General Comments

This consultation proposes the potential move to Foundation Trusts (FTs) for all NHS Trusts and an extended role for Monitor. Whilst the EPB understands the principle behind effective regulation of all healthcare providers, we have some concern that the role of Monitor has not been clearly defined and may impact upon almost every one of the 10,000 community pharmacies in England that provides additional services outside the remit of the core pharmacy contract.

The function of pharmaceutical supply is clearly stated as not being within the remit of Monitor. However, it is not clear if other service provision by a pharmacy, such as diagnostic testing, clinics involving the testing of blood samples e.g. NHS Healthchecks, anticoagulation clinics, will require licensing with Monitor.

The consultation clearly states that any organisation licensed with Monitor will also require a license with the Care Quality Commission (CQC). Pharmacies are also regulated by the General Pharmaceutical Council (GPhC) and we are concerned that the proposed new structure will increase the regulatory burden on pharmacy. It is also likely that every community pharmacy offering such services will be inspected by these separate regulators.

We fully support the Government plans to ensure that all service providers of services to patients and the public should be assessed against a consistent set of nationally agreed standards. The Royal Pharmaceutical Society, as a body akin to a Royal college, will be developing guidance and assurance frameworks for pharmacy and pharmacist provided services. The Government must work with the professional body in developing any nationally agreed standards to ensure consistency and avoid duplication. This will ensure that all providers succeed or fail according to the quality of care they give to patients and the value they offer to the taxpayer.

The EPB believes the current proposal by Government is likely to engender tension between Monitor and the CQC due to both regulators stressing the importance of their own focus; either cost effectiveness or quality and standards of care. Individual healthcare providers should endeavour to offer the highest standards of care for the lowest possible cost to the NHS, but there is a real danger that both regulators will expect service providers to favour their own focus rather than maintain a balance of both. Financial concerns must never trump high quality and safe services for patients.

The EPB also believes this situation can only be resolved if both regulators have a clear understanding of their role and that of their partner regulator ,  and that they have clearly defined and understood ways of working, transparent to all, including service providers.

 

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Specific questions   

1. Do you agree that the Government should remove the cap on private income of foundation trusts? If not, why; and on what practical basis would such control operate?

We have no comment to make in relation to this question.

2. Should statutory controls on borrowing by foundation trusts be retained or removed in the future?

We have no comment to make in relation to this question.

3. Do you agree that foundation trusts should be able to change their constitution without the consent of Monitor?

We have no comment to make in relation to this question.

4. What changes should be made to legislation to make it easier for foundation trusts to merge with or acquire another foundation trust or NHS trust? Should they also be able to de-merge?

We have no comment to make in relation to this question.

5. What if any changes should be made to the NHS Act 2006 in relation to foundation trust governance?

We have no comment to make in relation to this question.

6. Is there a continuing role for regulation to determine the form of the taxpayer’s investment in foundation trusts and to protect this investment? If so, who should perform this role in future?

We have no comment to make in relation to this question.

7. Do you have any additional comments or proposals in relation to increasing foundation trust freedoms?

We wish to endorse the Optical Confederation’s comment: “The community optometric sector consists of independent contractor businesses providing services under contract for NHS patients or to private patients.  As many in our sector are small businesses, and it is this diversity of providers and rigorous competition between them which provides such a good deal for the patient and the NHS, we would be fearful of Foundation Trusts abusing their monopoly positions to pursue vertical integration with the community sector at the expense of genuine local competition and a vigorous private sector market.”

We believe the same issues are pertinent to pharmacy and, if increased Foundation Trust freedoms go ahead, measures must be put in place to ensure there is no disruption of the network of community pharmacies across England.

8. Should there be exemptions to the requirement for providers of NHS services to be subject to the new licensing regime operated by Monitor, as economic regulator? If so, what circumstances or criteria would justify such exemptions?

It appears that pharmaceutical suppliers will not require licensing with Monitor and we would support this. However, it is unclear if other services provided by pharmacy will require a licence with Monitor, and therefore also need to be licensed with CQC. This one measure may require the current pharmacy inspection regime to be tripled. We are concerned about any additional regulatory burden for our members and seek assurance that a practical solution can be found. Additionally, we doubt that Monitor has the capacity to inspect every community pharmacy in England. It is likely that it will need to be substantially increased in size to manage such a role.

We note the response by the Optical Confederation: “Community optical practices - as registered optical businesses, optometrists and dispensing opticians - are already regulated by the General Optical Council.  As regulated providers they operate in a free market with open entry (subject to meeting quality criteria) with money genuinely following the patient.”

9. Do you agree with the proposals set out in this document for Monitor’s licensing role?

More clarity is required around the role of Monitor as it appears they will be able to carry out certain functions for all NHS service providers and adult social care providers, whether or not they are actually licensed with Monitor. We particularly seek clarity on what services, if any, provided by pharmacists would require licensing with Monitor. The RPS opposes the imposition of additional regulation on our members, except where it is clear that such regulation improves patient safety. There is a potential for duplication of effort leading to increased bureaucracy and we believe that a single registration system would be more beneficial.

Monitor’s primary role should be to regulate NHS Trusts (Foundation Trusts) and GP consortia rather than individual practices.

