Friedrich PÜRNER

Policy topics Friedrich PÜRNER is active on

What Friedrich PÜRNER has said (24)

• 2026-03-23 “Answer given by Mr Várhelyi on behalf of the European Commission 7.5.2026 Written question The Commission, in collaboration with the European Medicines Agency and its Medicines Shortages Steering Group, is closely monitoring the situation and potential impact of the conflict in the Middle East on the supply of medical products. As of mid-April, the situation appears to be stable, with minimal disruption to transport of medicines and no impact on manufacturing capacity. European air cargo companies, including commercial carriers, have indicated to have the capacity to support additional or rerouted medical supplies, if necessary. The Commission does not hold current data on price developments in the Member States, since the pricing of medicines is a national competence. However, the Commission is funding the European Integrated Price Information Database (EURIPID) [1] , on which Member States periodically share information on medicine list prices and sales volumes. Stockpiling of medical products at EU level is being initiated through rescEU which represents a critical component of the EU’s strategy to bolster collective preparedness for health emergencies and chemical, biological, radiological, and nuclear (CBRN) threats. rescEU encompasses medical and CBRN stockpiles hosted across 16 Member States with a total investment exceeding EUR 1.6 billion [2] . Fully integrated into the Union Civil Protection Mechanism (UCPM), these stockpiles are designed for rapid deployment, underscoring the EU’s commitment to swift, coordinated crisis response. Under the proposed Critical Medicines Act [3] , Member States would also have access to different collaborative procurement tools to increase the availability of critical medicines and other medicines of common interest. [1] The legal framework for the European Integrated Price Information Database consists of the framework partnership Agreement, the General Terms and Conditions to the framework Partnership Agreement of EURIPID Collaboration (GTC) and the Terms and Conditions of Use of the EURIPID Website (TCU). https://euripid.eu/. [2] https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32019D0570&qid=1730378629745. [3] COM(2025) 102 final.”
  Supply chain diversification requirements in medicine procurement · Joint EU procurement of medicines · Government stockpiling of critical medicines
• 2026-03-04 “Answer given by Mr Dombrovskis on behalf of the European Commission 21.5.2026 Written question The ‘One Europe, One Market’ roadmap was announced following the informal EU Leaders’ retreat of 12 February 2026 and further referred to in the Commission President’s letter to Leaders ahead of the March 2026 European Council and in the European Council Conclusions of 19 March 2026. The aim is for the European Parliament, the Council and the Commission to deliver swiftly on key initiatives for the Single Market with clear timelines for delivery by the end of 2027. The roadmap will establish measurable targets and provide a framework to ensure that strategic priorities are implemented and commitments delivered. The Commission remains committed to its better regulation high standards and to working in a transparent, inclusive and evidence-based manner. All Commission initiatives follow better regulation principles and guidelines, which include the built-in flexibility to account for urgencies and prepare legislation in a short time frame, if necessary. Further to adoption by the Commission, the proposals follow the interinstitutional negotiation process, in full respect of prerogatives and responsibilities of the co-legislators as foreseen by the Treaties.”
  EU political integration · EU engagement with citizens
• 2026-02-05 “E-000460/2026 Answer given by Mr Šefčovič on behalf of the European Commission The Commission concluded negotiations with India on a Free Trade Agreement (FTA) on 27 January 2026 1 . This agreement will strengthen the EU's trade relations with a key partner and is expected to be beneficial for the EU medical sector. The Commission does not expect the agreement to have a negative impact on EU production of medicines. Currently, the EU does not generally levy duties on imported medicines and thus the FTA will not further liberalise imports. Additionally, the agreement will uphold EU’s high standards on medicines. The Commission commissioned an independent Sustainability Impact Assessment (SIA) in support of the negotiations, which was published in December 2023. 2 This SIA concluded that the overall potential impact of the agreement would be minor on the right to health, also considering access to medicines. It also anticipated a slight decrease of production of medicines in the EU by assuming a reduction of the non-tariff measures applicable to bilateral trade in medicines, but such reduction did not materialise in the agreement. There is no contradiction between the objectives of the proposed Critical Medicines Act (CMA) 3 and the EU-India agreement. The CMA aims to strengthen the EU’s security of supply of critical medicines, which are essential for the functioning of public health systems. It will help to address vulnerabilities in the supply chains of these medicines, including by supporting investments into EU manufacturing capacities and procurement requirements that promote the security of supply in the Union. The CMA also proposes to form international partnerships to facilitate the diversification of the supply chains. 1 https://ec.europa.eu/commission/presscorner/detail/en/ip_26_184. 2 https://policy.trade.ec.europa.eu/analysis-and-assessment/sustainability-impact-assessments_en. 3 https://health.ec.europa.eu/medicinal-products/critical-medicines-act_en.”
