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The Pharmaceutical Journal
Vol 277 No 7431 p750-752
16 December 2006


Society summary


Council members praise Society's integrated role but accept need to consider a clearer separation

A professional body run by pharmacists

Two legal entities with shared facilities

Danger of oversimplification

Review will point to medical model

The good should not be thrown away

Council must show leadership

Independence of review is important

Integrates model serves public well

Decision should be evidence-based

The decision made at the December Council meeting to commission a review of the Royal Pharmaceutical Society's dual role of representation and regulation (see p749) followed a long debate during which Council members expressed confidence in the Society's ability to manage its dual role but accepted that external pressures dictated a greater, if not complete, separation of the roles.

Opening the debate, Jonathan Buisson said that the Council was on the verge of a momentous decision about the future of the Society. It was probably the most important decision the current Council would have to make and the second most important decision since the Society’s founders met in the Crown and Anchor in 1841. There was a range of options. At one end of the spectrum was keeping the Society exactly as it was; at the far end was setting up two completely separate independent bodies with no links between them.

Mr Buisson said that he welcomed the idea of an independent review before the Council made its decision. The review would help it decide how far along the spectrum it had to go to meet the recommendation of the Foster Review that the Society should “clarify the separation of its roles”.

He added that the Council had a duty to the Society and all its members, whether practising or non-practising, and whether or not their work was related to the NHS. The Society was not a pharmacy delivery agency for the NHS. That did not mean that it could not help members who worked in, for or around the NHS, but there were also plenty of other members who looked to it for support and who had nothing to do with the NHS.

A professional body run by pharmacists

Douglas Simpson pointed out that it was recorded in the minutes that Council policy was “support for a regulatory board with a lay majority”. The minutes also recorded that “the professional body must be run by pharmacists” — and it had been agreed earlier in the Council meeting that “run” meant “governed”.

Mr Simpson said: “A regulatory board with supremacy over a professional board is unacceptable. The integrated role and professional self-regulation are both dead ducks and there is no point in seeking to resurrect them. It is clear that there must be blue water between the regulatory and the professional; that is a given. I think that is the Government’s position, no matter what structure we propose. That is the end of the integrated role, it seems to me.

“Self-regulation post-Kennedy was a move to professional regulation with public participation. Post-Foster and Donaldson, it will be public regulation with professional participation. So professional self-regulation is also gone.”

Mr Simpson added that the two-board model — as approved by the special general meeting in 2002 — did not seem viable. It had made no progress then because it had lacked support from the Council of the day and the Department of Health. The chief pharmacist at the time (Jim Smith) had said that the Council could not abrogate its responsibilities for regulation (PJ, 3 August 2002, p158). The Government would only accept a two-board model today if the regulatory side was dominant, which was not acceptable to the Council.

“Pharmacists need a professional representative body that democratically represents their views,” he continued. “They have had one since 1841 and they continue to need one today. I believe that a body developing educational standards in the same way as a royal college could be part of the functions of the Society in the future. In the light of the Council decisions already made on the composition of a regulatory board and the supremacy of that board being unacceptable, and the official line on supremacy that I have indicated already, it does seem to me to require the existence of two bodies in the future.”

The Society should continue as a professional body, said Mr Simpson, and a separate regulatory board should be set up. This would fit best with Foster’s desire for a Northern Ireland-GB merger. The Pharmaceutical Society of Northern Ireland could also continue as a representative body with its regulatory side becoming part of a new UK regulatory board.

Because Foster had called for a further review in 2011, the Council needed to make a decision that would stand the test of time. Any review that was set up should be a “how to” review, not a “what do we do now” review, because open-ended reviews could come up with answers that were not acceptable to anybody.

Two legal entities with shared facilities

Perhaps the solution would be two legal entities, independently managed but sharing some facilities and with staff continuing in the same pension fund. But whatever was decided it would have to be confirmed by the membership.

On the Society’s assets, Mr Simpson said that the Society had owned valuable property since its foundation but it had only officially became a statutory regulator in the 1930s. Other Society property was owned by the Benevolent Fund, which did not have a regulatory role. Publications such as The Pharmaceutical Journal and Martindale were extremely valuable properties. Again, they could not possibly be regarded as regulatory property. The Society’s valuable museum collections could not possibly be said to have been assembled in any way as part of a regulatory function. Those matters needed to be borne in mind when the Council came to consider the assets of the Society.

