Committee on Public Health Ordinary meeting Joint meeting Committee on the Environment, Climate and Food Safety
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SANT European Parliament
Follow its sittingsAnja Hazekamp
Well, thank you, my co-chair Adam, for hosting today the SANT committee for this joint committee procedure on the accompanying biotech directives to the European Biotech Act. The co-rapporteurs, of which you are one, Mr. Chair, have tabled their draft report containing 62 amendments for the Commission proposal before the summer break, and we look forward to the joint presentation along with your co-rapporteur, Ms. Marta Temido. We would also like to thank our policy department who prepared the policy briefings for this joint report. I would now like to give the floor to the co-rapporteurs, and we start with the SANT rapporteur Adam, the floor is yours.
Adam Jarubas
Thank you, Anja. Let me speak in Polish.
Szanowne koleżanki, koledzy, na wstępie chciałbym podziękować sprawozdawczyni Komisji Środowiska Marcie Temido za doskonałą współpracę partnerską. Dziękuję obu sekretariatom współpracujących komisji, naszym doradcom za wsparcie i sprawne przeprowadzenie tego procesu. W imieniu Komisji Zdrowia Publicznego chciałbym przedstawić tę część projektu wspólnego stanowiska, która pozostaje w zakresie kompetencji naszej komisji zdrowia i dotyczy zmian w dyrektywie 2010/53 w sprawie norm jakości i bezpieczeństwa narządów ludzkich przeznaczonych do przeszczepiania. Zgodnie z podziałem pracy między komisjami ograniczę się zatem do zagadnienia przetwarzania narządów i jego znaczenia dla pacjentów, systemów transplantacyjnych oraz ochrony zdrowia publicznego. Punktem wyjścia dla naszego stanowiska jest przekonanie, że innowacje biotechnologiczne mogą realnie poprawić wyniki leczenia, zwiększyć dostępność narządów do przeszczepów, wydłużyć możliwy czas ich przechowywania oraz podnieść ich jakość.
Nie możemy jednak patrzeć na ten wniosek wyłącznie przez pryzmat rozwoju biotechnologii.
W przypadku narządów ludzkich mówimy o obszarze szczególnie wrażliwym etycznie, medycznie i społecznie, w którym podstawowym kryterium musi pozostawać wysoki poziom ochrony zdrowia ludzkiego, bezpieczeństwo pacjentów oraz zaufanie obywateli do systemu dawstwa organów i transplantacji. Dlatego proponujemy silniejsze i bardziej jednoznaczne osadzenie tej części wniosku w podstawie zdrowotnej prawa Unii, szczególnie w artykule 168 ustępie 4 Traktatu o funkcjonowaniu Unii Europejskiej, a także w prawie do ochrony zdrowia zapisanym w artykule 35 Karty Praw Podstawowych. Takie doprecyzowanie jest potrzebne, aby zachować właściwą równowagę między perspektywą rynku i innowacji a wymiarem medycznym, klinicznym i zdrowia publicznego. Po drugie, chcemy jasno wskazać, że przetwarzanie narządów powinno być wyraźnie objęte zabezpieczeniami pierwotnej dyrektywy o organach do przeszczepów z 2010 roku, zwłaszcza w zakresie jakości i bezpieczeństwa.
Ramy regulacyjne muszą umożliwiać praktyczne wykorzystywanie nowych technik, ale jednocześnie nie mogą pozostawiać luk prawnych ani ryzyka obchodzenia przepisów. Dotyczy to w szczególności sytuacji, w których przetwarzanie narządów styka się z regulacjami dotyczącymi produktów leczniczych, substancji pochodzenia ludzkiego czy wyrobów medycznych. Naszym celem nie jest tworzenie dodatkowych barier dla transplantologii ani opóźnianie dostępu pacjentów do innowacyjnych rozwiązań. Przeciwnie, chodzi o to, aby nowoczesne metody przetwarzania narządów mogły być stosowane w sposób bezpieczny, przewidywalny, etyczny i zgodny z zasadą niekomercjalizacji ludzkich narządów przeznaczonych do przeszczepiania. Jasne przepisy są warunkiem zarówno bezpieczeństwa pacjentów, jak i zaufania społecznego do systemu transplantacji.
Po trzecie, w projekcie stanowiska zwracamy uwagę na potrzebę pełnego uwzględnienia zastrzeżeń Europejskiego Inspektora Ochrony Danych. W procesach związanych z transplantacją przetwarzane są dane szczególnie wrażliwe, w tym dane dotyczące zdrowia i dane genetyczne. Dlatego przepisy powinny zapewniać zgodność z RODO oraz zamykać ewentualne luki definicyjne dotyczące planów monitorowania wyników klinicznych i samych danych o wynikach klinicznych.
Podsumowując, stanowisko SANT w części dotyczącej dyrektywy o organach opiera się na prostym założeniu. Innowacje w transplantologii są potrzebne i mogą przynieść pacjentom ogromne, ratujące życie korzyści, ale muszą być wdrażane w ramach jasnych, etycznych i stabilnych długofalowo regulacji. Naszą odpowiedzialnością jest dopilnowanie, aby europejskie przepisy wspierały postęp medyczny, a jednocześnie chroniły pacjentów, dawców, ich dane osobowe oraz zaufanie publiczne do systemów transplantacyjnych. W tym duchu przedstawiam państwu projekt stanowiska z perspektywy SANT i liczę na konstruktywną współpracę w dalszych pracach SANT-ENVI. Dziękuję.
Anja Hazekamp
Thank you, Adam. Now to the ENVI co-rapporteur, Ms. Marta Temido. Marta, you have the floor for four minutes.
Marta Temido
Thank you, Chair. First of all, let me allow me to to also appreciate the collaboration with my co-rapporteur, Sher Jadu-Bas.
As was mentioned, we welcome the Commission proposal to adapt Directive 2001 to the rapid pace of scientific progress in biotechnology regarding GMMs. The proposal accompanies the European Biotech Act, aiming to strengthen the EU biotechnology market and creating a tailored and streamlined regulatory framework for GMMs. In line with the Commission, our amendments stress that any adaptation to new biotechnology realities must firmly uphold the precautionary principle and ensure a high level of protection for human health, animal health, and the environment. Therefore, we introduce critical safeguards to regulatory framework proposed for GMMs. They are as follows.
First, having in mind the precautionary principle, our amendments replaced open-ended term "low-risk GMMs" with "low-risk profile GMMs", as we consider it more adequate to the categorization purpose. In addition, amendments clarify that any streamlined procedures for low-risk profile GMMs must reflect the environmental risk assessment of the Annex II.
Second, our amendments emphasize that qualified presumption of safety status represents a preliminary scientific indication of reduced risk based on a case-by-case assessment of taxonomic identity, rather than an automatic presumption of market safety or an exemption from safety demonstration. To reinforce clarity, we use the EFSA wording in the definition of QPS. Third, we explicitly reject the proposal for an open-ended, unlimited initial validity of market consent. Our amendments reinstate a mandatory initial 10-year assessment period before any unlimited validity for GMMs can be granted upon the first renewal. Fourth, for us monitoring is paramount.
Although the Commission proposal aimed at waiving monitor obligations under operators' notification, our amendments' option was to introduce written consent and to enhance post-market monitoring. Fifth, regarding the analytical methods, our amendments shift from generic detection methods to analytical methods.
To support operators and competent national authorities, the European Union Reference Laboratory, assisted by the European Network of GMO Laboratories, is mandated to adopt clear guidance on minimum performance requirements for identification and quantification methods. Finally, regarding delegated powers, our amendments consider that when modifying criteria for GMMs, the Commission must publish a comprehensive report including a scientific literature review. Also, that these delegated acts must not extend the scope of low-risk profile GMMs, and that a new reporting and evaluation clause ensuring that five years after application and every five years thereafter, the Commission must submit an implementation report is needed. So, dear colleagues, I hope our amendments on this file may be judged constructive and a contribution to a virtuous balance between innovation and precaution when it comes to GMMs. Thank you so much.
Anja Hazekamp
Thanks to both co-rapporteurs for their presentation. We now pass the floor to the shadows, each for two minutes, and three minutes maximum for speakers who speak on behalf of both committees. So let's start with, well, usually Jessica Polfjärd, but she will be replaced by Adam.
Adam Jarubas
Thank you, Anja, let me present a short statement on behalf of Jessica Polfjärd.
Thank you to the co-rapporteurs for their work on the draft report. I will limit my comments to the parts of the draft report concerning GMMs. I think this is an important proposal from the Commission. It is essential that Europe is open to scientific progress and provides European farmers, industry, and researchers with an appropriate regulatory framework. For this reason, I intend to place amendments to ensure that the directive both aligns with scientific advice and provides an effective and safe path to using new technology.
