The new Care Services Minister, Norman Lamb, was strongly critical of the Health and Social Care Bill in its original form.

His argument that the new NHS system was being “rushed into” without regard for the needs of GPs helped to stimulate amendments to the reform plans following the ‘listening exercise’.

Lamb is considered a leading Liberal Democrat spokesman on health, but political disagreements with Andrew Lansley led to his being denied a ministerial post until now.

In April 2011, Lamb threatened to resign from his position as chief political advisor to Nick Clegg if the Health and Social Care Bill was not amended.

His main concern was that the reform was not “evolutionary”: the changes were being “rushed into” without keeping GPs on board. He argued for a phased process that allowed GPs to ‘opt into’ the new system.

However, following the ‘listening exercise’, Lamb supported the amended Health Bill and said the Lib Dems had acted as a “safety valve” to allow its improvement.

Lamb’s appointment as Care Services Minister, replacing Paul Burstow, brings into the DH a major source of health expertise – potentially both a support and a counterpart to the new Health Secretary.

Other health ministers have moved on this week: Nursing and Public Health Minister Anne Milton is replaced by former journalist Anna Soubry; while Health Minister Simon Burns, promoted to Transport Minister, is replaced by former Health Select Committee member Dr Daniel Poulter.

Earl Howe, who steered the Health Bill through the House of Lords, keeps his ministerial role.

The Health & Social Care Bill has finally completed its arduous passage through parliament. In normal circumstances, the landmark of Royal Assent would provide a key moment of clarity for the future of the healthcare in the UK. But this is the NHS – and nothing is ever that simple. Whichever way you look, the health service is bedevilled by variability. NHS Alliance CEO Mike Sobanja and Cegedim Relationship Management’s David Round look at the implications of the Bill for industry in the next 12 months.

The Health & Social Care Bill has, as we all suspected it would, survived the onslaught and made the statute book. But the hard work really does start here. In truth, implementation of the reforms on the ground began many months ago – but the process will continue for some years to come. It is a time of great uncertainty for NHS and industry alike. We now have official confirmation of where we are heading, but do we really know how we are going to get there? And with health need omnipresent, what should we be doing to protect the needs of patients today as we journey towards the health system of tomorrow? The wider call is for more collaborative working between the industry and the NHS. And there is much that the industry can do to support the significant challenges its customers face.

So where are we now? And what do pharmaceutical companies, facing an NHS in flux and customer groups in transition, need to do to support the health service and drive improvements in care? At a time of uncertainty, the industry must first do two things: follow the law, and follow the money.

Following the law and the money
At the moment – in law – we still have the presence of 151 Primary Care Trusts (PCTs). These are, of course, clustering together, while alongside them a high number of Clinical Commissioning Groups (CCGs) are steadily being established. For now, however, PCTs remain legally responsible for the delivery of healthcare services in the UK – and will continue to do so until April 2013. PCTs are currently accountable for about 80% of a total NHS budget of roughly £110 billion. It is estimated that approximately £30 billion of this has already been delegated to around 250 CCGs. But whilst PCTs can legitimately delegate their powers, they cannot delegate accountability. If someone in a shadow CCG busts the budget or, worse still, a patient dies by virtue of a poor decision elsewhere – the ultimate responsibility still lies with the PCT.

The situation on the ground is therefore complicated. Power currently rests with a number of PCT clusters acting on behalf of still legal and existing PCTs, who are delegating cash and power on the ground to CCGs. In turn, the CCGs are enjoying increasing control over finances, though technically, they are not yet legally in existence.

So if the task for 2012 is to follow the law and follow the money, pharma must focus on developing its powers of local intelligence. The fundamentals are simple, but the devil is in the detail. The law tells us who is technically responsible, the money tells us who has been delegated the power and the pound. The £30 billion question for pharma, however, is: where has the money been delegated? And the answer, of course, varies from locality to locality.

Developing the knowledge: think local, and national
And so the industry is playing a new game called ‘Spot the Commissioner’. To compete, pharmaceutical companies – and in particular their field-based professionals – need to build and maintain knowledge of local circumstances that, to a large extent, they’ve not previously had.

The move towards a localised health service is a direction of travel rather than an absolute. Moving forward, the industry perhaps needs to view the NHS as a healthcare system that operates within a national framework, but with more local decision-making. The balance of power between local and national is dependent upon which aspect of the healthcare service, and which therapeutic area, is being discussed. NICE provides a good example. In theory, the statutes require that funding is made available for technology appraisals as formal TAGs within three months of NICE making a declaration. But the reality is that whereas NICE doesn’t have to consider affordability, local decision-makers do – and therefore exactly how they implement that will inform their local decision.

