6th April 2023
By Jean-Marc Bourez, CEO, EIT Health
As we observe World Health Day, which is this year focused on #HealthForAll, we call upon all actors to join us in shaping and accelerating the future of innovation.
In the aftermath of the pandemic, relevant actors have begun to awaken to the reality that healthcare represents a crucial area of investment, rather than a burdensome cost.
We are seeing a fast pace of transformation across Europe as member states look to modernise their approaches, keeping pace with the technological developments and societal demands that have emerged as a result of Covid-19.
Looking forward, we have coordinated our programmes and activities to meet four main challenges facing Europe in alignment with the New European Innovation Agenda, which looks to cement Europe as a leader in deep tech innovation.
Correspondingly, our four flagship initiatives are focused on increasing access to digital medical devices (DMDs), harnessing the full potential of healthcare data through effective implementation of the European Health Data Space, deploying a value-based conception of healthcare, and addressing market failures by championing the Important Project of Common European Interest in Health (IPCEI).
From these, two of the main opportunities that we must embrace lie in health data sharing and the development of a single, harmonised European path to reimbursement for digital medical devices (DMDs).
There are obstacles as well as enabling factors behind the advancement and adoption of these concepts. By fostering cross border and multi-disciplinary collaboration and uniting minds through our four flagship initiatives, we can tackle these pressing health challenges and deliver quality healthcare for all – today and well into the future.
The power of the Knowledge Triangle
History tells us that knowledge spurs progress. This is no exception in the context of healthcare.
Crucially, nurturing pathways between actors to encourage co-operation, collaboration and knowledge-sharing is paramount to plugging the gaps in the present market and developing a robust and resilient system.
To do this, we need to facilitate collaboration and communication across sectors to break down siloes and foster innovation that will further democratise and modernise our healthcare systems.
Our work is guided by the fundamental principle that when we break down the barriers between disciplines and champion collaboration, everyone reaps the rewards.
Rather than normalising the disconnect between the spheres of business, research, and education, we recognise the importance of joining up the dots and encouraging synergy between them through what we call the ‘Knowledge Triangle’.
Working with Partners across Europe representing the full value chain within healthcare from academia, hospital networks to corporates and research organisations, we are able to embrace the innovation pathway in its entirety and leverage our resources and those of our Partners to make the biggest impact.
Providing knowledge to encourage data sharing
Just as sharing knowledge and insight lends itself to better outcomes, sharing health data is invaluable for laying the groundwork for life-changing innovation.
While the merits of sharing health data are well recognised and understood, some actors may be hesitant to fully subscribe to the notion of a common health data space.
To address this, we are joining forces with the European Commission’s DG Sante to support the implementation of the European Health Data Space (EHDS), the European Union’s framework for the sharing of health data.
Led by EIT Health’s Think Tank, subject matter experts from across the Knowledge Triangle will come together to consider how best to fully embrace and implement all that the EHDS offers across differing members states whose infrastructure and systemic environments vary so widely.
Breaking down regulatory and reimbursement boundaries between countries
Fragmentation and variance between differing regulatory and reimbursement pathways from country to country holds entrepreneurs back from bringing their digital medical devices (DMDs) such as diagnostic tools, digital health solutions and digital therapeutics, to the market.
To promote widespread access to DMDs capable of addressing unmet patient needs, it is crucial that actors across the Knowledge Triangle work together to breaking down barriers between member states and smooth the path to market access.
As it stands, start-ups face a complex, time and cost-intensive route to market access in the EU. Innovators and tech providers developing DMDs must demonstrate the medical, clinical value and safety of their solution to first obtain a CE mark and then enter the reimbursement pathway to gain complete market access. Once a CE mark has been secured, innovators enter a country-specific process to secure reimbursement.
To ease the time and resource burden associated with this process, we actively champions digital solutions and helps start-ups navigate tricky regulatory landscapes. In fact, 10% of the devices on the official German Digital Health Applications (DiGAS) registrar were developed with support from EIT Health , emphasising the importance of supporting aspiring entrepreneurs.
We are leveraging our pan-European presence and regional footprint to contribute to the creation of an ecosystem conducive to digital innovation and the uptake of DMDs. Specifically, we have been appointed to assemble and coordinate a pan-European taskforce to draft common rules and guidelines to develop clinical protocol design to ease the burden of clinical trials for DMD start-ups navigating the European market.
By championing cross-border collaboration and moving towards a digital single market across Europe, we can rectify the differences between reimbursement paths from country to country. Notably, for the first time in European history, we have been able to set up the first single market for reimbursement of DMDs by helping two member states (Germany and France) align themselves to apply the same mechanisms. This milestone exemplifies the importance of fostering collaboration and embracing data sharing to invest in the future of healthcare and innovation in Europe.
While there is still work left to unite actors on all sides of the Knowledge Triangle for positive transformation in healthcare, the progress we have made with our Partners across Europe to date clearly demonstrates what is achievable.
By anchoring our four key flagship areas in the domains that are presenting the biggest challenges to European healthcare, we can mobilise our vast network across the Knowledge Triangle.
In doing so, we strive to accelerate the uptake of DMDs and encourage actors to harness the full potential of health data to make way for new ways of delivering healthcare capable of driving our system forward.
The future for a resilient, sustainable, digitalised, data driven provision of healthcare can be more fully realised if we choose to break down the boundaries between sectors, actors, and states to equip ourselves with the needed tools that will encourage life-changing innovation.
As a neutral, pan-European body straddling the worlds of business, policy, technology, science and healthcare, we have the privileged position of inspiring an ecosystem of Partners of excellence across Europe to prepare us to rise to the opportunities today to meet the health challenges of tomorrow.
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