 per cent of wall space open to the elements is unlikely to cause a problem on most summer days and on many late spring and early autumn days as well. I would not disagree. However, the winter months will be absolute hell—if hell can embrace being half frozen to death. High-level radiant heaters can help on a cold, still day when there is no wind or rain, but we do not get many such days in our Atlantic climate.

The problem is that this is a Henry VIII clause. I can well imagine the caustic comments that our late good friend Jack Simon, Lord Simon of Glaisdale, would have delivered had he still been with us. Henry VIII clauses deserve the closest parliamentary scrutiny. Giving both Houses more indirect input into the final regulations via the affirmative procedure would not necessarily result in a more equitable solution but it could, whereas the negative procedure would rule out any chance of effective parliamentary pressure.

I hope that the Government will reconsider and accept this amendment, not least because it will rectify an anomaly, in that all the other regulations proposed in the Bill, many of relatively minor importance compared to this one, are subject to the affirmative procedure. If, sadly, they do not feel able to, I hope that the official Opposition will. For many years now, the Conservative logo has been the torch of freedom—or that is what I interpret it to be. One has read that the present leadership considers that logo to be out of date and is considering replacing it. I trust that that is not indicative of any weakening of enthusiasm for individual rights and freedoms—in particular, the individual rights and freedoms of unfashionable minorities. If the Government hold firm, I hope that the Opposition will join us in the Division Lobby. I beg to move.

My Lords, I support this amendment on the basis of the arguments that have just been advanced by the noble Lord, Lord Monson, and the arguments advanced during the long debates in Grand Committee. The impositions on smokers and on publicans and restaurateurs are very severe. The Minister will remember that throughout Grand Committee those of us who opposed these provisions stated time and again that there was a better solution to what was being proposed—that is, the separation of smokers from non-smokers. That issue still rankles and is still being argued out even now. To suggest that the regulations that will state what is enclosed and not enclosed should be agreed by negative resolution adds insult to injury. It is important and necessary that when these regulations come before this House and the other place we have a good debate under affirmative procedure rather than having to pray against the regulations which are put before us.

The Government are increasingly using Henry VIII clauses, which I believe is altogether reprehensible. In a matter of this sort, when individual freedoms are not just under threat but going to be lost, the least the Minister could do is to say that under all those circumstances the regulations will be brought forward in an affirmative order, rather than us having to pray against an order, so that Parliament, this House and another place are well aware of the seriousness of the regulations, can debate them properly and—if necessary, in this place—vote against them.

My Lords, I assure the noble Lord, Lord Monson, that the commitment to liberty and individual rights in the party which I have the honour to represent is no less strong now than it has always been. However, I am not sure whether voting for or against this amendment should be seen as a particularly good bellwether of that political stance. I should have thought that what matters most in this context is the early publication of the Government's intentions on the definitions. We shall debate that issue in a moment or two.

My Lords, we have extensively discussed the issue of the definition of "enclosed spaces" before, both in Committee and on Report. I do not intend to go over those issues again. The noble Lords, Lord Monson and Lord Stoddart, have regularly invoked poor old Henry VIII, who I often think is a slightly misunderstood man. They say this is a Henry VIII clause. As I understand it, such clauses allow you to amend primary legislation through secondary legislation. These provisions do not do that, and I am not aware of any Henry VIII powers in Part 1 of Chapter 1 of the Bill.

The Government have accepted that a significant number of regulation-making powers should be subject to the affirmative resolution, and they are set out in Clause 79 of the Bill. The noble Lord, Lord Monson, tried to tempt me at an earlier stage into giving him advance notice of what the Government's reaction to this amendment was likely to be, and I succumbed. I will not disappoint him. I have already indicated our lack of sympathy for this amendment.

