Committee on Public Health Ordinary meeting
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SANT European Parliament
Follow its sittingsAdam Jarubas
Adopted. Amendment seven, who is in favor? Against? Abstention? Adopted.
Congratulations to the rapporteur for your great work. Thank you so much.
No, there is no final vote. Just this is a different proposal.
Yeah. Thank you so much. Okay, colleagues, let's have a one minute break. Okay, colleagues, please take your seat, we will continue our discussion. Let's move on to the five point presentation of the European Added Value Assessment report on cross-border healthcare.
Dear colleagues, this assessment has been prepared by European Parliamentary Research Service with a support of external expert.
The assessment was published on 31 August and shared with you ahead of this meeting. Today we welcome three experts that came to present their work on this study: Macarena Davies, the project leader and lead author, Mattis De Voert, who worked in the capacity of junior expert, and Luc Voarino, who worked on the assessment as senior expert. This European added value assessment has supported the work of the rapporteur. The accompanying expertise by the policy department likewise has already been of great value for the work up until this stage and will most probably prove valuable again later when negotiations mature. I will now give the floor to the authors of the study for four minutes each for their presentation.
After their presentation, I will give the floor to the SANT members, first to Giorgos Georgiou, who is the SANT rapporteur for the INL linked to this assessment, and then to the shadow rapporteur and to other members who wish to take the floor. I invite members who want to take the floor to indicate it to me and the secretariat. I will now give the floor to our distinguished guests: Macarena Davies, Mattis De Voert, and Luc Voarino. You have the floor for 12 minutes all together. Please.
Macarena Davies
Thank you very much. So, good morning everyone and thank you for this opportunity to present the results of our study on modernising the rules for patients' rights in cross-border healthcare. Over the next few minutes, we will focus on the main findings of the study and most importantly on the roadmap for EU action that emerges from this analysis. Next slide, please. I'll start very briefly with the study approach, so you know where we come from, what was the evidence that we collected, and the main challenges we identified on cross-border healthcare in the EU.
And then we will move to the roadmap and policy options that are proposed in this study. Next slide, please. So, the study followed four main steps. We started with a very extensive desk research, also building on the findings of the evaluation of the directive that we also conducted a few years ago, and a synthesis of evidence and data collected at European level and also member state. And we identified a set of challenges and issues affecting cross-border healthcare in the EU.
On that basis, we developed preliminary policy options that we then tested and refined with stakeholders. Finally, we assessed the impacts and the European added value of the resulting policy options. In terms of stakeholders that were consulted for this study, we conducted 14 interviews with national authorities, representative organisations of patients, of healthcare professionals, of insurers, also independent experts, and members from EU institutions and EU initiatives. We then, we also held a workshop with representatives of patients, healthcare professionals, insurers and experts to further test the relevance, the feasibility and the level of ambition of the proposed options.
Next slide please. So what did we... next slide, sorry. So what did we find in terms of challenges? The central finding of the study is that there remains an important gap between the rights that patients have on paper and their ability to exercise those rights in practice. Across the five areas that we examined, that you can see in the slide, we found persistent barriers.
So in terms of patients, they still face low awareness and fragmented information about their rights. Reimbursement and prior authorization procedures are still complex and unpredictable for many patients. Upfront payments and other costs create financial barriers. In terms of recognition of prescriptions and the transfer of medical information across borders, this can still be very difficult. On the healthcare system side, cross-border care remains constrained by fragmented digital infrastructure, limited interoperability of systems, and some difficulties ensuring continuity of care.
Most importantly, these barriers do not affect everybody equally. They have the greatest impact on people who rely most on cross-border healthcare, including rare disease patients, this includes children also, residents of border regions and mobile workers, and also patients with fewer financial resources or more limited language or digital skills. Next slide please. So building on these challenges, we proposed a roadmap organized around three pillars. These are three complementary pillars.
The first one is about patient access and making existing rights easier to understand and to be exercised in practice. The second pillar is about healthcare delivery. It's about enabling healthcare systems and professionals to deliver cross-border healthcare more effectively, for example through telemedicine and European reference networks. And the third block looks at the future of the system and it's about strengthening interoperability and making better use of developments such as the European Health Data Space while improving transparency also on quality and safety. Across these three pillars, we proposed eight policy options.
These options should not be understood as alternatives, they are largely complementary and they address different parts of the cross-border healthcare pathway. Next slide please. So I'm now going to present the first pillar, which is about empowering patients to access cross-border healthcare. The first issue is information. So we propose strengthening national contact point information, creating a single EU information entry point, and providing better tools and training for the intermediaries who often help patients navigate the system, such as healthcare professionals, insurers, and patient organizations.
The European Union, European added value here comes from reducing fragmentation and establishing a more consistent minimum level of information and support across the EU. The second option concerns reimbursement and prior authorization. Here the emphasis is on making procedures more transparent and predictable through providing clearer information on costs and timelines, minimum procedural standards, and greater digitalization.
Next slide, please. But access is not only an information or an administrative issue. It is also an issue of financial accessibility. So under the directive, patients may have to pay for treatment upfront and may also face travel, accommodation and other costs. This can effectively exclude patients who cannot afford those expenses.
So we propose exploring an EU solidarity mechanism targeted at vulnerable patients, helping with upfront payments and other necessary travel costs. Finally, we propose strengthening complaint and redress mechanisms through minimum accessibility standards, better multilingual guidance and greater use of existing EU cross-border mechanisms for dispute resolution. So pillar one, summarizing, is fundamentally about turning a legal entitlement into a right that patients can actually exercise in practice. And with that, I will hand over to Mattis, who will present the second pillar.
Mattis De Voert
Next slide, please. Thank you. The second pillar focuses on enabling more effective cross-border healthcare delivery, centered on two actions. Firstly, it focuses on integrating telemedicine into cross-border healthcare pathways and secondly, in strengthening the role of the ERNs in cross-border healthcare. The objective of the fifth policy option is to establish a clearer and more harmonized framework for cross-border telemedicine so that patients can access safe, high-quality and legally secure services across member states.
