/NEWS / Articles / Articles / Innovation in personalised medicine and healthcare...




Articles - Articles

Innovation in personalised medicine and healthcare as a whole is here among us and is moving swiftly.

Publication date: 15.09.2017
But policy, rules and regulations must keep up if we are to make the most of the many breakthroughs, optimise the use of Big Data and bring novel medicines to market more quickly.

The Brussels-based European Alliance for Personalised Medicine (EAPM) has worked continuously to bring stakeholders together to find a way through the legislative labyrinth that surrounds many issues affecting personalised medicine.

Europe has been slow in taking account of new technologies and, among other things, there is a clear need for new social contracts and relationships to be developed to facilitate collaboration and knock a big hole in ‘silo’ thinking. Meanwhile, legislation, regulation (as well as agreed standards) have to keep up.

“Stable” is all very well, as Theresa May, for one, keeps telling us. But it is not the be-all-and-end all when times and technology are moving so fast. In fact, it can lead to a gradual decline in our ability to stay up to speed with exciting new developments.

“Disruptive innovation” is playing its part in the modern world and we need some of that among legislative bodies before the rules are left behind by the realities. 

A note on disruptive innovation sees the broader picture: not so long ago the European Commission 
(and its independent Expert Panel on effective ways of investing in health) launched a public consultation on a preliminary opinion, which explored “the implications of disruptive innovation for health and healthcare in Europe”. 

It described disruptive innovation as “a type of innovation that creates new networks and players that tend to displace existing structures and actors. It constitutes a real paradigm shift in the organisation of healthcare”. Bingo.

The Commission document added that disruptive innovation as a healthcare concept has been developed in the US and looked to see how the concept can be applied in the European context.

OK, so far so good. The above should theoretically allow EU Member States to develop or strengthen public health communication strategiesincrease public awareness as regards both the benefits and risks of personalised medicine, as well as the citizens’ role and rights, and support appropriate access to innovative diagnostic methods and better-targeted treatment.

Unfortunately, despite all this new science, innovative and better ICT capacities and the ability to gather, store and disseminate Big Data, we are not making the most of it when it comes to giving the right treatment to the right patient at the right time.

A key reason for this is that much legislation is way behind the times and, until it gets up to speed, it will continue to constrict

We will not see the results immediately, but if we do not act now, as Janan Ganesh wrote this week in the Financial Times (albeit about the eventual results of Brexit): “It is the toll paid in decades, not moments, that promises the worst.” 

On a more positive note, he added that: “As performance director of British Cycling, David Brailsford attributed his success to the ‘aggregation of marginal gains’.”

Little by little, we need to change. We need a shift in thinking in regulatory and legislative terms,  to get us slowly but steadily to where we need to be.

One good recent development, of course, is 
the Clinical Trials Regulation, which seeks to turn outmoded trial models into those fit-for-purpose in today’s fast-moving health environment.

It was designed to significantly reduce red tape and simplify the bench-to-bedside’ process in many cases of innovative drugs and treatments, (although this usually applies when the medical product in question is perceived to carry less risk). 

This is all to the good and, across the field, regulations will be a key focus at EAPM’s Belfast Congress in November as will a focus on innovation, the importance of research, risk-based evaluations, stakeholder participation and the ongoing education of healthcare professionals in fast-moving fields.

The event will be held in partnership with Queens University Belfast and Visit Belfast, and is entitled ‘Personalising Your Health: A Global Imperative!’ and will take place from 27-30 November.

Bird Registration for the Congress has been extended to 22 September, allowing attendees to save up to 20% on registration fees. (A link is available at the end of this article.) Meanwhile, the majority of the speakers are now confirmed and the Alliance has, to date, received more than 200 abstracts.

The Congress will be the ‘go-to place’ for thought leaders in the field of personalised medicine and 

sessions will be highly interactive as EAPM wants to see as much participation as possible from the floor during the event.

The cutting-edge event, to be held at the Belfast Waterfront venue, will provide the biggest space to date to allow for such a meeting of minds and expertise. EAPM is essentially building a one-stop-shop for top-level discussion and the formulation of real action plans.

Belfast will see multi-stakeholders from the brave new worlds of genetics, imaging, novel IVDs and more. The plan is to build a better healthcare future for all Europeans through, among other things, shared decision making and cooperation.

A key aim is also
 to allow for cross-fertilisation between the different disease and policy areas, allow delegates to gain a greater depth of knowledge into barriers in the field of personalised medicine, and offer up valuable evidence and stakeholder opinion on which policy makers can base their decision making on how better to integrate personalised medicine into the EU’s healthcare services.

While personalised medicine is moving forward and having a profound effect in areas such as cancer, the full integration of personalised medicine into healthcare systems remains more of a dream than a reality.

Dreams are all very well, but we need realistic hopes for patients, parents, and their families (including their children and grandchildren) who are currently not receiving the best treatments and medicines available. 

This situation is to a large extent because we operate in a EU healthcare arena that is fragmented, underfunded and lacking in the necessary cooperation. Our aim and that of our stakeholders is to build one that is up-to-the-minute, sustainable and fit-for-purpose.

‘Smart’ regulation has a major role to play.

To view the Congress website, please see the following the link: www.eapmbelfast2017.com

To Register, please see the following link: https://confpartners.eventsair.com/eapm/registration2017/Site/Register

Author: Denis Horgan
» Back to articles