  Pharmaceutical imports & exports rules · Free trade agreements (FTAs)
• 2026-01-26 “E-000291/2026 Answer given by Ms Kos on behalf of the European Commission The Commission has been working with Ukraine and the US with input from the World Bank, on a single unified long-term prosperity framework, representing the collective vision of Ukraine, the US and the EU for Ukraine's post-war future based on a reform agenda embedded in the country’s EU accession path. The plan, which depends entirely on solid and robust security guarantees for Ukraine, was discussed with EU leaders at the informal European Council on 22 January 2026 1 . The Ukraine Investment Framework (under the Ukraine Facility 2 ) and the European Flagship Fund for the Reconstruction of Ukraine 3 are regarded as key channels for deploying investment support, complementing the EU’s ongoing budgetary assistance through the Ukraine plan. Together with reforms aimed at improving the business climate, these instruments are designed to mobilise private investment at scale. The Commission fully supports Ukraine’s accession path, recognising its resilience and commitment. Ukraine has set ambitious target dates for EU accession, and the Commission has made clear that the achievement of these objectives hinges on a sustained and accelerated reform effort, particularly on the fundamentals and the rule of law. Article 49 of the Treaty on European Union (TEU) is the legal basis for the accession of any new member state to the EU. It provides that any European country respecting the EU’s values enshrined in Article 2 TEU can apply for EU membership, and that the conditions of eligibility set by the European Council shall be taken into account. It further provides that the conditions of admission and the adjustments to the EU treaties which such admission entails shall be the subject of an agreement between the Member States and the applicant state. 1 https://ec.europa.eu/commission/presscorner/detail/en/ac_26_199. 2 Regulation (EU) 2024/792 of the European Parliament and of the Council of 29 February 2024 establishing the Ukraine Facility: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202400792 and https://enlargement.ec.europa.eu/funding-technical-assistance/ukraine-facility_en. 3 https://enlargement.ec.europa.eu/document/download/f39df847-82e7-4c21-8b8a339e71a98d7b_en?filename=European_Fund_Ukraine.pdf.”
  EU enlargement · EU-Ukraine relations
• 2026-01-05 “P-000015/2026 Reply On 18 December 2025, the European Council agreed to provide a loan to Ukraine of EUR 90 billion for the years 2026-2027 based on EU borrowing on the capital markets backed by the EU budget headroom. By means of enhanced cooperation (Article 20 TEU) in respect of the instrument based on Article 212 TFEU, any mobilisation of resources from the Union’s budget as a guarantee for this loan will not have an impact on the financial obligations of Czechia, Hungary or Slovakia. The text, supported by 25 Heads of State or Government, mentions that: ‘This loan would be repaid by Ukraine only once reparations are received. Until then, these assets will remain immobilised and the Union reserves its right to make use of them to repay the loan, in full accordance with EU and international law’. On 14 January 2026, following the European Council’s agreement, the Commission put forward a proposal for a EUR 90 billion limited recourse loan to Ukraine for 2026 and 2027 (‘the Commission proposal’). The proposed support would be structured in two components, with an indicative distribution of approximately two thirds (amounting to EUR 60 billion) dedicated to supporting Ukraine’s defence industrial capacities, and the remaining one third (corresponding to EUR 30 billion) provided for macro-financial assistance or for budget assistance to be implemented under the Ukraine Facility. The support will help Ukraine strengthen its defence capabilities and ensure the continued functioning of the state and basic public services, while also contributing to Ukraine’s resilience and its closer integration with Europe’s defence industrial base. According to recital 33 of the Commission proposal: ‘The implementation of the assistance to support Ukraine’s defence industrial capacities should be carried out in line with the principles of sound financial management ensuring the protection of the financial interests of the Union as set out in Article 223(4) of Regulation (EU, Euratom) 2024/2509 of the European Parliament and the Council. Detailed requirements in this respect might be entered into an arrangement to be signed between the Commission and Ukraine. Furthermore, for the management of the financial and economic assistance received to support Ukraine’s defence industrial capacities, Ukraine should open a single account via which to manage the assistance, where the Commission should be able to monitor that account’.”
  EU-Ukraine relations · Russia-Ukraine conflict (10th term)
• 2025-10-02 “E-003842/2025 Answer given by President von der Leyen on behalf of the European Commission Since the reply given to the previous question made by the Honourable Member on the same issue, no new elements have been brought to the Commission’s attention. Therefore, the Commission has to reiterate that, at this stage, the amount of the legal costs connected to case T-36/23 have not been liquidated and it is not yet possible to quantify them.”
