amendment list, 11 September 2026
Modernised rules for patients’ rights in cross-border healthcare
Document SANT-AM-792154 · (2025/2206(INL))
Committee on Public Health
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Text 857 paragraphs
Amendment 342
Margarita de la Pisa Carrión
Motion for a resolution
Paragraph 19 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 19a. Recalls that, in accordance with Article 168(7) of the Treaty on the Functioning of the European Union (TFEU), the definition of health policy and the organisation, management and allocation of resources for health services and medical care are the responsibility of the Member States, and they must be able to shape and manage their health systems in accordance with their national specificities, available resources and own priorities. |
Or. es
Amendment 343
Victor Negrescu
Motion for a resolution
Paragraph 20
| Motion for a resolution | Amendment |
|---|---|
| 20. Considers that the financial implications of the requested proposal should be covered by existing budgetary allocations; | 20. Considers that the financial implications of the requested proposal should be covered by existing budgetary allocations; calls on the Commission to propose, preferably under a strengthened stand-alone EU4Health programme, a Union solidarity mechanism supporting patients who require cross-border access to high-cost or highly specialised care that cannot be provided within a medically justifiable time limit in their Member State of affiliation; stresses that the mechanism should cover the part of the eligible treatment cost not reimbursed by the Member State of affiliation and pay it directly to the competent institution or healthcare provider, so that the patient is not required to advance or bear that cost; |
Or. en
Read the rest (845 paragraphs)
Amendment 344
Christine Anderson
Motion for a resolution
Paragraph 20
| Motion for a resolution | Amendment |
|---|---|
| 20. Considers that the financial implications of the requested proposal should be covered by existing budgetary allocations; | 20. Considers that the measures proposed in this report are likely to entail significant additional expenditure for national healthcare and insurance systems; insists that the Commission conduct a comprehensive impact assessment, including the financial consequences for Member States, patients and contribution payers, before presenting any legislative proposal; stresses that no new Union funding obligations should be created in an area for which the Member States remain primarily responsible; |
Or. en
Amendment 345
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Paragraph 20
| Motion for a resolution | Amendment |
|---|---|
| 20. Considers that the financial implications of the requested proposal should be covered by existing budgetary allocations; | 20. Considers that the financial implications of the requested proposal should be covered by the allocation of adequate funding within the next Multiannual Financial Framework (MFF); |
Or. en
Amendment 346
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Annex I – Part A – point 1
| Motion for a resolution | Amendment |
|---|---|
| 1. The revision of Directive 2011/24/EU aims to address the persistent financial and administrative barriers that prevent patients from effectively exercising their right to safe and high-quality cross-border healthcare, which currently risks exacerbating health inequalities across the Union. | 1. The revision of Directive 2011/24/EU aims to address the persistent financial and administrative barriers that prevent patients from effectively exercising their right to safe and high-quality cross-border healthcare, which currently risks exacerbating health inequalities across the Union, and should ensure that access to cross-border healthcare is determined by medical need rather than financial means. |
Or. en
Amendment 347
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Annex I – Part A – point 2
| Motion for a resolution | Amendment |
|---|---|
| 2. To ensure equitable access based on medical need rather than financial means, the proposal seeks to put in place mechanisms for direct financial compensation between Member States' institutions to alleviate the burden of upfront payments. Furthermore, it eliminates discriminatory reimbursement practices by requiring tariffs to be calculated based on public or contracted rates, and mandates fast reimbursement mechanisms for additional costs, based on income eligibility. | 2. To ensure equitable access based on medical need rather than financial means, the proposal seeks to put in place mechanisms for direct financial compensation between Member States' institutions to alleviate the burden of upfront payments. Furthermore, it eliminates discriminatory reimbursement practices by requiring tariffs to be calculated based on public or contracted rates, and mandates fast reimbursement mechanisms for additional costs, based on income eligibility. The proposal should also provide for direct billing, advance payment or other appropriate mechanisms where upfront costs constitute a substantial barrier, and ensure the reimbursement or direct coverage of necessary and reasonable travel, accommodation and subsistence costs where these are essential to accessing authorised cross-border healthcare, with particular consideration for children, persons with disabilities and patients with rare and complex diseases and, where necessary, their accompanying parents, guardians or caregivers. |
Or. en
Amendment 348
Valérie Deloge, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Motion for a resolution
Annex I – Part A – point 2
| Motion for a resolution | Amendment |
|---|---|
| 2. To ensure equitable access based on medical need rather than financial means, the proposal seeks to put in place mechanisms for direct financial compensation between Member States' institutions to alleviate the burden of upfront payments. Furthermore, it eliminates discriminatory reimbursement practices by requiring tariffs to be calculated based on public or contracted rates, and mandates fast reimbursement mechanisms for additional costs, based on income eligibility. | 2. The proposal respects the freedom of Member States to determine, in accordance with their national legislation, the arrangements for reimbursement and assumption of the costs of cross-border healthcare and does not impose a general mechanism abolishing the advance payment of costs. |
Or. fr
Amendment 349
Giorgos Georgiou
Motion for a resolution
Annex I – Part A – point 2
| Motion for a resolution | Amendment |
|---|---|
| 2. To ensure equitable access based on medical need rather than financial means, the proposal seeks to put in place mechanisms for direct financial compensation between Member States' institutions to alleviate the burden of upfront payments. Furthermore, it eliminates discriminatory reimbursement practices by requiring tariffs to be calculated based on public or contracted rates, and mandates fast reimbursement mechanisms for additional costs, based on income eligibility. | 2. To ensure equitable access based on healthcare need rather than financial means, the proposal seeks to put in place mechanisms for direct financial compensation between Member States' institutions to alleviate the burden of upfront payments. Furthermore, it eliminates discriminatory reimbursement practices by requiring tariffs to be calculated based on public or contracted rates, and mandates fast reimbursement mechanisms for additional costs, based on income eligibility. |
Or. en
Amendment 350
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Annex I – Part A – point 2
| Motion for a resolution | Amendment |
|---|---|
| 2. To ensure equitable access based on medical need rather than financial means, the proposal seeks to put in place mechanisms for direct financial compensation between Member States' institutions to alleviate the burden of upfront payments. Furthermore, it eliminates discriminatory reimbursement practices by requiring tariffs to be calculated based on public or contracted rates, and mandates fast reimbursement mechanisms for additional costs, based on income eligibility. | 2. To ensure equitable access based on healthcare need rather than financial means, the proposal seeks to put in place mechanisms for direct financial compensation between Member States' institutions to alleviate the burden of upfront payments. Furthermore, it eliminates discriminatory reimbursement practices by requiring tariffs to be calculated based on public or contracted rates, and mandates fast reimbursement mechanisms for additional costs, based on income eligibility. |
Or. en
Amendment 351
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Annex I – Part A – point 3
| Motion for a resolution | Amendment |
|---|---|
| 3. Administrative procedures must be streamlined and harmonised. The proposal requires the expansion of the voluntary prior notification system and demands that Member States publish clear and detailed lists of treatments subject to prior authorisation. To guarantee equal access to information, it mandates that National Contact Points provide this information at least in the official languages of the Member State. | 3. Administrative procedures must be streamlined and harmonised. The proposal requires the expansion of the voluntary prior notification system and demands that Member States publish clear and detailed lists of treatments subject to prior authorisation. To guarantee equal access to information, it mandates that National Contact Points provide this information at least in the official languages of the Member State and English. It should also establish binding maximum time limits for decisions on prior authorisation, accelerated procedures for urgent and time-sensitive cases, and safeguards against unnecessary or duplicative administrative and medical requirements, including where the patient's diagnosis or clinical need has already been appropriately established. To guarantee equal and transparent access to information, National Contact Points should provide clear, detailed and regularly updated information on prior-authorisation requirements and reimbursement rules in the official language or languages of the Member State, in an accessible and patient-friendly format. |
Or. en
Amendment 352
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Annex I – Part A – point 3 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 3a. The proposal recognises that in border regions cross-border healthcare is a structural component of the provision of care rather than an exception. It accordingly establishes a framework for cross-border healthcare access zones, within which residents may obtain care on the other side of the border without prior authorisation and without advance payment, and a framework for the cooperation of emergency medical and rescue services, based on the dispatch of the nearest available appropriate unit irrespective of the border. |
Or. en
Amendment 353
Valérie Deloge, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Motion for a resolution
Annex I – Part B – paragraph 11 – point 1
| Motion for a resolution | Amendment |
|---|---|
| (1) Directive 2011/24/EU of the European Parliament and of the Council requires targeted amendments to simplify the legal framework, reduce administrative burdens, improve transparency, strengthen digital integration, and ensure equity across Member States. | (1) Directive 2011/24/EU of the European Parliament and of the Council requires targeted amendments to simplify the legal framework, reduce administrative burdens and improve transparency, while fully respecting the responsibilities of the Member States for the organisation and delivery of health services and medical care, in accordance with Article 168(7) of the Treaty on the Functioning of the European Union. |
Or. fr
Amendment 354
Valérie Deloge, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Motion for a resolution
Annex I – Part B – paragraph 11 – point 2
| Motion for a resolution | Amendment |
|---|---|
| (2) Article 35 of the Charter of Fundamental Rights of the European Union states that everyone has the right of access to preventive health care and the right to benefit from medical treatment, It is necessary to guarantee that right in accordance with the overarching values of equitable access to good quality care and solidarity among Member States and to ensure that patients are treated equitably on the basis of their healthcare needs rather than their financial means or their Member State of affiliation. | (2) Article 35 of the Charter of Fundamental Rights of the European Union states that everyone has the right of access to preventive health care and the right to benefit from medical treatment. It is necessary to guarantee that right in accordance with the overarching values of equitable access to good quality care and solidarity among Member States and to ensure that patients are treated equitably on the basis of their healthcare needs rather than their financial means or their Member State of affiliation. However, this solidarity could only be justified where patients cannot find an appropriate diagnosis or treatment in their own country. |
Or. fr
Amendment 355
Giorgos Georgiou
Motion for a resolution
Annex I – Part B – paragraph 11 – point 2
| Motion for a resolution | Amendment |
|---|---|
