HSJ’s roundtable explored the potential benefits and risks of the ‘Sunshine Rule’, which would increase transparency about gifts and hospitality received by NHS staff. Alison Moore sat in

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Many public services – and private companies – have become increasingly transparent in the last few years. The public can now find out how much many organisations’ leaders are paid, whether their local hospital has met a plethora of government targets, and more information about outcomes for different treatments.

Part of this has been a focus on how organisations and individuals behave and whether this is ‘ethical.’ The Nolan principles, which lay down the expectations of public office holders, have been part of this change, along with a belief that transparency can drive change in behaviours as stakeholders become more questioning.

The panel

Adele Waters, executive editor HSJ - chair

Virginia Acha, executive director for research, medical and innovation, the Association of British Pharmaceutical Industry

Mark Duman, non-executive director, Patient Information Forum

Peter Ellingworth, chief executive, the Association of the British Healthcare Industries

Professor Martin Elliott, professor of paediatric cardiothoracic surgery at University College London and consultant, Great Ormond Street Hospital for Children Foundation Trust

Dr Karen Le Ball, consultant geriatrician, head of school of medicine and medical specialties, Health Education England (London and South East), and chair of UK Clinical Ethics Network

Dr Stephen McDonough, vice president medical director UK and Ireland, GSK

Celia Moore, assistant professor of organisational behaviour, the London Business School

Julie Wood, chief executive, NHS Clinical Commissioners

Prof Tarek Yousry, professor of neuroradiology at University College London Institute of Neurology

In the NHS this trend is about to take a step forward with the introduction of a ‘Sunshine Rule’ which will require disclosure of gifts and hospitality received by, and actual and potential conflicts of interest involving, staff employed by NHS organisations. A separate requirement for clinical commissioning groups means they will face more scrutiny around how they deal with conflicts of interests.

The proposed Sunshine Rule – contained in the NHS Standard Contract for 2016-2017 – was consulted on this month. HSJ brought together a panel of experts to debate whether it was the right way forward and what impact the proposed requirements would have on the NHS and those it works with.

HSJ executive editor Adele Waters started the debate by outlining the growing demand for transparency and the impact of disclosures of improper behaviour by a small number of NHS staff in the Daily Telegraph last year. However, she suggested there was a significant difference between industry-sponsored lunchtime medical education meetings and the sort of five star luxury trips revealed by the Telegraph.

Integrity in relationships

The panel – with representatives from both the NHS and industries which supply it – was supportive of the principle of transparency but keen to point out that joint working between industry and NHS brought benefits for all and should not be demonised.

Peter Ellingworth, chief executive of the Association of British Healthcare Industries, said: “I think integrity in the relationship between the industry that I represent and healthcare professions and institutions is really fundamental.”

Joint working between doctors and industry was essential in the development of safe, effective and useful medical devices, he added.

Discussions ended up focusing on the cost of meals and, when there were possible regulatory actions, journalists tended to focus on ‘who is going to be on the naughty step

There is already a code of conduct for his industry, he said, which would not allow five star trips and he suggested what had been reported was not ”the tip of an iceberg”. He added that the industry was moving towards stopping direct sponsorship of medical professionals at congresses because of how this could be viewed. It would continue to fund educational events but this would be done through healthcare organisations to remove any misunderstandings or misconceptions.

Executive director for research, medical and innovation at the Association of British Pharmaceutical Industry Virginia Acha suggested healthcare professionals accepting gifts or hospitality was the end of a process and the steps before this needed to be understood, not just the end point.

“No one talks about why it happens in the first place. There is a key reason why those engagements happen,” she said.

She questioned whether people realised all the different forms of interaction between the pharmaceutical industry and healthcare professionals and organisations – and why they happen, and the benefits which would be lost if they didn’t occur. This could range from involvement in scientific research – where industry might work with academia – to providing information on medicines.

’When we start to understand that, then we can ask what transparency is needed to demonstrate there is not a conflict of interest.’ Instead, she said, discussions ended up focusing on the cost of meals and, when there were possible regulatory actions, journalists tended to focus on ‘who is going to be on the naughty step.’

‘I am in favour of transparency as a principle. I think we have a moral obligation to sustain trust as much as we can

The ABPI has been involved in a European project that will lead to voluntary disclosures by healthcare professionals and procurement staff. A database on this will go live in June and, in a pilot, around 67 per cent of clinicians have said they would make disclosures.

Those who are at the front line of NHS work and research welcome such transparency but may have questions concerning  whether the right areas are targeted.

Professor of paediatric cardiothoracic surgery Martin Elliott said: ‘I am in favour of transparency as a principle. I think we have a moral obligation to sustain trust as much as we can.’

Bottle of wine

However, some people will always break the rules and behave badly, he said, and for them the measures did not feel appropriate. ‘I have been invited to give talks around the world and find myself at the back in the plane while a couple of registrars [are] at the front in Business Class paid [for] by a drug company,’ he said.