This would involve developing EU guidance on the scope of telemedicine services, professional qualifications, reimbursement, liability, patient information, data exchange and interoperability. Member states would also be encouraged to align their legal framework with the EU guidance and to exchange good practice. The EU added value of this measure lies in developing a common EU framework in an area where national rules and practices remain largely fragmented. EU coordination can make cross-border telemedicine more predictable for both healthcare provider to patient interactions and healthcare provider to healthcare provider interactions. It can support greater convergence while respecting member states' competences for organizing their own healthcare systems.
Such greater convergence on telemedicine adds value for all patients, but can especially help patients who live or move across borders and who live in remote or underserved areas. It can also help patients with rare diseases access specialized care abroad. The next policy option even more so adds value for people living with rare diseases, as it aims to make the European Reference Networks a more integrated, visible and sustainable part of national healthcare systems. This option builds on the current work being done by, for instance, the JARDIN joint action to integrate the European Reference Networks. It involves developing referral pathways and designating additional centers of expertise and affiliated members to improve geographical coverage across the EU.
and legal personality for the ERNs. The EU added value for this measure is particularly clear for patients living with rare diseases. ERNs allow Member States to pool specialized expertise, data and knowledge and cooperate in areas where it would not be efficient for every country to develop the same specialized structures independently. Strengthening them would therefore reinforce a shared European resource and improve access to specialized care across the Union. And with that I give the word to my colleague Luke for the next slide.
Luc Voarino
Thank you and next, perfect. The third and last pillar regroup measures aimed at strengthening the digital and information systems that underpin cross-border healthcare, so that existing rights and service can function more effectively in practice. So the first measure we propose is to support the effective implementation of the European Health Data Space. Recognizing the scale and the importance of this initiative for cross-border healthcare, the aim of this measure is to help realize the benefits of the Health Data Space more quickly and more evenly across Member States. In practical term, this measure would involve providing technical as well as financial support to Member States, promoting peer learning and the exchange of good practices, and developing clear guidance and practical tools for patients, healthcare providers and administrative staff.
This would bring clear EU added value as it addresses a cross-border implementation challenge that Member States cannot resolve as effectively or efficiency when acting alone due to the difference in digital systems and level of preparedness. In that regard, the EU support and coordination can help ensure a more consistent implementation, reduce fragmentation and strengthen interoperability across the EU. The second measure consists in strengthening transparency regarding quality and safety in cross-border healthcare. So the aim is to ensure that patients, healthcare providers and policymakers have access to comparable and reliable information on the quality and safety of care across borders. This will help patients make more informed choice, support improvements in regard to quality and safety, and strengthen patient trust in cross-border healthcare service throughout the EU.
This will be achieved by establishing an expert network to develop a core set of European indicators on quality and safety and support their gradual adoption by Member States and providers. This will also bring clear EU added value as patients seeking care abroad need information that is comparable across country in order to make an informed choice. EU coordination can add value by establishing a common benchmark, a common baseline, the exchange of good practice, and greater transparency for patients across borders. So taken together, those two measures of this pillar will help strengthen the digital and information system that underpin cross-border healthcare. So next slide please.
So in conclusion, our study found that the cross-border healthcare remains very much needed and relevant framework. However, more than a decade after its adoption, patients still face important practical barriers when trying to exercise their rights, including limited information, complex procedures, financial obstacles, and difference in digital readiness across Member States. The proposed roadmap address these challenge through those three complementary pillars that we just presented, with the aim to modernize and strengthen cross-border healthcare framework, making it more accessible, coordinated and digitally enabled. In conclusion, the objective of the proposed measure is not to harmonize national healthcare system, it is to make existing rights work more effectively in practice through targeted EU coordinated action. Thank you very much.
Adam Jarubas
Thank you so much for your presentation. Now I open the floor to the SANT members, first to the rapporteur and shadow rapporteurs of the INL report on modernized rules for patients' rights in cross-border healthcare for two minutes each, and after to the SANT members who expressed wish to take the floor. So Georgios Georgiou as a first please.
Giorgos Georgiou
Ευχαριστώ. I will speak Greek. Θα μπορούσα με μια πρόταση να πω ότι συμφωνώ σε όλα όσα έχουν αναφερθεί οι φίλοι από το EPRS, αλλά επιτρέψτε μου να πω δυο λόγια. Να τους ευχαριστήσω για την εξαιρετική δουλειά που έχουν κάνει. Η έρευνά σας αποτέλεσε βασικό πυλώνα στη διαμόρφωση της έκθεσης που ετοιμάσαμε.
Λειτούργησε ως πολύτιμο εργαλείο για την αποσαφήνιση κρίσιμων ζητημάτων και προσέφερε σταθερή επιστημονική βάση στην ανάλυσή μας. Όσον αφορά τα συμπεράσματά σας, συμφωνούμε πως μια βασική πρόκληση που έχουμε να αντιμετωπίσουμε είναι το χάσμα μεταξύ των δικαιωμάτων που θεσπίζει η οδηγία και της πρακτικής τους άσκησης. Βέβαια ένας βασικός λόγος για αυτό, όπως αναφέρετε και εσείς, είναι τα οικονομικά εμπόδια που σχετίζονται με τις προκαταβολικές πληρωμές και το πρόσθετο κόστος. Έπειτα, όπως ορθά τονίζετε, η επέκταση της κινητικότητας των ασθενών δεν πρέπει να είναι αυτοσκοπός, αλλά πρωταρχικός στόχος πρέπει να είναι η διασφάλιση ότι το πλαίσιο λειτουργεί αποτελεσματικά, προβλέψιμα και δίκαια για όσους το χρειάζονται. Σκοπός μας δεν είναι να εναρμονίσουμε τα εθνικά συστήματα αλλά να τα ενισχύσουμε, καθώς η εφαρμογή της διασυνοριακής περίθαλψης εξαρτάται σε μεγάλο βαθμό από την εθνική διοικητική ικανότητα.
