Improving Europe’s water quality - How can the revised UWWTD be implemented fairly and effectively?

Hello and welcome to today's your active debate where we are going to be asking how to improve Europe's water quality and how the revised urban wastewater treatment directive can be implemented fairly and effectively. My name is Jennifer Baker, I will be your moderator today guiding you through our panel. We do of course want those of you particularly online as well as here in the room to join in the conversation and we will be using Slydo to take your questions so you can scan the QR code that you see on the screen or you can go directly to Slydo in your browser slydo.com and put in UWTD and ask your question and we'll do our best to get as many of them answered by our excellent panelists in the next hour or so. And with that I'm going to introduce you to our speakers today who are going to be setting the scene for us. We're going to be tackling how the urban wastewater directive should be implemented. We're going to talk about the extended producer responsibility scheme and also looking at what micro pollutants there are and how that's all going to fit into a future that everyone can be happy with and deliver for the citizens of Europe and the environmental objectives of the EU. So to discuss that we have joining us from the DG Environment in the European Commission Veronica Manfredi, who is Director on Zero Pollution Water Resilience and the Green Urban Transition. We also have Secretary General of Europe, the European Drinking Water and Waste Water Services Association, Oliver Nobel. Joining us from a global industry leader, Warren Waste Water Rumble is Federica Lavosuskas and then joining us from the European Federation of Pharmaceutical Industries and Associations, or EFBIA, our hosts today and the Director General, Natalie Morgue. We're also going to be joined in due course by our representative from the European Parliament, Tommy Slavsoko, who is on the SANT Committee. Veronica, let me start with you. Set the scene first. Most people here, obviously, in those joining online are familiar with the Directive, but give us an update where we are at what the Commission's objectives are. So we are here tonight, obviously, to discuss about the Urban Waste Water Treatment that I think revision. We are talking about the Directive that has played a major role in leading by think water quality to really close to excellent status across majority of our coast. A super important directive to treat water coming from not only our households, but indeed, for example, hospitals and so many other centers of activity. And the recast has been building on scientific evidence that the type of substances that we really find hard to get rid of are micro pollutants, particularly persistent bio-communative micro pollutants. And because of the fact that the data reported by all the member states across the 27 member states has pointed to this as a very persistent problem, indeed, a vision that has been adopted by the ecologist later than now has entered into force. Since 1st of January 2025, we have decided to apply across European Union, but only for rather bigger towns, as from 150,000 population equivalent, Quaternary Treatment. This means a particularly advanced technique of water treatment. And the novelty is that for the first time in the liquid world, we have introduced what we call the extended producer responsibility system, which means those that are responsible for having introduced these micro pollutants into the water should contribute to financing the treatment cost. Important to underline, they wouldn't have to pay neither for the primary nor for the secondary, well for the cash or treatment. This is always paid by all of us citizens, it's public money, it's only for the Quaternary Treatment. And Parliament and Council agreed to say that this producer should pay at least 80% of this Quaternary Treatment cost that apply, as I said, for limited part of the National Seri bodies. Well, we'll get into that. I'm sure we will be discussing those decisions and whether they're accepted by the very many stakeholders that we will have represented. Thomas Lav, let me turn to you, as I said, you are on the sound committee, so you have been certainly following this and interested in setting out your position as far as it goes at the moment. Thank you very much. So it's become a very big topic, I would say, in the European institutions. I have to say I was informed about this pretty late. I have to say that the industry itself came to me sometimes in autumn, 2024, where the whole legislative process was finished, with the concerns which I find to be very, how should I put it, very important if they are the tools. Because essentially we have different sets of data depending on who you speak to. If you speak with the Commission, they gave you the impact assessment that was there. But then when we get the data from the industry, also part of from the Member States, it shows a completely different story. So in two ways. So first, what the industry claims is that the impact assessment first overestimates the industry's role in creating this toxic law that we have to clean from the wastewater, and that it also underestimates the impact on the industry, the financial impact on the industry. So here we have two dimensions of the problem. And these discrepancies are enormous. And definitely if we have such big discrepancies, then we definitely have to ask some questions. So there has to be some problem. The logical problem, some issue has to be there, which causes such big discrepancies. Because if we have one impact assessment, that says that the annual effect of this will be 1.2 billion euros a year. And we have other impact assessment, we have other studies and assessments which say that it is more than 11 billion euros. So that's by the factor of 10. Then obviously there's something wrong there. And we have to, we have to see what it is. Also, also what I saw from some of the materials is that is the one claim that only one cardiovascular medicine accounts for 41 percent of all toxic law denotes the wastewater. I mean that sounds from a common sense point of view that sounds a bit strange, let's say. So in science and methodology, if you have certain data which is an outlier, which is so different from anything else, then definitely this is something that should be additionally checked. And also if it's so that's the part in terms of how much does the industry contribute to the urban wastewater. And the question is the impact on the industry. Because if this is underestimated, then we can have big problems, especially if we speak about the prices of certain medicines which may become financially unsustainable and we can have shortages. And this is never not something that we want. Also, when we speak about some parts of the industry, which for instance generic industry which has pretty low margins, if this effect is underestimated, then it turns out that it is much more than originally assumed by the commission or assessed by the commission, then we can have a promise which could either result in first either in shortages or second in enormous increase in prices. And since for instance generic medicines are financed by the health insurance, in the end it should be paid by the citizens, right? Or either by either through social insurance contributions or if it is off-padded medicines which are paid over the counter then paid by the users themselves. In any case, the citizens will pay. Now, just nice the question to determine in what way this should be done. So since we have all of these concerns, such big discrepancies in terms of data, in terms of information, in terms of different studies, studies, etc. from depending on the source. This is why EPP has started an initiative that is stop the clock, that is stopped in pronunciation until we make new, more detailed independent impact assessment and determine what the actual situation is. Because this is not something that we can afford ourselves to get drunk. Because there could be consequences which are just, which cannot be remedied. So for that reason, the EPP position has been that we need