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Session 2009 - 10
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Delegated Legislation Committee Debates

Draft Pharmacy Order 2010



The Committee consisted of the following Members:

Chairman: Mr. Clive Betts
Battle, John (Leeds, West) (Lab)
Creagh, Mary (Wakefield) (Lab)
Gidley, Sandra (Romsey) (LD)
Griffiths, Nigel (Edinburgh, South) (Lab)
Jackson, Glenda (Hampstead and Highgate) (Lab)
Jenkin, Mr. Bernard (North Essex) (Con)
Kawczynski, Daniel (Shrewsbury and Atcham) (Con)
Keen, Ann (Parliamentary Under-Secretary of State for Health)
Lamb, Norman (North Norfolk) (LD)
Linton, Martin (Battersea) (Lab)
McCartney, Mr. Ian (Makerfield) (Lab)
Simmonds, Mark (Boston and Skegness) (Con)
Swire, Mr. Hugo (East Devon) (Con)
Waltho, Lynda (Stourbridge) (Lab)
Wilson, Phil (Sedgefield) (Lab)
Wilson, Mr. Rob (Reading, East) (Con)
Sarah Davies, Committee Clerk
† attended the Committee

Eighth Delegated Legislation Committee

Wednesday 13 January 2010

[Mr. Clive Betts in the Chair]