| (2) Article 35 of the Charter of Fundamental Rights of the European Union states that everyone has the right of access to preventive health care and the right to benefit from medical treatment, It is necessary to guarantee that right in accordance with the overarching values of equitable access to good quality care and solidarity among Member States and to ensure that patients are treated equitably on the basis of their healthcare needs rather than their financial means or their Member State of affiliation. | (2) Article 35 of the Charter of Fundamental Rights of the European Union states that everyone has the right of access to preventive health care and the right to benefit from healthcare treatment, It is necessary to guarantee that right in accordance with the overarching values of equitable access to good quality care and solidarity among Member States and to ensure that patients are treated equitably on the basis of their healthcare needs rather than their financial means or their Member State of affiliation. |
Or. en
Amendment 356
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Annex I – Part B – paragraph 11 – point 2
| Motion for a resolution | Amendment |
|---|---|
| (2) Article 35 of the Charter of Fundamental Rights of the European Union states that everyone has the right of access to preventive health care and the right to benefit from medical treatment, It is necessary to guarantee that right in accordance with the overarching values of equitable access to good quality care and solidarity among Member States and to ensure that patients are treated equitably on the basis of their healthcare needs rather than their financial means or their Member State of affiliation. | (2) Article 35 of the Charter of Fundamental Rights of the European Union states that everyone has the right of access to preventive health care and the right to benefit from healthcare treatment, It is necessary to guarantee that right in accordance with the overarching values of equitable access to good quality care and solidarity among Member States and to ensure that patients are treated equitably on the basis of their healthcare needs rather than their financial means or their Member State of affiliation. |
Or. en
Amendment 357
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point -1 (new)
| Motion for a resolution | Amendment |
|---|---|
| (-1) in Article 3, the following points are added: | |
| (n) ‘border region’ means a region situated along an internal border of the Union, or such an area as jointly defined by the Member States concerned; | |
| (o) ‘cross-border healthcare access zone’ means a geographical area designated jointly by the competent authorities of two or more neighbouring Member States, within which the residents of that area may receive healthcare from the healthcare providers listed in the act of designation, on the conditions laid down in Article 10a; |
Or. en
Amendment 358
Kristian Vigenin
Motion for a resolution
Article 1 – paragraph 1 – point -1 (new)
| Motion for a resolution | Amendment |
|---|---|
| (-1) In Article 3, a new point is added: | |
| (n) ‘telemedicine’ means the provision of healthcare at a distance, using information and communication technologies, where the patient and the health professional, or the health professionals involved, are not in the same location, for the purpose of prevention, diagnosis, treatment, monitoring or follow-up of a patient’s state of health. |
Or. en
Amendment 359
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point -1 (new)
| Motion for a resolution | Amendment |
|---|---|
| (-1) in Article 3, point m is replaced by the following: | |
| (m) ‘health records’ means all the documents containing data, assessments and information of any kind on a patient’s situation and clinical development throughout the care process. |
Or. en
Amendment 360
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph -1 (new)
| Motion for a resolution | Amendment |
|---|---|
| -1 (55) For rare and complex diseases, access to cross-border healthcare includes access to clinical trials, including early-phase trials. Low-intervention trials form part of standard treatment for certain conditions, while experimental therapies offered in selected centres may offer a second chance to patients with relapsed or refractory malignancies. Access to research conducted in centres across Europe is therefore an essential component of care for these patients. |
Or. en
Amendment 361
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph -1 a (new)
| Motion for a resolution | Amendment |
|---|---|
| -1a in Article 3, point m is amended as follows: | |
| ‘health records’ means all the documents containing data, assessments and information of any kind on a patient’s situation and clinical development throughout the care process.” | |
| "Telemedicine" means the delivery of health care services, where distance is a critical factor, by all healthcare professionals using information and communications technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and the continuing education of health care workers, with the aim of advancing the health of individuals and communities. | |
| “cross-border clinical trial” means a Clinical study conducted at a site in one or more countries that includes participants (patients) who travel from other countries to take part in the trial. | |
| “cross-border trial participants”’ means clinical trial participants who are joining a trial at a site located outside the country where they reside or hold citizenship. |
Or. en
Amendment 362
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 1 a (new)
| Motion for a resolution | Amendment |
|---|---|
| b) healthcare providers provide relevant information to help individual patients to make an informed choice, including on treatment options and relevant cross-border clinical trials, and on the practical steps for obtaining further information and support to access such trials, on the availability, quality and safety of the healthcare they provide in the Member State of treatment and that they also provide clear invoices and clear information on prices, as well as on their authorisation or registration status, their insurance cover or other means of personal or collective protection with regard to professional liability. To the extent that healthcare providers already provide patients resident in the Member State of treatment with relevant information on these subjects, this Directive does not oblige healthcare providers to provide more extensive information to patients from other Member States. |
Or. en
Amendment 363
Valérie Deloge, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "(g) a seamless communication and information exchange is established between professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format."; | "(g) where necessary for the continuity of cross-border care, secure communication and exchange solely of relevant medical data is established between professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format and in accordance with Regulation (EU) 2016/679, Regulation (EU) 2025/327 and the applicable national provisions, in particular on medical confidentiality."; |
Or. fr
Amendment 364
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "(g) a seamless communication and information exchange is established between professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format."; | "(g) a seamless communication and information exchange is established between professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format and shall be implemented in accordance with Regulation (EU) 2025/327 on the European Health Data Space "; |
Or. en
Amendment 365
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "(g) a seamless communication and information exchange is established between professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format."; | "(g) a effective communication and secure information exchange is established between professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format. established under the European Health Data Space"; |
Or. en
Amendment 366
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "(g) a seamless communication and information exchange is established between professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format."; | "(g) a seamless communication and information exchange is established between highly-educated and trained healthcare professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format."; |
Or. en
Amendment 367
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "(g) a seamless communication and information exchange is established between professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format."; | "(g) a seamless communication and information exchange is established between highly-educated and trained healthcare professionals and organisations responsible for the treatment in order to allow the safe handover of patients and continuity of care across borders. Such communication and information exchange shall be established by taking into account the mandatory use of the European electronic health record exchange format"; |
Or. en
Amendment 368
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| paragraph 2f. is amended as follows: “(f) in order to ensure continuity of care, patients who have received treatment are entitled to a written or electronic health record of such treatment, and access to at least a copy of this record in conformity with and subject to national measures implementing Union provisions on the protection of personal data, in particular Regulation (EU) 2016/679, Directive 2002/58/EC, and Regulation (EU) 2025/327 |
Or. en
Amendment 369
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| in order to ensure continuity of care, patients who have received treatment are entitled to a written or electronic health record of such treatment, and access to at least a copy of this record in conformity with and subject to national measures implementing Union provisions on the protection of personal data, in particular Regulation (EU) 2016/679, Directive 2002/58/EC, and Regulation (EU) 2025/327 |
Or. en
Amendment 370
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| in paragraph 2 point e is replaced by the following: | |
| (e) the fundamental right to privacy with respect to the processing of personal data is protected in conformity with national measures implementing Union provisions on the protection of personal data, in particular Regulation (EU) 2016/679, Directive 2002/58/EC, and Regulation (EU) 2025/327.”; |
Or. en
Amendment 371
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2 b (new)
| Motion for a resolution | Amendment |
|---|---|
| in Article 5 is amended as follows: | |
| (c) where a patient has received cross-border healthcare or participated in cross-border clinical trials and where medical follow-up proves necessary, appropriate arrangements are in place to ensure safe and coordinated continuity of care, including between the trial site and the patient’s healthcare providers in the Member State of affiliation patients, and where relevant their accompanying family members or caregivers, do not lose their social security entitlements, residence-based rights or benefits in the Member State of affiliation as a result of a temporary stay in or change of residence to another Member State in the framework of this Directive. |
Or. en
Amendment 372
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 1 – paragraph 2 b (new)
| Motion for a resolution | Amendment |
|---|---|
| in paragraph 2 point f is replaced by the following: | |
| (f) in order to ensure continuity of care, patients who have received treatment are entitled to a written or electronic health record of such treatment, and access to at least a copy of this record in conformity with and subject to national measures implementing Union provisions on the protection of personal data, in particular Regulation (EU) 2016/679, Directive 2002/58/EC, and Regulation (EU) 2025/327.” |
Or. en
Amendment 373
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 1 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (1a) in Article 5, point d is replaced by the following: | |
| (d) patients who seek to receive or do receive cross-border healthcare have remote access to or have at least a copy of their health records, in conformity with, and subject to, national measures implementing Union provisions on the protection of personal data, in particular Regulation (EU) 2016/679, Directive 2002/58/EC, and Regulation (EU) 2025/327.” |
Or. en
Amendment 374
Marta Temido, Kristian Vigenin, Vytenis Povilas Andriukaitis
Motion for a resolution
Article 1 – paragraph 1 – point 1 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (1a) in Article 1, the following point is added | |
| 4a. This Directive establishes a “One-Stop Shop for European Cross-Border Healthcare” set up by the Commission, providing information on patients' rights, healthcare providers, prior authorisation, reimbursement and additional expenses, quality and safety, and complaint and redress mechanisms; |
Or. en
Amendment 375
Aurelijus Veryga
Motion for a resolution
Article 1 – paragraph 1 – point 1 b (new)
| Motion for a resolution | Amendment |
|---|---|
| (1b) in Article 5 the following point (c) is amended as follows: | |
| “(c) where a patient has received cross-border healthcare and where medical follow-up proves necessary, the same medical follow-up is available as would have been if that healthcare had been provided on its territory; the Member State of affiliation shall facilitate, where appropriate, coordination between the healthcare provider in the Member State of treatment and the healthcare professionals responsible for subsequent care, including through the exchange of clinically relevant electronic health data necessary for such follow-up, in accordance with Regulation (EU) 2025/327.'' |
Or. en
Amendment 376
