Order of 16 December 2025

R e a s o n s :

A. 

1

Through his constitutional complaint, the complainant seeks to oblige the statutory health insurance to cover the cost of his treatment for an illness that is typically fatal with a drug which has not been approved for the intended use.

I. 

2

1. The complainant, who was born in 2004, suffers from Duchenne muscular dystrophy caused by a nonsense mutation of the dystrophin gene. Duchenne muscular dystrophy is a genetic, progressively worsening illness that typically results in premature death by the early years of adulthood. In 2015, the complainant lost his ability to walk. In July 2019, he applied for the cover of the costs of the drug Translarna (active ingredient: Ataluren). This drug was first approved for use in the European Union by the European Medicines Agency (EMA) in 2014 under certain conditions for the treatment of patients with Duchenne muscular dystrophy who had not yet lost the ability to walk (so-called Conditional Marketing Authorisation under Art. 14(7) of Regulation <EG> Nr. 726/2004 (old version)). The application of 3 February 2023 to renew this conditional approval was rejected on 28 March 2025, as recent studies were unable to sufficiently confirm the efficacy of the drug (cf. Commission Implementing Decision of 28 March 2025 - C(2025)2025 final -). Currently, approval for the drug only exists in a small number of states outside of the European Union.

3

In 2018, the manufacturer of Translarna applied unsuccessfully to the EMA for an expansion of the drug’s approval to the treatment of patients who are unable to walk. The denial of this application was primarily based on the assessment that the study data presented was unable to confirm the efficacy of the drug due to methodological problems relating to the way in which the data generated from a study conducted by the manufacturer was compared with the disease progression documented in other patients.

4

2. The health insurance provider, the defendant in the initial proceedings, denied the complainant’s 2019 application to cover the cost of Translarna. The Social Court (Sozialgericht) rejected the complainant’s lawsuit challenging this denial. The Higher Social Court (Landessozialgericht) reversed the decision of the Social Court and obliged the health insurance provider to cover the cost of Translarna for the complainant, as it held that there was new evidence to justify a claim to medical treatment under § 2(1a) first sentence of the Fifth Book of the Code of Social Law, Sozialgesetzbuch Fünftes Buch – SGB V (introduced with effect of 1 January 2012 – Federal Law Gazette, Bundesgesetzblatt – BGBl I 2011 p. 2983), and that the unsuccessful prior application for the expansion of the drug’s approval was irrelevant in this regard. The Higher Social Court found that, in the case of the complainant, there was a prospect of a positive effect on the course of his illness which is not entirely remote, as required by § 2(1a) first sentence of the Fifth Book of the Code of Social Law. It based this assessment on a specialist physician’s opinion as well as an expert recommendation published in 2020.

5

3. In the challenged judgment of 29 June 2023, the Federal Social Court (Bundessozialgericht) overturned the judgment of the Higher Social Court and rejected the appeal on points of fact and law against the decision of the Social Court. It held that the prerequisites of § 2(1a) of the Fifth Book of the Code of Social Law were not met. Due to the negative result of the assessment that led to the expansion of the drug’s approval being denied by the EMA under medicinal products law, there was insufficient prospect of a cure or a noticeable positive effect on the course of the illness. In this regard, the Federal Social Court held that case law establishing a preclusive effect of a denied approval of a drug continues to apply. An abstract balancing of the chances and risks involved cannot lead to a positive result if the competent authority has denied the expansion of the drug’s approval after a substantive assessment. If a drug manufacturer refrains from pursuing his application due to a negative assessment by the EMA, this has the same effect as a formal denial of the approval application. The Federal Social Court determined that this was the case even though the standards of assessment in medicinal products law and § 2(1a) of the Fifth Book of the Code of Social Law are not completely identical in their approach and particularly in cases where the (expansion of the) drug’s approval was denied only because the drug manufacturer failed to present sufficiently conclusive studies regarding it effectiveness. The Federal Social Court found that there were important reasons for retaining this assumption, including the legislative history of § 2(1a) of the Fifth Book of the Code of Social Law and here especially the explanatory memorandum to the draft act, the state’s duty of protection, which has been implemented through the law on the approval of medicinal products (Arzneimittelzulassungsrecht), the protection of the approval requirements for medicinal products, the lack of an inherent system of quality control measures within the Fifth Book of the Code of Social Law for the context of medicinal products, the flexibility of medicinal products law with regard to individual cases and the possibility of creating exceptions from the preclusive effect in cases where new facts are established over time. Because of this general preclusive effect, the Federal Social Court determined it need not be decided whether the Higher Social Court’s assumption that no generally accepted form of treatment which met the medical standard was available to the complainant was correct. Furthermore, whether the facts as established by the Higher Social Court could give rise to the assumption that a treatment of the complainant with Translarna would have created sufficient prospects of a noticeable positive effect on the course of his illness did not appear to be free of doubt.

