Order of 7 May 2025

R e a s o n s :

A.

1

The complainants, who are pharmaceutical entrepreneurs within the meaning of § 4(18) of the Medicinal Products Act (Arzneimittelgesetz – AMG), challenge several provisions inserted into the Fifth Book of the Code of Social Law (Sozialgesetzbuch Fünftes Buch – SGB V) by the Act for the Financial Stabilisation of the Statutory Health Insurance System (Gesetz zur finanziellen Stabilisierung der gesetzlichen Krankenversicherung, GKV-Finanzstabilisierungsgesetz; hereinafter: the Act) of 7 November 2022 (Federal Law Gazette, Bundesgesetzblatt – BGBl I p. 1990), which have in part been amended by the Act to Reduce Supply Bottlenecks for Off-Patent Medicinal Products and to Improve the Supply of Paediatric Medicinal Products (Gesetz zur Bekämpfung von Lieferengpässen bei patentfreien Arzneimitteln und zur Verbesserung der Versorgung mit Kinderarzneimitteln – ALBVVG) of 19 July 2023 (BGBl 2023 I no. 197). Both complainants challenge § 130a(1b) of the Fifth Book of the Code of Social Law (manufacturer discount of 12% for one year), § 130a(3a) of the Fifth Book of the Code of Social Law (extension of the price moratorium) and § 130e of the Fifth Book of the Code of Social Law (drug combination discount). The complainant in proceedings II. additionally challenges § 130b(3) first to sixth sentence of the Fifth Book of the Code of Social Law (guard rails). The complainant in proceedings I. additionally challenges § 130b(3a) second to ninth sentence (in part in conjunction with § 130b(4) third sentence) of the Fifth Book of the Code of Social Law (applicability of the reimbursement amount from the seventh month after market launch).

I. 

2

In adopting the Act, the legislator has taken a range of different measures to ensure the financial stability of the statutory health insurance system in terms of both revenue and expenditure. The explanatory memorandum to the draft legislation states that these measures became necessary due to an ever widening gap between the revenues and expenditures of statutory health insurance providers, which are due to a variety of reasons and can only be addressed through additional measures. According to the explanatory memorandum, the measures serve to limit an increase in the additional contribution rate paid by contributors to statutory health insurance (cf. Bundestag document, Bundestagsdrucksache – BTDrucks 20/3448, p. 2). The constitutional complaints are directed against those measures concerning expenditure that, in the view of the pharmaceutical companies, place particular burdens on them.

3

1. The Act inserted section (1b) into § 130a of the Fifth Book of the Code of Social Law. According to this provision, statutory health insurance providers, in deviation from § 130a(1) first sentence of the Fifth Book of the Code of Social Law, receive a discount of 12% on the pharmaceutical company’s selling price excluding VAT from pharmacies for medicinal products dispensed at statutory health insurance providers’ expense from 1 January 2023 to 31 December 2023. § 130a(1) and (1b) of the Fifth Book of the Code of Social Law in the version of 7 November 2022 read in relevant part as follows:

(1) ¹Statutory health insurance providers receive a discount of seven per cent on the pharmaceutical entrepreneur’s selling price excluding VAT from pharmacies for medicinal products dispensed at statutory health insurance providers’ expense. ²For medicinal products pursuant to section (3b) first sentence, the discount pursuant to the first sentence is six per cent. ³Pharmaceutical entrepreneurs are required to reimburse the pharmacies for the discount. ⁴To the extent that pharmaceutical wholesalers are involved under section (5), pharmaceutical entrepreneurs are required to reimburse them for the discount. ⁵Pharmacies and pharmaceutical wholesalers must be reimbursed for the discount within ten days of their claim. ⁶The first sentence applies to finished medicinal products whose pharmacy selling prices are determined by the pricing rules in the Medicinal Products Act or on the basis of § 129(3) third sentence or § 129(5a) and for medicinal products dispensed under § 129a. ⁷Statutory health insurance providers receive the discount pursuant to the first sentence for finished medicinal products in parenteral preparations, for finished medicinal products from which partial quantities are withdrawn and dispensed, and for medicinal products dispensed pursuant to § 129a, on the pharmaceutical entrepreneur’s selling price excluding VAT that applies when dispensing to consumers on the basis of pricing rules in the Medicinal Products Act or pursuant to § 129(3) third sentence. ⁸If only a partial quantity of a finished medicinal product is billed, the discount only applies to this partial quantity.

(1b) ¹In deviation from section (1) first sentence, statutory health insurance providers receive a discount of 12% on the pharmaceutical entrepreneur’s selling price excluding VAT from pharmacies for medicinal products dispensed at statutory health insurance providers’ expense from 1 January 2023 to 31 December 2023. ²If the discount pursuant to section (1) first sentence has been replaced by an agreement on reimbursement pursuant to § 130b, statutory health insurance providers receive a discount of 5% of the pharmaceutical entrepreneur’s selling price excluding VAT from pharmacies. ³Discounts pursuant to the first and second sentence can be replaced by a reimbursement agreement pursuant to § 130b concluded on or after 12 November 2022, provided that this has been expressly agreed.

4

2. At the same time, an existing price moratorium was extended until 31 December 2026 (§ 130a(3a) of the Fifth Book of the Code of Social Law). If a pharmaceutical company’s selling price increases compared to the price on 1 August 2009, statutory health insurance providers receive a discount in the amount of the price increase for medicinal products dispensed at their expense; this moratorium was extended until 31 December 2026. It does not apply to medicinal products for which a fixed price was determined on the basis of § 35 of the Fifth Book of the Code of Social Law. § 130a(3a) of the Fifth Book of the Code of Social Law in the version of 7 November 2022 reads in relevant part as follows:

(3a) ¹If a pharmaceutical entrepreneur’s selling price increases compared to the price on 1 August 2009, statutory health insurance providers receive a discount in the amount of the price increase for medicinal products dispensed at their expense in the period from 1 August 2010 until 31 December 2026; this does not apply to medicinal products for which a fixed price was determined on the basis of § 35. ²To calculate the discount in accordance with the first sentence, the price of 1 August 2009 is increased on 1 July 2018 for the first time, and on 1 July of each subsequent year, by the amount resulting from the change in the consumer price index for Germany as determined by the Federal Statistical Office compared to the previous year. ³For medicinal products that are placed on the market after 1 August 2010, the first sentence applies with the proviso that the price at market launch is applied. ⁴For new launches of a medicinal product for which the pharmaceutical entrepreneur has already placed on the market a medicinal product with the same active ingredient and comparable pharmaceutical form, the discount must be calculated on the basis of the price per unit of quantity of the packaging that most closely corresponds to the new medicinal product in terms of size of the packaging, taking into account the potency; this does not apply to new launches of an immunoglobulin of human origin which was licensed after 31 December 2018 in accordance with § 25(1) of the Medicinal Products Act or for which a marketing authorisation was granted in accordance with Article 3(1) or (2) of Regulation (EC) No. 726/2004, with the exception of the authorisation of other potencies or presentations. ⁵The fourth sentence applies accordingly with regard to changes to the information regarding the pharmaceutical entrepreneur or regarding co-distribution by another pharmaceutical entrepreneur. […] ⁷Discounts pursuant to sections (1), (1a), (1b) and (3b) are given in addition to the discount pursuant to the first to fifth sentence. (…)

5

Moreover, the existing rules regarding agreement of reimbursement amounts under § 130b of the Fifth Book of the Code of Social Law, which are based on added therapeutic value and on the patent status of the appropriate comparative treatment, were amended and made more restrictive at the expense of pharmaceutical companies. The fundamental concept can be summarised as follows: If a new, patented medicinal product has a similar benefit as an existing comparative treatment, the reimbursement amount may result in a maximum of 90% of the annual treatment costs of the comparative treatment. If a new, patented medicinal product has an added therapeutic value, this does not necessarily entail a higher reimbursement amount than that provided for the comparative treatment. If the medicinal product used in the comparative treatment is a generic medicinal product or subject to a fixed price, the rules are less strict. […]

6

3. Pursuant to § 130b(3a) first and second sentence of the Fifth Book of the Code of Social Law, the reimbursement amount agreed in accordance with § 130b(1) of the Fifth Book of the Code of Social Law applies to all medicinal products with the same new active ingredient that were placed on the market on or after 1 January 2011, starting from the seventh month (prior to the entry into force of the Act from the thirteenth month) after the first medicinal product with the new active ingredient was placed on the market. § 130b(3a) third to eighth sentence of the Fifth Book of the Code of Social Law extends the same rule starting the period of application from the seventh month onward to other cases (in particular when there is a new field of application, the sales threshold has been exceeded for orphan medicinal products, or when a benefit assessment pursuant to § 35a(5) of the Fifth Book of the Code of Social Law has been started). […]

7

§ 130b(4) third sentence of the Fifth Book of the Code of Social Law governs reimbursement amounts determined by way of arbitration proceedings pursuant to § 130b(4) first sentence of the Fifth Book of the Code of Social Law. According to that provision, the reimbursement amount determined in the arbitral award applies from the seventh month following one of the events listed in the second to sixth or the eighth sentence of section (3a).

