Patient Pack Initiative

HL Deb 14 May 1998 vol 589 cc1244-60

8.5 p.m.

Earl Howe

rose to ask Her Majesty's Government whether they will support patient organisations, doctors and the pharmaceutical industry in promoting the patient pack initiative.

The noble Earl said: My Lords, a simple definition of a "patient pack"—for those who are not aware of it—is medicine that is user friendly. A patient pack is one that has been prepared by the manufacturer rather than one made up from bulk supplies by the pharmacist. It is a pack which is of a size appropriate to the specific course of treatment and one which includes all the approved labelling and user information which may be necessary for the patient to get full benefit from the medicine.

Why should that be desirable? All too often medicines dispensed by the pharmacist in little brown bottles are taken home and then, out of ignorance, consumed incorrectly either in the wrong dosages or at the wrong intervals, or both, with the patient frequently omitting to finish the course. Not only does that fail to achieve the desired outcome for the patient; it is also wasteful and expensive for NHS budgets.

If instructions are misunderstood and a course of treatment is followed wrongly, the results may well be a return visit to the GP and repeat prescriptions, neither of which would be necessary if the medicine had been taken properly in the first place. The main benefits which spring from a patient pack are that the patient, because he is better informed, is more likely to take the medicine safely and correctly. Repeat prescriptions and waste are more likely to be eliminated and quality control of the medicine can be assured.

How significant are the problems I outlined? One indicator is a recent OPS survey which found that more than 40 per cent. of medicines prescribed had no information on the label about the length of time over which the medicine should be taken. It is no wonder perhaps that surveys which appear from time to time in relation to unused medicines suggest that large amounts of such medicines are thrown away every year because the patient failed to read the instructions properly and did not finish the course, had simultaneous courses of different lengths and wasted what he did not need—or thought he did not need—or simply did not understand that every course of medication needs to be completed.

The other side of the problem relates to over-prescribing. In 1993 the National Audit Office found that 14 per cent. by value of the items on multiple item prescriptions appeared to be excessive in terms of the underlying clinical requirement. Either way, its estimate was that up to £60 million worth of medicines dispensed in England each year may not be fully used.

Patient packs, every one of which contains a leaflet telling the user in simple terms everything he needs to know in order to understand his treatment and use the medicine properly, are a major step forward in reducing waste and wrong dosages and in improving awareness of possible adverse reactions. They bring benefits also to pharmacists. Up to 40 per cent. of a pharmacist's time is spent physically counting and repacking medicines. That leaves him commensurately less time in which to do what many would regard as his principal job; namely, giving advice and guidance to his customers. That advice and guidance can itself prevent waste and promote better compliance to the obvious benefit of the patient.

Those advantages for the patient pack have been widely acknowledged for a number of years. In 1995 it was agreed by all the major organisations involved in the delivery of healthcare in the UK—doctors, pharmacists, the pharmaceutical industry and the Department of Health—that an initiative to introduce patient packs as the standard method of dispensing all medicines should be commenced over a three-year period.

In the light of that agreement, the UK based pharmaceutical industry made a substantial investment in the equipment necessary to enable patient packs to be produced. Unfortunately, however, nearly three years on, not all is well. The initiative, though it is still proceeding, is faltering. It is doing so not because anyone has had second thoughts about the merits of the patient pack as a concept—if anything the reverse is true—but because the Department of Health expressed worries about the implementation of the project and, significantly, its cost.

The noble Baroness will, I hope, accept from me that it is not my purpose in this debate to cast a party political slant on the subject under discussion, but it is a matter of acute disappointment to many people that the present Government should have chosen to resile from the clear commitment of the previous administration to give unequivocal support to the patient pack initiative. Indeed, there are many who think that it is an extraordinary thing to have done in the face of the EU directive, due to come into force at the end of this year, which will oblige the UK to supply patients with information leaflets about their medicines and clear and accurate labelling on all packs.

Personally, I do not believe that there can be any better way of complying with that directive than to manufacture and supply medicine in a patient pack. That is because some of the information is safety related and can only be provided by the manufacturer; for example, the batch-specific information which identifies the production run and governs the expiry date. The idea that pharmacists could simply keep a stock of loose leaflets in the shop to hand out to customers as and when needed fails to meet that important requirement, quite apart from imposing a gigantic shelf-space problem for pharmacists.

It is worth taking a moment or two to scrutinise the department's current position. It is saying, as I understand it, that the introduction of patient packs will bring with it unwelcome complexity in terms of the changes to dispensing rules that are needed. I simply do not understand that point. The changes to dispensing rules are quite straightforward. Their aim would be to enable a pharmacist to round up or round down the quantity of medicine dispensed to match the size of the patient pack.

