A new ABPI Vaccine Group has replaced the 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 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.”

The NHS is limiting patient care by reducing access to medicines in order to achieve short-term cost control targets, the ABPI has said.

At its annual conference, the industry association emphasised that France, Spain and Germany spend three times as much per patient on new medicines as the UK.

While it focused on medicines, the ABPI statement echoed comments from the NHS Confederation on the way that ‘salami slicing’ of healthcare is being used as a short-term financial solution.

Both organisations are calling for service redesign to shift healthcare from the hospital to the community, rather than further cutbacks to existing services.

In particular, the ABPI noted, denying patients access to new medicines on grounds of cost is holding back the treatment of long-term conditions within the community, while giving hospitals more work.

Spending on new medicines is set to rise by only 1.3% by 2015 – half the projected increase in total NHS spend, and far below the rate of inflation.

The UK spends 74p per person per day on medicines, compared to over £1 in Spain, Germany and France. It spends only 7p per person per day on new medicines, compared to over 20p per day in those countries.

Stephen Whitehead, Chief Executive of the ABPI, said: “Our healthcare system needs to focus much more on caring for patients in their own homes and much less on treatment in expensive hospitals. Investing in new, innovative medicines will be absolutely key to this.

“By 2015, the new medicines which are being launched now will make up just 2.5% of the entire medicines budget, and yet it is these treatments which are able to transform the way many diseases are treated.”

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.

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.”

Novo Nordisk, the world’s leading supplier of medicines for diabetes care, has joined the ABPI for the first time.

The decision reflects the Danish company’s growing involvement in the UK health market, where the importance of diabetes care is growing rapidly.

It also reflects the increased profile of the ABPI in negotiations affecting the UK pharmaceutical industry, including the adoption of value-based pricing for drugs.

Novo Nordisk recently launched a new basal insulin, Tresiba, in the UK and celebrated 90 years in the diabetes care market.

Peter Meeus, UK General Manager of Novo Nordisk, commented: “As a growing player in the UK pharmaceutical market, we felt the time was right to join the ABPI. The ABPI has undergone real transformation in recent years and we are confident that as our business continues to grow in the UK, ABPI engagement will complement what we are doing to ensure we are better positioned to face the challenges and the opportunities in an increasingly dynamic business setting.”

“Novo Nordisk is a very welcome and important addition to our membership and will further strengthen the ABPI as the voice of the pharmaceutical industry,” said Stephen Whitehead, ABPI Chief Executive.

“We will be looking to support them and our wider membership to ensure that once a medicine has been approved for use in the UK, the NHS is able to adopt it and patients can fully realise its benefits.”

NICE will be responsible for assessing the value of medicines in the new value-based pricing (VBP) system to be implemented in 2014.

The Government’s decision to make NICE central to VBP follows recommendations by the Health Select Committee (HSC).

It also follows a report by the European Commission stating that NICE’s QALY metric, the basis of its current value appraisals, is unfit for purpose.

The new role in VBP assessment will enable NICE to broaden the scope of its appraisals of the costs and benefits of drugs.

This will simplify the current routine of NICE declaring a drug too expensive in draft guidelines and then revising its verdict when the company offers a confidential patient access scheme.

Health Minister Lord Howe said: “We are delighted to announce the central role NICE will take in assessing the value of new medicines. This will allow us to draw on NICE’s world-leading expertise as we develop the Value-Based Pricing scheme.”

From April, NICE will be led by new Chairman David Haslam (pictured). It will have responsibility for social care as well as the NHS and public health, enabling it to play a major role in the integration of care.

The Government approved three other HSC recommendations: NICE should develop healthcare quality standards for patients with long-term conditions, co-morbidities or complex needs; NICE should promote better-integrated commissioning and care; and industry should be more transparent as regards clinical trial data.

Stephen Whitehead, Chief Executive of the ABPI, commented: “What will determine whether value-based pricing works for the pharmaceutical industry, the NHS and most importantly patients is not who does the assessment, but how it is done and what goes into it.

“NICE has an important role in supporting growth, which is often overlooked. NICE needs to be an enabler of innovation by the NHS and this is lacking from the Government’s response.

“We urge the Government to keep its foot on the pedal in spreading innovation through the NHS and ensuring that NICE helps to deliver its part of the growth agenda.”

Patent restrictions on drug trials in the UK will be lifted, making it easier for new drugs to be compared with the standard treatment.

The new exceptions enable companies to trial a new drug or a generic version against an established brand without violating its patent.

The changes to the Patents Act could both strengthen the UK as a base for pharmaceutical R&D and improve the medical value of clinical trial findings.

Life science industry trade associations have welcomed the new regulations for the boost they offer to innovative drug development, despite potential losses to established brands.

An Intellectual Property Office consultation showed overwhelming industry support for both changes to the patent law: the ‘research exception’ for trials of new drugs and the ‘Bolar exception’ for trials of generic drugs.

