The medical technology sector in Europe is innovation-hungry. Still, it faces the complexity of navigating the intersection between data governance, privacy, and innovation – interview with Annabel Seebohm, Secretary General of the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR).
What is the condition of medical innovations made in Europe?
Europe has a long tradition in medical innovation and remains an established leader, especially in the field of medical technology. This is demonstrated, for example, by the high number of patent applications from this sector. In 2021 and 2022, the largest share of patent applications in medical technology was filed by member states of the European Patent Organisation. This is important since medical and digital health technologies enable better outcomes and better-quality healthcare provision across the continuum of care, from screening, early detection, and precision diagnosis through personalized treatment to outpatient care, monitoring, and rehabilitation.
However, the latest European innovation scoreboard also highlights that the EU is dependent on third countries for the supply of certain strategic and critical inputs, products, and technologies in numerous areas, including those in health. In addition, there is growing competition internationally.
Given that a flourishing and competitive medical technology sector is key to ensuring continued access to essential medical and digital health products, it is therefore critical that Europe stays at the forefront of medical innovation. This requires concerted efforts, including investments in research and innovation, ensuring a favorable policy landscape, and building a healthy and resilient innovation ecosystem where different stakeholders in healthcare come together.
Could you please sketch a big picture of how legislative changes in the EU in the last two decades helped and how they hampered the competitiveness of the medical technology sector?
The implementation of the latest revised medical device legislation had a direct impact on the industry's budgets. Medical device manufacturers have invested considerable resources to comply with new obligations and responsibilities and to adapt their conformity assessment processes. Manufacturers face a significant administrative burden due to the variety of different requirements they are expected to comply with at the national and international levels.
In addition, the sector must navigate the complex landscape of applicable horizontal laws resulting from the digital transformation and the green transition (such as GDPR, AI, and many others). This may result in conflicts or add on to medical device-specific provisions, leading to an environment of unpredictability, volatility, uncertainty, complexity, and ambiguity. These dynamics contribute to administrative inefficiencies and increased costs for developers and manufacturers in Europe. Consequently, many companies re-evaluate the European Union as their primary choice for releasing their products.
In the recently released position paper, COCIR calls for "keeping the European Union attractive to innovation." What is needed to make it happen?
A thriving R&I environment is essential for future-proofing healthcare, timely patient access to cutting-edge innovation, and economic growth and competitiveness. Keeping the EU attractive to innovation requires a comprehensive industrial strategy encompassing favorable legal, regulatory, and trade policy conditions and funding opportunities throughout the innovation cycle.
This can be ensured through a dedicated and integrated roadmap for funding the resilience, sustainability, and innovation of healthcare systems in the next EU Multiannual Financial Framework (MFF) and by enhancing the EU Recovery and Resilience Facility (RRF) and the EU Structural and Cohesion Funds to address health inequalities across Europe.
Another key instrument is the increased and more balanced involvement of the private sector in the next framework programme, for example, through the maintenance and expansion of public-private partnerships (such as the Innovative Health Initiative, IHI). Projects supported by this partnership are essential for bringing together a diversity of healthcare stakeholders and building a robust innovation ecosystem, as demonstrated by the initial achievements and impact of these projects to date.
How much is the hype around AI relevant to the industry in Europe?
COCIR has been raising awareness of the applications of AI in healthcare since 2019. We view it as an essential companion tool for physicians, enabling them to improve patient outcomes. As part of our awareness activities, we have also created a library of AI use cases. AI is now a key component of imaging and radiotherapy solutions on the market and has taken center stage in many events, such as the European Congress of Radiology and the recent DMEA in Berlin.
Europe recognizes AI as a transformative force with the potential to drive innovation, enhance productivity, and address societal challenges – in many sectors, including healthcare. The EU digital strategy, along with initiatives like the AI Act, underscores the importance of responsible AI development and deployment, positioning Europe as a global leader in ethical AI. AI in Europe seems instrumental in shaping the continent's future.
When the EU AI Act was voted in the EU Parliament, some said that "Europe is again regulating when the US is innovating," while some praised the new legislative framework for setting clear rules. What's your opinion?
The Act aims to strike a balance between fostering innovation and safeguarding fundamental rights, such as privacy and non-discrimination. By establishing rules and standards for AI systems, the Act seeks to enhance trust and confidence in AI technologies among consumers, businesses, and policymakers.
However, the Act's ultimate impact on innovation and competitiveness will depend on its implementation and enforcement. Therefore, ongoing dialogue and collaboration between policymakers, industry stakeholders, and civil society will be crucial to ensure that the regulatory framework is adaptive, proportionate, and conducive to innovation.
Investments in AI-based technologies in the US and China are multiple times higher than in Europe. Are you worried that Europe will be marginalized if the gap is not bridged soon?
We believe the EU can remain competitive if it keeps digital innovation as one of the focus areas in its funding programmes.
The significant gap in AI investments between Europe – when compared to the US and China – is of concern. While Europe boasts a strong industrial base, world-class research institutions, and a skilled workforce, it lags behind its global counterparts in AI investments and commercialization. This investment disparity not only threatens Europe's competitiveness but also undermines its ability to harness the full potential of AI technologies for economic growth and societal benefit.
To bridge this gap, Europe must adopt a multi-faceted approach that includes targeted investment incentives, regulatory reforms to foster innovation and entrepreneurship, and strategic partnerships between the public and private sectors. By leveraging its strengths in research, talent, and diversity, Europe can position itself as a global leader in responsible AI innovation while addressing societal challenges and promoting sustainable growth.
Another EU legislative initiative aims to boost the development of AI-driven and data-based innovations: the European Health Data Space (EHDS). In December 2023, COCIR called for legislative refinement of the EHDS and, in February 2024, issued recommendations on it. Is the new deal on EHDS what you were expecting?
We welcome the deal and will continue to advocate for an implementation that avoids fragmentation and ensures consistency in the conditions for data use and data access practices across Member States.
The EHDS has emerged as a cornerstone of Europe's digital health strategy, aiming to unlock the full potential of health data for research, innovation, and improved healthcare delivery. However, concerns raised by stakeholders, such as COCIR, regarding legislative refinement and protection of intellectual property rights highlight the complexity of navigating the intersection between data governance, privacy, and innovation.
Addressing these concerns will be essential to ensure that the EHDS legislation strikes the right balance between facilitating data sharing for research and innovation purposes while safeguarding individuals' rights and incentivizing investment in health technologies. Moreover, ensuring interoperability, scalability, and security of health data infrastructure will be critical to realizing the EHDS's full potential and driving Europe's competitiveness in the global healthcare market.
EU Data Act, EU AI Act, and EHDS are three flagship legislative initiatives. What should be the next one?
We need time to implement before proposing new legislation. It is time to focus on regulatory clarity, coherence, and clear guidelines.
With a clear EU roadmap for the digitalization of healthcare, Europe can create a conducive environment for sustainable innovation while upholding the highest standards.
What is unique about the medical industry in Europe that makes you optimistic about the future?
Our industry is unique because it develops and delivers products and services essential to a healthy population while also requiring a highly skilled workforce and advanced expertise.
Our industry sectors are investing in research and innovation and are committed to remain a trusted partner to EU policymakers.
