More than 2 years after the adoption of the ME/CFS resolution, the European Commission has finally taken an initiative to support research on ME/CFS. The Horizon Europe work program 2023-2024 includes a call on “tackling high-burden for patients, under-researched medical conditions.” This call gives ME/CFS researchers improved opportunities to compete for a big European grant but no funding on ME/CFS has been ensured yet. This article provides an overview of what has been decided by the Commission and which steps still need to be taken to get tangible results for ME/CFS patients.
Last week, we published a press release highlighting an important call in the new Horizon Europe work program. This call was inspired by the ME/CFS resolution and aims to support illnesses such as ME/CFS that have a high disease burden but have thus far been under-researched. Our press release focused on highlighting this important step forward and thanking the many patients and allies whose advocacy has made this possible. In the current article, we aim to provide more detail about the call, what it means, and how things could proceed from here.
What exactly has been decided?
The new work program 2023-2024 of Horizon Europe has been published and it includes a call that provides good funding opportunities for ME/CFS researchers.
Horizon Europe is the large 7-year research and innovation program of the European Union. It has an enormous budget of 95 billion euros and aims to fund research on topics as diverse as climate change, economic recovery, and digital innovation. The implementation of Horizon Europe is organized into several pillars and clusters. The one that interests us is the cluster Health which falls under pillar II.
Every two years, the European Commission publishes a work program that contains calls that describe the type of health research it aims to fund. Researchers can submit proposals for such a call which are then peer-reviewed. Only the best and most relevant research projects are funded.
We have previously reported about the 2021-2022 work program for the cluster Health. Unfortunately, it provided relatively few good funding opportunities for ME/CFS research. Most of the calls focus on broad health topics where ME/CFS researchers need to compete with research fields that have a bigger infrastructure, larger patient samples, and more funding behind them. ME/CFS research is also still in a pioneering stage where clues into the underlying pathology need to be discovered and studies have a higher chance of getting null results. This makes it difficult for researchers to remain in this research field.
The new work program 2023-2024, however, contains a call that focuses on high-burden under-researched medical conditions such as ME/CFS. It gives ME/CFS researchers improved opportunities to compete for a big European grant.
What is the call about?
This call, however, is not a call for research on ME/CFS. It focuses on a wide range of medical conditions that “fail to be recognised and/or be correctly diagnosed in a significant proportion of patients. As a consequence they are inadequately treated and often can become a chronic burden for the patient. These medical conditions may be insufficiently researched even though they manifest with high prevalence.” In a footnote, “chronic fatigue syndrome” is mentioned as an example but so is Lyme disease, and back pain.
Whatever happened with the scoping study?
The call will open on 30 March 2023, and we expect that its scope will be further refined in the future. A footnote explains that the European Commission has contracted a scoping study to help “identify under-researched high-burden medical conditions and define the type of research and/or research priorities to better address the different needs of patients with these conditions.”
This is the long-awaited scoping study on which we have reported several times. It was conducted by independent researchers at NIVEL, the Institute for Health Services Research in the Netherlands. EMEC was able to provide feedback to this study as were our colleagues at the World ME Alliance.
We stressed that the definition of high-burden, under-researched diseases should be strict and specific enough so that it focuses on the illnesses that have historically been most overlooked. We also argued that it should focus on diseases whose pathology is poorly understood and which have few treatment options. As an example, we referred to a 2020 call by the German Ministry of Education and Research (BMBF). This call encouraged research on unknown pathological mechanisms of illnesses with a high disease burden and insufficient treatment options. The results of the scoping study have not yet been published, so it is unclear how much the authors took our feedback into consideration.
How much money will be spent?
The call has a total budget of €25 million. It aims to fund 4 projects that will receive 6 to 7 million euros each. For comparison, DecodeME was awarded 3.2 million pounds, the PACE trial approximately 5 million pounds while in the US, NIH funding for 3 collaborative research centers and a data center combined is around 7 million dollars per year. If ME/CFS researchers could successfully submit a project, this call can give a significant boost to research on ME/CFS in Europe.
