A job not done yet

When Pharmaceutical Marketing spoke to the newly-elected President of the Association of the British Pharmaceutical Industry (ABPI), Chris Brinsmead, in November 2008, he raised three key considerations that he said would be focal points during his time in office. Sixteen months on, and just prior to him handing over office to president designate, Simon Jose, we were curious to find out how he faired and if the ABPI has delivered on its promises under his leadership.

In 2008 you said the National Institute for health and Clinical Excellence (NICE) was too blunt an instrument. Does this still hold true?
It seems like a long time ago now, and a huge amount has happened since. We should remember that at the time this statement was made we were about to sign a new Pharmaceutical Price Regulation Scheme (PPRS) with the government, which we did towards the end of that year. I had also just written to Gordon Brown stating we needed a better approach for this industry, which is not only important to the health, but also the wealth of this country. The positive outcome of this initiative was more collaboration between key stakeholders and the establishment of the Office of Life Sciences (OLS) at the beginning of 2009. The OLS constitutes the first time in history that any government has recognised the importance of a single sector and worked to get everyone around the table to shape the environment for its development. It brings together three key government departments, trade associations, diagnostics and industry members, and has helped create a deeper understanding of the issues and a joint approach to addressing them. Unfortunately, I still feel that NICE is too blunt an instrument, however the good news is we have made significant progress towards changing this. During the last two years we saw the Kennedy Review and Professore Mike Richards' review of Quality Adjusted Life Year (QALY). I'm not sure this has played out exactly as we thought it might yet, but there is more of a sense of recognition that we need to find ways to deal with it. As such, it's a case of the job's not done yet, but good progress has been made.

Chris Brinsmead

The second point you raised in 2008 was the need for an adult relationship between NICE, the NHS and the Department of Health (DH) as well as academia and other stakeholders. Has this been achieved?
Yes it has. The industry has a much better relationship with the people that run the NHS now. This has led to good dialogue and recognition that we can achieve more together than we can apart. Take the quality, innovation, productivity and prevention (QIPP) agenda, for example, which is forming the blueprint for healthcare service in the coming years. Industry is at the table through the ABPI, working with Jim Easton who is leading it, to make sure medicines are used in the most appropriate way possible.

Finally, back in 2008, you also highlighted access to medicines, trust and credibility as key considerations. How has the situation regarding these issues improved?
We have done a great deal to address these issues, with industry realising it must do a better job of recognising and communicating the value of its medicines itself. In the last few years we have seen many examples of industry working in partnership with NHS Trusts and, in some cases universities, and this has started to change the dynamic. For example, my own company – AstraZeneca (AZ) – is involved in a project in the North West of England where people in the NHS, Christie Hospital and academia are working in partnership on our emerging portfolio of cancer drugs to try and improve the chances of finding a cost-effective new medicine. Projects such as this not only help people see the value of medicines, but also engender a working relationship that is more trusting and adult in nature. There was great suspicion and uncertainty of each other in the past, but the projects that are up and running have helped people realise our common agenda and that, if we work together, we can achieve some fantastic results.

With regards to trust, the industry has worked hard to self regulate and to ensure that the Code evolves. In the year just gone we celebrated 50 years of our Code and held a debate called 'Nifty at Fifty', which Heather Simmonds, director of the Prescription Medicines Code of Practice Authority (PMCPA), set up. Out of this came recognition of what we have not got right. We realised, for instance, that we have to do more work around the area of continuing medical education (CME). We are consulting on changes to the Code that will most likely come into place early next year. This process has brought transparency and is moving the agenda forward. But again, as with all of the above, the job is not done yet. We need to see this way of working evolve and be adopted right through industry so that we can create better health for the patients that we are trying to serve.

What do you consider to be your greatest accomplishment and why?
This is a difficult question and perhaps one that others should answer on my behalf. If I had to pick one thing, however, it would be the increased collaboration and the sense of actually sharing a common agenda that has developed, not just at a national level, but also on the ground. We have moved a long way in two years and achieved a significant change in perception.