8

4. § 130e was likewise newly inserted into the Fifth Book of the Code of Social Law by the Act. Pursuant to § 130e(1) of the Fifth Book of the Code of Social Law, statutory health insurance providers receive a discount of 20% of the pharmaceutical company’s selling price from the pharmaceutical company if medicinal products with new active ingredients are used in a combination designated by the Federal Joint Committee (Gemeinsamer Bundesausschuss) pursuant to § 35a(3) fourth sentence of the Fifth Book of the Code of Social Law, unless the Federal Joint Committee has found that the combination of medicinal products is expected to generate at a minimum a considerable added therapeutic value. The Act to Reduce Supply Bottlenecks for Off-Patent Medicinal Products and to Improve the Supply of Paediatric Medicinal Products changed the rules regarding the drug combination discount. In particular, the Federal Association of Statutory Health Insurance Providers (Spitzenverband Bund der Krankenkassen) was tasked with setting out the details of the implementation of the drug combination discount by 31 October 2023 in agreement with the relevant umbrella organisations formed by the pharmaceutical companies to represent their business interests. […]

II. 

9

1. The complainants are pharmaceutical entrepreneurs within the meaning of § 4(18) of the Medicinal Products Act. The complainant in proceedings II. manufactures medicinal products that are subject to a marketing authorisation, and holds the relevant marketing authorisations (§ 4(18) Medicinal Products Act). The complainant in proceedings I. imports medicinal products that are subject to a marketing authorisation and distributes them in Germany (§ 4(18) second sentence Medicinal Products Act).

10

2. The complainant in proceedings II. asserts that the manufacturer discount and the extension of the price moratorium violate Art. 12(1) of the Basic Law (Grundgesetz – GG), that the guard rails violate Art. 3(1) of the Basic Law, and that the drug combination discount violates Art. 12(1), Art. 20(1) and (3) and Art. 19(4) first sentence of the Basic Law.

11-15

[…]

16

3. The complainant in proceedings I. asserts that the manufacturer discount, the extension of the price moratorium and the applicability of the reimbursement amount from the seventh month after market launch violate Art. 12(1), Art. 14(1) and Art. 3(1) of the Basic Law, and that the drug combination discount violates Art. 12(1) and Art. 14(1) of the Basic Law.

17-25

[…]

III. 

26

Statements on the constitutional complaints were submitted by the Federal Government, the Federal Association of Statutory Health Insurance Providers, the Federal Joint Committee, the Federal Social Court (Bundessozialgericht), the Association of Private Health Insurance Providers (Verband der Privaten Krankenversicherung e. V.) and the association Pro Generika e. V. Moreover, a joint statement was submitted by the Association of Research Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller e. V.), the Federal Association of the Pharmaceutical Industry (Bundesverband der Pharmazeutischen Industrie e. V.) together with the Federal Association of Importers of Medicinal Products (Bundesverband der Arzneimittelimporteure e. V.), and an additional statement was submitted by the Federal Association of Importers of Medicinal Products.

27-33

[…]

B. 

34

The constitutional complaints are admissible in part. Insofar as the complainants challenge the drug combination discount, the guard rails (only in proceedings II.) and the applicability of the reimbursement amount from the seventh month following the market launch of a medicinal product (only in proceedings I.), they are inadmissible because the constitutional complaints do not sufficiently demonstrate that they satisfy the principle of subsidiarity (see I. below). Insofar as the complainants challenge the manufacturer discount (see II. below) and the extension of the price moratorium (see III. below), they only meet the admissibility prerequisites in part.

I. 

35

In relation to the guard rails, the start of application of the reimbursement amount and the drug combination discount, the constitutional complaints do not satisfy the substantiation requirements under § 23(1) second sentence, first half-sentence and § 92 of the Federal Constitutional Court Act (Bundesverfassungsgerichtsgesetz – BVerfGG) with regard to the principle of subsidiarity.

36

1. a) Under the principle of subsidiarity reflected in § 90(2) of the Federal Constitutional Court Act, complainants are generally required to use any means at their disposal that might remedy the asserted violation of fundamental rights before lodging a constitutional complaint (cf. Decisions of the Federal Constitutional Court, Entscheidungen des Bundesverfassungsgerichts – BVerfGE 155, 378 <393 para. 32> – Act Amending the Atomic Energy Act). This also serves the purpose of ensuring that the Federal Constitutional Court does not have to take far-reaching decisions on an uncertain factual and legal basis. It is the ordinary courts – which are primarily responsible for the interpretation and application of ordinary law – that must first address the points of fact and law at issue. The principle of subsidiarity therefore generally requires that, before lodging a constitutional complaint, the complainants first pursue all available procedural options that might remedy the alleged violation of the Constitution or even prevent a fundamental rights violation in the first place. This also applies if it is unclear whether the type of remedy sought is admissible under the applicable ordinary law and can be admissibly lodged in the specific case (cf. BVerfGE 165, 1 <32 f. para. 45> – Police powers under the Security and Public Order Act for Mecklenburg-Western Pomerania; 169, 130 <155 f. para. 40> – Hessian Protection of the Constitution Act; 169, 332 <359 f. para. 62> – Federal Criminal Police Office Act II; established case-law). A complainant must try to obtain legal protection in the ordinary courts within the limits of what is reasonable (cf. BVerfGE 143, 246 <321 para. 209>; 146, 71 <111 f. para. 118 ff.>); this also includes going through legally mandated arbitration proceedings (cf. Federal Constitutional Court, Order of the Second Chamber of the First Senate of 10 October 2016 - 1 BvR 2136/14 -, para. 12).

37

Legal protection in the ordinary courts is generally not available when it comes to legislation (cf. BVerfGE 150, 309 <326 para. 42>; 165, 1 <33 para. 46>). Nevertheless, constitutional complaints directly challenging legislation are not automatically admissible simply because the complainants are individually, directly and presently affected by the legislation at issue. If a constitutional complaint directly challenges legislation, the legal remedies that must be sought beforehand may include the filing of a declaratory action or an action for an injunction with the administrative courts. This applies even if the provisions at issue are exhaustive and the best possible outcome of a review by the ordinary courts is that the challenged law is referred to the Federal Constitutional Court pursuant to Art. 100(1) of the Basic Law. It is all the more imperative to first seek legal protection in the ordinary courts when the challenged provisions contain legal terms that are subject to interpretation, and the interpretation and application of these terms significantly influence the extent to which complainants are adversely affected, both with regard to the facts and the law (cf. BVerfGE 162, 1 <54 f. para. 101> – Bavarian Protection of the Constitution Act; 165, 1 <33 para. 46>; 169, 130 <156 para. 41>; established case-law). If an interference is based on legislation that provides for exceptions, complainants must, before lodging a constitutional complaint, attempt to undo the interference by invoking the exception, unless this is clearly futile (cf. BVerfGE 78, 58 <69>).

38

By contrast, when the assessment of a challenged provision raises only specific questions of constitutional law that must be resolved by the Federal Constitutional Court, and no improved basis for decision-making can be expected from a prior examination carried out by the ordinary courts, there is no need for such prior decision (cf. BVerfGE 163, 107 <124 para. 43> – Veterinary prescription requirement; 165, 1 <33 para. 47>; 169, 130 <156 f. para. 42>; established case-law). The same holds true if the challenged provision forces the complainants to make arrangements that cannot be reversed later, or if they cannot be expected to seek legal protection in the ordinary courts because it is clearly pointless or futile (cf. BVerfGE 158, 170 <200 para. 71>; 162, 1 <55 para. 102>; 165, 1 <33 f. para. 47>; established case-law).

39

b) Pursuant to § 23(1) second sentence, first half-sentence and § 92 of the Federal Constitutional Court Act, complainants must demonstrate and substantiate in their constitutional complaint that they have met these requirements, unless it is clear that the requirements that follow from the above have been satisfied (cf. BVerfGE 129, 78 <93>).

40

2. Insofar as the constitutional complaints are directed against the guard rails (see a) below), the applicability of the reimbursement amount from the seventh month after the market launch of a medicinal product (see b) below) and the drug combination discount (see c) below), it has not been sufficiently demonstrated that they satisfy the principle of subsidiarity.

41

a) The complainant in proceedings II. failed to sufficiently demonstrate why it should have been unreasonable to expect the complainant to go through arbitration proceedings under § 130b(4) of the Fifth Book of the Code of Social Law before lodging a constitutional complaint regarding the guard rails (§ 130b(3) of the Fifth Book of the Code of Social Law) and, as the case may be, to seek legal protection in the ordinary courts against an arbitral award.

42

aa) It is true that the challenged provisions of § 130b(3) second to fifth and seventh sentence of the Fifth Book of the Code of Social Law set out a framework for the negotiation of prices of medicinal products, which is binding on the partners to the agreement (the complainant in proceedings II. and the Federal Association of Statutory Health Insurance Providers) and on the arbitration body and the ordinary courts. However, in the present case, it can be expected that a prior review by an ordinary court of an arbitral award handed down pursuant to § 130b(4) first sentence of the Fifth Book of the Code of Social Law will lead to an improved basis for decision-making for the Federal Constitutional Court, in particular with regard to matters of fact that may be relevant to the decision.

43

bb) In this regard, it must be noted that blended prices are frequently negotiated under § 130b of the Fifth Book of the Code of Social Law, since the outcome of the benefit assessment differs for different groups of patients and fields of application. The practice of blended pricing and the resulting case-law from the ordinary courts with regard to this practice may affect to what extent pharmaceutical companies in general (cf. BVerfGE 68, 193 <219>; 70, 1 <30>) are adversely affected by the challenged provisions.

