Draft Medicines Act 1968 (Pharmacy) Order 2011
The Committee consisted of the following Members:
† Barclay, Stephen (North East Cambridgeshire) (Con)
† Burns, Mr Simon (Minister of State, Department of Health)
† Burt, Lorely (Solihull) (LD)
Dobson, Frank (Holborn and St Pancras) (Lab)
† Ellis, Michael (Northampton North) (Con)
† Evans, Chris (Islwyn) (Lab/Co-op)
† Fovargue, Yvonne (Makerfield) (Lab)
† Gwynne, Andrew (Denton and Reddish) (Lab)
† Kirby, Simon (Brighton, Kemptown) (Con)
† McPartland, Stephen (Stevenage) (Con)
† Morris, Anne Marie (Newton Abbot) (Con)
† Pearce, Teresa (Erith and Thamesmead) (Lab)
† Ruddock, Joan (Lewisham, Deptford) (Lab)
† Shannon, Jim (Strangford) (DUP)
† Skinner, Mr Dennis (Bolsover) (Lab)
† Soubry, Anna (Broxtowe) (Con)
† Wright, Jeremy (Lord Commissioner of Her Majesty's Treasury)
Mark Etherton, Committee Clerk
† attended the Committee
First Delegated Legislation Committee
Tuesday 25 October 2011
[Mr Christopher Chope i n the Chair]
Draft Medicines Act 1968 (Pharmacy) Order 2011
10.30 am
The Minister of State, Department of Health (Mr Simon Burns): I beg to move,
That the Committee has considered the draft Medicines Act 1968 (Pharmacy) Order 2011.
It is a pleasure to serve under your chairmanship, Mr Chope. I also congratulate the hon. Member for Denton and Reddish on appearing as an Opposition Front-Bench spokesman for the first time. I hope that he enjoys the experience and that he goes on to spend many years in the same role.
The order will remove the restriction placed on pharmacists registered in Britain by virtue of a pharmacy qualification awarded by a relevant European state that prevents them from being in charge of a newly established pharmacy. That refers to any pharmacy that has been registered for less than three years and is commonly known as the “three-year rule”. The relevant European states referred to are Iceland, Norway, Liechtenstein, Switzerland and the European Union member states; it is not relevant to pharmacists who qualified in the United Kingdom. The order was debated in another place on Monday 17 October.
I should first give the Committee some background. All pharmacists practising in Britain must be registered by the General Pharmaceutical Council, as must all pharmacy premises. Some pharmacists are registered to practise in Britain under arrangements for the mutual recognition of pharmacist qualifications awarded by EU member states or other relevant European states. EU directive 85/433—now 2005/36/EC—includes provision for member states to place restrictions on the recognition of the qualifications of such pharmacists in the case of pharmacy premises registered for a period of less than three years.
In Britain, the restriction applies to the pharmacist in charge of such pharmacies, known as the “responsible pharmacist”. In other words, while all pharmacists registered in Britain under the mutual recognition arrangements may work in any British pharmacy, however long it has been registered, such pharmacists cannot hold the position of responsible pharmacist in a pharmacy that has been registered for less than three years. That derogation in the directive was originally established in the mid-1980s for economic reasons following concerns raised by UK MEPs, who believed that given the UK’s comparatively open arrangements in relation to pharmacy ownership, there was a risk that the mutual recognition arrangements would put existing UK pharmacists at a disadvantage. Since then, however, much has changed in terms of pharmacy arrangements in other EU member states and the evolution of domestic policy in Britain.
We have conducted a full public consultation on removing the restriction for established pharmacists, such as those registered with the GPC in part 1 of the register, and for visiting pharmacists, namely those temporarily practising in the UK and registered in part 4 of the register. However, the restriction has not affected any visiting pharmacist, as to date none has been registered. The response to the public consultation has been strongly in favour of removing the restriction. The proposal has the support of the GPC, the pharmacy regulator; the Royal Pharmaceutical Society, the professional body for pharmacists; the devolved Administrations; and all the main pharmacy representative organisations, including the Pharmaceutical Services Negotiating Committee, Community Pharmacy Scotland and the Company Chemists Association.
The proposal will encourage flexibility, efficiency and continuity of care within pharmacy. It will end the situation whereby a responsible pharmacist, registered here by virtue of the mutual recognition arrangements, can no longer continue in that role if their pharmacy relocates, even if it is only moving next door, and therefore becomes a newly registered pharmacy. The removal of that restriction will mean that patients can enjoy greater continuity of care in such circumstances; that all registered pharmacists will be placed on a level footing in terms of their employment prospects; and that employers will have a deeper pool of employees to draw upon and less bureaucracy to deal with when filling vacancies.