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| “1. Each Member State shall designate one or more National Contact Points for cross-border healthcare and communicate their contact details to the Commission. The Commission and the Member States shall make that information publicly available and easily accessible, also on a dedicated website. | “1. Each Member State shall designate one or more National Contact Points for cross-border healthcare and communicate their contact details to the Commission. The Commission and the Member States shall make that information publicly available and easily accessible, also on a dedicated website and in collaboration with frontline healthcare professionals, healthcare professional organisations, and patients’ organisations. |
| Member States shall ensure that the naJonal contact points consult and cooperate with patient organisations, healthcare providers and healthcare insurers. | |
| Member States should establish national cross-border navigator services to provide personalised, cost-free guidance to children with rare or complex diseases and their families throughout the cross-border care pathway, including administrative, linguistic and logistical support. |
Or. en
Amendment 377
Victor Negrescu
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| “1. Each Member State shall designate one or more National Contact Points for cross-border healthcare and communicate their contact details to the Commission. The Commission and the Member States shall make that information publicly available and easily accessible, also on a dedicated website. | “1. Each Member State shall designate one or more National Contact Points for cross-border healthcare and communicate their contact details to the Commission. The Commission and the Member States shall make that information publicly available and easily accessible, also on a dedicated website. The Commission and the Member States shall develop that website into a secure, multilingual and accessible single Union digital platform for cross-border healthcare, connected to National Contact Points, relevant national systems and, where appropriate, MyHealth@EU. The platform shall enable patients to identify suitable healthcare providers, specialised centres and relevant expert networks, consult applicable prior-authorisation and reimbursement conditions, submit and track requests and receive confirmation of coverage before treatment. |
Or. en
Amendment 378
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| “1. Each Member State shall designate one or more National Contact Points for cross-border healthcare and communicate their contact details to the Commission. The Commission and the Member States shall make that information publicly available and easily accessible, also on a dedicated website. | “1. Each Member State shall designate one or more National Contact Points for cross-border healthcare and communicate their contact details to the Commission. The Commission and the Member States shall make that information publicly available and easily accessible, also on a dedicated website and in collaboration with frontline healthcare professionals, healthcare professional organisations, and patients’ organisations. |
Or. en
Amendment 379
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point a
| Motion for a resolution | Amendment |
|---|---|
| a) proactively develop public awareness campaigns to inform citizens about their rights and about the role of the contact points; | a) a) proactively develop public awareness campaigns to inform citizens about their rights and about the role of the contact points and engage healthcare professional organisations, healthcare professionals, and patients’ organisations, in the development of such campaigns; |
Or. en
Amendment 380
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point a
| Motion for a resolution | Amendment |
|---|---|
| a) proactively develop public awareness campaigns to inform citizens about their rights and about the role of the contact points; | a) proactively develop public awareness campaigns to inform citizens about their rights and about the role of the contact points, engaging healthcare professionals, healthcare professional organisations and patients’ organisations in the development and implementation of those campaigns; ; |
Or. en
Amendment 381
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point a
| Motion for a resolution | Amendment |
|---|---|
| a) proactively develop public awareness campaigns to inform citizens about their rights and about the role of the contact points; | a) proactively develop public awareness campaigns to inform citizens about their rights and about the role of the contact points and engage healthcare professional organisations, healthcare professionals, and patients’ organisations, in the development of such campaigns; |
Or. en
Amendment 382
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak, András Tivadar Kulja
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point a
| Motion for a resolution | Amendment |
|---|---|
| a) proactively develop public awareness campaigns to inform citizens about their rights and about the role of the contact points; | a) proactively develop public awareness campaigns involving all stakeholders to inform citizens about their rights and about the role of the contact points; |
Or. en
Amendment 383
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point a a (new)
| Motion for a resolution | Amendment |
|---|---|
| aa) ensure regular communication to healthcare professionals and healthcare providers to ensure high awareness of the possibilities for patients to access specialist care across borders. |
Or. en
Amendment 384
Kateřina Konečná
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point a a (new)
| Motion for a resolution | Amendment |
|---|---|
| aa) ensure regular communication to healthcare professionals and healthcare providers to ensure high awareness of the possibilities for patients to access specialist care across borders. |
Or. en
Amendment 385
Elena Nevado del Campo, Dolors Montserrat
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point a a (new)
| Motion for a resolution | Amendment |
|---|---|
| aa) ensure regular communication to healthcare professionals and healthcare providers to ensure high awareness of the possibilities for patients to access specialist care across borders |
Or. en
Amendment 386
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b
| Motion for a resolution | Amendment |
|---|---|
| b) establish formal partnerships with patient organisations, healthcare providers and healthcare insurers and regularly consult them and cooperate with them”; | b) establish formal partnerships with patient organisations, healthcare professional organisations and healthcare providers and healthcare insurers and regularly consult them and cooperate with them”; |
| ensure regular communication to healthcare professionals and healthcare providers to ensure high awareness of the possibilities for patients to access specialist care across borders. |
Or. en
Amendment 387
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b
| Motion for a resolution | Amendment |
|---|---|
| b) establish formal partnerships with patient organisations, healthcare providers and healthcare insurers and regularly consult them and cooperate with them”; | b) establish formal partnerships with patient organisations, healthcare providers and healthcare insurers and regularly consult them and cooperate with them, including by developing tailor made awareness raising campaigns to inform them about cross-border healthcare rights for patients; |
Or. en
Amendment 388
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b
| Motion for a resolution | Amendment |
|---|---|
| b) establish formal partnerships with patient organisations, healthcare providers and healthcare insurers and regularly consult them and cooperate with them”; | b) establish formal partnerships with patient organisations, healthcare professional organisations, healthcare providers and healthcare insurers and regularly consult them and cooperate with them”; |
Or. en
Amendment 389
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b a (new)
| Motion for a resolution | Amendment |
|---|---|
| ba) provide information in an independent, objective and transparent manner, including on patients’ rights, reimbursement procedures, quality and safety standards, available healthcare providers and complaint and redress mechanisms. |
Or. en
Amendment 390
Marta Temido, Kristian Vigenin, Vytenis Povilas Andriukaitis
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b a (new)
| Motion for a resolution | Amendment |
|---|---|
| ba) set up a “patient navigator”, directly accessible for patients and their families, to provide information on the mechanisms and requirements to apply for cross-border healthcare; |
Or. en
Amendment 391
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b a (new)
| Motion for a resolution | Amendment |
|---|---|
| ba) cooperate with frontline healthcare professionals and consult healthcare professional organisations and patients’ organisations. |
Or. en
Amendment 392
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b a (new)
| Motion for a resolution | Amendment |
|---|---|
| ba) have adequate human, technical and financial resources to fulfil their tasks effectively; |
Or. en
Amendment 393
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b b (new)
| Motion for a resolution | Amendment |
|---|---|
| bb) provide, where necessary, personalised guidance to patients requiring additional assistance, including children and patients with rare and complex diseases, including through dedicated case navigator services;” |
Or. en
Amendment 394
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 – point b b (new)
| Motion for a resolution | Amendment |
|---|---|
| bb) have sufficient human, financial and technical resources, as well as appropriate expertise, to effectively perform the tasks assigned to them under this Directive |
Or. en
Amendment 395
Victor Negrescu
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a – paragraph 3 a (new)
| Motion for a resolution | Amendment |
|---|---|
| The Commission and the Member States shall establish a structured Union programme for cooperation between healthcare providers, including hospital twinning, short-term exchanges of healthcare professionals, joint multidisciplinary case reviews and the development of shared clinical protocols. Each supported project shall set measurable knowledge-transfer objectives and shall prioritise healthcare providers in rural, remote, border and otherwise underserved regions. |
Or. en
Amendment 396
Peter Agius
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point a a (new)
| Motion for a resolution | Amendment |
|---|---|
| aa) Stresses the need for multiannual, renewable cross-border care authorisations for patients with chronic, long-term or progressively deteriorating health conditions who require ongoing treatment, replacing the current practice of requiring repeated individual authorisations for each treatment episode, which places an unacceptable administrative burden on the most vulnerable patients; ensuring regular, accessible communication with healthcare professionals and providers concerning cross-border healthcare pathways, prior authorisation, European Reference Networks and the respective operation of Directive 2011/24/EU and Regulation (EC) No 883/2004; involve patient organisations in identifying recurring information and administrative barriers; |
Or. en
Amendment 397
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point b – paragraph 1
| Motion for a resolution | Amendment |
|---|---|
| the following paragraph is inserted: | the following paragraphs are inserted: |
Or. en
Amendment 398
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point b – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 3b. The Commission shall facilitate cooperation between National Contact Points and the competent national authorities to protect patients from misleading or unsafe healthcare services offered across borders. To this end, it shall establish or designate a Union-level reporting and coordination mechanism through which citizens, healthcare professionals, patient organisations and competent authorities may report healthcare services or treatment claims giving rise to patient-safety concerns. | |
| The mechanism shall facilitate the exchange of information between Member States, identify recurring cross-border practices, refer reports to the competent authorities for assessment and enforcement where appropriate, and support the dissemination of validated warnings and patient-safety information through National Contact Points. It shall not replace the responsibilities of national competent authorities for the regulation, supervision or assessment of healthcare providers and treatments. |
Or. en
Amendment 399
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point b a (new)
| Motion for a resolution | Amendment |
|---|---|
| (ba) the following paragraph is inserted: | |
| '3a. National contact points shall provide easily accessible information on the limits of application of this Directive to healthcare received in third countries. This information clarifies that patients receiving planned treatment outside the Union may not benefit from the rules, cooperation mechanisms or remedies provided for in Union law. They shall also address the importance of verifying, before undergoing treatment, the qualifications of healthcare professionals, healthcare providers' authorisation, the safety and traceability of medicinal products, medical devices and materials used, the existence of sufficient professional liability insurance coverage, the modalities of post-treatment care and the means available to obtain protection and compensation in the event of damage.’; |
Or. it
Amendment 400
