Health and Sport Committee, 09 Dec 2009

Meeting date: Wednesday, December 9, 2009

Official Report 230KB pdf

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Subordinate Legislation

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Pharmacy Order 2010 (Draft)

Agenda item 2 is subordinate legislation. The draft Pharmacy Order 2010 is going through the Scottish Parliament and the United Kingdom Parliament at the same time. Because of the length of time that the Subordinate Legislation Committee spent considering it, we have only this meeting to consider the motion and to recommend approval, as we must report on the order by 14 December. That means that we must dispose of the order at this meeting.

We will take oral evidence on the draft order. Members have a copy of it and of paper HS/S3/09/32/1, which sets out the errors that the Subordinate Legislation Committee has drawn to our attention. The order makes provision for the establishment of a new general pharmaceutical council and sets out the arrangements for the council's regulation of the professions of pharmacist and pharmacy technician in Great Britain. The order also amends current legislation in respect of the regulation and inspection of registered pharmacies. Those functions are currently undertaken by the Royal Pharmaceutical Society of Great Britain.

The Minister for Public Health and Sport, Shona Robison, is present to give evidence. She is accompanied by Scottish Government officials, who are Catherine Clark, head of the regulatory unit in the chief nursing officer directorate; Professor Bill Scott, the chief pharmaceutical officer; and Kathleen Preston, a health and community care solicitor with the legal directorate. I welcome you all and ask the minister to make any introductory remarks.

The Pharmacy Order 2010 will establish a new general pharmaceutical council as the regulator for pharmacists, pharmacy technicians and pharmacy premises in Great Britain. It will separate the regulatory function from the professional leadership, which will remain with the Royal Pharmaceutical Society of Great Britain. For pharmacy technicians in Scotland, regulation is devolved, which is why the order has been laid for approval by resolution of the Scottish Parliament as well as both houses of the UK Parliament.

The order is the next step in the implementation of the programme of reform and modernisation of health profession regulation that was set out in the UK Government white paper "Trust, Assurance and Safety—The Regulation of Health Professionals in the 21st Century". The programme is aimed at improving patient safety and the quality of services that are provided to the public. It addresses the public concern and doubts about the impartiality of regulators of the health care professions that came about as a result of high-profile cases—including that of Harold Shipman—and which threatened to undermine trust in our system of professional regulation.

The separation of professional regulation from professional leadership in pharmacy was signalled by powers that were taken in the Health and Social Care Act 2008. The order will bring pharmacy into line with the other regulated health care professions, whose regulatory bodies are separate from the bodies that represent the professions. The order will remove the conflict of interests that currently faces the RPSGB, which will now be able to focus on promoting and advocating for its professions. The changes will enhance public confidence in the ability of the pharmacy regulator to protect the public and deal with poor professional standards.

The order sets out the key functions of a professional regulator in the 21st century, governance arrangements and the core purpose, which of course is to safeguard patients and the public, particularly those who use the services of registrants. It sets criteria for entry to the register, educational requirements, the standards expected of those registered and the requirement that they continue to demonstrate how they meet the standards through continuing professional development. The order also sets out arrangements for entry to the register for those from the European Union and overseas. Fitness-to-practise procedures are set out alongside appeals and sanctions.

Schedule 5 contains transitional arrangements for the transfer of the regulatory functions from the RPSGB, which will ensure that no current student is disadvantaged, that fitness-to-practise cases already in progress can be completed and that the Transfer of Undertakings (Protection of Employment) Regulations 2006 will apply to affected RPSGB staff.

Before we proceed to discuss the order, members will want to be aware of some amendments that need to be made to the version before them. First, the Subordinate Legislation Committee highlighted the current reference in paragraph 2 of the preamble to

"the Secretary of State and the Scottish Ministers".

That will be replaced with "Her Majesty, with the advice of Her Privy Council", as this is an order in council that is ultimately for the Privy Council, following parliamentary approval. Secondly, the SLC also highlighted references in article 11(2) and 11(3) to article 11(1)(g), both of which are typing errors that need to be changed to refer to article 11(1)(f). Finally, three further small amendments to the order are now 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" now require to be replaced by references to "the EU Treaties". All those changes will be made before final printing.

