Why we need to improve heart health in Europe

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.

Much of the illness and death caused by CVD is preventable — in fact, 9 out of 10 heart attacks can be avoided.

At this moment it is unclear how the unmet medical need criteria in the legislation will apply to these and other situations. Policymakers should create a multistakeholder platform with the space to discuss patients’ needs, getting expert views from medical societies, patients and industry to better understand the innovation environment. The European Alliance for Cardiovascular Health (EACH), a multistakeholder network comprised of 17 organizations in the CVD space in Europe, stands ready to inform policymakers about the CVD burden and the pressing needs of patients. [6] EACH not only supports the EU´s endeavor to develop more policies on CVD, it also supports and promotes the idea of an EU Cardiovascular Health Plan to work towards better patients’ health care across the EU and more equal health standards. So far, structured discussions with such stakeholders do not sufficiently take place, and we risk missing those opportunities, and lose in both patient access as well as R&D attractiveness of the EU.

Primary and secondary prevention

As well as driving future innovation, Europe must also make the best possible use of the tools we have now. We must do what works — everywhere.

At the heart of this approach is prevention. Much of the illness and death caused by CVD is preventable — in fact, 9 out of 10 heart attacks can be avoided.[7] Primary prevention can dramatically reduce rates of heart attack, stroke and other CVDs. Secondary prevention, which includes screening and disease management, such as simple blood tests and urine tests, as well as blood pressure and BMI monitoring, has a key role to play in containing the burden of disease. [8]

Joint cardiovascular and diabetes health checks at primary care level, taking an evidence-based approach, would help diagnose and treat CVD before the onset of acute symptoms.[9] By following current treatment guidelines and protocols, health care professionals across Europe can help to prevent complications, improve health outcomes for patients and save health care costs. Also here, a multistakeholder approach is key. Policymakers should not miss out on listening to the CVD multistakeholder alliances that have already formed — at EU and at EU member countries level, as for example EACH. These partnerships are great ways for policymakers to better understand the needs of patients and to get the experts’ views.

Research-driven companies exist to meet the needs of patients in Europe and around the world. We need to create an environment that enables companies to embark on complex and unpredictable trials. That means having the rights incentives and clarity on the regulatory pathway for future treatments.


[1] https://www.escardio.org/The-ESC/Press-Office/Press-releases/Price-tag-on-cardiovascular-disease-in-Europe-higher-than-entire-EU-budget

[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/



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Not just Qatargate: Eva Kaili also faces probe into EU kickbacks scheme

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Voiced by artificial intelligence.

Qatargate aside, Eva Kaili is facing a world of pain for a different reason altogether. 

Documents seen by POLITICO reveal fresh details about a separate criminal investigation that the Greek EU lawmaker is facing regarding allegedly fraudulent payments involving four former assistants in the European Parliament from 2014 to 2020. 

The probe is looking at Kaili for three potential fraudulent activities: whether she misled Parliament about her assistants’ location and work activities; took a cut of their reimbursements for “fake” work trips she orchestrated; and also took kickbacks from part of their salaries, according to a letter from the European Public Prosecutor’s Office (EPPO) to Parliament President Roberta Metsola, seen by POLITICO. 

Another Greek EU lawmaker, Maria Spyraki, has also been part of the same probe. Investigators accuse her of misleading the institution about her assistants’ activities and of telling them to file expenses for fake work trips. However, the documents do not allege that Spyraki took kickbacks from salaries or false reimbursements.

In total, investigators say Kaili owes the European Parliament “around €100,000,” according to a person familiar with the case.

The details offer the first real insight into the inquiry since it became public in December, only days after Kaili was put in jail under suspicion that she was involved in an even bigger scandal, Qatargate — the alleged bribery ring that prosecutors say involved countries such as Qatar and Morocco paying off European Parliament members.

And with all Qatargate suspects now out of detention, and no new arrests since February, attention is now shifting to the fraud case. MEPs in the Parliament’s legal affairs committee will discuss Kaili’s case behind closed doors for the first time on Tuesday. 

Kaili, who was moved to house arrest earlier this month, is currently fighting the prosecutor’s request to strip her immunity — a privilege afforded to EU lawmakers. But the EU prosecutor’s office, which investigates criminal fraud linked to EU funds, has argued its probe is on solid ground.

