A new ABPI Vaccine Group has replaced its disbanded UK Vaccine Industry Group (UVIG), which represented UK vaccine companies for more than a decade.

Changes in the composition of the group include the addition of AstraZeneca and the loss of Sanofi Pasteur MSD.

The ABPI Vaccine Group will work in partnership with the new Public Health England and NHS England bodies to support UK immunisation programmes.

The new industry group has six members: Abbott Healthcare Products, AstraZeneca, GSK, Janssen, Novartis and Pfizer.

The ABPI’s disbanded UVIG also had six members: Baxter Healthcare, GSK, Novartis, Solvay, Sanofi Pasteur MSD and Wyeth (a subsidiary of Pfizer).

Sanofi Pasteur MSD, the manufacturer of Gardasil – recommended by NICE for immunisation against cervical cancer – plays a major role in the UK’s public health vaccination programmes.

Vaccination is an increasingly important strategy in global health protection, as ease of travel has made infectious diseases harder to control. According to the World Health Organisation, vaccines save 2.5 million lives each year.

Stephen Whitehead, Chief Executive of the ABPI said: “This addition to the ABPI strengthens the unity of the biopharmaceutical industry and further underlines the ABPI’s position as the leading life sciences trade association in the UK.”

“Vaccinations against disease play a vital role in improving public health and help protect us from preventable illnesses.”

GlaxoSmithKline (GSK) has said it aims to secure drug volume growth in China and other emerging markets by cutting its prices.

The UK’s largest pharmaceutical company has seen this strategy increase its sales in China by 20% in the last year.

The strategy is part of the company’s ongoing global drive to increase patient access to its products.

According to the GSK’s annual report, introducing price cuts in 2009 has caused unit sales of allergy drug Avamys to increase fivefold in emerging markets, while revenue from Avodart (a drug for enlarged prostate glands) has risen by 76%.

“Price reductions are in many ways very important in driving the access and take-up of healthcare coverage,” said GSK’s Chief Financial Officer, Simon Dingemans (pictured). “We see very good volume response to that, which shows the strategy is working.”

He noted that last year, GSK saw its sales rise by 20% in China (to £1bn) and by 5.6% across all emerging markets (to £1.56bn).

GSK is using the same price-cutting approach in another 10 Asian countries and 40 in Africa.

China is the world’s third largest pharmaceutical market, with annual spending on healthcare set to rise to $1 trillion by 2020.

GSK and MSD (Merck in the US) will reduce the price of their HPV vaccines, which protect against cervical cancer, in the world’s poorest countries.

The two pharma giants have allied to help improve access to HPV prevention in parts of the world where about 275,000 women die from cervical cancer each year.

The low price, about $4.50 per dose, will initially apply to a few million doses made available in Kenya, Ghana, Laos and Madagascar.

The alliance aims to have made the vaccines available to protect 30 million girls in 40 countries by 2020.

In the US, where the vaccine costs $130 per dose, the Center for Disease Control has described the uptake rate as “unacceptably low”. The reduced prices may result in uptake rate in the world’s poorest countries exceeding the US rate.

Dr Seth Berkeley, the alliance’s CEO, described the reduced price as a “ceiling” and predicted that it would drop further due to generic competition from companies in India and China.

The lowest current price for HPV vaccines is $13, paid by the Pan American Health Organization, which supplies medicines to Latin American countries.

The impact of the HPV vaccines could be increased by giving them to younger girls: only two doses are needed to immunise girls aged 9–13, but three are needed for teenage girls.

Both GSK’s Cervarix and MSD’s Gardasil protect against the strands of HPV (human papilloma virus) that cause cervical cancer, though Gardasil also protects against genital warts.

GSK has received £5m funding from the Wellcome Trust to support its collaborative work aimed at developing new drugs for diseases of the developing world.

The ‘open innovation’ research facility at Tres Cantos, Madrid, brings GSK’s drug discovery specialists together with 27 external researchers.

