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I am not an expert on the content of the Bill, but it seems to me from the debate I have heard today that it fails these tests in a number of ways. This is a massively important issue. There is hardly a more important issue facing public policy than how you address the challenge of coping with care for adults when we are faced with demographic changes over the next decade.

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The Government have, rightly, been struggling thoughtfully with that issue, as evidenced by the Green Paper. As a consequence, this is a huge policy shift, but we have not been given an explanation of the reasons for that shift. We do not understand how it will work in practice, nor what the consequences of the shift will be and for whom. We are certainly unclear whether this shift is sustainable: we see the trail of that in signals that this is only going to last for 18 months, with the hint that maybe it is going to be knocked on the head.

I would not normally speak against my Government in this way, but I do not believe I am actually doing so. Allowing the proper consultation to take place, particularly on the regulations, allows the House to be better informed and do better scrutiny in Committee. I speak with the experience of the Merits Committee behind me; these are important issues that should be transparent. I therefore support my noble friend Lord Warner.

Lord Butler of Brockwell: My Lords, I only want to add one sentence: for the reasons that have been given, I urge all those who care about the role of Parliament in these matters to support the amendment. We damage the House's reputation if, on a matter as important as this, we do not show that Parliament takes its responsibilities seriously.

Baroness Thornton: My Lords, at this stage I must set out very briefly a few issues responding to my noble friend Lord Warner's amendment and points other noble Lords have made.

In a personal comment to the noble Lord, Lord Warner, I say that he should have some faith and join us in making this happen on 1 October. I also say that to my noble friend Lord Lipsey.

The support that many stakeholders and charities have given this Bill has not just come today; it has been going on for months and months. That discussion continues right through the production of the draft guidance. All these organisations are taking part in good faith and I ask noble Lords to join them in doing so.

We have a duty in this House to ensure we appropriately consider the matters put before us in this Bill. The right place to do this is in Committee and indeed at other stages of this Bill. Noble Lords have suggested that we are just going to have a day in Committee. That is, of course, not true: we will also have the other stages of this Bill.

We should not be here to impede the passage of such a Bill. Let me be clear: this amendment from my noble friend is a wrecking amendment. It would do that, and it would in effect prevent the people who are most in need of receiving this personal social care at home from having it provided.

Noble Lords who have worked with me in the past on Bills will know I am completely committed to discussing these issues right across the House, and I will do that from tonight, if they wish.

I remind noble Lords once more that we have the opportunity in Committee to discuss this further, and I suggest that is when we should do it. I ask the House to reject my noble friend's amendment, see it for what it is, and let us get on with our job.



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8.02 pm

Division on Lord Warner's amendment.

Contents 23; Not-Contents 105.

Amendment disagreed.


Division No. 1


CONTENTS

Alton of Liverpool, L.
Bilimoria, L.
Birt, L.
Butler of Brockwell, L.
Cameron of Dillington, L.
Cobbold, L.
Colville of Culross, V.
Craigavon, V.
Falkner of Margravine, B.
Filkin, L.
Golding, B.
Haskins, L.
Hylton, L.
Lipsey, L.
Low of Dalston, L.
Mawson, L.
Miller of Chilthorne Domer, B.
Murphy, B. [Teller]
Norwich, Bp.
Stoddart of Swindon, L.
Turnbull, L.
Warner, L. [Teller]
Wilkins, B.

NOT CONTENTS

Acton, L.
Adams of Craigielea, B.
Adonis, L.
Anderson of Swansea, L.
Andrews, B.
Archer of Sandwell, L.
Bach, L.
Barnett, L.
Bassam of Brighton, L. [Teller]
Bilston, L.
Blood, B.
Borrie, L.
Boyd of Duncansby, L.
Bradley, L.
Brett, L.
Brookman, L.
Campbell-Savours, L.
Carter of Coles, L.
Clark of Windermere, L.
Clinton-Davis, L.
Crawley, B.
Cunningham of Felling, L.
Davidson of Glen Clova, L.
Davies of Coity, L.
Davies of Oldham, L. [Teller]
Desai, L.
D'Souza, B.
Elder, L.
Elystan-Morgan, L.
Evans of Parkside, L.
Farrington of Ribbleton, B.
Faulkner of Worcester, L.
Foster of Bishop Auckland, L.
Foulkes of Cumnock, L.
Gale, B.
Gibson of Market Rasen, B.
Giddens, L.
Gilbert, L.
Gould of Potternewton, B.
Graham of Edmonton, L.
Grocott, L.
Harris of Haringey, L.
Hart of Chilton, L.
Haworth, L.
Hilton of Eggardon, B.
Hollis of Heigham, B.
Howarth of Newport, L.
Howells of St. Davids, B.
Hoyle, L.
Hughes of Woodside, L.
Hunt of Kings Heath, L.
Jones, L.
Jordan, L.
Kinnock, L.
Kinnock of Holyhead, B.
Kirkhill, L.
Layard, L.
Lea of Crondall, L.
McDonagh, B.
McIntosh of Hudnall, B.
MacKenzie of Culkein, L.
Mackenzie of Framwellgate, L.
McKenzie of Luton, L.
Mandelson, L.
Martin of Springburn, L.
Massey of Darwen, B.
Maxton, L.
Moonie, L.
Morgan, L.
Morgan of Drefelin, B.
Morris of Aberavon, L.
Morris of Handsworth, L.
Morris of Yardley, B.
O'Neill of Clackmannan, L.
Pitkeathley, B.
Prosser, B.
Quin, B.
Radice, L.
Ramsay of Cartvale, B.
Rendell of Babergh, B.
Rogan, L.
Rosser, L.
Rowlands, L.
Royall of Blaisdon, B.
Sawyer, L.
Scotland of Asthal, B.
Sewel, L.
Simon, V.
Snape, L.
Soley, L.
Sutherland of Houndwood, L.
Symons of Vernham Dean, B.
Taylor of Bolton, B.
Thornton, B.
Tomlinson, L.
Tunnicliffe, L.
Turner of Camden, B.