Ασπαζόμαστε επίσης τον οδικό χάρτη που μας προτείνετε για δράση της Ευρωπαϊκής Ένωσης γύρω από τρεις πυλώνες: ενδυνάμωση των ασθενών για ευκολότερη πρόσβαση στη διασυνοριακή περίθαλψη, ενίσχυση της παροχής διασυνοριακής φροντίδας και τρίτον ανάπτυξη διαλειτουργικών και μελλοντικά έτοιμων συστημάτων. Η συμβολή της έρευνάς σας στην εξαγωγή και άλλων προτάσεων που καταθέτουμε στη δική μας έκθεση υπήρξε ουσιαστική. Θα αναφερθώ σε αυτά αργότερα. Σας ευχαριστώ και πάλι για τη μελέτη σας, η οποία φωτίζει ολιστικά το πρόβλημα που υπάρχει σήμερα με την υφιστάμενη νομοθεσία για τη διασυνοριακή περίθαλψη. Ευχαριστώ.
Liesbet Sommen
Yes, good afternoon everyone, colleagues. Thank you to the rapporteur and to everyone involved in this file for the preparations, and thank you, Chair, for giving me the floor. Of course, thank you to everyone today. I believe we can all agree that the directive on patients' rights in cross-border healthcare is an important piece of legislation, which definitely has its merits. But at the same time, as we already heard today, challenges persist and we see that the number of patients that use cross-border healthcare remains quite low, yeah, often because of a lack of knowledge, but also because of the financial hurdles and administrative burden that is linked to this.
Also the context has changed over the last ten years: the development of the European Reference Networks, increasing digitalization and the implementation of the European Health Data Space enable the use of telemedicine.
And we need to make sure that the directive follows this trend. So a modernization of the European cross-border patients' rights is necessary. First, we need to reduce existing hurdles which limit patient mobility, financial and administrative, and the rapporteur has made some suggestions here which can be the basis of our discussions. Thank you for that. Second, I believe we should focus even more on bringing the directive into the digital age.
Free movement of patients is important, but also the free movement of services. Third, the broadening of the scope to include cross-border clinical trials is important and needs to be developed further. For a lot of patients, accessing such clinical trials is a possibility due to a lack of treatment. And finally, we need to make sure that patients are properly informed on the treatment they seek in another member state, whether it is reimbursed or not. We increasingly see desperate patients accessing unproven treatments at huge costs, and it is simply unacceptable that some companies misuse this vulnerability of desperate patients in that way.
So many thanks. I look forward to working with you all. Of course, input and discussion is always very good, and I look forward to seeing you in the coming months.
Marta Temido
Obrigada, Chair. Vou falar em português. Nesta fase de perguntas sobre o estudo que nos apresentaram hoje, e porque isso é importante para o trabalho que vamos fazer a seguir de discussão do relatório de iniciativa e das nossas emendas, aquilo que gostava que pudessem deixar-nos ainda seriam propostas concretas em termos das modificações legislativas. As vossas conclusões são claras. Há muito mais a fazer em termos de implementação do que de alterações do quadro legal.
Ainda assim, há um conjunto de barreiras. Como é que elas podem ser enfrentadas, ultrapassadas por nós, que somos apenas legislador e não executivo? Muito obrigada.
Vlad Vasile-Voiculescu
Thank you so much, Chair, and thank you for this amazing study and for the conclusions that are more practical than what I've seen so far in relevant studies. We're talking about rights that are not translated in real patient access, and you've identified a couple of points that are particularly relevant. One is information. Second is the reimbursement process. Third is financial barriers.
Fourth is the role of ERNs and coordination in general. And that sounds like music to my ears as we've just today voted on a pilot project that will address exactly these four barriers for a particular set of patients, and that's children with cancer. That's going to address information, financial barriers, with a budget that would cover some of the travel costs, and you've mentioned those. These costs are a significant barrier, especially for vulnerable patients, but for any patient in Europe, if he or she needs to travel for months to get treatment in a different country, usually in a big city, because that's where specialized centers for rare diseases are, that costs a lot of money.
So this is a significant barrier that we're addressing alongside with information and coordination. And I fully agree on the fact that we need to involve the ERNs to have more powerful ERNs and more involved in particular cases. And it's next year is going to be 10 years since our friend and colleague here, Mr. Vytenis Andriukaitis made this possible. He was a health commissioner back then when it was 2017 when the ERNs came to life. It's 10 years and I think it's time that the ERNs gets more, get a much more important role in cross-border healthcare.
And I'm pretty sure that this pilot projects and the steps that we're taking today are going to contribute to this process. Thank you.
Tilly Metz
Yes, thank you very much. So this report comes to a very important moment, modernizing the framework for patients' rights in cross-border healthcare. And I think the starting point should remain somehow very simple. So cross-border healthcare must work for patients and for all the patient and not the other way round. And yeah, should also allow special treatments that are not possible in the in the home country.
And therefore, and you mentioned it, adequate information on cross-border healthcare is also key. So digital tools and stronger cooperation between member states can make a difference for patients, whether by facilitating access to healthcare across border, ensuring also a continuity of medication, or making services more accessible for living, for people living in border regions, which is really the case also around Luxembourg. But we should also be careful about what kind of system we are creating because there is the risk with digitalization also to create fragmentation across the system. So we should support digital solutions that respond really to patients' need while making sure that access to medicine and healthcare is not increasingly determined by commercial incentives or by where it is more profitable to provide a service. This is particularly important for patients who already are more likely to face barriers to care, including people living in rural or remote areas, older people, or people who have difficulties in accessing digital services.
So it should not increase inequalities and we need also to maintain the idea of sound healthcare systems in the member state. And finally, I believe that we need to look at cross-border healthcare through a gender-sensitive lens. So women and girls face specific barriers when accessing specialized care, including reproductive and maternal healthcare, as well as for conditions such as endometriosis and gynecological diseases. So I look forward to working constructively with Georges or the the rapporteur and colleagues and to work all together for a strong and patient-centered report. Thank you.