I look forward to cooperating with the co-rapporteurs and the other shadow rapporteurs. Thank you.
Anja Hazekamp
Thank you, Adam. We now go to Marta Tomido to speak on behalf of Romana Jerković.
Marta Temido
Thank you so much again, Chair. I will speak on behalf of my colleague Romana Jerković. As S&D rapporteur for organ processing, I would first like to welcome the Commission's proposal.
However, I believe the proposal could benefit from some additional safeguards and greater clarity in some areas. First, we need a strong framework for safety and evidence. Authorisation should be based on a comprehensive benefit-risk assessment, taking into account the scientific and clinical evidence, the organ concerned, the processing applied, the intended clinical indication, and the expected benefits and risks for the recipient. Second, we also need to avoid potential regulatory gaps where medicinal products, medical devices, or SOHO preparations are used in organ processing. While each of these may comply with its respective Union legislation, the interaction between the product or preparation and the processing applied to the organ may create additional risks that are not necessarily assessed under those frameworks.
My amendments therefore clarify that this interaction must be considered as part of the benefit-risk assessment of the organ processing, with cooperation between the relevant competent authorities where necessary. Point three: we need stronger European cooperation.
A serious safety concern identified in one member state may also affect patients in others. I therefore propose an EU alert mechanism for organ processing, allowing this information to be rapidly shared between competent authorities and the Commission. Fourth, recipients should receive clear and comprehensive information about the processing of their organ and any relevant additional risks or scientific uncertainty. We should also pay attention to whether the cost and availability of those new technologies create differences in access to transplantation across Europe. And while we want a strong European biotech sector, commercial interests must never determine who receives an organ.
We should also understand whether the cost and availability of these technologies, including intellectual property rights, affect access to transplantation. Our objective should be to embrace innovation while setting clear European rules that protect patients, support our biotech sector, and ensure that the benefits of progress are shared across the Union. I look forward to working constructively with colleagues on these amendments and towards a strong compromise. Thank you. Thank you so much for your time.
Anja Hazekamp
Thank you, Marta.
We now go to the PfE for the SANT committee, Ms. Jana Nagyová.
Jana Nagyová
Dear colleagues, now I'm speaking on behalf of Mr. Knotek. First of all, I'd like to thank both co-rapporteurs for their report, and I would like to briefly explain the main points of our amendments. First, we want a clear and future-proof definition of organ processing. Transplantation is developing quickly and new technologies are emerging. Some of these technologies can change biological or genetic characteristics of an organ or make it more suitable for transplantation.
Therefore, we need to make sure that these new technologies are covered by the rules while keeping high standards of quality and safety. Second, we want to avoid unnecessary duplication.
...will be covered by other EU legislation, for example on medicines or medical devices. We therefore need better cooperation between different competent authorities, which should share relevant assessment and expertise so that we do not create unnecessary procedures or additional administrative burdens. At the same time, transplantation authorities should remain responsible for the authorization of organ processing. Third, we want to protect basic principles of organ donation. The use of commercial or proprietary technology should not change the nature of organ donation.
Organ donation must remain voluntary and unpaid, and organ procurement must remain non-profit. Fourth, and the last one, we want a proportionate and clear system. We support innovation, but innovation must go together with safety and proper oversight. Our aim is therefore simple: to support innovation, avoid unnecessary bureaucracy, and protect safety and fundamental principles of organ transplantation. Look forward to working with the rapporteur, shadow rapporteurs, and all colleagues and to find balanced solution.
Thank you very much.
Anja Hazekamp
Thank you. Next speaker is Aurelijus Veryga for both ENVI and SANT on behalf of the ECR. You have three minutes.
Aurelijus Veryga
Thank you, chairs, colleagues. I welcome Commission proposal to revise directive on standards of quality and safety of human organs intended for transplantation. I support updating the provisions to ensure the quality and safety of organ transplantation while taking account of the latest scientific and clinical developments.
Innovation in organ processing can extend the time between organ procurement and transplantation, improve the functional status of organs and increase treatment options for patients on waiting lists. Directive should cover the processing of organs outside the body, beyond the preservation for both allogeneic transplantation and autologous use. Processing may maintain or improve an organ's function or modify its properties without altering its original functions. This could include genetic modification to improve immunocompetibility or the administration of medicinal products. Composite vascular tissues such as hands and faces share the main characteristics and time constraints of organs.
They should therefore be considered organs for the purposes of the directive. At the same time we must avoid regulatory duplication. The requirements concerning benefit-risk assessment, authorization and clinical outcome monitoring should not apply where the same processing method and clinical use have already been authorized under the relevant Union rules.
Aurelijus Veryga
Okay, I'll try.
I believe that sensitive and genetic data must be protected, and scientific progress must never undermine voluntary and unpaid donations or the prohibition on making the human body and its parts a source of financial gain. I also support more proportionate and risk-based framework for genetically modified microorganisms. This can reduce unnecessary regulatory burden, shorten time to market and encourage European innovation while maintaining protection of human health and the environment. But we should be realistic about risk. If our political objective becomes zero risk, our practical result will be often zero innovation.
The real task of regulation is therefore not to eliminate risk, but to identify it, assess and manage it responsibly. Properly regulated risk is not the enemy of progress, it is one of its drivers. For that reason, I believe environmental monitoring deserves particular attention. Streamlining authorization procedure should not mean creating blind spots, especially where authorization may be granted for unlimited period. Proportionate monitoring can provide us with evidence about unexpected, cumulative or long-term environmental effects.
Good post-market data allows developers to detect problems early, improve their technologies, and manage environmental risks before they become crises. So our objective should be smart regulation: freedom to innovate, responsibility to monitor, and the capacity to act when evidence shows a genuine risk. And I'm looking forward to look to work with all of you on this document. Thank you.
Anja Hazekamp
Thank you. Next speaker is Gerben-Jan Gerbrandy on behalf of Renew ENVI. You have two minutes.
Gerben-Jan Gerbrandy
Thank you, thank you, both co-chairs and the two rapporteurs for their work. It's, it's a delight to be here in the joint SANT-ENVI committee. It's good to hear balanced approaches from, from all sides. First of all, we from Renew are very pleased with the proposal from the Commission. The GMMs are moving incredibly fast and the opportunities for solving many societal problems are huge, not only in the SANT part, but also especially in the environmental field.
And we have to be careful that we're not over-regulating this field and stopping developments in Europe while at the same time in other parts of the world it's moving very fast. We do believe that currently there is a mismatch between this very fast technological development and the regulatory system and procedures, and we have to find a right balance there. It has to be fast, but it also has to be responsible, and I think that is the challenge that we are facing here. We as Renew, we want a science-based legislation, but at the same time procedures have to be accelerated in order to foster innovation and competitiveness. So we are strongly in favor of the precautionary principles in order to, well, to be able to control and at the same time, well, try to speed up the process.
The system has to be adaptive. The changes are moving so fastly that if we do not have legislation that is adaptive, we're simply, even if we want to control it more, we are constantly too late.
So that is where we have to find the right balance. And that's why at the moment we are still in favor of delegating powers to the Commission in order to move more quickly than having a full legislative procedure on every technical detail that we're confronted with. So those are the general lines that we want to be reflected in our amendments, and I'm looking very much forward to working with my colleagues and the two rapporteurs. Thank you.
Anja Hazekamp
Thank you, Gerben-Jan. We now go to Renew SANT Committee, Stine Bosse, two minutes.
Stine Bosse
Thank you very much. And obviously I echo what my colleague just said, and I also really want to stress that the words from our chairman, from our SANT chairman, I really also echo everything that was said.
So, on top of that, dear colleagues, 19 patients die every day across European region while waiting for a sustainable organ. And more than 56,000 new patients are added to European transplant waiting lists every year. The so-called ex vivo processing of organs is already clinical practice and it is a real life saver for patients. Such processing expands the donor pool by allowing the use of organs that would otherwise be discarded. This leads to better post-transplant outcome.
It expands preservation time and allows organs to travel further. Such bioengineering is key to deliver, for example, stem cell therapies and important for cancers and rare diseases therefore. So how can we improve this proposal, which is good and everything has been said? So, first, I believe that what we should do here must have a clear EU added value. We must minimize the administrative burdens when organs are moved, including across borders for the purpose of processing.
Second, we must interoperatively, we must have interoperability. Processors and process circuits should avoid the duplication of authorizations. Finally, we must enable collaboration across borders, including for clinical data and organ processing authorizations.
And I would like also to say that all changes obviously should be in the benefit of the well-being of our citizens and health, and the organ procurement must stay a non-profit area. Thank you very much.