I reassure noble Lords that the Government will undertake a full consultation on the draft regulations to be made under this Bill. The definitions in the regulations covered by this amendment will be part of that consultation. I have made it clear that we intend to follow the definitions in this area in Scotland's smoke-free legislation. I assert again that definitions of "enclosed" and "substantially enclosed" will be technical in nature, and it is usual for such technical regulations to be subject to the negative resolution procedure. That is not just my view; I remind the House again that the Delegated Powers and Regulatory Reform Committee were content with that approach. I also have some sympathy with the noble Earl, Lord Howe, that this is not likely to be the bellwether issue on freedom and liberty in this country.

My Lords, I am grateful to all the noble Lords who have contributed to this short debate. I shall take the Minister up on one point. He said that a significant number of regulations in the Bill will be subject to the affirmative procedure. Actually, they all will, with the exception of this one. As I said earlier, if this amendment is agreed to it will be correcting an anomaly. I am sorry the Government have not budged. They have not budged very much at all in our proceedings on this Bill. There have been a couple of minor concessions, but nothing to write home about.

It is not just because I have had a nightmare journey getting here due to the King's Cross fire, but because I am convinced that this amendment, if it is passed, has the potential to benefit to a significant degree a large number of perfectly respectable, law-abiding people who will otherwise lose out, that I wish to test the opinion of the House.

On Question, Whether the said amendment (No. 46) shall be agreed to?

Their Lordships divided: Contents, 41; Not-Contents, 143.

Resolved in the negative, and amendment disagreed to accordingly.

Schedule 8 [Minor and consequential amendments]:

moved Amendment No. 47:

Page 87, line 35, leave out "1" and insert "2"

On Question, amendment agreed to.

Schedule 9 [Repeals and revocations]:

moved Amendment No. 48:

Page 89, line 39, column 2, leave out "1" and insert "2"

On Question, amendment agreed to.

Clause 83 [Commencement]:

moved Amendment No. 49:

Page 63, line 2, at end insert ", and

(e) (except for section 36(2)) any other provision of this Act so far as it—

(i) confers power to make an order or regulations, or

(ii) defines any expression relevant to the exercise of any such power.

Subsections (2)(b) and (3) to (6) have effect subject to paragraph (e)."

My Lords, government Amendment No. 49 commences all provisions in the Bill containing regulation and order-making powers, including any definitions relevant to the exercise of any such powers on Royal Assent. I originally tabled this amendment in Grand Committee, but my noble friend Lady Royall agreed to withdraw it in order to give absent friends—if I may put it that way—the opportunity to hear the explanation at Report stage.

There is a convention that the provisions of an Act of Parliament should not normally be commenced until at least two months after Royal Assent. The purpose of the convention is to ensure that those who are affected by a legislative change have sufficient advance warning of that change in legislation to be able to adjust their behaviour accordingly. This is conducive both to ensuring that the law is applied in a fair way and to preserving legal certainty.

In this respect, the Health Bill will be no exception, with Clause 83(1) setting out just a few technical provisions that are needed mainly to make the Act, which will come into force on Royal Assent, work. The provisions in Clause 74, on "Transfer of criminal liabilities", will also come into force on Royal Assent, as it is entirely in the public interest for there to be no undue delay in the provisions taking legal effect.

However, the Government's view is that the commencement of regulation-making powers, either on Royal Assent or shortly after, does not breach the convention, provided that the coming into force date of the regulations does not fall within the two-month period governed by the convention. It is only when the regulations come into force that they have any legal effect.

As I am sure the House will appreciate, it is often desirable to be able to make regulations well in advance of the main provisions of an Act coming into force. For example, in relation to the smoke-free regulations permitted under Part 1, Chapter 1, it is clearly in the interests of industry to have sight of the final content of the regulations as far in advance of the summer 2007 implementation/coming-into-force date as is possible. It would, therefore, make no sense if regulations were ready to go, but could not be made or, in the case of any affirmative regulations, scrutinised by Parliament, until two months after Royal Assent. That would be to no one's benefit.

The Bill, as currently drafted, would already allow us to commence such regulation-making powers early through the laying of separate commencement orders—in other words, orders that simply switched on the powers to make regulations in advance of the main provisions being commenced. However, we believe that such an approach would be unnecessarily bureaucratic and unhelpful to the reader of the Act, who would be required to search out extra commencement orders which did nothing apart from switch on regulation-making powers.