to stop the clock, that we need to make a new separate independent impact assessment and then to see what the actual truth is. Because definitely there are some things which definitely raise a lot of questions. Well, you've set out the scope of our discussion for us and really not just starting at the beginning of the session, but several steps down the line because we are focusing today on the pharmaceutical sector and we will come to the knock-on impacts. Oliver, let me turn to you and give us your opening thoughts and a great broad sense, but perhaps also explain a little bit about your organisation for those who are not familiar with it. Yeah, trying to see the audience, but I'm really blinded by the sun, which is good in Brussels. So Euro is the European Association of Trinking Warden Wastewater Operators and we have 38 National Member Organizations in 33 countries, all EU countries, all FD countries and beyond. Most of our members are small, municipal, structures, either departments or companies. So really the average is a small structure. I would like perhaps to start from somewhere else because jumping on EPR is really not looking at the Urban Waste Water Treatment Director, which is a very complex piece of legislation. And to look at this, I will even go a step further to today's vote in the NV Committee in the European Parliament, where the NV Committee has approved the trilogue agreement on the Water Framework Directive. Now you will say, well, what's the link? Well, the Water Framework Directive sets tighter standards also, I think, for nine or so active pharmaceutical ingredients. The only way to meet these requirements is quaternary treatment in Urban Waste Water Treatment Plants. So the co-letters actually have voted today again for additional treatment, micro pollutants removal in Urban Waste Water Treatment Plants. So this perhaps is a framework. Then second point I would like to make, we have two very different sectors here on the stage today, pharmaceutical waste water. Do they have anything in common? Difficult. But when we look a bit closer, we are both active in the field of protecting public health. It's our mission and it's the mission of pharmaceutical companies. Of course, we also have a submission to protect the environment. We are both part of the one-heldset approach, important to note. We are both heavily regulated. We cannot set our prices ourselves the same, I think, for many pharmaceuticals. For us, it's also done by the regulators. In addition, the waste water sector is considered as critical entities, critical infrastructure. We deliver services that are essential to maintain vital societal functions under all circumstances. That's written in the Preparedness Union Strategy of the European Commission. And we have to respect the European right towards the sanitation, which includes affordability of the service. That's the UN requirement. Coming back to both sectors, I think we both recognize that there is a problem with pharmaceuticals in the environment. And I think we both recognize that urban waste water treatment plants are an important pathway of these substances. If actions need to be taken end of pipe, which we do not prefer, which is reality, then urban waste water treatment plants have to play an important role. And I think we both even recognize that EPR is a tool to tackle that problem. And we both recognize also that this must be fair and transparent. I think here we all agree. But the question is, of course, how do we define fairness? And the very last point, if we only look at EPR today, we will not look at the urban waste water treatment directive. All the articles and requirements are interlinked. So we will definitely lose out on a lot of the things that need to be done that are interacting. So just the warning that this might not lead to the truth. So thank you. Well, as you say, Olivia, it can sometimes be difficult to find common ground, but we will hopefully do our best to do that on the panel here today and find some sort of constructive steps to look to the future. And Fido Nica, same opening remarks from you, please, but also perhaps give us some thoughts on where you see the direction of travel. Yeah, thanks a lot. First, perhaps to very short introduce my organization. Rumble is a foundation owned engineering consulting and architecture company. We are for 85 years now consulting what the purpose for, sorry. Yeah, not a problem. What the purpose to create sustainable societies where people and nature can flourish, we do this consulting in an impartial way. Our approach is scientific and we try to look at the facts and to make develop scenarios and to give good advice, but of course not to decide where are just consultants. Looking at the open wastewater treatment directive is of course a milestone in environmental economics. As an economist, I'm happy about tools that come from the economy and that, for example, forbidding something but trying to solve topics in an efficient way. It can combine sustainable water ecosystems and health protection in Europe. And it's efficient because it incentivizes not doing everything end of pipe, but what is best perhaps done end of pipe and what can be solved otherwise to do it otherwise. So of course it stimulates innovation and it's of course also an incentive to reduce pollution and not to let it get to the water at all. So of course to implement this, you need this extended producer responsibility scheme and this as we already heard depends a lot on how you estimate the situation. What are the pollutants, what are the costs and how do we distribute the costs between polluters and yeah. So of course of biggest important for this topic is that you have a good methods and good data to come to decisions to have a representative picture. I think one important part of the open wastewater treatment directive is that it starts now and has already different phases of evaluation embedded. So there is time to really define how it will be implemented, how the regulations will be set, how the countries adopted, how flexibility is used and perhaps also which data and which methods have to be further developed to have a good assessment of the pollution. And that's why in our view it's so important that the water sector and producers should work together to implement the responsibility for removing micro pollutants. So it's really done effectively and fairly. I think there is, it's very important that there are discussions and also of course solution-oriented approaches to come together to a solution where you can assess the removal of micro pollutants in the best possible manner. Thank you and finally Natalie for opening remarks. Our main question today is how can it be implemented, effectively, fairly, sustainably, balancing those environmental needs and the public health needs is the side that you're coming from as well and that is if you're talking from your perspective a balance to be struck. How do we do that? What is your assessment? Thank you Jennifer and thank you to your active for organising this important discussion this moment in time. I think what we heard from the panel and I'm sure many people in the room we all share the same objective of having clean water in Europe and that's also something shared by the pharmaceutical industry and we support both the environmental and the public health ambitions of the director. That should never be taken into put into question. I also think often and luckily Veronica said at the beginning sometimes this topic is confused with a discussion on production of medicinal products. This is not about production of medicinal products where other standards and other kind of water treatments occur. This is really about the use of medicines by patients and the excretion of of those medicines in our water or the disposal, the erroneous disposal of the products. I think that's just important to keep that in mind and we recognise of course the presence of some of our products in the water. I think the most important part for us to answer your question Jennifer is that there's a really fair share of the cost of implementing the director among all the polluters that are present in the water not