Committee on Public Health Ordinary meeting
Legend
Transcript markers
- text Sentence being played
- text Search result
- text Intervention cited by the link you opened
Click a sentence to play the video from that moment. Select text to quote it with the speaker, timestamp and link.
More options
SANT European Parliament
Follow its sittingsVlad Vasile-Voiculescu
Europe produces excellent science. Europe produced the world's first randomized controlled trial on AI in cancer screening. The Massari trial in Sweden and the PRIME study in Germany showed that AI can detect more cancers while cutting radiologist workload by 44 percent. The evidence was generated in Europe on European patients within European screening programs. At the same time, a single American imaging company, RadNet, has absorbed three of Europe's leading cancer AI developers in under 3 years.
Quanti, Adence, Kiron were developed with tens of millions of euro they received through Horizon and ERDF to tackle prostate, lung, and breast cancer, three of the four most common cancers. Three companies developed inside the European research ecosystems with a meaningful public contribution are now American subsidiaries, licensed back to the European hospitals that helped build them. We are becoming the continent that funds the research and imports the product. This is also, or this is precisely why the next phase of the plan must come with outcome-based funding. We need stronger incentives for screening and vaccination uptake.
We need a real path for research to clinical, from research to clinical development, and we need faster and safer routes for proven innovations, especially in AI-supported screening. And we need proper parliamentary scrutiny. We need an annual structured dialogue here in SANTS because ambition without accountability is just a press release. If we say that every European life has equal value, then we must be serious about reducing inequalities. If we say that Europe should lead in innovation, then we must be serious about getting the innovation to the bad side.
And if we say that the European Union protects its citizens, then cancer policy is where we should prove it or where we will fail. That is the purpose of this report, to defend what has worked, to confront what has not, and to push for a beating cancer plan that saves more lives, that reduces inequalities, and that delivers results that citizens can actually feel. I look forward to working with you on getting this right.
Adam Jarubas
Thank you, Vlad. I will now move to the shadow rapporteurs, each for two minutes maximum. First, it is Barto Sharukovich. The floor is yours, please. Thank.
Bartosz Arłukowicz
Right. I would like to thank you very much for the material that he has drafted, and I would like to briefly relate to the way in which we are implementing the European Commission's plan regarding cancer for the next few years. I'm very sorry to say that in spite of the existence of this plan and in spite of the lengthy decisions and discussions that we held in our committee, unfortunately, I must say that the way this plan is being implemented, I can only assess it in a very negative way. Definitely, it's negative. In spite of the many rounds of discussions, we have not really introduced a plan in this respect.
I do understand that we should talk about the AI contribution, the state-of-the-art research. But in fact, in Europe, the same, a woman who has breast cancer will have different access to care and treatment depending on which part of Europe she lives. And we should be mindful of that. With all due respect to the conclusions of the document that we are discussing here, I do agree with all of that. I would like to underscore the fact that if we really want to beat cancer, we must ensure equal opportunities for access to treatment and rapidity of treatment.
And it seems to me that this is much more vital. Every patient needs to be diagnosed in due time, on time. They need to be diagnosed and treated and also receive post-treatment care. We need to have accessibility to treatment and drugs. We have been talking about that, but we do not do it.
We do not have common negotiations as regards pricing for the most up, state of the art technologies. It must we must not allow for a situation in which ministers of health of individual member states are left to their own devices while negotiating huge amounts of money with pharmaceutical companies. And this is why we are not really using the most advanced methods of treatment. And finally, I understand that we have been introducing and implementing different regulations also in our committee, but the truth is that we still have no efficient way of protecting patients against the temporary lack of various medical substances. And we see that patients who need to be treated day in, day out may sometimes reach a point where they cannot have access to their medication.
We haven't had efficient control of the way in which we are spending resources. And I would like to also mention that the European Commission has not really defined specific earmarked funds for combating cancer.
Alessandra Moretti
Thank you very much indeed, Chair. I shall be speaking Italian. I would like to thank WAD as well as the secretariat for this preliminary draft of the report. And I think it is a very sound point of departure, something that we will need to expand and amplify. It's very important, of course, for the lives of our citizens and for public health.
And a lot of colleagues will remember, prior to the pandemic, this committee had decided to initiate a specific Europe cancer plan, because we need to have a systemic approach to tackling this disease. You remember Stella Curiaquides, who was our health commissioner, and she played a very decisive role in launching this plan. And then in the wake of the pandemic, we decided that public health should be center stage of the European political debate. When we are looking at health and cancer, we have not paid sufficient regard to it in European political decisions. Look, for example, at the proposed budget cuts to the health budget, whereas in actual fact, we have diverted a lot of the funding to our competitiveness spending.
Whereas in actual fact, we need a resolute response from the parliament commission as well as member states, because in fighting cancer, we cannot move forward if we do not have dedicated programs. Now when we are looking specifically to tumors, a lot of the political forces think that we should take decisive action. Now when it comes to spending, a lot of tumors could be detected at an earlier stage, and we are therefore duty bound to help our citizens in making the correct choices and making sure that health care is more accessible. Now when it comes to World Cancer Day, I would remind all colleagues in this committee that we are the health committee, public health committee, and we should be mindful of that, because we should be in a position to make sure that public health and science take precedence over other matters. And we should therefore reject any proposals that have been coming in for many years from the lobbies to cut public health funding, which will impact the health of the weakest in society, above all.
Now this is a preliminary draft, and we should not have second class citizens anywhere depending on the country which you come from, and cancer outcomes are far too diverse. And that is why we need to tackle things at the European level. And we in the SED, therefore, call for this directive to be adopted, but guaranteeing a level playing field when it comes to our member states. And we should not see any backsliding when it comes to this proposal, because we need to tackle problems which are common to many European countries. But we're not all equal when it comes to facing up to cancer.
Socioeconomic factors have a crucial role in determining outcomes, and that is why we also need to tackle the socioeconomic factors, which have a role in cancer outcomes. Final point. We also need to look at the specificities of different sections of the population. We need to pay special attention to pediatric cancer care, and also need to look at the special needs of women as well as the elderly. It's important, therefore, to remember that we have had many forces working with us in recent years, and we would want to see us following the example of those who have bravely fought in recent years where we need to keep the bar high, and we need to work ambitiously in the interest of all our citizens.
Valérie Deloge
Thank you.
Very much, chairman. I'm speaking on behalf of Mister Nicolas, who's the shadow on this. Ladies and gentlemen, all steps forward in the fight against cancer are important for Europe. It's the second biggest cause of mortality, but 40 percent of cancer cases could be avoided. What we're doing here is an important milestone, the first real joint strategy to help.
And this is an opportunity to take a step back and to bolster our ambition and to push forward. In the Patriots group. We are in favor of this document, but we feel that this text is key, and it shouldn't just be on paper. We have a lot of promises, but we want to table a set of amendments to bolster it and to be able to use it as a lever to promote sports as a way of preventing cancer, and to promote public health. We want to invest in research and innovation and encourage those programs that have shown their efficiency and effectiveness, so we can have a quick and real impact.
And we have to make sure that we have the effect that we have access to health care, especially in rural areas where distance is a barrier. We mustn't forget the people in rural areas. Politicians must think of them. And we have to make sure that we have a balanced and effective approach when it comes to prevention. If we want there to be consistency, there have to be safeguards.
Let's take the tobacco. We have to be pragmatic. Let us protect young people from the dangers of tobacco. There are so many tobacco products being promoted, and young people are being targeted. And we have to make sure that we don't have over-regulation.
And when it comes to health, we need a balanced diet. We need to promote that and make sure that we don't make eating meat or give it any stigma. Now, let me say that the beating cancer plan has to be a plan for life that provides better information and accompanies those who have it. Prevention is better than cure, because we all know that prevention is cheaper than treating cancer. So in this battle, we shoulder an immense responsibility individually.