I am happy to take any questions on the draft order.

Thank you, minister. I remind members that this is an evidence session, so I invite questions from them.

I very much welcome the order, which is clearly another step along the road to improving the safety of the public in respect of professional activities and ensuring that the professions are governed in an appropriate way instead of there being conflicts of interest, as was the case under the previous system.

To get a flavour of how the order will work, I want to know how it will affect a particular problem that we currently face. Currently, the RPSGB issues ethical guidelines to its professional group. Will the new general pharmaceutical council issue those ethical guidelines? I am thinking in particular of the current conflict between community pharmacists and producers—of which I know the minister is well aware—whereby the producers are effectively rationing drugs to community pharmacists because some export drugs in much larger quantities than previously. The ethical guidance basically says that exports should not take place unless it is clear that they do not affect patient care. However, the net result of a few pharmacists undertaking that in a way that the industry regards as inappropriate is that every community pharmacist now spends the latter part of almost every supply month rushing around trying to get the appropriate drugs for their patients.

That is a practical example. I realise that this is quite a technical question, minister, but will the new council have any powers to bring in those pharmacists and say, "What you're doing is actually putting the public at risk"? Ultimately, that whole situation is putting the public at risk.

Who wants to answer that?

I will take Dr Simpson's question.

The current code of ethics places a duty on pharmacists to endeavour to do their best for patients, which includes getting medicines for them. The new general pharmaceutical council will publish its code of ethics. When it is seen that a pharmacist is adversely affecting patient care by their activity, they will be investigated.

Will the RPSGB continue to do that until the order comes into effect?

Yes, it will be done through the RPSGB's inspectorate.

Will the council's powers be significantly different from those of the RPSGB? In the example that I gave, were someone to be arraigned in front of the council, would they—

The powers will be transferred to the GPhC, which will determine whether an investigation should take place and what action should be taken against the pharmacist.

Finally, what right of appeal would that pharmacist have? Would they appeal to the Health Professions Council generally, or would the appeal mechanism be within the new body?

Who will answer that question? You may answer collectively.

The appeals mechanism is within the order.

And what is that? The order is a long document and I did not get to that point. Would the appeal go to the Health Professions Council, the central body, or would it be retained within the new body?

It would be within the new body. The new body will have its own fitness-to-practise investigating committee.

Are you content with that answer, Dr Simpson?

I am slightly concerned about that. One problem with the GMC has been the fact that a number of cases that it determined—admittedly, before it came under the Health Professions Council—ended up in court and there was criticism of the process in the GMC. There was also criticism of the fact that the appeal mechanism was within the body that made the initial decision. I am slightly concerned that we are replicating that system for pharmacists.

Steps are being taken to address that. There will be a new adjudicating body for doctors, in the first instance, and opticians, which will be called the office of the health professionals adjudicator. That will separate the appeals process from the new body.

Will that eventually apply to pharmacists as well?

That will be considered once we have seen how it is working. The regulation of pharmacists is reserved at the moment. Once we have seen how the office of the health professionals adjudicator is working, the process will apply to other bodies, too.

So that is work in progress.

I want to clarify one thing. The body that oversees the health professions regulators is the Council for Healthcare Regulatory Excellence, not the Health Professions Council.

Sorry.

The CHRE will assess how each body is doing, and all the regulators will be called to account each year—there will be an annual assessment of how they are carrying out their duties.

Thank you.

I have a couple of questions on the Executive note. I was surprised to read:

"A recent study found that over 3% of items dispensed in community pharmacy were subject to a dispensing error relating to labelling or content."

Are pharmacies currently regulated or audited? Will that dispensing error rate of 3 per cent be reduced by the order?

The number of prescriptions that are dispensed in the NHS in Scotland runs to more than 80 million, so 3 per cent is a significant number. However, those errors are picked up before they reach the patients. The premises themselves are regulated and any dispensing error is reported by the pharmaceutical inspectorate to the Royal Pharmaceutical Society of Great Britain. The new GPhC will have the same powers as the RPSGB and the pharmaceutical inspectorate, and it will regulate the premises. We will continue to promote good practice in pharmacies to reduce the number of errors as far as we can.

