Gerald HAUSER

Policy topics Gerald HAUSER is active on

What Gerald HAUSER has said (80)

• 2026-03-25 “Answer given by Executive Vice-President Séjourné on behalf of the European Commission 8.6.2026 Written question In July 2025, the Commission published its proposal for the European Competitiveness Fund (ECF) [1] , which, once adopted, will mobilise an unprecedented budget for European competitiveness. The Commission supports Member States to strengthen their health systems via funding, technical assistance, knowledge sharing and policy advice. Under the ECF proposal, the Fund aims to strengthen the efficiency, innovation and resilience of health systems. Member States can also use the national and regional partnership plans [2] to facilitate access to healthcare services and associated infrastructure. The ECF is proposed to support energy projects and infrastructure that will bring down energy costs overtime, mobilising the uptake of clean energy and related technologies. The ECF aims to support the creation of a digitalised, reliable and resilient European energy system and the single energy market. Moreover, the AccelerateEU Communication [3] presented on 22 April 2026 includes immediate targeted and temporary actions to be implemented by Member States to protect households and industry from high energy prices. Data protection and privacy are cornerstones of the European Digital Identity Wallets (EUDIWs). The General Data Protection Regulation [4] fully applies to data processing under the European Digital Identity Regulation [5] . The legal framework is built on the premise that EUDIWs users shall have full control of their wallet data and EUDIWs providers shall not collect information not necessary for the provision of wallet services. The use of EUDIWs will be voluntary and will offer a pseudonym function. [1] https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:52025PC0555. [2] https://commission.europa.eu/topics/budget/eu-budget-2028-2034-explained/investing-people-member-states-and-regions_en. [3] https://energy.ec.europa.eu/publications/accelerateeu-energy-union-affordable-and-secure-energy-through-accelerated-action_en. [4] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02016R0679-20160504. [5] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.257.01.0073.01.ENG.”
  Climate efforts · Defence spending
• 2026-03-20 “Answer given by Mr Hansen on behalf of the European Commission 20.5.2026 Written question 1. A simpler and more flexible Common Agricultural Policy (CAP) will be delivered through national and regional partnership (NRP) plans [1] . In the context of multiple pressing EU priorities to address, the proposal guarantees a minimum ring-fenced amount of EUR 293.7 billion for farmers income support. This shows a recognition of the crucial role of farmers and the CAP to build an attractive, competitive and sustainable agri-food sector. 2. The guaranteed amount in the legislation ensures stability and predictability for the farming community. The amount can and will need to be complemented by Member States in accordance with their needs, by accessing the unallocated part of the NRP fund. The Commission suggested a rural target of 10% [2] to strengthen support for rural areas. In addition, to ensure further resources are accessible for Member States as of 2028 for addressing the needs of farmers and rural communities, the Commission has proposed that Member States will be able to access to up to two-thirds of the flexibility amount [3] in the plans, normally available for the stage of the midterm review. 3. The advantage of a simpler, more flexible CAP, delivered through NRP plans, is that it offers Member States increased flexibility, bringing policies together to deliver better results. The NRP plans are tailored to Member States’ needs, while ensuring predictability for long-term investment and support for farmers and regions, and increased flexibility in a fast-changing world . The NRP plans provide a harmonised planning and reporting framework that foster synergies and a leverage effect across different funding elements, while supporting EU common objectives and priorities. [1] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52025PC0565&qid=1753801752960. [2] This translates into EUR 48.7 billion, or over EUR 63 billion if the Catalyst Europe loans are also included. Only the amounts dedicated by Member States towards rural areas beyond the ring-fenced amounts would count towards reaching this target (Proposal in the letter of the Commission President, November 2025) . [3] Amounting to around EUR 45 billion (Proposal in the letter of the Commission President, January 2026).”
  Direct payments to farmers (pillar 1) · Agricultural funding
• 2026-03-17 “Answer given by Mr Síkela on behalf of the European Commission 29.5.2026 Written question The Commission cooperates with a range of partners in Pandemic Preparedness, Prevention and Response (PPPR). All financial support is governed by the Financial Regulation [1] , with strict rules on transparency, avoidance of conflicts of interest and protection of the EU’s financial interests. Information on direct beneficiaries of EU funds is published via the Financial Transparency System [2] and annual reports on the implementation of the EU budget, allowing citizens to identify the beneficiaries and the amounts received. The Commission does not regard pandemics, vaccines or medicines as a ‘business model’. EU action on PPPR is set inter alia in the EU Global Health Strategy [3] , R egulation (EU) 2022/2371 on serious cross-border threats to health [4] , the Medical Countermeasures Strategy [5] , and the upcoming EU global health resilience initiative [6] . Objectives of these policies include protecting health and wellbeing, supporting resilient health systems through equitable access to safe, effective and affordable vaccines and medicines and universal health coverage, and strengthening prevention, preparedness and response to health emergencies. The Commission has not invested in the World Bank’s pandemic bonds launched in 2017 and consequently there were no related profits or losses. [1] https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32024R2509. [2] https://ec.europa.eu/budget/financial-transparency-system/index.html. [3] https://health.ec.europa.eu/publications/eu-global-health-strategy-better-health-all-changing-world_en and https://health.ec.europa.eu/latest-updates/report-implementation-eu-global-health-strategy-2025-07-10_en. [4] https://eur-lex.europa.eu/eli/reg/2022/2371/oj/eng. [5] https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en. [6] https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/17412-EU-global-health-resilience-initiative_en.”
  Support for international humanitarian organisations · EU Development & Humanitarian Aid
• 2026-03-09 “Answer given by Mr Várhelyi on behalf of the European Commission 7.5.2026 Written question Cancer incidence estimates and historical data for European countries are available in the European Cancer Information System (ECIS) [1] . The European Cancer Inequalities Registry [2] , a flagship of Europe’s Beating Cancer Plan [3] , tracks cancer disparities in the EU, Norway and Iceland. Its Data Tool integrates data from ECIS, whilst Country Cancer Profiles [4] and EU Analytical Reports [5] provide national analyses and EU-level comparisons. The reported number of new cancer cases grew across Member States up to 2020. This trend continued until 2022, when 2.78 million new cancer cases were estimated, a 2.4% rise from 2020. Since 2021, cancer incidence is stabilising or increasing moderately, with 2.7 million new cases estimated in 2024. However, data enabling robust analysis from 2021 will become available in the second half of 2026, following the 2026 ECIS update where incidence data for 2021-2024 will be published. Cancer incidence varies between Member States, with Central and Eastern European countries generally showing higher rates. However, in 2024 Denmark was estimated to rank highest for incidence (22% above the EU average) and Bulgaria lowest (26% below), in contrast to the general trend. These disparities likely stem from differences in prevalence of risk factors, population structures and ageing, existence and effectiveness of prevention and screening programmes, quality of diagnosis and treatment. From the data registration perspective, quality and completeness of cancer registries also play a role. Finally, the Commission refers the Honourable Member to the answer to Parliamentary Question E-002078/20257 [6] , detailing that there is no scientific evidence of any increase of cancer occurrence following COVID-19 vaccination. [1] https://ecis.jrc.ec.europa.eu/. [2] https://cancer-inequalities.jrc.ec.europa.eu/. [3] https://commission.europa.eu/topics/public-health/european-health-union/cancer-plan-europe_en. [4] https://cancer-inequalities.jrc.ec.europa.eu/country-cancer-profiles-2025. [5] https://cancer-inequalities.jrc.ec.europa.eu/sites/default/files/oecd-ecir-beating-cancer-inequalities-05022024.pdf; https://cancer-inequalities.jrc.ec.europa.eu/sites/default/files/docs/ar2026/Analytical-report-2026.pdf. [6] https://www.europarl.europa.eu/doceo/document/-ASW_EN.html.”
  Vaccination · Pharmaceuticals regulation in EU
• 2026-03-04 “Answer given by Mr Várhelyi on behalf of the European Commission 27.5.2026 Written question The EU import control system operates at several levels. It includes audits in third countries to verify that they have effective controls in place, preventing unsafe goods from being dispatched to the EU. It also provides for risk-based controls at EU borders to detect non-compliances upon entry, and random sampling and testing in the EU. The EU framework ensures that if an issue is detected after import, it is communicated through the EU rapid alert networks and addressed in a coordinated manner across all Member States. In this context, during the Commission audit in Brazil in October 2025 [1] , auditors identified consignments of beef from female cattle treated with a hormone banned in the EU, exported to the EU. Information was swiftly shared with all Member States that received these consignments. The Commission has no confirmation of hormonal residues found by Member States in any of these consignments. In response, the Commission increased the minimum frequency rates of physical check rates for bovine minced meat and meat preparations from Brazil up to 50%, and for other bovine fresh meat up to 30% [2] . Member States were advised to sample these products. None of the laboratory tests revealed unsatisfactory results. Under Regulation (EU) 2022/1646 [3] , Member States must test at least 7% of imported bovine consignments for pharmacologically active substances. Additionally, the Commission evaluates third countries' residue control plans, results of their implementation annually, and audits the execution of residue controls. For 2026 and 2027, the Commission has increased its audits on countries exporting to the EU by 50% and at border control posts by 33%. The EU’s system is designed to respond swiftly and effectively whenever a risk emerges. [1] https://ec.europa.eu/food/audits-analysis/audit-report/details/4975. [2] According to Article 5(3) of Commission Implementing Regulation (EU) 2019/2129 of 25 November 2019 establishing rules for the uniform application of frequency rates for identity checks and physical checks on certain consignments of animals and goods entering the Union. OJ L 321 12.12.2019, p. 122. (http://data.europa.eu/eli/reg_impl/2019/2129/2021-12-26). [3] Commission Implementing Regulation (EU) 2022/1646 of 23 September 2022 on uniform practical arrangements for the performance of official controls as regards the use of pharmacologically active substances authorised as veterinary medicinal products or as feed additives and of prohibited or unauthorised pharmacologically active substances and residues thereof, on specific content of multi-annual national control plans and specific arrangements for their preparation. OJ L 248, 26.9.2022, pp. 32. (https://eur-lex.europa.eu/eli/reg_impl/2022/1646/oj/eng).”
  Trade relations with Mercosur · Maximum residue levels · Import of agri-food products in the EU
• 2026-03-04 “Answer given by Mr Hansen on behalf of the European Commission 10.6.2026 Written question The Commission is closely monitoring developments in the Strait of Hormuz and their implications for fertiliser markets. In the short term, no immediate physical shortages of nitrogen fertilisers are expected in the EU, notably due to limited direct import exposure to this region of the world and recent increased imports in the EU. However, the events have contributed to increased global fertiliser price volatility, which is also reflected in EU markets. At this stage, no immediate risks to food availability in the EU are identified. In the medium term, sustained disruptions could further tighten global fertiliser supply, putting upward pressure on prices, including through higher energy costs affecting domestic production. Higher fertiliser prices also increase production costs for farmers and could, over time, contribute to increased food prices, depending on the duration of the disruption. The Commission is taking action through the Fertiliser Action Plan adopted on 19 May 2026 [1] , which includes measures to strengthen EU domestic fertiliser production capacity and reduce strategic dependencies on imported energy and fertiliser feedstocks. The Plan supports investment in low carbon, and bio-based fertilisers, promotes circular and recycled nutrients, and aims to diversify supply chains and improve resilience across the fertiliser value chain. The Commission is also supporting nutrient use efficiency to reduce dependency on imported mineral fertilisers over the longer term. [1] https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1099.”
  Use of fertilisers
• 2026-02-27 “E-000830/2026 Answer given by Mr Várhelyi on behalf of the European Commission The Commission, together with the European Medicines Agency (EMA) and Member States, monitors the safety of COVID-19 vaccines, including data from the scientific literature, through a robust pharmacovigilance system 1 . Based on the continuous monitoring and assessment of safety data from vaccination campaigns worldwide, there is no scientific evidence of any association between COVID-19 vaccines and impaired fertility in men or women. Detailed information on the continuous safety monitoring of COVID-19 vaccines can be found on the EMA website, including the Periodic Safety Update Reports 2 for each vaccine and the report on pharmacovigilance activities carried out by Member States and the EMA between 2019 and 2022 3 . While there have been some reports about the short-term variation of fertility trends during the pandemic, this was attributed to behavioural changes, as in most of the studied countries the fertility rates returned to pre-pandemic levels and no evidence of effect of COVID-19 vaccinations on fertility trends was found 4,5,6 . Based on the existing scientific evidence, the Commission does not consider a specific study on this matter to be necessary. It should be noted that EU citizens and healthcare professionals are informed in a timely manner about the latest scientific decisions taken by the EMA. Following each meeting of the EMA’s safety committee (Pharmacovigilance Risk Assessment Committee - PRAC 7 ), decisions are communicated through the PRAC highlights 8 . In addition, exceptional measures for COVID-19 medicines were implemented by the EMA to maximise the transparency of its regulatory activities related to COVID-19 medicinal products 9 . 1 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines/safety-covid-19-vaccines. 2 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines#authorised-covid-19-vaccines-14489. 3 https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview/legal-frameworkpharmacovigilance/implementation-pharmacovigilance-legislation#multi-annual-reports-on-pharmacovigilanceactivities-12875. 4 COVID-19 vaccination carries no association with childbirth rates in Sweden: https://www.nature.com/articles/s43856-026-01396-x. 5 Birth rate decline in the later phase of the COVID-19 pandemic: the role of policy interventions, vaccination programmes, and economic uncertainty: https://academic.oup.com/hropen/article/2024/3/hoae052/7754492#google_vignette. 6 Max Planck Institute for Demographic Research - How have Covid-19 vaccinations affected birth rates?: https://www.demogr.mpg.de/en/news_events_6123/news_press_releases_4630/news/how_have_covid_19_vacci nations_affected_birth_rates_14112/. 7 Pharmacovigilance Risk Assessment Committee (PRAC): https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac. 8 https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-912-march-2026. 9 Transparency: exceptional measures for COVID-19 medicines: https://www.ema.europa.eu/en/humanregulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/transparencyexceptional-measures-covid-19-medicines.”
  Sexuality and reproduction · Vaccination
• 2026-02-23 “E-000739/2026 Answer given by Mr Várhelyi on behalf of the European Commission In March 2025, the Commission proposed the Critical Medicines Act 1 (CMA) to strengthen the availability and security of supply of critical medicines. The CMA proposal follows the ordinary legislative procedure. In this context, the European Parliament proposed an EU coordination mechanism for critical medicines, allowing the Commission to monitor stock levels across the EU and manage stock redistribution between countries in cases of shortages. This redistribution mechanism is not part of the Commission’s proposal. The organisation of healthcare system is a national competence. The Commission’s proposal focuses on national contingency stock requirements, which are obligations imposed on supply chain actors to hold buffer stocks of certain medicines to mitigate the risk of supply chain disruptions. Member States must ensure that these national requirements do not adversely affect the supply to other Member States, are proportionate, and adhere to the principles of transparency and solidarity. Furthermore, the CMA proposes collaborative procurement mechanisms involving the Commission at the request of Member States. 1 Proposal for a Regulation of the European Parliament and of the Council laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest and amending Regulation (EU) 2024/795.”
  Government stockpiling of critical medicines · EU competences on health
• 2026-02-16 “E-000647/2026 Answer given by Executive Vice-President Séjourné on behalf of the European Commission The Commission does not systematically assess situations involving residence-based price differences. Where relevant, criteria for assessment may include capacity constraints, strain on infrastructure, the extent of public financing, geographical scope, and any quotas or time limitations. Such measures must aim to achieve a legitimate public interest objective and be appropriate, necessary and proportionate to that aim. Accordingly, such assessments are done on a case-by-case basis. The Commission is not aware of any EU projects involving residence-based tariffs. The European Court of Justice has recognised a range of public interest objectives which may justify restrictions of fundamental freedoms under the Treaty on the Functioning of the European Union, including when they affect recipients of services. These include public policy, public security, public health, consumer protection, the protection of the environment, the preservation of fair market conditions and the protection of recipients of services, among others. Member States are free to choose measures to protect these objectives, provided such measures are non-discriminatory, necessary, and proportionate in accordance with EU law 1 . 1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32006L0123.”