44

[…]

45

cc) […]

46

dd) […]

47

ee) […]

48

b) The constitutional complaint in proceedings I. likewise does not satisfy the substantiation requirements relating to the principle of subsidiarity with regard to the applicability of the reimbursement amount beginning from the seventh month after the market launch of the medicinal product (§ 130b(3a) of the Fifth Book of the Code of Social Law). The complainant failed to sufficiently demonstrate why it cannot be expected that prior proceedings in the ordinary courts would clarify the facts and the law in a manner relevant for the constitutional complaint proceedings. While the provision regarding the start of application of the reimbursement amount constitutes a separate interference that is distinct from the interference resulting from the reimbursement amount itself, the severity of interference of the challenged provision hinges on the severity of interference of the determination of the reimbursement amount, and therefore cannot be assessed without prior review in the ordinary courts. Therefore, the principle of subsidiarity also precludes the admissibility of the challenge regarding the constitutionality of the provision on the start of application of the reimbursement amount ([…]). This applies not only to manufacturers of medicinal products, but also to importers of medicinal products ([…]).

49-50

[…]

51

c) Finally, with regard to the drug combination discount under § 130e of the Fifth Book of the Code of Social Law, the complainants fail to sufficiently demonstrate why they should not be required to have recourse to the ordinary courts against the adverse effects of the provision before lodging a constitutional complaint. The constitutional complaints challenge a new law, the interpretation and application of which has not yet been examined in the ordinary courts, even though the assessment of the extent to which the pharmaceutical companies are adversely affected by the challenged provision may depend on this examination. The provision raises a number of questions of interpretation (see aa) below), which must first be resolved in the context of proceedings before the ordinary courts (see bb) below).

52

aa) Under § 130e(1) first sentence of the Fifth Book of the Code of Social Law, statutory health insurance providers receive a discount of 20% of the selling price from the pharmaceutical company if medicinal products with new active ingredients are used in a combination designated by the Federal Joint Committee pursuant to § 35a(3) fourth sentence of the Fifth Book of the Code of Social Law. Pursuant to § 35a(3) fourth sentence of the Fifth Book of the Code of Social Law, the Federal Joint Committee designates all medicinal products with new active ingredients which, based on their marketing authorisation, can be used in combination with the evaluated medicinal product for the field of application to be evaluated. The wording of the law does not clearly answer the question of when a medicinal product can be used in combination with the evaluated medicinal product based on its marketing authorisation. In the context of the consultation procedure for the amendment of the Medicinal Products Standard (Arzneimittel-Richtlinie), the Federal Joint Committee itself changed its approach from a broad interpretation (it is sufficient that the product information contains no contraindications for combination treatment – open combination) to a narrower interpretation (only if the product information contains indications for combination treatment – unspecific combination, or lists one or several active ingredients for such combination treatment – specific combination) ([…]). Furthermore, it is unclear whether the marketing authorisation of the evaluated medicinal product or the marketing authorisation of the other medicinal product is decisive or if it is irrelevant which marketing authorisation mentions combined use. Questions of interpretation may also include at what point a treatment constitutes combined use rather than monotherapy or a change of treatment. The explanatory memorandum to the draft Act to Reduce Supply Bottlenecks for Off-Patent Medicinal Products and to Improve the Supply of Paediatric Medicinal Products, which amended § 130e of the Fifth Book of the Code of Social Law, highlights the complexity and diversity of medical care situations that may constitute combined use which is subject to a discount. The memorandum therefore states that specification is required in delegated legislation (cf. BTDrucks 20/6871, p. 43).

53

bb) The complainants failed to sufficiently demonstrate why it should be unreasonable or impossible for them to take recourse to the ordinary courts in order to resolve these questions of interpretation before lodging their constitutional complaints. In relation to the designation of their medicinal products as combination medicinal products by the Federal Joint Committee, avenues of legal protection before the social courts should exist. Even in the absence of an express provision in this regard, the availability of a declaratory action is not completely ruled out. The designation of combinations of medicinal products is a provision in the Medicinal Products Standard. According to the established case-law of the Federal Social Court, instruments of legal protection exist if pharmaceutical companies seek to challenge a provision of the Medicinal Products Standard (cf. Decisions of the Federal Social Court, Entscheidungen des Bundessozialgerichts – BSGE 96, 261 <263 ff. para. 24 ff.>; 110, 20 <25 para. 19>; 116, 1 <3 para. 20>; Federal Social Court, Judgment of 5 September 2024 – B 3 KR 5/23 R -, para. 15). With these instruments, not only can the invalidity of delegated legislation be asserted, but also its erroneous interpretation or application, as well as a claim to amend such delegated legislation (cf. BSGE 96, 261 <264 para. 27>; 110, 20 <26 para. 21>; 116, 1 <3 para. 20>; Federal Social Court, Judgment of 10 September 2020 - B 3 KR 11/19 R -, para. 17; established case-law). Furthermore, legal protection in the ordinary courts may be obtained against the provision on implementation (cf. § 130e(2) fourth sentence of the Fifth Book of the Code of Social Law) and against implementation through determination by the Federal Ministry of Health pursuant to § 130e(2) third sentence of the Fifth Book of the Code of Social Law. Finally, it also does not appear impossible that the complainants can take legal action directly against claims of the drug combination discount by statutory health insurance providers (cf. also § 130e(2) fifth sentence of the Fifth Book of the Code of Social Law).

II. 

54

The constitutional complaints relating to the manufacturer discount under § 130a(1b) of the Fifth Book of the Code of Social Law are only admissible in part. They are not inadmissible on the grounds that the manufacturer discount only applied from 1 January 2023 to 31 December 2023 (see 1. below). The constitutional complaints are also compatible with the principle of subsidiarity in this regard (see 2. below). However, they only satisfy the substantiation requirements regarding the possibility of a fundamental rights violation in part (see 3. below).

55

1. In relation to the manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law, the constitutional complaints are directed against a provision which, due to its one-year time limit, has already ceased to have effect at the time of the decision on the constitutional complaint. However, given that this provision is the legal basis for the actual discount on the pharmaceutical companies’ selling price granted to the statutory health insurance providers for the medicinal products dispensed within the statutory health insurance system, the adverse effects on the complainants have not ceased with the expiry of the provision on 31 December 2023.

56-60

2. […]

61

3. That said, the constitutional complaints only satisfy the requirements regarding the substantiation of a possible violation of fundamental rights following from § 23(1) second sentence, first half-sentence and § 92 of the Federal Constitutional Court Act in part. According to these requirements, the constitutional complaints must address the underlying ordinary law and the constitutional assessment of the facts of the case and sufficiently substantiate that a violation of fundamental rights appears possible (cf. BVerfGE 140, 229 <232 para. 9>; 162, 1 <52 para. 94>; 169, 332 <358 para. 58>). Both constitutional complaints do sufficiently substantiate the possibility that the manufacturer discount violates Art. 12(1) of the Basic Law in conjunction with Art. 19(3) of the Basic Law. However, insofar as a violation of Art. 14(1) of the Basic Law is also asserted in proceedings I., this claim is not sufficiently substantiated (see a) below), and insofar as a violation of Art. 3(1) of the Basic Law is asserted, this claim is only substantiated in part (see b) below).

62

a) The complainants do not sufficiently substantiate that the manufacturer discount violates Art. 14(1) of the Basic Law. In this regard, the complainant in proceedings I. merely states that its business operations are affected and can no longer be continued in the same way as in the past. However, the constitutional complaint fails to address the case-law of the Federal Constitutional Court, according to which the protection of business operations cannot go further than the protection afforded to its economic basis (cf. BVerfGE 143, 246 <331 para. 240>; 155, 238 <274 para. 86 f.> – Offshore Wind Energy Act) and covers only the specific rights and goods that actually exist. By contrast, mere prospects for revenue and profits or actual circumstances are not covered by the guarantee of private property, including with regard to business operations (cf. BVerfGE 143, 246 <331 para. 240>; 155, 238 <274 para. 86>). The constitutional complaint fails to demonstrate why different standards should apply in the present case, even though (only) future services and deliveries of the complainant are affected by the rules.

63

b) Furthermore, the complainant in proceedings I. did not sufficiently substantiate its challenge regarding a violation of Art. 3(1) of the Basic Law (see aa) below) on the grounds of unequal treatment of the complainant, as an importer of patented medicinal products, compared to manufacturers of generics and manufacturers of medical devices (see bb) below). By contrast, the complainant’s assertion of impermissible unequal treatment compared to manufacturers of medicinal products is admissible (see cc) below).

64

aa) Art. 3(1) of the Basic Law requires that all people be treated equally before the law. The resulting requirement to treat equally that which is essentially alike and to treat unequally what is essentially different applies to both unequal burdens and unequal privileges. The finding of a violation of Art. 3(1) of the Basic Law on the grounds of unequal treatment requires that two comparable situations are treated differently. A violation of the general guarantee of the right to equality is ruled out if there are no comparable situations whose unequal treatment could reasonably be reviewed on the basis of Art. 3(1) of the Basic Law (cf. BVerfGE 133, 1 <20 f. para. 63>), for instance, because the different situations are governed by provisions from different legal areas and occur in disparate systematic contexts (cf. BVerfGE 40, 121 <139 f.>; 133, 1 <21 para. 63>). […]

65

bb) Insofar as the complainant challenges the unequal treatment of importers of patented medicinal products compared to the manufacturers of generics and/or medical devices, the constitutional complaint is inadmissible. It is true that, when adopting cost control measures in relation to statutory health insurance with the goal of achieving a structural balance, the legislator must, where applicable, also ensure a certain equality of burdens between different suppliers (cf. BVerfGE 70, 1 <32 ff.>; 103, 172<186>). However, this entails neither an obligation to involve all suppliers in cost-cutting measures based on their sales or contribution to the most recent cost increases, nor an obligation to use precisely these criteria and to pursue equality of burdens through a single law setting forth individual measures. Therefore, the mere fact that a supplier provides services in the statutory health insurance system is not sufficient to require justification under the right to equality in relation to the pharmaceutical companies burdened with the manufacturer discount, and the subgroup of importers of medicinal products in particular. The constitutional complaint fails to demonstrate and substantiate the presence of comparable situations in this respect. The complainant does not address the fact that manufacturers of generics and importers of medicinal products are subject to completely different regulatory regimes with regard to the medicinal products placed on the market by them (generics vs patented medicinal products) and that their pricing structures are hardly comparable, nor does it sufficiently discuss possible grounds justifying the unequal treatment. The same applies to the asserted unequal treatment compared to manufacturers of medical devices. The complainant fails to even give a detailed description of the comparison group of manufacturers of medical devices, which is likely to be very heterogeneous due to the differences between the various medical devices.