  Accounting and auditing of EU budget
• 2025-09-25 “E-003738/2025 Answer given by Mr Šefčovič on behalf of the European Commission In accordance with Article 5(1) of the Detailed Rules for the application of Regulation (EC) No 1049/2001, annexed to the Rules of Procedure of the Commission 1 (hereinafter, the ‘Detailed Rules’), ‘any content that constitutes important information that is not short-lived shall be registered pursuant to Article 7 of Commission Decision 2021/2121 2 ’. Article 5(2) of the Detailed Rules gives illustrative examples of how to apply the registration criteria of important and not-short lived documents. The Detailed rules also clarify that text messaging applications on corporate mobile phones shall not be used for important information that is not short-lived, unless where this is strictly required in the interest of the service and that they shall comply with the Commission’s information technology security recommendations for the automatic disappearance of messages (Article 5 paragraph 4). It is the professional duty of all Commission staff to make sure that these rules are properly followed and implemented. The Commission has a robust record-keeping policy as laid down in Commission Decision (EU) 2021/2121 on records management 3 , and in its internal guidelines, which provide for criteria for registration of documents, together with the above-mentioned provisions in the Detailed Rules. According to Article 3(a) of Regulation (EC) No 1049/2001, a ‘document’ shall mean any content whatever its medium (written on paper or stored in electronic form or as a sound, visual or audiovisual recording) concerning a matter relating to the policies, activities and decisions falling within the institution's sphere of responsibility’. Both Commission Decision (EU) 2021/2021 on records management and the Detailed rules are applicable regardless the technical medium or storage of a document. On top of this, the Commission central expert services are available for support, tailor-made training and coaching when needed. 1 Commission Decision (EU) 2024/3080 of 4 December 2024 establishing the Rules of Procedure of the Commission and amending Decision C(2000) 3614 (OJ L, 2024/3080, 5.12.2024, ELI: http://data.europa.eu/eli/dec/2024/3080/oj). 2 Commission Decision (EU) 2021/2121 of 6 July 2020 on records management and archives (J L 430, 2.12.2021, p. 30–41). 3 https://eur-lex.europa.eu/eli/dec/2021/2121/oj/eng.”
  Transparency requirements of EU institutions
• 2025-09-12 “E-003525/2025 Answer given by President von der Leyen on behalf of the European Commission The Commission invited a group of 25 content creators from across the EU to attend the delivery of the 2025 State of the Union Address. They joined a group of other content creators invited by the European Parliament. The selection of the participants tried to ensure a diversity of nationalities, profiles, and topics of interest. The group represented a wide geographical spread, ranging from Portugal to Sweden, from France to Latvia, from Luxembourg to Bulgaria. It also brought together creators focusing on different thematic areas, including youth opportunities, geopolitics, and democracy. The content creators were invited as visitors, with no requirement to produce or share content. They had full editorial freedom. The Commission covered their travel expenses to and from Strasbourg, as well as accommodation costs, in accordance with standard reimbursement rates. The objective of the Commission’s engagement with content creators is to reach out to citizens from all walks of life and communicate openly and transparently.”
  Accounting and auditing of EU budget · Budget for EU politicians
• 2025-09-05 “P-003450/2025 Answer given by Mr Serafin on behalf of the European Commission 1. The information concerning the reimbursed missions undertaken by the President of the Commission is publicly available 1 . The cost for this mission will also be made public once the billing process has been concluded. 2. On average thirteen passengers travelled on each flight. 3. In line with the data protection requirements laid down in Regulation (EU) 2018/1725 2 , the Commission cannot share the requested personal data in the present case. 1 https://ec.europa.eu/transparencyinitiative/meetings/mission.do?host=a2c7c963-a9ad-4c47-aa734bb46b06dd5d&missionsperiod=2025_4. 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, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC, OJ L 295, 21.11.2018, p. 39-98: https://eur-lex.europa.eu/eli/reg/2018/1725/oj/eng.”
  Budget for EU politicians · Accounting and auditing of EU budget
• 2025-09-03 “E-003375/2025 Answer given by Ms Roswall on behalf of the European Commission The Commission has indicated in its reply to the written question P-002320/2025 that operating grants comply fully with the EU programme for the environment and climate action (LIFE) Regulation 1 adopted by the co-legislators and that their management is fully in line with the EU Financial Regulation 2 . Furthermore, the findings and audits carried out in the context of the European Court of Auditors special report 11/2025 3 , while identifying transparency issues, did not indicate or report any compliance issues of the non-governmental organisation (NGO) grants audited. As indicated in the reply to the written questions E-002487/2025 and E-002488/2025, the NGOs supported by the LIFE programme have full independence in deciding the content and implementation of their work programme. The Commission has also confirmed in this reply that it has not had any exchange of information with ClientEarth regarding legal actions undertaken by the NGO against coal-burning plants in the period 2022-2023. Subsequently, there is no ground for any legal or administrative action against the aforementioned NGO or other NGOs that receive LIFE operating grants, or Commission officials engaged in the management of these grants. 1 Regulation (EU) 2021/783 of the European Parliament and of the Council of 29 April 2021 establishing a Programme for the Environment and Climate Action (LIFE), and repealing Regulation (EU) No 1293/2013, OJ L 172, 17.05.2021, p.53. 2 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (recast), OJ L, 2024/2509, 26.9.2024. 3 Special report 11/2025: Transparency of EU funding granted to NGOs - European Court of Auditors, https://www.eca.europa.eu/en/publications/sr-2025-11; and https://www.eca.europa.eu/Lists/ECAReplies/COMReplies-SR-2025-11/COM-Replies-SR-2025-11_EN.pdf.”
