Committee on Legal Affairs Ordinary Meeting
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JURI European Parliament
Follow its sittings
Valdis Dombrovskis
Our next steps will enhance transparency, stakeholder engagement and efficiency. A broader range of legislative initiatives will be accompanied by more pertinent impact assessments with a focus on cost-benefit analysis. We are also setting out a more thorough pathway for urgent initiatives to help ensure timely delivery underpinned by robust analysis. The goal is that even urgent initiatives are accompanied by impact assessments wherever it is possible.
The Regulatory Scrutiny Board will therefore perform its quality control in connection of a wider range of initiatives. This extension of the role of the board will be accompanied by a more effective review framework. Responding to the European Ombudsman's recommendations and stakeholder concerns, the Commission will assess the time sensitivity of each situation and possible detrimental consequences of delayed action to distinguish urgency from routine expediency. The urgency assessment and all derogations will be duly documented, recorded in a transparent manner and reported in the explanatory memoranda of the proposals.
In addition, our consultation system will become smarter and more flexible through optimized timelines and coordination. We will account for main holiday periods and avoid over-consultation while seeking diverse views and inputs. At the same time, these strengthened better regulation principles will not achieve their goals if they only apply to the Commission.
It is essential that the Council and Parliament engage with the Commission to develop and implement a common methodology so that each institution assesses its substantial amendments during the legislative process. So I hope to hear today also your perspectives on this and on how we could work together to make better regulation principles a reality across the whole legislative cycle. Otherwise, it will remain inefficient and incomplete. Under the third heading of the communication, we are launching a new bold action plan to bring more order into existing and large stock of EU legislation. The action plan on regulatory deep cleaning will tackle fragmented rules and reduce complexity across 12 key areas in 2026 and 2027.
It will lead to legislative and other measures that reduce burdens and improve coherence. This includes consolidating areas of law that are characterized by high regulatory fragmentation. Take public procurement where dozens of EU rules set substantive and procedural requirements. Our deep cleaning will streamline these rules, making implementation easier for administrations and contractors. Other examples are the simplification of banking rules, the ongoing digital fitness check and forthcoming housing simplification package.
These efforts will be supported by the new high-level stakeholder group, the simplification platform, which representatives from various sectors including civil society and small companies. The group will make suggestions on how EU rules and their implementation can be made simpler and easier to apply for the public, businesses and administrations, keeping track of progress and emerging needs. Fourthly, we are tackling the issue of regulatory gold-plating. This is where member states add stricter or wider rules than required by the EU law, thereby creating barriers, increasing costs and fragmenting the single market.
We will support the member states in their commitment to avoid gold-plating by providing best practices and transposition guidance. This includes better detection of instances of gold-plating and follow-up through tools such as the Single Market Enforcement Taskforce and the European Semester. Moreover, in instances of unlawful gold-plating, we will step up our enforcement too. And this brings me to the last point: the Commission has committed to faster and more robust enforcement of EU law. Even the best rules fail to have the intended impact when implementation is fragmented, delayed, or inconsistent across member states.
Credible and efficient enforcement is a backstop needed to achieve compliance with EU rules when support measures are unsuccessful. The Commission sets out a revamped enforcement approach based on faster procedures, more automatism, higher dissuasive penalties, and a focus on reducing long-standing cases across all areas of EU law. In addition, we have identified eleven focus areas for enforcement in relation to the Single Market. Resolving identified issues will remove barriers to the free movement of goods and services and freedom of establishment of businesses.
To conclude, honorable members, in today's unpredictable and challenging world, Europe must play to its strengths and sharpen its competitive edge. That is the only way that we can safeguard our long-term prosperity and security. And our rules have a crucial role to play in creating the conditions for supporting a highly competitive, innovative and sustainable social market economy. Since taking office, this Commission has delivered an unprecedented effort to simplify EU rules, including by proposing 10 omnibus packages and with more than half of the initiatives in our work program having a strong simplification dimension.
And actually, tomorrow we'll be presenting two further omnibuses. The changes outlined in this communication are another important step towards making our rules deliver the best possible results in a most efficient manner. We now call on the Council and the Parliament to also follow through and embrace these principles in practice. So I look forward to continuing working with you to deliver on these actions and the wider simplification agenda. Thank you.
Ilhan Kyuchyuk
Thank you, dear Commissioner Dombrovskis, for your presentation. I'll start with the coordinators or their representatives, and first will be Marion Walsmann.
Marion Walsmann
Sehr geehrter Herr Kommissar, ich spreche Deutsch.
Vielen Dank für Ihr Dasein und für Ihren Bericht. Ich habe zwei Fragen für unseren Austausch. Die Kommission erwägt, in Binnenmarktfragen gegebenenfalls häufiger auf unmittelbar geltende und vollharmonisierende Verordnungen anstatt auf Richtlinien zurückzugreifen.