Can you explain why the proposed merger with the BioIndustry Association (BIA) did not happen? Is there scope to revisit this in the future?
I would widen this question beyond BIA. In the last few years there has been recognition among trade associations and companies in general that we have a lot in common and that, by and large, our agendas have a significant overlap. The BIA, ABPI and others, have worked closely through the OLS and I think going forward you will see a much more cohesive group of trade associations with a common agenda. However, there is also recognition of differences in some areas eg, diagnostics. Our futures are interdependent and as our pipelines develop into more targeted medicines, which will use more diagnostics, it is easy to see that areas of interdependency will grow. If at some point in the future it's right that associations should merge, then they will do so, but I think what is more important for right now is joint working and a sense of constructive collaboration.

What is the single biggest challenge facing pharma globally?
I would say it is the dilemma of rising costs and the difficulty of developing new and innovative medicines that are not seen as too expensive. There is a lot of unmet need and we must work with society and payers to make sure that when we do develop new medicines, there are the funds to pay for them. It's a complex problem and one that I can't do justice to in just a few minutes, but I believe – again - that a solution is to find ways of working more collaboratively.

What is your view on value-based pricing?
It is hard to disagree with the concept that medicines should be rewarded for the value they bring, but one also has to realise that innovation is an incremental process. At the moment it is not clear what value-based pricing is and how it would work. The term was first used by the Office of Fair Trading, followed by a few others, before being adopted by the Conservative Party. Rather than me trying to give you the answer based on what I think it means, I would say this is another example of where there needs to be a dialogue and various stakeholders need to sit around the table to clearly define what value-based pricing actually entails.

It should be added that the PPRS expires in 2014 and it is important that this stays in place until then. This, however, gives ample time for any new administration to work with industry to evolve the scheme, and the Innovation Pass could help produce evidence on how to develop it. The Innovation Pass may not be very big at present, but it is a new approach and one that has the potential to revolutionise how we determine value. If I understand how it is likely to be rolled out it will mean patients all over UK have access to the drug, and the manufacturer will have to work with the health service during the time it is in the Innovation Pass to demonstrate value.

Industry comment on the work of Chris Brinsmead

Questions from ABPI's members

Nigel Brooksby, non-executive chairman of sanofi-aventis and former president of the ABPI:
The government wants to encourage more investment from life sciences into the UK, but other governments in Europe want to do the same. How is the UK going to differentiate itself?
It is not just other countries in Europe; many countries around the world have recognised the value of the life sciences sector.

In the face of global competition, the UK must build on its strengths and address its weaknesses. We have very good academia and fantastic universities and there is real strength in how we are viewed internationally in terms of basic science and translational medicine. All relevant parties, ie academia, the health service and industry, must come together to build on this. One great example of how this is being addressed is the super clusters concept, led by Professor Sir John Bell, which will pull together competency in a specific area. The first super cluster being worked on is inflammation and immunology.

We also need to show the rest of the world that we can be innovative and that we can translate ideas into new approaches, technologies and medicines. In the end if people look at the UK and see there is not an uptake of new technology in the health service or that it is slow and patchy, they will perceive the UK to be less innovative.

The UK is in the fortunate position that companies in other countries perceive this as a good place to do business in terms of our business environment and regulation. I would echo what the Confederation of British Industry (CBI) says however, and that is we must make sure the taxation regimen going forward remains attractive and competitive. I would also pay tribute to the OLS for proposals to introduce a Patent Box as I think this will make the UK much more attractive to investors.

Finally, we are very good at talking ourselves down in the UK; we need to start celebrating our successes and telling the world about our great scientists and the great ability we have to conduct clinical research with the health service. I will give you a super example: we recognised that we have not been as good in clinical trials in later stages and that we had lost ground to other countries. So to address this, Mike Farrar, chief executive of NHS North West, spearheaded the North West Exemplar, which got running with a number of clinical trials very quickly. This has resulted in a number of studies receiving NHS permissions, which demonstrates how effective we can be when we turn our mind to something. It is very important that we tell people about these examples.

Do you think we are now nearer in the UK to ensuring the right medicine is getting to the right patient at the right time?
Nigel coined this phrase and I think it is a super one. The answer is yes, I think we are closer to getting the right medicines to the right patients at the right time. Are we there yet? No. We need to continue working on it. I think that phrase will endure for many years to come and I don't think it ever should be something we put on the shelf.

