Unmet medical needs and migraine: assessing the added value for patients and society

Migraines often affect a young and female population who are highly engaged in the workforce but also have family responsibilities. It’s time for Europe to widen the definition of unmet medical needs, to ensure adequate quality of life for patients, and to prioritise funding where it’s needed.
The Parliament Events

By The Parliament Events

Our events bring together MEPs, policy-makers from across the EU institutions and influential stakeholders to share ideas and discuss the issues that matter at the heart of European politics

28 Nov 2023

With the upcoming review of the EU pharmaceutical legislation, patients and industry are exchanging views with policymakers to consider a wider legal definition on unmet medical needs (UNM). Patients argue that conditions like migraine, which affects roughly 41 million people in Europe, may not be life-threatening, but have a huge impact on the quality and well-being of their lives as well as on productivity and healthcare systems. The debate around the value for patients and society and the risks associated with having a very limited definition of UMN were the leading topics discussed on 7th November, at an event in the European Parliament, hosted by The Parliament in partnership with AbbVie.  

“I believe the EU should be more focused on this topic because migraines are affecting a lot of people, the majority being women under fifty. It’s the main incapacity in young women and the second major leading cause in disability in the world,” said MEP Alex Agius Saliba (S&D), who hosted the event. His colleague MEP Tomislav Sokol (EPP) observed that the number of European citizens affected by migraines was staggering: “This is definitely a significant topic that needs to be discussed and it’s important to consider it within the context of the pharma legislation.” In fact, Sokol said the definition of UMN “is one of the most complex aspects of the upcoming legislation. Subsequently, how these unmet needs will be addressed in practice. 

At an EU level, there is no official recognition of migraines MEP Saliba said, resulting in a lack of a harmonised approach to tackle neurological diseases. But to settle on a legal definition is intrinsically complicated due to the large divergence of views among stakeholders. “This is a problem that we should focus on when it comes to setting targets, making laws, providing more guidelines and tackling the taboo,” he added, talking about the stigma associated with migraines, which often leads to discrimination in the workplace. 

“It is true that we find that UMN definition falls short on including conditions such as migraine” 

Lucia Monton, European Migraine and Headache Alliance 

Speaking from a patients’ perspective on how migraine affects workers’ daily lives, Lucia Monton from the European Migraine and Headache Alliance (EMHA), acknowledged: “It is true that we find that UMN definition falls short on including conditions such as migraine.”  Monton said that even if it’s not “life-threatening or severely debilitating”, it has a huge impact on patients’ daily lives. Anette Dumas from the European Brain Council (EBC) shared the same view saying that migraines are not considered a non-communicable disease (NCD) tending to be neglected as UMN. Dumas said the EBC has conducted a significant amount of research on migraine and the value of treatment, notably pointing to the paper entitled “Rethinking Migraine in Times of Covid-19” and, most recently, the Brain Innovation Days session on Migraine Friendly Workplace.  

These initiatives aim to optimise research, care for brain disorders and to highlight the need for adequate funding. For funding, MEP Sokol suggested brain conditions, such as migraine, should receive extra funding from the Horizon Europe programme: “Brain conditions are definitely a topic that needs to be researched much more because there’s a big unmet potential and a huge opportunity for additional resources. There’s a lot of unknowns in the brain area, in general. If we’re to consider a new area of healthcare funding, it should be the brain.” 

“Migraine is pain. It’s a hammering pain that sometimes makes you think you’re going to die from it. But migraine is a neurological condition, it’s not just pain”

Viviana Di Leva, Therapeutic Area Lead Migraine, Europe Medical Affairs at AbbVie 

An eye doctor and a patient living with migraine, Viviana Di Leva, Therapeutic Area Lead Migraine, Europe Medical Affairs at AbbVie gave the audience an account of living with the condition: “Migraine is pain. It’s a hammering pain that sometimes makes you think you’re going to die from it. But migraine is a neurological condition, it’s not just pain.” She went on to describe symptoms of nausea, vomiting, dizziness, phonophobia and photophobia, meaning the impossibility of standing any kind of light or noise. These symptoms typically last between 2-3 days without interruption, Di Leva explained, leaving patients completely isolated and incapacitated in a dark room. “Living with migraines also means living with fear. Migraines will not kill you but neither [will they] let you live,” added Di Leva, further noting that the associated financial burden is roughly 27 billion euro every year in Europe — higher than blood cancers. 

Patrick Little, EMHA’s President, emphasised the importance of early diagnosis, stressing the disparities across Europe in terms of access to medications and services.  “It normally takes about six years for somebody to get an adequate diagnosis for migraine and during that time their lives can be completely debilitated in terms of their relationships going down, losing unemployment — all of this has a huge impact in the quality of life,” said Little. MEP Saliba asked Di Leva why it takes so much for patients to get a diagnosis since migraines are not regarded as a rare disease. “It’s a matter of awareness,” she answered. “Migraines are extremely common, but this awareness is still missing among the population and healthcare professionals.” EMHA’s Little shared similar thoughts: “There is a real issue about educating healthcare professionals so they can do proper assessments and provide access to correct medication.” 

“Brain conditions are definitely a topic that needs to be researched much more because there’s a big unmet potential and a huge opportunity for additional resources. There’s a lot of unknowns in the brain area, in general. If we’re to consider a new area of healthcare funding, it should be the brain”

MEP Tomislav Sokol (EPP, Croatia)

Talking about ways forward from a legislative standpoint, Dumas said unfatal and disabling diseases should be considered as part of UMN in the upcoming pharmaceutical legislation revision. “We should also look at prevention and insufficient diagnosis for some diseases, like migraine, and look at access to care. We also need more research in the mechanism of the disease and the impact it has on society,” Dumas added. She finished with a straightforward call: “We need to make it clear from a society perspective what migraine is and what headache is. That’s the way we will move forward.” The upcoming Health European Data Space will also make a difference, MEP Sokol added, as it seeks to get more real-world data available for clinical research.  

Policymakers in the room were eager to learn from patients about their needs and pledged to take notice of issues like funding, addressing elements in the definition of UMN that take into account the pain and suffering inflicted by migraines, and the value of improving the lives of patients living with it. “I think, as legislators, we need to amplify awareness campaigns, extra funding at national level to increase people’s awareness and ensure that access to treatment and medication is equal across Member States,” concluded MEP Saliba. 


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