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The criminal offences against corruption in healthcare introduced on 4 June 2016 have contributed to the wider adoption of healthcare compliance and corresponding preventive efforts by businesses in the healthcare sector. Official crime statistics nevertheless indicate that these offences play only a minor role in criminal justice practice. This is the case despite so-called net-widening effects resulting from criminal policy measures such as the establishment of units to combat misconduct in healthcare and the specialisation of investigating authorities. The healthcare market is changing. New legal questions concerning sections 299a and 299b of the German Criminal Code (StGB) arise in connection with patient support programmes, direct-to-patient models and the prescription of digital health applications. Thus, despite the resolution of some disputed issues, the development of the legal doctrine surrounding sections 299a and 299b StGB remains unfinished even after ten years.

Criminal case law has developed the legal doctrine of healthcare billing fraud in three stages. Initially confined to particular forms of unlawful billing by physicians providing statutory health insurance services, it first established an approach to fraud that depended on social law. Its premises were then extended to private medical billing and hospital billing. Today, the courts take a comprehensive approach tied to healthcare law, under which any violation of healthcare legislation by various participants in the healthcare sector may be relevant to fraud. The article analyses this development and sets out principles for limiting the reach of criminal law in response.

The courts have taken the view that a breach of the prohibition on arrangements under pharmacy law (section 11(1), first sentence, of the German Pharmacy Act, ApoG) may support an allegation that a pharmacist has committed fraud against the payer funding the supply of medicines. The position taken here, however, is that section 263 of the German Criminal Code (StGB) does not apply in these cases because there is no deception. Section 11(1), first sentence, ApoG is a rule governing market conduct, and its violation has no effect on the pharmacist’s entitlement to payment. In addition to the situations already regulated by statute, exceptions to the prohibition that are not expressly provided for in the legislation (praeter legem) must be recognised where the relevant agreements improve the safety of medicines or the security of their supply.

Despite declining inbound medical tourism, healthcare made in Germany continues to enjoy an excellent reputation. German hospitals, which generally have not yet devoted substantial attention to marketing, rely on intermediary agencies to attract patients from abroad. Since the introduction of sections 299a and 299b of the German Criminal Code (StGB) and growing awareness of corruption in healthcare, cooperation with these agencies has nevertheless been overshadowed by a latent risk of allegations of criminal conduct. Existing contributions on this subject leave the underlying concept of corruption ill-defined and do not establish the boundaries of permissible conduct with sufficient certainty. This article aims to close that gap.

Patient support programmes (PSPs) comprise services offered by pharmaceutical companies to improve patient compliance and adherence, achieve better treatment outcomes and reduce healthcare costs. They therefore follow a “medical rationale”. These services do not constitute benefits prohibited under section 7 of the German Therapeutic Products Advertising Act (HWG), because the Act seeks to ensure that treatment decisions are based on objective considerations, rather than to reduce the benefit to patients. PSPs that are not misused therefore also fall outside the scope of corruption offences. In particular, there is no unlawful agreement, since such an agreement requires a breach of rules governing market conduct outside criminal law.

Cooperation agreements with freelance physicians regularly create a criminal-law dilemma between the offence of withholding social security contributions under section 266a of the German Criminal Code (StGB) and the corruption offences under sections 299a and 299b StGB. To avoid the risk of criminal liability under section 266a StGB, employment status determination procedures under section 7a of Book IV of the German Social Code (SGB IV) are conducted. For the contracting parties, the outcome is often “negative” because it establishes an employment relationship. In view of the current divergence between employment-law and social-security-law case law, the authors propose a “hybrid model” of freelance cooperation with precautionary payment of social security contributions. Contrary to the view of certain state medical associations, paying these contributions does not provide evidence of an unlawful agreement relevant to criminal liability.

Discussion of the patient-referral aspect of sections 299a and 299b of the German Criminal Code (StGB) has so far focused primarily on whether the referring physician’s remuneration is appropriate. In this article, the authors clarify the concepts of “referral” and “patient”, which are at least equally relevant. They examine the scope and limits of these elements of the offences and illustrate the consequences of different interpretations using practical examples. Finally, they discuss the relationship between the alternative forms of market conduct covered by the same statutory offence.

Following a paradigm shift that occurred shortly before their adoption, sections 299a and 299b of the German Criminal Code (StGB), which entered into force on 4 June 2016, provide only one basis for an unlawful agreement: unfair preferential treatment in competition. The article examines the appropriateness of healthcare professionals’ (HCPs’) remuneration in the context of the Act to Combat Corruption in Healthcare. It considers cooperation between physicians and industry that provides physicians with additional income. The focus is on distinguishing remuneration that remains appropriate from market conduct that is already unfair, by differentiating between proportionality of remuneration in the broader and narrower senses. The first stage asks whether the agreement has a plausible economic benefit that does not depend on influencing the HCP’s market conduct and thereby favouring the contracting partner. Proportionality in the narrower sense concerns the relationship between the physician’s work and the remuneration paid for it.

The article criticises the methodology of deriving normative concepts from other areas of law in the field of economic criminal law as it applies to physicians. The authors discuss three recent decisions concerning section 263 of the German Criminal Code (StGB), in which the courts construct a financial loss by applying a “strictly formal approach”. They contrast this with a strictly economic analysis of the assets received, based on the principle of assessing the overall net change in assets. Referring to the draft section 299a StGB, they also discuss whether incorporating a dependence on social law into the Criminal Code through provisions that refer to rules outside criminal law would be sound criminal policy and constitutionally legitimate.