The real issue here is the need to educate both doctors and pharmacists in what they should now be doing. But that complication is hardly a show-stopper. Doctors and pharmacists have already been on the receiving end of a large amount of information designed to encourage a rapid shift to patient pack prescribing and dispensing. Any mismatch between prescribing patterns and pack sizes will not be a major difficulty and there is agreement among pharmacists that it is less complex for them to dispense using the bounded rounding rules than to continue to split packs of medicine inappropriately.

The department's other concern is cost. It has assumed that the whole programme of conversion to patient packs will involve a transition period lasting three years, during which costs will rise. In a Written Answer in another place last December from the Minister of State, Tessa Jowell, the net costs for the family health services and the Prescription Pricing Authority of implementing the previous government's proposals were put at about £60 million over the next three years. The pharmaceutical industry does not understand this calculation or its underlying assumptions. Those calculations which the department has shared with the industry suggest that not only are they a worst case—perhaps even an impossibly worst case—but that they omit altogether any savings arising from the two main benefits of this initiative.

The first of the benefits relates to generic medicines. There is a perfectly valid concern that the price of generic medicines that are switched across to patient packs will go up. It is certainly true that more generic medicines than branded medicines have still to come on board the scheme and costs will indeed rise more markedly for this group of drugs. But the real question is how much difference patient packs will make to the overall drugs bill for the NHS. The introduction of patient packs for generics will almost certainly enable more GPs to feel confident enough to prescribe generic products in circumstances where they would have prescribed a branded product before. As little as a 1 to 2 per cent. swing from branded to generic use would give a net saving in one year equal to the estimated costs of the entire patient pack initiative over three years. And that is before any account is taken of the savings to be generated from a reduction of waste.

I hope the Minister will not say that the reduction of waste cannot be relied on with certainty and is therefore a matter of speculation. For obvious reasons it is impossible to quantify such savings with any precision. But if it is true, as I mentioned earlier, that £60 million worth of medicines is thrown away every year, the scope for a very dramatic improvement is clear.

I should be grateful if the Minister would give us her own perspective on these issues. Does the department accept that significant savings are in the offing from the introduction of patient packs to offset—indeed, substantially offset—any additional costs? If she does not feel able to answer that question today, will she agree to allow representatives of the industry to sit down once more with Ministers and with DoH officials to look at the whole issue again? It is not too late to do so. The industry expressed its grave misgivings about the department's costings as soon as it saw them and it feels that it has not been given the opportunity to go through them in detail with officials.

The end that we should have in view is that all parties—industry, healthcare professionals and the Department of Health—should work together to ensure that patients benefit from the new regime which the European directive was designed to usher in. The regrettable fact is that this initiative, which is all about better care for patients and is supported by numerous professional bodies and patient organisations, cannot succeed as it should without the Government's backing. That backing, as the Minister will know, needs to include an amendment to prescribing and dispensing regulations. I believe that the barriers to agreement are not insuperable and I hope very much that the Minister will feel able to approach this matter again in her customary constructive spirit to the ultimate benefit of patients.

Lord Winston

My Lords, before the noble Earl sits down, will he clarify one point. He referred twice to £60 million of drugs being thrown away. Is that the basic NHS cost of prescribed drugs or is it based on retail prices, as there is a considerable mark-up in chemists' prices?

Earl Howe

My Lords, as I understand it, the figure was estimated by the National Audit Office and relates to the cost to the NHS of the drugs that are thrown away.

8.16 p.m.

Lord Jenkin of Roding

My Lords, my noble friend has admirably set out the case in favour of the patient pack initiative and has raised a number of questions for the Minister to reply to. I share his concern that what started three years ago as an agreed, collaborative rolling programme, with the Department of Health giving what has been described as "unequivocal support", seems now to be bogged down because this Government are now refusing to make the necessary changes in the regulations. That is what is really required of them.

I only want to add three points to the case made by my noble friend. First, there really can be no doubt whatever that to give every patient supplied with a prescription drug a full information leaflet is of great benefit to all concerned. Patients and their carers now, perfectly reasonably, demand more information. They want a clear statement of the benefits and a note of the possible side-effects of drugs. They want advice on storage and on the length of the treatment. For their part, doctors can assume that every patient will get the required information in a readily understandable form, which he or she can study at leisure. It is well recognised that patients do not always remember what is said to them in the doctor's consulting room. Pharmacists can dispense in an easily identifiable pack with the information already enclosed. As my noble friend said, the system should reduce the quantity of loose tablets and capsules stored, not always safely, in bathroom cabinets at home, which should not only reduce waste but should prevent the accidental poisoning of children.