As such, pharmaceutical sales professionals need to keep one eye on the national scene and one eye on the local scene – and apply that knowledge to their individual therapeutic area. They need to think very hard about how any national decisions will affect their product at a local territory level. The promotion of pharmaceuticals has moved beyond the traditional sequential sale – it is now much more sophisticated. This sophistication is only likely to increase in the future. An example of this will be the introduction of Health and Wellbeing Boards. These are already establishing under the umbrella of local authorities and will bring together interests from a wide variety of other groups: employers, magistrates, courts, local authorities etc. These will have a significant influence on local health services.

Variability: process, progress and prescribing
In such a changing and dynamic customer marketplace, the challenge of playing Spot the Commissioner becomes ever more difficult. Ironically, the only one constant is the prevalence of variability. There is variability right across the system, particularly in terms of progress around the health reforms. For example, there are local areas adjacent to one another where one locality has seen significant lawful delegation of powers to CCGs, while its neighbours have seen very little. This variability is likely to continue for some time – beyond the point where CCGs are authorised as official legal bodies. Authorisation itself is not a simple ‘yes’ or ‘no’ – it may be conditional. A conditional authorisation may mean that a CCG has power to make decisions over some things, but not others. A CCG may, for example, be authorised to commission acute services locally, but not mental health services.

At a wider level, variability in local progress with NHS reforms is surpassed by the even more significant issue of variability in care across the UK. The introduction of the Atlas of Variation in November 2010 has brought the issue into much sharper national focus and highlighted areas where progress can be made. There is, of course, variability in every disease area. Here are two very different examples. For patients with type II diabetes, the likelihood of suffering a lower leg amputation as a result of the disease is greater in the South West of England than it is in the South East. On the other hand, around the issue of cancer referral times, there is huge variation across the country in terms of GPs referring patients to secondary care for earlier diagnosis. The latter is an example of variability in health care – the former is a great illustration of variability in health outcomes.

Addressing inappropriate variability is a key priority for the NHS. And it is an area where the pharmaceutical industry can help make a real difference. Pharma companies could start by looking at the variability in the prescribing of their own products. If they can identify where that variability is and draw it to the attention of the health service locally, they will be better placed to offer support to help address it. The industry could consider undertaking Health Equity Audits to generate disease-specific data to support commissioning. For example, if you are a sales professional, what could you tell a customer about how your therapy is used in terms of its distribution among social classes, poor or rich and ethnic groups? What can you say about its relative prescribing across geographical areas? This is key information. It’s likely that there will be all kinds of variability going on that the industry could be helping the NHS address – and in doing so, it will also drive the market. By combining publicly-available prescribing data with activity data and other readily-available metrics, companies can improve their sales and marketing strategies by providing customers with the best information to help inform commissioning decisions.

The value of data
Robust data and information is the lifeblood of good commissioning, and good commissioning is the lifeblood of good health outcomes. At present, few, if any, commissioners will have complete and comprehensive access to the right data on which they can base critical commissioning decisions. But, in a collaborative environment, many would be willing to work with the industry to help create that evidence-base. As the NHS restructure unfolds, pharma can be a credible source of information for commissioners – though probably only one of a number of sources. Increasingly the health service will seek to identify data itself, and the Atlas of Variation is a good example of that. Increasingly, there are good examples of joint working where parties have come together and delivered results. In a collaborative era, wracked by challenge and change, the industry and the NHS have a responsibility to develop that relationship further.

Pharma can certainly emerge as a valuable partner to the NHS as it moves through its transition. But the generation and communication of robust and relevant data will be key to progress. In the game of Spot the Commissioner, the best sales professionals will be those who understand the local situation, understand what is driving it and align their key messages so that they are seen as part of the solution, not part of the problem. Undoubtedly, access to good data will underpin everything.

Mike Sobanja is CEO, NHS Alliance. David Round is General Manager, Cegedim Relationship Management.

Maxine Vaccine considers the motives of politicians, clinicians and the pharmaceutical industry and concludes that no matter what direction you approach it from, health is never a simple issue.

My last blog, ‘Life in the balance’, provoked some interesting feedback. I had argued that the current government’s application of free-market principles to the NHS would encourage those doctors who saw what they do primarily as a business rather than as a service. An industry expert commented that a series of health policies over the past two decades, from GP fundholding to QOF indicators, have promoted the same mentality.