Nach welchen Kriterien wird sie künftig entscheiden, wann eine vollständige Harmonisierung erforderlich ist und in welchen Bereichen des Binnenmarktes sieht sie derzeit das größte Potenzial, durch einheitliche europäische Regeln nationale Abweichungen zu beseitigen und gleiche Wettbewerbsbedingungen für Unternehmen zu schaffen? Und zweitens: Die Mitgliedstaaten können ja bereits heute anzeigen, wann ihre nationalen Umsetzungsmaßnahmen über die Anforderungen des EU-Rechts hinausgehen. Sie nutzen diese Möglichkeit nach Aussage der Kommission jedoch leider kaum.
Wird die Kommission deshalb eine verbindliche und transparente Meldepflicht für Gold-Plating einführen, durch die Unternehmen eindeutig erkennen können, welche Belastung aus dem EU-Recht und welche aus zusätzlichen nationalen Entscheidungen resultieren? Herzlichen Dank.
Ton Diepeveen
Thank you chair. I speak in Dutch. Voorzitter, commissaris. Commissaris, in uw paper zegt u dat gold-plating, ik heb u daarnet ook over gehoord, door de lidstaten, dat u dat wel gaat aanpakken. En dat is de praktijk dus waarbij lidstaten nationale koppen zetten op Europese regels.
En dat kan inderdaad leiden tot versnippering en ongelijke toepassing van Europese regels met gevolgen voor de competitiviteit van de Europese Unie. Anderzijds betekent gold-plating wel dat lidstaten gebruik maken van hun gedeelde en exclusieve nationale bevoegdheden om Europese regels aan te passen aan de democratische verwachtingen van het betreffende land waar het speelt. Mijn vraag is daarom de volgende aan u. Zal de Commissie lidstaten sanctioneren wanneer zij binnen hun bevoegdheden strengere regels invoeren, ook wanneer het gaat om bijvoorbeeld meer transparantie, betere rapportering of een sterkere betrokkenheid van sociale partners? Verder wilt u ook snellere inbreukprocedures opstarten tegen lidstaten.
Dat heb ik u net zojuist ook over gehoord. En we zien echter dat de meeste lidstaten de DORA-verordening over cyberveiligheid niet hebben omgezet. De Commissie voorziet in de digitale omnibus in een versoepeling juist van die DORA. Hierdoor lijkt het alsof de lidstaten die DORA wel tijdig hebben omgezet in hun nationale wetgeving en dus die hebben eigenlijk gegoldplated en de slechte leerlingen worden beloond. Hoe kijkt u daar zelf tegenaan?
Dan nog een laatste vraag. Handhaving vindt u belangrijk, vind ik zelf ook belangrijk, vinden wij belangrijk. Maar hoeveel formatieplaatsen, hoeveel mensen hebben we daarvoor nodig voor een goede handhaving?
En zijn we daar al mee op orde? En als we daar nog niet op orde zijn, wat gaat dat financieel eigenlijk betekenen voor de commissie? Ik dank u wel tot zover.
Mario Mantovani
Sì, grazie presidente. Sempre un piacere averla qui, commissario Dombrovskis, tenuto conto che le deleghe da lei attuate sono di grande interesse per la nostra commissione. E devo dire che la sua comunicazione riconosce problemi reali.
L'eccessiva densità, la complessità, la frammentazione delle norme europee. Ecco, servono semplicità, regole più snelle e una pulizia profonda delle leggi europee. Questa sua comunicazione è un segno che gli equilibri politici europei però sono cambiati e questo ci fa piacere. Solo nello scorso mandato sarebbe stato difficile assistere al dibattito di oggi. L'Europa si è finalmente resa conto degli eccessi del passato e spero li corregga presto.
Due osservazioni alla sua alla sua presentazione.
La prima è di metodo. Guardo l'ampiezza dei temi proposti, tutte le tematiche orizzontali, l'ambiente, i trasporti, l'energia, però mi colpisce che non sia stata individuata una categoria autonoma come la piccola e media impresa, soprattutto perché le microimprese, citate una sola volta nella sua relazione, pure sono il 90% delle imprese europee.
Nei loro confronti non si tratta solo di applicare più semplicità e una pulizia normativa, si tratta anche di garantire una serie di tutele. Un esempio: da una parte Omnibus I ha tolto un insieme di adempimenti informativi, ma dall'altra gli stessi obblighi sono richiesti loro dalla normativa prudenziale delle banche. E non crede che le piccole imprese meritino un'azione a parte, misurabile anche in termini di risultati? Concludo: lei parla di inasprire l'enforcement, ma l'enforcement e il miglioramento della legislazione devono andare insieme, non correre su due binari separati.
Quanto durerà il cantiere complessivo della better regulation e quali sono le garanzie che arrivi davvero al risultato senza che l'attività di enforcement risulti inutilmente afflittiva? Grazie presidente.
Dainius Žalimas
Thank you chair. I would like first of all to thank you commissioner for coming here and presenting the communication on a simpler, clearer and better enforced EU rulebook.
