Several Liberal Democrat peers are supporting a number of amendments to the Health Bill focused on the regulation of competition within the NHS.

Several senior Lib Dem peers support the amendments and could force the Government to change aspects of the controversial legislation following concerns the Bill could still extend the application of European competition law to the NHS.

Lord Clement-Jones, a former Lords health spokesman who backs the changes, says the amendments would “balance the competitive powers and the integrating duties”.

More than a dozen amendments have been tabled by Lib Dem peers. They include the constraint of Monitor’s action against anti-competitive behaviour, that private income generated by Foundation Trusts would be used solely for the benefits of NHS patients, and that public interest be considered when the Office of Fair Trading is consider mergers.

Speaking to the HSJ, Lord Clement-Jones said he and his colleagues aimed to “make sure we didn’t fall into having a health service covered by European competition law” and that “we don’t have competition red in tooth and claw across the health service”.

The consideration of the Bill at the committee stage in the House of Lords is set to continue until the New Year.

The BMA has set out eleven areas of continuing concern with the Health and Social Care Bill.

The Association says that a series of further amendments to the Bill are necessary in “order to mitigate damage” to the NHS.

Its recommendations include giving Clinical Commissioning Groups (CCGs) the freedom to commission the most appropriate services, and ensuring the Secretary of State retains ultimate responsibility for the NHS.

Dr Hamish Meldrum, BMA Chairman, says although the Association would prefer the Bill to be withdrawn, “there is scope for further significant change to be made” during its passage through the House of Lords.

In its latest briefing paper, the BMA also calls for an amendment which makes it explicit that patient choice will not be given priority over fair access for all. It also wants further safeguards which prevent providers of care or services ‘cherry-picking’ more profitable services.

On incentives for commissioning, the Association “continues to have serious concerns” about conflicts of interest with the link of financial incentives to the performance of CCGs.

Dr Meldrum hopes that peers in Lords will agree with the suggested amendments and change the controversial legislation before it progresses any further.

“Because so much of the detail won’t appear on the face of the Bill and will instead be left to secondary legislation and guidance, it is essential to have firm assurances now about the government’s implementation plans, for example, we continue to have serious concerns about the ethics of the current proposal to incentivise commissioners,” he said.

“Other areas where the BMA is seeking amendments relate to public health; the private patient income cap; the foundation trust failure regime; increasing bureaucracy and complexity, and information and confidentiality.”

Members of the BMA have previously expressed “major concerns” about the Health Bill on various occasions, calling for the Government to amend the plans back in June 2011.

The BMA has called again for the Health and Social Care Bill to be withdrawn or substantially amended in a letter and briefing paper sent to all House of Lords peers.

The Bill has passed its first reading in the House of Lords, and a second reading is planned for Tuesday 11 October.

In the letter, BMA Chairman Dr Hamish Meldrum argued that the current rollout of the planned NHS reforms, in advance of the legislation, makes the need for greater clarity regarding the plans more urgent.

The Health Bill will “make it harder to create the seamless, efficient care that everyone agrees is key to future sustainability,” Meldrum claimed.

The key issues highlighted by the BMA as needing attention from the House of Lords are:

• The need for a clear statement that the Secretary of State will remain responsible for providing a comprehensive health service.
• The need for assurance that increasing patients’ choice of providers will not be prioritised over the development of fair access and integrated services.
• The need for more clarity on what will happen to services when a hospital is ‘failing’ in financial terms.

In addition, the BMA expressed concern regarding the future capability of public health; the excessive new bureaucracy around NHS commissioning; and the potential impact of abolishing the cap on the income that Foundation Trusts can generate from private patients.

Dr Meldrum concluded that “The BMA still believes the Bill, as it currently stands, poses an unacceptably high risk to the NHS in England.”

The BMA has again called for the Health and Social Care Bill to be withdrawn or undergo further substantial amendments in a letter to peers in the House of Lords.

Although BMA Chairman Dr Hamish Meldrum recognises significant changes have already been introduced, he outlines how the Bill lacks clarity and how the reforms offer serious problems for the NHS.

In the letter, Dr Meldrum says “the BMA still believes the Bill, as it currently stands, poses an unacceptably high risk to the NHS in England”.