He questioned whether gifts from patients might also be caught by the Sunshine Rule and said there was a need for high level clarification. ‘How does the bottle of wine from a grateful patient fit in?’

Professor Tarek Yousry, of the Institute of Neurology, added there was strict governance around research which meant transparency was key. He identified a more significant issue around the introduction of new devices without proper trials having been carried out, saying: ‘This is an area which is really grey and I would really like to see some clarification as it is a big problem.’

The Sunshine Rule is not designed to deal with issues such as the one Professor Yousry highlighted. However, initiatives such as this, which require employees to declare gifts and hospitality, might be seen as ways to ensure good behaviour.

Assistant professor of organisational behaviour at the London Business School Celia Moore questioned how effective it would be and whether it was the right way to address concerns.

How do you remove the concept of interest is what we should be asking, not how do we make sure everything is written down?

‘From a policy perspective the question is not whether it is a good thing but how can it be effectively implemented’ she said. ‘Having PDFs that list $25 meals creates a level of bureaucratic onerousness for people. It is not necessarily clear to what end. If we want to be transparent about where the influence is, there are other ways of getting to that end.It is important to think through transparency - for what and how do we reach the goals we are looking for?

‘There is good research that even a $5 pizza changes a doctors’ prescribing habits. It is easy when there is exposure of really lavish gifts to think if we write it all down and make it public, then it is going to be OK. It’s not that easy. ”How do you remove the concept of interest?” is what we should be asking, not ”how do we make sure everything is written down?”’

One approach adopted by some hospitals in the US was simply to ban all gifts, she said.

‘A study had shown that only 1 per cent of doctors thought they were influenced by pharmaceutical representatives while they believed 33 per cent of their colleagues were, she pointed out’

Dr Moore said she was concerned about systems which put the onus on people to identify the conflict of interest they are in. ‘Humans are really terrible at identifying conflicts of interest. People always underestimate the extent to which they are influenced. People believe they are immune to influence,’ she said.

She pointed to a study that found while just 1 per cent of doctors thought they were influenced by pharmaceutical representatives, they believed 33 per cent of their colleagues were. New research also which suggested that when people declare conflicts of interest, it increases their bias in judgement.

Clinical commissioning groups already have to grapple with issues around conflicts of interest – partly because their members may both provide services and be involved in commissioning. Julie Wood, chief executive of NHS Clinical Commissioners said: ‘Transparency is a good thing but it is about how you implement it. It is about being clear about the activity that you are involved in.’

Gifts and hospitality

She acknowledged conflicts of interest might occur when commissioners wanted to redesign a pathway. CCGs needed to be able to deal with this in a way that did not limit clinicians’ involvement but which was fair and transparent.

‘We need to focus on what are the potential conflicts of interest and how do you manage that,’ she added. Declaring gifts and hospitality was probably the easy part.

But is the Sunshine Rule really focused on what matters to patients and what would publishing information on gifts and hospitality mean for them? Mark Duman, a non-executive director with the Patient Information Forum, ’How does that impact on care? Will it make care better for patients? If not, it is just another onerous thing to do. Are we taking more people away from the frontline?’

’If you are trying to improve care then transparency of outcomes might do more good than declaring a bottle of wine’

He pointed out there were cases where transparency had made an enormous differences to outcomes for patients. For example, information about outcomes from cardiothoracic surgery had been credited with influencing standards and leading to more lives being saved.

‘If you are trying to improve care then transparency of outcomes might do more good than declaring a bottle of wine,’ he said. ‘Studies have showed that of the 12 most important things to patients, it is the doctor-patient relationship that is key. If you have to declare that (bottle of wine) then perhaps it becomes to feel a bit intrusive – the process takes over from the outcome.’ Issues around gifts and hospitality came about eighth in the list, he added.

The demands for transparency present challenges for pharmaceutical companies. Dr Stephen McDonough, vice president medical director UK and Ireland, GSK, said it was important to provide information around the safe and effective use of products but he recognised there were potential conflicts of interest that needed to be addressed.

Best pathways

‘How do we become as transparent as possible? As a company we are very aligned to transparency. We do think we should move beyond what is there in the rules at the moment,’ he said. The company has already introduced - and will be introducing a number of other - changes.

For example, it is reviewing the issue of ‘congress support’, which meets some of the costs of healthcare professionals attending events. This was permissible under the ABPI code, he said, but there were concerns about the ethics of support extending to specific individuals approved by the sponsor rather than to general departments.

‘We would traditionally as a company have paid healthcare professionals to speak at our meetings. But we think that’s a potential perceived conflict of interest and we have stopped doing that – that is a global change for GSK,’ he added.

