ORDER OF THE GENERAL COURT (Fourth Chamber)
18 February 2026 (*)
( Actions for annulment – Environment – Urban wastewater treatment – Articles 1, 2, 9, 10 and 30 of, and Annexes I and III to, Directive (EU) 2024/3019 – Extended producer responsibility for medicinal products for human use and cosmetic products – Standing to bring proceedings – Lack of individual concern – Inadmissibility )
In Joined Cases T‑156/25, T‑157/25, T‑159/25 to T‑168/25, T‑170/25 and T‑171/25,
Accord Healthcare France SAS, established in Lille (France),
applicant in Case T‑156/25,
Dermapharm AG, established in Grünwald (Germany),
applicant in Case T‑157/25,
Adamed Pharma S.A., established in Pieńków (Poland),
applicant in Case T‑159/25,
Fresenius Kabi Deutschland GmbH, established in Bad Homburg vor der Höhe (Germany),
Fresenius Kabi Italia Srl (FKI),
established in Verona (Italy),
Fresenius Kabi Polska sp. z o.o., established in Warsaw (Poland),
applicants in Case T‑160/25,
hameln pharma GmbH, established in Hamelin (Germany),
applicant in Case T‑161/25,
Hexal AG, established in Holzkirchen (Germany),
applicant in Case T‑162/25,
Exeltis Healthcare, SL, established in Azuqueca de Henares (Spain),
Medical Valley Invest AB, established in Höllviken (Sweden),
applicants in Case T‑163/25,
Zakłady Farmaceutyczne Polpharma S.A., established in Starogard Gdański (Poland),
applicant in Case T‑164/25,
Puren Pharma GmbH & Co. KG, established in Munich (Germany),
applicant in Case T‑165/25,
E G Labo – Laboratoires Eurogenerics, established in Issy-les-Moulineaux (France),
applicant in Case T‑166/25,
Teva Nederland BV, established in Haarlem (Netherlands),
ratiopharm GmbH, established in Ulm (Germany),
Teva Santé, established in Paris (France),
Teva Pharma, SL, established in Madrid (Spain),
Teva Denmark A/S, established in Søborg (Denmark),
Teva BV, established in Haarlem,
applicants in Case T‑167/25,
Zentiva k.s., established in Prague (Czech Republic),
Zentiva Pharma GmbH, established in Frankfurt am Main (Germany),
Winthrop Arzneimittel GmbH, established in Frankfurt am Main,
Zentiva Italia Srl, established in Milan (Italy),
Zentiva France, established in Paris,
Zentiva SA, established in Bucharest (Romania),
applicants in Case T‑168/25,
represented by T. Voland, U. Reese, M. Petite, P. Leven, L.-I. Dietz, M. Steininger and K. Schroeder-Finckh, lawyers,
BGP Products SRL, established in Bucharest,
Meda OTC AB, established in Stockholm (Sweden),
Mylan Germany GmbH, established in Troisdorf (Germany),
Mylan Ireland Ltd, established in Dublin (Ireland),
Mylan Pharmaceuticals Ltd, established in Dublin,
Viatris Healthcare GmbH, established in Troisdorf,
Viatris Santé, established in Lyon (France),
represented by K. Roox, M. Navin-Jones, C. Dumont, T. Voland, M. Petite, U. Reese, L.-I. Dietz, M. Steininger, K. Schroeder-Finckh and P. Leven, lawyers,
applicants in Case T‑170/25,
Laboratorios Normon, SA, established in Tres Cantos (Spain), represented by T. Voland, U. Reese, M. Petite, P. Leven, L.-I. Dietz, M. Steininger and K. Schroeder-Finckh, lawyers,
applicant in Case T‑171/25,
v
European Parliament, represented by L. Taïeb, W. Kuzmienko and A. Droin, acting as Agents,
and
Council of the European Union, represented by A. Maceroni and O. Segnana, acting as Agents,
defendants,
THE GENERAL COURT (Fourth Chamber),
composed of G. De Baere, President, J. Svenningsen (Rapporteur) and D. Jočienė, Judges,
Registrar: V. Di Bucci,
having regard to the written part of the procedure, in particular the decision of 16 May 2025 joining Cases T‑156/25, T‑157/25, T‑159/25 to T‑168/25, T‑170/25 and T‑171/25 for the purposes of the written part of the procedure, the oral part of the procedure, if any, and the decision which closes the proceedings,
makes the following
Order
1        By their actions under Article 263 TFEU, in Cases T‑156/25, T‑157/25, T‑159/25 to T‑168/25 and T‑171/25, Accord Healthcare France SAS, Dermapharm AG, Adamed Pharma S.A., Fresenius Kabi Deutschland GmbH, Fresenius Kabi Italia Srl (FKI), Fresenius Kabi Polska sp. z o.o., hameln pharma GmbH, Hexal AG, Exeltis Healthcare, SL, Medical Valley Invest AB, Zakłady Farmaceutyczne Polpharma S.A., Puren Pharma GmbH & Co. KG, E G Labo – Laboratoires Eurogenerics, Teva Nederland BV, ratiopharm GmbH, Teva Santé, Teva Pharma, SL, Teva Denmark A/S, Teva BV, Zentiva k.s., Zentiva Pharma GmbH, Winthrop Arzneimittel GmbH, Zentiva Italia Srl, Zentiva France, Zentiva SA and Laboratorios Normon, SA seek, principally, in essence, the annulment of Article 1, Article 2(19), (20) and (26), Articles 9 and 10, and points (c) and (g) of the second subparagraph of Article 30(1) of, and Annex III to, Directive (EU) 2024/3019 of the European Parliament and of the Council of 27 November 2024 concerning urban wastewater treatment (OJ L, 2024/3019), and, in the alternative, the annulment of that directive in its entirety.
