Tomislav SOKOL

Policy topics Tomislav SOKOL is active on

What Tomislav SOKOL has said (57)

• 2026-06-17 “Vice president, commissioner, colleagues, Europe cannot longer close its eyes before the fact that social platforms are designed to attract and make children stay in the on the platform. Algorithms analyze the interest of children, and they continuously produce new content to make them glued to the screen. And then they overwhelm them with all these contents. This is practice which is to make profit for the tech giants. Every 2nd adolescent claims that they are online all the time almost, and we are faced with a challenge that poses a risk to mental mental health concentration of our children. At the same time, experts warn that, overall exposure, to Internet is connected to low self esteem and higher risk of, anxieties. This means that we need to control, access to social media for children with parental control. Also, 13 years as a minimum age for access needs to be secured. We need to have a digital, space where children are protected. The digital world needs to be designed for children and not for the logic of profits.”
  Age restrictions on children's access to social media
• 2026-02-06 “E-000495/2026 Answer given by Mr Šefčovič on behalf of the European Commission The Commission acknowledges the significance of the concerns relating to the misuse of blasphemy laws in Pakistan, including false accusations that have led to violence and serious human rights violations. While criminal prosecutions fall under Pakistan’s sovereign responsibility, the EU expects the authorities to ensure accountability for abuses of these laws, including action against those who deliberately make false accusations. Respect for due process, protection of minorities and compliance with international human rights obligations remain essential elements of EUPakistan relations, including under the Generalised Scheme of Preferences Plus (GSP+) framework 1 . As for any GSP+ beneficiary, Pakistan is subject to continuous monitoring of its implementation of 27 international conventions listed in the GSP Regulation 2 , including the International Covenant on Civil and Political Rights (ICCPR). The EU conducted a GSP+ monitoring mission in Pakistan in late 2025 during which the issue of false accusations of blasphemy was highlighted to the Pakistani authorities as one of the priority areas for corrective action. The Commission will continue to monitor developments closely and assess progress. A GSP monitoring report will be issued to the European Parliament and the Council by the summer of 2026. This will include the EU evaluation, incorporating also findings from UN bodies and civil society. If Pakistan re-applies for GSP+ under the new GSP Regulation, it will be required to devise a plan of action on the effective implementation of all GSP+ conventions under the new Regulation, including the ICCPR. The issue of false accusations of blasphemy will also be discussed in that context. 1 EU’s Special Incentive Arrangement for Sustainable Development and Good Governance of the EU’s Generalised Scheme of Preferences Plus (GSP+). Regulation (EU) No 978/2012 of the European Parliament and of the Council of 25 October 2012 applying a scheme of generalised tariff preferences and repealing Council Regulation (EC) No 732/2008; https://eur-lex.europa.eu/eli/reg/2012/978/oj/eng - https://eurlex.europa.eu/eli/reg/2008/732/oj/eng. 2 Regulation (EU) No 978/2012 of the European Parliament and of the Council of 25 October 2012 applying a scheme of generalised tariff preferences and repealing Council Regulation (EC) No 732/2008.”
  EU competences on human rights
• 2026-02-05 “E-000477/2026 Answer given by Ms Kos on behalf of the European Commission The Commission is aware of the expulsions and addressed the issue during an emergency debate at the European Parliament on 12 February 2026. As an EU candidate country and member of the Council of Europe, Türkiye is expected to apply the highest democratic standards and practices. Measures affecting freedom of thought, conscience, and religion must be proportionate and should not be treated as national security issues without justification or judicial remedies. The Commission recalls that according to Article 9 of the European Convention on Human Rights, everyone has the right to freedom of thought, conscience and religion and of manifesting it. The latter shall be subject only to such limitations as are prescribed by law and are necessary in a democratic society in the interests of public safety, for the protection of public order, health or morals, or for the protection of the rights and freedoms of others. The 2025 Enlargement report on Türkiye 1 notes the deportations of foreign Protestant pastors and Jehovah’s Witness ministers and the ongoing cases 2 in the European Court of Human Rights. It states that the situation of freedom of thought, conscience and religion need to be improved and that the EU’s serious concerns about the continued deterioration of democratic standards, the rule of law, the independence of the judiciary and respect for fundamental rights were not addressed. The Commission will continue to call on Türkiye to comply with its obligations under international law, and to respect and protect, and fulfil human rights and the rule of law, and will continue to raise these issues in its contacts with the Turkish authorities, including in the context of the relevant sub-committee established under the Association Agreement with Türkiye 3 . 1 https://enlargement.ec.europa.eu/turkiye-report-2025_en. 2 https://hudoc.echr.coe.int/eng#{%22itemid%22:[%22001-234570%22]} and https://hudoc.echr.coe.int/#{%22itemid%22:[%22001-248520%22]}. 3 https://eur-lex.europa.eu/resource.html?uri=cellar:f8e2f9f4-75c8-4f62-ae3fb86ca5842eee.0008.02/DOC_2&format=PDF.”
  EU engagement with Christian communities inside and outside the EU · EU-Turkey relations
• 2025-07-16 “E-002932/2025 Answer given by Mr Várhelyi on behalf of the European Commission In Europe’s Beating Cancer Plan 1 , the Commission indicated that it would ‘explore measures on exposure to ultraviolet radiation, including from sunbeds…’. The Commission concluded that more information on the effectiveness of preventive and mitigation measures is needed to have a comprehensive understanding of how policy recommendations could lead to a better protection of EU citizens from health risks associated with the use of sunbeds, beyond the protection already provided under the Directive 2014/35/EU 2 (the Low Voltage Directive – LVD) 3 . All sunbeds used for tanning purposes must comply with the health and safety requirements set in the LVD, which covers cancer-related risks. The LVD covered the conditions relating to the placing on the market of sunbeds. The harmonised standard on sunbeds under the LVD (EN 60335-2-27:2013/AC:2021-11 4 ) may be used by manufacturers to prove compliance with the LVD requirements. National authorities are responsible for transposing, implementing and enforcing the LVD. As for the safety aspects and risks relating to the use of sunbeds which are not covered by the LVD, the General Product Safety Regulation (EU) 2023/988 5 applies. Furthermore, the general consumer protection rules on misleading and comparative advertising apply. The Commission will consider further measures if there is compelling evidence that such measures would result in a better protection of EU citizens from health risks associated with the use of sunbeds and provided that such measures respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care (Article 168(7) TFEU). 1 https://commission.europa.eu/strategy-and-policy/priorities-2019-2024/promoting-our-european-waylife/european-health-union/cancer-plan-europe_en. 2 http://data.europa.eu/eli/dir/2014/35/oj. 3 See also reply to Parliamentary Question E-0101259/2025: https://www.europarl.europa.eu/doceo/document/E10-2025-001259-ASW_EN.html. 4 https://ec.europa.eu/health/scientific_committees/scheer/docs/sunbeds_co44_en.pdf. 5 http://data.europa.eu/eli/reg/2023/988/oj.”
  EU measures on lifestyle-related behaviours (smoking, drinking, eating, etc.) · Smoking regulation
• 2025-07-16 “E-002931/2025 Answer given by Executive Vice-President Séjourné on behalf of the European Commission As announced in the 2025 Single Market Strategy, the revision of the EU public procurement legislation aims to strengthen the strategic role of public procurement and to mainstream the use of sustainability, resilience and social criteria in EU public procurement 1 . The Commission acknowledges the critical nature of the healthcare sector and intends to ensure that the revision is coherent with EU health and investment policies and legislation, in line with Better Regulation principles. As part of its evaluation of the public procurement directives, the Commission has already been actively engaging with health stakeholders through various projects such as the ‘Big Buyers Working Together’ 2 initiative and the Public Buyers Community Platform 3 . Furthermore, the Commission consulted widely with stakeholders through a public consultation and a call for evidence 4 . In the context of its preparatory work for the revision, the Commission intends to assess various policy options, which might include for instance technical guidance or capacitybuilding. The Commission is also convinced of the importance of maintaining high standards of innovation and safety in health and, more generally, of improving EU citizens health. It intends to assess the impact of the various revision policy options on these important objectives. 1 COM(2025)500 - Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions - The Single Market: our European home market in an uncertain world - A Strategy for making the Single Market simple, seamless and strong; Brussels, 21.5.2025. 2 https://public-buyers-community.ec.europa.eu/about/big-buyers-working-together. 3 https://public-buyers-community.ec.europa.eu. 4 https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14427-Public-procurement-directivesevaluation_en.”