My noble friend mentioned the EU directive which will require us to ensure that essential information is provided to patients. If this is to be given effect to, the Government will have to take the steps necessary to ensure that this country complies. The patient pack initiative has until now been seen as the way ahead. My first question to the noble Baroness is this. Do the Government still accept this case; and if not, why not? If they do, why do they not get on and deal with it?

My second point—I am glad to see the noble Lord, Lord Winston, in his place—arises from the report published by the Select Committee on Science and Technology a week or two ago entitled Resistance to Antibiotics. There is much said in that report about the need to ensure compliance with prescribing recommendations.

I had the honour to serve on that committee, as indeed did the noble Lord. We said at paragraph 2.47, The Royal Pharmaceutical Society has addressed this problem in a valuable document entitled From Compliance to Concordance". It is a very interesting study. We went on to say, The RCGP observe that compliance can be encouraged by drug and regimen design, and by patient information, on which there is recent EU legislation which they support. The ABPI are 'particularly keen' on improving compliance by means of new formulations; and they support the Patient Pack Initiative on patient information". We have some fairly convincing evidence to support that statement in the report from the evidence presented to us by the Royal College of General Practitioners at paragraph 3.7. They said, We also support better provision of written information and instructions to patients in line with recent EU legislation and we support the recent initiatives of the Royal Pharmaceutical Society of Great Britain in respect of compliance/concordance". The ABPI also gave us strong evidence. This is all in the context of avoiding the continuing build-up of resistance to antibiotics. They pointed out in their evidence that, Antibiotic resistance is a global problem and needs "better education". They said, The Patient Pack Initiative will ensure that all patients will receive a patient information leaflet with all their medicines. The leaflet for antibiotics will remind patients that they should take the medicines as prescribed and must finish the course even though they may well feel better. The reason for this will also be explained. When the report was published the Government made it clear that they regard the whole problem as a desperately serious issue, as indeed it is. The committee was very alarmed by much of the evidence that we heard. I suggested that we might call our report, "How can we stop the bugs winning?". How can we avoid going back to the horrors of the pre-antibiotic age? The committee indicated that the patient pack initiative can help in that battle and yet here, almost at the first hurdle since the report was published, we have the Government dragging their feet and refusing to work with the industry and the professions to make the PPI effective.

My last point is that I believe it is really a matter of good faith. In 1995 the Department of Health, at ministerial level, gave the pharmaceutical industry what it describes as "an unequivocal assurance" that the scheme had the department's support. On the basis of that assurance, the industry has spent millions of pounds in gearing itself up in order to be able to implement the initiative only now to find, three years later, that the department is resiling from its commitment.

Therefore, I ask the noble Baroness how the Government will ensure compliance with the EU directive which, as I understand it, is binding on us and has to be effective by the end of this year? Can they not, even now, come clean and give the industry and all the professions involved, who support this initiative, as my noble friend made clear, the assurance that they, the Government, will play their part in implementing this initiative?

I regard this as a sorry tale of a government apparently reneging on a clear promise made to those with whom the 1995 agreement was concluded after 18 months of negotiations. It is not too late to make amends and I hope that the noble Baroness will tell the House this evening that that is exactly what they are going to do because I believe we should expect nothing less.

8.23 p.m.

Baroness Cumberlege

My Lords, I am sure that the Minister will have rejoiced with me if she saw the recently published annual report of the World Health Organisation which stated that more people reached the age of 50 in Britain than anywhere else in the world. Five years ago the WHO cited the Government's policy for the health of the nation as a model for other countries to follow. I would not for a moment claim that 18 years of Conservative Government is solely responsible for the healthiest middle aged population in the world. Likewise the pharmaceutical industry, which is recognised globally as being outstanding in its development and manufacture of therapeutic products, would not claim that it has been responsible for achieving this cadre of energetic and healthy 50 year-olds.

But I believe that we would all acknowledge that its contribution has been immense, not least in the field of HIV and AIDS, a field in which I know the Minister has extensive knowledge and expertise. It is wonderful to see these young people who were previously doomed to die, now living and working, leading almost normal lives, thanks to the ingenuity and the investment of drug companies in producing effective combination therapies.

However, medication, if not treated responsibly, can be exceedingly dangerous. As my noble friends have said, its use does require a partnership between patients, doctors, pharmacists, manufacturers, the MCA, the Committee on the Safety of Medicines and the Government.

Close working between all parties is essential and from the patient's point of view there is a very strong wish for better communication, as my noble friend Lord Jenkin has said, and a thirst for knowledge on the efficacy and side effects of the medication prescribed, which is, of course, why the patient pack initiative is so crucial. This in no way erodes the duty of care that doctors have in carrying out their prescribing, but it is essential for safety both in use and manufacture.

The Minister, after a year in government, will have discovered the difficulties of introducing any new initiative, especially where the Treasury has an interest. In my experience there is hardly a nook or cranny in government in which the Treasury does not have an interest.