David Carter said that he shared Mr Simpson’s views. There was a clear steer from the Government to separate the regulatory and professional functions. If he had to vote today, he would vote in favour of beginning the separation process. However, the Charter required the membership, not the Council, to take the decision. Therefore, to give the members the chance to take an informed view and fully understand all the options and pitfalls, an independent review had to be commissioned, but it should be a quick review with a publicity campaign to go with it.

Danger of oversimplification

Stephen Denyer said that Council members were in danger of oversimplifying what they read and the messages they believed they were receiving. It was important to test what separation of function could mean. There was strength in having a regulatory organisation informed by professional understanding and leadership; there was strength in a professional organisation being advised, supported and weighted by the presence of regulation.

The President said that he would like to hear the views of all other pharmacist members of Council first, followed by the pharmacy technicians and lay members.

The Vice-President said that ministerial opinions and decisions made it clear that a Society in which the regulatory authority was subservient to a professional authority was unacceptable. It was also clear that a model in which the two roles sat level or equal was unlikely to succeed. The two roles had to be separated for the public benefit and for the benefit of pharmacy — although that was not to say that they could not exist alongside each other in separate bodies. His personal belief was that there should be two organisations working closely together — one a professional body in the form of the Society and one a regulatory pharmacy council that could also cover Northern Ireland.

He added that the Council needed to make a decision on the way forward and the review should follow that decision.

Brian Curwain said that much detail had to be sorted out. A review was essential. It needed to be by someone independent and it needed to be as quick but thorough, because the decision had to be right. The Council also needed to reaffirm publicly its desire to continue to work with the Government. To close any doors would be unhelpful. He was happy to end with two separate organisations, but the Society needed to be clear about how it was to be done before making a public statement about exactly what would happen.

Review will point to medical model

Martin Astbury expressed the view that both the public and the profession were best served by the integrated role. But it had become apparent that the present model was no longer acceptable. He believed the review would almost certainly point in the direction of the medical model.

Sid Dajani said that he endorsed the medical model. He did not need a review to tell him what was needed. “The only people who want a review,” he suggested, “are people who want to waste time, procrastinate and hope things will change for the better. The truth is that it won’t change. We have had so much direction, so much future progression on the Government’s side. They want a ‘one size fits all’ for all regulatory bodies. They do not want to see how well we have done in the past. They want us to fit into a nice little pigeonhole, and unfortunately the Society has never worked like that.”

Dorothy Drury said that, because the regulatory function had to be supreme, there could not be true leadership for pharmacists in a dual-role body. She saw no problem with pharmacists paying fees to two bodies.

Davan Eustace said that, like Mr Astbury, she had long been wedded to the integrated role. It had taken a long time to reach a decision, but she now believed that separation along the lines of the medical college model was the best way to go. It was important to have a strong leadership body as well as a strong regulatory body and the only way to achieve this was along these lines.

John Gentle said that the Government wanted the Society to split but it did not want to be responsible. It wanted the Society to make the decision. Bearing that in mind, it seemed that it would allow the Society some leeway. The conditions were now right for the Society to get the best deal for the profession and the public. The decision should be taken now and the review should be about how to do it, not whether to do it.

Mr Gentle added that he too had always believed that the integrated route was the best way to go, but there was no longer any point. What the Council now had to aim for was the best it could get away with, not the best.

Andrew Gush agreed that the Council needed to show leadership and make an immediate decision about where it wanted to be, followed by a review to show how to get there. He wanted the Society to be a separate, independent, professional organisation with no regulatory function. Although having a strong regulator with a lay majority was in the public interest, it was also important for pharmacy to have a strong representative body, independently governed to guide it through times of great professional change, to challenge the regulator and to drive the profession forward.

Graham Phillips said he concurred with the points made by others. The simple truth was that the profession was over-regulated and under-represented. That was not in its interest. More significantly, it was not in the public interest.

He added that pharmacists were now petrified of their professional body because the regulatory agenda had overwhelmed the professional agenda, in terms of strategy and resources. To continue with an integrated fudge would only make matters worse. A clear separation was inevitable, even though the requirements of the profession and the Government were aligned in many ways. The Council should show leadership and make a decision. Continuing uncertainly was unfair for the profession and for the Society’s staff.

If one looked at the responses to the consultation on the draft Section 60 order, every pharmacy body apart from the Society had argued for a split. There was no feeling in the profession that the integrated role should be maintained.

Mr Phillips added that he was in favour of a review. The Council needed to decide not whether to have a review but what the review should be about.