  EU policy on sustainability criteria in public funding · EU policy on social criteria in public funding
• 2025-05-26 “E-002093/2025 Answer given by Mr Várhelyi on behalf of the European Commission The European Medicines Agency (EMA) is responsible for hosting and maintaining EudraVigilance 1 - the EU system for collecting and monitoring reports of suspected side effects. According to the EMA, a small number of reports on off-label use in gender dysphoria have been received, mainly outside the EU for leuprorelin (seven spontaneous cases, all non-EU) and a few EU cases for triptorelin (nine spontaneous cases in total from 2012–2025). It is also important to note there has been no EU pharmacovigilance signal procedure related to the off-label use of Gonadotropin-Releasing Hormone agonists (GnRH-agonists) in the context of gender dysphoria. Additionally, all GnRH-agonists are subject to regular EU-wide safety assessments. It is important to note that patients receiving such treatment are typically under the care of specialised healthcare professionals who closely monitor their health and overall wellbeing and who are primarily tasked to raise awareness about, or address particular adverse reactions. 1 https://www.ema.europa.eu/en/human-regulatory-overview/research-development/pharmacovigilance-researchdevelopment/eudravigilance.”
  Pharmaceuticals regulation in EU · EU policy on mental health
• 2025-04-22 “P-001596/2025 Answer given by Mr Várhelyi on behalf of the European Commission Certain medicinal products and active pharmaceutical ingredients (APIs) are imported into the EU from third countries, including the United States, and some of these imports play a critical role in the EU healthcare system. While comprehensive data or classification of such pharmaceutical dependencies for each medicinal product is not yet available, the Commission is aware that, in specific cases, there may be limited or no immediately adequate substitutes produced within the EU. This is for instance the case for certain plasma-derived medicinal products, where supply chains are highly complex, with different stages of production processes often happening in several different countries. Broader supply chain vulnerabilities were examined under the Structured Dialogue on security of medicines supply 1 , with findings presented in the 2022 Commission Staff Working Document on the vulnerabilities of the global supply chains of medicines 2 . In April 2023, the Commission proposed a new EU pharmaceutical legislation 3 , which introduces the EU-level identification of critical medicines and the analysis of the vulnerabilities in their supply chains. It also includes regulatory measures to strengthen their supply security. To complement these efforts, the Commission adopted the proposal for a Critical Medicines Act 4 on 11 March 2025, which proposes additional measures to reinforce EU manufacturing capacities and diversify supply sources for critical medicines. Together, these initiatives aim to increase the resilience of the EU pharmaceutical sector while supporting patient access to critical medicines. 1 https://ec.europa.eu/health/human-use/strategy/dialogue_medicines-supply_en. 2 https://health.ec.europa.eu/system/files/2022-10/mp_vulnerabilities_global-supply_swd_en.pdf. 3 COM/2023/193 final; COM/2023/192 final. 4 COM(2025) 102 final.”
  Pharmaceutical imports & exports rules · Government stockpiling of critical medicines · Pharmaceuticals regulation in EU
• 2025-04-22 “E-001595/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission acknowledges that health workforce shortages are a challenge in the EU 1 . Under Article 168(7) of the Treaty 2 , Member States are responsible for the organisation of their health workforce. Healthcare innovations can help address workforce shortages, but a skilled and involved workforce is essential for their impact. Several initiatives strengthen digital health skills and promote health innovations. The European Health Data Space (EHDS) 3 optimises health data use to enhance healthcare, drive innovation and support policymaking. The XiA Project 4 empowers healthcare professionals with skills for real-world application of EHDS-related standards. The BeWell 5 partnership develops digital health competencies for the health workforce. Seven training projects 6 strengthen digital skills for (non-)clinical staff, crucial for transforming health systems. Another action 7 integrates Artificial Intelligence (AI) in healthcare by building expert communities, promoting education for healthcare providers, and supporting policymaking. MS also receive direct grants to establish Health Data Access Bodies (HDAB) 8 , and a capacity-building project enhances HDAB’s staff skills, supporting innovation and AI-driven advancements. The European Partnership Transforming Health and Care Systems 9 under Horizon Europe enhances the availability, skills and wellbeing of the healthcare workforce and boosts 1 OECD/European Commission (2024), Health at a Glance: Europe 2024: State of Health in the EU Cycle, OECD Publishing, Paris, https://doi.org/10.1787/b3704e14-en. Commission Communication on Labour and skills shortages in the EU: an action plan, COM(2024) 131 final (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52024DC0131) page 2 and 14. 2 Treaty of the Functioning of the European Union: http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:12012E/TXT&from=en. 3 European Health Data Space Regulation (EHDS) https://health.ec.europa.eu/ehealth-digital-health-andcare/european-health-data-space-regulation-ehds_en. 4 https://health.ec.europa.eu/ehealth-digital-health-and-care/ehds-action/projects-supporting-ehds_en https://brudhi.iscte-iul.pt/2025/01/21/introducing-the-xia-project-transforming-healthcare-through-digitalinteroperability-education/. 5 https://bewell-project.eu/. 6 Skills and Healthcare: training opportunity for Health Professionals under the EU4Health Programme: https://year-of-skills.europa.eu/news/skills-and-healthcare-training-opportunity-health-professionals-undereu4health-programme-2023-10-16_en. 7 EU-funded projects contributing to the implementation of the European Health Data Space: https://hadea.ec.europa.eu/news/eu-funded-projects-contributing-implementation-european-health-data-space2025-03-28_en. 8 EU-funded projects contributing to the implementation of the European Health Data Space: https://hadea.ec.europa.eu/news/eu-funded-projects-contributing-implementation-european-health-data-space2025-03-28_en. 9 European Partnership on Transforming Health and Care Systems | THCS | Projekt | Fact Sheet | HORIZON | CORDIS | European Commission https://cordis.europa.eu/project/id/101095654/fr.”
  Medical devices · Processing of health data
• 2025-04-22 “E-001593/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission, in line with the Parliament’s Special Committee on Beating Cancer report 1 , recognises the importance of nutritional support in cancer care. The review of Europe’s Beating Cancer Plan 2 updated on its implementation. Based on stakeholder consultations, it concluded that the current Cancer Plan remains relevant, with the focus on continuing to implement ongoing actions. As the review was just published in February 2025, the Commission is not currently planning an additional review. Through the EU funded project INTERACT-EUROPE 100 3 , training to ensure diagnosis of malnutrition risks and personalised nutrition interventions is provided to health professionals. This inter-specialty training programme is being implemented in 100 cancer centres across the EU. A dedicated course covers nutritional aspects in cancer, including its impact on treatment outcomes, nutritional screening, interventions, and nutrition in palliative and end-of-life care. Furthermore, the European Quality Assurance Scheme for Breast Cancer Services, developed by the Commission’s Joint Research Centre, supports quality improvement across the entire care pathway. The scheme recommends that breast cancer services offer nutrition counselling. To be certified according to the scheme, services need to have protocols in place covering nutrition and physical activity programmes. The Commission also recognises the importance of nutritional care in cancer survivors. The Joint Action JANE 4 is creating seven cancer-related Networks of Expertise. In particular, the Survivorship Network intends to create a framework to follow-up care, prioritising the prevention and management of adverse effects, with an emphasis on nutrition and diet. 1 https://www.europarl.europa.eu/cmsdata/243836/BECA%20final%20report_tabled_PE693752v02-00EN.pdf. 2 https://health.ec.europa.eu/publications/europes-beating-cancer-plan_en. 3 https://www.europeancancer.org/eu-projects/impact/interact-europe-100. 4 https://jane-project.eu/.”
  Nutrition
• 2025-04-22 “E-001594/2025 Answer given by Mr Várhelyi on behalf of the European Commission Vaccination programmes and services are a competence of national authorities. The Commission supports Member States in increasing and maintaining high vaccination coverage rates and in a lifelong approach to vaccination. It is a theme of #UnitedInProtection 1 , the Commission’s campaign promoting safe and effective vaccines’ benefits. Immunosenescence is a scientific challenge. In general, a clear understanding of the protective human immune response to infection is key to selecting and designing the right vaccine antigens. New or more specifically targeted formulations may be needed to improve response to existing vaccines in different population groups such as the elderly that may mount a suboptimal immune response to vaccination. The European Centre for Disease Prevention and Control (ECDC) regularly generates estimates of vaccine effectiveness for key vaccination programmes, such as seasonal influenza and COVID-19 vaccines 2 , with specific attention towards older groups. The ECDC also regularly provides summaries of scientific data available on the performance of newer vaccines 3 which may help to address some of the challenges related to immunosenescence. This scientific evidence, together with existing complementary research in the field, can help to inform on where gaps exist, including areas where research and development for newer and more effective vaccines targeting specific population group needs is key. The ECDC also regularly publishes overviews on the performance of national immunisation groups, such as for seasonal influenza vaccination in older age groups 4 . Such overviews include public health considerations on how Member States and stakeholders can strengthen the implementation of existing programmes. 1 https://vaccination-protection.ec.europa.eu/index_en. 2 Please consult Vaccine Effectiveness, Burden and Impact Studies (VEBIS) on the ECDC website for an overview of ongoing studies and latest results available: https://www.ecdc.europa.eu/en/infectious-diseasetopics/related-public-health-topics/immunisation-and-vaccines/vaccine-0. 3 https://www.ecdc.europa.eu/en/publications-data/systematic-review-update-efficacy-effectiveness-and-safetynewer-and-enhanced. 4 https://www.ecdc.europa.eu/en/publications-data/survey-report-national-seasonal-influenza-vaccinationrecommendations.”