Anja Hazekamp
Thank you. We now move to the Greens, first ENVI shadow rapporteur Martin Häusling. You have two minutes.
Martin Häusling
Yeah, thank you, I will make my speech in German. Ja, ich mache kein Geheimnis daraus, dass wir große Bedenken haben gegenüber dem Vorschlag der Kommission bei gentechnisch veränderten Mikroorganismen, weil wir wissen noch relativ wenig über gentechnisch veränderte... über Mikroorganismen, und jetzt wollen wir sie gentechnisch verändern und in die Umwelt freilassen. Ich glaube, da befinden wir uns in vielen Bereichen in einer Blackbox und wissen nicht, was dabei rauskommt. Bei allen, die jetzt hier denken, das ist eine Rieseninnovation, für mich ist es und für meine Fraktion ist es eher ein Roulettespielen mit Natur und Gesundheit von Mensch und Tier. Die zweite Frage ist, warum brauchen wir diese Deregulierung überhaupt?
Viele Funktionen, die jetzt erfüllt werden sollen, gibt's ja natürlicherweise schon: Stickstoffbindung, Phosphatmobilisierung und Unterdrückung von Krankheitserregern.
Und selbst da wissen wir relativ wenig, wie das in der Umwelt, in der Natur passiert. Und wenn wir jetzt zusätzlich gentechnisch veränderte Mikroorganismen freisetzen, dann erhöhen wir das Risiko und senken es nicht. Und deshalb müssen wir uns tatsächlich erstmal wissenschaftlich intensiver damit beschäftigen. Wir wissen erst seit ein paar Jahren, wie der menschliche Körper überhaupt mit den vielen Mikroorganismen funktioniert. Und deshalb halte ich die Vorlage der Kommission wirklich für nicht ausgereift, um es deutlich zu sagen.
Und deshalb sollten wir sehr kritisch an diese Vorlage herangehen. GMMs stellen bei der Freisetzung eine besondere Herausforderung dar. GMMs können sich sehr schnell vermehren. Das ist nicht wie bei Pflanzen, die ein Jahr lang wachsen, sondern GMMs können sich innerhalb von Tagen, ja teilweise Stunden vermehren. Und wir wissen nicht, welche Wechselwirkungen in der Natur stattfinden.
Es gibt sehr viele komplexe Wirkungen, die da stattfinden, und wir kennen die eigentlich noch gar nicht. Und jetzt wollen wir gentechnisch verändern und wollen die sozusagen in die Umwelt entlassen, während wir das Risiko gar nicht kennen.
Und wenn GMMs einmal in die Umwelt entlassen sind, dann wissen wir auch nicht, wie sie dann wirken mit natürlichen Mikroorganismen. Das zweite Problem, was wir sehen, ist, was ist eine Definition von Low Risk? Gibt es da überhaupt eine Definition von Low Risk? Ich finde den Vorschlag bei Low Risk, der ist nicht gerechtfertigt und der hat auch keine wissenschaftlich haltbare Begründung. Deshalb wollen wir diesen Begriff nicht.
Mit einem neuen Etikett senken wir nicht das Risiko. Und deshalb stehen wir dem ganzen Entwurf sehr kritisch gegenüber. Wir sollten erst mehr wissenschaftlich forschen in dem Bereich, bevor wir Risiken eingehen, die wir alle hier nicht genau kennen und die vielleicht im Nachhinein für uns schwerwiegende Folgen haben werden. Vielen Dank.
Anja Hazekamp
Thank you. Next speaker is Ignacio Roberto Marino for the Greens, SANT Committee.
Ignazio Roberto Marino
Thank you very much. And I would like to thank you both rapporteurs, Marta Temido and Adam Jarubas, our president, for their work on this important file. I have heard and I'm very happy from many about the advances in technology.
And I want to focus on two points where if we approve the amendment that I'm going to propose, we can literally save thousands, thousands of lives every year in Europe. The first one is just to explain how organ preservation worked and is working today. Until a couple of years ago, the organ was placed in ice and the time for using that organ was four hours for a heart, seven hours for a liver, and 12 hours for a kidney. Now we have machine perfusion, hypothermic and normothermic. This allow us to actually see and test how the organ works.
So we will know before transplanting the organ if the heart is beating, if the liver is producing bile, and if the kidney is producing urine. On the top of that, we can preserve the organ for a long period of time. And this incredibly great development in technology allow us to save more people. Why? Because we have people that are at risk of dying in the next 24 or 48 hours for a life-saving organ like heart, liver, or lung.
And until a few years ago, we could not transport the organ, for example, from Italy to Lithuania or from Croatia to Spain.
Now we can, and very safely. So I think we should have a unified system where the first patient that is risking his life is supported by the entire continent, as, for example, exists in United States, where the first patient that is at risk of life get the first available organ. The second is people that are highly sensitized. Means that, for example, I am looking for a kidney for myself, but I have a lot of antibodies against many, many different antigens. So it's almost impossible to find an organ in my country.
But because of the different ethnicity in Europe, we can find an organ that is perfect for me, and in that country, another organ is perfect for another patient. So we can increase kidney pair donation across the continent. So I think if we want to save more lives, and we need to consider that as we speak today, we have 96,000 patients waiting for an organ. Thank you, Mr. Chair.
Anja Hazekamp
Thank you so much. Now we go to the left.
First of all, I want to say that members who wish to speak on this topic, please indicate so, then we give you the floor in the catch-the-eye round. And now I will give myself the floor to speak on behalf of the left. I would also like to thank both rapporteurs for their work on the draft report. Emma Fourreau, the Left ENVI shadow, could not be present here today, but she asked me to share her concerns about the proposal on her behalf. Authorizing the deliberate release of genetic modified microorganisms created in laboratories is a biological time bomb with serious and unpredictable consequences, including the disruption of microbiota's essential functions, impacts of the resilience of ecosystems and reduced resistance to climate stress.
Once introduced, these organisms are impossible to control. This is not a law in the interest of citizens and farmers.
It is a law designed to facilitate agribusiness access to new markets. It deregulates and considerably weakens the European Union safety standards regarding the deliberate release of GMOs. It is incompatible with the precautionary principle. Well, this was the message my colleague Ferrot wanted to share here. Now I will continue on my own behalf as shadow from S&D.
With regards to the genetically manipulated microorganisms, I fully agree with Emma that this part of the proposal should be rejected. It is in my view utterly irresponsible to deregulate the essential risk assessment, authorization and monitoring of genetic alterations of microorganisms. On the organ proposal, I'd like to thank the rapporteur for addressing the concerns raised by the European Data Protection Supervisor, which is indeed a very important topic for my group. Another important concern with this part of the proposal remains the threat of commodification of organs.
We need to ensure that organ donation is always the conscious choice of the donor and their family, from their own free will and not induced by financial gains or pressure. And we need also to make sure that organs will remain organs, also after processing, instead of turning into something like medical devices or medical products to be sold to the patients or even to be sold back to the patients at a price. This is not only unethical, but also threatens the very core of the solidarity that underlies our organ donation today. I hope we can find ways to reinforce the text on this essential point and I will table amendments on this and look very much forward to the collaboration. Thank you.
Now I have to find my other list. The next speaker on behalf of the ESN ENVI, Mr. Marc Jongen. You have two minutes.
Marc Jongen
Yes, thank you, Chair. I'm also going to speak for SANT, but I don't need more than two minutes. And I'm going to speak in German. Aus unserer Sicht sind hier zwei Aspekte zu berücksichtigen.
Zum einen braucht Europa eine wettbewerbsfähige Biotechnologie, und übermäßige Bürokratie darf nicht dazu führen, dass Forschung, Innovationen und Produktion nach China oder in die USA vollständig abwandern. Aber zum anderen darf weniger Bürokratie auch nicht zu weniger Sicherheit führen. Gerade bei genetisch veränderten Mikroorganismen muss das Prinzip der Vorsicht gelten. Deshalb lehnen wir unbefristete Zulassungen ab. Wirtschaftliche Lebensdauer und mögliche biologische Auswirkungen sind zwei verschiedene Dinge.
Zulassungen müssen zeitlich begrenzt und regelmäßig überprüft werden, denn wir kennen die Auswirkungen dieser Mikroorganismen auf die Umwelt noch nicht, und die Risiken sind beträchtlich. Besondere Vorsicht ist bei genetisch veränderten Viren geboten. Hier darf es keine automatische Einstufung als geringes Risiko geben. Wir brauchen eine Einzelfallprüfung und eine wirksame Überwachung. Ein zentraler Punkt ist für uns außerdem die Verarbeitung und Herkunft von Organen.
