Medicines Act 1968 (Pharmacy) Order 2011

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.