• Stephen Whitehead

    Posted in category News by Stephen Whitehead on 11/04/2014

    Speech by ABPI Chief Executive Stephen Whitehead at the ABPI's Annual Conference 2014 (abridged version)

Welcome to the ABPI conference – ‘Securing a future for innovative medicines’.

 

​Thank you for coming.  It’s so good to see so many people here from across our industry and beyond. I want to take the opportunity to thank you all for coming and to thank our sponsors, media partners and exhibitors for supporting today’s event.

Let’s turn the clock back one year.  Do you remember me speaking to you this time last year?  Do you recall the changes we were facing? 

- The campaign for data transparency continuing relentlessly;

- the NHS reforms and new commissioning structures going live;

 - the fallout from Mid-Staffordshire and the Francis Report - with a spotlight on safety and quality of care;  

- the ABPI embarking on negotiations for the new pharmaceutical pricing scheme for the next five years.

 - Yet, all within a constrained NHS budget in times of extreme austerity.

We knew we were on the cusp of dramatic change, but we were struggling to understand the precise nature of the change…how the new NHS would respond to the challenges it faces… how our industry would need to adapt its business models and ways of working to ensure commercial success in an ever more complex environment.  

Achievements in the last year

I always said that two core issues would be fundamental to our future: partnership and value –

  • partnership – to ensure the industry is recognised as a trusted and valued partner at national, regional and local level;
  • value – to show the value of medicines in improving patient outcomes and the value of medicines and the industry to the UK economy.

So where do things stand one year on? 

On partnership, 

  • Through the work of the ABPI’s NHS Partnerships team, we understood the new NHS architecture and strengthened our partnerships with NHS organisations.
  • Partnership agreements signed with NHS England and NICE.
  • A compact agreement made with Clinical Reference Groups.
  • Representation on the Board of Innovation, Health and Wealth….indeed, we were there at its very inception.
  • Industry leads from member companies for all 15 Academic Health Science Networks.
  • The ABPI Patient Organisation Forum established, to facilitate a constructive and open dialogue with patient groups.
  • Tough engagement on the data transparency debate and disclosure of payments to HCPs

In terms of the value of this industry: 

  • We have continued to push for implementation of the UK Life Sciences strategy and we took stock of progress two years since it was launched.
  • We launched the ‘big data road map’, a four point plan to enable us to use data as a powerful catalyst for improving patient outcomes.
  • We were instrumental in securing new medical reviews in Scotland, Wales and Northern Ireland.
  • And, of course, we negotiated the new pricing deal, the PPRS.

As many of you will know, the negotiations were the most complex ever. Against the worst economic backdrop since 1945. We were challenged with a new pricing scheme, VBP, that threatened the very strategic position of the UK in our industry for the first time. A populated statutory scheme and the threat to tear up a five year policy framework that the industry wanted to protect. We have a deal that provides stability, a viable operating framework for the UK to embrace innovative medicines, and opportunities to shape the NHS patient access story in a far more positive way than we’ve known in the past. 

So, with partnership and value at the heart, we embraced change and worked to actively shape it. 

But I don’t want to be unrealistic about the scale of the challenges that we still face. 

Low and slow / barriers  

The UK remains a low and slow market for new medicines.  

Low in terms of use – with market share of newly launched medicines below 3% of the total prescription market, behind all our Western European neighbours.  

Slow in terms of adoption – even five years after launch, usage of new medicines in the UK is on average nearly 60% lower than 16 comparable countries.  

Low in terms of spending – in comparison to other developed healthcare systems – the NHS spends less than 1% of GDP on medicines, a third lower than France, for example.  

We still have to shift the mentality where medicines are seen only as a cost to be controlled. The NHS employs 1,700 officials to say no to innovation!  

We still have to overcome the disincentive infrastructure, dis-incentivising the use of medicines, adding to clinicians’ frustrations and depriving patients of the medicines that NICE has recommended as cost-effective.  

This goes beyond the NHS - with changes in medicines development, technology, data opportunities and stratified approaches – responsibility will be increasingly dispersed across a range of organisations, budgets and stakeholders.  

We still have to address the short-termism: a quick cost containment drive today that stifles innovation tomorrow. Look at antibiotics, life-saving medicines, in the last couple of decades – when payers said, ‘we won’t pay a premium for incremental innovation because we have what we need’, and now governments turn round and ask ‘why has industry largely withdrawn from this space?’ Let’s remember that ‘Aricept’ – the only medicine for dementia we have seen approved for use by NICE – was only after a judicial review!

Candidly, I am, like I am sure everyone in this room, sick and tired of the scratchy and tetchy discussions aimed at securing access to medicines in the current environment.

The debate needs to change, and if it doesn’t, I am afraid UK patients will be left behind.

Simply, the UK healthcare  environment is struggling to be fit for purpose today, never mind the colossal challenges we are about to face.

What does the future look like?  

New and exciting science, new biologics, a new generation of vaccines against non-communicable as well as communicable diseases, immunotherapy, regenerative cell and gene therapies, targeted cancer treatments; working with genomics and precision molecular diagnostics.

All these developments hold out the potential to transform healthcare delivery, and above all, offer the promise of superior outcomes for patients: increased quantity and quality of life as never before in history.

Today we are publishing a report on the emerging innovation landscape, with some pointers on how to get the system - in fact a web of systems and policies - fit for purpose.  

The report shows us how drug development, and the science behind it, is changing enormously.  

This is leading to a new R&D ecosystem, whose vitality depends upon new ways of working, links and collaborations with and between universities, medical research charities, biotech, clinicians and patients.  Britain’s biopharma industry, traditional strong science base and the size and reach of the NHS put us in an potentially strong position to foster that new R&D ecosystem in the UK for the benefit of the system and the patient. BUT at the current time we are not there!

But the new R&D ecosystem calls for a new model, new approaches and new relationships - not only for pharma R&D departments, but for the whole lifecycle of support for innovation, including the commercial environment, the regulatory environment, the healthcare system, the payers and the health economists.

We are no longer designing, developing and manufacturing a medicine in a big shed, and then lobbing it into the NHS to buy it. And there is no longer a separation of what we traditionally call R&D and commercial. Let me explain further…

We are now at the stages of:

  • using molecular profiling to tailor the right therapy for the right person at the right time;
  • adaptive clinical trial design, using biomarkers, modelling and simulation;
  • harnessing ‘big data’, going beyond the randomised control trial and tapping into observational data sets, and using real world evidence and real-time monitoring;
  • deploying new e-health technologies in diagnosis and healthcare delivery, where the digital revolution has transformed the way we work and shop, but still hasn’t yet revolutionised healthcare.

This means that we must adapt the way we relate and  reinforce value and partnership and also develop a new relationship with all stakeholders from regulators, NICE, the NHS and patients. The relationships between us and our stakeholders need to be seamless and patient-focused and utilise the skill sets of all parties. We all have a role to play in this new game.

I am extremely optimistic about my industry. I have seen us triumph over AIDs, CHD, diabetes, cancer and countless more diseases, each of which is a single human tragedy.

Tomorrow brings enormous challenges, but I never doubt our capacity to meet these.

 

Thank you.

 
 
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