2        By their action under Article 263 TFEU, in Case T‑170/25, BGP Products SRL, Meda OTC AB, Mylan Germany GmbH, Mylan Ireland Ltd, Mylan Pharmaceuticals Ltd, Viatris Healthcare GmbH and Viatris Santé seek, principally, the annulment of Article 2(14), (17) and (19) and Articles 9 and 10 of, and Annexes I and III to, Directive 2024/3019, and, in the alternative, the annulment of certain parts of those provisions and annexes.
Background to the dispute
3        The applicants are undertakings
that produce generic medicinal products.
4        Directive 2024/3019 provides for a recast of Council Directive 91/271/EEC of 21 May 1991 concerning urban waste-water treatment (OJ 1991 L 135, p. 40), as amended by Regulation (EC) No 1137/2008 of the European Parliament and of the Council of 22 October 2008 (OJ 2008 L 311, p. 1), by introducing an obligation for Member States to ensure that certain discharges from urban wastewater treatment plants comply with the requirements for quaternary treatment.
5        Quaternary treatment, also established by Directive 2024/3019 and defined in Article 2(14) thereof, is a means of treating urban wastewater by a process taking place after traditional treatment (primary, secondary and tertiary), which reduces a broad spectrum of micropollutants in urban wastewater.
6        Given that quaternary treatment involves additional costs, Directive 2024/3019 relies on the polluter-pays principle in order to cover them.
7        In that regard, recital 20 of Directive 2024/3019 states that pharmaceuticals and cosmetic residues currently represent the main sources of micropollutants found in urban wastewater requiring quaternary treatment.
8        Article 9(1) of Directive 2024/3019 introduces a system of extended producer responsibility (‘the EPR system’) for two categories of products listed in Annex III to that directive, namely medicinal products for human use falling within the scope of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), and cosmetic products falling within the scope of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ 2009 L 342, p. 59).
9        Article 9(2)(a) and (b) of Directive 2024/3019 provides for two exemptions from the EPR system, namely (i) an exemption for producers in respect of which the total quantity of substances contained in products placed on the EU market amounts to small quantities, that is to say, less than one tonne per year, and (ii) an exemption for producers in respect of which the substances contained in the products they place on the market are rapidly biodegradable in wastewater or do not generate micropollutants in wastewater at the end of their life.
10      Article 9(3) of Directive 2024/3019 provides that Member States are to ensure that producers of medicinal products for human use and cosmetic products exercise their extended producer responsibility collectively through an organisation that fulfils the minimum requirements set out in Article 10 of that directive.
11      Article 10 of Directive 2024/3019 lists the minimum requirements for producer responsibility organisations which Member States must lay down.
12      Article 10(5) of that directive provides, specifically, that ‘Member States shall organise regular dialogues on [the] implementation [of the EPR system]’ and ‘shall ensure that those dialogues involve relevant stakeholders and, where relevant, associations of stakeholders involved in the implementation of extended producer responsibility, including producers and distributors, producer responsibility organisations, private or public operators of urban wastewater treatment plants, local authorities and civil society organisations’.
13      Article 30 of Directive 2024/3019 further provides that, by 31 December 2033, and then by 31 December 2040, the European Commission shall carry out an evaluation of that directive based on a number of elements and assess the possibility of adapting the list of products covered by the EPR system.
