The plan to introduce value-based pricing (VBP) for NHS drugs was “flawed from the start” and should be scrapped, according to a healthcare think tank.

A report from 2020health argues that VBP could reduce patient access to expensive drugs by replacing the existing patient access schemes.

It also argues that VBP will “politicise” drug pricing by exposing it to lobbyists and media campaigns.

Under the current Pharmaceutical Price Regulation Scheme (PPRS), companies’ total income from the NHS is restricted but individual drug prices are not.

VBP, currently being negotiated between the Government and the ABPI and due to be introduced in 2014, aims to relate drug pricing to value in a broad sense – i.e. to apply NICE’s current decision-making process to drug prices.

The report states: “Value-based pricing sounds like an excellent idea with a well-researched methodology. On further examination the cracks begin to appear... The real concerns of patients, doctors, and carers are only hidden from view.”

One problem, it says, is that the drug access schemes negotiated by the industry and the Department of Health will disappear, potentially reducing patient access to much-needed drugs at a time of NHS austerity.

Another is that “patients could become political pawns” if the availability of a particular drug is focused on by “the press, a political party or an MP”.

Julia Manning, Chief Executive of 2020health, said: “The Government’s new plans for pricing will politicise a formerly non-contentious issue. Despite the intensive negotiations and new promises to include patients further in deliberations, this is an idea it seems was flawed from the start.”

The report urges the Government to improve the existing drug pricing system by further encouragement of patient access schemes, and by tightening controls on any one company’s revenue from the NHS.

The Royal Pharmaceutical Society (RPS) has published a guide to medicines optimisation for primary care professionals.

Medicines Optimisation: helping patients make the most of medicines places emphasis on safe and evidence-based medicine use to reduce wastage and improve patient outcomes.

The guide, endorsed by the ABPI and the Royal College of General Practitioners, reflects the growing role of community pharmacists in medicines management and the care of people with long-term conditions.

Sir Bruce Keogh, Medical Director of NHS England, said the guide “could revolutionise medicines use and outcomes”. It outlines four basic principles:

• Aim to understand the patient’s experience.

• Make sure the choice of medicine is made on the best available evidence.

• Ensure that medicines use is as safe as possible.

• Make medicines optimisation part of routine practice.

“I would encourage everyone to adopt these principles whether prescribing, dispensing, administering or taking medicines,” Keogh concluded.

The RPS guide is partly a response to evidence that 30–50% of patients are not compliant with prescribed medication, and £300m worth of NHS medicines are wasted each year.

Shilpa Gohil, Chair of RPS England, commented: “As care shifts towards primary care prevention, unprecedented economic challenges combined with problems around medicines waste, adherence and safety mean that medicines optimisation is now essential to good patient care and the effective use of NHS resources.

“Medicines optimisation will require health professionals to work across boundaries to individualise care and work in partnership with each other and patients to secure better outcomes and drive improved adherence.”

This month Brigadier Pinching shares a surprisingly palatable civil service coffee with the Department of Health’s NHS/big pharma relationship expert, Naima Khondkar.

I love Elephant and Castle. If you are in any doubt about where you are, just outside the station, there is large sculpture of... an elephant and a castle. Oxford Circus, King’s Cross and Cockfosters have clearly missed out on a neat trick. Anyway, I digress, for I was in central London on important business – to chat with Naima about how the private and public sector could make their marriage work. Having spent six years in curious governmental buildings, this was my territory. Bring on the future!

Hi Naima, what’s your story?

At the Department of Health I work in the Medicines, Pharmacy and Industry Group. The head is Giles Denham and he has a number of teams which sit under him. One looks after the pricing environment – which is very topical right now because of the negotiations – while the pharmacy team takes care of community and pharmacy issues. Another concentrates on prescription policy, and I’m in the industry sponsorship team.

How do you guys roll?

We’re almost account managers for the pharmaceutical industry, within government, and also the first port of call on health policy issues concerning research-based pharma companies, including global outfits that have locations in the UK. There’s a very high-level of strategic engagement, driven by the Ministerial Industry Strategy Group, which combines global heads of pharma, from as far afield as Japan and America, and ministers from health, business, the treasury and UKTI (UK Trade and Investment). The discussions are a great way to highlight how government policy can help partnerships. Our minister, Earl Howe, is a particularly engaging contributor, while ‘No 10’ frequently sends along a representative, indicating how serious the Government is about forming cohesive inter-sector partnerships.

How has the concept of joint working progressed?

Over the last few years we have carefully considered how to fundamentally improve the relationship between industry and the NHS, and a lot of this consideration has been carried out in conjunction with colleagues at the ABPI. There is still a lot of mistrust on both sides, however, and that is one of the greatest challenges reform needs to overcome. The NHS has the perception of pharma as being a big bad wolf, just above the arms and tobacco industries in terms of popularity! For some reason people have a big problem with the pharmaceutical industry making any kind of money. Sometimes I think the level of suspicion is unjustified, but then again, I don’t think pharma do themselves many favours sometimes. It’s important to be open and honest about these things! Equally, the NHS can sometimes be over-sensitive – they don’t like to be told by other people how to do their job.

What needs to change?

There needs to be a shift in how people on both sides view one another and they must learn to wipe the slate clean. Bad relationships can date back to minor incidents that happened 25 years ago, when a young, naive rep went into a meeting with a box of doughnuts to help flog a new product. Something as trivial as this may have resulted in a door being shut. Whereas now NHS representatives need to re-engage, open doors and think about the broader benefits of working together with the pharmaceutical industry towards joint goals. It’s really important that both sides build allegiances and forget past animosities. Ultimately this will benefit everyone.