Angesichts des internationalen Organhandels müssen wir sicherstellen, dass die Herkunft von Organen lückenlos nachvollziehbar ist und höchste ethische Standards eingehalten werden. Organe dürfen nicht zu einer Handelsware werden. Niemand darf zur Organspende gedrängt oder gar gezwungen werden. Gerade wenn neue Verfahren die Verarbeitung und Nutzung von Organen erleichtern, dürfen wir bei Kontrolle, Rückverfolgbarkeit und ethischer Beschaffung keine Abstriche machen.
Auch weitreichende delegierte Befugnisse für die Kommission sehen wir kritisch. Entscheidungen über Sicherheit und Risikobewertung gehören unter demokratische Kontrolle. Also Fazit: Innovation ja, aber nur unter Einhaltung grundlegender ethischer und Sicherheitsstandards. Und genau in diesem Geist sind auch unsere Änderungsanträge verfasst. Vielen Dank.
Thank you. This brings us to the end of our shadow rapporteurs. Now we go over to the catch-the-eye. I have two speakers on the list so far. We start with the S&D group.
Mr. Andriukaitis Vytenis, you have the floor.
Vytenis Povilas Andriukaitis
Aš kalbėsiu lietuviškai. Jeigu galima, aš kalbėsiu lietuviškai. Tai šiuo atveju aš tikrai pritarčiau išsakytoms pagrindinių pranešėjų pozicijoms. Neabejotina, kad jeigu mes kalbėsime apie atsargumo principą, apie mokslinio aiškumo, patikimumo ir taip toliau visus visus principus, kurie vardijami arba dėl kurių keliame tam tikrų abejonių, pavyzdžiui, mokslinio neaiškumo abejonės ir panašiai, jie visi iš tiesų labai puikiai sudėti į visą eilę saugiklių. Ir mes tikrai turime dar kartą atkreipti dėmesį, kad svarstome ne tik konkurencingumą.
Ir mes tikrai turime dar kartą atkreipti dėmesį, kad svarstome ne tik konkurencingumą, mes iš tiesų svarstome daugelio žmonių gyvybių klausimus. Aš tikrai norėčiau pritarti toms mintims, kurias čia dėstė mano kolega Ignazio Marino, kalbėdamas kaip žmogus, turintis patirtį transplantacijoje, kaip chirurgas, persodinęs kepenis žmonėms, kad būtent šiandien mes turime labai aiškiai suvokti, kodėl mums reikalingas proveržis ir ypatingai tos technologijos, kurios sutrumpina ir padidina persodinamų organų gyvybingumą, taip pat padidina galimybes įveikti atstumus ir suteikti ekstra pagalbą ypač tiems žmonėms, kurie jau sudėtingoj padėty tiesiog turi vienintelį išsigelbėjimą – tai gauti organą, vienintelį išsigelbėjimą.
Todėl kalbant apie šias visas problemas, kurios, tarkim, susijusios ir su genetiniu modifikavimu, mes tikrai turime suprasti, kad visi esame, kaip sakyt, pašaukti atsargumui, bet žmonių gyvybės klausimas šiandien ypač.
Marie-Luce Brasier-Clain
Merci Monsieur le Président. Tout d'abord, merci aux rapporteurs pour leur travail. Sur les micro-organismes génétiquement modifiés, nous avons un certain nombre de points d'accord, notamment avec les modifications apportées à la définition de MGOM à faible risque, à la durée des autorisations limitée dans un premier temps à 10 ans, au statut de présomption d'innocuité reconnue et au pouvoir de délégation conféré à la Commission. Nous sommes également d'accord avec la volonté des rapporteurs de faire respecter le principe de précaution. Et c'est justement à ce titre que nous voudrions aller plus loin car il est vrai que la législation en vigueur doit être mise à jour.
On ne parle plus d'une simple actualisation mais d'une vraie dérégulation opérée par la Commission. Nous voulons maintenir une évaluation des risques performante et doutons de la possibilité offerte au requérant de déroger aux règles de détection et d'identification car sans ces méthodes de détection, il sera impossible de tracer et d'assurer la surveillance post-commercialisation. Une mise à jour de la réglementation est nécessaire mais avec des garde-fous.
Je vous remercie.
Nicolás González Casares
Gracias, presidenta, y gracias al señor Jarubas y a mi compañera Marta Temido por su trabajo. Y yo creo que lo esencial en este debate no es resolver un problema técnico de clasificación normativa, sino evitar la mercantilización indirecta del órgano. La reforma que se propone de trasplantes es una reforma corta impulsada por el avance tecnológico que permite realizar operaciones sobre los órganos que antes no eran posibles. Sin embargo, esta pequeña reforma condiciona cómo se escribirá el futuro de la sanidad europea. Un trasplante, y créanme que yo he participado en coordinación de trasplantes, es una operación de altruismo, confianza y virtuosismo sanitario que nos permite salvar vidas de otra manera que de otra manera serían imposibles.
Por ello, cuando se pretende avanzar, lo más importante es no retroceder.
Los sistemas de trasplante en Europa se sostienen sobre principios que no son negociables: donación voluntaria y no remunerada, la asignación del órgano según criterios estrictamente médicos y de necesidad, nunca según capacidad de pago, y la solidaridad entre donante, receptor y sociedad. Y estos principios no son una construcción nacional aislada, están refrendadas por instituciones europeas. Por lo tanto, si permitimos que por la vía de un producto vinculado inseparablemente al órgano se introduzca un beneficio comercial, estaríamos vulnerando ese principio, aunque formalmente el órgano en sí no se venda. Sabemos, no obstante, que la ciencia avanza: la perfusión ex vivo, la terapia génica o la reconstrucción celular aplicadas a órganos destinados a trasplante son ya una realidad que ningún marco actual regula con claridad. Por eso en el reglamento de biotecnología propusimos una sandbox regulatorio como una forma de generar un marco jurídico que permita el avance tecnológico y de seguridad al sector, sin renunciar a los principios que acabo de exponer.
Si el órgano, tras el proceso, sigue cumpliendo su función como órgano, permanece bajo el sistema de donación y trasplante, sujeto a una autorización de uso, no de comercialización, coordinada entre las autoridades de órgano, el SoHO Coordination Board y la EMA.
Y ese mismo razonamiento debe trasladarse a la directiva. De lo contrario, reproduciríamos por vía indirecta lo ocurrido, por ejemplo, con los linfocitos CAR-T, que el órgano modificado acabaría comercializado a través del producto que lo modifica, aunque nominalmente solo se venda el fármaco. Con un añadido grave: lo que puede ser discutible para un linfocito no puede ser admitido para un órgano humano completo. Por lo tanto, por coherencia legislativa, creo que debemos avanzar en este sentido. Muchas gracias.
Anja Hazekamp
Thank you. I have no more speakers on behalf of the Parliament, so now I would like to give the floor to the Commission. We have two speakers, three minutes each.
Speaker 18
Honorable members, I would like to begin by thanking the rapporteurs for their work on this report concerning the Commission proposal to amend Directive 2010/53/EU as regards organ processing. Your efforts have helped to frame an important discussion on how to respond to scientific and technological progress in transplantation. I would like to mention in particular the clarifications proposed on the status of processed organs.
It is essential that organs which undergo processing continue to be treated as non-commercial substances of human origin, as mentioned by many of you, and remain fully subject to the rules and ethical principles for organ donation and transplantation in the EU. The report clearly underlines that an organ undergoing processing remains subject to the rules on quality and safety for organs. We also note the emphasis placed on the potential benefits of innovative organ processing techniques. As the report recognizes, these developments extend the time available for transplantation, increase the number of available organs, and enhance organ quality, thereby improving access and outcomes for patients. As mentioned by some of you, this should be assessed by organs' NCAs to ensure that the benefits and risks of organ processing are fully accounted for in collaboration with authorities in other sectors.
As regards the safeguards for sensitive personal data, we fully agree that data protection is of fundamental importance in this field. At the same time, we consider that this aspect is already sufficiently covered by the Commission proposal, which ensures that organ processing and related activities respect the existing Union framework on protection of personal data. In conclusion, this is an important proposal that can support innovation while preserving the core ethical and safety principles of the Union's transplantation framework. We look forward to continuing to work constructively with Parliament on this file.
Irina Sanchez
Honorable members, good morning. I will continue on the GMMs and Directive 2001/18. I would also like to start thanking the co-rapporteurs for their work on the draft report and the opportunity to discuss it today. Now, when it comes to the GMMs, in the view of the Commission, the adaptation of the legal framework based on currently available scientific evidence is necessary to allow novel bio-based solutions to reach the market. You might have seen that since the last discussion in this committee last March, the Joint Research Centre has published two reports on the applications of GMMs, showcasing the very wide array of potential applications and benefits in areas like agriculture, environmental bioremediation, and others.