My noble friend Lord Howe has raised the issue of costs so I am not going to go into those in detail, but simply ask the Minister, as he has done, on what basis the department has reached its figures. There is a suspicion that they are based on a worst case scenario and that in itself has been exaggerated. We really do not know whether there is a solid foundation for these estimates. I am not suggesting that the figures are at all false, but we need to know on what they are based. I did give notice earlier today to the Minister that I was going to ask these questions. I hope that she will be able to go into some detail to help us understand how the figures are made up.

The Minister will be aware also that the industry, frustrated by the Government's procrastination, has recently announced its decision to go ahead to introduce patient packs itself, and that is not surprising since it has invested many millions of pounds in this initiative. Therefore, it would be understandable if the Government felt that there is no need to lay the necessary regulations.

But there are two points that I wish to make here. The first is the safety of patients and, secondly, the European dimension. When the initial launch took place two or three years ago, there was strong support from not only the bodies which had a direct interest such as the BMA, the ABPI, the Royal Pharmaceutical Society and so on, but also from seven of the leading voluntary organisations: the National Osteoporosis Society, the Parkinson's Disease Society, the Depression Alliance, the National Eczema Society, the British Epilepsy Association, the National Asthma Campaign and the Patients Association.

I mention all these organisations because they are highly respected for their integrity and professional approach and represent a vast number of patients. These organisations have continued to campaign for the patient pack initiative on the grounds of safety, saving on wastage, non-compliance and repeat visits to the GP. They also make the very cogent argument that if the packs contain information on the availability of confidential helplines, they will be able to give advice and answer the queries which some patients find too embarrassing to ask their doctor.

Perhaps I may give an example of HRT for osteoporosis. I know that some women, once they are prescribed that medication, go home and then think, "If I am taking this drug and I have a period, will that mean I could get pregnant?" That person may be far too shy to go back and ask her doctor, whereas an anonymous osteoporosis nurse, at the end of a helpline, would be of enormous value in answering her concerns. I do believe that men taking HRT are not worried about this particular issue, but they also have very real worries. Information on helplines accompanying the medication, would be of enormous value to patients.

Since the pharmaceutical industry is going to introduce these packs and leaflets of its own volition, there is a danger that the Government may feel that the issue has evaporated. But that is a non sequitur as the pharmaceutical industry cannot cover all prescriptions and it will miss around 20 to 25 per cent. a year. In percentage terms this does not sound much but it represents about 125 million prescriptions a year which is a huge amount. That is why it is essential that the Government should produce the necessary regulations.

Both the ABPI and the Royal Pharmaceutical Society are anxious that some discretion should be built into the regulations so that common sense can prevail. With the cutting of packs there is no guarantee that leaflets will not be separated from the medication to which they belong. The cutting of packs anyhow is a nonsense if it can be avoided.

There are a number of very good reasons for the patient pack initiative, many of which have been or will be raised in the debate. But there is also the requirement referred to by my noble friend Lord Jenkin to comply with the European Council Labelling and Leaflet Directive which comes into force in January 1999. In a Written Answer on 12th December of last year the noble Baroness's honourable friend the Minister of State, Tessa Jowell, said: We … are considering whether it will be necessary to implement the European Council Labelling and Leaflet Directive by other means".—[Official Report, Commons; 12/12/97; col. WA 736.] Can the Minister inform the House whether in the intervening five months the department has reached a conclusion on that matter? If there are other means can she outline them? Listening to those who are involved in this issue, there is a genuine desire to resolve it in partnership with the Government. Perhaps the Minister can be generous tonight and give an undertaking that her door will be open to all those who are anxious to see this matter concluded and that she will work closely with them in the spirit of partnership so extolled by the Government.

Dr. Peter Read, the recently retired and distinguished president of the ABPI, has stated: Patient packs are the best, simplest and most convenient method of ensuring that patients get full details about their medicine. This has been standard practice throughout Europe for many years now, and I can see no justification for continuing to deny it to large numbers of people in this country". I say amen to that.

Finally, I have a cutting from Tuesday's edition of the Daily Telegraph which bears the headline, "Ministers to get a 'school report—. The article went on to explain the plans drawn up by the Cabinet Office to monitor the performance of Ministers. None of us can have any doubt about the competence of the noble Baroness, but if she is to receive an alpha plus I believe that she must lay these regulations before the House. I believe that from the point of view of the National Health Service and those who are involved in this issue she will certainly get top of the class.

8.32 p.m.