I agree with my colleagues that for both citizens and businesses, complex and difficult to navigate regulation remains one of the major challenges in the European Union. Equally, a fragmented implementation and enforcement of EU law continue to create barriers in the single market and limits Europe's growth potential. It is therefore essential that this simplification agenda and the broader effort to modernize how EU laws are designed, implemented, and enforced becomes more than a box-ticking exercise and is firmly grounded in evidence-based policy making and lessons learned from the past experience. I have two questions. First, successive better regulation initiatives have sought to reduce regulatory burdens and improve the quality of EU legislation.
At the same time, concerns persist regarding the growing volume and complexity of the EU acquis. Has the Commission assessed the extent to which previous simplification and burden reduction measures have contributed to addressing these concerns, and what lessons from that assessment have informed the present communication?
And the second, the communication announces, and you mentioned, a major regulatory deep cleaning exercise covering 12 policy areas, but provides few concrete criteria for measuring success. Could you explain what objective methodology will be used to identify legislation for simplification, amendment, or repeal, and how the European Parliament will be able to scrutinize those decisions throughout the process? Thank you.
Ilhan Kyuchyuk
Thank you. The next is Jörgen Warborn, our standing rapporteur for better law-making.
Jörgen Warborn
Thank you, Chair, and thank you, Commissioner. First of all, congratulations on a good path forward when it comes to the simplification agenda.
I think the Commission is on the right track here. I mean, first of all, because we know that competitiveness is one of the problems in Europe and simplification is one of the solutions, not the entire solution, but one of the solutions. And that this is addressed by the Commission is very important. SMEs are, there is a huge potential for SMEs. That's why I'd like to ask you about the think small first principle.
Because I have the feeling that we speak about the think first small principle, but that we actually do not work according to it. That we rather shape the legislation for big corporations and then we make exceptions for the small ones. And I think we could do the other way around. And I'd like to have your, pick your brain on this and see if we can change, change it a bit.
Then, next issue is administrative burden versus regulatory burden. Because for businesses as a whole, it's the cost that matters. We have to cut the cost for businesses. And I think sometimes we focus too much or only on the administrative burden, and it's the entire regulatory burden that is affecting the, the amount of cost. So, are you focused on the entire cost or only on the administrative burden?
Then, um, I don't know how to follow the one-in-one-out principle. I know with the omnibuses you have the goal of achieving 37.5 billion euros in in cost reduction, but there are of course some legislations that put that adds to that cost. Could you give me a sense of where we're heading in in the net cost and how much we add and how much we actually aim for deduct?
Finally, I couldn't agree more. I think when it comes to impact assessment, they are very important and I'd like to look at myself and my colleagues in the Parliament, we have a big role to play here. I've tried sometimes to have impact assessment on on big amendments and haven't really achieved a majority for it and I think we have to work on that to be honestly in the in the Parliament as well and see see what we do. Finally, all the commissioners have in their mission letters that they should work on the simplification agenda and you are coordinating this. How is that coordination going?
How are you dealing with the other commissioners and are all of them equally good or equally bad or what is your next step in order to step up the game? Thank you.
Angelika Niebler
Thank you so much, Mr. Chairman.
I'm going to talk into my mother language in German. Ja, vielen Dank erstmal, Herr Kommissar, dass Sie heute hierher gekommen sind und uns Ihr Rulebook vorgestellt haben. Ich begrüße das außerordentlich und kann mich den Kollegen nur anschließen, die sagen, es ist gut, dass wir auf der Simplifizierungsagenda einfach weiterarbeiten. Und die letzte Frage vom Kollegen Warborn finde ich auch super. Haben Sie denn eine Hitliste?
Wer sind denn die Top-Simplifier bei Ihnen in der Kommission? Also würde mich interessieren, ob es da so ein Ranking oder sowas gibt. Aber ich habe zwei Anmerkungen und ich habe zwei Fragen noch mal. Die erste Anmerkung, auch da kann ich Bezug nehmen auf das, was Kollegen schon gesagt haben.
Ich glaube, das größte Komplex ist die bei unserer ganzen Regulatorik ist die Komplexität, ist vor allen Dingen auch die Detailverliebtheit. Bis ins kleinste Detail wird alles hier durchdekliniert und durchreguliert und auch dieser das Fehlen von einem kohärenten Ansatz. Also und das merke ich auch, wenn wir an den Omnibussen arbeiten. Also mein Eindruck ist, mir geht's immer so, wie wenn ich auf dem Tennisplatz stehe und ich returniere einen Ball und dann kommen aus der Ballmaschine wieder zehn Bälle auf mich zu. Und so ein bisschen habe ich den Eindruck auch, dass nach wie vor viele, viele Vorschläge kommen, die das, was man mühsam, sage ich mal, abgebaut hat an an Regulatorik, dann hier wieder hochgefahren wird.
Und da müssen wir ran und da hoffe ich, dass eben auch Ihr Rulebook da jetzt einiges erleichtert. Die zweite Anmerkung, die ich machen möchte, ist noch mal zu dem Thema Better Enforcement, weil ich glaube, das ist wirklich Kern, ja, eine realistische Umsetzung. Wir haben jetzt mehrere legislative Vorschläge ja auf dem Tisch gehabt, wo wir als Parlament gesagt haben: Stop the clock. Also Beispiel die Entwaldungsverordnung, die haben wir einfach jetzt hier ausgesetzt. Warum? Weil die Kommission selbst nicht fertig war, die nicht so umgesetzt wurde, dass man operativ damit arbeiten kann.