II. 

6

In his constitutional complaint, filed on 29 September 2023, the complainant asserts that the judgment of the Federal Social Court resulted in a violation of Art. 2(1) of the Basic Law in conjunction with the principle of the social state and of Art. 2(2) first sentence of the Basic Law. The complainant argued that the categorical denial of a claim to medical treatment under § 2(1a) of the Fifth Book of the Code of Social Law in case of an unsuccessful application for drug approval without further consideration of the individual circumstances of the insured individual was in violation of the standards established by the Federal Constitutional Court (cf. Decisions of the Federal Constitutional Court (Entscheidungen des Bundesverfassungsgerichts – BVerfGE) 115, 25). The complainant argued that the ‘categorical assumption of a general preclusive effect’ runs contrary to the requirement of an examination of the prospects of success of the treatment in the individual case as established therein. The complainant argued that this means that the Federal Social Court replaces its own assessment with the decision of a third party, most commonly that of the EMA, without critically examining its content. The unsuitability and generalisation of a preclusive effect resulting from the proceedings regarding the expansion of the drug’s approval was also demonstrated by the fact that the different measures taken by the approval authority and the diverging underlying substantive reasons were not distinguished. In particular, it could not be assumed that a preclusive effect would be created even in cases where the manufacturer decided not continue to pursue an application to expand the drug approval for commercial, typically purely economic, reasons. Furthermore, it would have been necessary to consider the fact that the negative outcome of the proceedings regarding the expansion of the drug’s approval could be based on a myriad of substantive considerations (lack of safety, lack of effectiveness, insufficient data to assess the effectiveness, methodological problems with the assessment of the data).

III. 

7

The Federal Constitutional Court gave the Federal Ministry of Health, the Federal Social Court and the defendant in the initial proceedings the opportunity to submit a statement. The German Medical Association, the Federal Institute for Drugs and Medical Devices, the Federal Institute of Vaccines and Biomedicines (Paul-Ehrlich Institut), the Federal Joint Committee, the National Association of Statutory Health Insurance Physicians, the Federal Medical Service, the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the Federal Working Group of Patient Organisations and Initiatives (administered by GesundheitsAkademie e.V.), the Federal Association of Pharmaceutical Manufacturers e.V., the Federal Association of the Pharmaceutical Industry e.V., the German Working Group of Self-Help Groups e.V., the German Disability Council, the German Foundation for Patient Protection, the Association of Private Health Insurance Companies e.V., the Association of Research-Based Pharmaceutical Manufacturers e.V., as well as the Federal Association of Consumer Organisations e.V. were also given the opportunity to submit statements as expert third parties. These parties were asked to address questions related to the relationship between the law on the approval of medicinal products and the purpose of § 2(1a) of the Fifth Book of the Code of Social Law, the possible reasons for the lack of success of an application for drug approval, the practical and economic implications of the use of a drug beyond its approval, as well as the possible need to develop the principles laid down in the Decision of the First Senate of the Federal Constitutional Court on 6 December 2005 (BVerfGE 115, 25), which were codified in § 2(1a) if the Fifth Book of the Code of Social Law.

