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More palace intrigue from the Parliament, prospective Health Commissioner Olivér Várhelyi did not receive the nod yesterday evening from the European Parliament. Why? Read the latest from Thomas Mangin [TM].
From the pandemic agreement negotiations, it’s confirmed, they won’t be able to cut a deal before the end of the year. Emma Pirnay [EP] has the latest. |
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| | | | Decision on Várhelyi postponed to Wednesday |
| Olivér Várhelyi will have to wait until Wednesday, 13 November, to find out whether or not he will become the next European Commissioner for Health.
The European Parliament’s political groups were supposed to make a decision this Monday (11 November) after analysing the written responses from the candidate designated by Budapest, but, under pressure from the S&D, the deadline has been pushed to Wednesday.
“We just decided to postpone the decision on the Fidesz Commissioner,” MEP Pascal Canfin, group coordinator for the centrist Renew in the ENVI committee, wrote on X.
Sources indicated to Euractiv that the S&D’s request for extra time is part of a broader framework of negotiations and discussions on other upcoming hearings.
“It’s part of the political game. The S&D wants to wait until Teresa Ribera is appointed,” a source from The Left told Euractiv. The former Spanish Minister for Ecological Transition was designated by Madrid to occupy the powerful post of Executive Vice President for a Clean, Fair, and Competitive Transition.
“MEPs also want to see how tomorrow’s hearings will go before deciding on Olivér Várhelyi, to see if the executive vice-presidents will pass and how the groups will behave with Raffaele Fitto (designated by Rome as Vice-President of the Commission for Cohesion and Reforms) and Teresa Ribera,” confirmed another source from the Renew Europe group to Euractiv. Read the full story here. Back to the top |
| | Will Várhelyi’s answers pass the bar? |
| On Friday (8 November) we looked at the additional questions fired at Health Commissioner-designate Várhelyi. Will the answers pass the bar?
Women’s reproductive health: On the specifics, MEPs wanted a commitment to update the Cross-border Healthcare Directive to ensure that women can access reproductive healthcare in another EU country. Várhelyi didn’t quite deliver this, but he did make a commitment to improve compliance with the directive. ❌ He did, however, revisit his answers on promoting women’s rights using more diplomatic language to say that he would do what was possible within the EU’s competence, adding that he strongly supports the UN goal of universal access to sexual and reproductive care. ✅
Vaccines: Asked what he would do to promote the uptake of “EMA-approved” vaccines and tackle related disinformation and misinformation in all countries, “including your own?” Várhelyi rebuffed the implied criticism of Hungary’s, pointing out that the pharmaceutical legislation allows EU member states to issue emergency use authorisations at national level, “as was the case during the COVID-19 pandemic.” ❌ But, wrote that, “under the proposed pharmaceutical reform, there is a possibility to grant faster temporary emergency marketing authorisations at EU level to address public health emergencies based on a robust assessment by the EMA, enabling a coordinated EU approach in such situations.”✅
AMR: The third question concerned antimicrobial resistance targets. The Parliament said simple monitoring of progress until 2027 will not be sufficient and wanted to know if he will consider legislative actions before 2027. MEPs did not receive this commitment. ❌ But, Várhelyi reassures that he will “step up targeted support” for national action plans and “where needed “ make recommendations for further action under the Serious Cross-Border Health Threats Regulation.✅
Nutrition: MEPs wanted a commitment to “front-of-pack nutrition labelling to promote healthy choices?” Várhelyi described this as “one of the many tools” to inform consumers, without making a commitment. ❌ But, he “will engage [...] on a comprehensive approach that addresses issues including food reformulation, food information, and the marketing of unhealthy food.” ✅
Whether MEPs find these answers satisfactory remains to be seen, but we expect - all other things being equal (see above) - this will be enough to reach a simple majority from committee MEPs. [CF] Back to the top |
| | | | Diplomats ready to cut Gordian knot on regulatory data and market protection periods? |
| Member states will address the issue of market protection periods on 12 and 13 November, as part of ongoing discussions on reform of the EU’s pharmaceutical legislation.
"We are about to get into the real substance of negotiations, and it’s going to get very interesting," a diplomatic source told Euractiv.
"We’ll see if we remain ‘stuck’ on the issue or if we gain some momentum," added the same source.
According to our source, the discussions are expected to take a "highly political" turn, up until now discussions within the Council’s Pharmaceuticals and Medical Devices Working Group have primarily focused on technical questions. Positions on protection periods have to date remained entrenched.
Last week’s working party meetings were dedicated to the issues of market authorisation procedures and drug withdrawals. "It’s technically very important, but it’s not at all political," another source told Euractiv.
