Main points
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The Council of the Royal Pharmaceutical Society has reaffirmed its policy that it is in the public interest to improve access to emergency hormonal contraception through community pharmacies. At a special meeting on May 10, the Council also agreed that it should be made clear that, whether or not any EHC product became available for sale as a pharmacy medicine, the Council would also wish to see a mechanism available for supply free of charge from community pharmacies to women who could not afford to purchase the product.
The Council made its decision after considering two documents, one prepared by the Policy Support Unit and one prepared by Mr Patel.
The PSU paper, produced at the request of the April Council meeting, had been prepared to set out the advantages and disadvantages, for the public interest as well as for community pharmacy, of changing the Society's policy to one which opposed provision of EHC as a pharmacy product through community pharmacies. The paper noted that all EHC products were currently classified as prescription-only medicines. They were already available by a variety of routes, including supply by a general medical practitioner on prescription, supply from some hospital accident and emergency departments, supply under protocol by nurses in family planning clinics and elsewhere, supply by pharmacists under the emergency supply regulations, supply by pharmacists under group protocols in some health action zone pilot schemes, and supply by mail order from at least one family planning organisation.
In addition, one product, Levonelle-2, could become available for sale as a pharmacy medicines if an application to the Medicines Control Agency by Schering Health Care was successful. But the Government did not intend to restrict the product's availability through other routes if it was deregulated. Availability by other routes was likely to increase, not decrease, regardless of whether it was deregulated.
Opposition to a POM-to-P switch would be inconsistent with the Society's wish for the extension of prescribing powers to pharmacists. Widespread, successful provision of EHC as a P medicine would provide a good foundation for arguing that pharmacists should be empowered to prescribe beyond the limitations of patient group directions. There was a danger that if pharmacy opposed deregulation of Levonelle-2, the Government would simply use other means and other health care professionals to pursue its policy objectives of widening and speeding up public access to health care.
Mr Patel's paper set out a number of perceived disadvantages in the supply of EHC as a P medicine compared with supply through pharmacies under protocol. One was the barrier of having to pay for the product, which would make it inaccessible to a vulnerable group. Another was the comparative difficulty of measuring health gain in the absence of any formal recording system.
Further advantages of a protocol system included capture of patient, drug and area data for sharing in the NHS and demonstrating the benefits of including pharmacy within the NHSnet. Other benefits for pharmacy would include education and training, clinical governance and public involvement in service development.
Mr Patel also placed before the Council a letter from Ms Melanie Ogden, pharmaceutical adviser to Manchester health authority, stating that the steering group for the Manchester pilot EHC scheme felt that such schemes were preferable to allowing over-the-counter sale.
Mr Patel said he was totally driven by the statement in his paper that: "Women with comparable needs should receive the same level of care regardless of factors such as where they live, income or age."
Mr DARLING said that he supported an NHS supply mechanism for EHC by community pharmacists but he also supported a reclassification from POM to P. Whatever the situation, the Society's Standards of Good Professional Conduct would require the same standard of pharmaceutical care and the protection and well-being of the woman should be paramount in the minds of the pharmacist.
Mr DAJANI suggested that what the Council should be looking at was ensuring that EHC had the widest possible accessibility and that it was available free to all, so that there was no discrimination against those who could not afford to pay for it. The mechanics of implementing it was up to the Government.
Mrs REMINGTON said that it needed to be made clear that the Manchester model involved supply under patient group directions. It was nothing to do with prescribing by pharmacists, which would require legislation. Pharmacist prescribing was not an immediate option. It was at least two years off.
Mrs STONE said that, while she was sympathetic to Mr Patel's view, Council members had to accept that EHC might become a P medicine. The use of a group protocol might well be one of a variety of supply methods but it would not be the only way. She would like to ensure that there was rapid access to provide the greatest health gain to the greatest number of people by having EHC available in the simplest way - as a P medicine. If one could layer on top of that any other mechanisms that made it accessible to those for whom payment was a barrier, that was fine, but to say that those people should stop the rest having it was wrong.
The Society should support the switch from POM to P of EHC when it was appropriately proved to be safe and should support its supply through as many community pharmacies as possible, with appropriate training when necessary so that pharmacists could supply it correctly and properly. In addition, there should be negotiations with relevant bodies to facilitate supply to those where finance was a barrier.
