Preclusive effect of denied approval of a drug
In an order published today, the First Senate of the Federal Constitutional Court rejected a constitutional complaint that challenged decisions of the social courts which had upheld the denial of coverage for a drug by the statutory health insurance.
The complainant, who suffers from an illness that is fatal in most cases, brought a constitutional complaint seeking to oblige the statutory health insurance to cover the costs of a drug whose approval for the intended use had been denied. The constitutional complaint is inadmissible due to insufficient substantiation. In particular, the complainant did not keep the assertions in his constitutional complaint with regard to the issues of standing to lodge a constitutional complaint or a recognised legal interest in bringing an action sufficiently up to date. Given the fact that the drug’s approval for use in the European Union expired completely during the course of the proceedings, a corresponding update to the complainant’s assertions in this regard was required.
Facts of the case:
The complainant, born in 2004, suffers from Duchenne muscular dystrophy. Since 2015, he has been unable to walk. Duchenne muscular dystrophy is a genetic, progressively worsening disease that typically results in premature death by the early years of adulthood.
In July 2019, the complainant applied to the health care insurance provider, the defendant in the initial proceedings, to cover 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 in 2014 under certain conditions for the treatment of patients with Duchenne muscular dystrophy who had not yet lost the ability to walk. The most recent application to renew this conditional approval was rejected on 28 March 2025, as recent studies were unable to sufficiently confirm the efficacy of the drug. In 2018, the manufacturer of the drug applied unsuccessfully for an expansion of the drug’s approval to the treatment of patients who are unable to walk. The European Medicines Agency’s rejection of this application was based in particular on the assessment that the data from existing studies could not confirm that patients unable to walk gained a benefit from treatment with the drug.
The health care insurance provider denied the complainant’s application to cover the cost of the drug. The Social Court (Sozialgericht) rejected the complainant’s lawsuit challenging this denial. The Higher Social Court (Landessozialgericht) overturned the decision of the Social Court and obligated the health care insurance provider to cover the cost of the drug as sought by the complainant. 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.
With his constitutional complaint, the complainant challenges the judgment of the Federal Social Court. He asserts a violation of his fundamental rights under Art. 2(1) of the Basic Law (Grundgesetz) in conjunction with the principle of the social state and under Art. 2(2) first sentence of the Basic Law.
Key considerations of the Senate:
The constitutional complaint is inadmissible.
While the complainant demonstrates the possibility that the judgment of the Federal Social Court, in its interpretation and application of § 2(1a) first sentence of the Social Code Book V (Sozialgesetzbuch V –SGB V), does not meet the standards laid out in the decision of the Federal Constitutional Court of 6 December 2005, the constitutional complaint nevertheless fails to sufficiently demonstrate that the judgment of the Federal Social Court results in a possible violation of the complainant’s rights. In particular, the complainant did not keep the assertions in his constitutional complaint up to date, even though this was necessary under the circumstances.
The complainant does not provide specific information regarding the extent to which a generally recognised method of treatment which conforms to medical standards has not been made available to him. Nor does he address the decisions of the European Medicines Agency not to expand the approval for use and to deny the renewal of approval of the relevant drug, specifically with regard to the extent that the drug can promise a not entirely remote prospect of a cure or a noticeable positive effect on the course of his illness.
Moreover, the complainant was required to demonstrate, with regard to the continued existence of a recognised legal interest in bringing an action, whether the legal remedy he sought was still attainable despite the expiration of the conditional approval of the drug for patients still able to walk. On this point, it would have been necessary to discuss whether it would even have been possible to import the drug into the European Union in the specific case in which a previously existing European approval has expired, without violating medicinal products law. The complainant did not fulfil these re