  EU Competition policy
• 2026-02-05 “E-000461/2026 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Commission firmly rejects the censorship allegations made in the report of 3 February 2026 by the Judiciary Committee of the U.S. House of Representatives, which are unsubstantiated and unfounded. The Digital Services Act (DSA) 1 protects freedom of expression by empowering users to obtain explanations and redress if their content is removed or restricted. It sets unparalleled standards for user empowerment, fundamental rights safeguards, transparency 2 . It also requires all key enforcement decisions to be published, which is done on a dedicated website 3 . Engaging with providers on how their systems and practices operate is a normal and necessary part of regulatory oversight. Interpreting such exchanges as a means to influence political debate misrepresents the nature of regulatory dialogue. The Code of Conduct on Disinformation 4 is a self-regulatory instrument developed by its signatories, including online platform providers and other relevant players. It promotes a transparent and fair online environment while fully upholding freedom of speech: the Code focuses on providing more context for users to navigate safely in the online environment and counter manipulative practices (e.g. the use of fake accounts or bots), not on removing content. The Commission does not provide financial support to signatories for their participation in the Code 5 . None of the instruments mentioned by the Honourable Member provides grants or financial support to any other organisations. Every year, the Commission reports to the European Parliament and the Council on the costs of the Commission's actions in the scope of the DSA 6 . 1 Regulation (EU) 2022/2065 on a single market for digital services and amending Directive 2000/31/EC (Digital Services Act), http://data.europa.eu/eli/reg/2022/2065/oj/eng. 2 https://digital-strategy.ec.europa.eu/en/news/two-years-digital-services-act-allows-50-million-contentmoderation-decisions-platforms-be-reversed. 3 https://digital-strategy.ec.europa.eu/en/policies/list-designated-vlops-and-vloses. 4 https://digital-strategy.ec.europa.eu/en/library/code-conduct-disinformation. 5 All the information about EU funded projects is available at the EU Funding & Tenders Portal, https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/home. 6 Latest report on the overall amount of the costs incurred for the fulfilment of the tasks under DSA; for the year 2024, https://digital-strategy.ec.europa.eu/en/library/annual-report-costs-incurred-fulfilment-commissions-tasksunder-digital-services-act-dsa-2024.”
  Disinformation & online freedoms · Digital platforms liability for harmful and illegal content
• 2026-02-03 “E-000422/2026 Answer given by Mr Várhelyi on behalf of the European Commission With regard to gain-of-function research, the Commission refers the Honourable Member to the answers to Parliamentary Questions E-002369/2025 1 and E-004131/2025 2 , detailing the Commission's risk management measures, eligibility criteria, ethical considerations and security checks to support gain-of-function research on respiratory diseases. It is imperative that all research activities rigorously adhere to established scientific methods, demonstrate measurable scientific excellence, and operate within the bounds of the applicable legal frameworks, including strict compliance with norms, safety regulations, and security standards, particularly when research involves the handling or manipulation of pathogenic viruses. Beyond ensuring compliance with relevant national, EU, and international legislation, research activities funded through Horizon Europe must also strictly follow the principles of research ethics and integrity 3 . Any research activity that presents disproportionate or unmitigated risks to human health, the environment, or society at large is deemed ineligible for funding. This ensures that Horizon Europe upholds the highest standards of responsibility, safety, and societal accountability. With regard to the origin of the COVID-19, the Commission refers the Honourable Member to the answers to Parliamentary Questions E-003628/2025 4 , E-002534/2025 5 , E-001403/2025 6 and E-001040/2025 7 , detailing when and from what source EU institutions became aware of a possible upcoming COVID-19 pandemic and the Commission’s view of the origin of the SARS-CoV2 virus. 1 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 2 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 3 As spelled out in Article 19 of the Horizon Europe Regulation: ELI: http://data.europa.eu/eli/reg/2021/695/oj. 4 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 5 https://www.europarl.europa.eu/doceo/document/P-10-2025-002534-ASW_EN.html. 6 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 7 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html.”
  EU competences on health · Pharmaceuticals regulation in EU
• 2026-01-30 “E-000398/2026 Answer given by Mr Várhelyi on behalf of the European Commission mRNA vaccines authorised in the EU against COVID-19 are not genetically modified organisms and do not contain genes as their active substance. They are not used with the aim to restore, correct, or modify human genes. Therefore, they are not considered a gene therapy. mRNA vaccines are biotechnology medicinal products regulated under the EU pharmaceutical legislation to ensure their quality, safety, and efficacy. The definitions and detailed requirements for gene therapy and somatic cell therapy medicinal products were updated in 2009 1 to take into account scientific and technical progress in the field of advanced therapies, as reflected in Regulation (EC) No 1394/2007 2 . Hundreds of millions of people worldwide have received the mRNA COVID-19 vaccines. All EU-authorised medicines, including mRNA vaccines, are continuously and rigorously monitored. According to the European Medicines Agency, enhanced monitoring has found no safety issues related to the distribution of vaccine components 3 . 1 ELI: http://data.europa.eu/eli/dir/2009/120/oj. 2 ELI: http://data.europa.eu/eli/reg/2007/1394/oj. 3 COVID-19 vaccines: key facts: https://www.ema.europa.eu/en/human-regulatory-overview/public-healththreats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-vaccines-key-facts#mrna-covid-19-vaccines7221.”
  Pharmaceuticals regulation in EU · Vaccination
• 2026-01-29 “E-000367/2026 Answer given by Mr Várhelyi on behalf of the European Commission Data on COVID-19 mortality were updated and publicly reported by the European Centre for Disease Prevention and Control (ECDC) on a daily basis at the beginning of the pandemic. Those data reflected the rapid data collected by ECDC from the individual Member States. All countries that made these data available were included in the statistics at any time. The vaccines used during the COVID-19 pandemic 1 went through rigorous testing in clinical trials to prove their safety and efficacy and have been authorised on the basis of a positive risk/benefit balance. The approval process used in the EU is described on the European Medicines Agency (EMA) website 2 . It is estimated that COVID-19 vaccination prevented 2.5 million deaths during the pandemic globally 3 and 1.6 million in Europe 4 , mostly among older adults. The Commission would like to note that the article on ‘Hydrothermotherapy’ referenced in the question is described by the authors as a hypothesis report and not a study of cause and effect 5 . 1 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines/covid-19-vaccines-key-facts. 2 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-public-health-emergency-international-concern-2020-23/covid-19-vaccines-developmentevaluation-approval-monitoring. 3 https://jamanetwork.com/journals/jama/fullarticle/2837831#250554726. 4 https://pubmed.ncbi.nlm.nih.gov/39127051/. 5 https://pmc.ncbi.nlm.nih.gov/articles/PMC7668174/.”
  Vaccination · EU measures on lifestyle-related behaviours (smoking, drinking, eating, etc.)
• 2026-01-29 “Answer given by Mr Jørgensen on behalf of the European Commission 27.5.2026 Written question Data on evictions are collected, analysed and disseminated by national authorities in the Member States. Any potential future developments at EU level in this regard would need to meet the core quality requirements [1] . The Affordable Housing Database [2] developed by the Organisation for Economic Cooperation and Development includes data on evictions, however it has several limitations, related to different stages of an eviction process, timing of data collection, uneven coverage of jurisdictions, and gaps regarding mortgage foreclosures. The Commission is advancing the implementation of the European Affordable Housing Plan (EAHP) [3] , and as part of the actions thereof, seeks to identify successful models and best practices that align property rights protection with tenant security. Regarding EU funds available for housing, at least EUR 45 billion have been mobilised in housing related investment [4] . Overall, it is challenging to get more granular data per year on disbursement of funds given that no granular data collection on housing, nor on evictions, is available under the existing reporting setup. Housing supply is subject to many rules at various levels — most rules being set at Member State, regional or local level — which aim to preserve safety and quality of life, promote social and economic objectives, and protect environment and cultural heritage . But too often they lead to unnecessary administrative complexity resulting in unnecessary costs and delays, restricting the supply of housing where it is most needed. As announced in the EAHP, the Commission will contribute to cutting red tape to facilitate the supply of affordable and sustainable housing where it is most needed by presenting a housing simplification package in 2027. [1] Ones that would be aligned with the European Statistics Code of Practice. [2] https://www.oecd.org/en/data/datasets/oecd-affordable-housing-database.html. [3] COM/2025/1025 final, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC1025. [4] This amount includes (1) the Recovery and Resilience Facility that supports housing investments and reforms for a total of EUR 19.6 billion, (2) the Cohesion Policy where EUR 10.4 billion is dedicated for energy efficiency and social housing and EUR 3.3 billion has been received from Member States and regions to reprogramme Cohesion funds under the Mid-term review, (3) the European Social Fund+ that finances a number of activities for a total of EUR 4.4 billion, (4) the InvestEU Fund that fosters public and private investment through an EU budget guarantee (app. EUR 7 billion mobilised by December 2025) and provides local project development support (EUR 25 million by December 2025) via the InvestEU Advisory Hub, (5) the LIFE programme that has devoted EUR 138 million by December 2025 for market uptake and capacity building activities and (6) the Horizon Europe programme that has invested EUR 540 million by December 2025 for research and innovation.”
  EU housing policy · EU expenditure on social policy
• 2026-01-20 “Answer given by Mr Várhelyi on behalf of the European Commission 7.4.2026 Written question 1. The Commission did not issue guidance about the use of ICD-10 codes, — the International Classification of Diseases, Tenth Revision, Clinical Modification [1] — for classifying deaths as due to COVID-19. The European Centre for Disease Prevention and Control (ECDC), in order to facilitate surveillance of the disease at EU-level, issued COVID-19 surveillance guidance [2] . EU-level reporting to the ECDC was carried out by collecting data on the basis of definitions established at national level. 2. The investigation, and correction of doubtful medical diagnoses and statistics in a specific Member State falls within the competence of that Member State. 3. As regards secondary use of personal electronic health data, the European Health Data Space Regulation [3] focuses on making existing data available cross-border, and on making data quality transparent. It does not regulate the collection of data at source. [1] https://www.cdc.gov/nchs/icd/icd-10-cm/index.html. [2] https://www.ecdc.europa.eu/sites/default/files/documents/COVID-19-surveillance-guidance.pdf. [3] Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847, OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj.”
  Processing of health data · EU competences on health
• 2026-01-12 “Answer given by Ms Šuica on behalf of the European Commission 23.3.2026 Written question The Commission acknowledges the importance of addressing demographic trends in the EU. It also notes the challenges posed by declining birth rates and is committed to promoting policies that support families, whilst recognising women’s autonomy in deciding whether to have children or not. The Demography Toolbox [1] is the EU response to current demographic challenges. It includes a wide range of measures structured around four pillars, one of them devoted to help create favourable conditions for people to pursue their life and family aspirations, while fostering gender equality. In this respect, taking into account the division of competences with Member States, the EU has put forward the Work-Life Balance Directive [2] , the Pregnant Workers Directive [3] , the Child Guarantee [4] , the Council Recommendation on early childhood education and care [5] and the Gender Equality Strategy [6] . The Work-Life Balance Directive introduced the right to compensated paternity and parental leave, a right to carers’ leave and a right to request flexible working arrangements for all working parents. The assessment of the implementation of the Work-Life Balance Directive, due in 2027, will provide an opportunity to assess whether the rules still fit the evolving working practices. [1] Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Demographic change in Europe: a toolbox for action COM/2023/577 final. [2] Directive (EU) 2019/1158 of the European Parliament and of the Council of 20 June 2019 on work-life balance for parents and carers and repealing Council Directive 2010/18/EU. [3] Directive 92/85/EEC on the introduction of measures to encourage improvements in the safety and health of workers who are pregnant, have recently given birth or are breastfeeding. [4] Council Recommendation (EU) 2021/1004 of 14 June 2021 establishing a European Child Guarantee. [5] Council Recommendation of 8 December 2022 on early childhood education and care: the Barcelona targets for 2030 (2022/C 484/01). [6] https://commission.europa.eu/strategy-and-policy/policies/justice-and-fundamental-rights/gender-equality/gender-equality-strategy_en .”
  Sexuality and reproduction · Support for families · EU strategy on population growth
• 2025-11-20 “E-004637/2025 Answer given by Ms Lahbib on behalf of the European Commission The Health Emergency Preparedness and Response Authority (HERA) is a service of the Commission, not an EU decentralised agency. HERA is fully integrated into the Commission’s administrative, financial and governance framework. The European Court of Auditors (ECA) systematically audits HERA’s budget and financial transactions as part of its audits of the Commission. The implementation of HERA’s budget is subject to the same budgetary control procedures as the other Commission services, with ensured political accountability. HERA mobilises funds under various programmes, with budgets set by the budgetary authority. For 2022-2027, HERA draws its budget from the EU budget with a budget initially estimated at EUR 6 billion 1 and subsequently adjusted downwards by the budgetary authority as part of the midterm revision of the current multi-annual financial framework 2 . 1 See COM(2021) 576 of 16.09.2021. 2 See Council Regulation (EU, Euratom) 2024/765 of 29 February 2024 amending Regulation (EU, Euratom) 2020/2093 laying down the multiannual financial framework for the years 2021 to 2027.”
  Accounting and auditing of EU budget · Size of EU budget
• 2025-10-29 “E-004254/2025 Answer given by Mr Várhelyi on behalf of the European Commission The European Medicines Agency considers the totality of safety data when monitoring the safety of COVID-19 vaccines, including the medical literature. This specific study, and other relevant studies, are reviewed as part of the continuous safety monitoring of all approved medicines. At this time, there has been no confirmed signal of cancer following COVID-19 vaccination. Causes of cancer are multifactorial, with established risk factors including, among others, smoking, obesity, ultraviolet radiation, alcohol, diet, infections including human papillomavirus (HPV), pollution, hormones, age, and genetic predisposition. Accounting for all the relevant risk factors already present in the general population and the lag time between exposure to any of these risk factors and a cancer diagnosis poses significant methodological challenges for studies aiming to link cancer to specific causes. The European Medicines Agency and Member States continue to monitor all evidence on the safety of COVID-19 vaccines and investigate any possible causal link with vaccinations as part of the continuous monitoring. If a risk is identified, it will be included in the vaccine’s product information and the Commission will take any necessary regulatory action as needed, including to ensure appropriate communication by the European Medicines Agency to healthcare professionals and patients. It is noteworthy that a recent study published in Nature, showed that on the contrary, mRNA COVID-19 vaccination improved survival of patients that were treated with specific anticancer medicines 1 . 1 SARS-CoV-2 mRNA vaccines sensitize tumours to immune checkpoint blockade https://www.nature.com/articles/s41586-025-09655-y.”
  Vaccination · Pharmaceuticals regulation in EU
• 2025-10-27 “E-004218/2025 Answer given by Mr Várhelyi on behalf of the European Commission Regulation 1049/2001 1 applies to requests for access to documents received by the Commission. Although the disclosure of documents is the principle, certain public and private interests must be protected through specific exceptions. According to Article 4(1)(a), first indent of the aforementioned Regulation, the Commission must refuse access to a document if its disclosure would undermine the protection of the public interest concerning public security. Reports from simulation exercises pertain to general emergency responses that have or could have direct impacts on public health. Disclosing these documents would reveal details that could be exploited to jeopardise the public security of the Union. The Commission has reported to the Honourable Member of the European Parliament in its answer of 23 September 2025 to E-003130/2025 2 , as well as in its answer of 30 June 2025 to E-001040/2025 3 , about the background, scope, scenario, key elements and the nature of specific lessons and conclusions from the exercise. Findings from simulation exercises are an important tool to assess and, where appropriate, update preparedness plans and working procedures. 1 https://eur-lex.europa.eu/eli/reg/2001/1049/oj/eng. 2 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 3 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html.”
