Why we need to improve heart health in Europe – POLITICO

Cardiovascular diseases (CVDs) are the number one killer in Europe. They cost the EU an estimated €282 billion in 2021, larger than the entire EU budget itself.[1] Sixty million people live with CVDs in the EU, while 13 million new cases are diagnosed annually.[2]

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.

Sixty million people live with CVDs in the EU, while 13 million new cases are diagnosed annually.

Cardiovascular health is a priority not just because of the scale of its impact, but because of the scope we see for significant advances in outcomes for patients. We should take inspiration from the past: between 2000 and 2012, the death rate from CVDs fell by 37 percent in the five largest western European countries (France, Germany, the U.K., Spain and Italy).[2] This progress was achieved through a combination of medical innovations, and supported by a mix of health care policies and guidelines that propelled progress and improved patients’ lives.

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 progress, this downward trend has reversed and we are seeing an increase in the CVD burden across all major European countries.

And the research continues. Precision medicines are in development for inherited CVD-risk factors like elevated lipoprotein(a), which affects up to 20 percent of the population.[3] A new class of anti-thrombotics promises to bring better treatments for the prevention of clotting, without increasing the risk of bleeding. New precision cardiology approaches, such as gene therapy in congestive heart failure, are being investigated as potential cures.

Despite progress, this downward trend has reversed and we are seeing an increase in the CVD burden across all major European countries.[4]

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.

Unmet medical need criteria currently included in the draft Pharmaceutical Legislation would do a disservice to patients by downplaying the chronic nature of many CVDs, and the importance of patient-reported outcomes and experience.[5] And many of the advances seen in recent decades would fall short of the narrow definition under consideration. This limited approach disregards incremental innovation, which might otherwise reduce pain, slow disease progression, or improve treatment adherence by taking account of patient preferences for how therapies are administered.