We welcome that the draft report, like the Commission proposal, supports adapting the rules to scientific progress and to the specificity of GMMs, while maintaining the safety standards of the GMO legislation. And I would like to stress that according to the proposal, but also based on the draft report, all GMMs would be subject to an environmental risk assessment and authorization.
So there is no deregulation here. We welcome also that the draft report maintains key elements, the key elements of the Commission proposal, while trying to take it further by specifying, clarifying the text on issues such as definitions, the framing of delegations to the Commission, guidance and reporting. As we proceed in the negotiations, for the Commission what is going to be very critical is to preserve the goal of the proposal to adapt and to streamline and to add flexibility while maintaining the safety standards. And in this regard, we note that the draft report proposes to delete the empowerment to the Commission to adapt the procedure for low-risk GMMs. In practice, this would mean that low-risk GMMs would be subject to exactly the same procedure applicable to all microorganisms, and therefore we would not be delivering an accelerated procedure that takes into account that certain safety data have been addressed through the qualified presumption of safety.
So this is something that we will want to discuss with you at a later stage. We look very much forward to working with you in the subsequent steps and with you and the Council for a swift adoption of this important text as soon as possible. Thank you very much.
Anja Hazekamp
Thank you very much for your contribution. I'd like to give the floor back now to the two co-rapporteurs for their concluding remarks, and I will start with Ms. Temido. Marta, the floor is yours.
Marta Temido
Thank you so much, Chair. Thank you so much, dear colleagues, for all your contributions. For sure, we look forward to working with all of you. I just want to conclude by saying that it will be a mistake thinking that this proposal is deregulation. It is not, it is exactly the opposite.
It introduces specific, tailored regulation to GMMs, and even if we do not agree or have differences between us regarding the options taken, I think that we owe it to the public to discuss it further. Thank you so much.
Adam Jarubas
Thank you, colleagues, for this substantive and constructive debate. Today's exchange has confirmed that the Commission's proposal addresses issues of great importance for patients, healthcare systems, and trust in the European transplantation framework. As I underlined in our proposed joint SANT and ENVI position together with MEP Marta Temido, we sought to ensure the right balance between supporting innovation and maintaining the highest standards of safety, quality, ethics, including data protection. I believe that many of the comments raised today, once translated into amendments, will help further strengthen this direction. I'm confident that our further work will allow us to develop an ambitious position and a legal framework that is ready for the current and future development of technology, focused above all on the well-being of patients and on protecting citizens' trust in the system of organ donation and transplantation.
Thank you.
Anja Hazekamp
Thank you.
I want to thank all of all of you for the for this exchange on this important topic. I remind you that the deadline for amendments is set for tomorrow, September 3rd, at 11:00 AM. I will now give the floor back to the SANT chair for his concluding remarks.
Adam Jarubas
Thank you, Anja. Thank you all for the excellent debate today. We look forward to continuing to work together on this proposal. With this, I declare this agenda point closed. Let's move on to the next point.
Presentation. Yes, presentation of the Policy Department study on the health effects of fine particles. Welcome to the speakers and please join us to the podium.
Okay, colleagues, let's get started. Please take your seat. We continue our discussion. Dear colleagues, we move to the next joint point, which is the presentation of the Policy Department study on the health effects of fine particles. I'm pleased to welcome today the co-authors of the study Health Effects of Fine Particles, Arno Luc de de Danton and Nikki Woolhop.
This study was requested last year by the coordinators of the ENVI and SANT committees. Protecting public health is the core mission of the SANT committee.
Air pollution is not only an environmental challenge, it is also a major public health concern. A substantial body of scientific evidence shows that exposure to fine particulate matter is associated with adverse health effects across virtually every major disease category, including respiratory and cardiovascular diseases, cancer, dementia, and premature mortality. The impacts are particularly severe for vulnerable and high-risk groups. As this study highlights, children are especially vulnerable because their lungs and brains are still developing. Older adults face increased risk due to reduced physiological resilience and a higher prevalence of underlying health conditions.
In addition, people living in lower-income regions or households are often exposed to a higher level of pollution while also experiencing greater health impacts.
This study deepens our understanding of the health consequences of exposure to fine particles by presenting the latest scientific evidence and setting out policy recommendations. I thank the researchers for their work and look forward to hearing their findings and discussing how they can contribute to our shared objective of improving people's health. Now I'm passing the floor to President Hazekamp, please.
Anja Hazekamp
Thank you, Chair, and thank you for highlighting the serious implications of fine particle pollution on public health. As you have rightly said, air pollution is not only a public health challenge, but also an environmental one. This is where the work of the ENVI Committee comes in. Our responsibility is to ensure that the European Union's environmental legislation effectively addresses the sources of pollution and contributes to cleaner air for all in Europe. The ENVI Committee has been at the forefront of shaping the EU's air quality policy, including through the revision of the Ambient Air Quality Directive.
And as we move towards transposition and implementation, it is essential that our work continues to be guided by the best available scientific evidence. This study therefore comes at a particularly timely moment. It not only deepens our understanding of the health effects of exposure to fine particulate matter, but also provides valuable evidence to inform future policy making and support the effective implementation of the EU's air quality legislation. I would also like to thank the authors for their work and I look forward to the presentation and to our discussion. So now I would like to give the floor to the authors of the study for eight to ten minutes.
And it will be shared by the sons.
Adam Jarubas
Thank you, Anja. Mr. Dunton and Mr. Voorhoop, you have the floor for eight minutes altogether, please. Go ahead.
Nikki Vermeulen
Honorable members, on behalf of the Accorus team and our associated experts, I would like to thank you for the opportunity to present our study on the health effects of fine particles. Let me start with one simple observation. Air pollution policy in Europe can be considered a public health success story, but it's far from completed. Over the last two decades, Europe has substantially reduced exposure to fine particles and related health burden. Yet fine particles are still one of the largest environmental risks to the health of European citizens.
Thank you.
Nikki Vermeulen
It has therefore been a privilege and an honor to contribute to this study and hopefully to support future improvements in the air quality and the public health across the EU. In the following ten minutes, we'll present the key findings of our study, which looks at four topics: the associated health outcomes of exposure to fine particles, exposure trends and health trends across the EU, the effectiveness of existing policy frameworks, and our recommendations for further reducing health risks.
Over a period of six months, we have combined an umbrella review of almost 200 peer-reviewed articles, multiple analyses based primarily on European Environment Agency data, a regulatory mapping, and case studies with 12 stakeholder interviews. Now looking at the relation between exposure to fine particles and adverse health outcomes, we would like to state that the evidence is generally extensive and consistent. PM 2.5, which are particles with a diameter up to 2.5 micrometers, generally show stronger and more consistent associations with adverse health outcomes than its larger-sized PM 10. And as you can see here, there's a wide spectrum of adverse health outcomes related to exposure to fine particles. The strongest evidence links increased exposure to premature all-cause mortality, cardiovascular disease, respiratory disease, and lung cancer.
In addition, we found growing evidence linking long-term PM 2.5 exposure to neurological outcomes, including cognitive decline and dementia, as well as adverse pregnancy and child development outcomes.
Now, it's important to emphasize that many of these adverse outcomes are also observed at concentrations below the current EU limit values, and the evidence has not identified a safe threshold for fine particle exposure. Now, while the EU has made much progress on fine particle exposure and concentrations in recent years, the remaining health burden is still quite substantial. On this visual, you can see what PM 2.5 exposure looks like in 2023. At that time, three quarters of regions already meet the 2030 Ambient Air Quality Directive limit of 10 micrograms per cubic meter. But as you can see, there are quite substantial differences between regions, with high exposure clusters in several parts of Southern, Central, and Southeastern Europe.
Now the good news is that across almost every EU Member State, we see a range from small to substantial reductions of around 40 to 50%, while progress was more gradual elsewhere. However, and we see this trend correlating with reduced health impacts on European citizens. Since 2005, the premature deaths related to PM2.5 in the EU have fallen by 57%. Again, this progress varies between countries, but we can see that where exposure has fallen the most, the health gains have been the largest. Now, these adverse health outcomes are generally felt more by children, elderly people, and those with pre-existing health conditions.
And in addition, populations living in lower-income regions face higher exposure levels and therefore also higher health risks. This is an important finding, as it indicates that improving air quality is, in addition to an environmental and a public health objective, also a social equity objective.
And with that, I now pass the floor to my colleague Arnaud Deu.