1 Feb 2010 : Column 85

Wall of New Barnet, B.
Warwick of Undercliffe, B.
Watson of Invergowrie, L.
West of Spithead, L.
Whitaker, B.
Whitty, L.
Woolmer of Leeds, L.
Young of Norwood Green, L.

Bill read a second time and committed to a Committee of the Whole House.

Pharmacy Order 2010

Pharmacy Order 2010

Motion to Approve

8.13 pm

Moved By Baroness Thornton

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

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

Baroness Thornton: My Lords-

Noble Lords: Hurray!

Baroness Thornton: This is my reward.

The Pharmacy Order 2010 will establish the General Pharmaceutical Council (GPhC), the new regulator for pharmacists, pharmacy technicians and registered pharmacy premises in Great Britain. It will complete the separation of professional regulation from professional leadership in pharmacy signalled by the powers taken in the Health and Social Care Act 2008. Measures included in the Health and Social Care Act 2008 enable the transfer of all the regulatory functions of the RPSGB and the Pharmaceutical Society of Northern Ireland (PSNI) to the new body, the GPhC. I have tried to minimise the number of initials, but their use seems inevitable. Northern Ireland Ministers have taken the decision not to transfer the PSNI's functions at this stage, but they have the power to do so in the future should they so wish. My remarks are fairly long because this is a detailed order. I hope that noble Lords will bear with me because it is important that we look at the order. I know that this is the third time that it has been scheduled, so it is important that we get through it this time.

Any Section 60 order to make these changes would be subject to consultation and the affirmative resolution procedure, with debate in the Northern Ireland Assembly. The Pharmacy Order will enhance public confidence in the ability of the pharmacy regulator to protect the public, deal with poor professional standards and allow the leaders of the pharmacy professions to advocate for the professions. The order has been laid in the Scottish Parliament, as the regulation of pharmacy technicians is a devolved issue. It was debated in the other place on 13 January and the passage of the order was agreed. I draw noble Lords' attention to two small typographical errors in the order, for which I apologise.

Legal advice from both the Department of Health and the Scottish Government is that the order can be amended prior to it being made and my officials will therefore arrange for a corrected version to be presented in Privy Council. The second paragraph of the preamble to the order should have referred to Her Majesty, with the advice of Her Privy Council, as the person making

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the instrument as opposed to the Secretary of State and Scottish Minister. Similarly, the references to paragraph (1)(g) in Article 11(2) and (3) should in fact be references to paragraph (1)(f). I also draw the attention of noble Lords to three further small amendments to this order which are now required as a result of the Lisbon treaty entering into force on 1 December. References in Articles 21(4)(b), 22(2)(b) and 66(2) to "the Treaties" are now required to be replaced by references to "the EU Treaties".

The order continues the process of implementing the Government's programme to improve patient safety through the reform and modernisation of the regulation of the healthcare professions, as set out in the White Paper, Trust, Assurance and Safety. The order brings pharmacy into line with the arrangements for other healthcare professions that have separate bodies for regulation and representation for the profession. Both roles are necessary, but cannot be performed in the same organisation without creating a conflict of interest between the needs of public safety and professional leadership. As the order is a substantial document, I will go through the provisions.

Part 1 contains preliminary matters, including commencement provisions and interpretation. Part 2 makes provision for the establishment of the council and its statutory committees, in addition to setting out the key functions and core purpose of a professional regulator, which is to safeguard patients and the public, in particular those using the services of registrants and those services provided by registered pharmacies.