Mr KOZIOL said that he agreed with both policies. It was in the public interest to improve access through community pharmacists, and he supported Mr Patel's view that in needy cases supply should be made free. If one could agree with both policies, why could the Council not agree to one policy that encompassed both?
Mr ARGOMANDKHAH agreed that making EHC available as a P medicine did not prevent its supply under the NHS, whether under group direction or on a doctor's written prescription. But, if it became P, the Society should push strongly for equitable access.
Dr HAWKSWORTH said that the Council needed to be unequivocal and leave no doubt of its commitment to improved access to EHC in the public interest. Responsible provision of a P medicine would make a good case to support pharmacy prescribing in the long term. The Society needed to help pharmacists to prepare for this provision and provide the tools to do it. It was an inevitable situation because the process was already in motion to secure the option of a P medicine.
Mr NATHAN suggested that it would be political and professional suicide to oppose POM-to-P deregulation. The Society had campaigned for deregulation of Schering PC4, so how could it oppose deregulation of a more effective and safer alternative? It would be the end of pharmacy medicines, because the Government would just deregulate medicines to the general sale list.
If accessibility of EHC to people without the financial means was to be ensured, there were already mechanisms available - if the Government had the will to use them.
Mr EMSON said that it was clear that the Society's position embraced Mr Patel's position. It was not an either/or decision. A lot of commentators would say that, unless there was a public safety argument, Levonelle-2 was likely to gain P status, and if that happened the Council would be in difficulty if it had taken a POM position.
Mr Emson supported Mr Patel's position on free supply at point of access. He saw no reason why the Society should not endorse what would be open to all health authorities and that was, as part of their health programmes in support of Government priorities and their own priorities, where appropriate, in appropriate demographic areas, to provide separate funding to support supply through some prescription-only method funded by local health authorities. There was no reason why the Society could not embrace that in its public comments.
Another point Mr Patel had made strongly was the issue of effective health gain and the information gathering exercise. Certainly, from the Nottingham head lice experience, there was no reason why, if minds were applied to the matter, the necessary information could not be gained to contribute to the national health debate as well.
Mrs HOARE said that, when she had spoken on EHC to one of the Society's branches, the overwhelming vote of the people there had been that the Council should not withdraw its support for deregulation. But, either way, the branch members wished the Society to write to the Government to add its support for free supply and to support prescribing by pharmacists.
Mrs BANKS suggested that, to avoid confusion, the Council should amplify its policy statement so that it was absolutely clear what was meant. Words could be added to make clear that the Society wanted pharmacy access both by reclassification to P where it was safe to do so and by instituting measures to ensure that those who could not afford to buy EHC as a P medicine could obtain it through community pharmacists free of charge. How to get to that position should not be part of the policy but could be part of a debate with the Government.
Mr CURPHEY said that the Manchester trial had originally involved Schering PC4, not Levonelle-2, and therefore the issues of public safety and involvement were different. He would be uneasy about Schering PC4 being a P medicine, but the application would be for Levonelle-2, which was by all accounts a safe medicine. If the Society opposed deregulation when there were no safety grounds then, as Mr Nathan had said, it would be professional suicide. All those who understood the position knew that it was a matter of a mixture of routes. He did not want to see pharmacy hung out to dry by going down one route only which turned out not to be the route of choice for anyone else.
Mr Curphey added that the issue of the collection of data was a red herring because there was nothing to stop the Council recommending that pharmacists keep data if that was what it believed.
Mr ALLEN said that it was important to get the core roles in community pharmacy right. Pharmacists had to be seen to be providing the service and the advice and the consultation at the point of need, whether the patient was paying for the product or getting it on the NHS for free. The Council still had to address that issue.
Mr PATEL emphasised that at the previous meeting, having made it clear that that he wanted the Society to press to have EHC retained as a prescription only medicine under protocol on the ground of public health, he had gone on to say that the Society should take such action as was necessary to ensure that EHC was made available free of charge to the clients, whatever the mechanism by which it was supplied. Many people had chosen to ignore that last phrase.
