Germany: Compensation after delivery failures?

Many crucial questions regarding claims for damages in the event of delivery failures under pharmaceutical rebate agreements remain unresolved

In brief

At the turn of the year, supply shortfalls under pharmaceutical rebate agreements pursuant to Section 130a (8) SGB V ("rebate agreements") that occurred three to four years ago regularly come back into the spotlight when statutory health insurance funds suddenly send letters to claim damages after years of inactivity and assert alleged claims for damages in court shortly before the end of the calendar year. 

The background to this is usually the impending limitation period for potential claims. This year, claims for damages due to delivery failures from 2020 and 2021 are affected. Affected pharmaceutical companies are often surprised by the sudden service of a lawsuit by the locally competent social court.

Many fundamental legal questions regarding the validity and enforceability of such claims for damages have still not been conclusively determined by the courts. In individual cases, there are often promising approaches for pharmaceutical companies to successfully defend themselves against such claims.  

In this article, we provide an overview of the most important issues. Please feel free to contact us at any time for further advice.


Social law or civil law - which applies?

Rebate agreements intersect social and civil law. As contracts under public law, they find their legal basis in Section 130a (8) SGB V and thus in the fourth chapter of SGB V, which regulates the relationship between health insurance funds and service providers in the statutory health insurance funds system. However, apart from the substitution regulation in Section 129 para. 1 sentence 3 SGB V and the recently introduced regulation on lot formation in rebate agreements for off-patent antibiotics in Section 130a para. 8a SGB V, SGB V does not contain any other specific provisions on the design and processing of rebate agreements. In particular, SGB V does not contain any provisions on performance disruptions under rebate agreements or legal bases for claims for damages.

Against this background, statutory health insurance funds generally stipulate an obligation in rebate agreements to guarantee the ability to deliver and sanction any breach of this obligation with a contractual penalty calculated as a lump sum. Contractual provisions on claims for damages in the event of delivery failures are often not included, especially in older rebate agreements. If there is a delivery failure, health insurance companies therefore generally base claims for damages on a corresponding application of the general civil law provisions on damages in Sections 280 et seq. German Civil Code. 

Is there a legal basis for claims for damages?

A fundamental question of application already arises in this context. This is because the legal relationships between the health insurance funds and the service providers are "conclusively" regulated by Sections 63, 64 SGB V and the fourth chapter of SGB V in accordance with Section 69 (1) sentence 1 SGB V. These legal relationships are only "otherwise" subject to the provisions of the BGB "insofar as" they are compatible with the provisions of Section 70 SGB V and the other tasks and obligations of the parties involved in accordance with the fourth chapter of SGB V. According to the case law of the Federal Social Court, the provisions of the BGB can therefore only be applied accordingly insofar as this is necessary to close gaps in social law regulations

Following on from this, the social courts regularly tend to take the view that recourse to the general civil law compensation provisions of Sections 280 et seq. BGB in the event of delivery failures under rebate agreements if the legal consequences of the delivery failure are already regulated in the form of contractual penalties - and thus conclusively under social law.   

There is therefore much to suggest that claims for damages due to delivery failures based on a corresponding application of Sections 280 et seq. BGB already lack the necessary legal basis if the delivery failures are already sanctioned by contractual penalties under the rebate agreement. Claims for damages based on this would therefore be unfounded from the outset.

Three-year or four-year limitation period applicable 

Following on from this, the question arises as to the period of limitation for civil law claims for damages due to delivery failures. This is currently particularly relevant for the lawsuits filed shortly before the turn of the year concerning alleged claims for damages for delivery failures from 2020 and 2021.

This is because claims for damages under civil law generally become time-barred within the standard limitation period of three years under civil law in accordance with Section 195 (1) BGB. In contrast, statutory health insurance funds regularly take the position that a general limitation period under social law of four years also applies to these claims, which the Federal Social Court derives from Section 45 (1) SGB I in certain constellations. However, this question has not yet been decided by the social courts for claims for damages due to delivery failures under rebate agreements, which are based on a corresponding application of Section 280 (1) BGB. 

However, depending on the circumstances of each individual case, there are good and convincing legal arguments against the cherry-picking often carried out by the health insurance funds and in favor of a uniform application of the civil law provisions. Accordingly, claims for delivery failures that are more than three years in the past would already be time-barred.

Claims for proof of damages and responsibility

Irrespective of the questions regarding the applicability of the civil law on damages, claims for damages due to delivery failures under rebate agreements are often difficult for health insurance companies to substantiate in practice. 

The claims asserted are based on different facts and depend on many variables. The delivery situation cannot always be sufficiently reconstructed with regard to the assertion of claims after the health insurance funds have waited for years in some cases. The fact that a rebateed medicine is not in stock at the pharmacy in an individual case and therefore has to be replaced by a non-rebateed medicine (which must be explained and, if necessary, proven by the health insurance company) can be due to many causes. Many potential causes are not the responsibility of the pharmaceutical company - such as stockpiling by pharmacies and wholesalers or the behavior of suppliers. Pharmaceutical companies can therefore often successfully exculpate themselves from the claimed delivery failures. 

If a rebate agreement provision unilaterally stipulated by the health insurance funds provides for a no-fault liability on the part of the pharmaceutical company - or if the health insurance fund subsequently attempts to interpret a corresponding increase in liability into the rebate agreement provisions in - the question also arises as to the effectiveness of the corresponding provision in the context of the content review under general terms and conditions law

Sometimes the pharmacies' documentation is also inadequate, meaning that the alleged unavailability of the rebateed product or the lack of cheaper alternatives cannot be adequately proven. In addition, the question of who is liable for multi-partner rebate agreements if the partners are also unable to deliver in accordance with the contract is becoming increasingly common. As the individual rebate rates are often strictly confidential in the face of tough price competition - also in the interests of the health insurance companies - it is particularly difficult to balance the damage contributions between the rebate agreement partners. 

This mixed situation represents a considerable hurdle for the necessary presentation and proof of the damage claimed by the health insurance companies. 

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