Welcome to the new Science|Business blog about “future-proofing medicines,” which will follow the EU’s new pharmaceutical strategy, related legislative revisions and the European Health Data Space, among others. Our blog is part of a major Science|Business initiative to inform Europe’s rethinking of its medicines regulatory framework, bringing together experts in a series of workshops to debate how to best develop and assess Europe’s next generation of medicines and health technologies.
The series will kick off in Copenhagen on 27 June with a high-level roundtable on how to harness the power of data. Follow along with us for the latest from Denmark and other countries throughout the next year.
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On 29 September 2022 in Berlin (14:15 – 15:45 CEST), Science|Business, with the active support of EIT Health, will stage its second national workshop in a series about “future-proofing” Europe’s framework for regulating medicines and therapeutics. The high-level public debate – to be staged in German as part of the KassenGipfel Congress and livestreamed on the Science|Business website – will explore a number of strategic questions through the lens of Germany’s approach to developing and assessing new drugs and devices:
- Can Germany’s current system meet its future health needs?
- What lessons have been learned from the response to COVID-19 that could inspire a more agile, dynamic process?
- Will a new regulatory framework be capable of driving innovation and supporting industrial competitiveness?
- What are the keys to success in harmonising the German health data landscape?
Experts from the German healthcare system – including BfArM president Karl Broich, EIT Health supervisory board chair Freimut Schliess, and TU Berlin president Geraldine Rauch – will provide insights on what lies ahead, along with recommendations for future policy priorities and opportunities. See here what they have to say.
What’s next for the Science|Business Future-Proofing Medicines initiative? The discussions will continue in Berlin on 29 Sept, as part of the Kassengipfel health insurance summit. This second national roundtable in Germany will explore how to accommodate breakthroughs in medical science and digital technologies in future regulatory frameworks.
To facilitate greater health data-sharing in the EU, Denmark’s trust-building process and designs could be exported to other EU member states, suggested Science|Business moderator Simon Pickard in wrapping up the first national roundtable of the Future-Proofing Medicines initiative on 27 June 2022.
Participants had earlier cautioned against the EU “reinventing the wheel” that Denmark has well established, noting the need for flexibility and compatibility with the country’s existing health data system. “When you’ve spent over 20 or 30 years building a system that works, the last thing you want to have to do is adapt to a European standard that erodes those foundations,” Pickard noted.
As an influencer on the EU Data Quality Framework Initiative, Denmark can help drive data quality standards. In particular, it can help determine what is acceptable to regulators in terms of real-world data and evidence, and how to harmonise those standards globally. Ultimately, Denmark aims to shape “the learning healthcare system where data comes back as knowledge,” one participant said.
A key challenge is ensuring that all types of data from patient registries, biobanks, pharmaceutical companies, etc. have the same quality. Another is to define how to get new medicines into the hands of patients in a cost-effective way, and the methodology for conducting clinical trials with medical technology inputs need to be ironed out. Ensuring there are enough educated staff to unlock data is also critical.
One roundtable participant suggested conducting pharmaceutical trials in Danish hospitals, while another called for pharmaceutical companies to collaborate on open innovation (within the relevant legal boundaries).
Denmark’s acclaimed health data strategy and network was dissected during the first national roundtable of the Future-Proofing Medicines initiative. It is the only EU member state with a life science strategy. It has a clear political vision for the future of health built on a “double helix” of excellence in research, as well as data science and analytics. The successful combination of these two factors will pave the way for personalised medicine, the roundtable heard.
In the short-term, Denmark aims to create a one-stop shop for data, centralising its extensive network of data repositories, to support its entire research community. This ambition is aligned with that of the European Health Data Space – with the caveat that Denmark’s data remains at home. International researchers would be granted permission to access Danish data in a patient-protected way.
As they regard education and training in data management and usage as critical, Danish policymakers have implemented various higher education programs in data science. The first graduates are now entering the labour market. Retaining this talent will depend on the speed of health innovation in Europe versus other continents, roundtable participants noted.
Equally, retaining high levels of trust among citizens is a cornerstone of Denmark’s model health ecosystem. While this trust cannot be exported to other EU member states, the trust-building process can be, including transparency, demonstration of the public benefits of data-sharing and spirit of collaboration.
Trust matters most when it comes to data sharing to support scientific research and national health policy goals, noted participants in the first national roundtable of the Future-Proofing Medicines initiative. And that trust has to be earned every day. While big and real-world data and artificial intelligence are becoming critical to develop, approve and use medicines, the roundtable observed that the data employed must be continuously monitored as part of a societal contract.