He adds that the proposed reforms will make it harder for the health service to “create the seamless, efficient care that everyone agrees is key to future sustainability”.

While the Association is not against all of the proposals in the Bill, it says the Government’s plans are the “most radical restructuring of the NHS in a generation”.

Ahead of the second reading of the Bill next Tuesday, the BMA believes the most pressing concerns the House of Lords needs to address are:

• The need for an explicit provision that the Secretary of State will retain ultimate responsibility for health services
• Assurance that increasing patients’ choice of provider for specific elements of care will not be given priority over the development of NHS services and fair access for all
• Greater scrutiny of the plans to tackle underachieving hospitals

Concerns were also raised by Dr Meldrum about the threat to the capability of public health in the future; unnecessary and unhelpful bureaucracy around the development of CCGs and the NHS Commissioning Board; and the plans to abolish the income cap Foundation Trusts can generate from private patients.

The BMA’s letter follows a similar epistle from 400 public health experts who voiced their concerns over the reforms and called for Lords to reject the proposals.

Read more on this story on Medtech Business.

Further delays to the progress of the controversial Health and Social Care Bill are expected due to several challenges to its proposals during its passage through the House of Lords.

Baroness Glenys Thornton intends to seek crossbench alliances in order to question aspects of the reforms, including the role of the health secretary and competition regulation.

Labour’s health spokeswoman said to the HSJ that peers were likely to “demand” that the legislation was analysed in a Lords bill committee, rather than on the floor of the house.

A bill committee is the only way the house can hear evidence from external bodies.

The Baroness says the rare move away from a discussion on the floor would be justified due to the Bill’s length, complexity and as it has been significantly amended following the Government’s NHS Future Forum’s recommendations.

It’s believed that the move to a committee discussion has support from Lib Dem peers, although it is understood the Government has serious concerns about the resistance and further delays.

Baroness Thornton raised a number of issues that had not been discussed in the House of Commons because a lack of time and other amendments had not been scrutinised fully.

She said that due to the Bill’s impact being so “big and fundamental” it would usually be subject to a comprehensive parliamentary debate and a draft bill before the proposed legislation was published.

“There is certainty a case that some parts of this bill need more attention,” she said.

“Clearly the Government might find itself in some difficulty.

“We are taking this bill very seriously… There is a cohort of members who are well informed about this bill.”

She added that it was impossible to predict likely further delays but said that royal assent may be take place beyond when it is currently expected in early 2012.

The ABPI is proposing the PCMPA’s Constitution and Procedure be amended so that any future change to its Code of Practice can be done so without calling a general meeting.

The Association is obliged to implement any amendments the European Federation of Pharmaceutical Industries and Associations (EFPIA) makes but currently has to arrange a formal procedure to do so.

Its Board of Management is now requesting that where “changes arise solely” from amendments to the EFPIA Code they’re introduced without a general meeting.

The ABPI says companies would then be consulted regarding any changes.

The EFPIA recently made amendments to its Code on the Promotion of Prescription-Only Medicines to, and Interactions with, Health Professionals and to its Code of Practice on Relationships between the Pharmaceutical Industry and Patient Organisations.

The proposals have now been sent to the Medicines and Healthcare products Regulatory Agency (MHRA), the British Medical Association (BMA), the Royal Pharmaceutical Society of Great Britain (RPSGB), and the Royal College of Nursing (RCN) as required by the existing Constitution and Procedure.

Although consultations are welcome on the proposals, it is anticipated they will be discussed before the ABPI’s bi-annual general meeting in November, with a view to approval by member companies.

The new measures would then come into effect from 1st January 2012, and become fully operative on 1st May 2012.

The revised Health and Social Care Bill remains contentious, but appears likely to pass into legislation. Simone Carron-Peters of Frost & Sullivan analyses its probable impact on the UK healthcare market.

The Government’s contentious Health and Social Care Bill has raised many concerns among the various stakeholders. The eight-week NHS listening exercise conducted by the NHS Future Forum has resulted in the proposal of multiple changes to the Bill, whose passage towards legislation is summarised in Figure 1 below.

This article evaluates the planned NHS reforms for impact on the health system and the life science industry.