I should now explain the change required to the final version of the explanatory note on the order. In undertaking preparatory work for this debate on the draft order, officials in my Department realised that an error had been made. Contrary to previous understanding, visiting pharmacists, a sub-category of registrants from relevant EU states who do not go through the full registration procedure, are covered by the removal of restrictions that the draft order would achieve. Previously, it had been understood that a separate statutory instrument would be needed to accomplish that. The intention has always been to remove the restriction on responsible pharmacists for all those registered to practise in Great Britain under the EU mutual recognition arrangements, whether visiting or not. The consultation reflected that, and the order as currently drafted would achieve this. As a result of this misunderstanding, the earlier version of the accompanying draft explanatory memorandum that hon. Members may have seen, and the explanatory note of the order, suggested that the order did not remove the restriction in relation to visiting pharmacists.
In fact, the substantive provisions of the order achieve what was intended and a further instrument is therefore not required. However, the text in the explanatory note that refers to the register requires a small correction and so the reference to “Part 1” of the register will not appear in the final version. I apologise if any confusion has been caused by this late change, and I commend the order to the Committee.
10.36 am
Andrew Gwynne (Denton and Reddish) (Lab): May I also say how pleased I am to serve under your chairmanship, Mr Chope? I thank the Minister for his kind welcome to my role as shadow health Minister. Some of us have
greatness thrust upon them; others get to lead for Her Majesty’s Loyal Opposition on the draft Medicines Act 1968 (Pharmacy) Order 2011.I am sure that the Committee will be pleased to hear that I shall be brief. I remember when I was serving as a Government Parliamentary Private Secretary that the Whips used to assure all the Back Benchers that the debate on the statutory instrument would be short, and it always surprised me how much the then Opposition managed to fill 90 minutes with debate. Of course, this issue touches on the thorny issue of Europe, and I hope that yesterday’s debate in the Chamber does not spill over into today’s. I am sure that it will not.
As the Minister said, the Government have consulted on whether we should remove the three-year rule from new pharmacies. The consultation found that support for removing the restriction was high. Respondents were inclined to see benefits from its removal rather than risks. However, I would like to ask a few questions about the statutory instrument.
The consultation raised questions about competence in English. We know that a check on language knowledge and the competence of a pharmacist from outside the UK who seeks work in the NHS is applied by the prospective employer, but no check is made at the point of registration. The Social Policies and Consumer Protection EU Sub-Committee in the other place also outlined that concern last week in its report on the mobility of health care professionals. It found that the rules that allow health care professionals to practise throughout the EU pose an unacceptable risk to the safety of patients. Indeed, the Committee recommended that regulatory bodies should be allowed to test the language skills of all non-UK applicants. Are there any plans to ensure that those in charge of a pharmacy have a high enough standard of English language to avoid all risk of a patient misunderstanding any advice given to them?
Other questions have been raised about the qualifications of pharmacists, including the need to look at the competencies of the pharmacists and the person’s ability to manage a pharmacy. As the consultation outlined, a newly qualified pharmacist from Europe could obtain registration in Great Britain and establish a pharmacy with newly recruited staff and newly developed procedures, and they would be the responsible pharmacist. Are there plans to introduce a standardised competency test to ensure that a pharmacist from the countries mentioned in the order placed in charge of a new pharmacy will have all the required skills and competencies?
We also need to consider the wider question of European pharmacists working in Britain and what safeguards the Government will put in place to ensure that information on fitness to practise is efficiently shared. How can an employer determine whether the pharmacist in question is qualified in their own country and has no pending fitness to practise cases to answer? How can we ensure that we do not just rely on the good will of the practitioner to declare any previous or current cases?
I look forward to the Minister’s responses to my handful of questions. That said, it is broadly recognised that the proposed changes will bring in many benefits and, with some assurances on the matters that I have raised, the Opposition Front Bench will not be opposing the Government’s proposals.
10.41 am
Mr Burns: I am grateful to the hon. Gentleman, who raised three issues, which I should like briefly to deal with in order to assure him and the Committee.
The first issue was fluency in English for those practising as pharmacists or in the pharmaceutical world. Let me assure the hon. Gentleman that the Government are concerned to ensure that those working in the NHS with patients, whether in pharmacies, hospitals, GP practices or out-of-hours services, are fluent in the language and can understand it, so that they can converse with patients—and patients can understand what is said to them—and do their jobs properly. The Government’s response to the European Commission’s consultation on the recognition of professional qualifications directive clearly sets out the view that in the health care professions the ability to communicate with patients and service users is vital.