only because that will make sure that we this is a sustainable and fair, let's say proportionate application director, but also to incentivise the greening not just of pharmaceutical products and cosmetics that are the only two sectors that have been singled out of the moment but of all the sectors that are contributing to micro pollution. I mean if this is the objective of the director as well from a public health and an environmental point of view then we need to be very coherent with that. I think today we feel and I think it's obvious that this should be done in an effective fair way and based on scientific evidence. At the moment there are two sectors singled out that have to pay for up to 80% of the cost of these quaternary water treatments and we as far as we've seen from the data and a few comments have been made that also by Mr. Sockle, the data and methodologies that have been at the base of this directive have not been fully disclosed. those dog validated as far as we're concerned. So I think that the oversight, as we've evaluated, will have a really enormous impact, not only on the pharmaceutical industry as such, but most importantly, on medicine supply and on patients who are dependent on medicines and on the global competitive of our industry. I think here, risk benefit analysis based on access to medicines for patients hasn't been taken into consideration and is something crucially important. The environment is very important, but the health and the safety of our patients and their accessibility of medicines is also very important. So I think here we would agree with what MEP soccer was mentioning in terms of pausing the implementation and taking a serious look at the data, assessing which other sectors could contribute to, so the scope of the directive and also doing a risk benefit in terms of what this means for the industries that then have been singled out. Thank you, Jennifer. - Thank you. Now, I think we're stepping quite a few steps ahead, Veronica. So let me come back to some of the issues that have been raised regarding the targeted industries for the EPR. At the moment, we're talking about pharmaceuticals and cosmetics. Even those who agree with polluter pays principle want those payment assessments to be fair and the commission often talks about how everything is evidence-based and science-based. How are you managing that? 'Cause we're hearing criticism. Yes, we're reading criticism, but on the other way around, it's fair to say that the commission feels in very good conscience to have done a very diligent piece of work when presenting to the EPR, the proposal for Eric Cast of the Urmawis Water Treatment Directive. We based ourself, first of all, on the data that are collected by the member states, that are known and consulted one also with the water sector, gather across the entire European Union across all the thousands of Urmawis Water Treatment plants that we dispose of. We carried out a feasibility study that led us to identify 1,300 substances. And then we went through very granular analysis of attribution of origin of these substances. So the presentation of the fact that today, the vast majority of persistent, non-biodegradable residues that stay in our Urmawis Water comes mainly from pharmaceutical and to a lesser extent, but still significant from cosmetics is a scientific fact for us. I must say that also as a citizen, if you ask me, I have difficulties in imagining much other sources that could be the source of this, if you look at daily life at home, the other typical ingredient would have been detergents. But as you know, the detergents have been subjected to very, very straight regulation, the latest legislation has just been apparent. And I think we can be collectively proud of the fact that the level of toxicity of the detergents, as indeed, very significant we use. I think some decades ago possibly that would have been the cause of bigger problems. So on the one hand, these are facts on which we have based our analysis. We have carried out a very thorough, as I said, feasibility study looking at economic implications and then in path assessment. We consulted that lined all the sectors, and I always repeat because I'm proud that if PM, particular, is a member of the Human Solutions to call their platform, they were present when we presented even some ideas. And I mean, of course, not the entire draft, but ideas about the PR system for the Urbano-Goeswater treatment narrative. And as colleagues know, let's say, thinking about how to tackle pharmaceutical indivirament, dates back to several years ago, ready back under the Junker Commission, the Commission adopted the strategy on pharmaceutical indivirament, looking at very many aspects of measures that can be taken in order to alleviate the loads that come in particular from hospitals, air-duty houses, et cetera, et cetera. So the problem is known since years. And I think, as Natali very correctly said, largely shared. So this I can testify. If he has always been saying, we also want to contribute, we recognize the challenge. Essentially, we find ourselves in the position to say, well, if we allow this persistent, non-biodegradable microbolutance to stain our waters, they do enter our aquatic ecosystem. They do hamper and represent a major reason vanpering our water resilience. They will sooner or later even end up in our ground water that we use for abstraction of drinking water. And this is not what we want. The cost is there. As I said, is not the primary, is not the secondary, is not the tertiary treatment. It's the advanced quaternary treatment that, for which the colleges say to have agreed to have it applicable and binding only for towns beyond 150-- 150,000 inhabitants plus a limited number of agglomeration as from 10,000 inhabitants, where the waters are discharging to particularly sensitive areas. We have a very time frame trajectory for the implementation of these requirements by 2033, 20% of these larger agglomeration and 10% of these smaller ones discharging in sensitive areas will have to comply. And indeed, the directive is very clear in saying the commission has 20 made expert groups to secure that, you know, the producers, the member states, all the relevant stakeholders come together and discuss. And I would like simply to read, but on one point, colleges later didn't think of affordability of medicines. Yes, they did. They did in recitals and in an explicit provision of the directive that obliges the member states at all times to take into account whether the implementation of the scheme put at risk the affordability of prices. So there is a linear requirement written in the law. In no way-- I mean, we could start in fringe when proceedings against member states, essentially, don't take its sufficient account the affordability of medicine. So I don't see exactly how this concern was not tackled on the contrary. It was very much in everyone's minds. And we did study to prove that. The impatassessment comes to figures that are contested, but which have been recently reassessed in an ad hoc study by colleagues of the Joint Research Center that lead to the conclusion that it remains by a large, a very solid piece of work. So let me come back to you. I mean, you're discussing a pause. So I mean, firstly, I'd like you to react to those who would say, actually, this would cause more uncertainty. I mean, people are pushing back against that in certain sectors. And then what would come do with this pause? What would have to happen to the PR scheme to ensure that, in your view, it is fair? Is that about the specific industry's targeted? Is that about the methodology? I actually see-- we've already got a lot of questions coming in. I also had to see Lucille Label is asking, what are your views on the Commission's updated study and how would the sources of methodologies in the future EPP study differ? So what would you do with a pause? What would be the studies? A lot. OK, so first, I would like to thank you for telling us what we think. Since I was also the member of parliament in the previous mandate. So I like it that somebody tells me what I think or what they do not think. So thank you very much for that. So