Baroness Eccles of Moulton

My Lords, I am very grateful to my noble friend for tabling this Unstarred Question as not only does it give us an opportunity to discuss the important subject of the dispensing of drugs but also to touch on one or two of the wider issues relating to the part that drugs play in the health service as a whole. When the initiative on patient packs was launched in 1995, four advantages were highlighted—compliance, assurance, safety and effectiveness—and there can be little doubt that these are objectives worthy of support. The initiative also took account of the EC directive that came into force in 1994 which sets out in detail the information that should be available to patients when drugs are dispensed.

However, nothing is ever as simple as it may appear at first sight. At present, the majority of branded drugs are pre-packed and accompanied by the appropriate information. This is not always the case with generic drugs. One of the considerable impacts on the NHS drugs bill is caused by the difference in cost of branded and generic drugs. If every generic drug were blister-packed, for instance the 75 milligrams of aspirin which is taken to prevent coronary heart disease, the cost would become prohibitive. On the other hand, there are other drugs where the advantages of pre-packing outweigh any additional cost that may be incurred; for example, where medication is prescribed for high blood pressure. Hypertension is asymptomatic, but the drug therapy can make the patient feel dizzy and unable to sleep at night. Compliance is essential to prevent further cardiac problems and other organ damage. A patient pack which has the days of the week printed on it would encourage the patient not to miss a dose. Therefore, it is very important that the campaign to provide drugs in patient packs where this is known to have considerable advantages is vigorously pursued.

My noble friends Lord Howe, Lord Jenkin and Lady Cumberlege have emphasised most effectively the importance of the patient pack initiative. Rather than repeat what has already been said, I take a minute or two to describe a pilot scheme involving regular repeat instalment dispensing which is now running in Ealing, Hammersmith and Hounslow Health Authority of which I am chairman. This is one of five schemes supported and funded by the Department of Health. The scheme has several purposes: first, to involve the pharmacist more directly in the continuing drug treatment of individual patients; secondly, to increase compliance; and, thirdly, to prevent waste. In the authority nine GPs and 240 patients have been recruited to the pilot scheme. Our pilot is slightly different from the other four in that patients may take their prescriptions to any pharmacy in the three boroughs. This means that there is 100 per cent. participation in the scheme by pharmacists, although those who operate within the catchment areas of the nine practices will obviously be most involved.

Under present arrangements, if medication is prescribed for six months the patient is usually issued with a prescription for one to three months, depending on individual practices' repeat prescribing policy. The patient will then go back to reception at the surgery for a repeat for a further three months without necessarily seeing the GP.

Under the pilot scheme, the difference is that the patient is issued by the GP with an initial prescription and five repeats, all with a distinctive identification. As each prescription expires, the patient returns to the pharmacist and together they complete a patient assessment form. The next month's medication is then issued and this is repeated until the six months are up. If the patient is having problems, these are discussed with the pharmacist who can take one of three courses of action. He can try to persuade the patient to continue with the medication, or agree with the patient that it is right to stop the medication, or refer the patient back to the GP. The pharmacist receives a fee for each intervention and the trial runs for six months.

The data that has been returned so far from the Prescription Pricing Authority indicates that already savings can be identified. However, it will not be until October, when data covering the whole of the six months is received and analysed by the authority, that it will be known what effect the scheme has had on the prescribing pattern. After the project ends in June there will be meetings with patient and GP focus groups and a full report will be written up by the beginning of next year.

Already a number of benefits can be identified. For instance, the scheme creates an incentive for pharmacists to monitor medication and not issue drugs where that is inappropriate. It also has benefits for the patient. Regardless of whether or not it is rolled out nationally when the results of all the pilots are known, it is a system which would lend itself very well to being operated by individual primary care groups. The co-operation and enthusiasm that patients, GPs and pharmacists are all demonstrating is most encouraging.

I have spent some time describing this pilot, although it is not directly connected with patient packs, because it is another way of increasing patient understanding of the drugs they are taking and compliance with their drug regime. It seems to me to be a very good way of increasing the involvement of our highly skilled body of pharmacists in direct patient care.

Although waste has already been referred to, I should like to remind noble Lords that 10 per cent. of the total NHS budget goes on funding drugs. Historically, this percentage has been rising despite the rise in the total NHS budget. Of all drugs issued, 64 per cent. are for repeat prescriptions. Of that 64 per cent. it is calculated that 50 per cent. is wasted. This is a staggering amount. Any initiative which not only reduces waste of NHS funds but increases patient compliance—non-compliance has the double effect of reducing benefit to the patient and wasting resources—must be vigorously pursued.

My noble friend Lord Jenkin used the word "concordance". It has been drawn to my attention that that word should now be used instead of "compliance" because "concordance" more accurately reflects a sense of partnership and co-operation between patient and doctor or pharmacist.