Every amendment, every change can make a difference. So we have to help those and make sure that we don't leave them alone, facing this disease. Mister Marina from The Green.
Ignazio Roberto Marino
Thank you, Mr. Chair, to congratulate Vlad for the very comprehensive presentation that he did today. I will just stick to three simple points. Hopefully, Vlad could integrate them into his work. The first one, we just heard that prevention is less expensive than treatment.
I fully agree with that. And one of the things that I do not understand why we don't do in Europe is what was proposed by many scientists more than 25 years ago, that smokers should undergo a simple CT scan without contrast, which probably costs $200, €200 yearly. And in this way, you can do early detection. If you do a detection of a lung tumor when it's 5 millimeters and you remove it with a wedge resection, that patient is considered cured. He doesn't need radiation, doesn't need chemotherapy, so it's much better than treating it later.
The second point is about environmental prevention. I guess all of you have a smartphone, and probably most of you have the app for the weather. If you look at the weather today in Brussels, the quality of the air is very poor. It means there are a lot of air pollutions and widespread chemical exposure, which is as dangerous as a smoker smoking. So prevention of the environment, and what Vitani discussed before, the exposome is extremely important.
Third, just for saving money, we don't do in any of the state members in Europe a real follow-up after a cancer surgery. You know, for example, if a woman and we know that one woman out of 9 will have cancer in her life, breast cancer, undergoes surgery for the breast cancer, the year later she will have just a chest x-ray and ultrasound. Instead, she should have a CT scan and a PET scan to detect early recurrence. And we don't do that because we want to save money today, and spend more money and lose more lives in the future.
Sebastian Everding
You, chair. I will continue in German.
From my perspective, thank you very much indeed to the rapporteur for this preliminary draft. Cancer affects virtually all European families. And so the chapter at the beginning makes reference to competitiveness on four occasions. And I find that a bit jarring, because we're not talking about a competitive economy. We're talking about people's health. Now we have very alarming prospects because we are expecting an 18 percent rising cases and a 26 percent increase in mortality.
And if we look at the resources we have, at the knowledge we have, then this really is a wake-up call. We have to act as a matter of urgency. First thing to do is work on prevention. And, of course, our lifestyles have a huge impact on that, and the plant-based diet can have enormous benefits. And I would contradict my colleague from another political group who talked about not stigmatizing meat eaters, but it's very important that we look at the benefits of a plant-based diet.
Now, at the same time, I am very worried about a resurgence in tobacco use among young people. Now, how can we countenance such a state of affairs? How can we tolerate that? It's vital that we inform consumers about the salt and sugar content of foods, and the danger thereof, if we wish to effectively tackle cancer. Now, early detection is most important.
Screening saves lives and, in the long run, of course, saves money. We also need to target our efforts at risk groups and make sure that people have access to health care. And I would, perhaps, direct a remark to the government of Germany, Mister Metz. Now I think we are headed in the wrong direction. I think we have to invest far more in early detection.
That way, we could save millions of lives if we detect cancer early. And perhaps just to round off, allow me to say.
that
Sebastian Everding
Following on from a survival of cancer, used to ensure that people are not disadvantaged for the rest of their lives. It's important that we look at what needs to be done and act, and I very much hope that this text is a good start.
Adam Jarubas
Shadows around, starting with catch the eye. Elena Nevada del Campo is the first.
Elena Nevado del Campo
Thank you, presenter. You will speak in Spanish. First.
Of all, I would like to thank the rapporteur and all the shadow rapporteurs for all the work that they've done. Because when you hear that every two minutes someone dies of cancer, it sends shivers down your spine. And according to the WHO forecasts, there could be 35 million deaths by 2050 around the world. So, but let me say that we cannot have a pessimistic message because the beating cancer plan has worked, and there has been substantial progress. It has shown that when you are politically ambitious, then there can be effective results.
I think that the key point is whether we are sufficiently politically ambitious to harness the potential that is there. Now health falls within the remit of the member states. It's a national power. And the member states shoulder a huge responsibility to make sure that there is equity and fairness. And they are responsible for implementing the health plan.
And it's up to them to, and it's also crucial for them to look at how much they're investing in their health system, and to look at how much they are investing in prevention and in treatment and monitoring. But there's something else we have to worry about, and that is the upcoming IMF. There isn't a single independent large-scale health program such as the Europe for Health. Instead of this one all-encompassing program, we have 13 in the competitiveness fund, and the direct investment in health will then hinge on the flexibility of the member states and on the capacity that member states have to negotiate their national plans. Now, without stable financing, there isn't continuity.
And without continuity, there are no results. Thank you.
Vytenis Povilas Andriukaitis
Thank you very much, chair. I would like to continue in the key and because it was a good opportunity to say a few words in the key and thank you. I
Understand completely and would like to thank all the reporters. It's absolutely true what you all said. At the first question, the commission decided to cut 1,000,000,000 in financing from the euro beating cancer plan. It's unforgivable. If we look at how many projects were not financed, where they stopped, you will see how many of them have been frozen.
And the second question, the U4Health program. We don't know whether we'll have this program or not. The MFF is upon us. What will we do if we don't have the financial instruments and say strictly that they have to reach objectives? We should give a gift to the members heads of states with a sand clock for them to see that every two minutes a person dies, to see what the economic damage is done by this.
And the implementation of a tobacco directive, it's ridiculous. I stopped being a commissioner in 2019 and raise questions about when the implementation will be completed. This is the simplest sphere. We don't need much financing to combat the use of tobacco. We have to defend these directives to defend the financing, and the EU health unions have to come back to their agenda.
Fight against cancer has to have much more effort.
Thank.
Gerald Hauser
Thank you very much. Previous speakers have talked about the shocking increase in the number of cases of cancer every year. Of course, that is something we're all upset about, but what we need to do is tackle the reason for the increase in cancer cases. So where should we go in? Where should we act?
And I haven't heard a lot of people talking about the causes. People talk about lifestyle. Obviously, that's linked to eating meat and so on, but people have been eating meat for many years. But what this parliament keeps sweeping under the carpet is a link between the explosion in cancer cases and increased vaccination. And people can share, shake their heads all they want.
We've got 8,400,000 people studied. We split these people into two groups. The ones that were vaccinated against COVID and ones that weren't. And we see an explosion in cancer cases in the group that was vaccinated. I've got up-to-date figures from Austria.
This is not something that we came up with. This is something from the Austrian government. And the figures have shown that cases of cancer from 2020 to 2024 after the mRNA COVID vaccinations have increased by 4,000. Before, it took ten years to have that much of an increase. So there may well be an intensive link.
There is an intensive link, and nobody is looking at this. And there's a review that's been published. They've looked at worldwide literature between 2020 and 2024. And it showed that 69% of publications in Onco Daily have shown that there is a link between cancer cases and COVID vaccination. So this has got something that is very clear.
When are we going to have a study on the carcinogenic nature of the COVID vaccine?
Thank.
Peter Agius
You, chair. First of all, thank you to the rapporteur for this report. I'd like to jump in on two key points. First of all, I think addressing the causing factors of cancer is a fundamental point that, as legislators, we cannot ignore. I think tobacco, food, environmental factors, we are living in the age of misinformation.
So many families are left in the dark as to what is causing cancer in so many loved ones and their families. The second point is that there should be cohesion in health. I think, as the reporter pointed out, as many of our colleagues also pointed out, there are huge disparities in different member states when it comes to cancer care and treatment. I come from Malta. We have one of the best success rates when it comes to treating, for instance, breast cancer because we have the numbers, and we can invest in that.
Malta is a small population, barely half a million people, but we invested in some of the most common cancers, and we have very success rates thanks to excellent doctors. But when it comes to rare cancers, we have one of the worst survival rates. So this is where Europe needs to play its magic. We need to have cohesion in health care, and this beating cancer plan has been a great success simply because it has given us a glimpse of what we can do together, of the great potential of Europe. Colleagues, Europe needs to deliver results for the citizens to remain relevant.
