- 2026-03-19 “Answer given by High Representative/Vice-President Kallas on behalf of the European Commission 10.6.2026 Written question Plans to establish a structure such as an ‘intelligence cell’ are subject to exchanges between the Commission and the European External Action Service, in full compliance with relevant Treaty principles. Currently, the European External Action Service hosts the EU Intelligence and Situation Centre which has a specific mandate. The European Union pursues its objectives by appropriate means commensurate with the competences which are conferred upon it by the Treaties.”
EU competences on defence · EU competences on foreign affairs
- 2026-03-13 “Answer given by Mr Várhelyi on behalf of the European Commission 4.5.2026 Written question The Commission would like to inform the Honourable Member that both EU citizens and healthcare professionals receive timely updates on all scientific recommendations taken by the European Medicines Agency (EMA). Following each meeting of the EMA’s safety committee (Pharmacovigilance Risk Assessment Committee — PRAC [1] ), the key outcomes are communicated through the PRAC highlights [2] . Furthermore, during the pandemic, the EMA implemented additional measures for COVID-19 medicinal products to maximise the transparency of its regulatory activities related to COVID-19 medicines [3] . Furthermore, all three extraordinary PRAC meetings (18 December 2020, 4 January 2021 and 22 January 2021) were convened to enable the PRAC to provide advice on the Risk Management Plans (RMPs) for the respective vaccines prior the Committee for Medicinal Products for Human Use (CHMP) plenary meeting on the vaccines marketing authorisation applications aiming at issuing a scientific opinion. The outcome (minutes) of these extraordinary PRAC meetings were subsequently incorporated into the minutes for the following PRAC plenaries, which are publicly available [4] , [5] . Additionally, the PRAC recommendations to the CHMP on the RMP are also included in the marketing authorisation assessment reports. They are therefore reflected in the respective European public assessment reports , in particular in the assessment reports for Vaxzevria [6] , [7] and Spikevax [8] , [9] . The PRAC committee operates under EMA’s responsibility. [1] https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac. [2] https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-9-12-march-2026. [3] https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/transparency-exceptional-measures-covid-19-medicines. [4] https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-23-26-november-2020_en.pdf. [5] https://www.ema.europa.eu/en/documents/minutes/minutes-prac-meeting-11-14-january-2021_en.pdf. [6] https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria. [7] https://www.ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf. [8] https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax. [9] https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf.”
Transparency of EU medicines governance process · Pharmaceuticals regulation in EU
- 2026-03-13 “Answer given by Mr McGrath on behalf of the European Commission 5.5.2026 Written question The European Centre for Democratic Resilience is a cooperation framework, under the leadership of the Commissioner responsible for democracy, justice, the rule of law and consumer protection, for exchange primarily between EU institutions, Member States and civil society to empower, protect, and promote strong and resilient democracies across the EU. The Centre is a core component of the European Democracy Shield [1] , which defines a broad, whole-of-society and whole-of-government approach to strengthening democracy. There are no planned organisational, functional or reporting links between the Centre and any intelligence structure. The Centre fully respects EU and national competences and the independence of existing structures at national and EU level. It will be rolled out progressively, based on Member States’ voluntary participation, and on their input and needs for support and cooperation, to ensure that it delivers the best support to national authorities and jointly at EU level. The Centre brings together expertise and resources to increase collective capacity to anticipate, detect and respond to threats to our democracies, such as foreign information manipulation and interference (FIMI) and disinformation. The Centre builds on existing networks and structures working on prevention, detection, analysis, and response to patterns of threats in the information space. The information shared via the Centre is based on open sources . The Centre will also support capacity-building activities, including trainings. It could further support response capacity. [1] JOIN(2025) 791 final.”
Disinformation & online freedoms · Foreign interference in Europe
- 2026-03-12 “Answer given by Mr McGrath on behalf of the European Commission 30.4.2026 Written question The European Centre for Democratic Resilience (the Centre) announced in the European Democracy Shield [1] (EDS) is a voluntary cooperation framework primarily bringing together expertise and capacities from Member States and relevant EU institutions and bodies, building on existing networks and structures. This work will contribute to supporting the EU’s whole-of-society approach to increase awareness and build democratic resilience. The Council conclusions of May 2024 [2] highlighted the need to bring these efforts together. The Council conclusions of March 2026 [3] invite the Commission to make the full use of the relevant EU instruments, take note of the establishment of the Centre and underline the commitment to work together with the Commission and the European External Action Service to enhance the EU’s democratic resilience. The Centre fully respects the competences of the EU and its Member States and the independence of existing structures. Its work does not interfere with Member States’ competences in the areas highlighted by the Honourable Member, such as the organisation and running of electoral processes, national security or counterintelligence. The information shared in the framework of the Centre is based on open sources. The Centre is also supported by the Rapid Alert System [4] , an established mechanism to address foreign information manipulation and interference. [1] https://commission.europa.eu/document/2539eb53-9485-4199-bfdc-97166893ff45_en. [2] The Council conclusions of May 2024 on democratic resilience, https://data.consilium.europa.eu/doc/document/ST-10119-2024-INIT/en/pdf. [3] The Council conclusions of March 2026 on advancing the European Union’s capacity to counter hybrid threats, https://data.consilium.europa.eu/doc/document/ST-7349-2026-INIT/en/pdf. [4] https://www.eeas.europa.eu/eeas/factsheet-rapid-alert-system_en.”
Foreign interference in Europe · EU competences on foreign affairs
- 2026-02-04 “P-000438/2026 Answer given by Mr McGrath on behalf of the European Commission The proposed amendments of the General Data Protection Regulation 1 (GDPR) enhance legal clarity, cut unnecessary administrative burden for operators and data protection authorities and contribute to a more consistent application of the GDPR which also benefits data subjects. The Commission considers that the amendments comply with the EU Charter of Fundamental Rights 2 and there is not a need for an additional fundamental rights assessment beyond what is already presented in the accompanying Commission Staff Working Document 3 . As the Commission previously replied, cross-system profiling is prohibited under the specific legal instruments, and these instruments are not affected by the proposed amendments 4 . For example, the European Digital Identity Regulation 5 limits the personal data processing to what is necessary for the provision of the wallet services and provides for privacy preserving techniques to ensure unlinkability, thereby effectively prohibiting profiling across systems. The Commission will continue supporting the co-legislators in their discussion on this proposal. 1 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 (General Data Protection Regulation). 2 Charter of the Fundamental Rights of the European Union, https://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:12012P/TXT. 3 See also Commission Staff Working Document accompanying the Commission’s Proposal, SWD (2025) 836 final, Section 1.2. 4 Reply to written question E-004566/2025, https://www.europarl.europa.eu/doceo/document/E-10-2025004566-ASW_EN.html; reply to written question P-004565/2025, https://www.europarl.europa.eu/doceo/document/P-10-2025-004565-ASW_EN.html. 5 Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC.”
Privacy & digital economy
- 2026-02-02 “E-000410/2026 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Digital Services Act (DSA) 1 requires providers of very large online platforms (VLOPs) and very large online search engines (VLOSEs) to diligently identify and assess at least once a year, and to put in place effective measures to mitigate the systemic risks stemming from the design, functioning or use made of services, including any actual or foreseeable negative effect to civic discourse and electoral processes. Providers of VLOPs and VLOSEs should also analyse whether and how these risks are influenced by a manipulation of their service, such as the use of bots or fake accounts. The DSA does not prescribe which content is illegal; this is determined purely by national law or other EU laws. The DSA does not regulate electoral processes or political debate. The DSA empowers citizens and helps protect fundamental rights, including freedom of expression. It requires providers of online platforms to, amongst others, put in place an internal complaint-handling mechanism for users who deem they have faced an undue moderation decision. Since its application, platforms have overturned 30% of appealed moderation decisions 2 proving users have real recourse mechanisms. When applying regulatory responses, Member States and the Commission must respect the Charter of Fundamental Rights. Decisions can be challenged respectively before national courts or the Court of Justice of the EU. It should be noted that the EU has imposed targeted restrictive measures on certain Russian state-controlled outlets, which have played a key role in spreading war propaganda related to Russia’s illegal war of aggression against Ukraine. These outlets are included in Annex IX to Council Decision 2014/512/CFSP 3 and Annex XV to Council Regulation (EU) No 833/2014 4 . 1 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act), OJ L 277, 27.10.2022, pp. 1–102, https://eur-lex.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://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014D0512-20251224. 4 https://eur-lex.europa.eu/eli/reg/2014/833/2025-05-21/eng.”
Disinformation & online freedoms · Foreign interference in Europe
- 2026-01-30 “Answer given by Ms Lahbib on behalf of the European Commission 15.6.2026 Written question The LGBTIQ+ [1] equality strategy does not encourage minors to socially or medically transition . Healthcare policy remains the competence of Member States, who define healthcare policies and clinical practice, based on scientific evidence and national legal frameworks . As set out in previous replies [2] , the Commission considers that protecting children’s fundamental rights and those of LGBTIQ+ people are complementary. Equality and non-discrimination are core EU values, enshrined in the EU Treaties, the Charter of Fundamental Rights of the European Union [3] and the European Pillar of Social Rights. The LGBTIQ+ equality strategy [4] aims to ensure protection against discrimination for all. Protecting children’s rights is also a core EU objective. Under Article 24 of the Charter of Fundamental Rights, the child’s best interests must be a primary consideration in all actions concerning them, and children have the right to express their views in line with their age and maturity [5] . The EU’s comprehensive approach to mental health [6] supports vulnerable groups, such as children and young people. This includes initiatives like an EU-funded prevention toolkit, to support policymakers in addressing children’s mental and physical health [7] . EU funding objectives are set in programmes adopted by the Council and Parliament. Implementation occurs through work programmes approved by Member States and open calls for proposals. Grants are awarded competitively to top-ranked proposals that best meet programme goals. They may be suspended, terminated, reduced or recovered, if eligibility requirements are infringed. Beneficiaries may be excluded from future EU funding if misconduct, such as incitement to discrimination, hatred and violence, affect or risk affecting their performance of legal commitments. [1] Lesbian, gay, bisexual, trans, non-binary, intersex and queer. [2] https://www.europarl.europa.eu/doceo/document/P-10-2025-004175-ASW_EN.html; https://www.europarl.europa.eu/doceo/document/E-10-2025-004108_EN.html; https://www.europarl.europa.eu/doceo/document/E-10-2025-004040_EN.html; https://www.europarl.europa.eu/doceo/document/E-10-2025-004172_EN.html. [3] https://eur-lex.europa.eu/eli/treaty/char_2012/oj/eng. [4] https://commission.europa.eu/document/download/b4952371-4308-47ad-b995-02c539b75dda_en?filename=JUST_template_comingsoon_standard.pdf.. [5] In line with Article 12 of the UN Convention on the Rights of the Child https://www.ohchr.org/en/instruments-mechanisms/instruments/convention-rights-child. [6] https://commission.europa.eu/topics/public-health/european-health-union/comprehensive-approach-mental-health_en. [7] https://ec.europa.eu/newsroom/sante/items/863796/en.”
Gender roles, equality and inclusion · LGBTIQ+
- 2026-01-20 “P-000206/2026 Answer given by Mr McGrath on behalf of the European Commission The General Data Protection Regulation (EU) 2016/679 (GDPR) obliges Member States to provide for exemptions or derogations from Chapter VI (independent supervisory authorities) if they are necessary to reconcile the right to the protection of personal data with the freedom of expression and information. In such cases, Member States must, in any event, fulfil the requirements laid down for ‘a control by an independent authority’ under Article 8(3) of the Charter of Fundamental Rights 1 . They are essentially the same as those in Article 52 GDPR, notably the authority tasked with the supervision must act objectively and impartially, free from external influence, and be structurally capable of exercising its functions independently. According to the case-law of the Court of Justice, the processing for ‘journalistic purposes’, as referred to in Article 85(2) GDPR, refers to situations where the sole purpose of publication is to disclose information, opinions or ideas to the public. Any processing for other purposes, such as administrative or technical purposes, must be carried out in compliance with all the requirements set for supervision under Chapter VI of the GDPR. The Commission has collected information from the Member States on the application of Article 85 GDPR and the topic has been discussed in several meeting of the Member States’ experts group on the GDPR and the Data Protection Law Enforcement Directive 2 . The overview of Member States’ legislation is available in the Register of Commission expert groups. 3 The Commission is also following the application of Article 85 in the context of its general monitoring of the application of the GDPR. 1 https://eur-lex.europa.eu/eli/treaty/char_2012/oj/eng. 2 https://eur-lex.europa.eu/eli/dir/2016/680/oj/eng. 3 Register of expert groups https://commission.europa.eu/about/service-standards-andprinciples/transparency/register-expert-groups_en.”
GDPR
- 2026-01-13 “Answer given by Mr Várhelyi on behalf of the European Commission 23.3.2026 Written question The Commission is aware of the retraction mentioned by the Honourable Members but has not requested the European Food Safety Authority (EFSA) or the European Chemicals Agency (ECHA) for an opinion. The retraction concerns a review article, which analyses other scientific publications or studies and does not constitute original primary research. EFSA considered the importance of such review articles (including the retracted publication) in the assessment of glyphosate in 2017 [1] , and found that such review articles have low weight in scientific assessments [2] . In the hazard assessment conducted as part of the procedure leading to the last renewal of approval of glyphosate, the retracted paper is not cited in the opinion of the Risk Assessment Committee of ECHA [3] . It is also not referenced in the relevant parts of the EFSA Conclusion from July 2023 [4] or referenced in the assessment of long-term toxicity and carcinogenicity [5] . Therefore, it played no role in the last review of the approval of glyphosate, and the retraction does not impact at all the overall assessment and conclusions reached. The Commission is not in a position to investigate conflict of interests or any other bias in academic publishing as this is the responsibility of the journal editors. However, every literature study referenced in an application dossier is assessed for its relevance and reliability, in the same way as regulatory studies conducted by applicants under good laboratory practice and following validated methodologies. Such regulatory studies are also subject to the provisions of the Transparency Regulation [6] and all raw data must be submitted, which provides a higher level of transparency compared to peer-reviewed literature studies. [1] https://www.efsa.europa.eu/sites/default/files/topic/20170608_glyphosate_statement.pdf. [2] ‘ The weight of these two review papers in the overall scientific assessment of glyphosate was therefore very limited because EU experts had access to, and relied primarily on, the findings of the original guideline studies and the underlying raw data to produce their own conclusions. The review papers simply served to summarise or substantiate the industry position on glyphosate that had been presented, as required by the regulatory framework, in the applicant’s dossier and in the commenting rounds during the assessment ’ . [3] European Chemicals Agency (2022). Opinion of the Committee for Risk Assessment proposing harmonised classification and labelling of glyphosate (ISO); N-(phosphonomethyl)glycine (EC Number: 213-997-4; CAS Number: 1071-83-6) https://echa.europa.eu/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e185e41a77. [4] The final list of ‘Tests, studies and information submitted’ in Volume 2 of the Renewal Assessment Report. [5] Volume 3 — B.6.5 (AS) of the Renewal Assessment Report. [6] Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC http://data.europa.eu/eli/reg/2019/1381/oj.”