Do the ‘different’ motivations of the public and private sector make gelling difficult?

There is an incorrect perception that, because pharma makes money, someone else has lost. We must remember that if people have their lives extended due to better treatment then NHS, industry and wider society has won. Recently Helen Bevan, NHS Director for Transformation, said both industries have been very target driven in the last 15 years and, consequently, the humanity factor has eroded. Healthcare professionals on the frontline have been too busy with waiting lists and reductions, while sales reps have been under enormous pressure to shift products and been too focussed on sales. Patient cases have become about performance measurement rather than health outcome, or quality of experience. Clearly there needs to be a radical change in priorities.

What can big pharma do to engender trust?

Their approach can be ill-informed sometimes. Often they think they know the NHS, but actually they need to fully appreciate the complexities of what is an ever-evolving beast. Companies need to consider who they make responsible to forge vital connections and forming sustainable relationships. They regularly send an under-qualified person, who might have the enthusiasm, but not the authority. With joint working one of the big issues has been compliance and, often, the pharma representative at the table can’t actually make a decision about whether a company can work in a certain way. This is one of the areas we are really trying to help with.

How should they alter their approach?

If pharma goes in simply looking for a market share increase, they’ll get figured out straight away. Representatives of the big companies need to prove that they genuinely want to improve a health economy or health outcome, before profits. These are the aspects that make the whole system better, and ultimately everyone wins. The CCGs want more people appropriately treated and that means less hospital admissions and, in turn, more financial resources will be available for commissioning. In this respect pharma needs to look at the bigger picture. Remember, every service that the NHS uses is a business – from nurses to bed sheets – but because of the fractious history, the NHS is suspicious about pharma making money. When they do engage the NHS needs to feel like pharma is an integrated and credible part of the solution, as opposed to a procured service. It’s a fine balancing act.

What are the priorities when it comes to galvanising joint working?

Since joint working was outlined as part of NHS reform we have been keen to establish how it can be improved. A policy working group in 2007 carried out some market research and they came up with some recommendations. The two major areas of focus, on our side, were the issuing of guidance – clear definitions of how the NHS works - and the language that should be used. This is a refreshingly concise 11 page document. We also addressed the practical side by combining with the ABPI to launch the, ‘Joint Working tool kit’. It’s an interactive quick-start guide, which includes exactly what the NHS’s definition of joint working is, essential templates and a versatile project management tool. Above all, it avoids jargon and allows people to understand what is required straight away. This has been endorsed by NICE, the NHS Alliance and Confederation among others. We will be looking again at how we can update these documents and make them more practical in the ‘new world’ and also partnering with industry [through the ABPI] and the NHS to review and revitalise both these tools.

Are you optimistic about fruitful partnerships?

Joint working will continue to be an important focus and a part of my day job. QiPP came and went, so we had to hold fire for a while, but now Innovation Health and Wealth (IHW) has provided a restructure, we are pretty sure of what is happening; six months ago we sat down and established that the shift of power is moving to CCGs. Now individual CCGs. Director of Partnerships, Ivan Ellul is particularly keen on localised, dynamic relationships and Mike Farrar is also a champion. Ian Carruthers is the NHS England lead for IHW and is also keen to encourage this type of engagement.

Do you feel that the tide is turning already?

I’m resolutely positive about changes within the NHS. I’ve had heated discussions with clinicians and pharma about joint working, because a lot of them see it as more rhetoric. Some companies, however, are hugely proactive and want to be pioneers of change. GSK are a good example. They’ve shifted their entire salesforce to encourage new ways of working with NHS counterparts. Their leader, Andrew Witty, is passionate about successfully transforming approaches and he’s someone you can believe in, because GSK have freed up patents, conformed to the ‘alltrials’ ideology and shared data. This has filtered down to the way they engage with the NHS and the company have been very smart, as they realise it’s about increasing the whole market. If a healthcare pathway improves it will produce better diagnosis, and better diagnosis means more appropriate and timely use of medicines.

Well said, thanks Naima!

The rapid pace of NHS reform means that the pharmaceutical industry needs new strategies for joint working to create and sustain commercial opportunities. Diana Vegh, NHS Partnership Manager at the ABPI, describes how the Association is working to develop a joined-up partnership strategy across the new NHS landscape.

The NHS has been going through one of the largest reorganisations since its inception – Sir David Nicholson famously describing it as “so big, you can see it from space” – and the implications for the pharmaceutical industry, particularly regarding the joint working agenda, are significant. So much so that the ABPI has established an NHS Partnerships Team, led by Kevin Blakemore, with one senior manager covering each of the four NHS England regional offices. The concept has been driven by Stephen Whitehead, our CEO, and was piloted several years ago as the ABPI Outreach Team – which made constructive inroads in the South-West, a challenging health economy to work in.

I am one of those regional managers, ex-NHS and industry, based in Devon, and covering a territory that stretches from Penzance to Margate. The population is 13.4 million, with a budget of £21.1 billion and 110 NHS organisations. There are 1,873 GP practices, 34 local authorities (with three unitaries), four clinical senates, five Academic Health Science Networks, seven Area Teams, three specialised commissioning hubs and 51 CCGs. And it’s a 14-hour return journey from one end to the other. Plus we’re a trade association, with limited resources. With such a large number of potential customers and new organisations, how do we make the best use of our time?