8

The Federal Ministry of Health, the health insurance provider that was the defendant in the initial proceedings, the National Association of Statutory Health Insurance Funds, the Federal Joint Committee and the German Medical Association consider the case law of the Federal Social Court on the preclusive effect of medicinal products law on claims in the field of statutory health insurance to be constitutional. [...]

9

According to the Association of Research-Based Pharmaceutical Manufacturers, the Federal Association of Pharmaceutical Manufacturers and the Federal Association of the Pharmaceutical Industry, who submitted a joint statement, as well as the National Association of Statutory Health Insurance Physicians, the approval procedure under medicinal products law does not sufficiently ensure that the requirements prescribed by § 2(1a) of the Fifth Book of the Code of Social Law, or Art. 2(1) of the Basic Law in conjunction with the principle of the social state and Art. 2(2) first sentence of the Basic Law, regarding the obligations of statutory health insurance in case of life-threatening or typically fatal illnesses, are satisfied. [...] According to the Paul-Ehrlich-Institut, there is evidence for certain uses of medicines which are not covered by the approval and which do not become part of the approval proceedings. […] According to the Federal Medical Service, the inability to overcome the hurdles of quality, effectiveness and harmlessness in the assessments conducted during the approval procedure indicates that these criteria are not met or not sufficiently met.

10

In the view of the German Foundation for Patient Protection, the decision of the Federal Social Court challenged by the constitutional complaint does not meet constitutional requirements […].

11

The Association of Private Health Insurance Companies and the German Disability Council declined to make a statement. The Federal Working Group of Patient Organisations and Initiatives, the German Working Group of Self-Help Groups and the Federal Association of Consumer Organisations did not make use of their opportunity to submit a statement. The Federal Constitutional Court had access to the files of the initial proceedings.

B. 

12

The constitutional complaint is inadmissible. It neither demonstrates the possibility of a violation of fundamental rights of the complainant through the challenged judgment of the Federal Social Court (see I. below), nor an ongoing recognised legal interest in bringing an action after the application to renew the conditional approval of the desired drug was denied (see II. below) in a way that meets the requirements of § 23(1) second sentence, § 92 Federal Constitutional Court Act (Bundesverfassungsgerichtsgesetz – BVerfGG).

I.

13

The complainant does not demonstrate, in a way that meets the requirements of § 23(1) second sentence, § 92 of the Federal Constitutional Court Act (see 1. below), that the judgment of the Federal Social Court results in a possible violation of his own fundamental rights (see 2. below).

14

1. a) In order for the reasoning of a constitutional complaint to meet the requirements of § 23(1) second sentence, § 92 Federal Constitutional Court Act, the events that cause the violation of fundamental rights must be presented in a coherent and substantiated manner (cf. BVerfGE 81, 208 <214>; 130, 1 <21>; established case-law). The constitutional complaint must address the ordinary law which forms the subject matter of the complaint and conduct an analysis of the facts of the case under constitutional law. It must demonstrate the possibility of a violation of fundamental rights in a sufficiently substantiated manner (cf. BVerfGE 140, 229 <232 para. 9>; 157, 300 <310 para. 25> – Signature quorums in Bundestag elections; established case-law). This also includes specifying which right has allegedly been violated and presenting the facts resulting in the violation in a substantiated manner with reference to the specific circumstances of the individual situation (cf. BVerfGE 159, 223 <270 para. 89> – Federal pandemic emergency brake I <Curfews and contact restrictions>, with further references; 170, 377 <395 para. 28> – Electricity cost controls). If the constitutional questions raised by the constitutional complaint have already been addressed in the case-law of the Federal Constitutional Court, the alleged violation of fundamental rights must be substantiated with reference to the standards developed therein (cf. BVerfGE 163, 165 <210 para. 75> – Act of approval to ESM amendments; established case-law).