Arnaud Deu
Thank you. Moving on to the regulatory map that can help explain this progress. On screen are the main instruments that support the targets. The AQD sets the annual limits by 2030. The National Emission Ceilings Directive sets the national reductions, including particulate matter and its main precursors, ammonia and sulfur and nitrogen oxides.
For industry, the IED regulates large-scale industry and livestock. For medium combustion power plants, there's a directive that also covers PM limits for smaller power plants. In transport, vehicle standards Euro 6, Euro 7 and non-road mobile machinery set binding limits for exhaust pipes and engines, and the Fuel Quality Directive limits sulfur in road fuels. In agriculture, the Nitrates Directive and the CAP, of course, govern nitrogen and ammonia, but the gap is on the obligations on emissions to air. For instance, the Nitrates Directive addresses ammonia emissions to water only.
Other indirect instruments are also relevant. I will only highlight the Ecodesign Regulation because it provides the legal basis for reducing emissions for relevant heating products. Now, what has worked? Most reductions are attributable to binding standards on vehicles, on large industries and on fuel quality.
And it's the legally binding limits that have been effective, not so much the voluntary measures. On the ambition gap, the AAQD tightens the target for 2030 while remaining above the WHO health-based guidelines. What is at stake today is an estimate 182,000 premature deaths yearly and an estimate 2 million life years lost estimated in 2023. Where the gaps that we see and what are our key recommendations? Agriculture ammonia is the main precursor source of secondary particulate matter and has barely reduced since 2005.
Here, the NEC directive could set national sectoral targets for agricultural ammonia. The nitrates directive could also include air emissions as well as the current emissions to water that it does include. On residential wood burning, which is important for some EU regions, because household heating products don't include standards for particulate matter emissions, setting standards for appliances and fuels could reduce indoor exposure and also build coherence with the ecodesign directive. On the AAQD limits, in Article 3 in the AAQD, it establishes a regular review for assessing the timelines to align with the WHO air quality guidelines and most up-to-date scientific evidence.
This is a key tool available for the 2040 trajectory. And this will be my final slide in the interest of time. On the issue of postponement, the AAQD delays allows delays for up to 10 years beyond 2030, and member states with the most highly burdened regions are also those that are most susceptible of using the postponement clause. The legal lever available here is Article 18, which involves firstly the eligibility criteria for the postponements, and secondly, when postponements are applied, it could require, excuse me, it could require public reporting on the health cost of each delay. Implementation and enforcement of air quality plans routinely miss establishing concrete targets, responsibilities, and dedicated funding, and low emission zones are a key example of this where we see highly inconsistent enforcement.
The policy lever here could be A, to expand, sorry, the policy lever could be the mandatory content, sorry, excuse me. Yeah. The policy lever here could be the mandatory content for air quality plans for setting quantified measures and targets, budgets, and responsible authorities.
On health integration, particulate matter harm is measured currently mainly as premature deaths, and health authorities are almost always outside of air quality design. The levers here are, firstly, to expand the burden of EU metrics to include morbidity in the socio-economic valuations, and secondly, to require air quality roadmap to embed also health authorities in the design. The final point on equity. We have seen how particulate matter exposure and health burden affect low-income, urban, and vulnerable groups the most, but air quality plans are not yet required to target them. This could be included, for example, by identifying high-exposure groups and setting targeted measures within the air quality plans and roadmaps.
Honorable members, thank you for your attention, and we remain at your disposal for questions.
Adam Jarubas
Thank you so much. Thank you for your presentation. Now we are open the discussion with MEP, and Ljudmila Novak is the first, please.
Leire Pajín
Thank you, Chair. I'm going to speak in Spanish.
Quiero empezar agradeciendo a los investigadores por el estudio y por su presentación. Este es un buen ejemplo de cómo tenemos que tomar decisiones políticas basadas en la evidencia científica y también un buen ejemplo de la necesidad de que nuestras políticas tengan el enfoque de One Health, la relación entre los temas ambientales y la salud es evidente y tenemos que seguir trabajando en ese sentido. Las partículas finas, como se ha recordado, son a menudo invisibles a simple vista, pero dañan nuestra salud, acortan vidas y agravan las desigualdades. Y el estudio recoge una estimación especialmente grave, la de que en 2003 aproximadamente 182.000 muertes prematuras en la Unión Europea fueron atribuibles a la exposición prolongada. Por tanto, nos demuestra en primer lugar que estamos hablando de que la polución y la contaminación que respiramos mata, pero también que es evitable si somos valientes en las políticas públicas.
Por eso quiero poner en valor la legislación que hemos aprobado en los últimos tiempos en este Parlamento sobre la reducción de emisiones, liderada por nuestro compañero Javi López, pero también por políticas públicas que muchas ciudades están poniendo en marcha y que funcionan. Es el ejemplo de la ciudad de Barcelona, que lleva tiempo trabajando en la protección de entornos escolares y de reducción de zonas de emisiones que están dando resultados, y también poner el acento en aquellas que están dando marcha atrás. Desgraciadamente hay otras ciudades que empezaron por ese camino, como la ciudad de Valencia, pero ahora están dando marcha atrás. Necesitamos, por tanto, políticas valientes, políticas públicas que sabemos que tienen resultados. Déjenme acabar con otro tema que está muy conectado, aunque no es el foco de este estudio, que es también de salud laboral y el daño causado por la exposición a determinados materiales.
Es el caso de la sílice cristalina respirable y la silicosis, que no figuran, como digo, en el estudio, pero que es importante. Hace unos meses nos reunimos aquí en el Parlamento con afectados y organizaciones. Es una verdadera alarma esta exposición en la manipulación de materiales y me gustaría saber si la Comisión tiene también planes para regular y proteger más a estos trabajadores que se ven expuestos a la inhalación de estas partículas y que causan graves daños a la salud. Gracias.
Annalisa Corrado
Thank you, Annalisa Corrado on behalf of ENVI.
Grazie. Parlerò in italiano. Grazie mille. Concordo totalmente con quanto detto adesso dalla collega e anche per l'importanza di avere una base scientifica in questo caso per capire a cosa sono esposti i cittadini europei e la loro salute. E parliamo soprattutto del PM 2.5 capace di penetrare profondamente nei polmoni e raggiungere il ciclo sanguigno.
Quindi 182.000 morti premature sono state attribuite a questo tipo di esposizione con effetti che riguardano il sistema respiratorio, cardiovascolare, ma anche tumori, diabete, demenza e altre patologie. L'inquinamento poi aumenta la nostra vulnerabilità di fronte ad altre emergenze come abbiamo visto per il COVID-19 dove ci sono state maggiori incidenza, gravità e mortalità. E lo vediamo anche durante le ondate di calore come quella infinita che stiamo attraversando in questa estate torrida. Alte temperature e inquinamento atmosferico interagiscono amplificando gli effetti deleteri sulla salute. Non parliamo di rischi lontani, futuri o astratti, ma dell'Europa di oggi.
Ma da dove provengono queste particelle?
Dove possiamo intervenire? Riscaldamento degli edifici, trasporti, industria, agricoltura: una parte importante è legata direttamente ai processi di combustione o indirettamente, ed è qui che le politiche europee devono fare la differenza. Decarbonizzare ed elettrificare trasporti e riscaldamento, aumentare l'efficienza energetica, sviluppare città con meno traffico, più trasporto pubblico e mobilità sostenibile, più alberi e spazi verdi significa migliorare davvero la qualità dell'aria, riducendo insieme le emissioni climalteranti e la dipendenza dalle fonti fossili e, tra l'altro, dalla volatilità dei loro prezzi. Per questo auspico che nei prossimi mesi possa esserci un lavoro proficuo tra le forze politiche che sostengono la Commissione europea e che non negano la drammatica realtà. Parleremo della revisione dell'ETS, delle emissioni delle automobili, dell'Industrial Accelerator Act, delle nuove politiche per l'elettrificazione, senza dimenticare l'ETS 2 e l'importanza dei Social Climate Plans.
Quando ne parleremo, ricordiamoci che stiamo parlando dei costi che sosteniamo per non fare la transizione e di salute pubblica. Grazie.
Marie-Luce Brasier-Clain
Thank you, Marie-Luce Brasier-Clain, please.
Merci, Monsieur le Président. Merci aux experts pour la qualité de ce rapport.
Je voudrais vous demander des éclaircissements notamment sur la méthodologie employée. Dans le tableau des études de cas, vous indiquez par exemple un décès pour 100 000 habitants en Finlande contre 180 en Bulgarie. Or, ailleurs dans le rapport, les chiffres 2023 sont respectivement de 39 et 172 pour 100 000. Sur les chiffres globaux, l'AEE présentait le chiffre de 182 000 décès imputables aux particules fines dans l'UE en 2023, or pour 2022, il était de 239 000. Comment expliquez-vous un tel écart ?