10. Under what circumstances should providers have the right to appeal against proposed licence modifications?

There must be a right to appeal in order to give providers confidence in the regime. For matters relating to general licensing, groups of providers or the bodies that represent that group of providers should have the right to appeal.

11. Do you agree that Monitor should fund its regulatory activities through fees? What if any constraints should be imposed on Monitor’s ability to charge fees?

Pharmacists already pay to be regulated, by the General Pharmaceutical Council (GPhC), who regulate pharmacists and pharmacy premises. A new, additional cost burden would prove unacceptable for many pharmacists.  The alternative of government funding would be more efficient. If fees were introduced, these costs incurred by NHS providers would be charged back to the NHS either directly, or through an increase of charges for the NHS services. We would prefer funding to be used more directly for patient care. Any new regulatory regime must be proportionate in its activity and costs. We would like to see strict outcome criteria applied to Monitor to ensure it is delivering value to the NHS and patients

12. How should Monitor have regard to overall affordability constraints in 28 regulating prices for NHS services?

Monitor must ensure that tariff setting and price regulation does not disadvantage any one provider and that a fair and transparent system is operated. Monitor has a responsibility to ensure that services are commissioned across a wide variety of providers and that there is no bias towards GP or hospital led services.

13. Under what circumstances and on what grounds should the NHS Commissioning Board or providers be able to appeal regarding Monitor’s pricing methodology?

We would seek clarity, both within the Principles and rules of Cooperation and Competition and in the responsibilities of Monitor’s pricing methodology, of the appeals process.

14. How should Monitor and the Commissioning Board work together in developing the tariff? How can constructive behaviours be promoted?

We believe that pharmacy should be consulted when setting tariffs as they have expertise in the procurement of medicines. The tariffs must be inclusive and be fully justifiable and transparent.

15. Under what circumstances should Monitor be able to impose special licence conditions on individual providers to protect choice and competition?

It appears that Monitor can impose powers on health and social care providers irrespective of whether or not they hold a license with Monitor. This role for Monitor needs greater clarity. Additionally, we question how this would work alongside ‘Control of Entry’ requirements for pharmacy.

16. What more should be done to support a level playing field for providers?

The EPB suggests that 8 issues need to be tackled to ensure a level playing field within Primary care:

a) A consistent series of metrics with which to measure all professions and providers: patient outcomes, cost, speed of delivery.

b) Open access to relevant data for patients and providers.

c) Stability of circumstances for providers delivering care services: consistency of reporting information, duration of reporting process, length of contract etc.

d) Consistency of levels of support. Some providers receive funding for IT, equipment and staff costs and paid time away from service provision for continuing professional development. Others do not.

e) Full information on patients and the public seeking care. 

f) An understanding that some providers, whilst able to deliver services, may have no experience of producing tender documents or even participating in the commissioning process. They will require support to do this.

g) The use of service specifications that do not favour abilities or working practices of any single provider.

h) A clear and transparent commissioning process that is clear to all when contracts are being tendered and the decision-making process around selecting a provider.

17.  How should we implement these proposals to prevent anti-competitive behaviour by commissioners? Do you agree that additional legislation is needed as a basis for addressing anticompetitive conduct by commissioners and what would such legislation need to cover? What problems could arise? What alternative solutions would you prefer and why?

The EPB believes that the Government’s proposals outlined in these consultation documents are likely to promote anti-competitive behaviour. There appears to be little scrutiny on commissioner activity, where GP consortia seem able to appoint constituent GP practices and colleagues as providers. The EPB believes that it may be necessary for GP practices to be service providers to their consortia; however we are keen to ensure there is a robust provider – commissioner split.

The EPB wishes to see a robust scrutiny process, examining the tender process. We also wish to see the commissioning of multidisciplinary teams, utilising professionals best placed to provide every individual aspect of specific patient care pathways. The EPB believes this approach will make most effective use of healthcare professional time and reduce costs to the NHS overall.

The ‘any willing provider’ model has the potential to deliver services in a way that is more effective for patients and efficient for the NHS but it could equally limit the ability of some providers to enter the market. We have some reservations over how this measure is expected to work but need to see more detail before offering comment.

18.  Do you agree that Monitor needs powers to impose additional regulation to help commissioners maintain access to essential public services? If so, in what circumstances, and under what criteria, should it be able to exercise such powers?

We have no comments on this question

19.  What may be the optimal approach for funding continued provision of services in the event of special administration?

We have a concern over continuity of care; there must be a mechanism in place for services to be transferred in the event of special administration. Business continuity plans should be in place at national, regional and local levels and appropriate funding should be agreed in advance.

20.  Do you have any further comments or proposals on freeing foundation trusts and introducing a system of economic regulation?

We are of the view that Monitor’s role to assess mergers and acquisitions should refer solely to the NHS and not the private sector.

21.   What action needs to be taken to ensure that no-one is disadvantaged by the proposals, and how do you think they can promote equality of opportunity and outcome for all patients, the public, and where appropriate, staff? 

We would emphasise the importance of including pharmacy in the key decision making areas of these proposals. Ensuring the most appropriate provider delivers the service will deliver the best outcomes for patients.

For further information or any queries you may have on our consultation response please contact Heidi Wright at  or 0207 572 2602.

 

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