  Vaccination
• 2025-03-11 “E-001048/2025 Answer given by Executive Vice-President Mînzatu on behalf of the European Commission According to Article 168 of the Treaty on the Functioning of the European Union, Member States are responsible for the organisation and delivery of their health services and medical care, in full respect of EU law. Cross-border mobility of health care workers is ensured via the rules laid down in Directive 2005/36/EC on the recognition of professional qualifications 1 . Based on the available information, the undergoing reform has no impact on the application of Directive 2005/36/EC on the recognition of professional qualifications in case of temporary provision of services in another Member State. The undergoing reform has no impact on the free movement of health care workers wishing to exercise their profession in another Member State regulating this profession with regard to qualifications. Those workers can still have their qualification recognised in line with Directive 2005/36/EC. While there is no systematic mechanism to monitor national legislative processes, the Commission is open to receiving information about the effects of legislation and possible impact on the single market. 1 Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications (OJ L 255 30.9.2005, p. 22) - https://eur-lex.europa.eu/eli/dir/2005/36/oj/eng.”
  Public and private sectors role in healthcare services
• 2025-02-26 “P-000845/2025 Answer given by Mr Várhelyi on behalf of the European Commission The EU’s actions in the field of rare diseases as laid down in the Council Recommendation 1 are still valid. The Commission has been pursuing ambitious actions with significant impact for more than 20 years, strongly supporting Member States. This includes proposing legislation on orphan drugs and medical devices, funding research projects, funding the European Reference Networks for Rare Diseases (ERNs) and developing patients’ registries. The Joint Action JARDIN 2 aims to provide a comprehensive overview of the rare disease landscape in the EU, suggest best practices, and inform possible decisions. The Commission’s funding amounts to more than EUR 120 million under the EU4Health Programme and up to EUR 150 million for the European Rare Disease Research Alliance (ERDERA) 3 . Furthermore, the revision of the pharmaceutical legislation encourages the development of treatments for rare diseases. The European Health Data Space will build upon the efforts of the European Platform on Rare Disease Registration to tackle the problem of dispersed data on rare disease patients throughout Europe and will boost research in this area. Following the 2022 report on the operation of the Directive on the application of patients’ rights in cross-border healthcare 4 , the Commission is working on reducing administrative burden. A new Omnibus Directive 5 amending Directive 2011/24/EU 6 was adopted, bringing the evaluation of its implementation in line with the evaluation of the ERNs. In addition, in the past months, the Commission co-organised ten workshops to raise awareness of patients’ rights in cross-border healthcare and of the ERNs. The forthcoming report on the implementation of the Directive in 2027 will guide possible next steps. 24 ERNs support the Member States in pooling resources and expertise on rare diseases, allowing specialists to discuss rare disease patients’ cases across borders to provide the best diagnosis and treatment, so that the expertise travels and not the patients. 1 Council Recommendation of 8 June 2009 on an action in the field of rare diseases OJ C 151, 3.7.2009, p. 7–10. 2 Joint Action on the integration of ERNs into national health systems, more information: https://jardin-ern.eu/ 3 https://erdera.org/ 4 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare OJ L 88, 4.4.2011, p. 45–65. 5 Directive (EU) 2019/2161 of the European Parliament and of the Council of 27 November 2019 amending Council Directive 93/13/EEC and Directives 98/6/EC, 2005/29/EC and 2011/83/EU of the European Parliament and of the Council as regards the better enforcement and modernisation of Union consumer protection rules OJ L 328, 18.12.2019, p. 7–28. 6 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare OJ L 88, 4.4.2011, p. 45–65.”
  Pharmaceuticals regulation in EU · EU competences on health
• 2025-02-17 “E-000711/2025 Answer given by Mr Várhelyi on behalf of the European Commission The 2022 Council Recommendation on cancer screening 1 states that screen-and-treat strategies for the bacterium Helicobacter pylori, responsible for around 89% of all gastric cancers, should be considered in countries or regions with high gastric cancer incidence and death rates. Such pilot studies are considered necessary before population-based screening programmes can be implemented. The Commission has been providing funding through the EU4Health Programme to the projects EUROHELICAN 2 and TOGAS 3 . They aim to help policymakers across the EU to incorporate gastric cancer screening into their healthcare priorities and balance effectiveness, feasibility and acceptability with potential adverse longterm effects. Additionally, through the Joint Action EUCanScreen 4 , a pilot study will look into the feasibility of integrating gastric cancer screening into colorectal cancer screening programmes. The EU4Health-funded project CAN.HEAL 5 is focusing on the implementation of genomics and personalised medicine in clinical practice, including non-invasive screening methods, such as next-generation sequencing and liquid biopsy. The Horizon Europe 6 EU Mission: ‘Cancer’ 7 and the European partnership on Personalised Medicine 8 drive research into the development and uptake of as well as access to screening and early detection technologies in national healthcare systems. Both initiatives will cooperate with the Joint Action on Personalised Cancer Medicine which is expected to be launched in the second half of 2025. The latter Joint Action will also build on OncNGS 9 , Instand NGS4P 10 , and other Horizon Europe-funded collaborative projects, which develop and address uptake of genomics and personalised medicine. 1 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2022.473.01.0001.01.ENG 2 https://health.ec.europa.eu/non-communicable-diseases/cancer/europes-beating-cancer-plan-eu4healthfinanced-projects/projects/eurohelican_en 3 https://health.ec.europa.eu/non-communicable-diseases/cancer/europes-beating-cancer-plan-eu4healthfinanced-projects/projects/togas_en 4 https://www.dypede.gr/eucanscreen/ 5 https://health.ec.europa.eu/non-communicable-diseases/cancer/europes-beating-cancer-plan-eu4healthfinanced-projects/projects/canheal_en 6 https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-opencalls/horizon-europe_en 7 https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-opencalls/horizon-europe/eu-missions-horizon-europe/eu-mission-cancer_en https://www.eppermed.eu/ 9 https://oncngs.eu/; Focuses on research into affordable solutions to provide next generation sequencing tests for all solid tumours. 10 https://www.instandngs4p.eu/”
  EU competences on health · Vaccination
• 2024-12-09 “E-002833/2024 Answer given by Mr Várhelyi on behalf of the European Commission Infection prevention and control (IPC) is a major pillar of the EU efforts to tackle antimicrobial resistance (AMR), given that over 70% of its health impact is linked to healthcare-associated infections (HAI) 1 . The Commission, together with the European Centre for Disease Prevention and Control (ECDC) is working on EU Guidelines for IPC in human health. Action on IPC is also part of the EU co-funded joint action on AMR with a budget of EUR 62.5 million 2 . In addition, IPC forms an integral part of the prevention, preparedness, and response planning capacities of Member States, pursuant to the Regulation on serious cross-border health threats 3 . These capacities, together with capacities on AMR and HAI, are subject to regular ECDC assessments and possible Commission recommendations to support Member State action 4 . The Commission also funds research and development activities through the research and innovation framework programmes 5 and, develops and implements, in close collaboration with Member States, innovative actions to secure the availability and accessibility of antimicrobials and other AMR medical countermeasures. The proposal for the reform of the pharmaceutical legislation 6 is expected to offer additional opportunities for tackling AMR once adopted. The 2023 Council Recommendation on stepping up EU actions to combat AMR in a One Health approach 7 sets various targets regarding AMR and human health that go in the same direction as the United Nations political declaration adopted in September 2024 8 . The Commission, together with EU agencies, is closely following Member States’ progress, and regularly exchanges with Member States’ competent authorities on best practices and followup actions in the AMR One Health Network. 1 https://www.ecdc.europa.eu/sites/default/files/documents/EAAD-infographic-2022.pdf 2 EU JAMRAI 2, https://eu-jamrai.eu/prevention-control/ 3 Regulation (EU) 2022/2371 https://eur-lex.europa.eu/eli/reg/2022/2371/oj 4 As per Articles 8 and 9 of Regulation (EU) 2022/2371. 5 https://research-and-innovation.ec.europa.eu/research-area/health/antimicrobial-drug-resistance-amr_en 6 https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceuticallegislation_en 7 Council Recommendation on stepping up EU actions to combat antimicrobial resistance in a One Health approach C 220, 22.6.2023, p. 1. 8 https://www.unep.org/news-and-stories/press-release/world-leaders-commit-decisive-action-antimicrobialresistance#:~:text=New%20York%2C%2026%20September%202024%20%E2%80%93%20Global%20leaders, reducing%20the%20estimated%204.95%20million%20human%20deaths%20”
  Antimicrobial resistance
• 2024-11-11 “E-002495/2024 Answer given by Mr Várhelyi on behalf of the European Commission The role of the EU in healthcare is defined by Article 168 of the Treaty on the Functioning of the European Union 1 , which in the field of substances of human origin (SoHO) like blood, is limited to adopting measures setting high standards of quality and safety. In that legal context, the Commission has recently proposed to the co-legislator such measures, that were adopted with the 2002 Blood Directive (2002/98/EC) 2 and the 2024 SoHO Regulation (EU/2024/1938) 3 . The Commission has, therefore, no direct role in the management of specific diseases like anaemia. The importance of an appropriate use of SoHO is fully recognised in the new SoHO Regulation, which refers explicitly to the Patient Blood Management (PBM) approach 4 and its endorsement by the World Health Organization. Furthermore, the Commission has supported the development of a Guide for Health Authorities to build national programmes of PBM in the EU 5 and a complementary guide for hospitals 6 to help implement PBM. 1 http://data.europa.eu/eli/treaty/tfeu_2008/art_168/oj 2 http://data.europa.eu/eli/dir/2002/98/oj 3 http://data.europa.eu/eli/reg/2024/1938/oj 4 Recital 67 of Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC. 5 https://health.ec.europa.eu/document/download/e0e9ebc8-ac93-4124-88a24352360371b0_en?filename=2017_eupbm_authorities_en.pdf 6 https://health.ec.europa.eu/document/download/d0926de8-aaed-4c07-a50ee5daf5f01e10_en?filename=2017_eupbm_hospitals_en.pdf”