66

cc) […]

III. 

67

With regard to the extended price moratorium (§ 130a(3a) of the Fifth Book of the Code of Social Law), the constitutional complaints only satisfy the substantiation requirements following from § 23(1) second sentence, first half-sentence and § 92 of the Federal Constitutional Court Act insofar as they challenge a violation of Art. 12(1) of the Basic Law, but not insofar as (in proceedings I.) they challenge a violation of Art. 3(1) and Art. 14(1) of the Basic Law, for essentially the same reasons as those set out above with regard to the manufacturer discount. This also applies to the assertion by the complainant in proceedings I. of unjustified unequal treatment compared to manufacturers of medicinal products, given that the complainant does not sufficiently address the fact that § 130a(3a) sixth sentence of the Fifth Book of the Code of Social Law exempts imported medicinal products from the manufacturer discount extended by the price moratorium insofar as the imported medicinal products (after the price increase) remain cheaper for statutory health insurance providers than the reference medicinal product, within the scope determined in § 129(1) first sentence no. 2 of the Fifth Book of the Code of Social Law.

C. 

68

To the extent that the constitutional complaints are admissible, they are unfounded. Neither the manufacturer discount (§ 130a(1b) of the Fifth Book of the Code of Social Law; see I. below) nor the extension of the price moratorium (§ 130a(3a) of the Fifth Book of the Code of Social Law; see III. below) violate the complainants’ fundamental right under Art. 12(1) of the Basic Law. The challenged provisions also do not violate the fundamental right under Art. 3(1) of the Basic Law of the complainant in proceedings I. (see II. below). The cumulative effect of the legislative measures does not merit a different assessment (see IV. below).

I. 

69

The manufacturer discount of 12% of the pharmaceutical company’s selling price constitutes an interference with the complainants’ freedom to practice an occupation under Art. 12(1) of the Basic Law (see 1. below), which is, however, justified under constitutional law (see 2. below).

70

1. a) aa) Art. 12(1) of the Basic Law guarantees all Germans a comprehensive fundamental right to freely choose and practice their occupation. ‘Occupation’ is any activity that is practised on a long-term basis and serves to create and maintain a livelihood (cf. BVerfGE 103, 172 <182 f.>; 145, 20 <67 para. 120>; 161, 63 <89 para. 43> - Wind farm participatory companies). Occupational freedom also encompasses the right of those operating in the market to determine the conditions of their market participation themselves. In particular, suppliers can determine the type and quality and the price of the goods and services they provide themselves (cf. BVerfGE 106, 275 <299>). The fundamental right also includes the freedom to negotiate binding remuneration for occupational services (cf. BVerfGE 101, 331 <347>; 117, 163 <181>; 134, 204 <222 para. 66>; 142, 268 <281 para. 49>). Insofar as the conduct of market participants is restricted by statutory provisions, the applicable standard must be the fundamental rights of the affected market participants, rather than those of other market participants (BVerfGE 106, 275 <299>).

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bb) The complainant in proceedings II. manufactures medicinal products and distributes them. Both activities are occupational activities protected by Art. 12(1) of the Basic Law. Moreover, the complainant conducts research and develops new medicinal products with a view to marketing them profitably, and therefore also pursues an occupation in this respect. The complainant in proceedings I. imports medicinal products to Germany which the marketing authorisation holder and/or manufacturer markets in other Member States of the European Union or the European Economic Area in order to place them on the market in Germany, in parallel with the original pharmaceutical company. As set out above, this constitutes an occupational activity protected by Art. 12(1) of the Basic Law. Both complainants can invoke their occupational freedom as domestic legal persons under Art. 19(3) of the Basic Law.

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b) aa) The protection afforded by Art. 12(1) of the Basic Law only applies to legal provisions or acts of public authority that either directly concern occupational activity or, where this is not the case, change the framework in which the practice of the occupation occurs and, as a result of their design, are so closely related to the practice of an occupation that they objectively have a regulatory effect (objektiv berufsregelnde Tendenz) (cf. BVerfGE 97, 228 <25 – Interest on nuclear fuel tax; 163, 107 <134 para. 73>). Remuneration is typically agreed in contracts, and freedom of contract is protected by the fundamental right to general freedom of action under Art. 2(1) of the Basic Law (cf. BVerfGE 65, 196 <210>; 74, 129 <151 f.>). However, where a statutory provision affects freedom of contract in the context of occupational activities that are specifically protected by Art. 12(1) of the Basic Law, the general freedom of action is not the primary standard of review (cf. BVerfGE 68, 193 <223 f.>; 128, 157 <176>; 134, 204 <222 f. para. 67>). Therefore, rules on remuneration imposed by the state and decisions taken on this basis that have a considerable impact on income that can be generated by an occupational activity, and thereby also on livelihood, restrict the freedom to practise an occupation (cf. BVerfGE 101, 331 <347>; 134, 204 <222 para. 66>). Compulsory price discounts to be granted to statutory health insurance providers must therefore be reviewed on the basis of occupational freedom under Art. 12(1) of the Basic Law (cf. BVerfGE 114, 196 <244>). A price discount de facto regulates prices and thus constitutes interference with occupational freedom in the form of a rule regarding the practice of an occupation (cf. BVerfGE 68, 193 <218>; 114, 196 <244>; cf. also Federal Constitutional Court, Order of the Third Chamber of the First Senate of 15 May 2007 - 1 BvR 866/07 -, para. 16).

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bb) Based on this standard, the manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law interferes with the complainants’ freedom to practice an occupation. The provision affects the freedom of contract directly in the context of an occupational activity in the form of price regulation.

74

2. The interference with the pharmaceutical companies’ occupational freedom resulting from the manufacturer discount is justified. Restrictions of the freedom to practice an occupation are compatible with Art. 12(1) of the Basic Law if they have a statutory basis, serve reasonable purposes of the common good, are suitable and necessary to achieve these purposes and do not excessively affect those practising an occupation, i.e. if they satisfy the principle of proportionality (cf. BVerfGE 7, 377 <405 f.>; 77, 308 <332>; 111, 10 <32>; 117, 163 <182>; established case-law). The manufacturer discount is based on a law that is formally constitutional (see a) below). It is also substantively compatible with Art. 12(1) of the Basic Law, in particular, the interference satisfies the proportionality requirements. It serves a legitimate purpose (see b) below) and is suitable (see c) below), necessary (see d) below) and appropriate (see e) below) to pursue this purpose.

75

a) The practice of an occupation or profession may be regulated by or pursuant to a law. This law must be formally compatible with the Basic Law. This is the case here. In particular, the federal legislator could base the law on its concurrent legislative powers with regard to social security under Art. 74(1) no. 12 of the Basic Law.

76

Social security within the meaning of Art. 74(1) no. 12 of the Basic Law must be understood as a broad category. It typically covers systems that meet the social need to compensate for special burdens and provide for independent institutions or corporations under public law, which raise their funds mainly through contributions. This includes the types of insurance that were known at the time the Basic Law was created, which serve to compensate burdens arising from sickness, old age, invalidity and accidents (cf. BVerfGE 11, 105 <111 ff.>); it thus also includes statutory health insurance (cf. BVerfGE 114, 196 <221>). It also covers areas that are closely linked to a traditional social insurance provider without necessarily requiring the payment of contributions, because social insurance has always been characterised by the combination of the insurance principle with elements of public welfare (cf. BVerfGE 126, 369 <389>). Given that the aspects of contributions and services are central to the concept of social security, the competence covers legislation on the financing of the tasks to be performed, which not only includes contributions in the narrower sense, but also rules regarding financial relief for social security systems (cf. BVerfGE 113, 167 <195>; 114, 196 <221>). Both elements serve to maintain the viability of these systems. It is therefore irrelevant whether the federal legislator could additionally base the statutory obligations to grant discounts on its legislative competence for the law on medicines under Art. 74(1) no. 19 of the Basic Law (cf. BVerfGE 102, 26 <36 ff.>; 114, 196 <221 f.>).

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b) The manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law pursues a legitimate purpose. The objectives pursued by a law can be derived not only from the legislative materials (cf. BVerfGE 159, 223 <298 para. 169> – Federal pandemic emergency brake I <curfews and contact restrictions>; 161, 163 <268 f. para. 291> – Economic costs of child-raising in the social security system; 163, 107 <138 f. para. 86>), but also from the objective intent of the legislator (cf. BVerfGE 161, 63 <93 para. 57>; 167, 163 <213 para. 115> - Contergan II). It is only if there are no constitutionally recognised purposes whatsoever that a provision is declared unconstitutional (cf. BVerfGE 163, 107 <139 para. 87>).