first, recital is not legally binding part of legislation. That's one thing. It's not a normative part. The second thing is if you just pull certain vague concepts, which can be interpreted in various different ways, then definitely it doesn't have the same strength as if you have a concrete provision which says, you have to pay this amount. So it's not the same. So definitely what legally can be made on basis of this is very doubtful. So it can be interpreted in different ways. So definitely not enough in terms of legal certainty. That's the first thing. The second thing on the data, I don't know. If somebody else comes to me and says that they have lab tests for sure, completely different levels of toxicity, then it's in the impact assessment. Then something is wrong here. So these are not small differences. It's not like the question of a bit divergences, small divergences in measurement. These are substantial, essential differences, which need to find what lies behind it. The third thing is I'm not speaking about any kind of EPP study, which would EPP probably make for political reasons, or whatever, but an independent study done by the independent experts. So we are not calling for some kind of politically biased whatever. That's some of the implies. We want an independent study. We will not have to be the last to choose who will make this study, but it needs to be independent. But we need to check the data. Because as I said, we have different sources, sources of data, different information, which tell a completely different story. So something is wrong there. And as I said, some numbers just don't feel right. They don't seem right. If it is true that one medicine causes 41% of all the toxic load in urban areas. wastewater, to me it sounds strange. I'm not a scientist but still this is something that at least should be checked, at least in my opinion. And on the polluter pace we have no problem with polluter pace. That's everybody agrees on that. The question is how to implement it, but you also have to see about the consequences. It's also true that for some of these medicines, even if they are such a big part of toxicity and toxic load in the wastewater, it's not just easy to take a replace it like that. Okay, you'll just take another substance, it will be clean and it will reduce, etc., etc. So maybe if there are some of the medicines which should cause such a big amount of toxic load, then we should also make sure to see whether we can find substitutes. Because the consequences of having to put, for instance, some of these medicines of the market on public health can be detrimental, can be much worse than the impact of the waste motor. So a lot of different things need to be taken into account and don't think that things are such clear cut. And for that reason we want to have the possibility to get more in depth into into our midst. That's the whole thing. I'm going to come back on your point about ingredients or products in a bit. But first, Natalie, I have here a question. What role does robust scientific data and transparent methodology play in effective implementation? I mean, we've already get into the importance of that. So tell us from your perspective, I mean Thomas Love is raising the issue that there are different sets of data. How do we ensure transparency? How do we assess and measure that? So I think it's going to be fundamental because this is a directive that is now in force and we are working as sectors to implement it. So I just wanted to say that because I haven't mentioned that yet, even though we're contesting and asking for a stop the clock and questioning the attribution because it is a directive, we are working together all the associations, the pharmaceutical ones and the cosmetic ones on implementation so that we can implement the directive. But to implement directive, you also need to have transparency and clarity about the scientific data on which you're basing, you're going to share in every member state who pays for what. And at the moment, we don't have that clarity and that is the very concerning element. So we can put up the framework and we can work on the EPR scheme but when we then come down to deciding, well, how much the generous pay, how much the innovative medicines pay, how much the small at the moment, there is the conflicting data that that MEP Socle is talking about that creates real concern in terms of implementation as well. So you're going to get stuck even further down the pipe if we're talking about pipes and that that's concerning to us. I think there would be a lot of sense in stopping the clock and making sure that you have, you know, the policy making is based on a science-based assessment that is shared by everybody that there must be, I mean, we've, there are lots of piece of legislation based on science-based assessments. Our industry is basically regulated in that way. So I'm pretty sure we could agree on toxic load and quantities and hazards of the various substances. If we could just see the 3000 substances and look at all of them and not just a subset of them today. And then we could decide what the fair burden sharing is or the various pollutants. And I think what MEP Socle was also saying is that this, this is a piece of environmental legislation that is not necessarily balanced with public health needs and industrial competitiveness. And of course, it's an old piece of legislation. It's been reviewed from an environmental perspective but there are other, if you target our sectors, maybe if other sectors come into play they'll have other considerations. I don't know, I only know my sector. You have to decide a balance between the environmental need that you're trying to fix and what effect will that have on patients and can you substitute? When can you substitute? Should you have a phased approach for some medicines? So I think it's a bit fast and the problem is being a directive, it gives a lot of flexibility to member states on how they want to implement it. So you're going to have a lot of disparate implementations and an industry desperately trying to do the right thing without having the right data. And that's not a great recipe for success. Peter Wigg, staying with this question of data and if you've got discrepancies around it, I mean how important then are transparent methodologies? We'll unpick that a little bit for us please. Yes, yes of course, methodologies is key in this topic. I think it's also clear from the different arguments we just heard that there is data running around from every party involved at the moment in this discussion. There has been quite some scientific research on micro pollutants over the past years. Of course it's getting more and more known what comes to the wastewater because the analytical methods get better and better. And there are many studies about it. Of course it's always important to continue and to look for further sources of pollution. And by the way this is also one point that it's important. This data topic can also of course be drawn forward on national level. There is ongoing analysis in member states like for example in Denmark and member states are they can in implementing can take further data into account from their country and also address further industries within also already this first phase of implementation. So yes of course it can always be driven further forward this data and method and it's of course certainly necessary. But there has already been also a substantial part of analysis and research. And it's the best way we it's the best status we can know at the moment and bring it forward. But I have some figures of those national points you were mentioning. I don't have the Danish one but I have the German one which estimates the cost of about five times the four times the cost estimated by the commission in terms of millions so between eight hundred and eighty five million to one billion and then the French ones are about five times higher than the estimated cost for France in the in the commission so yeah. Well I don't know the the French data I know the German data I think there's one misunderstanding in this study in my view it's they calculate investment per year and not a cup of which