Official Report: Minutes of Evidence

The Chairperson (Ms Maeve McLaughlin): Today we have Heather Stevens, director of the human resources directorate at the Department, Joyce Cairns and Kieran McAteer, who are also from the human resources directorate and Dr Mark Timoney, chief pharmaceutical officer at the Department. You are all very welcome. Heather, I do not know whether you are taking the lead on this, but if you can make your presentation, we will then open it up to members.

Ms Heather Stevens (Department of Health, Social Services and Public Safety): Thanks very much, Chair, and good afternoon. I will give the Committee a brief overview of how the draft Bill has evolved as well as some background on the decision to include Northern Ireland in its scope.

In July this year, Jeremy Hunt MP, Secretary of State for Health, wrote to former Minister Poots seeking his agreement to a legislative consent motion (LCM) in relation to provisions in the private Member's Bill (PMB) introduced by Jeremy Lefroy MP. The relevant provisions relate to the regulation of healthcare professionals. That is a devolved matter in Northern Ireland, and, therefore, a legislative consent motion is required.

The full title of the Bill is the Health and Social Care (Safety and Quality) Bill, and it has a wider patient safety theme that follows on from events at the former Mid Staffordshire NHS Foundation Trust. It includes three other patient safety-related measures that apply to England only. However, it is intended that the regulatory provisions in the Bill will apply on a UK-wide basis. That is because, with the exception of pharmacy, the jurisdiction of the healthcare professional regulators affected is UK wide. The Bill, which has the Government's full support, was introduced to the House of Commons on 2 July 2014 and is scheduled to have its Second Reading on 7 November.
At the time of the initial letter from Jeremy Hunt, the Bill included two provisions that related to the regulation of healthcare professionals. However, the Bill has since been updated, and now only one measure remains that is proposed to be extended to Northern Ireland. That provision, which seeks to introduce an overarching public protection objective for healthcare professional regulators and the Professional Standards Authority (PSA), has also been updated since it was first introduced. The Department of Health considered the provision in discussion with the regulators, who highlighted in particular that the principle of public protection must have primacy.

The updated clause introduces an overarching objective of public protection, with further objectives relating to public health and safety, public confidence in the profession and proper professional standards of conduct, each with equal importance. In exercising their functions, regulators must have regard to those. That will be in, for example, handling complaints, disciplinary hearings and fitness-to-practice cases. The approach therefore secures the focus on public protection, which regulators were keen to emphasise while ensuring that regulatory bodies are able to act where appropriate in the absence of an explicit patient safety issue. That could be, for example, where a registrant has engaged in behaviour that may undermine public confidence in the profession such that it would make the public reluctant to seek their help but the issue was not related to their professional competence.

The Bill also requires the regulators' panels and committees dealing with fitness-to-practice issues to have regard to the objectives. In practice, that should help regulators to respond more effectively in fitness-to-practice cases by being able to take timely and robust action. That in turn will help to contribute to ensuring ongoing public confidence in the professional regulatory system.

Based on its discussions with the organisations, the Department of Health (DH) has confirmed that the Professional Standards Authority and the affected regulators are content with the Bill's regulatory provisions. However, the position of those bodies is that the Bill does not go far enough as the legislative framework needs more significant reform through a Government Bill taking forward the Law Commission's recommendations. As you will be aware, the Law Commission published its review of the regulation of healthcare professionals in April 2014, and a copy was laid before the Northern Ireland Assembly. The aim of that work was to make recommendations for a clear, modern and effective legal framework for now and the future. In fact, the regulatory provisions in the private Member's Bill are derived from one of the Law Commission's recommendations.

DH and the devolved Administrations agree that a Bill is needed to achieve the reforms set out by the Law Commission, and they remain committed to taking forward that legislation when parliamentary time allows. That will be done on a four-country basis, and the Department here will be kept fully involved in that process. We will update the Committee in due course as that develops.

DH identified issues when applying the public protection objective measure to the Pharmaceutical Society of Northern Ireland. Those difficulties emanate from the society's dual role, as it is currently both the regulator and the professional leadership organisation for the pharmacy profession. Its current objectives, as set out in the 1976 Pharmacy Order, are more reflective of a leadership and membership organisation rather than focused on public protection. Therefore, introduction of the proposed new public protection objective would represent a fundamental change to the society's objectives.

