#EAPM: Ground-breaking congress to tackle regulation in personalised medicine era

There is so much exciting innovation in the field, but much of it either fails to see the light of day due to a lack of incentives or struggles to be incorporated into the EU’s health-care systems, sometimes because of regulatory issues that slow down the process

EAPM would like to see incentives for innovation that specifically allow for earlier diagnoses, for example. Currently, these fall well short of the optimal.

This topic will be among many others to be discussed at a ground-breaking four-day personalised medicine congress to be held in Belfast from 27 November.

The event in Northern Ireland’s capital is entitled ‘Personalising Your Health: A Global Imperative!’. This one-stop-shop will feature around 250 speakers drawn from all stakeholder groups, all of whom are experts in their own area of personalised medicine and healthcare.

The event will also feature 200 scientific abstracts alongside the 500-plus delegates in attendance.  This represents the biggest multidisciplinary Congress to date focused solely on personalised medicine in the European Union.

Given the Brexit deadline of May, 2019, it is possible that the event will be the last EU Presidency Congress to be held in the UK.

There are around three weeks to go until the Congress takes place and, for those who have yet to register, here is a link. Also, the programme is available to download, here.

Obviously, one can not regulate for everything that will happen down the line when an area, in this case personalised medicine, is developing so swiftly. The future, to an extent, is behind a curtain. So to attempt to legislate for every possible scenario can be counter-productive.

Yet still we need new frameworks for the here-and-now, as well as for tomorrow and tomorrow and tomorrow…

Technology in the realm of health care is changing quickly and without a framework that allows certainty and patient guarantee of safety, then there will be a blockage in attempts to bring innovation into health care.

Obviously, it doesn’t help from a pan-European perspective that member states have competence under the Treaties for their own health-care systems, meaning the EU regulators can only get involved to a certain extent.

Despite this, they have formulated recent regulations on IVDs, clinical trials and the General Data Protection Regulation (GDPR). And there is more scope for making changes and improvements in an EU health arena that, pre-Brexit, attempts to care for 500 million citizens, many of them ageing.

Many of the changes needed are technological, scientific and clinical. These are often complex and specific areas. But many of the required are closely linked to public policy, and demand a new consciousness among public authorities and politicians.  This will be a focus of the different sessions at the Congress. 

Driving that process depends on the work of a coalition of the willing, a partnership of pioneers committed to exploiting the potential of personalised medicine and health care who will work with one another to achieve a positive and lasting impact on health care.

From legal and regulatory perspectives Europe needs frameworks that can facilitate such a scenario. This is not to encourage over-regulation (more the opposite) but to provide systems and instruments that, for example, support and encourage diagnosis and early treatment. 

EAPM’s annual conferences, and now its Presidency Congress, attempt to build a bridge between stakeholders and the institutions with this in mind.

A conscious decision at a high political level needs to be prioritized to harmonize the multiple strands of activity and responsibility in health. Defining a clear objective would be to mobilize the existing resources, to exploit the emerging possibilities, to incentivize all stakeholders to surmount any traditional barriers that unnecessarily impede their progress, and to link them more effectively in pursuit of a common goal.

This requires that researchers and industry, health officials and regulatory bodies, patient organizations and payers and politicians come together to give substance to a vision built around coherent strategies for prevention, early detection, and treatment. 

Generally speaking, there needs to be a broader trust between stakeholders with an ample governance framework. What this process entails is for platforms for real dialogue to be created, involving all relevant stakeholders working together. This is a key element of the Congress in Belfast.

During the event, the Brussels-based Alliance will provide a platform to bring the heath eco-system together in order to help create and better understand the necessary frameworks and incorporate the essential role of member states, as well as that of the EU institutions.

Remember that under current frameworks the Clinical Trials Regulation took more than ten years to revise and problems arose with the sharing of health data during the drawing-up of the GDPR.

Meanwhile, the revised legislation on IVDs came on the back of the Poly Implant Prothèse scandal in France. The latter was reactionary, as was GDPR which took into account social media and government leaks, but very little in respect of vitally needed data in the health sphere.

Going forward, policymakers and regulators at both EU and national level have a significant role to play in bringing about a Europe in which personalised medicine, in all its forms, can be integrated into national healthcare systems, via the sharing of data, cross-border collaboration in research projects and the exchanging of best practices.

But first Europe’s policymakers and regulators must listen and thoroughly understand all of the issues affecting access to personalised medicine for its citizens, because solutions need to be found, and quickly.  EAPM Presidency Congress provides the space to bring on all stakeholders in a neutral platform. 

To register for the Congress, click here.

To view the Congress programme, click here.