Jaroslava POKORNÁ JERMANOVÁ

Policy topics Jaroslava POKORNÁ JERMANOVÁ is active on

What Jaroslava POKORNÁ JERMANOVÁ has said (7)

• 2025-07-15 “P-002901/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission's pharmaceutical reform proposal 1 aims to enhance patient safety through accurate information on medicines and introduces electronic alternatives to paper package leaflets. These electronic formats are intended to improve medicine access and distribution within the Union, offering at least equal, if not superior, quality of information compared to paper leaflets. The shift to electronic leaflets addresses issues like medicine shortages, multilingual packaging, timely updates in patients' languages, small market needs, hospital requirements, health emergency availability, and reduced administrative burdens, all while being environmentally friendly. Recognising varying digital literacy and internet access across Member States, the proposal permits discretionary measures for electronic information provision, ensuring no patient is left behind. It considers different age groups and digital literacy levels, ensuring accessibility for all patients. If Member States choose electronic-only leaflets, paper versions must remain available on demand, free of charge. The proposal retains the requirement for medicine labelling and package leaflets to be available in the official language(s) of each Member State, ensuring clarity and comprehensibility for all users. The Commission also believes that electronic product information is not directly linked to parallel trade, which is driven by price differences in the EU rather than regulatory requirements. The proposal is under discussion by the co-legislature, with both the European Parliament and the Council proposing amendments while recognising the benefits of electronic product information. 1 COM/2023/192 final.”
  Pharmaceuticals regulation in EU
• 2025-05-21 “E-002033/2025 Answer given by Mr Várhelyi on behalf of the European Commission The Commission recognises the strategic importance of the medical devices sector. Therefore, it is a priority to work on addressing challenges identified in the regulatory framework for medical devices and in vitro diagnostic medical devices. The Commission is conducting a targeted evaluation of the concerned regulations. In 2025, based on this targeted evaluation, the Commission will propose legislation that strikes a balance between simplifying EU regulations related to medical devices and in vitro diagnostics, with a view to facilitate businesses’ operations across the EU single market and effectively protecting patient safety and public health 1 . The targeted evaluation is part of the Commission's ongoing work to streamline and improve the EU's rules for medical devices. On 25 June 2025, the Commission adopted an implementing regulation that simplifies the provisions of instructions for use of medical devices and further digitalises healthcare systems 2 . On 7 July 2025, it adopted a decision to establish an expert panel to provide scientific and clinical advice concerning devices intended for small patient populations, such as children or patients with a rare disease 3 . Further measures are in preparation. One of the tasks of the Medical Device Coordination Group (MDCG), set up by the Regulation on medical devices and composed of representatives of each Member State, is the development of guidance aimed at ensuring effective and harmonised implementation of the Regulations on medical devices and in vitro diagnostics 4 . The MDCG has produced more than 100 guidance documents that are available online 5 . 1 See Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, Choose Europe for life sciences: A strategy to position the EU as the world’s most attractive place for life sciences by 2030, COM(2025)525 final, 2.7.2025. 2 Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form, OJ L 26.6.2025, ELI: http://data.europa.eu/eli/reg_impl/2025/1234/oj. 3 https://eur-lex.europa.eu/eli/dec_impl/2025/1324/oj/eng. 4 See Article 105, point (c), of Regulation (EU) 2017/745 on medical devices, OJ L 117, 5.5.2017, p. 1, ELI: http://data.europa.eu/eli/reg/2017/745/oj. 5 See Guidance - MDCG endorsed documents and other guidance https://health.ec.europa.eu/medical-devicessector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en.”
  Medical devices
• 2025-04-30 “P-001769/2025 Answer given by Executive Vice-President Séjourné on behalf of the European Commission The European Chemicals Agency’s Committee for Socio-Economic Analysis concluded 1 in its assessment that the proposed restriction of lead in ammunition is proportionate, i.e. the expected benefits compensate the expected costs. The Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) 2 does not provide for compensatory mechanisms, because restrictions are proposed after thoroughly assessing their estimated costs and benefits. In its proposal, the Commission paid close attention to preserving Member States’ defence preparedness as well as the Union’s strategic autonomy and security of supply. To this end, it (i) excludes all military and defence applications from the scope, and (ii) allows the continued use of lead bullets (the most common ammunition used for defence purposes) in civilian sports shooting ranges, without conditions. This will ensure that the demand for lead bullets remains at pre-restriction levels as the market for lead bullets is driven by bullets for sport shooting. Production lines for lead bullets will therefore remain economically viable and available should there be a need to scale up production for military uses. The restriction is not expected to bring new dependencies from third countries as most lead and steel used in ammunition already come from outside the EU. The proposed obligation to recover spent lead will rather help reduce the existing dependence. 1 Committee for Risk Assessment (RAC), Committee for Socio-economic Analysis (SEAC). Opinion on an Annex XV dossier proposing restrictions on Lead and its compounds (2 December 2022). https://echa.europa.eu/documents/10162/2c82ef18-ce5d-4b4f-8ff0-002932154acc. 2 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 396 30.12.2006, p. 1). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02006R1907-20241218.”
  EU industrial funding
• “As said, defense cooperation is vital. Representatives of the British Parliament and government said that they were ready to cooperate with us on defense and military and police cooperation. We would like to deepen even more the structured dialogue we have between the EU and the UK. This also applies to the access to public markets on both sides. This should happen in a reciprocal way and coordination mechanisms need to be clearly spelled out at this time. Particularly, cooperation on defence is of vital importance. We would also hope that the UK's visa system will be able to allow more EU workers to enter the country. The sponsoring system is too bureaucratic and often very opaque. Cultural organisations, researchers, service providers and others are facing obstacles when it comes to accessing the British market. There are tariffs, taxes that are going up and up and simplification really is necessary. The UK said that it hoped and hoped to deepen cooperation when it comes to service provision, but to do that we need to ensure that there is a friendly atmosphere. So we are calling for cooperative dialogue when it comes to cutting red tape, making it easier for EU workers to access the UK market, and particularly when it comes to cultural fields and IT fields. It's important that we don't make people's lives more difficult. We see positive developments when it comes to service provisions, but we do need to apply pressure to the UK government so that there aren't any unnecessary hindrances.”
  EU-UK relations
• “Thank you, Madam Chair. I will continue in Czech. Madam chair. A rapporteur. Distinguished colleagues, as we pointed out at the last meeting on the 20th of May. We support the association agreements between EU and do a small but important countries and and San Marino. The agreement brings a specific benefits for both parties, including ourselves, the countries of the European Union to support our markets, support our entrepreneurship as well as cross-border service provision. The same tariff rules and sales rules for goods and services will follow EU standards. We have no significant comments or objections. We only wanted to have explanations on one of the amendments which will be clarified later. Thank you.”
  EU-Switzerland relations
• “Thank you for the floor. I will continue in Czech. I would like to ask the representatives of the Commission how do what the national systems will do if the Commission has new powers in case of serious breaches of the law. What is the experience in, uh, areas where it already exists, for example, DSA.”
  EU Supervision of the Rule of Law
• “Thank you for the floor. I will continue in Czech. I would like to ask the representatives of the Commission how do what the national systems will do if the Commission has new powers in case of serious breaches of the law. What is the experience in, uh, areas where it already exists, for example, DSA.”
  EU Supervision of the Rule of Law