Und deshalb begrüße ich alle die Vorschläge, die eine realistische Umsetzung hier auch im Auge haben. Und ich kann Sie nur ermuntern, auch in diesem Sinne hier weiter aktiv zu sein. Meine zwei Fragen sind relativ kurz.
Sie sagen, wir machen einen Reality Check. Finde ich super, Reality Check. Also wie funktioniert unsere Gesetzgebung in der Praxis? Ich mache das, indem ich in die Firmen gehe und schaue, wie sie klarkommen mit ihren legislativen, mit unseren legislativen Vorgaben. Aber wie macht's denn die Kommission?
Also da wäre ich noch mal interessiert zu wissen, in der Praxis. Schicken Sie dann Ihre Beamten hin, die auch mal irgendwie das eruieren, oder geht's nur mit Antwortfragebogen oder so? Also wie machen Sie das in der Praxis? Und im Anschluss an die Frage der Kollegin Marion Walsmann, auch beim Goldplating, glaube ich, ist wirklich noch Nachholbedarf.
Und auch da die Frage: Wie läuft's denn in der Praxis? Also wie verhindern Sie denn, dass dann alle Mitgliedstaaten da wieder noch ein bisschen was drauf satteln auf jeden einzelnen Gesetzgebungsvorschlag und wir in der Folge dann wieder nicht diesen Binnenmarkt haben, den wir eigentlich alle wünschen und den wir Europäer so dringend brauchen? Vielen Dank.
Ilhan Kyuchyuk
Thank you, Angelika Niebler. That was it from the members, dear Commissioner. And I would like to give you back the floor for your answers.
Valdis Dombrovskis
Yes, thank you, Chair, colleagues. Okay, so on the first set of questions for this full harmonization.
Indeed, so that's what we are intending to do. That for legislation which concerns the single market, to the extent possible, we will be proposing full harmonization, so regulations as opposed to directives or maximum harmonization as opposed to minimum harmonization, exactly to avoid the fragmentation in the single market.
So that's clearly indicated. Then on this question, quite a few asked you questions on this gold plating, how we are going to detect it, how we are going to deal with this. So basically, in a sense, we will work in three directions: better detection, follow-up, and prevention. So first, to improve detection, we will use the consultations which we have, including implementation dialogues at the commissioner level and reality checks. I'll come back to reality checks a bit later.
We'll also obtain information from enforcement investigations in a focus, in the context of single market focus areas for enforcement. And Commission will flag potential gold-plating risks to member states early on, so during the transposition period when member states are preparing the transposition of a directive. And to improve the follow-up, we'll be using single market enforcement task force and European Semester. And to improve prevention, we are developing a toolkit with criteria to help member states identify and avoid gold-plating in the national transposition and implementation of EU legislation. Then there was a question on possible sanctions on gold-plating.
Of course, our enforcement action infringements are there in the breach of EU law. So if this gold-plating amounts to the breach of EU law, then we can follow up with enforcement action and what we indicate in this communication that that is our intention to do so. Because the problem with the gold-plating is that if each member state start adding things to the EU requirements and does so in kind of inconsistent and uncoordinated way, then we have 27 different shades of gold-plating and those are all at the end of the day single market barriers.
It fragments the single market, and then if we want to use the full potential of single market, again we are just hitting barrier after barrier.
So that's why there is this focus on single market as such and also addressing the question of gold plating with very much of this single market considerations in in mind. Then well in terms of well this what what implications in terms of availability of resources it it has for a commission this strong enforcement. Well we are not now expecting you know massive new kind of financial or personnel requirements in this regard if we go for a faster more streamlined procedures that probably does not require more personnel just that we are spending less time on on individual procedures.
So we describe in our communication also quite a bit where do we intend to streamline and fasten up the procedures for enforcement. Then the question of simplification for SMEs. Well, that's obviously very high on our agenda. That's why when we set our overall administrative burden reduction target of 25%, we set a 35% reduction target for SMEs because we know that for SMEs that is a major concern.
So if we look at like business surveys, majority of entrepreneurs are saying that excessive administrative burden is an issue for growth and investment in the EU, and majority of SMEs are saying that that is their biggest burden. So really we have to take it very seriously and that's why we have this focus on SMEs a lot in this regard.
Then there was a question, okay, on this simplification, how do we make sure that we do better than in previous attempts, because indeed that's not the first time we are undertaking certain simplification or better regulation initiatives and so to say results had been limited so far. Well, and also from from the practice which I'm seeing now, what I can what I can say in this, that that requires sustained political action and top-down approach.