RIGS strike oil

Each of us has produced a regional business plan, aligned to member company priorities, broadly supporting our themes of value and partnership, and clustered around 11 core corporate objectives. These have all been discussed and agreed by our Board of Management, which is made up of member company executives. The most important objective for my team is improving the environment for access and uptake of innovative medicines. We’ve segmented our rapidly evolving customer base and developed stakeholder maps for engagement. But pivotal to helping us navigate this complex structure has been the establishment of our Regional Industry Groups or RIGs, one per region, which meet monthly. General managers of our member companies have nominated senior representatives to sit on these groups, and we are adding associates who will join us virtually, i.e. online, via WebEx and telephone conferencing.

My RIG is chaired by Lisa Rosewarne from MSD, and our deputy Chair is James Steed from Pfizer. We have agreed our Terms of Reference and work plan for 2013, with a series of five workstreams and virtual task and finish groups led by RIG members, focusing on industry-wide issues from medicines optimisation to the Formularies Good Practice Guide. We often have external speakers who may not meet with single companies but are happy to talk to a group – such as Steve Sparks from NICE, who manages the field-based Implementation Team, and who recently gave an excellent presentation at one of our meetings. We also connect our RIG to the national policy work we do, and communicate across the other ABPI teams.

We’ve had a number of ‘bids’ from the NHS and healthcare companies who are interested in working with the pharmaceutical that there is a need for external organisations to understand better what joint working truly means in terms of the ‘Moving Beyond Sponsorship’ work done by the ABPI and the Department of Health in 2010. Our key tool for this has been the Joint Working Guide, and in particular the sections on pages 7 and 8. One of our RIG workstreams is to use these guidelines to engage with potential partners in order to share constructive feedback and highlight examples of best practice that we are collecting from member companies.

We showcased this at a conference with the NHS Confederation in February this year, in London. We have a Memorandum of Understanding with the NHS Confederation and the ABHI to work on the Innovation, Health and Wealth agenda collectively; and this national policy work is essentially what we’re putting into practice in our regions.

Rules of engagement

In my day-to-day job and in my meetings with NHS stakeholders, I work to promote the whole pharmaceutical industry and a more mature working relationship with us. The majority of my discussions have been very positive, with a clear desire to move away from the old models of promotional metrics and explore a new way of working. Some CCGs, such as Torbay and South Devon, are striving to be ahead of the curve. Others are more conservative and prefer to agree a new policy on joint working first, and we’re trying to encourage the use of our toolkit and case studies.

But one thing I’m very clear to emphasise is that my team isn’t ‘the’ route into pharmaceutical companies. If an NHS organisation wishes to work directly with a company, of course it can. We are not competing with market access teams – we are enablers and facilitators – and the ABPI Code of Practice gives the NHS assurances about governance and conduct. But some organisations remain difficult to reach. I’m using good examples of joint working elsewhere in the NHS, or pragmatic discussions in other parts of the organisation, to overcome those barriers.

After all, partnership isn’t about pretending that everything’s fine and there aren’t any problems. But it is about moving to a place where you can agree to disagree, and solve your problems together even if you have differences. . e table above shows the framework I base my work on.

On the whole, projects seem to fall into three categories. The first category is disease specific projects, which often relate to long-term conditions such as COPD, diabetes or vascular health. Some of these can be quite broad, while others can be about specific service redesign projects in a particular health economy and relate to implementing new national guidance. The second category is projects that relate to an NHS priority, such as reducing inequalities, where industry expertise in social marketing and media has been put to excellent use. The final category, and the one expanding most rapidly, is where we have shared aims: improving patient safety, reducing medicines wastage, better adherence, realising the benefits of treatments – i.e. the medicines optimisation agenda.

Moving the goalposts

Those of you with a lot of experience may be reading this with a sceptical eye. Hasn’t this all been done before? Talked about before?

Yes. But this time, there are some key differences. The clinical voice is louder, and often in a leadership position. Attention is far more on quality than in the past, and the sanctions are greater. And while our austere financial climate is squeezing medicines spending, increasingly senior people are seeing that it is disingenuous to look at medicines solely as a cost pressure, and far more beneficial to see them as a means of improving health outcomes – on which the NHS is now being more tightly measured. New organisations also have a legal duty to innovate, which is now in primary legislation as part of the Health and Social Care Act. The new Academic Health Science Networks have been set up as companies, and though many focus on the earlier part of the medicines life cycle they will all be looking for new partnerships.

Pharmaceutical companies are also changing. We’ve gone from Share of Voice to Key Account Management, and the skills and competency mix of pharmaceutical field teams is very different from how it was a few years ago. When I’m out and about I’m meeting people with new roles, such as service development managers, NHS business managers and strategic account managers. And there have been a lot of redundancies in the NHS which have seen knowledge and skills move into the pharmaceutical industry. Today I had an email from a CCG asking me how they could second someone into an ABPI member company.

We are in a ‘perfect storm’ of policy, and the organisational turbulence we’ve all experienced is bringing some very forward-thinking and creative people into senior positions. Let’s make the most of that, and work together to get better outcomes for the populations that we live in and for the organisations that employ us.

Classified drugs, which are potentially dangerous and liable to abuse, have legitimate uses but also turn up on the black market. What does this mean for industry – and how has the internet affected this problem?