Forms of order sought
14      In Cases T‑156/25, T‑157/25, T‑159/25 to T‑168/25 and T‑171/25, the applicants claim that the Court should:
–        principally, annul Article 1, in so far as it refers to the implementation of the polluter-pays principle, Article 2(19), (20) and (26), Articles 9 and 10, and points (c) and (g) of the second subparagraph of Article 30(1) of, and Annex III to, Directive 2024/3019;
–        in the alternative, annul those provisions and annexes, in so far as they concern the applicants;
–        in the further alternative, annul Directive 2024/3019 in its entirety, and
–        order the European Parliament and the Council of the European Union to pay the costs.
15      In Case T‑170/25, the applicants claim that the Court should:
–        principally, annul Article 2(14), (17) and (19) and Articles 9 and 10 of, and Table 3 of Part C of Annex I and Annex III to, Directive 2024/3019;
–        in the alternative, annul certain parts of those provisions and annexes;
–        order the Parliament and the Council to pay the costs.
16      In their pleas of inadmissibility, the Parliament and the Council contend that the Court should:
–        dismiss the actions as inadmissible;
–        order the applicants to pay the costs.
17      In their observations regarding the pleas of inadmissibility, the applicants in Cases T‑156/25, T‑157/25, T‑159/25 to T‑168/25 and T‑171/25 claim that the Court should:
–        reject the pleas of inadmissibility;
–        order the Parliament and the Council to pay the costs.
18      In their observations regarding those pleas of inadmissibility, the applicants in Case T‑170/25 claim that the Court should:
–        principally, reject the pleas of inadmissibility;
–        in the alternative, open the oral part of the procedure in accordance with Article 130(6) of the Rules of Procedure of the General Court;
–        in the further alternative, reserve its decision on the pleas of inadmissibility until it rules on the substance of the case;
–        order the Parliament and the Council to pay the costs.
Law
19      Under Article 130(1) of the Rules of Procedure, the Court may give a decision on inadmissibility without going to the substance of the case if a defendant submits an application asking it to do so. Under Article 130(7) of those rules, the Court is to decide on the application as soon as possible or, where special circumstances so justify, reserve its decision on that application until it rules on the substance of the case.
20      In the present case, as the Parliament and the Council have applied for a decision on inadmissibility, the Court, considering that it has sufficient information from the material in the case file, has decided to give a decision on those applications without taking further steps in the proceedings.
21      It should be recalled that the fourth paragraph of Article 263 TFEU provides for two situations in which natural or legal persons are accorded standing to institute proceedings against an act which is not addressed to them. First, such proceedings may be instituted if the act is of direct and individual concern to those persons. Second, such persons may bring proceedings against a regulatory act not entailing implementing measures if that act is of direct concern to them (judgment of 13 March 2018, European Union Copper Task Force v Commission, C‑384/16 P, EU:C:2018:176, paragraph 32).
22      Directive 2024/3019, which was adopted on the basis of Article 192(1) TFEU in accordance with the ordinary legislative procedure, is a legislative act within the meaning of Article 289(3) TFEU, with the result that the examination of the admissibility of the present actions does not fall within the second situation referred to in paragraph 21 above, since the third limb of the fourth paragraph of Article 263 TFEU relates to regulatory acts, which, according to the case-law, are acts of general application other than legislative acts (see, to that effect, judgment of 3 October 2013, Inuit Tapiriit Kanatami and Others
v Parliament and Council, C‑583/11 P, EU:C:2013:625, paragraphs 60 and 61).
23      Thus, the argument raised in the alternative by the applicants in Case T‑170/25, relating to the nature of ‘regulatory acts’ within the meaning of the third limb of the fourth paragraph of Article 263 TFEU, of Article 9(1) and of Article 33 of Directive 2024/3019, must be rejected.
24      Accordingly, the applicants fall within the first situation referred to in paragraph 21 above and must be directly and individually concerned by the provisions which they contest.
25      It should be noted that, principally, the applicants seek the annulment, in Cases T‑156/25, T‑157/25, T‑159/25 to T‑168/25 and T‑171/25, of Article 1, in so far as it refers to the implementation of the polluter-pays principle, Article 2(19), (20) and (26), Articles 9 and 10, and points (c) and (g) of the second subparagraph of Article 30(1) of, and Annex III to, Directive 2024/3019, and, in Case T‑170/25, also of Article 2(14) and (17) of, and Table 3 of Part C of Annex I to, that directive (together, ‘the contested provisions’).
26      The applicants seek the annulment of the contested provisions in so far as they establish the EPR system. Therefore, it is in the light of the scope of that system as defined in Annex III to Directive 2024/3019 that it is necessary to examine whether the applicants are individually concerned by the contested provisions.