EU policy on pesticides · Glyphosate
- 2026-01-13 “Answer given by Mr McGrath on behalf of the European Commission 22.4.2026 Written question The complaint procedure referred to is still pending. The Commission cannot offer further details at this stage. Following the case law of the Court of Justice on Article 267 of t he Treaty on the Functioning of the European Union , national courts may refer questions regarding the interpretation of EU law to the Court of Justice and must do so if they are courts of last instance . However, courts of last instance are not required to request a preliminary ruling from the Court of Justice in cases where the question posed is irrelevant, where the EU legislation has already been interpreted by the Court of Justice, or where the application of EU law is clear and leaves no room for reasonable doubt [1] . [1] See also judgment of 23 November 2001, C-564/19, IS, ECLI:EU:C:2021:949, p.61 and Judgment of the Court (Grand Chamber) of 24 March 2026 in Case C-767/23: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62023CJ0767&qid=1774375930787.”
Privacy & digital economy · Jurisdiction conflicts between EU and national courts
- 2025-11-28 “E-004727/2025 Answer given by Mr Serafin on behalf of the European Commission The Commission publishes an overview of mission expenses per Member of the Commission every two months covering all missions undertaken, in accordance with the Code of Conduct for the Members of the European Commission 1 . The Honourable Member will find all relevant information on the total expenditure incurred by the Members of the Commission in the current year for its participation in G7, G20 and COP30 meetings, on dedicated webpages which ensure transparency of missions for the public 2 . The Commission regrets to inform further the Honourable Member that the information technology tool used for managing missions does not enable the Commission to automatically extract the specific data requested, especially because preparatory meetings, technical working groups or other meetings may take place in the framework of other missions. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32018D0221%2802%29. 2 See the dedicated ‘transparency’ section within each website of the Members of the Commission via the following link: https://commission.europa.eu/about/organisation/college-commissioners_en.”
Accounting and auditing of EU budget · Budget for EU politicians
- 2025-10-24 “E-004202/2025 Answer given by Mr Hoekstra on behalf of the European Commission The Commission is committed to transparency in its relations with interest representatives, including non-governmental organisations (NGOs) and other stakeholders. Interest representatives carrying out activities to influence EU policy or legislation must register in the Transparency Register, irrespective of their country of establishment. The Commission requires prior registration for any related meetings with its decision-makers at political and administrative level or for participating in Commission expert groups. EU and third-country NGOs are required to provide in the register the information, including financial information, set out in Annex II to the applicable Interinstitutional Agreement 1 . To increase the transparency and democratic accountability of activities impacting EU decision-making processes, the Commission also adopted in 2023 its proposal for a Directive on interest representation on behalf of third countries. The proposed harmonised transparency requirements would apply to entities carrying out interest representation on behalf of third countries, regardless of their legal form. The proposal is currently being discussed by the colegislators. The Commission exercises the necessary scrutiny and due diligence when selecting NGOs with which it partners in the use of EU funds. The Financial Regulation includes a definition of NGO to ensure the reliability and transparency of information in the Financial Transparency System, where information on recipients is available. In the event of incorrect implementation or in cases of fraud, irregularities, substantial errors or serious breach of contractual obligations, including the violation of EU values, the grant may be suspended, terminated or reduced and funds may be recovered. 1 OJ L 207, 11.6.2021, p.1.”
EU-China relations · Foreign interference in Europe
- 2025-10-24 “P-004203/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Commission does not comment on individual national legal proceedings. The Commission stresses that the Digital Services Act 1 (DSA) is content-agnostic - it does not define what is illegal. The substantive rules determining the legality of content are not contained in the DSA, but in other pieces of national or, exceptionally, EU legislation. The DSA explicitly protects freedom of expression online and protects users in the EU against over-removal of lawful content by ensuring transparency in the policies of intermediary services providers. The DSA created a set of redress mechanisms for users: when platforms remove or demote content, they must inform the user that posted the content, explain why they took the decision, and offer the opportunity to challenge it 2 . On 24 October 2025, the Commission communicated its preliminary findings in relation to the provision of TikTok, Facebook and Instagram in the EU. The Commission took the preliminary view that TikTok and Meta were in breach of their transparency obligations under Art. 40, 20 (1) and 20 (3) of the DSA 3 . Under the DSA, trusted flaggers are entities with expertise in detecting certain categories of illegal content, which they flag to platforms for assessment. Trusted flaggers are appointed by the Digital Services Coordinators in each Member State. They must meet the eligibility criteria set out in Article 22(2) DSA, which include independence from online platforms, diligence, and objectivity. Their status can also be revoked in case of misuse. While notices by trusted flaggers must be processed with priority, the providers of online platforms remain fully responsible for assessing how legitimate notices are. The DSA has brought transparency and safeguards to this practice. 1 https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng. 2 See Articles 14 ‘Terms and Conditions’; Art. 17 ‘Statement of Reasons’; Art. 20 ‘Internal Complaint-Handling System’; and Art. 21 ‘Out-of-Court Dispute Settlement’ of the Digital Services Act: Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=CELEX%3A32022R2065. 3 DSA - Commission preliminarily finds TikTok and Meta in breach of their transparency obligations https://ec.europa.eu/commission/presscorner/detail/en/ip_25_2503.”
Disinformation & online freedoms
- 2025-10-15 “E-004048/2025 Answer given by Mr McGrath on behalf of the European Commission The European arrest warrant is an entirely judicial procedure between judicial authorities in the EU Member States based on the particular circumstances of each individual case where surrender is requested. Neither the Commission nor the Member States' governments can interfere, or influence decisions taken by judicial authorities. In its Rule of Law Report 1 , the Commission monitors developments in all Member States, including Poland, in four areas: the effectiveness of justice systems, anti-corruption frameworks, media pluralism, and other institutional issues related to checks and balances. 1 The 2025 Rule of Law Report and country chapters can be found here: https://commission.europa.eu/strategyand-policy/policies/justice-and-fundamental-rights/upholding-rule-law/rule-law/annual-rule-law-cycle/2025rule-law-report_en.”
EU Supervision of the Rule of Law · EU law enforcement cooperation in criminal matters
- 2025-09-18 “E-003631/2025 Answer given by Mr Várhelyi on behalf of the European Commission In March 2021, the European Medicines Agency (EMA) was made aware, through report of the Comirnaty marketing authorisation holder, of cases of myocarditis reported in Israel, where the vaccination campaign was more advanced than in the EU. The first cases of myocarditis and pericarditis occurring in the EU/European Economy Area were reported to the EMA in the March and April 2021 through monthly safety reports for Spikevax and Comirnaty, respectively. Based on these first reportings, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) requested the marketing authorisation holders to provide a cumulative review on cases of myocarditis and pericarditis to be assessed. The EMA communicated about this emerging safety issue at the different phases of its assessment. When first measures were taken in early May 2021 through both the EMA’s PRAC highlights 1 , and in the monthly safety updates for the public of the same month 2 . The EMA issued further communications in June 2021 3 , and then in July 2021 when the evaluation ended and the PRAC recommended listing myocarditis and pericarditis as new side effects in the product information for these vaccines, together with a warning to raise awareness among healthcare professionals and people taking these vaccines 4 . 1 https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-36-may-2021. 2 https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-updatecomirnaty-11-may-2021_en.pdf. https://www.ema.europa.eu/en/documents/covid-19-vaccine-safety-update/covid-19-vaccine-safety-updatespikevax-previously-covid-19-vaccine-moderna-11-may-2021_en.pdf. 3 https://www.ema.europa.eu/en/news/covid-19-vaccines-update-ongoing-evaluation-myocarditis-pericarditis. 4 https://www.ema.europa.eu/en/news/comirnaty-spikevax-possible-link-very-rare-cases-myocarditispericarditis.”
Pharmaceuticals regulation in EU · Transparency of EU medicines governance process
- 2025-09-17 “E-003593/2025 Answer given by Ms Roswall on behalf of the European Commission The EU Deforestation Regulation (EUDR) 1 applies even handedly to products produced inside and outside the EU, similarly to the EU Timber Regulation (EUTR) 2 , in compliance with EU’s international commitments including World Trade Organisation requirements and EU trade agreements. Pursuant to Recital 85 of the EUDR, in accordance with the principle of proportionality, the Regulation does not go beyond what is necessary in order to achieve its objectives. The entry into application of the EUDR repeals the EUTR, meaning that the products in its scope cannot be subject to double or conflicting provisions. Chapter 3 of the EUDR Guidance 3 document provides information and a dedicated decision table on the applicable legislation, depending on the date of production and date when the product was placed on the market. The Commission presented a proposal to amend the EUDR in order to reduce the load on the EUDR Information System and ease the administrative burden for economic operators, while maintaining the Regulation’s environmental integrity. On 4 December 2025, the co-legislators agreed on the revised EUDR 4 . The new date of entry into application will be 30 December 2026 for all companies except for most micro- or small operators, for which it will be 30 June 2027. For micro- or small operators already covered by the EU Timber Regulation, the entry into application will be 30 December 2026. The amendments to the EUDR also limit the obligation to submit due diligence statements to the first operator placing the relevant products on the market. Downstream operators, such as retreading industry or craft businesses, will no longer need to submit due diligence statements, nor to pass on the reference numbers further in the supply chain. 1 Regulation (EU) 2023/1115 of the European Parliament and of the Council of 31 May 2023 on the making available on the Union market and the export from the Union of certain commodities and products associated with deforestation and forest degradation and repealing Regulation (EU) No 995/2010, OJ L 150, 9.6.2023, p. 206–247. 2 Regulation (EU) No 995/2010 of the European Parliament and of the Council of 20 October 2010 laying down the obligations of operators who place timber and timber products on the market, OJ L 295 12.11.2010, p. 23. 3 Commission Notice – Guidance Document for Regulation (EU) 2023/1115 on Deforestation-Free Products, OJ C, C/2025/4524, 12.8.2025. 4 Regulation (EU) 2025/2650 of the European Parliament and of the Council of 19 December 2025 amending Regulation (EU) 2023/1115 as regards certain obligations of operators and traders, OJ L, 2025/2650, 23.12.2025.”
Due diligence in supply chains (environmental and human rights) · Trade impact on forests
- 2025-09-17 “E-003592/2025 Answer given by Mr McGrath on behalf of the European Commission The impact and challenges brought by the COVID-19 pandemic from a rule of law perspective have also been examined in the Commission’s Rule of Law reports. The Commission made clear from the outset that the response to the COVID-19 pandemic must fully respect the fundamental principles and values as set out in the Treaties. Emergency measures had to be limited to what is necessary, strictly proportionate, clearly restricted in time, and in line with constitutionally enshrined safeguards, as well as European and international standards. The Commission has no competence to comment on individual cases. The Commission can only intervene with the Member States in the area of fundamental rights if an issue of EU law is involved 1 . The organisation of and the delivery of healthcare services, such as COVID-19 testing, are the competence of EU Member States. In such cases, it is for Member States, including their judicial authorities, to ensure that fundamental rights are effectively respected and protected, in accordance with their national legislation and constitution, as well as their international human rights obligations. Contrary to the statement in the question, the Commission and the European Centre for Disease Prevention and Control have reviewed pandemic restrictions for proportionality, effectiveness and social impact 2 . 1 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:12012P/TXT&from=EN. 2 See for example https://www.ecdc.europa.eu/en/publications-data/ecdc-expert-consultation-implementationand-evaluation-non-pharmaceutical, https://www.ecdc.europa.eu/en/publications-data/covid-19-after-action-review-public-health-response-slovenia, https://www.ecdc.europa.eu/en/publications-data/lessons-covid-19-pandemic-may-2023, https://www.ecdc.europa.eu/en/publications-data/covid-19-after-action-review-finnish-advice-making-schoolinterventions, and others.”
EU competences on health · Vaccination
- 2025-09-01 “E-003340/2025 Answer given by President von der Leyen on behalf of the European Commission The Commission attaches utmost importance to press freedom and transparency and actively promotes them through its policies and actions. It believes that a free and independent press is vital for fostering informed public debate. To this end, the Commission strives to maintain the highest standards of transparency, accessibility, and openness in its interactions with the media and the public, providing timely and accurate information to facilitate informed reporting and public scrutiny. These principles underpin all press events with the participation of the President of the Commission, where journalists are free to ask any questions they consider relevant. Before press conferences abroad involving the President of the Commission, the press team seeks to identify in advance key issues of interest to the local media. To this end, press officers liaise with their national counterparts. In preparation for the press conference of the President of the Commission and Prime Minister Kristrún Frostadóttir in Reykjavík, the Commission’s press team reached out to the press office of the Icelandic Ministry of Foreign Affairs. The exchange focused on practical aspects of the event organisation such as expected media attendance and the main topical issues for the Icelandic press.”
Discharge of EU institutions and agencies
- 2025-08-22 “E-003273/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The EU follows a multi-faceted approach to countering threats related to disinformation that fully upholds the freedom of expression. Next to regulatory and co-regulatory measures, this includes support for media literacy, strategic communication, and support for research. The European External Action Service (EEAS) through its relevant Task Forces monitors foreign information manipulation and interference (FIMI) activities, including disinformation 1 . FIMI has been used by some third countries and their proxies to manipulate and interfere with democratic processes and societies. In this context, patterns of inauthentic behaviour, such as the impersonation of media outlets or institutions, can indicate intentional actions. In designing its strategic communication, the Commission follows closely the methodologies of the EEAS’s investigations into FIMI. The Digital Services Act (DSA) 2 is content-agnostic, and the Commission and Member States as regulators do not moderate content or impose any specific approach to moderation. The DSA aims to contribute to an online environment that protects efficiently fundamental rights, including the freedom of expression. The DSA regulates responsibilities for the providers of very large online platforms (VLOPs) and very large online search engines (VLOSEs) and requires they assess – and if needed mitigate – the possible systemic risks that could stem from their services. The DSA explicitly protects users against over-removal of lawful content through a set of redress mechanisms: when platforms take decisions affecting online content, they must inform the affected user, explain the decision, and offer the opportunity to challenge it. 1 For more information, see Learn - EUvsDisinfo https://euvsdisinfo.eu/learn/. 2 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act).”
Disinformation & online freedoms
- 2025-08-22 “E-003270/2025 Answer given by Mr Tzitzikostas on behalf of the European Commission Incapacitation or poor performance of the flight crew due to medical reasons is one of the safety risks monitored by the European Union Aviation Safety Agency (EASA) who conducts aviation safety risk assessments and assists and advises the European Commission on aviation safety matters. After COVID vaccination started in the EU, EASA was not able to confirm any inflight incapacitation related to vaccination, nor any severe adverse reaction to vaccination affecting flight safety. This conclusion was reached after contacts with medical assessors of the National Aviation Authorities, and a review of occurrence reports and safety investigation reports to which the Agency has access. Since EASA has to date not detected any serious adverse reactions to vaccination that affect aviation safety, no mitigation measures are required.”
Vaccination
- 2025-08-22 “E-003271/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Digital Services Act (DSA) 1 applies solely within the EU, and it does not regulate content, nor can it be used to censor any specific viewpoint online. Providers of online platforms have both the right and ability to implement content moderation policies tailored to regional laws and cultural contexts, or to voluntarily apply certain terms and conditions in a harmonised manner. Such regional adaptation is standard practice; platforms routinely adjust their systems and procedures to comply with diverse regulations worldwide. The Commission has never instructed nor encouraged platform providers to apply the DSA outside the EU. The DSA is applicable and enforced only within the EU. The DSA does not impose any content restrictions. On the contrary, the DSA makes online platforms accountable to citizens of the EU, including by mandating transparency around content moderation, and by granting appeal rights. These rights are used actively to protect freedom of expression: for instance, using the DSA’s mandatory complaint-handling system, EU users challenged more than 16 million content removal decisions by Meta and TikTok in the second half of 2024. Thanks to the DSA, almost 35% of the removals done by online platforms were overturned and the affected content was restored. 1 https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng.”