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point c – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "5. The information referred to in this Article shall be easily accessible, provided in clear and plain language, and in at least at the official language of the country, to guarantee equal accessibility for incoming patients. It shall be made available by electronic means and in formats accessible to persons with a disability. Member States shall ensure that National Contact Points make publicly available explicitly detailed lists of the specific healthcare treatments that are subject to prior authorisation." | "5. The information referred to in this Article shall be easily accessible, provided in clear and plain language, and in at least at the official language of the country and English, to guarantee equal accessibility for incoming patients. It shall be made available by electronic means and in formats accessible to persons with a disability. Member States shall ensure that National Contact Points make publicly available explicitly detailed lists of the specific healthcare treatments that are subject to prior authorisation and clear and regularly updated information on applicable reimbursement rules, tariffs, healthcare providers, specialised centres, European Reference Networks, relevant clinical trials and innovative therapies and cross-border digital healthcare services." |
Or. en
Amendment 401
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point c – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "5. The information referred to in this Article shall be easily accessible, provided in clear and plain language, and in at least at the official language of the country, to guarantee equal accessibility for incoming patients. It shall be made available by electronic means and in formats accessible to persons with a disability. Member States shall ensure that National Contact Points make publicly available explicitly detailed lists of the specific healthcare treatments that are subject to prior authorisation." | "5. The information referred to in this Article shall be easily accessible, provided in clear and plain language, and in at least at the official language of the Member State concerned and, where appropriate, in additional languages to facilitate access for cross-border patients, to guarantee equal accessibility for incoming patients. It shall be made available by electronic means and in formats accessible to persons with a disability. Member States shall ensure that National Contact Points make publicly available explicitly detailed lists of the specific healthcare treatments that are subject to prior authorisation." |
Or. en
Amendment 402
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak, András Tivadar Kulja
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point c – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "5. The information referred to in this Article shall be easily accessible, provided in clear and plain language, and in at least at the official language of the country, to guarantee equal accessibility for incoming patients. It shall be made available by electronic means and in formats accessible to persons with a disability. Member States shall ensure that National Contact Points make publicly available explicitly detailed lists of the specific healthcare treatments that are subject to prior authorisation." | "5. The information referred to in this Article shall be easily accessible, provided in clear and plain language or languages, and in at least at the official language of the country and one more commonly used EU language, to guarantee equal accessibility for incoming patients. It shall be made available by electronic means and in formats accessible to persons with a disability. Member States shall ensure that National Contact Points make publicly available, both online and offline, explicitly detailed lists of the specific healthcare treatments that are subject to prior authorisation." |
Or. en
Amendment 403
Marta Temido, Kristian Vigenin, Vytenis Povilas Andriukaitis, Victor Negrescu
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point c – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "5. The information referred to in this Article shall be easily accessible, provided in clear and plain language, and in at least at the official language of the country, to guarantee equal accessibility for incoming patients. It shall be made available by electronic means and in formats accessible to persons with a disability. Member States shall ensure that National Contact Points make publicly available explicitly detailed lists of the specific healthcare treatments that are subject to prior authorisation." | "5. The information referred to in this Article shall be easily accessible, provided in clear and plain language, and in at least at the official language of the country, to guarantee equal accessibility for incoming patients. It shall be made available both by non-digital and by electronic means and in formats accessible to persons with a disability. Member States shall ensure that National Contact Points make publicly available explicitly detailed lists of the specific healthcare treatments that are subject to prior authorisation." |
Or. en
Amendment 404
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point c – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 6)Member States should establish national cross-border navigator services to provide personalised, cost-free guidance to children with rare or complex diseases and their families throughout the cross-border care pathway, including administrative, linguistic and logistical support. |
Or. en
Amendment 405
Peter Agius
Motion for a resolution
Article 1 – paragraph 1 – point 2 – point c a (new)
| Motion for a resolution | Amendment |
|---|---|
| ca) Stresses that patient organisations must be formally involved in the operation and governance of National Contact Points (NCPs) to ensure that the information provided meets the real-life needs of patients; stresses the importance of ensuring sustainable, objective and transparent public funding for patients’ organisations to enable their presence in the public sphere and governance structures, and to provide them with financial independence; recognises that the obligations placed on National Contact Points must be implemented effectively in Member States with limited administrative capacity and calls on the Commission to facilitate, with Union support and without prejudice to national responsibility, the voluntary pooling of technical tools, training, translation and back-office functions between National Contact Points; |
Or. en
Amendment 406
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 1
| Motion for a resolution | Amendment |
|---|---|
| the following paragraph is inserted: | the following paragraphs are inserted: |
Or. en
Amendment 407
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 1
| Motion for a resolution | Amendment |
|---|---|
| the following paragraph is inserted: | the following paragraphs are inserted: |
Or. en
Amendment 408
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "1a. This Article shall also apply to healthcare received via telemedicine. If the insured person is entitled to healthcare in the Member State of affiliation, that Member State shall not refuse the reimbursement to the insured person solely on the grounds that healthcare was delivered via telemedicine. "; | "1a. This Article shall also apply to healthcare received via telemedicine. If the insured person is entitled to healthcare in the Member State of affiliation, that Member State shall not refuse the reimbursement to the insured person solely on the grounds that healthcare was delivered via telemedicine. "; |
| "1b. This Article and the scope of this Directive shall also include participation in cross-border clinical trials, including early-phase trials, for rare and complex diseases, such as rare and paediatric cancers.” |
Or. en
Amendment 409
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Ingeborg Ter Laak, András Tivadar Kulja
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "1a. This Article shall also apply to healthcare received via telemedicine. If the insured person is entitled to healthcare in the Member State of affiliation, that Member State shall not refuse the reimbursement to the insured person solely on the grounds that healthcare was delivered via telemedicine. "; | "1a. This Article shall also apply to healthcare received via telemedicine, including interactions between healthcare providers. If the insured person is entitled to healthcare in the Member State of affiliation, that Member State shall not refuse the reimbursement to the insured person solely on the grounds that healthcare was delivered via telemedicine. Member States shall allow the reimbursement of a combination of cross-border healthcare received physically and cross-border healthcare received via telemedicine."; |
Or. en
Amendment 410
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "1a. This Article shall also apply to healthcare received via telemedicine. If the insured person is entitled to healthcare in the Member State of affiliation, that Member State shall not refuse the reimbursement to the insured person solely on the grounds that healthcare was delivered via telemedicine. "; | "1a. This Article shall also apply to healthcare received via telemedicine. If the insured person is entitled to healthcare in the Member State of affiliation, that Member State shall not refuse the reimbursement to the insured person solely on the grounds that healthcare was delivered via telemedicine, provided that such healthcare meets the applicable quality and safety requirements under Union and national law. "; |
Or. en
Amendment 411
Elena Nevado del Campo, Dolors Montserrat
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 2 – point a (new)
| Motion for a resolution | Amendment |
|---|---|
| (a) This Article and the scope of this Directive shall also include participation in cross-border clinical trials, including early-phase trials, for rare and complex diseases, as well as rare and paediatric cancers. |
Or. en
Amendment 412
Peter Agius
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| In Article 7(1), the following subparagraphs are added: | |
| "Where entitlement to a benefit depends on the treatment concerned being normal, appropriate or established, that condition shall be assessed by reference to what is sufficiently tried and tested by international medical science, and not by reference to practice within the Member State of affiliation. Where benefits are defined by reference to categories of treatment rather than to specified methods, a method not practised in the Member State of affiliation which falls within such a category shall be regarded as among the benefits to which the insured person is entitled. The first subparagraph shall not apply where healthcare is not among the benefits provided in the Member State of affiliation by reason of that Member State lacking the capacity to provide it, rather than by reason of a determination made under paragraph 3 not to assume its costs. This subparagraph shall not extend to treatment which is not sufficiently tried and tested by international medical science."; |
Or. en
Amendment 413
Kateřina Konečná
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| "1b. This Article and the scope of this Directive shall also include participation in cross-border clinical trials, including early-phase trials, for rare and complex diseases, such as rare and paediatric cancers.” |
Or. en
Amendment 414
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 1b. This Article and the scope of this Directive shall also include participation in cross-border clinical trials, including early-phase trials, for rare and complex diseases, such as rare and paediatric cancers.” |
Or. en
Amendment 415
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak, András Tivadar Kulja
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point a – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 1b. This article shall also apply to participation in cross-border clinical trials, including early-phase trials and trials for rare diseases, paediatrics and advanced therapies. |
Or. en
Amendment 416
Valérie Deloge, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b
| Motion for a resolution | Amendment |
|---|---|
| b) paragraph 4 is replaced by the following: | deleted |
| "4. The costs of cross-border healthcare shall be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State of affiliation, had the healthcare been provided in its territory without exceeding the actual costs of healthcare received. Member States shall base the reimbursement tariff on the costs that would be borne for care received from a public or contracted healthcare provider in the Member State of affiliation, regardless of who has supplied the healthcare in the Member State of treatment. | |
| Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. In doing so, it shall simplify and streamline the administrative procedures for patients. | |
| Member States shall establish clear, accessible, and fast mechanisms for the reimbursement of additional costs that persons with disability may have to bear when receiving cross-border healthcare, ensuring that the application of those provisions does not impose disproportionate administrative burdens."; |
Or. fr
Amendment 417
Peter Agius