27      The Parliament and the Council contend that the fact of belonging to a group defined by Annex III to Directive 2024/3019, which lists only two categories of products, namely medicinal products for human use and cosmetics, is not sufficient to conclude that the applicants are individually concerned. Their situation is no different from that of any other producer placing medicinal or cosmetic products on the market.
28      The Parliament and the Council add that the fact of belonging, as producers of generic medicinal products, to a subgroup of the broader category of producers of medicinal products is also not sufficient to conclude that the applicants are individually concerned. In that regard, they point to settled case-law according to which the fact that certain operators are more affected by a measure of general application than others is irrelevant for the purpose of assessing whether those operators are individually concerned.
29      The applicants submit that producers of generic medicinal products, a subgroup of the category of producers of medicinal products for human use to which they belong, are particularly affected by the contested provisions as a closed group.
30      First, the applicants maintain that their situation is different from that of any producer whose products are not covered by Annex III to Directive 2024/3019. In that regard, they claim that they must bear the costs of the quaternary treatment of micropollutants for which such producers are responsible, whereas those producers are exempt from at least 80% of the costs of the quaternary treatment of micropollutants which they have actually contributed to causing.
31      Moreover, the applicants argue that their situation is also different from that of other producers whose products fall within Annex III to Directive 2024/3019, namely producers of innovative medicinal products and producers of cosmetics.
32      As regards producers of innovative medicinal products, first, the applicants submit that, unlike those producers, which market patent-protected products, they do not enjoy any market exclusivity rights, but are rather subject to a complex set of statutory and contractual provisions in all Member States, such that they can market their products only at very low margins. Next, they state that generic medicinal products are the most widely used in the European Union and, consequently, that they have to bear the majority of the costs imposed by the contested provisions, since the obligation to bear the costs of quaternary treatment is based on the quantities of substances contained in the products placed on the market. Lastly, the applicants claim that they do not have either the financial means or the technical expertise enabling them to carry out research and to develop new active ingredients that could reduce micropollutants in wastewater and, therefore, reduce their costs of participating in the EPR system. As a result, they maintain that they will no longer be able to produce a number of critical medicinal products at acceptable margins.
33      As regards producers of cosmetics, the applicants submit that it is possible for such producers to change the composition of their products without the need for prior authorisation, whereas the applicants cannot do so since the medicinal products market is highly regulated.
34      Second, the applicants dispute the application of the case-law relied on by the Parliament and the Council according to which a legal person cannot be considered to be individually concerned where the application of a measure takes effect by virtue of an objective legal or factual situation defined by the measure in question, even if this entails major economic disadvantages for that person. According to the applicants, the application of that case-law to the present case would result in an infringement of Article 47 of the Charter of Fundamental Rights of the European Union.
35      Third, the applicants submit that they are in a situation comparable to that of the applicants in the cases which gave rise to the judgments of 18 May 1994, Codorniu v Council (C‑309/89, EU:C:1994:197), and of 22 June 2006, Belgium and Forum 187 v Commission (C‑182/03 and C‑217/03, EU:C:2006:416).
36      In that context, the applicants in Case T‑170/25 add that, since they are marketing authorisation holders in respect of certain medicinal products containing substances listed in Table 3 of Part C of Annex I to Directive 2024/3019, they are also affected by that annex within the meaning of the judgment of 22 June 2006, Belgium and Forum 187 v Commission (C‑182/03 and C‑217/03, EU:C:2006:416).
37      In addition, the applicants maintain that the Opinion of Advocate General Emiliou in Nicoventures Trading and Others v Commission (C‑731/23 P, EU:C:2025:435) confirms that they are individually concerned by the contested provisions in the light of a more flexible and open interpretation of the condition relating to individual concern.
38      It should be recalled that persons other than those to whom a measure is addressed may claim to be individually concerned, within the meaning of the fourth paragraph of Article 263 TFEU, only if that measure affects them by reason of certain attributes which are peculiar to them or by reason of circumstances in which they are differentiated from all other persons and by virtue of those factors distinguishes them individually just as in the case of the person to whom such a measure is addressed
(judgments of 15 July 1963, Plaumann v Commission, 25/62, EU:C:1963:17, p. 107, and of 13 March 2018, European Union Copper Task Force v Commission, C‑384/16 P, EU:C:2018:176, paragraph 93).
39      In that regard, it is settled case-law that the fact that a contested measure is legislative in nature or of general application does not in itself prevent it from being of individual concern to some of the persons affected (see, to that effect, judgment of 18 May 1994, Codorniu v Council, C‑309/89, EU:C:1994:197, paragraph 19, and order of 26 March 2021, SATSE v Commission, T‑484/20, not published, EU:T:2021:172, paragraph 52).