  EU competences on health
• “(09:43:17 – 09:46:11): Thank you. Thank you very much. Thank you, sir, for giving giving me the floor. I'll go straight to the point. So the agreement on the critical medicines act demonstrates that when Europe's health security and strategic autonomy are at stake, EU can act decisively and deliver concrete results. The parliament entered these negotiations with a clear objective. The CMA had to become more than a symbolic response to shortages. It had to provide practical tools to strengthen security of supply, reinforce European manufacturing capacities, and reduce our dependencies on third countries. And I would also like to add to that, also achieving or facilitating equal access to medicines because it is unacceptable that that, innovative medicines, go get to some markets, some national markets 2 or 3 years after some other markets in the EU, which is unacceptable, and CMA also tried to tackle that to a significant extent. I would like to highlight 3 key achievements secured by the parliament during the negotiations. So first on the scope. Parliament successfully secured the inclusion of all orphan drugs, orphan medicines in key provisions of this act. Patients suffering from rare diseases are often among the most vulnerable, and thus, it was essential that they were not left behind. And I would like to mention that, here here specifically that 95 percent of patients suffering for rare diseases do not have a treatment. So facilitating and incentivizing development of new medicines, for rare diseases in Europe should be 1 of the main strategic priorities of the EU. So as a result, orphan medicinal products will be eligible for collaborative procurement at European level, allowing member states to join forces and improve access to these medicines. We also ensure that orphan medicinal products can benefit from the streamlined permitting procedures established under the act. Strategic projects involving these products will therefore have access to faster and more predictable authorization procedures, helping to attract investment and strengthen production capacity within the EU. So, essentially, this means that development of new orphan drugs will be much easier, simpler, and faster than than before. And through collaborative procurement will strengthen the negotiating position of member states, which make it easier for them to acquire these medicines faster and at a lower cost, which is extremely important in terms of ensuring the quality of access for patients. Second, on procurement and the buy European approach. For too long, procurement of medicines has been driven almost exclusively by the lowest price. While this may have reduced costs in the short term, it also contributed to the relocation of production outside Europe and increased our dependence on fragile global supply chains, especially in combination with, with having only 1 1 winner in the tenders. So combination of low of lowest price and 1”
  Pharmaceuticals regulation in EU — innovation/access axis
• “President, dear colleagues, we know from experience that directive on unfair trading practices does not give enough support in cross-border cooperation. Therefore, the proposal of the Commission on the new directive is another step of the Commission to strengthen the position of producers in the chain. This should be a case when producers are in different countries so that they do not escape control because they trade cross-border. We need now the revision of the Directive on Unfair practices, which will forbid which will impose a ban on selling under producer price, which is a problem in Croatia. This would be a good mechanism to improve the position of farmers and strengthen the common market. Also, a business secret and other intellectual property rights have to be protected. This is the basis of the market and strengthens business doing business in the EU. I do believe that this can make a change for all the elements in the change, and we are awaiting the new directive on unfair trading practices to protect our markets.”
  EU policy on farmer–buyer relations in the agri-food supply chain
• “Uh, and finally, on collaborative procurement, that's the last point. We clarified the conditions under which member States and the Commission can lodge collaborative procurement to strengthen coordination and avoid conflicting negotiations. So we really try to streamline things, to clarify things, to simplify them, to reduce to, to. For instance, we merge two different methods which were proposed by the commission. We didn't narrow down the scope itself because we think that the collaborative procurement is important, but we try to simplify things, to clarify things, and to create more legal, legal certainty that everybody knows what in which cases collaborative procurement can happen. Uh, so to sum up, uh, we try to balance all the interests having in mind that we want to that we want to strengthen European competitiveness, our strategic autonomy, autonomy, less dependency on the others. Patient safety and especially equal access to for all the patients in the European Union. And I hope we were able to achieve that. And I look forward to what to to the comments and suggestions from all the shadows and all the other colleagues, which we will try to obviously incorporate as much as possible. So thank you very much and I'll look forward to the discussion.”
  "Buy European" provisions
• “Madam president Mr commissioner colleagues single market is one of the biggest successes in the European Union and the foundation for our competitiveness however we haven't realized its full potential. I'd like to emphasize that we need to strengthen the services market which is still underdeveloped this is a problem that I as the rapporteur for the services on the single market have warned several times. We also have unfair practices that are a huge problem the same products in the same retail chains are as 3x more expensive than in members other member states and there are no reasons for this. This is what we see in Croatia this is a violation of the competition through price arrangements of the big companies these practices are not to be allowed and they need to be sanctioned. Only by doing this we can secure the trust of our consumers and the single market this is why I welcome this new strategy that was presented in May and recognizes the terrible ten colleagues only a fair and solid single market can secure the prosperity that we need for our citizens thank you.”
  EU Single Market harmonisation
• “But I would also like to emphasise that we in the Parliament got a very strong mandate on this, with more than 500 members voted in favour, a very small number voting against. So definitely Parliament's plans to stick to its position in the negotiations. So how does the presidency assess the feasibility and political acceptability of these elements within the Council? And do you see room for convergence with Parliament on these points? Thank you very much.”
  EU political integration
• “(11:05:15 – 11:07:28): Thank you very much. Thank you for very interesting presentation on a topic which should definitely not be underestimated even though I have to say we saw that, that several years ago during the COVID pandemic and right after, the resilience was definitely a big focus, a big priority of the EU. But I'm seeing that we are kind of losing the momentum, and that's definitely not a good development because all of these threats are still here. Some of them have been mentioned that we had several cases of outbreaks of different diseases, which could potentially threaten Europe. So, definitely, it's important that we do not forget the lessons we learn from COVID and that we need to still make a considerable effort in strengthening our health security from improving surveillance and crisis response mechanism to reinforcing supply chains and preparedness planning. So resilience is not only about responding to the next crisis. It's also about ensuring that our health systems can withstand long term pressures such as demographic change, workforce shortages, increasing chronic diseases, antimicrobial resistance, and emerging health threats. And we have tried to tackle a lot of these things through legislation, for instance, through providing different incentives for development of new antibiotics, also through critical medicines act to strengthen our supply chains and security, and decrease the dependence of our medicine supply. So, definitely, these long term projects and long term efforts are very important. So preparedness must move from strategy papers to practical implementation. Citizens expect public authorities not only to anticipate risks, but also to guarantee continuity of care and equitable access to health services when crisis occur. So I have a very concrete question. What do you see as the single most critical gap that still prevents European public health systems from being truly resilient and crisis ready? And what concrete actions should EU and member states prioritize over the next five years to address this gap while ensuring efficient use of public resources and avoiding unnecessary duplication of structures? Or in other words, what do you see as still the main problem that you need to tackle? Thanks.”
  Government stockpiling of critical medicines
• “Mr. Commissioner, colleagues. Obesity is one of the most serious public health issues in the European Union. According to the Eurostat data, more than one half of the adult population in the EU is overweight. Unfortunately, the statistics show that Croatia, a country I come from, is the state with the most citizens who are overweight. More than 60% of people in Croatia are overweight. It is particularly worrying that approximately 35% of children are facing this issue as well as well. This means that they have been challenged with this issue from an early age, which is of course, um, very threatening for our public health care system. Obesity is the leading cause of certain types of cancer and diabetes. It increases the costs of health care and it decreases the quality of life. This is why we need to focus on obesity in the context of our initiatives, whose aim is to, um, prevent cardiovascular diseases. So we need to promote healthy diet, for example, Mediterranean diet based on olive oil and not processed foodstuffs. We also need to educate our citizens, especially children and youth, so that they acquire healthy nutrition from an early age. Also, we need the front of label packaging because this would enable consumers to recognize healthy products. They need to get the information on the food they eat, which today, unfortunately, is not the case. I also need to emphasize the importance of a physical activity by increasing the availability of other sport content and possibilities. To do sports, we can increase the quality of life of our citizens. Dear colleagues, it is a high time to focus on this topic because this means stronger and more resilient Europe.”