“The current investigation pertains to strong suspicions of repeated fraud and/or other serious irregularities,” European Chief Prosecutor Laura Kövesi said in the letter seen by POLITICO, which was sent to Parliament in December and requested both Kaili and Spyraki be stripped of their immunity. 

EPPO declined to comment on the case for this article. Kaili, through an attorney, said she has promised to pay back any money owed and to comply with any recommendations. Spyraki told POLITICO that her case has nothing to do with Kaili, and she confirmed she has never been accused of taking kickbacks.

“I have no dispute on the budget based on my responsibility as supervisor,” she said. “I have already paid the relevant amount and I have already asked the services to reassess my case financially.”

Kickbacks

The European prosecutor went public about the fraud inquiry on December 15, just days after Kaili had been arrested in Brussels in connection with Qatargate. 

The notice named both Kaili, who belonged to the center-left Socialists and Democrats grouping, and Spyraki, a former journalist and former spokesperson for the center-right Greek party New Democracy, which is affiliated with the large European People’s Party group in Brussels.

The announcement came the same day Kövesi sent her immunity-lifting request to Metsola. The documents also named four former staffers of Kaili and two former assistants to Spyraki as potentially participating in the different schemes. 

But officials publicly offered few specifics about the inquiry, only noting that it was unrelated to the Qatargate affair, which had also ensnared Kaili’s life partner Francesco Giorgi, as well as several other current and former EU lawmakers. 

Now the details are starting to emerge. 

According to the letter seen by POLITICO, the EPPO probe is examining both Kaili and Spyraki over irregularities regarding their assistants’ “physical presence at the place of employment” and “related European Parliament decisions on working time.”  

According to the same letter, another line of inquiry is “fake missions, submission of false supporting documents and undue reimbursement claims for missions expenses by the APAs on the request of Ms Kaili and Ms Spyraki.” APA is an acronym for accredited parliamentary assistant.

Eva Kaili poses for the “MEPs for #millennialvoices”campaign in 2016 | European Parliament

Kaili specifically is also under investigation for receiving “payback” from her assistants’ salaries and the falsified expenses.

The public prosecutor’s probe follows an investigation by the EU’s anti-fraud office, known as OLAF, which was completed on November 23 of last year. OLAF then transferred its case to EPPO, it said in a December statement.

OLAF said it would leave any follow-up to the public prosecutor’s office, declining to comment beyond its statement four months ago. 

Immunity fight

The EPPO case is also becoming entangled in the fight over whether to lift Kaili’s immunity.

Immunity is a special privilege MEPs enjoy that is intended to protect them from being arbitrarily prosecuted for what they say or do as EU lawmakers. It can be waived following a recommendation by the legal affairs committee and a vote by all MEPs.

Parliament is now starting that process for Kaili, having already kicked it off for Spyraki. MEPs will discuss Kaili’s immunity at the legal affairs committee gathering on Tuesday.

Investigators say Kaili owes the European Parliament “around €100,000” | European Parliament

Spyros Pappas, Kaili’s lawyer, argued that typically, such fraud cases are closed after OLAF finishes its probe — as it did with Kaili — with the lawmaker paying back whatever the office says is owed. He also questioned how officials could justify lifting immunity for actions that stretch back to 2014. 

“One cannot but question both the legality and the opportunity of the initiative taken by EPPO,” he said. “The answer can only be given by the General Court of Justice of the EU.”



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A plan for competitive, green and resilient industries

We, Renew Europe, want our Union to fulfil its promise of prosperity and opportunities for our fellow Europeans. We have championed initiatives to make our continent freer, fairer and greener, but much more remains to be done.

We are convinced that Europe has what it takes to become the global industrial leader, especially in green and digital technologies. Yet it is faced with higher energy prices and lower levels of investment, which creates a double risk of internal and external fragmentation.

The Russian aggression against Ukraine has shown us that our European way of life cannot be taken for granted. While we stand unwaveringly at the side of our Ukrainian friends and commit to the rebuilding of their homeland, we also need to protect our freedom and prosperity.