40      Similarly, it has been accepted in the case-law that, where a measure affects a group of persons who were identified or identifiable when that measure was adopted by reason of criteria specific to the members of the group, those persons might be individually concerned by that measure inasmuch as they form part of a limited class of traders (see, to that effect, judgment of 27 February 2014, Stichting Woonpunt and Others v Commission, C‑132/12 P, EU:C:2014:100, paragraph 59).
41      On the other hand, where a measure applies to objectively determined situations and produces legal effects with respect to categories of persons envisaged in a general and abstract manner, the persons belonging to those categories are not regarded as individually concerned by that measure (see judgment of 6 November 2018, Scuola Elementare Maria Montessori v Commission, Commission v Scuola Elementare Maria Montessori and Commission v Ferracci, C‑622/16 P to C‑624/16 P, EU:C:2018:873, paragraph 31 and the case-law cited), even if it is possible to determine more or less precisely the number, or even the identity, of the persons to whom a measure applies (judgment of 12 July 2022, Nord Stream 2 v Parliament and Council, C‑348/20 P, EU:C:2022:548, paragraph 157).
42      In the present case, the applicants rely on the case-law referred to in paragraph 40 above in order to establish that they are individually concerned.
43      At the outset, it must be observed that the contested provisions do not expressly refer to any specific operator as being subject to the EPR system.
44      On the contrary, that extended responsibility is determined in a general and abstract manner, referring to producers of medicinal products for human use falling within the scope of Directive 2001/83 and to producers of cosmetic products falling within the scope of Regulation No 1223/2009, as is apparent from a combined reading of Article 9(1) of, and Annex III to, Directive 2024/3019.
45      Therefore, the EU legislature did not refer specifically to any of the applicants or even to the category of producers of generic medicinal products.
46      It must therefore be examined whether the applicants are individually concerned inasmuch as they form part of a closed group or a limited class, in that the contested provisions affect that group by reason of criteria specific to its members, which were identified or identifiable on the date on which Directive 2024/3019 was adopted.
47      In that regard, first, it must be observed that neither Directive 2024/3019 nor its travaux préparatoires suggest that the EU legislature intended, or was required, to take
into consideration the specific situation of producers of generic medicinal products.
48      It is apparent from recital 20 of Directive 2024/3019 that the EU legislature considered that extended producer responsibility should apply to producers of two categories of products which represent the main sources of micropollutants found in urban wastewater requiring quaternary treatment.
49      Recital 20 of Directive 2024/3019 also highlights the fact that the EPR system should apply regardless of how the two categories of products in question are manufactured or distributed.
50      Moreover, the applicants have not demonstrated that there is a specific provision, either higher-ranking or of secondary legislation, which would have required the EU legislature, during the process of adopting Directive 2024/3019, to take any particular account of the situation of producers of generic medicinal products vis-à-vis the situation of other producers covered by Annex III to that directive and of producers which are not covered by that annex (see, by analogy, judgment of 2 March 2010, Arcelor v Parliament and Council, T‑16/04, EU:T:2010:54, paragraph 102).
51      In that regard, the alleged failure by the Commission to carry out a ‘proper’ impact assessment prior to the adoption of Directive 2024/3019 is irrelevant.
52      Thus, the contested provisions are of general application and apply to categories of persons envisaged in a general and abstract manner, namely to any producer of medicinal products for human use or cosmetics.
53      Second, contrary to what the applicants claim in referring to the judgments of 18 May 1994, Codorniu v Council (C‑309/89, EU:C:1994:197), and of 22 June 2006, Belgium and Forum 187 v Commission (C‑182/03 and C‑217/03, EU:C:2006:416), the contested provisions do not call into question any acquired right on which they might rely.
54      In that regard, the applicants’ situation differs substantially from that of the applicants in the two cases which gave rise to the judgments referred to in paragraph 53 above.
55      In the case which gave rise to the judgment of 18 May 1994, Codorniu v Council (C‑309/89, EU:C:1994:197), the applicant’s individual concern arose from the fact that, following the adoption of the regulation contested in that case, it was impossible for it to use a graphic mark which had previously been registered.
56      In the case which gave rise to the judgment of 22 June 2006, Belgium and Forum 187 v Commission (C‑182/03 and C‑217/03, EU:C:2006:416), the applicant’s individual concern arose, inter alia, from the fact that the decision contested in that case, by which the Commission declared an existing aid scheme incompatible with the internal market and ordered its cessation, had the effect of depriving some of the applicant’s members of their right to maintain a tax scheme until its initial expiry date.