The issue of marketing authorisations had already been raised within this working group at the very beginning of October. [TM] Back to the top |
| | | | Pandemic agreement delayed until 2025 |
| The pandemic agreement will be delayed until the World Health Assembly in May 2025, confirmed the intergovernmental negotiating body (INB) on Monday evening (11 November).
Monday was the deadline for agreeing on an extraordinary convening of the World Health Assembly before the end of the year.
Why has it been delayed? The pandemic agreement has now been three years in the making, but key aspects of it still need to be addressed, such as prevention and the pathogen access and benefit-sharing (PABS) system, said French INB ambassador Anne-Claire Amprou in a press briefing.
Precious Matsoso, INB Bureau Co-Chair (South Africa), said that agreeing on the pandemic agreement text was only one phase of the actual treaty, then “real work must begin.”
Asked about the impact of the recent US election, its participation in INB talks and future pandemic treaty negotiations, the WHO’s legal counsel said that the country was only one of the world body’s 194 member states and could not make any speculations about Donald Trump entering office in 2025. “It is not the secretariat’s role to address this,” he said. [EP] Back to the top |
| | Humanitarian situation in Gaza, Lebanon and Sudan has ‘only gotten worse,’ says WHO |
| The convergence of famine, heavy bombardment and attacks on healthcare workers and facilities in Gaza, Lebanon and Sudan has “only gotten worse,” said Dr Hanan Balkhy, World Health Organization (WHO) Eastern Mediterranean regional director on Monday (11 November).
Balkhy spoke of the dire humanitarian situation and famine in northern Gaza, which was recently described as “apocalyptic” by United Nations officials. On Sunday (10 November), the Global Famine Review Committee declared that there is a “strong likelihood that famine is imminent” in the area. “There is no safe place in Gaza, let me reiterate that,” said the regional director.
The WHO said they were able to transfer 90 patients from Gaza to the UAE and Romania in recent days, stating that while safe evacuation is a success, this means “civilians leave their communities and families behind, who are trapped.”
Additionally, they were able to carry out seven humanitarian missions to north Gaza, adding that several more were planned but not facilitated.
In Lebanon, the regional director said the situation was “equally distressing,” counting 103 attacks on healthcare since 8 October in the country.
“As of today, 17 hospitals have either ceased functioning or have damaged infrastructure. And 127 primary healthcare centres and dispensaries were forced to close,” said Dr Balkhy.
Describing the famine in Sudan, she said that every second Sudanese person requires humanitarian aid. “This agriculturally rich land is encountering one of the world’s worst famines,” she said.
The regional director also spoke of WHO vaccination efforts to slow the cholera outbreak in Sudan, which has reported 3,328 cases since January 2024. [EP] Back to the top |
| | | | | Greece, Slovakia and Poland’s clinical trial performance points to EU fragmentation |
| Greece, Poland, Slovakia - Despite a global surge in clinical trials over the past decade, Europe’s role in advancing new medical treatments is waning. As the EU struggles to regain competitiveness, fragmentation is dragging the sector.
A report on clinical trials conducted by IQVIA for EFPIA and Vaccines Europe shows significant country-level variation within the EEA. Even those who register some rise in percentages, like Greece and Slovakia, still face obstacles that restrain meaningful growth.
“European clinical trials are hampered by a slow and fragmented research ecosystem, and current initiatives, at the current pace, are insufficient to stop and reverse a decade of decline,” Nathalie Moll, Director General of EFPIA, said in the press release.
To increase Europeans’ opportunities to access medical breakthroughs and for Europe to be competitive, “It needs to function as a unified region, not as individual Member States and be supported by policies to attract global research investment,” she added.
Greece needs an improved incentive system: The report shows that all but three EEA countries registered a fall in the absolute number of trials starting in 2023 compared to 2018. Greece had 105 commercial clinical trials starting in 2018 and recorded a steady rise to 151 in 2022, but the number fell to 106 in 2023.
A study conducted by SFEE in collaboration with PwC underlined the need for a national strategic plan to facilitate patient participation, simplify procedures, reduce bureaucracy, improve approval times, provide incentives for research and development, and promote the training of hospital administrative staff.
“In a moderate scenario, that is, if we manage to reach the European average based on the size of our country, we can attract an initial investment - over a three-year period - of €400-500 million per year. In this way, we can achieve GDP growth and create thousands of new jobs,” Himonas of SFEE said.
Slovakia witnesses a drop in trials: The executive director of AIFP, the Slovak Association of Innovative Pharmaceutical Industry, Iveta Pálešová, explained, the number of trials and patients included have been dropping.
“If we compare the data from the same survey in previous years (excluding the COVID-19 period), we see that the number of clinical trials and treated patients has been systematically decreasing.”