would mean depreciation per year so I'm really into invest will be depreciated over thirty years so it's it's the investment is far too far it's front loaded and it's yeah I want to let Oliver react to what you've heard so far on on all these questions of data before I come back to Veronica on the specific questions of calculations so your thoughts on this this whole area of Oliver please. Yeah first thought stopping the clock would not solve the problem we would continue to conduct studies spend money come up with different data without really saying well that's now the holy grail now we know exactly what it costs we can't know it today we do not know energy prices in twenty years we do not know the technologies we have in twenty years from now and also very practical reasons that directive is includes a risk assessment for smaller treatment plants we may not need to install or upgrade them with what kind of retreatment if there is no risk for for example compliance with the water framework directive or drinking water resources so there are flexibilities and there are options also to use the years now to reduce the toxic load the directive also includes a lot of flexibilities what can be done what cannot be done and those should also be used at the end of the day there is a cost so on the college's latest have decided that those should not be put on the shoulders of local businesses of the barber shop of the local farmer the private household but on those who put those substances on the market and the positive aspect of this this is the only way to include also substances that are made outside of Europe in paying contributing to quarterly treatment if we remove EPR it will be put on local businesses 100% if we have EPR foreign companies putting products on our markets or European companies producing outside Europe putting their products on the market here have to contribute as well so it's also a matter of local fairness and competitiveness so for me stopping the clock would lead to substantial uncertainties in our business I can tell you that many of our larger treatment plants are already working on the first steps in the planning progress if this was suspended now we would of course also lose all the working hours already invested there without really solving the problem the key solution the easiest solution for me is really to start the process by the end of 2028 the P.O.s will need to know which water amount of money they need we will have to have delivered our cost estimates, then we will really know what it costs. And we also know that the first years, in the first years the costs will be very low. So only very few treatment plants will need to be equipped or will have to be equipped at that stage. And this is then also the moment where we can fine tune the system. And I fully agree with Natalie, we need a fair system and we need a transparent system but it's new. Let's work together, fine tune it whenever necessary and even improve it if necessary. But if we don't start it today, we will never get to a working system really. Well we will talk about how we fine tune and how we get to that system. But I will take one more comment from, that's come in via Slido from Henry Graimert, is saying that he had another study is suggesting that the director will cost 1.3 billion euros in Germany or is the commission JRC study says it will only cost 166 million. How does the commission explain the difference before we park this ongoing discussion? Look, one of the major reasons for these discrepancies of that analysis is linked to the fact that some of these costs calculation by other stakeholders or in a couple of cases may be even member states have been done based on the commission proposal. But the actual proposal is agreed by the college is later is different. It has restricted the amount of agglomerations that would have to install a quarter-hour treatment. It has indeed a subject to risk assessment, the analysis has to weather smaller towns would need to install it as well. So we have changed the scope of what we want to do. We have reduced the cost, the commission proposal was talking of 100% cost to be paid by the polluters. We have achieved agreement on 80%. So if the calculations are done on the wrong assumption, it's only normal that you see a pretty exponential difference because geographically we are talking about very different areas of obligation. If I may a very brief reaction also on the point how much is the directive really striking the right balance between public health and environmental protection and industrial competitiveness? Honestly, I would not be able to say to commission Roswell the first time I have a water resilience commission that she can reach water resilience if this directive is not put in motion in full speed. It contains all the provisions that we need in order to stimulate water use. It is the one that will secure that all the modernization of our infrastructure really takes place according to a predictable trajectory that is fixed by law and that is moving already now because we see our cities, our municipality, our regions in action. It is the directive that in a natural really secures the good functioning of water supplies, water sanitation across the European Union. So I think we have a lot of vested interests for our own security to keep it going. Let's also not forget and let's hope we will never need it. It's the directive that has now made it compulsory that we monitor our waste waters to anticipate risks of new pandemics. This is what we have learned during the COVID-19 pandemic. You get fantastic alerts through monitoring of waste water. This has become now compulsory. So a strategic element in the preparedness and security agenda of the European Union. So I must say I find the directive a lot of energy neutrality. In times where we are, where the energy prices are spiking, we are driving the energy neutrality of the entire urban waste water treatment sector. I mean do we want to wait until we go ahead on this super crucial, I think, elements for our strategic autonomy and competitiveness. So as Olivier also put it on top of the fact that the requirement is on those who place on the market, it means that these requirements we are discussing here apply to any producer, including producers in third countries that may come with pharmaceutical products and are in competition with those made in the EU and that will be obliged to appoint, you know, authorised representative. So I see a lot of reasons for going ahead. Nonetheless we don't go ahead blindly and indeed there is a time. Some aspects as we all collectively know are under the scrutiny right now of the Court of Justice. Did that line for the member states to set up this producer responsibility scheme is around 2028 but just to have a mapping then there is still time for the cost really to kick in up until the beginning of the 2030-2033. So there is a timeline and I'm very confident that we will hear more from the Court of Justice by then including on the issue of allocation attribution of substances. On top indeed we've just agreed on new water pollutants and if you ask me what are the water pollutants in service and garaboters I can tell you it's essentially pesticides, pharmaceuticals and cosmetics. Oliver let me ask you and then I'll invite Thomas Love as well. I want to tell him how policymakers can ensure this balanced burden sharing amongst the different sectors but while promoting sustainability and securing the investment needed to achieve the objectives. So there are a few different elements in there that I'd like you to address. Yeah, first of all the directive clearly serves the environment and public health. I think this was made very clear. So these are key objectives that will be certainly improved and met over the next years. No, I forgot the part of the question. Sorry. How do we ensure this balance? Yeah, balance. First of all I think there was a agreement to say well, for you the pace principle is applicable. EPR is a tool to implement it. We are a pathway. We are not the polluters but we may still have to show the 20% of the overall costs so we could also say this is crossly unfair. We accept it