78

In enacting the manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law, in combination with other measures provided for in the Act, the legislator seeks to react to the uneven development of revenue and expenditure in the statutory health insurance system and thus ensure the financial stability of this system (see para. 2 above). This is a legitimate aim (cf. BVerfGE 68, 193 <218>; 103, 172 <184 f.>; 123, 186 <264>).

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c) The interference with fundamental rights resulting from § 130a(1b) of the Fifth Book of the Code of Social Law is suitable for achieving the purpose pursued by the provision.

80

aa) An interference is suitable if it furthers the purpose of a provision. The suitability requirement is satisfied under constitutional law if there is a possibility of achieving the legislative purpose with the provision (cf. BVerfGE 161, 299 <367 para. 166> – Proof of vaccination <COVID-19>; established case-law). With regard to a measure for the financial stabilisation of the statutory health insurance system, it can be sufficient for purposes of the suitability requirement that the savings achieved are small (cf. BVerfGE 70, 1 <29>) and the achievement of savings is furthered (cf. Federal Constitutional Court, Order of the Third Chamber of the First Senate of 20 December 1990 - 1 BvR 1418/90 u. a. -, DtZ 1991, p. 91 <92>).

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bb) Based on these standards, the manufacturer discount is suitable for lowering expenditure for medicinal products and thus for contributing to the financial stabilisation of the statutory health insurance system. According to the legislator’s assessment, the manufacturer discount results in savings of one billion euros, despite being limited to the year 2023 (cf. BTDrucks 20/3448, p. 5). The same applies with regard to the inclusion of importers of medicinal products into the scope of application of the manufacturer discount under § 130a(1b) of the Fifth Book of the Code of Social Law. Insofar as the complainant in proceedings I. argues that importers will then no longer be able to supply more affordable imported medicinal products, this argument concerns potential future effects which are not specified or proven. It is obvious that the application of the manufacturer discount to imported medicinal products also contributes to expenditure reductions. The plausibility of the legislator’s assessment to this effect is not called into question by the argument that this might result in medicinal products no longer being parallel imported.

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d) The provision also satisfies the constitutional requirement of necessity.

aa) Interferences with fundamental rights must not go further than is necessary to achieve the legislative purpose. A measure falls short of this standard if an equally effective means is available to achieve the aim of the common good that would be less intrusive for the affected fundamental rights holders and would not entail greater burdens for third parties or the general public. It must be clearly established that the alternative measure is equally effective in every respect for achieving the purpose pursued. In principle, the legislator has a margin of appreciation when assessing the necessity of a law. This margin of appreciation includes, among other things, appraising the effects of the chosen measures in comparison with other, less intrusive measures. The margin may be narrower depending on the fundamental right affected or the severity of interference. Conversely, the more complex the matter addressed by the legislator, the broader the margin (cf. BVerfGE 161, 63 <119 para. 125>; 161, 299 <378 para. 187>; 162, 378 <428 para. 117> – Proof of vaccination <measles>).

83

bb) Based on these standards, the interference with fundamental rights resulting from § 130a(1b) of the Fifth Book of the Code of Social Law is necessary to achieve legitimate purposes of the common good. While the savings could probably also have been achieved through measures in other areas, this does not preclude the necessity of the increased manufacturer discount, given that measures in other areas would impose greater burdens on third parties or the general public. It is not for the Federal Constitutional Court to decide whether other equally effective measures are conceivable when it comes to cost control measures in the statutory health insurance system (cf. BVerfGE 68, 193 <218>). When the legislator uses diverse means to pursue a complex goal, such as ensuring the financial stability of statutory health insurance, a measure taken in this context does not fail to meet the necessity requirement on the grounds that those affected see greater potential for savings elsewhere (cf. BVerfGE 103, 172 <183>; cf. also Chamber Decisions of the Federal Constitutional Court, Kammerentscheidungen des Bundesverfasssungsgerichts – BVerfGK 2, 283 <288>).

84

e) The interference with fundamental rights resulting from § 130a(1b) of the Fifth Book of the Code of Social Law also satisfies the requirements of proportionality in the strict sense. The principle of proportionality in its strict sense requires that in an overall assessment, the severity of the legislative restriction of a fundamental right (see aa) below) not be disproportionate to the importance (see bb) below) and the urgency (see cc) below) of the reasons invoked to justify it. In this respect, an appropriate balance must be struck between the severity of interference resulting from the statutory provision and the legislative aim pursued (cf. BVerfGE 83, 1 <19>; 133, 277 <322 para. 109>; 161, 63 <122 para. 134>; established case-law) (see dd) below). In an overall assessment (see ee) below) balancing the severity of the burdens against the importance and urgency of the reasons invoked to justify it, the limits of what is reasonable must be observed (cf. BVerfGE 152, 68 <137 para. 183> – Sanctions imposed under social law; established case-law). When assessing whether a provision impacting the economic structure in the context of the practice of an occupation is reasonable, it is not individual interests that are decisive; rather, a general assessment is required that looks at the affected industry in its entirety (cf. BVerfGE 30, 292 <316 f.>; 68, 193 <219>; 70, 1 <30>).

85

aa) Where interferences with the right to free price formation are concerned, an important aspect is the extent of the burdens imposed on the affected industry (cf. BVerfGE 68, 193 <219>), in particular their scale and duration (cf. Federal Constitutional Court, Judgment of the First Senate of 28 November 2024 - 1 BvR 460/23 inter alia -, para. 112 f. – Electricity price controls, to be published in BVerfGE 170). Moreover, it is significant whether the burdens imposed adversely affect past or future investment decisions or whether those affected could otherwise have developed the legitimate expectation that free price formation would continue unchanged (cf. Federal Constitutional Court, Judgment of the First Senate of 28 November 2024 - 1 BvR 460/23 inter alia -, para. 122). It can also be relevant whether those affected have market possibilities to react to the burdens and whether there are exemptions for atypical cases (cf. also BVerfGE 103, 172 <193>). Finally, the question to what extent the conduct of those affected has brought about (or contributed to) the risk to the common good that the interference serves to address can be included in the balancing of interests (cf. Federal Constitutional Court, Judgment of the First Senate of 28 November 2024 - 1 BvR 460/23 inter alia -, para. 112).

86

In the present case, the interference with fundamental rights is moderate. Statutory price discounts in the context of statutory health insurance have typically been considered minor interferences (cf. BVerfGE 68, 193 <219>; 108, 45 <50 f.>). What is more, the one-year period of application of § 130a(1b) of the Fifth Book of the Code of Social Law is very limited (regarding other cases of interference subject to time limits cf. BVerfGE 70, 1 <30>; Federal Constitutional Court, Order of the Second Chamber of the First Senate of 8 October 2004 - 1 BvR 682/01 -, NVwZ-RR 2005, p. 1 <2>). Nevertheless, in light of the volume of savings of more than one billion euros, the discount of 12%, the application of manufacturer discounts in different forms beginning at the latest from 2002 and the additional hedge through the price moratorium under § 130a(3a) of the Fifth Book of the Code of Social Law, the interference must be considered to be of greater weight than merely low severity; this is the case at least from 2009 onwards and in view of the lack of possibilities of avoiding it. Nor can those affected switch to the market outside statutory health insurance (cf. in this regard BVerfGE 106, 275 <301 f.>), because the manufacturer discount also takes effect in the context of private health insurance and state healthcare benefits for private health insurance via § 1 of the Act on Rebates for Medicinal Products (Gesetz über Rabatte für Arzneimittel). The considerable weight of interference applies irrespective of the mitigating factors, namely that the manufacturer discount under § 130a(1b) of the Fifth Book of the Code of Social Law does not apply to all medicinal products on the market, that the legislator provided for the possibility of exemptions for special cases in § 130a(4) of the Fifth Book of the Code of Social Law, and that the negative impact on future investment decisions will likely not be too great given the time limit of the manufacturer discount.

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bb) The interference must be viewed in light of its purpose of ensuring the financial stability of statutory health insurance, an exceptionally significant task of the common good (cf. BVerfGE 70, 1 <25, 28f., 30>; 103, 172 <184 f.>;114, 196 <244, 248>; 123, 186 <264>; Federal Constitutional Court, Order of the Third Chamber of the First Senate of 20 December 1990 - 1 BvR 1418/90 inter alia -, DtZ 1991, p. 91 <92>; Order of the Second Chamber of the First Senate of 1 September 1999 - 1 BvR 264/95 inter alia -, para. 10) that the legislator is not only authorised, but also required to pursue (cf. BVerfGE 68, 193 <218>). Where healthcare is to be provided to the population through a social security system, its financing constitutes an exceptionally significant interest of the common good, which may, and must, guide the legislator when designing the system and steering the behaviour of service providers (cf. BVerfGE 103, 172 <185, 192 f.>).

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cc) The legislator assumed that the aims pursued by it were so urgent as to justify legislative action. Contrary to the complainants’ submissions, this assessment is not constitutionally objectionable.

89

Insofar as the legislator seeks to guarantee healthcare for the population through statutory health insurance, it must reconcile different interests of the common good and fundamental rights positions of many groups that sometimes conflict with one another (BVerfGE 114, 196 <248>). Therefore, due to risks to the financial stability of the statutory health insurance system arising from the complexity of the system, the review of cost control measures in the context of statutory health insurance is typically restrained, taking the form of a review of evident errors or a review of whether the legislator’s assessment is plausible (cf. also BVerfGE 68, 193 <224 f.>; 114, 196 <248>). Based thereon, there are no indications that the legislator’s assessment of urgency (see (1) below) was not plausible (see (2) below).