  Transparency requirements of EU institutions
• 2025-10-21 “E-004131/2025 Answer given by Ms Zaharieva on behalf of the European Commission We refer the honourable member to the answer to Parliamentary Question E-002369/2025, detailing the Commission's risk management measures, eligibility criteria, and security checks to support gain-of-function research on influenza.”
  EU competences on health · Vaccination
• 2025-10-14 “E-004023/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission has no evidence that increased IgG4 antibodies observed over repeated mRNA COVID-19 vaccinations reduced the protective immunity conferred by the vaccines. Intensive safety monitoring of mRNA COVID-19 vaccines administered to hundreds of millions of people has not detected any safety issue linked to the distribution of the vaccines’ components in the human body. The mRNA is broken down by cell mechanisms, thus spending a relatively short time in the body. Animal studies with much higher mRNA doses than in the vaccines given to people showed that the mRNA and lipid nanoparticles stayed mainly at the injection site and lymph nodes 1 , where other studies detected the spike protein, not detected in organs such as the lung, heart or brain 2 . No safety issues were reported in relation to a potential frame shift during the production of the spike protein. Specific sequences for the non-infectious parts of the naturally occurring simian virus 40 (SV40) are commonly present in plasmids used for manufacturing of biological active substances. During the manufacturing process, these sequences are broken down and removed. Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled. There is no evidence that any of these SV40 fragments can act as integrate into Deoxyribonucleic acid (DNA) and cause cancer. The quality of every batch of COVID-19 vaccines is checked before it is released for use in the EU. Evidence from more than 13 billion vaccines given worldwide shows that COVID-19 vaccines have a very good safety profile in all age groups. The benefits of the approved vaccines far outweigh the possible risks. The vast majority of known side effects are mild and short-lived. 1 https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf. 2 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines/covid-19-vaccines-key-facts#mrna-covid-19-vaccines-7221.”
  Vaccination
• 2025-09-23 “E-003677/2025 Answer given by Mr Várhelyi on behalf of the European Commission The individual workshops were organised at the European Centre for Disease Prevention and Control (ECDC) in Stockholm, Sweden. The workshops were organised in three consecutive weeks: (1) 5-6 March 2019 involving 11 EU/European Economic Area (EEA) countries, (2) 12-13 March 2019 involving 10 EU/EEA countries, and (3) 19-20 March 2019 involving nine EU/EEA countries. The participants were experts from the national competent authorities for the planning, implementation and evaluation of pandemic preparedness plans 1 from (1) Czech Republic, Denmark, Estonia, Finland, Germany, Iceland, Latvia, Lithuania, Norway, Poland, Sweden; (2) Bulgaria, Cyprus, France, Greece, Hungary, Italy, Malta, Portugal, Romania, Spain; and (3) Austria, Belgium, Croatia, Ireland, Luxembourg, Netherlands, Slovakia, Slovenia, United Kingdom. The participation of experts was funded by the ECDC according to the applicable financial regulation by reimbursing travel, accommodation, and per diem rate. The topics were the same in each of the workshops and were based on the World Health Organization/ECDC Guide to the revision of national pandemic influenza preparedness plans: ‘Lessons learned from the 2009 A(H1N1) pandemic’ 2 , as well as based on a review which the ECDC conducted on influenza preparedness planning in 2016 3 . The topics included pandemic planning, coordination, and control; risk communication; pandemic vaccines and joint procurement; antivirals and other essential medicines; nonpharmaceutical public health measures; and approaches to test and evaluate preparedness plans and operational procedures. References to national influenza pandemic preparedness plans are published 4 . 1 If applicable in the respective country, experts specific to influenza planning, implementation and evaluation of pandemic preparedness plans were participating. 2 https://ecdc.europa.eu/sites/portal/files/documents/Guide-to-pandemic-preparedness-revised.pdf. 3 https://www.researchgate.net/publication/329720063_European_Pandemic_Influenza_Preparedness_Planning_ A_Review_of_National_Plans_July_2016. 4 https://www.ecdc.europa.eu/en/seasonal-influenza/influenza-pandemic-preparedness.”
  EU competences on health · Vaccination
• 2025-09-18 “E-003628/2025 Answer given by Mr Várhelyi on behalf of the European Commission The ‘Lemkin’ Simulation Exercise took place in Athens, Greece on 29-31 October 2019. The exercise was commissioned by the European Centre for Disease Prevention and Control (ECDC) acting on its mandate to help EU/European Economic Area (EEA) countries to build robust preparedness systems through the delivery of preparedness workshops and simulation exercises 1 . The main purpose of this exercise was to coordinate law enforcement and public health sectors to respond to a cross-border health threat. The scenario was a hypothetical release of a biological agent causing Glanders (Burkholderia mallei) in Europe. The exercise gathered 56 participants from 25 Member States and two EEA countries, including law enforcement representatives from 11 Member States and public health representatives from 26 EU/EEA countries. The report of the exercise has not been published 2 . The handbook in question has not been finalised. Neither coercive public measures, nor restrictions on fundamental rights, nor measures of media control or censorship were tested during the exercise. The Commission, in its reply of 30 June 2025 to Parliamentary Question E-001040/2025 3 (Preparedness for the COVID-19 pandemic) already answered when and from what source EU institutions became aware of a possible upcoming pandemic. The ECDC published its first COVID-19 related Rapid Risk Assessment on 17 January 2020 4 , which outlines that on 31 December 2019, in the Municipal Health Commission in Wuhan City, China reported a cluster of 27 pneumonia cases of unknown aetiology, including seven severe cases, with a common reported link to Wuhan's Huanan seafood wholesale market. 1 In line with Decision 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC. 2 The information contained in the documents covers, inter alia, general emergency response capabilities affecting or likely to affect public health. The disclosure of these documents would reveal details about how preparedness exercises are organised, including details about the information flow within and between European institutions and bodies as well as Member States and hypothetical scenarios and put at risk the public security of the Union, as any possible weakness could be exploited against the Union interests, including in possible future emergency situations. 3 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 4 Rapid Risk Assessment ‘Cluster of pneumonia cases caused by a novel coronavirus, Wuhan, China, 2020’: https://www.ecdc.europa.eu/en/publications-data/rapid-risk-assessment-cluster-pneumonia-cases-caused-novelcoronavirus-wuhan.”
  Vaccination · EU competences on health
• 2025-09-16 “E-003565/2025 Answer given by Mr Várhelyi on behalf of the European Commission Scientific bodies like the European Food Safety Authority (EFSA) and the World Health Organization identified essential micronutrients which include a range of vitamins and minerals 1 , but not lithium. Studies suggest that abnormal lithium metabolism might play a role in neurodegenerative diseases, and lithium containing drugs are being tested for treating Alzheimer's disease. However, to Commission’s current knowledge, there is no proof that lithium from the diet is crucial for cognitive function, that low intake affects it negatively, or that deficiency symptoms can be reversed by dietary lithium; the key factors for a nutrient to be considered essential. The Commission will consult with EFSA whether further examination of the potential essentiality of lithium, based on the information in the article referred to by the Honourable Member would warrant an EFSA opinion. Annexes I and II to Directive 2002/46/EC 2 on food supplements establish lists of vitamins and minerals and the forms that may be used for the manufacture of food supplements. Chemical substances used as nutrient sources in food supplements should be safe and bioavailable to the body and only nutrients normally consumed as part of the diet should be allowed in food supplements, although this does not mean that their presence therein is necessary. Both annexes may be revised by the Commission following an opinion of the Standing Committee on Plants, Animals, Food and Feed upon request by an interested party, and provided that the substance has been positively evaluated for its safety and bioavailability by EFSA. The Commission also recalls that a substance that is novel pursuant to Regulation (EU) 2015/2283 3 must obtain an authorisation before being placed on the Union market. 1 Such as Vitamin A, Vitamin B1 (Thiamine),Vitamin B2 (Riboflavin),Vitamin B3 (Niacin),Vitamin B5 (Pantothenic acid),Vitamin B6 (Pyridoxine),Vitamin B7 (Biotin), Vitamin B9 (Folate/Folic acid),Vitamin B12 (Cobalamin),Vitamin C, Vitamin D, Vitamin E, Vitamin K, Calcium, Chloride, Copper, Iodine, Iron, Magnesium, Manganese, Molybdenum, Phosphorus, Potassium, Selenium, Sodium, Zinc. 2 Directive of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, (OJ L 183, 12.7.2002, p. 51). 3 Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001, (OJ L 327, 11.12.2015, p. 1).”
  EU policy on novel foods · Nutrition
• 2025-09-03 “E-003388/2025 Answer given by Mr Várhelyi on behalf of the European Commission In line with the applicable European legislation, the conditional marketing authorisations granted for the COVID-19 vaccines Comirnaty, Spikevax and Nuvaxovid were converted into standard marketing authorisations on 10 October 2022, 5 October 2022 and 4 July 2023, respectively, once the specific obligations imposed on the marketing authorisation holders were fulfilled. The COVID-19 vaccine Bimervax was granted a standard marketing authorisation, based on a full dossier application, on 30 March 2023. Like for all medicines authorised in the EU, the European Medicines Agency (EMA) and national authorities continuously monitor the COVID-19 vaccine safety assessing all available data, including EudraVigilance 1 reports, scientific literature and studies to determine if there is a causality between an adverse effect and a medicine and take action as appropriate. There is so far no evidence justifying the revocation of the marketing authorisations for any COVID-19 vaccine authorised in the EU. On the contrary, there is an unprecedented amount of supportive data on the efficacy and safety of COVID-19 vaccines authorised in the EU, which has been gathered following the use of the vaccines in hundreds of millions of people worldwide. The contracts for the purchase of COVID-19-vaccines contain clauses that outline in detail the obligations and responsibilities of the contractual parties involved regarding potential losses, damages, liabilities, or legal claims arising from the COVID-19 vaccines. However, claims for damages resulting from harmful events suffered, including from healthy people with no pre-existing conditions, by the use of COVID-19 vaccines are subject to the rules laid down in the legislation of Member States. 1 https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-researchdevelopment/eudravigilance.”
  Vaccination · Covid-19 vaccines procurement
• 2025-09-02 “E-003369/2025 Answer given by Mr Várhelyi on behalf of the European Commission According to Article 168(7) of the Treaty on the Functioning of the European Union 1 , Member States are responsible for the definition of their health policy and for the organisation and delivery of health services and medical care, including pharmacies. Challenges in access to healthcare vary significantly and Member States can leverage opportunities provided by EU funds to develop targeted initiatives. Online sales of prescription medicines can only be performed in line with national rules, and transposing the relevant provisions in the Directive 2001/83/EC 2 . As regards online trade in medicines, the European Anti-Fraud Office (OLAF) plays an active role in investigating fraudulent imports of counterfeit medicines via e-commerce. Member States can invest through the Common Agricultural Policy (CAP) 3 in i) rural businesses, which might be well-suited for businesses such as pharmacies; ii) small-scale basic services and infrastructure. Through ‘multi-service hubs’ medicines or mobile health units can be delivered 4 . Through the Rural Pact 5 , the Commission invites Member States to take an integrated approach to rural areas, including regarding the provision of services. The European Regional Development Fund (ERDF) supports rural areas through innovation, improving infrastructure, urban-rural links and strengthening the role of small and medium towns. The Talent Booster Mechanism 6 Working Group on Health drafts recommendations on overcoming talent challenges in the healthcare sector. The European Social Funds Plus (ESF+), key EU instrument for investing in people, supported around 1.4 million people from rural areas (18% of ESF+ beneficiaries) by the end of 2024. 1 Treaty on the Functioning of the European Union, https://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:12008E168:EN:HTML. 2 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67, ELI:http://data.europa.eu/eli/dir/2001/83/oj). 3 Regulation (EU) 2021/2115 http://data.europa.eu/eli/reg/2021/2115/oj. 4 LEADER/CLLD | EU CAP Network https://eu-cap-network.ec.europa.eu/networking/leader_en. 5 https://ruralpact.rural-vision.europa.eu/publications/making-rural-pact-happen-member-states_en. 6 https://ec.europa.eu/regional_policy/policy/communities-and-networks/harnessing-talent-platform/talentbooster-mechanism_en.”
  Public and private sectors role in healthcare services · Pharmaceuticals regulation in EU
• 2025-07-29 “E-003127/2025 Answer given by Mr Várhelyi on behalf of the European Commission EU legislation provides a robust system to constantly monitor medicines, including vaccines, for potential new risks (and the impact on the benefit/risk balance), throughout their life cycle. The EudraVigilance is a central pillar, enabling effective monitoring of suspected adverse reactions and detection of risks related to medicines. Timely detection and assessment of safety signals from EudraVigilance complement the routine benefit-risk evaluation of authorised medicines performed by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee through periodic safety update reports and risk management plans submitted by the marketing authorisation holder as per legal obligations. EudraVigilance screening continues to be the major source of potential signals 1 . However, the European Medicines Agency (EMA) continuously explores ways to improve the operation of EudraVigilance to gain efficiencies in an already robust system. When deciding on temporary measures, several factors are considered, including the risk's severity, evidence strength, and population exposure. Direct comparisons of reported adverse drug reactions between vaccines lack scientific robustness due to variations in affected population, demographics of the vaccinated population, and reporting practices between products (as it is for example the case for the COVID-19 vaccines compared to chikungunya virus vaccines). EMA’s scientific committees scrutinise whether available evidence indicates a link to a new or serious adverse event and consider this evidence alongside the benefits of the vaccine. For more information, including where to find reliable information about side effects 2 , please consult the EMA website. 1 For more information, please refer to the public annual report on EudraVigilance providing comprehensive details on EudraVigilance-related activities and outputs (see: https://www.ema.europa.eu/system/files/documents/report/2024-annual-report-eudravigilance-en.pdf). 2 COVID-19 vaccines: key facts https://www.ema.europa.eu/en/human-regulatory-overview/public-healththreats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-vaccines-key-facts.”
  Vaccination · Pharmaceuticals regulation in EU
• 2025-07-29 “E-003130/2025 Answer given by Mr Várhelyi on behalf of the European Commission The European Court of Auditors report 28/2016 1 recommended continuous improvement of collaboration in times of crises as well as regular testing and exercising between the Commission services and the agencies. In line with this report, the ‘Blue Orchid’ exercise tested internal procedures and communication channels between the Commission and the European Centre for Disease Prevention (ECDC) in a crisis situation 2 . The scenario was designed to reflect the initial response to the importation of a single case of pneumonic plague into a Member State as being a likely future scenario based on past pandemics 3 . Key elements were to test the channels of communication between the Commission and the ECDC, including Information Technology (IT) tools such as the Early Warning and Response System, video/audio-conferencing and formal requests between the institutions. The specific lessons and conclusions that have been learned from the exercise included the need for improvement of the functioning of IT back-up services, to build up a common IT technology platform between the institutions, as well as to improve communication procedures and protocols. These lessons learned have assisted the Commission and the ECDC to better respond to the COVID-19 pandemic 4 . The Commission and the ECDC have not published information on this internal exercise. 1 https://www.eca.europa.eu/Lists/ECADocuments/SR16_28/SR_HEALTH_EN.pdf. 2 In the implementation of Decision (EU) 1082/2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC: https://eur-lex.europa.eu/eli/dec/2013/1082. 3 As example, but evidence not limited to this reference: https://www.ecdc.europa.eu/en/publicationsdata/severe-acute-respiratory-syndrome-sars-annual-epidemiological-report-2015. 4 https://www.eca.europa.eu/en/publications/SR-2024-12.”