The funding will help to build on early-stage research to develop new medicines for tropical diseases including malaria, TB, Leishmaniasis and sleeping sickness.

The Open Lab facility, created by GSK in 2010, aims to develop two significant experimental drugs over the next five years, based on the most promising early-stage research both at Tres Cantos and at GSK.

GSK’s commitment to ‘open innovation’ was signalled by CEO Andrew Witty’s comment in 2012 that “the market has failed” to bring forward new drugs that are needed but will not generate immediate high revenues.

Dr Nick Cammack, Head of GSK’s Tres Cantos Medicines Development Campus, said: “This support highlights a growing recognition that collaborative and open research is the key to tackling these devastating diseases.

“Since adopting an open approach to discovering new medicines for developing world diseases, we’ve hosted some of the world's brightest academic scientists at Tres Cantos. The fusion of their academic excellence with GSK expertise has yielded some really exciting research projects.

“This tremendous show of support from the Wellcome Trust means we now have the potential to start driving these projects further towards finding new medicines.”

The Wellcome Trust is an independent global charitable foundation that supports research to improve human and animal health.

Dr Richard Seabrook, the Trust’s Head of Business Development, commented: “Academic researchers are making incredible progress in our understanding of neglected diseases, yet we’ve still got a bottleneck when it comes to the development of new drugs.

“Taking a more collaborative approach, as GSK have through their open lab, will see these advances reap the full benefit of the industry’s commercial expertise to give us the best chance of securing new treatments for these devastating diseases.”

The European Medicines Agency (EMA) has been told to accept the gagging orders of two US pharma companies pending a decision by the EU General Court.

Legal challenges by AbbVie and InterMune to the EMA’s policy of publishing clinical trial data relevant to its drug assessments must be accepted until a final judgement is made, the court said.

The US companies’ action contrasts with the growing trend in European pharma, with GSK and Roche both pledging to improve their clinical trial data transparency.

In accordance with a policy declared in 2010, the EMA is granting access to all clinical and non-clinical information (including clinical study reports) submitted by companies in their applications for marketing authorisation.

This is the first time that its policy of full disclosure of clinical trial data following the authorisation decision has been legally challenged.

The EMA is considering whether to appeal the interim decision that the AbbVie and InterMune clinical trial data cannot be made public. It has stated the need for clinical data transparency to enable scrutiny of its recommendations.

Since the filing of the two legal challenges in March, the EMA has received statements of support from the European Ombudsman, national competent authorities, members of the European Parliament, academic institutions and scientific journals.

The Agency will continue to draft its policy on clinical trial data.

The Government has launched a ‘catch-up’ programme to give the MMR vaccine to a million children in England who lack full protection against measles.

The campaign, in which Public Health England and NHS England will work together, was provoked by the recent outbreak of measles in Swansea.

Most of the children targeted are aged 11–16, a group made vulnerable by a steep decline in uptake of the MMR vaccine following the publication of a medical paper in 1998 claiming it was linked to autism.

The paper has since been exposed as fraudulent, though its claims are still supported by some anti-NHS tabloids.

In the mid-1990s, measles had almost been eradicated in the UK. But by the year 2000, uptake of the MMR vaccine had dropped to 80%, allowing the virus to circulate widely.

In 2012, there were nearly 2,000 cases of measles in England – the highest level in two decades. This year, an outbreak in Wales has infected over 900 people.

The million children in England targeted by the new NHS campaign form three similar-sized groups: children aged 11–16 who have received no vaccine; children aged 11–16 who have received one vaccine dose without the ‘booster’ jab; and children in other age groups who lack protection.

Local area teams will use general practice case registers to identify children at risk and ensure their vaccination in schools and GP surgeries.

Mary Ramsay, Head of Immunisation at Public Health England, said that although take-up of the MMR vaccine had returned to a high level, there was a “legacy of under-vaccinated children” who needed protection.

MMR vaccines, which protect against measles, mumps and rubella, are available from GSK and Sanofi Pasteur MSD.

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!

