Parliament negotiators reached a provisional agreement with the Council presidency on 5 November on legislation establishing a mechanism that would allow the suspension of budget payments to a member state violating the rule of law.
The decision on the suspension will have to be taken by the Council acting by a qualified majority on the proposal of the European Commission.
MEPs have been warning that European values are at risk and that EU funds from the long-term budget and the recovery plan should not be put into the hands of those working against democracy and fundamental rights in Europe.
In a report adopted on 7 October, MEPs called for reinforcement of the rule of law across Europe through a new mechanism andfor effective sanctions on member states found to be in violation. They also insisted that the EU institutions should agree clear rules that link receiving EU funds to how a member state respects the rule of law.
What is rule of law?
Rule of law is laid down in the EU treaties as one of the values on which the Union is based. It means that governments should be bound by law, that they should not take arbitrary decisions and that citizens should be able to challenge their actions in independent courts.
It also enshrines the fight against corruption, which unfairly favours some to the detriment of others, and the safeguarding of media freedom, thus ensuring the public is properly informed about the work of government.
Rule of law is a common concern among Europeans. In a 2019 Eurobarometer survey, at least 85% of respondents across the EU considered each of the different aspects of the rule of law as essential or important. Another survey, from October 2020, found that 77% of Europeans support the concept that the EU should only provide funds to EU countries if they are in compliance with the rule of law and democratic principles.
EU mechanisms for the protection of rule of law
The EU has existing tools at its disposal to protect the rule of law. On 30 September 2020, the European Commission published the first annual rule of law report that monitors both positive and negative developments relating to the rule of law in all member states. It has been monitoring Romania and Bulgaria since they joined the EU in 2007.
There is also dialogue on the rule of law in the Council and the current German presidency plans to have country-specific discussions in November starting with five EU countries.
If the Commission is of the view that a member state is violating EU law, it can start infringement proceedings that may lead to financial sanctions determined by the European Court of Justice. Another procedure, under Article 7 of the Treaty on European Union, allows the Council to make recommendations or decide by unanimity on sanctions against a member state, including the suspension of membership rights.
The case for further measures
MEPs have argued that existing tools are insufficient. While there are ongoing hearings in the Council under Article 7 regarding Poland and Hungary, Parliament has expressed its regret about the lack of significant progress by the two member states in addressing the issues.
In a plenary debate on 5 October, MEPs welcomed the annual rule of law report launched by the Commission, but called for more action on enforcement. “Monitoring alone will not bring back judicial independence in Poland, nor will it save the Index media [outlet] in Hungary,” said Michal Šimečka (Renew Europe, Slovakia).
Šimečka drafted a report adopted on 7 October, calling for a mechanism that consolidates existing instruments and establishes an Annual Monitoring Cycle, with country-specific recommendations, timelines and targets for implementation. The cycle should serve as the basis for triggering Article 7 or suspending budget funds for a member state.
Protecting EU financial interests
Corruption or dependent courts may mean there is no protection against misuse of EU money allocated to a member state. The Commission put forward a legislative proposal in 2018 that aims to defend the Union’s financial interests, should deficiencies in the rule of law be detected.
Parliament adopted its position on the proposal in early 2019. The file is linked to the outcome of the negotiations on the EU long-term budget and Parliament has insisted that an agreement on the 2021-2027 budget is only possible if there is sufficient progress on this legislation.
EU leaders agreed in July 2020 to introduce rule of law conditionality, i.e. to make receipt of EU funds by a member state dependent on its respect for the rule of law. The German Council presidency put forward a compromise proposal in early autumn, which MEPs criticized as insufficient during the plenary debate on 5 October.
“A mechanism that cannot ever be triggered in practice due to backdoors or indecisive processes serves only the interests of those who do not wish to see any measures taken,” said Petri Sarvamaa (EPP, Finland).
Agreement with the Council
MEPs started negotiations with the Council in October. Parliament’s co-rapporteurs on the file are Sarvamaa and Eider Gardiazabal Rubial (S&D, Spain).
An agreement was reached on 5 November. Parliament’s negotiators secured a broad scope of the legislation, ensuring it will not only apply to cases of corruption and fraud, but will also cover breaches of fundamental values such as freedom, democracy, equality and respect for human rights including the rights of minorities.
The agreed text also protects the final beneficiaries of the funds such as students, farmers or NGOs. They will be able to claim their due amounts from the Commission.
“For us it was crucial that final beneficiaries won’t be punished for the wrongdoing of their governments and that they continue receiving funds that have been promised to them,” said Gardiazabal Rubial.
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EAPM: Keeping tabs on lung cancer and Commission pharma strategy
Good day, and welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week. We have more news on the upcoming EAPM round table on lung cancer, as well as all the usual health-care updates, writes European Alliance for Personalised Medicine, Executive Director Denis Horgan.