This of course is true. Not only are New Labour’s fingerprints all over the current phase of NHS reforms, but the medical profession has never been unified in its perspective on the relationship between health and financial priorities. Different doctors have different attitudes – or have various attitudes in different proportions. Where important decisions are concerned, most of us have mixed motives.

However, it’s rather in the nature of blogs, Twitter feeds, press releases and Parliamentary statements that we pretend otherwise. “Only one thing matters to me” is the opening clause (explicit or implicit) of almost any public statement. “I’m torn” would be bad business, bad politics and bad bedside manner... but it would, almost every time, be the truth.

So let’s be clear that when doctors say “We are motivated only by clinical priorities” it is not necessarily the pure truth. They are motivated to succeed at a professional and business level, and that may extend to practice finances. When the BMA decided to oppose the Heath and Social Care Bill it was not only on clinical grounds, but because the business proposition did not appeal despite its lucrative potential. Maslow’s ‘hierarchy of needs’ is a relevant concept here: the fear of losing control may override the desire to increase your income.

And when politicians say “Our priority is only to improve services” that is not necessarily the pure truth either. Most comment on the NHS reforms has focused on whether the Government is right to believe the new system will deliver better patient outcomes. But is that the only issue? Politicians are not doctors, and – as recent events have proved – they don’t even want to listen to doctors. It’s not cynical to see NHS reform in terms of wider political priorities for society and the economy: that is precisely how politicians see it.

There’s no doubt that Andrew Lansley would like to see patient outcomes improve. But his sense of what can achieve that does not come from expert medical opinion: it comes from the political ideology that assumed privatisation would make the rail service cheaper, safer and more reliable. At least as important, from his viewpoint as health secretary, is the priority of breaking down the national and public sector employment basis of health workers, so that local employers can set their own terms and conditions.

As for the pharma industry – well, it depends on who you talk to. Your CEO will tell you (and the media) that everything your company does is driven by a passionate commitment to making a difference for patients. The public largely believe that everything your company does is driven by the need to make a difference for shareholders. The truth is that even a humble field representative is motivated by a complex blend of factors: short-term targets, longer-term business growth, customer relationships, clinical success, public reputation and the need to laugh once in a while.

Like mixing a drink, medical sales is all about finding the right balance – and not losing your own.

Maxine’s views are not necessarily those of Pharmaceutical Field.

The UK cabinet’s veto on publication of the NHS transition risk register was an “unjustified” policy change, according to the Information Commissioner.

In a report to Parliament, Christopher Graham said the circumstances of the Health and Social Care Bill were not so “exceptional” as to justify the measure.

The cabinet’s decision was “a significant step” in the use of security legislation to conceal non-military information, he said.

Health Secretary Andrew Lansley said that publication of the document noting possible consequences of the NHS reforms would endanger the “safe space” of policy development.

But the veto – only previously used in the context of war – could not validly be used for such purposes, Graham said, noting: “None of the criteria for ‘exceptional cases’... are met in the present case.”

A DH spokesperson responded that the NHS reform legislation took place at “a particularly sensitive time when the need for a ‘safe space’ was especially high”.

Shadow Health Secretary Andy Burnham said the Information Commissioner’s report was “severely embarrassing” for the Government.

Responding to a delegate’s query at the NICE Conference, Andrew Lansley insisted he had kept within the bounds of the Freedom of Information Act.

The new NHS reforms will make it more difficult to track and remedy health inequalities, according to experts writing in the BMJ.

The fact that CCGs and can take patients from anywhere in the UK threatens the comparative value of their health data, the authors said.

In addition, the fact that they are likely to outsource public health services to the private sector means that data quality and completeness will not be regulated.

Professor Allyson Pollock, Professor Alison Macfarlane and Sylvia Godden argued that the new Health and Social Care Act has “severe implications” for data regarding health needs and access to care.

Although it will be possible to compare the patient populations of the new CCGs, the authors said, “the instability of the denominator population will hinder accurate interpretation of the data”.

Public health services such as childhood vaccination, mental health and sexual health are now the responsibility of local government, which will subcontract them to CCGs – which, in turn, may outsource them to private providers.

As a result, crucial data on unmet needs and access to treatment may not only be sourced in inconsistent ways but be subject to commercial criteria including the confidentiality of business information.

Cancer registries will also be affected, the authors warned, with health data being treated as commercial property rather than as a shared resource.

They concluded: “The abolition of area-based structures and the transfer of most responsibilities to non-geographically based CCGs undermines the availability of information and routine data required to monitor the comprehensiveness of the health service, inequalities in access, the resourcing of services, and outcomes of care.”