The good should not be thrown away

Colin Ranshaw said that the Society’s current integrated role was not perfect but it had worked. There had been an independent Statutory Committee not accountable to the Council for almost 60 years. There had to be some good in that, and it should not be thrown away. He did not want to be told what direction the review should take. He wanted all the information in front of him to assess what direction to take, accepting that the current situation was not acceptable to the Government.

One concern was whether the Government would regulate industrial pharmacists, academic pharmacists and others not working directly with patients. Did they need to be regulated? At the moment, the Society had power to regulate them and take appropriate sanctions if they did not perform to a set level of practice.

He also did not know where education sat. The regulatory body would only be concerned with the NHS side of education. Where would that leave the education of Qualified Persons, for example?

He did not know the answers, but hoped that the review would bring them forward. A review was needed to give the debate to the membership. The review should not be directed down one single tunnel.

Stephen Wells said that he still believed that the integrated role was fit for purpose but now strongly believed that the way forward was to form two separate bodies. He saw the Society becoming the professional leadership body, but it also had a duty to ensure that a strong regulator was formed to work alongside it. Working closely together would lead to a healthy tension between the two, which would drive forward innovation. An independent review was essential to show that this was the true way forward and to consider the interests of all the parties involved — the public, the members and the Society’s staff.

Council must show leadership

The Treasurer said that the most important factor was for the Council to show leadership and reach a decision. Matters should not be delayed any longer. The Society had had a clear direction from the chief pharmaceutical officers and it would be negligent to disregard that view. He believed that a review should only be undertaken after the Council had made the principal strategic decision as to what direction the Society should take. It did not have time on its side to delay the decision.

Rose Marie Parr and Peter Jones both believed it was important to give members around Britain a chance to contribute to the debate.

The President replied that the Council would not make a final decision until after consultation with all the members. He then asked the two pharmacy technician members of Council for their views.

Corinne Hunt said that, while listening to the debate, her views had swung between integration and separation. On the strength of that alone, she believed there should be a completely independent review about which way to go, with a follow-on from that to how it should be done.

Lesley Morgan said that the Council needed to know the implications of different possible directions of travel. “Until we have got all those facts, I do not think we can make our decision or guide our members, because you can be sure that when we go out to consultation, members will ask us the nitty-gritty. If we cannot answer those questions, that is where we lack leadership.”

The President then asked lay members to give their views.

Michael Schofield said that some separation was clearly needed. The Government wanted it and the profession now appeared to be taking that view. But there was also a need for good linkage between regulation and representation and pursuit of professional interests. If the Society could produce a practical working model, the Government would take it seriously. In a sense, it would have done the Government’s work for it. But if it could not do so, and the question of regulation was left to the Government, then one could not tell what the outcome might be. It might be a general pharmaceutical council, but there were other ways of regulating the profession. There was already the Health Professions Council which, to anyone taking a simplistic view, would appear to be a possible option.

Professor Schofield added that the Society’s trump card was cost, because any model that had close linkages (and maybe shared accommodation and shared facilities) would be cheaper than any other. And that mattered in Whitehall.

He warned that it would take time. It was a marathon, not a sprint, and to cover the first 100 yards of a marathon in 10 seconds was not a good idea. He added that the General Medical Council had asked Niall Dixon from the King’s Fund to undertake a review. It had helped the GMC get a better deal out of Donaldson than it thought possible. That was one of the things a sensible review could achieve.

Concluding, Professor Schofield said: “I have tremendous sympathy and support for those who want to see a separation. It is how to achieve it and I think we should take it in a measured way, because I think that will keep our options open until we are quite sure what it is we want to go for.”

Independence of review is important

Marcia Saunders said that for her the independence of the review was most important. It should be about how to clarify the two main areas of function. The Council was in danger of pushing the Society into crisis if it made a snap decision. There were huge risks — financial, legal and human resources. The Council had to be seen to be acting reasonably, and the way to act reasonably was to commission a genuinely independent inquiry. She agreed with those who had spoken about keeping the options open. Council members also had a fiduciary responsibility for sound stewardship, and should get legal advice on their own personal responsibilities. The Council should not destabilise the Society and do things like float off a regulator if that had a profound effect on its financial viability.

So, to show that the Council was acting reasonably, a properly independent review should look at all the options. The big question was how to clarify the separation of functions between the professional and regulatory responsibilities.