The Government also said in their response that it is vital that employers and organisations contracting with health care professionals undertake effective checks on language and communication competence. The management of the NHS is devolved, but in England there are statutory requirements relating to applicants wishing to provide NHS services as a pharmacy contractor. That means that their applications may be refused if they do not satisfy the local primary care trust that they have the knowledge of English necessary for the provision of pharmaceutical services in their area. We expect and encourage those carrying on pharmacy businesses to engage staff—including those who may serve as “responsible pharmacists”—who have a knowledge of English appropriate for the role that they will be undertaking. In addition, the General Pharmaceutical Council, the regulator for pharmacists and pharmacy technicians in Great Britain, requires as part of its standards of conduct, ethics and performance that pharmacy professionals must be able to communicate effectively with patients and the public and take reasonable steps to meet their communication needs.
On the question of EU staff and competence, any pharmacist wishing to practise in Great Britain who registers in part 1 of the register held by the General Pharmaceutical Council, including those wishing to register under the EU mutual recognition provisions, must declare any criminal convictions or fitness to practise determinations when they register, as well as any ongoing criminal or fitness to practise investigations. In addition, the General Pharmaceutical Council also requires what is called a letter of good standing or a certificate of current professional status from the relevant competent authority—that is, the relevant regulatory or Government body in the country concerned that is equivalent to the General Pharmaceutical Council. That is the mechanism by which any fitness to practise issues in the home member state are brought to the attention of the General Pharmaceutical Council.
Before they begin to practise, visiting pharmacists registered in part 4 of the register are also obliged to provide, among other things, evidence of their qualification and evidence that they are lawfully established and have not been prohibited from practising in their home member state. Registration is for 12 months and may be renewed.
The hon. Gentleman’s final point was about introducing a standardised competence test to ensure that pharmacists from the countries mentioned have all the required skills
to do their jobs in this country. Under directive 2005/36/EC, on the recognition of professional qualifications, a pharmacist holding a recognised qualification issued by one member state is entitled to have it recognised in another, and would therefore be entitled to register with a competent authority, such as the General Pharmaceutical Council. However, employers of pharmacists should ensure that those they employ have the skills required to undertake their specific posts. The General Pharmaceutical Council’s standards of conduct, ethics and performance, among other things, require the pharmacist to recognise the limits of their professional competence and practise only in those areas in which they are competent to do so. Their continued registration is subject to adherence to the General Pharmaceutical Council’s requirement for continuing professional development and its standards of conduct, ethics and performance.I hope that that answers the hon. Gentleman’s questions and that he is reassured.
10.46 am
Stephen Barclay (North East Cambridgeshire) (Con): I am sure that the Minister is familiar with the case of David Gray, my constituent who was unlawfully killed by a German qualified doctor, Dr Ubani. While I shall support the motion today, I want to place on record two issues that apply not only to doctors but to pharmacists. The Minister referred to the entitlement to registration. That is the EU legal position, but as we know from the case of David Gray there is a concern that EU law is used as a block to any testing where suspicions are raised by the relevant medical profession. The many other concerns that I have raised with the Secretary of State about doctors and GPs are pertinent to this order. Perhaps the Minister could take that issue away and consider it.
I have also raised with the Home Secretary another issue that, again, applies to today’s order. Where errors are made, there is an issue of enforcement. The way in which enforcement applies across jurisdictions, for pharmacists as well as for doctors, results in a patchwork of enforcement in matters such as data protection. The differences between the ways in which professional bodies regulate across the EU confine the ability to enforce, which is one of the problems that Mr Gray’s family have encountered.
I just wanted to put those issues on record. Perhaps the Minister can look at them in due course.
10.48 am
Mr Burns: I am grateful to my hon. Friend. As he will appreciate, the point about Dr Ubani and the out-of-hours service is well beyond the scope of the order, as it deals only with pharmacies. However, I can reassure him that, as he will be aware from the speech of my right hon. Friend the Secretary of State at the Conservative party conference, we take seriously the problems that that sad and tragic case highlighted. We are determined to look closely at them and make changes to require people providing GP services to patients in this country to be fully conversant with and understand the English language. We seek to minimise the possibility of a recurrence of that case.
My hon. Friend’s second point was about uniformity of enforcement. I have heard what he has said. I think I can reassure him on one point, which is that we have in Britain a regime with proper enforcement. We are not complacent and we keep it under review to make sure that there is no deterioration, but I am satisfied that the system works in the way that is intended. I will certainly bear in mind my hon. Friend’s points vis-à-vis other EU states.