Steve Poulton, commercial director and head of the established business unit at Pfizer:
I always think that the pharma industry has many characteristics akin to the financial services industry – regulation, intermediaries but increasingly direct relationship with end customers, long-term pipelines, portfolios ranging from simple traditional to highly-complex technical products, importance of innovation, lack of trust, etc. Therefore, what can our industry learn from the recent financial crisis and its aftermath?
I am sure every industry can learn from what's happened. I am not sure they are directly comparable however – pharma, over the last few years, has had its failures and they are well documented. That said, there is no doubt that the way industry goes about its business is important. We have self regulation and independent regulators such as the MHRA and I think it is important that we continue to recognise the strength of this and ensure industry works in a manner that meets the Code and regulation.

The surveys I have seen suggest pharma is relatively highly regarded by the public and by politicians and we have got to continue doing the things we are doing. If we focus on these things we will succeed.

Stuart Rose, managing director of Merz Pharma:
Against increasing pressures that make the UK a more hostile environment for pharmaceuticals, what words of encouragement could you give to somebody considering embarking on a career in the industry?
I think this is a fascinating industry and will continue to be a really interesting place to work in the years ahead, whether you are a scientist or a commercial person or someone in manufacturing. At the heart of what we do is providing treatments that will improve peoples' conditions or keep them alive and I think we forget that sometimes. There will still be a lot of work going on from basic research, through to translational medicine, through to development work, and so there will still be a vibrant marketplace going forward. I am of the opinion that our industry will never lose the need to talk to customers because the products we develop are complex and need to be used in the right way in the right patient. Yes, industry is reshaping and we will need to adopt new behaviours, but we are not even close to solving the problems of healthcare. I have thoroughly enjoyed working in the industry and would say to anyone embarking on a career that it's going to continue to be a great place, filled with important challenges and rewards.

The OLS appears to really want to make a difference. How soon does it need to deliver a tangible win?
There are some tangible wins already, embodied in the blueprint published in July and the delivery document published in January, in the form of the Patent Box and the Innovation Pass. I don't think the Innovation Pass is live yet, but the intention is that it will happen this year. Going forward the OLS needs to continue to be supported by government and by industry because Stuart is right, it needs to deliver the things it said it would deliver and it needs to evolve that strategy because the world won't stand still. I think this year we will see tangible things being delivered that will make an impact. In short, it is delivering, it's got to continue to deliver, and we have to continue to support it.

Amit Makwana, managing director of Astellas Pharma:
What are the two or three things that pharma needs to change over the next two years?
We need to work out a development and commercialisation model that will somehow stop the cost of development rising so fast, and we need to work more collaboratively so that when we get something developed it can be adopted more quickly. Unfortunately we still have a situation where new medicines indicated for small patient populations, such as those for some cancers, are more expensive due to population size, and because NICE's methodology is too narrow, are being rejected. This is disappointing because it impacts lives.

We also need to develop our ability for partnership working. There are many examples that have been hugely powerful, but we have got to do more of it and we must learn how to do it better.

What would you like to see the ABPI achieve over the next two years?
We need to deliver the things that we started, ie continue to support the OLS and work with the government to ensure the OLS delivers its strategy for the UK, as well as evolves. It should be mentioned that the ABPI and other trade associations have worked effectively across political parties and, while there is an awful lot of work that I refer to with government, there has also been tremendous engagement with the Conservative Party and some with the Lib Dems, which is not as publicly recognised. There is a real desire to ensure all politicians understand the importance of the industry to the health and wealth of the country.

In addition, we need to continue working with the NHS leadership on QIPP to ensure industry plays its part in helping the NHS deliver its agenda. We have to continue to engage with NICE and other stakeholders to ensure new medicines come through and can be used by the health service and we are going to have to continue to monitor and manage the way we behave as an industry. The issue of industry trust never goes away. Self regulation is a very powerful thing, but we must recognise that the environment is changing and make sure that our Code changes to keep pace with it.

My main job in the next few months will be to set up a good board to pursue this agenda going forward. The ABPI has done a good job of refocusing itself and has brought key great people into the organisation. It needs to continue its transformation to become even bolder and stronger, without compromise to its integrity.

Chris Brinsmead's ABPI  Presidency - 
A list of achievements

The Author
Chris Brinsmead spoke to the group editor of Pharmaceutical Marketing, Natalie Uhlarz, in March 2010.

To comment on this article, email pm@pmlive.com