Commenting on Mr Darling's point about standards, Mr Patel said that it was an important point and one that he had made at the last meeting. Whether EHC was supplied over the counter or on prescription, the standards had to be the same. In fact, when EHC was supplied through community pharmacy, it should be seen not just as a mere supply but as a process that included full pharmaceutical care, including capture of data.
Mr Patel said that many questions needed to be answered. More work was needed on the policy statement. His views were based on a mistrust of the Government which since coming into power had done nothing for community pharmacy or for the development of pharmacy services. To believe that it would suddenly help community pharmacists achieve this objective was plain nonsense. When Levonelle-2 went from POM to P one could kiss pharmacist prescribing of EHC goodbye.
The PRESIDENT then suggested that the Council should take up Mrs Banks's suggestion that the policy should be amplified.
After further discussion, the Council agreed to reaffirm its policy that it was in the public interest to improve access to emergency hormonal contraception through community pharmacies and to ask the office to draft for circulation and agreement an acceptable form of words that recognised and reflected the sentiment of the debate and the conclusions reached.
The Council agreed to investigate an ambitious proposal for upgrading the Society's headquarters building. The proposal involved filling in the L-shape of the building above the ground floor and adding a sixth and seventh floor. The building's capacity would be increased by 70 per cent, and a flexible design would allow the Society to generate income by letting out parts of the building not needed for its own purposes.
The proposal was made by property advisers LSM Partners, which had been retained by the Society to examine a building refurbishment scheme approved in principle by the Council in December, 1999.
In a presentation to the Council, Mr Andrew Smith (LSM Partners) said that it was that important that any solution to the Society's space utilisation problem also looked after its long-term assets. Of the various options open to the Society, that of doing nothing could not be recommended because of pressing issues such as space planning, the work space quality, security and the need to improve the reception area and the museum facilities.
Another option was to carry out a limited upgrade of parts of the building. But although this was a comparatively low-cost option, it could not be packaged very cost effectively and it would be a relatively short-term solution because it lacked flexibility.
The "winter garden" scheme already presented to the Council would provide a good base for the Society going forward but as a package did not make best use of the site value. The building that would result would be an excellent building but would still be very heavily tailored to the Society's current needs. It would not be flexible in use and would not retain its asset value for long. The building would not be particularly suitable as a financial instrument if one needed to raise funds to carry through the development. It would also limit any future work. He did not think that the full cost implications and space utilisation issues had been fully addressed in the "winter garden" scheme.
The final option was a further development of the "winter garden" scheme that LSM Partners called the "forum" scheme. It was designed to maximise the asset value inherent in the site. It would produce a usable, flexible, design-led ideal building for the Society - an excellent asset value for the long term. It would produce a good presence and image for the Society for a long time. It would leave four clear office floors for work space which could be occupied by the Society progressively or let out if there was surplus to capacity. It could be subdivided easily.
Mr Smith said that the building costs for this option would be substantial, at about £14m, but it would ensure a surplus of retained value. The scheme would produce a positive financial result which other options would not. The pay-back pattern planned into the scheme included capital receipts, revenue streams, on-going operational savings, better facilities and services for members, efficient use of space, financial and operational flexibility and asset value enhancement, all wrapped in a prestigious, modern and forward-looking head office.
The "forum" scheme would cost a great deal more than the "winter garden" scheme, but would deliver a great deal more. It would use all the potential of the site, would work well for the Society as an occupier and would work well in the short and long term.
Mr JOHN GREENFIELD (architect, Parameta) then described the proposals in details, floor by floor, reminding the Council that it was a feasibility study rather than a firm proposal. He said that the two additional floors could possibly accommodate four two-level penthouses as part of the revenue stream or could even be used as offices if that became necessary.
Mr ARGOMANDKHAH asked why LSM Partners had not considered the option of realising the capital from the building and moving out to where space was cheaper?
Mr SMITH replied that the headquarters building was already in a relatively cheap location. Moving would not necessarily assure the value improvement the Council you might be seeking to obtain.
Mr EMSON said that he had been inspired by the presentation but, as a member of the Society, he would expect and recognise an obligation to get maximum value for the Society's assets. It would be prudent to do more work on the financial implications and also to involve the Society's members in the discussion.