Overview of the Bill

The Health and Social Care Bill proposes to create an independent NHS Board, promote patient choice and reduce NHS administration costs.
Its key focus areas are:

• To establish an independent NHS Board to allocate resources and provide commissioning guidance.
• To increase GPs’ powers to commission services on behalf of their patients.
• To strengthen the role of the Care Quality Commission.
• To develop Monitor, the body that currently regulates NHS Foundation Trusts, into an economic regulator to oversee aspects of access and competition in the NHS.
• To reduce the number of health bodies, including abolishing PCTs and SHAs, in order to help the Government cut NHS administration costs by one-third.

More power (and money) to the GPs

In its initial form, the reform aimed to improve the quality of service delivery by devolving NHS commissioning powers and responsibility into the hands of GPs. The GP consortia would receive budgetary allocations from the new NHS Commissioning Board, which would be responsible for managing and allocating about £80 billion of the health budget. The consortia would, in turn, devolve the funds to the various practices under them.

The new GP consortia would replace the 302 PCTs in England, which would be abolished by 2013. All NHS trusts were set to become Foundation Trusts by April 2014. It was anticipated that the consortia would require significant assistance, including support from the private sector, in exercising these new commissioning functions.

Medical organisations and NHS trusts were immediately sceptical about the implementation of this reform, saying that the changes could have negative effects on NHS services. Some trusts argued that it is risky to reduce the central grip on commissioning at a time where urgent savings are being made. Others agreed that GPs are well positioned to make decisions on the use of resources for their patients.

The BMA: a critical response

The reform plans have also not gone down well with the British Medical Association (BMA), who expressed concerns about the level of responsibility being bestowed on GPs. One of the BMA’s major concerns was the lack of clarity in the Bill with regard to the roles that the GP consortia would be expected to perform. The BMA also believes that it is important to ensure the funding for GP practices remains distinct from other budgets, as it would cause significant complications if GP consortia were to be made responsible for amalgamated budgets that included the management of standard GP contracts.

Currently there are about 177 GP ‘pathfinders’ (pilot groups of GPs testing the system’s concepts and functions) who are taking the lead in implementing the new commissioning roles.

In May 2011, the BMA’s Health Policy and Research unit conducted a national survey of GP opinion that received a response rate of 39%. The survey findings revealed an alarming 55.8% of the respondents citing NHS reforms as a reason for their intention to retire in the next two years. That figure was composed of 59.4% of the 688 principal or contracted GPs, 41.1% of the 30 employed salaried GPs and 35.8% of the 39 freelance GPs who participated in the survey.

The survey also asked GPs how confident they were that the GP commissioning consortia would be appropriately skilled and supported. 65.6% were ‘not confident’ that the consortia would be appropriately skilled, while only 15.8% were ‘confident’ that they would be. In addition, 70.9% of the respondents stated that they were ‘not confident’ that the consortia would be supported, while just 10.2% were ‘confident’ that they would be.

Amendments to the Bill

Based on the recommendations of the NHS Future Forum, the Health Secretary announced changes to the Health and Social Care Bill in June 2011. The Bill is due for its third reading on the 6th and 7th September 2011.

The role and functions of GP consortia are now better-defined. The consortia – now called Clinical Commissioning Groups (CCGs) – would be required to publish details on their constitution and how the allocated budgets have been used. They would also be required to follow guidelines from, and be accountable, to the NHS Commissioning Board. GPs are also bestowed with a responsibility to promote research and innovation.

The plan for all NHS trusts to become Foundation Trusts by April 2014 has been amended. NHS trusts would become Foundation Trusts by 2016, based on their clinical readiness for transition. They would be given the liberty to make use of private health treatments, and would compete among themselves for patients.

The role of the National Institute for Health and Clinical Effectiveness (NICE) would increasingly focus on giving authoritative advice to clinicians on when and how the most effective treatments can best be used, and also on the development of quality standards for the NHS to aim for in the treatment of certain conditions.

Value-based pricing (VBP) would replace the Pharmaceutical Price Regulation Scheme (PPRS), which has existed since 1957. The purpose of VBP is to improve NHS patients’ and clinicians’ access to effective and innovative drugs and medical technologies by ensuring they are available at a price that reflects their value, based on an assessment of the outcomes they can achieve.