Lung-cancer screening and European Beating Cancer Plan
Yes, we are all aware that by far the best way to reduce numbers of lung cancer patients is to persuade smokers to stop. Although not all sufferers are, or have ever been, smokers. High-risk groups exist, of course, and early diagnosis is vital. Currently, five-year survival rates stand at a mere 13% in Europe and 16% over in America. This will be discussed in our upcoming event on 10 December.
It is the most commonly found cancer in men and lung cancer in women is being represented by a “worrying rise” according to the World Health Organization. Some one billion people on the planet are regular smokers. And figures show that lung cancer causes almost 1.6 million deaths each year worldwide, representing almost one-fifth of all cancer deaths.
The European Respiratory Society and the European Society of Radiology (also a supporter of the event, as is the European Cancer Patient Coalition - ECPC), the societies have recommended screening for lung cancer under the following circumstances: “In comprehensive, quality-assured, longitudinal programmes within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres.”
NELSON and victory?
The NELSON study into computed tomography (CT) screening of lung cancer showed that such screening reduces lung cancer deaths by 26% in high-risk asymptomatic men. The findings also indicated that, with screening, the results could be even better in women.
For screening to be cost effective, it has to be applied to the population at risk. For lung cancer, this is not simply based on age and sex, as it is in the majority of breast or colon cancer screening. Europe needs to involve all key groups in developing recommendations and guidelines for implementation, adapted according to the healthcare landscape of individual countries.
Various member states have already shown a willingness to move forward in lung-cancer screening, and several countries representatives will take part in the event.
The Alliance and its stakeholders realize that, among other elements, what is required in Europe is: continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted.
All of the above will be discussed at the lung-cancer screening event, and it is envisaged that a coordinated plan will emerge, which will make its way to Commission and Parliament policymakers and member state health system chiefs.
EU Pharma strategy on the horizon
Affordability, availability and sustainability are the main focus points of the EU’s new pharmaceutical strategy, due to be published tomorrow (25 November). Coming in the wake of the COVID-19 pandemic, the EU’s pharmaceutical strategy aims to “future-proof” the European health-care sector. The new strategy, set to be unveiled on Wednesday, is designed to improve and accelerate patients’ access to safe and affordable medicines while also supporting innovation in the EU pharmaceutical industry.
Health Commissioner Stella Kyriakides has previously described the strategy as a “cornerstone” of health policy over the next five years. It is considered a key pillar of the Commission’s vision to build a stronger health union, as President von der Leyen set out in her 2020 State of the Union speech. It will also inform the newly proposed EU4Health Programme and align with the Horizon Europe programme for research and innovation, as well as contribute to Europe’s Beating Cancer plan.
And the European Commission has unveiled the first building blocks of a broader health package aimed at increasing the range of preparedness tools to respond to future cross-border health threats. Patient-oriented approach A first part of the strategy underlines that “research priorities should be aligned to the needs of patients and health systems.”
Therefore, the whole EU system of pharmaceutical incentives should be reoriented to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases as well as pediatric cancer. An example of unmet medical needs mentioned in the document is antimicrobial resistance (AMR), which decreases a doctor's ability to treat infectious diseases and perform routine surgery. By 2022, the Commission will explore new types of incentives for innovative antimicrobials, as well as measures to restrict and optimise the use of antimicrobial medicines.
The US drug regulatory agency, FDA (Food and Drug Administration), has just issued an Emergency Use Authorization (EUA) for the treatment of mild to moderate intensity COVID-19 in adult and pediatric patients who they have not been hospitalized. The therapy, still under investigation, is based on monoclonal antibodies and goes by the name of bamlanivimab. This therapeutic agent, developed by the pharmaceutical company Eli Lilly, is a monoclonal antibody (mab) similar to those that were part of the cocktail of drugs for COVID-19 that was administered to Donald Trump.
Beginning EU Health Union
The European Commission is beginning the building of the new European Health Union to help strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. The creation of the European Health Union was announced by the European Commission‘s President, Ursula von der Leyen, in her State of the Union address. The Commission is putting forward a set of proposals to reinforce Europe’s health framework as more co-ordination is needed at an EU level in order to step up the fight against the COVID-19 pandemic and future health emergencies.
Protecting the health of European citizens
The proposals focus on revamping the existing legal framework for serious cross-border threats to health, as well as reinforcing the crisis preparedness and response role of key EU agencies such as the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). President of the European Commission, Ursula von der Leyen stated: “Our aim is to protect the health of all European citizens.
The coronavirus pandemic has highlighted the need for more coordination in the EU, more resilient health systems, and better preparation for future crises. We are changing the way we address cross-border health threats. Today, we start building a European Health Union, to protect citizens with high quality care in a crisis and equip the Union and its member states to prevent and manage health emergencies that affect the whole of Europe.”