As a result, they argued, it will become “almost impossible to take the action needed to tackle inequalities in health and in access to healthcare.”

Health Secretary Andrew Lansley has said the amendments made to the Health and Social Care Bill in its passage through Parliament made no fundamental difference.

The purpose of the ‘listening exercise’ was primarily to help clinicians understand the Bill better, Lansley told the journal GP Business.

A British Medical Association spokesperson said the Health Secretary’s statement was “not a remote surprise” to its members.

In an interview, Lansley claimed the main reason for opposition to the Health Bill was that critics had not read the White Paper Liberating the NHS – “or even if they had read it they had not really understood it or engaged with it”.

However, he expressed regret that the ‘listening exercise’ had not taken place “three or four months earlier”.

The many amendments to the Health Bill conceded by the Government at the House of Lords stage were needed to compensate for the slow engagement of NHS professionals with the reform process, Lansley asserted.

“Although we made further amendments in the Lords, in truth, a lot of those amendments were practical things in order to give further reassurance,” he said. “They did not really fundamentally change the principles at all.”

The BMA, which opposed the Health Bill after what it considered the failure of the ‘listening exercise’ to deal with the concerns of doctors, responded angrily.

“The majority of the health profession is aware the Bill’s fundamental principles look pretty similar to its original draft – it is not a remote surprise,” said Dr Laurence Buckman, Chair of the British Medical Association’s GP Committee.

“Furthermore, the amendments made to the Bill have certainly not offered the profession any reassurance and in fact some of the reform’s implementation plans have been made less attractive by the changes made to the legislation.”

The new Bribery Act makes UK pharma companies legally responsible for any kickbacks their reps or distributors may offer to health officials anywhere in the world. Maxine Vaccine asks whether UK politicians who point the finger at traders can really be serious.

Compliance is the new CRM. In an era of globalised pharmaceutical trading, the UK Bribery Act and the US Foreign Corrupt Practices Act have sent a shock wave of pure terror through the industry. Basically, what the new legislation means is that a company is responsible what anyone acting on its behalf, even under contract, may do to advance its business. A local sales team or freelance distributor on the other side of the world might treat a village doctor to a bottle of whisky in return for a commission – and a biotech company in Cradley Heath might find itself fined out of existence. It’s scary.

According to a new Cegedim report 94% of life science companies now enforce corporate standards for spending on HCPs, while over half have a project team to address compliance issues. However, Cegedim warns that good intentions are not enough: without robust surveillance and reporting systems, those unmarked envelopes may slip through the cracks.

Closer to home, the ABPI Code of Conduct imposes very strict limits on the industry’s freebies and favours to its customers. Marcus Brigstocke raised some nervous laughter at last week’s Pf Awards by suggesting that pharma reps might moonlight as biro salesmen. The rules on hospitality threaten drug reps with wholesale loss of mates. Bourbons are completely banned. Only digestives are permitted, and they must be from Costcutters. In fact, you can offer branded biscuits only when selling generic drugs.

Compliance means more than just obeying those rules you know about in those transactions you personally carry out. You have to find out what all the relevant rules are and then apply them to every commercial interaction that touches your company. Being compliant takes proactive commitment, intelligence and good teamwork. Though when I put ‘Totally compliant’ on my Facebook profile I got some interesting messages.

So it was with some amusement that I read a recent newspaper story: the Conservative Party’s co-treasurer Peter Cruddas told undercover journalists posing as financiers that a minimum donation of £250,000 to Party coffers would gain them direct access to the PM’s policy unit. Make with the cash, he told them, and “things will open up for you”. In case they were unsure what that might be worth, he clarified the point: “It will be awesome for your business.”

Pardon my naive attitude, but WTF? The only part of ‘Foreign Corrupt Practices’ not implied by such promises is the word ‘Foreign’. Perhaps, before they legislate to rein in pharma industry reps, some of these politicians should look in the mirror.

It’s worth noting here that the private healthcare corporations currently in line for a share of the NHS franchise now the new Health Bill has become law are major donors to the Conservative Party, just as they were to Andrew Lansley’s campaign fund when he was Shadow Health Secretary. In addition, the BMJ reports that half of the doctors on the new CCG boards have financial interests in private healthcare companies that will be bidding to provide NHS services.

And meanwhile, we get stamped on for giving away a few biros. Are they having a laugh?

Maxine’s views are not necessarily those of Pharmaceutical Field.