Tomislav Sokol
Thank you very much. Thank you for a very good, very good study, I would say with much more concrete, concrete proposals as usual, as my colleague Vlad already mentioned. Couple of points. So first, I think the main problems are as you rightly identified. First, patient, average patient in Europe does not know anything about this.
Second, rules are extremely complicated. You need to be health law expert to know what your rights are. Reimbursement procedure is also pretty complicated and it takes a long time, also prior authorization. And and the rules and the rules themselves are a problem, especially since you under the directive have to pay upfront for the treatment and ask for reimbursement later, which obviously if the if the cost is high is a big problem.
One thing that I do not agree with you is that it's only a matter of implementation, because this, the reimbursement procedure, whereby you have to pay first and ask for reimbursement later, is in the directive. You cannot change this without changing the directive. So this is not just the question of implementation, it's the question of changing the rules, because Article 7 of the directive is pretty clear that this procedure, paying upfront and then asking for reimbursement, is the primary way of covering the costs. Unlike the social security coordination regulation, where you actually have the health insurance funds settling the cost between themselves, where you only have to pay for the co-payment in the state of treatment. So, which is my first question, so can you tell us more, have you analyzed the interaction between the cross-border healthcare directive and the social security coordination regulation?
Because it's, I think more patients actually access healthcare abroad, cross-border healthcare, through the coordination, because they don't have to pay upfront, than through the cross-border healthcare directive. So that's my first question. The second question is about this solidarity mechanism. So this is a very good, this would be a game changer if we really made it possible for vulnerable patients that their costs are covered by some special mechanism. But my question is, how would it work in practice?
How would it be financed? Would this be part of the EU budget? And do you have any kind of estimate of what would be the actual costs of this? Because I think if this is something to be implemented, we need to know it now, that we can also use this in the negotiations on the future EU budget in the next MFF and funding and everything else. So I think that you highlighted important things.
I think we have to simplify the rules. We have to change some of them. We have to find a way how to interact with social security coordination and clarify rights for the patients. We need to provide more information for them. And of course, we need to utilize the ERNs, I agree, which are extremely important, which can be used much more than they are now.
And of course, we have to find funding for ERNs as well, but this is our job in the Parliament to fight for this. Thank you.
Vytenis Povilas Andriukaitis
Thank you, colleagues. Thank you very much for your excellent study. Frankly speaking, I didn't surprise about your findings. Absolutely, 100 percent, nothing new. And now we have 10 years.
And I am fully in line with what just Tomislav said and Vlad said. You know, now we can see situation. Yes, no one country can solve problems with rare diseases being alone. No one. But we are defending that it is national competence.
It's strange. You have national competence, but you have no chance to treat your people with rare diseases. It means that we need to go forward and to see maybe we can have regulation related to European rare disease patients and reference networks. And then to have quite harmonized regulation, because now uneven implementation of directive is absolutely clear. Absolutely, fragmentation and so on and so on and so on.
And just I couldn't repeat the same. And of course, also we need to think about possibility to have permanent, predicting funding for all EU stakeholders working across member states, so they can continue to connect expertise, support national implementation, and help reduce persistent inequities in access to diagnosis, care, treatment across European Union. And now we are speaking about Biotech Act. It is good time also to include European reference networks as infrastructure which can help us improve innovations, research and so on and treatment and access to treatment. And of course, we need to safeguard health as a visible priority and provide resources needed to turn cross-border cooperation from an exception into practical route.
We need to have now as never before brave and and common solutions. I encourage you to think about possibilities to strong improvement of of course social security coordination regulation and cross-border directive, changing the directive into regulation.
Stine Bosse
Thank you very much. I love that passion. And I will continue on the same note because it is completely true that that as much as we should cherish your findings because now we have it in written and sort of more officially, it is it is well known. I mean, and and I know this, some of you, I've also tried it on on in my own close family. So, what do we what do we need more?
I would hope that there in your report and in your findings are also some more country-specific information. If not, I would encourage you to also present this because that is what we also need to go back to our respective countries and ask questions. Why is this not happening? Why are they better at doing this in other countries and so on and so forth? One.
Second, on the finance. I will put forward in connection with the Biotech Act one, an idea of encouraging the Commission to think about a fund. A fund that would also involve contributions from the pharmaceutical sector to make sure that we can actually now finance, beef up the ERN systems, finance and beef up the health database because we cannot sit here year on year and Andriukaitis knows this well because he was here also when when the ERN systems were invented. We need to act. So so an idea here is to start working on how do we finance these areas collectively together involving the pharmaceutical sector, who also benefits from this by the way if we get it right.
And then also we should all respect fully that things on the national level remain what they are and and it's a national competence, but I can only echo what Andriukaitis just said. There are areas, I mean rare diseases is one, and it is so obvious. You cannot talk about rare diseases as soon as it gets out of the country because it then becomes much more common. I mean, you can't say that rare is 36 million people. So we have to think of this differently.
And the minute we start that, it also travels into rare cancers. And rare cancers are becoming less and less rare because again, we we now see that, you know, cancer is not cancer anymore. Lung cancer, there are several types of lung cancer. So all this is happening. And if we don't get this right and use our cross-border muscles, and I also want to echo what the colleague said over here regarding also cross-border trials and all this we should also fuel this, then we are letting our citizens down.
And I know that you have lifted the hammer, so I will now end. Thank you very much.
Peter Agius
Thank you Chair. I think it's very clear to all of us that the cross-border health directive was a great idea in theory, but it's not really working in practice. And if you see what what's behind the idea of member states when this was negotiated, I mean their biggest fear was how much is it going to cost them, right? Now we have this study by EPRS, by the reporting states at least, showing that it's costing 0.004 of the national health budgets.
So now it's time to be more ambitious. There is no longer an excuse. We need clearer cross-border health directive. Now I want to share with you some insight from Malta. You know, I come from Malta.