Another factor that increases pressure on the budget is the coming on stream of expensive new drugs. This is probably occurring on an unprecedented scale. For instance, my health authority has recently received a request for the funding of a new drug with life-saving properties to treat a rare condition. At the moment, that drug could cost up to £300,000 per year per patient. The benefits to the patient versus equity and opportunity costs are still being calculated in this case. New drugs such as Orlisat for the treatment of obesity, and the much publicised Viagra, will add to funding pressures and difficult decisions which could involve rationing will have to be taken. Progress in drug technology is controlling hitherto uncontrollable symptoms and extending life. At the same time new drugs are becoming available at ever-increasing cost to the NHS.

There is so much that can be done to advance the four factors set out in the case for patient packs, with considerable benefit to patients, but also with the effect of directing the budget in a way which prevents waste. I hope that all sensible proposals will be listened to, and pilots that prove successful will become widespread practice.

8.40 p.m.

Baroness Thomas of Walliswood

My Lords, in the absence of my noble friend Lord Alderdice it falls to me to welcome the debate which has been stimulated by the noble Earl, Lord Howe's Question.

I come to this matter with a lack of prejudice born of ignorance. I have become increasingly sceptical as I read the sort of material, which has clearly been used by other people, about the Minister's stated reasons for putting into question the introduction of patient packs to which the previous government committed themselves in 1995. It is bad practice in this kind of case to renege on commitments made by previous governments. Obviously you cannot keep everything, but if you have a situation where large numbers of partners—including the companies which produce the drugs—have been involved in taking a decision, which has been confirmed by the department, and has resulted in them taking actions affecting their own businesses, and then the whole thing is put into doubt, it is a marginal case but it is not an attractive way of conducting government.

This is particularly so in the case where the Government have committed themselves to the standing programme of their predecessors which contained, no doubt, an element for the expenditure which it was then anticipated would be involved in pushing this initiative further. There is a question over this whole action.

Earlier speakers, the noble Earl, Lord Howe, the noble Baroness, Lady Cumberlege, the noble Lord, Lord Jenkin of Roding and the noble Baroness, Lady Eccles of Moulton, have all made out very clearly the advantages of this particular approach of patient packs. Without going through it all in detail, it aids prescription and dispensing of medicine. The packs provide not just the right dose which the patient requires, but the information which enables the patient to take control of his own use of that medicine and to understand why he should complete the course. That is a particularly important point which the noble Lord, Lord Jenkin of Roding, made because of his particular knowledge. The need to complete courses of antibiotics is something of which some of us are aware, but many people are not.

There is a safety element in the home in that it reduces the amount of left-over and unlabelled bits of medicine lying about in people's houses. There is an element of the reduced cost to the health service in as much as there is greater efficiency in the dispensing of medicines, in the prescription of medicines, and there is therefore less waste.

Dispensing chemists are not obliged to spend large proportions of their time counting pills and can therefore spend more of their time performing the other part of their job which is advising the customers who come to their shops and counters for their prescriptions as to how they can best use the information and the drugs with which they are being supplied.

Noble Lords would not expect me to underestimate the importance that the use of such packs would have in enabling the UK to comply with the 1994 EU directive on drug labelling and leaflets, an initiative which the previous government supported. This could ensure that the UK met the deadline for that compliance.

A number of reasons have been put forward as to why the Government might have changed the approach of their predecessor. The one that strikes most strongly is the question of cost. Is it the cost of £60 million to £67 million over four years which has deterred the Government from continuing with this agreed approach to solving a particular range of projects? I have seen some material with some information about government costs in this connection—obviously that material is not very detailed—and I support the questions asked by other people about what the basis for these calculations has been.

I spent 12 years in local government and I learned—as many hundreds of thousands of people have before me and, no doubt, many more thousands since I left—that when you read a paper provided by officers you should ask yourselves not only whether you agree with what is in that paper, but what has not been included. When you are providing a rationale for taking or not taking decisions, normally the officers provide a cost benefit analysis. The financial benefits of this particular approach have been clearly outlined by the noble Earl, Lord Howe; I will repeat only one of them. If clear labelling of all the generic medicines, and the accompanying of those medicines with the correct information, were to increase the proportion of generic medicines prescribed by only 1 or 2 per cent., you would much more than offset the cost, on an ongoing basis, of the introduction of this pack system. One has to ask why the cost benefit of this new system has not apparently been considered, at any rate not recently.

My second question is directed at the value-for-money concept. Even if there are some costs associated with the patient pack approach, is not the value which the approach brings worth at least some cost? We are not talking about better value for no money at all but better value for money in public services.

My final question is if the Minister is unable to reassure the House that the patient pack initiative will go ahead in a co-operative way between the Government and other partners rather than by the decision of one partner how do the Government propose to meet the EU directive in time and in an orderly fashion?

8.40 p.m.