Draft Pharmacy Order 2010

2.30 pm
The Parliamentary Under-Secretary of State for Health (Ann Keen): I beg to move,
That the Committee has considered the draft Pharmacy Order 2010.
It is a great pleasure to serve under your chairmanship, Mr. Betts. The order establishes the General Pharmaceutical Council—the GPhC—which will be the new regulator for pharmacists, pharmacy technicians and pharmacy premises in Great Britain. It will complete the separation of professional regulation from professional leadership in pharmacy, signalled by the powers under the Health and Social Care Act 2008. Measures in the Act enable the transfer of all the regulatory functions of the Royal Pharmaceutical Society of Great Britain and the Pharmaceutical Society of Northern Ireland to the GPhC.
Northern Ireland Ministers have decided not to transfer the functions of Northern Ireland’s pharmaceutical society at this stage, but they have the power to do so in the future. A section 60 order to make such changes would be subject to consultation and the affirmative resolution procedure, with debate taking place in the Northern Ireland Assembly. The 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 those professions.
The order was approved by the Scottish Parliament in December last year, as the regulation of pharmacy technicians is a devolved issue. For the Committee’s information, it will also be debated in the other place tomorrow.
I bring to the attention of hon. Members two small typographical errors in the order. 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 to the Privy Council.
The references to paragraph (1)(g) under article 11(2) and (3) should, in fact, be references to paragraph (1)(f). [Interruption.] I ask the Committee to bear with me, Mr. Betts. Similarly, 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 the instrument, as opposed to the Secretary of State and the Scottish Minister.
I want also to bring to the Committee’s attention three further small amendments to the order, which are 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 health care professions, as set out in the White Paper “Trust, Assurance and Safety”. It also brings pharmacy into line with the arrangements for other health care 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.
I am aware that, during public consultation on the order, there was a great deal of debate on restricted titles and the proposal not to have a non-practising register. I would therefore like to take time to go through the provisions of the order and deal with some of the issues that have been raised.
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 in the 21st century, which is to safeguard patients and the public—in particular, those using the services of registrants and the services provided by registered pharmacies.
Part 3 sets out the powers the council will have with regard to registered pharmacies. For the first time, there will be a power to set standards for pharmacies. Provision is also made for the inspection of premises and the powers of inspectors appointed by the GPhC are set out. What sets the pharmacy regulator apart from other professional health and social care regulators is the regulation of registered pharmacy premises. We have chosen to maintain the regulation of professionals and premises within the same organisation so that a more holistic approach to the delivery of pharmaceutical services can be taken forward.
We have heard concerns about the potential for the duplication of regulation and inspection, and I assure members of the Committee that provision has been made in the order for sharing information with other regulators to help to avoid duplication of activity.
Part 4 sets out the criteria for an individual pharmacist 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 will 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 from overseas. Schedule 2 covers entry to the register for “visiting” practitioners. Fitness to practise procedures are set out alongside appeals and sanctions in part 5.
Amendments, repeals, transitional provisions and savings are dealt with under schedules 4, 5 and 6. Schedule 4 amends the Medicines Act 1968. As that Act is a UK-wide instrument, the arrangements ensure that the current position in relation to pharmacy premises in Northern Ireland remains untouched. Particular attention has been paid to ensure the smooth transfer of the regulatory functions from the RPSGB to the GPhC under schedule 5 transitional arrangements. That means that no current student will be disadvantaged by the transfer, and fitness to practise cases already in train can be completed. TUPE—the Transfer of Undertakings (Protection of Employment) Regulations 1981 and 2006—for affected staff is covered here, and I assure members of the Committee that a communications programme is in place to keep the staff well informed.
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 deal with what are termed “restricted titles” and the non-practising register. The RPSGB has traditionally held a non-practising register for those pharmacists who are no longer working in the profession, but who wish to maintain their contact. They will now be able to join the professional leadership body and continue their allegiance with pharmacy. Given that option for those who have retired and are no longer practising, we propose that the regulator should concern itself only with registering and regulating active professionals.
However, the restricted titles of “pharmacist” and “pharmacy technician” are bound by membership of the RPSGB. In future, they will be restricted to registrants of the GPhC. The loss of those titles has been felt keenly by a small but vocal minority of, in the main, retired pharmacists. Clearly, they are eligible to call themselves retired pharmacists, but they 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 their systems are already regulated, which seems to miss the point of professionalism. There is an individual obligation above and beyond that of systems regulation that defines a health care professional as opposed to any other member of the work force.
Mr. Hugo Swire (East Devon) (Con): The issue of retired pharmacists is interesting. Given their tremendous expertise, often built up over a lifetime, they would be a loss to the medical world should they be unable to practise or have their knowledge accessed in some way. If they are to be retained the register, therefore, will they be kept up to date with modern science, and the prescription of modern drugs in particular? The technology is changing quickly and they could do refresher courses now and then to keep them live, as it were.
Ann Keen: I believe that that comes under the leadership area of the order. Many retired pharmacists have already expressed their willingness to be involved in that leadership, where their continuing interest and possible development may take place.
To continue, as opposed to any other member of the work force, a health care professional has a different obligation. Such professionals must ensure that the patient’s interest and public safety are paramount. That applies to those teaching the next generation of professionals and to those developing, licensing and marketing new medicines. For those reasons, the order requires that such professionals must register with the GPhC if they want to use the restricted titles.
In closing, I thank you, Mr. Betts, and commend the order to members of the Committee.
2.41 pm
Mark Simmonds (Boston and Skegness) (Con): I join the Minister in saying what a pleasure it is to serve under your guidance, Mr. Betts. I also thank the Minister for her introductory remarks. I would like to probe some of the issues she raised and elicit a little more information about why the Government have come to some of their conclusions.
There is cross-party support for the importance of the role that pharmacy has in providing health care. All political parties want an increased and enhanced role for pharmacy—not just in providing services, but in the all-important dissemination of information to patients and in the prevention and public health arena in particular. Obviously, the Conservative party is keen for the opportunity to create a greater such focus to be given.
I shall not repeat what the Minister explained about the order, but it is important for the Committee to be aware that the pharmacists themselves are generally in favour of it and the distinct separation to which she referred, which, as she said, will bring pharmacy into line with other medical professions. We think that important, as does the RPSGB, which the Minister, the hon. Member for Romsey, who speaks for the Liberal Democrats, and I met and kept in contact with as the order was being drawn up.
I want to raise 10 key points. It would be helpful if the Minister and her key civil servants responded to them this afternoon. First, on the timing of the order, clearly, the RPSGB was disappointed that it was not introduced earlier. It has been in train for a considerable time and I would like her to explain the delay.
The Committee may be interested to know that there is an obscure Government document, which can be found on the internet, called “The Government’s Forward Regulatory Programme”. There are two annexes to the programme, which detail the progress of subsequent regulations. Annex B—Measures without a definite implementation date—says:
“Following review, these will not be brought in before April 2011 at the earliest, and subject to further consultation some may never come into force.”
The order is one of those.
The Minister and her civil servants might like to look at page 86, which clearly includes the order creating the GPhC. I am interested to know why it appears in that document—we are discussing it today, however—because its appearance clearly caused angst in the pharmaceutical world.
The second issue is whether the Minister thinks it appropriate that the pharmaceutical council was appointed in September 2009, with all the costs inherent in that appointment, even though it could not come into operation prior to the order being put in place. Was it right for pharmaceutical bodies to do that before the Committee had scrutinised the order?
The Minister rightly raised a concern in relation to pharmacists in industry, who do not have a patient focus or a role in interacting with patients. There seems to be evidence that there will be duplication between the role of the Medicines and Healthcare products Regulatory Agency in regulating professional pharmacists in industry and the proposals set out in the order.
I take the Minister’s points about professionalism and the importance of having the register in one place, but there is far too much duplication in many areas of the national health service already and we do not want to create more. That is particularly important in relation to the continuing professional development of those in industrial pharmacy. It is important that CPD, which is a critical part of a pharmacist’s role, as my hon. Friend the Member for East Devon correctly pointed out, is relevant to the role of the individual pharmacist. It would be helpful if the Minister explained that further, particularly as part 2 says that its main purpose
“is to protect, promote and maintain the health, safety and well-being of the public when exercising functions that affect the public.”
Clearly, pharmacists working in industry do not fit comfortably into that category.
Mr. Ian McCartney (Makerfield) (Lab): The hon. Gentleman has made an interesting point. Pharmacists may not have a relationship with a patient, but they would certainly have a relationship in the workplace with fellow workers and, potentially, with customers of the organisation that they work in. Health and safety would be paramount irrespective of any patient relationship.
 
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Prepared 14 January 2010