Commenting on Ms Saunders’s reference to Council members’ fiduciary responsibilities, Rob Darracott, director of corporate and strategic development, said that the Society had already sought advice on the matter. There could be implications in relation to Council members’ fiduciary responsibility to the Council whichever route was taken.

Alan Kershaw said that that information spoke clearly to the need for a properly independent review. He went on to say that it was unsubtle to talk about just two roles. He saw three strands — regulation, leadership and representation. It was also unsubtle to talk about a “royal college model” as if there was only one such model, because the royal colleges were not all the same. And he was also a little alarmed about the apparent enthusiasm for the medical model: “Let us not get all starry-eyed about it, because we are all quite happy to bash it from time to time when it does things badly, as it does.”

Commenting on Mr Phillips’s reference to the views of other pharmacy bodies, Mr Kershaw warned that some of them may have their own motives for wishing to see the Society split in two.

Mr Kershaw added that he would not decide which model he favoured until he had seen the arguments properly considered. There was nothing to lose from a truly independent review and a great deal to gain.

Integrates model serves public well

Ray Jobling said that he was one of those who believed that the integrated role model had served the public interest well in pharmacy. But the external environment had changed, and in the shifting social climate there had to be a separation.

Regulation had to continue as a partnership between professionals and lay people, but it was now clear that in future it would be led by the latter. He believed there would be a lay chairman and a clear lay majority, with all the regulators appointed rather than elected. That was one thing a review should discuss.

Professional leadership benefited from informed lay involvement, but the professional leadership body, if it were a separate body, would be chaired by a professional and have a predominating professional majority. Furthermore, there was more to professional leadership than simply representing the interests of the profession in a narrow sense. There was a public interest here too, which pharmacy recognised but which needed to be written more clearly.

It was the medical profession that had led pharmacy into this mess, which it did not deserve, but now the medical profession had pointed the way. The review should be thorough but not needlessly long. The membership was waiting for it and the public, in so far as it was aware of it, was waiting for it. Certainly the Government was waiting for it. But the membership issue had to have priority, and the membership did not yet have the issues and the options put properly before it.

Lorna Jacobs said that instigating a review would not delay a decision for more than a few months but it would ensure that the decision was well founded. Council members clearly had a number of ideas and their experience and wisdom needed to be fed into the review. The review would also allow an opportunity to clarify the legal and financial complexities to find the most sustainable structure that was in line with the Society’s vision and the constraints of the current political environment.

Sylvia Hikins recommended standing back, taking the heat out of the situation and looking in a cool, rationale way at the future pathway for the Society. A review was an important step. She hoped all Council members would keep an open mind, even though they might have inclinations and leanings. “Let us have an independent person whom we can all respect, who is respected out there by the membership, to look at the different ways of separating the roles, because that is the issue.”

John Hanlon said that the Government would make the final decision. The Society could only help to influence it. But one immediate decision for the Council was to seek independent advice on the human resources and legal issues.

Another necessary decision was to set up a small review group to oversee the review process, because a 30-strong Council would not be able to manage it.

Phillida Entwistle said that it would not be abrogating leadership to proceed with caution and to obtain as much evidence as possible via a review before making recommendations to the membership. The review should find out what the risks were and how they might be managed.

She added that, if separation was inevitable, she wanted to know why. Her gut feeling was that it is inevitable, but the Council should proceed with caution. The Society would not be able to go back if it makes the wrong decision.

Decision should be evidence-based

Seema Agha said that the words “split” and “separate” had not helped the debate. She had sympathy for pharmacists because she, too, was a regulated professional and knew how difficult the decision was but, as a lay member, she wanted to act with caution. Her advice as a lawyer was that the decision should be evidence-based and take account of the risks and the conflicts. Whatever decision was to be delivered, it had to be acceptable to the membership and the public and be robust.

She wanted an open-minded review that would clarify the issues. “What are the risks? What are the options? How do we achieve the clarity of the separation, if that is a recommendation of the models? What costs are involved? What has not worked elsewhere? What lessons are to be learnt? I want the review to be timely and evidence based.”

Closing the debate, the President agreed with the consensus that the current model was not sustainable. Even if it were, the Government would want a lay majority on the Council, which would not be acceptable to the Council or the profession. So the Council had to consider either an internal separation of roles or an external separation.

His personal feeling was that, subject to a review, by 2009 the main role of the Society should be to provide professional leadership and to support pharmacists in their education, practice and standards setting. In addition, it had to ensure there was an excellent Benevolent Fund.

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