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The European Digital Health Area - a joint private-public task (Guest blog)

In the innovative centres of science and research, the European Data Space has long been a reality. This is the conclusion drawn at an international conference in the associated program of the German EU Council Presidency. The organisation of the European research clusters "ScanBalt" has gathered more than 30 promising examples of digital solutions for dealing with the COVID 19 crisis from 15 different European regions. The main lesson to be learned from the COVID-19 crisis is that joint projects need a framework that combines their flexibility with the necessary legal certainty and makes them usable throughout Europe.

Cooperation with private companies
Many initiatives to tackle the COVID 19 pandemic are based on collaboration between public research and private companies. I would like to mention just three:
  • The training and organisation of the staff of the Hannover COVID-19 emergency clinic was carried out using digital tools from a private Norwegian company.
  • The "Supercomputing Project" of the University Hospital of Barcelona is bringing together data from COVID-19 patients from private and public hospitals for research purposes (and has identified a considerable backlog of work on uniform data standards).
  • In the Italian research region of Milan - which was particularly hard hit by the first corona wave - the existing biobank cooperation between the university hospital, research institutions and private pharmaceutical companies such as Novartis were also used for basic COVID-19 research within a short time.
Declaration of the European Research Clusters
The European research clusters have pooled their experience and adopted a declaration at the ScanBalt Forum 2020: "Towards a European Common Dataspace in Health in the Time of COVID-19 and beyond". It describes deficits in the European Data Space and proposes concrete solutions. The declaration brings together countries with innovative digital health systems as well as regions where Corona has greatly accelerated digital care approaches: The declaration was signed by regions from 16 European countries, including France, Great Britain, Poland, Sweden and Germany. As the "voice of European civil society" they support the digitisation initiative of the German EU Council Presidency. Their conclusions and recommendations coincide at key points with the positions of industry associations such as the European Federation of Pharmaceutical Industries and Associations (EFPIA). This underlines once again that functioning data projects are created where academic and industrial know-how come together and jointly contribute to solutions.

Free movement of persons and data protection
The emphasis on data protection and data sovereignty of the population is crucial for academia and industry alike. A free European Data Space will only work if all citizens have access to their complete electronic health record and remain in control of it in accordance with the EU basic data protection regulation. They must be free to choose to whom they disclose their data for medical treatment, preventive services, research and product development or for any other purpose they deem appropriate. A prerequisite is that potential partners in health care and research are reliably authorised and are subject to constant review. European supervisory authorities have a key role in a digital health space.

Successful standards with the industry
Data standardisation will only be successful if it is developed together with industry. Therefore, the European Federation of Pharmaceutical Industries and Associations (EFPIA), which offers the expertise of its members, sees itself as a partner in the European data ecosystem. The first priority is to create a uniform legal framework that clearly regulates the handling of patient and research data for all parties involved. European citizens must be able to rely on their data being secure and used with a positive intention. The three guiding principles outlined in the Strategic Research and Innovation Agenda of the European Open Science Cloud (EOSC) can guide action:
  • Data "as open as possible and as closed as necessary”
  • Compliance with the FAIR principles (Findable, Accessible, Interoperable, and Re-usable)
  • Incentives for open data exchange and improved data management.
Incentives, codes of conduct and risk-based supervision
A mix of financial and non-financial incentives for institutional data holders is conceivable (reciprocity in access to data offers, recognition of data providers in publications or IP-based incentives). The examples of the ScanBalt conference have shown that clarity about the concrete use of data - and its risks and opportunities for all stakeholders - is a basic prerequisite for the necessary trust in industrial and public partners.

EFPIA is committed to working with the European Commission and other relevant institutions to develop codes of conduct for the handling of patient data. This will harmonise the rules applicable in Europe and reduce the complexity of cross-border projects. The German EU Council Presidency is also pursuing this approach with the creation of a uniform "Code of Conducts", an initiative supported by the pharmaceutical industry.

Healthcare decisions can be critical. Their supervision requires strict ethics and governance rules. We therefore suggest that a risk-based policy with supervision that is proportionate to the intended use and guided by defined risk categories should be developed.

European Health Data Institute
The ScanBalt conference has shown that developments initially take place in specific regions or in specific disease environments such as COVID-19 research. In order to make these results as beneficial as possible for Europe as a whole, a structured exchange of knowledge is needed and pilot projects should be rapidly expanded. The ScanBalt Declaration proposes a two-year EU progress report, listing examples of best practice and supporting their further introduction and implementation.

EFPIA envisages that the sender of these measures should be a European Health Data Institute, which will define data quality and interoperability standards; initiate educational programmes to equip data consumers and data producers with the necessary skills to build a sustainable ecosystem for the use of health data. The full scope, role and activities of the proposed Institute should be defined in dialogue with all stakeholders in Brussels and in the EU Member States.

Outlook
Only a single European Health Data Space will secure our health care and Europe as a location for innovation in the long run. For a research-based pharmaceutical company such as Novartis, digitisation is a prerequisite for making medical innovations available to patients more quickly and in a more targeted manner. On average, it takes ten to twelve years for a potential active substance to pass through all clinical trials and reach the market.

Approximately only one in ten investigated substances receives approval and makes it to the market. Data uses such as artificial intelligence (AI) are early warning systems for us to identify potential dead ends earlier. This helps us to limit exploding research and development costs and to find therapies faster for diseases for which there are limited or no treatment options today.

English version of an article first published in the German OBSERVER GESUNDHEIT https://observer-gesundheit.de/der-digitale-europaeische-gesundheitsraum-eine-privat-oeffentliche-gemeinschaftsaufgabe/ (11.11.2020)

Knut Mager (Novartis)

Knut Mager is Novartis’ Head Global Data Privacy and Group Data Protection Officer.   Knut contributes actively...
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