By Paweł Świeboda, CEO of EBRAINS and Director General of the Human Brain Project.
2022 has seen spectacular progress with respect to anchoring brain research and brain health in policy agendas in Europe and internationally. The Lancet Neurology anticipated these developments when it foresaw in its Editorial that “2022 is likely to bring a historic policy change with the potential to impact neurological services worldwide” (1). Not only did those hopes materialise when the WHO’s Action Plan on epilepsy and neurological disorders was adopted unanimously in May, and the European Commission included a powerful plan of action in its “Healthier Together” initiative in June (2); much more has been achieved, as shown by the launching of the European Mental Health Initiative by President of the Commission Ursula von der Leyen in her State of the Union Address in September.
The community has stepped in to support these developments. The European Academy of Neurology published a path-breaking brain health strategy in May, tellingly called “One Brain, One Life, One Approach” (3). The World Health Organisation contributed in August with a landmark position paper on “Optimising brain health across the life course” (4). Scientists have been discussing the “Next decade of digital brain research” agenda that originated in the Human Brain Project and rapidly involved many other communities (5). Finally, the Shared European Brain Research Agenda (6) has been drafted with a powerful list of recommendations. This activity has been importantly supplemented by advocacy efforts, such as the OneNeurology (7) initiative, that have put patients and patient well-being at the forefront. The conceptual underpinning for the centrality of brain health and brain skills was provided by the notion of brain capital (8), also launched in the course of 2022.
Significantly, all these developments are not one-offs, but massively push the needle towards building an ecosystem in Europe that will support much-needed brain health innovation. Several components are of essence in this journey. They start with continued research excellence, sustainability of results, and convergence of research agendas. The EU remains a strong R&D performer in health industries with an almost 20% share of the global investment. As for brain research, there is a strong emphasis at the EU level, with 5.2 billion euro invested in the Horizon 2020 programme between 2014-2020. The Horizon Europe programme puts focus on more impact for patients and synergies with other programmes.
Several challenges are clear. There are more horizontal funding calls and fewer domain-specific ones. This may seem to pose a difficulty at first instance but is also an opportunity, particularly to work in a more interdisciplinary way, producing solutions which are sufficiently generic to be applied in different fields. At the same time, a number of questions are firmly domain-specific and they ought to be treated separately with relevant funding. The second challenge is the need to overcome fragmentation and achieve alignment of research agendas across Europe. This will be addressed in the forthcoming European Partnership on Brain Health. Thirdly, given that most projects are short, sustainability of results needs to be ensured.
Apart from research excellence, the brain health innovation ecosystem needs to be supported by a powerful impulse on the demand side. This is one of the objectives of the Innovation Procurement Platform which aims to reach a common understanding on key clinical, procurement, and organisational priorities among actors on the demand-side of health and social care innovations. A network of public and private procurers will be created to identify potential areas for Innovation Procurement, and mainstream the approach in Europe’s health sector by engaging key stakeholders, especially patients.
As for the links with industry, one cannot overstate the importance of the Innovative Medicines Initiative launched in 2008, now turned into the Innovative Health Initiate: a neutral platform for competing industry players to come together and work with academia. Its focus has been on common problems deemed as pre-competitive. As someone who drove these developments for a number of years, Pierre Meulien pointed out in his farewell reflection (9) as Executive Director that IMI/IHI had supported 182 large-scale projects pursued over 14 years, with a total budget of 4.2 billion euro from public and private sources. Such new ways of working between researchers, clinicians, scientists, and industrialists, as well as regulatory bodies, patients and their advocates, health economists, and payers, are of vital importance.
Advancing scientific and innovation breakthroughs is powerfully supported by European Research Infrastructures. EBRAINS (10) serves as the domain specific infrastructure of reference for neuroscience, brain health, and brain-derived technology. It is now an ESFRI-listed Research Infrastructure with an emerging system of 11 National Nodes and the scientific strategy to support the broad community and pursue state-of-the-art developments, particularly in the area of virtual twin technology. In addition, the European Alliance of Medical Research Infrastructures (11) was launched in 2022 to offer a one-stop-shop for industry and academia.
As for the regulatory framework, the introduction of the Medical Device Regulation led to the harmonization of the way EU Member States handle assessment and approval of medical devices. Strong emphasis has been placed on the protection of rights, including to physical and mental integrity, privacy, and protection of data. However, significant concern has been raised that regulatory requirements are more extensive than those previously applicable in the Member States with less scope for developing and applying devices in-house. In the US, regulatory hurdles have been reduced by the FDA breakthrough device therapies and fast-track designation policies. Since 2015, 126 neurological devices have been accepted in the Breakthrough Device Program. Early feasibility and first-in-human studies would benefit from a European enabling mechanism.
Finally, 2022 has brought the promise of a step-change in accessibility to health data with the launch of the European Health Data Space (EHDS), following the Commission’s publication of draft legislation. The EHDS will be a common European approach for the use and re-use of health data that complements and builds on the General Data Protection Regulation. In terms of secondary use of data, it will help to overcome the replicability and reproducibility crises that stifle progress in research. The effects of the EHDS will be significant: it suffices to say that one request is meant to be sufficient to gain access to all required data sets in 15 mandatory categories of data in the different European countries.
Legislative work on the proposal takes place hand-in-hand with a pilot project to prepare the infrastructural basis for EHDS, led by the French Health Data Hub. While being part of the pilot, EBRAINS will in 2023 present its HealthDataCloud solution to provide a GDPR-compliant, federated research data ecosystem to enable research consortia across Europe and beyond to work with sensitive brain data originating from human subjects, as well as defined routes for sharing of the data and results.
There is no doubt that the centrality of brain health has been increasingly recognised at the level of policy, in Europe and internationally. As The Economist wrote in September “neuroscience is undergoing a renaissance” and the “toolkit for tackling brain dysfunction is expanding rapidly” (12). This makes the prospect of a range of new developments in 2023 a truly exciting one.