Not only does the rule that head-to-head clinical trials infringe patent make it harder to establish new drugs, it has also led to widespread criticism of clinical trials that compare a new drug with placebo – which no doctor prescribes.

Most EU countries exempt clinical trials from patent infringement, and the UK law has been a barrier to clinical trial work in the UK.

“The Government is keen to create a supportive environment for pharmaceutical research and development in the UK,” said Lord Younger (pictured), Minister for Intellectual Property.

“Helping the industry get their products to market as quickly as possible will benefit patients, the industry and the economy.”

Stephen Whitehead, CEO of the ABPI, commented: “This is a welcome development that will make the UK a more attractive place in which to conduct clinical trials, which in turn will encourage pharmaceutical companies to continue operating here.”

The number of new drugs becoming available to NHS patients is not in decline, contrary to widespread industry rumours.

Researchers analysing the British National Formulary found that the average number of drugs introduced per year is marginally higher than in the 1970s.

There was a dip in the number of new drugs becoming available between 1998 and 2006, but the pipeline has since become stronger.

A team at Birmingham University looked at drugs introduced to the Formulary from 1971 to 2011.

The average number of drugs introduced per year was just under 23, with the current level 0.16 above the level of the 1970s.

The report noted that short-term fluctuations have given rise to impressions in the past that pharmaceutical innovation, or NHS uptake of it, is in decline.

According to author Dr Derek Ward, “We started this research because there was a great deal of pessimism within the industry and among pharmaceutical companies about the number of new drugs that were getting to the market.

“We found that looking at the data over the longer term there was a slight increase. This is obviously a good thing for patients.”

ABPI Chief Executive Stephen Whitehead commented: “It is a common myth that our industry has struggled to develop new medicines, when in reality the research pipelines of companies are healthy.”

The report noted that the time and cost of drug development are increasing and the innovation model is becoming more complex.

Dr Phil L’Huillier of Cancer Research UK noted: “The landscape is shifting, with pharmaceutical companies increasingly collaborating with academia for discovery and development of drugs.”

The ABPI and the Pharmaceutical Marketing (PM) Society have formally agreed to work together in promoting and advancing the UK pharmaceutical industry.

The two organisations have signed a memorandum of understanding (MoU) committing them to align activities that are relevant to their shared interests.

Areas of joint working suggested by the MoU include training, events and member surveys to identify issues and facilitate planning in the industry.

The PM Society promotes marketing excellence in the healthcare industry. Run by volunteers as a non-profit organisation, it has members in 230 UK companies.

In 2012 the PM Society introduced a number of Interest Groups focused on current challenges: market access, digital marketing, NHS partnerships, patient engagement and personal development.

The ABPI represents research-based biopharmaceutical companies in the UK, and is recognised by the Government as the body negotiating on behalf of the branded pharmaceutical industry.

“The PM Society reaches out to the operational heart of the UK pharmaceutical and life sciences industries and is a natural partner to promote debate and discussion with the people we serve,” said ABPI Chief Executive Stephen Whitehead.

“The working groups in market access, NHS partnerships and patient engagement, aligned as they are with many of our strategic imperatives, offer particular potential for joint working.”

Neil Copping (pictured), Chairman of the PM Society, commented: “Since we redefined the Society early last year, we have looked to address members’ needs more effectively in the rapidly changing healthcare environment.

“Aligning strategic and grass roots level activities by joining forces with the ABPI, we aim to open new doors and deliver increased value and benefit to both organisations’ membership.

“It will also avoid duplication on initiatives that are relevant industry-wide and might otherwise have been under discussion by both organisations.”

A limited ‘experimental’ version of the Government’s Innovation Scorecard points to variation and low overall levels in patients’ access to new NICE-approved medicines across England.

The spreadsheet and report published by the Health and Social Care Information Centre summarise the existing data on the availability of 76 medicines and 6 medical technologies recommended by NICE through NHS organisations.

While the initial ‘scorecard’ cannot be used to assess the performance of individual organisations, it will stimulate discussion on how to develop a fuller and more accurate version.

The goal of the Innovation Scorecard is to support the uptake of innovative therapies by the NHS, in line with the Government’s ‘Innovation, Health and Wealth’ strategy.

More information is needed to address the causes of the variation in availability of these treatments, since patient demographics and local purchasing arrangements may influence the data.

The report includes: estimates of actual and expected use of medicines; volumes of medicines used in primary care (daily dose per 100,000 of CCG population); and volumes of medicines used in secondary care (mg of drug purchased by hospital trust per 100,000 bed days).

The ABPI has expressed concern that the initial ‘scorecard’ not only reveals widespread variation but also shows the uptake of new medicines to be generally well below the expected level.

Stephen Whitehead, ABPI Chief Executive, commented: “This first Scorecard is less detailed than ABPI hoped for and we envisage future scorecards offering more details on how the NHS is complying with NICE guidance. But we welcome its publication as a first step on a transparency journey in the new NHS.

“I believe the Government understands the challenges, but it must act quickly and decisively to drive the adoption and diffusion of the newest and most innovative medicines across England.”