Take a look at any list of ‘drugs’ banned in the context of recreational use – or more accurately, abuse – noted by the Home Office, social services or avant-garde novels. They fall into three categories. Drugs made from natural sources – marijuana, opium and magic mushrooms. Synthetic drugs that have no medical function – ecstasy (MDMA) is the classic example. And drugs that have been patented by pharmaceutical companies and released for medical use – that’s all the rest.

Heroin, cocaine, amphetamines, tranquillisers, barbiturates – you name it, doctors have prescribed it and addicts have taken it, with or without prescription, and often with bad consequences. In the past, many psychoactive drugs were shifted from medical sources to the black market via theft or bribery. Today, they are more likely to be manufactured in secret labs in Latin America, the Far East or that odd little house in your street with the blacked-out windows. You might be surprised at how strong the UK pharmaceutical manufacturing base really is.

You may wonder why that’s a problem for industry. When you’re talking about drugs that affect the nervous system – killing pain, inducing sleep or keeping people awake – the subjective factor is important. If a patient knows the drug they get on prescription is also available on the street corner, they may react in various ways. They may decide, on the basis of news or hearsay, that the drug is too dangerous to take. Alternatively, they may decide they want more of it than their GP will provide – and their friends want some too. Either way, the drug’s value chain gets tangled up with barbed wire. It’s not your fault, but that doesn’t mean it’s not your problem.

Two recent events reflect the pervasiveness of this issue. Firstly, the Advisory Council on the Misuse of Drugs recommended that the painkiller tramadol should be made a Class C drug – with penalties of up to two years for possession and 14 years for supply. Tramadol has both opioid and antidepressant properties, making it a potent euphoric but increasing the clinical dangers of overdose.

Secondly, Roche took Valium off the market after fifty years of iconic status as ‘mother’s little helper’. Forty years after patent expiry, the black market had finally pushed the brand into the red.

The only chemistry

The UK’s classification system for ‘dangerous drugs’ is based on the Misuse of Drugs Act 1971, which gave the Home Offie a role in drug licensing by defining the boundaries between legitimate and illegal use of medicines. The Act defined four types of drug crime: unlawful possession; possession with intent to supply; supplying, even if no money changes hands; and allowing your premises to be used for producing or supplying a controlled drug.

The Act also divided controlled drugs into three classes in terms of the penalties for illegal use:

• Class A – up to seven years’ imprisonment for possession, up to life imprisonment for supply

• Class B – up to five years’ imprisonment for possession, up to 14 years’ imprisonment for supply

• Class C – up to two years’ imprisonment for possession, up to 14 years’ imprisonment for supply

An unlimited fine can be imposed instead of, or in addition to, any of these sentences. The law is designed to come down most heavily on illegal manufacturers and suppliers – in other words, the people doing illegally what you do within a legitimate business framework. In practice, of course, it’s mostly the end users who get caught, tried and jailed.

Down at the doctor’s

What should pharmaceutical sales professionals keep in mind when working with controlled drugs? I won’t insult your intelligence by telling you not to break the rules. It’s the things that can happen that aren’t your fault you need to worry about.

Doctors and pharmacists have strict guidelines about using only legitimate suppliers. However – as the recent scandal of counterfeit cancer drugs being found in US pharmacies proved – the pressure to use cheaper suppliers means the audit trail of many drug supplies is extremely complex. If the drug is a controlled one, the threat of illicit sources to the supply chain is much greater.

It’s important to distinguish between ill-effects of drug abuse and potential side effects of legitimate drug use. The negative impact of abuse on a drug’s reputation is considerable – and, in addition, studies of abuse provide genuine insight into the risks and benefits of a drug. So be prepared for that side of things to make your discussions with customers more complex – maybe more difficult, but also maybe more fruitful if you’re well informed.

The internet has made the supply network for illegal drugs both more diverse and more immediate. The user can access a global black market without needing to hang out in dangerous places or carry cash. Every bedroom is a car park now: the black market in drugs has no limits as regards time, place or who is involved.

Be aware of security issues. Andrew Bolan at ABPI comments: “All activities related to the legitimate manufacture, distribution, supply and storage of controlled drugs are subject to the regulations made under the Misuse of Drugs Act. All actors in the legitimate supply chain will hold the appropriate licences and have the necessary facilities and systems to ensure the secure supply of these products to patients, and all these elements are subject to scrutiny and control by the appropriate authorities.

“While every effort is made via these systems to prevent the illicit diversion of these products, the issue of theft is a concern and, despite the best efforts of all in the supply chain, there will always be a risk of such events. The pharmaceutical industry is always willing to work with other partners in the supply chain to seek to enhance the already high level of security that is applied to the movement of controlled drugs.”

Blues run the game

One of the great blockbuster drugs, Valium (diazepam) helped to make Roche a leading global pharma company. While known primarily as a tranquilliser, it has also been used as an anti-convulsant, a muscle relaxant and an anti-depressant. The brand’s popularity among the general public as a means of coping with stress earned it the nickname ‘mother’s little helper’, and kept Valium on the market for forty years after its patent expiry.

However, the addictiveness of Valium soon became notorious, with some experts arguing that it induced serious physical dependency. This, combined with the emergence of SSRIs as more successful anti-depressants, led to diazepam being increasingly used only for short-term sedation, where branded Valium had less commercial traction over generic equivalents.