Baroness Jay of Paddington

My Lords, I am very grateful to the noble Earl for raising this Question and to those other noble Lords who have taken part in this short but nonetheless interesting debate.

The brief answer to the noble Earl's Question is that the Government, of course, support the intentions of the European labelling and leaflet directive. We particularly always support provisions which enable patients to have a better understanding of the treatments they are being offered and, in the case of medicines, the medicines that they are using. However, we do not support the details of the complex and costly plans developed by the previous administration, which have become known as the patient pack initiative. The present Government cannot justify diverting large sums of money from the NHS budget to meet the additional costs involved in these plans. We believe, to put it simply, that as far as possible NHS resources should be spent on direct patient care.

I find it somewhat extraordinary that the noble Lord, Lord Jenkin of Roding, and the noble Baroness, Lady Thomas of Walliswood, should be surprised and see it as almost politically unacceptable that the Government should change health service policy this area. I am almost tempted to ask them whether they regard it as dishonourable that we move to dismantle the GP fundholder system in which many people under the previous administration had a vested and large interest and under which many commitments were given by the previous government—

Baroness Thomas of Walliswood

My Lords, I did not suggest that it was dishonourable. I said that it was a marginal case and not very desirable.

Baroness Jay of Paddington

My Lords, perhaps "dishonourable" was the stronger language used by the noble Lord, Lord Jenkin of Roding.

Lord Jenkin of Roding

My Lords, with respect, I said that it was a breach of faith. And that it most certainly is. The Minister has been the most ready to defend every action of the Government by reference to their manifesto, but there was nothing in the Labour Party manifesto about this.

Baroness Jay of Paddington

My Lords, I hesitate to enter a long debate on this not totally central point of the discussion. But, frankly, what is agreed between officials and Ministers in a previous administration does not in any way constitute a faithful commitment to a subsequent administration.

It is worth reminding your Lordships of the present state of play as regards this issue. The basic requirements of the European legislation have already been introduced into British domestic law. It is the case that in most other member states the directive has been simple to implement because medicines are placed on the market in pre-packed packs with patient information sealed into them. In this country, our pharmacists are required to dispense precisely what a doctor prescribes and not to dispense packages of fixed size with a fixed number of pills chosen by the manufacturer rather than by the doctor. The question has therefore been how best to ensure that patients in this country receive the information which they should have and which now by law they are entitled to have.

For many medicines, the question is already answered. As the noble Baroness, Lady Eccles, pointed out, according to the pharmacy industry's information—I refer to the Association of the British Pharmaceutical Industry 1997 annual report—more than 80 per cent. of medicines are already available in patient pack form and 67 per cent. of prescriptions are dispensed in this way. Where possible, the Department of Health has been working closely in partnership with the industry and the professions to match pack sizes to appropriate treatment lengths to avoid waste and additional costs.

However, over many years NHS patients have benefited and continue to benefit from so called generic medicines. The suppliers of these medicines have kept prices low by supplying them in bulk to pharmacists. Pharmacists then dispense them in the exact amounts shown on any prescription in small containers. It is therefore in respect of those medicines that we need to be sure that patients receive proper information leaflets on compliance or concordance, dosage and other relevant matters. They need that information when they receive their medicines.

The previous government developed a complex and costly set of proposals—those which we have discussed tonight as the so-called patient pack initiative—in an attempt to cope with the situation. Plans were based on detailed changes to pharmacists' dispensing rules with a view to moving rapidly to a situation where manufacturers' packs could be routinely dispensed for every medicine. The Government's analysis of the money which would be diverted from direct patient care to meet the additional costs associated with these plans would have been up to £60 million extra over the first three years of any scheme and some £15 million a year after that.

I am well aware that the industry has challenged these figures which were provided to it in detail by officials last November. However, the industry has been invited to provide its own detailed costings, but it has not yet done so. The noble Earl was kind enough to inform me that he might raise the issue of sufficient discussion between the department and the industry on these costings. I took the opportunity of his early warning to consult with officials in the department. Frankly, they expressed incredulity at that accusation. Without referring to detailed diaries they suggested that they had had at least half a dozen meetings on this issue with members of the industry. The accusation of lack of information may therefore be somewhat misplaced.

As the noble Earl and the noble Baroness, Lady Cumberlege, asked me to detail some of the costs and explain how they were arrived at, I am delighted to do so. I apologise to the House if it may seem somewhat detailed. Officials at the Department of Health wrote to the Association of the British Pharmaceutical Industry and other groups in November last year with an explanatory note on the costings. The projected cost of the proposals had an overall figure of about £60 million. Those were the figures for the plans developed under the previous government.

The main cost component was an increase in the price of generic drugs. The industry has said that it would have to increase its prices if it were producing medicines in small patient packs rather than in bulk supplies. The industry apparently reached an agreement with the previous government that the cost increase would be up to £25 million.

