State of play
The aim of Europe’s policies and actions in public health is to improve and protect human health, and to support the modernisation of Europe’s health systems – which the EU sees both as improving the quality of its citizens’ lives, and as a contribution to goals involving growth and jobs.
While the responsibility for health lies principally at the level of individual Member States, EU institutions have an important role in promoting, coordinating and complementing national actions and in driving collaboration and cooperation.
The Commission’s key role is to support Member States’ efforts to protect and improve the health of their citizens and to ensure the accessibility, effectiveness and resilience of their health systems.
Work by proponents of personalised medicine has, in recent years, laid the foundation for bringing an advanced personalised healthcare approach into effect in a realistic timeframe.
Leverage among the many distinct stakeholders across the complex context of personalised healthcare has opened up new possibilities for sophisticated engagement and imminent tangible change.
Such activity undertaken by the European Alliance for Personalised Medicine has complemented, reinforced and influenced European thinking and the need for reinforcement is evident.
A future in view
A new approach towards personalised medicine can bring major benefits by the end of the next legislature, by fully exploiting the potential of personalised health with a new vision of coherent strategies based around prevention, early detection, and treatment.
This will mean making optimal use of Big Data’s ability to modify what is possible in medical research and patient care.
It will depend on more effective leverage of new technologies, to sharpen the impact of R&D on early diagnostics.
It will mobilise diagnostics to guarantee patient access to personalised healthcare.
And closer collaboration between authorities involved will ease the demonstration of the value of personalised medicine, so that regulators, payers, and policymakers respond by incentivising innovation.
Of course, there are barriers to be overcome. And among them are the limited availability of open enrolling clinical trials, a limited evidence base, the absence of profiling from most local/national guidelines, and the absence of personalised healthcare in most cure pathways – compounded by little consensus on clinical utility.
There are also varying standards and uneven quality among providers, plus an absence of advocacy in some regions, a lack of awareness or a reticence among healthcare professionals, and wide variations in relevant professional education.
There is certainly insufficient coordination among policymakers and regulators, leaving personalised healthcare development often impeded by incoherence.
And there are also gaps in arrangements for governance.
We need to build up on the merits of existing policy, and to complement it where it still has gaps in respect of maximising the benefits of personalised medicine.
There is already a vision of personalised medicine changing healthcare, by tailoring healthcare solutions to the individual patient, instead of relying on a ‘one-size-fits-all’ approach.
Healthcare services will increasingly deliver the right intervention to the right person at the right time, improving the outcomes for patients and cutting down unnecessary treatments.
Personalised medicine has a major potential role in prevention, with genome sequencing having the ability to spot a tendency to develop disease, opening the way to more focused approaches to top-of-the-range imaging, vaccinations and screening led by appropriate guidelines.
A substantial, ‘smart’ shift in the way health services spend could help respond to growing pressures on resources – and currently Europe is under-using its ‘cash for care’.
Many deaths can be traced to behavioural causes, which can be as obvious as obesity or cigarette smoking, and attempts at prevention would benefit from better education and awareness campaigns related to modern-day lifestyles.
But fundamentally, the need is for greater investment in prevention – and for the policy modifications that underlie such a move.
Meanwhile, one of the revolutionary technological advances that makes personalised healthcare possible is the capacity for precision profiling through molecular diagnostics. This can deliver individual and societal benefit, but there are currently no externally governed industry standards to guarantee the necessary accuracy and reliability of techniques.
But there is a need for agreement on standards, and improvements to regulatory pathways, as well as an appropriate regulatory and medical framework.
Alongside this, given the reality that many common medicines are not effective in treating large numbers of the patients they are supposed to help, personalised medicine offers a promising alternative.
Its tailor-made treatment strategies for individuals or groups of individuals permit patients to receive the specific therapies that work best for them, and eliminating waste on trial and error.
Unfortunately, at present, regulatory and reimbursement systems are not adapted to respond to the new opportunities that these novel therapeutics offer.
Greater understanding could help unleash waves of new medicines that would improve patients’ lives, and transform society’s approach to healthcare.
All stakeholders, including Europe’s policymakers at EU and national level, need to play their part in imbedding personalised medicine into Europe’s healthcare systems as quickly as possible.