That is why Europe needs an urgent and ambitious plan for a competitive, productive and innovative industry ‘made in Europe’. Our proposals below would translate into many more jobs, a faster green transition and increased geopolitical influence.

We must improve the conditions for companies, big and small, to innovate, to grow and to thrive globally.

1. Reforms to kick start the European economy: A European Clean Tech, Competitiveness and Innovation Act

While the EU can be proud of its single market, we must improve the conditions for companies, big and small, to innovate, to grow and to thrive globally.

  • In addition to the acceleration of the deployment of sustainable energy, we call on the Commission to propose a European Clean Tech, Competitiveness and Innovation Act, which would:
  • While the EU can be proud of its single market, we must improve the conditions for companies, big and small, to innovate, to grow and to thrive globally.
  • In addition to the acceleration of the deployment of sustainable energy, we call on the Commission to propose a European Clean Tech, Competitiveness and Innovation Act, which would:
  • Cut red tape and administrative burden, focusing on delivering solutions to our companies, particularly for SMEs and startups.
  • Adapt state aid rules for companies producing clean technologies and energies.
  • Introduce fast-track permitting for clean and renewable energies and for industrial projects of general European interest.
  • Streamline the process for important Projects of Common European Interest, with adequate administrative resources.
  • Guarantee EU-wide access to affordable energy for our industries.
  • Strengthen the existing instruments for a just transition of carbon-intensive industries, as they are key to fighting climate change.
  • Facilitate private financing by completing the Capital Markets Union to allow our SMEs and startups to scale up.
  • Set the right conditions to increase Europe’s global share of research and development spending and reach our own target at 3 percent of our GDP.
  • Build up the European Innovation Council to develop breakthrough technologies.
  • Deliver a highly skilled workforce for our industry.
  • Deepen the single market by fully enforcing existing legislation and further harmonization of standards in the EU as well as with third countries.

We need to reduce more rapidly our economic dependencies from third countries, which make our companies and our economies vulnerable.

2. Investments supporting our industry to thrive: A European Sovereignty Fund and Reform Act

While the EU addresses, with unity, all the consequences of the war in Ukraine, we need to reduce more rapidly our economic dependencies from third countries, which make our companies and our economies vulnerable.

In addition to the new framework for raw materials, we call on the Commission to:

  • Create a European Sovereignty Fund, by revising the MFF and mobilizing private investments, to increase European strategic investments across the Union, such as the production on our soil of critical inputs, technologies and goods, which are key to the green and digital transitions.
  • Carry out a sovereignty test to screen European legislation and funds, both existing and upcoming, to demonstrate that they neither harm the EU’s capacity to act autonomously, nor create new dependencies.
  • Modernize the Stability and Growth Pact to incentivize structural reforms and national investments with real added value for our open strategic autonomy, in areas like infrastructure, resources and technologies.

While the EU has to resist protectionist measures, we will always want to promote an open economy with fair competition.

3. Initiatives creating a global level playing field:

A New Generation of Partnerships in the World Act

While the EU has to resist protectionist measures, we will always want to promote an open economy with fair competition.

  • In addition to all the existing reforms made during this mandate, notably on public procurement and foreign subsidies, we call on the Commission to:
  • Make full use of the EU’s economic and political power regarding current trade partners to ensure we get the most for our industry exports and imports, while promoting our values and standards, not least human rights and the Green Deal.
  • Promote new economic partnerships with democratic countries so we can face climate change and all the consequences of the Russian aggression together.
  • Ensure the diversification of supply chains to Europe, particularly regarding critical technologies and raw materials, based on a detailed assessment of current dependencies and alternative sources.
  • Use all our trade policy instruments to promote our prosperity and preserve the single market from distortions from third countries.
  • Take recourse to dispute settlement mechanisms available at WTO level whenever necessary to promote rules-based trade.
  • Adopt a plan to increase our continent’s attractiveness for business projects.
  • Create a truly European screening of the most sensitive foreign investments.
  • We, Renew Europe, believe that taken together these initiatives will foster the development of a competitive and innovative European industry fit for the 21st century. It will pave the way for a better future for Europeans that is more prosperous and more sustainable.



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