Amendment No. 49, therefore, automatically "switches on" all regulation and order-making powers within the Bill on Royal Assent. We believe that this is a much less bureaucratic approach than going down the route of individual commencement orders and will provide greater clarity to the Act. Of course, in line with the convention, any regulations would not have a coming-into-force date sooner than two months after Royal Assent.

Given that no one stands to gain anything from the switching on of regulation-making powers through separate commencement orders, we have decided to try to apply the amendment to all subordinate legislation within the Bill, with the exception of Clause 36(2). The Scottish Executive have indicated their wish to retain control over when that provision is commenced.

It is important to emphasise that the making of regulations is not the same as the coming-into-force date of regulations. The amendment does not permit us to do anything that we cannot already achieve through other means; it is simply about removing an unnecessary layer of bureaucracy and providing greater clarity to the Act, as the reader would not be required to search out extra commencement orders which did nothing more than switch on regulation-making powers.

Finally, it is also worth adding that a similar provision was included in the Health and Social Care (Community Health and Standards) Act 2003. I am not sure why we did not include such a provision in the Bill from the outset, but it is before us now, and with the explanation that I have given at some length, because noble Lords were concerned about the matter, I hope that noble Lords will support the amendment. I beg to move.

My Lords, I am more than willing to oppose the Government at every suitable opportunity, but this is a case where I urge your Lordships to agree to what is now being proposed. I have had extensive discussions with the British Beer and Pub Association, which represents about 60 per cent of pubs and bars in the country. It is anxious to see two things, above all, as regards the smoke-free provisions of the Bill. The first is the publication of the draft regulations at the earliest possible opportunity. The association wants clarity about what is being proposed and a reasonable length of time in which to work with the Government to sort out any points of difficulty that may arise in the detail. The amendment is wholly conducive to that wish and, on that count, is to be welcomed.

However, the second thing that the trade is anxious to see is a sensible and workable implementation date for the regulations. If it is to be a date in 2007, as the Government have previously indicated, there are several relevant points for consideration. The first is that, as we debated in Grand Committee, many pubs will wish to make provision for smokers by means of outside shelters which conform to the rules of what is deemed to be an unenclosed space. Many of these extensions and additions will require planning consent. It will be necessary to submit planning applications for that purpose and, alongside that, many pubs will also need to submit applications to vary the conditions of their licence.

It is a fact that the smaller local authorities do not have the resources to deal with large numbers of applications at once, but 2007 brings added complications because, in the spring of that year, many areas of the country will have across-the-board local government elections. In those circumstances, next year no planning decisions will be taken from about the middle of March until the third or fourth week of May. If the pubs are to have a proper chance of having their planning and licensing applications considered and dealt with by the time the smoke-free regulations come into force, they need not only the earliest possible publication of the draft regulations but also a recognition that the time available in local planning departments in the first part of next year will be much reduced compared with normal. Indeed, prior to that, we need to remember that over Christmas many planning departments cease to function properly for the best part of a month.

That is why I ask the Government to rule out any possible thought that the smoke-free regulations might be brought into force before July of next year. I seriously suggest that, if they are thinking of the end of May—one rumour that is going about—that is unreasonably early. If the draft regulations are not published until the late autumn or early winter of this year, then implementation at the end of May will mean an interval of seven or eight weeks in which pubs will need to draw up proposals, submit them and have them considered and dealt with. A date in July would provide a more workable interval, assuming early initial publication of the regulations, and I very much hope that the Government will agree to that.

My Lords, I have listened to the Minister and the noble Earl, Lord Howe, and, as the Government and the Opposition agree about the amendment, I am not going to oppose it. If the noble Earl, Lord Howe, can get an assurance from the Minister that implementation will not take place until July 2007, then, although I should prefer it to be July 2008—the preferred date of the right honourable Mr Reid when he was the health Minister—I would be altogether satisfied with that.