Quelle part provient de la baisse de la pollution et des évolutions méthodologiques ? Toujours sur le plan méthodologique, le rapport fait état d'une baisse importante de la mortalité, moins 57 % depuis 2005, mais dans le même temps d'une augmentation de la charge de morbidité dans plusieurs États membres en raison de l'intégration de nouveaux paramètres comme les nouvelles pathologies ou la structure démographique.
Alors dans quelle mesure ces estimations sont comparables dans le temps si les paramètres du modèle évoluent ? Le rapport affirme que la Finlande et la Norvège montrent qu'un niveau proche de 50 microgrammes mètre cube, soit les recommandations de l'OMS, est réalisable en Europe. Mais ces pays sont-ils vraiment comparables à des régions comme la vallée du Pô ou la Silésie en termes de climat, de géographie ou de densité ? Idem pour les secteurs. Vous mettez l'accent sur l'agriculture sans qu'on sache s'il est techniquement et économiquement réalisable d'y baisser les émissions d'ammoniac.
Pourquoi ne pas déjà agir par exemple sur le chauffage au bois qui, bien que renouvelable reconnu, est une source majeure de particules fines ? Je vous remercie.
Aurelijus Veryga
Merci. Next speaker is Aurelijus Veryga.
Thank you very much, Chair, and thanks for the presentation and for the data you have presented today.
And you have mentioned the long-time existing sources of pollution and risk factors, but my question would be, did you look to a new potential risk factors that are associated with the new developments and new regulation? For example, high energy efficient houses that are usually very closed and the air quality very much depends on ventilation systems that should be very advanced. So that's the one potential source of the problem. And then another potential source is the vaping that is very widely in society still understood as a risk reduction for traditional smoking, which you can usually, you cannot smell inside, but it also consists from the fine particles. So is it somehow evaluated and included into your data and research?
Thank you.
Tilly Metz
Thank you. Ignazio Marino? No, no, no. Tilly Metz.
Thank you, dear Chair, happy to see you. What strikes me most about today's presentation and the study is that it makes something very clear. Air pollution cannot be treated as an environmental issue with consequences for health, air pollution is a public health issue.
And this matters because the sources of our exposure do not sit within one policy area. They are linked on the way how we produce energy and food, how we heat our homes, how we organize transport and mobility, and how we design our cities. We therefore need to change really the paradigm and address air pollution across all these policies, avoiding silos. The numbers we heard during the presentation are a reminder of why this matters. 182,000 premature deaths in the EU were still attributable to PM 2.5 in 2023, and you mentioned even the figure of 239,000 premature deaths due to air pollution.
We know that 90% in the EU of the emission of particles, of particles exceed the WHO guidelines. So what makes these particles particularly dangerous is, and it was mentioned already, we do not see them. And the evidence also shows that this is a life course issue. For instance, let's think about during pregnancy, people with existing conditions are particularly vulnerable. Being exposed during one period of our lives can have consequences for years.
So yes, this is the proof that strong environmental and public health policies can save lives. There is, on the other hand, no safe level of exposure identified in the evidence. And the study estimates that even full compliance with the current EU 2030 limit could leave 60,000 to 70,000 premature deaths every year. So we should not only ask whether a policy reduces emissions. We should also ask whether it makes people healthier, whether it protects those who are the most exposed.
So we saw that it has fallen 57% since 2005.
We saw the inequalities that are there. And this has to be part of our response also to climate change. So I come to my questions. From a public health perspective, where do you see the biggest gap today between what we know about health effects of fine particles and the policies we actually implement? And which policy areas should we prioritize to close this gap?
Thanks.
Anja Hazekamp
Thank you. Anja Hazekamp, please.
Yes, thank you, Chair. And thank you to the experts for your study.
As rightly pointed out in your study, one of the main contributors is agriculture, and in particular the intensive livestock industry. There has not been significant reduction since 2005 of the ammonia emissions, which form a large share of fine particles. Would you agree with me that it is very urgent to change this big gap in the legal framework on air quality, and what would your main recommendations be to reduce the agricultural emissions? And I also wonder if you would comment on the conclusion of a study by the Dutch Health Council that people living within a one-kilometer radius of a goat farm appear to be at a significant higher risk of developing pneumonia than those who do not live close to goat farms. And they say it is plausible that cases of pneumonia in the vicinity of goat farms are caused by a combination of various factors, with emissions of microorganisms, endotoxins, and particulate matter playing a significant role.
They plead for reducing emissions at source as the most appropriate way to limit exposure among local residents. And would you agree that we would also need binding EU legislation to curb the dangers to our health relating to these specific forms of air pollution? Thank you.
Nicolás González Casares
Gracias, gracias a los autores por este brillante ejercicio de salud planetaria que nos ha dejado claro una vez más que la calidad del aire importa para la vida y que las partículas pequeñas matan y que, por lo tanto, reduciendo la exposición a estas partículas pequeñas podemos salvar vidas. Me quedo con dos asuntos fundamentales de su informe. Primero, que las desigualdades influyen en la atribución de la mortalidad con lo que tiene que ver con las partículas pequeñas. Y esto es importante tenerlo en cuenta cuando se diseñan políticas públicas, singularmente en ciudades, para para abordar esas desigualdades, que es donde mejor se localizan y se pueden abordar. Y lo segundo, ustedes lo han dicho.
Son las medidas obligatorias las que permiten obtener mejores resultados, no las voluntarias. Por lo tanto, la regulación salva vidas. Hacer leyes adecuadas salva vidas. Lo que me lleva a que desregular probablemente no las salve, sino que al contrario, aumente la mortalidad. Y cómo ven ustedes, esa es mi pregunta, cómo ven ustedes esta ola de llamada simplificación, que en realidad quiere decir desregulación?
Creen que esta ola desregulatoria, mal llamada simplificadora, puede tener consecuencias para la salud de los europeos y europeas en lo que tiene que ver con la atribución de enfermedades por las partículas finas? Muchas gracias.
Martin Häusling
Thank you. Martin Häusling, please.
Ja, vielen Dank für den Bericht. Zunächst mal klingt das ja ganz erfreulich, dass die Zahlen sinken und ich glaube, da wird deutlich, wir müssen gesetzgeberisch handeln und dann sinken auch die Zahlen.
Also stimme dem Kollegen durchaus überein, Liberalisierung in dem Bereich schadet letztendlich der Gesundheit. Sie haben besonders den Bereich Landwirtschaft nochmal genannt. Und wenn ich richtig informiert bin, haben wir da eigentlich in den letzten Jahren ziemliche Probleme. Wir haben keine Senkung von Ammonium. Und deshalb die Frage: Halten Sie die NEC-Richtlinie denn für ausreichend, dass die Mitgliedsländer bis 29 dann auch entsprechende Maßnahmen durchsetzen sollen?
Halten Sie das für ausreichend, um da die Ziele tatsächlich zu erreichen? Interessant fand ich Ihren Vorschlag, einen Grenzwert, Nitratgrenzwert für Luft einzuhalten. Das wäre ja eine völlig neue Geschichte. Ich hoffe, es kommt dann nicht so wie bei Wasser, da erreichen wir die Zielsetzungen in vielen Bereichen ja auch nicht bei Nitrat. Was würden Sie da vorschlagen, was sinnvoll wäre für einen Grenzwert?
Und letzte Frage: Thema Holzverbrennung. Ist ja in vielen Regionen wirklich ein Problem. Müssen wir da Maßnahmen ergreifen bezüglich der Reinhaltung der Luft bei Holzverbrennung oder halten Sie das für vernachlässigbar? Vielen Dank.
Adam Jarubas
Thank you. I will now give the floor back to our experts. Could you comment the question posed by our MEPs? Six minutes both.
Arnaud Deu
Many thanks. We will comment on the questions that we are qualified to respond to.
And I will start with the first question which was asked in Spanish, so I will attempt to respond also in Spanish. Las políticas públicas y en especial las zonas de bajas emisiones son un claro ejemplo de la diversidad en la aplicación y en el éxito o manca de que hemos observado en la aplicación de la regulación. Es algo que hemos oído también por parte de las autoridades a las que hemos entrevistado. A veces la falta de soporte, líneas, guidance que puedan recibir por parte de la administración europea en la implementación. Pero también es una zona donde hay espacio para que los planes de zonas de bajas emisiones o más abiertamente los planes de calidad del aire y las roadmaps, los trayectos de calidad del aire, pueden también contener espacio para dar medidas concretas.
Porque una de las cosas que está faltando a veces es establecer los términos, establecer el budget, la cuantía dedicada y establecer las responsabilidades.