Impact assessment of the health reforms

The implementation of the Health and Social Care Bill will witness an increase in private sector and voluntary involvement in the delivery of healthcare. GP commissioning will allow the use of private healthcare for NHS patients. Healthcare vendors and providers can capitalise on this shift by offering products and services best suited to patients’ needs in order to influence GP commissioning.

The aim of value-based pricing is not to achieve the lowest price possible, but to encourage the development of new therapies and promote innovation. The principle of linking the price of innovations to their value has already received support from a broad range of stakeholders.

The priorities of the health reforms are ambitious; if instituted, they will have far-reaching effects on the way the British public accesses the health system. It will also affect the role of the private sector in the UK healthcare system, increasing opportunities for private providers of both clinical and support services to become involved in providing healthcare to NHS patients.

According to the Government’s calculations, the reforms will bring about a huge cost saving for the NHS. However, negative consequences such as redundancy for administrative staff in the health authorities will pose a huge socio-economic threat.

How will the savings affect the prospects for innovative medical technologies? The adoption of such products has always been necessary for medical professionals, predominantly because new technology aims to provide healthcare at a quicker rate – minimally invasive technologies being a major example. The Government has vowed to ensure the system delivers effective and appropriate healthcare to all who need it. Moreover, GPs have a greater understanding of patients’ needs than the managers or PCTs who at present make funding decisions. Thus the demand for innovative devices will arise regardless of the allocated NHS budgets.

One of the main objectives of the reforms is to put patients and public first by implementing a ‘no decision about me without me’ policy. National standards and independent inspection will continue to assure patients that all NHS-funded services are safe and of a high quality. Patients will have much more information about individual services and their performance, enabling them to choose the services that best meet their needs.

The reforms will ensure that services are easier to access and more responsive. Shorter patient waiting times, one-stop clinics for diagnostics, and increased provision of healthcare in patients’ homes are some examples of services that are likely to develop in response to new incentives. Patients will be able to gain access to healthcare in new ways that are more flexible. This is likely to mean more services delivered in local communities, such as urgent, preventative and rehabilitative care, thus helping to avoid unnecessary hospital admissions. Better information will help patients to understand and make the best use of the options available.

The reforms will also support services to become more integrated. Improved information systems will play a key role, enabling healthcare providers to exchange clinical data more easily and so gain a complete view of the patient’s condition. Increasingly, there will be opportunities for patients to influence the pattern of services within their locality. Local practices will have incentives to provide locally-based health improvement and health protection services. Patients will be in a better position to manage their own health.

Financial goals

The Government is confident that the health reforms will allow it to save billions. Figures from the Impact Assessment published alongside the Health and Social Care Bill earlier this year claim that the structural reforms to the NHS will save £5 billion per year, though this is a gross rather than net figure. The Bill promises to reduce NHS administrative costs while promoting patient choice. However, time alone will tell whether these reforms prove to be economic.

 

Simone Carron-Peters is a Research Analyst for growth consultants Frost & Sullivan.

The BMA has called for the revised Health and Social Care Bill to be withdrawn or substantially amended, arguing that its plans for competitive and market-led NHS reform still threaten the quality and integrity of services.

In a letter to all MPs, BMA Council Chairman Dr Hamish Meldrum has said that even in its current revised form, the Bill presents an “unacceptably high risk to the NHS, threatening its ability to operate effectively and equitably, now and in the future.”

The third reading of the Health and Social Care Bill in the House of Commons is due to take place on 6 and 7 September, after which the Bill will transfer to the House of Lords.

Dr Meldrum argued that the Bill places “an inappropriate and misguided reliance on ‘market forces’ to shape services”, with the “potential to destabilise local health economies” and, in the long term, to harm public health.

He also noted that, far from overcoming bureaucracy, the Bill is now creating a US-style legalistic environment of “excessive complexity and bureaucracy” to support competition between providers.

The BMA’s main concerns include:

• The Secretary of State is still not responsible for providing a comprehensive health service, only for ‘promoting’ one.
• The removal of the cap on Foundation Trusts’ income from private patients could lead them to focus their resources on private care.
• Forcing all NHS Trusts to become FTs could compromise patient safety and quality of care by placing a premium on financial targets.
• Promoting an increase in choice of providers appears to be a higher priority than tackling health inequalities and promoting integrated care.

