Better heart health should be a more urgent EU policy priority
Beating 100,000 times daily, the heart is a vital organ, supplying our bodies with nutrients and carrying away waste. When the cardiovascular system malfunctions, the health consequences can be serious. That happens to too many of us too often.
Cardiovascular diseases (CVDs) are disorders of the heart and blood vessels. They are the world’s leading cause of death, killing almost 18 million people annually1. In Europe, CVDs account for 36% of all deaths, causing more mortality than any other disease2. Each year, CVDs claim 1.8 million lives in the EU. CVDs cost the EU’s economy more than €210 billion annually3. Some 60 million Europeans live with CVDs, with women, at 47%, more likely than men, at 39%, to die from these diseases4.
Most CVD deaths are due to heart attack and stroke which are typically acute events mainly caused by a blockage that stops blood from flowing to the heart or brain. That happens when fatty deposits gather on the inner walls of blood vessels supplying the heart or brain. Strokes can be caused by bleeding from a blood vessel in the brain or from blood clots.
The risks of getting CVDs can be significantly reduced by avoiding smoking tobacco, eating healthily, exercising, drinking less alcohol and living in a cleaner environment. Behavioral change and treatments can help to manage CVDs but it is important to detect the diseases early.
We should not overlook the significant burden to patients and society caused by inherited, non-preventable CVDs. These conditions are often less well-known and, as a result, they are often misdiagnosed and under-diagnosed. For example, cardiomyopathies are a group of diseases of the heart muscle affecting one in 330 Europeans and rising5.
As well as the personal toll of CVDs and the strain on healthcare systems, the economic cost in the EU through lost productivity is estimated at more than €200 billion annually6. Due to ageing populations and negative climate change impacts, the incidence of heart disease and stroke could rise7.
For decades, Bristol Myers Squibb has been a trailblazer in cardiovascular health. Scientists are working on disease-modifying medicines that could help patients living with arterial thrombosis, defined sets of heart failure and cardiomyopathies. We take a translational approach to cardiovascular medicines discovery and development, subtyping patient populations to identify targeted therapeutics, expanding the use of biomarkers and real-world data to better design trials and ultimately determining which patients are most likely to benefit from treatments. We are collaborating to improve patients’ access to adequate cardiovascular care, treatments and diagnosic tools.
More Innovation
But more innovation is needed. European policymakers can strengthen healthcare systems and stimulate research for new treatments through the upcoming revision of the EU General Pharmaceutical Legislation (GPL). This includes tackling unmet medical need (UMN) which is significant for CVDs. These diseases need more innovation - a point recognized by the MEP Heart Group8. Policymakers acknowledge that much less public funding is invested in understanding the complex genetic basis of some inherited CVD conditions. The European Innovation Council recently urged a pathfinder challenge to find breakthrough treatments for major CVD conditions, including hemorrhagic and ischemic stroke, aneurysm, cardiomyopathy and certain types of arrhythmias. The challenge is aimed at disrupting the practice of cardiology by focusing on the molecular pathogenesis underlying a CVD condition’s pathology. That could accelerate personalized care in CVDs.
Better Policy
The European Commission’s Healthier Together plan, covering the 2022 to 2027 period, aims to help countries to tackle major non-communicable diseases, including CVDs. Since most of Europe’s CVD patients are managed in primary care, our industry has urged the introduction of annual heart health checks to screen for metabolic and inherited risk factors9. This population-wide measure, alongside harmonized data registries, could tackle unequal CVD health outcomes in the EU. The proposal for a European Health Data Space is already taking bold steps towards better use of health data for disease prevention, diagnosis and treatment.
Horizon Europe is an ambitious €96 billion EU research and innovation agenda that includes health. Another program, EU4Health, like Horizon Europe, sights 2027 as the target year to have made progress on improving healthcare research and building more resilient healthcare systems. But neither program makes specific mention of CVD research. Some European advocacy groups have urged more funding for basic and translational clinical research, integrated cardiovascular patient registries and national strategies for CVD10.
If European policymakers want to focus on “health as an investment, rather than as a cost”11, then scientific support for CVD research and responsive health systems that prioritize fast CVD prevention, diagnosis and treatment should be fostered. Otherwise, CVD will become an even more existential threat to European societies.
Bristol Myers Squibb funds Cardiomyopathies Matter, a multi-stakeholder initiative aiming to raise awareness of this group of diseases of the heart muscle and ensure they receive the policy attention they warrant. The initiative includes experts in cardiology, health economics, patient advocacy and policymaking. It has made several recommendations, especially to boost early diagnosis, access to specialist care, holistic support and patient empowerment, as well as research and innovation.
EU GPL
Innovation depends on a predictable policy environment that enables the translation of science into treatments and delivers them fast to patients. This is particularly true of CVD where trials are lengthy and complex because they require “using clinically evident cardiovascular endpoints for approval rather than biomarkers or putative surrogates”, and face regulatory uncertainty and the high bar set by previous progress12. By updating the legislative framework for medicines through the proposed revision to the EU GPL, policymakers can signal that the EU wants to be at the heart of global health innovation. But the proposal tabled by the European Commission reduces Regulatory Data Protection (RDP) which is vital to spur innovation. It sets unviable conditions to ‘earn back’ extra periods of RDP. The move would significantly set back the EU’s global innovation proposition. The European Commission’s proposed definition of UMN, based on narrow criteria, could hinder CVD research by disregarding the chronic nature of many of these diseases, as well as the role of incremental innovation.
Tackling CVD mortality and morbidity requires decisive and holistic policy action. We support the adoption of a dedicated EU Cardiovascular Health Action Plan, as well as national CVD plans (Spain adopted one in March 2022), including the introduction of a cardiovascular health check for all EU citizens13, as proposed by the European Alliance for Cardiovascular Health.
Heart health is important. While the science is improving, too many people are dying from CVDs and access to the latest treatments in the EU is too slow14. Legislators should match an ambition to improve heart health with a policy environment that truly enables the discovery, development and delivery of innovation to patients.
References:
1. World Health Organization
2. European Alliance for Cardiovascular Health
3. European Commission
4. European Alliance for Cardiovascular Health
5. Cardiomyopathies Matter Policy Roadmap
6. European Heart Network
7. US Environmental Protection Agency
8. Fighting CVD - A Blueprint For Action
9. EFPIA
10. Science Business
11. European Parliament
12. Cardiovascular Drug Development: Is It Dead Or Just Hibernating?
13. European Alliance for Cardiovascular Health
14. EFPIA