  Regulation of NGOs in Europe · Accounting and auditing of EU budget
• 2025-08-11 “E-003222/2025 Answer given by Mr Šefčovič on behalf of the European Commission 1. As set out in the Commission decision C(2025) 5429 of 28 July 2025, which is publicly available on the Electronic Access to Commission Documents Portal, the sole aim of these text messages was to ensure the respective availability of the President of the Commission and of the Chief Executive Officer of Pfizer for subsequent calls in the context of the ongoing global pandemic. Since the content of these text messages was short-lived and did not require any follow-up by the Commission and its services, the text messages did not fulfil the registration criteria set out in Article 7(1) of the Commission Decision (EU) 2021/2121 1 . As a consequence, these text messages were not registered in the records management system of the Commission. Please note that the General Court in the recent judgement (T-36/23) 2 did not put into question these conditions for the registration of documents by the Commission. 2. Having said so, the Commission adopted in December 2024 updated rules for the application of Regulation (EC) No 1049/2001 3 clarifying that text messaging applications on corporate mobile phones shall only be used for information that is short-lived, unless where this is strictly required in the interest of the service. In any case, the registration criteria set out in Article 7(1) of the Commission Decision (EU) 2021/2121 apply. 3. The Commission stands for the highest standards of transparency across its activities and decision-making processes. The Commission staff consistently apply the rules on records management and archives (Decision (EU) 2021/2121) and the institution’s information technology security recommendations for the acceptable use of public instant messaging applications and any other corporate communication tool. 1 https://eur-lex.europa.eu/eli/dec/2021/2121/oj/eng. 2 Judgement 14 May 2025, Stevi and The New York Times v Commission T-36/23, ECLI:EU:T:2025:483. 3 Commission Decision (EU) 2024/3080 of 4 December 2024 establishing the Rules of Procedure of the Commission and amending Decision C(2000) 3614 (OJ L, 2024/3080, 5.12.2024, ELI: http://data.europa.eu/eli/dec/2024/3080/oj).”
  Transparency requirements of EU institutions · Covid-19 vaccines procurement
• 2025-08-05 “P-003182/2025 Answer given by Mr Šefčovič on behalf of the European Commission In its judgment of 14 May 2025 in case T-36/23 1 concerning an access to documents request, the General Court found that the Commission should have provided a more detailed explanation in its decision that it does not hold documents of the requested type. In order to implement the judgment, on 28 July 2025, the Commission has adopted a new confirmatory decision C(2025)5429, providing a more detailed explanation. The Commission would like to refer the Honourable Member to this decision publicly available on the Electronic Access to Commission Documents Portal 2 . 1 Judgment of 14 May 2025, Stevi and The New York Times v Commission, T-36/23, ECLI:EU:T:2025:483. 2 https://ec.europa.eu/transparency/documents-request/search/document-details/16708.”
  Covid-19 vaccines procurement · Transparency requirements of EU institutions
• 2025-07-30 “P-003152/2025 Answer given by Mr Šefčovič on behalf of the European Commission On 27 July 2025, the President of the Commission and the President of the United States (US) reached a political agreement on tariffs and trade. The Commission has kept informed and engaged with both the Council and European Parliament throughout the previous months leading up to this leaders’ meeting. The subsequently issued Joint Statement on an EU-US framework on an agreement on reciprocal, fair and balanced trade 1 of 21 July 2025, confirmed the outcomes of the leader’s meeting. The Joint Statement is a political commitment that outlines the key parameters for the relations between the EU and the US going forward. It is a first step in a process that will restore stability in the transatlantic relations and avoid lose-lose tariff escalation. The Commission has initiated the process to implement the Joint Statement by introducing two legislative proposals 2 under Article 207 of the Treaty on Functioning of the EU implementing the tariff commitments made under Section 1 of the Joint Statement. These proposals are now in the hands of the co-legislators and are subject to an ordinary legislative procedure. The Joint Statement is a first step in a process to continue to improve market access and increase the EU-US trade and investment relationship. It serves as a roadmap for continued negotiations and collaboration between the EU and the US, which will be conducted in line with the applicable procedures, involving the Council and the European Parliament as foreseen by the treaties. 1 https://policy.trade.ec.europa.eu/news/joint-statement-united-states-european-union-framework-agreementreciprocal-fair-and-balanced-trade-2025-08-21_en. 2 COM(2025) 471 final, https://ec.europa.eu/transparency/documentsregister/detail?ref=COM(2025)471&lang=en and COM(2025) 472 final, https://ec.europa.eu/transparency/documents-register/detail?ref=COM(2025)472.”
