#EAPM: Keep it as simple as possible - and improve patient lives

In these fast-changing times, with ageing populations and stunning breakthroughs in genomics, are we failing to ask the right questions in health care while making patients’ access to novel treatments more complicated than necessary, wonders European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Legislative issues that come up time-and-time again include examples of over-regulation and the simple fact that a lot of the rules governing health care’s many aspects are outdated and are failing to keep up with the amazing science that has seen, among other things, the rapid emergence of personalised medicine.

This largely genetics-based process and philosophy aims to give the right treatment to the right patient at the right time and is as individually targeted as medicine has ever been to date.  Personalised medicine brings with it a wealth of new possibilities for European patients and society through the increased adoption of these targeted approaches to medicine.

But if its potential is to be fully realised, then changes are necessary in, for example, the way medicines are developed and regulated, the way innovation is incentivized, and in the involvement of patients every step of the way.   Of course, there’s no denying that the field of regulatory affairs in the European Union is by its very nature a complex one.

Perhaps nowhere more complex than in the arena of health – and certainly extremely complicated when it comes to legislating for the exciting advances and growing expectations being brought about by personalised medicine.  The issues and rules surrounding, for example, in-vitro devices and data protection were, are, and will continue to be labyrinthine.

There are some 500 million citizens in the current 28 member states to consider regarding health care, plus so many disciplines, industries and other stakeholders involved that it is often a struggle for legislators to formulate regulations that are satisfactory for all, are up-to-date and progressive, and do the job they are supposed to do. This despite the best efforts from all involved.

But the bottom-line is that legislative and regulatory systems need to catch up with science - and soon. New approaches are needed in research, regulation, education, and the use of medical Big Data, to name but a few.  There are certainly ways to make things easier and more efficient. One of the issues noted by EAPM is that there is insufficient collaboration between all stakeholders currently operating within their own ‘silos’. Also key is that patients are rarely involved in the process of making decisions about their own health.

This is a major problem in many areas of health generally, and personalised medicine in particular, covering everything from education to information sharing, and from authorities deciding patient access to the need for one, clear voice to communicate with legislators (in a process that also empowers the patient).

Another problem is that much legislation tends to be reactive rather than proactive. Again, with better collaboration between all involved stakeholders it will be possible to foresee potential problems that could occur down the line, rather than acting in an ad-hoc manner if and when these problems do occur.

EAPM believes that the EU - while it does not have legal competence over healthcare under the Treaties - needs to continue and step up the work that has seen it propose and introduce legislation involving member state adherence in areas such as clinical trials, medical devices and data protection.

Such legislative areas and initiatives have proven that it does have an important influence on member state health policy, albeit not directly in areas such as National Cancer Plans and health system drug choices and budgeting.  But it can, and needs to, encourage more cooperation in areas such as medical data gathering, sharing and storage, cross-border interoperability and cross-border healthcare, electronic health records and cooperation over research to discourage unnecessary duplication.

To take Health Technology Assessment (HTA) for an example, critical assessments and related decisions about the value of medicines come under member state competence, although most drugs in the EU are centrally authorized by the soon-to-be Amsterdam-based European Medicines Agency,

However, under an upcoming European Commission proposal, HTA bodies in member states would be encouraged to collaborate in a wide range of areas. Also key aim of the new Commission proposal will be to reduce duplicated work across the bloc.

Of course, the overall aim of HTA is to identify the greater value of a medicine. But in practice, there are limitations to the applicability of HTA methodologies, certainly when it comes to personalised medicine. HTA procedures often lack flexibility and suffer from excessive bureaucracy and high fixed costs.

Also, there are also inconsistent methodologies used in assessing companion diagnostics and associated treatments. As EAPM has said before, HTA faces new circumstances created by specificities of the -omics technologies and personalised medicine. It appears that the Commission is trying to address some of the issues - albeit largely on a voluntary cooperation basis - and this is to be broadly welcomed.

The Commission at least appears to be asking some of the right questions as the ageing population, co-morbidities and the attendant cost, both fiscally and to society on a broader scale, threaten to undermine the sustainability of healthcare.  It also needs to play its part in answering them. And working towards a Europe that makes patient access to the best available health care easier, rather than more difficult.

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