We have a lot of tools at our disposal. We are already doing a lot: critical medicines act, pharmaceutical package. Now we have biomedic biotech act in front of us, but we must make all this work better through a better framework led by the European Commission and good funding, as colleagues already put forward. Christophe Clerjou, please.
Christophe Clergeau
Thank you very much. I'll be speaking French. I have three points to make. First of all, many of my colleagues from the EPP and the socialists have said that the issue of the plan's funding in the upcoming MFF will be key, and that is obvious. So I hope that altogether, we'll be able to fight for an EU health program with €10,000,000,000 funding that will be high enough to fund the beating cancer plan.
This is something crucial that we have to fight for here in this committee. And then the rapporteur is right. The prevention shortcomings are extremely serious from a moral and policy point of view. And we really have to focus on this, and we have tools for this. We've heard about the exposome and how exposure to different factors can trigger chronic diseases, such as cancer.
And then in the exposome, you have individual behavior, you have the life environment and working life conditions, inequalities, lack of equal access to health care. And all of this is part of a whole. And I think that we're going to have to face this reality. Yes. We're going to talk about alcohol and tobacco again.
Yes. We're gonna talk about pollution and toxic substances. And, yes, we're gonna talk about equal access to health care, but then we'll have to see how people vote. We're gonna have to see which way people swing. And I'd like to talk to the French MEPs.
When you have a colleague from Yuma Group who speak in the French parliament and who say that cancer case increases and people say that it's because of COVID vaccinations, do you contradict them? What do you say as patriots? Do you say anything to your colleagues? Do you think that COVID is linked to this increase in cancer? I want an answer from you because you just hide behind vague words.
But when the time comes to fight against pollution, pesticides, and toxic substances, you are never there. And then you back tests that are not funded, underpinned by science. And if you don't say anything against us, you are criminals.
Nikos Papandreou
Thank you very much. Yeah. Thank you. There are studies on what our colleague has been talking about. Anyway, I think there's a to shift the discussion, there's a tension of what we can do as a health committee, and what we want to do, and what we can do.
And I think this report tries to solve the tension. And I like the practical elements involved, because we don't have, as Vitani says many times, we don't have legislative power, and the health of each country depends on their own decisions, and not on us. So here are some very specific proposals. For example, very simple. I like simple.
Regulatory sandbox by August. Every country has very specific rules. Also, the idea of a dashboard. The dashboard, how does the dashboard work? It puts political pressure on the countries to not be at the bottom of the list of EU countries in terms of screening.
That is a big pressure on any country. So these are the practical results, and the four shifts that are mentioned in this, which is to get the research out from the lab and into practice, is very practical. How do we do that? Well, we've talked about the funding. Okay, that's very important.
So I think the practical elements, which we didn't discuss here, are something that I agree with, because we won't make a revolution. When I was 18, I thought we could change the world in one night. But now we can do it with 10 small steps, or four small steps. So I want to focus on these things. And finally, in my own amendments, I'm gonna look at something which I think is important.
The patient journey and the role of patients' associations and how we can bring them closer to the health institutions. So that will be my focus among many focuses. Thank you very much.
Nicolás González Casares
Thank you very much, Chair. I'd like to congratulate the rapporteur for his report. I think that it is spot on, and it tackles key issues. As Nicolas Papandreou mentioned just now, we have to reduce inequalities. This is a very important point.
It was one of the key planks in the beating cancer plan. How do we reduce inequalities linked to geographical location or socioeconomic situations? I would say that when it comes to tobacco, we shouldn't just include data and talk about the data. Tobacco is one of the main causes of cancer in Europe, and tobacco consumption is increasing across the board. We need legislation now, and we can come up with EU legislation.
We can't wait, or rather, we don't have to wait for the member states. We can act now. We can act already. Of course, we need to do that. So, and if the cancer strategy is to work, we need EU funds.
And I've heard right-wing groups say that we need more health in the MFF. But then if the EPP doesn't want a European budget with a strong health component, given that you have a majority in the College of Commissioners, then you can imagine. Let me say something to the far right. To say that COVID vaccinations cause cancer is absolutely outrageous. But let me say that we're gonna hear this less.
Do you know why? Because you're no longer in vogue. You're no longer in fashion. Your science lies are no longer in lies, and you saw what happened to Orban last Sunday. So, wait.
Just be careful, because you might be next.
Adam Jarubas
Our discussion, I will give the floor for 4 minutes to the commission. It is represented today by Philippe Rue, head of unit council health in all policies at DigiCentre. Mister Roo, you have the floor for 4 minutes, please.
Speaker 28
Thank you, Mr. Chair. First of all, I really want to express the fact that we appreciate the strong demands to the commission you have. And also the rigor of the rapporteur, Voin Kulesko, whom I had the honor to meet for a fruitful exchange for the success of the cancer plan, which was mentioned as an unprecedented initiative in the field of health. This support for counter action at EU level is also shared by other EU institutions, notably the European Court of Auditors, that no one can claim is not serious in its work. And in its special report released in February, they provided the assessment on the implementation along with recommendations, and I'm sure you have seen them.
They suggest we strengthen alignment with the member states' needs and capacities and to enhance monitoring and evaluation. We have accepted these recommendations and are now planning to take forward these necessary follow-up actions. We will approach the European Parliament report with the same diligence and will provide written input during the coming discussion process on the final text. We have already carefully reviewed the draft report and taken note of the discussions and questions raised by the committee today. We welcome that the report acknowledges the concept plan as the most comprehensive EU-level concept framework to date, catalyzing real achievements, including the 2022 Council recommendation on cancer screening and the launch of the new network of comprehensive cancer centers.
Both are tools that can respond to the elements and questions and elements raised today. Finally, the commission appreciates the numerous efforts of the European Parliament to provide ideas for securing the long term impact and funding of the cancer plan. While we cannot make commitments at this stage, given that the next multi-annual financial framework is still under negotiation, as you well know, we take note of the proposals put forward. And, again, I would just like to thank you for your continued efforts to advance cancer prevention and care across the EU and look forward to your continued collaboration, because it is very true that it is thanks to the parliament that twenty years ago, the first push on cancer was existing at what was a community at the time. And now with the union, you have pushed a lot for the effort to continue, and we are very grateful for that.
Thank you, mister chair, and thank you to the rapporteur again for its impressive work.
Adam Jarubas
Thank you. Finally, I'd like to ask the rapporteur for his reaction to the comments.
Vlad Vasile-Voiculescu
Thank you. As a rapporteur, my goal here is to reach some kind of compromise for this report and for the actions that will follow it. So what I heard in the room was basically from everyone that we are not ambitious enough. We're not politically ambitious enough. And that's what I've also heard, and this I I'll also share my opinion pretty bluntly.
I think this is we are in a sort of a dolce vita in the field of health care, not only in Europe. We have allowed ourselves to postpone stuff, to postpone things, to postpone policy measures that shouldn't have been postponed for a day. Screening has been mentioned. Breast cancer, it's around 10 percent in the Eastern part of Europe, almost 90 percent in other parts of Europe. Breast cancer screening.
HPV vaccination. So I heard that some vaccines might produce cancer. I don't believe that at all, but, I think no one will say that HPV vaccines produce cancer. On the contrary, we have the example of Australia that basically eradicated cervical cancer with the HPV vaccine. So this is something that we can definitely agree upon.
Then we have heard, and I've heard from the patriots, I'm grateful for that, actually, about young people taking up smoking. We have allowed ourselves to be fooled by lobbyists. And two, three days before any vote here in this parliament, the phones are ringing and pressures are being put on each of us here. We have the largest number of young people taking up smoking in the world. Every fifth youngster, 15 year old, every fifth 15 year old is taking up ecigarettes, has been vaping over the last 30 days.