90

(1) In enacting the manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law, in combination with other measures provided for in the Act, the legislator seeks to react to the uneven development of revenue and expenditure in the statutory health insurance system and thus ensure the financial stability of this system. The legislator states several factors that have brought an end to a proportionate development of revenue and expenditure seen until 2019 (termination of the federal subsidy paid in the context of COVID-19, demographic change, decline in the number of contributors, disproportionate cost increases in several areas). The legislator assumes that the increase in income subject to statutory health insurance contributions will likely also be lower for the coming years, just as it was for 2020 and 2021; factors contributing to this development are demographic change and the anticipated decline in the number of employees. In order to not impose the entire burden of the gap in the financing of statutory health insurance that has grown since 2020 on contributors, the gap is to be closed by drawing on the financial reserves of statutory health insurance and providing more federal funds on the revenue side, and by a stabilisation in view of the increasing expenditure for medicinal products on the expenditure side. According to the legislator, the increases in expenditure in the coming years are expected to be shaped primarily by advances in medical technology, an ageing society and rising wages due to the shortage of skilled workers. Without additional measures, the average additional contribution rate paid by contributors to statutory health insurance would increase from 1.3% by approximately one percentage point in 2023 and subsequently, due to the gap between revenue and expenditure, by another 0.2 to 0.3 percentage points each year. Currently, one percentage point amounts to approximately EUR 16 billion. The legislator intends to reduce the anticipated increase in the additional contribution rate by 1%, which means that the scale of the cost containment measure is not disproportionate to the reasons for taking such a measure (cf. BTDrucks 20/3448, p. 1 ff.).

91

(2) It is not ascertainable that the legislator’s assessment, according to which a widening gap between revenue and expenditure of statutory health insurance would arise unless legislative measures were taken, is flawed.

92

This applies first and foremost to the challenge of demographic change invoked by the legislator. According to the 15th coordinated population projection of the Federal Statistical Office ([…]), the ratio of people of working age (here: from 20 to 66 years) to people over 67 will increase towards people over 67 in all variants of the forecast over the next 15 years. The dependence of statutory health insurance on demographic developments is also evident in the projected increases in the net recipient ratio, which reflects the ratio of net recipients to net contributors in statutory health insurance (cf. Federal Court of Audit, report under § 88(2) of the Federal Budget Code to the Bundestag Budget Committee, Committee on Labour and Social Affairs and the Committee on Health – Demographic development: Financial risks for the Federation arising from its participation in the financing of social security of 23 May 2022, p. 43).

93

This is another reason why the legislator was entitled to assume that the ratio of revenue to expenditure in statutory health insurance had been growing increasingly skewed in recent years. Over the past two decades, the expenditure of statutory health insurance rose by an average of 1.08 percentage points more per year than the income subject to statutory health insurance contributions. The majority of the revenue of statutory health insurance is based on contribution payments from income subject to contributions. According to forecasts by the Federal Court of Audit, changes in the structure of those insured and the development of average per-capita expenditure and average per-capita income mean that expenditure and revenue from contributions are diverging (cf. Federal Court of Audit, loc. cit., p. 46).

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dd) The legislator accords great importance to the manufacturer discount and in particular its combination with the range of other measures provided for by the Act. The manufacturer discount specifically serves to further the legislative aims. The anticipated gaps in revenue relating to the termination of the federal subsidy paid in the context of COVID-19 are in part offset by the manufacturer discount for one year, until other measures take effect. This is also not objectionable under constitutional law (regarding the standard cf. para. 89 above). In the present case, it cannot be assumed that the significance of the public interest in the financial stability of statutory health insurance is reduced by a conflicting interest of the common good (cf. in this regard Federal Constitutional Court, Judgment of the First Senate of 14 January 2025 - 1 BvR 548/22 -, para. 85), such as ensuring the supply of innovative medicinal products. The evaluation commissioned by the Federal Ministry of Health does not provide any indication beyond speculation that the measures could adversely affect the security of supply of innovative and cost-effective medicinal products ([…]).

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ee) In weighing the burden resulting from the manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law on the one hand against its effect of furthering interests of the common good on the other, the outcome is that the challenged provision is appropriate. This follows from the fact that the provision specifically serves to further an exceptionally significant interest of the common good while resulting in interference of moderate severity in an area where the legislator is afforded broad leeway. In addition, the particular features of the statutory health insurance system must be taken into account (see (1) below). The provision also does not exceed the limits of what is reasonable due to a risk of stifling the affected industry (see (2) below). The same applies to importers of medicinal products (see (3) below).

96

(1) When assessing the appropriateness of interferences with the freedom to practice an occupation that have a financial effect and which serve to ensure the financial stability of statutory health insurance, it must be taken into account that the statutory health insurance system is for the most part not driven by market forces (see (a) below) and that the legislator bears special responsibility for the cost stability of statutory health insurance (see (b) below). This means that service providers are particularly subject to the effects of legislation concerning the social state (see (c) below). The protection of legitimate expectations regarding interferences that serve to ensure the stability of the statutory health insurance system is limited (see (d) below). This is especially the case when the legislator imposes burdens on those who, in its view, bear particular responsibility for the cost increases (see (e) below). In light of the foregoing, the manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law is appropriate (see (f) below).

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(a) The statutory health insurance system is for the most part not driven by market forces. Prices of goods and services are not freely negotiated in the context of free competition (BVerfGE 103, 172 <185>). Service providers that challenge cost containment measures do not challenge state measures that concern their own activities and services in a free market; rather, such challenges concern their involvement in the comprehensive social system of statutory health insurance which is financed by the contributions of those insured and for which the state is responsible with regard to its proper functioning (cf. BVerfGE 70, 1 <31>; 103, 172 <185 f.>). In principle, this has not been changed by the introduction of elements generating competition, such as the free choice of a health insurance provider by those insured or the introduction of risk structure equalisation between different types of statutory health insurance providers through the Healthcare Structure Act (Gesundheitsstrukturgesetz) of 21 December 1992 (BGBl I p. 2266) (cf. BVerfGE 113, 167 <233>).

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(b) It is inherent in the system that the legislator bears special responsibility for the cost stability of statutory health insurance, which is a necessary part of the social state. The German statutory health insurance system is a pay-as-you-go healthcare system financed by contributions to provide full healthcare to almost 90% of the population ([…]). Insurance benefits are largely provided as benefits in kind, without any direct cost sharing by those insured. Such a system tends to see cost increases. The identification of needs and cost control are not done by the same body (cf. BVerfGE 103, 172 <173>). In view of these factors and the general economic conditions, it is for the legislator to determine what contributions are reasonable for those insured, their employers and the pension insurance providers and which healthcare services can be paid from the funds available (BVerfGE 103, 172 <186>).

99

(c) The legislator’s obligation to design the statutory framework also comprises the involvement of service providers. They are beneficiaries of the system of benefits in kind of statutory health insurance, which provides greater economic security than free competition (cf. BVerfGE 70, 1 <30>). This applies to pharmaceutical companies in particular. Ultimately, statutory health insurance providers (via wholesalers and pharmacies, which only acquire medicinal products to resell them) are customers who are obliged to supply the medicinal products prescribed by contracted doctors to those insured. While such pharmaceutical companies compete with other pharmaceutical companies, statutory health insurance providers are generally obliged to provide insured persons with prescription drugs that have been prescribed by their contracted doctor. This differs from the situation in a free market, where consumers can reject a product (for example because the price is too high). Once the eligibility requirements stipulated by health insurance law, which go beyond those stipulated by medicinal products law, are met, statutory health insurance providers are obliged to provide benefits to insured persons as end consumers. In view of this involvement in the obligation to provide benefits of statutory health insurance providers on the one hand, and participation in a market the general functioning of which is to be ensured by legislative measures on the other, pharmaceutical companies, just as other providers, are particularly subject to the effects of legislation concerning the social state (cf. BVerfGE 68, 193 <220 f.>; 70, 1 <31>; 103, 172 <185>). This must be taken into account when determining the limit up to which the legislator may permissibly regulate the amount of remuneration for services provided so as to align the expenditure and revenue of statutory health insurance (cf. BVerfGE 68, 193 <221>). In setting the framework for the financing of statutory health insurance, the legislator must also determine the conditions for service providers in such a way that statutory health insurance providers can fulfil their mandate to guarantee sufficient healthcare. This requires capable suppliers in the healthcare system (cf. regarding doctors BVerfGE 103, 172 <186>).

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(d) To the extent that protected legitimate expectations of pharmaceutical companies as to the invariability of the pricing rules in the statutory health insurance system exist at all, they are very limited. As the flip side to the state’s responsibility to provide stability, this applies above all in relation to measures that serve to counteract structural deficits in the statutory health insurance system (cf. BVerfGE 106, 275 <304>). But pharmaceutical companies must also expect mere cost containment measures, particularly when these are known as measures in the respective areas of service (cf. BVerfGE 70, 1 <27>; 114, 196 <242 f.>), price formation was not free even before the new rules entered into force (cf. BVerfGE 114, 196 <242 f.>), or when prior cost containment measures must be ‘improved’ and/or consequences must be drawn from their shortcomings (cf. BVerfGE 68, 193 <218 f.>; 70, 1 <26>; 114, 196 <245>).