15

b) If the constitutional complaint challenges a decision of the ordinary courts, an in-depth discussion of the details of that decision and its reasoning is generally required (cf. BVerfGE 140, 229 <232 para. 9>; 149, 346 <359 para. 24>). It must be shown that the decision is based on the application of unconstitutional laws (cf. BVerfGE 169, 1 <17 para. 30, 62 para. 109> – Paternity challenges) or that, through the application of ordinary law, specific provisions of constitutional law (cf. BVerfGE 134, 242 <353 para. 323>) or the prohibition of arbitrariness (cf. BVerfGE 152, 345 <382 para. 98> – Removal from public service by administrative act) were violated (cf. Federal Constitutional Court, Judgment of the First Senate of 14 January 2025, - 1 BvR 548/22 -, para. 37 – Policing costs for high-risk football matches).

16

c) Complainants are obligated to keep their constitutional complaint up to date in light of changes in the factual or legal situation that are relevant for the decision and, if necessary, to supplement their constitutional complaint after the expiry of the time limit (cf. BVerfGE 158, 170 <194 para. 57> – IT security vulnerabilities; Federal Constitutional Court, Order of the Second Chamber of the First Senate of 18 December 2024 - 1 BvR 2116/24 -, para. 12).

17

2. The complainant asserts that the judgment of the Federal Social Court may not meet the standards established by the Senate decision of 6 December 2005 because of the way in which § 2(1a) first sentence of the Fifth Book of the Code of Social Law was interpreted and applied therein. In this regard, it need not be decided whether these standards must be upheld (see a) below). Notwithstanding the complainant’s assertion, he does not show how the interpretation by the Federal Social Court may violate his own fundamental rights (see b) below).

18

a) According to the decision of the Federal Constitutional Court of 6 December 2005, a violation of both Art. 2(1) of the Basic Law in conjunction with the principle of the social state contained within the Basic Law, as well as the state’s duty of protection regarding the right to life in Art. 2(2) first sentence of the Basic Law may arise if, in case of life-threatening or typically fatal illnesses for which there is no set treatment in conventional medicine, an insured individual is excluded from treatment covered by health insurance, despite there being an indication based on evidence that the treatment promises a not entirely remote prospect of a cure or a noticeable positive effect on the course of the illness (cf. BVerfGE 115, 25 <49 f.>).

19

According to the challenged judgment of the Federal Social Court, however, a denial of the request for the desired medicine was warranted simply due to a lack of a not entirely remote prospect of a cure or a noticeable positive effect on the course of the illness, because the application to expand the drug approval which referenced the intended use had failed after substantive review (Preclusive effect of denied approval of a drug; cf. Decisions of the Federal Social Court (Entscheidungen des Bundessozialgerichts – BSGE) 136, 185 <193 para. 33 ff.>). This preclusive effect continues to apply within the scope of application of § 2(1a) of the Fifth Book of the Code of Social Law (cf. BSGE 136, 185 <194 para. 38>), although the standards of assessment under medicinal products law and those in § 2(1a) of the Fifth Book of the Code of Social Law are not entirely identical in their approach (cf. BSGE 136, 185 <193 para. 36>) and the presumption of a general preclusive effect of an application to expand the drug approval is in clear conflict with the claim to medical treatment established by § 2(1a) of the Fifth Book of the Code of Social Law (cf. BSGE 136, 185 <194 para. 37 at the end>). The complainant thus points to a possible conflict between the interpretation by the Federal Social Court and the case-law of the Federal Constitutional Court. He points out that in the challenged judgment, the assessment of effectiveness in the individual case that is required under the case-law of the Federal Constitutional Court (cf. BVerfGE 115, 25 <50>) did not appear assured, since, in the specific case of an unsuccessful application to expand drug approval, the challenged judgment wholly refrains from conducting a case-by-case assessment. The complainant argues that because the approval under medicinal products law, by its very nature, must apply general standards, it appeared possible that a drug could, despite not meeting the standards of medicinal products law, present a not entirely remote prospect of a cure or a noticeable positive effect on the course of an illness.