GSK and Roche have discussed clinical data transparency in a House of Commons Science and Technology Committee session.

Both companies expressed a commitment to greater disclosure of clinical trial results, acknowledging that public opinion on this issue had changed.

Leading medical academic Dr Ben Goldacre (pictured), author of Bad Pharma, questioned the speakers on how effectively these ideals would be realised by industry.

The issue of access to clinical trial data was highlighted by recent controversy over Roche’s trials of the antiviral Tamiflu, data from which were promised but not delivered to the Cochrane research group.

A campaign for the publication of all clinical trial data was fronted by Goldacre and supported by Cochrane, NICE and the BMA.

In recent months, GSK has pledged to publish all clinical trial data relevant to its currently available drugs, while Roche has promised to make redacted versions of the ‘missing’ Tamiflu trials available to Cochrane.

The Parliamentary session debated the industry’s principles and practices in this contentious area.

James Shannon, GSK’s Chief Medical Officer, said the company would only submit clinical study reports to a regulator if it were applying for a product licence – but “all of those studies would be published in a peer-reviewed journal”.

That might be true for GSK, Goldacre commented, but it was not generally true for the industry.

William Burns, a director at Roche, stated: “What we’ve seen is an increasing requirement over recent years for more stakeholders to have more access to the data, and if society wants that to happen, then we have to respond.”

Goldacre replied that Roche was “making exactly the right kind of noises” about transparency, but had not yet delivered on its “aspirations”.

Both companies reiterated that they were committed to meeting clinical demands for data transparency.

Contrary to long-standing opinion, new research has found that younger employees value job satisfaction over financial reward. Jessica Pryce-Jones examines why this change of thinking has evolved.

In uncertain economic times, the need to retain and nurture key existing talent is a priority. Organisations do not want to invest both time and energy into training key employees to discover that the benefits will be realised by another company.

This issue is particularly relevant when applied to ‘Generation Y’ employees: the demographic cohort born after the early 1980s and before early 2000s. This 20-to-30- something workforce has heavily influenced the socially networked, multi-channel society and is the management class of the future. However, they demonstrate a new-found job mobility which, from an employer’s perspective, is a ticking time-bomb of potential cost and disruption to their business.

The need to foster and retain employees is not an entirely foreign concept to the pharmaceutical industry. Nevertheless, a more concerted effort is needed. A recent RSA survey of 400 life science executives discovered that, while over 90% identified talent management as a key priority, only a quarter (26%) had an active strategy in place for retaining talent. More than two-thirds (68%) had no clear leadership succession plan at all.

Forward thinking

New research by the iOpener Institute for People and Performance, which analysed responses from more than 30,000 professionals in Europe, US, Australia, India, China and Africa, has shown the digital friendly Generation Y values job fulfilment over financial reward. Whilst pay levels still matter to this demographic – individuals are not prepared to be under-paid for their work – there is no significant correlation between increased levels of pay and greater talent retention.

The research analysis also looked at the correlation between job fulfilment and the likelihood of moving jobs. Job fulfilment was measured by the extent to which people stated that they ‘love their job’. Here, a very strong correlation emerged, definitively showing that a fulfilling job is what keeps the Gen Y employee on board, not simply throwing money at them. A single point of increase in job fulfilment brings down the intention to leave by 0.8 points. Statistically speaking, job fulfilment or, rather a lack of it, explains almost 60% of the variance in a Gen Y employee’s desire to leave. This suggests that Gen Y is not inherently interested in jumping ship for the sake of a bigger pay packet. Instead, Gen Y is simply not prepared to stay in jobs that make them unhappy.

This point is of particular importance to the pharmaceutical sector. Whilst pay levels are, on average, 20% higher than other manufacturing sectors, analysis of the iOpener database, which includes information from workers across a range of industries, reveals some areas of job fulfilment where pharma is specifically underperforming. Happiness and well-being are not ambiguous ideas. They can be finely measured by assessing the identifiable key components of happiness at work – positive factors such as recognition, respect and time on task, as well as negative indicators such as the likelihood of leaving or having sick days off.