The funding amount, however, will likely be split among multiple collaborators. An application requires researchers from minimally 3 different EU countries and many European grants include even larger consortia. Researchers from the UK and the US can join in to become partners and receive funding under this call.
How much funding will go to ME/CFS research?
No European funding on ME/CFS has been secured yet, unfortunately. European grants usually do not focus on individual diseases but on broad health topics. Therefore, it was not possible to get ring-fenced funding for ME/CFS as was the case in Canada and Australia.
European calls for health research have a wide-ranging scope that is often related to improving infrastructure such as digitalizing health records or preparing for future pandemics. Even for big disease groups such as cardiovascular diseases and neurology, it often requires some creativity to find a call that is relevant enough to submit a proposal. That is why we think the new call on “tackling high-burden for patients, under-researched medical conditions” is an importantstep that will significantly increase the chances of ME/CFS researchers to obtain a big European grant.
How much European funding ME/CFS research receives will depend on the number and quality of proposals that are submitted. As the call focuses not only on ME/CFS but on various high-burden, under-researched diseases, there will likely be fierce competition amongst these groups. ME/CFS researchers will have to collaborate and submit high-quality proposals otherwise it could be that all the funds go to other types of research. One upside is, however, that research on other, high-burden under-researched diseases such as fibromyalgia, postural orthostatic intolerance syndrome (POTS), irritable bowel syndrome, and chronic Lyme disease might also be relevant for ME/CFS, as there are many overlapping symptoms.
Are there other interesting calls in the work program?
Yes. Remarkably, there is another call in the Horizon Europe work program 2022-2023 that provides good funding opportunities for ME/CFS researchers. This call focuses on the relationship between infections and non-communicable diseases. The description writes that “increasing evidence suggests that several infections might influence the development of many non-communicable diseases (e.g. multiple sclerosis, Alzheimer, post-covid-19 condition)…” Submissions for this call are expected to elucidate causative links between infections and non-communicable diseases onsets.
Given that many ME/CFS patients report that their illness started with an infection, this call might provide funding for longitudinal studies to test why the incidence of ME/CFS is increased after certain types of infection. The Dubbo study and prospective studies on Epstein-Barr Virus have previously found that this is the case but larger sample sizes are needed to identify risk factors for developing ME/CFS.
This call has a budget of 30 million. It aims to fund 4 projects that will receive 6 to 7 million euros each. The planned opening date is 12 January 2023, which is much sooner than the above call on high-burden and under-researched illnesses. We hope that ME/CFS researchers will also submit competitive proposals for this call, possibly in collaboration with Long Covid researchers.
What are the next steps?
We are advocating for the call on “tackling high-burden for patients, under-researched medical conditions” to be repeated in future versions of the Horizon Europe work program. That way it would be a structural measure to address the lack of funding of research on these conditions. In the long run, this approach could be more valuable than a one-time investment in ME/CFS research that receives no follow-up.
Horizon Europe work programs, for example, have a recurrent call for research on rare diseases because market mechanisms often fail to provide necessary incentives for researchers to study these conditions. We argue that something similar is true for stigmatized, poorly understood illnesses with a high disease burden of which ME/CFS is a prime example.
What else could be done?
The European Union is not directly comparable to the Federal government in the United States. The Cluster Health of Horizon Europe, for example, has a budget of approximately 6.9 billion euros for a 7-year period while the NIH has a yearly budget of 45 billion dollars. Most of the funds for health research and medical care in Europe are located at the level of the Members States.
The European resolution explicitly calls on the Member States to ensure due recognition of ME/CFS, to gather data on disease prevalence, and follow best practices for diagnosis and treatment of ME/CFS. Thus far only Germany has taken measures in response to the European resolution, but we hope that other countries will follow.
The ME/CFS resolution ensures that ME/CFS patient organizations across Europe do not stand alone in their advocacy work. They can point out that the European Parliament recommended taking action and fund research on this disabling disease.
EMEC will continue to support ME/CFS researchers and make sure they have fair funding opportunities in the EU. We hope that this will lead to ME/CFS research on a larger scale so that effective treatments can be found.