Status, points of attention and insights
The nexus between biomedical research, data and digital opportunities has become a critical and crucial driving force in fostering innovation and competitiveness in the life science sector. To that end, human materials and, associated clinical and research data, are becoming increasingly important as a basis for fundamental, basic and translational research as well as innovation to enhance the competitive space of startups, scale-ups and incumbents in the life science industry.
A rich variety of extensive data collections, originating from across different geographies and trial conditions, add scientific power to clinical studies and treatment investigations by better capturing patient heterogeneity. Currently, the use of human materials and associated clinical and research data can be further optimized by overcoming the fragmented conditions for accessing samples and data across Europe.
The European Health Data Space (EHDS) attempts to harmonize those fragmented conditions and to ensure maximal access of data related to human materials and clinical investigations for scientific research. EHDS therefore has the potential to create value for innovation and subsequent competitive performance. To that end, well-organized access via secured processing environments enables data security and privacy while respecting both patient and ownership rights. It provides an opportunity to turn health data into strategic assets in an era where the success of AI for health will be determined by how robust and comprehensive the data to train it is. Assets and benefits are judged to be multiple, for patients, for hospitals, for research and its translation into market-relevant innovations through business ventures (newly created and incumbent).
At the same time, for health data to be translated into meaningful and sustainable innovations, intellectual property regimes are essential. While data should be easily available for research, patent protection of inventions generated from research with human data (as an input) is essential to guarantee exclusivity for industry or investors to invest in the long and capital-intensive development of novel therapies, treatments, diagnostics, …
EHDS does not overrule IP rights. Access to data under the EHDS framework does not affect the allocation of intellectual property rights on the results of the underlying research. Patient data are owned by the patient, while care and research institutions, biobanks, etc. are the guardians of the data. The role of EHDS is to regulate data access and reuse conditions, but intellectual property in resulting research outputs is determined independently under existing legal frameworks by the relevant and involved institutional actors. Ownership is determined by general IP law (patent law), inventorship rules, copyright law, database regulation, know-how protection, employment law and contracts, and hence not by EHDS, considering inventorship basics:
- Contributes to the conception (“devising”) of the invention, and makes a technical contribution reflected in at least one claim, when focusing on patent applications. The differences between US and Europe should be considered, whereby inventorship in Europe is defined by national law which leads to potentially different interpretations.
- Mere execution, routine experimentation, supervision, funding, or administrative involvement does not confer inventorship. While adding the nuance that research may lead to ownership residing with, e.g., the institution even if the invention was conceived by the researcher or employee.
- Providing access to human data is not an inventive contribution.
- Tangible contributions based on clinical-basic collaborations are a basis for co-inventorship (e.g. unique investigator-driven trials, ‘devising’ the research path to actionable insights...).
Timing of the obligation to make data available should hence be aligned with the relevant processes for scientific publication, regulatory strategy (for regulatory clinical trials) and patenting. Peer review ensures data quality and robustness of the conclusions drawn from these data. Peer reviewed publications on “omics data” often summarize 2-5 years of research. Time for seeking patent protection, which guarantees incentives for industry to innovate, should be provided. Data on clinical trials in a regulatory context (e.g. product approvals) can only be made available at publication of clinical trial results, given legitimate concerns around the disruption of regulatory process, the need for additional patenting, as well as securing exclusivity and securing competitive dynamics. It is obvious that enforcement of publication on companies developing novel agents would cause real economic damage. It would cause companies to avoid Europe as a center stage for health innovation. Publications, patenting, communication, fund-raising, etc. are dimensions of a highly orchestrated process for any biotech or pharma actor. Hence, companies should be able to reasonably postpone accessibility until publication. Also, data on failed clinical trials should be made accessible to create both a research and innovation flywheel.