The alleged justification for these price increases was that there would be a corresponding saving of around £25 million in the allowance paid to pharmacists and dispensing doctors for repackaging medicines; the so called "container allowance". But the actual savings would have been much less than that, according to the department's analysis, and would have been around £16 million to £18 million by the end of the implementation period. This is because pharmacists would relatively often have needed to break the packs in order to meet doctors' prescriptions. Even with some degree of rounding, obviously within clinically acceptable bounds, there will remain a number of cases where the amount the doctor prescribes is not sufficiently close to an available pack size to justify rounding. The net effect of these two factors—the price increases and the container allowance savings—would, it was estimated, have been a cost to the NHS of around £8 million by the end of the implementation period.

The other main cost elements were, first, some upward drift in the quantity of drugs dispensed in the NHS as a result of the proposed rounding rules at an annual cost of between £2 million to £5 million. In essence, there would have been more rounding up for acute medicines than rounding down. Secondly, there would have a pharmacists' compensation claim of £9 million for residual stock which became unusable as a result of a switch to patient packs. It was estimated that the cost would be £3 million a year during the implementation period. In addition, increased operational costs for the Prescription Pricing Authority to administer the complex new dispensing and reimbursement rules for pharmacists and dispensing doctors were estimated to be around £3 million a year.

It was estimated that the total cost would have been just under £20 million, with these major components, by the end of the implementation period, or around £15 million once the compensation for residual stock was no longer payable. During the implementation period, the analysis showed that the average annual cost would have been slightly higher, primarily because reductions in the container allowance would have lagged behind increases in prices.

I am sorry if the explanation has been drawn out and long-winded, but I was asked for the details and I am happy to give them. It is important to emphasise that the costs were associated with a particular set of proposals which we inherited from the previous government; the so called patient pack initiative. There is no inherent reason why the price tag has to be attached to having a greater number of prescriptions met by patient packs and certainly not to providing patients with the right information when they need it.

Progress is being made on several fronts. As already mentioned tonight, the pharmaceutical industry, through its representative body, the ABPI, announced last month that it would be moving in any event into patient packs because, as it said in its press release when it made the announcement, it had not struck a deal with the Department of Health. We welcome this—not that it has not struck a deal but that it is moving ahead under its own steam.

The size of the packs which it seeks to introduce has to be determined primarily on the basis of clinical decisions by doctors. As I said earlier, what a GP prescribes should be determined by what is right for the patient and the NHS rather than simply a marketing decision by the manufacturer. We will, of course, encourage close working between industry and the professions to facilitate that.

We are also willing in principle, and this is in the light of the noble Earl's request to me to be constructive, to consider some rounding rules, perhaps downwards, within clinically acceptable limits. But for the foreseeable future there will continue to be a bulk supply of some medicines. To ensure that these medicines are dispensed with appropriate labels for pharmacists and leaflets for patients, the Medicines Control Agency will shortly be starting a consultation process on regulations. The NHS needs to be certain that manufacturers and suppliers are providing sufficient quantities of the right quality information.

In conclusion, I should like to repeat that for the Government and the health service the important principle is that patients must get the information they need and the medicines they want in a form which is most clinically and cost effective.

We will indeed work with the manufacturers and suppliers of medicines, with the clinical professions and with pharmacists to achieve what we see as this common aim. But we do not intend to spend up to £60 million of public funds to underwrite a commercially very successful industry to comply with the legal requirement to market its products in a safe and appropriate way.

Baroness Cumberlege

My Lords, before the noble Baroness sits down, I thank her for that detailed reply on the costings. Some of the elements that she has mentioned have been challenged by the industry. I have the correspondence here but I think it would be inappropriate to go through that tonight. Perhaps I may also ask her if she would answer my question about complying with the EU directive, especially in the light of the comments made by her honourable friend, Tessa Jowell, as to how the Government propose to get over this problem. She said that the Government are considering whether it will be necessary to implement the European Council labelling and leaflet directive by other means. Can the Minister say what those other means are?

Baroness Jay of Paddington

My Lords, I am grateful to the noble Baroness for raising the question of the challenge to those costs which I mentioned as being something the industry has taken up with the department. However, I should like to repeat that it has not come up with an overall figure of its own to counteract that.

On the issue of the alternatives I hope that in the later stages of my remarks when, for example, I spoke about the Medicines Control Agency consultation on regulations and on our willingness to consider in principle the possibility of rounding down prescriptions in order to extend their use, I gave some indication of the direction of travel on implementing the directive.

Baroness Ramsay of Cartvale

My Lords, I beg to move that the House do adjourn during pleasure until 9.5 p.m.

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

[The Sitting was suspended from 9.3 to 9.5 p.m.]