  EU measures on lifestyle-related behaviours (smoking, drinking, eating, etc.)
• “Thank you very much. Thank you, commissioner, for coming to present something which is is, I think, very timely and very important. And I think it's definitely a step in the right direction. I would say that we that for too long, we assumed that having an open market would automatically guarantee competitiveness. However, it has turned out that we we that we thought that we can compete with our global competitors with 1 hand tied behind our back. So, while we were trying to be perfect in that sense, our global competitors have actively supported their industries, strengthened their domestic production capacities, and secured strategic supply chains. So we definitely cannot, cannot afford to be the only major economy which does not act strategically in defense of its industrial base. So I think it's an this is an important political sing signal that we want to to remain not only a market, but also a manufacturing powerhouse. And I think that global geopolitical context shows us that we cannot cannot afford to become dependent on anybody, especially China, but the others as well. Of course, we should remain open to trade and investment, but this may be based on reciprocity. And I fully agree that that access to European market should not be unconditional when European companies face barriers, discrimination, or close procurement markets abroad. However, so reciprocity definitely is something that I that I support, but definitely the rules should be simple. And I I agree with my colleague that with all of these different, additional conditions, exceptions, etcetera, that things are getting pretty, pretty complicated. So, definitely, 1 plea to me would be to try to reduce the amount of exceptions and special rules, etcetera, and that, to make things easier and more certain for European economy. I have 2 very concrete questions. So first, about the scope. So annex 2 and 3, do you think that the scope is made in the right way or that this should be maybe extended a bit because we hear a lot from the industry? And second, can the commission guarantee that the upcoming revision of the public procurement directives will fully take into account the sector specific rules of the IIA? So how will this play out and be aligned with the revision of the general public procurement rules? Thanks.”
  "Buy European" provisions
• “Dear Commissioner, dear colleagues, this report shows clearly that cost deriving from excessive regulation, both European and national, is still too high for European companies. This burden and fragmentation is especially weighing on small enterprises and stops innovation and our competitiveness at global level. More than four years ago, as rapporteur for the committee, I was warning about these obstacles on the market. But this sector, which employs two thirds of the workforce and creates nine out of ten jobs, is still lagging behind on the market and really lagging behind in terms of competitiveness. Unless we overcome these obstacles and unless we transform this potential, in the more jobs and more growth, we will not be able to compete at global level. We need to ensure a fair market. Cartels of multinational companies, which maintain high food prices and high prices of other products, are also inadmissible. In addition, there is a digital market where the digital giants are holding sway and reducing. This must be our priority. We need to give priority to European products because this is a legitimate option to protect our interests. We need to protect consumers from dangerous goods that they buy online from third countries. Digital platforms must bear a liability for this damage that they cause customers, and only in this way we'll be able to control what is being sold on online and protect our customers. Thank you.”
  Liability for online marketplaces
• “Vice president, Commissioner. Colleagues. The European Union cannot be a victim of damaging foreign interference, which not only come from far away, but from neighbouring countries such as Serbia. This shows that a state outside of the EU can destabilise our neighbourhood, and especially when it comes to a candidate country. We can see that in Montenegro, where pro-serbian parties and the Serbian Orthodox Church follow this kind of damaging policy. We think that this package protects our European Union and the message is clear. We want to protect the European Union from manipulation by foreign actors. If we want a secure and safe Europe. We need to send the clear message that projects such as the Serbian world and interference into European Union policies are not acceptable. Thank you.”
  Foreign interference in Europe
• “(09:46:14 – 09:50:04): So combination of of 1 winner tenders and the lowest price resulted in increased dependence on imports, especially generic medicines from India and China, which for us, from a point of view of security of supply, is unacceptable. So the agreement fundamentally changes this approach. For critical medicines where there is a high level of dependency on a single or a limited number of third countries, preference should be given to production based in the European Union. Price will no longer be the sole or dominant criterion in public procurement. Instead, contracting authorities will be able to favor suppliers of critical medicines and their active substances manufactured in the union by applying a scoring system that proportionately rewards the share of manufacturing taking place within the EU. In this context, contracting authorities may allocate additional points to manufacturers that offer 50% or more of the medicinal products and their active substances manufactured in the union. This creates a strong incentive for companies to invest in European production capacities and supply chains. This is not about protectionist. It is about resilience, reliability, and security of supply. Europe cannot continue outsourcing the production of critical medicines while expecting guaranteed access during crisis. Strategic autonomy in health care is no longer optional, but a necessity. The same principles will also apply to collaborative procurement conducted at European level, helping to strengthen supply supply security across the union. And third, on solidarity and contingency stocks. So parliament insisted that measures introduced in 1 member state must not create shortages in in another, which unfortunately sometimes takes place. We therefore secured a clear safeguards stating that contingency stock requirements supplied in 1 member state must not have a negative impact on the availability of medicines in other member states. But even further than that, member states will be required to inform the critical medicines coordination group of their intention to introduce or significantly modify contingency stock requirements. This will increase transparency and allow exchanges based on the principles of proportionality and solidarity. We also strengthened the link with the European voluntary solidarity mechanism. When the mechanism is activated, member states will provide information on available stocks of critical medicines that can be relocated to countries facing shortages. And where voluntary measures are not sufficient, recommendations may be issued inviting member states to adapt contingency stock requirements in order to facilitate the supply of medicines to member states who are experiencing shortages and ensure optimal allocation of critical medicines across the EU. So on this, this is, like, I would say the only part where the parliament was not able to, achieve all of its objectives from the mandate in a sense in a sense of, of adopting a mandatory redistribution mechanism. But definitely, when taking into account everything that I mentioned in terms of solidarity, transparency, on the European level, I think that we achieved a major major a may major improvement when compared to what we have today. So overall, this agreement strengthens Europe's ability to prevent shortages, supports investment in manufacture pharmaceutical manufacturing, modernizes procurement rules, and reinforces the competitiveness of our pharmaceutical sector. So in the end, I would like to thank the council presidency, and the commission for their constructive cooperation throughout the negotiations. The result is, I think, balanced and ambitious agreement that puts European patients, European resilience, and European competitiveness at its center. Thank you.”
  Supply chain diversification requirements in medicine procurement
• “Thank you very much. Thank you for for coming, uh, to to present the situation with the transposition, even though a bit late. Uh, I think this directive was definitely a breakthrough in terms of consumer protection. I think we made a lot of progress on many, on many issues, and that we struck the right balance between the right to protect consumers rights on one side, but and the the need to also facilitate the provision of services on the other. So I think the most important things are that banks will no longer be allowed to send unsolicited credit cards to consumers, home addresses. They will not be able to to unilaterally increase limits for overdraft facilities. For the first time, advertisements for credit will be required to include clear warnings about the potential negative effects of borrowing, including the real risk of overindebtedness, which is very important in terms of informing the consumers so that they actually know what their rights are and that they can be alarmed at the right at the right moment. In addition, consumers will continue to benefit from 14 day withdrawal period, during which they may cancel a credit agreement without providing any justification. And one thing that I would personally like to highlight, which was which was for me personally, extremely important, is the inclusion of the right to be forgotten for cancer survivors, to protect them from discrimination in access to credit. I think this was really a milestone, and this should be the the role model for other rules on financial services, that we should follow suit there as well.”
  Financial regulation
• “Vice President, Commissioner, colleagues throughout the European Union in 2023 and 2024, we had a record lacks of medicines, 130 medicines were lacking behind such a medicine. There is a destiny of a child or a patient that cannot be treated. We are increasingly dependent on generic medicines from China and India, and security of supply is a key question of European security. Um, most of the member states have some kind of legislation for obligatory stockpiling, and this can be good for our systems, but this can also lead to a lack of medicines in other states. And this is something that goes against the principle of solidarity. Therefore, I am very proud of the agreement that we achieved last year, because the fundament of this agreement is solidarity between member states. This means that stockpiling of one member state cannot negatively affect another member states. That means that certain member states, big member states, will not be able to have to stockpile a lot of medicines to the detriment of smaller member states. But the Critical Medicines Act goes even further. We have a mechanism of solidarity Distribution of medicines, which means that we will have um, data sharing of the stockpiles of medicines among member states. Colleagues, European solidarity is not an abstract phenomenon. It means that no citizens in the European Union can be without a certain medicine, because someone else has been stockpiling a lot. And only with solidarity we can be able to secure supply of medicines for everyone.”