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "4. The costs of cross-border healthcare shall be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State of affiliation, had the healthcare been provided in its territory without exceeding the actual costs of healthcare received. Member States shall base the reimbursement tariff on the costs that would be borne for care received from a public or contracted healthcare provider in the Member State of affiliation, regardless of who has supplied the healthcare in the Member State of treatment. | "4. The costs of cross-border healthcare shall be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State of affiliation, had the healthcare been provided in its territory without exceeding the actual costs of healthcare received. Member States shall base the reimbursement tariff on the costs that would be borne for care received from a public or contracted healthcare provider in the Member State of affiliation, regardless of who has supplied the healthcare in the Member State of treatment. |
| Member States shall publish those tariffs or, where no tariff schedule is maintained, the methodology by which the cost is determined. Where the Member State of affiliation has no land border with another Member State, or where the patient is resident in an island region, an estimate cost of travel for the patient and for a companion whose presence is clinically necessary shall form part of the cost of the authorised healthcare. |
Or. en
Amendment 418
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak, András Tivadar Kulja
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "4. The costs of cross-border healthcare shall be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State of affiliation, had the healthcare been provided in its territory without exceeding the actual costs of healthcare received. Member States shall base the reimbursement tariff on the costs that would be borne for care received from a public or contracted healthcare provider in the Member State of affiliation, regardless of who has supplied the healthcare in the Member State of treatment. | "4. The costs of cross-border healthcare and costs of cross-border clinical trial participation that are not covered by the trial budget shall be reimbursed or paid directly by the Member State of affiliation up to the level of costs that would have been assumed by the Member State of affiliation, had the healthcare or clinical trial been provided in its territory without exceeding the actual costs of healthcare received. Member States shall base the reimbursement tariff on the costs that would be borne for care received from a public or contracted healthcare provider in the Member State of affiliation, regardless of who has supplied the healthcare in the Member State of treatment. |
Or. en
Amendment 419
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| Member States shall ensure that reimbursement levels are transparent, non-discriminatory and based on the costs that would normally have been covered for equivalent healthcare provided within their healthcare system. |
Or. en
Amendment 420
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 2 b (new)
| Motion for a resolution | Amendment |
|---|---|
| For patients with rare or complex conditions receiving cross-border healthcare, the calculation of these costs shall encompass all necessary diagnostic tests prescribed and performed by the treating centre of expertise, as well as the costs associated with post-intervention follow-up care delivered by the healthcare provider responsible for routine care in the Member State of affiliation, provided such care is administered in coordination with the centre of expertise." |
Or. en
Amendment 421
Victor Negrescu
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 3
| Motion for a resolution | Amendment |
|---|---|
| Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. In doing so, it shall simplify and streamline the administrative procedures for patients. | Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. Where those costs are eligible, the Member State of affiliation shall, at the insured person’s request, provide an advance payment or arrange direct settlement with the relevant transport or accommodation provider; the insured person shall not be required to pre-finance the covered amount. For cross-border healthcare provided to a minor, those costs shall include the medically necessary travel and accommodation costs of the minor and of at least one accompanying parent or legal guardian. A single financial guarantee shall cover the entire authorised course of treatment, including medically necessary follow-up care and repeat journeys, and shall not require renewal for each treatment episode. In doing so, it shall simplify and streamline the administrative procedures for patients. |
Or. en
Amendment 422
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 3
| Motion for a resolution | Amendment |
|---|---|
| Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. In doing so, it shall simplify and streamline the administrative procedures for patients. | Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. Such mechanisms shall give particular consideration to patients requiring highly specialised care, children, women, persons with disabilities and patients with rare or complex diseases. In doing so, it shall simplify and streamline the administrative procedures for patients and carers. For children receiving cross-border healthcare, the Member State of affiliation shall reimburse the travel and accommodation costs of the child and of one or more accompanying parents, siblings or legal guardians, in recognition of the inseparability of family support from effective paediatric care. |
Or. en
Amendment 423
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 3
| Motion for a resolution | Amendment |
|---|---|
| Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. In doing so, it shall simplify and streamline the administrative procedures for patients. | Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. In doing so, it shall simplify and streamline the administrative procedures for patients. |
| For children receiving cross-border healthcare, the Member State of affiliation shall reimburse the travel and accommodation costs of the child and of one or more accompanying parents, siblings or legal guardians, in recogni5on of the inseparability of family support from effective paediatric care. |
Or. en
Amendment 424
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 3
| Motion for a resolution | Amendment |
|---|---|
| Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. In doing so, it shall simplify and streamline the administrative procedures for patients. | Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall guarantee the mandatory, non-discretionary reimbursement and upfront coverage of other related non-clinical costs, including travel, accommodation, and subsistence, for paediatric patients, rare disease patients, and their necessary accompanying family caregivers. In order to eliminate the de facto 'upfront payment barrier' that financially excludes low-income and vulnerable families, Member States shall establish mechanisms to cover these expenses through advance bookings, direct payment systems, or direct advance funding managed by competent national institutions or Case Navigators." |
Or. en
Amendment 425
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 3
| Motion for a resolution | Amendment |
|---|---|
| Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. In doing so, it shall simplify and streamline the administrative procedures for patients. | Where the full cost of cross-border healthcare or remaining costs of cross-border clinical trial participation exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare and cross-border clinical trials, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. Member States of affiliation shall also reimburse additional costs incurred by parents, legal guardians or a designated responsible person accompanying minors. In doing so, it shall simplify and streamline the administrative procedures for patients. |
Or. en
Amendment 426
Aurelijus Veryga
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 3
| Motion for a resolution | Amendment |
|---|---|
| Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse other related costs, such as accommodation and travel costs, in accordance with national legislation and on the basis of on income eligibility and financial vulnerability criteria. In doing so, it shall simplify and streamline the administrative procedures for patients. | Where the full cost of cross-border healthcare exceeds the level of costs that would have been assumed had the healthcare been provided in its territory, the Member State of affiliation may nevertheless decide to reimburse the full cost on the basis of income eligibility and financial vulnerability criteria. To ensure equitable access to healthcare, the Member State of affiliation shall establish a mechanism to reimburse necessary costs related to cross-border healthcare, including accommodation and travel costs and, where relevant, costs associated with clinically necessary repeat visits or medically necessary accompaniment, taking into account the requirements of the individual care pathway and, where appropriate, income eligibility and financial vulnerability criteria. |
Or. en
Amendment 427
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 3 a (new)
| Motion for a resolution | Amendment |
|---|---|
| Where upfront costs constitute a substantial barrier to accessing necessary cross-border healthcare, Member States shall provide for direct billing, advance payment or other appropriate mechanisms to ensure that patients are not disproportionately disadvantaged by the requirement to advance such costs. |
Or. en
Amendment 428
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 4
| Motion for a resolution | Amendment |
|---|---|
| Member States shall establish clear, accessible, and fast mechanisms for the reimbursement of additional costs that persons with disability may have to bear when receiving cross-border healthcare, ensuring that the application of those provisions does not impose disproportionate administrative burdens."; | Member States shall establish clear, accessible, and fast mechanisms for the reimbursement of additional costs that persons with disability or persons accompanying them may have to bear when receiving cross-border healthcare, ensuring that the application of those provisions does not impose disproportionate administrative burdens."; |
Or. en
Amendment 429
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b – paragraph 4 a (new)
| Motion for a resolution | Amendment |
|---|---|
| Where the presence of an accompanying parent, guardian or caregiver is necessary for the effective provision of care to a child, a person with a disability or a patient with a rare or complex disease, the necessary and reasonable travel, accommodation and subsistence costs of that accompanying person shall also be reimbursed or directly covered in accordance with this paragraph.” |
Or. en
Amendment 430
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 3 – point b a (new)
| Motion for a resolution | Amendment |
|---|---|
| ba) paragraph 8 is replaced by the following: | |
| 8. The Member State of affiliation shall not make the reimbursement of costs of cross-border healthcare subject to prior authorisation except in the cases set out in Article 8. By way of derogation from Article 8, the Member State of affiliation shall not, in respect of healthcare of an urgent nature, including emergency medical transport and the transfer of patients, refuse reimbursement on the sole ground of the absence of prior authorisation. |
Or. en
Amendment 431
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 3 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (3a) Article 8 is amended as follows: | |
| (a) the following paragraph is inserted: | |
| "5a Where documented clinical urgency requires healthcare to be provided without delay, reimbursement shall not be refused solely on the ground that prior authorisation could not reasonably be obtained before the healthcare was provided." | |
| (b) the following paragraph is inserted : | |
| "7a The Member State of affiliation shall take a decision on a request for prior authorisation within a binding maximum time limit established in accordance with this Directive. Member States shall provide for an accelerated procedure for urgent and time-sensitive cases, taking into account the patient’s clinical condition and individual circumstances." | |
| (c) the following paragraph is inserted: | |
| "7b For healthcare requiring recurring treatment, the Member State of affiliation shall provide for multiannual and renewable prior authorisations where clinically appropriate." |
Or. en
Amendment 432
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 3 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (3a) In article 8 paragraph 4 is amended as follows: | |
| 4. Where a patient affected, or suspected of being affected, by a rare disease applies for prior authorisation and specialist clinical assessment is necessary for the decision, the competent institution shall ensure access to appropriate expertise in the disease or condition concerned. Where such expertise is not available in the Member State of affiliation, the competent authority may, where necessary, seek appropriate expert or scientific advice, including through the relevant European Reference Network or another appropriately qualified expert or centre of expertise in another Member State. The need to obtain such expertise shall not result in undue delay in deciding the request |
Or. en
Amendment 433
Liesbet Sommen, Pascal Arimont, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 3 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (3a) in Article 8, paragraph 4 is replaced by the following: | |