57      In the present case, the contested provisions merely impose, under the EPR system, new burdens on producers of the products covered by Annex III to Directive 2024/3019.
58      In that regard, the fact that, in that context, producers of products covered by Annex III to Directive 2024/3019 are subject to obligations to which producers of products not covered by that annex are not subject cannot, as the applicants maintain, be regarded as calling into question acquired rights.
59      Similarly, the fact that the applicants hold marketing authorisations in respect of medicinal products containing substances expressly referred to in Table 3 of Part C of Annex I to Directive 2024/3019 is irrelevant, since that directive does not in any way call those marketing authorisations into question (see, to that effect and by analogy, judgment of 30 October 2025, Fugro v Council, C‑146/24 P, not published, EU:C:2025:841, paragraph 43).
60      Even if that were the case, it should be pointed out that the existence of an actual or individual right, including that conferred by a provision of general application, the scope or exercise of which is potentially affected by the contested measure, is not as such capable of distinguishing the rightholder individually, in particular where other operators may enjoy similar rights and hence be in the same situation as that rightholder (see, to that effect and by analogy, order of 7 September 2010, Etimine and Etiproducts v Commission, T‑539/08, EU:T:2010:354, paragraph 104), as is the case regarding all producers of products covered by Annex III to Directive 2024/3019.
61      Third, the applicants have failed to identify in a convincing manner the closed group or limited class to which they allegedly belong.
62      While it is true that the applicants submit that they belong to the closed group or limited class of producers of generic medicinal products, their line of argument based on the difference in treatment between producers of products covered by Annex III to Directive 2024/3019 and producers of products not covered by that annex tends to show that they form part of a closed group or limited class that is significantly broader than the one to which they claim to belong.
63      In maintaining that the contested provisions result in producers of medicinal products for human use and producers of cosmetics bearing most of the costs associated with the elimination of micropollutants also caused by producers of other products, they argue that those provisions discriminate against those two categories of producers and thus affect the interests of a category of operators that not only is broader than the category of producers of generic medicinal products by itself, but is also defined in a general and abstract manner.
64      That confusion is reinforced by the applicants’ line of argument seeking to show that, among the producers of products covered by Annex III to Directive 2024/3019, the pharmaceutical sector as a whole – and not specifically the sector of generic producers – is the most impacted.
65      This is apparent in particular from the references made by the applicants, in their observations regarding the pleas of inadmissibility, to various positions adopted by the Parliament and the Commission, and also from the line of argument according to which the regulatory framework applicable to cosmetic products is significantly less restrictive than the one applicable to medicinal products.
66      The confusion is further reinforced by the fact that, in their written pleadings, the applicants very regularly claim – without further clarification – that they form part of a ‘specific (sub-)group’ and consider that sub-group at times to be that of producers of medicinal products, and at other times to be that of producers of generic medicinal products.
67      Moreover, although they maintain that the composition of generic medicinal products or the placing on the market of such medicinal products is entirely specific, it is not apparent from the written pleadings how such composition or placing on the market differs from that relating to non-generic or originator medicinal products.
68      Fourth, the applicants’ claim that producers of generic medicinal products are more financially impacted than other producers of products whether or not covered by
Annex III to Directive 2024/3019 is not sufficient to distinguish them individually from those other producers, since the application of the contested provisions takes effect by virtue of an objectively determined situation (see, to that effect, judgment of 2 March 2010, Arcelor v Parliament and Council, T‑16/04, EU:T:2010:54, paragraph 106 and the case-law cited).
69      In that regard, the mere fact that natural or legal persons may all lose even a major source of income as a result of new legislation is not sufficient to establish that that legislation applies to them individually, those persons having to adduce proof of circumstances which make it possible to consider that the harm allegedly suffered is such as to distinguish them individually from all other economic operators concerned by that legislation in the same way as they are (see, by analogy, order of 21 December 2023, Broad Far (Hong Kong) and M21 v Commission, T‑791/22, not published, EU:T:2023:875, paragraph 45 and the case-law cited).
70      It is true that, in support of their line of argument, the applicants claim, with documentary evidence, that generic medicinal products represent approximately 70% of the volume of medicinal products sold, but only 19% of the value of the pharmaceutical market, and that the contested provisions would lead them to bear between 57% and 62% of the total fees under the EPR system, which would undermine their business model and, ultimately, the security of supply of generic medicinal products.
71      However, those factors are not such as to establish that the applicants are individually concerned, in respect of which it has already been found, in paragraphs 58 to 60 above, that their acquired rights were not affected.