  EU-US trade relations
• 2025-06-10 “P-002320/2025 Answer given by Ms Roswall on behalf of the European Commission 1. The EU programme for the environment and climate action (LIFE) 1 provides, amongst others, financial support for the functioning of non-governmental organisations (NGOs) supporting civil society’s participation in policy making. It thereby promotes a pluralistic approach and ensures that NGOs are an integral part of a well-functioning democratic system. The NGO’s work programmes, which are annexed to the grant agreements, may include advocacy related to environmental, climate and energy transition policies. The Commission does not prescribe the specific activities to be carried out by the NGOs in their work programme, nor does it instruct them to support specific positions. The Commission emphasises that operating grants comply with the LIFE Regulation 2 adopted by the colegislators and that their management is fully in line with the EU Financial Regulation 3 . 2. With regard to the publication of all grant agreements with NGOs, as the Commission stated in its replies to written questions 4 and to the European Court of Auditors special report 11/2025 5 , the Commission adheres strictly to its transparency obligations under Article 38 of the Financial Regulation, which require publishing information about recipients of funds and do not require the disclosure and publication of the grant agreements. 3. The Commission has issued guidance 6 for existing grant agreements and future calls for proposals, addressed to all Commission services and applicable to all spending programmes. The guidance clarifies which activities should not be mandated as a requirement or condition for EU financing. The Commission adopted the Implementing Decision on the Financing of the LIFE programme and its work programme for the period 2025-2027 on 15 April 2025 7 . The Commission does not intend to withdraw the Decision. 1 https://cinea.ec.europa.eu/programmes/life_en. 2 Regulation (EU) 2021/783 of the European Parliament and of the Council of 29 April 2021 establishing a Programme for the Environment and Climate Action (LIFE), and repealing Regulation (EU) No 1293/2013, OJ L 172, 17.05.2021, p.53. 3 Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union (recast), OJ L, 2024/2509, 26.9.2024. 4 P-000317/2025, P-000280/2025, E-000336/2025 and E-000701/2025. 5 Special report 11/2025: Transparency of EU funding granted to NGOs - European Court of Auditors, https://www.eca.europa.eu/en/publications/sr-2025-11; https://www.eca.europa.eu/Lists/ECAReplies/COMReplies-SR-2025-11/COM-Replies-SR-2025-11_EN.pdf, Point 2, Section III. 6 https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/guidance-fundingdev-impl-monit-enforce-of-eu-law_en.pdf. 7 Commission Implementing Decision on the financing of the LIFE programme and the adoption of the work programme for the years 2025, 2026 and 2027, C(2025) 955 final. Available at: https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/programme-environmentand-climate-action-life_en.”
  Accounting and auditing of EU budget · Regulation of NGOs in Europe
• 2025-06-10 “E-002321/2025 Answer given by Ms Kos on behalf of the European Commission Following the decision to grant Ukraine EU candidate status in June 2022, Ukraine is currently in the screening phase of accession negotiations. The assessment to open cluster 1fundamentals, is with the Council. In terms of reforms, Ukraine established a transparent preselection system for Constitutional Court judges and further reformed the judicial governance bodies. It has strengthened its institutional anti-corruption framework and its legislation on anti-money laundering, smuggling and financial investigations. It has adopted a law reforming the Economic Security Bureau, a new media law, and revised legislation on national minorities. Further progress is needed, including on judicial and prosecutorial appointments, vetting and disciplinary procedures, safeguarding the independence of anti-corruption institutions and advancing the reform of law enforcement agencies. Following the revised enlargement methodology 1 which made the EU accession process more credible, predictable, and dynamic, there have been no changes to the requirements. EU accession negotiations remain based on merit and equal treatment, putting the rule of law at the core of the process. The Commission continues to support all enlargement partners towards EU accession. Overall, enlargement is and will remain a priority for the Commission not least because of the geopolitical context, including Russia’s war of aggression against Ukraine. The geopolitical context might have an impact on the path but does not exempt a candidate country from fulfilling all necessary obligations to join the EU. As in previous rounds of EU accession negotiations transitional arrangements will be exceptional and limited in time and scope. 1 COM(2020) 57 final.”