  EU competences on health
• 2025-07-29 “E-003124/2025 Answer given by Mr Várhelyi on behalf of the European Commission 1. Several EU institutions, bodies and agencies are directly or indirectly involved in the health sector 1 , contributing to a comprehensive approach to health policy in accordance with the Union’s role as set out in Article 168 of the Treaty of the Functioning on the EU 2 . Within the Commission, the Commissioner for Health and Animal Welfare oversees the DirectorateGeneral for Health and Food Safety (DG SANTE), which deals with EU health policies. The Commissioner for Equality, Preparedness and Crisis Management oversees the DG responsible for the health emergency preparedness and response (DG HERA), which works to improve preparedness and response to serious cross-border threats in the area of medical countermeasures. The Commissioner for Social Rights and Skills, Quality Jobs and Preparedness oversees the DG for Employment, Social Affairs and Inclusion (DG EMPL). DG SANTE is the partner DG of the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). DG EMPL is the partner DG of the European Agency for Safety and Health at Work (EUOSHA). The European Health and Digital Executive Agency (HaDEA) is an executive agency mandated by the Commission to, amongst others, implement a significant part of the EU4Health programme. 2. The budget and staffing figures for the agencies mentioned above for the years 2020-2025 are included in the annex. 3. The beneficiaries of the EU4Health Programme are, amongst others, non-governmental organisations, foundations, and international organisations. While the Financial Transparency System (FTS), until now 3 , does not include information about beneficiaries of funding of decentralised agencies, the Commission and HaDEA provide information on beneficiaries of EU funding in the FTS 4 and the decentralised agencies publish their annual lists of contracts 5 . 1 It is difficult to provide an exhaustive list of EU bodies involved directly or indirectly in the health sector as it is a theme that in a way, concerns to a greater of lesser extent almost all EU actors. We could recall that as the TFEU states, ‘A high level of human health protection shall be ensured in all Union policies and activities’, meaning that all EU institutions, all services of the Commission, EU agencies or authorities are concerned by the theme of health. 2 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C:2008:115:FULL. 3 The beneficiaries of funding of decentralised agencies will be included in the FTS in 2026, in line with Article 38 of Regulation 2024/2509 (the ‘Financial Regulation’ (FR)). The information to be published in the FTS must include information on recipients of funds from Union bodies referred to in Articles 70 and 71 of the FR i.e. the decentralised agencies and joint undertakings. 4 https://ec.europa.eu/budget/financial-transparency-system/index.html. 5 EMA: https://www.ema.europa.eu/en/about-us/procurement/procurement-archive; ECDC: https://www.ecdc.europa.eu/en/about-ecdc/procurement-and-grants/ex-post-publicity; EU-OSHA: https://osha.europa.eu/en/about-eu-osha/procurement.”
  EU competences on health
• 2025-07-25 “E-003088/2025 Answer given by Ms Zaharieva on behalf of the European Commission Loneliness is an important topic, and the Commission paid special attention to it during the COVID-19 pandemic. An analysis 1 of the Commission’s own Joint Research Centre (JRC) shows that social distancing increased loneliness across the EU. In 2016, about 12% of Europeans reported feeling lonely “most or all of the time”, whereas during early lockdowns this share doubled to roughly 25%. It should be noted though that the increase of loneliness during the pandemic period as a result of (different) social distancing measures implemented by the Member States at the time had to be balanced with the need to contain the spread of the virus in order to prevent further direct health impacts, including lethal, of a scale which often overwhelmed public health systems. No official data exist on how many people died in the EU specifically “as a result of the effects of loneliness” during lockdowns nor is there specific data available tracking suicides in relation with the lockdowns. The data available by Eurostat shows that suicides did not increase in the EU 27 during the period 2020 and 2021. 2 Looking at a larger time span, it can be observed that suicides in the EU decreased by 10% between 2011 and 2021. Importantly, the study also found that poor health and unfavourable economic conditions are critical loneliness risk factors, and that loneliness of individuals in poor health is mostly chronic, i.e. persistent over time, with no statistically significant variations between normal and exceptional circumstances. 1 https://publications.jrc.ec.europa.eu/repository/handle/JRC130751. 2 https://ec.europa.eu/eurostat/databrowser/view/tps00122/default/line?lang=en&category=t_hlth.t_hlth_cdeath.”
  EU policy on mental health
• 2025-07-24 “E-003072/2025 Answer given by Mr Várhelyi on behalf of the European Commission The International Health Regulations (IHR) amendments 1 adopted on 1 June 2024 were notified by the World Health Organization (WHO) Director-General to all States Parties on 19 September 2024. Consequently, and in accordance with Article 59 of the IHR, as amended in May 2022, the 2024 amendments will enter into force on 19 September 2025, unless a State Party notified a rejection or reservation to one or more amendments to the WHO DirectorGeneral no later than 10 months after their notification, namely by 19 July 2025 In the case of Slovakia, the Netherlands, Iran and New Zealand, which rejected the amendments to Article 59 of the IHR adopted in May 2022 and aimed to shorten the period for the rejection of, or reservations to, future IHR amendments from 18 to 10 months, as well as the period for their entering into force from 24 to 12 months, the date for notification of rejection is 19 March 2026 and the entry into force of the 2024 amendments is 19 September 2026, provided that the States concerned do not notify a rejection or reservation to one or more amendments to the WHO Director-General by 19 March 2026. Information available to the Commission until now indicates that Argentina, Austria, Brazil, Canada, the Czech Republic, Germany, Israel, Italy, the Netherlands, the Philippines, and the United States of America (USA) have notified rejections of the 2024 amendments to the WHO Director General. With the exception of Argentina, Israel, Italy and the USA, they provided an explanation for their rejection, which related to their need to await completion of relevant domestic processes, and which could be followed by a withdrawal of their rejection pursuant to Article 63 of the IHR. Confirmation of this information will be provided by the WHO in due course. 1 https://apps.who.int/gb/ebwha/pdf_files/WHA77/A77_ACONF14-en.pdf.”
  Vaccination · EU competences on health
• 2025-07-03 “E-002718/2025 Answer given by Ms Lahbib on behalf of the European Commission The procedure to claim compensation for damages presumably resulting from administered COVID-19 is regulated by the laws of the Member States. National legal frameworks provide citizens with rights concerning the applicable procedure, such as the ability to file the claim in their national courts. The Commission does not keep records on the number of successful claims against Member States related to adverse events from COVID-19 vaccines. Legal responsibility for the damages lies with the vaccine manufacturers. However, under the (Advance) Purchase Agreements for COVID-19 vaccines, Member States indemnify vaccine manufacturers for the compensation of damages and legal costs on the condition that the claim is successful, except in certain cases, for instance where the damages result from wilful misconduct or a failure to comply with EU good manufacturing practices by the vaccine manufacturers.”
  Covid-19 vaccines procurement · Pharmaceuticals regulation in EU
• 2025-07-03 “E-002731/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission, in close collaboration with the European Medicines Agency (EMA) and Member States, continuously monitors the safety of all authorised medicines, including COVID-19 vaccines, through a robust pharmacovigilance system 1 . While there have been some reports about the short-term variation of fertility trends during the pandemic, this was attributed to behavioural changes, as in most of the studied countries the fertility rates returned to pre-pandemic levels and no evidence of effect of COVID-19 vaccinations on fertility trends was found 2 . The long-term safety data of COVID-19 vaccines to date remain very reassuring, including regarding fertility. The findings come from some of the largest clinical trials ever conducted for vaccines, involving tens of thousands of participants, as well as real-world data collected over more than three years of large vaccination campaigns. Companies are also legally obliged to submit periodic safety update reports 3 , which provide a re-evaluation of the benefit-risk balance of a medicine at regular timepoints after its authorisation. Any new or emerging data is included in these reports and assessed by the EMA. Finally, the Commission places strong importance on women’s health and the safety of all authorised medicinal products, including vaccines. It expects that potential adverse effects are thoroughly investigated, irrespective of the patient’s gender. While certain differences in vaccine reactions between sexes may occur, often linked to hormonal factors, these are closely monitored and evaluated. As for every authorised product, the patient and prescriber information summarise the current scientific knowledge, including benefits, risks and specific warnings. 1 https://health.ec.europa.eu/medicinal-products/pharmacovigilance_en, https://www.ema.europa.eu/en/humanregulatory-overview/pharmacovigilance-overview. 2 Exploring associations between the Covid-19 vaccination campaign and fertility trends: A population-level analysis for 22 countries, MPIDR - How have Covid-19 vaccinations affected birth rates? Birth rate decline in the later phase of the COVID-19 pandemic: the role of policy interventions, vaccination programmes, and economic uncertainty; Human Reproduction Open; Oxford Academic. 3 https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-postauthorisation/periodic-safety-update-reports-psurs.”
  Vaccination · Sexuality and reproduction
• 2025-07-03 “E-002717/2025 Answer given by Ms Lahbib on behalf of the European Commission The Joint Negotiation Team (JNT) was composed of experts from France, Germany, Italy, Poland, Spain, Sweden, and the Netherlands, with Sweden later replaced by Portugal together with Commission’s officials. The Vaccines Steering Board included representatives of all EU Member States. The Commission is not in a position to disclose the names of individual JNT or Board members, including from Austria, as disclosure of this type of information would undermine the protection of the privacy of these individuals in accordance with EU data protection legislation 1 . All participants were appointed by their respective governments 2 . The Board was kept informed by the JNT throughout the negotiation process via regular meetings, where updates on the state of play were provided on a continuous basis. The Board discussed and reviewed all aspects of the (Advance) Purchase Agreements for COVID-19 vaccines before they were signed by the Commission on behalf of the Member States. All Member States had the opportunity to comment on contractual clauses and were granted optout periods in case they chose not to participate in a particular agreement. 1 https://eur-lex.europa.eu/eli/reg/2018/1725/oj/eng. 2 https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_1662.”
  Covid-19 vaccines procurement · Transparency of EU medicines governance process
• 2025-07-01 “E-002656/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission and the relevant EU agencies (e.g. European Centre for Disease Prevention and Control (ECDC), European Medicines Agency (EMA)) value the scientific input of EU/ European Economic Area (EEA) national public health institutes for combatting cross-border threats to health, such as the Robert Koch Institute. Since January 2020, under Decision No 1082/2013/EU 1 , the Commission convened the Health Security Committee for regularly exchanging on the fast-growing evidence of the COVID-19 pandemic and for coordinating the response measures. Minutes of those meetings are available publicly 2 . Furthermore, EU/EEA Member States reported relevant information via the Early Warning and Response System, via the ECDC, and EMA networks, and via the Integrated political crisis response mechanism 3 . Germany reported via those channels. In return, Germany received protocols, data, recommendations and information about the COVID-19 pandemic from the Commission and its relevant agencies since 2019 until today via the same channels 4 . However, neither Decision No 1082/2013/EU 5 , nor Regulation (EU) 2022/2371 6 mention ‘unrestricted’ exchange of information between Member States and the Commission in case of a pandemic. The exchange of information is done between Germany as a Member State and the Commission. Therefore, the Commission is not in a position to assess which of the COVID19 relevant information that has been officially submitted by the appointed competent authorities of Germany to the Commission has originated specifically from the internal findings of the Robert Koch Institute's COVID-19 crisis management unit. The Commission promotes publicly available references to scientific information. 1 The Health Security Committee was provided for in Article 17 of Decision No 1082/2013/EU and, is now provided for in Article 4 of Regulation (EU) 2022/2371 on serious cross-border threats to health, which repeals Decision No 1082/2013/EU (https://eur-lex.europa.eu/legalcontent/EN/ALL/?uri=CELEX:32022R2371#:~:text=Regulation%20%28EU%29%202022%2F2371%20of%20t he%20European%20Parliament%20and,NL%2C%20PL%2C%20PT%2C%20RO%2C%20SK%2C%20SL%2C %20FI%2C%20SV%29). 2 https://health.ec.europa.eu/health-security-and-infectious-diseases/crisis-management/list-authoritiesrepresented-health-security-committee/health-security-committee-reports_en#2020. 3 https://www.consilium.europa.eu/en/press/press-releases/2020/03/02/covid-19-outbreak-the-presidency-stepsup-eu-response-by-triggering-full-activation-mode-of-ipcr/. 4 https://www.ecdc.europa.eu/en/covid-19. 5 https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=uriserv%3AOJ.L_.2013.293.01.0001.01.ENG&toc=OJ%3AL%3A2013%3A293%3AFU LL. 6 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32022R2371.”
  EU competences on health
• 2025-06-25 “E-002573/2025 Answer given by Mr Várhelyi on behalf of the European Commission 1. In addition to the Staff Regulations and the independence policy adopted by each Agency, the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) adopt policies which define cases of field-specific competing interests, for members of scientific committees and experts. The EMA’s policy identifies competing interests both as direct and indirect interests. The list is non-exhaustive, further measures can be adopted on a case-by-case basis. This policy also applies to the Committee for Medicinal Products for Human Use. The EMA code of conduct 1 and the policy on competing interests 2 are publicly accessible. The ECDC-specific conflicts of interests may stem from previous involvement of the member or expert in the pharmaceutical industry, research grants and consultancy. The ECDC independence policy for staff 3 and non-staff 4 and the policy on scientific integrity and independence 5 are publicly accessible. The Commission supervises the independence of EU agencies, focusing on strong policies, transparency, and inter-agency collaboration. The above-described system protects the decision-making process from arising conflicts of interest. 2. Both the ECDC 6 and the EMA 7 publish the declarations of absence of conflict of interest of management staff and members of their governance bodies. 3. The abovementioned policies are periodically reviewed. Declarations on interests are submitted before appointment, annually or whenever the situation of the member or expert changes. In duly identified cases, members or experts are prevented from participation to meetings if a risk of conflict is envisaged in relation to one agenda item. 1 https://www.ema.europa.eu/en/documents/other/code-conduct-european-medicines-agency_en.pdf. 2 https://www.ema.europa.eu/en/documents/other/policy-44-european-medicines-agency-policy-handlingcompeting-interests-scientific-committees-members-experts_en.pdf. 3 https://www.ecdc.europa.eu/en/publications-data/independence-policy-ecdc-staff. 4 https://www.ecdc.europa.eu/en/publications-data/revised-independence-policy-non-staff. 5 https://www.ecdc.europa.eu/en/publications-data/ecdc-policy-scientific-integrity-and-independence. 6 https://www.ecdc.europa.eu/en/about-ecdc/who-we-are/our-guiding-principles/annual-declarations-interestand-declarations. 7 https://www.ema.europa.eu/en/about-us/who-we-are/management-board/members.”
  Transparency of EU medicines governance process · Pharmaceuticals regulation in EU
• 2025-06-12 “E-002369/2025 Answer given by Ms Zaharieva on behalf of the European Commission Gain-of-function research involves genetically altering an organism to enhance its biological functions and is undertaken to better understand diseases and develop therapies and vaccines. The potential risks associated with creating more infectious or deadly pathogens need to be carefully managed and weighed against the benefits for public health. The Commission’s approach to protection from potential biological weapons is guided by the 2017 Action Plan to enhance preparedness against chemical, biological, radiological and nuclear (CBRN) security risks 1 . In this context, the Commission established the Customs Crisis Management function, enabling rapid response by customs authorities to security risks stemming from EU imports, including potential biological weapons. This mechanism has been activated in past crises such as the COVID-19 pandemic. The support to gain-of-function research is possible under the EU research and innovation framework programme 2 , subject to strict eligibility criteria and ethical conditions, verified through a scientific and ethical evaluation and screening of proposals and projects raising ethical issues, and where appropriate a security check. The programme has supported gain-offunction research on influenza virus to improve the response to emerging infectious diseases 3 . The Commission will continue to implement the highest levels of ethics integrity in the research and innovation domain, and to protect in this context EU values and security. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:52017DC0610. 2 Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013. 3 Horizon 2020 COMPARE project carried out at Erasmus Medical Centre, Rotterdam in the Netherlands: Collaborative Management Platform for detection and Analyses of (Re-)emerging and foodborne outbreaks in Europe (2014-2019; https://cordis.europa.eu/project/id/643476).”
