The importance of enhancing cardiovascular wellness in Europe.
CVDs, or cardiovascular diseases, are the leading cause of death in Europe. In 2021, it is estimated that they will cost the EU €282 billion, which is more than the entire EU budget. Around 60 million individuals in the EU are currently living with CVDs, and approximately 13 million new cases are diagnosed each year.
Behind this data are individual stories of suffering and loss, of lives limited and horizons lowered by, for example, heart attack and stroke. These diseases directly affect every community in every country. And they strain our health services which must respond to cardiac emergencies as well as the ongoing care needs of chronic CVD patients.
In the European Union, there are currently 60 million individuals living with CVDs and approximately 13 million new cases are diagnosed each year.
Improving cardiovascular health is crucial, not only due to its widespread effects, but also because there is potential for significant progress in patient outcomes. We can look to the past for motivation: from 2000 to 2012, the mortality rate from CVDs decreased by 37% in the five largest western European countries (France, Germany, the U.K., Spain, and Italy).[2] This success was a result of a combination of medical advancements, along with healthcare policies and guidelines that drove progress and enhanced the lives of patients.
New treatments can now help prevent strokes or treat pulmonary embolisms. Others can delay kidney disease progression, while at the same time preventing cardiovascular events.
Despite making advancements, the decline in this trend has shifted and there has been a rise in the burden of cardiovascular disease in all major European countries.
Ongoing research is being conducted on precision medicines for inherited risk factors related to cardiovascular disease, such as elevated lipoprotein(a) which impacts around 20% of the population. A new type of anti-thrombotics shows potential for improved treatment of clotting without increasing the risk of bleeding. Additionally, new precision cardiology methods, such as gene therapy for congestive heart failure, are being explored as possible solutions.
Getting the definitions right
This year’s World Heart Day, spearheaded by the World Heart Federation, comes amid the revision of the EU pharmaceutical legislation. The European Commission’s proposal of a narrow definition of unmet medical need, which could hamper innovation is causing deep concern across stakeholders.
Instead, a patient-centered definition of unmet medical need taking the full spectrum of patient needs into consideration, would incentivize more avenues of research addressing the needs of people living with chronic conditions. It would provide a basis for drafting the next chapter in the history of cardiovascular medicines — one that we hope will be written in Europe and benefit people in the EU and beyond. Not only would this inspire advances that help people to live longer, but it would also improve quality of life for those at risk of, and affected by, cardiovascular events.
The proposed Pharmaceutical Legislation’s criteria for unmet medical needs could harm patients by not acknowledging the long-term impact of various CVDs and the significance of patient-reported outcomes and experiences. Additionally, several advancements made in recent years may not meet the strict definition being considered. This restricted perspective ignores the potential benefits of incremental innovation, which could potentially reduce pain, delay disease progression, or enhance treatment compliance by considering patient preferences for treatment administration.
A large portion of the sickness and fatalities linked to CVD can be prevented – specifically, 9 out of 10 heart attacks can be averted.
Currently, it is uncertain how the requirements for unmet medical needs outlined in the legislation will be applied in various situations. To gain a better understanding of the innovation landscape, policymakers should establish a forum for multiple stakeholders to discuss the needs of patients and seek expert opinions from medical societies, patients, and industry. The European Alliance for Cardiovascular Health (EACH), a network of 17 organizations in Europe focused on cardiovascular disease, is prepared to advise policymakers on the burden of CVD and the urgent needs of patients. [6] EACH not only supports the EU’s efforts to develop more policies on CVD, but also advocates for an EU Cardiovascular Health Plan to improve healthcare for patients across the EU and promote equal health standards. However, there is currently a lack of structured discussions with these stakeholders, which could lead to missed opportunities and hinder the EU’s attractiveness for patient access and research and development.
Primary and secondary prevention
In addition to promoting future advancements, Europe must also optimize the current resources at our disposal. We need to implement effective strategies that are applicable everywhere.
The main focus of this method is to prevent. A large portion of the sickness and mortality linked to CVD can be avoided – in fact, 9 out of 10 heart attacks can be prevented. By implementing primary prevention strategies, rates of heart attack, stroke, and other CVDs can be significantly reduced. Secondary prevention, which involves screening and managing the disease through simple tests like blood and urine, as well as monitoring blood pressure and BMI, plays a crucial role in controlling the impact of the disease.
Conducting comprehensive screenings for cardiovascular disease (CVD) and diabetes at the primary care level, using evidence-based methods, could aid in early detection and treatment of CVD before severe symptoms arise. By adhering to current treatment guidelines and protocols, healthcare professionals throughout Europe can prevent complications, improve patient outcomes, and reduce healthcare expenses. Furthermore, a collaborative approach involving multiple stakeholders is crucial. Policymakers should not overlook the valuable insights provided by CVD multistakeholder alliances, such as EACH at both the EU and member country levels. These partnerships offer policymakers a better understanding of patient needs and access to expert opinions.
Companies driven by research aim to satisfy the demands of patients in Europe and globally. It is important to establish a conducive setting that allows companies to undertake intricate and uncertain trials. This involves having appropriate incentives and a clear understanding of the regulatory process for future therapies.
The cost of cardiovascular disease in Europe exceeds the entire EU budget, according to a press release from the European Society of Cardiology.
[2] https://iris.unibocconi.it/retrieve/handle/11565/4023471/115818/Torbica%20EHJ%202019.pdf
[3] https://www.acc.org/Latest-in-Cardiology/Articles/2019/07/02/08/05/Lipoproteina-in-Clinical-Practice
[4] https://www.efpia.eu/about-medicines/use-of-medicines/disease-specific-groups/transforming-the-lives-of-people-living-with-cardiovascular-diseases/cvd-dashboards
[5] https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en
[6] https://www.cardiovascular-alliance.eu/
[7] https://www.ahajournals.org/doi/10.1161/STROKEAHA.119.024154
[8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5331469/
[9] https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/because-we-can-t-afford-not-to-let-s-make-a-joint-health-check-for-cardiovascular-disease-cvd-and-diabetes-happen/