Part 3 sets out the powers the council will have with regard to registered pharmacists. For the first time, there will be a power to set standards for registered pharmacists. It also makes provision for the inspection of pharmacy premises and sets out the powers of the inspectors appointed by the General Pharmaceutical Council. The regulation of registered pharmacy premises sets the pharmacy regulator apart from other professional health and social care regulators. We have chosen to maintain the regulation of professionals and registered pharmacy premises within the same organisation so that a holistic approach can be taken towards the delivery of pharmaceutical services. I have heard concerns about the potential for duplication of regulation of inspection and assure the House that provision has been made in the order for the sharing of information with other regulators to help avoid such duplication of activity.

Parts 4 and 5 set out the criteria for an individual pharmacist's or pharmacy technician's entry to the register and the educational requirements of both professions. It also sets out the standards expected of those who are registered and the requirement that they continue to demonstrate how they meet those standards through continuing professional development. In addition, it describes the arrangements for entry to the register for those coming from the European Union and elsewhere overseas. There are also provisions for temporary registrations to be used in the event of an emergency. Fitness-to-practise procedures are set out alongside appeals procedures in Parts 6 and 7.

Schedule 1 provides more detail on the constitution of the council and governance arrangements. Schedules 2 and 3 deal with matters relating to visiting practitioners.

1 Feb 2010 : Column 87

Amendments, repeals, revocations, transitional provisions and savings are dealt with in Schedules 4, 5 and 6. I draw your Lordships' attention to Schedule 4 in particular, which amends the Medicines Act 1968. As the Act is a UK-wide instrument, the amendments ensure that the current position in relation to registered pharmacies in Northern Ireland remains untouched.

A great deal of attention has been paid to ensure the smooth transfer of the regulatory functions from the Royal Pharmaceutical Society of Great Britain to the new GPhC in the Schedule 5 transitional arrangements. That should mean that no current student is disadvantaged by the transfer and fitness-to-practise cases already in train can be completed. TUPE for affected staff is covered here. I assure noble Lords that a communications programme is in place to keep staff well informed. Staff transferring to the GPhC will be eligible to join the NHS pension scheme and, subject to individual choices, able to transfer contributions from their existing pension provider to the NHS scheme.

I am aware that the Royal Pharmaceutical Society of Great Britain, while not wishing to impede the Pharmacy Order, is concerned that it might adversely affect its closed staff pension scheme, at least for some of its members. I assure the society that my Department takes the matter most seriously and is working to ensure that the transfer of staff from the RPSGB scheme to that of the GPhC does not worsen the funding position of the closed scheme.

The separation of professional leadership and regulation in pharmacy received widespread support during the consultation on the draft order. However, it would be remiss of me not to reflect the discussions on the issue of restricted titles and the proposal not to have a non-practising register. The RPSGB has traditionally held a non-practising register for those pharmacists no longer working in the profession but who wish to maintain their contact. These people will now be able to join the professional leadership body and continue their allegiance with pharmacy.

Given this option for those who have retired or who are no longer practising, we propose that the regulator should concern itself only with registering and regulating active professionals. The current restricted titles of pharmacist and pharmacy technician are bound by membership of the RPSGB. In the future they will be restricted to registrants of the GPhC. The loss of these titles has been keenly felt by a small but vocal minority of mainly retired pharmacists. Clearly they are eligible to call themselves retired or former pharmacists but must not mislead the public on the currency of their advice or expertise.

Others have suggested that academic or industrial pharmacists do not need to register because the systems they work in are already regulated. The nub of their argument is that they do not wish to be regulated but wish to continue to call themselves pharmacists. They argue that only those providing direct services to patients need regulation. This would mean pharmacists in supervisory or strategic roles, education and industry would not be covered by the requirement to register and therefore not subject to requirements for continuing professional development. That is the nub of the issue.

1 Feb 2010 : Column 88

We believe that there is an individual obligation above and beyond that of any additional systems regulation-be that in industry, education or the NHS-that defines a healthcare professional as opposed to any other member of the workforce.

Those people must ensure that the patient's interests and public safety are paramount. This applies to those teaching the next generation of professionals and to those developing, licensing and marketing new medicines. For these reasons, the order requires that such professionals must register with the GPhC if they want to use the restricted titles. I commend the order to the House.

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

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

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

All that will change with this order. My understanding-it would be helpful if the Minister could confirm this-is that the definition of "practises" in Article 3(2) is drawn widely enough to be able to include those pharmacists who have no direct interface with the public, such as those working in academia or industry. However, use of the title "pharmacist" will now be exclusively restricted to those whose name is

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on the practising register. Anyone who wishes to be included on the new register will be subject not only to a statutory requirement to participate in continuing professional development but also to paying the not insubstantial registration fee.

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

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

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

8.30 pm

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

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risk for someone with a pharmacy degree, or a number of medals or awards, or practising in academia or industry, to call themselves a pharmacist, even though they are not on the council register?

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


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