Though the data is clear. They are some of the industry is saying or the industry is saying that they are gonna leave smoking, give up smoking, and take up more healthier alternatives. This is not true. A young person that starts with vaping is three times, will three times more likely by three times that he or she will take up smoking. These are factors.
These are clear studies. We have 16,016 flavors, influencer marketing, colorful designs that mimic toys and candies that make young people take up vaping and then smoking. So this is not accidental. This is business, and it's bad business for all of us. Then we have allowed ourselves to have for treatment, to have little centers of lack of less than excellence everywhere in Europe.
Whereas for rare diseases, we should have a common approach, a common European approach. And finally, for research, we have allowed ourselves to fund research that does not result in commercial or policy actions that are actually in favor of the, of the European citizens. I'll stop here and looking forward to working with you on that.
Adam Jarubas
Thank you, Vlad. Thank you all for this discussion. I announced that, now the deadline for tabling amendments is set to 20 April at eleven. Let's move on to the next point, Sandmission to Cyprus. Dear colleagues, the next item on our agenda is the reporting back from Sandmission to Cyprus from 16 to 18 February this year.
The delegation was composed of 8 members in total. The objective of this mission was to discuss health care in Cyprus, its best practices and challenges, the health priorities in the scope of the Cyprus presidency of the council of the EU, and other health subjects relevant to Sands' work program. We have met with civil society organizations, the minister of health, the president of the Cyprus House of Representatives, and the deputy chair of the committee on health affairs. Also, have visited the Cyprus Institute of Neurology and Genetics, the Nicosia General Hospital, and the Medical School of the University of Cyprus. Moreover, we have had hard exchange of views with their representatives of these institutions and were able to experience the organization and the work developed by them.
During these days, we have gathered valuable information on the health care reality in Cyprus and on its current challenges. The participating members have gotten familiar with the difficulties of the Cyprus population in accessing medicines, the reality of citizens with rare diseases, the impact of workforce shortage, and the burden of mental health. We have heard and seen the strong performance of the Nicosia General Hospital, the Cyprus Institute of Neurology and Genetics, and the Medical School of the University of Cyprus, where EU funding is well used. During the visits and exchange, we have learned that certain challenges similar to the rest of the EU still persist in Cyprus, such as shortage of nursing personnel and to a level playing field for affordable, available, and accessible medicines for all across the EU. We have discussed the aging population.
This is a crucial issue which will have a huge impact on health systems across the EU. Artificial intelligence as an assistant tool to critical medical professionals was also put on the table, and the debate developed on how we can ensure that AI will affect the medical sector positively. From our discussions with various NGOs active in the health sector, other organizations, and health professionals on the island, we got the feeling that Europe is perceived as a good way to address health challenges and that more Europe is both needed and wanted in order to address certain key health issues. We have also exchanged views on the EU financing after 2028. Adequate financing for half is crucial.
The current EU funding program EU for half ends in 2027. And now, undergoing negotiations on the new MFF, we are strongly pushing for half to be kept as a top priority. The Cyprus Minister of Half showed confidence in positive results on half in the next MFF. Paradises is also featured high on our agenda during the visit. There is still a lot of work to do also on our side, and we need to come forward with coordinated and comprehensive EU action on this.
In conclusion, the mission was very successful. The debates and visits were enriching and fruitful and have laid the ground for a close cooperation on health issues at the start of the Cyprus presidency of the Council of the EU. I would like to ask if any other members of the delegation would like to take the floor. Thank you. If not, Nikos, could you comment shortly, please?
Nikos Papandreou
Very shortly. One thing that was very important was they managed to solve a rare disease, thalassemia, with full screening, and there's no more children born in Cyprus with the gene of thalassemia from the premarital screening. So it's mandatory, and it's a rare disease. And with their genetic center, they managed to solve the problem, which is an example for the rest of us. Thank you.
Adam Jarubas
Thank you. Any other comments? If not, I thank the members for their feedback, and consider the mission report to be adopted. We continue our discussion. I'd like to welcome commissioner Oyvara Varkheli to discuss medical devices regulation.
And now I'd like to ask my colleague, vice president, Romano Yerkovich, for leading this, because I must be going to next.
Romana Jerković
Okay, dear colleagues. Today, as you heard, we have a pleasure to welcome Commissioner Vaheli for the presentation of her proposal for a regulation to simplify rules on medical devices and in vitro diagnostic devices. This important legislative proposal seek to strengthen Europe's competitiveness in medical technology, and it should simplify complex regulatory frameworks to reduce administrative burdens and accelerate market access for breakthrough and orphan devices. Its core objective is to ensure that medical device innovation, investment, and continuous supply remain robust in Europe. And now allow me to briefly to the commissioner for a maximum of eight minutes.
It will be followed by the intervention of the repertoire and the shadow repertoires of the subcommittee. And in the second round, I will give the floor to the repertoire from the opinion-giving committee and internal, on the internal market, and to sound members who wish to take the floor. So, I invite you, to all of you who would like to intervene, take part in the discussion, to indicate that to me or to the secretary during the commission's intervention. So, commissioner, you have the floor for initial statement of maximum eight minutes, please.
Olivér Várhelyi
Thank you very much, Chair, honorable members. First of all, I want to thank you for the opportunity to present you the commission's proposal to revise the medical devices regulation and also the in vitro diagnostics regulation. This proposal is an important part of the commission's broader health package, which we have proposed just before the end of last year. The purpose of the health package, I think, by now is clear to all of us. Europe needs to modernize its health ecosystem if we want to preserve what matters most to Europeans, and that is high-quality, accessible, and universal health care coverage.
Today, health systems are under immense pressure, chronic diseases, geopolitical tensions, and aging societies. And we need them to roll out the prevention and diagnostics parts of the Safe Hearts Plan. Medical devices and in vitro diagnostics are present at every stage of the patient journey. Those devices are regulated by a regulatory framework that, due to its last revision, has become too complex, too slow, and too burdensome for all the stakeholders. For the 38,000 medtech companies, out of which 90% are SMEs, but also for nearly 6,000,000 health care professionals working in 15,000 hospitals using these devices every day.
Medtech sector is facing a comparatively high administrative burden in the European Union and absorbing hundreds of thousands of euros for repetitive procedures that do not add to patient safety. And they are suffering, if not already, about closing their businesses. In addition, some rules have not been interpreted consistently by the notified bodies, who also lack regulatory capacities. As a consequence, innovation is not supported enough since new ideas face great risks of ending up in a regulatory labyrinth or finding markets elsewhere. All this has led to issues around the availability of devices, undermining patient care, and ultimately, patient safety.
And unavailability of devices or not making them more efficient is ultimately a problem of patient safety. Let me be very clear on this. It is not an issue of having the highest standards. Is an issue of making these standards too complex. This is why our proposal is both aimed at achieving a high level of patient safety and making the system easier, faster, more effective, and predictable.
First, we reduce the unnecessary administrative burden. Devices should no longer need automatic recertification every 5 years. However, risks presented by the device may justify limited certification periods. So no compromise on safety. Second, we make the framework more proportionate and more risk-based.
This will free up capacity for assessing truly novel or higher-risk devices. For well-established technologies that we will soon list in a delegated act and lower-risk products, scrutiny on requirements should be lighter where evidence and experience justifies it. Regular reporting on the safety of most devices will be less frequent, to really focus on the higher risk products. We will expand the scope of clinical data that can be used to demonstrate safety and efficacy, and it will be easier to refer to the clinical data of an equivalent device. To give you a very practical example of what this all means, currently, the screwdriver, which is made for a pacemaker, is under the current framework classified as a class three product, so like the pacemaker itself.
In our proposal, we would like to ease the burden by putting the screwdriver, created for the pacemaker, to class one. Third, we strengthen harmonization and scientific support. After broad support from the member states, we will soon publish the implementing act on regulating notified bodies' timelines. Basically, it was adopted by consensus. A device may be assessed in 110 days, which would be the shortest in the world.
