Overcoming the political hurdles to deliver on the promise of personalised medicine

Rob Walton

Wisper Public Affairs

An interesting story on personalised medicine appeared in the UK press last month. In an interview with Mark Henderson, science editor at The Times, the British Government’s chief genetics advisor, Sir John Bell said that the UK National Health Service was “completely unprepared” to deliver personalised, genome-based medical care.

This news came hot on the heels of another UK report about a four- year- old girl who was diagnosed with a serious and rare skeletal disorder by the country’s first use of whole genome sequencing to detect disease. This development was not only highly significant to the little girl and her family, even though there are no new treatment options available to them currently, but also critical to innovators in Europe in that it demonstrated clearly how the greatest challenges to delivering on the promises of personalised medicine (such as improved accuracy of diagnosis and highly specific and effective treatment) are more likely to be found in Europe’s political chambers than its laboratories. If we are to seize the opportunity presented by personalised medicines, it must be recognised that the development of sound scientific and health policy in this area is as important as the science itself, and that there is still much to do in this area.

Referring to the UK, Sir John identified a number of challenges to the uptake of personalised medicines. These include failures to plan for the future, a lack of incentives for commercial development, unsuitable evaluation procedures for genetic tests and a widespread lack of understanding of the uses of genetic testing among health professionals. The factors he listed should not come as a surprise to us – despite the fact that our sector has been talking in earnest to policy makers about personalised medicine for almost a decade – and we will all probably recognise that they are not specific to the UK. They are shared across almost every member state in Europe, as well as in Brussels, and collectively reflect the reason why healthcare systems and politicians have not focussed on the adoption of personalised medicines, namely they aren’t really sure what they are looking at. This demonstrates a failure on the part of the European science-based industry to make effectively the case for personalised medicines in a clear and compelling way.

“If we are to seize the opportunity presented by personalised medicines, it must be recognised that the development of sound scientific and health policy in this area is as important as the science itself…”

Part of the problem is that communicating scientific ideas to non-scientific audiences is not easy. It involves taking complicated concepts and making them simple and easy to understand by people with limited knowledge on the subject. The ability to do this is, however, critical for the development of personalised medicines, not simply because of the natural complexity of the science itself, but because of the implications personalised medicines hold for both public and private health service providers across Europe. The technology of personalised medicine has the potential to drive a revolution in healthcare delivery, alongside unprecedented improvements in outcomes. If, as Sir John asserts, healthcare professionals don’t fully understand personalised medicines, then there is even less chance for elected officials who – for better or worse – don’t need a science degree to do their job.

I have little doubt that our sector’s communications to policy makers about personalised medicine are carefully constructed and well delivered, however, if Sir John’s comments tell us anything it is that the message is not getting through. We urgently need to review our approach in order that the human and economic value of a flourishing European-led personalised medicines industry is received, understood and acted upon.

A first step towards this might be to address the uncertainty that still exists around basic terminology. In some places medicines are “personalised”, in others they are “stratified”. On closer inspection, the nomenclature changes even more. Similarly, there is a lack of definition of what the overarching promise of scientific innovation is. Because personalised medicine has enabled breathtaking innovation in diagnosis and treatment, among other things, a clear vision has proved difficult to convey amid a cacophony of conflicting voices. Of greater concern still is the voices of some stakeholders who believe that personalised medicine should be promoted at the expense of existing or “old” therapies. This all needs to be addressed.

To move forward, industry must recognise the remarkably broad array of interests that hold a stake in the development of personalised medicines. It goes far beyond our core interests and those of patient associations and scientific societies to myriad organisational agendas that conflict and correspond with our own viewpoints. From those who develop our macro-economic policy or set stratagem on industrial competitiveness, to the family of the little girl waiting for new treatment options, we need to understand these diverse interests better and distil distinct perspectives into simple, singular recommendations for reform. By facilitating consensus and championing common cause we can help to cement the promise of personalised medicines and the steps needed to realising it in the minds of European policy makers.

“…communicating scientific ideas to non-scientific audiences is not easy.”

We need to look more deeply too. Beyond the critical issues of regulation and access to personalised medicines, significant changes need to be made in national health infrastructures to harness the benefits of the emergent science. This means developing a strong common vision of how health services will be configured in the future, with new roles and accountabilities for existing specialties. Pathology, for example, will need to find new ways of working, as well as need a significant injection of resources to cope with even the most limited demand in new diagnostic technologies. Industry should be front-and-centre when it comes to identifying what the future will look like and in charting the route towards it.

Further still, we need to do more to help policy makers see the bigger picture. By enabling the science of personalised medicine to realise its commercial potential, Europe can benefit in many ways – from increased workforce productivity, through improved treatment outcomes, to new revenues from royalties and increased private investment in sophisticated scientific research. Given the current economic climate it is difficult to think of a better opportunity to draw the attention of policy makers to the innovative agenda for health and wealth that personalised medicine encapsulates.

Complex issues in populous stakeholder environments should be communicated simply, in a highly-targeted way. The pharmaceutical industry knows this more than most and is better placed than many to do it well. Just like our scientists, our communicators should be out there at the leading edge, convening disparate voices, identifying common ground and proposing high-value solutions. If we are unwilling or unable to take leadership, then progress towards a Europe that embraces personalised medicines will be slow and stilted.

We have the incentive and the know-how to develop a blue print for the development of personalised medicines in Europe that everyone can read and understand. Not only do we owe this to our sector, but to the patients and families who are waiting for more of these innovations to move out of the lab and into the doctor’s office.

About the author:

Rob Walton is Managing Partner at Wisper Public Affairs, a member of the iS Health Group of companies.

How can we overcome hurdles to delivering personalised medicine?