So to say, we cannot expect bureaucracy to reduce itself, it requires in a sense top-down steer. And but also I would say the situation which forces us to act now is different than maybe it was previously because indeed we have this accumulation of rules with current more complicated and more conflictual geopolitical situation with also emerging economies in a sense seeking a greater role in both global geopolitics and economics. Our competitiveness and productivity issues are becoming more apparent, our productivity growth already for two decades is lagging behind other major economies. So the need to act is also more apparent.
So that's why I think it will be easier to sustain this top-down political push on this simplification agenda. And that we also came with a kind of clear quantitative targets which are measurable so one can assess whether we were successful in delivering on our simplification agenda or let somehow, you know, this momentum expire somewhere. So that's maybe on on on this.
Well, on this question of regulatory deep cleaning, indeed, so we identified the priority areas for regulatory deep cleaning. So how we'll identify issues to simplify again through all of our consultation tools, through consultations with stakeholders, through implementation dialogues, through reality checks, also through, for example, when we discuss single market barriers, through systematic issues which are also appearing through the SOLVIT platform and and so on and so forth.
So I think generally speaking we are not short of inputs to see where the focus areas should should be. And obviously if it leads to legislative proposal, as a co-legislator European Parliament is fully involved in in co-deciding then on how those specific initiatives go.
Well, um, on applying the think small first principle and maybe also on on some other elements as having maybe coming to other colleagues' questions, too many proposals or in terms of in context of enforcement, also making sure that we set from the beginning realistic transposition and implementation deadlines that we do not run into issues in this regard and so on. On all of this, I would say the proof of the pudding will be in the eating. We have a good communication. Well, I'm in charge of this communication, it's my duty to say so, but objectively I think it is a good communication, yeah.
There are many good intentions, many good points, but of course now we must follow through. And that also requires discipline and attention. And it's also my task to coordinate this work in the Commission because of course often we see that, you know, we want to have a proposal in this area, that area, that area, that area. Oh, and then we want to move it faster and then we cut corners on our better regulation processes. Well, that requires, so to say, discipline and again sustained pressure to make sure that we are following through on all of this.
Because indeed, the intentions there are very laudable and it's important that we actually deliver on this. But that obviously brings some of you, brought this point also me back to this question on applying those principles throughout the legislative process. Because what matters for citizens and businesses is not what the Commission proposes, but what comes out of the legislative process. And that brings us back to the topics of applying those principles in the legislative process, impact assessing substantial amendments. We are kind of trying to actively engage on this already since the beginning of this mandate to make sure that co-legislators are following it through.
So that's better lawmaking, it's not something just Commission can make, that's a joint responsibility of the Commission and co-legislators. So then on this question on measuring administrative burden versus regulatory burden or compliance costs. Well, yes, we are focusing primarily on administrative burden. Obviously there are also compliance costs in terms of if we take some new rules, it may require investments from businesses to to adjust, to develop new processes.
If we think, for example, of our Green Deal targets, obviously they require massive investments. So, and there are also estimates on those investments needed. But the question is then whether we then are not doing it because it requires substantial investment. So that's why the compliance cost is obviously an issue. And as I was mentioning that we also in new legislative proposals also intend to look at this cost-benefit analysis.
But for kind of this regulatory simplification, we are focusing on administrative burden. And then, well, what in a sense we committed to do, you asked about this 37.5 billion euros figure, that is a net figure. That should be the net reduction of administrative cost at the end of this mandate. So that's what what the intention is. So, okay, how does it work proceeds in a commission?
Are all commissioners equally good or so?
Well, we are all different and also therefore, you know, those discussions with different colleagues are different, but it's a clear commitment and something which is clearly in a mission letter of each member of the Commission. So each colleague has to deliver on this and we are working to make sure that this is happening.
Then there was a question on on how those reality checks work in reality. Well, reality checks is more indeed like a technical level exercise, which is with our experts in specific policy areas and experts from relevant sectors of economy or from relevant national parts of national administration to see indeed how the rules are being implemented in practice by those people who are actually implementing them in practice and to get the direct feedback from from them. So we actually drove quite heavily on on the German experience of so-called Praxis-Checks, so I'm sure you are familiar with this, so that's more or less the model we are trying to use here.
But then of course we have also our implementation dialogues which are at the political level, at so to say connect the technical level with the political level. So those are different consultation tools serving slightly different purposes or using somewhat different methods but at the end of the day contributing to the same simplification and better regulation agenda. Thank you.
Ilhan Kyuchyuk
Thank you, dear Commissioner. We have still some time for follow-up questions if there are some. Okay, please, Mr. Warborn.
Jörgen Warborn
Well, thank you very much, Commissioner, for your answers.
You are working with the one-in, one-out principle and have been doing so since I think it is 2022. And there is this annual burden survey, or maybe you call it something else, I think, but the survey checking how we are doing with the one-in and one-out.
And I know since we argued or had a debate last week in the plenary that the 37.5 billion reduction in administrative costs, it's much more than one-in, one-out, of course. We have been calling as a Parliament for the one-in, two-out principle, meaning that for every euro you add in cost, you deduct two, and preferably that would be used on regulatory burden, not administrative burden. And I think there is good reasons for having this principle since it puts some kind of a healthy constraint on adding new cost, and since the Commission are on the pathway to deducting it, I cannot really understand, and as you said in plenary last week, even more than the one-in, two-out.