“Meaningful, sustainable reform needs to have the full confidence of patients and those working in the health service,” Dr Meldrum concluded – and despite its apparent benefits to their professional interests, GPs remain predominantly opposed to the Government’s plan for the NHS.

The amendments in the Health Bill to the commissioning landscape may have
been small but they are significant for pharma. David Round (pictured) outlines the
implications of these changes to the care pathway and the new opportunities
for joint working.

The dust is beginning to settle on the amendments to the Health and Social Care Bill and it is now time to assess just what the changes in commissioning structure will mean in practice. How will the renamed Clinical Commissioning Groups (CCG) approach the creation of care pathways? Will there be much change from the model used by the previous Primary Care Trust (PCT), or will these new organisations opt for a ‘business as
usual’ approach where possible in order to simply get commissioning processes up and running in a timely fashion?

And what opportunities does the increasingly local focus on commissioning provide pharmaceutical companies to deliver added value services over and above drug products
that are increasingly viewed as a commodity across the NHS?

For pharmaceutical companies the good news is that the changes to the Bill, following the ‘pause and listen’ process, are not overwhelming. The coalition Government has accepted
many of the recommendations of the NHS Future Forum but the essence of the shift towards greater local commissioning remains the same.

The newly created GP Commissioning Consortia (GPCC) remain in place – albeit under the new name of CCG to reflect the inclusion of nursing and hospital consultants on the main board. The pressure is also off CCGs to be ready for the 2013 deadline – although those that are ready will be able to proceed with their commissioning plans sooner. In areas where CCGs are not ready to undertake commissioning duties, the National Commissioning Board will take over from the PCT Clusters for an interim period.

There is also a move towards greater local accountability, with CCGs now required to consult with a raft of new local bodies, including Clinical Senates – responsible for ensuring
CCG clinical plans are robust and meet local requirements – local NHS Commissioning Boards, and Health and Well Being Boards.

New constellations

All of these groups will have an influence on the evolution of the care pathway and must, therefore, be considered within the pharmaceutical market access strategy. Clinical Senates will work alongside the existing clinical networks – such as cancer networks – to ensure CCGs take local and disease specific requirements into consideration. If the Clinical Senate believes that care pathway plans are not good enough it can recommend the NHS Commissioning Board steps in before the CCG is authorised to act as a commissioning group.

As yet, the makeup of these Clinical Senates and local NHS Commissioning Boards is not clear. However, with the continuing exodus from PCTs, there is no doubt that some familiar names will reappear in these new roles.

It is also clear that there is a fast developing gap between the most advanced CCGs and the rest. Some, indeed, have already set their clinical priorities and are looking at care pathways. Within this process, these CCGs will have taken into account the views and concerns of local clinicians and local clinical requirements. The difference now is that there will be formal bodies in place to undertake that local clinical accountability.

For pharmaceutical companies the message remains consistent: market access strategy success will depend upon gaining an in depth insight into not only the CCGs and the speed
with which they are progressing and embarking towards clinical decision making, but also understanding the new influencers within the Clinical Senates and local NHS Commissioning
Boards.

Understanding the mission

However, there is one change to the Bill that also presents significant opportunities to pharmaceutical companies – the decision to place medical research at the centre of the
NHS mission. Under the amended proposals, ­The Secretary of State for Health will be given a statutory duty to promote research, while the new CCGs will be actively required to encourage research, innovation and the use of scientific evidence through their decisions.

This move is fundamental, and addresses criticism that the original Bill did not encourage doctors to make use of improved therapies or the latest evidence on clinical best practice.

For pharmaceutical companies, this shift in emphasis opens the door towards more innovative, cooperative working; and for embarking on joint working initiatives with CCGs. It also ensures doctors and pharmacists will continue to be involved in research projects, from clinical research to patient care, patient outcomes and procedures.

Indeed, some of the CCGs are already actively seeking more opportunities to get involved in programmes and projects that can deliver better patient outcomes by reconfiguring patient services. These leading groups want to work with pharmaceutical companies on research projects that could, if successful, be rolled out across a number of CCGs and allow them to deliver care pathways that meet budgetary constraints.

