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Medicines Act 1968 (Pharmacy) Order 2011

Volume 731: debated on Monday 17 October 2011

Considered in Grand Committee

Moved By

That the Grand Committee do report to the House that it has considered the Medicines Act 1968 (Pharmacy) Order 2011.

Relevant document: 28th Report from the Joint Committee on Statutory Instruments.

My Lords, the Medicines Act 1968 (Pharmacy) Order, being debated today, will remove the restriction placed upon pharmacists registered in Britain by virtue of a pharmacy qualification awarded by a relevant European state that prevents them being in charge of a newly established pharmacy. This 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 (EU) member states. It is not relevant to pharmacists who qualified in the United Kingdom.

I should first give the Grand 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. The current restrictions on visiting pharmacists owning pharmacy businesses or acting as superintendents are not affected by this order.

The derogation in the directive was originally put in place in the mid-1980s for economic reasons, following concerns by UK MEPs. They 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 pharmacies at a disadvantage. Since then, however, much has changed both 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, both for established pharmacists—those fully registered with the General Pharmaceutical Council in part 1 of the register—and for visiting pharmacists—those temporarily practising in the UK and registered in part 4 of the register. However, the restriction has not affected any visiting pharmacists as, to date, none has been registered.

The response to the public consultation has been very much in favour of removing the restriction. The proposal has support from the General Pharmaceutical Council, the pharmacy regulator, the Royal Pharmaceutical Society, the professional body for pharmacists, as well as all the main pharmacy representative organisations, including the Pharmaceutical Services Negotiating Committee, Community Pharmacy Scotland, the Company Chemists Association and the devolved Administrations.

The proposal will encourage flexibility, efficiency and continuity of care within pharmacy. It will end the situation where 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 only moves next door, and therefore becomes a newly registered pharmacy. Removing this 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 potential employees to draw upon and less bureaucracy to deal with when filling vacancies.

I should now explain the revision of the draft Explanatory Memorandum laid before your Lordships today and 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 the Department of Health realised that, contrary to previous understanding, “visiting pharmacists”, a sub-category of registrants from relevant European states who do not go through the full registration procedure, are covered by the removal of restrictions that the draft order would achieve. It will not, therefore, require a separate legal instrument to remove the restriction upon their acting as “responsible pharmacist” at new pharmacies. Up to this point, it had been thought that a separate legislative instrument would be required to achieve this. The confusion appears to have arisen in the understanding of the differences between the restrictions applying to those who either may own, or carry on, a pharmacy business or act as superintendent, on the one hand, and the provisions relating to the responsible pharmacist on the other. A superintendent manages a pharmacy on behalf of a company. A responsible pharmacist is in charge of a pharmacy at a given time, and takes on responsibility for the effective management of pharmacy law and practice within a single branch at a particular time. If the draft order is approved, it will still not be possible for a visiting pharmacist to carry on—that is, to own a new pharmacy—or act as a superintendent in relation to a new pharmacy.

However, a visiting pharmacist, and any other pharmacist registered by virtue of the mutual recognition arrangements, would, upon the coming into force of the order, be entitled to be the responsible pharmacist in charge of a newly registered pharmacy in Britain. It is the similarity between the different concepts of control that appears to have led to the confusion. 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 this and the order as currently drafted would achieve this.

Because of the misunderstanding, the earlier version of the accompanying draft Explanatory Memorandum, and the Explanatory Note on the order itself, suggested that the order did not remove the restriction in relation to visiting pharmacists. In fact, the substantive provisions of the order achieve the intention and a further instrument is not, therefore, required. However, the text in the Explanatory Note that refers to the register was incorrect, and the reference to part 1 of the register will not appear in the final version. I apologise for any confusion caused by this late change. I commend this order to the Committee.

As the noble Earl stated, a lot has changed since the derogation in the directive was put in place. Much has changed in pharmacy arrangements in other EU member states and in the evolution of domestic policy. The reasons, as the Minister stated, were commercial.

In England, for example, there has been a welcome change over the past few years making it easier for people to get to a chemist, given that there are new pharmacies with longer opening hours. Clearly, such market restrictions are not appropriate today, and their removal will assist by increasing the pool of available pharmacists and ensure improved continuity of service delivery. I note that the change has also been welcomed by the key representative bodies of pharmacies.

I of course recognise that the restriction affects a relatively small number of pharmacies—just over 10 per cent, and just over 5 per cent of all pharmacists registered to practise in Great Britain. I also understand and accept the reasons for the change in the Explanatory Memorandum. However, these changes in the legislation raise broader issues relating to the competencies of the pharmacist and the person’s ability to manage a pharmacy. For example, the report on the consultation noted that concerns were expressed by respondents on competency in English. The Department of Health in its response stated that in the UK a check on the language knowledge of a pharmacist from outside the UK who is seeking work within the NHS is applied by the prospective employer, but that there is no check made at the point of registration.