  EU enlargement · EU-Ukraine relations · EU relations with Western Balkans
• 2025-05-14 “P-001943/2025 Answer given by President von der Leyen on behalf of the European Commission The Commission is still analysing the judgment of the General Court and will comply with its duty to take the necessary measures to comply with the judgment in due course. In particular, since the General Court has found that the Commission should have provided a more precise explanation of its statement according to which it does not hold the requested documents, the Commission will review the situation in light of this finding and will adopt a new decision. The General Court has ordered the Commission to pay the costs of the case. Since they have not yet been liquidated, it is not possible to quantify them at this stage. The General Court does not put into question the Commission's documents registration policy. These rules aim to ensure the integrity and validity of the Commission's records and that important documents drafted or received by the Commission can be retrieved and eventually made accessible to interested EU citizens. The Commission will continue to strictly abide by the solid legal framework in place for access to documents. The Commission remains fully committed to maintaining openness, accountability and clear communication with all stakeholders, including EU institutions, civil society, and interest representatives.”
  Activities of EU Ombudsman · Transparency requirements of EU institutions
• 2025-04-28 “P-0001695/2025 Answer given by Mr Várhelyi on behalf of the European Commission The highest standards in the evaluation of COVID-19 vaccines were applied by the European Medicines Agency (EMA). As for every other product it evaluates, EMA’s human medicines committee 1 (CHMP) considered the need for good clinical practice (GCP) inspections. Studies supporting the authorisation of a medicine must comply with GCP. Regulators can request and conduct inspections to verify compliance with the standards. Criteria used to select a GCP inspection is published 2 . When a GCP inspection is requested by the CHMP, EMA makes a call for available EU national GCP inspection resources. The Member States have the final say on whether to send inspectors for an EMA-coordinated inspection. During the COVID-19 pandemic, due to the restrictions to travel with a view to protect public health, regulators assessed the need for inspections and decided on a case-by-case basis the most appropriate and viable approach to take. The European Public Assessment Reports for Vaxzevria 3 and Comirnaty 4 are publicly available. The first cases of myocarditis that occurred in Israel in 2021 following vaccination with Comirnaty triggered a formal review by EMA 5 . The outcome was that the risk for myocarditis and pericarditis was overall ‘very rare’ (up to one in 10,000 vaccinated people may be affected) with the highest risk in younger males 6 . The product information of Comirnaty and Spikevax was revised adding myocarditis and pericarditis as new side effects with a warning to raise awareness. 1 https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp. 2 https://www.ema.europa.eu/en/documents/other/points-consider-assessors-inspectors-european-medicinesagency-inspection-coordinators-identification-triggers-selection-applications-routine-cause-inspections-theirinvestigation-scope-such_en.pdf. 3 Vaxzevria (previously COVID-19 Vaccine AstraZeneca), INN-COVID-19-Vaccine-(ChAdOx1-S[recombinant]) https://www.ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19vaccine-astrazeneca-epar-public-assessment-report_en.pdf. 4 https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf. 5 https://www.ema.europa.eu/en/documents/report/report-pharmacovigilance-tasks-eu-member-states-andeuropean-medicines-agency-ema-2019-2022_en.pdf. 6 Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 November - 2 December 2021 https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessmentcommittee-prac-29-november-2-december-2021.”
  Pharmaceuticals regulation in EU · Transparency of EU medicines governance process
• 2025-03-20 “P-001202/2025 Answer given by Mr Kubilius on behalf of the European Commission The deterioration of the security context requires Member States to rapidly invest in defence, with a major impact on public finances. This exceptional situation, beyond Member State control, justifies Article 122 of the Treaty on the Functioning of the European Union (TFEU) 1 as a legal basis, allowing the Council to adopt measures in crisis situations. Security Action for Europe (SAFE) is a new specific and temporary instrument in the form of a Regulation. The role of the European Parliament is pivotal, and the Commissioner for Defence and Space is committed to regularly engage with the European Parliament. Defence is a Member States’ prerogative. The Commission has the economic and regulatory means to support them. SAFE loans are not expenditure arising from Common Foreign and Security Policy (CFSP) operations with military or defence implications pursuant to Article 41(2) of the Treaty on European Union 2 . These loans are provided on the basis of Article 122 of the TFEU. The allocation of the EUR 150 billion loans to Member States for common procurements will be demand driven. Member States wishing to receive loans will have to submit a Defence Industry Investment Plan to the Commission. The plan will need to include the loan size and pre-financing, a description of the activities, expenditures and measures for which the loan is requested, and, where relevant, the foreseen benefits for Ukraine. Member States will report every six months on the progress. Where the Commission concludes that the report is unsatisfactory, the payment of all or part of the loan shall be suspended. The Commission will provide an annual report on the use of financial assistance to the European Parliament and the Council. 1 https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX%3A12008E122%3AEN%3AHTML. 2 https://eur-lex.europa.eu/eli/treaty/teu_2008/art_41/oj/eng.”