But users – in both senses – rush in where doctors fear to tread, and ‘blues’ are now a staple of the illegal drug world. Their widespread legitimate use has helped to fuel an illegal supply chain via many forms of theft and fraud. While Roche gave the long-term effect of patent expiry as its reason for taking the brand off the market, it would appear likely that a fuller explanation lies both in Valium’s dwindling legitimate market and in its rapidly growing online illegal market.

Diazepam tablets that look like Valium, thus retaining elements of brand appeal, are being marketed by MSJ Industries, a subsidiary of the Sri Lankan manufacturer J.L. Morison Son & Jones (Ceylon) PLC. Stamped ‘MSJ’, they are legitimate pharmaceutical products, but are being diverted to the black market – where they are known as ‘MSJs’, ‘vals’ or ‘blues’ – in large quantities.

As an example of the information available, Pf found an easily accessible online forum with a thread titled ‘MSJ blue pills (Vals?)’, featuring comments from people around the UK. One forum member offered to supply MSJs at the remarkably cheap rate of £20 for a hundred 10mg pills, or £80 for 500. Others commented:

• “I took two of them last night meaning it should have been a 20mg dose. But these two I took sent me well off.  It was like I had just taken 60mg or something. Couldn’t move.”

• “the msj are from sri lanka mate. they are the real mccoy. due to no standards and/or no quality control means that some msj tabs have 8mg-28mg per pill. i hope this helps you.”

• “msjs are the best valium about beat roche hands down”

 These words leave you wondering what ‘controlled drugs’ really means. For the pharmaceutical industry, that’s not a comforting thought.

We scour the dusty Pf archive vaults to find out what was happening in the pharma industry and wider world beyond five years ago.

April 2008

One of the most shocking stories in a generation made front page news around the globe when details of Josef Fritzl’s incarceration of his daughter for 24 years were reported. Fritzl had built a cellar under his home where he kept his daughter, raped her and fathered seven of her children – three of whom were also held underground.

In politics, Harriet Harman became the first Labour woman to answer Prime Minister’s Questions. Bertie Ahern announced his resignation as the Irish PM, whilst Silvio Berlusconi celebrated with a bunga bunga party after he was re-elected as the Italian PM for a third time.

Comply or Die won the 2008 Grand National, Trevor Immelman beat Tiger Woods by three shots to win the 72^nd Masters and Liverpool and Arsenal played out a thrilling 4-4 draw at Anfield – Andrey Arshavin scored all four goals for the visitors.

Future pharma reps studying at universities around the world rejoiced as Grand theft Auto IV was released and quickly became the fastest selling computer game within 24 hours after more than 609,000 copies were sold. But it was not a stellar month for either film or music. Madonna’s 4 minutes stayed at the singles chart for a month – ironic really when the record lasted four minutes too long – and the ‘comedies’ Leatherheads, Forgetting Sarah Marshall and Harold & Kumar Escape from Guantanamo Bay were released in UK cinemas. Hollywood mourned the death of legendary actor Charlton Heston.

The April issue of Pf was as relevant then as it is today with reps questioned on whether they had the skills to succeed in a rapidly evolving customer environment. Other features provided an insight into commissioning on a national and local level. Readers also found out how their customers viewed salespersons. In news, research by the ABPI found the majority of pharma companies had no confidence in the UK market and 83% expected the situation to deteriorate further. However, the ABPI did have reason to celebrate as it marked the 50^th anniversary of the ABPI Code with its ‘Still nifty at fifty’ campaign. 

Most UK pharmaceutical companies will disclose the payments they make to healthcare professionals (HCPs) from 2015 onwards.

ABPI member companies have agreed to publish details of payments made to individuals in fees and sponsorship for training.

As a start, they will shortly publish aggregate totals of payments made to HCPs in 2012, estimated to amount to £40m for the UK pharma industry.

The ABPI said it hoped the greater transparency would not only improve trust but also raise awareness of the benefits to healthcare of industry sponsorship.

From 2016 (covering 2015 figures), ABPI member companies will disclose the payments made to sponsor and support HCPs – for example, paying for them to attend international conferences – as well as fees for advisory and speaker roles.

They will also reveal how many HCPs they have made payments to in each year from 2015 onwards.

The new transparency standards for industry have been developed by the Ethical Standards in Health and Life Sciences Group (ESHLSG), which is seeking to promote partnership between industry and the NHS.

Stephen Whitehead, ABPI Chief Executive, commented: “The industry is proud of its collaboration with healthcare professionals. By publishing these figures industry’s aim is to ensure these vital relationships are open and transparent.

“It is right that professionals are reimbursed fairly for the time and expertise they regularly provide the industry in developing the next generation of medicines. These figures also show another way in which the pharmaceutical industry adds value to the NHS by supporting training and development and medical education.

“It is right that companies are transparent about the support they provide and it is important that we also recognise the benefits this delivers the NHS.”

The Hotel Russell, Bloomsbury, sets the scene as Detective Inspector Pinching pulls up two tan leather armchairs for another caffeine-laced exchange. The man he’s facing is GSK’s Director, Academic Liason, CBE and Harry Redknapp-tormentor, Malcolm Skingle.

It’s bloody freezing. I need a chat that’s going to warm my cold editor’s heart. I arrive, and an incredibly enthusiastic woman leads me into the upmarket reception room of this legendary bed and breakfast establishment. Malcolm has the relaxed expression of a man who has stayed in practically every hotel on Trip Advisor. It was time to talk about football, erm, I mean pharma.

Hello Malcolm, what’s your story?