The Department of Health’s risk register on the NHS reforms has been leaked online on the day the Health Bill reached Royal Assent.

The Transition Risk Register raised a host of concerns about the introduction of the Health and Social Care Bill including the NHS losing control of finance and performance, the morale of staff and dispute with unions.

Health Secretary Andrew Lansley had previously claimed the register was a “worst case scenario”.

Labour MP John Healey had requested the DH release the register whilst he was shadow health secretary in November 2010 under the freedom of information law.

A tribunal ruled earlier this month that the risk register should be published before the Bill had passed through Parliament. However, the DH indicated it would appeal the decision and the publishing of the register was again delayed.

The version which was leaked online is one of the first iterations of the register. Dated 28 September 2010, it was created three months after the Government’s initial white paper was published.

The most significant and likely risks, the document reveals, surround the loss of control of finances and performance. It states: “By dismantling the current management structures and controls, [there could be] more failures, including financial, e.g. GP consortia go bust or have to cut services, and credibility of the system declines as a result.”

Worries were also raised that the NHS Commissioning Board “is not sufficiently developed” and that consortia or GP leaders who are not sufficiently developed “may be drawn into managerial processes which drive clinical behaviour (rather than the other way around)”.

The document also warns that the “new system” will be designed from an internal perspective without considering the views of the general public and patients and lead it to being “difficult for the public to navigate or hold to account”.

Risks referring to the Treasury include: an inability to reduce running costs due to the number of consortia; a reduction in the amount of time GP spend with patients due to management responsibilities; ‘postcode’ commissioning; an increase in “catastrophic failure” with no system management; and GPs creating an increase in their remuneration by “playing the system”.

The register also indicated the Government was considering splitting the Health Bill into two parts as it faced a host of opposition against the controversial reforms in the autumn of 2010. However, there were worries over whether parliamentary time could be found for two separate pieces of legislation.

The Government looks set to have won its battle over the Health and Social Care Bill after the last attempt to halt the legislation failed in the House of Commons.

An emergency debate by Labour to block the changes to the Bill until a risk register was published was defeated by 328 votes to 246.

Andy Burnham, Shadow Health Secretary – who pushed for the risk register to be published – said that the general public would “struggle to understand” how MPs had made “such momentous decisions” without considering all of the evidence on the reforms.

Final amendments to the controversial reforms were approved by MPs paving the way for Royal Assent for the Bill before the break for Easter next week.

Peers in the House of Lords approved the Bill on Monday evening.

The changes to the structure of the NHS will see Strategic Health Authorities and Primary Care Trusts abolished in favour of local Clinical Commissioning Groups. The move, which will see GPs given budgetary responsibilities and the opportunity to outsource services privately, has been widely opposed.

Mr Burnham admitted that the legislation becoming law was inevitable and the only hope left to defeat the Government’s plans would be a “change of heart” from the Lib Dems.

“We have given this fight everything that we had,” he said. “All I can say is our fight will go on to protect and restore this party’s finest achievement.”

The Health and Social Care Bill has passed its final reading in the House of Lords and is now only days from becoming law.

The final vote in the House of Commons today will follow an emergency debate forced by the opposition.

An attempt to delay the Lords vote until the publication of the risk register for the planned NHS reforms was defeated by Conservative and Lib Dem peers.

During the final Lords debate, 25 protests against the Health Bill took place across the UK.

A motion tabled by Labour peer Baroness Thornton called for the Bill to be dropped because it did not have the support of patients, clinicians or the public and would drive the “fragmentation and marketisation” of the health service.

It was defeated by 269 votes to 174, with the support of only one Lib Dem peer.

A further motion by crossbench peer Lord Owen, calling for the Bill’s third Lords reading to be delayed pending the publication of the NHS transition risk register, was defeated by 328 votes to 213.

The Freedom of Information Tribunal recently upheld the decision by the Information Commissioner that the risk register, which the Government has now withheld for 15 months, must be published.

Shadow Health Secretary Andy Burnham commented that it was “highly unsatisfactory” for the information about the risks of the Bill’s implementation to be denied to MPs until after their final vote.

“Parliament has a right to know, before it is asked to make a final judgment that will have huge implications for every person in this country,” he said.

However, Health Minister Earl Howe (pictured) told the Lords that considering the transition risk register to offer some “deep insight into what this bill means for the NHS” was “an absurd proposition”.

Labour has forced a 90-minute emergency debate today on whether MPs can approve the Bill before the risk assessment has been published.

If approved by the Commons today, the Bill could receive Royal Assent and become law later this week.