  EU competences on defence · Defence spending
• 2025-02-11 “P-000621/2025 Answer given by Ms Šuica on behalf of the European Commission Each contribution agreement with pillar-assessed entities 1 outlines the conditions under which the implementation of the contract may be fully or partially suspended, as specified in the general conditions 2 . Before deciding on suspension, each situation must be carefully assessed based on substantiated evidence in order to guarantee a proportional and gradual approach. While suspending funds might appear to be a prompt response to human rights’ concerns, it can also deprive vulnerable populations of essential support provided through EU funds. Strengthening monitoring mechanisms and tools are essential to reinforce accountability and ensure human rights’ compliance; implementing partners play a crucial role by providing detailed context assessments, conducting risk analyses, and identifying mitigating measures. Additionally, EU Delegations intensify their engagement through missions, meetings and policy dialogue with relevant stakeholders, including authorities and internal security forces. All this information serves as a basis for dialogue and guides the implementation of EU actions. Moreover, the Commission is working on enhancing internal procedures to ensure stronger implementation of the human rights-based approach in EU-funded migration programmes with partner countries and more effectively following up on allegations of human rights violations. 1 Pillar Assessment is a process used by the Commission to evaluate the eligibility and suitability of partner organisations to work under indirect management. The purpose of such assessment is to ensure that the partner organisation’s systems, rules and procedures provide a level of protection of the EU’s financial interests, equivalent to the one that is provided when the Commission manages the budget directly itself. 2 General Conditions for Contribution Agreements, Articles 11 and 12, https://internationalpartnerships.ec.europa.eu/document/download/005e7241-6726-4c5e-b8223b51c28a8819_en?filename=contribution-agreement-annex-ii_en.pdf”
  EU development aid (migration conditionality)
• 2024-11-06 “P-002453/2024 Answer given by Ms Šuica on behalf of the European Commission The position of the Commission is clear when it comes to human-rights based approach to migration management. The protection of life and the respect for human rights and human dignity of all migrants, refugees and asylum seekers are fundamental principles of all Commission’s financial assistance, including those on migration and border management, in line with obligations under international law. The EU is working with partner countries, international organisations, local partners, and civil society organisations, to improve the situation of migrants and refugees. When managing EU programmes, the Commission adopts a rights-based approach, embedding the respect of human rights in each phase of the project cycle. The Commission holds the partner countries’ authorities and the implementing partners responsible for ensuring the respect and protection of human rights. In case of allegations, clarification and follow up process is taking place via the EU Delegation. Additionally, the contractual clauses entitle the Commission to suspend or terminate any contract if it has evidence that, or needs to verify whether, the beneficiary has breached any of its obligations. Finally, the Commission has already in place several monitoring tools for its programmes, including regular reports from implementing partners, on the spot verification missions, results-oriented monitoring exercises and external evaluations. Work is ongoing in Tunisia to strengthen existing monitoring mechanisms and tools.”
  Asylum & border control · EU relations with the Southern Neighbourhood · EU-Tunisia relations
• 2024-11-05 “E-002413/2024 Answer given by Executive Vice-President Ribera on behalf of the European Commission 1. Commission decisions are taken collegially by all Commissioners. Competition law decisions are subject to several stages of scrutiny and review prior to adoption, including consultation of associated services and review by the Commission’s Legal Service, to minimise the risk of annulment in case the addressee brings an action for annulment to the Union Courts. In the EU legal system based on the rule of law, all final decisions in competition investigations, and in particular any decision involving the imposition of fines by the Commission can be appealed before the Union Courts which in turn review the legality of the Commission’s decisions, and, which, in some cases, can result in the Union Courts cancelling, reducing or increasing the fines. 2. In case of Intel, as clarified by the European Court of Justice (ECJ)’s judgment of 11 June 2024 in case C-221/22 P Deutsche Telekom, the Commission was obliged under Article 266(1) of the Treaty on the Functioning of the EU, in order to comply with the annulment by the General Court of Intel’s fine, to compensate Intel, who had provisionally paid the fine with interest at a standard rate for the loss of enjoyment of the monies paid. In complying with this obligation, following a settlement with Intel, the Commission paid Intel on 6 November 2024 the appropriate interest compensation of EUR 515 547 908.15. The Commission notes in addition that, while the ECJ annulled one part of the Commission’s decision of 2009, namely the one concerning conditional rebates, it upheld the part concerning naked restrictions, namely payments in return for the cancellation of existing projects or the limitation of their reach. This led the Commission to impose, by decision of 21 September 2023, a new fine of EUR 376 358 000 to sanction the naked restrictions for which Intel was found to be liable. Intel waived claiming its legal costs from the Commission.”