There was a strong code of practice, he said, which the behaviour highlighted in the Telegraph articles, had breached. He thought there were opportunities for greater transparency but warned that bureaucracy could take over the Sunshine Rule quickly and could be a burden.

‘How is it going to work for the NHS? We really need to retain the industry and clinical relationships so we understand how medicines can be best used and what are the best pathways,’ he added.

Dr Karen Le Ball, chair of the UK Clinical Ethics Network and a community geriatrician in Scotland, said that the behaviours which had prompted the government to announce the Sunshine Rule were far from typical.

‘I slightly feel this is a bit more than required. There is an assumption that if you learn something from a pharmaceutical rep and it influences your prescribing, that is a bad thing,’ she said.

Limited and underfunded

But giving doctors that information may be useful in making them think about prescribing, she said. However, it was important there was a moral code around the interaction and a means of identifying people who were not following it.

She used to refuse to see company representatives but later found they gave useful information on areas where she was less knowledgeable, Now that she is working in the north of Scotland, reps are few and far between.

Clinicians in the meeting agreed that pharmaceutical support was vital for some medical education and a reduction in this could be disadvantageous. Professor Elliott said support for post-graduate education beyond fellowship level was often limited and underfunded, and congresses were important in providing it. Dr Le Ball, who is also head of school medicine and medical specialties at Health Education England (London and South East), said cardiology education would not be able to run in the same way without sponsorship.

’I have never yet had one international conference call where someone on the NHS has not had problems’

Alternatives to travelling to take part in educational events, such as conference calls and video links, had been tried but were not always successful. Prof Elliott said international video links were often disrupted by ‘data security issues’ on the NHS’s side. ‘I have never yet had one international conference call where someone from the NHS has not had problems,’ he said.

Dr McDonough stressed the industry wanted to be viewed differently, not just as the sponsor of events or a means to attending conferences. ‘Are we just the companies that bring sandwiches to meetings? We need to move towards being partners,’ he said.

So what impact will the demands of implementing the Sunshine Rule have on NHS organisations? While panelliests susptected clinicians would comply with it, they expressed concerns that it could have some negative effects. Prof Yousry said there needed to be a way of declaring that did not involve a lot of bureaucracy. He felt it would be better to declare everything rather than getting into debates about whether any lower limit should be £20, £25 or £50.

Some of the details of how the Sunshine Rule will work in practice are still unclear. ‘The issue for me is around what does ”prompt disclosure” look like. What do ”full and accurate details” look like? If they have a sandwich on the Wednesday does it have to be on the trust website on the Thursday?’ Ms Wood said. ‘If a member of staff does some work in their annual leave, does that count as well? I suspect it does apply but are we clear about that? As a commissioner I would want to be clear this is happening, but what about co-commissioning in primary care? What do we need to do there?

Conflicts of interest

There is already a requirement for CCGs to have details in their constitution about how they handle conflicts of interest. There are also moves in the NHS England CCG assessment process for 2016-17 to assess CCGs by a number of areas, including “well led”, which includes how conflicts of interest are handled. ‘CCGs need to be very clear how they handle potential conflicts of interest,’ she said.

Other panellists had ideas of how the draft, and transparency in general, could be improved. Ms Acha suggested case studies of what good and bad practice looked like would be useful: ‘If you want people to do something differently, have a conversation about what that looks like.’ Dr McDonough said there was a need for consistency across the NHS to make it easier to engage

De Le Ball said: ‘I think we should be focused on words like declarations of influence rather than conflicts of interest, we should be talking about how that is going to be perceived by the public. The phrasing is very important.’

And she summed up the mood of the panel, saying: ‘We don’t want to lose the relationship between the industry and the NHS.’

 

What the draft Standard Contract says

GC27 Conflicts of Interest and Transparency on Gifts and Hospitality

27.1 If a Party becomes aware of any actual or potential conflict of interest which is likely to affect another Party’s decision (that Party acting reasonably) whether or not to contract or continue to contract substantially on the terms of this Contract, the Party aware of the conflict must immediately declare it to the other. The other Party may then, without affecting any other right it may have under Law, take whatever action under this Contract as it deems necessary.

27.2 The Provider must ensure that, in delivering the Services, all Staff comply with Law, Guidance and Good Practice in relation to gifts, hospitality and other inducements and actual or potential conflicts of interest.

27.3 The Provider must ensure that all Staff promptly disclose to the Provider full and accurate details of:

27.3.1 all gifts, hospitality or other inducements received by or offered to them by or on behalf of any manufacturer, distributor or vendor of pharmaceuticals, medical devices, consumables or equipment of a type which is or could be used in the delivery of the Services; and

27.3.2 any other actual or potential conflicts of interest on their part in relation to the delivery of the Services. The Provider must maintain and publish on its website an up-to-date register containing full and accurate details of all such gifts, hospitality, inducements and actual or potential conflicts of interest.