One big leap

For pharmaceutical companies this will necessitate a new approach. It may require a shift in budget towards a significant up-front investment in developing a new service within a
CCG with a view to recouping that investment further down the line when the service is successful. Fortunately, with companies no longer able or willing to spend money on certain promotional items and activities due to ABPI code changes and the new Bribery Act, there are opportunities to redirect funds towards such programmes.

Key to the success of such joint working is openness: both pharmaceutical companies and the NHS need to clearly understand the benefits to both sides of the venture. ­The  pharmaceutical company cannot simply put in a new service in order to improve product sales; that will not work in today’s NHS. The emphasis must be on implementing a service
that raises the profile of the disease area, which in turn leads to an increase in the whole market – generating additional sales – but reduces the overall burden of the disease on the
local health economy. For the NHS, there will be an investment in resource that effectively identifies certain types of disease earlier, enabling cost savings through improved preventative care.

There is a valid concern amongst smaller and medium-sized pharmaceutical companies that they simply cannot fund joint initiatives on this scale. Feedback from the NHS suggests that companies will be encouraged, even expected, to band together to create a joint working partnership.

Looking into outer space these changes are significant. But they are also taking place within an environment of increasing financial constraint. It is essential that pharmaceutical companies understand the genesis of change; to identify the changes in care pathway and patient pathway that are occurring as a result of natural budgetary restraint and those that
are a direct result of the shift in commissioning structure.

Armed with this insight, companies can ensure messaging remains valid and effectively targeted and reflects the changes that can and are being made by CCGs. Messaging must
reflect the huge pressure on CCGs to reduce costs whilst also improving patient outcomes. And it must recognise the fact that many of these organisations are and will be looking
for partners that can offer innovative solutions and services – from specific procedures to drugs or devices – proven to meet these objectives.

It is those organisations that can take that messaging, that can identify and engage with the CCG vanguard and, where appropriate, embark upon joint initiatives that can be extended over time that will be well placed to meet the needs of increasingly local
commissioning policies.

David Round is the UK General Manager of Cegedim Relationship Management.

The Health and Social Care Bill has been significantly modified to take account of the recommendations of the NHS Future Forum, following the 10-week ‘listening exercise’.

The revised Bill reduces the emphasis on competition between providers, relaxes the schedule of reform and widens the scope of clinician involvement in commissioning.

The BMA has expressed approval of the amendments, but said it will wait for further details before commenting on the revised Bill as a whole.

Key modifications to the Health and Social Care Bill include:

• The legal responsibility of the Health Secretary for the overall performance of the NHS will be reinstated.

• The primary role of Monitor will be to increase ‘patient choice’ rather than enforce competition.

• The 2013 deadline for the new commissioning arrangements has been relaxed – the new National Commissioning Board will control budgets until GP consortia are “able and willing” to take over.

• The new health and wellbeing boards to be set up by councils will have more power to oversee commissioning and represent patients.

• Hospital doctors and nurses will have a stronger role alongside GPs in the commissioning process.

Prime Minister David Cameron has also placed emphasis on the change in wording from “any willing provider” to “any qualified provider” (will be allowed to compete for NHS service contracts).

The Health Bill will now return to committee stage in the House of Commons. The revised Bill is expected to become law by May 2012.

David Cameron commented: “The fundamentals of our plans – more control to patients, more power to doctors and nurses, less bureaucracy in the NHS – they are as strong today as they've ever been. But the shape of our plans, the detail of how we're going to make all this work, that really has changed as a direct result of this consultation.”

The BMA, which had raised concerns about the impact of provider competition and financial incentives on NHS care, has welcomed the amendments to the Bill. Dr Hamish Meldrum, Chairman of Council at the BMA, said: “It seems clear that what we are likely to see is a very different Bill, and one which puts the reforms on a better track. There is much in the government’s response that addresses the BMA’s concerns.”

However, Meldrum noted, “The success of the reforms will very much depend on how the various elements link together and work on a practical level, and on how much they engage clinicians and patients locally.” In particular, there will need to be “robust safeguards to ensure that vital services are not destabilised by unnecessary competition.”

 
David Cameron