I spoke to a lot of doctors. I have tried to help a number of patients in the past to use this directive. And there are two points which need to be taken into account. First of all, if you take a reference year, let's say 2021, which I have managed to find data for, in Malta we sent 15 cases, only 15 cases to the 26 member states. You know how much people we send to the UK with which we have a bilateral agreement with the NHS?
We send thousands of people. Thousands of people to the UK. Now the UK is out of the EU, but we still have a very good agreement there and that has to be sustained as well from the Maltese perspective. But we have 26 other member states to whom we're sending only 15 cases a year. And why is that?
I spoke to the doctors. I spoke to the people in the national health system and they point to two aspects which are already very clear in our discussion here. First, the payment. How can you make the courage to send your loved ones to Germany if it's costing you, let's say 30k? In the UK you go there, if you're Maltese, and it's integrated in the health bill at home, you know, it's paid by the state or you need to contribute to that, but you see to that later.
So we need a system for a deposit at least, okay? That's very clear. The second point is the reference networks. When I speak to doctors in Malta, we've been in the EU for over 20 years, I tell them, do you know about these reference networks? Not much.
Very few people use them. And we know they have a huge potential. We know they can deliver so much. So we need to strengthen these reference networks. And the third point I want to make, I think it's very important.
I think it has to be in our discussion as well and I have not seen it clearly so far. What if there are clinical disagreements between doctors? You know, I speak for Malta where we have in some specialties you can have only just one guy specializing in that. Smaller member states do not have the facilities of the big ones. So what happens if your consultant, let's say in Malta or Cyprus or wherever, does not give you a hope, but someone in another member state has a solution?
We have to have an appeal mechanism, maybe integrated in the national system, whereby a patient brings forward this possibility as a matter of urgency, of course. Thank you, colleagues.
Victor Negrescu
Thank you, chair. The mobility of patients has always been a key priority on my agenda and I have had the honor to work with Commissioner Kyriakides on drafting the directive on the patients' rights on cross-border healthcare. And it's not only about mobility, it's about a right and how we transform it from a need in something that can practically happen for as many people as possible because unfortunately we have a lot of citizens that do not have access to the best healthcare solutions in their home countries. So we need to reinforce the cross-border mobility and it's clear also in the study that was presented to us that this is not a financial burden for our healthcare system. Furthermore, there are a lot of opportunities also to learn from each other.
And I think of course in terms of solution we have to reinforce this transfer of know-how and also finance the possibility for medical professionals to learn from each other while in the same time providing support for patients.
In the same time it is clear that we need to simplify. Two third of member states are blocking this kind of mobilities due to restrictive authorization mechanisms. Only less than half of the member states have an online portal so maybe we should also reflect about creating a common portal. We also have to improve the reimbursement mechanism to make this as easy as possible in particular for children. And I'm a strong supporter of this solidarity mechanism that actually I have promoted several times through different amendments in this house.
And I think we have the resources to do that and we have also again to to support this idea of having specific allocation for health in the next multi-annual financial framework to support this kind of mechanism. This being said I think of course we have to involve patients organizations we have to involve organizations representing medical professionals to make sure this is happening. We need to revise the directive and we need from the parliament side to be very clear in what we want from the commission but also from member states to do on that and transform as I said the mobility of patients in an actual right accessible for as many patients as possible.
Tomislav Sokol
Yes I just to reflect on what my colleague Adjus said. So that's a big problem that we that in the end who decides about whether to give authorization for treatment abroad your domestic experts. And in many cases they give preference to domestic treatment over a foreign treatment which is maybe more advanced better etc etc. So we have an inherent conflict of interest there. In many cases domestic doctors do not know that there is a more advanced treatment available in other country.
This is why we need and I've been saying that for a long time now we need to use European reference networks to provide patients the right to second opinion. So that the patient can say okay you say that the best treatment available is in my country let's check with European reference network with the best experts in Europe whether there is a more advanced treatment available in other country. So this is something that I've been advocating all along I'm glad that my colleague Adjus mentioned this because I think this is also very very important.
Speaker 29
Thanks. Thank you. I give the floor back to our expert. Five minutes please. I know it's hard to.
Macarena Davies
Thank you very much. First of all thank you very much for the positive comments on the on the analysis and the study overall. The the idea was to provide concrete ideas of what can be done. As many of you have said these are well-known problems and challenges and when we did the evaluation of the directive a few years ago we identified the same problems. Some of them have not changed very much some of them have become more complex.
So I'm I agree with with this comment about we know what the problems are. Some of the questions and comments that were made are out of the scope of the study in the sense that now is the time to legislate or investigate further on some of the issues or proposals that are presented in the study. I would like to clarify one thing which is about implementation. It's it's true we are focusing on the practical aspects of cross-border health but this doesn't mean that all the measures presented in the study are non-legislative. Some of them may require a legislative measure so that is that this would be like the next step building on the results of the study.
I would also like to stress the importance of intermediaries, and these are doctors, insurers, so because NCPs, of course, these are normally the ones who are helping patients navigate the system. So it's very difficult and complicated to train patients about what they have to do in a cross-border health situation, but it is maybe more feasible, more effective to also focus on intermediaries who are the ones who will refer the patients and might be able to provide advice of where to go as a start to the NCP. Another thing that I wanted to mention is it's true that the number of patients traveling abroad is low, and there are other studies of a different nature, more sociological studies that show that patients prefer to stay at home for receiving healthcare. So, but this, as was said in the comments, this is about making it possible for those who need it, and that is especially the case of patients with rare diseases. It's important also, I agree, in terms of digitalization, which is very important, to pay attention also to the digital gaps, not to generate further inequalities.
What else? The solidarity mechanism, that there were several comments on this. We provide the proposal of a solidarity mechanism, but of course this needs further investigation in terms of costs, and here we are also, we also faced during the study some limitations in terms of data availability. So in terms of data that is provided by member states and the possibility of estimating some of these costs may require further investigation. Anything else, maybe?