I trained as a pharmacologist and this defined the first half of my career, before I eventually started running a research group. I was fortunate to be part of a great department and during my time in the labs we discovered and developed some ground-breaking medicines including, Zantac, Trandate, Salbutamol, Salmeterol, Imigran and Zofran. After 20 years of bench science, I went to work at the interface of academia and industry, and this is an area I now know well. In the past the interactions between universities, medical schools, funders and pharma were clunky, and the challenge has been to vastly improve these vital relationships.

What exactly does your job involve?

I leverage science that helps underpin what GSK is doing. That might involve a technology that the company needs to drive one of its programmes, or talking to the head of a funding agency about working together on a certain scientific topic. I’ll form collaborations with anybody, either carrying out or funding good science; this includes government departments, charities such as the Wellcome Trust, the research councils and universities. We have academic collaborations in around 50 UK universities and interact with educational institutions in over 25 other countries.

How has your role changed over the years?

Universities and pharma companies are now far more open to collaboration. Twenty years ago big pharma would work in secret and not share information and best practice. We used to be fat cats, and money wasn’t an issue, but things have changed quite dramatically as companies try to get their research budgets to stretch further. We now work together in consortia, underpinning in-house efforts. The Structural Genomics Consortium, Dundee signalling consortium and EU Innovative Medicines Initiative are all collaborations where several pharma companies fund joint projects and share information. This type of activity will increase in the future as we collectively create the new knowledge required to develop new medicines.

What is your relationship like with the ABPI?

I sit on the Innovation Board and chair their academic liaison group. GSK takes the lead in several areas and we use it to share best practice. Pooling knowledge and data is positive for the industry.

How pivotal is the ABPI’s role in terms of reform?

They’ve got big responsibilities when it comes to collating messages from different pharma companies, who may not always have identical views on certain topics. Stephen Whitehead works hard to collate and articulate a consensus view.

Where do you stand on Ben Goldacre (metaphorically speaking)?

I’ve never met him, but I’d like to. The industry gets a bit beaten up in his book, but I do agree that we need to build greater trust with both the public and media. You need radicals like Ben Goldacre to make people rethink certain issues. I joined Glaxo straight from school; did my degree and PhD through the organisation and, in 40 years, I can put my hand on my heart and swear on my children’s lives, that I have never seen anything unethical.

How important is transparency and sharing information?

Companies are at different stages of wanting to share. Our Chief Executive, Andrew Witty, is a great leader and the sort of guy you would follow over the wall into battle. He was the first pharma chief exec to say that we’re going to publish all our clinical trial data. Some other companies aren’t quite there yet, but I am sure they will come around in the near future. It is vitally important to share data with other scientists, so that it can be validated.

GSK seems like an organisation that likes to be ‘out there’

We’re easily the most visible pharma company at the academic-industry interface and we have more collaborations than anyone in the country. This includes, not only pharma, but also companies from other sectors like aerospace and energy. Every two years the ABPI collect the data from all UK pharma, and GSK publish it. Part of my mission is to go around talking about what we do and I am passionate about GSK being transparent, our great science and being a good partner.

What partnership venture are you most excited about?

We’ve got an open access lab in Tres Cantos, Madrid, working on diseases in the developing world. This includes high containment facilities for pathogens, 120 GSK scientists and the capacity to take an additional 60 outsiders. The open access agreements mean that if someone has a bright idea for treating malaria or TB, for example, you can go there and have access to our chemistry and drug development technology. We’re serious about making a difference.

What successes have emerged from this project?

Five of our scientists screened two million compounds, by hand, in order to find leads against the deadliest malaria parasites. We then published a database last year containing all the 13,500 structures, which anybody can access as potential leads. Over 80% of these were proprietary and discovered by GSK. We want to share, as we can’t possibly carry out all the science connected with something like malaria on our own, so we stimulate interest in order to take a drug through. It’s been so successful that MMV (Medicines for Malaria Venture) has provided our compounds to more than 100 labs around the world. People feel proud to work for the company because of that.

Tell me more about what you’re doing with the universities

The most fruitful thing we do is post-doc collaborations that involve intellectual inputs from both the academics and us. We will also, at any one time, have around 250 PhDm studentships, which we co-fund with the research councils.

Are GSK keen to continue operating in the UK?

We’ve got a chief executive who is British, he’s Chancellor of Nottingham University and we’ve got our headquarters in Brentford. Does that sound like a company that’s just about to bugger off to New Jersey?

Malcolm, you’re clearly on the road a lot how do you strike the old work/life balance?

My wife is very understanding – I earn reasonable money and she’s good at spending it – and I’ve got two wonderful daughters. I love sport and used to play semi-pro football in the Isthmian League, and that has helped me to apply myself 100% to everything I do.

Hold on, who did you play for?

Firstly, Bishop Stortford – my home town – then Borehamwood for six years, before the company moved me to Greenford, and I joined Kingstonian. When they moved me back again, I played for Hertford. We had a few cup runs at Borehamwood, drawing at home with Swindon Town in the FA Cup, and losing the replay 2-0; we also won the league with 103 points. I don’t think that total has ever been beaten.

What position did you play?

I was a winger and also used to score goals, playing off a big man. When I got slower I drifted into central midfield.

Did you encounter any big names?

Yeah, I would regularly play against people, either on their way up or coming back down, like Gordon Hill, who was at Southall and went on to play for Manchester United and England. Sometimes I think I’m dreaming it, but when Bobby Moore finished playing and West Ham more or less dumped him, he managed the Oxford City team that I scored against. I remember it was pouring down with rain that day and Harry Redknapp was playing for them, just before his managerial career took off.