because we are committed really to sustainability and public health but we have to think whether this is a fair solution in the future or whether this should be reduced. I will not comment on the scientific basis of all the studies on concentrations of specific micro pollutants in wastewater because the composition of wastewater is specific to each place. So we wouldn't come to terms here but we are as a sector not opposed to including other sectors also. So this was our position from the very beginning. This is also public. We had even hoped that the directive would include the possibility for the commission to add sectors through delegated acts and not going through code decision procedure but this has not happened. But we have a review clause in the directive at the end of 2030-2033 and then of course there is an opening, there is a possibility to add other sectors also based on formal data that we will have by that time and also on the experience that we have with the first year of working with EPR, working together with all the sectors really. We will come back to this question of what might be possible in 2030-2033 in a moment but Thomas Love, I did ask Olivia what did he think that the legislator should do but I mean from your perspective what would you like to see your co-legislators doing in terms of this balance of securing competitiveness, securing sustainability, promoting sustainability because there is a lot of different moving parts. I would just like to comment on a few things that were said. So one thing that was said that we still actually don't know and you will see as things go along. I am not sure if that is the best methodology to say we still don't know but then as things go along then we will adapt because maybe somethings will not be remedied. For instance if you have a medicine which is put off the market because it becomes expensive and then patients can suffer from that and in these kinds of cases it is not lightweight and see. I don't think that weight and weight and see is the best approach. And also what you said about that levels of toxicity are different depending on the location then I definitely have to again ask the question on what was this whole assessment based on. Was it just some kind of models which made a lot of assumptions or actual measurements and if these measurements differ depending on the location then the question is how can we make general rules on basis of that. So this I don't to be honest after hearing this discussion I'm even less convinced in the data that I was when the whole thing started. Sorry for that. I'm a lay person I'm a lawyer I have to say maybe I don't understand some things but when I'm listening to this it doesn't seem very convincing to be honest. On who pays I mean it won't be the shareholders who will pay. If somebody thinks that shareholders of big pharma companies sorry that Italy will pay for that they will not. In the end this will either be rolled over on the consumers all the health insurance systems which means again the citizens or if for certain specific medicines the price goes to high and it cannot be raised because of regulatory issues like the generic medicines etc. then they will just be put off the market. So but they will trust me it will not be the dividends of the shareholders who will take money who will chip in and pay and pay for this. In the end, it will be rolled over on the patients or on the health. system, people who pay health insurance contributions to the center in the end. So let's also make this very clear. On what the college legislators want or don't want, so as I said, so we initiated this debate resolution in the parliament. It will be next week in the so-called mini-planar in here. And then you'll see what the parliament, as one of the college legislators, thinks in the light of the new data information that you now have conflicting data and conflicting information, then you'll see what the college, one of the college legislators thinks. The thing is that we do not have the right to propose legislation. So called right to off legislative initiative, rest solely with the commission. So the commission would have to propose any kind of change. One of ideas was to put it in the so-called environmental omnibus, but it was not done. But there are other ways how to do that. But if the parliament sends a strong message that we want to stop the clock, this definitely is something that commission should at least take into account. Because that shows that we have certain new information, certain new data, which definitely makes us rethink what was decided previously. And I think that this needs to be taken into account. But just a quick follow-up on that. Do you see a cost then of not implementing EPR? Because I'm sure you're hearing from all sides. Of course, I mean, there are costs in any case. Of course, there is still some time to go. But I think the bigger damage would be to make rules on basis of wrong assumptions or wrong data and then to suffer consequences issue, which could not be remedied. So I think here, as I said, better, let's get a critical data, which is clear on which we have a consensus and then make decisions on basis of that. Natalie, let me get you to expand a bit on some of Thomas Love's thing about medicine availability, patient access, patient payments, and pharmaceutical innovation as well. I mean, break it down a bit for us from the inside. Can I also, and I'm sorry, can I also answer all of us a point of let's just start and then see how it goes. I think, and the revision of 2033 when other stakeholders can come in and start paying, we will have done most of the work by then. So we will have paid for the setup of the quarterly treatments. I mean, they can come in by then, but it's a bit unfair. So I hear you and I know what you're saying, Oliver and I know we've talked about it together. But I don't think that later added on sectors can just hop on once everything has been done and say, oh, sure, we'll contribute. That doesn't sound fair to me. And it also, again, going back to the objective, the whole directive, which is to, I'm sure, suggest or encourage sectors to produce greener products, although medicines and whatever meant to be green, they're not supposed to be biodegradable always, they wouldn't work, but greener products, if only two sectors are paying for everything, it's a bit like at a home, if I tied in my children's room, they'll never tie to their room. I mean, what's the incentive? I'm tying it for them. So I think there we have to be a bit smart in terms of what is really the objective and how do we set that up. In terms of competitiveness, so our prices are fixed, we can't increase prices based on anything. So this is something that is highly regulated. What will really, what will happen and what is happening and what we hear CEOs are talking about is that this is yet another disincentive to operate in Europe. So it's not so much about the cost, it's about the general overall environment, sustainability environment, attractiveness of Europe in terms of innovation, certainly, and I'm sure also for generics. And why does this matter right now? Because we are in a global race, in a world that is decoupling, I won't say "de-globalizing" but it is decoupling. And as Veronica said, very importantly, resilience of our region Europe is fundamental. And we can't be resilient if we don't have the pharmaceuticals that we need. This is just, I mean, pandemic is the worst case scenario, so forget that would be even worse. But in general, we cannot be resilient if suddenly we don't have the right ecosystem to allow us to invent, develop, manufacture and release our products onto the market. And unfortunately, the way it's written, the urban waste water treatment and directive targeting only two sectors without taking the other sectors into consideration. There are the polluting sectors, two A shareholder and two A CEO looks like a further disincentive lack of predictability because the numbers don't fit. We don't know. I mean, when I present this to CEOs, they're really, I mean, even more confused than we can be on all the numbers. And that's not what we need right now in Europe. We need