20

b) However, the complainant does not sufficiently demonstrate how his fundamental rights could have been violated by the interpretation and application of § 2(1a) first sentence of the Fifth Book of the Code of Social Law conducted by the Federal Social Court. If a violation of a claim to medical treatment is asserted with reference to the standards established in the case-law of the Federal Constitutional Court, it must be sufficiently shown that all prerequisites of the claim under constitutional law, as established by the case-law of the Federal Constitutional Court and introduced into ordinary law in § 2(1a) first sentence of the Fifth Book of the Code of Social Law, were met in the case of the complainant (cf. BVerfGE 140, 229 <234 para. 14>). This includes showing that one suffers from a life-threatening or typically fatal illness. Furthermore, it must also be demonstrated that no sufficient methods of treatment in conventional medicine exist, meaning that these methods either have been exhausted or are not indicated for use. Finally, it must be shown that the desired treatment has, in this specific case, a realistic chance of success (cf. BVerfGE 115, 25 <45 and 49>), because it promises, based on evidence, a not entirely remote prospect of a cure or at least a noticeable positive effect on the course of the illness (cf. BVerfGE 115, 25 <49>; 140, 229 <233 f. para. 12>). A constitutional complaint meets these requirements if it is shown that an overall assessment of all evidence for or against an effectiveness in the individual case, conducted in adherence to fundamental scientific principles and in consideration of all the risks involved in the treatment, supports this view. This applies regardless of the requirements for a medically substantiated prospect of a cure or an effect on the course of an illness established under constitutional law (cf. on the requirement of a certain amount of scientific data, Federal Constitutional Court, Order of the Third Chamber of the First Senate of 25 September 2023 - 1 BvR 1790/23 -, para. 18).

21

The constitutional complaint did not meet these requirements, even at the time at which it was lodged (see (aa) below). Ultimately, however, this issue does not have to be decided, as the complainant, in any case, was required to update his constitutional complaint and failed to do so (see (bb) below).

22

(aa) The complainant shows that he suffers from a life-threatening illness. However, he does not provide any details on the extent to which generally accepted methods of treatment in line with medical standards are unavailable, or the extent to which the drug in question promises a not entirely remote prospect of a cure or a noticeable positive effect on the course of his illness. The central arguments of the constitutional complaint concern the fact that the drug in question is the only causal treatment, meaning that it is the only treatment that attaches directly to the genetic defect and that the manner in which the drug works offers the prospect of slowing down the course of the illness. To support this, the drug’s approval for patients who have not yet lost the ability to walk is referenced, as well as the fact that the expansion of the drug’s approval failed due to methodological flaws. Annexes to the constitutional complaint include an expert opinion, which recommends continuing treatment with the drug even after the ability to walk has been lost for patients who began treatment with the ability to walk, as well as a scientific study on the effects of the drug from the year 2021. Beyond the fact that a mere reference to documents submitted with the constitutional complaint does not meet the requirements of substantiation, the complainant fails to present his specific medical situation, even if these annexes are taken into account. Furthermore, it would also appear not unreasonable to require a response to the doubts voiced, with detailed reasons, by the Federal Social Court regarding the soundness of this reasoning at that time. This is because these doubts concern the actual weight to be given to the evidence relevant for the claim to medical treatment, even if these doubts were not decisive in the case at hand. Ultimately, however, this issue need not be decided.