101

(e) If a measure specifically targets an area that the legislator has identified as the reason for the big increase in expenditure, this strengthens its constitutional justification (cf. BVerfGE 68, 193 <219>; 70, 1 <33 f.>; 114, 196 <245>). That said, contrary to the submissions of the complainant in proceedings II., the legislator is, when faced with an increasing financial deficit, not obliged to take action involving those that bear particular responsibility for the increasing deficit, nor is the legislator obliged under constitutional law to act exclusively based on the respective shares of responsibility. If, in turn, the legislator seeks to counteract excessive deficits that have been identified or will likely arise through cost containment measures, it is relevant when it comes to the appropriateness of the measures that the legislator takes action involving those that have at least contributed to the deficit to a particular degree (cf. also BVerfGE 70, 1 <33 f.>). According to the legislator’s unobjectionable assessment, which the Federal Constitutional Court only reviews as to its plausibility (see para. 88 above), the cost increases in statutory health insurance that have occurred and can be expected in the future are based precisely on a disproportionate increase in spending on medicinal products (see (aa) below). This applies in particular to pharmaceutical companies that place patented medicinal products on the market (see (bb) below).

102

(aa) According to the legislator’s assessment, the increase in expenditure for medicinal products in recent years has been greater in percentage terms than the increase in total expenditure by statutory health insurance providers (cf. BTDrucks 20/3448, p. 40). This assessment is based on sufficiently sound statistical data and is therefore plausible. It follows from the figures regarding statutory health insurance for 2023 published by the Federal Ministry of Health ([…]), which are also referenced in the Ministry’s statement, that the percentage increase in expenditure for medicinal products from 2019 to 2022 was higher than the increase in expenditure for all benefits provided by statutory health insurance. The increase in expenditure for medicinal products over the last ten years was six times higher than the increase in expenditure for all benefits per insured person.

103

The calculations submitted by the complainants, and in part also by the associations asked to submit a statement, are not capable of refuting this legislative assessment. They do not call into question the tenability of the calculations on which the legislator based its assessment (and that were submitted by the Federal Ministry of Health); rather, they use different points of reference and calculation methods and thus arrive at a different result. It has certainly not been demonstrated that the legislator’s assessment of the development of expenditure for medicinal products is so flawed that the legislative leeway has been exceeded.

104

(bb) The legislative materials and the statement of the Federal Ministry of Health set forth that it is necessary to stabilise the considerable development of expenditure – in particular with regard to patented medicinal products (cf. BTDrucks 20/3448, p. 1). The manufacturer discount – just like other measures of the Act that are not directly under review in the present proceedings – concerns new, patented medicinal products in particular. The legislator’s assessment that the most recent cost increases can be attributed to patented medicinal products in particular is likewise not evidently flawed. According to the figures generally available and submitted in the statements in these proceedings, the share of patented medicinal products in total sales of medicinal products, like the sales of patented medicinal products, has increased disproportionately for the most part. The same applies to the annual treatment costs of new medicinal products ([…]).

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(f) In light of the foregoing, the manufacturer discount is appropriate. The legislator’s special responsibility for the cost stability of statutory health insurance and the particular effects that legislation concerning the social state has on pharmaceutical companies, which, in the legislator’s view, have some responsibility for cost control, mean that the aim of the common good pursued by the legislator must clearly prevail. Specific circumstances exist based on which the Act pursues the aim of ensuring the financial stability of statutory health insurance. The measure significantly furthers the aim of the common good. The cost containment pursued with the set of measures is not inappropriate in relation to the underlying reason. The legislator bases the manufacturer discount on existing instruments whose effects alone are, in the legislator’s view, no longer sufficient for the future. Moreover, the manufacturer discount is not a stand-alone measure, but is part of a range of measures that also affect other service providers (cf. BVerfGE 70, 1 <33 f.>; 114, 196 <245>; Federal Constitutional Court, Order of the Second Chamber of the First Senate of 8 October 2004 - 1 BvR 682/01 -, NVwZ-RR 2005, p. 1 <2>). Finally, it also appears plausible that if the state seeks to phase out special state support provided to the statutory health insurance system in the context of the pandemic and return to pre-pandemic levels, the state should use an instrument that is effective in the short term for a transitional period of one year, before other, stronger measures that are directed at long-term consolidation take effect (cf. BTDrucks 20/3448, p. 40 f.).

106

(2) It is also not ascertainable that the limits of reasonableness have been exceeded due to a risk of stifling the affected industry (cf. in this regard BVerfGE 68, 193 <223>; 114, 196 <246>). Although the cost containment of EUR 1.3 billion resulting from § 130a(1b) of the Fifth Book of the Code of Social Law is considerable in itself, particularly in an ex post assessment, it does not exceed the limits of reasonableness. This is not only the case because, according to the evaluations available, there is no evidence of instability in the pharmaceutical industry in Germany or of threats to the security of supply of medicinal products (cf. BTDrucks 20/10008, p. 8; […]). It must also be taken into account that prices for identical medicinal products have been higher on average in Germany than in other European countries ([…]); it has neither been submitted nor is it otherwise ascertainable that the manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law in effect until 31 December 2023 has led to relevant market adjustments, especially because reimports and parallel imports of medicinal products remained possible. Furthermore, the Federal Government submitted that Germany ranks among the top internationally when it comes to access to new medicinal products, which suggests that the profitability of the occupational activities of pharmaceutical companies is currently not at risk. So far, there has not been a relevant decline either in the number of businesses or the number of employees in the pharmaceutical industry ([…]).

107

(3) The extension of the manufacturer discount to importers of medicinal products is also not inappropriate. In this regard, it must be taken into account that the legislator has plausibly identified pharmaceutical prices as the cause for the considerable increase in expenditure. Importers of medicinal products are required, under § 129(1) first sentence no. 2 of the Fifth Book of the Code of Social Law, to keep their selling prices 15% (or, depending on the selling price, EUR 15 or 5%) lower than the prices of the original manufacturer of the medicinal product. However, due to this link of prices to the original medicinal products, it is plausible that parallel imports of patented medicinal products also result in increases in expenditure. It is also in the interest of the security of supply for those insured, and thus within the legislator’s discretion, to promote parallel imports as an essential factor to maintain competition, while at the same time ensuring that parallel imports have a competitive effect. In order to maintain the price differential between original medicinal products and parallel imports, price regulations must also apply to such imports.

II. 

108

The manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law also does not violate the fundamental right under Art. 3(1) of the Basic Law of the complainant in proceedings I. While there is no differentiation between importers and manufacturers of medicinal products (see 1. below), this lack of differentiation is justified (see 2. below).

109

1. Importers and manufacturers of medicinal products are grouped together as pharmaceutical companies in § 4(18) of the Medicinal Products Act. They are therefore subject to the manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law regardless of whether they manufacture medicinal products and place them on the market or whether they import them from other countries and place them on the market in Germany.

110

2. Art. 3(1) of the Basic Law requires that all people be treated equally before the law. This results inter alia in the requirement to treat equally what is essentially alike and to treat unequally what is essentially different. The legislator is, however, not required to differentiate among unequal matters under all circumstances (cf. BVerfGE 161, 163 <252 para. 239>). That said, if a lack of differentiation leads to unequal burdens, it requires justification. The significance of the aims pursued by the lack of differentiation must be appropriate to both the existing factual inequalities arising from the subject matter addressed by the law and the extent of the disadvantaging effect resulting therefrom (cf. BVerfGE 161, 163 <276 para. 314>). The standard of constitutional review applicable here, which derives from the principle of proportionality, is a fluid one whose contents and limits cannot be determined in the abstract, but instead must be determined by the particular subject matters and regulatory areas affected by the law at issue (cf. BVerfGE 138, 136 <180 para. 121>; 139, 285<309para. 70>; 161, 163 <252 f. para. 239>). The criteria for the detailed determination of the extent of the binding effect correspond to those resulting from the general guarantee of the right to equality in the form of the prohibition of unequal treatment (see para. 64 above).

111

In the present case, the justification requirements arising from the lack of differentiation by the legislator are not stringent. It is true that measures amounting to interference with occupational freedom that is not inconsiderable may lead to stricter justification requirements arising from Art. 3(1) of the Basic Law (regarding the prohibition of unequal treatment cf. Federal Constitutional Court, Judgment of the First Senate of 14 January 2025 - 1 BvR 548/22 -, para. 123 f.). In the present case, however, the justification requirements are limited to the prohibition of arbitrariness, because the (lack of) differentiation is linked neither to a person nor to a product, but only to a distribution channel, and it concerns an area in which the legislator is afforded broad leeway and discretion.

112

Based on this standard, a violation of Art. 3(1) of the Basic Law can be evidently ruled out. In providing for the lack of differentiation, the legislator pursues the aim of cost containment specifically with regard to patented medicinal products and therefore also includes importers of patented medicinal products in the cost containment measure. A general exemption of importers of medicinal products from the manufacturer discount would make it more difficult to achieve the provision’s purpose. Importers of medicinal products are required, under § 129(1) first sentence no. 2 of the Fifth Book of the Code of Social Law, to keep their selling prices 15% (or, depending on the selling price, EUR 15 or 5%) lower than the prices of the original medicinal product. However, due to this link of prices to the original medicinal products, it is plausible that parallel imports of patented medicinal products also result in increases in expenditure.