  Pharmaceuticals regulation in EU
• 2025-06-11 “E-002331/2025 Answer given by Mr Várhelyi on behalf of the European Commission Article 168(7) of the Treaty on the Functioning of the European Union 1 states that Union action shall respect the responsibilities of Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. This includes ensuring an adequate supply of healthcare professionals. Union action shall complement national policies. The Action Plan on labour and skills shortages 2 focuses on this challenge, including in health. The 2024 report Health at a Glance: Europe 3 underscores health workers’ shortages and outlines various initiatives launched by the Commission to help Member States address this. They include EU4Health programme actions such as on health workforce planning 4 , addressing nursing shortages 5 , digital skills development projects 6 , training and capacitybuilding programmes aligned with the pillars of the European Health Union 7 , the WHO-led survey on the health professionals’ mental health. The results of the survey, planned to be published in October 2025, feed into a set of policy actions to protect the mental health of the health workforce, planned before the end of 2025 8 . Under the Pact for Skills 9 , three largescale skills partnerships have been launched, focusing on health professionals, long-term care, and the medical industry. Additionally, Erasmus+ supports the BeWell project 10 , which will develop a skills strategy and innovative training curricula for the health workforce. The Commission’s Healthcare Systems Performance Assessment Expert Group 11 is collaborating with Member States to explore staffing level solutions in healthcare. Furthermore, other funds 12 support complementary, country-specific interventions. 1 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. 2 Commission Communication on Labour and skills shortages in the EU: an action plan, COM(2024) 131 final (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52024DC0131). 3 Health at a Glance: Europe, joint report by the Commission and the Organisation for Economic Cooperation and Development https://health.ec.europa.eu/state-health-eu/health-glance-europe_en. 4 EU4Health Programme: https://www.agenas.gov.it/ricerca-e-sviluppo/ricerca-internazionale/personalesanitario-ri/heroes-health-workforce-to-meet-health-challenges. 5 EU4Health programme: https://health.ec.europa.eu/publications/2024-eu4health-work-programme_en. 6 EU4Health programme: https://health.ec.europa.eu/publications/2022-eu4health-work-programme_en; AMR EDUCare https://www.amreducare.eu/; e-Hospital4Future https://eh4future.eu/; GESEA Educational Programme https://gesea.eu/; DigiCanTrain https://digicantrain.turkuamk.fi/contact-us/; DDS-MAP https://ddsmap.easpd.eu/; TRANSiTION https://ehma.org/projects/transition/; EHMA https://hpass.healthworkforce.eu/. 7 Initiatives covering for example areas of mental health, cancer, digitalisation, AMR (antimicrobial resistance). 8 https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-waylife/european-health-union/comprehensive-approach-mental-health_en. 9 https://pact-for-skills.ec.europa.eu/index_en. 10 Erasmus+ programme: https://bewell-project.eu/. 11 https://health.ec.europa.eu/health-systems-performanceassessment_en#:~:text=The%20Expert%20Group%20supports%20tailored%20activities%20in%20countries. 12 Cohesion Policy: https://ec.europa.eu/regional_policy/2021-2027_en; Recovery and Resilience Facility https://commission.europa.eu/business-economy-euro/economic-recovery/recovery-and-resilience-facility_en; Technical Support Instrument (TSI): https://commission.europa.eu/funding-tenders/find-funding/eu-fundingprogrammes/technical-support-instrument/technical-support-instrument-tsi_en.”
  Public and private sectors role in healthcare services · EU competences on health
• 2025-05-27 “E-002126/2025 Answer given by Ms Lahbib on behalf of the European Commission The (Advance) Purchase Agreements for the supply of COVID-19 vaccines were neither negotiated nor signed independently. The negotiations were concluded in full transparency with the Member States and carried out by a Joint Negotiation Team 1 . This team reported regularly to a Vaccines Steering Board co-chaired by the Commission and a Participating Member State, which provided guidance. When the final text of the contract was negotiated, the signature was executed by the Commissioner in charge, not independently, but after approval by the College. Therefore, the process was based on a joint effort and collective decision-making, both in the negotiation and the signature of the contracts. The first COVID-19 vaccines were granted a conditional marketing authorisation (CMA), a specific type of marketing authorisation to facilitate access to medicines that fulfil an unmet medical need, including in emergency situations such as the COVID-19 pandemic, whilst a comprehensive data dossier is not yet available. It allows regulators to authorise such medicines as soon as sufficient data demonstrate that the medicine's benefits outweigh its risks, with robust safeguards and controls in place post-authorisation: the marketing authorisation holder must fulfil specific obligations (e.g. conduct further studies and provide more data to confirm efficacy or safety) within defined timelines. CMAs are valid for one year and can be renewed annually. If the specific obligations are fulfilled, CMAs can be converted in full marketing authorisation, as it happened for COVID-19 vaccines. The updated product information 2 and assessment reports 3 of COVID-19 vaccines have always been made timely publicly available. 1 Joint Negotiation Team consisted of the Commission and of several Member States: https://ec.europa.eu/commission/presscorner/detail/en/qanda_20_1662. 2 https://ec.europa.eu/health/documents/community-register/html/index_en.htm. 3 https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when/european-public-assessmentreports-background-context.”
  Covid-19 vaccines procurement · Transparency of EU medicines governance process
• 2025-05-22 “E-002076/2025 Answer given by Mr Várhelyi on behalf of the European Commission Artificial Intelligence (AI) systems intended for medical purposes are subject to several EU laws, including the Medical Devices Regulation (Regulation 2017/745) 1 , In Vitro Diagnostic Medical Devices Regulation (Regulation 2017/746) 2 , and the AI Act (Regulation 2024/1689) 3 . The AI Act under certain conditions classifies them as high-risk AI systems and sets out obligations for providers and deployers including on data quality and governance, transparency, human oversight, accuracy, robustness, and cybersecurity. The General Data Protection Regulation (Regulation 2016/679) 4 and, in the near future, the recently adopted European Health Data Space Regulation (Regulation 2025/327) 5 may also apply if personal data, including personal health data, are being processed. Liability for damage caused by the use of AI is regulated by both EU and national laws. The Product Liability Directive (Directive 2024/2853) 6 provides that victims can seek compensation from manufacturers if harm is caused by defective products. Liability for the negligent use of AI is then regulated under national liability regimes. The AI Act requirements on human oversight and transparency for high-risk AI systems aims to facilitate AI systems that are designed and used as tools that serve people, respect fundamental rights, health and safety, and remain subject to meaningful human control. 1 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, OJ L 117, 5 May 2017, at 1; ELI: http://data.europa.eu/eli/reg/2017/745/oj/eng. 2 Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices, OJ L 117, 5 May 2017, at 176; ELI: http://data.europa.eu/eli/reg/2017/746/oj/eng. 3 Regulation (EU) 2024/1689 of 13 June 2024 laying down harmonised rules on artificial intelligence, OJ L 1689, 12 July 2024, at 1; ELI: http://data.europa.eu/eli/reg/2024/1689/oj/eng. 4 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, OJ L 119, 4 May 2016, at 1; ELI: http://data.europa.eu/eli/reg/2016/679/oj/eng. 5 Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space, OJ L 327, 5 March 2025, at 1; ELI: http://data.europa.eu/eli/reg/2025/327/oj/eng. 6 Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products, OJ L 2853, 18 November 2024, at 1; ELI: http://data.europa.eu/eli/dir/2024/2853/oj/eng.”
  Medical devices · Processing of health data
• 2025-05-22 “E-002078/2025 Answer given by Mr Várhelyi on behalf of the European Commission There is no scientific evidence of any increase of cancer occurrence following COVID-19 vaccination. Increased incidences of cancer have been linked primarily to lifestyle factors. At the time that the Europe’s Beating Cancer Plan was launched in early February 2021 1 , the first COVID-19 mRNA vaccine had just received a conditional marketing authorisation. Therefore, no studies on a link between COVID-19 mRNA vaccines and cancers are included in the Cancer Plan. A review based on an extensive stakeholder consultation in 2025 confirms the validity of the objectives and priorities of the plan 2 . Simian virus 40 (SV40) is a naturally occurring virus. A non-infectious fragment of SV40 is present in the deoxyribonucleic acid (DNA) plasmid starting material of Comirnaty. The virus itself is not used in the manufacturing process of the vaccine. During the manufacturing process, this sequence and other plasmid DNA sequences are broken down and removed. Fragments of the SV40 sequence may only be present as residual impurities at very low levels that are routinely controlled. There is no scientific evidence that any of these SV40 fragments can act as insertional mutagens. The European Medicines Agency (EMA) continuously monitors and supervises the safety of medicines and vaccines that have been authorised in the EU 3 . The EMA coordinates the EU pharmacovigilance system and operates services and processes to support pharmacovigilance in the EU 4 . 1 Communication from the Commission to the European Parliament and the Council, Europe's Beating Cancer Plan COM/2021/44 final. 2 https://health.ec.europa.eu/publications/review-europes-beating-cancer-plan_en. 3 https://vaccination-info.europa.eu/en/reporting-side-effects. 4 https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview.”
  Vaccination · Pharmaceuticals regulation in EU
• 2025-05-22 “E-002077/2025 Answer given by Mr. Várhelyi on behalf of the Commission 1. The genotoxicity potential of Kostaive was assessed and is part of the assessment report which is published on the European Medicines Agency (EMA) website 1 . A lipid nanoparticle (LNP), similar to that used in Kostaive (contained in ARCT-810), was tested for its genotoxicity potential. The studies were completed by in silico modelling which are robust methods to predict the mutagenic potential (ability to induce genetic alterations) of molecules. These tests concluded no genotoxic potential. In addition, based on the data accumulated during the vaccination campaigns, there is no evidence supporting genotoxicity of any mRNA vaccines. 2. The clinical study reports that supported the authorisation of Kostaive have been published on EMA’s clinical data website 2 . 3. The Commission’s authorisation decisions are based on the EMA scientific assessments, whose transparency is ensured through the publication on the EMA website as referred above. 1 https://www.ema.europa.eu/en/documents/assessment-report/kostaive-epar-public-assessment-report_en.pdf. 2 https://clinicaldata.ema.europa.eu/web/cdp/home.”
  Disclosure vs. confidentiality of pharma companies processes · Pharmaceuticals regulation in EU · Vaccination
• 2025-04-28 “E-001696/2025 Answer given by Mr Várhelyi on behalf of the European Commission The assessment of a medicinal product is based solely on scientific evidence 1 , not political pressure. There is a robust procedure established that must be followed before granting a marketing authorisation 2 . When an application for a marketing authorisation of a medicinal product is submitted in the EU, the information included in a dossier is carefully assessed by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use 3 . This assessment is summarised in a publicly available report (European Public Assessment Report 4 ) that also includes the verification of the compliance of good clinical practices. The criteria used to consider the need of an inspection are published on the EMA website 5 . In some cases, inspections may not be feasible or necessary. Instead, alternative methods that provide the required level of assurance, including inspections conducted by other globally recognised regulatory authorities, may be considered. The decision is based on the triggers identified. During COVID-19, the need for inspections was assessed and decided on a case-by-case basis. In the EU, there is a robust safety monitoring and risk management (pharmacovigilance) system to supervise every medicinal product throughout its use in healthcare practice. For each medicinal product, safety updates are regularly assessed through the Periodic Safety Update Reports (PSURs 6 ). These assessments are carried out by the EMA’s Pharmacovigilance Risk Assessment Committee 7 and permit to identify any new potential risks. The safety and efficacy of all medicinal products, including COVID-19 vaccines, have always been a top priority for the Commission. 1 How EMA evaluates medicines for human use https://www.ema.europa.eu/en/about-us/what-wedo/authorisation-medicines/how-ema-evaluates-medicines-human-use#assessment-process-13164. 2 Authorisation of medicines https://www.ema.europa.eu/en/about-us/what-we-do/authorisation-medicines. 3 Committee for Medicinal Products for Human Use (CHMP) https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp. 4 European public assessment reports: background and context https://www.ema.europa.eu/en/medicines/whatwe-publish-medicines-when/european-public-assessment-reports-background-context. 5 https://www.ema.europa.eu/en/documents/other/points-consider-assessors-inspectors-european-medicinesagency-inspection-coordinators-identification-triggers-selection-applications-routine-cause-inspections-theirinvestigation-scope-such_en.pdf. 6 https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-postauthorisation/periodic-safety-update-reports-psurs. 7 https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac.”
  Transparency of EU medicines governance process · Pharmaceuticals regulation in EU · Disclosure vs. confidentiality of pharma companies processes
• 2025-04-28 “E-001702/2025 Answer given by Mr Dombrovskis on behalf of the European Commission The Commission will not comment on developments with respect to the chairmanship of the World Economic Forum. It is the sole responsibility of the World Economic Forum to investigate alleged breaches of its own rules and codes of conduct. The Commission condemns racism, misogyny or any other expression of hatred, and has put forward respective strategies to achieve a Union of Equality 1 . The Commission has a zero-tolerance approach towards misuse of EU funds as well as a proactive approach to promote diversity and inclusion in its workplace. 1 https://commission.europa.eu/strategy-and-policy/policies/justice-and-fundamental-rights/combattingdiscrimination/racism-and-xenophobia/eu-anti-racism-action-plan-2020-2025_en; https://commission.europa.eu/document/99cc0720-68c2-4300-854f-592bf21dceaf_en; https://commission.europa.eu/strategy-and-policy/policies/justice-and-fundamental-rights/genderequality/gender-equality-strategy_en; https://commission.europa.eu/strategy-and-policy/policies/justice-andfundamental-rights/combatting-discrimination/lesbian-gay-bi-trans-and-intersex-equality/lgbtiq-equalitystrategy-2020-2025_en; https://commission.europa.eu/strategy-and-policy/policies/justice-and-fundamentalrights/disability/union-equality-strategy-rights-persons-disabilities-2021-2030_en.”
  EU foreign policy approach
• 2025-04-25 “E-001675/2025 Answer given by Mr Várhelyi on behalf of the European Commission The authorisation of COVID-19 vaccines is based on a thorough scientific assessment by the European Medicines Agency (EMA) about the vaccine quality, safety, and efficacy 1 . Initially, COVID-19 vaccines were granted a conditional marketing authorisation (CMA) 2 , a pathway used to expedite access to medicines addressing unmet needs, particularly during public health emergencies. A CMA requires the marketing authorisation holder to provide further data post-authorisation to confirm the benefit-risk balance. Following authorisation, all medicinal products authorised in the EU, are subject to continuous and rigorous safety monitoring, which was further enhanced for COVID-19 vaccines. The EU pharmacovigilance system detects, assesses, and addresses potential side effects 3 , with the EMA’s safety Committee (PRAC) 4 analysing new risks that may emerge from various sources, including clinical practice, clinical studies, and medical literature. Current scientific data from over 13 billion COVID-19 vaccine doses administered worldwide shows a very good safety profile. Most adverse drug reactions are mild and short-lived. Serious effects are very rare 5 and thoroughly assessed. In 2022, PRAC concluded that there was no evidence supporting a causal link between mRNA COVID-19 vaccines and AIH 6 . Each vaccine has published product information and an assessment report detailing all examined aspects 7 . If a reasonable possibility exists that a side effect is linked to the vaccine, it is included in the product information to ensure transparency for healthcare professionals and patients. 1 Approval of vaccines in the EU: https://vaccination-info.europa.eu/en/about-vaccines/approval-vaccines-eu; COVID-19 vaccines: development, evaluation, approval and monitoring: https://www.ema.europa.eu/en/humanregulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-public-health-emergencyinternational-concern-2020-23/covid-19-vaccines-development-evaluation-approval-monitoring. 2 Conditional marketing authorisation: https://www.ema.europa.eu/en/human-regulatory-overview/marketingauthorisation/conditional-marketing-authorisation. 3 Pharmacovigilance: Overview: https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilanceoverview. 4 Pharmacovigilance Risk Assessment Committee (PRAC): https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac. 5 Safety of COVID-19 vaccines: https://www.ema.europa.eu/en/human-regulatory-overview/public-healththreats/coronavirus-disease-covid-19/covid-19-medicines/safety-covid-19-vaccines#suspected-side-effects13834. 6 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 April 2022: https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-47-april-2022. 7 COVID-19 medicines: https://www.ema.europa.eu/en/human-regulatory-overview/public-healththreats/coronavirus-disease-covid-19/covid-19-medicines.”