Luc Voarino
And maybe just to build on what's been said as well, one aspect that we tried to do with the study is to not reinvent the wheel, so to say. There's a lot of initiatives, some of which were mentioned, like the European Health Data Space, which will aim to solve some of those issues, like on patient summary, on e-prescriptions, which are also issues which are barriers to the cross-border healthcare. So yes, our aim in the study was really to try to build and complement those existing framework or developing framework as quite critical also for cross-border healthcare. And yes, on the solidarity mechanism, I think that's a very, very good point, and we did suggest different potential measures, such as focusing maybe on vulnerable population, like children, as were mentioned, or focusing on those with recurrent costs or those with more catastrophic costs. So there's different measures that we propose in the, in our report, but of course those would then need to be carefully, carefully calculated based also on what the need is and what is, can be feasible and can be politically done.
Adam Jarubas
Thank you so much. Thank you for your valuable contribution and great presentation, good, good report. Thank you all for this exchange. Dear colleagues, let's move on to the next point, strictly connected to this issue: modernized rules for patients' rights in cross-border healthcare, consideration of draft report. So I'd like to ask Mr. Giorgos for a short presentation, please, generally before we running out of time, generally if I, if I ask you for a little shorter presentation, please.
Giorgos Georgiou
Ευχαριστώ κύριε πρόεδρε. Θα είμαι σύντομος και εκτός κειμένου θέλω να σας πω δυο παραδείγματα που σχετίζονται απόλυτα με αυτό που συζητάμε. Ο εγγονός μου είναι έξι χρονών. Πρόσφατα εντοπίστηκε με μια σπάνια ασθένεια. Κανείς στην Κύπρο δεν μπορούσε να μας πληροφορήσει τι είναι αυτή η ασθένεια και πώς μπορεί να θεραπευτεί.
Το ψάξαμε μόνοι μας σε Αγγλία, Γαλλία, Βέλγιο, Ηνωμένες Πολιτείες. Μια άποψη που μας ήρθε από ένα πανεπιστημιακό νοσοκομείο του Λονδίνου είναι ότι αν θέλετε ειδική θεραπεία για τον εγγονό σας θα πρέπει να διαθέσετε χρήματα, να χρηματοδοτήσετε την έρευνα η οποία μπορεί να πάει μέχρι και 500.000 ευρώ, 600.000 ευρώ. Πόσοι έχουν τόσα χρήματα για να λύσουν το πρόβλημα; Δεύτερον, εγώ είμαι εκπαιδευτικός. Ένας μαθητής μου πρέπει να κάνει μεταμόσχευση καρδιάς.
Χθες, χθες ακριβώς σε ένα χωριό στην επαρχία της Λάρνακας μαζεύτηκαν οι κάτοικοι του χωριού να αγοράσουν λαχεία, να κάνουν έρανο δηλαδή για να δώσουν στην οικογένεια η οποία έχει πρόβλημα να πάει το παιδί στη Γερμανία να κάτσει όσο χρειαστεί για να γίνει η μεταμόσχευση. Αυτά νομίζω δεν τιμούν κανέναν που θέλει να λέγεται ότι είναι ευρωπαϊκό κράτος. Θα είμαι σύντομος κύριε πρόεδρε, θα περάσω στα γρήγορα αυτά που ήθελα να πω. Ότι έχουν περάσει 13 χρόνια, πάρα πολλοί ασθενείς συναντούν τοίχο όταν χρειάζονται περίθαλψη έξω από τη χώρα τους. Έχει ζητήματα η διασυνοριακή περίθαλψη γιατί εξαρτάται από τη χώρα διαμονής, την οικονομική κατάσταση και πόσο καλά γνωρίζει ο ασθενής το σύστημα.
Άρα δεν χρειάζεται να την αναθεωρήσουμε αλλά να την επικαιροποιήσουμε ουσιαστικά. Μας τα λέει αυτά τα πράγματα και το Ελεγκτικό Συνέδριο από το 2019 ότι με τα ζητήματα της προκαταβολής, της προηγούμενης έγκρισης, της ελλιπούς πληροφόρησης ότι υπάρχουν πάρα πολλά προβλήματα. Και πέρα από τα όσα ακούστηκαν από τους συναδέλφους και οι εισηγητές με τους οποίους συμφωνώ απόλυτα σε όσα έχουν πει. Εκείνο που θέλω να σημειώσω από κάποια από αυτά που ακούστηκαν, ρωτήθηκαν οι φίλοι μας από το EPRS, υπάρχουν πάρα πολλά εμπόδια, πώς θα τα ξεπεράσουμε; Δεν θα μας υποδείξουν αυτοί πώς θα τα ξεπεράσουμε.
Εμείς μέσα από τις πολιτικές μας ομάδες και τη δράση μας είναι που θα υποδείξουμε προς την Ευρωπαϊκή Επιτροπή τι πρέπει να κάνει για να ξεπεράσουμε αυτά τα εμπόδια. Τρεις συνάδελφοι, ο κύριος Ανδρουλάκης, η κυρία Μπος, ο κύριος Άκιους, ο κύριος Βίχτορ έθιξαν το πιο κρίσιμο από όλα, το ζήτημα του κόστους. Δίνουμε σήμερα για την υγειονομική διασυνοριακή περίθαλψη 0,004%. Αυτό δεν μπορεί να παραμείνει έτσι, πρέπει να αυξηθεί. Θέλω να ευχαριστήσω επαναλαμβάνω και κλείνοντας όλους τους συναδέλφους.
Να τους πω ότι έχω ακούσει με πολλή προσοχή όσα είπαν. Συμφωνώ σε όλα ουσιαστικά. Θέλω ιδιαίτερες ευχαριστίες να απευθύνω στον κύριο Βολκούλεσκου ο οποίος ήταν εκείνος που είχε τη σκέψη την αρχική να γίνει αυτή η έρευνα και να διαφοροποιήσουμε τον προϋπολογισμό. Όλοι οι συνάδελφοι που μίλησαν οι σκιώδεις εισηγητές διετέλεσαν είτε υπουργοί είτε ασχολήθηκαν με την ασφάλιση υγείας είτε με τις χρόνιες παθήσεις και τα δικαιώματα των ασθενών.