As a consequence, Minister Wells wrote to his counterpart in England on 13 October this year confirming his agreement that the private Member's Bill was not the appropriate vehicle to implement such a change to the arrangements for the regulation of the pharmacy profession in Northern Ireland. The Pharmaceutical Society has not raised any objections to its exclusion from the Bill. The Minister also stated in his letter that such a fundamental change to the society's objectives would merit careful local consideration and consultation with stakeholders. That development is, in fact, consistent with previous considerations on the difficulties presented by the society's dual role. For example, in April 2014 the Law Commission reported in its review that it was concerned that, by retaining its dual role, the society has adopted a fundamentally different approach to healthcare professional regulation from that in the rest of the UK. We share the Law Commission's view that the society's role is fundamentally different to that of the other UK healthcare professional regulators, which is based on independence from the profession that they regulate.

The Law Commission's review concluded that the society should not be incorporated into the proposed legislative scheme unless its representational role is removed. In addition, former Minister Poots, during an Assembly debate in January 2012 on changes that were introduced at that time to modernise the society, noted that the society had developed a "partial separation" of its regulatory and professional leadership functions but that he wished to follow up with the society how full separation could be achieved in the interest of the public and the profession.

The emergence of the private Member's Bill has once again brought the issue to the fore. So, Minister Wells has agreed in recent weeks that officials should begin preparatory work to explore options for the future arrangements for the regulation of the pharmacy profession in Northern Ireland. That will include consideration of the society's existing professional leadership role, and the exercise is aimed at providing assurance on arrangements for public protection, maintaining public confidence and upholding standards in the professional regulatory system. The Department has written to senior officials in the society to outline the intention to undertake that options analysis and to ensure that they are included at the outset. The project will, of course, involve full consultation and engagement with relevant stakeholders both locally and nationally. We will be happy to brief the Committee further as that work develops.

The Committee should also note that, in addition to the Pharmaceutical Society, the private Member's Bill will not introduce the public protection objective for the General Medical Council (GMC), as that is being done on a four-country basis through a different ongoing legislative vehicle.

As the regulation of healthcare professionals is a devolved matter in Northern Ireland, Executive approval has been sought for the legislative consent motion. We have also carried out an equality impact screening exercise of the provisions extending to Northern Ireland, and no adverse impact has been identified in connection with any of the section 75 categories.

As I said, the regulation measure in the private Member's Bill is, in fact, derived from a key recommendation made by the Law Commission in its review, and the commission consulted widely when developing its report and findings, including contacting over 100 organisations in Northern Ireland.

Furthermore, DH England has been engaged directly with the regulators on work arising from the Law Commission's review on behalf of the UK government Departments through a series of meetings beginning in February this year. That has included ongoing engagement on the private Member's Bill. Departments from each of the devolved Administrations have also been kept involved throughout. In particular, we have also engaged directly with the Pharmaceutical Society of Northern Ireland because of its particular circumstances.

The Department supports the Bill as it relates to the regulation of healthcare professionals. We believe that it is important that those provisions extend to Northern Ireland to ensure that we retain parity with the rest of the UK in this so that the public in Northern Ireland can be assured that they are safeguarded in the same way and afforded the same protections as other UK citizens. Maintaining consistency in that way also ensures that professional registrants are treated equally across the UK and that there are no variances in the regulatory requirements or processes to which they are subject or, indeed, potential obstacles to their mobility.

Thank you again for the opportunity to discuss the proposed provisions with you. We are happy to receive any comments or questions that the Committee may have.

The Chairperson (Ms Maeve McLaughlin): Thank you, Heather. I have just a couple of comments, probably just for clarity in the first instance. You referred to the PMB as it is currently defined being taken directly from some of the Law Commission's recommendations. Is that right?

Ms Stevens: The regulatory provisions in the private Member's Bill are directly derived from the Law Commission report; that is right. It is an early opportunity to implement those recommendations.

The Chairperson (Ms Maeve McLaughlin): The other issue is that there is a view that the Bill is not the appropriate vehicle for the Pharmaceutical Society and the General Medical Council, but no objections have been raised.

Ms Stevens: The same provisions are being introduced for the General Medical Council through a slightly different mechanism. Another legislative vehicle is already being progressed for the GMC. Given that the Pharmaceutical Society's objectives and the way it is established are set up in a fundamentally different way, a private Member's Bill is not the appropriate vehicle to take forward the objectives for it. It needs further, more detailed consideration about the duality of its role.