Disinformation & online freedoms
- 2025-08-22 “E-003272/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Digital Services Act (DSA) aims to contribute to a safe, predictable and trusted online environment, in which fundamental rights enshrined in the Charter 1 , including freedom of expression, are effectively protected. The DSA does not define which content is illegal. This is governed by other applicable EU and national laws. Rather, the DSA requires platforms in the EU to act transparently and fairly when moderating content in the EU, in accordance with their own rules. To enhance transparency and facilitate scrutiny over content moderation decisions, the online platforms are required to provide clear reasons to affected recipients and to publish them in a Transparency Database 2 . In addition, under the DSA, there is a prohibition to impose general monitoring obligations on providers of hosting services. If a removal order is issued at national level, Member States are required to ensure that those orders meet the conditions set out in Article 9 DSA, including the territorial effect of an order, which is, in principle, confined to the jurisdiction of the issuing Member State. A broader territorial scope may be justified but only where the illegality of the content derives directly from EU law, or where the issuing authority determines that the protection of the fundamental rights concerned requires such an extension, provided this remains consistent with EU and international law and is applied with due regard to international comity. The DSA introduces harmonized due diligence obligations and liability exemption conditions for providers of platforms across the EU. At the same time, any legislation applying EU law that limits freedom of expression of EU citizens must comply with conditions laid down in the Charter of Fundamental Rights of the EU. 1 https://eur-lex.europa.eu/eli/treaty/char_2016/oj/eng. 2 https://transparency.dsa.ec.europa.eu/.”
Disinformation & online freedoms
- 2025-08-13 “E-003238/2025 Answer given by Mr McGrath on behalf of the European Commission The annual Rule of Law Report covers all Member States objectively and on an equal footing, fully in line with the Report’s methodology that has been discussed with the Member States and is publicly available on the Commission’s website 1 . The assessments, and consequently also the recommendations, contained in the Report are based on a careful analysis of the situation in each Member State as well as information and evidence provided by a broad variety of sources, including national authorities, civil society and international institutions. The Rule of Law Report already covers four areas of systemic importance: national justice systems, anti-corruption frameworks, media pluralism and media freedom and other checks and balances. However, it is not foreseen to extend the material scope of the Rule of Law Report to cover the protection of minorities. The report is only one part of a broader effort at EU level to strengthen the founding EU values, including democracy, equality, and respect for human rights. This includes the 2020 Strategy to strengthen the application of the Charter of Fundamental Rights in the EU 2 with its thematic annual reports and targeted strategies to address the needs and challenges of specific groups of rights holders. As stated in the Charter strategy, as guardian of the Treaties, the Commission continues to monitor the implementation and enforcement of the fundamental rights in the Member States and may decide to take appropriate action, including by launching infringement proceedings as appropriate. 1 https://commission.europa.eu/document/72742fd9-3ce0-4d23-9086-58f885f84cdd_en. 2 COM(2020) 711 final.”
Jewish culture and antisemitism · Disinformation & online freedoms · EU Supervision of the Rule of Law
- 2025-08-13 “P-003237/2025 Answer given by High Representative/Vice-President Kallas on behalf of the European Commission China employs various foreign information manipulation and interference (FIMI) tactics to manipulate global information for its interests 1 . These include, beyond state media, private public relations firms and local influencers, but also government-organised non-governmental organisations (GONGOs). Additionally, China engages in transnational information suppression to silence critical voices through coercion or incentives (often difficult to detect) and targeting institutions like businesses, civil society, universities, governments and especially diaspora individuals and their families. In response, the European External Action Service (EEAS) is boosting situational awareness, enhancing EU and its partners’ capabilities to counteract such manipulation and developing policies to impose costs on FIMI perpetrators. The EEAS’ efforts are complemented by the Commission’s work on the democracy shield. 1 3rd EEAS Report on Foreign Information Manipulation and Interference Threats, March 2025: https://www.eeas.europa.eu/sites/default/files/documents/2025/EEAS-3nd-ThreatReport-March-2025-05Digital-HD.pdf.”
Foreign interference in Europe · EU-China relations
- 2025-07-17 “E-002953/2025 Answer given by Mr Hoekstra on behalf of the European Commission 1. The Commission agrees that science is a dynamic process grounded in testing and reassessment. Scientific findings that inform EU policy are not treated as immutable truths, but as the best available evidence, to be regularly reviewed as new insights emerge. The Commission draws on expert input from the Intergovernmental Panel on Climate Change, the European Scientific Advisory Board on Climate Change, the Joint Research Centre and the Scientific Advice Mechanism. 2. The Commission distinguishes clearly between legitimate scientific dissent and disinformation, defined as the intentional spread of false or misleading claims. The former is essential to science; the latter undermines public trust. The Commission’s actions aim to protect the integrity of evidence while keeping debate open. 3. The Commission’s efforts to counter disinformation do not suppress public debate. They protect citizens’ right to accurate information, which is essential for democracy. According to the 2025 Eurobarometer, 52% of Europeans find media coverage on climate unclear and 49% struggle to identify credible sources online. The Commission remains committed to freedom of expression and open, informed public discourse.”
Climate efforts
- 2025-07-01 “P-002674/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Commission’s calls for proposals for media are open to all types of news media organisations. Applicants are free to propose activities to be implemented in response to the objectives and expected deliverables set out in the Commission’s open calls for proposals. Beneficiaries operate in full editorial independence from the Commission and any other authority, as per the provisions of the calls for proposals and the ensuing grant agreements. The Commission’s calls for proposals aimed at increasing media coverage on European topics are not restricted to news media outlets based in Brussels. They are open to media operating in all Member States. As a result, awarded projects involve different types of media across the European Union. Funding is modest, considering the overall size of the media market in the European Union. The Commission is strongly committed to promote media freedom and pluralism. The European Media Freedom Act 1 , which will generally apply from 8 August 2025, has established in a specific piece of Union legislation safeguards for the independent functioning of the media. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024R1083.”
EU industrial funding · Size of EU budget
- 2025-06-24 “E-002529/2025 Answer given by Mr McGrath on behalf of the European Commission Article 11 of the Charter of Fundamental Rights of the European Union provides that everyone has the right to freedom of expression. According to its Article 51(1), the Charter applies to EU institutions, and to Member States when they are implementing EU law. The final interpretation of the Charter belongs to the Court of Justice of the European Union. To exercise their freedom of expression, rightsholders may use all forms of expression, whether a direct medium with full human control or expression that takes place indirectly through a generative Artificial Intelligence (AI) tool. Journalists may use automated systems to create and publish content, which falls within the scope of the freedom of expression and freedom of the media. In view of the risks recalled in its reply to question E-001160/2025 1 , as well as risks of foreign information manipulation and interference 2 , the Commission considers that the identification of the artificial character of content generation, as provided for in the AI Act 3 , is central for ensuring the protection of fundamental rights, the rights of others and intellectual property rights. The Digital Services Act contains specific guarantees for the use of the freedom of expression in content moderation, such as by providing for transparency obligations to service providers on their moderation policies, allowing individuals to contest moderation decisions, and requiring very large platforms to assess and mitigate systemic risks to freedom of expression 4 . 1 Answer given by Mr McGrath on behalf of the European Commission, E-001160/2025: https://www.europarl.europa.eu/doceo/document/-ASW_EN.html. 2 3rd EEAS Report on Foreign Information Manipulation and Interference Threats, 19.03.2025, available here: https://www.eeas.europa.eu/eeas/3rd-eeas-report-foreign-information-manipulation-and-interference-threats0_en. 3 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence, OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj. 4 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act), OJ L 277, 27.10.2022, p. 1–102, ELI: http://data.europa.eu/eli/reg/2022/2065/oj.”
Transparency and oversight of AI-generated content · Disinformation & online freedoms
- 2025-06-24 “P-002534/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission is closely monitoring studies on the origins of COVID-19 and, based on existing scientific assessments, it believes there is no need for a Commission independent assessment. Current evidence does not definitively support one theory over another, nor question a zoonotic origin. The World Health Organisation (WHO)’s 2021 Global Study on the origins of SARS-CoV-2 suggested three possible zoonotic pathways for the introduction of the virus and concluded that the introduction through a laboratory incident was extremely unlikely 1 . Furthermore, a scientific review indicated that the strongest evidence supports a zoonotic origin 2 , finding no support for virus manipulation through reverse genetics, as such modifications typically show detectable signs in genomic sequence 3 . While the presence of a furin cleavage site in SARS-CoV-2 raises questions, similar sites are found in other viruses like influenza 4 , and it remains uncertain whether this site was acquired naturally through mutation or recombination in an intermediate host, or artificially. It is well recognised that coronaviruses are prone to mutations and recombination. The latest WHO report dated 27 June 2025 5 , concludes that the zoonotic origin remains the best supported hypothesis, and that the laboratory theory cannot be ruled out nor can be proven as the Republic of China has not provided further evidence. Understanding the origins of SARS-CoV-2 remains incomplete with the evidence currently available, and the WHO urges governments, researchers, and scientists to share information and data from investigations of the earliest human cases. The Commission continues to follow closely the WHO efforts to determine the origin of the virus. 1 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/origins-of-the-virus. 2 https://pubmed.ncbi.nlm.nih.gov/36897098/. 3 https://microbenotes.com/gene-cloning-requirements-principle-steps-applications/. 4 https://pmc.ncbi.nlm.nih.gov/articles/PMC8625184/, and other coronaviruses like MERS-CoV https://pmc.ncbi.nlm.nih.gov/articles/PMC11575293/. 5 https://www.who.int/publications/m/item/independent-assessment-of-the-origins-of-sars-cov-2-from-thescientific-advisory-group-for-the-origins-of-novel-pathogens).”
Vaccination
- 2025-06-04 “E-002237/2025 Answer given by Mr Brunner on behalf of the European Commission Member States bear the responsibility for maintaining law and order and safeguarding national security. As recalled in the Commission Communication adopted in December 2024 1 , if Member States facing weaponisation of migration by Russia, assisted by Belarus, decide to take exceptional measures to counter this threat, the measures taken must be temporary, proportionate and limited to what is strictly necessary. While such measures may affect certain fundamental rights, for example the right to asylum, they must respect non-derogable rights and principles. The construction or reinforcement of physical border barriers fall outside of the mandate of the European Border and Coast Guard Agency (Frontex). Frontex officers are deployed to support Member States to help ensure the safety of the operations and the effective management of the external borders of the EU. Frontex operational activities in a given Member State are agreed upon between the Agency, based on its mandate, and the host Member State. 1 Communication from the Commission to the European Parliament and the Council on countering hybrid threats from the weaponisation of migration and strengthening security at the EU’s external borders, COM/2024/570 final.”
Asylum & border control
- 2025-06-04 “E-002236/2025 Answer given by High Representative/Vice-President Kallas on behalf of the European Commission The EU and its Member States have developed a foreign information manipulation and interference (FIMI) toolbox, endorsed by the European Council in 2023 1 , which outlines options, including for Member States, to tackle threats by FIMI actors. In its monitoring of information environments in the Middle East and North Africa region, the European External Action Service has consistently reported to EU institutions, bodies and agencies and Member States about acts and actors of manipulation. The Terrorist Content Online Regulation 2 allows Member States to issue removal orders on terrorist content disseminated online in the context of the Hamas attack of 7 October 2023. For example, the implementation report of 14 February 2024 3 under the Regulation shows that after the attack of 7 October 2023, the German competent authority issued several removal orders targeting terrorist content online related to Hamas. In addition, the EU has strong common rules for online platforms and Member States to stop the dissemination of terrorist and violent content online. Under the Digital Services Act 4 and its Code of conduct on hate speech, very large online platforms are obligated to assess and mitigate systemic risks on their platforms, including risks related to illegal content and civic discourse, such as those stemming from FIMI. Such obligations do not relate to specific content or narratives, but rather to risks of a systemic nature and the relevant processes put in place by the platform. 1 Council conclusions of 15 December 2023, EUCO 20/23. 2 Regulation (EU) 2021/784 of the European Parliament and of the Council of 29 April 2021 on addressing the dissemination of terrorist content online, OJ L 172, 17.5.2021. 3 Report from the Commission to the European Parliament and the Council on the implementation of Regulation (EU) 2021/784 on addressing the dissemination of terrorist content online, COM/2024/64 final. 4 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services and amending Directive 2000/31/EC (Digital Services Act).”
Foreign interference in Europe · Disinformation & online freedoms · Relations with Israel - Palestine
- 2025-06-04 “E-002239/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission In the EU, the Digital Services Act (DSA) reinforces freedom of expression and of information. The law ensures that both under-removal and over-removal of content on grounds of illegality are avoided. For example, EU Member States cannot force digital services to do generalised online surveillance of citizens. Also, digital services are not liable for illegal online content generated by users, unless they are aware and do not act expeditiously to remove it. This helps digital services of any size disseminate information to their users, and enhances access to information in the Union, including across borders. Moreover, the DSA does not define what online content is illegal. The illegality of certain online content stems from existing EU laws, and laws of EU Member States. Laws that determine illegality of such content at the EU level, or by Member States when they implement EU law, must comply with the EU Charter of Fundamental Rights. Any limitation to freedom of expression, including the criminalisation of certain online content must be provided in law, respect the essence of such freedom, and made only if necessary to meet the legitimate aim they pursue according to the principle of proportionality. Measures to protect the rights of EU citizens online are thereby subject to strict scrutiny of European courts. In the EU, designated digital services need to annually assess the systemic risks that their services pose to freedom of expression and of information, among other systemic risks. Independent auditors and the Commission oversee this. The reports on the risk assessments by the providers are publicly available. These obligations stem from the DSA and reflect the EU’s human rights-based approach to online platform governance.”
Disinformation & online freedoms · Privacy & law enforcement
- 2025-06-04 “E-002238/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Digital Services Act (DSA) 1 requires as part of the enhanced due diligence obligations that providers of Very Large Online Platforms (VLOPs) and Very Large Online Search Engines (VLOSEs) diligently assess the systemic risks stemming for the design, functioning and use made of their services and related systems (including algorithmic systems) and put in place effective measures to mitigate the identified risks. Such assessment must cover and be tailed to risks listed in the DSA, including the dissemination of illegal content, any actual or foreseeable negative effects on civic discourse and electoral processes, and effects on the exercise of fundamental rights. This evaluation standard applies to both professional factchecking and community-based initiatives such as community notes if the relevant provider of the VLOP or VLOSE has chosen to use such mitigation measures. The cost-effectiveness of community-based initiatives, such as community notes, to address misinformation varies greatly, and depends on how the specific system is utilised on a particular service. The obligation to put in place effective and tailored-made mitigation measures is applicable to providers VLOPs and VLOSEs. The Commission is competent to supervise the enforcement and compliance of the DSA by providers, therefore, it assesses whether the risk assessment has been diligently conducted and whether effective and tailored-made mitigation measures have been put in place by the relevant provider to tackle the identified risks in compliance with the DSA. The Commission is aware that the effectiveness of Community Notes is subject to several ongoing research projects by third parties and is closely following the latest insights on this topic. 1 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services and amending Directive 2000/31/EC (Digital Services Act).”