| 4. When a patient affected, or suspected of being affected, by a rare disease applies for prior authorisation, a clinical evaluation may be carried out by experts in that field. If no experts can be found within the Member State of affiliation or if the expert’s opinion is inconclusive, the Member State of affiliation may request scientific advice. The Member State of affiliation shall ensure patients seeking cross-border healthcare have the right to request a second opinion, including from healthcare professionals in another Member State. Without prejudice the rules for reimbursement set out in Article 7, such second opinion shall be reimbursed. |
Or. en
Amendment 434
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point a – paragraph 1 a (new)
| Motion for a resolution | Amendment |
|---|---|
| "The Member State of affiliation shall ensure that administrative procedures regarding the use of cross-border healthcare or cross-border participation in clinical trials and reimbursement of costs of healthcare incurred in another Member State are based on objective, non-discriminatory criteria which are necessary and proportionate to the objective to be achieved. | |
| Member States shall set out reasonable periods of time within which requests for cross-border healthcare or cross-border participation in clinical trials must be dealt with and make them public in advance. When considering a request for cross-border healthcare, Member States shall take into account: | |
| Member States shall ensure that individual decisions regarding the use of cross-border healthcare or cross-border participation in clinical trials and reimbursement of costs of healthcare incurred in another Member State are properly reasoned and subject, on a case-by-case basis, to review and are capable of being challenged in judicial proceedings, which include provision for interim measures | |
| (a) the specific medical condition; | |
| (b) the urgency and individual circumstances." |
Or. en
Amendment 435
Vytenis Povilas Andriukaitis
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "5. Member States shall establish a system of prior notification that allows those patients to receive, upon request, a written confirmation of the amount to be reimbursed on the basis of an estimate. That estimate shall take into account the patient’s clinical case and specify the medical procedures that are likely to be applied."; | "5. Member States shall identify and remove structural barriers, and establish a system of prior notification that allows those patients to receive, upon request, a written confirmation of the amount to be reimbursed on the basis of an estimate. That estimate shall take into account the patient’s clinical case and specify the medical procedures that are likely to be applied."; |
Or. en
Amendment 436
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "5. Member States shall establish a system of prior notification that allows those patients to receive, upon request, a written confirmation of the amount to be reimbursed on the basis of an estimate. That estimate shall take into account the patient’s clinical case and specify the medical procedures that are likely to be applied."; | "5. Member States shall establish a system of prior notification that allows those patients to receive, upon request, a written confirmation of the amount to be reimbursed on the basis of an estimate. That estimate shall take into account the patient’s clinical case and specify the healthcare procedures that are likely to be applied."; |
Or. en
Amendment 437
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point a – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "5. Member States shall establish a system of prior notification that allows those patients to receive, upon request, a written confirmation of the amount to be reimbursed on the basis of an estimate. That estimate shall take into account the patient’s clinical case and specify the medical procedures that are likely to be applied."; | "5. Member States shall establish a system of prior notification that allows those patients to receive, upon request, a written confirmation of the amount to be reimbursed on the basis of an estimate. That estimate shall take into account the patient’s clinical case and specify the healthcare procedures that are likely to be applied."; |
Or. en
Amendment 438
Valérie Deloge, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point c
| Motion for a resolution | Amendment |
|---|---|
| c) the following paragraph is added: | deleted |
| "7. Member States shall put in place mechanisms for direct financial compensation between competent institutions across borders in order to eliminate the need for patients to advance upfront payments for cross-border healthcare."; |
Or. fr
Amendment 439
Victor Negrescu
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point c – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "7. Member States shall put in place mechanisms for direct financial compensation between competent institutions across borders in order to eliminate the need for patients to advance upfront payments for cross-border healthcare."; | "7. Member States shall put in place mechanisms for direct financial compensation between competent institutions across borders in order to eliminate the need for patients to advance upfront payments for cross-border healthcare. For medically necessary care that cannot be provided within a medically justifiable time limit in the Member State of affiliation, the Commission shall establish, under the relevant Union health programme, a European Health Solidarity Mechanism to co-finance the eligible difference between the amount payable under Article 7(4) and the applicable public or contracted tariff in the Member State of treatment. The mechanism shall complement national obligations, and the covered amount shall be paid directly to the competent institution or healthcare provider, without being advanced or borne by the patient."; |
Or. en
Amendment 440
Michalis Hadjipantela, Tomislav Sokol
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point c – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "7. Member States shall put in place mechanisms for direct financial compensation between competent institutions across borders in order to eliminate the need for patients to advance upfront payments for cross-border healthcare."; | "7. Member States shall put in place mechanisms for direct financial compensation between competent institutions across borders in order to eliminate the need for patients to advance upfront payments for cross-border healthcare. For patients requiring regular and scheduled therapy, including dialysis, Member States shall provide for simplified arrangements for the authorisation, coordination and direct settlement of treatment received during a temporary stay in another Member State, subject to medical appropriateness and the capacity of the healthcare provider. "; |
Or. en
Amendment 441
Christine Anderson
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point c – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "7. Member States shall put in place mechanisms for direct financial compensation between competent institutions across borders in order to eliminate the need for patients to advance upfront payments for cross-border healthcare."; | "7. Member States shall ensure that insured persons are reimbursed for eligible cross-border healthcare without undue delay. Reimbursement shall not exceed either the actual costs incurred or the costs that would have been assumed for the same healthcare in the Member State of affiliation, whichever is lower.. No obligation to establish direct financial settlement between competent institutions or healthcare providers in different Member States shall arise under this Directive."; |
Or. en
Amendment 442
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point c – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "7. Member States shall put in place mechanisms for direct financial compensation between competent institutions across borders in order to eliminate the need for patients to advance upfront payments for cross-border healthcare."; | "7. Member States shall put in place, particularly for vulnerable patients and high-cost treatments,mechanisms for direct financial compensation between competent institutions across borders in order to eliminate the need for patients to advance upfront payments for cross-border healthcare."; |
Or. en
Amendment 443
Peter Agius
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point c – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 8. Any decision refusing prior authorisation on the ground referred to in Article 8(6)(d) shall be taken and signed by a medical practitioner holding a specialist qualification in the field concerned, shall be reasoned in writing by reference to the individual clinical circumstances of the patient, including the history and probable course of the illness, the degree of pain and the nature and extent of any disability, and shall not be based on the existence of waiting lists. | |
| 9. Where authorisation is refused, or a referral declined, on the ground referred to in Article 8(6)(d), the patient may require the competent institution to seek an opinion from a virtual consultation panel of the relevant European Reference Network convened through the Clinical Patient Management System. That right shall be exercisable by the patient directly and shall not be conditional upon the support of any practitioner. The competent institution shall follow that opinion or shall state in writing, by reference to clinical criteria, its reasons for departing from it; it shall not depart from it on financial grounds. | |
| 10. Member States shall lay down periods within which decisions under this Article are to be taken, and shall provide for a shortened period and for authorisation to be deemed granted on its expiry where a treating practitioner certifies that the case is time-critical. Member States shall ensure a right of appeal against such decisions to a body whose membership includes independent clinical members; where the number of specialists in the field concerned within the Member State is insufficient to provide members who are independent, such members shall be drawn from another Member State. |
Or. en
Amendment 444
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point c a (new)
| Motion for a resolution | Amendment |
|---|---|
| ca) the following paragraph is added: | |
| Member States shall apply the mechanisms of financial compensation between the competent institutions as provided for by Regulation (EC) No 883/2004 in where cross-border healthcare is authorised for rare or complex conditions. |
Or. en
Amendment 445
Kateřina Konečná
Motion for a resolution
Article 1 – paragraph 1 – point 4 – point c a (new)
| Motion for a resolution | Amendment |
|---|---|
| ca) the following paragraph is added: | |
| "8. Member States shall ensure that decisions on prior authorisation and reimbursement decisions are taken within maximum time limits established at Union level, with expedited procedures where clinically necessary.” |
Or. en
Amendment 446
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 4 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (4a) in Article 10, paragraph 1 is replaced by the following: | |
| 1. Member States shall render such mutual assistance as is necessary for the implementation of this Directive, including cooperation on standards and guidelines on quality and safety and the exchange of information, especially between their national contact points in accordance with Article 6 and in close cooperation with healthcare professional organisations and patients’ organisations, including on provisions on supervision, mutual assistance to clarify the content of invoices and the provision to patients of adequate information on the quality and safety of care. |
Or. en
Amendment 447
Marta Temido, Kristian Vigenin, Vytenis Povilas Andriukaitis
Motion for a resolution
Article 1 – paragraph 1 – point 4 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (4a) the following paragraph is added: | |
| Member States must ensure that all patients using cross-border healthcare have access to complaint and redress mechanisms, and that patients facing cross-border disputes are able to navigate procedures and seek remedies regardless of where care was received. To that effect, the Commission establishes common minimum EU procedural requirements for complaint and redress procedures for cross-border healthcare, while respecting national administrative and legal frameworks |
Or. en
Amendment 448
Christine Anderson
Motion for a resolution
Article 1 – paragraph 1 – point 5
| Motion for a resolution | Amendment |
|---|---|
| (5) in Article 10, paragraph 2 is replaced by the following: | deleted |
| "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive.”; |
Or. en
Amendment 449
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 1 a (new)
| Motion for a resolution | Amendment |
|---|---|
| paragraph 1 is amended as follows: | |
| “1. Member States shall render such mutual assistance as is necessary for the implementation of this Directive, including cooperation on standards and guidelines on quality and safety and the exchange of information, especially between their national contact points in accordance with Article 6, which must work in close cooperation with healthcare professional organisations and patients’ organisations, including on provisions on supervision and mutual assistance to clarify the content of invoices, as well as in relation to adequate information on the quality and safety of care." |
Or. en
Amendment 450
Kristian Vigenin