This leads to three specific questions to the Minister. First, are there plans to introduce a standardised competency test to ensure that any pharmacists from the countries mentioned in the order who are in charge of a new pharmacy have all the required skills and competences? Secondly, are there plans to ensure that those in charge of a pharmacy will have a sufficiently high standard of English to avoid all risk of a patient misunderstanding any advice given? Thirdly, 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?

My Lords, I declare an interest as chairman of the council of the School of Pharmacy of the University of London. I thank the noble Earl, Lord Howe, for a crystal clear explanation. I suppose, perforce, it had to be crystal clear to clear up some confusion arising from the Explanatory Memorandum. This is precisely the kind of uncontroversial deregulation that is important in the context. From both professional and consumer perspectives one could say that it is a perfectly formed small regulation. It affects a limited number of people who could not be responsible pharmacists in certain circumstances, but will now be able to be so where there are no significant safety implications from deregulating in the way that this order does.

I want to raise the issue of reciprocity. The noble Earl mentioned that the reason for deregulation is that circumstances have changed. The noble Lord, Lord Collins, also referred to that. I am sure that in broad terms that is the case, but I should be extremely grateful to hear what the noble Earl believes the level of that deregulation would be. I remember doing a study of several EU countries, looking into what was permissible in pharmacy ownership and the level of regulation. That was about five years ago, when the level of regulation was extremely high—not just pharmacy regulation but the kind of licensing required to run a retail outlet, and so on. We have some extremely well run chains in this country, which would like to expand their offer in the EU more broadly. They have been largely frustrated from doing so by some of the regulation that applies. Therefore, reciprocity in these circumstances is extremely important. I am interested to hear just what the Minister believes to be the level of significant deregulation that has taken place.

My Lords, I am grateful to both noble Lords for their support for the order. The noble Lord, Lord Collins, asked me three questions. The first was about whether there are any plans to introduce a standardised competency test to make sure that pharmacists from the various countries mentioned have all the required skills to do their job. Under directive 2005/36/EC on the recognition of professional qualifications, which I mentioned, a pharmacist who holds a recognised qualification issued by one member state is entitled to recognition of that qualification in another member state, and would therefore be entitled to registration with a competent authority, such as the General Pharmaceutical Council.

However, employers of pharmacists should ensure that anybody they employ has the skills required to undertake the specific post. 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 in only those areas in which they are competent. Their continued registration is subject to adherence to the council’s requirement for continuing professional development—CPD—and standards of conduct, ethics and performance.

Secondly, the noble Lord asked whether there are plans to make sure that those in charge of a pharmacy have a high enough standard of English. The UK Government’s response to the European Commission’s consultation on the review of the directive on the recognition of professional qualifications clearly sets out the view that in the healthcare 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 healthcare professionals undertake effective checks on language and communication competence. The management of the NHS is devolved, but in England I can say that there are statutory requirements relating to applicants wishing to provide NHS services as a pharmacy contractor; that means that their applications must 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, with a knowledge of English which is 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.

The noble Lord’s third question was how an employer is supposed to determine whether a pharmacist from overseas is qualified in their own country and has no pending fitness-to-practise cases to answer. Any pharmacist wishing to register in Great Britain with the regulator, including those wishing to register under the EC mutual recognition provisions, must at the point of registration make declarations about any criminal convictions as well as ongoing criminal investigations.

In addition, the General Pharmaceutical Council also requires what is called a “letter of good standing”, or a certificate from the relevant competent authority— that is, the relevant regulatory or government body responsible in the country concerned, which is equivalent to the General Pharmaceutical Council. This 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.

The noble Lord, Lord Clement-Jones, asked a broader question about deregulation and reciprocity in our partner countries. At the time when the directive was made, most member states had greater restrictions on pharmacy ownership than the UK. That point in particular caught the attention of UK MEPs at the time. The UK has had the least restricted system for many years, with pharmacies owned by pharmacists and non-pharmacists—for instance pharmacy chains—but in some other member states, pharmacies have to be owned by pharmacists and they can only own one pharmacy, and not a chain of pharmacies.

That was the situation as it used to obtain. It is now a number of years since the directive was first cast, and some other European states allow ownership of pharmacies by non-pharmacists, enabling ownership by UK pharmacy chains. The level of reciprocity on pharmacy ownership, including for pharmacy chains, is very much improved.

As regards any restrictions which may apply to pharmacists who have qualified in Great Britain practising in other EU member states—which I think is part of the question my noble friend asked—our information is that only one other member state apart from Great Britain now operates a restriction under the derogation permitted by directive 2005/36.

Motion agreed.