Disinformation & online freedoms
- 2025-06-03 “E-002215/2025 Answer given by Mr McGrath on behalf of the European Commission Neither the Gesellschaft für Freiheitsrechte nor the European AI & Society Fund are beneficiaries of EU funding. The Digital Freedom Fund is the beneficiary of an EU grant for the implementation of project DIGIRISE, ‘Developing Information, Guidance, and Interconnectedness for (Charter) Rights Integration in Strategies for Enforcement’ 1 . The project has been selected under the call CERV-2022-CHAR-LITI 2 to ‘promote capacity building and awareness on the EU Charter of Fundamental Rights 3 and activities on strategic litigation relating to democracy, the rule of law and fundamental rights breaches’. The objectives of the project are to raise awareness of the Charter’s relevance for protecting digital rights and to improve knowledge of judicial pathways to enforce digital Charter rights. Through annual calls for proposals, the Commission funds projects to support civil society and other relevant actors in raising awareness on the Charter, which is binding primary EU law. The eligibility and award criteria are specified in the call documents. The projects are selected by independent experts. Under the ethics criteria, all funded projects are required to comply with the founding values of the EU as set out in Article 2 of the Treaty on European Union and with Article 21 of the Charter. The project does not foresee the possibility of redistributing EU funding to third parties. 1 DIGIRISE – Digital Freedom Fund: https://digitalfreedomfund.org/digirise-2/. 2 Call for proposals CERV-2022-CHAR-LITI - Commission: https://www.eacea.ec.europa.eu/call-proposalscerv-2022-char-liti_en. 3 Charter of Fundamental Rights of the European Union, OJ C 326, 26.10.2012, p. 391–407.”
EU engagement with civil society · Regulation of NGOs in Europe
- 2025-06-03 “E-002214/2025 Answer given by Mr Várhelyi on behalf of the European Commission The European Medicines Agency (EMA) recommends granting marketing authorisation to new vaccines that are similar to authorised vaccines on the basis of adequate comparative immunogenicity and safety data showing a positive benefit-risk balance. Such an approach is possible because the level and type of antibodies triggered against SARS-CoV-2 can be compared with those triggered by an already authorised vaccine whose efficacy has been established in large placebo-controlled efficacy studies. If a new vaccine can trigger an immune response in people comparable to that of an existing vaccine, it is concluded that the vaccine provides protection against the disease. This approach, called immune-bridging, is in line with established EU guidance for the development of vaccines 1,2 . The EMA is currently updating its guideline regarding the authorisation of novel COVID-19 vaccines, i.e., those for which a similar comparator is not yet authorised. In such cases, the EMA may require demonstration of clinical efficacy against placebo, in addition to immunogenicity data, at least in some age groups. Studies have shown that matching the content of vaccines to the circulating viruses improves protection against the disease 3,4,5 . For these reasons, the COVID-19 vaccine composition has been updated since the virus established itself in humans. While the EMA recommends the authorisation of vaccines based on evidence that they protect against disease and a positive benefit-risk balance, it is up to the national authorities in the Member States to decide who should be offered COVID-19 vaccination and when, based on infection and hospitalisation rates, risks to vulnerable people, vaccination coverage and other factors. 1 Multidisciplinary: vaccines https://www.ema.europa.eu/en/human-regulatory-overview/researchdevelopment/scientific-guidelines/multidisciplinary-guidelines/multidisciplinary-vaccines. 2 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-evaluation-vaccines-revision1_en.pdf. 3 ETF statement on use of recently updated COVID-19 vaccines: https://www.ema.europa.eu/en/documents/other/etf-statement-use-recently-updated-covid-19-vaccines_en.pdf. 4 Cele S, Jackson L, Khoury DS, et al. Omicron extensively but incompletely escapes Pfizer BNT162b2 neutralization. Nature. 2022;602(7898):654-656. doi:10.1038/s41586-021-04387-1. 5 Winokur P, Gayed J, Fitz-Patrick D, et al. Bivalent Omicron BA.1-Adapted BNT162b2 Booster in Adults Older than 55 Years. N Engl J Med. 2023;388(3):214-227. doi:10.1056/NEJMoa2213082.”
Pharmaceuticals regulation in EU · Vaccination
- 2025-06-03 “E-002216/2025 Answer given by Mr Serafin on behalf of the European Commission As the Commission noted in its replies to written questions E-000411/2025 and P001177/2023, photographic coverage of College members’ activities across the EU is essential for informing citizens about the Commission’s work and ensuring transparency. All photos are provided to media free of charge on the Commission’s audiovisual portal 1 for news reporting or educational purposes. For the period from 1 December 2024 to 31 May 2025, the total expenditure for photographers was EUR 878 000, covering hundreds of events in all Member States and outside the EU. This includes salaries and travel costs. There is no expenditure for hairdressers charged to the EU budget. Make-up services are provided to prepare the Commissioners for their television studio interviews, press room appearances and video statements. Such services are included in the overall framework service contract to run the television studios at the Commission headquarters. For the period from 1 December 2024 to 31 May 2025, make-up service costs are expected to amount to EUR 56 000, in line with the dedicated budget foreseen under this contract. These services are used by all members of the College. Make-up services are also available for Commission staff when conducting television interviews, participating in video recordings and similar activities. The Commission is committed to transparency and sound financial management. Information regarding the procurement of such services is publicly available on the Financial Transparency System 2 . 1 https://audiovisual.ec.europa.eu/en/. 2 https://ec.europa.eu/budget/financial-transparency-system/index.html.”
Accounting and auditing of EU budget · Budget for EU politicians
- 2025-05-26 “P-002107/2025 Answer given by Ms Albuquerque on behalf of the European Commission The EU has imposed unprecedented restrictive measures (sanctions) in response to Russia’s war of aggression against Ukraine, including far-reaching trade restrictions in several economic sectors, and specific financial measures against Russian individuals and entities. As the Honourable Member is aware, these sanctions are adopted under the EU’s Common Foreign and Security Policy and are aimed to maximise their impact on Russia’s ability to conduct and finance its war of aggression. On 10 June 2025, the Commission President and the High Representative/Vice-President 1 stated that the joint proposal for the 18 th sanctions package includes, among other measures, sanctions on the Nord Stream pipelines. This measure should prevent Russia from generating any revenue in the future by using those pipelines to transport natural gas. Those future measures are currently discussed in the Council and require a unanimous adoption. The proposals and the negotiations in the Council are not public. Hence, the Commission is not able to comment further on measures prior to their adoption in the Council. The Commission will continue to cooperate and coordinate closely with Member States and operators on the implementation and enforcement of sanctions once they are adopted. 1 https://www.eeas.europa.eu/eeas/ukrainerussia-press-remarks-high-representativevice-president-kaja-kallasjoint-press-conference_en.”
EU-Russia relations (from March 2022)
- 2025-05-26 “E-002108/2025 Answer given by Ms Roswall on behalf of the European Commission The Commission conducted a timely impact assessment 1 to accompany its 2022 proposal for a revised Directive on Urban Wastewater Treatment (UWWTD) 2 . It draws notably on a feasibility study 3 which analysed the impact of extended producer responsibility (EPR) on the price of pharmaceuticals, including on metformin. It concluded that the cost of the EPR is expected to have a marginal overall impact 4 on the pharmaceutical sector in the EU. The revised Directive notes that, based on available data, the potential increase of costs of products or the potential reduction of the profit margins of the industries placing products on the EU market due to the EPR application would neither endanger the affordability nor the availability of those products on the EU market 5 . As announced in the European Water Resilience Strategy 6 , adopted on 4 June 2025, the Commission will, in the context of the implementation of the EPR, conduct an updated study of its costs and its potential impacts on concerned sectors. This update will focus on the cost of quaternary treatment and does not constitute a new impact assessment. Should there be concerns over potential effects on specific products at national level, the industry, under the control of Member States, can propose safeguards in the way the contributions are calculated 7 . Exemptions are possible for products placed on the EU market under certain conditions 8 . A full evaluation 9 of the Directive is planned by 2033. 1 Impact assessment accompanying the proposal for a Directive concerning urban wastewater treatment (recast), 2022: https://environment.ec.europa.eu/publications/proposal-revised-urban-wastewater-treatment-directive_en. 2 Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (recast), OJ L, 2024/3019, 12.12.2024. 3 Feasibility of an EPR system for micro-pollutants: https://op.europa.eu/en/publication-detail//publication/14249cbc-5f1c-11ed-92ed-01aa75ed71a1/language-en. 4 Ibid. 5 Recital 21 of Directive (EU) 2024/3019. As regards the proposed Critical Medicines Act, it aims to support manufacturing and improve the availability of critical medicines in the EU, without prejudice to the applicable EU environmental rules, https://health.ec.europa.eu/medicinal-products/legal-framework-governing-medicinalproducts-human-use-eu/critical-medicines-act_en. 6 https://commission.europa.eu/topics/environment/water-resilience-strategy_en.. 7 Recital 21, articles 9 and 10 of Directive (EU) 2024/3019. 8 Article 9.2 of Directive (EU) 2024/3019. 9 Article 30 of Directive (EU) 2024/3019.”
Pharma companies manufacturing and production obligations · Pharmaceuticals regulation in EU
- 2025-04-23 “E-001633/2025 Answer given by Mr Brunner on behalf of the European Commission Hybrid threats arising from the weaponisation of migration by Russia, assisted by Belarus, pose a risk to sovereignty, national security and territorial integrity of the concerned Member States, but also to the security of the EU as a whole. The Commission, together with EU Agencies, have provided support to Member States since Russia and Belarus started using migration for political purposes. In December 2024, the Commission adopted a Communication on countering hybrid threats from the weaponisation of migration and strengthening security at the EU’s external borders 1 . This Communication recalled the legal context in which any exceptional measure to tackle this threat can be taken, taking into account the case-law of the Court of Justice of the EU that provides guidance as regards the conditions and limits. The Commission does not have aggregate figures relevant specifically to returns of those third country nationals who crossed the EU borders with Russia and Belarus. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52024DC0570.”
Asylum & border control
- 2025-04-08 “E-001427/2025 Answer given by Mr McGrath on behalf of the European Commission As enshrined in Articles 2 and 10 of the Treaty on European Union, democracy is a founding value on which the EU is built. Free and fair elections are at the core of democracy. Their conduct and organisation are the competence and responsibility of the Member States, in accordance with their constitutional and legislative rules, subject to EU law and their international obligations. National competent authorities and courts have the primary responsibility of ensuring compliance with these rules, as well as of protecting the fairness and integrity of the electoral processes. Experience shows how close coordination and cooperation at national and EU level can make a key contribution in this respect. The value of close cooperation in safeguarding free and fair elections in the European Union has been acknowledged also by the Council 1 , which called, among other things, on the comprehensive use of all established mechanisms, networks and tools in order to ensure such cooperation and support the integrity of democratic processes, including elections. The Commission plays a supporting role in this area, facilitating coordination and cooperation among relevant authorities, in different frameworks, such as the European Cooperation Network on Elections, the Rapid Alert System and the cybersecurity coordination networks. As guardian of the Treaties, the Commission is also responsible for ensuring the correct application of EU electoral law and other pieces of EU legislation, relevant in the context of elections, such as the Regulation (EU) 2022/2065 (Digital Services Act) and the Regulation (EU) 2024/900 on the transparency and targeting of political advertising. 1 Council conclusions on democratic resilience: safeguarding electoral processes from foreign interference approved on 21 May 2024 (https://data.consilium.europa.eu/doc/document/ST-10119-2024-INIT/en/pdf); Council conclusions on strengthening EU democratic resilience approved on 27 May 2025 (https://data.consilium.europa.eu/doc/document/ST-9463-2025-INIT/en/pdf).”
EU Supervision of the Rule of Law
- 2025-04-07 “E-001403/2025 Answer given by Ms Zaharieva on behalf of the European Commission The Commission has not been informed by any national or European authority about intelligence indicating that COVID-19 originated in a laboratory. The Commission closely monitors scientific studies on the origin of SARS-CoV-2 and supports the research of the World Health Organization (WHO) 1 . The WHO’s Global Study on the origins of SARS-CoV-2 suggests three possible zoonotic pathways for the introduction of the virus and concludes that the introduction through a laboratory incident is extremely unlikely 2 . Furthermore, a 2023 scientific critical review concluded that the strongest evidence supports a zoonotic over a laboratory origin 3 . The Commission supported research on infectious diseases via its framework programmes for Research and Innovation 4 . Prior to the pandemic, the Commission provided financial support to institutions engaged in high-risk virological research including Wuhan Institute of Virology via two EU-funded projects 5 . The Commission ensures transparency, traceability and safety in EU-funded research 6 , including gain-of-function and dual use research. The Commission implements ethics assessments and promotes transparency through open-access publication of research results. Security checks are conducted as part of the ethics and security scrutiny process 7 , with clearance required from the Security Scrutiny Group 8 before funding is granted. In addition, project monitoring is ensured until the end of a project to check its proper implementation and compliance with the obligations laid down in the grant agreement. 1 https://www.eeas.europa.eu/eeas/eu-statement-who-led-covid-19-origins-study_en. 2 https://www.who.int/emergencies/diseases/novel-coronavirus-2019/origins-of-the-virus, WHO-convened Global Study of Origins of SARS-CoV-2: China Part Joint WHO-China Study, page 9. 3 Alwine JC, Casadevall A, Enquist LW, Goodrum FD, Imperiale MJ. A Critical Analysis of the Evidence for the SARS-CoV-2 Origin Hypotheses. mBio. 2023 Apr 25;14(2):e0058323. doi: 10.1128/mbio.00583-23. Epub 2023 Mar 28. PMID: 36897098; PMCID: PMC10127682. 4 Including https://cordis.europa.eu/programme/id/FP6, https://cordis.europa.eu/programme/id/FP7, https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-opencalls/horizon-2020_en and https://commission.europa.eu/funding-tenders/find-funding/eu-fundingprogrammes/horizon-europe_en. 5 Grant agreements: https://cordis.europa.eu/project/id/653316; https://cordis.europa.eu/project/id/871029. 6 https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/opportunities/projects-results. 7 https://webgate.ec.europa.eu/funding-tendersopportunities/display/OM/Special+procedures%3A+Ethics+review%2C+security+scrutiny%2C+Ownership+co ntrol+check. 8 Composed of national security experts nominated in agreement with their national security authorities.”
EU competences on health · Pharmaceuticals regulation in EU
- 2025-04-07 “P-001402/2025 Answer given by Mr Várhelyi on behalf of the European Commission As regards the regulatory requirements for the manufacturing and importation of medicinal products for human use the main legal acts are: Directive 2001/83/EC 1 on the Community code relating to medicinal products for human use, Commission Directive (EU) 2017/1572 2 on the principles and guidelines of good manufacturing practice for medicinal products for human use, and Delegated Regulation (EU) No 1252/2014 3 on principles and guidelines of good manufacturing practice for active substances for medicinal products for human use. Specific manufacturing rules for investigational medicinal products are established in Regulation (EU) 536/2014 4 on clinical trials and Delegated Regulation (EU) 2017/1569 5 on good manufacturing practices for investigational medicinal products. All these legal acts are complemented by guidelines on good manufacturing practice for medicinal products and active substances, published by the Commission on its website (Eudralex volume IV) 6 . 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. 2 Commission Directive (EU) 2017/1572 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use. 3 Delegated regulation (EU) No 1252/2014 supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use. 4 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. 5 Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and the guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections. 6 EudraLex - Volume 4: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en.”
