Denis Horgan, executive director of the European Alliance for Personalised Medicine (EAPM), takes a look at some possible stakeholder New Year resolutions.
New year, new challenges. As we swing into 2018 there are many issues in the arena of health care that will substantially affect the lives and work of patients, health-care professionals, medical researchers, members of the pharmaceutical industry, EU and national regulators, politicians and more.
The field of personalised medicine is among the fastest moving and requires more cross-fertilisation between different disease and policy areas. Within this growing sphere, there is a need to offer up valuable evidence and stakeholder opinion on which policy makers can base their decision making on how better to integrate personalised medicine into EU health-care services.
EAPM already regularly brings together different streams (all of the stakeholders mentioned above, in fact) in order to allow decision makers to understand changes that are required, now and down the line.
Each stakeholder group has its part to play and, perhaps, the same New Year’s resolution is necessary in each case: to step outside their silos and cooperate and collaborate more with each other and across each other’s different disciplines.
Patient groups need to be listened to more, throughout all stages of the medical process (it is about them in the end, after all) yet they also need to be better educated about their illnesses and the potential best treatments (including clinical trial opportunities).
For their part, health-care professionals (HCPs) really do need to get up-to-speed with advances in personalised medicine, so ongoing training is vital.
EAPM’s education working group has noted that if personalised medicine is to be in line with the EU and Member State principle of universal and equal access to high-quality healthcare, then clearly it must be made available to many more citizens than is currently the case.
It is more important than ever to bring Europe together in a way that improves the already significant skills that HCPs possess to enable co-decision making which will effectively empower the patient.
In this modern era, patients are demanding to become more-and-more involved in their own treatments. They know more than ever before and have a right to dialogue with their doctors, nurses and surgeons.
But in the age of personalised medicine it has become clear that neither the patients nor the healthcare professionals (HCPs) know quite enough. Crucially, the same holds true for regulators and policymakers.
The two are definitely linked as more understanding at every level will bring about greater awareness of stakeholder issues and will inevitably lead to better regulation and legislation from on high.
So regulators please take note, just in case you were short of a New Year’s resolution…
Meanwhile, improved health literacy has been proven to save money in healthcare budgets, and the WHO, among others, has called for policy action to strengthen it.
Evidence has been shown that strengthening health literacy builds individual and community resilience, helps to address health inequities and improves health and well-being.
Fortunately, in Europe, health literacy among patient is a key part of Health 2020, the European health policy framework which, in 2012, was adopted by member states in 2012. The bottom line, though is that education among both patients and HCPs needs to be stepped up swiftly.
Indeed, EAPM’s Congress in Milan later this year will address, among many other matters, complex inter-related topics to embrace thinking on the need for improved health literacy (for patients, HCPs and, yes, those regulators), and ongoing training for HCPs.
Meanwhile, in the vital field of research, European researchers have been at the forefront of major scientific healthcare discoveries in areas such as cancer, cardiovascular disease, genetic disorders, and infectious disease.
The challenge now and for each new year is how best to translate this knowledge and expertise into advances that improve outcomes for patients.
In this area, the Alliance working group for a Research Road Map for Personalised Medicine asks the EU to commit to the development of a European Translational Research Platform that enables the efficient translation of research discoveries to innovative diagnostics, therapeutics, products and processes that will benefit European patients, industries and societies.
At the end of the day, though, more collaboration is needed within member states and across borders.
Let’s take genomics from a search angle: Our understanding of genomics has increased substantially since 2000, by which point the majority of the genome had been sequenced as part of the Human Genome Project.
Research since then has greatly improved understanding of the genome’s implications for health. These advances have been matched by a revolution in technology, including the development of next-generation sequencing in which a rapid reduction in costs are making the technology more available for clinical applicability. It is fantastic progress, yet the research must go on, much of which relies heavily on Big Data.
On that topic, EAPM’s working group on Big Data (chaired by INTEL), will resolve to reinforce its key ask which is that, by 2020, the EU should endeavour to achieve widespread benefits for patients and citizens from personalised healthcare by defining, and subsequently executing, a Data Strategy for personalised medicine.
Again, it is vital that legislators and politicians step up to the plate to make the most of this incredible and ever-growing resource.
Also, Europe needs to facilitate the IT infrastructure and processes to provide the necessary evidence base using real-world data, and tech industry players are vital here.
But, lest we forget, as personalised medicine evolves, there needs to be more and better incentives for innovation.
The big question is how to fully integrate Europe's brilliant research into national healthcare systems, especially as the ’system’ of getting efficacious, innovative drugs and treatments affordably to those who need them is no longer fit for purpose.
Obviously, the price of new treatments may cause problems in all countries that provide state-based health-care assistance to their citizens.
Industry clearly has a key role to play here, but not on its own. What is needed is a form of collaboration: pharmaceutical companies have a right to make profit, the state - and therefore its citizens - has a right to obtain access to effective treatments at an acceptable price.
EAPM’s working group on access and value, chaired by industry giant Roche alongside the European Patient Forum, aims to ensure that healthcare resources are allocated to development and utilisation of personalised medicine, and to effect a paradigm shift in pricing and reimbursement to recognize the societal value of a medicine.
Overall in the field of personalised medicine, there is certainly a need for a responsive regulatory environment that responds to the needs of all stakeholders whilst ensuring patient safety, with the end result of ensuring development of treatments for patients.
Politicians, such as MEPs and member state health ministers, need to carry on the good work that has brought about necessary Council Conclusions on personalised medicine as well as new, updated regulations on everything from data protection to IVDs to clinical trials.
In the end, though, every stakeholder should resolve and strive this year (and into the future) to put the patient at the centre of his or her own health care and to deliver the right treatment to the right patient at the right time.
Happy New Year!