  Government stockpiling of critical medicines
• “Madam vice president, Mr.. Commissioner, colleagues this 2030 consumer agenda must be a strong reply to the challenges that the European consumers face every day during my work. In the EPP, I have participated participated in numerous initiatives whose goal was to protect consumers. For example, labeling also new rules pertaining to the loans. These are only some initiatives that we have worked on and whose goal was to protect the consumers. Our consumers enjoy the highest levels of consumer protection in the world. However, we must not stop at that 2030 consumer agenda should be even more ambitious, especially when we talk about unfair commercial practices of large companies at times of high inflation. We are witnessing many misuses of commercial positions. It is particularly worrying that products are sold in different member states at different prices. For example, in Croatia, prices are 2 to 3 times higher than in our than in other member states, especially when it comes to food. We need to end this practice, which is why I call for a very adamant resolution of this problem and directive on unfair practices. We must not have consumers of first class and second class.”
  EU restrictions on unfair commercial practices
• “Madam president, dear colleagues, there is no competitiveness while we are paying for the energy much more than the United States and China. The situation where renewable energy sources need to be connected to the system, and more than 40% of distribution networks are older than 40 years. So as far as I have seen from the media, the official explanation for the blackout in Spain is that the nuclear that the power plants couldn't stabilize the system. The these sabotage stories are really not convincing. However, we can draw some conclusions. Relying on solar and wind leads to destabilization of the network. We need energy mix that will prevent these situations. This means hydro energy, nuclear energy and hydrogen. We shouldn't we shouldn't decide not to use some of these energy sources because of ideology. €600 billion will be needed by 2030 in order to modernize the system. This will bring about a strategic strategic independence from import.”
  EU approach to energy security (home-made vs import sources)
• “Dear mister vice chair, commissioner, ladies and colleagues, medical crisis have shown in the last years how important it is that the EU acts in solidarity and quickly. The recent case, Hondavaris, the MV Hondius is a proof that the public health threats may appear fast, and the coordinated quick response is also key. Therefore, the framework for health security is being strengthened in the past years and regulation on cross border health threats is very important. And the EU has, in this regulation, managed to reply to cross border crisis to exchange information better, coordinate better, and manage crisis situations much better. We also have strengthened the ECDC and other European bodies, but have also established capacities for common procurement of procedure, vaccines, and medicines. Honda's case has shown that this coordination is important. When there is a doubt of a potential infectious disease on a passenger ship, we need to act swiftly and to have clear protocols. We have a increased mobility of population today, but this increased risks also increases the potential of infectious diseases. So our message is clear. The EU must not be unprepared for the upcoming health crisis. We need to invest in common capacities, in the strength of our systems, and develop European Health Union. Health security is not only a national issue, but rather European security stability issue and the issue of the belief and faith of the citizens in the EU. Only timely reactions can efficiently protect the health of EU citizens. Thank you.”
  EU competences on health (internal-competence axis, sharpened)
• “President. Dear colleagues, the Commission Work Programme for 2025 is a strategic document which should make a strong shift for Europe, which would make our continent more secure and more competitive. We had to make a compromise with the irrational green policies, which. Brought about the industrialization of the EU. Yes, we must protect the environment, but we must also protect the economy. I hope that this work programme of the Commission will enable us to keep up with our geopolitical partners, and will make Europe attractive for investments. This especially goes for biotech. The adoption of the Act on Critical Medicines is an absolute priority for this year. In addition, when speaking about competitiveness, we have to talk about the price of energy and reduce the dependence of Europe on foreign sources. How can we compete on the market if we pay higher energy prices? This is why we must diversify. And the energy mix. The focus must be on clean but reliable energy sources like nuclear energy and hydrogen. We have to build Infrastructure. The interconnection to interconnect the energy market. We need a clear vision and we need to act fast. Unless we act fast, the other global forces will engulf us. And I'm glad that the European Commission is on the right path.”
  Energy (green transition)
• “Well, one citizen out of every six amongst young people has difficulties with their mental health, so that is something that we have to act upon. So finally we have a report here, there are specific objectives to achieve what we need to do. It's important to have that financing so that we can better understand the causes of these mental illnesses. I think it is very important to have the appropriate medical care. We need to legislate to avoid negative consequences for young people when dealing with the online world and to tackle those who are posting such negative content that leads to these mental health problems. This is something we need to deal with. That's a fact of everyday life. Sixty-seven percent of citizens feel this mental burden. They're at risk of burnout, so it is very important to act. Otherwise it's a risk for our families and our loved ones. Mental health needs to stop being a taboo subject and needs to be given full attention in our political work to tackle all of these risks.”
  EU policy on mental health
• “Mr. president, Commissioner, colleagues, high retail food prices are one of the key issues for millions of consumers of consumers in the EU. Inflation has slowed down in certain sectors, but when it comes to food it is extremely high. Households across Europe have to make difficult decisions every day. They have to choose between quality and quantity, between healthy foods and what they can afford. Big corporations want to increase their profits, and this is putting extreme pressure on prices and on the single market. According to Eurostat, between 2015 and 2024, food prices and beverage prices have increased by over 40%. Basic foodstuffs have been especially affected. What is worrying is that these same food products in same supermarket chains have different prices across different member states. In sum, there are three times higher, three times more expensive than in neighbouring countries and there is no justification for this. This type of practice is unacceptable and it shows that the single market has certain cracks. Moreover, there is a pattern that shows that there may be a cartel of international companies who are actually defining prices together. This not only distorts competition, it harms consumers, and it endangers our basic principles. Ladies and gentlemen, we cannot allow for Europe to become a Europe with two types of consumers. So the European Commission is called to revise the directive on unfair commercial practices. And as soon as possible, we need to protect consumers from big multinationals.”
  EU restrictions on unfair commercial practices
• “So so only those member states who want to take part in the joint procurement, uh, will, will, will, will, will be there so that that, that that means that that why would member state, uh, take part in joint procurement if they don't want to reimburse to, to purchase the medicine? It doesn't make any sense. I understand what has been said, uh, related to Covid, but Covid was a very different, specific context, and I don't think that we should make any kind of parallels there. So I think the idea is that those member states who want to be part of joint procurement, who want to use this to have a better bargaining position, better negotiating position with the industry to reduce prices, etc., should have the possibility to do so. And of course, why would they be part of that if they don't want to buy the same medicine? Doesn't make doesn't make any sense. Especially I think that this joint procurement for small member states like Malta, like Croatia, etc. is extremely important because it will make it possible for them to buy, for instance, orphan drugs with with lower with lower prices and in a better bargaining position than they have now. Thirdly, about bureaucracy. Yes, I saw. So someone said that one of the problems is problems in bureaucracy.”
  Covid-19 vaccines procurement
• “On the other hand, with all of these achievements, on the other hand, we are shooting ourselves in the foot with the Urban Wastewater Directive. Urban Wastewater Treatment directive, where I the more I get into into it, the more questions are being raised and not more answers. Uh. For me, it seems completely senseless that the claim that that four medicines account for 60% of toxicity in urban wastewater, and also taking into effect that it seems that no actual measurements were carried out as part of this impact assessment definitely also raises concerns about about whether this directive was based on real facts and data. So my question. So my question is what is your position on this both in terms of measuring the actual contribution of the pharma industry to the to the toxicity of urban wastewater, but also the effects on the industry itself. Because if if it seems that if we implement this, that this will lead to shortages of medicines in Europe, and this is not something that we want. So what is your position on this, and what do you think should be the next steps and could stop the clock be an option until we carry out a new impact assessment? Thanks.”
  Water pollution
• “Thank you very much. Thank you Commissioner. First, I would like to commend you for the work ethic because rolling out Critical Medicines Act, revision of the Medical Devices Regulation Biotech Act and the safeguards plan is definitely something that a lot of other parts of the Commission could take some lessons from, because I think this really covers almost all important things that that were that were mentioned in this in this mandate, or at least for the first half of the mandate. Obviously, for the second half, there are some other initiatives that the Parliament will also call for. But this is definitely a big achievement, and I think we made great progress, uh, with all of these proposals in terms of achieving strategic autonomy of the European Union, in terms of production of medicines and medical devices, cutting red tape, enabling access to medical devices and pharmaceuticals in the EU and, but also enabling equal access, which I think is also important. And I also hope that in terms of Critical Medicines Act, where we have these two main objectives. So Autonomy and equality of access that will be able to make a breakthrough soon. I'm not saying that this will be in the last round in the next trilogue, but I hope that it will at least make a significant progress.”