Pharmaceutical imports & exports rules · Pharmaceuticals regulation in EU
- 2025-04-07 “E-001401/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission would like to stress that the European Medicines Agency (EMA) cyberattack in 2020 was successfully contained without affecting the evaluation and approval of COVID-19 vaccines and therapeutics. The EMA swiftly launched a full investigation, in close cooperation with the Dutch police, the Cybersecurity Service for the Union institutions, bodies, offices and agencies (CERT-EU) and Europol, the EU agency for law enforcement cooperation. The law enforcement investigation did not confirm the identities of the suspects involved in this criminal attack. The EMA remains vigilant and has subsequently further strengthened its defensive cybersecurity capabilities to be better prepared for cyberattacks. The EMA has also published a wealth of information about the evaluation of COVID-19 vaccines, including the clinical data submitted for assessment and the detailed assessment reports. The cyberattack did not impact the integrity of the data that were assessed by the EMA. The Commission and the EMA would like to stress the importance of consulting reliable information sources and refer the public to the documents published on the EMA website. The EMA will continue releasing documents to the public in line with its legal obligations and its transparency policy.”
Disinformation & online freedoms
- 2025-03-19 “E-001160/2025 Answer given by Mr McGrath on behalf of the European Commission Freedom of expression is enshrined in the Charter of Fundamental Rights 1 and a cherished value of the EU. It applies to all forms of expression within the scope and limits provided for in the EU Treaties, international human rights law and the national laws. Human rights are inherent to all human beings 2 . Putting people and their rights at the centre of the digital transformation are also core principles in the EU approach to digitalisation and technological advancement. Technology must support rights and democracy. It is always the individuals who may avail themselves of free expression rights and their protection. Automatically generated and published content does not in itself enjoy any protection in this respect. Artificial intelligence (AI) systems can support people’s exercise of freedom of expression and freedom of information with a variety of tools, such as search engines or translation software. As provided for in the AI Act 3 , certain AI systems intended to interact with natural persons or to generate content may pose risks of impersonation or deception. The AI Act contains rules to distinguish between AI generated content and human generated content, including rules to ensure that the use of AI systems to generate content such as deep fakes should clearly and distinguishably disclose the artificial character of the content generation. Inauthentic use or tactics involving artificially generated content, including the use of online bots, could also lead to the widespread dissemination of illegal content online and contribute to disinformation campaigns. The Digital Services Act provides obligations for providers of very large online platforms and very large online search engines to assess and mitigate systemic risks stemming from their services, including negative effects on freedom of expression 4 . They shall act in a diligent, objective and proportionate manner in applying content moderation restrictions, with due regard to freedom of expression. 1 Charter of Fundamental Rights of the European Union, OJ C 326, 26.10.2012, p. 391–407. 2 United Nations, Universal Declaration of Human Rights, 1948, https://www.un.org/en/about-us/universaldeclaration-of-human-rights. 3 Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence, OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj. 4 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services and amending Directive 2000/31/EC (Digital Services Act), OJ L 277, 27.10.2022, p. 1–102.”
Disinformation & online freedoms · Transparency and oversight of AI-generated content
- 2025-02-27 “E-000875/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission Prebunking is generally understood as helping citizens recognise and avoid false claims. In practice, it often entails the development of awareness raising campaigns to encourage critical thinking. 1 Since 2015, the Council has called on the Commission to counter disinformation in several Conclusions 2 . The Defence of Democracy Communication 3 and Commission Recommendation (EU) 2023/2829 4 acknowledge that prebunking and debunking can be effective to counter foreign information manipulation and interference (FIMI) and disinformation, while fully upholding fundamental rights, including freedom of expression. Whereas the Digital Services Act (DSA) 5 does not explicitly address prebunking or debunking, it requires providers of very large online platforms and search engines to assess the systemic risks to which their service gives rise in relation to inter alia civic discourse, electoral processes and public security, and to put in place measures to mitigate such risks. The DSA election guidelines recommend developing measures that pre-emptively build resilience against possible disinformation narratives and manipulation techniques by informing users. 6 The Commission’s approach is based on a variety of tools to promote critical thinking and empower individuals to recognise and respond to disinformation effectively. The upcoming European Democracy Shield will provide a strategic framework to better protect and promote democracy in the EU, ensuring respect for democratic values and fundamental rights, including freedom of expression. It aims, among others, at reinforcing societal resilience and preparedness, including our capacity to detect, analyse and respond to FIMI and disinformation. 1 For instance European Digital Media Observatory: ‘Prebunking AI-generated disinformation ahead of EU elections’, 27 March 2024: https://edmo.eu/publications/prebunking-ai-generated-disinformation-ahead-of-euelections/ 2 See, European Council meeting (19 and 20 March 2015): https://www.consilium.europa.eu/media/21888/european-council-conclusions-19-20-march-2015-en.pdf, Council conclusions on Foreign Information Manipulation and Interference (FIMI) 18 July 2022: https://data.consilium.europa.eu/doc/document/ST-11429-2022-INIT/en/pdf, Council conclusions on democratic resilience: safeguarding electoral processes from foreign interference 21 May 2024: https://data.consilium.europa.eu/doc/document/ST-10119-2024-INIT/en/pdf 3 Communication from the Commission on Defence of Democracy. 4 Commission Recommendation (EU) 2023/2829 of 12 December 2023 on inclusive and resilient electoral processes in the Union and enhancing the European nature and efficient conduct of the elections to the European Parliament. 5 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 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 6 Communication from the Commission: Commission Guidelines for providers of Very Large Online Platforms and Very Large Online Search Engines on the mitigation of systemic risks for electoral processes pursuant to Article 35(3) of Regulation (EU) 2022/2065 https://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=OJ:C_202403014&qid=1714120357136”
Disinformation & online freedoms
- 2025-02-26 “E-000851/2025 Answer given by Mr McGrath on behalf of the European Commission The European Public Prosecutor’s Office (EPPO) is independent from the Commission and all EU institutions, bodies, offices and agencies, as well as from the Member States. The Commission and other external entities are not involved in the recruitment, appointment and management of the EPPO’s staff, except for the cases provided for by Regulation (EU) 2017/1939 1 , such as the appointment of the European Chief Prosecutor, which is done by common accord of the European Parliament and the Council. The Commission has been working intensively with the EPPO to achieve the EPPO’s IT independence from the Commission. As soon as the EPPO will achieve such independence, the EPPO will be disconnected from the Commission’s IT infrastructure. The Commission emphasises that the provision of IT Digital Workplace services to the EPPO until its IT independence does not affect the EPPO’s full responsibility and exclusive control on its IT systems. The Commission has constantly supported the availability of sufficient financial and human resources for the EPPO since its setting up. The 2025 EPPO budget amounts to EUR 85.9 million, which is more than 12 million above the annually updated financial programming. Moreover, the EPPO was originally due to reach its full size at 115 staff in 2023 and operate thereafter under stable staffing. In 2025, the EPPO has however a staff number of 307, not counting the European Delegated Prosecutors. All EU institutions, bodies, offices and agencies need to operate within the limits of the Multiannual Financial Framework (MFF) and in line with the stable staffing and sound financial management principles. The Commission underlines that the EPPO’s budget is ultimately decided by the European Parliament and the Council as Budgetary Authority. 1 Council Regulation (EU) 2017/1939 of 12 October 2017 implementing enhanced cooperation on the establishment of the European Public Prosecutor’s Office (‘the EPPO’), OJ L 283, 31.10.2017, p. 1–71.”
Transparency requirements of EU institutions · EU law enforcement cooperation in criminal matters
- 2025-02-26 “E-000855/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Digital Services Act (DSA) 1 mandates the Commission to designate an online platform or online search engine as a very large online platform (VLOP) or very large search engine (VLOSE) when their number of average monthly active recipients in the EU for the last six months is equal or higher than 45 million, 2 making them subject to additional due diligence obligations. As clarified by the recital 75, this is due to the importance of VLOPs and VLOSEs, given their reach, in facilitating public debate, economic transactions, the dissemination of information, opinions or ideas, and in influencing how recipients obtain and communicate information online. 3 VLOPs and VLOSEs may cause societal risks with a different impact than smaller platforms, and it is required from them to bear the highest proportional standard of due diligence obligations. 4 The provider may exercise its right to be heard in the process leading up to the designation of its service. As any Commission decision, the designation of a service as a VLOP or VLOSE is subject to judicial review by the Court of Justice of the European Union, 5. To tackle the different potential societal and economic risks VLOPs and VLOSEs may pose in view of their extended reach and network effects, the specific obligations applicable to them essentially define a risk-based framework where potential risks specific to their characteristics and features needs to be assessed and corresponding mitigation measures defined and audited. This ensures proportionality of the measures in line with the actual level of risk of the platform and their characteristics. Finally, under DSA Article 91 6 the Commission shall evaluate and report 7 on the current process for designation of VLOPs and VLOSEs 8 . 1 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (Text with EEA relevance). 2 Article 33(1) and (3) DSA. 3 Recital 75 DSA. 4 Recital 76 DSA. 5 Article 263 of the Treaty on the Functioning of the European Union. Currently 6 designations have been challenged in front of the Court of Justice of the European Union. 6 By 17 November 2025. 7 To the European Parliament, the Council and the European Economic and Social Committee. 8 DSA Article 33.”
EU rules on digital competition
- 2025-02-26 “E-000850/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Commission is not in a position to comment on or assess the requests for user data issued by German authorities or by the authorities of any other Member State on the basis of the applicable Union law or national law in compliance with Union law. It is for Member States to ensure compliance with the relevant legislation, including on privacy and protection of personal data. As to the Digital Services Act (DSA) 1 , Article 10 DSA sets certain minimum conditions related to orders to provide specific information about one or more specific individual recipients of the service. The transmission of an order fulfilling the minimum conditions gives rise to the obligation on providers to inform the relevant authorities about the effect given to those orders. Article 10 DSA further requires providers to inform the recipient of the service concerned of the order received and the effect given to it. Such information provided to the recipient of the service shall include a statement of reasons and the possibilities for redress that exist. The legal basis to issue such an order to provide information is Union law or national law in compliance with Union law. The Commission is constantly monitoring the implementation of the DSA, including any possible infringements thereof. The Commission is at present not in possession of any information regarding any conflicts between the national framework in question and the DSA. 1 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act), OJ L 277, 27.10.2022, p. 1.”
Privacy & law enforcement
- 2025-02-26 “E-000854/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Digital Services Act (DSA) 1 and the Code of Practice on Disinformation 2 aim to help ensure a safe, transparent online space in the EU where users’ fundamental rights, including freedom of expression, are respected. The DSA does not define what type of content users may or may not post online nor what content constitutes disinformation. It obliges very large online platforms and search engines to assess and mitigate systemic risks 3 , including to civic discourse, stemming from their services. It also mandates transparency and accountability from online platforms 4 . The DSA contains the world’s strongest safeguards of users’ rights online, e.g. by requiring platforms to publish online 5 statements of reasons for any content moderation decisions by platforms, internal and external complaint mechanisms for appealing content moderation decisions, allowing users to contest decisions and ensuring due process. Decisions taken by the Commission under the DSA can be challenged in front of the Court of Justice of the European Union. Those taken at national level are subject to oversight of the respective legal systems in each Member State. The Commission is bound by the Charter of Fundamental Rights 6 to respect the rights, freedoms and principles, including that to freedom of expression. Regarding the independence of fact-checking organisations, the Commission supports the most stringent standards of integrity and accountability. This is why the EU has supported the independent creation of the European Fact-Checking Standard Network’s (EFCSN) Code of Standards 7 , the worlds’ strongest framework to maintain the highest standards of methodology, ethics and transparency. 8 These standards are upheld and enforced independently by the EFCSN. 1 https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng 2 https://digital-strategy.ec.europa.eu/en/policies/code-practice-disinformation 3 As defined in Article 34 and 35 of the DSA. 4 Article 37, Article 42 of the DSA. 5 https://transparency.dsa.ec.europa.eu/?lang=en 6 https://eur-lex.europa.eu/eli/treaty/char_2012/oj/eng 7 https://efcsn.com/code-of-standards/ 8 The project was funded in the course of the Integrity of Social Media call for proposals, https://digitalstrategy.ec.europa.eu/en/funding/call-proposals-integrity-social-media”
Disinformation & online freedoms
- 2025-02-26 “E-000853/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission The Digital Services Act 1 (DSA) requires the providers of Very Large Online Platforms (VLOPs) and of Very Large Online Search Engines (VLOSEs) to perform annual risk assessments of the systemic risks stemming from the functioning, design and use of their services. The assessment must cover certain risks defined in the DSA, such as the dissemination of illegal content and any actual or foreseeable negative effects on civic discourse and electoral processes. Moreover, the DSA requires providers of VLOPs and VLOSEs to put in place reasonable, proportionate and effective mitigation measures tailored to those risks. The DSA leaves VLOPs and VLOSEs the choice of the mitigation measures they wish to use, as long as those measures are reasonable, proportionate, effective and tailored to the specific risks identified. This evaluation standard applies to both centralised fact-checking and decentralised initiatives such as community notes. When implementing such measures, the providers of VLOPs and VLOSEs are also required to consider their impacts on freedom of expression and other fundamental rights. Adherence to the Code of Conduct on Disinformation 2 may constitute an appropriate risk mitigation measure. Additionally, DSA provides recipients of the service with mechanisms to challenge content moderations decisions made by the providers of online platforms. Whether community notes can be considered as content moderation decisions in this sense, depends on how the community notes system of the specific provider operates. Relevant factors for this assessment are the involvement of the provider in the decision process and the potential restrictions that follow from the community note. 1 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services and amending Directive 2000/31/EC (Digital Services Act). 2 https://digital-strategy.ec.europa.eu/en/library/code-conduct-disinformation”
Disinformation & online freedoms
- 2025-02-26 “E-000849/2025 Answer given by Mr McGrath on behalf of the European Commission Freedom of expression is a fundamental right and a cherished value. There is, however, a line drawn by human rights law: it must not be exploited to incite hatred and violence. Illegal hate speech represents a systemic risk for democracy and fundamental rights, and a threat to the common values of respect for human dignity, freedom, democracy and equality enshrined in the Treaty on the Functioning of the European Union (TFEU ) 1 . The Council Framework Decision on combating racism and xenophobia 2 requires Member States to consider hate speech as a criminal offence, i.e. the public incitement to violence or hatred, on grounds of race, colour, religion, descent or national or ethnic origin. The Directive on combating violence against women and domestic violence, adopted in 2024, provides that Member States will also have to penalise the public incitement to violence or hatred by reference to gender, when committed online 3 . Under both instruments, Member States may choose to limit criminal liability to conduct which is either carried out in a manner likely to disturb public order or which is threatening, abusive or insulting. Any infringement procedures initiated by the Commission have been strictly related to the transposition and implementation of the Council Framework Decision on combating racism and xenophobia 4 . A study commissioned by the Commission provides a detailed mapping of the legal frameworks in Member States criminalising hate speech and hate crime 5 . There is no other Commission studies on the subject matter suggested by the Honourable Member. Should the Commission conclude that Member States have failed to fulfil their obligations under the EU law framework acquis, it may decide to use its power under Article 258 TFEU to initiate infringement procedures. 1 OJ C 202, 7.6.2016, p. 1–388 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=oj:JOC_2016_202_R_TOC 2 https://eur-lex.europa.eu/legal-content/en/ALL/?uri=CELEX%3A32008F0913 3 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32024L1385 4 Information on such infringement proceedings are available through the infringement database of the Commission: https://ec.europa.eu/atwork/applying-eu-law/infringementsproceedings/infringement_decisions/?lang_code=en&langCode=EN&version=v1&typeOfSearch=byDecision&p age=2&size=10&order=desc&sortColumns=decisionDate&legalBasis=32008F0913 5 Directorate-General for Justice and Consumers, Spark Legal Network, TIPIK, Ypma, P., Drevon, C. et al., Study to support the preparation of the European Commission’s initiative to extend the list of EU crimes in Article 83 of the TFEU to hate speech and hate crime – Final report, Publications Office of the European Union, 2021.”