And this would be the first time in your via the expert panels. We will also guide notified bodies how to assess breakthrough technologies and will regulate their fee structures as well. The future and already the present, in fact, is digital as we all know it, and so should be our rules. Therefore, we create modern and single regulatory pathways for innovation. This matters especially for AI-enabled medical devices. We have proposed to amend the EU Artificial Intelligence Act to remove duplication and overlap between the medical device regulations and the AI Act.
This will provide a single regulatory framework for artificial intelligence systems that qualify as medical devices while maintaining our current level of AI standards. Thanks to the empowerment, we will be able to mirror the standards of the AI Act in the medical devices context even faster. On top of that, electronic submission of documents would become the default option in all the procedures. Fifth, we build a new framework for devices used by small patient groups. Older orphan devices certified under the old directive can remain on the market, and new ones will enjoy preferential treatment during the conformity assessment.
We also want to support patient-centered innovation. So we proposed expedited conformity assessment pathways for breakthrough innovative devices, and we enable regulatory sandboxes to make sure new solutions reach patients much faster, again, and without giving up on safety. So what does this mean in practice? It means economic operators remaining in Europe because they can stay in Europe, because they can save more than €3,000,000,000, which they could spend on innovation now. It means innovators are more likely to develop and scale the next generation of breakthrough technologies here in Europe.
It means better-equipped health systems. It means patients having access to newer and safer devices. And it means our children will keep on having access to the size required by their autonomy. Anatomy. Honorable members, this proposal has now entered the ordinary legislative procedure, and this house has begun examining it.
I listened very carefully to you during my hearing here in this house, and I agree, the needs on the ground are immediate. And this is why I devoted high priority to deliver it as promised at the hearing by 2025. This is why we have been acting swiftly, and this is why I think that we trust the core legislators will also devote the same attention and urgency to this fight. Thank you very much.
Romana Jerković
Thank you, commissioner, for these clarifications. Now I will give the floor to the reporter, Oliver Ashen. You have a floor for 4 minutes.
Oliver Schenk
Thank you very much indeed, commissioner. Dear colleagues, thank you very much indeed for giving us this opportunity to have an exchange of views on what I'm sure is a very important subject for all of us. And I'm delighted and I'm certain that I speak on behalf of all our colleagues that, on the basis of your proposal, we will now be able to move forward. And your draft encompasses many of Parliament's demands. You will be aware, of course, that this is an extremely important subject for all of us.
You alluded to public health across Europe, and I think this is an important advance. Now it's a matter of urgency because, as we have seen, when we have failed in our regulatory overhauls in the past, many of our SMEs encounter huge difficulties, and ultimately, this becomes a problem for all of our patients. Now SMEs, of course, are the backbone of our economies. You alluded to that. You said that 90% of medtech companies are small and medium-sized.
And if we don't make regulatory advances, then we will lose out in terms of competitiveness, as well as certainty for our patients. Now you have mentioned many of the important planks trying to reduce red tape and also making sure that we can plan more effectively and more speedily. Now, of course, that is all working in the right direction. But as a rapporteur, I say great store by us working at pace and that we be able to rapidly debate your proposal and do our bit to make sure that all of this enters into force swiftly, making sure, as I say, that we progress rapidly and allow speedy access on the part of patients to medical progress. Now perhaps just picking up on a couple of points, I think it's good that we do attempt to achieve the 100 day, regulatory approval target, but, of course, we need to be able to rely on qualified and named centers.
And we have suggested that in the case of SMEs that we significantly scale back costs, because, obviously, all of this is well intended. But at the same time, we have to make sure that we do have sufficient qualified centers across Europe that are accessible, and that we do not, at first sight, have something that is advantageous to SMEs, but that in the end, they lose out. And that is something I think we need to look at afresh together. Now there has been some discussion about the classification of software having that in class one, and perhaps you could say a little bit more about that to further clarify, because I don't think that everybody has yet possibly fully understood the implications of that. So we need to talk about simplification and speeding things up.
Second point, I think that we all realize that we cannot be competitive if we are isolated, work in silos. Rather, we need to look at advances in other political areas, to have horizontal political responsibility. And, therefore, I welcome the fact that you have talked about how we have proper interplay between these regulations and the AI act, and I think that we should focus on all of that. But we need to talk about cybersecurity as well. It's all well and good having this digitalization, but we need to look at how this applies to the research sector.
What do you think is necessary here? What kind of future initiatives do we need to beef up the regulatory approach to our health care provision? Now, of course, we've got sandboxes and other important components that need to be further rolled out. Now connected to all of that, of course, is the competitiveness of the sector as a whole across Europe, particularly since there are other competitors, the US, for example. And if we look at the dynamic and look at the momentum in China right now, you are, of course, responsible for one part of this.
Other commissioners are also responsible for deregulation. Is this sufficient, or do we need to take further steps to keep up, to keep pace, if we are to play a significant role in this sector in the future? So these are some of the main points, particularly close to my heart. Now, of course, as the committee, we intend to work constructively with you. Of course, we need rapid progress, particularly when it comes to certification, those that are likely to expire in the near future.
But what we are together seeking to achieve is a robust regulatory framework, which is to the benefit of our patients as well as to our economy in Europe. Thank you very much.
Romana Jerković
Now, I will give the floor to the Sant Shadows repertoire, so two minutes each, and we will start with the S and D group. Please, Timo, you have the floor.
Tiemo Wölken
Thank you very much, chair, and thanks, mister commissioner, Eva Heberlichter Stutte. So thanks for being here and for the overview. I would like to underline that patient safety must be our top priority. Past scandals involving dangerous breast implants, for example, and faulty hip implants have shown just how essential strong European standards are for the approval and certification of medical devices. There are the reasons that the medical devices regulation and IVDR were introduced in the first place.
Right? So at the same time, I agree with you, Commissioner. The MDR and IVDR have created significant challenges for the industry over the years. Duplicate assessments, overlapping reporting obligations, limited harmonization and oversight, as well as the insufficient use of digital solutions have led to a heavy administrative burden for both authorities and economic operators. Parliament has recognized these issues for a long time and called for a revision.
In that regard, I welcome the draft proposal. At first reading, it appears to address many of the challenges, indeed, faced by the industry. However, as always, the devil is in the details, so we must ensure that proposed changes do not undermine patient safety. Instead, we need transparent, balanced, and sustainable solutions, ones that strengthen both Europeans' capacity for innovation and long term provision of health care for our citizens. At the same time, I want to stress the importance of getting the timeline right.
So we must take the time needed to develop a strong and well-considered parliament position. A rush process would, serve neither industry nor health care professionals using the devices of patients, would serve, obviously. We should not repeat the mistakes made over a decade ago. This time, we must get it right for industry and, above all, for our patients. And, five more seconds, I'll have to repeat a point I've raised before on the Critical Medicines Act and on the Biotech Act.
It is regrettable that this proposal is once more not accompanied by an impact assessment, something parliament explicitly asked for just in October 2024. Thank you very much.
Romana Jerković
Thank you. And now I give the floor to Patriots and Valerie Delange. She will speak on behalf of Laura Angola Castillo. Please, you have the floor.
Valérie Deloge
Yes. Miss, madam, thank.
Thank you very much, Judy, madam chair. Commissioner, thank you very much indeed for taking us through this revision of the regulation on medical devices, which was presented last December. So it's been highly awaited, and there are a number of very positive points of which you've reminded us and which we very much welcome, because it will make it possible for thousands of European patients to have more rapid access to innovative technologies which have been unduly hampered by excessive red tape and overburdensome regulations. The commissioner responsible has also carried out online consultations in order to get feedback from patients' organizations as well as companies and various organizations, and they are worth considering. But allow me to put a number of questions to you.