113

It is also in the interest of the security of supply for those insured, and thus within the legislator’s discretion, to keep the price differential between original medicinal products and parallel imports as an essential contribution of parallel imports to maintaining competition (see para. 107 above).

III. 

114

§ 130a(3a) of the Fifth Book of the Code of Social Law (extension of the price moratorium) also results in interference with the complainants’ freedom to practice an occupation under Art. 12(1) of the Basic Law (see 1. below), which is likewise justified (see 2. below).

115

1. The obligation to grant statutory health insurance providers a discount in the amount of the price increase for a certain period amounts to direct interference with the complainants’ freedom to determine prices, and thus with their freedom to practice an occupation. With regard to the complainant in proceedings I., it must be taken into account that § 130a(3a) sixth sentence of the Fifth Book of the Code of Social Law (in part) exempts imported medicinal products from the obligation to grant a discount pursuant to § 130a(3a) first sentence of the Fifth Book of the Code of Social Law, insofar as the imported medicinal product (after the price increase) remains cheaper for statutory health insurance providers than the reference medicinal product, within the scope determined in § 129(1) first sentence no. 2 of the Fifth Book of the Code of Social Law. Yet insofar as the imported medicinal product does not retain the minimum price differential under § 129(1) first sentence no. 2 of the Fifth Book of the Code of Social Law, it is also subject to the manufacturer discount based on the price moratorium, meaning that the freedom to practice an occupation of the complainant in proceedings I. is also affected.

116

2. The interference with the pharmaceutical companies’ occupational freedom resulting from the extended price moratorium is justified. It is compatible with the principle of proportionality because it serves a legitimate purpose (see a) below) and is suitable, necessary (see b) below) and appropriate (see c) below) to pursue this purpose.

117

a) § 130a(3a) of the Fifth Book of the Code of Social Law is part of the set of measures adopted by the legislator with the Act, which serves to ensure the financial stability of statutory health insurance. This is an exceptionally significant interest of the common good that the legislator was entitled to invoke (cf. the considerations regarding the manufacturer discount, para. 77 ff.). According to the legislator’s assessment, which is plausible, the extension of the price moratorium beyond 31 December 2022 until 31 December 2026 is an essential factor for the stabilisation of expenditure for medicinal products as it prevents expected price increases (cf. BTDrucks 20/3448, p. 41). The price moratorium serves to prevent increases in the manufacturers’ selling price from adversely affecting the statutory health insurance system.

118

b) The price moratorium is suitable for achieving the aim of financial stabilisation of the statutory health insurance system, given that price increases result in an obligation to grant a discount in the amount of the price increases. It is not ascertainable that other equally effective means would be available to counteract increased expenditure due to price increases.

119

c) The extended price moratorium does not impose unreasonable burdens on the complainants. In a balancing of the effects of the fundamental rights interference on the pharmaceutical companies on the one hand (see aa) below) and the legitimate interests of the common good pursued by the legislator on the other (see bb) below), the interests of the common good pursued by § 130a(3a) of the Fifth Book of the Code of Social Law prevail (see cc) below).

120

aa) It is primarily the scale of the discount (see (1) below) and the time of application (see (2) below) that determine the severity of interference. Other important aspects are possibilities of inflation adjustment (see (3) below) and existing exemptions (see (4) below) as well as the protection of legitimate expectations (see (5) below). In light of this, the extended price moratorium, which must de facto be classified as a price cap, constitutes considerable to serious interference with fundamental rights.

121

(1) If a pharmaceutical company’s selling price increases compared to the price as determined in § 130a(3a) and (3d) of the Fifth Book of the Code of Social Law, statutory health insurance providers receive a discount in the amount of the price increase. The price is, as it were, ‘frozen’ at the manufacturer’s selling price on 1 August 2009 (or, in the case of market launch after 1 August 2010, at the time of market launch), albeit subject to inflation adjustment from 1 July 2018.

122

(2) When assessing the severity of interference resulting from the price moratorium, it does have to be taken into account that its extension through the Act only concerns the period from 1 January 2023 until 31 December 2026, i.e. only four years. That said, the price moratorium, initially applicable until 31 December 2013, was extended several times in the past, meaning that it has now been in effect for more than 14 years and therefore no longer constitutes a short-term measure in an overall assessment.

123

(3) The inflation adjustment provided for in § 130a(3a) second sentence of the Fifth Book of the Code of Social Law mitigates the price-dampening effects of the extended price moratorium somewhat. In this regard, it must be taken into account that a price freeze without inflation adjustment generally requires that general price increases during this period are limited (cf. BVerfGE 70, 1 <301>).

124

(4) § 130a(4) second sentence of the Fifth Book of the Code of Social Law also provides for exemptions for particular reasons, based on Art. 4 of Council Directive 89/105/EEC of 21 December 1988. Applications for such exemptions are decided by the Federal Office for Economic Affairs and Export Control. Pursuant to § 130a(9) of the Fifth Book of the Code of Social Law, the possibility to obtain an exemption also applies to orphan medicinal products. When assessing the appropriateness of the price moratorium for importers of medicinal products, the exemption of § 130a(3a) sixth sentence of the Fifth Book of the Code of Social Law must also be taken into consideration (see para. 115 above). These provisions likewise slightly mitigate the severity of interference.

125

(5) Before the entry into force of the Act, the price moratorium was limited until 31 December 2022. It is true that an explicit time limit on an intrusive measure typically gives rise to a greater expectation on the part of those affected that the burden will cease once the time limit expires. However, as the price moratorium was already extended several times previously and as it (also) serves to prevent pharmaceutical companies from circumventing their obligations to grant discounts, an extension of the price moratorium was at least plausible, such that no special expectations that the price moratorium would be lifted could develop.

126

bb) The interference must be balanced against an exceptionally significant interest of the common good, which, according to the plausible assessment of the legislator, is significantly furthered [by the measure resulting in interference] (cf. para. 90).

127

cc) The impairment of the pharmaceutical companies’ occupational freedom protected by Art. 12(1) of the Basic Law resulting from the extended price moratorium is not disproportionate to the significance and urgency of the financial stability of statutory health insurance. This follows – just as for the manufacturer discount – from the exceptional significance of the interest of the common good in consideration of the legislative leeway (cf. BVerfGE 114, 196 <248>), which is capable of justifying even a considerable to serious interference. It must also be taken into account that those affected stand to benefit from the financial stability of statutory health insurance and are subject to legislation concerning social policy to a particular degree (see para. 99 above). Moreover, it must be considered that past and future cost increases in statutory health insurance can be attributed in particular to the sale of patented medicinal products (see para.101 above). Further, the Act does not significantly impair the legitimate expectations of pharmaceutical companies, as it is based on known cost containment measures taken in response to specific circumstances (see para. 100 above). It is also not ascertainable that the limits of what is reasonable have been exceeded due to the risk of stifling the affected industry (see para. 106 above).

128

When assessing the appropriateness of the price moratorium for importers of medicinal products, the exemption of § 130a(3a) sixth sentence of the Fifth Book of the Code of Social Law must also be taken into consideration. The exemption provided for by the legislator reflects the limited possibilities of importers of medicinal products to offset price increases in foreign markets while also guaranteeing that the statutory price differential to the reference medicinal products is maintained, including in the context of the provisions regarding increases of prices for statutory health insurance providers. This helps maintain competition through affordable imports of medicinal products (cf. BTDrucks 16/194, p. 10).

IV. 

129

Even in a cumulative assessment of the legislative measures, no violation of the complainants’ constitutional rights can be found. In principle, it is possible that the combined effect of various individual interferences with fundamental rights which are minor when viewed in isolation can lead to serious impairment that might exceed the severity of interference that is tolerable under the rule of law (cf. BVerfGE 112, 304 <319 f.>; 114, 196 <247>; 159, 223 <349 para. 290>). However, no such impairment is ascertainable in the present case.

130

It is true that the challenged provisions affect the same group of addressees (pharmaceutical companies), take effect simultaneously (due to the time limit on the manufacturer discount, this was only true until 31 December 2023), that each provision interferes with the freedom to practice an occupation of those addressed by them and that the provisions essentially serve the same purpose – the decrease of expenditure on medicinal products and thus the financial stabilisation of statutory health insurance. However, with regard to the question of whether the severity of interference resulting from the provisions is no longer tolerable under the rule of law, it must be taken into account that the aim pursued by the challenged provisions – the financial stabilisation of statutory health insurance – is an exceptionally significant aim of the common good that is considerably furthered by the provisions, and that the pharmaceutical companies are beneficiaries of the statutory health insurance’s system of benefits in kind and are thus particularly subject to the effects of legislation concerning the social state. Moreover, the burdens are limited in time. The manufacturer discount pursuant to § 130a(1b) of the Fifth Book of the Code of Social Law was only applicable for one year (until 31 December 2023) and has since expired. The simultaneous effects of the manufacturer discount and the price moratorium were thus limited to 2023. Moreover, pharmaceutical companies can apply for exemptions pursuant to § 130a(4) second sentence of the Fifth Book of the Code of Social Law in cases of hardship. In an overall assessment, no impairments are ascertainable that would exceed the severity of interference tolerable under the rule of law. There is also no evidence that the cumulative effects of the manufacturer discount and the extended price moratorium seriously jeopardise the complainants’ business model – even when taking into account existing restrictions. The other cost containment measures in the Act cannot be included in the assessment. Insofar as the complainants did not sufficiently demonstrate that they complied with the principle of subsidiarity, no final examination of the cumulative effects of the interferences can be carried out (see para. 40 above).