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 1 a (new)
| Motion for a resolution | Amendment |
|---|---|
| In Article 11, a new point (7) is added: | |
| (7) Member States shall facilitate the secure cross-border dispensing of medicinal products on the basis of an electronic prescription issued in another Member State and made available through the interoperable MyHealth@EU infrastructure. For that purpose, Member States shall ensure that their national rules and procedures governing dispensing enable authorised pharmacists to access, verify and process such electronic prescriptions, in accordance with Union and national law. |
Or. en
Amendment 451
Victor Negrescu
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive.”; | "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive. The Commission shall establish a European Medical Expertise Exchange Scheme supporting short-term exchanges of healthcare professionals, partnerships between hospitals and medical universities, cross-border multidisciplinary teams and tele-expertise. Each supported action shall include measurable knowledge-transfer objectives and deliver joint clinical protocols or training programmes, with priority given to healthcare providers in Member States and regions where specialised capacity is limited or unavailable. ”; |
Or. en
Amendment 452
Vytenis Povilas Andriukaitis
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive.”; | "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive. Member States should promote the early identification of eligible patients, especially for rare and complex therapies that are available only at Centres of Excellence in a limited number of Member States, and ensure their timely referral to centres with the necessary expertise; underlines that the European Reference Networks provide a framework for identifying and referring such patients across borders. ”; |
Or. en
Amendment 453
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive.”; | "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. Member States whose territory includes a border region shall cooperate with the neighbouring Member State with a view to ensuring the continuity and the complementarity of the healthcare offer in that region, including as regards the planning of hospital capacity, emergency departments, maternity units and specialised services. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive.”; |
Or. en
Amendment 454
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive.”; | "2. Member States shall facilitate cross-border cooperation in healthcare provision, both at regional and local level, through ICT or by other means. In the event of a recognised public health emergency, within the meaning of Article 23 of Regulation (EU) 2022/2371 on serious cross-border threats to health, Member States may waive prior authorisation procedures covered by Article 8 of this Directive and apply simplified reimbursement procedures covered by Article 7 of this Directive and, where necessary and proportionate, apply fast-track reimbursement and direct-payment procedures. ”; |
Or. en
Amendment 455
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| Paragraph 3 is replaced by the following: | |
| 3. Member States shall, in respect of each of their internal borders, cooperate with the neighbouring Member State with a view to concluding agreements on the provision of cross-border healthcare in the border region concerned, including on the designation of cross-border healthcare access zones and on the cooperation of emergency medical and rescue services. Member States shall involve the competent regional and local authorities of the border regions concerned and, where those authorities are competent for health, shall enable them to conclude such agreements. Member States shall not terminate or materially restrict an existing agreement without prior consultation of those authorities and of the patient organisations concerned, without publishing an assessment of the effects on access to healthcare in the area concerned, and without providing for an adequate transitional period. The Commission shall support that cooperation, in particular by making available a model agreement, and shall report to the European Parliament and to the Council on the internal borders at which no such agreement is in place |
Or. en
Amendment 456
Peter Agius
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| In Article 11, the following paragraph is inserted: "1a. Where a medicinal product lawfully prescribed in another Member State holds no marketing authorisation in the Member State of affiliation, or is not in practice obtainable there, the recognition of the prescription required by paragraph 1 shall not by itself discharge the obligations of that Member State. The Member State of affiliation shall take the measures necessary to secure supply of the product to the patient, including where appropriate under Article 126a of Directive 2001/83/EC, or shall assume the cost of the continued provision of the treatment in the Member State of treatment. Member States shall report annually to the Commission on the medicinal products authorised in the Union which are not placed on their market, and the Commission shall publish that information."; |
Or. en
Amendment 457
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 5 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| 3. The Commission shall encourage Member States, particularly neighbouring countries, to conclude agreements among themselves. The Commission shall also encourage the Member States to cooperate in cross-border healthcare provision or cross-border access to clinical trials in border regions. |
Or. en
Amendment 458
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 5 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (5a) the following article is inserted: | |
| Article 10a | |
| Cross-border healthcare access zones | |
| 1. The competent authorities of two or more neighbouring Member States may jointly designate a cross-border healthcare access zone, specifying the geographical area covered, the healthcare providers concerned and the categories of healthcare covered. | |
| 2. Insured persons residing in a cross-border healthcare access zone shall be entitled to receive the healthcare covered by the designation from the healthcare providers concerned without prior authorisation, without upfront payment and on the same conditions as insured persons in the Member State of treatment. | |
| 3. For the purpose of this Article, reimbursement shall be made according to the rules set out in Article 7 of this Directive. | |
| 4. Member States shall notify designated zones to the Commission, which shall maintain and publish a register of them. National Contact Points shall make the content of the act of designation publicly available. | |
| 5. This Article shall be without prejudice to arrangements existing on the date of entry into force of this Directive which are more favourable to patients.”; |
Or. en
Amendment 459
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 5 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (5a) in Article 11, the following paragraph is inserted: | |
| "6a Member States shall facilitate the secure and interoperable cross-border transmission, recognition and dispensing of electronic prescriptions issued in another Member State through MyHealth@EU, in accordance with this Article and Regulation (EU) 2025/327. Such transmission, recognition or dispensing shall be without prejudice to the rules of the Member State of dispensing concerning prescribing, dispensing, substitution, classification, reimbursement, the organisation of pharmacy services and the supply of medicinal products to the public, including by distance means. Where the distance supply of medicinal products is permitted, the medicinal product shall comply with the legislation applicable in the Member State of destination. The implementation of this paragraph shall not create unjustified administrative or technical barriers to patients’ access to prescribed medicinal products in another Member State." |
Or. en
Amendment 460
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 5 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (5a) in Article 10, paragraph 4 is replaced by the following: | |
| 4. Member States of treatment shall ensure that information on the right to practise of health professionals listed in national or local registers established on their territory is, upon request, made available to the authorities of other Member States, for the purpose of cross-border healthcare, in accordance with Chapters II and III and with national measures implementing Union provisions on the protection of personal data, in particular Regulation (EU) 2016/679, Directive 2002/58/EC, and Regulation (EU) 2025/327, and the principle of presumption of innocence. The exchange of information shall take place via the Internal Market Information system established pursuant to Commission Decision 2008/49/EC of 12 December 2007 concerning the implementation of the Internal Market Information System (IMI) as regards the protection of personal data. |
Or. en
Amendment 461
Elena Nevado del Campo, Dolors Montserrat
Motion for a resolution
Article 1 – paragraph 1 – point 5 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (5a) in Article 11, the following paragraph is inserted: | |
| "7. Where a medicinal product is supplied at a distance across borders, where permitted under Union and national law, Member States shall ensure that the supplier is duly authorised and subject to effective supervision; that the applicable obligations on verification and decommissioning of safety features, storage, transport, traceability and delivery are complied with; and that the patient has effective access, before and after supply, to an identifiable pharmacist exercising professional responsibility and providing appropriate advice. Equivalent standards of quality, safety, accountability and patient protection shall apply irrespective of the channel used." |
Or. en
Amendment 462
Liesbet Sommen, Pascal Arimont, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 5 b (new)
| Motion for a resolution | Amendment |
|---|---|
| (5b) the following Article is inserted: | |
| Article 10b | |
| Emergency medical and rescue services in border regions | |
| 1. Member States shall ensure that, in border regions, emergency control centres are able to dispatch, to request and to receive the nearest available and appropriate emergency unit, irrespective of the Member State in which that unit is stationed. To that end, they shall ensure direct alerting between the emergency control centres concerned, the availability in real time of information on the availability and location of units, agreed common dispatch criteria and the necessary linguistic capacity. | |
| 2. Member States shall ensure that emergency calls made to 112, including automatically generated calls and caller location information, which are received by an emergency control centre of a Member State other than that in which the caller is located, can be transferred without delay and without loss of location information. | |
| 3. Member States shall ensure legal certainty for cross-border deployments, in particular as regards: (a) the recognition, for the duration and purposes of the deployment, of the professional qualifications and the scope of practice of the health professionals and rescue personnel concerned; (b) civil and criminal liability and insurance cover; (c) the use of warning devices and derogations from traffic rules; (d) the carriage across the border and the administration of the medicinal products carried, including controlled substances; (e) the interoperability of emergency communications; (f) the processing of personal data concerning health; and (g) the settlement of the costs of the deployment between the services concerned. | |
| 4. Member States shall ensure the reciprocal exchange in real time of information on the availability of hospital emergency, intensive care and specialised treatment capacity in border regions, and shall integrate their arrangements for time-critical care, in particular for major trauma, stroke, myocardial infarction, severe burns, high-risk obstetrics, neonatology and paediatric intensive care, across the borders concerned. | |
| 5. Member States shall organise joint training and joint exercises for the services concerned.”; |
Or. en
Amendment 463
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 1 a (new)
| Motion for a resolution | Amendment |
|---|---|
| Article 20, is amended as follows: | |
| a) paragraph 2 is replaced by the following : | |
| 2. The Commission and the Member States shall establish a comprehensive monitoring and evaluation framework to assess cross-border healthcare access under this Directive and under Regulation (EC) No 883/2004, with particular attention to patients living with rare and complex diseases. | |
| The framework shall be based on a balanced set of structural, process and outcome indicators, enabling the continuous assessment of the quality, effectiveness and equity of cross-border healthcare over time and providing the evidence base necessary to identify barriers to access and to implement corrective measures where such barriers arise. | |
| These indicators shall measure all relevant dimensions of access, including the availability, affordability, acceptability and adequacy of cross-border healthcare, and shall enable the monitoring of inequities in access. To that end, Member States shall provide data disaggregated, where feasible, by socioeconomic status, health condition, including rare diseases, and other factors relevant to identifying unequal access. | |