With the NHS in flux, there has never been a better time for joint working – but pharma might need some help to negotiate the new relationships. Pf looks at the key role of third parties in bringing industry and the NHS together.

Pharmaceutical companies in the UK might be forgiven for wondering if this is really the right time to engage in joint working (JW) projects with the NHS. There seem to be a few questions in the air. What is the NHS now? Who is making decisions there? What are the real priorities? Going into partnership with the NHS might seem like dating someone with too many unresolved ‘issues’ for it to stand much chance.

However, if you keep your nerve, there has never been a better time for JW. The combination of profound structural change and austerity budgeting means that the NHS badly needs support – and the need for healthcare to shift its focus from acute to chronic illness means that the right ways to transform the care pathway are at a premium. Suddenly that mythical bird of business transactions, the win-win, has to be real.

But the opportunities for partnership are highlighting the culture gap between pharma and the NHS. Meeting on the internet and getting married on the run may be romantic, but it won’t lead to a sustainable relationship. The partners need to learn each other’s language, meet each other’s family. This is where mediators and consultants can really make a difference by providing expertise and experience.

Pf talked to two companies that are actively involved in guiding and building JW relationships – one as a facilitator, the other as an active participant. Three common points emerged from their perspectives:

1. The major changes in healthcare in the UK are creating opportunities for pharmaceutical companies to work in partnership with CCGs, local authorities and providers.

2. The payoff for the pharma company is in terms of better medicines management, leading to the company’s products being used more widely and effectively.

3. Realistic mutual understanding is critical for JW – no amount of rhetoric about values and beliefs will help unless there are shared objectives and ways of working.

Embracing the unknown

Chris Morgan of ZS Associates argues that JW does not come easily to either side: “A true appreciation of the value of partnership is still fairly rare, within both pharma and the NHS.” For years, ZS Associates has emphasised the critical importance of key account management for pharma. The current NHS reforms and the development of the JW agenda have strengthened this argument and underlined the consultancy’s role as a thought leader for pharmaceutical sales and management.

“The established relationship between pharma and the NHS can be pretty toxic,” Morgan says. “ There isn’t a whole lot of trust established there. Before we can partner, we have to earn that trust.” He gives the example of a company ZS worked with that had spent six months piloting a new service idea with a PCT. “The PCT loved it, it worked well for the company, the patients loved it – and then they packaged it up and gave it to all their other account execs to sell, and a year later they had sold none.”

Why was that? “The first time they sold it, they thought they were developing a service – but what they were actually developing over six months was the trust required for the customer to buy that service. Then, when they showed up to every other PCT subsequently, the response was ‘Who the hell are you?’”

Too often in pharma, ‘trust’ is interpreted as meaning ‘goodwill’. That might work when the culture is the same on both sides, but between pharma and the NHS it won’t hold. Morgan explains that without clear mutual understanding “it’s not clear who is living up to their end of the deal, and it’s not even clear to you whether you’re living up to what the other person perceives as being your end of the deal.”

In addition, he argues, “those circumstances for partnership where it’s clear that everyone has something to gain end up being easier to defend, and more ethical, than those JW situations where there’s no apparent gain for the pharma company.” If a company sponsors an initiative in a therapy area where it has no products, two questions arise: does the company have the expertise needed, and what are its motives? JW has to be about “genuine mutual interest”. Quid pro quo agreements are not only non-compliant, but make no business sense: “I can sell you £10 notes for a fiver all day. There is no rational economic reason why you should reciprocate to a value greater than what I’ve just given you.” JW has to generate value, to the objective benefit of both sides.

Another key issue is defining who the customer is, and here Morgan illustrates the value of the KAM approach. “Too often we try and define the customer as being the doctor, the patient or the payer – but the only time you find genuine mutual value is when you think about all three stakeholders together.” Pharma companies need to involve providers as well as commissioners in JW projects, since the most successful providers “are actively going out and engaging with commissioners” to redesign care pathways – and thus are already on the JW road.

The best JW projects, Morgan says, often involve “care pathway re-engineering”. An area ripe for partnership is diabetes care, as its problems are well-known: poor service integration, poor medication compliance, high levels of complications. The JW opportunity is for the pharma company to help commissioners and providers improve care by improving diagnosis, monitoring or compliance, thereby reducing complications and hospital admissions. “The pharma company benefits as well because its product is used earlier, more persistently or in a larger or more appropriate group of patients.” The win-win is not only real, it is flying.

A time of change

Karen Bell, Business Manager at Ashfield In2Focus, argues that a window of opportunity exists now for pharma in terms of JW, and that there’s no time to waste. Ashfield In2Focus provides a range of services to pharmaceutical companies to help them develop and implement JW relationships with the NHS. Most importantly, it provides quality healthcare development managers (HDMs) and key account managers (KAMs), many of whom have NHS backgrounds, to mediate between the two sides and facilitate the process.

There are three reasons why this is a crucial time for JW, Bell explains. Firstly, the drive towards more patient-centred care, the QIPP agenda and the increasing role of private provider competition are all making the NHS engage with industry in new ways. Secondly, the Department of Health and ABPI guidance around JW have made the NHS “less nervous about working with industry and more open to win-win types of partnership”. Thirdly, its new emphasis on innovation has made the NHS more aware of its weaknesses in that area, and more ready to involve people with different experience.