A menudo faltan estas y se quedan los planes en el establecimiento de objetivos y estamos preparados quizás para dar un paso un poco más concreto, al menos esto es parte de lo que recomendamos. Another comment, I will switch now to English, on the coherence with other climate policies. Of course, this is a clear example of the less emissions that include CO2 involve indirectly or directly less emissions also to fine particulate matter. So this is very clearly a strong relation. And of course much of the reduction that we've seen since 2005 and 2013, the two periods that we've been looking into, come precisely from vehicle emission standards, from cleaner fuels, from cleaner vehicles.
This is a very clear result. I'd like to bring up here Norway because it provides an interesting example of they have a particularly rapid fleet turnover and a lot of the turnover involves electric vehicles and that explains part of their success in managing a paired decarbonization with a reduction of particulate matter.
Moving on to a speaker asking about potential risk factors, for instance in high energy-efficient houses. This is an interesting point, and also there is space for the... for the EPBD to include particulate matter amongst the criteria that is used. So there is, I agree with the speaker, a chance for building in policy coherence. It is amongst the indirect measures that we're listing that can affect, so it's not a direct way because it's not related directly to emissions, but of course it is related to air circulation and quality. The point on clarification on methodology, I will allow my colleague Nikki to respond after I finish, but allow me to move on to the public health perspective, the question about how the recommendation fixes air quality plans and roadmaps, and if there's space to bring in health authorities.
The answer is absolutely yes, this is one of our recommendations. The air quality plans and air quality roadmaps do not currently systematically include health authorities.
And this is something that not many member states have proactively reached and done. Therefore, there is space within the AQD in the establishment of air quality plans to include within the one health policy framework the inclusion of health authorities within that design because they are sometimes the authorities that are capable also to point to the questions that either the climate, energy efficiency and environmental authorities may have blind spots. And finally on the issue about equity, voy a responder también a la pregunta en español. De nuevo nos referimos a los planes de calidad del aire. Es un espacio donde en los planes no hay un espacio, una definición de quiénes son los miembros vulnerables y si se tiene que tener un trato especial.
Por lo tanto, incluir en los planes segmentos en los que A, se manda la identificación de la población vulnerable y B, se indican cuáles son las medidas que se dan.
Evidentemente, hay enorme variedad en los Estados miembros, por lo tanto, esas guidelines no pueden ser extremadamente rígidas, pero el espacio para que haya esa discusión actualmente en los planes no existe, por lo tanto, hay espacio para incluirlos. I will pass it on to my colleague Nikki. Thank you.
Nikki Vermeulen
Thank you, Arno, and thank you for these questions. I would like to dive into the question on the methodology and specifically on the one where about the comparison between the Scandinavian regions, which, you know, show consistently very low PM concentration levels and the more difficult regions such as Silesia and the Po Valley. And I think it's unreasonable, right, to think that with all these different circumstances, there is a one-fit-all approach where reduction can be at the same level at some point. So you shouldn't ignore these circumstances such as these industrialized environments or the basin in the Po Valley, which all have very functional or, you know, external influences on the exposure and concentration.
But you have these regional differences and these challenges are not something to ignore. I don't think that in our report we have the answer on how to get to those very low levels or even beneath the WHO standard of five micrograms per cubic meter. It does show that you would need a policy that should be adapted to regional circumstances to continue to reduce exposure. I think that is the, based on our report, the one answer I can give to that question. And also thank you on the question on the goat farms.
I have seen the report as well. We in our study did not specifically assess the effect of goat farms on pneumonia risks. And I know that the mechanism is still an active area of research currently. So, you know, as we do not focus on that in the report, I would like to not speculate on that and stick to our scope. And I think that's all the questions.
Arnaud Deu
Allow me to build on it because there is a good link, I think, with one of the policy recommendations on, because I think a question that I missed was about, of course, the link with agricultural ammonia. And the question was about which are the levers that can be used. There is one clear lever, which is the Nitrates Directive, currently addressing only water emissions, so that is to freshwater and to groundwater. And there is space there for it to include air emissions, of course. So this is a clear result of the study.
For anyone who doesn't know about the chemistry of particulate matter, ammonia is one of the main precursors and therefore it binds to other types of emissions, mostly industrial and road emissions, to form the finest PM 2.5 particulate matter.
So, it doesn't surprise me that nearby goat farm there could be more air emissions of ammonia, but we're not in a clear position to comment on that. The other regulation that has space for including ammonia is in the NEC Directive, which establishes, of course, the emission ceiling limits, but it does not establish any national sectoral limits. And therefore, an agricultural inclusion in NEC specifically for ammonia emissions could be a tool leveraging that result. Thank you.
Adam Jarubas
Thank you. Thank you so much for your presentation. Dear colleagues, we've just closed the speaker list, but we have one indication yet. Christine Singer wants to take the floor. We have enough time, so go ahead, please.
Christine Singer
Ja, vielen Dank. Ich würde mich gerne noch zur Landwirtschaft äußern. Dass Feinstaub gesundheitliche Gefahren mit sich bringt, steht außer Frage. Und diese Risiken müssen wir auch ernst nehmen. Und selbstverständlich müssen alle ihren Beitrag zur Verbesserung der Luftqualität leisten, und dazu gehört auch die Landwirtschaft.
Aber gerade deshalb ist es wichtig, auch anzuerkennen, was in den vergangenen Jahren bereits erreicht wurde und was auf den Weg gebracht wurde. Und dieser Aspekt fehlt mir ein bisschen auch hier in den Ausführungen. Die Landwirtschaft hat erhebliche Anstrengungen unternommen, um Ammoniak-Emissionen zu reduzieren.
In Deutschland wurde beispielsweise in den letzten Jahren massiv in die bodennahe Ausbringung von Gülle investiert. Und die aktuell laufenden Maßnahmen greifen bereits tief in die betriebliche Praxis. Die Landwirtschaft investiert hier enorm. Und wenn vor diesem Hintergrund dann von einem Stillstand in der Landwirtschaft bei der Reduktion von Ammoniak-Emissionen gesprochen wird, dann wundert mich das schon. Und deshalb möchte ich noch mal ausdrücklich darauf hinweisen.
Vielen Dank.
Adam Jarubas
Thank you so much. On behalf of President Hazekamp and mine, I would like to thank all for the excellent discussion today, especially to our experts for your valuable contribution to our work. Dear colleagues, we've just finished the first part of today's meeting. The next one will start at 11:15 in this room, so we have a half-hour break. Thank you so much.
I'm in the process. So 11:20, yes, we should start. Dear colleagues, please take your seat. We will start in a minute. Please take your seat.
Thank you. Let's get started. You received the agenda. Can we adopt the agenda of today's meeting? Thank you so much.
The agenda is adopted. Point three, chair's announcements. The summary of the decision taken during the SANT coordinators' meeting on 14th of July was circulated by the secretariat on 16th of July. Dear colleagues, we start today's meeting with the adoption of budget amendments of the general budget of the European Union for the financial year 2027. We have information about replacing.
Mr. Jerković will be replaced by Tonino Picula. Mrs. Jerković, of course. Sorry. Before proceeding with the vote, I give the floor to the rapporteur, Michalis Hadjipantela, for a one-minute statement, please.
Michalis Hadjipantela
I would like to thank all the colleagues for the cooperation. We have shown as a European Union that we are united in health issues and we want to give the signal to the whole of Europe that health is a priority for the European Union and us as members of the SANT committee will be fighting to increase the budget for European Union health for the next years. Thank you.
Adam Jarubas
Thank you, Mr. Hadjipantela, for your great work to have a joint compromise on this file. Okay, dear colleagues, we have, I propose to have a roll-call vote test, roll-call vote first.
I open the vote. It doesn't work. Oh, maybe sorry, sorry, sorry. My bad. I close the vote.
Please press the button. I closed the vote. It it works good. Okay.
Okay, colleagues, let's now proceed to the vote. Amendment 1, who is in favor by raising hand? Against? Abstention? Adopted.
Amendment 2, who is in favor? Against? Abstention? We should check it. Yeah, I open the vote.
I close the vote. Adopted. So we go to the amendment 6. Who is in favor? Against?
Abstention? Let's check this. I open the vote.
I close the vote. Adopted. Amendment seven. Who is in favor? Against?
Abstention? Adopted. Congratulations to the rapporteur for your great work. Thank you so much.
Speaker 38
Just as a different proposal. Yeah. Thank you so much. Okay, colleagues, let's have a one minute break.
Adam Jarubas
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 experts.
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 Davis, the project leader and lead author, Mathis de Vert, 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 provide further input for the upcoming work on the report.
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