In response to the European Parliament’s historic vote on 17th June 2020 urging the Commission to transform the ME research landscape, the European Commission released its work programme of Horizon Europe 2023 – 2024 last December in which approximately €13.5 billion was made available for European research and innovation. 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” funding stream. It was deemed likely that this heading (p102) would 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.
The European Commission has now published a discussion paper on ‘Scoping study on evidence to tackle high-burden under-researched medical conditions’ taking its basis of evaluation as
“Diseases or conditions that receive insufficient research funding relative to the expected level of funding based on their burden.” This working definition, derived from literature and stakeholder consultation, is based on the assumptions that the burden stems (partly) from lack of evidence regarding the conditions, and that conditions with a high burden for patients, should receive a higher share of the total funding for medical research, than conditions with a low burden. Rare diseases (i.e. diseases affecting less than 1 in 2000 European citizens) did not fall within the scope of the current study, as the EC has specific funding for rare diseases.
The authors of the report acknowledged that there is ‘no gold standard’ on how to identify high-burden under-researched medical conditions, but used 4 four complementary perspectives to compose a list of possible high-burden under-researched medical conditions in the EU. These being
- The amount of EU funding per group of medical conditions (based on the International Classification of Diseases, version 11) was examined. The five groups of medical conditions that received the least EU funding were selected.
- The amount of funding was related to the burden of medical conditions, expressed in prevalence, disability adjusted life years (DALYs), years of life lost (YLL), and mortality (based on the Global Burden of Diseases study). For each of these burden metrics, the 10 most relatively under-funded (groups of) conditions were selected for the list. In addition, (groups of) conditions mentioned in the top 50 of all burden metrics (i.e. prevalence, DALY, YLL, and deaths) were identified for the list of high-burden under-researched medical conditions.
- A short literature search in PubMed was carried out to identify why (with what complaints) patients visit their general practitioner (GP). This perspective led to an overview of common complaints, symptoms or conditions for which European citizens visit their GP and may thus be considered high-burden.
- Stakeholders were asked to indicate any additional high-burden under-researched medical conditions, leading to 20 additional conditions.
Conditions were excluded from the final list of high-burden under-researched medical conditions if: a) it concerned a rare disease, b) there was no evident knowledge gap concerning aetiology and treatment for the particular condition, and c) the funding received was relatively high.
Using their methodology (which has its limitations), the following were identified as possible high-burden under-researched medical conditions
It is to be noted that Fatigue/Weakness appears as it was highlighted in the third of the four perspectives – GP visits and high burden. ME/CFS, as a disease, was highlighted by stakeholders under the fourth perspective.
It is also to be welcomed that autoimmune diseases, PoTS, and chronic Lyme Disease have also been included in the list.
Given the aims and objectives of the EU Horizon programme it is not surprising that stakeholders felt the following was required to increase research activity –
- create more/better national, EU, and international funding opportunities
- stimulate the creation of large research networks
- make incentives sufficiently accessible to do research on these medical conditions
- stimulate researcher mobility
- stimulate the organisation of specific conferences in the medical areas
- increase incentives (other than financial) to do research on these medical conditions
As a minimum research requirement the need for cohorts, biobanks, clinical trials, networks and large databases were highlighted.
Discussions over the paper will no doubt ensue but it is vital that ME/CFS is recognised as a high-burden under-researched medical condition to allow researchers to access desperately needed funding.