  Vaccination · Pharmaceuticals regulation in EU
• 2025-04-15 “E-001538/2025 Answer given by Mr Várhelyi on behalf of the European Commission As the Commission pointed out in its reply to written question E-002978/2024 1 , Article 55(2) of the International Health Regulations (2005) (hereafter the ‘IHR’) provides that the Director-General of the World Health Organization (WHO) shall communicate the text of any proposed amendment to all State Parties at least 4 months before the World Health Assembly at which it is proposed for consideration. In fulfilment of this requirement, the WHO Secretariat circulated all proposals for amendments to the IHR, submitted by the IHR State Parties in September 2022, on 16 November 2022, that is 17 months before the 77 th World Health Assembly, which began on 27 May 2024, and during which the amendments were adopted. As also pointed out by the Commission in its reply to the same written question, the WHO Secretariat has complied with the technical requirements set out under Article 55(2) of the IHR by communicating not only the original proposals for amendments to the IHR on 16 November 2022, but also by communicating to all IHR States Parties all draft changes to these original proposals, as developed by the Working Group on IHR amendments (hereafter the ‘WGIHR’) 2 . These communications, which occurred at the conclusion of each WGIHR meeting, have ensured that all IHR State Parties had adequate time to fully consider the amendments to the IHR under negotiations, in view of their adoption at the 77 th World Health Assembly. 1 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 2 The WGIHR was established by the World Health Assembly in May 2022 for the negotiations on the IHR amendments and operated as a subdivision of the Assembly. It was composed of all 196 States Parties to the IHR, and of the EU as a regional economic integration organisation.”
  EU competences on health
• 2025-04-10 “E-001492/2025 Answer given by Mr Várhelyi on behalf of the European Commission The increasing dependence on third countries for the manufacturing of medicinal products and their components is a pressing concern. In response, the Commission has undertaken a range of measures to strengthen the security of supply, including initiatives to incentivise the manufacturing of critical medicines inside the EU. A cornerstone of these efforts is the Commission’s proposal for a Critical Medicines Act 1 , adopted on 11 March 2025. The proposed Act aims to bolster EU-based manufacturing capacity for critical medicines by identifying strategic projects and leveraging public procurement mechanisms. The proposed Act also recognises the importance of ensuring affordability of medicinal products. While enhancing supply security may entail additional costs, the proposed Critical Medicines Act aims to foster cooperation amongst the Member States, enabling a coordinated and cost-efficient approach to invest in security of supply and thereby reduce the important burden of critical shortages for patients, health care providers and society. The Commission remains firmly committed to ensuring that patients have access to the medicines they need, when they need them. 1 COM/2025/102 final.”
  Government stockpiling of critical medicines · Pharmaceuticals regulation in EU · Supply chain diversification requirements in medicine procurement
• 2025-04-10 “E-001495/2025 Answer given by Ms Lahbib on behalf of the European Commission The (Advanced) Purchase Agreements for the supply of COVID-19 vaccines to the Member States were concluded in full transparency with the Member States. Negotiations were carried out by a Joint Negotiation Team that consisted of representatives of the Commission and of several Member States. This team reported regularly to a Vaccines Steering Board co-chaired by the Commission and a Participating Member State, which provided guidance throughout the process. The Commission has provided information to the Parliament on a continuous basis, in line with its Treaty obligations and the Framework Agreement on relations between the two institutions 1 . All mRNA vaccines that receive a marketing authorisation are based on a thorough review by the European Medicine Agency (EMA), of clinical evidence confirming a favourable benefitrisk profile. Adapted versions are also approved based on data showing their ability to induce an immune response that can predict clinical efficacy and safety. The safety profile of all medicinal products authorised in the EU, including mRNA vaccines, is subject to continuous monitoring. There is a robust pharmacovigilance system established in the EU to detect, assess, and address potential side effects 2 . The Commission and Member States considered early introduction of the vaccine to be in the interest of public health. Member States were therefore willing to reduce manufacturers’ risks linked to liability for adverse effects 3 . A citizen who has suffered adverse effects from one of the COVID-19 vaccines purchased under the contracts can claim damages against the manufacturer of the vaccine 4 . 1 The Commission has pro-actively published redacted versions of the contracts concluded with the vaccine producers on its website. 2 https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview. 3 This was intended as a risk sharing principle in the vaccine strategy. 4 If the claim is successful, the Member State that administered the vaccine can, under certain conditions, be responsible for compensating the injured party and paying the vaccine manufacturer’s legal costs (indemnification).”
  Disclosure vs. confidentiality of pharma companies processes · Covid-19 vaccines procurement
• 2025-04-10 “E-001491/2025 Answer given by Mr Várhelyi on behalf of the European Commission 1. A ‘health emergency’ definition is not included in EU legislation. However, Article 3(1) of Regulation (EU) 2022/2371 1 defines a serious cross-border threat to health. Internationally, a public health emergency of international concern is set in the International Health Regulations 2 . 2. The EU can recognise a public health emergency on its own. The procedure for the recognition is set in Article 23 of Regulation (EU) 2022/2371 3 , which foresees a consultation with relevant agencies and bodies 4 . The recognition has a form of an implementing act, requiring a favourable opinion of the Member States. The Commission does not have to consult the World Health Organization (WHO) before the recognition, but should nonetheless inform the WHO about its intention to adopt such decision. 3. The substantial conditions for the recognition stem from Articles 2(1) and 3(1) of Regulation (EU) 2022/2371. In particular, the cross-border nature of a health threat and the need for EU-level coordination must be identified. 1 Article 3(1) of Regulation (EU) 2022/2371: ‘serious cross-border threat to health’ means a life-threatening or otherwise serious hazard to health of biological, chemical, environmental or unknown origin, as referred to in Article 2(1), which spreads or entails a significant risk of spreading across the national borders of Member States, and which may necessitate coordination at Union level in order to ensure a high level of human health protection (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L:2022:314:FULL&from=EN). 2 https://iris.who.int/bitstream/handle/10665/246107/9789241580496-eng.pdf (Article 6 and Annex II of the International Health Regulations). 3 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32022R2371&qid=1673887469777. 4 The European Centre for Disease Prevention and Control, or the Advisory Committee on public health emergencies (referred to in Article 24 of Regulation (EU) 2022/2371) or any other relevant Union agency or body.”
  Vaccination · EU competences on health
• 2025-04-09 “E-001476/2025 Answer given by Mr Várhelyi on behalf of the European Commission As indicated in the Commission’s reply to the parliamentary question E-000607/2025 1 , the World Health Organization (WHO) is a key partner for international health cooperation. The EU stands firmly behind the WHO and its vital work. The EU is a major donor and an informal observer within the WHO. The EU will continue advocating for a strong and resilient WHO, within the global multilateral system. The Commission and EU bodies and agencies have not received any funding from the WHO or its partners since the COVID-19 pandemic began in 2020. The Commission invites the Honourable Member to consult the Financial Transparency System 2 and its Annex I. The portal makes available to the public information on recipients of funds financed from the budget and implemented under direct management mode, as well as information on implementing partners which implement the budget under indirect management mode. In the area of health, examples of Commission funding instruments are EU4Health 3 covering 2021-2027 period, and the third Health Programme 4 covering 20142020. 1 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 2 https://ec.europa.eu/budget/financial-transparency-system/index.html. The annual publications are based on Article 38 of the Financial Regulation (OJ L 2024/2509, 26.9.2024, p. 1–239), and in accordance with the third paragraph of the article, information on recipients is not disclosed in specific cases outlined therein. 3 https://hadea.ec.europa.eu/programmes/eu4health_en. 4 https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/programmes/3hp.”
  EU competences on health · Vaccination
• 2025-03-11 “E-001040/2025 Answer given by Mr Várhelyi on behalf of the European Commission The European Centre for Disease Prevention and Control (ECDC) published its first Rapid Risk Assessment ‘Cluster of pneumonia cases caused by a novel coronavirus, Wuhan, China, 2020’ on 17 January 2020 1 . The ECDC closely followed the situation and updated its Rapid Risk Assessments when trustworthy scientific information became available. The ECDC published its second update to this Rapid Risk Assessment on 26 January 2020 2 , which considered the potential impact of 2019-nCoV outbreaks as high and further global spread as likely, thus warning a pandemic could occur. Neither the Commission, the ECDC or the European Medicines Agency were involved nor participated in the simulation exercises (Atlantic Storm, CLADE X, Event 201 and Spars Pandemic 2025-2028). Therefore, the Commission cannot comment on them. Before the COVID-19 pandemic the Commission routinely organised capacity building activities to prepare for possible cross-border threats to health. These trainings on prevention, preparedness and response to cross border threats to health, contingency planning for animal diseases and zoonoses 3 , and simulation exercises focusing on rapid risk assessment of chemical threats 4 . Furthermore, the Commission and the ECDC organised the exercise ‘Blue Orchid’ 5 to test crisis management functions, procedures, and communication channels between the Commission and the ECDC. They also carried regional expert workshops on pandemic preparedness planning in March 2019 to coordinate national approaches applied by EU/European Economic Area countries to planning, implementation, and evaluation of (influenza) pandemic preparedness plans. The ECDC published a Handbook on simulation exercises in the EU public health settings on 2 June 2014 6 . 1 https://www.ecdc.europa.eu/en/publications-data/rapid-risk-assessment-cluster-pneumonia-cases-caused-novelcoronavirus-wuhan. 2 Risk assessment: outbreak of acute respiratory syndrome associated with a novel coronavirus, China; First cases imported in the EU/EEA; second update: https://www.ecdc.europa.eu/en/publications-data/riskassessment-outbreak-acute-respiratory-syndrome-associated-novel-0. 3 https://better-training-for-safer-food.ec.europa.eu/training/. 4 https://health.ec.europa.eu/scientific-committees/former-scientific-committees/scientific-committee-healthenvironmental-and-emerging-risks-2016-2021/scheer-minutes-working-groups-2016-2021_en. 5 Organised on 8 February 2019. 6 Handbook on simulation exercises in EU public health settings: https://www.ecdc.europa.eu/en/publicationsdata/handbook-simulation-exercises-eu-public-health-settings.”
  EU competences on health · Covid-19 vaccines procurement
• 2025-02-21 “P-000805/2025 Answer given by Mr Várhelyi on behalf of the European Commission 1. The amendments to the International Health Regulations (IHR) adopted by the World Health Assembly (WHA) on 28 May 2022 were notified by the Director-General of the World Health Organization (WHO) to all IHR State Parties on 31 May 2022, through circular letter C.L.26.2022. These amendments, which relate to Articles 55, 59, 61, 62 and 63 of the IHR, aim to shorten the period for rejection of, or reservation to new amendments from 18 to 10 months from the date of the Director-General’s notification of adoption of the amendments, and to reduce the period for their entry into force from 24 to 12 months from the same date. 2. For IHR State Parties to which the 2022 amendments apply, the period for rejection of, or reservation to the IHR amendments adopted by the WHA on 1 June 2024 will expire on 19 July 2025. For IHR State Parties to which the 2022 amendments do not apply, the period for rejection of, or reservation to the IHR amendments adopted by the WHA on 1 June 2024 will expire on 19 March 2026. 3. As the Commission pointed out in its reply to written question E-002978/2024 1 , all proposals for amendments to the IHR submitted by the IHR State Parties in September 2022, were circulated by the WHO Secretariat on 16 November 2022. This is 17 months before the 77 th WHA, which began on 27 May 2024. The amendments (as finalised in the Working Group on the IHR amendments open to all IHR State Parties) were finally adopted on 1 June 2024. The requirement to communicate the text of any proposed amendment to all State Parties at least 4 months before the WHA at which it will be proposed for consideration has therefore been fulfilled. 1 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html”
  EU competences on health
• 2025-02-20 “E-000790/2025 Answer given by Mr Serafin on behalf of the European Commission The Commission has not received any funding from USAID during the COVID-19 pandemic from 2020 onwards. The Commission has not received any funds as external assigned revenues from the USAID for the EU budget, the European Development Fund 1 or the EU Trust Fund 2 after 2020. Nor did the European Medicines Agency (EMA), the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC) receive any funds from the USAID. The Health Emergency Preparedness and Response Authority (HERA) 3 , established in September 2021, has not received any funding from the USAID either. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=LEGISSUM%3Ar12102. 2 https://international-partnerships.ec.europa.eu/funding-and-technical-assistance/funding-instruments/trustfunds_en. 3 https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera_en.”
  EU-US relations
• 2025-02-12 “E-000663/2025 Answer given by Mr Várhelyi on behalf of the European Commission The purpose of Regulation (EU) 2015/2283 on novel foods 1 is to ensure a high level of protection of human health and consumers' interests and the effective functioning of the internal market. Any novel food must be authorised prior to its placing on the market. Companies wishing to obtain an authorisation for a novel food must submit an application which is subject to a comprehensive safety evaluation by the European Food Safety Authority (EFSA). The Regulation does not foresee other factors such as the necessity for a particular novel food to be available on the market. It is for companies to decide whether they wish to apply for authorisation and for consumers to decide whether they wish to buy authorised novel foods. In 2015, EFSA adopted a scientific opinion on the risk profile related to the production and consumption of insects as food and feed 2 . According to this opinion, while insect farming systems generally do not use hormones, antibiotics or chemicals, with the exception of biocides used to disinfect the production environment in between batches, in intensive production systems, antibiotics may be used to treat or prevent diseases, such as in apiculture. In this context, the provisions on the use of antimicrobials included in Regulation (EU) 2019/6 on veterinary medicinal products 3 for food producing animals are also applicable to insects intended for human consumption. In all its scientific opinions on insects as novel foods, EFSA has not reported the use of antibiotic or antifungal substances in the rearing of the authorised insects, nor the presence of any residues. Therefore, there was no need to consider risk management measures such as specific labelling in this regard. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32015R2283. 2 https://www.efsa.europa.eu/en/efsajournal/pub/4257. 3 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02019R0006-20220128.”
  EU policy on novel foods
• 2025-02-12 “E-000666/2025 Answer given by Ms Lahbib on behalf of the European Commission Various forms of centralised procurement of medical countermeasures create the possibility for participating Member States to benefit from collective bargaining power, and – in cases of limited supply – to avoid competition between Member States. This ensures equitable access to medical supplies and promotes cost efficiency. Should the participating Member States agree to the exclusivity of a centralised procurement, as was the case for COVID-19 (advanced) purchase agreements, this further strengthens their negotiation position. During preparedness mode, joint procurement of medical countermeasures is conducted by the Commission to enhance preparedness and response against serious cross-border health threats based on Regulation (EU) 2022/2371 1 . This collaborative approach helps to reinforce the individual capabilities of each country while strengthening the overall resilience of the EU’s public health response mechanisms. Participation in joint procurement and other forms of centralised procurement is voluntary for the participating countries, thus fully preserving the competence of the Member States to organise their national health services and medical care, as prescribed by Article 168(7) Treaty on the Functioning of the European Union (TFEU). Possible restrictions to parallel procurement and negotiation activities by the participating countries for the medical countermeasure in question are only possible if the Parties to the Joint Procurement Agreement agree to such restrictions. The division of competences between the Commission and the Member States is based on TFEU and remains unchanged. A recent Commission Communication 2 provides an overview of the actions undertaken in the area of health policy. 1 Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health https://eur-lex.europa.eu/eli/reg/2022/2371/oj/eng 2 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - The European Health Union: acting together for people's health - https://commission.europa.eu/document/download/98c6e4dc-0fc3-4ec6-8ec2bfcdcb2f018a_en?filename=policy_com-2024-206_en.pdf”
  EU competences on health · Joint EU procurement of medicines
• 2025-02-11 “E-000609/2025 Answer given by President von der Leyen on behalf of the European Commission 1. The Commission has not received any official information from the European Public Prosecutor’s Office regarding the alleged appeal mentioned by the Honourable Member. 2. The Commission does not comment on national Court proceedings 1 . 1 https://www.eppo.europa.eu/sites/default/files/202107/2021.073_Agreement_EPPO_European_Commission_final.pdf.”