So why couldn't we have an agreement that we should start working with this since you're overachieving already? Because if we set this principle for a long term, I'm sure it will continue to reduce the cost, it will continue to increase the competitiveness. And it's good if we even could have it in agreement between the Parliament and the Commission for a long-term principle. And I know that several member states in the European Union and in the OECD, they even have one-in-three-out. So with a majority decision, the Parliament had one-in-two-out, why are you holding back?
Ilhan Kyuchyuk
Thank you. Any other colleague wishing to speak?
That is not the case, so Commissioner, back to you.
Valdis Dombrovskis
Yes, thank you for those questions. Yeah, so how those different elements interact and so.
Okay, so one in one out is basically going forward and the net result of one in one out should be kind of a stable level of administrative burden. With this simplification agenda and 25% reduction target, well, the aim is to reduce the administrative burden by 25% or 37.5 billion euros. So that's already going below obviously one in one out, which should stay keep the administrative burden stable and it's as a result more ambitious as one in two out, but it's a different way of measuring things. So we said we want achieve 25% reduction of the burden and set this as a goal and that's how we measure.
One-in-two-out would be a different goal and different way to measure. But both going the same direction. But well, what we are arguing is that this 25% target is more ambitious than what one-in-two-out principle would deliver. Okay, probably now not able to enter into detailed methodological discussions on regulatory versus administrative burden. So the distinction we more frequently use is well, administrative burden and also overall compliance costs.
With compliance costs including also the investments which companies in different sectors of economy need to make in order to comply with the regulation. Okay, whether we can apply compliance cost one-in-two-out or 25% reduction of compliance cost realistically, I think that's a big question mark. Just for a sake of argument, take those Green Deal targets which we all agreed and by and large are not questioning.
So climate neutrality by 2050, we have 2030 targets, 2040 targets in between. All this requires massive investment. How do we do now one-in-two-out with this investment? We cannot really annul the investment which is needed to achieve the decarbonization if we want to achieve the goals of decarbonization.
We can reduce administrative burdens related to this, but this investment still needs to be done. So I agree with you that this investment needs to be measured and we need to be clear on cost-benefit analysis, how much it costs, what we achieve with this. But it would be difficult now to ensure, so to say, ever less investment to comply with our ever more ambitious Green Deal targets. So there I think that requires some, you know, thinking and reflection and probably the direction to look there is more on this cost-benefit analysis.
How much it costs in terms of overall compliance burden or, okay, I would not now compare it methodologically with what you call regulatory burden, and what exactly we are achieving in a kind of a broader societal goods. Thank you.
Ilhan Kyuchyuk
Thank you very much, dear Commissioner, for your presence and also for this very open exchange, and we look forward to continue our good cooperation with you. Thank you, Valdis.
Okay, dear colleagues, the next item on our agenda is establishing a framework of measures for strengthening EU's biotechnology and biomanufacturing sectors, particularly in their health and amending several regulation, and this is well known as European Biotech Act.
And the rapporteur is Mr. Timo Wölken. Due to family obligations, Timo is not able to be here today and has asked me to speak on his behalf regarding the Biotech Act. As already mentioned during the presentation of the regulation, the rapporteur appreciates Commission's proposal.
However, in his draft report, the rapporteur has particularly scrutinized the Commission's proposals to extend the supplementary protection certificate by 12 months for medical products developed using biotechnology processes and advanced therapy medical products. Based on Commission staff working document, this proposal could have consequences for patients, and namely, and I'm quoting, "a fall in the number of patients treated accompanied by increase in spending", end of quote.
New quote, fewer available treatment options and delayed expansions of supply patients, end of quote, as well, a new quote, an increase spending, and end of quote for national healthcare budgets. Considering that the Commission has not provided a proper impact assessment and that no alternative measures have been sufficiently explored, the rapporteur has deleted this patent extension, also taking into account the recently finalized revision of the pharmaceutical package.
As the Biotech Act is also intended to strengthen Union's strategic autonomy while increasing production capability within the EU in line with the objectives of the critical medicines act to ramp up production within the EU, the rapporteur proposes extending stockpiling waiver for biosimilar medicines. This would allow EU produced biosimilars to be distributed within the EU on day one after patent expires and during that they can be used by European patients rather than only being exported to third countries.
Moreover, JURI is responsible for addressing the intersection of artificial intelligence and ethics while artificial intelligence is a rapidly evolving technology with the potential to contribute to economic, environmental and social progress across various sectors. Its deployment, particularly in healthcare, raises significant ethical concerns that must be carefully addressed. The potential benefits of artificial intelligence in healthcare, such as improved diagnostic accuracy, optimized treatment plans and personalized care, are undeniable.