I want to raise one point. I am not entirely clear about what will happen in this respect. Landlords of pubs, restaurateurs and so on are entitled to know in advance exactly what they are required to do. That is fair enough, but Clause 4 continues to worry me, as it worried Members of the Grand Committee. It appears that the Minister has now announced that Clause 4 could be used for banning smoking in the entrances to offices, in bus queues and in bus shelters. That takes us further than we thought the Minister was going in Grand Committee.

I wonder whether there will be consultation with those who might queue for a bus, those who operate bus shelters and those who have office doors. I do not know what will happen if smokers are banned from smoking outside office doors. It seems to me that that is carrying smoke-free places to a ridiculous degree. Perhaps the Minister will comment on that aspect. I am sure he does not want to appear to be introducing ridiculous legislation, but I can assure noble Lords that most people to whom I have spoken think that that is taking things a little too far.

My Lords, first, I shall deal with the points raised by the noble Earl, Lord Howe. I can assure the noble Earl that the draft regulations will be published very soon. The timescales, much further into the year, of which he may have been thinking, are probably not right. I cannot give him a precise date, but it will be very soon. It is worth reiterating that we have already announced many definitions here, as in Scotland, so that people can begin the planning work. I cannot give him—I suspect the noble Earl would not expect me to—a categoric assurance about July 2007; at present, I can say nothing more than the summer of 2007. We are talking to the industry about implementation, including dates. An announcement will be made as soon as possible, but I cannot go further than the position we have already reiterated. The summer of 2007 is the period that we have in mind.

The noble Lord, Lord Stoddart, raised the issue of Clause 4. I believe I am a slightly misunderstood man. Earlier during Report stage, I put forward limitations on the provisions in Clause 4. I was asked about the circumstances in which the regulations might be applied—I emphasise "might be applied". They would have to pass a significant risk test in the amendment that we put forward, so we have made Clause 4 more restrictive in its regulation-making capacity than was originally proposed. I was not expecting a great deal of thanks from the noble Lord, Lord Stoddart, but I thought I should correct the record.

My Lords, I am most obliged to the Minister. If he looks at our previous proceedings, he will find that I expressed my gratitude for the small concessions he brought forward.

My Lords, I am grateful for the noble Lord's recognition of the powerful concessions that we made on Clause 4. I can also tell him that we wish to proceed with all the other arrangements for a comprehensive ban, for which we are aiming to introduce changes by the summer of 2007. It may put a spring in the step of the noble Lord when he leaves the House if I say that it is not our intention to use any powers in Clause 4 as part of that process. We will wait and see how things go before taking any action under Clause 4, and would certainly consult fully if we did so but on a totally different timescale. I remind the noble Lord that any regulations made under Clause 4 would be subject to the affirmative procedure. I hope that gives him some assurance that we do not have up our sleeves a Clause 4 plan which we are trying to implement by summer 2007.

On Question, amendment agreed to.

moved Amendment No. 50:

Page 63, line 16, leave out "paragraphs 24(a) and 43" and insert "paragraph 24(a)"

My Lords, Amendments Nos. 50 to 56 are technical drafting amendments. I do not think that I need to go into any more detail; they are self-explanatory. I beg to move.

On Question, amendment agreed to.

moved Amendments Nos. 51 to 56:

Page 63, line 17, leave out "those paragraphs" and insert "that paragraph"

Page 63, line 29, leave out "and Schedule 3" and insert ", Schedule 3 and paragraph 43 of Schedule 8"

Page 63, line 29, leave out from "bodies" to end of line 30.

Page 63, line 32, leave out paragraph (f) and insert—

"(f) so far as relating to Welsh NHS bodies, any provision of Schedule 9 which repeals or revokes an enactment amending or repealing section 98 of the 1977 Act, and"

Page 63, line 34, at end insert "(d),"

Page 63, line 35, at end insert—

"In this subsection "Welsh NHS body" has the meaning given by paragraph 2 of the Schedule 12B inserted by Schedule 3."

On Question, amendments agreed to.