| The report referred in article 20.1 shall cover: (a) the indicators referred to in this subparagraph, including data disaggregated to monitor inequities in access; and (b) patient flows, the financial dimensions of patient mobility, the implementation of Article 7(9) and Article 8, and the functioning of the European reference networks and national contact points. To this end, the Commission shall conduct an assessment of the systems and practices put in place by the Member States in the light of the requirements of this Directive and of the other Union legislation relating to patient mobility. The Member States shall provide the Commission with assistance and all available information necessary for carrying out this assessment and for preparing the reports, including the disaggregated data to measure unequal access." |
Or. en
Amendment 464
Michalis Hadjipantela, Tomislav Sokol
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System."; | 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System. Member States shall ensure that patients with rare and complex diseases are provided with timely information on the availability of specialised healthcare providers in other Member States. Where the required specialised healthcare is not available in the Member State of affiliation within a medically justifiable timeframe, the competent authorities shall give due consideration to the patient’s informed preference and the opinion of the treating clinician when determining the appropriate cross-border provider. Calls, in this regard, for the establishment of a European Agency for coordinating treatment, research and innovation for rare diseases. |
Or. en
Amendment 465
Valérie Deloge, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System."; | 1a. The Commission and the Member States shall facilitate, on a voluntary basis, the cooperation of the European reference networks with national healthcare systems and the establishment of clear patient referral pathways, while respecting the responsibilities of the Member States for the organisation and financing of healthcare. |
Or. fr
Amendment 466
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System."; | 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System. Member States should put in place adequate EU-supported measures to ensure the development of a sustainable and resilient, domestically educated and trained EU healthcare workforce."; |
Or. en
Amendment 467
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System."; | 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System. ember States should put in place adequate EU-supported measures to ensure the development of a sustainable and resilient, domestically educated and trained EU healthcare workforce "; |
Or. en
Amendment 468
Vytenis Povilas Andriukaitis
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2
| Motion for a resolution | Amendment |
|---|---|
| 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System."; | 1a. The Commission and the Member States shall ensure the sustainable financing and structural integration of the European reference networks into national healthcare systems, and the establishment of clear patient referral pathways. The European Reference Networks can be further harnessed to collect evidence on structural barriers to cross-border healthcare collaboration. Member States shall establish appropriate tariffs for healthcare professionals taking into account the time dedicated to diagnose and treat patients via cross-border virtual consultation panels, in particular those convened through the Clinical Patient Management System."; |
Or. en
Amendment 469
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| in Article 14, paragraph 2 is replaced by the following: | |
| 2. The objectives of the eHealth network shall be to: | |
| (a) work towards delivering sustainable economic and social benefits of European eHealth systems and services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and high-quality healthcare, in line with Regulation (EU) 2025/327 (EHDS); | |
| (b) draw up guidelines on: | |
| (i) a non-exhaustive list of data that are to be included in patients’ summaries and that can be shared between health professionals to enable continuity of care and patient safety across borders, in line with the primary use of data rules established in the EHDS and the mandatory use of the European electronic health record exchange format ; and | |
| (ii) effective methods for enabling the use of medical information for public health and research, in line with the secondary use of data rules established in the EHDS and the mandatory use of the European electronic health record exchange format; | |
| (c) support Member States in developing common identification and authentication measures to facilitate transferability of data in cross-border healthcare. | |
| The objectives referred to in points (b) and (c) shall be pursued in due observance of the principles of data protection as set out, in particular, Regulation (EU) 2016/679, Directive 2002/58/EC, and Regulation (EU) 2025/327. |
Or. en
Amendment 470
Tilly Metz
on behalf of the Verts/ALE Group
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| In article 13 The title of the section is amended as follows | |
| “Rare and Complex Conditions” | |
| c) ensure that patients with rare, complex or life-threatening diseases are made aware of, given access to and par5cipation in relevant clinical trials, including early-phase trials, conducted at healthcare providers or centres of expertise in another Member State. | |
| Ca) make patients, healthcare professionals and those bodies responsible for the funding of healthcare aware of the possibilities of cross-border access to clinical trials for rare diseases where no treatment is yet available or treatment option are unsuitable, have been exhausted or offer limited benefits. |
Or. en
Amendment 471
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| in Article 12 paragraph 2 point (c) is replaced by the following: | |
| (c) to facilitate improvements in diagnosis and the delivery of high-quality, accessible and cost-effective healthcare, including access to relevant clinical trials conducted by healthcare providers or centres of expertise in another Member State, for all patients with a medical condition requiring a particular concentration of expertise in medical domains where expertise is rare; |
Or. en
Amendment 472
Giorgos Georgiou
Motion for a resolution
Article 1 – paragraph 1 – point 6 – paragraph 2 a (new)
| Motion for a resolution | Amendment |
|---|---|
| “1b. In order to support the delivery and continuity of quality care in the EU, the Commission and Member States shall put in place measures to ensure the implementation of Safe Staffing Levels, and the development and harmonisation of Advanced Practice Nursing (APN). |
Or. en
Amendment 473
Michele Picaro
Motion for a resolution
Article 1 – paragraph 1 – point 6 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (6a) Article 13 is amended as follows: | |
| The Commission shall support Member States in cooperating to strengthen diagnosis, referral and treatment pathways for people living with rare diseases, in particular by aiming to: | |
| (a) support awareness and effective use by healthcare professionals of Union-level tools and expertise relevant to the diagnosis and management of rare diseases, including the European Reference Networks; | |
| (b) provide patients, healthcare professionals and competent authorities responsible for the funding of healthcare with clear information on the possibilities available under this Directive and Regulations (EC) No 883/2004 and No 987/2009 for referral to another Member State where the necessary diagnosis, treatment, expertise or infrastructure is not available in the Member State of affiliation; | |
| (c) support clear and coordinated pathways between referring healthcare providers, European Reference Networks and appropriately qualified specialised treatment centres, including, where relevant, centres administering highly specialised and advanced therapies, in order to facilitate patient identification, referral, transfer and continuity of care; | |
| (d) facilitate the exchange of best practices between Member States on the organisation of cross-border pathways for people living with rare diseases,while respecting Member State competences concerning the organisation and financing of healthcare. |
Or. en
Amendment 474
Kateřina Konečná
Motion for a resolution
Article 1 – paragraph 1 – point 6 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (6a) in Article 20 is amended as follows: | |
| a) paragraph 1 is replaced by the following: | |
| “2. The report shall in particular include comprehensive information on patient flows, financial dimensions of patient mobility, the implementation of Article 7(9) and Article 8, and on the functioning of the European reference networks and national contact points. To this end, the Commission shall conduct an assessment of the systems and practices put in place in the Member States, in the light of the requirements of this Directive and the other Union legislation relating to patient mobility. | |
| The Member States shall provide the Commission with assistance and all available information for carrying out the assessment and preparing the reports. This information shall include total numbers of requests for information, and the number and proportion of positive and negative decisions, with associated information on the therapeutic areas concerned. Member States will also report on the conduct of communication and promotion activities.” |
Or. en
Amendment 475
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 6 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (6a) In Article 14, the following paragraph is inserted: | |
| "3a Member States and the Commission shall ensure that the use of digital tools and services in cross-border healthcare respects patient choice, facilitates direct access to healthcare professionals and maintains appropriate non-digital alternatives for patients who cannot or do not wish to use digital means. Digital solutions shall support continuity, safety and accessibility of care and shall not undermine the professional independence of healthcare professionals or create unjustified barriers to access to healthcare." |
Or. en
Amendment 476
Valérie Deloge, Aleksandar Nikolic, Laurent Castillo, Margarita de la Pisa Carrión, Marie-Luce Brasier-Clain
Motion for a resolution
Article 1 – paragraph 1 – point 6 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (6a) (7) In Article 13, the following point is added: | |
| “(c) encourage Member States, in accordance with their national legislation, to provide mechanisms to facilitate care for patients with rare diseases where an appropriate diagnosis or treatment is not available or cannot be provided within a medically justifiable period in the Member State of affiliation, including, where they deem it appropriate, mechanisms to limit the advance payment of costs.” |
Or. fr
Amendment 477
Liesbet Sommen, Tomislav Sokol, Adam Jarubas, Sirpa Pietikäinen, Dan-Ştefan Motreanu, Radan Kanev, Dolors Montserrat, Ingeborg Ter Laak
Motion for a resolution
Article 1 – paragraph 1 – point 6 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (6a) in Article 13, the following paragraph is added: | |
| (c) make patients, healthcare professionals and those bodies responsible for the funding of healthcare aware of the possibilities of cross-border access to clinical trials for rare or seriously debilitating diseases where no treatment is yet available or treatment options are unsuitable, have been exhausted or offer limited benefits. |
Or. en
Amendment 478
Elena Nevado del Campo, Dolors Montserrat
Motion for a resolution
Article 1 – paragraph 1 – point 6 a (new)
| Motion for a resolution | Amendment |
|---|---|
| (6a) in Article 13, the following paragraph is inserted: | |
| "(c) ensure that patients with rare, complex or life-threatening diseases, including rare and paediatric cancers, are adequately informed about and given access to and participation in relevant clinical trials, including early-phase trials, conducted at healthcare providers or centres of expertise in another Member State." |
Or. en
Amendment 479
Vlad Vasile-Voiculescu, Billy Kelleher, Veronika Cifrová Ostrihoňová
Motion for a resolution
Article 1 – paragraph 1 – point 6 b (new)
| Motion for a resolution | Amendment |
|---|---|
| (6b) In Article 20, paragraph 2 is replace by the following: | |
| "The report shall in particular include information on patient flows, financial dimensions of patient mobility, the implementation of Article 7(9) and Article 8, and on the functioning of the European reference networks and national contact points. It shall also include comparable information, where available, on the use of telemedicine and other forms of cross-border digital healthcare, cross-border prescriptions and dispensing, the processing times for prior authorisation and reimbursement, and the use of mechanisms for direct payment or advance payment of cross-border healthcare costs. Such information should, where possible, be disaggregated by relevant patient characteristics, including age, disability and whether the patient is affected by a rare or complex disease, in order to assess the accessibility and equity of cross-border healthcare. To this end, the Commission shall conduct an assessment of the systems and practices put in place in the Member States, in the light of the requirements of this Directive and the other Union legislation relating to patient mobility.The Member States shall provide the Commission with assistance and all available information for carrying out the assessment and preparing the reports." |
Or. en