However, these benefits must be balanced against the associated risks, including algorithmic bias, lack of transparency, and potential reduction of human oversight in critical decision-making processes. Without robust ethical safeguards, artificial intelligence systems could exacerbate inequalities, undermine patient autonomy, or result in harmful outcomes due to errors or biases in data and system design. In this regard, and in line with previous reports, the rapporteur has further strengthened the provisions within the Biotech Act by ensuring the rigorous implementation of ethical rules, which are of paramount importance in the healthcare sector.
The deadline for amendments is 25th of June. The rapporteur looks forward to the amendments tabled by the members in order to work towards a balanced compromise. That was on behalf of our rapporteur Tiemo Wölken, and now I open the floor for the shadow rapporteurs, starting with the replacement of ECR shadow rapporteur Mr. Mantovani for ECR.
Mario Mantovani
Sì, grazie presidente. Ma dunque, il Biotech Act è un dossier che noi consideriamo certamente strategico.
E la proposta della Commissione è un buon testo e lo accogliamo con favore. Semplificazione, riduzione dei tempi, progetti strategici e attenzione alle PMI. Sulla relazione invece ho qualche perplessità. La soppressione della proroga del certificato protettivo complementare è sbagliata. È un incentivo selettivo, meritocratico, a costo zero per i bilanci pubblici e agganciato alla produzione in Europa.
Stiamo vedendo gli effetti che ha in Europa la clausola Most Favored Nation americana ed eliminare la proroga sarebbe un segnale sbagliato proprio a chi investe. Se il nostro obiettivo è mantenere un'Europa e attrarre nuovi capitali, dovremmo pensare di estenderlo di 24 mesi e non di 12.
E vorrei migliorare ulteriormente la proposta della Commissione, renderla più favorevole alle piccole e medie imprese, alle startup, alle microimprese, estendendo l'accesso prioritario ai regulatory sandbox, rendere lo sportello dedicato una garanzia e non un'eventualità, introdurre esenzioni tariffarie per micro e piccole imprese, garantiamo un accesso facilitato agli appalti pubblici, fissiamo un termine alla decisione della Commissione sul riconoscimento, introduciamo il principio una tantum e rafforziamo il digitale predefinito. Sull'accesso ai capitali dobbiamo essere pratici. Purtroppo non saranno i progetti pilota a risolverlo. Serve un Nasdaq europeo e serve subito. Grazie.
Speaker 12
Thank you very much. Can I give you the floor, Mr. Snaitham, as shadow for EPP?
Lukas Mandl
Thank you very much. Sorry for just rushing in. The committee is faster than the schedule.
Lukas Mandl
JURI will be the committee for Formula 1. Europe is facing increased competition from the United States and China in biotechnology, one of the most strategic sectors of the future. If we want innovative companies, investment, and highly skilled jobs to remain in Europe, we need a framework that rewards innovation and provides long-term certainty. This is exactly why SPCs exist.
Biotechnology companies often spend more than a decade navigating clinical trials and regulatory approvals before a product reaches patients. During that time, a significant part of their patent protection is already lost. An SPC extension helps compensate for this reality, particularly for advanced therapies and innovative biotechnology products that require long development timelines and substantial investment. Strong intellectual property rights remain one of the key drivers of innovation. They help attract capital, support research and development, and ensure that Europe remains an attractive place to develop and manufacture breakthrough technologies.
For this reason, removing the SPC extension from the Biotech Act would be a mistake. Even more, deleting the SPC provisions entirely would send the wrong signal at the wrong time. At the same time, we must avoid measures that unintentionally weaken the incentives for innovation.
The current SPC manufacturing waiver already provides a balanced solution by allowing manufacturers to prepare for immediate market entry after expiry through a six-month stockpiling period. Europe needs to stay an attractive location for cutting-edge biotechnology research and development, as well as maintain investor confidence. At a moment when Europe is trying to strengthen its competitiveness and retain innovative companies, weakening intellectual property protection would undermine investor confidence and risk pushing future investment towards competing regions. Ultimately, the question is simple: do we want the next generation of breakthrough therapies to be developed and commercialized in Europe or somewhere else? Maintaining the SPC extension is an important step towards ensuring that Europe remains a global leader in biotechnology innovation and patient access to cutting-edge treatments.
Ilhan Kyuchyuk
Thank you, Lukas Mandl. Now I would like to give the floor to Renew shadow Dainius Žalimas.
Dainius Žalimas
Thank you, thank you, Chair. Indeed, biotechnology is becoming increasingly important for Europe's competitiveness and therefore I would like to thank the rapporteur for many strong and constructive proposals already included in the draft opinion. One of the most important issues in this opinion, as well as in the report, is the extension of supplementary protection certificates.
If we want innovative and competitive biotech companies to invest and grow in Europe rather than elsewhere, we need a framework that rewards innovation. Therefore, I support extending the proposed SPC extension period from 12 to 24 months. Beyond this, a key objective is to provide greater legal certainty for innovators. More consistent application of EU law across member states would help reduce regulatory fragmentation and create a more predictable environment for research and innovation.