23

(bb) In any case, at the current point in time, the arguments submitted no longer establish the possibility of an individual violation of fundamental rights as a result of the denial of the complainant’s claim to medical treatment under § 2(1a) first sentence of the Fifth Book of the Code of Social Law in the challenged judgment of the Federal Social Court. The denial of the extension of the drug approval based on scientific conclusions on effectiveness (Commission Implementing Decision of 28 March 2025 - C(2025)2025 final -), required a discussion of whether it had become necessary to conduct a new assessment on the presumed manner in which the drug works. If it is argued that the treatment with the drug, despite a negative decision on its approval based on evidence, offers a real prospect of a cure in the individual case, then this requires an analysis of the considerations on which the negative decision on the approval is based. In such analysis and, in particular, in addressing the general evidence appearing to run contrary to this assertion that this involves, it must at least be shown, with reference to the particular case, that there are sufficient reasons to assume that, despite the general evidence, the treatment creates a not entirely remote prospect of a cure or at least a noticeable positive effect on the course of the illness. If the decision on the denial of the extension of the drug approval is made after the constitutional complaint is lodged, the argument submitted must be supplemented accordingly. This is entirely lacking here.

II.

24

Furthermore, the constitutional complaint does not demonstrate, in a way that meets the requirements of § 23(1) second sentence, § 92 of the Federal Constitutional Court Act (see (1) below) an ongoing recognised legal interest in bringing an action (see (2) below).

25

1. The admissibility of a constitutional complaint generally requires that there is a recognised legal interest in seeking a reversal of the challenged act of public authority or, at the very least, a finding of unconstitutionality (cf. BVerfGE 81, 138 <140>; 146, 294 <308 f. para. 24>; established case-law), in other words, there needs to be legitimate interest that is worthy of recognition (cf. BVerfGE 103, 44 <58 f.>). This recognised legal interest must still exist at the time when the Federal Constitutional Court renders its decision (cf. BVerfGE 21, 139 <143>; 106, 210 <214>; 146, 294 <309 para. 24>; established case-law). If necessary, the existence of this recognised legal interest at the time when the Federal Constitutional Court renders its decisions must be demonstrated by the complainant in a way that fulfils the requirements of § 23(1) second sentence, § 92 of the Federal Constitutional Court Act. This may also include addressing the issue whether the legal protection sought through the constitutional complaint can still be achieved in the initial proceedings (cf. BVerfG, Order of the Third Chamber of the Second Senate of 23 July 2024 - 2 BvR 557/19 -, para. 41; Orders of the Second Chamber of the First Senate of 9 April 2025 - 1 BvR 1618/24 -, para. 46 and of 10 April 2025 - 1 BvR 842/24 -, para. 14).

26

2. In his constitutional complaint, the complainant, irrespective of the question whether he sufficiently substantiated his claim of a chance of a cure in this particular case, also failed to update his argument with respect to the recognised legal interest in a way that met the requirements. For example, he did not update his argument with regard to the question whether he could still achieve the legal protection sought, despite the expiration of the conditional approval of the drug for patients who had not yet lost the ability to walk. This would have required a discussion as to the extent to which it would even have been possible to import the drug into the European Union in this specific case in which a prior European Marketing Authorisation had since expired (cf. § 30(4) of the Medicinal Products Act (Arzneimittelgesetz – AMG) and the application of this provision by the social courts in the decision BSGE 94, 213 <218 f. para. 21 ff.>, including on the relationship of that provision with § 73(3) Medicinal Products Act). According to the view adopted by the social courts, the illegality of the import of the drug would have made it impossible for the statutory health insurance to cover the costs of the drug, due to the resulting violation of medicinal products law (cf. BSGE 96, 170 <175 ff. para.27, 35>; 136, 185 <192 para. 28>). The constitutional complaint lacks both an analysis of this situation under the applicable administrative and social law provisions, as well as an indication of the fact that the European Commission, in its decision of 28 March 2025 on the denial of the renewal of the drug approval, pointed out that it would be possible for individual member states, for the duration of a transitional period, to adopt extraordinary measures in accordance with Art. 117(3) or Art. 5(1) of Directive 2001/83/EG of the European Parliament and of the Council.