Sorry, but you have not answered my question. We are told on page 16 of the Executive note, under the heading "Avoidance of serious misconduct incidents", that the errors lead to a reduction in life expectancy and the deaths of 20 patients. I hope that what is before us today will reduce the number of such errors. I am asking for assurance that that will happen, and I do not think that I have quite got that.

I think that Professor Scott said that it is significant.

It is significant, but I hope that the proposal that is before us today will reduce the number of those errors. I am not sure that I quite got that answer.

That is something that we continue to work at. The GPhC, as well as the new professional body, will continue to put in place procedures to ensure that we reduce the number of errors to a minimum.

I will leave that question there.

Page 6 of the same document says:

"The provisions in the Order focus on setting standards so that the public can be clear about what they can expect from the profession and the profession is clear what is expected of it."

Will you explain that to me? I am not sure that the public know what to expect.

Draft standards have gone out for consultation. It is the intention of the GPhC to ensure that there are good communication strategies and that the public are aware of its function and how they can communicate with it if they are dissatisfied with the pharmaceutical service.

In other words, it will ensure that the public are aware of how to make a complaint, if they want to.

So the public will be more aware of how to make a complaint—not of what to expect from the service, which is what the explanatory memorandum says.

It will be both. They will be more aware of what to expect and what to do about it if the standards are not achieved and they are not satisfied with the service.

The memorandum says that they will be told what to expect.

My final question is for the minister. The Subordinate Legislation Committee says that it

"has considered the Scottish Government's proposal for remedying the error and considers that, in the circumstances, a full explanation of the errors and the intention to correct them should be provided to the whole Parliament prior to seeking its approval of the instrument."

What is the minister's response to that recommendation?

I dealt with the errors in the order in my opening remarks. Whether the Parliament as a whole wants to debate them is a matter for the Parliament. I have come here to ensure that the committee is aware of the errors, most of which are technical; they have no fundamental impact on the order itself.

Convener, it is unusual for the Subordinate Legislation Committee not to expect the subject committee to deal with the matter but to recommend that the whole Parliament deal with it. I wanted a response to that point.

You have had that. The minister has put on the record fully how the errors will be remedied. If members of the Parliament are concerned, it is up to them to pay attention—as I am sure they do—to what the committee does.

My question follows on from Mary Scanlon's point. The problem that faced the Subordinate Legislation Committee was the fact that one section of workers is covered by reserved powers and another is covered by devolved powers. That creates a problem when it comes to putting legislation right. I can think of one way in which that could be solved, but that is for another occasion. Sir Kenneth Calman has produced a report—which seems as if it might be adopted—that makes recommendations on the matter of reserved and devolved regulatory powers. How would that affect such a situation in the future?

Calman's recommendation is that all health care regulation be reserved, which would be a retrograde step. It is important that the differences between the health systems be recognised and, in the current arrangements, the views from Scotland on health care regulation be listened to and taken on board. In the work in which we have all been involved through implementing "Trust, Assurance and Safety", it has been important for the Scottish view to be heard.

If all health profession regulation was reserved to Westminster, there would be no statutory role for the Scottish Government at all. Whether we would be listened to would be down to whether the Department of Health was inclined to listen to us, rather than any requirement on it to hear Scotland's views on how regulation may impact on the Scottish health service.

Despite its complexity, the current system works reasonably well. The current vehicle—the order under section 60 of the Health Act 1999—allows both Parliaments a role in the regulation of new professions. That works reasonably well and it would be a retrograde step to change it.

As there are no further questions, we move to agenda item 3.

As no member wishes to debate the order, I invite the minister to move the motion.

Motion moved,

That the Health and Sport Committee recommends that the draft Pharmacy Order 2010 be approved.—[Shona Robison.]

Motion agreed to.

Thank you, minister. We will not have a break because we have just started, but we will pause to allow the witnesses to change.