The protection of intellectual property rights and confidential business information is equally important, as both remain essential for attracting investment and strengthening Europe's competitiveness. Another area that deserves attention is the growing interaction between biotechnology and artificial intelligence, where AI is used in drug discovery, clinical trials, diagnostic or regulatory assessments. Full consistency with the AI Act, together with clear accountability, transparency and traceability requirements, will be important. Clinical trials should also better reflect the needs of women through the appropriate inclusion of female participants where relevant.
Finally, regulatory sandboxes can play a useful role in accelerating innovation, provided that they offer legal certainty, protect intellectual property and confidential business information, and include clear rules on ownership, liability and confidentiality. We will table amendments along these lines and looking forward to working constructively on the opinion. I wish the rapporteur every success as work on this important file progresses. Thank you.
Ilhan Kyuchyuk
Thank you, Mr. Žalimas.
Do other members wish to speak? No, that is not the case. And then I would like to give the floor immediately to the representative of the European Commission. And today we have Cristina Modoran, Ms. Cristina Modoran, Head of Policy Strategy Unit in DG SANTE. You have the floor, ma'am.
Cristina Modoran
Thank you very much. Thank you for the discussion today and for the opinion that was presented and for the views. We take due note of the positions expressed and we are happy to continue the engagement with honorable members as this file progresses.
We do share the sense of urgency and the importance. This is also why the Biotech Act was proposed as a priority at the end of last year. We do agree with the expressed views on the need to address the current challenges that the sector faces in the EU.
From our point of view, we see the biotech regulation proposal not as an isolated initiative, but as part of a bigger legislative package that the Commission has proposed over the last years, including the new pharma legislation, the Critical Medicines Act, and the proposal on medical devices and in vitro diagnostics that was proposed at the same time with the Biotech Act. Because we realize that the challenges are important and we are committed to work together with the co-legislators to address these challenges.
The Commission shares the central objective of creating an enabling framework for biotechnology in Europe with a primary focus on health biotechnology through this proposal, while of course safeguarding the best standards for patients.
We are committed to work together with you to ensure that these objectives are fully delivered in the through this legislation. We take note of the different views on the supplementary protection certificate and of course we understand the need to strike a careful balance between extending and supporting manufacturing and ensuring that we continue to support affordability and access to innovative products throughout the life cycle of a medicine.
What we want to stress is that of course our proposal was carefully tailored to be targeted and to support very innovative biotechnology products that were developed and manufactured in Europe.
So from our point of view, this is by no means an unconditional gift, but it, the extra 12 months that the Commission proposed come with very stringent conditions that aim at re-establishing the positioning of the EU as regards clinical trials, but also as regards manufacturing in view of our strategic autonomy. The Commission has looked very seriously into the broader environment for this sector. We looked both at push and pull incentives, and this element is just one tool among the several tools that we proposed in this initiative.
Of course, we fully concur with the need to ensure that the highest ethical norms are respected. And we are committed to continue to work with you on the various topics that are of particular interest for this house. Thank you very much.
Jörgen Warborn
Yes, if I can have a question to the Commission. And first of all, thank you for the presentation. On the previous point on the agenda, we talked about better regulation and simplification. And the Commissioner explicitly mentioned the importance of having impact assessment, even if there were urgent urgent files.
And this is of course one file that does not have an impact assessment. So it would be interesting to listen to the Commission on why that is. And it was also said that there should be a staff working document. I haven't seen it, I guess it's there. And I'm especially interested in the cost-benefit analysis within the staff working document if you could specify the amount of costs that it adds for businesses and the costs that it deducts.
That would be fantastic. Thank you.
Thank you very much. As I mentioned, last year we were all working under a sense of urgency and we came with a proposal forward in this context of geopolitical pressures and the realization of a need to act as fast as possible.
Cristina Modoran
Then of course we did and published recently a staff working document that looks into the impact of the measures proposed in the regulation. And we do feel that we have provided there very detailed information on the estimated impacts for the proposed measures.
As regards the the concrete question on the on the precise costs, we estimate that the additional year of originator exclusivity delays biosimilar competition resulting in a combined social cost of approximately 205 million euros per qualifying medicine. And this is a range that we estimate at between 140 to 290 million euros, comprising also 135 million euros in delayed patient access value and 70 million euros in direct payer expenditure.
But we are happy to discuss further the numbers and the details that are also regarding our methodology that is used in our staff working document.
Ilhan Kyuchyuk
Thank you very much and thank you for today's discussion. Let me remind you that the deadline for amendments to table amendments is on 25th of June at noon time, so 12:00. That concludes item 21 and now we move to any other business. Looking to my left, to my right, to the center, no any other business, that is not the case. And the next meeting is on 2nd of July, 2nd of July, 9:00 AM Brussels.
Thank you.
Speaker 19
Mesdames et messieurs, petites entre- on va faire une petite- un petit essai, d'accord? Bonjour, j'espère que vous m'en- ah sorry, sorry. I will speak English because you will translate into- into French.
Welcome to this meeting of the European Parliament. I'm really happy to see you on those debates that we are going to have of the committee of the protection of the environment. I know that you are well... Vous n'entendez pas ? Tu es déjà en retard !
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