Already notable for the high levels of trust that citizens have in it and the agencies responsible for governing it, the Danish health system recently launched a Data Ethics Charter. But roundtable participants also called for a common interpretation and practical application of the EU General Data Protection Regulation (GDPR), which continues to confuse various stakeholders.
Another challenge lies in integrating all the available data sets (i.e., medical, genomic and molecular) to usher in a new era of personalised medicine. Education could help. Denmark’s investments in data science curricula are making a difference and offer a competitive advantage, proponents claim. For example, the country has formed clusters of excellence in data science. Looking to the future, Denmark is also aiming to teach the importance of data sharing at an early age.
The opening session of the first national roundtable of the Future-Proofing Medicines initiative identified seven critical elements to accelerate Europe’s transition to a data- and evidence-based health ecosystem:
1) End silo thinking among the European Commission, Directorate Generals and parliament committees; 2) facilitate efficient public research spending and spend the money each country has promised; 3) improve access to data and trials; 4) preserve incentives for investments; 5) invest in education and attract talent in health and life and data sciences; 6) encourage flexibility and innovation in regulations, especially medicine trials during times of crisis; and 7) dialogue between researchers, policymakers and patients.
Collaboration is the red thread. In Denmark, for example, the healthcare sector and industry have collaborated for years, including the ministries of health and business affairs.
Participants emphasised that EU member states have much to learn from each other’s competences and can ask each other for inspiration. In addition, the EU should play a more active role globally, they contended.
In summary, the revised EU pharmaceutical legislation must be ambitious to ensure greater access to medicines, sustain industrial competitiveness and encourage more investment in research to keep scientific talent in Europe.
The Danish Medicines Agency, which approves medicines and monitors their safety and effectiveness, is becoming more and more data-driven, according to Jesper Kjær, director of the agency’s Data Analytics Center. “Real-world data plays a really important role in our ability to do a solid evaluation and [to] support our regulatory decision-making,” he told Science|Business, in the first podcast related to the new Future-Proofing Medicines initiative.
This applies to both the reimbursement and repurposing of medicines, allowing products to benefit people beyond those for whom the medicines were originally developed. “This is where the health data we have access to can [help] without having to do expensive clinical trials,” Kjaer noted.
His agency is integrating data extensively into the EU medicine regulatory network to help member states collaborate on using real-world data in regulatory decision-making. The European Health Data Space is going to drive a common language, definitions around good quality and build an infrastructure, Kjaer said. “All of that is going to allow us to work more efficiently with the data. As we come together on the European continent, we’ll also make a big global impact on how we develop these things.”
Learn more about Kjær’s views of the future of medicines in this podcast:
Denmark’s fully digitalised healthcare system may be a window into the future. It has more than 350 national registries, biobanks, a national genome centre and regional warehouses with electronic health record data. That’s why the EU is looking at it as a pilot for the new European Health Data Space.
In the first podcast of the Science|Business Future-Proofing Medicines initiative, Jesper Kjaer, head of the data analytics centre of the Danish Medicines Agency, explains its role in the heart of the Danish Health Information System. He describes how it integrates data with other national agencies and balances data quality with privacy protection.
Moreover, Kjaer outlines Denmark’s interest in international cooperation on health data and how the European Health Data Space can facilitate it, while peering into the crystal ball to explore the future role of real-world evidence, big data and artificial intelligence in developing new medicines.
Tune into this Future-Proofing Medicines podcast on Monday, 27 June.
On 27 June 2022 in Copenhagen, Science|Business will stage its first national workshop in a series about “future-proofing” Europe’s framework for regulating medicines and therapeutics, starting with how best to use health data. It will explore:
- How this data can be harmonised across the EU while ensuring international trust and protecting individual privacy.
- How data quality, access and interoperability can be ensured.
- The roles of big data, real-world evidence and artificial intelligence in developing new drugs and devices
- The staff, skills and resources needed to accelerate patients’ access to novel, effective treatments.
Also in this workshop, Science|Business will consider what other EU countries can learn from Denmark with respect to the digitalisation and usage of health data. It has a large collection of databases and registries covering the entire lifecycle. How can Denmark centralise all of this data? What can the rest of Europe learn from the Danish system?
Experts from the entire healthcare system representing public authorities, hospitals, universities, insurance, academia, investors and more will provide insights and recommendations on both national and EU levels. See here what they have to say.