  Activities of EU Ombudsman · Transparency requirements of EU institutions
• 2025-02-11 “E-000608/2025 Answer given by Ms Lahbib on behalf of the European Commission 1. The list of participating countries is available in the contract award notice that was published on 24 January 2025 1 . The framework contract was signed by the Commission on behalf of the participating countries. 2. As the Commission pointed out in its reply to written question P-000356/2024 2 , the framework contract signed with Moderna in January 2025 is fully flexible and does not bind the contracting authorities to make any purchase. Indeed, the volume of 146 million doses is the maximum ceiling that contracting authorities could purchase if they would have a need during the whole duration of the framework contract. In order to establish the ceiling, the Commission has consulted the contracting authorities prior to launching the call for tender and asked them about their estimated possible needs in case of crisis. 3. The Spikevax (Moderna COVID-19 vaccine) received a marketing authorisation based on a thorough review by the European Medicine Agency (EMA), of clinical evidence confirming a favourable benefit-risk profile 3 . The vaccine was initially assessed in around 30,000 adults and over 3,000 children 4 . Adapted versions targeting emerging variants, like JN.1, are also approved based on data showing their ability to induce an immune response that can predict clinical efficacy and safety 5 . EMA monitors EudraVigilance data 6 from millions of vaccinated people, reviewing safety information from clinical studies, medical literature and periodic safety update reports to identify and investigate safety signals. 1 https://ted.europa.eu/en/notice/-/detail/51540-2025 2 https://www.europarl.europa.eu/doceo/document/P-9-2024-000356-ASW_EN.html 3 https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-modernaepar-public-assessment-report_en.pdf 4 https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax 5 https://pubmed.ncbi.nlm.nih.gov/39591137/ 6 https://www.ema.europa.eu/en/human-regulatory/research-development/pharmacovigilance/eudravigilance”
  Covid-19 vaccines procurement · Transparency of EU medicines governance process
• 2025-02-11 “E-000607/2025 Answer given by Mr Várhelyi on behalf of the European Commission 1. The EU and its Member States are the largest contributors to global health financing, including through contributions to the World Health Organization (WHO), with whom the EU collaborates in line with its commitments and available resources. 2. The negotiations on the WHO Pandemic Agreement were successfully concluded by the Intergovernmental Negotiating Body on 16 April 2025 and the text has been formally adopted at the 78 th World Health Assembly on 20 May 2025. The Assembly has set out the arrangements for finalising the work on the Annex on Pathogen Access and Benefit Sharing, and for the eventual opening for signature of the Agreement. Throughout the negotiations, the Commission, acting as the Union Negotiator pursuant to Council Decision (EU) 2022/451 1 , has cooperated closely with Member States. 3. Cooperation between EU and the United States of America (USA) agencies on health is ongoing, including between the European Medicines Agency (EMA) and the USA Food and Drug Administration (FDA), as well as between the European Centre for Disease Prevention and Control (ECDC) and the USA Centres for Disease Control and Prevention (CDC). Such cooperation contributes to improving the health of both EU and USA citizens. 1 The Commission negotiates the Pandemic Agreement on behalf of the European Union, for matters falling within Union competence, based on an authorisation from the Council of the European Union set out in Council Decision (EU) 2022/451 of 3 March 2022 authorising the opening of negotiations on behalf of the European Union for an international agreement on pandemic prevention, preparedness and response, as well as complementary amendments to the International Health Regulations (2005) (OJ L 92, 21.3.2022, p. 1). The Commission, as the Union negotiator, is guided by the negotiating directives annexed to the Decision, laying down the main objectives and principles to be achieved.”
  EU-US relations · Support for international humanitarian organisations
• 2025-02-05 “E-000538/2025 Answer given by Mr. Várhelyi on behalf of the European Commission Insect producers are food business operators and therefore must be registered and comply with the same safety requirements and Good Hygiene Practices as for any other food, including Regulation (EC) 852/2004 1 on the hygiene of foodstuffs. These requirements need to be controlled by the competent authorities in accordance with Regulation (EU) 2017/625 2 on official controls. In 2015, the European Food Safety Authority (EFSA) concluded in a Scientific Opinion providing a risk profile related to production and consumption of insects as food and feed 3 that: ‘Despite the documented occurrence of parasites in insects and the linkage between sporadic human parasitic disease and insect consumption (in certain third countries), a properly-managed closed farm environment would lack all the hosts necessary for the completion of parasite life cycles and proper management before consumption, relying on freezing and cooking, can eliminate risks.’ Directive 2003/99/EC 4 obliges Member States to monitor and report zoonoses and zoonotic agents, compiled by EFSA in the annual European Union One Health Zoonoses report 5 . No zoonotic parasites in insects have been reported in these reports, demonstrating the validity of the EFSA opinion and the efficiency of the existing hygiene rules. 1 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. OJ L 139 30.4.2004, p. 1. 2 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 07/04/2017, p. 1). 3 https://www.efsa.europa.eu/en/efsajournal/pub/4257 4 Directive 2003/99/EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90/424/EEC and repealing Council Directive 92/117/EEC (OJ L 325 12.12.2003, p. 31). 5 Latest (2023 data) available at https://www.efsa.europa.eu/en/efsajournal/pub/9106”
  EU policy on novel foods
• 2025-01-28 “E-000373/2025 Answer given by Mr Várhelyi on behalf of the European Commission The main aim of any vaccine is to protect people against a disease, they do not fully protect people against infection. COVID-19 vaccines have been shown to protect people against severe COVID-19, hospitalisation and death; they do not fully protect people against infection. There is no evidence that the risk of being infected increases with increasing number of vaccinations. There is a robust system for safety monitoring of all medicines authorised in the EU with suspected side effects reported at national level and collected centrally in EudraVigilance 1 . Healthcare professionals are encouraged to report side effects. All suspected side effects are assessed alongside clinical study results and scientific literature to identify unusual patterns, which warrant further investigation. Long Covid should not be confused with COVID-19 vaccine adverse reactions 2 . Scientific evidence has shown that infection with SARS-CoV-2 can lead to long COVID, including thousands of cases before COVID-19 vaccines were introduced. There has been no safety signal from the very large body of data held by international regulators 3 suggesting that long COVID is a possible side effect of COVID-19 vaccination. On the contrary, several studies indicate that vaccinated people who are subsequently infected with SARS-CoV-2 are less likely to report symptoms of long COVID than unvaccinated people. The benefits of COVID-19 vaccines continue to outweigh their risks, especially for more vulnerable people. EMA continues to monitor emerging evidence on the safety of COVID-19 vaccines. In case of any safety concern, as usual the Commission will take necessary regulatory action as needed. 1 https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-researchdevelopment/eudravigilance 2 https://www.science.org/doi/10.1126/science.adl0867 3 https://www.icmra.info/drupal/en/strategicinitiatives/vaccines/safety_statement#:~:text=Evidence%20from%20 the%20more%20than,effects%20are%20mild%20and%20temporary”
  Pharmaceuticals regulation in EU · Vaccination
• 2025-01-27 “E-000345/2025 Answer given by Mr Síkela on behalf of the European Commission The Commission does not finance private foundations of the United States, including the Bill Gates Foundation. The Commission contributes (as many EU Member States and other major donors) to independent multi-partner global funds and initiatives of which the Bill and Melinda Gates foundation is also often a major investor. In respect of the EU’s Financial Regulation 1 , EU development funding implemented by foundations or other civil society organisations (CSOs) is awarded through competitive calls for proposals. Recourse to an award of a grant without a call for proposals can be justified only in exceptional cases. All development projects funded by the EU and implemented by CSOs are subject to strict and rigorous monitoring and reporting procedures on an annual basis. The EU projects, implemented by foundations or CSOs, are subject to audits and/or a specific result-oriented monitoring to ensure the attainment of agreed results. The reporting from all projects at corporate level allows for assessment of their impact through analysis of results and indicators. 1 https://op.europa.eu/en/publication-detail/-/publication/990fe2a6-8f52-11ef-a130-01aa75ed71a1/language-en”
  Accounting and auditing of EU budget · EU engagement with civil society · Transparency requirements of EU institutions
• 2025-01-27 “E-000344/2025 Answer given by Mr Serafin on behalf of the European Commission The Commission would like to kindly refer the Honourable Member to the publicly available Financial Transparency System (FTS) 1 . In accordance with Article 38 of the Financial Regulation 2 , on the FTS portal, the Commission makes available information of grant recipients of funds financed from the budget. The information concerning financial year 2024 will be published in June 2025. The Commission implements EU funding fully in line with the relevant EU legislation adopted by the EU legislator, in particular the Financial Regulation, which sets out the relevant provisions to ensure that the financial interests of the Union budget are protected. For example, the Financial Regulation sets out specific rules to ensure that procurement and grant funding from the EU budget respect equal treatment, non-discrimination and transparency. 1 https://ec.europa.eu/budget/financial-transparency-system/index.html. The annual publications are based on Article 38 of the Financial Regulation (OJ L 2024/2509, 26.9.2024, p. 1–239), and in accordance with the third paragraph of the article, information on recipients is not disclosed in specific cases outlined therein. 2 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202402509”
  Transparency requirements of EU institutions · Accounting and auditing of EU budget
• 2025-01-10 “E-000074/2025 Answer given by President von der Leyen on behalf of the European Commission The visual that the Honourable Members refer to is an artistic illustration of the EU and Ukrainian flags, used for communication purposes. It symbolises European solidarity with Ukraine. This is just one of several examples of artistic interpretation of flags used for communication purposes also by other EU institutions. No member of the College has provided comments on the use of this visual.”
  EU-Ukraine relations · EU public communication strategy
• 2025-01-10 “E-000075/2025 Answer given by Mr Várhelyi on behalf of the European Commission Directive 2009/120/EC 1 , amending Directive 2001/83/EC 2 , excludes vaccines against infectious diseases from the definition of gene therapy medicinal products. mRNA vaccines authorised in the EU against COVID-19 are not genetically modified organisms and do not contain genes as their active substance. They are not used with the aim to restore, correct, or modify human genes. mRNA vaccines are biological medicines regulated under the EU pharmaceutical legislation to ensure their quality, safety, and efficacy. Under the legislation, the Committee for Medicinal Products for Human Use (CHMP) may also recommend additional measures, such as long-term monitoring, based on specific risks following a case-by-case assessment 3 . The safety and efficacy of mRNA vaccines authorised in the EU against COVID-19 have been rigorously assessed through clinical trials and post-authorisation monitoring. The European Medicines Agency (EMA) and Member States continuously monitor the safety of COVID-19 vaccines to ensure any possible risks are detected and managed as early as possible 4 . All data confirm that COVID-19 vaccines have a favourable safety profile. Regarding safety concerns in respiratory syncytial virus (RSV) vaccine trials in infants, these are not linked to the mRNA technology 5 but rather to challenges previously observed with other RSV vaccines in this age group. Currently, RSV vaccines are only authorised for use in adults 6 , with trials ongoing to assess their safety and efficacy in infants and toddlers. The Commission remains committed to ensuring that all medicines, including vaccines, authorised in the EU meet the highest standards of safety, efficacy, and quality, in full compliance with the EU pharmaceutical legislation. 1 https://eur-lex.europa.eu/eli/dir/2009/120/oj/eng 2 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj 3 https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp 4 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines/safety-covid-19-vaccines 5 https://www.fda.gov/media/184301/download 6 https://www.ema.europa.eu/en/medicines/human/EPAR/abrysvo; https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy; https://www.ema.europa.eu/en/medicines/human/EPAR/mresvia”
  GMOs
• 2025-01-08 “E-000049/2025 Answer given by Mr Várhelyi on behalf of the European Commission 1. Vaccination is a key tool for prevention of communicable diseases. The study referred to in the question does not adhere to basic quality standards of scientific research, and the results are not in line with existing studies that do. Vaccination is a national competence, but the Commission supports Member States in achieving or maintaining high vaccination coverage rates. With the support of the European Medicines Agency and in cooperation with the European Centre for Disease Control (ECDC), the benefits and risks of vaccines/vaccinations are continuously monitored at EU level. The confidence of EU citizens in vaccines is overall high as reflected in Commission-funded studies on the topic 1 . 2. The Commission is not aware of comprehensive research directly comparing chronic disease rates between vaccinated and unvaccinated populations in Europe. Multiple studies from peer-reviewed journals highlight the essential role of vaccination in preventing infections that could otherwise lead to chronic health issues 2,3 . There is also no evidence linking routine vaccinations to an increased risk of chronic diseases 4 . In fact, evidence indicates that vaccines may help prevent conditions such as heart disease 5,6 or diabetes 7 . 3. Socio-economically disadvantaged groups may have lower vaccination coverage rates than the general population. Member States monitor vaccination coverage rates, including at a subnational level. In its revised mandate 8 , the ECDC is tasked to monitor the vaccination coverage for major communicable diseases in Member States. Efficient monitoring of vaccination coverage rates, including through electronic vaccination registries, is key to inform targeted public health action in the field. 1 https://op.europa.eu/en/publication-detail/-/publication/678e38ae-a154-11ea-9d2d-01aa75ed71a1/language-en, https://op.europa.eu/en/publication-detail/-/publication/b8b69b9c-8965-11ec-8c40-01aa75ed71a1/language-en, https://op.europa.eu/en/publication-detail/-/publication/b89452df-6958-11ed-b14f-01aa75ed71a1/language-en 2 https://pmc.ncbi.nlm.nih.gov/articles/PMC9144632/ 3 https://pubmed.ncbi.nlm.nih.gov/35318115/ 4 https://www.nejm.org/doi/full/10.1056/NEJMoa021134 5 https://pubmed.ncbi.nlm.nih.gov/37370193/#:~:text=Influenza%20vaccination%20was%20associated%20with, %2D0.95%2C%20p%20%3D%200.0227%2C 6 https://pubmed.ncbi.nlm.nih.gov/31504439/ 7 https://pmc.ncbi.nlm.nih.gov/articles/PMC8427438/ 8 https://eur-lex.europa.eu/eli/reg/2022/2370/oj/eng”
  Vaccination
• 2025-01-08 “E-000051/2025 Answer given by Mr Micallef on behalf of the European Commission Measures to make local infrastructure, such as ski lifts, more accessible to area residents, in particular low-income ones, can benefit the local community (also because they may improve the local residents’ health) and promote inclusivity. Moreover, ski lift prices for local residents might be influenced or decided by regional or local authorities in view of the situation of local residents. (This may depend on whether the applicable national, regional and/or local rules allow this, an on whether the ski lift operator is controlled by the municipality). However, it may be that certain rules of EU law apply to certain ski lift operators in a Member State, including their pricing policy. If so, public authorities should abide by the relevant EU rules. For instance, the EU’s State aid rules may be applicable where trade between Member States is affected. Subject to specific requirements, these rules allow, inter alia, support having a social character and directed to individuals. One of the objectives of the EU Work plan for Sport 2024-2027 1 is to increase participation in sport and health-enhancing physical activity and improve accessibility for vulnerable groups, in order to promote an active and environmentally friendly lifestyle, social cohesion and active citizenship. The Member States are invited to engage in implementation of this Work Plan. 1 https://eur-lex.europa.eu/eli/C/2024/3527/oj/eng”
  EU competences on social policies · EU housing policy
• 2025-01-08 “P-000048/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission shall adopt its decision on Kostaive based on the scientific evaluation of the quality, safety, and efficacy of the vaccine by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). On 12 December 2024 the CHMP concluded that the benefits of the vaccine outweigh any potential risks and recommended granting marketing authorisation for the prevention of COVID-19 in adults 1 . The EMA was aware of concerns expressed by some academics in Japan during its assessment. Research into self-amplifying mRNA vaccines has been ongoing for over two decades. Notably, the self-amplifying mRNA technology, like other mRNA vaccines, does not interfere with a person’s genetic code. The CHMP identified no major safety concerns, and data indicate that Kostaive’s safety profile is comparable to that of existing mRNA vaccines. The most common side effects observed in clinical trials were mild, including pain and tenderness at the injection site, tiredness, headache, muscle and joint pain, chills, dizziness, and fever. Patients involved in the studies with Kostaive have been followed for at least one year. Kostaive’s safety will be closely monitored by EMA and national authorities in the EU to ensure any possible risks are detected and mitigated as early as possible 2 . The assessment report as well as the risk management plan for the vaccine, will be published on EMA's website. In the framework of marketing authorisation of medicines, the Commission relies on the scientific advice provided by the EMA's scientific committees. Concerns and developments from other jurisdictions in relation to medicines are noted but do not alter the EU’s commitment to upholding its rigorous safety, efficacy, and quality standards. 1 https://www.ema.europa.eu/en/medicines/human/EPAR/kostaive 2 https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid19/covid-19-medicines/safety-covid-19-vaccines”