72      First of all, the arguments based on the public health implications of the contested provisions cannot be taken into consideration for the purpose of determining whether the applicants are individually concerned, since such implications do not concern
them.
73      Next, while it is true that the data provided by the applicants render the financial implications of the contested provisions for producers of generic medicinal products likely, the fact remains that those financial implications stem from an objective legal or factual situation defined by those provisions and entailing legal effects with respect to categories of persons envisaged in a general and abstract manner, namely all producers of products covered by Annex III to Directive 2024/3019 (see, to that effect, order of 8 April 2008, Saint-Gobain Glass Deutschland v Commission, C‑503/07 P, EU:C:2008:207, paragraphs 70 and 71 and the case-law cited, and judgment of 2 March 2010, Arcelor v Parliament and Council, T‑16/04, EU:T:2010:54, paragraphs 106 to 108 and the case-law cited).
74      Moreover, those financial implications are in part hypothetical, in so far as the price of generic medicinal products is, as the applicants have argued, highly regulated by the Member States and, as a result, is likely
to be adjusted during the period for the transposition of Directive 2024/3019, in order to take precise account of the additional costs likely to be incurred as a result of that transposition, inter alia in the light of public health considerations.
75      Lastly, the arguments alleging that it is impossible for producers of generic medicinal products to change the active substance of their medicinal product, to withdraw their medicinal product from the market or to bear the additional costs likely to be incurred as a result of the contested provisions are not such as to establish the existence of harm that distinguishes those producers individually.
76      Such commercial choices are specific to each producer of generic medicinal products, if not to each active substance concerned, but are also closely linked to the size of each producer’s portfolio of medicinal products or to its commercial policy.
77      The applicants have therefore failed to demonstrate that they are individually concerned.
78      That conclusion is not called into question by the argument based on the Opinion of Advocate General Emiliou in Nicoventures Trading and Others v Commission (C‑731/23 P, EU:C:2025:435), since the Court of Justice – and a fortiori the General Court in a separate case – is not bound either by that Opinion or by the reasoning on which the Advocate General based it (judgment of 25 July 2018, Société des produits Nestlé and Others v Mondelez UK Holdings & Services, C‑84/17 P, C‑85/17 P and C‑95/17 P, EU:C:2018:596, paragraph 31).
79      Furthermore, since the conditions of direct concern and individual concern are cumulative (order of 11 November 2014, Nguyen v Parliament and Council, T‑20/14, EU:T:2014:955, paragraph 55, and judgment of 16 May 2018, Netflix International and Netflix v Commission, T‑818/16, not published, EU:T:2018:274, paragraph 70), it is not necessary to ascertain whether the condition relating to direct concern is satisfied.
80      In the light of the foregoing, it must be held that the applicants have not demonstrated that they have standing to institute proceedings against the contested provisions.
81      Such a conclusion does not entail any infringement of Article 47 of the Charter of Fundamental Rights.
82      In that regard, it suffices to state that, while it is true that the conditions of admissibility laid down in the fourth paragraph of Article 263 TFEU must be interpreted in the light of the fundamental right to effective judicial protection, such an interpretation must not have the effect of setting aside the conditions expressly laid down in that Treaty (see, to that effect, judgments of 3 October 2013, Inuit Tapiriit Kanatami and Others v Parliament and Council, C‑583/11 P, EU:C:2013:625, paragraph 98, and of 28 April 2015, T & L Sugars and Sidul Açúcares v Commission, C‑456/13 P, EU:C:2015:284, paragraph 44).
83      In the present case, since the applicants have not demonstrated that they are individually concerned by the contested provisions, according them standing to institute proceedings would de facto entail setting aside one of the conditions expressly laid down in the fourth paragraph of Article 263 TFEU, which would be contrary to the case-law referred to in paragraph 82 above.
84      Therefore, the applications for annulment of the contested provisions must be rejected as inadmissible.
85      It follows that the second heads of claim, raised in the alternative, and seeking the annulment of the contested provisions in their entirety, by the applicants in Cases T‑156/25, T‑157/25, T‑159/25 to T‑168/25 and T‑171/25, and of ‘the relevant parts [of those provisions]’, by the applicant in Case T-170/25, must also be rejected as inadmissible.
86      By their third head of claim, also raised in the alternative, the applicants in Cases T‑156/25, T‑157/25, T‑159/25 to T‑168/25 and T‑171/25 seek the annulment of Directive 2024/3019 in its entirety.
87      It suffices to observe that the applicants do not claim to be individually concerned by any provisions of Directive 2024/3019 other than the contested provisions. That finding is sufficient for the purpose of also rejecting the third head of claim as inadmissible.
