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This is the modern world: Time for regulation to move with the times

Publication date: 25.11.2016

Almost one year 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”. writes Denis Horgan, Executive Director, European Alliance for Personalised Medicine. 

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”.

The Commission document added: “Disruptive innovation has the potential to reduce costs and complexity whilst simultaneously providing patients with improved access to healthcare resulting in better health and patient empowerment”, and also pointed out 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. When disruptive innovation comes into play, often through start-ups in a business context and new technologies in a broader one (as has been the case in the field of personalised medicine), the old foundations start to rock a little and, in some cases, a lot.

Let’s take a look at the late 2000s in communication and other technologies: From 2006 to 2008, Apple released the first iPhone, Facebook went ‘public’ rather than merely operating in education strongholds, Twitter really started to move, ‘the cloud’ got off the ground, Kindle gave readers broader options, Google showed the world Android and IBM launched ‘Watson’, a cognitive computer which can understand papers on cancer and even offer advice to healthcare professionals.

Meanwhile, Intel found new ways to produce microchip transistors and kept Moore’s Law moving, and the internet passed one billion users.

At around about the same time, new software emerged allowing the storage and analysis of huge amounts of information (a forerunner of the Big Data phenomenon) and the cost of the gene sequencing of a human being went into free fall. Wow! The world changed forever.

The above should theoretically allow EU Member States to develop or strengthen public health communication strategies, increase 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, and I’ve written this on many occasions, 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 innovation. 

We need a ‘changing of the guard’ in regulatory and legislative terms, as the old guard have concerns, worries and, it has to be said, prejudices that lead to caution in the face of radical advancement.

Many are simply bewildered by the new technology as many of our great-grandparents will have been bewildered by air travel. In the same way their children, our grandparents, will have been knocked sideways by first television, then colour television, jetliners, super-fast cars, space programmes and even, in some cases, currency changes (imperial to decimal in the UK, the Irish pound to euros etc).

It’s was all so new, and a little scary. Now, though, it’s all normal and today’s younger generations (and those way older than Millennials) have adapted to recent disruptive technology in the blink of an eye (just show an eight-year-old a TV remote recording scheduler, for example). 

OK, in context, the European Alliance for Personalised Medicine is not suggesting that Millennials be put in charge of the legislative/regulatory agenda but its stakeholders believe that we do need some fresh, up-to-the-moment thinking and resultant changes.

Many of our ‘knowledge leaders' with influence in dozens of fields are simply behind the times and still taking us down the bumpy slow roads when the ‘real’ world has shifted to high-speed, overtaking lanes on technological superhighways.

Too much, or the wrong, legislation can act as a red traffic light to innovation and progress. If legislators had known about the potential of, say, Google, it’s difficult not to think that they would have stamped lots more rules on the internet way before any of its vast potential was even realised. In retrospect, that would have been a disaster for innovation in communication.

It has even been the case that some Asian countries have integrated new technology into their cities that makes these conurbations more advanced than many built and run by their western counterparts. They’ve hit the ground running while we in the west need to go back, knock down old infrastructures and start again.

It is very clear that emerging and fast-developing technologies (such as energy efficient building and genome sequencing) have facilitated human ingenuity and added to vital knowledge dissemination (often to the great benefit of medical research, for example).

EAPM believes that Europe cannot afford to kill off the positive knock-on effects of innovation. And if such innovation is disruptive and leads to those ‘paradigm shifts’, then all the better.

It’s time for regulation in Europe to start keeping up.

Author: Denis Horgan
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