First of all, how can you remedy the lack of harmonization in the certification files for similar medical devices, which can be dealt with in a variety of different fashions depending on the notified body? Secondly, are you planning to introduce mandatory timelines depending on the different risk categories in order to provide greater planning certainty to stakeholders? Thirdly, are you going to shift the burden of risk to the industry, because that would turn the precautionary principle on its head and would therefore extend the timelines? Is the commission planning to bring in other delegated acts in order to provide these further clarifications? Thank you very much.
Romana Jerković
Thank you. On behalf of ECR, I will give the floor to Ruggero Razza, please.
Ruggero Razza
Grazia. I speak Italian.
Thank you very much. Thank you very much to the commissioner once again. I would like to reemphasize just how important this proposal is, and I am delighted that we are able to tackle two objectives: protecting patients, making sure that we have effective devices, and that they can be brought to market in accordance with the rules as quickly as possible. And secondly, making sure that we do not place additional burdens on the pharmaceutical or med tech industry, and make sure that we do not add to their challenges in the global environment. We must work towards greater simplification and also bring down burdens on entrepreneurs and also make sure that we can make savings.
And I think that is one of the added values of this proposal. Because if we can save 3,300,000,000 per year, 2,400,000,000 of that will be savings on red tape, then that, I think, in itself shows the merit of the commission's proposal. And it would also be achieving other objectives, namely, to boost the competitiveness of the European pharma industry. So although, of course, we fully go along with everything that you have talked about in terms of cutting the Ministry of Burden, there are a number of critical points that I would like to bring to your attention. One of those has to do with those products which already have an EC marking, and I'm referring to article 4 on medical devices and article 3 of the in vitro diagnostics regulation.
So we are talking here about reevaluating this certification that's already been achieved. And you obviously, there would be a huge role for the EMA to play in all of this, but there's a risk of. Our question is that if we are seeking greater simplification, then, of course, I mean, I can't say any more. I know that, I've used up all my speaking time, but I know that the commissioner will be willing to come back to us on this. And I know that you will be willing to talk to us as well as the rapporteur to improve this proposal in the interest of industry and as of the patient.
Andreas Glück
Yeah. The chair, dear commissioner, thank you very much. The topic of medical devices is really close to my heart. Yesterday, I was working in a hospital on patients with medical devices. And today, I can sit here and discuss with you medical devices in parliament.
So I'm really keen on working on this. I always try to bring those two worlds together, to bring this political world together with the real hospital world out there. Therefore, I also organized an exhibition in Strasbourg already this year. What we've seen is that under the current MDR, a lot of medical devices have disappeared from the market often due to bureaucratic burdens and not to safety concerns, and this is a problem. Patient safety goes first.
I completely agree to what my colleague, Wilkin, said before. But let's not always make laws stricter. If somebody is breaking the law, like, for example, with what you described before with the breast implants with the silicone, it doesn't make sense to make the law stricter. We have maybe to go for better controls. But if it doesn't make sense, if somebody's breaking the law to make the law stricter, we have to go for better controls.
And this is the problem with the current MDR. This revision now is a great opportunity, and I wanna say time is of the essence because every single day, we are losing, we as medical doctors, are losing medical devices in the treatment of patients. And therefore, time is of the essence. The revision goes in the right direction. I wanna say to the commission, you really did a good job here, but it is our job to make something good even better.
So that we mentioned article 17. There are a lot of reasons why there might be single-use items in a hospital. Maybe it is because I don't really need the item very often in a hospital, and sterilization is too complicated or whatever. At the end of the day, the customers of the medical devices producers decide what they wanna buy. So it's not actually only the producers of medical devices.
So here, we have to work on it. Other thing is rule 11. I believe that, like, with low risk medical software, this is often over classified. We really have to work on this. Also, please keep in mind the overlaps with the other legislation.
So, for example, when we talk about PFAS, we must not like accelerate on one hand and then break it down on the other side. As I wanted to say, patient safety is like in the center. I'm looking forward. I'm really keen to work on this topic with you. Time is of the essence.
As I said, thank you very much.
Romana Jerković
Thank you. And now, on behalf of Green and EFA, colleague Ignacio Marino. Please.
Ignazio Roberto Marino
Thank you, Oliver. Thank you, commissioner Varelli, for your important presentation, and I think this is a very important topic. And you said at the beginning of your mandate that you would have worked very hard on this. I have only a couple of minutes, so I will just go directly to a couple of points related mainly to artificial intelligence. You mentioned that, as an important tool, and I myself believe that is an important tool.
But I think that we need to be a little careful about simplification, and simplification cannot become a shortcut just to make more money in a hospital. I make you two examples. I used the Easter break to go back to do some work at my university in the United States, and I was a little concerned about the fact that in order to allow the physician to see more patients during a morning, they put, you know, in the exam room a system with artificial intelligence that listens to all the conversation between the physician and the patient. And at the end of the day, the artificial intelligence prepares the notes of all the visit that the physician did. And I believe that, you know, there is something more than just words when you meet a patient.
Is, you know, a human touch, a human feeling, and the body behavior that you that the machine cannot put in a chart. The second thing I mentioned today at the coordinator meetings is that just last week, the CEO of an important hospital system in New York, the New York Hospital, announced that he will replace all of his radiologists with artificial intelligence. Well, myself, I've been saying for many years that in the future, I would like to have my CT scan read by artificial intelligence, but with the supervision of a human being. And at the same time, you know, it's a very interesting last week, the University of Stanford published a study showing that the artificial intelligence when it reads a mammogram, if it's not sure what it is reading, the artificial intelligence will not leave you with a question mark. It will give you a diagnosis and it will invent a diagnosis.
And I think this is very dangerous. Thank you.
Romana Jerković
Thank you. And now on behalf of the left, Valentina Palmisano. You have the floor.
Valentina Palmisano
Thank you very much, madam chair. Thank you, commissioner, for your presentation. As was said, today, we're talking about striking a very delicate balance, the balance between the right to access treatment, the issue of patient safety on the one hand, and on the other hand, the need to make sure that there's competitiveness and innovation in our markets. For a whole set of reasons that you touched upon, at the moment, we have a system that doesn't manage to make sure that we do have access to these devices, especially for rare diseases and for lesser-known technology. This is often because of red tape, the certification process, and high cost.
For all these reasons, there is a huge pressure on the sector. So what's happening? That means that SMEs are leaving the market. And what does that mean in practice? That means that there's a lack of medical devices.
When a device disappears, then it is first and foremost a health problem, especially for those patients who depend on that specific device. So, of course, we are in favor of all the simplification measures that you want to put in place. And we want to have the best possible results that will strike the best possible balance between these two factors. So on the one hand, we want a system that is going to be more efficient, but without deregulation. Because if we deregulate this sector, then this will be tantamount to backsliding, and we cannot allow that.
And then there's also a political issue. We have to ask ourselves who benefits from this revision. So I think the main challenge for all of us will be to make sure that if we reduce the burden, this will translate into more affordable prices and better accessibility and real advantages for the public health system. Because as representatives, this is what we have to stand for. We have to support the public health sector.
Thank you.
Romana Jerković
Was the first round of questions. Commissioner, now I will give you the floor to react. You have five minutes. Please, you have.
Olivér Várhelyi
Five minutes to all of these questions. I will try my best. First of all, to Rappotoshenk. Thank you very much for confirming, the main thrust of the proposal. And, I also want to again underline that we are in the last moment to save this unique industry where Europe is still strongest at the global level.
And I also confirm to you that, of course, our SMEs are at the very heart of the whole sector. Of course, we have big players in it, but this industry is very innovative, is characterized by SMEs, and they are extremely vulnerable to takeovers. Hostile takeovers, for example, from China. Now what we see, for example, in the Medtech Valley in Germany, in Tuttlingen, is a very aggressive tendency of buying them up because of the very technology they represent. So now is the time to make our system much more efficient.