Disinformation & online freedoms
- 2025-02-26 “E-000852/2025 Answer given by Executive Vice-President Virkkunen on behalf of the European Commission ]) The crisis response mechanism outlined in Article 36 of the Digital Services Act (DSA) 1 only applies in extraordinary circumstances that pose a serious threat to public security or public health in the EU. Activation of this mechanism requires a recommendation from the European Board for Digital Services 2 , which comprises independent national regulators. No such recommendation has so far been issued and, therefore, the provision has never been enforced. If the Board recommends activating the crisis response mechanism, the Commission may request providers of very large online platforms or search engines to assess if their services significantly contribute to the serious threat. If so, they are to identify appropriate mitigation measures. The DSA does not prescribe the measures to be taken by the provider, but sets out effective safeguards for fundamental rights. As stated in Article 36, proposed measures must be strictly necessary, justified, proportionate and respect the fundamental rights enshrined in the Charter 3 . Such measures must also be limited to a reasonable period not exceeding three months. The Commission monitors the application of mitigation measures, regularly updates the Board, and reports to the European Parliament and the Council on the application of the measures taken by providers. Regarding content removal, the DSA does not define what type of content users may or may not post online. The DSA lays down the world’s strongest safeguards of users’ rights online, e.g. by requiring platforms to publish online 4 statements of reasons for any content moderation decisions by platforms, and provide complaint mechanisms for appealing content moderation decisions, allowing users to contest decisions and ensuring due process. 1 https://eur-lex.europa.eu/eli/reg/2022/2065/oj/eng 2 https://digital-strategy.ec.europa.eu/en/policies/dsa-board 3 https://eur-lex.europa.eu/eli/treaty/char_2012/oj/eng 4 https://transparency.dsa.ec.europa.eu/?lang=en”
Disinformation & online freedoms
- 2025-02-11 “P-000624/2025 Answer given by Mr Várhelyi on behalf of the European Commission The COVID-19 pandemic was an unprecedented public health crisis which required facilitation of the development, authorisation and deployment of COVID-19 vaccines and treatments. It was in this context that vaccine manufacturers requested a temporary derogation from serialisation requirements on the outer packaging of their vaccines to ensure continuous supply of the vaccine in the critical stage of the pandemic. The derogation was granted, upon consultation with Member States under clearly specified conditions, including the obligation to report immediately any relevant incidents to ensure accountability and reconciliation of distributed products. The derogation was granted on the basis on Article 63(3) of Directive 2001/83/EC 1 without prejudice to the manufacturer’s liability. It should be also pointed out that the continuous monitoring of the quality, safety and efficacy of medicines was organised independently and not impacted by waiving the serialisation requirement. Each batch was tested prior to its release by Official Medicines Control Laboratories of the Member States. Moreover, in the EU, a robust pharmacovigilance system is in place to collect and assess potential adverse drug reactions (ADRs). EudraVigilance, the European database managed by the European Medicines Agency, compiles all ADR reports. Moreover, healthcare professionals were required to report ADRs for each patient following COVID-19 vaccination. 1 http://data.europa.eu/eli/dir/2001/83/oj”
Covid-19 vaccines procurement · Pharmaceuticals regulation in EU · Disclosure vs. confidentiality of pharma companies processes
- 2025-01-14 “P-000116/2025 Answer given by President von der Leyen on behalf of the European Commission Democracy is a founding value of the EU. Free and fair elections are at its core. Their organisation and conduct are the competence and responsibility of the Member States in line with their legislation, subject to their international obligations and EU law. The Commission supports open debate and discussion in full respect for national constitutional prerogatives and does not intervene in the domestic political debate in Member States. The President has been, is and will continue to be a promoter and defender of all the common values of the EU, including democracy and freedom of expression.”
EU public communication strategy · Von der Leyen
- 2024-12-17 “E-002991/2024 Answer given by Ms Albuquerque on behalf of the European Commission The first set of calculations made by the Commission on the costs of the Corporate Sustainability Reporting Directive (CSRD) 1 were explained under the impact assessment document accompanying the CSRD proposal 2 . In this document, the total incremental recurring costs of reporting against sustainability reporting standards in all 27 Member States were estimated at EUR 2.1 billion per year, plus additional recurrent costs for audit and assurance and the one-off implementation costs. Subsequently, when adopting the European Sustainability Reporting Standards (ESRS) Delegated Act, the Commission estimated EUR 1.7 billion in annual recurring costs across the EU for reporting against ESRS 3 . This recurring costs estimate shows a reduction compared to the estimate in the 2021 CSRD impact assessment as a result of various simplifications made. On 26 February the Commission adopted legislative proposals to modify the CSRD, as part of the ‘Omnibus’ initiative to reduce administrative burden on companies. The Commission estimates that the proposed modifications would exempt about 80% of companies from reporting under the CSRD and lead to CSRD/ESRS reporting cost savings of EUR 1.2 billion per year, plus savings on the related audit and assurance costs. Beyond this, companies would also benefit from being exempted from taxonomy reporting and future simplifications of the ESRS. As set out in more detail in the assessment accompanying the omnibus proposal, 4 the combined cost savings resulting from the proposed changes to the CSRD scope (including the exemptions this would bring for Taxonomy reporting), plus the modifications of the future ESRS, have been estimated to amount to EUR 4.4 billion per year. 1 OJ L 322, 16.12.2022, p. 15–80. 2 Impact assessment, SWD/2021/150 final: https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=CELEX:52021SC0150 Summary of the impact assessment, SWD/2021/151 final: https://eur-lex.europa.eu/legalcontent/EN/TXT/?uri=CELEX:52021SC0151 3 EUR-Lex - Ares(2023)4009405 - EN - EUR-Lex and https://www.ceps.eu/ceps-publications/cost-benefitanalysis-of-the-first-set-of-draft-european-sustainability-reporting-standards/ 4 SWD(2025) 80 final.”
Energy (green transition)
- 2024-12-17 “E-002995/2024 Answer given by Mr Jørgensen on behalf of the European Commission The EU is facing a severe housing crisis impacting millions of people. To help tackle this crisis, the Commission has appointed the first-ever Commissioner for Housing and has established a Task Force for Housing. It assists the Commission in coordinating the work among its services and supporting Member States, Mayors and local authorities to address structural drivers, to unlock public and private investment for affordable and sustainable housing, and to add value at EU level, where needed. The Commission will be working closely with the European Parliament and the Council, across institutions and different levels of public administrations, and across sectors. The Commission will assess various aspects of the lack of affordable housing. Throughout 2025, the Commission intends to extensively consult all relevant stakeholders. All this will feed into the European Affordable Housing Plan (EAHP) and ensure that the plan is well-targeted. In addition, the Commission services are examining how State aid rules for housing could be revised to enable housing support measures, notably for energy efficiency and social housing, and conduct an analysis of the impact of housing speculations and its economic consequences. The Commission will also work together with the European Investment Bank to establish a pan-European investment platform for affordable and sustainable housing and work closely with other international financial institutions, national promotional banks, and institutions and other stakeholders in this work. The Commission will also develop a European Strategy for Housing Construction. Regarding the impact of migration on the housing market, the Commission will assess it during the development of the EAHP.”
EU competences on social policies · EU housing policy
- 2024-12-17 “P-002990/2024 Answer given by Mr Várhelyi on behalf of the European Commission The Commission is in contact with Member States and the European Medicines Agency (EMA) to ensure the continuous quality, safety and efficacy of medicines, including COVID19 vaccines. EMA continuously monitors safety signals and investigates whether there is a causal link between specific batches and reported adverse events. EMA has no evidence so far suggesting that some batches of Comirnaty caused more (or more serious) side effects than other batches 1 . The quality of every batch is checked by Official Medicines Control Laboratories in Member States and only those complying with the approved quality specifications can be released in the EU. Regulators request and collect batch numbers for vaccines to allow them to establish patterns and determine whether suspected side effects are linked to a specific batch. The Paul-EhrlichInstitut (PEI) reports suspected side effects with Comirnaty, but it does not confirm these as side effects, nor does it link them to specific batches. Most side effects of Comirnaty are mild. These are not batch specific and are clearly listed in the product information with the respective frequency. A conditional marketing authorisation was granted by the Commission to Comirnaty in December 2020, based on EMA’s rigorous scientific evaluation, weighing up the benefits and risks. The conditional marketing authorisation was converted into a standard marketing authorisation on 10 October 2022. After authorisation in 2020, EMA has been continuously monitoring suspected side effects and evaluating any new information that emerges 2 . This evaluation is conducted by EMA's expert committees, and action is taken, if necessary. Comirnaty continues to fulfil the necessary requirements for authorisation in the EU. 1 Vaccine safety (Comirnaty): https://www.ema.europa.eu/en/human-regulatory-overview/public-healththreats/coronavirus-disease-covid-19/covid-19-medicines/covid-19-vaccines-key-facts 2 https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty#authorisation-details”
Pharmaceuticals regulation in EU · Vaccination
- 2024-12-12 “E-002900/2024 Answer given by Mr Brunner on behalf of the European Commission The rules for the revocation of a refugee or subsidiary protection status are laid down in the Qualification Directive 1 , in particular in Article 14 (for the revocation of a refugee status) and Article 19 (for the revocation of a subsidiary protection status). These provisions require that the Member States that have granted international protection demonstrate on an individual basis that the person concerned has ceased to be or has never been entitled to such protection. Procedural rules are laid down in Articles 44 and 45 of the Asylum Procedure Directive 2 . The revocation of the refugee or subsidiary protection status should be based on an individual assessment pursuant to the aforementioned provisions of EU law. Likewise, the granting of refugee or subsidiary protection status should be based on an individual assessment as set out in Article 4(3) of the Qualification Directive. The Commission is in constant exchange with the Member States in the context of the implementation of the Pact on Migration and Asylum 3 and provides support as needed. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32011L0095 2 https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32013L0032 3 https://home-affairs.ec.europa.eu/policies/migration-and-asylum/pact-migration-and-asylum_en”
Asylum & border control
- 2024-10-24 “E-002252/2024 Answer given by Ms Kos on behalf of the European Commission On 20 October 2024, the people of the Republic of Moldova voted in a referendum on Moldova’s EU path. Despite massive interference and hybrid campaigns by Russia, including blatant vote-buying, they expressed majority support for anchoring their future within the EU. The Commission took note of the results reflecting diverse opinions among Moldova’s citizens and will keep working closely with the country to build consensus on its path towards EU membership. Moldova has continued to make progress as recognised by the EU leaders during the European Council in March 2024. However, since the start of Russia’s war of aggression against Ukraine, Moldova has been tackling challenges related to slow economic growth, supporting a large number of Ukrainian refugees, inflation, disruption to its energy supplies and cyber-attacks. For this reason, in October 2024, the President of the Commission announced the Commission’s proposal for a Growth Plan for the Republic of Moldova 1 . Its aim is to support the Moldovan economy with EUR 1.8 billion between 2025 and 2027. It also provides Moldova with similar financial support to that offered to Western Balkan countries and to Ukraine, reflecting their aspirations to join the EU. The co-legislators adopted Regulation (EU) 2025/535 of the European Parliament and of the Council of 18 March 2025 establishing the Reform and Growth Facility for the Republic of Moldova 2 . The EU condemns the unprecedented malign interference by Russia into Moldova’s elections and will continue supporting Moldova’s resilience and progress on its EU accession path. 1 https://ec.europa.eu/commission/presscorner/detail/en/ip_24_5124 2 https://enlargement.ec.europa.eu/regulation-eu-2025535-european-parliament-and-council-18-march-2025establishing-reform-and-growth_en”
EU enlargement
- 2024-10-24 “E-002253/2024 Answer given by Ms Albuquerque on behalf of the European Commission European Sustainability Reporting Standards (ESRS) 1 will benefit companies by improving access to sustainable finance and reducing the burden caused by multiple overlapping voluntary reporting standards and frameworks. They will help European companies to identify and manage their sustainability impacts and risks, enhancing their resilience and international competitiveness in the medium and long term. The Commission acknowledges that the new rules create costs, especially in the short term. To address this the Commission has: i) agreed with the Parliament and the Council to postpone by two years the deadline for adoption of sector standards; ii) raised the monetary thresholds to define large companies, thus reducing the number of companies in scope by 14%; iii) required EFRAG 2 to provide additional guidance for companies; iv) published Question & Answers to clarify key questions 3 ; v) written to Member States to urge them to adopt a proportionate approach to enforcement; vi) and mobilised EU funds for the provision of technical support to companies at national level. In addition, the Commission is working towards adopting an Omnibus Simplification package, that will look, among other legislation, at the Corporate Sustainability Reporting Directive (CSRD) 4 . The Commission estimated at EUR 1 700 million the total annual recurring costs of reporting 5 . It is a significant reduction compared to the estimates in the 2021 CSRD impact assessment 6 which was published before the adoption of the ESRS. Assuming that about 49 000 groups are in scope, the estimated average recurring costs would be approximately EUR 35 000 per group. With the increase of the monetary thresholds for ‘large undertakings’, the total costs should be even lower. 1 https://finance.ec.europa.eu/news/commission-adopts-european-sustainability-reporting-standards-2023-0731_en 2 Commission’s advisory body on ESRS 3 https://finance.ec.europa.eu/publications/frequently-asked-questions-implementation-eu-corporatesustainability-reporting-rules_en 4 OJ L 322, 16.12.2022, p. 15–80. 5 According to the ESRS for companies within its scope. 6 SWD/2021/150 final.”
Energy (green transition)
- 2024-10-23 “E-002235/2024 Answer given by Mr Brunner on behalf of the European Commission 1. The Commission is aware that some Member States have observed movements of beneficiaries of international protection, travelling back to their country of origin and subsequently returning to the EU. 2. The Commission will continue to monitor any developments and engage closely with the Member States and other key stakeholders to provide support by promoting information-sharing and cooperation. 3. Beneficiaries of international protection in the EU possess either residence permits and/or special travel documents issued to such beneficiaries of international protection. Third-country nationals possessing such documents therefore do not need Schengen short-stay visas to cross the external borders of the EU. Regarding visas granted by third countries to beneficiaries of international protection holding special travel documents issued by Member States, the format of the visas issued by these third countries and rules to affix to travel documents depends on each third countries legislation and practices.”