Take, for example, contribution, which is one of the most important factors that influences happiness at work. Contribution is a two-way concept. It is not only about what the employee puts in but also what they get out of working. Therefore, as well as feeling that they are achieving goals and contributing to the working of the organisation, the employee also needs to be given feedback, respect and appreciation in return. By analysing the responses of employees in the pharmaceutical sector, we can see that they display 4% less contribution than the average across other industries.

New approach

The strategic direction that an employer is pursuing particularly applies to the working beliefs of Generation Y. iOpener research found a correlation between the trust that Gen Y employees have in their leaders’ vision and their intention to leave the organisation. In short, the more Gen Y believes in the leadership’s corporate strategy, the less likely they are to leave.

This last point should not go unnoticed in the context of the pharmaceutical sector where scandals have weighed heavily on the industry over the past few years. The most notable of which was the $3 billion fine against GSK – the largest fine ever imposed to a pharmaceutical company by the US Department of Justice. Indeed, GSK are not alone – the total cost of industry fines is more $20bn in last two decades. These episodes have damaged the sector’s reputation, not just amongst the public but also within current and potential employees.

Deficiencies aside, it is also important to recognise where the pharmaceutical industry is performing well. For example, employees report feeling that their job has a positive impact on the world – 22% more than average across all sectors – and that what they’re doing is worthwhile, 14% higher than average.

Different mindset

Organisations are quickly recognising that Generation Y is distinct from the previous generations, especially in terms of job mobility. No organisation wants to invest in the next generation of talent if that investment is compromised by job mobility. While this recognition is shared by the pharmaceutical industry, few companies have strategies in place to retain talent.

Gen Y employees need to feel a sense of job fulfilment and this can be finely measured by analysing the components of happiness at work. Research, based on the analysis of thousands of responses obtained by iOpener, clearly demonstrates that simply throwing money at Generation Y will not be enough to retain them.

After analysing employees across the pharmaceutical industry as a whole, it’s clear that whilst employees feel that their jobs have a greater sense of purpose and meaning, feelings that they are contributing to the working of their organisation are low. These are factors to be taken into consideration as pharmaceutical companies formulate talent retention strategies which will contribute to their growth and ultimately, to the success of the sector as a whole.

Jessica Pryce-Jones is joint founder and partner of the iOpener institute for People & Performance which examines the factors that contribute to resilience and how it can be maintained.

GSK has been accused by the Office of Fair Trading of protecting its Seroxat revenues from 2001–2004 by illegally paying off three generic competitors.

The OFT claims that GSK abused its market position by making “substantial” payments to Alpharma, Generics (UK) and Norton Healthcare to delay their launch of generic paroxetine.

The deals meant that the NHS, which paid £100m for Seroxat in 2001, lost an opportunity for “significant” cost savings, the UK trading watchdog said.

Paroxetine, an SSRI that targets anxiety-based depression, has already caused GSK some anxiety.

In 2002, the company was fined $2bn by the US Government for illegally promoting the drug’s off-label use in children and young adults. CEO Sir Andrew Witty said GSK’s actions had been “unacceptable” and would “never” happen again.

The current OFT accusations relate to deals that applied from 2001 to 2004 – since which time, GSK’s paroxetine brands (Seroxat in the UK, Paxil in the US) have steadily lost ground to generic equivalents.

If found guilty of breaking competition law, GSK faces a UK fine of up to £2.6bn, 10% of its annual global revenue.

The OFT’s Ann Pope commented: “The introduction of generic medicines can lead to strong competition on price, which can drive savings for the NHS.

“It is therefore particularly important that the OFT fully investigates concerns that independent generic entry may have been delayed in this case.”

In a public statement, GSK said: “We very strongly believe that we acted within the law, as the holder of valid patents for paroxetine, in entering the agreements under investigation.”

It also noted that the European Commission had reviewed these issues and declared that it would take no action against GSK.

The company has until August to respond to the OFT’s charges.