Να πω ότι η έκθεση περιλαμβάνει πάρα πολλά από αυτά τα οποία ακούστηκαν. Για αντικειμενικούς λόγους δεν μπορούσαμε να έχουμε πάρα πολύ μεγάλο κείμενο. Άρα έρχονται τροπολογίες που θα καταθέσουμε και εμείς, αλλά θα λάβουμε πολύ σοβαρά υπόψη και όσα είπατε, κυρία Voss, για τις γυναίκες, παραδείγματος χάρη, τα οποία θα προσπαθήσουμε να συμπεριλάβουμε μέσα από τις τροπολογίες μας στο κείμενο. Ευχαριστώ ξανά όλους πάρα πολύ.
Liesbet Sommen
Thank you, Chair. I will not entirely repeat what I already said earlier, but thank you for the study that has been presented and which we also already looked into. It's a very solid base for the further work here in Parliament. Like I already said and which has been mentioned by a lot of colleagues here, this is an important directive. It needs to be brought up to speed with, let's say, new developments that we have.
And of course, we need to make sure that this cross-border health is being used by patients that can actually use it, that actually need it, in very specific cases, especially when the national healthcare system is not, cannot provide with the necessary solutions. And this means that we need to tackle the hurdles that exist today, financially, administratively. We need to find out a solution for this payment that patients often have to do to use cross-border health. So that is especially important in this regard. Digitalize the digitalized area and so make sure that the directive is in line with this.
But also what I mentioned is we need to tackle the opportunity here to make sure that we give access to clinical trials because in certain instances our patients in very heavy circumstances don't have access to this in their own country, but maybe abroad they do. And this can also save lives in some instances. So maybe this is an opportunity to seize here. And like I said, some kind of abuses where patients are being lured into treatments that are not actually with added value, also need to make sure that we can tackle the opportunity here to make sure to put it into the report. But happy to work all of you together and let's make sure that we can upgrade the cross-border health use in Europe.
Thank you.
Marta Temido
Obrigada, Chair. Portuguese. Thank you. Creio que há algo que fica evidente depois de tudo o que já foi dito. A criação desta diretiva gerou um conjunto de expectativas.
E essas expectativas foram de alguma forma goradas. Portugal, o meu país, de acordo com os números disponíveis, enviou em 2025 cinco doentes para tratamento ao abrigo da diretiva. A questão que temos que considerar subjacente à discussão que vamos ter é até que ponto é que nós não estamos a querer utilizar a diretiva para algo diferente daquilo para o que ela foi concebida. A minha pergunta é: pode uma vaca voar? Pode, mas com dificuldade.
A diretiva foi concebida, e quando nós vamos aos trabalhos e estão aqui pessoas que estiveram presentes, vemos isso, para corporizar um direito de mercado, liberdade de circulação para doentes, liberdade de prestação de serviços de saúde. E o que nós fizemos foi introduzir na diretiva acesso a outros aspetos, designadamente as redes de referenciação e tratamentos raros. Isso provavelmente leva-nos a precisar de agora, na sua proposta de revisão, considerar duas linhas distintas: a circulação normal de doentes para a prestação de cuidados de saúde como um direito de circulação das pessoas dentro da União Europeia, que está na base da criação desta diretiva, e estas novas necessidades.
Speaker 34
Vamos procurar com as nossas emendas responder às limitações identificadas, mas também a estas novas necessidades. Muito obrigado.
Vlad Vasile-Voiculescu
Thank you. Yeah, I would also like to thank the rapporteur for his work and on this draft report. I very much welcome its overall direction and its clear focus on patient rights and equitable access to healthcare. We all agree that the current framework of cross-border healthcare was an important step forward, but there is still much work to be done. I will also support what Tomislav Sokol said earlier.
ERN have a very clear role to play and very easy for everybody to understand. This is the place patients with rare diseases, for example, should be able to get their second opinion from. Second, I would also like to underline what my colleague said about access on to clinical trials. This is particularly important both for patients who don't have any other option, but also for science. If we talk to pharma companies, if we talk to people active in this field, we're going to see that finding patients is a challenge.
And we have those patients in Europe. We just need to make sure that those patients have access to the clinical trials that can help them and can help all of us by developing the innovation that we need. I will also stress the needs of children and people with disabilities. And I will end by saying we don't have the institutions right now to make it a free market, as Mato was saying earlier, to make it available for everyone. We should start somewhere and we should make sure that this instruments that we would need for perfectly functioning union, healthcare union, will start working.
And I think we should start with kids. And I think we should start with rare diseases, maybe with kids with rare diseases. And we should build on that. We should make sure that our ERNs and our digital framework is capable to absorb that, to serve those people and then expand it. That's what I would do.
Thank you.
Thank you, Tilly Metz.
Tilly Metz
Yeah, I'll try to be short. First of all, it was mentioned several times, we see that we speak already for years about cross-border healthcare and that we have really big issues on the implementation of it and a lot of barriers that are still there. Let me make just a few points. First of all, on digitalization and when we see the discussion that we had on the European Health Data Space and all the sensitivity regarding also exchange of health data, I think there is still a work to do also in building trust among the people on this communication of health data. And then another thing we have to do and several of my colleagues said it, I think we need to advocate and boost and campaign for the European Reference Networks, the ERN, because I made the same experience as my colleague from Malta, if you ask the doctors, they are not really using it.
Thinking there of my socialist colleague, Andriukaitis, at the end of the day we need much more harmonization in the health sector and also coming at one moment more harmonization when it comes to reimbursement. I know that is a long way to go, but key points are really that patients' needs and public health should stay in the center and that we should not increase inequalities through cross-border healthcare possibilities and that digital solutions should complement healthcare systems, not fragment them more. And then again, I say what I said before, I think a gender-sensitive approach is needed and also tackling, targeting especially vulnerable population that they can be part of it. And I wanted to be short. Well.