Asylum & border control
- 2024-10-23 “E-002237/2024 Answer given by Mr Várhelyi on behalf of the European Commission 1. The Commission is not aware of similar cases, nor did it perform an assessment of this or any similar practices in terms of a level playing field in the internal market. 2. Pricing and reimbursement measures for medicines are a Member State competence, as per Article 168 (7) of the Treaty on the Functioning of the EU 1 . Financial Managed Entry Agreements (MEAs) are a common practice in Member States. This may include national agreements on the confidentiality of pharmaceutical prices. The Commission has not performed an assessment of the potential risk of market distortion due to such measures. 3. The Pharmaceutical Strategy for Europe acknowledges that fostering transparency may help Member States taking better pricing and reimbursement decisions 2 . The Commission therefore supports the development of cooperation in the group of National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers (NCAPR). The Commission is also funding, through the EU4Health Programme 3 , relevant activities aimed at improving the transparency of pharmaceutical markets. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12008E168 2 COM(2020)761 final: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020DC0761 3 https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en”
Pharma price transparency · EU competences on health
- 2024-10-23 “E-002238/2024 Answer given by Mr Brunner on behalf of the European Commission Personal data in the EU digital travel application will be protected through strong encryption methods, appropriate cybersecurity measures and consent rules. The General Data Protection Regulation 1 and the Data Protection Regulation 2 for the EU institutions, bodies, offices and agencies will apply in full for the processing of personal data, within their respective scope of application. The Commission proposal 3 for a regulation establishing an application for the electronic submission of travel data stipulates that the use of digital travel credentials will remain voluntary for travellers. Member States will allow travellers to use digital travel credentials for the purpose of crossing external borders once the application is operational, but travellers will continue to be allowed to use their physical passports. The division of competences between the EU and its Member States is laid down in the EU Treaties. The area of freedom, security and justice is an area where the EU and the Member States have a shared competence. When taking measures in relation to border controls and security, the Commission acts in full respect of the division of competences and the principles of subsidiarity and proportionality. 1 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, 4.5.2016, p. 1–88. 2 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the EU institutions, bodies, offices and agencies and on the free movement of such data. OJ L 295, 21.11.2018, p. 39–98. 3 COM(2024) 670 final.”
Privacy & law enforcement · Electronic identity
- 2024-10-23 “E-002236/2024 Answer given by Executive Vice-President Séjourné on behalf of the European Commission 1. Public procurement is decentralised and each contracting authority or entity is responsible for its own purchases. Proper application of the rules is controlled by appropriate administrative and juridical mechanisms of Member States and later by the Commission within its enforcement powers. In parallel, Member States and the Commission have a possibility of organising joint procurement 1 . During the COVID-19 pandemic, the Commission and participating countries jointly procured 2 several types of supplies, including personal protective masks 3 . The Commission managed joint procurement procedures with countries, while the latter made individual purchases under the joint contract 4 . The Commission also procured masks using EU funds under the Emergency Support Instrument and donated them to EU Member States 5 . 2. The direct budgetary consequences of irregularities in the procurement of protective face masks do not appear to significantly contribute to non-compliance with the EU fiscal rules by Member States in a situation of excessive deficit, i.e. with deficits above the 3% of gross domestic product reference value 6 . 3. One of the key elements of effective functioning of public procurement is the procurement remedies system. The newly adopted Internal Market Emergency and Resilience Act 7 , the Regulation on serious cross-border threats to health 8 , the Regulation on supply of crisisrelevant medical countermeasures 9 as well as the recast of the EU Financial Regulation 10 provide possibilities of more adequate procurement reaction to a crisis, reducing risk of disfunction or abuse. 1 Pursuant to Article 168(2) of Regulation (EU, Euratom) 2024/2509 on the financial rules applicable to the general budget of the Union (recast), OJ L 2024/2509, 26.9.2024. 2 In accordance with a voluntary Joint Procurement Agreement for medical countermeasures established pursuant to Article 5 of Decision No 1082/2013/EU that has been repealed and replaced by Article 12 of Regulation (EU) 2022/2371, OJ L 314, 6.12.2022. 3 https://commission.europa.eu/strategy-and-policy/coronavirus-response/public-health/ensuring-availabilitysupplies-and-equipment_en#public-procurement-of-medical-and-protective-equipment 4 The Joint Procurement Agreement determining the practical arrangements governing the joint procurement procedure can be found here: https://health.ec.europa.eu/health-security-and-infectious-diseases/preparednessand-response-planning_en#joint-procurement-of-medical-countermeasures-ensuring-proper-preparedness. A flowchart of its implementation can be found here: https://health.ec.europa.eu/publications/flowchartimplementation-joint-procurement-agreement-different-steering-committees_en The decision process of the Steering Committees managing the joint procurement mechanism can be found here: https://health.ec.europa.eu/publications/decision-process-steering-committees-managing-joint-procurementmechanism_en 5 https://ted.europa.eu/en/notice/-/detail/221190-2020 6 On 26 November 2024, the Commission came forward with recommendations for the Council to set the fiscal paths to correct the excessive deficits of eight Member States under an excessive deficit procedure. 7 Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98. 8 In particular Article 12 (3) d), see also: https://eur-lex.europa.eu/legalcontent/EN/TXT/HTML/?uri=CELEX:32022R2371 9 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32022R2372 10 https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32024R2509”
Public and private sectors role in healthcare services · Covid-19 vaccines procurement
- 2024-10-21 “E-002196/2024 Answer given by Executive Vice-President Séjourné on behalf of the European Commission The public procurement Directives 1 rules regulate in a comprehensive way various aspects of public procurement procedures. As they are Directives, they leave a certain degree of discretion for EU Member States on how to transpose the rules into their national laws and ensure effective implementation. Furthermore, these rules are implemented by some 250 000 public procurement buyers in the EU. These elements may generate differences in the implementation of the rules. The indicators of the Single Market Scoreboard on public procurement provide some basic but clear indications on these differences 2 . Beside addressing serious legal inconsistencies through its enforcement action and the opening of infringement procedures, the Commission discusses the implementation of EU public procurement rules with the government experts of the Member States in regular meetings throughout the year 3 . Currently, the Commission is starting an evaluation of the 2014 Directives 4 . The objective is to assess to what extent the current Directives have been effective, efficient, relevant, coherent and have provided an EU added value; the evaluation is expected to provide useful insights, including some detailed statistics on implementation per Member State. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0023; https://eurlex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014L0024; https://eur-lex.europa.eu/legalcontent/EN/TXT/HTML/?uri=CELEX:32014L0025 2 https://single-market-scoreboard.ec.europa.eu/business-framework-conditions/public-procurement_en 3 https://ec.europa.eu/transparency/expert-groups-register/screen/expertgroups/consult?lang=en&do=groupDetail.groupDetail&groupID=2679 4 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14427-Public-procurement-directivesevaluation_en”
EU Single Market harmonisation · "Buy European" provisions
- 2024-10-21 “E-002197/2024 Answer given by Mr Várhelyi on behalf of the European Commission The Commission has launched several studies to understand the possible long-term impacts on children of school closures during COVID-19. The project RESPOND 1 concluded that young people were hit hard by the pandemic measures and family functioning was disrupted by the closing of schools. PERISCOPE 2 found that children and young people were massively impacted by reduced face-to-face education and less social interaction. The project COVINFORM 3 found a negative impact on the wellbeing of vulnerable young individuals due to lack of social interaction. Moreover, two expert networks – the European Expert Network on Economics of Education and the Network of Experts working on the social dimension of education and training – produced three studies on the topic 4,5,6 . These studies found that school closures had a negative impact on children’s educational performance and exacerbated educational inequalities. The studies also identified types of policy interventions to help address learning losses. Furthermore, the Commission published analyses of the impact of COVID-19 physical school closures on student performance in Europe 7 and countries of the Organisation for Economic Co-operation and Development 8 , both demonstrating the clear association between the length of physical school closures and children’s learning losses and rising educational inequalities. Additionally, it published reports on the likely impact of COVID-19 on education 9 and on emergency remote schooling during COVID-19 10 , and has investigated possible measures to counteract the negative effects of the pandemic on student outcomes and well-being. Finally, according to Article 168 of the Treaty on the Functioning of the EU, decisions on public health measures, including school closures, are a national competency. 1 Improving the Preparedness of Health Systems to Reduce Mental Health and Psychosocial Concerns resulting from the COVID-19 Pandemic (RESPOND): https://cordis.europa.eu/project/id/101016127 2 Pan-European Response to the ImpactS of COVID-19 and future Pandemics and Epidemics (PERISCOPE): https://cordis.europa.eu/project/id/101016233 3 COronavirus Vulnerabilities and INFOrmation dynamics Research and Modelling (COVINFORM): https://cordis.europa.eu/project/id/101016247 4 https://eenee.eu/en/resources/library/policy-measures-to-monitor-and-mitigate-the-negative-impacts-of-covid19-and-covid-19-related-policy-measures-on-education/ 5 https://nesetweb.eu/en/resources/library/the-impact-of-covid-19-on-the-education-of-disadvantaged-childrenand-the-socio-economic-consequences-thereof/ 6 https://eenee.eu/en/resources/library/covid-19-learning-deficits-in-europe-analysis-and-practicalrecommendations/ 7 https://journals.sagepub.com/doi/full/10.1177/09589287221091687 8 https://publications.jrc.ec.europa.eu/repository/handle/JRC134506 9 https://publications.jrc.ec.europa.eu/repository/handle/JRC121071 10 https://publications.jrc.ec.europa.eu/repository/handle/JRC125787”
EU competences on health · EU policy on mental health
- 2024-10-16 “E-002092/2024 Answer given by Mr Reynders on behalf of the European Commission According to settled case-law of the Court of Justice of the EU, it is for each Member State, having due regard to international law, to lay down the conditions for the acquisition and loss of its nationality 1 . In situations covered by EU law, Member States’ rules in the sphere of nationality must, however, have due regard also to EU law 2 . The conditions and procedures for obtaining citizenship of the Member States are thus regulated by the national law of each Member State, subject to due respect for EU law. When exercising their prerogative to grant citizenship, it is the Member States’ responsibility to ensure that all requirements for naturalisation are actually met and that the applicable security and criminality checks have been carried out. The Commission considers that the operation of investor citizenship schemes, that is, the systematic granting of EU citizenship in return for pre-determined payments or investments without a genuine link to the naturalising Member State, is contrary to EU law on EU citizenship and the principle of sincere cooperation. The Commission has taken action against all Member States operating or having operated investor citizenship schemes. In particular, the Commission launched, in October 2020, infringement proceedings against Cyprus and Malta 3 . On 21 March 2023, the Commission referred Malta – the only Member State that continues to operate an investor citizenship scheme – to the Court of Justice regarding its investor citizenship scheme 4 . The Court case 5 against Malta is still pending before the Court of Justice. Based on the current case-law of the Court of Justice in the area of nationality, the Commission does not generally collect information on naturalisations granted by the Member States. 1 See judgments of the Court of Justice of the European Union in Cases Micheletti and Others v Delegación del Gobierno en Cantabria, C-369/90, ECLI:EU:C:1992:295; Kaur, C-192/99, ECLI:EU:C:2001:106, para. 19; Rottmann, C-135/08, ECLI:EU:C:2010:104, para. 39; Tjebbes and Others, C-221/17, ECLI:EU:C:2019:189, para. 30; V.М.А., C-490/20, ECLI:EU:C:2021:1008, para. 38; Wiener Landesregierung, C-118/20, ECLI:EU:C:2022:34, para. 37. 2 C-135/08, Rottmann, para. 41 and 45; C-221/17, Tjebbes and Others, para. 32; V.М.А., C-490/20, ECLI:EU:C:2021:1008, para. 38; C-118/20, Wiener Landesregierung, para. 37. 3 https://ec.europa.eu/commission/presscorner/detail/en/ip_20_1925 4 https://ec.europa.eu/commission/presscorner/detail/pt/ip_22_5422; Case C-181/23, Commission v Malta. 5 Case C-181/23 https://curia.europa.eu/juris/liste.jsf?language=en&jur=C%2CT%2CF&num=C181/23&parties=&dates=error&docnodecision=docnodecision&allcommjo=allcommjo&affint=affint&affclo se=affclose&alldocrec=alldocrec&docdecision=docdecision&docor=docor&docav=docav&docsom=docsom &docinf=docinf&alldocnorec=alldocnorec&docnoor=docnoor&docppoag=docppoag&radtypeord=on&newf orm=newform&docj=docj&docop=docop&docnoj=docnoj&typeord=ALL&domaine=&mots=&resmax=100 &Submit=Rechercher”
Anti-money laundering regulation · Legal migration
- 2024-10-16 “P-002093/2024 Answer given by Executive Vice-President Vestager on behalf of the European Commission Based on the limited information available to the Commission on the topic of alleged barriers to entry to Formula 1 for new teams, the Commission cannot assess whether such barriers to entry are the result of anticompetitive conduct in breach of Article 101 and/or Article 102 of the Treaty on the Functioning of the EU. As such, the Commission is currently not considering any measures, nor is it planning to investigate the impact of the alleged barriers on innovation, jobs and the competitiveness of the motor sport and automotive sector in the EU. However, the Commission stands ready to review any evidence of anticompetitive conduct that interested parties may bring to its attention.”
EU Competition policy
- 2024-10-14 “E-002057/2024 Answer given by Executive Vice-President Vestager on behalf of the European Commission 1. The Digital Services Act 1 (DSA) sets out clear criteria to qualify for the status of ‘trusted flagger’ under Article 22, which includes independence from online platforms. Furthermore, the provisions of this article ensure the objectivity and accountability of trusted flaggers to safeguard freedom of expression. 2. The status of trusted flagger is awarded by national Digital Services Coordinators (DSCs), provided that the applicant meets all conditions of Article 22. Article 50 of the DSA requires complete independence for national DSCs, including from governments and political parties. 3. The reliance on public funding by trusted flaggers can be compatible with the DSA, as long as this does not compromise their independence from online platforms and their diligence, objectivity and accuracy in sending notices. The Commission will continue to assess the implementation of the DSA and ensure its impartiality and effectiveness. 1 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services and amending Directive 2000/31/EC (Digital Services Act) (Text with EEA relevance). PE/30/2022/REV/1. OJ L 277, 27.10.2022, p. 1–102.”
Disinformation & online freedoms
- 2024-10-14 “E-002056/2024 Answer given by Mr McGrath on behalf of the European Commission Protecting and promoting the EU values and the fundamental rights enshrined in Article 2 of the Treaty on European Union and in the Charter of Fundamental Rights of the European Union, including democracy and the right to freedom of expression, is a priority for the Commission and a shared responsibility at national and European level. The Commission monitors the general situation of democracy in Austria and Germany, as in all other Member States. The composition of government coalitions and corresponding appointment processes fall primarily within the scope of national constitutional frameworks. It is for the competent national authorities to ensure compliance with applicable law and possible relevant international standards.”