Pálešová estimates that even though the European information system for clinical trials was launched in 2022, its functionality will not benefit patients unless conditions for conducting clinical trials improve directly in Slovakia and their implementation becomes a priority within Slovak healthcare.
“The establishment of a permanent advisory body for clinical trials within the Ministry of Health offers hope and a means to achieve this goal. This body could contribute to unifying the regulatory environment for clinical trials, as well as bring about further administrative improvements," she said.
Poland has something to aim for: “Poland’s potential is far greater, and if we begin to see clinical trials as an integral part of the healthcare system, the country has significant scope to increase the volume of clinical trials,” said Michał Byliniak, Director-General of The Employers’ Union of Innovative Pharmaceutical Companies (INFARMA) told Euractiv.
According to Byliniak, this is evidenced by Poland's rate of commercial clinical trials per capita, which is currently at 0.82, “while in some countries, it’s twice as high, giving us something to aim for.”
“This is not only important for the economy and medical advancement but most importantly for patients who are losing access to the latest therapies, often therapies of last resort,” he added. Read the full story here. Back to the top |
| | Mental health support for Valencia flood victims |
| Spain - Following that catastrophic floods in Valencia (DANA), Spain’s Health Minister Mónica García has approved additional mental health support for the region.
Fourteen “direct action” mental health multidisciplinary teams will be established, García said, “We face the devastating psychological impact that a catastrophe of this type can leave in the long term.”
“We guarantee immediate support to reduce psychological suffering, but we also promote a model of ongoing mental health care, designed to address the emotional consequences that may arise or worsen in the long term, once the emergency has passed.”
The response has two layers, one community-based, the other at a specialized level, where clinical conditions such as Post-Traumatic Stress Disorder will be treated.
“Every story counts and we care about mental health as much as physical health,” she said. “Once the floods have passed, accompanying these experiences and providing support is as important as restoring infrastructure.” Back to the top |
| | Italy marks its first ‘National Mens’ Health Day’ |
| Italy - "We wanted to promote this Day to focus attention on human health and the importance of preserving it in all phases of life, with an increasingly personalised medical approach,” said Italian Health Minister Orazio Schillaci, on the occasion of the first edition of the National Day for Men's Health, which took place in Rome on 11 November 11, in collaboration with the Federation of Italian Medical-Scientific Societies, FISM.
"Compared to women, men have a lower life expectancy and many studies confirm that women pay more attention to health and disease prevention than men, who are more exposed to cardiovascular and oncological diseases,” said the minister. “Among these, the most frequent inthe male population is prostate cancer, a challenge that we are facing thanks to a first-level urological and andrological scientific community.”
“To live better and longer, prevention is essential. For this reason, we are committed to increasing awareness of the importance of adopting correct lifestyles, participating in screening programs and periodic check-ups,” the minister said that this was important for all age groups. Back to the top |
| | | | | | | | | INB, Pandemic Agreement, Geneva |
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| | Briefing Health Emergencies in the Eastern Mediterranean |
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| | LinkedIn live Q&A session about antimicrobial resistance |
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| | | | | Working Party on Pharmaceuticals and Medical Devices |
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| | Commissioner-designate hearings 14:30 - 17:30 Stéphane Séjourné, Executive Vice-President-designate of the European Commission for Prosperity and Industrial Strategy 18:30 - 21:30 Teresa Ribera, Executive Vice-President - Spain Commissioner-designate: Clean, Just and Competitive Transition* |
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| | INB, Pandemic Agreement, Geneva |
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| | | | | Working Party on Pharmaceuticals and Medical Devices |
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| | Request for Council authorisation for Commission’s endorsement, on behalf of the Union, of the “Jeddah commitments” from the 4th global high-level ministerial conference on antimicrobial resistance |
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| | | New date for Olivér Várhelyi approval as EU Health Commissioner |
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| | INB, Pandemic Agreement, Geneva |
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| | | Steering Group on Shortages and Safety of Medicinal Products (MSSG) |
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| | | | Mini-plenary, Brussels Debate on Enhancing Europe’s civilian and defence preparedness |
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| | INB, Pandemic Agreement, Geneva |
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| | | | | Case T-36/23 Stevi and The New York Times v Commission Access to text messages exchanged between the President of the Commission and the Chief Executive Officer (CEO) of the pharmaceutical company Pfizer. |
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| | *Hearings followed by the health team |
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| | | | | Today’s brief was brought to you by Euractiv’s Health team |
| | | | | Today’s briefing was prepared by the Health team: Catherine Feore, Clara Bauer-Babef, Emma Pirnay, Thomas Mangin, and Lydia Williams. Additional reporting by Filip Áč, Vasiliki Angouridi and Paulina Mozolewska. Share your feedback or information with us at digital@euractiv.com. |
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