I agree with you that the timeline is key. This is why we pushed for, finally, a European timeline and predictable system of procedures so that not only the SMEs, but also those hospitals and doctors waiting for the technology to arrive to them will know more or less when these products are going to be available. I took very good note of your remark related to the need to keep the notified bodies. Of course, they represent quality, but we want them to be more predictable. We want them to be more effective when it comes to their assessments, and we want them to provide an even higher quality assessment while creating the opportunity for SMEs to get discounts.
And this is what we're going to propose. We will have an additional implementing act in which we are likely to propose discounts for micro enterprises, roughly around 50%, and 25% discount for SMEs. I hope that it means that we will have even more applications than we have today. And one remark on this, of course, all these fees will have to be representing the costs. They will have to be proportioned.
So we will make sure that we're not undercutting the costs of the notified bodies because we need them to work diligently in this area. On your second question, about the software reclassification, yes, we are proposing to clarify where software should be put into which class, and we are proposing, as a general rule of thumb, to put them in class one. I can give you an example on this. Currently, the BMI calculators, which are not terribly complicated, they are put to class two a for no obvious reason. So we are proposing to put them to class one, but we have not changed one very important principle, and this is across the board.
And this is also a response to all of you concerned about patient safety. The basic functionality and the risks of the product come first. So even for software, there are exemptions put into this general rule of putting everything to class one. For example, for those softwares that are used by invasive medical devices, then the software shares the classification of the medical device. So we will always have a very high standard of patient safety.
The interplay between artificial intelligence and cybersecurity rules. Maybe I can give also an answer right away to mister Marino as well, if you don't mind? To break it very simply, we have tried to achieve two things. One is to have the most state-of-the-art set of rules that facilitates the use of artificial intelligence, and that should put us ahead of our competition, including the US and China. This is one.
And the other one is to make sure that artificial intelligence use in the medical sector, which is a very specific area and where risks are very high, will keep us always in control. So there will always be a human control and a very high level of patient safety and security all across. So I would very hardly imagine that in Europe, could establish things like, I just heard from mister Marino, like replacing completely imaging by artificial intelligence. It will always be a doctor's responsibility. Yes.
Diagnostics, for example, in imaging are now already done mainly by artificial intelligence. But, of course, it will be always for the doctor to verify whether this is in accordance with the medical rules and the patient safety rules. And these are extremely clear also in our rules. The second remark you made about cybersecurity is that this is why we have opted for another way of regulation than what you have in the artificial intelligence general legislative framework. Because the risks are so specific, we want to be able to follow-up any evolution of this area.
This is why the commission is proposing to have implementing acts to be able to adjust the frame as the artificial intelligence evolves, because this is going to evolve, for sure. And we want to be able to react fast to any changes so that we don't have to come back with legislative proposals all the time, but to be able to follow as the science grows in this area. Global competition, fully agree with you. We should make sure that what we are adopting now will be future proof. So we will be competitive also five, ten, twenty years from now with whatever we adopt.
To Mister Volcan, although he's not here, I still want to answer. Patient safety is our priority. We have not lowered patient safety in any respect. He mentioned the famous cases of implants. If you look at the transparency rules, we have even increased the transparency criteria for all implants.
And we are not making any compromise when it comes to patient safety, and cutting red tape is only possible where it does not compromise patient safety. And I think we have been clear about this all the way. On the lack of the impact assessment, I have tried to meet two criteria. I wanted to meet the criteria created during my hearing, which is that I should come forward with this proposal still last year, while also providing a sufficient assessment of the economic impact. And maybe we don't have a stand-alone impact assessment to the proposal, but we have a very detailed assessment of the possible impacts.
This is why you will find it in the proposal what is the cost saving that we hope to gain from this, at least €3,000,000,000 per year. And we have had a call for evidence. We have had public consultations. We have had other consultation activities. We had desk research.
We had various workshops. We had expert studies commissioned to this, and we had two reality check exercises as well. So I think we have covered everything an impact assessment covers or even more. To missus Delors, the different classifications, at the notified bodies, yes, this is one of the big challenges that we face. This is why we have tried to make it even clearer when it comes to the classification.
And this is why we have also increased the expert panels in the most critical areas like the orphan and the pediatric ones. And we do hope that with the increased capacities of the expert panels, we will have even more clarity and more application of the rules the same way, all across the board in each and every notified body. Timelines and predictability, I think I have covered. And whether we will have further impact implementing acts for further clarifications, yes, of course. One is in the pipeline already on the timeline, and there's the other one about the low risk classifications.
To Mister Radza, yes, the point you are raising is a very complicated one. I don't want to dwell into it because it's technically very complex, but we are ready to sit down. What we need to make sure is that the cooperation between the EMA and the national authorities is seamless. But the responsibility for those kinds of products will still be a national competence and a national issue. But EMA is, of course, ready to help, but all the decisions on the specific products will still have to be made by the national pharmaceutical authorities.
To Mister Gluck, thank you for confirming that time is of the essence. You are a practitioner, so you know. And I want to also agree with you that we run a major risk of losing products every day. What we see is that, especially with the problems we see in The US where we might have issues of disruption of supplies. So now we really need to speed up our work.
The single-use products. We didn't want to make it difficult. That was not the idea. But the idea was this, to put it very bluntly out in the open, is what we have seen is that in many cases, the producers have opted to switch from multiple use products to single use products, while the product has not changed or the function has not changed so much. On the other hand, this puts quite a cost on the hospitals using it.
To give you one example, you will understand it, the surgical knives. Surgical knives have become complex products by now with several elements fitted to them so that they are not reusable, although a surgical knife should be reusable. So what we want to encourage, with what we propose, is to keep as many products in that category, and to also put an incentive on the producers to think about reusable products more. And we do hope that this will also lower the burden on our health care system. Finally, to Mrs. Palmisano, cost savings should result in better health care.
This is what I have written down as your conclusion. I fully agree with you. What we want to achieve with this reform is two things. First of all, to save costs not only for the industry, but also for the public health system. This is why, for example, single use products are so important.
But the second is that we want cost saving also through the availability of always the best available treatments. Because what we see is that outdated treatments, at the end of the day, will always cost us more. So we will want to use the cost saving to make sure that our companies are going to supply us and our health care system will always be able to provide the best available therapy for everybody.
Romana Jerković
Thank you, commissioner. I didn't want to interrupt you because this is an important discussion for us, and there were a lot of questions. Okay. Now I will give the floor to a reporter for opinion of the committee on the internal market. And colleague Maria Guzanina, you have the floor for two minutes.
Thank you.
Maria Guzenina
Thank you so much. Thank you for your words, Commissioner Var Haley. As I'm an this file from the angle of competitiveness and internal markets, strengthening it, but at the same time, patient safety must be in the core of everything. And we talk about diapers, bandages, to complex technologies such as robotic surgical systems. So the scope is really large.
And we have had, in the past, scandals. The PEEP scandal has already been mentioned here. It affected half a million women. So it's not a small issue, it's a huge issue. So medical devices, they need to be available, they need to be up-to-date.
Europe must remain a place where innovative devices can be developed and brought to patients efficiently, but we have to have the safety at the core of everything. So I'd like to answer so far, but can you be more specific? Because when we're talking about the reduction in notified body involvement, for example, downgrading certain high risk products, reducing audits, how do we ensure that scandals like the BIP scandal do not repeat themselves? Because in the worst-case scenario, we're again in a situation that we're facing tragedies in individual humans' lives. Thank you.
Romana Jerković
Thank you. And now let's see who asked for the floor in the catch the eye. I remind you that you have one minute at your disposal. We will start with Petalize. Please, you have the floor.
Peter Liese
Thank you, chair. Thank you, commissioner, and thank you to the rapporteur, Oliver Schenck. Indeed, the proposal is very important, and I'm grateful to you, commissioner, that you presented it fast. Of course, it's about industry when we speak about simplification. But in this case, for me, it's even more about patience.
