The European Parliament’s historic vote on 17th June 2020 urging the Commission to transform the ME research landscape was widely acclaimed as a major step forward. The problem being that a Resolution of the European Parliament is not binding and was always only a request to the Commission to act.
The European Parliament returned to the issue and, on 1st December 2021, when the Committee on Petitions of the European Parliament (PETI) held a second discussion on the Petition 0204/2019 where Ms. van Den Brink (also co-founder of the European ME Coalition (EMEC)) spoke to the MEPs and contrasted the progress made in funding for research in Australia, Canada, and the USA with the lack of concrete results since the resolution was adopted saying: “Things are moving very slowly and, frankly, it is not clear in which direction.”
In response, the representative of the European Commission, Ms. Catherine Berens, highlighted ways the Commission says it has supported research in the past but
The Commission acknowledges that myalgic encephalomyelitis/chronic fatigue syndrome imposes a heavy burden on patients and their families and recognizes that the lack of specific diagnostic tools and treatments to tackle this serious condition is a matter of concern.
The Commission has now acted – sort of. The EU does not fund research into specific illnesses but rather make calls for research to tackle areas of highlighted concerns. However, the new work programme of Horizon Europe 2023 – 2024 has been published.
Horizon Europe is the EU flagship programme for research and innovation. It sets the best minds in Europe and the rest of the world to work on delivering excellent solutions to the key issues of our time, supporting the EU’s policy priorities and building a better future for the next generations in Europe.Horizon Europe Work Programme 2023 – 2024 – General introduction
Divided into various ‘pillars’ and policy documents, the overarching 7-year scheme enjoys a budget of €95.5 billion with approximately €13.5 billion having been made available for European research and innovation in this segment. Contained within policy 4-Health Destination 3 is the snappily entitled “HORIZON-HLTH-2024-DISEASE-03-14-two-stage: Tackling high-burden for patients, under-researched medical conditions”. It is likely that this heading (p102) will be the area under which ME/CFS research may find funding given it is estimated that 2 million EU citizens are affected by the illness and the dearth of research into the disease.
This two-stage process opening would be open for ME/CFS research but is not limited or dedicated to the disease. The call opens on 30th March 2022.
The Commission estimates that an EU contribution of €6 – 7 million per project would allow tackling high-burden for patients, under-researched medical conditions to be addressed appropriately. The total indicative budget for the topic being €25 million. The outcomes are wide but does contain a commitment that “Patients and caregivers are constructively engaged with the research, which also caters for their needs.”
As the policy states
A number of medical conditions 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. This topic excludes rare diseases.
Proposals should address all of the following aspects:
1. Proposals should address the gaps in robust, scientific evidence for improved policies and practices to tackle such medical condition(s), and aim at identifying the pathophysiological mechanism(s) (e.g. genetic, cellular and molecular) and potential risk factors (e.g. psychological and environmental) of the medical condition(s) through basic, pre-clinical and/or clinical research. These efforts should underpin the development of diagnostics, therapeutics, and/or preventive strategies for the condition.
2. Proposals should demonstrate that the medical condition(s) under study is/are insufficiently understood, inaccurately diagnosed or inadequately treated in a significant proportion of patients, and as such represent a high burden for patients and society. This could be through referencing key literature.
3. Sex and gender aspects, age, ethnicity, socio-economic, lifestyle and behavioural factors should be taken into consideration. In addition, the emotional and societal long-term effects of these chronic disorders for the affected individuals should be addressed.
4. Where applicable, the development of biomarkers and other technologies for diagnosis, monitoring in patients, and stratification of patient groups should be considered.
5. Where applicable, the development of clinically relevant, (non-)human model systems that can complement clinical investigations should be considered.
6. Exploitation of existing data, biobanks, registries and cohorts is expected, together with the generation of new (e.g. genomics, epigenomics, transcriptomics, proteomics) data.
It is to be regretted that the phrase “may be insufficiently researched even though they manifest with high prevalence” leads to a footnote (175) which states “Examples of medical conditions include Lyme disease, Chronic Fatigue Syndrome and back pain.” It would have been more encouraging if M.E. or ME/CFS was listed rather than Chronic Fatigue Syndrome which is a separate condition. The breadth of the wording also allows other conditions of interest to ME/CFS researchers to be examined e.g. fibromyalgia and postural orthostatic intolerance syndrome (PoTS) which have oft been seen to have similarities and overlaps with ME/CFS.
Entities from the USA, low and middle income countries, and those who have negotiated associate Horizon status are eligible. For the UK, associate partner status is available with funds from the UK government rather than the EU. An application requires researchers from minimally 3 different EU countries or associated countries to be considered.
ME/CFS research could also find other avenues for funding, such as that opening on 12 January 2023 concerning ‘Tackling diseases and disease burden‘ whose scope narrates that
Increasing evidence suggests that several infections might influence the development of many non-communicable diseases (NCD) (e.g. multiple sclerosis, Alzheimer, post-covid-19 condition), or that NCD may be influenced by concurrent presence in the same individual of one (or more) infections. On the other hand, NCDs might represent risk factors for Infectious Diseases. The proposals are expected to elucidate and provide a better understanding of causative links between infections and non-communicable diseases onsets
Given interest in viruses and their connection to ME/CFS generally this is to be welcomed. It will be recalled that ME Research UK launched a specific funding Call centred on Viruses and ME and presently Dr Bhupesh Prusty is examining ‘Infectious triggers and mitochondrial dysfunction in ME/CFS’ as an ME Research UK-funded study.
The EU’s initiative opens the door to increased funding for ME/CFS research but the monies on offer are not ring-fenced and so ME/CFS research applications will need to compete with diseases equally deserving of research. There is no guarantee that ME/CFS research will be funded at all despite the calls of the EU Parliament in their Resolution. Progress has been made but outcomes are awaited.