Rule of law and democracy in the EU (political compass)
- 2024-10-09 “E-002005/2024 Answer given by Mr Várhelyi on behalf of the European Commission During the pandemic, the European Centre for Disease Prevention and Control (ECDC) monitored the national COVID-19 vaccination campaigns and made data regarding vaccination rates, efficacy, effectiveness, and safety of COVID-19 vaccines available. ECDC published two reports on the impact of COVID-19 vaccines on hospitalisations and deaths 1 . As part of the support provided during the response to the COVID-19 pandemic, the Commission developed a European Strategy for COVID-19 vaccines 2 . However, the definition of health policies including for vaccination, has been and still is responsibility of the Member States, and public health measures such as the introduction of vaccination programmes are taken at the national level. In this respect, the Commission supports Member States to achieve or maintain high vaccination coverage rates for public health reasons, not only for COVID-19, but for all infectious diseases for which a vaccine is available. The Commission facilitates information sharing among Member States via the Health Security Committee (HSC) that met frequently during the COVID-19 pandemic 3 , and continues to meet regularly. The HSC issued an opinion with guidance for the Member States regarding respiratory diseases and related vaccination last year 4 . While the HSC can issue opinions and has a coordinating role, the Member States remain free to define their national vaccination policies. 1 https://www.ecdc.europa.eu/en/publications-data/interim-analysis-covid-19-vaccine-effectiveness-againsthospitalisation-due-covid 2 https://commission.europa.eu/strategy-and-policy/coronavirus-response/public-health/eu-vaccines-strategy_fr 3 https://health.ec.europa.eu/health-security-and-infectious-diseases/crisis-management/list-authoritiesrepresented-health-security-committee/health-security-committee-reports_en 4 https://health.ec.europa.eu/publications/opinion-health-security-committee-preparing-winter-20232024address-respiratory-infections-caused_en”
Vaccination · Covid-19 vaccines procurement
- 2024-10-09 “E-002004/2024 Answer given by Mr McGrath on behalf of the European Commission Pursuant to Directive 2004/38/EC 1 , pensioners of one Member State have a right to reside in another Member State for longer than three months if they have sufficient resources and have comprehensive sickness insurance cover. Member States may expel persons who no longer satisfy the requirements for exercising a right of residence 2 . The Commission is not aware that Spain would discriminate German pensioners. As regards tourists, the Commission is unaware that the protests target German nationals. In line with the Transition Pathway for Tourism 3 and the Agenda for Tourism 2030 4 , the Commission supports sustainable tourism that is inclusive, accessible to all and that benefits both residents and visitors. Member States have committed to implement socially sustainable tourism 5 . The European Regional Development Fund supports the diversification of the tourist offer in the Balearic Islands. Under the shared management principle, project selection and implementation fall under the remit of the regional authorities. The Commission channels EU funding to the authorities responsible for reimbursing expenditure incurred by beneficiaries. The Commission also pays a pre-financing scheme which ensures that the responsible authorities have the means to provide support to beneficiaries from the start of the implementation of the programme. In addition to overseeing the implementation of Directive 2004/38/EC, in its role of the guardian of the treaties, the Commission issued guidance 6 covering the notion of ‘sufficient resources’ and the right on equal treatment. 1 Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the EU and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC, OJ L 158, 30.4.2004, p. 77 http://data.europa.eu/eli/dir/2004/38/oj 2 C-94/18, Chenchooliah, ECLI:EU:C:2019:693, and C-719/19, Staatssecretaris van Justitie en Veiligheid, ECLI:EU:C:2021:506. 3 https://op.europa.eu/en/publication-detail/-/publication/404a8144-8892-11ec-8c40-01aa75ed71a1 4 https://www.consilium.europa.eu/en/press/press-releases/2022/12/01/new-european-agenda-for-tourism/ 5 https://transition-pathways.europa.eu/policy/palma-declaration-eus-journey-community-sustainability-tourism 6 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202301392”
EU policy on integration and ethnic, racial and religious discrimination · EU political integration (free access)
- 2024-07-24 “E-001412/2024 Answer given by Executive Vice-President Vestager on behalf of the European Commission 1. The Commission rejects Microsoft’s accusation. Microsoft’s comments appear to relate to a unilateral public undertaking it made in July 2009 about interoperability with certain products, including Windows. While the Commission welcomed the initiative at the time, the unilateral undertaking in question was informal vis-à-vis the Commission. More importantly, the Commission stresses that Microsoft remains free to decide on its business model and to adapt its security infrastructure to respond to threats, provided this is done in line with EU competition and cybersecurity law. 2. The Commission is committed to doing its part to ensure that all EU citizens and businesses are well protected against cybersecurity risks. The NIS2 Directive 1 now being transposed by Member States, raises the level of ambition on cybersecurity in a future-proof way, through a wider scope, clearer rules and stronger supervision tools. Furthermore, the upcoming Cyber Resilience Act 2 will further strengthen supply chain security by introducing cybersecurity requirements for all hardware and software made available in the EU. Additionally, the Commission continues to be engaged in mapping dependencies that can pose cybersecurity risks. 3. The Commission considers that competition law does not impede on IT security. In the application of competition law, the Commission seeks to ensure that companies compete on equal terms across Member States, while at the same time incentivising them to offer the best products at the lowest price. When justified, the Commission takes into account in its assessment objective justifications put forward by companies (which can include IT security issues), following the principles developed in the case-law of the Union courts. 1 Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive). 2 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on horizontal cybersecurity requirements for products with digital elements and amending Regulation (EU) 2019/1020.”
EU rules on digital competition
- 2024-07-23 “E-001406/2024 Reply It is not for the Council to comment on positions expressed by the Commission.”
Rule of law in Hungary · EU political integration (free access)
- 2024-07-18 “E-001379/2024 Answer given by Mr Reynders on behalf of the European Commission Safeguarding democratic values is a key priority for the Commission. In this regard, the Commission has taken many measures to promote free and fair elections, including putting forward a Recommendation on inclusive and resilient elections 1 . The Recommendation recognises that the use of surveillance can under certain conditions be a matter of national security and states that national security should be interpreted in compliance with the case law of the Court of Justice of the European Union to preserve the effective application of the EU law. The Charter of Fundamental Rights of the European Union applies to Member States only when they are implementing EU law, in line with its Article 51(1). Based on the information available, the situation described by the Honourable Member does not appear to fall within the scope of application of EU law. In such cases, it is for Member States, including their judicial authorities, to ensure that fundamental rights are effectively respected and protected, in accordance with their national legislation and international human rights obligations. The European Commission promotes and protects the rule of law and carefully monitors the situation in all Member States, including Germany. This is reflected in the recently adopted 2024 Rule of Law Report, including the country chapter on Germany 2 . 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023H2829 2 https://commission.europa.eu/publications/2024-rule-law-report-communication-and-country-chapters_en.”
Rule of law and democracy in the EU (political compass) · Surveillance equipment & spyware
- 2024-07-18 “E-001377/2024 Answer given by President von der Leyen on behalf of the European Commission The Commission strives to bring the EU closer to its citizens by informing and engaging them on the role of the EU and EU policies and initiatives, or how EU citizens can make the best of their rights in the EU. To achieve this, it uses a wide range of communication tools. These include public communication campaigns and advertising. As part of specific communication actions, the Commission also engages with content creators by providing them with information on EU topics and organising study visits to the EU institutions. The Commission’s communication actions involving advertising or work with social media influencers are carried out in full transparency and respect the editorial independence of the media. When running advertising campaigns, the Commission adheres to applicable national legislation and uses the transparency tools provided by each media and social media platforms, such as transparency labels and notices. As regards political advertising, Regulation (EU) 2024/900 on the transparency and targeting of political advertising 1 sets, among others, new rules on labelling and transparency notices, including to provide information about the sponsor of the political advertising, the amounts spent and their sources, which will enter fully into application from October 2025. The Commission provides financing in the limit of the authorised appropriations for this purpose in accordance with the rules under the Financial Regulation 2 . In the period 20212023, the Commission had an annual budget of EUR 30 million used to finance EU-wide corporate communication campaigns, including advertising in media outlets. Recipients of EU funds of EUR 15 000 and above are listed in the Financial Transparency System 3 . 1 https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32024R0900 2 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32018R1046 3 https://ec.europa.eu/budget/financial-transparency-system/index.html”
Transparency requirements of EU institutions · EU public communication strategy
- 2024-07-18 “PE763.373v02-00 EN P-001378/2024 Answer given by Ms Johansson on behalf of the European Commission 1. Any items and measures funded by the EU must comply with the EU acquis and ensure the respect of human rights in line with the EU Charter of Fundamental Rights 1 and international obligations. The Commission considers that EU funds are best used to support an integrated approach to border management, in line with EU law and European values, to ensure that irregular border crossings are detected and migration and asylum are properly managed. 2. Accordingly, the Commission has been actively supporting efficient border management solutions, such as border surveillance, in compliance with EU law, including on fundamental rights. Concretely the Instrument for Financial Support for Border Management and Visa Policy (BMVI), established in the programming period 2021-2027 2 , finances mobile and stationary units, border surveillance systems and equipment, refurbishment of border crossing points, new installations for IT systems, and the maintenance of equipment. As regards their effectiveness, the Commission is carrying out a mid-term evaluation of the BMVI to examine its effectiveness, efficiency, relevance, coherence and EU added value. The results of this evaluation will be made publicly available. 3. The Political Guidelines of the President-elect for the next Commission 2024-2029 3 , presented to the European Parliament on 18 July 2024, set out the envisaged actions for stronger common borders and the management of migration. 1 https://commission.europa.eu/aid-development-cooperation-fundamental-rights/your-rights-eu/eu-charterfundamental-rights_en 2 https://home-affairs.ec.europa.eu/funding/borders-and-visa-funds/integrated-border-management-fund-bordermanagement-and-visa-instrument-202127_en#:~:text=IBMF%20is%20set%20up%20for,billion%20for%20the%20same%20period. 3 https://commission.europa.eu/document/download/e6cd4328-673c-4e7a-8683f63ffb2cf648_en?filename=Political%20Guidelines%202024-2029_EN.pdf”
Asylum & border control
- 2024-07-16 “E-001366/2024 Answer given by Mr Reynders on behalf of the European Commission The Commission condemns any type of violence aimed at disrupting the free and fair political participation. The Commission proposed a ‘whole-of-society’ approach in supporting the democratic process. In the Recommendation on inclusive and resilient elections adopted as part of the 2023 Defence of Democracy package 1 , the Commission encouraged political parties, among others, to adopt codes of conduct on election integrity and fair campaigning. Ahead of the 2024 European elections, all European political parties signed a code of conduct in which they committed to inclusive political discourse and to an ethical and transparent use of campaign tools, among other things. Following several attacks on politicians, the Commission triggered a targeted discussion on 31 May 2024 within the European Cooperation Network on Elections on safety in politics and supporting measures. This Network remains a solid framework for further exchanges of best practices and mutual learning. The Commission will review the follow-up being given to the 2023 Recommendation by Member States in the context of the Commission’s Report on the 2024 European elections 2 . The Political Guidelines for the next Commission cement democracy at the heart of the EU and highlight that strengthening this further will be the Commission’s daily work and duty. This will include work to better protect the safety of political candidates and elected representatives who face mounting threats to their security and undue pressure. 1 Commission Recommendation (EU) 2023/2829 of 12 December 2023 on inclusive and resilient electoral processes in the Union and enhancing the European nature and efficient conduct of the elections to the European Parliament, C/2023/8626, OJ L, 2023/2829, 20.12.2023. 2 Point 46 of Recommendation 2023/2829 on inclusive and resilient electoral processes in the Union and enhancing the European nature and efficient conduct of the elections to the European Parliament indicates that the Commission will assess the impact of such Recommendation in the context of its report on the 2024 elections to the European Parliament, taking into account the information transmitted by Member States on the conduct of those elections in their territory.”
EU law enforcement cooperation in criminal matters
- 2024-07-16 “E-001365/2024 Answer given by Vice-President Jourová on behalf of the European Commission The Commission is committed to safeguarding pluralistic and independent media, essential for democracy and the rule of law, and to the functioning of the internal market for media. As part of its annual Rule of Law Report, the Commission assesses the situation regarding media freedom and pluralism in the Member States 1 . The chapter on Germany describes the wellestablished federal legal framework guaranteeing media freedom and pluralism, based on multiple levels of safeguards and oversight 2 . The European Media Freedom Act (EMFA) 3 provides a reinforced framework for media service providers. Article 4(1) EMFA, which will apply as of 8 February 2025, provides that media service providers shall have the right to exercise their economic activities in the internal market without restrictions other than those allowed pursuant to EU law. Recital 16 clarifies that such restrictions may derive from measures applied by national public authorities in compliance with EU law. The Commission understands that the German Federal Minister for the Interior on 16 July 2024 took action against the publishers of the magazine ‘Compact’ on the basis of German law that allows for the prohibition of associations ‘directed against the constitutional order’. Articles 62, 52(2) of the Treaty on the Functioning of the European Union allow the freedom to provide services to be restricted on grounds of public policy, public security or public health. The Commission does not assess individual cases in the Member States. The Commission will continue to closely monitor the state of media freedom in all Member States in its annual Rule of Law Report 4 . 1 COM(2024) 800 final: https://commission.europa.eu/document/download/27db4143-58b4-4b61-a021a215940e19d0_en?filename=1_1_58120_communication_rol_en.pdf 2 SWD(2024) 805 final: https://commission.europa.eu/document/download/3d1a2f80-5989-4364-a9e6d925d4a1c900_en?filename=16_1_58059_coun_chap_germany_en.pdf 3 Regulation (EU) 2024/1083 of the European Parliament and of the Council of 11 April 2024 establishing a common framework for media services in the internal market and amending Directive 2010/13/EU (European Media Freedom Act). 4 https://commission.europa.eu/strategy-and-policy/policies/justice-and-fundamental-rights/upholding-rulelaw/rule-law/annual-rule-law-cycle_en”
EU Supervision of the Rule of Law · Disinformation & online freedoms
- 2024-07-16 “E-001364/2024 Answer given by Ms Kyriakides on behalf of the European Commission The European Medicines Agency (EMA) and the Member States continuously monitor reports of suspected side effects of medicinal products, including COVID-19 vaccines, to detect any safety issues. Suspected side effects, which are reported by a vaccinated person or by healthcare professionals, are collected in the EudraVigilance database 1 . Information about possible side effects is included in the vaccine’s publicly available product information. This information includes the likelihood of the side effect occurring and how to reduce the possible risk. Quick regulatory action, such as suspension or revocation of the marketing authorisation or prohibition of the supply of the medicinal product, can also be taken as appropriate. Under EU law, in case of demonstrated breach by marketing authorisation holders of their regulatory obligations, which include an obligation to supply new information that may influence the evaluation of the risks and benefits balance of the products, the Commission may take certain actions and/or impose financial penalties according to the legislation 2 . 1 https://www.adrreports.eu/ 2 Article 84a of Regulation (EC) 726/2004, OJ L 136, 30.4.2004, p. 1.”
Pharmaceuticals regulation in EU · Vaccination
- “Thank you. Well, before we rush to a plane platforms we should not forget online platforms have done more for free speech than many governments ever dared. For centuries, publishing power was held by only a few monarchs, kings, churches, state broadcasters. Today, thanks to the digital revolution, anyone with a phone has what Gutenberg gave the world a press of their own. Online platforms are the 21st century's printing press. They have amplified voices from every corner of society, from the world, from whistleblowers to exiles, dissidents to working class critics. Yes, there is chaos and misinformation. But as John Milton already said in the 17th century, give me liberty to know, to utter, and to argue freely, according to conscience, above all liberties. Online platforms have democratized the liberty, the liberty of free speech. They've given voice to the voiceless. They exposed corruption connected dissidents across the border. Yes, there is also some noise and some nonsense. But free societies are built on the ability to sift through those, through that nonsense and the noise and not to silence it. So my question to the panelists. Shouldn't the responsibility for sustaining democracy rest first with informed, engaged citizens and not with tech executives or EU regulators? And if we continue outsourcing that responsibility, are we not at risk of hollowing out the very civic resilience that democracy depends on? And finally, Mr. Kelly, you mentioned in your presentation. Of course, we cannot have a ministry of truth, and I might have heard some regret, as you said, that. But nevertheless, you said it at least. But isn't what we are discussing here exactly that the establishment of a ministry of truth? Thank you.”
Disinformation & online freedoms