to have that clarity, that predictability, that fairness and a hell of a lot of attractiveness to make sure that what we've already lost in terms of R&D and in terms of investment and in terms of clinical trials, in terms of innovation comes back. And this doesn't help in that sense. So it doesn't mean, no, we don't want the urban waste. Please don't get me wrong. We're absolutely committed to the objective of the urban waste water treatment directive. If it is shared fairly based on scientific data and that it is applicable in a way that will actually be feasible for all of us and make products greener and greener. Peter Wicker, try and, we've had a lot of comments. So I mean, you want to react to a few of those, I'm sure. I would like to add one point to sharing the balanced burden sharing. Sharing it now, what would it mean? It would mean that the cost would be included in tariffs and paid by every household. So this is of course, if we talk about balancing burdens, it's always important to see at which degree the instrument is developed and there has been a lot of work done. And one very important part of the instrument is the risk-based approach. I think this has perhaps not had such a tension yet, but it's about where do we put the investments to best reach what our targets are. And combine this with the clear governance structure gives clarity to everyone. That's why I think it's so important that the water sector and the sectors that are covered by the waste water treatment directive work together to develop a solution that is perhaps inspiring and a balanced burden. The more important, I think this is my conclusion from this discussion. It's not stop it, but talk together and make it better. I mean, yes, all of that. The directive, as I said in the beginning, is very complex with many, many requirements. And if we just stop one bit of it or saying this part will not be implemented, this will bring the whole planning for all the other parts into trouble. So upgrading from primary to secondary to tertiary treatment, nutrients recovery, all of this is interlinked when I do my planning, my technological planning. It's one big thing that I need to plan. So we cannot just stop a part of it and saying, well, let's think more. So for us, really, it would be a disaster. And when, again, I would like to hint at all the possibilities the PROs have to distribute the cost fairly so that within the PRO organization. So there is no need to increase all prices by certain percentage points. There can be choices. So for life saving for crucial medicines, for example, the increase can be lower and others pay more as long as hasadness and the quantities put on the market are taken into account. So in here, I would also encourage the sectors and we have no say in it, obviously, to use these flexibilities and ensure that patients keep access to medicines. Quite a few questions, some challenging ones coming in from our audience as well. And Tibo Moto is asking, how does the director of ensure fair responsibility across the value and sharing, considering recyclists may be penalized for legacy contamination that they didn't create while many might put pollutants arise during the use phase? Anyone like to tackle that? Veronica? Yes. So the point would be how to avoid that we attribute to, let's say, the producers, the result of legacy pollution instead. Well, this is something that certainly we are very keen about and that is technically possible. This is very important to note. I mean, we have by now technologies that do allow us to really crack the microbolutants and attribute them with much, much bigger clarity than we used to do even just 10 or 15 years ago. So you can distinguish legacy from less legacy pollution. This would be my main answer. But in an event, the directive works not only and not so much with checking what is in the water, but also with the declaration that would come from the producer themselves, sitting in the producer responsibility organization, on the amount of substances they introduce on the market and their azardosness. So there is a principle of trust that regulates and disciplines actually the functioning of these piéros. And on this point, I must say that I've also welcomed the fact that in the revision of the pharmaceuticals legislation, which has been agreed by the college's later recently, the college's leaders have agreed to consider at some stage to introduce the environmental risk assessment for the production of pharmaceuticals, because could it be that this is one of the big hoop loopholes? It's not that we want to discriminate at all, the pharmaceuticals, if anything, we love them, not that other products, since they're really important for our health, of course. But it is a reality that for other industrial sectors, its ears that the relevant producers are used to calculate the environmental impacts of what they produce. So certain impacts can be better understood also by design and other pieces of the key. I'm thinking here, of course, of the industrial emission directive regulate them stringently as well. So the notion of better, better inside knowledge by design on the toxicity in part of what is produced is very important, because you would reduce the problem more upstream on the other way around. Of course, what we see also is that we have to look at the typologies of substance that we are discussing about. Big chunk of the substances actually are painkillers, and even among the painkillers, there are some that buy you the grade or at least, let's say, persistent and others. So it's an entire innovation debate that we all know is going on, because we're following the developments in the area of green innovation, green pharmacy. A lot of our eyes on Europe, man, is also going to support innovation in the pharmaceutical sector as well. And we want this to continue. So it's a transition phase that we can pile it together if we really work responsibly indeed fairly and disclosing the data that are available to each of the parties around the table. Natalie, you wanted to react to some of that. I just wanted to react on the environmental risk assessment because I don't want anybody to leave this event either online or in the room thinking that we never did environmental risk assessment for our medicines. So that was always part of the dosis that we have to submit to EMA for approval. The directive, the revision, has just slightly shared that with that. But I just want to make sure that you don't think that we're putting products on the market without checking their environmental risk assessment. You never know. Some people think, listen, and then here, just pick up little pieces and then things. So I think that's important. That's always been there. And there are also a lot of requirements for us as producers in terms of how we manage our waste waters from our plants. So the environmental approach to our medicines is not limited to the urban waste water treatment directive. I just want to put that out there. Just in case there was any misunderstand. Thank you. Thank you. Nikolai Kojimijev is raising the question of energy costs with the introductions of Quattanova purification known technologies will increase energy consumption by 10 to 30%. I can't verify that. But that's our audience members saying, how is this in sync with energy neutrality? Oliver, perhaps you could at least dig into the question of energy efficiency as it pertains to the directive. So the waste water sector is obviously massive energy consumers. So this is well known. On the other hand, there's a huge potential also to generate energy. So compensate for the energy we use, but also introduce energy efficiency measures. So we have a few energy neutral treatment plants in Europe, not all of them can go down that way, but there is really a potential to reduce the requirement to import energy into the system. But it is true. So depending on the technologies, on the systems you have in place already, Quattanova treatment will lead to a massive increase in energy use. And this of course brings us into trouble because we have this energy neutrality requirement in the directive. And treatment plants that are energy neutral