András Tivadar Kulja
Thank you very much, Chair. Thank you very much for the report and the previous presentation. And I would like to jump back to one slide you just showed us, improving national contact points, creating single EU information entry point and providing better training tools for those who help patients navigate cross-border. I think it's a very, very important point, particularly for patients with rare diseases. They often face extremely fragmented informational landscape and and may have to find their way between different national systems and reimbursement rules, centers of expertise very difficult.
So but improving access to information should not only mean providing more information, but providing information in a understandable way because in this time we face the false and misinformation all across the internet and social media and this can very easily mislead our patients and destroy the trust in the healthcare system. So my question would be how can we or or how the proposed information entry points could actively guide rare disease patients towards trusted sources and recognized centers of expertise because I believe it is very important to to create an evidence-based, up-to-date, transparent sources for patients which are regularly updated and and and that's also can improve the trust in the whole healthcare system in the EU. Thank you.
Vytenis Povilas Andriukaitis
Okay, only last comment. Interoperability, interconnectivity can help us to to connect all 27 member states, centers, contact point centers, European reference networks and so on. We need to have stable financial means to guarantee investment in infrastructure. And then we will solve a lot of problems, including possibilities to have pan-European additional reimbursement system. We need to now to reassess situation about social security coordination issues and cross-border healthcare, you know, directive.
It is up to us now to do it in front of new MFF.
Adam Jarubas
Thank you. I'd like to ask the representative of the Commission, Philippe Roux, head of the Health Monitoring and Cooperation Health Networks unit at DG SANTE.
Philippe Roux
Thank you very much, Mr. Chair. Thank you for inviting the Commission to this important discussion on the report, the committee report on modernized rules for patients' rights in cross-border healthcare. I mean, ensuring high-quality healthcare for all citizens is a priority for the European Union. It was mentioned by the presenters. It's also in line with the approach by the Commission since now years.
It's a consensus, I think. And as rightly said, the issues that have been mentioned exist, we know them and we are working on how making them less burdensome. One first element, I think it's important to mention and of course you well know it, but it's central to me to mention is that EU citizens may receive healthcare in another Member State under two legal frameworks: the Directive, of course, but also the Social Security Coordination Regulations. And I think these frameworks differ in scope, reimbursement and authorization requirements. The Directive of course offers broader options but requires upfront payments, while the Regulations typically cover public healthcare services with direct payment among the national authorities.
So both systems coexist. Together, they enable access to treatment abroad while balancing patient's mobility with the financial sustainability of national healthcare systems, because I mean the figures that have been mentioned are very important and interesting, but also they reflect also the difficulty of using them. So this element has to probably to be investigated more. Under the Directive, prior authorization must remain an exception. And I think that's important for me to mention because that was foreseen like this and I heard it was an element that was mentioned before by presenters of their report.
And it should be justified in line with the Directive and the Court of Justice law cases. And the Directive already sets out clear rules for reimbursement, including reimbursement equivalent to domestic rates and upfront payment followed by reimbursement. And the 22 evaluation indeed found that the Directive was successful in safeguarding patient's rights, promoting e-health and promoting European Reference Networks, while also, as it was done here, identifying challenges related to limited public awareness, procedural complexity and administrative burden. So that was already known and in response to that, the Commission is finalizing now the implementation of the related action plan with a focus on simplification, digitalization and making procedures more transparent and less burdensome for patients, while respecting Member States' responsibility for the organization and delivery of health services, because it was mentioned, this is under the authority of Member States. To raise awareness to these rights under the Directive, I wanted to mention that the Commission and the Member States organized national and regional workshops on reimbursement, prior authorization and notification procedures, the Reference Networks and the regional cross-border cooperation.
So that was done in the majority of Member States, so it can be repeated, of course. Furthermore, the European Health Data Space, which was mentioned, is designed to facilitate cross-border healthcare by harmonizing rules and legal frameworks for cross-border electronic health data exchanges, supported by the MyHealth@EU infrastructure, which will provide a common interoperability platform for health data exchange across the EU. So we are already working on that. Rare diseases, as mentioned several times, remain a key public health priority. The 24 European Reference Networks are crucial indeed for improving diagnosis, care and treatment for patients across Member States.
That was said also by a number of you and indeed it is clear also in the minds of officials in the Commission. And to support their integration into national healthcare systems, the Commission has launched, and it has been mentioned by the rapporteurs, the joint action JARDIN, which helps Member States develop rare disease plans and patient pathways to access ERNs expertise. So that is also on its way and it's still to bear fruits even more. And this work is running until 2027 and may inform future policy development. So we have elements that have started that you may take also into account for the future.
And for me, the directive remains a key pillar supporting competitiveness, ensuring rights-based patients' mobility and enabling collaborative healthcare across borders. Thank you, Mr. Chair.
Adam Jarubas
Thank you, Mr. Rou. Dear rapporteur, would you like to summarize very, very shortly?
Giorgos Georgiou
Οι αρχαίοι Έλληνες ήταν αρκετά σοφοί και έλεγαν μία φράση: άμα έπος, άμα έργον. Δηλαδή μόλις πεις κάτι, είναι ανάγκη να το πράξεις, να το κάνεις. Έχουμε πει πολλά, έχουμε ακούσει πολλά. Εκείνο που απομένει είναι πολλά από αυτά τα οποία είτε συμπεριλήφθηκαν στην έρευνα, είτε θα συμπεριληφθούν στην έκθεση και μέσα από τις τροπολογίες, να γίνουν πράξη. Για να γίνουν πράξη, θα πρέπει η Ευρωπαϊκή Επιτροπή να συμβάλει με συγκεκριμένο τρόπο να ενισχύσει οικονομικά αυτήν την προσπάθεια.
Ευχαριστώ.
Adam Jarubas
Thank you so much. Dear colleagues, thank you all for this excellent debate, especially to our experts. I announce now the deadline for tabling amendments which is set for 10th September at 11:00. Dear colleagues, I close this morning's meeting. We will meet again at 3:00 in the same room for the Gold September event with opening remarks of President Roberta Metsola.
Thank you so much.