  EU Competition policy
• 2024-10-12 “P-002037/2024 Answer given by Ms Kyriakides on behalf of the European Commission The Commission is aware of supply challenges related to isotonic saline solutions in the EU. To respond to critical shortages of medicines, including isotonic saline solutions, the European Medicines Agency (EMA) and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) continuously monitor and investigate signals of (potential) supply disruptions escalated to EU level by national competent authorities. In this context, EMA is currently evaluating the supply situation of isotonic saline solutions across EU/European Economic Area countries and potential impact on patients and users. The potential effect on prices depends on the national context, as pricing and reimbursement of medicines are the responsibility of Member States. After assessing the situation in the different countries, EMA and MSSG will determine if actions should be taken at EU level to respond to potential shortages of these medicines. Any actions would be taken ahead of the revision of the pharmaceutical legislation currently under negotiation 1 . Regarding shortages, the Commission has proposed to reinforce the role and powers of EMA 2 and MSSG 3 to take actions in case of (potential) critical shortages of medicines outside crises times. More specifically, the Commission has proposed to strengthen the obligation to notify potential shortages early, require companies to have shortage prevention plans for all medicines, and introduce additional tools to monitor and mitigate risks of shortages for critical medicines on a Union list 4 . 1 https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceuticallegislation_en 2 http://data.europa.eu/eli/reg/2022/123/oj 3 https://www.ema.europa.eu/en/about-us/what-we-do/crisis-preparedness-management/executive-steeringgroup-shortages-medicinal-products/executive-steering-group-shortages-safety-medicinal-products-mssgmeetings 4 https://www.ema.europa.eu/en/news/first-version-union-list-critical-medicines-agreed-help-avoid-potentialshortages-eu”
  Pharmaceuticals regulation in EU · EU policy against medicines shortages
• 2024-09-26 “P-001831/2024 Answer given by Ms Kyriakides on behalf of the European Commission The Commission authorises medicines based on a recommendation by the European Medicines Agency (EMA). The vaccine Imvanex 1 is authorised in the EU to protect against smallpox, mpox and diseases caused by vaccinia virus in individuals aged 12 and older. The product information 2 includes advice on the use of Imvanex in vulnerable populations, such as immunocompromised, pregnant women or children. The recommendation to extend the use of Imvanex to adolescents is based on the interim results of a study 3 showing its ability to generate an immune response in adolescents similar to that in adults. No additional risk was identified for the use of Imvanex in adolescents compared to adults. EMA requested the marketing authorisation holder to submit the study final results by 30 May 2025 to further characterise the safety information for adolescents 4 . As for all medicines, data on the use of Imvanex are continuously monitored. Side effects reported with Imvanex are evaluated, and any necessary action taken to protect patients. On 13 September 2024, Imvanex was prequalified by the World Health Organisation (WHO) 5 , with EMA as regulatory agency of record, i.e. EMA’s assessment was the basis for WHO prequalification to facilitate timely and increased access to this vaccine in communities with urgent need. WHO also cooperated in EMA’s assessment of the extension of indication to adolescents, a population particularly vulnerable to mpox. The Commission will continue to strive for the greatest transparency possible by complying with Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents 6 when applicable. 1 Union Register of medicinal products https://ec.europa.eu/health/documents/communityregister/html/h855.htm 2 IMVANEX II-108 https://ec.europa.eu/health/documents/communityregister/2024/20240919164097/anx_164097_en.pdf 3 A Phase 2 Randomized Multisite Trial to Inform Public Health Strategies Involving the Use of MVA-BN Vaccine for Mpox https://www.clinicaltrials.gov/study/NCT05740982 4 EMA recommends extending indication of mpox vaccine to adolescents https://www.ema.europa.eu/en/news/ema-recommends-extending-indication-mpox-vaccine-adolescents 5 https://www.who.int/news/item/13-09-2024-who-prequalifies-the-first-vaccine-against-mpox 6 https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX%3A32001R1049”
  Pharma transparency · Vaccination
• “Ladies and gentlemen, people have had enough. For months, I've been receiving all kinds of complaints from concerned citizens who are concerned about lack of cash with bank branches closing down, ATMs disappearing and people not being able to get an appointment with some person in a bank without not being able to speak to a person without an appointment. The message is do everything digitally or don't do it at all. This might be convenient for some, but for older people or people with disabilities, this is going to exclude them. It's discriminatory. People who built this country are being sidelined because they don't have a smartphone or a fast internet connection, or because they can't make a digital payment. This is discrimination against the elderly. And if you attack cash, you attack freedom. What is convenient today will be mandatory tomorrow and control perhaps the day after. Therefore, we have to keep our cash.”
  Cash as means of payment