today, tell us we won't be neutral tomorrow because of Quattanova treatment. So for us, this is of course an additional burden, which is not factored in the Quattanova treatment cost, but which basically falls on our shoulder to find additional resources, additional ways to decrease the energy demand. So it's a massive challenge for us. I can tell you. Thomas Lav, Anders Finneson, is raising the point that wastewater bills would have to be borne by European farmers or the food industries if it wasn't for cosmetics and pharmaceuticals. Can you react to that? I mean, is one sector more worthy than another in so-called quotes? I mean, we said, I mean, polluter pays, but the first thing we have to determine who the polluter is, that's the main point, and to what extent? And then measure the actual outcome because even if it is true, even though all of these doubts that is really caused by the two sectors, but then the question is, again, what will be the consequences, the actual consequences of this? And then this is what we are speaking about and we say about balancing the thing. Because if application of this leads to, I don't know, some medicines having to be put off the market because financial data, the production is not sustainable or something like that, then this is something that definitely needs to be taken into account. So I wouldn't get into the question of who is more worthy or not, but let's first determine what the facts are and then let's determine the impact and then see what exactly we want to achieve and what are the consequences of that. But first, let's go step by step. I think that's the main point. Yes, over. So it has to be then to talk about concentrations of various pollutants in wastewater, not that toxicity, concentrations. Why is that so? Because according to what we know and this is confirmed by various countries, one substance will make a hell of a difference. I just got data from Finland. If this substance remains on the market, it's a pharmaceutical. 80 treatment plants will have to be upgraded. If it's taken from the market, it will be eight, 10 times difference. For one active pharmaceutical substance, it's generic. So for us, the calculation is a bit different than just looking at concentrations. We see that the single substance can lead to a situation where we need to upgrade based on the risk assessment. So this needs to be taken into account somehow. I see just a few questions. We won't have time to get them, but I'll acknowledge them. I have Michael Nicholson asking what the UK could possibly learn from this journey. I don't think Michael anyone's going to tell you what we've learned just yet. Louise Rhodes is asking if the commission is so confident in its figures whether we're willing to cap the costs. And then Cataline Habsler is saying, how can we ensure that member states calculate fees and so on in a separate way? And how can we prioritize which facilities to upgrade for us given that they're competing regulatory, environmental and financial pressures? A lot of questions. Thank you so much. And I know we don't have time for them all because I want to get a final round from everyone here. Just on the very broad question, like what would the successful implementation of the directive look like from your perspective and what do you predict will be next to happen. And I'll get each of you to do that for me. Successful implementation would look like indeed there is transparent sharing of data. Presentation of costs that are fair, pretty comparable across member states, on which we are again also legally obliged to keep a very strong eye because it's about internal market functioning of course. The directive has not required the decommission to come up with a capping of the data. So we would a capping of the costs as such, but it's true that we have come up with pretty clear figures in our input assessment, which so far, have not found arguments that really dispute them very much. We are talking about a risk of increase of price performance futiles in the range of two comma five, maybe three euros in 2045. This is representing less than zero comma five percent of the annual average spending that we all go through when we buy our pharmaceuticals. So we don't think that there are major reasons to risk, neither the affordability nor the facing out of pharmaceutical production that none of us wants. But in an event, the successful implementation would look like we continue having a very clear dialogue. The prices are brought forward. The agreements are stipulated, the commission plays its role as guardian of the treaty securing a very sound implementation on the ground and the trajectory for the modernization of this indispensable infrastructure for the business of our economy continues. Thomas Lough. Thank you. I will also say that medicines are indispensable and also the fact that again, there is no consensus on what the actual impact an increasing prices would be. That is the whole point because not everybody would agree that this would be two to three years, etc. So I think that so ought to be the success. To achieve the objectives of the directive that we all share, so to have cleaner water that the polluter pays, but without jeopardizing medicine supply in Europe. I think that's the most important thing. And also that also means without jeopardizing public health. And again, we believe that we need more data to be sure of that. We always need more data. We always come to that conclusion on these panels. Oliver, your expectations or your aspirations please? No, it would be fantastic if you managed to fulfill all the requirements by the final deadline. So this would be my dream really that the directive is extremely ambitious, but also as Veronica has pointed out, it's essential to guarantee Europe's water resilience. And we have a road to play really for the European economy to keep it going. We need our services also to be effective. It will require, and this was pointed out also, cooperation. And he really would like to put the focus on that word, cooperation between all the sectors. We had good contacts with FBN, very grateful also for your openness. We need cooperation at the national level, between national governments, regional governments, local governments and wastewater treatment plans because the directive addresses different levels. So we all need to work together. We need clear governance structures, clear reporting structures, but also stable long-term financing. So we need stability to plan the investments. And without this, the directive will fail. So really, bringing this about would be for me the biggest dream really. Veronica, you take away what you want to leave our audience with. Well, Manchester has said, perhaps in George, EPR is a clear governance structure and a tool and a solution-oriented approach to develop it together. I think already in this discussion there were many options, how this could work from brisk base to flexibility and to common approach on how you look at pollution. And Natalie, finally, you've supported today's event. And I think it's been a particularly frank conversation. I agree. I hope that's not just for some Patrick's, but it's also in terms of environment. I think just a 30,000 feet objective. So the goal would be fair and effective environmental legislation that is science-based. If we achieve that, then I'm absolutely sure we can have continued access to medicines for Europeans, support for the health sector and a better environment. The ingredients are pretty simple. It's just that we need to tick all the boxes of fair, effective and based on science, I think. Thank you. Well, thank you all very much indeed. Thank you to FPR for supporting today. And of course, the entire ERACTive team for putting together today's discussion and for you, the audience, both here in the room and those joining us online for your fascinating questions and your interest. But that is it. We have run out of time for today. So thank you for joining this ERACTive Hybrid Conference and do keep an eye out for future discussions. I'm sure we'll be of plenty more to debate on this topic for the future, but that's it. For now, have a great evening. [Music] [Music]