  GMOs
• 2025-01-08 “E-000050/2025 Answer given by Mr Várhelyi on behalf of the European Commission The EU ensures that traditional remedies are accessible, safe, and of high quality through a regulatory framework tailored to their specific nature. Directive 2001/83/EC 1 , as amended by Directive 2004/24/EC, has established a simplified registration process, under the responsibility of Member States, for herbal medicinal products with a long tradition of medicinal use (at least 30 years, including 15 in the EU), which do not fulfil the ‘well established use’ requirements for marketing authorisation. The registration is further simplified in case of herbal medicines that are included in the Community list of herbal substances, preparations and combinations thereof. All those measures facilitate the availability of these products to citizens seeking alternative or complementary treatments. With regard to the manufacturing and quality of traditional herbal medicines, applications for registration of these products have to fulfil the same requirements as applications for a marketing authorisation. This is important as natural is not always equal to safe and herbal remedies may interact with other treatments or may be inappropriate for individuals with certain medical conditions. In addition, the EU under its flagship research and innovation programme Horizon Europe 2 funds research into traditional remedies through the EthnoHERBS Project 3 on medicinal properties of plants of the Balkan Peninsula. 1 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, 28.11.2001, p. 67–128. 2 https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-opencalls/horizon-europe_en 3 See EthnoHERBS Project Fact sheet at: https://cordis.europa.eu/project/id/823973”
  Pharmaceuticals regulation in EU
• 2024-11-20 “E-002597/2024 Answer given by Mr Várhelyi on behalf of the European Commission 1. As the Commission noted in its reply to Question E-003117/2023 1 , ‘the European Medicines Agency (EMA) and national authorities evaluate data on reported events in EudraVigilance 2 to determine if there is any signal indicating causality and take action as appropriate’. EMA and national authorities closely monitor emerging data and will take regulatory action if new evidence indicates any causal relationship. 2. The Commission relies on EMA to continuously monitor the COVID-19 vaccine safety assessing all available data, including EudraVigilance reports, scientific literature, and studies 3 . EMA has reviewed the study mentioned in the Honourable Member's letter and concluded that, given the methodological limitations of the study- which was withdrawn from a scientific journal because of serious concerns about its quality- considers no action necessary at this stage. 3. The Commission considers safety a core requirement for all vaccines. COVID-19 vaccines used in the EU have undergone EMA's rigorous scientific assessment. Information on risks, including rare side effects, are publicly available in resources such as product information 4 , the European Public Assessment Reports 5 , and periodic safety update reports (PSURs) 6 , which are regularly updated to keep healthcare professionals and patients informed. When necessary to ensure vaccine safety regulatory actions are taken in accordance with the applicable legislation. 1 https://www.europarl.europa.eu/doceo/document/-ASW_EN.html 2 https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-researchdevelopment/eudravigilance 3 https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pharmacovigilancemarketing-authorisation/risk-management/risk-management-plans 4 https://ec.europa.eu/health/documents/community-register/html/index_en.htm 5 https://www.ema.europa.eu/en/medicines/what-we-publish-medicines-when/european-public-assessmentreports-background-context 6 https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-postauthorisation/periodic-safety-update-reports-psurs”
  Vaccination
• 2024-11-05 “E-002411/2024 Answer given by Mr Várhelyi on behalf of the European Commission Data on excess mortality in EU/European Economic Area (EEA) countries is collected by the EuroMOMO project and by the Eurostat, the Statistical Office of the EU. The EuroMOMO project is a European mortality monitoring activity based on overall mortality, but not causespecific, supported by the European Centre for Disease Prevention and Control (ECDC) and the World Health Organization (WHO), and hosted by Statens Serum Institut, Denmark 1 . The statistical office of the European Union (DG ESTAT) publishes an excess mortality indicator, which is based on data from National Statistical Institutes on weekly deaths on a voluntary basis since April 2020 2 . In the years 2020-2023 the excess deaths rates correlate with the COVID-19 waves and are inversely correlated with vaccination coverage, as highlighted by the WHO 3 . The Commission supports ongoing studies on post-COVID and its link to various disease outcomes, such as heart disease, diabetes, cancers, or neural dysfunctions 4 . The ECDC recommends further immunisation as the most effective measure to protect against severe viral respiratory diseases 5 and scenario modelling has shown that high vaccine uptake at the population level is strongly correlated with reduced disease burden. 1 https://www.euromomo.eu/ 2 https://ec.europa.eu/eurostat/statisticsexplained/index.php?oldid=509982#Recent_data_on_excess_mortality_in_the_EU 3 https://www.nature.com/articles/s41586-022-05522-2 4 https://research-and-innovation.ec.europa.eu/research-area/health/coronavirus_en 5 https://www.ecdc.europa.eu/en/news-events/acute-respiratory-infections-eueea-epidemiological-update-andcurrent-public-health-0”
  Vaccination · Covid-19 vaccines procurement
• 2024-10-17 “E-002146/2024 Answer given by Ms Lahbib on behalf of the European Commission The Commission is not in a position to disclose the requested information about the price paid under the Commission contract for Mpox vaccines, neither about the contracts that were signed under the Joint procurement Agreement for Mpox vaccines and the Mpox therapeutic Tecovirimat. The disclosure of the price per unit would undermine the protection of commercial interests of the contractor, which is also protected by confidentiality obligations set out in the contracts.”
  Pharma price transparency · Pharma transparency
• 2024-10-17 “E-002145/2024 Answer given by Mr Várhelyi on behalf of the European Commission The European Medicines Agency (EMA) already has a dedicated committee, the Pharmacovigilance Risk Assessment Committee (PRAC) 1 , responsible for monitoring the safety of all authorised medicinal products in the EU, including COVID-19 vaccines. PRAC conducts robust scientific assessments and monitors potential risks to ensure the safety of medicines, updating product information as soon as new evidence becomes available. The EU pharmacovigilance system is one of the most advanced in the world and was further strengthened during the COVID-19 pandemic, particularly through enhanced real-world monitoring of vaccine safety. Given the existing framework, the establishment of an additional committee would not provide added value. The Commission listens attentively to the concerns and calls of EU citizens. However, it is important to note that the authorisation and oversight of COVID-19 vaccines authorised at Union level are based on rigorous scientific assessments by the EMA. Safety monitoring is continuous, with the EMA and Member States working together to detect and address potential risks as early as possible. The primary responsibility for the safety of an authorised product lies with the marketing authorisation holder. This includes monitoring adverse reaction reports and ensuring that the benefit-risk balance remains positive. 1 https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committeeprac#:~:text=The%20Pharmacovigilance%20Risk%20Assessment%20Committee%20%28PRAC%29%20is%2 0the,agendas%2C%20minutes%20and%20highlights%20of%20its%20plenary%20meetings”
  Vaccination · Pharmaceuticals regulation in EU
• 2024-09-25 “E-001820/2024 Answer given by Mr Serafin on behalf of the European Commission The Commission has several technical systems in place to protect and safeguard its digital workplace infrastructure from harm and misuse. These systems include a web filtering proxy and other solutions provided by leading providers in the industry. The 'Der Status' website is not restricted within the Commission, and news websites from various political perspectives are also accessible. The relevant departments in the Commission address staff concerns about inappropriate blocking of content and can modify the filtering system settings. This filtering system categorizes websites broadly and allows exceptions. Blocked websites typically include those with addictive or non-work-related content, such as adult websites, online games, and gambling platforms.”
  Transparency requirements of EU institutions · Disinformation & online freedoms
• 2024-09-19 “E-001768/2024 Answer given by Ms Kyriakides on behalf of the European Commission 1. The farmers’ rights are recognised by the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) 1 . No regulation may contradict the ITPGRFA, as stipulated in Article 9(3) that ‘Nothing in this Article shall be interpreted to limit any rights that farmers have to save, use, exchange and sell farm-saved seed/propagating material, subject to national law and as appropriate’. Saving and using of farm-saved seed/propagating material are not subject to the current EU seed legislation 2 and the Commission’s proposal for a new Regulation on plant reproductive material 3 does not introduce any rules on these either. Exchange and selling however are regulated in order not to undermine the general seed certification system which ensures the identity and quality of seed for farmers. Other legislation may be applicable as well, for instance on plant health 4 and on plant variety rights 5 . 2. The Commission’s proposal introduces several new measures aiming to increase agrobiodiversity. These include facilitated market access for genetically diverse reproductive material, for example conservation varieties and heterogeneous material, as well as a framework for exchanges of seed in kind between farmers. These will contribute to the availability and use of more diverse reproductive material in agricultural fields and gardens. 3. Stakeholders had the opportunity to provide feedback during the consultation period 6 but they do not participate in the negotiations on the Commission’s proposal. These negotiations are strictly carried out between the two co-legislators - the European Parliament and the Council - and the Commission. 1 https://www.fao.org/plant-treaty/en/. 2 https://food.ec.europa.eu/plants/plant-reproductive-material_en. 3 COM(2023) 414 Proposal for a Regulation of the European Parliament and of the Council on the production and marketing of plant reproductive material in the Union, amending Regulations (EU) 2016/2031, 2017/625 and 2018/848 of the European Parliament and of the Council, and repealing Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 2002/53/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC, 2002/57/EC, 2008/72/EC and 2008/90/EC (Regulation on plant reproductive material): https://eur-lex.europa.eu/legalcontent/EN/HIS/?uri=COM:2023:414:FIN. 4 https://food.ec.europa.eu/plants/plant-health-and-biosecurity/legislation_en. 5 https://food.ec.europa.eu/plants/plant-variety-property-rights_en 6 All feedback responses are published on the ‘Have Your Say’ web portal at https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/13083-Plant-and-forest-reproductivematerial-revised-rules-_en.”
  GMOs
• 2024-09-05 “P-001626/2024 Answer given by Ms Kyriakides on behalf of the European Commission In 2022 the Commission purchased 334,540 doses of the MVA-BN vaccine (called Jynneos in the United States and Imvanex in the EU) and donated those to the Member States to respond to the global outbreak of mpox in Europe. The Commission also concluded framework contracts under the Joint Procurement Agreement (JPA) that allow participating countries to purchase up to 2 million doses of vaccine until the end of 2024 and 10 million courses of the therapeutic Tecovirimat SIGA until mid-2026. The Commission is currently in discussions with the JPA participant countries and the manufacturer Bavarian Nordic to conclude a new vaccine framework contract. Imvanex is the only vaccine authorised at Union level for adult immunisation against mpox. The European Commission issued a decision extending the indication of use for Imvanex to include adolescents from 12 to 17 years of age on 19 September 2024. Tecovirimat SIGA is the only medicine authorised at EU level for treatment of mpox in adults and children weighing at least 13 kg. Following the World Health Organisation (WHO) declaration of a Public Health Emergency of International Concern on 14 August 2024, the Commission donated 215,420 vaccine doses to Africa via the Africa Centres for Disease Control and Prevention. To date, 200,000 of these doses have been delivered to the Democratic Republic of Congo. The Commission is also coordinating the response by the EU and Member States in a Team Europe approach where Member States have so far committed to donating approximately 360,000 additional doses to Africa as soon as an agreement is reached on allocation and acceptance of these doses by recipient countries.”
  GMOs
• 2024-09-05 “E-001627/2024 Answer given by Ms Kyriakides on behalf of the European Commission The notification by the Director-General of the World Health Organization of the amendments to the International Health Regulations (2005), adopted on 1 June 2024 by consensus at the Seventy-seventh World Health Assembly, occurred on 19 September 2024 and was addressed to all State Parties to the International Health Regulations (2005) 1 . This includes EU Member States, which are all Parties to this international instrument. The notification was however not addressed to the EU, which is not a Party to the International Health Regulations (2005). 1 https://www.who.int/news-room/questions-and-answers/item/international-health-regulationsamendments#:~:text=With%20respect%20to%20the%20four%20States%20Parties%20that%20rejected%20the”
  Vaccination
• “And so I think we need to discuss the shadow sides of these technologies as well here. For example, Kennedy in the US. Has reported of 500,000 people who have suffered from these vaccines, and yet nobody seems to be talking about. We've never had a discussion about it. And I think it's incredibly important, even in the first step of this discussion, for us to talk about mRNA technologies and for us to talk about the Covid 19 vaccines, because they had huge side effects for certain people. But this is a discussion that seems we're not going to have and we've never had. I think it's incredibly important for us to recognize the problems that these technologies can bring with them, because it is only by doing that that we're going to be able to look at the next step. I think it's not right to just ignore the problems of these mRNA technologies, because it's had a huge effect on so many people throughout Europe, and I think that needs to be done before we move to the next step. Thank you.”
  Vaccination
• “This was a statement that was made at the World Economic Forum in 2019. What's your assessment thereof? Are these facts virus? Not not natural in nature, no natural origin, and that big companies already knew that a pandemic was going to be coming. And the task if your agency is to fight against natural viruses, not against artificial ones that are produced in laboratories and that come from who knows where. So Miss Cook also talked about the 30 billion doses of that were produced for an illness that was actually produced by someone. So that's one question. On the other hand, we've seen that in the fall, the Court of Auditors, also the Court of Auditors, Court of Auditors gave a report saying that Ecdc not you personally, but uh, but the Ecdc. In the beginning of March in 2020, said that there was only a moderate or low level of danger in the W.H.O. on the 11th of March, called on a pandemic on the 12th of March. Isn't that interesting? Your desk already said. Oh yes, indeed. Now we're going to actually have to take some sort of action. Now the virus is dangerous. I think it's interesting that a specialized agency would just but wait on coming up with an assessment of the situation until so late. So what is your opinion of that, please?”
  Vaccination
• “So that means, as a result, that too much of the funding is being leaked out into the bureaucracy and stays there. And I think what we're going to do now is just create another bureaucracy monster. And you have to think of what the national states have to think about. What are they doing? They want to reduce bureaucracy. So they have they want to ensure that the money in the health system actually arrives at the citizen level. So what we need is slimmed down structures, less bureaucracy Significantly less bureaucracy. Just look at this report from the Austrian, Austrian, uh, Court of Auditors from 2017. Just look at this. So we have to see that we in the member States have the potential to ensure this money and have taking this money and then be able to buy critical medicinal products. So what we need, of course, we need more power. And we have to ensure that the, um, active ingredients are available because when they're available in the EU, then of course pharmaceutical manufacturers will then produce that because the money is available.”
  Accounting and auditing of EU budget
• “Thank you very much, chair. I see this round as just one part of a longer discussion. Obviously, we are going to be talking about the opportunities that biotech will offer us. It's a very, very big topic. It's got a lot of possibilities included in it. But here specifically we're talking about medicine. And when we're talking about medicine, we're talking about its use for people. And when we're talking about this, it isn't anti-European, as a shadow rapporteur seems to be saying, and it's not unscientific either to represent certain points of view. For me, first and foremost, what we are talking about here is examining why, um, mRNA research hasn't worked very well in the past. And I think here in this committee and in Parliament, we need to have this discussion and we need to have it openly and very clearly here in this House. We weren't talking about the side effects of Covid vaccines in the past. And because of all the mRNA work that was done there, I have never received an answer to all of the questions that I have raised in this committee on that.”
  Vaccination