Cardiovascular health takes centre stage at the European Parliament
It came at a key moment for EU health policy. Following the publication of the EU Safe Hearts Plan, the Council of the European Union is expected to discuss a protocol for cardiometabolic health checks later this year. A number of significant pieces of EU law have also been discussed by legislators in recent months. Notably, the European Parliament’s Committee on Public Health (SANT) approved the compromise texts on the EU General Pharmaceutical Legislation Reform in late March, and the Parliament adopted its position on the Critical Medicines Act in January, with trilogue negotiations now underway.
The key message of the event was 'Know Your Numbers'. Many people in Europe are not aware of cardiovascular risk factors such as high blood pressure, cholesterol and diabetes. Now more MEPs are aware of their own risk profile and have first-hand experience of health checks. By offering MEPs health checks in their workplace, the initiative demonstrated how prevention can be integrated into everyday settings.
EU pharma reform shows value of advocacy
Following the political agreement reached at the end of last year, both the Council and the European Parliament’s Committee on Public Health (SANT) have endorsed the compromise texts for a revised EU medicines framework – the first major overhaul in more than 20 years – which is now entering the final steps toward formal adoption. The reform package was agreed after years of political discussion as well as continuous engagement with stakeholders, including the ESC.
The ESC welcomes the more inclusive approach to unmet medical need (UMN) and stakeholder engagement in the compromise texts.
The adopted approach to UNM is expected to better capture real-world therapeutic gaps in cardiovascular health, including in areas where treatments exist but are remarkably sub-optimal. Previous drafts reflected a narrower approach, which risked deprioritising research in highly prevalent cardiovascular conditions where unmet needs persist.
"The agreed definition of UMN appears more flexible and reflects a broader understanding of clinical benefit. It is expected to go beyond mortality and morbidity, allowing consideration of additional patient-centred dimensions, such as quality of life and treatment-related side effects", Prof. Piotr Szymanski, Chair of the ESC Regulatory Affairs Committee said.
Now attention turns to the European Medicines Agency (EMA), which will devise Guidelines on UMN. Crucially, this work will be developed with input from stakeholders, including patients and healthcare professional representatives.
The final text also features a more inclusive approach to stakeholder engagement. This is exemplified by the restoration of voting rights for healthcare professionals and patient representatives within the EMA Committee for Medicinal Products for Human Use (CHMP), which had been curbed in the Council position. For the ESC, this decision is a welcome change and reaffirms the central role of clinical expertise in regulatory decision-making. "That means the future EMA guidance on UMN is more likely to support comparative, patient-relevant and access-relevant endpoints, rather than morbidity and mortality endpoints only", Prof. Szymanski added.
"We welcome the new text which ensures that we are not only observers, but can speak and vote", he said. "On some topics voting rights will be key to shaping decisions on which medications reach the market. The voice of patients and healthcare professionals has been preserved."
While the conclusion of negotiations on the EU pharmaceutical reform is a major milestone, there is still much work to do. The ESC’s advocacy efforts are now focusing on the key issue of medicine shortages.
"The revised pharmaceutical regulation strengthens engagement with healthcare professionals and patients when Member States identify critical medicines. However, the criteria for defining critical medicines should reflect the priorities of clinicians and patients", Prof. Kostrubiec said. A medicine may remain critical for patients even if an alternative product exists – especially if those alternatives are not clinically equivalent for a specific patient subgroup.
"The current list of critical medicines primarily includes medicines that are not widely used, but it does not include products which many of our patients rely on, such as antiarrhythmic or heart failure drugs", Prof. Kostrubiec said. "We need to better understand how this list was devised and ensure that the needs of cardiovascular patient populations are taken into account."
The list provides the basis for targeted EU-level actions to improve security of supply, including measures reflected in the Critical Medicines Act currently under negotiation. When it comes to this file, the ESC is calling for stronger European-level coordination, including joint procurement, common approaches to stockpiling, and enhanced information-sharing between countries.
Bringing cardiologists’ voice to Europe – every day
A European Cardiovascular Health Plan, new medicines legislation, forthcoming protocols for health checks – it has been an exceptionally action-packed period for the ESC’s policy teams. However, while cardiovascular disease has been in the headlines in recent months, advocacy is about the sustained effort to build long-term relationships with decision-makers.
"We remain in regular contact with the individuals who work every day on the issues that matter to us", Prof. Szymanski explains. "It is crucial that these interactions are mutually constructive. We are recognised for the expertise we offer and, as a result, we are able to help inform legislation and, crucially, how it is interpreted in practice."
Ultimately, ESC input seeks to improve patient outcomes and to advance equality in healthcare. "Politicians and lawmakers benefit from our advice as it helps them draft better legislation", says Prof. Maciej Kostrubiec. "The ESC’s consistent advocacy is helping to improve the environment for cardiology and for patients across Europe."
Our advocacy work continues apace, including ongoing discussion on a new protocol for cardiometabolic health checks. And, as set out in the EU Safe Hearts Plan, the ESC will continue to offer support to national societies in developing cardiovascular health plans for their countries.