  Medical devices
• “Dear Commissioner, dear colleagues, in 2023, we presented a new pollinator plan with a key objective to reverse the trend of population decline. This is not only the ecological measure, but it is deeply strategical. Without pollinators, we have no food security or healthy environment. I support this initiative and I emphasize the protection of natural habitats and biodiversity. However, the new pollinators plan should go hand in hand with the strategy for beekeepers who fight the disloyal competition every day from third countries, and the data is not good, according to research. Every other honey jar contains forage. Honey are beekeepers who produce high quality honey, cannot keep up with lowered standards and fake declarations. In the last mandate, we managed to prohibit false labels and each production country should be explicitly stated. This was a huge step forward for the consumer protection, but also to for our beekeepers to survive. But this is not the end. We have to use custom mechanism. Increased border controls, stronger export controls and protect beekeeper interests in negotiations with third countries. Also, new pollinators would not be effective without the ban on detrimental pesticides or new techniques, which should not negatively impact the food security. We should support the local food production. We should immediately analyze the results of our agricultural strategies and complemented with the challenges that beekeepers face. We must protect bees, but we also must protect our beekeepers interests. Thank you.”
  Import of agri-food products in the EU
• “On the question of voluntary participation, we emphasize this that both from the member states side and both from the company side, if they want to take part in the joint procurement, that this will be voluntary. So we have we made explicit provision there to also to really to really make this make this clear. Uh, on on additional administration, additional bureaucracy. Uh, the commission will be the one that will be in charge of this coordination mechanism and the gathering of information on stockpiles. But you already have a lot of mechanisms in place. So the idea is to merge everything under one umbrella to make things simpler, to have everything in one, let's say, register instead of these different, different types that we already have now. And I think by doing that, we can also make sure that we actually in the end, we clarify things, we simplify things, and we actually reduce bureaucracy instead of instead of adding adding on top. But maybe some things can be made clear there. But that's, that's that's the objective on the on the question of funding from the EU, we agree fully. So this is why we strengthened the provisions on funding. We think that the EU should also actively take part in this, but this is part of a broader discussion of the role of health in the next MFF.”
  "Buy European" provisions
• “Commissioner. Colleagues, the EU has all it needs to be a leader in global tech. We have the knowledge base, university innovation potential. But in order to use this potential, we need to act Decisively. This is not going to be based on cheap workforce, but on investments into innovation. So first we need to identify strategic sectors in which we can lead, such as biotechnology or medicine production. We do not have capacities to invest into everything so that everybody would be happy. But we have to prioritize. Also, let us not forget that without Europe, there is not no cheap production for digital technology. Look at ASML key. Cheap product producer, which shows that we have strengthened the global geopolitical competition. But to be successful in innovation, we need knowledge and protection of knowledge and intellectual property rights, which will make the EU attractive, attractive, attractive for research and innovation also. We need to support our startups and smaller companies which are the basis of technological development. They need better access to capital through a combination of public and private financing and from EU budget, and also prioritise financing of EU companies. Also, cutting red tape has to be priority and finally, we need to enable good competition. The act on digital markets now bans misuse of dominant position on the market, and it's now time to apply it. Dear colleagues, the new geopolitical circumstances give possibility to Europe to become independent in all ways and let us use it.”
  EU digital & tech sovereignty
• “Thank you very much. Thank you all the shadow rapporteurs and all the other colleagues for a lot of different suggestions. I'm glad that you're already speaking about very concrete things, not just a broad, vague principles, but that we already have the kind of overall picture of what we want and what we want to achieve. And I think this is good, and this will make us, uh, make it possible for us to move faster. I think in principle that we all generally agree. I didn't see conceptually that there are major, major differences, but there are some things that need to be addressed. Uh, so first, one overall question about so lack of competitiveness of our industry, underlining causes, the fact that we only have one, uh, one real big producer of, uh, active ingredients for, uh, antimicrobials. So there are different reasons, but one of the underlying causes is the fact that we have public health systems, which essentially have monopoly on the demand side. And of course, this makes it possible for us to have better bargaining position. I mean, us and I say us, I mean member states, national public authorities, health insurance funds, etc.. And this also helps us, helps us bring prices to a level which is acceptable for our healthcare budgets, but also for the patients. On the other hand, in the US, where they have a different logic, they do pay higher prices and this is why they are resorting to all of this, a lot of these things that they are resorting to today.”
  Antimicrobial resistance
• “In the conditions of European digital market, it is difficult to talk about our independence and sovereignty. This is confirmed that among 10,000 platforms in the EU, only Seven of the biggest ones realized 60% of the profit in key segments like social media. We have foreign platforms, which is unsustainable. When talking about competitiveness, the digital market acts must enable the European companies finally become seriously competitive with European American companies. Interoperability, access to data, prohibition of discrimination of European companies must be applied in practice, and not only a dead letter. At the same time, Europe must invest in the development of own databases and create conditions for their growth. Without a strong digital sector in the EU, there is no strong data protection nor digital sovereignty. This is why we have to fight foreign pressures, especially the ones from Washington, and start defending the interests of our citizens and not of Chinese and American big tech.”
  EU digital & tech sovereignty
• “Commissioner. Colleagues, the single market is the cornerstone of our economic power and our greatest advantage, particularly compared with the USA and China. And we have now a space of almost 450 million people that supports innovation and economic growth. But unfortunately, the single market is not yet complete. We can see that in particular in the services sector, which accounts for the majority, but it's fragmented and there are still many obstacles between member states. If we want Europe to be competitive. We have to remove the red tape and really make it possible for our economy to grow. And that has to happen hand in hand with addressing unfair competition. We have very high standards compared with other competitors, and we can't accept the fact that others with lower standards than ours should undermine our and destroy our producers, our economy and our agriculture. Another problem is inflation, particularly the increase in food prices. Very often food. Can cost up to two times more. I look at the situation in Croatia, and therefore I would call on the Commission to look at the provisions on unfair trade practices and review them once again. It's not acceptable to have second class citizens. Thank you.”
  EU Single Market harmonisation
• “In parallel, negotiations at technical level are already advancing, which I'm very glad, and we are now preparing the second political trialogue, which is expected to take place on 16th of March. This structured approach should allow us to make sufficient progress while fully safeguarding Parliament's mandate and political priorities. So essentially, as usual, the first trialogue was about just stating the positions of both co-legislators and also the Commission by giving mandate to the technical level to proceed with negotiations. Of course, we didn't agree substantially anything in the trialogue, because that's just the procedure. And now we are working already strongly on the technical level to come to the trialogue on 16th of March with some concrete things to discuss on the political level. Again, I would like to thank all of you for your support. We have a very strong mandate for the Parliament, more than 500 votes in favour, and this gives us a strong incentive to fight for our main political priorities. So thank you very much.”
  EU political integration
• “In objective mainstream media, violence is always attributed to the right. But the murders of Quentin, Deron and Charlie Kirk show that murders often come from the extreme left? Also in alliance with Islamist group. And they are the biggest threat to European security and way of life. But the background for this had been set a long time ago. The left is dominating the media. They have a monopoly over the truth, and they tell us what we can and we cannot do. Uh, who does not think like them is dehumanized and is, uh, labeled, uh, xenophobe and fascist. This has led to a mass migration that prevents women from freely walking the European streets. And we have a massive promotion of gender ideology. If we let this continue, this will be the end of European civilization. It is time to say enough.”
  EU policy on integration and ethnic, racial and religious discrimination
• “Mr. president, the technology is crucial for the European and the sector. And this is also in the report. This is the most concurrent, um, competitive industry, which is based on the innovative technology without which we cannot do. And it is not surprising that Trump emphasized this after introducing Losing 15% of tariffs, and this actually forced these industries to move into the US. What are we doing? The Critical Medicines Act represents a step forward, but it is not enough. We urgently need Biotechnology Act, which will create conditions in Europe and make us independent of India, China and US. Unfortunately, this act was postponed to the second half of 26 and until then, all large companies will sign agreements of hundreds of billions of dollars of investment in the US. The consequences will be seen in a decade when we will become fully dependent from medicines abroad. So I'm asking you that biotechnologies and medical products become a priority. On the other hand, we are dealing with topics we are not supposed to deal with LGBTQ strategy. On the 15th page, it is stated that the European Commission will support gender recognition based on self-determination without age restriction. Does it mean that children will be able to, without their parents input, select their gender? For me, it is unimaginable and I want to see that. I want to believe that I misunderstood. I'm asking president von der Leyen to explain this to me. Thank you.”
  Gender roles, equality and inclusion
• “So I think developing this common European mechanism instead of different national priorities and different national mechanisms, I think should be the the main priority. And the second important point that should be upgraded is the funding. So we believe that for strategic projects, for major projects, uh, European funding should also be used. I think I think and I've spoken with her many times and that there are some possibilities how to define the sources for this, for this funding and definitely the next EU budget, the next in the next time. If we should have strong budget also for the implementation of the CMA. This is why it's very important to to have a separate EU health program in the next budget. And I'm counting on you and on DG to really fight for that. Because for us this is a major this is a major, major priority. And there are also some other things. For instance, I think there are some things that could be better defined. For instance the for instance the the scope this what are the projects of common interest? I think that there are things we can define things in a better way, a clear way to have more legal certainty and predictability. So definitely I think we have our work cut out, but I think the overall concept is good. I think the overall priorities are good, and definitely the European Parliament will improve on that. So and I hope and I look forward to working together. Thanks.”