Von der Leyen urges gradual lifting of coronavirus lockdowns
European governments should lift coronavirus lockdowns and other social restrictions gradually to prevent a third wave of infections, according to European Commission President Ursula von der Leyen. Europe has been grappling with a second surge in Covid-19 infections since September which has led to the re-introduction of lockdowns in certain countries and an overall stepping up of restrictions across the region.
Despite a slowdown in cases in some countries in recent days, the numbers are still high and are not yet showing clear signs of a cresting. In the meantime, Europeans are pondering whether they’ll be able to gather with their families over the holiday period.
News that the AstraZeneca/Oxford vaccine is effective and could have up to 90% efficacy was met with widespread joy on Monday (23 November). “We expect COVID-19 vaccines to develop into a significant market as new products gain approval and begin to meet the high demand for protection from the disease,” according to a brief analysis by Fitch Solutions. It notes that with more products looking likely to pass regulatory hurdles, “these products will help to develop COVID-19 vaccines into a multi-billion-dollar commercial opportunity”.
“Prices are expected to rise in the short-term as countries look to secure access in light of positive Phase 3 trial results, but over the long-term are expected to fall back as new products enter the market,” the briefing added. “Companies will soon be in a position to capitalize on success in Phase III trials through commanding high prices for vaccines,” the analysis states.
Extra plenary session between Christmas and New Year’s Eve
The European Parliament is preparing for an extra plenary session between Christmas and New Year’s Eve to give its consent to a possible post-Brexit trade deal with the UK, according to several EU officials and diplomats. It is likely to be held on 28 December, to give EU governments the opportunity to have the very last say, as foreseen by the bloc’s procedures, before the end of the UK’s Brexit transition period on 31 December.
Private Greek hospitals compelled to take COVID-19 patients
The Greek government took over two private hospitals in Thessaloniki on 19 November in which transmission of the coronavirus has been particularly widespread. The decision was reached after the private clinics failed to voluntarily provide 200 beds for COVID-19 patients despite appeals by the Health Ministry. Public hospitals in Thessaloniki and other parts of northern Greece have been struggling to cope with the influx of coronavirus patients, adding beds from other wards and setting up isolation tents after reaching their official capacities. .
And that is everything from EAPM for now, do stay tuned during the week for further updates on all health-related issues, stay safe, and remember to check out the agenda of EAPM’s 10 December lung cancer round table here, and register here.
Trial of ex-French president Nicolas Sarkozy begins
Nicolas Sarkozy has been under investigation for years He was nicknamed the "bling-bling" president for what many in France saw as his lavish tastes - but now Nicolas Sarkozy (pictured) faces the stark reality of a soulless courtroom. He has gone on trial accused of corruption and influence-peddling, for allegedly trying to bribe a magistrate in return for information about an investigation into his party finances.
Sarkozy is the first ex-president in modern France to appear in the dock. He led France from 2007 to 2012. His first court appearance was brief, however. The session was suspended after 30 minutes - until Thursday - because a key figure in the case, former senior judge Gilbert Azibert, is required to have a medical examination. He is 73 and did not appear in the dock with his co-accused - Sarkozy, 65, and the ex-president's former lawyer Thierry Herzog. There is a question mark over the court proceedings because of the general coronavirus disruption. The trial is set to run until 10 December.
If found guilty, Sarkozy could face a 10-year prison sentence and €1m (£889,000) fine. Another former right-wing president, Jacques Chirac, was given a two-year suspended prison sentence in 2011 for diverting public funds and abusing public trust. The offences dated back to his time as mayor of Paris. But he did not appear in court, owing to ill health. He denied wrongdoing. French magistrates have spent years investigating allegations of corruption dating back to Sarkozy's election campaigns and period in office.
This case is linked to a long-running investigation into the right-wing politician's suspected use of secret donations to fund his 2007 presidential campaign. The prosecution alleges that Sarkozy and lawyer Thierry Herzog sought to bribe Gilbert Azibert with a prestigious job in Monaco in return for information about that investigation.
It is known as the "wiretapping case" in France, because phone calls between Sarkozy and Herzog were tapped in 2013-2014, in which Sarkozy used the alias "Paul Bismuth" and they discussed Judge Azibert. French media report that Sarkozy was heard telling Herzog "I'll get him promoted, I'll help him."
Sarkozy denies any wrongdoing - and he points out that Judge Azibert did not get the Monaco position. "Gilbert Azibert got nothing, I made no approach [on his behalf] and I've been rejected by the Court of Cassation," Sarkozy said in 2014, referring to his battle to clear his name. In October 2013 magistrates dropped him from their investigation into claims that he had accepted illicit payments from L'Oreal heiress Liliane Bettencourt for his 2007 presidential campaign.
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