And I cannot repeat enough what Andreas Glück and others said. Patients are in danger because of too much bureaucracy. I worked in pediatrics, and my former colleagues tell me that they have a shortage of important medical devices because of over bureaucratic rules from the European Union. And especially the recertification of well-established products, it doesn't make sense. It only makes things more complicated.
That's why we really need to support the proposal. I have one exception, and here I refer to the Imcor rapporteur. What was the main reason for the PIP scandal? The reason was that the paper was fine, but the company changed the recipe of the product. And this can be stopped by unannounced inspections.
That was a key of the existing legislation. And while many of the issues that parliament and council introduced are bureaucracy, this principle of unannounced inspection, I don't think it should be abolished. So let's work fast. Let's adopt the proposal soon, but also do some fine tuning so that we really can say the products are safe, but with much less bureaucracy. Thank you.
Romana Jerković
Thank you. Now I give the floor to battalion Andrew Kaitis. Please, you have the floor.
Vytenis Povilas Andriukaitis
Thank you, Sergio, so much, commissioner. Welcome, and I listened very carefully to your presentation. You know, I know three words: better regulation, simplification, and deregulation. All these three words are empty for me because I need reasonable regulation, good regulation, responsible economically based regulation, so on and so on. Now we are all repeating better simplification, so to say, issue is very important.
Now comes some conclusions where in our hands, one Europe, one market. Now comes some conclusions. It's time to speak about more centralized, more standardized, more efficient system, which should be in some medical devices, which should be assessed at EU level and should be available in all 27 member states. Now we have jungles of notifying borders, jungles of, you know, of overlappings, and so on and so on. And bureaucracy is not because of Brussels.
Bureaucracy is because member states are introducing a lot of bureaucracies. We need to go into understanding. We need a common European device policy, keeping in mind much more centralized decisions and standardized and very well equipped and mandatory participation and mandatory uptake. This mantra is crucial.
Romana Jerković
Thank you. Now I give the floor to colleague Vlad Voigolesko. Please.
Vlad Vasile-Voiculescu
Thank you, commissioner, and to the reporters for the work done. You actually answered my question, commissioner. I was going in the direction of showing the potential advantages of AI and where we are and why we need to speed up things. We've discussed earlier in the committee about the research funds that we are providing, and I think I'm not the only one having any imprint impression that Europe funds research while others are developing their industries and their products, and we end up buying a license for several products that have been actually developed or at least partially developed here in Europe. And second on AI, and I would like to take a different angle from my colleague, Matthew, also coming from a part of Europe which definitely needs additional capacity, so we could use some help from AI.
Now in The United States, AI medical devices receive FDA clearance in about a median of 142 days. In Europe, CE marking other than medical devices regulation takes an estimated 13 to 18 months. I hope I'm mistaken. I hope the data I have is just wrong. This was better actually before the MDR took effect in 2021.
Europe was actually ahead of the US in approving AI medical devices, whatever was out there. But now we also know that the FDA has authorized over 1,200 AI devices. We don't know exactly, at least I don't know it. I don't know how many Europe actually authorized. I wasn't able to find any centralized register or comparable count for this.
Thank you.
Romana Jerković
Thank you. And the final one is Katharina Martins. Please, you have the floor. Thank.
Catarina Martins
Thank you very much. I'd like to thank the commission, and I'd like to thank the operator for the work done. I'd like to draw your attention to another aspect. We can't talk in terms of simplification if we don't talk about the correction. We haven't taken into account gender.
And as a model, across the board, you take the male, and you can't always do that. There are variations depending on gender and age. And so far, it's been considered that collecting aggregate data is optional, but it should not be optional. We should disaggregate on the basis of sex and age. There should be a representative sample of the overall population, and there must be differentiated analysis.
There must be information about safety and efficacy depending on the demographic group and the number of participants. And we should also have public data to avoid any problems, because there might be a device which works for a man of 40, but it does not work for one of 60. It's considered safe.
Romana Jerković
Now I'm giving the floor to you for your final remarks and for answering the question, please.
Olivér Várhelyi
Thank you very much. First of all, to the Imco Committee. I want to confirm that, of course, we are not lowering the patient safety regulations. On the contrary, we are, for example, reinforcing the traceability rules. We will have digital traceability across the board for all devices.
So this is something that is coming actually on top of what you have seen so far. And when it comes to the scandal in question, the implants, they were not changing the rules. On the contrary, we want the same level of scrutiny. The scrutiny is to be carried out by the notified bodies, and they can, and this is also a question and answer to mister Liza. They can carry out any controls locally at any moment when they deem necessary.
This is how the system works now, and this is how it will stay. So we're not touching that part of the regulations. To mister Andrew Coitis. Standardized systems should be created. Well, that would have been a bit more than just a simplification exercise if we did that.
But what we try to achieve with what we're putting on the table is to make sure that the rules are enforced equally and in a standardized way. And this is why we will have more implementing acts. This is why we want to accompany the notified bodies with more scientific committees so that we make sure that there are no or very little national differences when it comes to the implementation of these new rules. To mister Vojkulevsko, I agree with your remark that we fund we're cost funding, basically, if I want to be honest with you. We are funding universities.
We are not funding science that makes it to the economy. I fully agree with you. And the big challenge is that in the negotiations of the next MFF, we should make sure that we also create a new category, which is that we are funding success. So we should put a premium on success. And my personal challenge in this is going to be how to create our part of the competitiveness fund to reflect that, but also the part in the horizon which is that it's going to be dedicated to health.
So I would be more than a partner to you, to work on this. On your numbers, yes. For the FDA, it takes 140 days, roughly, to authorize an artificial intelligence algorithm. You said that they have authorized more than 200. That's not the right figure.
They have authorized more than 1,000 already. Already. Already. And we actually don't know how many have been authorized in Europe. But we are now establishing the EuDaMed system, which will make it possible to check at least how many have been approved.
And, yes, I agree with you. Under the current system, it takes roughly 13 to 18 months to get an approval at a notified party. This is why it was so important to go forward in parallel with the timeline proposal that was adopted by the member states, so we can now get it out by the end of the month, and we are going to have a limit of 110. So it's extremely important to make sure that our procedures are going to be really predictable, when it comes to timelines and costs. Now maybe one other element to the AI, now that you have raised it, which I haven't addressed in the previous responses, is that currently, if there is an area where the use of artificial intelligence is moving forward the fastest, it is actually the medical sector.
And it is in this sector where we have most standards already established. We are above 70, something standards already established for algorithms, which is unique. There's no other area where artificial intelligence is used. And this is why it was so important to make sure that this sector can go ahead, regardless of the legislative proposals made related to the general rules on artificial intelligence. This is why we want to maintain this edge of the medical devices sector to be able to really profit from the artificial intelligence, because the medical devices regulations are ready for artificial intelligence already now.
So we want to really make use of that. Finally, to Missus Martins on gender not being reflected enough, let me give you one example. Of course, there are devices that can only be used for women, and there are devices that can only be used for men. But if you look at, for example, our proposal related to the safe hearts plan, and if you look at all the implications related to gender specific research and also prevention, you will see a whole new approach emerging, especially related to women in cardiovascular health where we have a major gap. And in that, of course, medical devices are going to be also fundamental to prevent these diseases, and the tragedies that are coming with them.
I hope I answered all your questions.
Romana Jerković
Thank you, commissioner, and thank you all for the excellent debate. You showed a strong interest in this file. And commissioner, we look forward to continuing our collaborative work on this proposal. Dear colleagues, SANTE committee, meeting is closed, and our next meeting will take place on April 23. Thank you all.
Thank you.
Speaker 47
Because I have an appointment at 03:30 with iTech. Yes. It's fixed an appointment because there's someone open until. But, otherwise, feel free to
Ask anything about this video — I analyse its transcript to answer.