The focus of JW projects is closely linked to the NHS’ need for increased patient throughput, especially in primary and community-based healthcare. “Typically the JW projects which we tend to see succeeding are in CHD, diabetes, women’s health, mental health – really any long-term condition, and also where there’s a drive to keep patients out of hospital” – while “for the sponsoring pharma company it means more patients going into the total patient pool for their product”.

However, the current business climate does not reward risks. Aren’t those pharma companies who decide to wait until things settle down being sensible? Bell’s response is emphatic: “They’ll miss the boat. Because we are now in a time of change or flux, with innovation and efficiency high on the agenda, the NHS is very open to hearing about and indeed engaging in new ways of doing things. Those pharmaceutical companies who go out there and talk about these initiatives now, and those NHS organisations who engage with them, will be the ones who will capitalise in the longer term.”

Even so, why is a mediator needed – isn’t that one partner too many? Bell argues that as a service provider already working with the NHS and industry, Ashfield In2Focus is a key link between the two cultures. It provides experience of working on both sides and knowledge of the regulations around the provision of NHS services. Any service it provides is backed up with the necessary documentation to “protect the NHS, the patient and the pharmaceutical company”.

In addition, Bell argues, Ashfield In2Focus is well placed to bridge the culture gap between the NHS and pharma: “When our HDM teams talk to an NHS customer, they can often be having a peer to peer conversation, and that facilitates the whole partnership process, building engagement, mutual understanding and trust from the start. As many of them have come from that background (we employ a number of ex-commissioners or Department of Health personnel), they understand the world of the NHS, and they can more effectively identify and implement a solution.”

JW projects require the right people to engage with “the new NHS stakeholders” and “to develop and carry through these initiatives and make them sustainable”.  They also need to be able to influence local authorities and Health and Wellbeing Boards, and to “talk coherently around the joint strategic needs assessment process”.

In classical mythology, Hermes was the messenger between worlds. Bell uses a similar image: “People sometimes see our staff as being one step removed from pharma – working for us on behalf of a pharmaceutical company, but not directly for them. Our nursing services are a perfect example of this.” In addition, she says, Ashfield In2Focus attracts and recruits quality personnel for these roles, through its vast database and network of contacts, by offering a permanent contract of employment to potential employees in uncertain times – reafirming the value of the third-party role for pharma and the NHS.

We look back through the pages of Pf at what was happening in the pharma industry and the world five years and ten years ago.

March 2008

March 2008 was a turbulent month, with rioting in Tibet, bombing in Gaza, a Columbian raid on Ecuador, and the collapse of the Antarctic ice shelf. 

Arthur C. Clark, visionary author of 2001, died at the age of 90. The cinemas captured the mood of crisis, with a British SF film about a lethal virus sharing audiences with a satire on McCarthyism adapted from the work of Dr Seuss. New albums from Nick Cave, Bauhaus, Counting Crows and Nine Inch Nails underlined the disturbed mood, though Du†ffy’s Rockferry kept the UK public dancing around its increasingly empty handbags.

The lead article in the March Pf was ‘The changing face of sales’, an examination of the growing importance of networking and teamwork for medical sales professionals seeking to engage with the NHS. Sales has its own ‘open innovation’, and this article’s insights are still valid. Other articles looked at aspects of commissioning, compliance and coaching. In a new 

series, ‘Confessions of a medical representative’, our correspondent turned around a “lose-lose situation” with an honesty born of despair. A pro€file of Boehringer Ingelheim enticed the BI-curious by emphasising the company’s high levels of staff† retention and employee satisfaction.

The news section featured criticisms of the pharma industry – in particular, accusations of concealing evidence from clinical trials, promoting psychiatric drugs more widely than their e†ffectiveness justi€fied, and ‘evergreening’ (covertly blocking generic competition to brands). The ABPI declared the accusations unfounded. Some things never change.

March 2003

In March 2003, documents presented by the US government as proof that Iraq was developing a nuclear bomb were exposed as crude forgeries. None the less, the invasion began on schedule. Country rock band the Dixie Chicks told a London audience “We’re ashamed the President of the US is from Texas,” then went home to face a vicious backlash. Steps were taken worldwide to control the threat of SARS, a deadly form of pneumonia. Cinema audiences took comfort from the adventures of Piglet and the courage of a young Sikh woman leaving home to be

The March Pf examined the issue of flexible working, with new employment legislation helping companies and staff to tailor their contracts through job sharing, home working, flexitime and similar arrangements. Does that mean a better work-life balance or just a loss of job security? Managers at Pfizer, Abbott Laboratories and Alchemy discussed the flexible working arrangements they had introduced – all of which, in their experience, were full of win.come a footballer.

Other articles examined the skills needed for first-line sales management, explained how medical sales professionals can support GPs through the trauma of appraisal, and broke down the physician and nursing teams of a large hospital into manageable components for business engagement. A profile of Futures Resourcing explained its strategy of meeting the broad recruitment needs of clients and the long-term employment needs of candidates – from contract sales professionals to senior management – by functioning as a ‘total resourcing organisation’.

The news section featured Boehringer Ingelheim’s approval of a High Court judgement obliging parallel importers to respect product packaging and trademark rights. This was such good news, in fact, that Pf printed it twice: as industry news and again as product news. Other news stories included the new GP contract and the approval of Schering-Plough’s Remicade (infliximab) for treatment of two painful conditions, Crohn’s disease and ankylosing spondylitis, in the EU. These were covered once only, but with no less attention to detail.