Pharmacy Order 2010

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 Safety have 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 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? 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 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. The order makes provision for the council to regulate premises, as well as people, and the noble Baroness mentioned this. What premises are we talking about here, other than retail and manufacturing pharmacies? Does the definition include hospital and prison pharmacies, and if not, why not? It would be helpful if the Minister could say precisely in what sense premises will be regulated, because, as we know from the Health Act which we debated last year, PCTs will also have authority to regulate pharmacists’ premises. Where will the dividing line of responsibility fall? I appreciate that there are currently no statutory standards for registered pharmacy premises within existing legislation, and it is clear that the council has a direct interest in promoting safe and effective practice in pharmacies. However, we do not want PCTs doubling up on this kind of oversight and effectively second-guessing the council by applying a different set of standards. What safeguards will there be to prevent this happening? I should like to turn finally to Articles 10 and 11 of the order, which deal with the power of entry to premises and the powers of an inspector. In any legislation in which provision is made for these kinds of power, I always think that we should take a particularly close look at the wording to make sure that the powers are framed in a way that preserves an appropriate balance of rights between those who are charged with protecting the interests of the public and those whose privacy is being invaded. In this case we find wording that appears somewhat vague and, therefore, potentially unsatisfactory. Article 10(1) says that an inspector may, subject to producing the relevant documentation, enter, ""any registered pharmacy or other premises at any reasonable hour"." "Other premises", one takes it, could refer to any office or commercial building, but could also include a pharmacist’s private dwelling. Paragraph (2) deals with private dwellings by saying that they may be entered, ""only if 24 hours notice … has been given to the occupier"." There is nothing about obtaining the consent of the occupier first. I am concerned by such an unfettered power being vested in a body such as the inspectorate. Paragraph (3) then appears to qualify the preceding provision by creating a series of exceptions under which a justice of the peace may order entry to a registered pharmacy or other premises; for example, if the case is urgent, the occupier is absent or there is a need for an element of surprise or secrecy. Again, one takes it that other premises may include a private dwelling-house. Provided that a justice of the peace can be satisfied on one or more of the four conditions, it would seem that he can issue a warrant authorising entry to someone’s private dwelling-house, by force if need be. At that point, an inspector is empowered under Article 11 to search the premises and inspect and remove anything he likes. He does not have to account for what he does; he does not have to issue a receipt for what he takes; he is not liable to make good any damage caused by forcible entry, provided reasonable force is used; and he does not, it would appear, have to confine the timing of his entry to reasonable hours. I confess to being troubled by this series of provisions. I ask the Minister whether I have read the regulations correctly. Is she satisfied that these powers are appropriate and proportionate? If so, can she point to equivalent powers conferred on other regulatory bodies, particularly in relation to private dwelling-houses? Under Section 62(4) of the Health and Social Care Act 2008, premises used wholly or mainly as a private dwelling are explicitly excluded from the scope of the power of entry conferred on the Care Quality Commission. What is the justification for giving the General Pharmaceutical Council’s inspectorate these more far-reaching powers? Amendment to the Motion Moved by