88      Accordingly, the actions must be dismissed in their entirety as inadmissible.
The applications to intervene
89      Pursuant to Article 144(3) of the Rules of Procedure, where the defendant lodges a plea of inadmissibility or of lack of competence, as provided in Article 130(1) of those rules, a decision on the application to intervene is not to be given until after the plea has been rejected or the decision on the plea reserved. In addition, pursuant to Article 142(2) of those rules, the intervention is to become devoid of purpose, inter alia, where the application is declared inadmissible.
90      In the present case, on the one hand, Hofmann & Sommer GmbH und Co. KG, Pharma Deutschland eV, Medicines for Europe, Pro Generika eV, Asociación Española de Fabricantes de Sustancias y Especialidades farmacéuticas Genéricas, Bundesverband der Pharmazeutischen Industrie eV, Biogaran SAS and Egis Gyógyszergyár have applied for leave to intervene in support of the applicants.
91      On the other, the Commission, Bundesverband der Energie- und Wasserwirtschaft (BDEW) eV and Verband Kommunaler Unternehmen (VKU) eV have applied for leave to intervene in support of the Parliament and the Council.
92      Since the pleas of inadmissibility raised by the Parliament and the Council have been upheld and the present order therefore closes the proceedings, there is no longer any need to adjudicate on the applications to intervene.
Costs
93      Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the applicants have been unsuccessful, they must be ordered to pay the costs in accordance with the forms of order sought by the Parliament and the Council.
94      In addition, under Article 144(10) of the Rules of Procedure, if, as in the present case, the proceedings in the main case are concluded before the application to intervene has been decided, the applicant for leave to intervene and the main parties are each to bear their own costs relating to the application to intervene. Given that the applications to intervene were not notified either to the applicants or to the Parliament and the Council and they were therefore not put in a position where they might incur costs in that regard, it must be held that Hofmann & Sommer, Pharma Deutschland, Medicines for Europe, Pro Generika, Asociación Española de Fabricantes de Sustancias y Especialidades farmacéuticas Genéricas, Bundesverband der Pharmazeutischen Industrie, Biogaran, Egis Gyógyszergyár, the Commission, BDEW and VKU shall each bear their own costs relating to the applications to intervene.
On those grounds,
THE GENERAL COURT (Fourth Chamber)
hereby orders:
1.      The actions are dismissed as inadmissible.
2.      There is no longer any need to adjudicate on the applications to intervene made by Hofmann & Sommer GmbH und Co. KG, Pharma Deutschland eV, Medicines for Europe, Pro Generika eV, Asociación Española de Fabricantes de Sustancias y Especialidades farmacéuticas Genéricas, Bundesverband der Pharmazeutischen Industrie eV, Biogaran SAS, Egis Gyógyszergyár, the European Commission, Bundesverband der Energie- und Wasserwirtschaft (BDEW) eV and Verband Kommunaler Unternehmen (VKU) eV.
3.      Accord Healthcare France SAS, Dermapharm AG, Adamed Pharma S.A., Fresenius Kabi Deutschland GmbH, Fresenius Kabi Italia Srl (FKI), Fresenius Kabi Polska sp. z o.o., hameln pharma GmbH, Hexal AG, Exeltis Healthcare, SL, Medical Valley Invest AB, Zakłady Farmaceutyczne Polpharma S.A., Puren Pharma GmbH & Co. KG, E G Labo – Laboratoires Eurogenerics, Teva Nederland BV, ratiopharm GmbH, Teva Santé, Teva Pharma, SL, Teva Denmark A/S, Teva BV, Zentiva k.s., Zentiva Pharma GmbH, Winthrop Arzneimittel GmbH, Zentiva Italia Srl, Zentiva France, Zentiva SA, BGP Products SRL, Meda OTC AB, Mylan Germany GmbH, Mylan Ireland Ltd, Mylan Pharmaceuticals Ltd, Viatris Healthcare GmbH, Viatris Santé and Laboratorios Normon, SA shall bear their own costs and pay those incurred by the European Parliament and the Council of the European Union.
4.      Hofmann & Sommer, Pharma Deutschland, Medicines for Europe, Pro Generika, Asociación Española de Fabricantes de Sustancias y Especialidades farmacéuticas Genéricas, Bundesverband der Pharmazeutischen Industrie, Biogaran, Egis Gyógyszergyár, the Commission, BDEW and VKU shall each bear their own costs relating to the applications to intervene.
Luxembourg, 18 February 2026.
V. Di Bucci
G. De Baere
Registrar
President
*      Language of the case: English.