The Chairperson (Ms Maeve McLaughlin): Is work being developed on that?

Ms Stevens: That work has just begun.

Dr Mark Timoney (Department of Health, Social Services and Public Safety): Yes, indeed, Chair. I have been in touch with the Pharmaceutical Society for some weeks now on how we progress and research the options that are available to modernise, strengthen and ensure independence for the regulation of pharmacists here in Northern Ireland. As Heather indicated, the society agrees that the private Member's Bill is not the vehicle through which to deliver that, so we will conduct a complete and comprehensive options survey and appraisal so that we can consult widely with all stakeholders on the best mechanisms to ensure that strengthening of regulation for pharmacy professionals here in Northern Ireland.

The Chairperson (Ms Maeve McLaughlin): So, that is a separate, ongoing piece of work.

The other question I have is about timescale. Is there any indication of when the LCM will be brought before the Assembly?

Ms Stevens: The Executive are due to consider it on 20 November, after which point it will be tabled before the Assembly.

Mr McCarthy: For clarification, you mentioned the Law Commission — I presume that that is the Law Commission here in Northern Ireland.

Ms Stevens: The Law Commissions of all four jurisdictions were involved in the review. The Law Commission of Northern Ireland was definitely involved.

Mr McCarthy: Did the Department ask it for the way forward on that? How was its involvement —

Ms Stevens: Do you mean how it was initiated? The Law Commission is independent and can decide on its own programme, so it was not invited by this Department to look at the regulation of healthcare professionals. It decided to undertake that work.

Mr McCarthy: Our own Law Commission was involved in that. OK; that is fine.

Mr McKinney: I have one brief question. I apologise for not being here at the start of your presentation but thank you for it. How is the Pharmaceutical Society reacting to this?

Dr Timoney: As I said, the Pharmaceutical Society has been engaged on the issue, and it is agreed that the private Member's Bill is not the mechanism with which to fundamentally change the front page of the governing legislation for the society, which is the Pharmaceutical Order 1976. Any change to that is a devolved matter. We actively research the mechanisms that are available to us to bring forward modernisation of regulation for pharmacists in Northern Ireland. They are currently the only health professionals that are not regulated on a UK basis. The other anomaly is, of course, the idea that the society retains the function of professional representation as well as regulatory responsibility. It is important that regulators are seen to be independent and impartial in their regulation, and that is what we will seek to explore with the society.

Mr McKinney: Will we be exploring that further as time progresses, Chair?

The Chairperson (Ms Maeve McLaughlin): Yes.

Mr McKinney: So, this is really just an introduction. I will leave that there, then, and do some more work on it.

The Chairperson (Ms Maeve McLaughlin): Yes. I advise members at this point that, after the motion is laid before the Assembly, it will be referred back to the Committee, and we will be expected to make a short report on it at that point. We will be coming back to it.

Ms McCorley: Go raibh maith agat, a Chathaoirligh, agus go raibh maith agaibh for the presentation. I have just a small point to make. Looking at it in a different way, from your point of view, is there anything to be regretted by the fact that the Pharmaceutical Society is not going to be included?

Dr Timoney: In the past number of years, we have taken some steps to ensure a strengthening of the society's regulatory function. In 2011, we amended the Pharmacy Order to reform the society's council to ensure that there was appropriate parity between lay and professional members on that council; that the council has a responsibility to set standards for the delivery of pharmaceutical services; and that its members were attending to continuing professional development. We reconstituted its statutory committee and established a scrutiny committee. We gave it a range of sanctions, from advice and warnings all the way through to striking off, so that it has proportionate measures to take. An effort has been made to ensure the strengthening of regulation as things stand. The Professional Standards Authority has audited the society and expressed satisfaction that those processes are working well in the public interest as things stand. We have modernised it, made it more responsive and strengthened regulation. I suppose that the other issues that we need to look at very carefully now are independence and impartiality.

Ms McCorley: I wonder whether that means that you are content with the way that things are, or would you prefer it if the society were included?

Dr Timoney: The PSA, which regulates the regulators, has indicated to us through its processes that it is satisfied with how the society's council exercises its regulatory function in the public interest at present.

The Chairperson (Ms Maeve McLaughlin): As there are no other comments at this point, I thank you all for your attendance and presentation. Obviously, we will return to this as it develops. I ask members at this point whether we are generally content with the proposals, given that we will return to them. Can I assume from what we heard that we are content?