Mrs BANKS asked why the options did not include a tight, non-ambitious approach which nevertheless improved the building's asset value.
Mr GREENFIELD said that to get the kind of improvements that were being looked for one had to take a huge step. Increasing the floor plate of the offices by more than a very small amount involved sinking new foundations, and the more one could build on those foundations the more value one would get in return.
The VICE-PRESIDENT said that the debate needed to be put in a broader context. First, one of the Council's roles was to protect the asset value of the Society and the asset value of the building was declining in relative terms. Secondly, the working conditions of the staff compared unfavourably with working conditions in many modern offices in and around London and had to be put right. Finally, the Council had to manage the Society's financial affairs in the future to ensure that there was enough income stream to do all that it wanted or needed to do in the future, and any development of the building had to be put in that context as well.
On the motion of the PRESIDENT, the Council then agreed to set up a steering group to consider the proposal in detail. It was also agreed to start the procedure for preparing a planning application for submission to Lambeth council.
The Council agreed that the Society should proceed with completing the purchase of a flat in the "Parliament View" development adjacent to the headquarters building.
The Council was reminded that accommodation outside the headquarters building would be needed either to free space for other uses within the building or to help break the logistical log jam of making changes to the building. The flat was a better facility than the existing President's flat and was already worth more than the Society had agreed to pay for it.
On a vote, the Council approved the purchase. There was one abstention and no votes against the proposal.
The Council approved a proposal that the Society should establish a system of internal audit, separate and distinct from its external audit, with the appointment of internal auditors and the establishment of an audit committee. The system would be set up immediately and reviewed after 12 months.
The internal auditors would initially be concerned only with financial internal control but would be expected to extend their remit to include other control mechanisms. Among other things, the audit committee would examine the Society's accounts before they were presented to the Council for endorsement.
The committee would be chaired by a Privy Council nominee member of Council who had relevant knowledge and experience in the area. Its members would include two other Council members and a member of the Society with relevant knowledge and experience who was not a member of Council.
Presenting a paper on the proposal, Mr DARLING said that the paper sought to take further an agreed policy that the Council's affairs should be managed in a way that facilitated transparency, accountability and probity. Most organisations of the Society's size and larger had as a matter of course an independent internal audit function. The paper proposed an internal audit function that would be an independent arm of the Resources Directorate. The internal auditors could be appointed from within the Society or the Society could employ an external body or person to undertake internal audit.
The audit committee would monitor both internal and external auditing functions. It would ensure that proper terms of reference, audit plans and systems were in place, it would consider recommendations and what action to take, and it would monitor implementation of agreed actions. The proposed constitution of the committee mirrored that in other types of organisations.
Mr Darling added that at some point consideration would have to be given to the future role of the honorary auditors.
Council briefsWelsh Executive The Council approved the submission to the Privy Council of a proposed amendment to the Society's Byelaws to take account of changes it had approved in the arrangements for the Welsh Executive (PJ, February 12, p249). The revised Byelaws would specify that the secretary of the Welsh Executive should be resident in Wales and based in the Society's headquarters in Cardiff. They would also change the Welsh version of the name of the executive. RoSPA The Council agreed that Mrs Hoare should represent the Society at meetings of the Royal Society for the Prevention of Accidents. She would succeed Mr Ian Caldwell, who, on retiring from the Council last year, had agreed to continue to represent the Society until June, 2000. |
Those present at the meeting, which took place on May 10, 2000, at 1 Lambeth High Street, London SE1, were the President (Mrs Christine Glover), the Vice-President (Mr Marshall Davies), the Treasurer (Dr Gordon Appelbe), Mr David Allen, Mr Hassan Argomandkhah, Mrs Terri Banks, Mr Peter Curphey, Mr Sultan Dajani, Mr William Darling, Professor William Dawson, Mr Digby Emson, Dr Gillian Hawksworth, Mrs Patricia Hoare, Mr Mark Koziol, Mr Alan Nathan, Mr Hemant Patel, Mrs Helen Remington, Mrs Linda Stone and the Secretary and Registrar (Miss Ann Lewis). Also present was the chairman of the Welsh Executive (Mr Colin Ranshaw).
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