  Size of EU budget · EU energy infrastructure integration
• “Thank you very much. So on, on in my role as the shadow for the regulation, I would just like to make two comments. So first, in general about about the whole package. So both directive and regulation. I think that it's I would like to commend the council for being able to come up with the composition before the end of the Polish presidency. I wasn't that optimistic, but they proved me wrong. I think it's a good approach. I think it's pretty close to Parliament's position. It tries to strike the balance between the need to incentivise research and innovation in Europe on one side, but also the necessity to protect the interests of the generic industry, to facilitate access of generic medicines to market, but also the quality of access. And I think this kind of a compromise between incentives on one side, strong border exemption on the other, which makes it possible for generic medicines to come on the market right away after the protection expires. But also the obligation to provide medicines to all member states when they make a request. Is very important. So so by doing that, we are the balance struck between the innovators. The generic ones, but also the quality of access which I think is most important. What cannot happen anymore is that we have first and second class citizens in the EU. So I think that the Parliament and council position are pretty close. I'm also glad that the council has protected the vouchers. So they they want to retain the vouchers. We are also clear, very close to the position in some other areas. I think in terms of antimicrobials, the Parliament's position contains some additional incentives on top of the voucher, like milestone payments, which I think are important to be kept. But I think all of these differences between the Parliament and the council are not so big that it would be impossible to reach an agreement, and I'm definitely optimistic in that sense, and I'm glad that we definitely came together in finding the right balance. And I'm optimistic about the future trialogues after the summer. Thanks.”
  Pharma IPRs
• “When we were drafting this, we didn't know what will be the outcome of the Eu-us trade negotiations. We didn't know that there will be no, uh, reciprocal, reciprocal tariffs from the EU side. But in case that happens, I think that we should also be prepared. And this funding, this money should go in investing into projects like this to to strengthen the security of supply in the European Union. Next, the award criteria. The report also makes clear that procurement cannot be based on price alone. We already have that in the commission proposal, but we try to even emphasize that and make this even stronger. So member states must implement multi-winner procurements. We know that this is something that is very important for the industry, and what we learned from discussions with different tiers of the industry, both innovative and generic industry, and apply procurement requirements that include more than just costs. Public procurement must use an appropriate and predictable mix of qualitative criteria with clear weighting, weighing in order to guarantee sufficient volumes for companies and give them the stability to invest. So we try to clarify what these criteria are, but also something which is very important for predictability and certainty for the industry that also fixed quantities, defined quantities are included in the tenders in advance.”
  "Buy European" provisions
• “Thank you very much. Thank you. Thank you for the presentation. My specific question relates to small particles, because we have a lot of studies which shows that small particles, microparticles are one of the leading causes of death from environmental issues, from environmental factors in the European Union. And in my country, in Croatia, that's, I believe, one of the one especially problematic, one of the, one of the main, I would say public health problems, partly because of the heating in houses, especially in, in especially, especially in family, in family homes where a lot of wood and other things are used for heating and but also the fine particles which are emitted from, uh, from coal based power plants in neighboring countries in Bosnia and Herzegovina and Serbia. And, and and we see during the winter especially that our capital, Zagreb is one of the most polluted cities in the European Union. So my question is, uh, what what what what do you think that that we should do about it? What kind of a problem do you think that is? Do you think that this is a major public public health concern? Uh, what are the main causes of this? So am I right when I'm saying that that heating is a big part of it? What are the other causes, whether it's transport, cars, etc.? And what do you think that we should do about it on the European level? Thanks.”
  Air quality policy
• “Thank you very much producing food and medicine is of strategic importance for the European Union. But digital technology as well. And digital technology, we should be the ones who determine the rules that will be on the common market we have managed to reach our sovereignty with our laws. By this we give better possibilities to choose to our consumers and we want to prevent that. Only some giants in the digital field control everything. We should decide who is going to lead us in order to become independent and sovereign in digital matters. Europe does not need, does not need to succumb to any kind of blackmail, be it from the United States.”
  EU digital & tech sovereignty
• “Vice president Commissioner colleagues Mr. Demers report states that 4.6 billion small passes were imported into the EU under the value of €150. We spent millions on buying these products, which is damaging for our small companies in Europe, and therefore I'm in favour of the proposal to do away with this threshold and to focus on the deemed importer to ensure that somebody is held responsible for the goods imported into the EU, and that will give us more money in our budget. The customs authorities must carry out checks at the borders and be able to stop these damaging products, if they are indeed dangerous at the border. A two year handling fee per parcel. Must not the damage or be liable or be liable to the final user? The end user must not be obliged to pay for that. We must protect our consumers from, um, imports from China that are not safe, and everything that goes through our borders must be controlled. We cannot leave everything to. It can't turn into a Wild West situation. We need some order. We need to comply with the regulations. Thank you.”
  EU policy on custom fee on non-EU imports
• “1 in 6 young people are victims of harassment. Online violence of digital platforms is expanding rapidly and leaves long standing consequences, especially on young people and children, despite the existing European legislation. Um, cyber bullying is on the increase. Uh, un unfortunately, uh, victims are not evenly protected. So safety should not depend on where one resides. At the same time, there are more and more complex forms of harassment, from sharing intimate content to challenges posed by AI. This requires a unified EU answer. We need to urgently act at the European level in order to implement the existing legislation to implement the existing sanctions for cyberbullying, to restrict access of children to internet, and to invest more into preventing violence online. At the same time, awareness raising should be a key tool to fight against this problem. This is the right of every individual, irrespective of the country where they live. Thank you.”
  Safety features & content control for child protection online
• “Thank you, Mr. Vice President. The protection of young people on the internet is very important. Parents used to know where problems might arise, so they just had to make sure not to let them stay on the street for too long. Or make sure that they are surrounded by good people. But now we think that we have the situation under control because now children are living offline and online. So Recommendations on handling minors profiles are very welcome. I think that we need to be careful when it comes to rules, because the legislator must not trump upon other people's rights and the rights of those who are not doing anything wrong. Because we need to make sure not to overstep our mark.”
  Safety features & content control for child protection online
• “This so-called deal is a one sided deal. It's not balanced. However, there are some positive elements within it when it comes to generics medicines that's been covered. But really, it is a detail. We have 450 million consumers in the in Europe, and we have a deficit when it comes to products when it comes to services. We haven't really done very much productive during these negotiations. We got some guarantees, but I'm afraid they're not safe guarantees and we haven't received certainty. Into the US side is now putting pressure on us. They're putting pressure on us when it comes to digital corporations and asking us to change our measures. It was predictable, really. New partnerships with Japan, Canada, Australia, countries of Latin America. You know, this is what we're now talking about again. And we need to make sure that our interests are protected in these talks. We also need to insist on reciprocity in these agreements, and we need to strengthen our European industry. That's the only way of achieving a strong Europe for our citizens and our companies.”
  EU-US trade relations
• “In parallel, negotiations at technical level are already advancing, which I'm very glad, and we are now preparing the second political trialogue, which is expected to take place on 16th of March. This structured approach should allow us to make sufficient progress while fully safeguarding Parliament's mandate and political priorities. So essentially, as usual, the first trialogue was about just stating the positions of both co-legislators and also the Commission by giving mandate to the technical level to proceed with negotiations. Of course, we didn't agree substantially anything in the trialogue, because that's just the procedure. And now we are working already strongly on the technical level to come to the trialogue on 16th of March with some concrete things to discuss on the political level. Again, I would like to thank all of you for your support. We have a very strong mandate for the Parliament, more than 500 votes in favour, and this gives us a strong incentive to fight for our main political priorities. So thank you very much.”
  EU political integration
• “Dear Vice President, Commissioner, honourable members, cardiovascular disease is the leading cause of death in the EU. 1.7 million lives are lost every year. Besides it really, it incurs as much as €200 billion in costs every year. Safe heart plan covers early detection and health checks. Treatment and rehabilitation such as such a comprehensive treatment is what we wanted because cardiovascular disease cannot be tackled partially. Special attention to risk factors such as tobacco, ultra processed food, sedentary lifestyle. All these contribute to the cardiovascular diseases. I come from Croatia, which has a problem with many of those health, um, risk factors. What we expect from commission is improved labeling of food so that the consumers can get timely and high quality information about what they're consuming. This plan is also focused on the research and reducing differences between the member states and providing support to the development of the national cardiovascular health plans. But what is the most important at the moment is to provide available funding. Therefore, I call on you, Commissioner, to work together with us to provide necessary funds through a dedicated line. A separate budget for health is the only way to keep it as priority, and for us also to achieve our targets for the benefit of all our citizens. Only a healthy union can be a strong and competitive union. Thank you.”
  Food labelling harmonisation at EU level